RU2712082C2 - Implantable lubricating device - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine. Implanted lubricant for lubricating a joint of a patient being a human or mammal by adding a lubricant fluid comprises an implantable reservoir, an implantable replenishment inlet, an implanted infusion needle and an implantable drive unit. Implanted reservoir is configured to replenish and store lubricant fluid medium. Implantable filling inlet channel is connected to the above implanted reservoir for replenishment of the above implanted reservoir. Implanted infusion needle is fluidly connected to said implanted reservoir. Said implanted infusion needle is made for longitudinal displacement and has a tip having an outlet for fluid delivery. Implanted drive unit is connected to the implanted infusion needle and is configured to move and withdraw the tip of the implanted infusion needle to introduce said lubricant fluid into the area of said joint.EFFECT: invention provides sufficient joint lubrication with minimum risk of infection.20 cl, 60 dwg

Description

BACKGROUND

[001] The present invention relates to an implantable lubricant device for lubricating a joint of a patient that is a human or mammal animal, an implantable lubricating system, and methods for treating a human or mammal animal using said system.

In particular, the present invention is suitable for long-term or continuous administration of a lubricating fluid into a joint, i.e. for its constant or from time to time introduction for long periods of time, for example, for several years.

Lubricating fluid (synovial fluid) reduces friction between the articular cartilage and other tissues in the joint, lubricates and absorbs bone and tissue components of the joint during movement. If the lubricating fluid has a negative effect and / or if the articular cartilage, usually covering the articular bone, is damaged, which in most cases occurs in older patients and / or due to a prolonged extensive or abnormal load on the joints of a person or a mammal (e.g., knee joint, hip joint), a degenerative joint disease (also known as osteoarthritis), characterized by painful joint inflammation, can develop. With a pathological decrease and change in the composition of the lubricating fluid in the joint space, consisting of articulated surfaces of adjacent bones, where the joint is stabilized and covered by the joint capsule and synovial membrane, the lubricating fluid can no longer perform its usual function, i.e. lubrication of joint areas and cushioning, coupled with articular cartilage.

[002] If the articular cartilage is also severely damaged due to osteoarthritis or a similar disease and / or if the synovial fluid is reduced or altered relative to its composition, which reduces the ability of the fluid to reduce friction in the joint, the articular surfaces appear to be subject to significant friction and increased wear, resulting in painful joint inflammation. This can lead to significant restrictions on freedom of movement, especially when standing and walking, which further aggravates the degenerative processes of the joint. Degenerative joint diseases are widespread in the West, and this disease is one of the leading causes of chronic disability in Europe and the USA.

Patients suffering from osteoarthritis need regular long-term treatment, in which a lubricating fluid is injected into the affected joint, which, on the one hand, as far as possible, restores the physiological performance of the damaged joint, and on the other hand, causes a minimum of additional stress, as physical and psychological for the patient.

[003] A known standard method of treatment involves the periodic extracorporeal injection of synthetic lubricating fluid into the joint space through a syringe to replace absent physiological lubricating fluid. When applying such a standard treatment method, the inconvenience for the patient is to deliver a lubricating fluid to the joint through the skin and joint capsule at regular intervals by means of a syringe. In addition, this procedure can lead to damage to the skin and joint capsule, which increases the risk of serious infections of sensitive tissues of the joint. In view of the foregoing, an injection can be performed no more than once every six months.

However, many patients require more frequent replenishment of the lubricating fluid, i.e. in the continuous replenishment of small volumes of lubricating fluid.

SUMMARY OF THE INVENTION

[004] Therefore, it is an object of the present invention to provide an improved method for lubricating a damaged or worn joint of a human or mammalian patient, which, on the one hand, provides sufficient lubrication to the joint and, on the other hand, entails a minimal risk of infection.

The implantable lubricant device comprises first, at least a reservoir for storing the lubricant fluid, and secondly, a fluid connection that introduces the stored lubricant fluid into the damaged joint when the lubricant device is implanted into the patient’s body. A lubricating device can be fully implanted in the patient’s body so that the damaged joint can be sufficiently lubricated after surgery from within the patient’s body. This significantly reduces the risk of infection of the patient and allows for the postoperative supply of lubricating fluid to the damaged joint continuously, intermittently, periodically or as needed, for example, depending on the level of fluid in the joint.

The implanted lubricant system according to the present invention comprises an implanted lubricant device and a lubricant fluid stored in a reservoir of the device that is inserted into the joint by means of a fluid connection of the device.

[005] Additional mandatory or optional components of the implantable lubricant device, such as a reservoir, pump or motor, energy source, control unit, can also be completely implemented inside the patient’s body. Such components may be part of an implantable infusion device or may be an internal part of an implantable lubrication system separate from the current implantable infusion device. Due to the fact that the implantable lubricant device can be fully implanted into the patient’s body, i.e. the implanted lubrication system has both a storage function and a function of transferring the lubricating fluid into the patient’s body; the entire flow path of the lubricating fluid for lubricating the joint is located inside the patient’s body. Consequently, the need for extracorporeal injections into the joint has been eliminated.

The fluid connection comprises a fluid connection device connecting the reservoir of the implantable infusion device and the joint, thereby setting the flow path of the lubricating fluid from the reservoir to the joint. The fluid connection device is also fully implantable, and preferably consists of a flexible tube or the like, suitable for postoperative transfer of lubricating fluid stored in the reservoir to the joint.

[006] In addition, the fluid connection includes an infusion element connected to the fluid connection device. The infusion element can be inserted into the patient’s body at a site nearby or within the joint during surgery so that after the operation, a lubricating fluid can be introduced into the joint. The infusion element may be configured to introduce lubricating fluid into the joint intermittently, for example periodically or when the fluid level drops below a predetermined threshold, for example, as a result of actuation by means of a drive mechanism and depending on the sensor data. In another preferred embodiment, the infusion element may also be configured to continuously introduce lubricating fluid into the joint, for example, a predetermined volume of lubricating fluid over a certain period of time, for example, dropwise per hour, etc.

Intermittent or intermittent administration can be achieved, for example, by means of an infusion needle located close to the joint during surgery, as a result of which, after surgery, the specified needle can be periodically moved into the joint in the correct position and retracted by means of a drive mechanism, which allows for intermittent lubrication of the joint through the tip infusion needle. The drive mechanism is configured to advance and divert the tip of the infusion needle into and out of the joint. Despite the fact that the drive mechanism can be performed separately from the infusion needle and / or fluid connection device, it is nevertheless made integrally with the implantable lubricating device in such a way that it is completely implanted into the patient's body.

[007] In yet another embodiment, the infusion element may comprise an infusion tube resident in the joint for continuously introducing lubricating fluid into the joint. In this case, there is no need for a separate drive mechanism for advancing / retracting the infusion needle, since the infusion needle can be made of a sufficiently soft material that does not completely or does not have a significant negative effect on the normal functioning of the joint. Thus, the infusion tube can be placed inside the joint on an ongoing basis, as a result of which a lubricating fluid can be continuously introduced into the joint space.

Preferably, the reservoir of the implantable lubricant device comprises a reservoir associated with a fluid connection device for storing the lubricant fluid. Lubricating fluid is typically contained in a reservoir. The reservoir can be made in the form of a separate part of an implantable lubricating device, which is implanted in the patient’s body separately. To establish the proper flow of lubricating fluid to the joint, the reservoir may be configured to change the volume of the reservoir to form the proper pressure inside the fluid connection device and the infusion member to transfer the lubricating fluid to the joint.

Thus, at least a portion of the periphery of the reservoir may comprise a flexible outer wall for changing the volume of the reservoir by deforming the flexible material as the reservoir is filled with lubricating fluid or as the fluid is drawn from the reservoir, and also to generate fluid flow from the reservoir to the joint through fluid connection device.

[008] Therefore, the reservoir may be a balloon type reservoir. The flexible material may comprise a polymer membrane. A corrugated structure having pre-curved folds is preferred to reduce structural failure during long-term use. Pulling fluid from the reservoir into the fluid connection device and into the joint can lead to a decrease in pressure in at least a portion of the reservoir, resulting in a negative pressure compared to the pressure in front of the infusion needle or infusion tube at the joint end of the fluid connection device . For example, the reservoir may comprise a gas chamber and a liquid chamber, said chambers being separated by a membrane, for example a polymer membrane, and acting as a spring to change the volume of the reservoir so that the pressure in the gas chamber decreases as the lubricating fluid is drawn from the liquid chamber into the connection device for fluid.

The reservoir may also have a replenishing inlet channel for replenishing the lubricating fluid from outside the human body into the implanted reservoir. Thus, the reservoir and fluid connection device implanted in the patient’s body can be small in size, since the reservoir can be easily refilled at suitable intervals. Preferably, the inlet channel contains a self-sealing material, sealing holes made with a replenishing syringe, usually used to replenish the reservoir through the patient’s skin. Preferably, the reservoir of the lubricant device, or at least the self-sealing inlet port of the reservoir, is subcutaneously implanted into the patient's body to provide easy access for replenishment by syringe.

[009] Although the reservoir may be manually compressed to introduce a lubricating fluid through a fluid connection device and an infusion needle or infusion tube into a patient's joint, preferably a pump is provided to said device to provide communication between the reservoir and the infusion element for the purpose pumping lubricant fluid from the reservoir to the joint. By means of a pump, it is easy to measure the exact dose of the lubricating fluid, and thereby continuously or intermittently deliver an appropriate amount of the lubricating fluid to the joint.

The implantable pump preferably comprises a valve device having a first and second valve, each of which has a smooth surface facing each other to form a tight contact between the first and second valves, and also having various fluid channels that can be leveled by moving two smooth surfaces relative to each other while maintaining tight contact. This type of pump is described in detail in WO 2004/012806 A1. The first and second valves are preferably made of ceramic material due to its excellent sealing properties over a long period of time, as well as its inertness with respect to many substances. The pump may be a diaphragm type pump, also described in WO 2004/012806 A1, but is not limited to this type of pump. A diaphragm type pump may comprise a membrane configured to move by means of a piston as it moves, the piston being coupled to a valve device to provide a sliding movement of the first and second valves relative to each other when the piston moves.

[010] Preferably, the manual actuation of one of the pump or drive mechanism simultaneously causes the actuation of the other, ie drive mechanism or pump. For example, the pressure injected by the pump can cause the infusion needle to advance through the drive mechanism, and when the infusion fluid is delivered through the needle tip to the patient’s body, reducing the pressure in the pump allows the return spring or other resilient means to divert the infusion needle.

The implanted pump can be actuated by means of a mechanical remote control device, by means of a pressure regulator made in such a way that it can be controlled manually when it is implanted subcutaneously into the patient’s body, or by means of a sensing mechanism that measures the level of fluid in the joint and drives a pump (and a drive mechanism for advancing and / or retracting the infusion needle) and a driving pump if the measured fluid level falls below a predetermined point orog.

Preferably, the actuation of one of the pump or drive mechanism simultaneously causes the actuation of the other, i.e. drive mechanism or pump. For example, the pressure injected by the pump can cause the infusion needle to advance through the drive mechanism, and when the lubricating fluid is delivered through the tip of the infusion needle to the patient’s body, reducing the pressure in the pump allows the return spring or other resilient means to divert the infusion needle.

At least one of the lubricating fluids can be actuated to drive a pump or, when using, a drive mechanism for advancing and / or leading the infusion needle into or out of a joint, as well as for directly or indirectly generating a flow of lubricating fluid into the joint within the lubricating device. engine. The motor may be performed, for example, to provide electrical, magnetic or electromagnetic actuation of the pump and / or drive mechanism or to provide hydraulic actuation of the pump and / or drive mechanism. Preferably, the engine is configured to drive one of the pump or drive mechanism, thereby causing the simultaneous actuation of the other, i.e. drive mechanism or pump. An engine may also be configured to drive any other energy-consuming part of the infusion device.

[011] The term "motor" in relation to the present invention includes any device that uses energy other than physical force, and either automatically converts the specified energy into kinetic, hydraulic or other energy, or directly uses the specified energy to drive the pump, the drive mechanism and / or other parts of the implanted lubricant device. Thus, a part of the drive mechanism can also form part of the engine, for example, in the case of an electromagnetically driven drive mechanism.

The engine forms part of the lubricant device, and it is implanted in the patient’s body either separately from the lubricator device body for remote implantation in the patient’s body, or is contained in the lubricator device body. For electrically conductive or wireless transmission of energy from the outside of the device to the engine, communication elements can be made. For example, an engine may be configured such that it is actuated wirelessly by an external electromagnetic field. It is also possible to use an external energy source for use outside the patient’s body, such as a primary energy source or battery, in particular a rechargeable battery mounted on the patient’s skin to provide energy to the pump and / or drive mechanism and / or other energy-consuming part of the lubricating device. In particular, the energy source may be coupled to at least one engine to drive said components. An external energy source for wireless energy transmission may be configured to form an external field, such as an electromagnetic field, a magnetic field or an electric field, or to generate a wave signal, such as an electromagnetic or sound wave signal.

[012] If energy is transmitted to the implanted lubricant device wirelessly, a conversion device may be constructed to convert the wirelessly transmitted energy into electrical energy. Preferably, said converting device is arranged to be placed directly under the patient’s skin in order to minimize the distance and the amount of tissue between the converting device and means for supplying energy outside the patient’s body.

A device for transmitting energy for wirelessly transferring energy from an energy source and / or energy storage means to a conversion device may be configured to create an electromagnetic field. In another embodiment or in addition, a device for transmitting energy for wireless transmission of energy may be configured to create a magnetic field. In addition, the device for transmitting energy for wireless transmission of energy can be configured to create an electric field. Wireless energy may also be transmitted by the device for transmitting energy through at least one wave signal. Such a signal may comprise an electromagnetic wave signal, including at least one of an infrared light signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, an RF signal, an X-ray signal, and a gamma signal radiation. The waveform may also comprise an audio or ultrasonic waveform. In addition, wireless energy can be transmitted as a digital or analog signal, or a combination thereof.

Instead of or in addition to an external energy source, the implantable lubricant device itself may be provided with an energy source. The specified energy source may be part of a lubricating device or may be contained in its housing. However, the energy source can also be made separately from the housing of the lubricating device for remote implantation into the patient’s body.

[013] Such an implantable energy source preferably comprises energy storage means, such as a long-life battery or, more preferably, a battery. The advantage of the battery is that it can be recharged. Preferably, the battery comprises a secondary battery and / or a capacitor.

In this case, communication elements can also be made to transfer electrically conductive or wireless energy from the primary energy source outside the device to the battery in order to charge the battery from outside the patient’s body when the device is implanted in the patient’s body. Similarly, a battery may comprise communication elements for supplying conductive or wireless energy to at least one motor of the infusion device.

Despite the fact that at least one engine can be made with actuating means for manually actuating the engine, it is also preferable to provide a control unit for controlling at least one engine. The control unit can also be used to control the pump, drive mechanism and / or any other energy-consuming part of the implanted lubricant device, and if the device contains an internal or external energy source, the control unit can also be used to control the specified energy source. The control unit can be adjusted according to the individual requirements of the patient, such as administering an appropriate amount of the drug at appropriate intervals. Automatic administration essentially helps the patient.

[014] Preferably, the control unit has a data port for transmitting data between the external data processing device outside the patient’s body and the control unit implanted in the patient’s body, regardless of whether the control unit is contained in the housing of the lubricating device or implanted in the patient’s body outside lubricator housing. The specified data port allows control over the control unit to adapt the infusion device to the changing needs of the patient. Preferably, the data port is a wireless port for data transfer to allow free exchange of data between the control unit and the data processing device, for example, during a doctor's examination. Most preferably, the control unit is programmable to further enhance its adaptability.

The control unit - with or without a data port - can also be made extracorporeal, for example, it can be installed on the skin of a patient. The advantage of an external control unit is that it can be freely accessed in the event of a malfunction. The control unit is preferably configured to wirelessly remotely control at least one engine implanted with the infusion device.

The control signal transmission device may be configured to wirelessly transmit the extracorporeal control signal to the implanted engine.

Similarly, for wireless data transmission from outside the patient’s body to a control unit implanted inside the patient’s body, a data interface may be provided. And in this case, the wireless control signal and / or data transmission may contain one of the above wave signals, which is a digital, analog or a combination of these signals. More preferably, the control signal can be transmitted in the same way that energy is transmitted to the engine. For example, a control signal may be transmitted by modulating an energy signal that serves as a carrier wave signal for a digital or analog control signal. In particular, the control signal may be a signal modulated in frequency, phase and / or amplitude.

[015] Separately from the control unit or as part of the control unit, feedback means can be provided that provide information on parameters related to the treatment of the patient. These parameters may be the physical parameters of the patient and / or process parameters of the device. To this end, at least one feedback sensor has been made to detect these parameters. For example, a feedback sensor may detect the level of lubricating fluid in the joint or other parameters related to the condition of the joint and its lubrication. Feedback sensors may be connected to a control unit, which may include a control program for controlling the delivery of lubricant fluid to the joint in response to at least one signal from the feedback sensors. Additionally or in yet another embodiment, feedback data may be transmitted from the control unit to an external data processing device. The indicated feedback data may be useful in establishing a diagnosis by a physician.

Preferably, the fluid connection device consists of two parts of the fluid connection, each of which is connected to the reservoir and has at its open end an infusion element inserted into the joint space. The two parts of the fluid connection can be made inside the patient’s body so that after surgery they form a circulating path for the flow of lubricating fluid through the joint, i.e. from the pump and / or reservoir to the joint (through the first part of the fluid connection) and back to the pump and / or to the reservoir (through the second part of the fluid connection). Under the pressure generated by the pump or the flexible outer wall of the reservoir, the lubricating fluid may intermittently or continuously circulate through the circulating current path, the second part of the fluid connection taking the lubricating fluid into the joint space after the fluid has been introduced into the joint space through the first part of the connection for the fluid.

[016] Since, due to the circulating current path, the lubricating fluid is at least partially reused after passing through the joint, the fluid is contaminated with impurities or other foreign particles over time, which may reduce the quality and the desired effect of the lubricating fluid. The circulating fluid connection device of the implantable lubricating device may thus comprise a filtering device having a filter connected to the circulating current path to remove contaminants from the contaminated circulating lubricating fluid. Preferably, the filter device is configured to regularly clean the filter and remove particles filtered from the lubricating fluid. These removed impurities or foreign particles can then be placed in an airtight space for deposits or can be returned to the patient’s body, for example, into the surrounding tissue, blood vessel or the like.

A lubricating device can be implanted in the patient’s body in different areas, preferably as close as possible to the damaged joint, which should be lubricated. For example, it is possible to implant a lubricant device or part of it in the thigh to lubricate the spherical part of the hip joint or knee joint. When the lubricant device or, for example, its reservoir has a relatively large volume, it may be preferable to implant a lubricant device with a completely filled reservoir, since replenishment of the reservoir in the abdominal cavity can be difficult. However, in this case, it may be appropriate to use a subcutaneous replenishing inlet channel connected to the reservoir via a tube. In yet another embodiment, a lubricating device may also be implanted subcutaneously. If necessary, subcutaneous implantation allows you to expand the possibilities of wireless transmission of energy and / or data to or from a lubricating device. In addition, the replenishment of the reservoir through the replenishing inlet channel by means of a replenishing syringe penetrating the patient’s skin is greatly facilitated when the lubricating device is implanted subcutaneously.

Depending on the individual treatment, it may be preferable to implant the lubricant device into the adipose tissue either intramuscularly or adjacent to the joint so that the lubricating fluid can be introduced into the specific joint.

[017] In addition to the above lubricating device and its various components, the implanted lubricating system according to the present invention contains a suitable lubricating fluid configured to be stored in a reservoir and introduced into the joint by means of an implanted fluid connection. Preferably, the lubricating fluid is resorbable and biocompatible to provide resorption and biological and chemical interaction with the synthetic lubricating fluid through the human body in the same manner as in the case of physiological lubricating fluid. Preferably, the lubricating fluid is hyaluronic acid or the like.

In one embodiment, the implantable medical device is configured to lubricate at least one artificial weight bearing contact surface in a joint when implanted into a specified human or mammalian body, said artificial contact surface replacing at least one of at least one of at least one two contact surfaces of the joint of a mammal, wherein said medical device also comprises at least one outlet configured to y receiving lubricating fluid from the specified reservoir, and moreover, the specified medical device is configured to operate controlled by an artificial working device to distribute lubricating fluid from the specified reservoir and transfer it to at least one artificial contact surface.

The implantable medical device may have spaced said reservoir and joint, and comprises a fluid connection between the reservoir and the joint.

a. [018] The implantable medical device may have a reservoir configured to subcutaneously or to be placed in a body cavity in an area of a patient’s body selected from the group of areas consisting of:

b. abdominal

c. inguinal area

d. pelvic area and

e. thigh area.

Thus, an implantable medical device can be placed in the abdominal cavity.

The replenishing inlet channel may be adapted to be implanted subcutaneously or in conjunction with a bone.

The implantable medical device may be adapted to lubricate one artificial contact surface and the opposite contact surface of the hip or knee joint of a human or mammalian patient.

A knee joint having medial and lateral contact bearing surfaces, wherein said implantable medical device can be adapted to lubricate said artificial contact surface on the medial side of the knee joint of a human or mammalian patient.

A knee joint having a medial and lateral contact bearing surface, wherein said implantable medical device can be adapted to lubricate said artificial contact surface of the lateral side on a knee joint of a human or mammal.

A mammalian joint having at least two contact surfaces. The medical device is configured to lubricate at least one artificial contact surface that replaces at least the surface of at least one of the contact surfaces of the joint of a mammal in the specified joint. In addition, the medical device comprises at least one inlet configured to receive lubricating fluid from the reservoir.

[019] Typically, at least one channel is at least partially embedded in the artificial contact surface in connection with at least one inlet for distributing lubricant fluid over the surface of the artificial contact surface. The medical device may be configured to operate controlled by the operating device to distribute lubricant fluid from the reservoir. The ability to inject lubricant fluid intermittently or on demand reduces friction in the joint and allows for optimal lubrication in the joint. According to one embodiment of the implantable medical device, it can be arranged to distribute a lubricating fluid over the surface of the artificial contact surface on at least two parts of the artificial contact surface for lubrication. Distribution over more than one part can provide a more uniform distribution of the lubricating fluid. According to another embodiment of the medical device, the reservoir configured to hold the lubricating fluid may be an implantable reservoir placed subcutaneously in the body cavity or in connection with the bone. The implantable medical device may also include a working device configured to transfer the lubricating fluid from the specified reservoir to the artificial contact surface for lubricating it.

[020] According to one embodiment, the reservoir may be configured to hold the lubricant fluid, and the operating device according to any of the embodiments disclosed herein may be configured to transfer the lubricant fluid from the reservoir to the artificial contact surface for it grease. The working device may be mechanized and may include a pump configured to pump fluid from the reservoir to the artificial contact surface to lubricate it. An operating device according to any of the embodiments disclosed herein may comprise a reservoir preloaded with pressure lubricating fluid. According to yet another embodiment, the implantable medical device may also comprise an implantable inlet channel configured to preload the reservoir with pressure lubricating fluid by introducing it into the inlet channel.

An implantable medical device according to one embodiment may also include a valve configured to close the connection between the reservoir and the artificial contact surface. The tank can be made with the possibility of its placement in a block separated from the artificial contact surface, and can be made with the possibility of its connection with the artificial contact surface through the channel.

The reservoir may comprise a movable wall portion configured to move and change the volume of the reservoir, the wall portion may be a mechanized wall portion that may comprise an engine.

[021] According to yet another embodiment, the implantable medical device may include at least one outlet and at least one additional channel at least partially embedded in the artificial contact surface. The medical device may be configured to circulate a lubricating fluid from the artificial contact surface through the outlet and into the artificial contact surface through the inlet. The circulation of the fluid can be carried out by means of a working device configured to circulate the lubricating fluid. The circulatory system may include a reservoir configured to add fluid to the circulating lubricant fluid and / or a filter for cleaning the circulating lubricant fluid.

The operating device according to any one of the embodiments may be adapted to occasionally transfer the lubricating fluid to the artificial contact surface.

An implantable medical device according to one embodiment may include a sensor configured to determine a physical parameter within a joint or pressure or volume of a lubricating fluid or a functional parameter of a working device for controlling it to adjust the flow of lubricating fluid to an artificial contact surface.

[022] The reservoir according to any one of the embodiments may be connected to the artificial contact surface via a channel. The inlet may include a connecting part for connecting the channel to any part of the medical device. A channel according to any one of the embodiments may comprise several parts that can be made to be connected to each other by means of a connecting part. The first part of the channel can be connected to a medical device, and the second part of the channel can be connected to a reservoir. A channel according to one embodiment may be configured to pass through the bone of the patient’s body for long-term preservation of the open path through the bone, which allows the lubricating fluid to reach the artificial contact surface. According to another embodiment, the channel is configured to pass through the joint capsule of the patient’s body for long-term preservation of the open path through it, which allows the lubricating fluid to reach an artificial contact surface, and according to another embodiment, the channel is configured to pass through the pelvic bone with the back of the acetabulum and the hip joint. An implantable medical device may be configured to lubricate a patient's hip joint; in this case, the artificial contact surface of the medical device may be configured to at least partially replace the contact surface of the acetabulum and / or femoral head.

An implantable medical device according to one embodiment may lubricate a second artificial contact surface. According to one embodiment, the first artificial contact surface has a convex shape towards the center of the hip joint, and the second artificial contact surface has a concave shape towards the center of the hip joint. The first artificial contact surface according to this embodiment is adapted to attach to a human pelvis bone, and the second artificial contact surface is adapted to attach to a human femur. The artificial contact surface can be made with the possibility of introducing into the hip joint through an opening in the pelvic bone, from the abdominal side of the pelvic bone, the method of the operation allowing to keep the joint capsule of the hip joint unscathed.

[023] The reservoir according to one embodiment may be arranged to be placed inside or at least partially inside the patient’s bone, the bone may be, for example, a femur, a pelvic bone or a neck of a patient’s femur.

According to another embodiment, the reservoir may be configured to be subcutaneous or placed in a cavity in the body, which may be a cavity in an area selected from a group of areas consisting of: the abdominal region, inguinal region, pelvic region, and thigh region.

An implantable medical device according to one embodiment may comprise an inlet for filling the reservoir. The inlet channel may comprise a self-sealing membrane, which for example may be a silicone membrane coated with parylene. The inlet can be adapted to be implanted subcutaneously, in conjunction with a bone or in a body cavity.

The reservoir may be configured to accommodate the lubricating fluid under pressure. To achieve pressure, the reservoir may be spring-loaded, comprise a chamber configured to hold compressed gas, or comprise an elastic wall configured to create pressure. According to one embodiment, the reservoir comprises a silicone elastic wall coated with parylene.

[024] According to yet another embodiment, the implantable medical device is adapted to lubricate a patient's knee joint. The lubricated artificial contact surface according to one embodiment may be configured to at least partially replace the contact surface of the femur, which may be the contact surface of the tibia and / or femur.

According to one embodiment, the medical device is adapted to lubricate at least one of the medial and lateral parts of the contact surface of the tibia of the knee joint, and according to yet another embodiment, the implantable medical device is adapted to lubricate at least one of the medial and lateral parts of the contact surface of the femur of the knee joint. In another embodiment, the medical device is configured to lubricate the contact surface of the femur of the knee joint and the contact surface of the tibia of the knee joint.

According to one embodiment, the reservoir according to any one of the embodiments is configured to be replenished from outside the human body, and it can be carried out by means of an implantable inlet channel.

According to one embodiment, the reservoir is configured to maintain a pressure that can be increased by introducing a lubricating fluid through the inlet.

[025] An implantable medical device according to any one of the embodiments may be implemented as part of a system that may also comprise at least one switch implantable in a patient for manual and non-invasive control of the implantable medical device. The live system allows the operating device to control the lubrication process performed by the medical device.

The system according to one embodiment may also comprise a hydraulic device having an implantable hydraulic reservoir that can be hydraulically connected to an implantable medical device. The implantable medical device can be made with the possibility of non-invasive control by manually pressing the hydraulic reservoir.

According to yet another embodiment, the system may also comprise a wireless remote control device for non-invasively controlling an implantable medical device. The wireless remote control device may include at least one external transmitter and / or signal receiver, and also includes an internal receiver and / or signal transmitter implanted in the patient to receive signals transmitted by an external signal transmitter or transmit signals to an external signal receiver. The wireless remote control device may also be configured to transmit at least one wireless control signal for controlling an implantable medical device. The wireless control signal may comprise a signal modulated in frequency, amplitude, phase, or a combination of these options. The wireless remote control device may also be configured to transmit an electromagnetic signal of a carrier wave for transmitting a control signal.

According to yet another embodiment, the system may comprise a device for transmitting wireless energy for non-invasively providing the implantable energy-consuming components of the implantable medical device with wireless energy. Wireless energy may contain a wave signal selected from the following group: sound wave signal, ultrasonic wave signal, electromagnetic wave signal, infrared light signal, visible light signal, ultraviolet light signal, laser light signal, microwave signal, RF signal, signal in the form of x-rays, gamma radiation signal, electric field, magnetic field, combined electric and magnetic field.

[026] The control signal in the system may comprise an electric field, a magnetic field, a combined electric and magnetic field. The signal may comprise an analog signal, a digital signal, or a combination of an analog and digital signal. To provide power to the energy-consuming components of an implantable medical device, the implantable system may comprise an implantable internal energy source. According to another embodiment, the system comprises an external energy source for transmitting energy wirelessly, the internal energy source being rechargeable energy transmitted wirelessly.

According to yet another embodiment, the system may also comprise a sensor or a measuring device for determining or measuring a functional parameter associated with energy transfer to charge an internal energy source, and a feedback device for sending feedback data from the inside of the patient's body to the outside, the feedback data may be associated with a functional parameter defined by a sensor or a measured measuring device.

According to another embodiment, the system may also include a feedback device for sending feedback data from the inside of the patient’s body to the outside, wherein the feedback data is associated with at least one of a physical parameter of the patient and a functional parameter related to the implantable medical device.

[027] The system according to one embodiment may also comprise a sensor and / or measuring device and an implantable internal control unit for controlling the implantable medical device in response to data associated with at least one of a patient’s physical parameter defined by the sensor or measured measuring device, and a functional parameter related to an implantable medical device as determined by a sensor or measured by a measuring device. The physical parameter according to one embodiment may be pressure or motor activity.

A system according to one embodiment may comprise an external data transmitter and an implantable internal data transmitter coupled to an external data transmitter, the internal transmitter delivering data related to the implantable medical device or patient to an external data transmitter and / or an external data transmitter delivering data to an internal data transmitter.

A system according to any of the embodiments disclosed herein may also include a motor or pump for operating the implantable medical device or a hydraulic operating device for operating the implantable medical device. The working device may include a servo drive, configured to reduce the force required by the working device to ensure the operation of the implantable medical device instead of the long-term operation of the working device, with an increase in the time of a given action.

[028] According to one embodiment, the system may also comprise an operating device for controlling an implantable medical device. Wireless energy in a wireless state can be used to directly actuate a working device to generate kinetic energy for the operation of an implantable medical device, since wireless energy is transmitted by the device for transmitting energy. The system may also include a device for converting wireless energy transmitted by a device for transferring energy from a first form of energy to a second form of energy.

The device for converting energy can be configured to directly supply the implantable energy-consuming components of the implantable medical device with second-form energy due to the conversion of first-form energy transmitted by the energy transfer device to second-form energy by the energy conversion device. The energy of the second form may contain at least one of direct current, pulsating direct current and alternating current. The energy of the first or second form may contain at least one of magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy, thermal energy, non-magnetic energy, non-kinetic energy, non-chemical energy, non-sonic energy non-nuclear energy and non-thermal energy.

[029] To provide protection for the system or parts of the system, it may also comprise an implantable electrical component comprising at least one voltage level protection device and / or at least one DC protection device. A control device for controlling the transfer of wireless energy from the device for transmitting energy and an implantable internal energy receiver for receiving the transmitted wireless energy can be made, the internal energy receiver can be connected to implantable energy-consuming components of the implantable medical device for directly or indirectly supplying received energy to them; the system may also include a detecting device configured to determine the energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy-consuming components of the implantable medical device, and the control device can be configured to control the transfer of wireless energy from an external device for transmission energy based on the energy balance determined by the determining device.

The detection device may be configured to detect changes in the energy balance, the control device may be configured to control the transfer of wireless energy based on the detected changes in the energy balance. In turn, the detection device may be configured to detect differences between the energy received by the internal energy receiver and the energy used for the implantable energy-consuming components of the implantable medical device, and the control device may be configured to control the transmission of wireless energy based on the detected energy difference .

[030] An energy transfer device may include a coil located outside the human body, which in turn may also include an implantable energy receiver for placement inside the human body, and an electrical circuit connected to an external coil for powering it through electrical pulses for transmitting wirelessly energy, and the electrical pulses have leading and trailing edges, and the electrical circuit is configured to vary the first time intervals between successive leading and leading edges and / or second periods of time between successive trailing and leading edges of electrical pulses in order to vary the power of the transmitted wireless energy, the power receiver receiving the transmitted wireless energy having varying power. The electrical circuit may be configured to deliver electrical pulses that remain unchanged with the exception of varying first and / or second time intervals.

The system according to one embodiment may have an electric circuit having a time constant and configured to vary the first and second time periods only within the first time constant so that when the duration of the first and / or second time periods varies, the power transmitted over the coil varies.

The implantable internal energy receiver for receiving wireless energy may comprise a first internal coil, a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having a second external coil and a second electronic circuit connected to the second coil, the second external coil of the energy transmitter transmits the wireless energy received by the first coil of the energy receiver, and the system further comprises a power switch for I turn on and off the connection of the first internal coil and the first electronic circuit in such a way that the external energy transmitter receives feedback data related to charging the first coil, in the form of fluctuations in the load resistance of the second external coil, when the power switch turns on or off the connection of the first internal coil and first electronic circuit.

[031] The system may also include an implantable internal energy receiver for receiving wireless energy having a first internal coil, a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy having a second external coil and a second electronic circuit connected to the second coil, and the second external coil of the energy transmitter transmits wireless energy received by the first coil of the energy receiver, and the system further comprises a feedback device ide for reporting data on the amount of energy received in the first coil as feedback data, the second electronic circuit comprising a sensing device for receiving feedback data and for comparing the amount of energy transmitted by the second coil with feedback data related to the amount of energy received in the first coil, in order to obtain the connection coefficients between the first and second coils.

In embodiments in which the system comprises a second external coil, which may be movable relative to the first internal coil to establish the optimal placement of the second coil at which the coupling coefficient is maximum. The second external coil may also be configured to calibrate the amount of energy transferred to obtain feedback data in the sensing device to achieve the maximum coupling coefficient.

[032] According to a second aspect, a method for implanting a medical device according to any of the embodiments disclosed herein is provided. The method includes the following steps: forming an opening extending from the outside of the human body into the joint, making an artificial contact surface to the joint, attaching the artificial contact surface to the joint, implanting the reservoir into the human body, and lubricating the artificial contact surface with the lubricating fluid contained in the reservoir.

The step of lubricating the contact surface of the joint or the artificial contact surface with the lubricant fluid contained in the reservoir may include implanting a working device configured to transfer fluid from the reservoir to the artificial contact surface. According to another embodiment, the step of lubricating the artificial contact surface with the lubricating fluid contained in the reservoir includes performing an energy source for powering the operating device.

According to yet another embodiment, the step of lubricating the contact surface of the joint or the artificial contact surface with the lubricating fluid contained in the reservoir may include powering the working device through an energy source.

[033] The step of implanting a reservoir into a human body according to one embodiment may include the step of implanting a working device integrated in the reservoir, which allows the step of lubricating the artificial contact surface with the lubricating fluid contained in the reservoir, by means of a working device transferring fluid from the reservoir to artificial contact surface.

Implanting a reservoir according to any one of the embodiments may include the step of implanting the reservoir at least partially within the patient’s bone, which may be the patient’s femur, patient’s tibia and / or patient’s pelvis.

The step of delivering the artificial contact surface may include the step of delivering the artificial contact surface from the ventral side of the pelvic bone.

The step of implanting the reservoir into the human body may comprise the step of implanting the reservoir subcutaneously. The subcutaneous placement of the reservoir allows easier access to the reservoir and eliminates the need for a long passage between the inlet and the reservoir.

The subcutaneous reservoir implantation step may include the step of implanting the reservoir in at least one area of the patient’s body selected from the group of regions consisting of: the abdominal region, inguinal region, pelvic region, thigh region and lower leg.

[034] An additional step of implanting an inlet to fill the reservoir may be carried out. Implanting an inlet can include the step of implanting an inlet in conjunction with a bone.

According to one embodiment, the medical device comprises an artificial contact surface configured to carry a load in the joint of a patient, and which may include at least one channel for transferring lubricating fluid, and the method includes the following steps: implanting a medical device into a human joint, implanting a channel configured to connect to a medical device, implanting a working device for transferring a lubricating fluid into the channel, imp the removal of the reservoir, which is capable of holding the lubricating fluid, and, at least after surgery, the transfer of the lubricating fluid from the reservoir to the artificial contact surface in the channel by means of a working device, and then along the channel to the artificial contact surface, thereby providing the possibility of application lubricating fluid to the artificial contact surface.

Typically, a lubricating device can be implanted during standard surgery with an endoscopic or laparoscopic method. Further, it is necessary to distinguish between methods of implanting a lubricant device having an infusion needle for occasionally introducing a lubricant fluid, and methods of implanting a lubricant device having an infusion tube for continuously introducing a lubricant fluid.

[035] When implementing a method of treating a human or mammalian joint, for example, in osteoarthritis of the human hip or knee, by providing the joint with a lubricating fluid by means of an implantable lubricating device, surgical dissection of a suitable location including the region of the joint is performed, and the surgical intervention may particularly include cutting a patient’s skin and dissecting a suitable area for a lubricant fluid storage tank. The lubricating device is then placed in a suitable area open by dissection so that the fluid connection allows the lubricant to enter the joint after surgery. To this end, a hole is formed in the joint capsule in the dissected region of the joint and the infusion tube is inserted into the hole so that the open end of the infusion tube is in constant communication with the joint to ensure that the lubricating fluid stored in the reservoir is introduced into the joint on an ongoing basis after operation. That is, the infusion tube is introduced into the hole so that, firstly, the open end of the infusion tube is in constant communication with the lubricated joint and, secondly, the infusion tube is in contact with the fluid connection device and therefore with the reservoir . After placement of the lubricant device, the patient’s body is closed so that the lubricant device is completely implanted in the patient’s body. This procedure can preferably be carried out in layers and by means of seams or staples or adhesives and the like. Finally, after completion of the implantation procedure, after the operation, a lubricating fluid is introduced into the reservoir so that the operation of the implanted lubricating device allows sufficient lubrication of the joint.

[036] In another embodiment, if the fluid connection contains a periodically operating infusion needle as the infusion element, the lubricant is placed on a dissected suitable site in the joint region by placing the infusion needle so close to the dissected region of the joint that the drive mechanism of the infusion needle can periodically insert the infusion needle into the joint and withdraw from it in such a way that the lubricating fluid stored in the reservoir is periodically introduced into the joint. That is, the infusion needle is placed in the immediate vicinity of the dissected area of the joint so that the needle can be periodically inserted into the joint to lubricate it and can subsequently be retracted by a suitable drive mechanism coupled to a drive mechanism or other similar element.

Another method of treating a human or mammal with an implantable lubricant device is carried out using endoscopic or laparoscopic methods to form a region of the joint through which the lubricating fluid can be introduced into the joint by means of an infusion element. The specified area of the joint is formed by, firstly, expanding the cavity located in the immediate vicinity of the joint by introducing a needle-shaped or tubular instrument into the patient’s body and introducing gas through the needle-shaped or tubular instrument to fill the tissue with gas and then expanding the cavity in the immediate vicinity of the joint . Then at least two laparoscopic / endoscopic trocars and a chamber are placed in the cavity, and at least one dissecting instrument is inserted into the cavity by means of laparoscopic trocars. The joint area is then dissected by means of an inserted dissecting instrument. In addition, a suitable area is cut to accommodate the remaining components of the lubricating device, such as a reservoir, pump or engine, etc. Then, the lubricating device is placed in a suitable area, and the fluid connection with the infusion element is formed in the laparoscopically dissected region of the joint so that the lubricating fluid is introduced into the joint. After placement of the lubricant device, the patient’s body is closed, as a result of which the lubricant device is completely implanted in the patient’s body. Then, after the operation, a lubricating fluid can be introduced into the reservoir so that the fluid connection device and the infusion element sufficiently lubricate said joint.

[037] A laparoscopic approach can also be used to implant a lubricant device having an infusion tube or infusion needle. In the first case, the reservoir is placed in a suitable area, a hole is formed in the joint capsule in the laparoscopically dissected region of the joint, and the infusion tube is inserted into the hole so that the open end of the tube is in continuous communication with the joint, and the stored lubricating fluid can be continuously introduced into joint. In the second case, after placing the reservoir on a suitable site, the infusion needle and the drive mechanism are placed in the immediate vicinity of the laparoscopically dissected area of the joint so that the drive mechanism can periodically insert (and withdraw) the infusion needle into the joint (and out of it) to provide time from the time the stored lubricant fluid is introduced into the joint.

Closing a patient's body, or in particular his skin, may for example include suturing, gluing, and other suitable methods. The lubricating device can be placed subcutaneously in the patient's body, in adipose tissue or intramuscularly. If necessary, the lubricating device can also be placed in the gastrointestinal tract or urinary tract of the patient or in their immediate vicinity. When the device is located in close proximity to the tract, it can be attached to the gastrointestinal tract or urinary tract through a holder connected to a lubricating device. In yet another embodiment, a lubricating device may be placed in the chest or abdominal cavity of the patient. For example, a reservoir may be placed in the abdominal cavity or chest. In another embodiment, a lubricant device or part thereof, such as a reservoir, may be implanted by open surgery; in this case, the chest or abdominal wall is opened to place a lubricant device in a suitable area inside the patient’s chest or abdomen, and then the skin and other tissue layers are closed, for example by suturing, preferably stitching in layers. Replenishing the reservoir preferably includes the step of introducing a volume of lubricant through an inlet connected to and / or integrated into the peripheral part of the reservoir, for example, the reservoir.

[038] Under functional hip movements should be understood hip movements, at least partially corresponding to the natural movements of the thigh. In some cases, the natural movement of the hip joint may be somewhat limited or altered after surgery on the hip joint, resulting in functional movements of the hip joint with artificial surfaces to some extent different from the functional movements of the natural hip joint. The functional position of an implantable medical device or hip prosthesis is a position in which the hip joint can perform functional hip movements. The final position should be understood as a functional position in which a further change in the position of the medical device is not required. The functional movements of the knee should be understood as the movements of the knee, at least partially corresponding to the natural movements of the knee. In some cases, the natural movements of the knee joint may be somewhat limited or altered after surgery on the knee joint, as a result of which the functional movements of the knee joint with artificial surfaces are somewhat different from the functional movements of the natural knee joint. The functional position of the implantable medical device or knee prosthesis is a position in which the knee joint can perform functional movements of the knee.

A functional knee joint is a knee joint capable of performing functional knee movements with or without an implanted medical device or prosthesis. Under the full functional size should be understood the size of the medical device for the knee when it is implanted in the knee joint.

[039] Arthroscopy should be understood as a minimal surgical procedure performed in the joint, and due to the fact that the arthroscopic procedure can be performed in the patient’s abdominal cavity, some steps of this procedure are more laparoscopic, but in the framework of the present invention, the terms “arthroscopy” "and" laparoscopy "are synonymous, and the main reason for using these methods in the framework of the present invention is their minimal invasiveness.

The medical device according to any of the embodiments may contain at least one material selected from the group consisting of: polytetrafluoroethylene (PTFE), perfluoroalkoxy copolymer (PFA) and a copolymer of tetrafluoroethylene and hexafluoropropylene (FEP). The material may also contain an alloy of metals, such as an alloy of cobalt, chromium and molybdenum, titanium or stainless steel, or polyethylene, such as mesh polyethylene or gas sterilized polyethylene. It is also possible to use a ceramic material such as zirconium or zirconia ceramic or alumina ceramic in artificial contact surfaces or in the entire medical device. The part of the medical device that is in contact with the human bone for attaching the medical device to the human bone may contain a porous structure, which may be a porous micro- or nanoconstruction made with the possibility of facilitating the ingrowth of a human bone into a medical device for fixing a medical device. The porous structure can be made by applying a hydroxyapatite coating or a coarse open-pore titanium coating, which can be performed by air-plasma spraying; It is also possible to use a combination of a coarse open-pore titanium coating and a top layer of a hydroxyapatite coating. The contact parts may be made of a self-lubricating material, such as a waxy polymer, such as PTFE, PFA, FEP, polyethylene or ultra-high molecular weight polyethylene, or from powder metallurgy material, into which a lubricant, preferably a biocompatible lubricant, can also be introduced, such as a hyaluronic acid derivative. It is also possible that the material of the contact parts or surfaces of the present medical device is capable of continuous or intermittent lubrication. In some embodiments, parts of the medical device may comprise a combination of metallic materials and / or carbon fibers and / or boron, a combination of metallic and plastic materials, a combination of metallic and carbon based materials, a combination of carbon and plastic based materials, a combination of flexible and rigid materials, a combination of elastic and less elastic materials, corian and acrylic polymers.

[040] It should be noted that any implementation option or part of an implementation option, as well as any method or part of the method, can be combined in any way. All the above examples should be considered as part of the general description, as a result of which they can generally be combined in any way. It should be noted that the description as a whole should be considered as a description of the device and method.

Various of the above features of the embodiments may be combined in any way, if the specified combination does not contain obvious contradictions. Embodiments of the present invention are described below with reference to the accompanying drawings. In the same way, individual features of various embodiments may be combined or interchangeable if said combination or replacement does not contradict the overall function of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

[041] In FIG. 1 shows a patient’s body with an implanted lubricator for lubricating the hip joint and / or knee joint;

In FIG. 1A and 1B show the hip and knee joints of FIG. 1, respectively, into which an infusion element of an implanted lubricant device is inserted; In FIG. 1C shows a side view of the knee joint with a medical device.

In FIG. 1D is a sectional view of a medical device according to one embodiment.

In FIG. 1E shows the main components of an implanted lubricant device; In FIG. 1F shows a motor driven implanted lubrication device that establishes a circulating current path. In FIG. 2A shows an implanted lubricant device with an infusion needle and a drive mechanism.

In FIG. 2B schematically shows the lubricating device of FIG. 2A with some modifications. In FIG. 2C is a cross-sectional view of a compiled embodiment of an implantable infusion device. In FIG. 2D shows a motor driven pump unit suitable for use with the embodiment of FIG. 1F. In FIG. 3 shows a medical device according to one embodiment comprising an artificial contact surface.

In FIG. 4 is a sectional view of a medical device according to one embodiment, comprising an artificial contact surface.

In FIG. 5 shows a front view of a person with a visible hip joint. In FIG. 6 shows a sectional side view of a person during a laparoscopic / arthroscopic procedure.

In FIG. 7 shows a cross-section of the hip joint when making an opening in the pelvic bone. In FIG. 8a shows a sectional view of the hip joint when making a small hole in the pelvic bone. In FIG. 8b shows a sectional view of the hip joint when the medical device is made through an opening in the pelvic bone. In FIG. 9a shows a sectional view of the hip joint when performing a medical device through an opening in a pelvic bone. In FIG. 9b shows a sectional view of the hip joint when the medical device is made through an opening in the pelvic bone. In FIG. 10 shows a cross-section of the hip joint when performing a medical device connected to an implantable lubrication system.

In FIG. 11a-c show a surgical instrument used in a method of manufacturing a medical device according to any one of the embodiments disclosed herein.

In FIG. 12b is a sectional view of the hip joint when a medical device is implanted and connected to an implantable reservoir. In FIG. 13a shows a sectional side view of the hip joint when making an opening through the femur. In FIG. 13b shows a cross-section of the hip joint when performing a medical device through an opening in the femur. In FIG. 13c is a sectional view of the hip joint when the medical device is made through an opening in the femur.

In FIG. 13d shows in more detail a reservoir configured to connect to a medical device.

In FIG. 14 shows a process for introducing a lubricant fluid into an implantable inlet channel.

In FIG. 15 shows an implantable medical device in the opposite embodiment.

In FIG. 16 shows a hip joint in section with an implantable medical device in accordance with the opposite embodiment.

In FIG. 17 shows a hip joint in section with an implantable medical device in accordance with the opposite embodiment.

In FIG. 18 shows a hip joint in section with an implantable medical device according to the opposite embodiment, made and connected to a reservoir.

In FIG. 19 is a front view of a human knee joint.

In FIG. 20 shows a front view of a person’s knee joint with a medical device.

In FIG. 21 shows an implantable lubrication system.

In FIG. 22a shows a side view of the knee joint with a medical device performed on the femur.

In FIG. 22b shows a side view of the knee joint with a medical device on the tibia.

In FIG. 23 shows a medical device comprising an artificial knee joint surface.

In FIG. 24 is a sectional view of a medical device containing an artificial surface of a knee joint.

In FIG. 25a shows a medical device comprising several parts of a medical device.

In FIG. 25b shows an assembled medical device comprising several parts of a medical device.

In FIG. 26 shows the placement of a medical device containing several parts of a medical device when attached to the tibia.

In FIG. 27 shows an implantable medical device according to one embodiment when attached to the tibia, the device being connected to a reservoir and an inlet.

In FIG. 28 is a front view of a person with an implantable lubrication system.

In FIG. 29 shows an implantable lubrication system in more detail.

In FIG. 30 shows an implantable circulatory lubrication system in more detail.

In FIG. 31 shows in more detail an implantable circulating lubricating system comprising a filter.

In FIG. 32 shows an implantable lubrication system for lubricating an artificial hip surface.

In FIG. 33a shows an implantable lubrication system comprising a retracting needle in a first position.

In FIG. 33b shows an implantable lubrication system comprising a retracting needle in a second position.

In FIG. 34 shows a system for treating a disease, the system comprising an apparatus of the present invention implanted in a patient.

In FIG. 35-49 schematically show various embodiments of a system for wirelessly powering the installation of FIG. 34.

In FIG. 50 is a schematic block diagram illustrating an arrangement for supplying the exact amount of energy used to operate the apparatus of FIG. 34.

In FIG. 51 schematically shows an embodiment of a system in which the installation operates on conductive energy. In FIG. 52 shows a more detailed block diagram of an arrangement for controlling the transmission of wireless energy used to operate the installation of FIG. 34.

In FIG. 53 shows the electrical layout of FIG. 52 according to a possible implementation example. In FIG. 54-60 show various layout options for the hydraulic or pneumatic supply of a patient implanted device.

DETAILED DESCRIPTION OF THE INVENTION

[042] The following is a detailed description of preferred embodiments. Similar figures in the drawings indicate identical or corresponding elements. You must understand that these drawings are given as an illustration and in no way limit the scope of the invention. Thus, any direction designations, such as "up" or "down", refer only to the directions shown in the drawings. In addition, all dimensions and other similar indications are for illustrative purposes only.

It should be noted that any implementation option or part of an implementation option, as well as any method or part of the method can be combined in any way. All the above examples should be considered as part of the general description, as a result of which they can generally be combined in any way.

In FIG. 1 shows a patient’s body with an implanted lubricant device consisting of a main body 1401 and two fluid connection tubes 1402 transferring the lubricant fluid stored in the reservoir to the lubricated joints, in this case, the hip joint and knee joint. For this reason, the main body 1401 contains a reservoir for storing the lubricating fluid, and may also contain additional components, such as a pump, motor, control unit, etc. Lubricating device, i.e. all its components are fully implantable in the patient’s body in such a way that sufficient postoperative joint lubrication can be provided regardless of any extracorporeal components or injections that significantly reduce the risk of infection of the patient. Depending on the type of joint and the degree of damage, it can be lubricated intermittently / periodically, continuously or as needed, for example, depending on the level of lubricating fluid in the joint. In general, the main body 1401 of the lubricant device can be implanted subcutaneously to provide easy access, for example, to replenish the reservoir or set functions or modes of operation via a wireless control unit or the like.

[043] FIG. 1A and 1B, two oiled joints of FIG. 1, the hip joint and knee joint, respectively, are shown in more detail. According to FIG. 1A and 1B, the fluid connection tube 1402 has at its end an infusion element inserted into the joint capsule and transferring the lubricating fluid to the joint. In FIG. 1A shows an infusion needle 1403 inserted through a joint capsule into the space of the hip joint. The infusion needle 1403 in conjunction with a drive mechanism (not shown) can be advanced into and removed from the joint to provide periodic lubrication of the joint. In another embodiment, as shown in FIG. 1B, the infusion element is an infusion tube 1404 permanently located in the articular space so that a continuous flow of lubricating fluid reaches the joint. The material of the infusion tube 1404 may be a soft material that does not interfere (or only minimally interfere) with the normal functioning of the joint. For the infusion tube 1404 of FIG. 1B no drive required.

In general, there are two main methods for implanting a lubricant device: the standard method, during which the joint area is dissected and the infusion needle 1403 or infusion tube 1404 is placed in the dissected area; and a laparoscopic method, during which the joint cavity is laparoscopically expanded and the infusion needle 1403 or infusion tube 1404 is placed in the cavity by laparoscopic trocars. If the fluid connection tube 1402 terminates in an infusion needle 1403, as shown in FIG. 1A, the infusion needle 1403 is placed near the joint capsule or in the opening in the joint capsule so that the needle drive mechanism can periodically insert and withdraw the infusion needle 1403 into and out of the joint so that the introduction of lubricating fluid stored in the reservoir occurs periodically. In another embodiment, the fluid connection tube 1402 terminates in the infusion tube 1404, as shown in FIG. 1B, a constant opening is made in the joint capsule in which the tube is placed on an ongoing basis so that a lubricating fluid can be continuously introduced into the joint.

[044] In FIG. 1C shows a medical device according to an embodiment in which the medical device comprises a first artificial contact surface 1101 adapted to replace the distal surface of the femur 102, which is part of the knee joint. The first artificial contact surface 1101 may be configured to replace the surface of the lateral condyle, the medial condyle, or the lateral and medial condyles. The medical device of FIG. 1C further comprises a second artificial contact surface 1102 configured to replace the contact surface of the tibia, which is another contact surface of the knee joint. The implantable medical device comprises an inlet 1104 adapted to receive lubricating fluid from a reservoir 1108, which in this embodiment is located on the rear side of the tibia 102 and on the back side of the femur 102, respectively. According to this embodiment, the reservoir 1108 is configured to be replenished by an inlet 1107 located in fluid communication with the reservoir 1108. The reservoir 1108 supplies a lubricating fluid to the inlet 1104; 1123 through a channel 1106 providing a fluid connection between the medical device and reservoir 1108. According to this embodiment, the reservoir is configured to be pressurized by said inlet 1108 comprising a compressed gas chamber, further compressed when filling the reservoir 1108 through the inlet 1107. Inlet 1104; 1123 transfers the lubricating fluid to the channel 1105, at least partially embedded in said artificial contact surfaces 1101, 1102. According to the embodiment of FIG. 1, channel 1105 is fully integrated into the medical device. Channel 1105 distributes the lubricant fluid to the artificial contact surfaces 1101, 1102, and thereby lubricates the artificial contact surfaces 1101, 1102 and improves their performance due to reduced friction. An implantable medical device can also be configured to implant another mammal, such as a horse, into the knee joint.

[045] In FIG. 1D shows an implantable medical device according to an embodiment in which the medical device is adapted to replace parts of the hip joint. The medical device comprises several channels 1105 configured to lubricate the artificial contact surface of the hip joint with a lubricating fluid introduced into the channel through a channel 1106 located centrally in the implantable medical device. Channel 1106 provides fluid connection of several channels 1105 to a reservoir 1108 located in the trunk of said medical device configured to be secured in the human femur. Channel 1106 transfers the lubricating fluid to the inlet 1123 for further distribution through channels 1105. According to the embodiment of FIG. 1D, the reservoir 1108 is spring loaded with a spring 1109 that pushes the movable wall portion in the form of a piston 1110 to pressurize said lubricating fluid. The reservoir 1108 is configured to replenish through the inlet 1107 located on the side of the medical device. The introduction of the lubricating fluid through the inlet 1107 compresses a spring 1109, which puts the lubricating fluid under pressure, which pushes the lubricating fluid through the channel 1106 to the channels 1105 for lubrication of the human hip joint. The spring loaded reservoir 1108 may be replaced by other types of reservoirs configured to pressurize the lubricating fluid, such as reservoir 1108 comprising a chamber filled with compressed gas further compressed by introducing the lubricating fluid through the inlet; it is also possible that reservoir 1108 is an elastic reservoir, in which case the elastic properties of the elastic reservoir exert pressure on the lubricating fluid.

[046] In FIG. 1E shows an implanted medical device and its main components. The lubricating device of FIG. 1E comprises a reservoir R for storing a lubricant fluid and a fluid connection tube 1402 connecting the reservoir R to the infusion tube 1404 arranged so that its open end is constantly located in the joint space. In order to generate sufficient pressure to expel the lubricant fluid from the reservoir R through the fluid connection tube 1402 and the infusion tube 1404 into the joint, a gas chamber 1407 is configured inside the reservoir R to provide the required pressure while expanding the chamber volume. In addition, the reservoir is implanted subcutaneously in such a way that the replenishing inlet channel 1406 provided on the outer wall of the reservoir R is accessible through the skin of the patient 1405 so that the reservoir R can be replenished with lubricating fluid through a syringe inserted through the skin of the patient 1405. Thus The replenishing inlet channel 1406 can be made of a suitable membrane, for example, of a polymeric material that is self-sealing when an injection syringe penetrates.

In FIG. 1F shows another embodiment of a lubricant device according to the present invention. A pump P driven by a motor M connects the reservoir R to the fluid circulating pipe 1402, consisting of two pipe parts 1402a, 1402b, which form a complete circulating current path for the lubricating fluid through the reservoir R and the lubricated joint. Each of the two tube parts 1402a, 1402b contains a separate infusion tube 1404a, 1404b inserted into the articular space, where the lubricant fluid stored in the reservoir is introduced into the articular space through the tube part 1402a with the infusion tube 1404a, and the used lubricant fluid is taken out of the joint back into the reservoir through the tube portion 1402b with the infusion tube 1404b and through the filter device 1427 with a filter 1428 located on the current path partially defined by the tube portion 1402b. Under the pressure generated by pump P, the lubricating fluid continuously circulates on the circulating current path formed by portions 1402a, 1402b of the fluid connection tube so that the lubricating fluid after passing through the joint can be reused at least partially. However, to ensure reuse of the lubricating fluid flowing from the joint into the infusion tube 1404b, possible contaminants and impurities or other foreign particles entering the lubricating fluid as it passes through the joint are removed by means of a filter device 1427 to ensure the quality and desired lubricating effect fluid during repeated use. The filter device 1427 has a filter 1428 located on the current path so that all lubricating fluid passes through the filter. The filter device 1427 is configured to regularly clean the filter 1428 by removing the filtered particles from the filter 1428 and placing them in an airtight sediment space 1433. In another embodiment, the removed particles can also be returned to the patient’s body, for example, to a blood vessel or the like.

[047] Although the embodiment of FIG. 1F may comprise a reservoir of a plurality of views, a specific view of the reservoir is described below. The volume of the reservoir R shown in FIG. 1F is divided into two sections by means of a membrane 1429. One section is filled with gas and the other section is filled with a lubricating fluid. A replenishing inlet channel 1430 provides replenishment of the reservoir R with infusion fluid through a replenishing needle through the skin of the patient 1405. When the reservoir R is full, the gas compartment is at atmospheric pressure or under high pressure. As the lubricating fluid is drawn from reservoir R during each lubrication cycle, the pressure in the gas compartment decreases to below atmospheric pressure, i.e. to a negative relative value. Depending on the type of pump P, it may be preferable to design an active spherical valve 1431 to prevent backflow from pump P to reservoir R, and another active spherical valve 1432 to prevent backflow from reservoir R to fluid connection passage 1402b.

The engine M is controlled wirelessly by means of a control unit C, also implanted in the patient’s body. However, the control unit C can also be placed outside the patient’s body, and wireless communication can be established between the control unit C and the engine M; or galvanic contacts can be made through the skin of the patient. Preferably, the control unit C is implanted with the engine M, the control unit C is preferably made programmable from outside the patient’s body wirelessly or via galvanic contacts, in order to ensure that the control unit is properly configured in accordance with changing requirements. The control unit C determines the time interval between infusion cycles, as well as the amount of lubricating fluid introduced into the joint space during each infusion cycle. In addition to, or instead of, a control unit C, a pressure regulator may be performed subcutaneously to drive the engine M.

[048] There are many ways to provide engine M with energy. For example, energy can be supplied from outside the patient’s body, for example, to charge battery A, such as a battery and / or capacitor. In the embodiment of FIG. 1F, an extracorporeal primary energy source E transmits first-form energy through a patient’s skin 1405 to an energy converting device T that converts first-form energy into second-form energy, such as electrical energy. Electric energy is used to recharge battery A, which, if necessary, provides secondary energy to engine M.

In general, the external energy source E may be configured to form an external field, such as an electromagnetic field, a magnetic field, or an electric field, or to generate a wave signal, such as an electromagnetic or sound wave signal. For example, the energy converting device T of FIG. 1F can serve as a solar cell, but adapted to the specific form of the wave signal of the primary energy source E. The device T for converting energy can also be configured to convert temperature changes into electrical energy. Instead of an external primary energy source E, an implantable primary energy source E can be used, such as a conventional battery with a long service life instead of battery A. The energy signal can also be used to transmit the control signal of the control unit C by modulating the energy signal accordingly , energy is transmitted wirelessly or wired, whereby the energy signal serves as a carrier wave signal for digital or analog Vågå control signal. In particular, the control signal may be a signal modulated in frequency, phase and / or amplitude.

[049] In FIG. 2A, an implanted lubricant device comprising an infusion needle 1403 having a tip 1408 is shown in detail. The tip 1402 at the distal end is closed and has a lateral outlet channel 1409 for delivering a lubricating fluid. The needle 1403 is longitudinally movable inside the fluid connection tube 1402 open at the ends when driven by the drive mechanism D.

A fluid connection tube 1402 is attached to an implanted pump P. Pump P is shown schematically and can be implemented in a variety of ways. In FIG. 2A, the reservoir R holding the lubricating fluid introduced into the joint space of the patient is part of the pump P. Alternatively, the reservoir R can be formed separately from the pump P and connected to it, for example, as essentially shown in FIG. 2B. However, in FIG. 2A, a movable or flexible wall 1410 of pump P, which may be in the form of a piston or similar element, is electrically (or manually) movable to occasionally pump lubricating fluid from reservoir R through fluid connection pipe 1402 in the direction to the infusion needle 1403. The pump P can be, for example, a driven engine, and the engine can be controlled automatically to introduce from time to time a certain volume of lubricating fluid into the joint space through spaced intervals by means of an infusion needle 1403. The reservoir R, pump P and / or other components of the implanted lubrication device, such as the aforementioned engine, automatic engine control device, etc., are preferably implanted with the infusion needle 1403 and drive mechanism D. Naturally , other relevant modifications are possible, obvious when a detailed consideration of other embodiments of the present invention.

[050] In the lubricating device shown in FIG. 2A, an increase in pressure in the reservoir R due to actuation of the movable / flexible wall 1410 causes the infusion needle 3 to move in the opposite direction to the force of the spring 1411 of the drive mechanism D. Thus, the tip 1408 of the infusion needle 1403 passes into the lubricated joint space. When the return spring 1411 is fully compressed and the pressure exerted on the lubricating fluid by the movable / flexible wall 1410 is further increased, the spherical valve 1412 moves in the opposite direction to the second return spring 1413, which has a greater force than the first return spring 1411. B In this case, while maintaining a sufficiently high pressure level, the lubricating fluid will be pumped from the reservoir R through the fluid connection pipe 1402, the hollow infusion needle 1403, and the needle outlet 1409 into the joint space of the patient. After depressurization, the spherical valve 1412 closes due to the action of the return springs 1411 and 1413, after which the infusion needle 1403 is retracted to its original position, as shown in FIG. 2A. The specified process is periodically repeated depending on the condition and type of the lubricated joint, which allows for periodic lubrication of a particular joint.

It should be noted that the force acting on the infusion needle 1403 for advancement can be calculated as the product of the actual pressure and the cross-sectional area of the needle 1403. Since the cross-sectional area of a conventional infusion needle is relatively small, to penetrate into the joint space and overcome the opposing forces of the return springs 1411 and 1413 need high pressure. Thus, it is preferable to perform the drive mechanism D in such a way that two strictly separated chambers are made in front of and behind the drive mechanism. Thus, when the chamber behind the driving mechanism D is held under low pressure, such as atmospheric pressure, the force acting on the infusion needle 1403 corresponds to the product of the actual pressure and the total cross-sectional area of the driving mechanism D, and therefore, the indicated force is much higher.

[051] This principle is shown in FIG. 2B. The drive mechanism D comprises a piston 1414 to which an infusion needle 1403 is attached, as shown in FIG. 3. The piston 1414 separates the first chamber 1415a in front of the piston 1414 and the second chamber 1415b behind the piston 1414. While the pressure in the first chamber 1415a corresponds to the pressure created by the pump P, the pressure in the second chamber 1415b can be kept lower. For example, chamber 1415b may be filled with compressible gas. In this case, you can not use the return spring 1411, since the compressed air independently creates the force of abstraction of the needle.

However, tight sealing of the gas chamber presents a certain complexity. For this reason, the second chamber 1415b, on the contrary, is filled with a fluid, such as a lubricating fluid, and the fluid can be forced into the flexible volume 1416. The flexible volume 1416 can be made in the form of a simple balloon, which allows it to be filled without causing significant opposing forces . In another embodiment, the flexible volume 1416 may comprise a gas chamber separated from the fluid of the second chamber 1415b by means of a flexible membrane. In this case, you can also not use the return spring 1411.

[052] Instead of flexible volume 1416, channel 1417 (acting as fluid connection tube 1402) can connect a second chamber 1415b to reservoir R. Thus, as the infusion needle 1403 advances, fluid is expelled from second chamber 1415b through channel 1417 to reservoir R and when the infusion needle 1403 is retracted by the return spring 1411, the fluid is drawn from the reservoir R through the channel 1417 back into the second chamber 1415b. The pump P and reservoir R are implanted into the patient’s body together with the drive mechanism D and the needle 1403 separately or, if necessary, as a single unit.

In FIG. 2C shows a very compact lubricant device implanted subcutaneously in the immediate vicinity and in a proper position relative to the joint being lubricated so that the needle 1403 can be periodically advanced into the joint when actuated by the drive mechanism D. The individual components of the device are contained within a common housing 1418 containing an external wall 1419a, 1419b. The volume defined by the outer wall 1419a, 1419b is completely filled with a lubricating fluid. The wall portion 1419a is made flexible to allow for volume changes occurring with each insertion and replenishment. The wall portion 1419a is made of a polymer material that is self-sealing when the infusion needle 1403 penetrates. Thus, the lubricant device can be replenished with lubricating fluid through the polymer wall portion 1419a during subcutaneous implantation.

[053] The other wall portion 1419b is rigid to provide some stability to the individual components contained within the housing 1418. The window region 1420 is formed on the rigid wall portion 1419b, and the permeable membrane 1421 is hermetically pressed into the window region 1420. The permeable membrane 1421 is made of a material self-sealing with respect to penetrations caused by the infusion needle 1403, said needle being made so as to penetrate the window region 1420 and thereby penetrate the lubricated joint space. The needle 1403 is connected to a piston 1414 separating the first chamber 1415a in front of the piston 1414 from the second chamber 1415b behind the piston 1414 according to the above description and FIG. 2B. A return spring 1411 and a spherical valve 1412 with a return spring 1413 are also provided. Holes 1422 are made for connecting the second chamber 1415b to the reservoir R so that when the pressure in the first chamber 1415a is increased, the piston 1414 can push the lubricant fluid out of the second chamber 1415b through the holes 1422 into reservoir R under atmospheric pressure.

[054] The pressure in the first chamber 1415a is increased by means of a pump P comprising a movable / flexible wall 1410 moved back and forth by means of a suitable drive mechanism, motor, or the like. In the housing 1424, in which the piston 1410 is movably made, a current path 1423 is formed. The current path has a current limitation 1425 and an outlet 1426 inside the housing 1424. The infusion device of FIG. 2C acts as follows. When actuating the movable / flexible wall 1410 (i.e., moving in the direction of the arrow), the lubricating fluid contained in the first chamber 1415a will not flow back to the reservoir R through the current path 1423 due to the limitation of the current 1425 on the current path 1423; instead, the piston 1412 with the needle 1403 is forced to move toward the window region 1420, pushing the lubricating fluid from the second chamber 1415b through the openings 1422 into the reservoir R. When the piston 1412 is in its final position and the movable / flexible wall 1410 moves further to in the direction of the arrow, the pressure in the first chamber 1415a gradually rises to a level sufficient to overcome the spring force of the return spring 1413, which opens the spherical valve 1412 and allows the release of the lubricating fluid s through the cannula 1403, the tip 1408 which simultaneously penetrates the membrane 1418 and the joint, wherein the housing is suitably 1418 lubricator. After the pressure in the first chamber 1415a is reduced due to the sliding of the movable / flexible wall 1410 backward, the spherical valve 1412 closes immediately 1412, and the piston 1412 with the infusion needle 1403 are simultaneously pulled back to the retracted position. A current path 1423 is needed to allow further movement of the movable / flexible wall 1410 backward after the piston 1412 has reached its initial position, thereby allowing the additional lubricating fluid to be drawn from reservoir R to the first chamber 1415a, said additional lubricating fluid compensating for the amount of lubricating fluid delivered to the patient during periodic cycles of administration. In addition to the occasional insertion and removal of the drive mechanism D, the drive mechanism of the lubricating device of FIG. 2C may also comprise means for laterally moving the tip 1408 of the infusion needle 1403 to prevent fibrosis and the like.

[055] The lubricating device of FIG. 2C provides several advantages, such as the absence of any gas chambers and the absence of the need to seal the movable / flexible wall 1410 and the piston element 1412. It should be noted that all components of the infusion device of FIG. 2B may be made of polymeric material, but preferably at least the infusion needle 1403 and return springs 1411, 1413 are made of inert metal. In FIG. 2D is a cross-sectional view of a pump-motor unit that can be used in the arrangement shown in FIG. 1F. The specified pump-motor unit is described in detail in WO 2004/012806 A1, and other pumping units disclosed herein can also be used according to the present invention. The pump-motor unit comprises a valve pump assembly, the diaphragm pump P and the valve pump device 1434 being the two main elements of the assembly installed in the cylindrical housing 1435. The valve assembly 1434 contains the first valve in the form of a ceramic disk 1436 fixedly mounted on the housing 1435 and attached to it, and a second valve in the form of a ceramic disk 1437, facing the ceramic disk 1436, in contact with it and made with the possibility of rotation relative to the fixed disk 1436. Engine 1438 is mounted on the housing 1435, covering ceramic disks 1436 and 1437. The engine 1438 comprises a grooved motor shaft connected to corresponding grooves in a lower central hole in the rotary disk 1437, which allows the disk 1437 to move substantially axially relative to the motor shaft 1439 despite so that the disk 1437 rotates together with the engine 1435. A locking element 1440 and a spring washer 1441 are installed on the shaft 1439 of the engine, exerting a slight pressure on the disk 1437, pressing it against the fixed disk 1436.

[056] Pump P comprises a pump membrane 1451, which may be any kind of membrane. Preferably, the membrane 1451 is a metal membrane, for example a titanium membrane, or a membrane made of coated plastic material to provide a long service life and prevent liquid diffusion through the membrane 1451 over time. The operating device, in this embodiment, built into the valve pump assembly, comprises a cam clutch 1452, which has a groove with two opposed cam surfaces 1453, a cam gear 1454 that rotates in the groove against the cam surfaces 1453, and a pump shaft 1455 connected to the rotary disk 1437. The cam gear 1454 through the cam gear shaft 1456 is mounted on the pump shaft 1455. The rotation of the pump shaft 1455 is effected due to its connection with the rotary disk 1437 by means of a groove shaft 1461 connected with corresponding grooves in the upper central hole 1461 in the rotary disk 1437. The grooved connection described above allows displacement of the disk 1437 essentially in the axial direction relative to the pump shaft 1455. The pump shaft 1455 is mounted in an airtight ball bearing 1458 and is axially stationary relative to the ball bearing 1458. Several elongated grooves 1459 on the pump shaft 1455 extend beyond the ball bearing 1458 and serve as fluid flow paths between the first channel 1442 of the stationary disk 1436 and the pump chamber 1460 below the membrane 1451.

[057] When the engine 1438 is rotated, the diaphragm 1451 moves up and down. As the diaphragm 1451 moves up and down, the rotary disk 1437 connects the first channel 1442 alternately with the second and third channels 1444 and 1445 so that the fluid moves from the second channel 1444 or the third channel 1445 to the pump chamber 1460 or passes from the pump chamber 1456 into a second channel 1444 or a third channel 1445. In FIG. The 2D first channel 1442 is shown connected to the second channel through an open channel 1450 so that the second channel 1444 receives fluid from the chamber 1460 through the first channel 1442. The choice of material for making the disks 1436 and 1437 is important because it must be able to function at very accurate values of stability so that the disks do not stick to each other over time. There are a number of materials available that are suitable for this purpose, such as ceramics or ceramics mixed with other materials, such as carbon fiber.

In FIG. 3 shows a medical device according to an embodiment in which the medical device is adapted to replace a contact surface of a human femoral head. In the medical device according to this embodiment, the artificial contact surface 1103b of the medical device comprises several channels configured to lubricate a human hip joint by means of a lubricating fluid. The medical device also includes a mounting portion 44 for attaching the medical device to the femoral head and / or the femoral neck.

[058] In FIG. 4 shows the medical device of FIG. 3 is a sectional view containing several channels located in a fluid connection with a reservoir (not shown) by a channel 1106 centrally located on the mounting portion 44, the channels 1105 being fully integrated into the medical device. Channel 1106 transfers the lubricating fluid to inlet 1123 for further distribution through channels 1105. The channel ends with a connecting section 1111 configured to connect the channel to a second channel 1106, a reservoir, or additional channels.

In FIG. 5 shows a front view of the human body and illustrates a laparoscopic / arthroscopic method of surgery on the hip joint for performing a medical device according to any of the embodiments disclosed herein on the back of the acetabulum 8. The hip joint comprises the acetabulum 8 and the femoral head 5. Small incisions 14 in the wall of the human abdominal cavity provide the possibility of introducing laparoscopic / arthroscopic trocars 33 a, b, c into the patient’s body. Then, through the indicated laparoscopic / arthroscopic trocars 33 a, b, c, at least one of the following elements can be inserted into the patient’s body: a chamber 34, a surgical instrument configured to make holes in the pelvic bones 35, or instruments 36 for insertion, placement , connecting, attaching, forming, or filling an implantable medical device.

[059] In FIG. 6 shows a side view of the human body, with the hip joint shown in section. The hip joint comprises a femoral head 5 located on the uppermost part of the femoral neck 6, which is the upper part of the femur 7. The femoral head 5 is connected to the acetabulum 8, which is the cup-shaped part of the pelvic bone 9. Laparoscopic / arthroscopic trocars 33 a, b, c are used to achieve the hip joint 39 with at least one of the following components: a chamber 34, a surgical instrument 35 configured to make holes in the bones 9 of the pelvis or instruments 36 for insertion, placement, connection, attaching, forming, or filling in an implantable medical device.

In FIG. 7 shows the process of making the hole 18 in the pelvic bone 9 after dissection of the pelvic bone 9. The hole 18 is made from the abdominal side of the pelvic bone 9 by repeatedly or sequentially moving a hole forming device 22 located in the human body from the abdominal side of the pelvic bone 9. The hole 18 extends into the hip joint 19 through the pelvic bone 9 on the back side of the acetabulum 8. According to the first embodiment, the hole 18 is made large, which allows the implantable medical device to pass through the hole 18 in its full functional size.

[060] In FIG. 8a shows a second embodiment in which the opening 20 made by a surgical or laparoscopic / arthroscopic method is significantly smaller, as shown in FIG. 8a, whereby a hole-forming device 22 can be used to make the smaller hole 20, which also makes it possible to reduce the incision and dissection carried out in the human body.

In FIG. 8b shows a cross-section of the hip joint when a medical device is placed between the femoral head 5 and the acetabulum. The medical device according to this embodiment comprises channels 1105 connected to a channel 1106, which in turn is connected to a connecting part located in an opening in the pelvic bone 9. Channel 1106 transfers the lubricating fluid to the inlet 1123 for further distribution through the channels 1105. For insertion through the hole 18 into the bones 9 of the pelvis and smaller than the medical device, the latter can be rolled up or compressed or, according to another embodiment, molded on the site or in a form made with the possibility of resorption by the human body, melting or performing the function of the surface of a medical device. The medical device may be adapted to be fixed by adhesive or by a mechanical fastener.

[061] In FIG. 9a shows a cross-section of the hip joint when a medical device is placed through an opening 18 in the bone of the pelvis 9 to replace the contact surface of the femoral head 5. The medical device comprises an artificial contact surface 1103b and a mounting part 44 located centrally in the medical device and configured to attach the medical device to the femoral head 5. The medical device comprises several channels 1105 located on an artificial contact surface for lubrication of the hip joint. The channels are in fluid communication with a channel 1106, which in turn is connected to a connecting part 1111b configured to connect the channel to a second channel 1106b or a second part of the channel 1106b, which in turn is in fluid communication with a reservoir 1108, located in the femur of 7 people. The reservoir 1108 is located in the femur 7 and is configured to hold the lubricating fluid under pressure, according to the embodiment of FIG. 9a provided by said reservoir 1108, spring-loaded by means of a spring 1109 connected to the movable part of the wall in the form of a piston 1110 compressing a lubricating fluid. The reservoir 1108 is also connected to an inlet 1107 located in conjunction with the femur 7 below the greater trochanter 1186, however, other suitable placement in conjunction with the bone, in the cavity, or subcutaneously, is also possible. The medical device according to the embodiment of FIG. 9a is configured to operate using a pressure vessel, however, according to other embodiments, the medical device is configured to operate by means of a working device with a drive, such as an implantable pump, which can be driven by direct traction, such as inductive or magnetic traction, or through an accumulator energy source, such as a battery. The channels according to one embodiment (not shown) may include a valve for closing the flow of lubricating fluid through channel 1106 or channel 1105, thereby closing the connection between the reservoir and the artificial contact surface. The valve can be made with a drive, and with the ability to control it from outside the human body through, for example, remote control.

[062] In FIG. 9b shows a sectional view of the hip joint when the medical device according to another embodiment is implemented in the hip joint, replacing the contact surface of the femoral head. The medical device comprises an artificial contact surface 1103b containing several channels 1105 connected to a channel 1106, 1106b located in the mounting part of the medical device. The channel, in turn, is in fluid communication with a reservoir 1108 located inside the femur, preferably in the spongy portions of the femur, and the reservoir is in fluid communication with the channels of the medical device for lubricating the artificial contact surface 1103b of the medical device.

In FIG. 10 shows a cross-section of the hip joint when the implantable medical device is configured to replace the contact surface of the acetabulum. The medical device comprises an artificial acetabular surface 65 containing several channels connected to the channel 1106 by means of a connecting part 1111. The medical device according to the embodiment of FIG. 10 is configured to be placed in the hole 18 in the pelvic bone to replace the contact surface 65 of the acetabulum. In FIG. 10 also shows the block to which channel 1106 is connected, according to one embodiment, the block comprises a reservoir 1108 and two pumping devices 1113a, 1113b configured to generate pressure to compress the lubricating fluid to expel said lubricating fluid through the channel 1106 and further through several channels 1105 for lubrication of the implantable medical device. Channel 1106 transfers the lubricating fluid to the inlet 1123 for further distribution through channels 1105. The injection devices may be spring loaded or may consist of an element filled with compressed gas, which is further compressed by introducing the lubricating fluid into the reservoir 1108. The block also includes an inlet channel 1107 comprising a self-sealing membrane 1112, which is preferably a silicone membrane coated with parylene. According to another embodiment, the unit comprises a working device with a drive, such as a pump located in container 1113a and pumping lubricating fluid from reservoir 1108 through channel 1106 to several channels 1105. According to one embodiment, the pump is driven by a battery located in Division 1113b.

[063] In FIG. 11a shows a surgical instrument configured to insert a medical device according to any of the embodiments disclosed herein, or a form for performing a medical device according to the first embodiment. The surgical instrument comprises a grasping part 76 and a working part 77. According to the embodiments shown in FIG. 11 a, b, c, the tool further comprises a pivoting element 78, providing a rotation of the gripping part 76 relative to the working part 77, but it is possible to perform a surgical instrument not provided with the specified pivoting element 78.

In FIG. 11b shows a surgical instrument configured to insert a prosthesis, parts of a prosthesis or parts necessary to form or make a surface of a hip joint according to a second embodiment. According to this embodiment, the surgical instrument further comprises a parallel movable portion 79, which allows to increase the reach of the instrument and facilitate the process of reaching the hip joint through an opening in the pelvic bone on the opposite side of the acetabulum 8.

[064] FIG. 11c shows a surgical instrument configured to insert a prosthesis, parts of a prosthesis or parts necessary to form or execute a surface of a hip joint according to a third embodiment. According to this embodiment, the surgical instrument further comprises two angle adjustment elements 80a, b. The angle adjustment elements can be adjusted to change the angle of the specified exciting part 76 relative to the working part 77, or fixed at an angle suitable for work in the hip joint through an opening in the pelvic bone on the opposite side of the acetabulum 8.

In FIG. 12 is a sectional view of the hip joint with a medical device. The implantable medical device is capable of replacing the surface of the acetabulum, and is inserted through the hole 18 into the bones of the pelvis 9, but in other embodiments, the medical device may be configured to be inserted through the hole in the femur 7 or capsule of the hip joint. The medical device comprises several channels 1105 connected to each other via a channel 1106, which provides a fluid connection of channels 1105 to each other. Channel 1106 transfers the lubricating fluid to inlet 1123 for further distribution through channels 1105. Channel 1106 is also connected to a first portion of a connecting portion 1111 configured to connect to a second portion of a connecting portion 1111b. The connecting part 1111 connects the first part of the channel 1106 with the second part of the channel 1106, which allows you to enter the first part of the channel 1106 from the side of the acetabulum of the pelvic bone 9, and enter the second part of the channel 1106 from the side of the pelvis or from the opposite acetabulum of the side of the bone 9 of the pelvis. The connection of the two parts of the channel 1106 is particularly advantageous when the medical device is inserted through an opening 18 in the femur 7 or the capsule of the hip joint, and the reservoir 1108 is implanted in the abdominal cavity of a person or in another area on the abdominal side of the pelvic bone 9. Channel 1106 is then also connected to reservoir 1108 and is configured to transfer lubricant fluid from reservoir 1108 to the hip region. Tank 1108 according to the embodiment of FIG. 12 is configured to pressurize the lubricating fluid by means of a spring 1109, which exerts a force on the moving part of the wall in the form of a piston 1110, pushing the lubricating fluid through the channel 1106 and then through the channels 1105. The reservoir 1108 further comprises an inlet channel 1107 located in the upper part reservoir 1108 to replenish reservoir 1108 and the concomitant increase in pressure of the lubricating fluid.

[065] FIG. 13a shows a side view of a person with a hip joint, shown in section. The femur 7 has a proximal part containing the neck 6 of the femur and, at the proximal site, the head 5 of the femur. In FIG. 13a, a hole 82 is made by an incision made in the thigh, the hole extends into the femur 7, along the neck 6 of the femur and exits through the head 5 of the femur into the hip joint. The hole is used for placement in the hip joint of a medical device, which preferably can be rolled up or bent for insertion through said hole 82.

In FIG. 13b, a cross-sectional view illustrates a hip joint with a medical device placed through an opening 82 in the bones of the pelvis 7 and fixed in the acetabulum 8. The medical device comprises several channels 1105 connected to each other via channel 1106. According to other embodiments, the medical device may be placed through the capsule of the hip joint or through an opening in the bones of the 9th pelvis. After placing the medical device, a tool 1180 is used that holds the reservoir 1108 connected to the channel 1106 'to place the reservoir 1108 in the opening 82 in the femur 7 and to connect the reservoir to the channel 1106 of the medical device.

[066] In FIG. 13c shows a section through the hip joint with a reservoir 1108 located in an opening 82 in the femur 7 and connected to a medical device. Also made channel 1106 ', passing from the reservoir 1108 to the inlet channel 1107 to replenish and / or compress the reservoir 1108.

In FIG. 13d a tank unit is shown in more detail; the tank unit contains a connecting part 1111 located on the end part of the tank unit, the compressed tank 1108, according to the embodiment of FIG. 13d, is compressible by a spring 1109 pushing the movable wall part 1110 in the form of a piston 1110. The tank unit further comprises a channel 1106 ′ connected to the tank and with an inlet 1107 for filling and / or compressing a reservoir 1108 containing a lubricating fluid. The inlet 1107 comprises a self-sealing membrane, which may be a self-sealing silicone membrane coated with parylene, to restrict cell migration on the surface of the inlet. A cross-section along line AA shows a centrally located channel 1106 in the center of the reservoir 1108 for filling and / or compressing the reservoir 1108.

[067] FIG. 14 is a cross-sectional side view of a person introducing a lubricant fluid into the inlet 1107 by means of an insertion member 92 comprising a container 1115 configured to contain the injected lubricant fluid. The inlet channel is connected to an implantable medical device located in the hip joint through a channel 1106 configured to provide a fluid connection between the inlet channel and the medical device. The medical device, in turn, contains several channels 1105 for lubricating artificial contact surfaces, and accordingly, lubricating the hip joint. According to the embodiment shown in FIG. 14, the medical device is supplied from the abdominal side of the pelvic bone 9 through an opening made in the pelvic bone, and subsequently replenished with a removed bone filling, sealed and fixed by means of a mechanical fastener attached by screws. According to other embodiments, the medical device is placed on the hip joint side of the pelvic bone 9 through the capsule 12 of the hip joint or femur 7, and then connected to the canal 1106 on the ventral side of the pelvic bone 9 via the connecting part 1111. This allows the inlet duct 1107 to be placed in the abdominal cavity, subcutaneously, in the cavity and / or with the maintenance of muscle tissue or fascia tissue.

[068] In FIG. 15 shows a medical device according to the opposite embodiment, comprising a first artificial contact surface 112 having a convex shape toward the center of the hip joint. The first artificial contact surface 112 is configured to attach to a human pelvis bone 9. The convex artificial surface 112 of the hip joint is adapted to be attached to the bone 9 of the pelvis and inserted through the hole 18 into the bone 9 of the pelvis. The medical device comprises a nut 120 threaded for tightly attaching the medical device to the pelvic bone 9. The medical device further comprises a prosthetic part 118 adapted to be placed in an opening 18 made in the pelvic bone 9 after implantation of the medical device in a patient. The prosthetic part 118 contains the supporting elements 119, made with the possibility of contact with the bone 9 of the pelvis and to facilitate bearing the load exerted on the medical device by a person’s weight during normal use. Normal use is understood to mean use identical to the use by a person of a natural hip joint. In addition, the medical device includes a locking element 116 containing a surface 117 made with the possibility of contact with the convex artificial surface 112 of the hip joint. The locking element 116 further comprises locking elements 115 configured to facilitate the attachment of the locking element 116 to the head 5 or neck 6 of the femur, which in turn fixes the convex artificial surface 112 of the hip joint. The convex artificial surface 112 of the hip joint is attached to a mounting rod 113 provided with a thread 114 corresponding to a thread of a nut 120 connected to the prosthetic part 118. The medical device comprises several channels 1105 adapted to lubricate the artificial contact surface 112. Several channels 1105 are connected to each other through a channel 1106 configured to transfer lubricant fluid from a reservoir 1108 to several channels 1105 that are fully integrated into the artificial contact The surface 112 of the medical device for lubricating the artificial contact surface 112, and accordingly, the lubrication of the hip joint.

[069] In FIG. 16 shows the medical device of FIG. 15, located inside the hip joint. The first artificial contact surface having a convex shape towards the center of the hip joint is housed in the second artificial contact surface 109 having a concave shape towards the center of the hip joint. The second artificial contact surface 109 is placed and secured in the head 5 and neck 6 of the femur, and is attached by means of a locking element 116 containing the surface 117 facing the first convex artificial contact surface 112. The medical device contains several channels 1105 connected to the channel 1106 located in the medical device in the center, to provide the medical device with a lubricating fluid and for lubricating the artificial contact surface 112, and accordingly, the hip with of the charter.

In FIG. 17 shows the process of placing the prosthetic portion 118 in the hole 18 in the pelvic bone 9. The prosthetic part 118 contains the supporting elements 119, made with the possibility of contact with the bone 9 of the pelvis and to facilitate bearing the load exerted on the medical device by the weight of the patient during normal use.

[070] In FIG. 18 shows an embodiment of a medical device according to the opposite embodiment, in which a part of a medical device containing a concave artificial surface of the hip joint located in the head 5 and neck 6 of the femur contains several lubricating channels 1105 connected to the channel 1106b, establishing a fluid connection between the medical device and the reservoir located in the cancellous bone of the femoral neck 6. The reservoir is adapted to be replenished through the inlet 1107, which according to the embodiment of FIG. 18 is located in conjunction with the femur 7 and is located below the major trochanter 1186. The reservoir block and its operation are described in more detail with reference to FIG. 9a and 9b. In FIG. 18 also shows the prosthetic portion 118 attached to the pelvic bone 9 by means of screws 121. Instead of screws or in addition to them, adhesive can be used applied in connection with the screws or on the surface S between the prosthetic portion and the pelvic bone 9.

In FIG. 19 shows the right foot of a person. A femur having a distal portion containing the lateral condyle 105, the medial condyle 106 and the region between these lateral and medial condyles. The distal portions of the femur 102 comprise contact surfaces of the knee joint. The knee joint also contains a patella 101, which is a triangular bone articulated with the femur 102 and covering and protecting the knee joint. The knee joint also contains menisci 107, 108, which are cartilage elements inside the knee joint, serving as articulated surfaces to protect the ends of the bones from rubbing against each other. Menisci 107, 108 also play the role of shock absorbers in the knee joint to absorb shocks that occur when a person moves. In each knee there are two menisci 107, 108 - the medial meniscus 107 and the lateral meniscus 108. In patients suffering from osteoarthritis, menisci 107, 108, playing the role of articulated surfaces, i.e. bearing surfaces, wear out and, in severe cases, the bone in the joint may be exposed. The knee joint is protected by a capsule of the knee joint, also known as a capsule of the knee joint or knee ligament of the knee joint. The capsule of the knee joint is wide and weak; thin front and sides and contains a patella 101, ligaments, menisci 107, 108 and bursa, which are small bags filled with fluid from white fibrous tissue. The capsule of the knee joint consists of a synovium and a fibrous membrane, separated by fatty deposits in front and behind.

[071] In FIG. 20 shows the knee joint with artificial surfaces of the knee joint 130, 116a located on the distal part of the femur 102 and on the proximal part of the tibia 104. The lateral and medial canals 125a, b supply contact surfaces and, accordingly, the knee joint with a lubricating fluid for the purpose reduce knee friction.

In FIG. 21 is a front view of a human body, where a reservoir unit 127 is implanted subcutaneously in a human abdominal cavity. The reservoir block according to this embodiment comprises a working device in the form of a pump 130, driven by a battery 128, for pumping fluid from the reservoir 129 through a channel into a channel 125 supplying artificial contact surfaces of the knee joint with a lubricating fluid. The reservoir block is attached to muscle tissue or fascia 1181 of the abdominal wall by clamping muscle tissue or fascia 1181 between the reservoir block and the inlet channel 1107, made on the outside of the muscle tissue or fascia 1181.

In FIG. 22a shows an embodiment in which the medical device comprises an artificial surface 115 of the knee joint clamping the medial, lateral or medial and lateral condyle 106 of the knee, which is the distal part of the femur 7. The medical device according to this embodiment contains several channels 1105 for lubricating artificial contact surfaces, these channels are in fluid communication with each other through channel 1106, which in turn is located in a fluid connection to a reservoir 1108 containing an inlet 1107 for replenishing the reservoir or compressing the lubricating fluid contained in said reservoir 1108. The channel 1106 transfers the lubricating fluid to an inlet 1123 for further distribution through channels 1105.

[072] In FIG. 22b shows a side view of the knee joint with a medical device containing an artificial contact surface 1102 and placed on the proximal part of the tibia 104, together with the tibia 103 forming the lower leg. The artificial surface of the knee joint contains several channels 1105 in fluid communication with a channel 1106 adapted to transfer lubricant fluid from the reservoir 1108. The reservoir 1108 according to the embodiment of FIG. 22b is located on the rear side of the tibia 104 and is attached to the tibia 104, and contains an inlet 1107 for introducing lubricating fluid into the reservoir 1108 and / or for compressing the lubricating fluid contained in the reservoir 1108. The duct 1106 transfers the lubricating fluid to the inlet 1123 for further distribution through channels 1105.

In FIG. 23 shows in more detail a medical device for implantation in the knee joint. The medical device comprises several channels 1105 located along the artificial contact surface of the medical device for lubricating the contact surface of the medical device. The channels 1105 are connected to a channel 1106 for transferring lubricating fluid along the artificial contact surface 1101 of the medical device. Channel 1106 transfers the lubricating fluid to inlets 1123 for further distribution through channels 1105.

[073] FIG. 24 is a cross-sectional side view of a medical device in which channels 1105 are completely integrated into the artificial contact surface and connected to each other, channel 1106 supplies lubricating fluid to channels 1105 for lubricating the artificial contact surface of the medical device. Channel 1106 transfers the lubricating fluid to inlet 1123 for further distribution through channels 1105.

In FIG. 25a shows a medical device for implantation in the knee joint of a person, comprising several parts 119 of a medical device configured to connect to each other and to a part of the base 118 of the medical device by means of mechanical fixation elements 120, ensuring the shape of several parts 119 of the medical device and part of the base 118 The portion of the base 118 of the medical device also comprises a mounting portion 117 configured to mechanically attach the medical device triplets to the human bone, such as the proximal part of the tibia. Part of the base 118 of the medical device further comprises a channel for supplying a lubricating fluid to the artificial contact surface of the knee joint.

In FIG. 25b shows the medical device of FIG. 25a assembled.

In FIG. 26 shows the medical device of FIG. 25a and 25b attached to the tibia 104.

[074] FIG. 27 shows the proximal portion of the tibia 104, with the medical device containing the artificial contact surface 116 attached to the tibia 104. The artificial contact surface channel 1105 is connected to a channel 1106 providing a fluid connection between the channel 1105 of the medical device and the first and second reservoirs 1108 located inside the tibia 1104 on the medial and lateral side. The channel also connects the first and second reservoirs to an inlet channel 1107 located on the medial side of the pelvic bone to replenish and / or compress the reservoirs 1108. The reservoirs 1108 according to the embodiment shown in FIG. 27 are configured to place the lubricant fluid under pressure, which causes the lubricant fluid to be expelled from the channels 1105 onto an artificial lubricating surface to lubricate the knee joint. To this end, reservoir 1108 comprises a spring 1109 connected to the movable wall portion in the form of a piston 1110 to compress the lubricating fluid.

In FIG. 28 is a front view of a person with an implanted lubrication system 120. The implantable lubrication system 120 is configured to continuously introduce, inject from time to time, or inject lubricating fluid into said hip joint, if necessary. According to the embodiment shown in FIG. 61, the implantable lubrication system comprises two interconnected units 121, 122. Two interconnected units are located in the human abdomen and are connected to the hip joint through a channel 1106.

[075] FIG. 29 shows in more detail an implantable lubrication system 120 that can be used in combination with any medical devices disclosed herein. According to the shown embodiments, the implantable lubricating system comprises a first block 121 comprising a pump element 123 configured to pump lubricating fluid from a reservoir 1108 into the region of the hip joint. The first block 121 also comprises an inlet 1107 for filling the reservoir 1108 from outside the human body without the need for a surgical procedure. The inlet 1107 comprises a self-sealing membrane permeable through a needle attached to a syringe. The first unit 121 further comprises a wireless energy receiver 124, preferably comprising a coil. The specified wireless energy receiver is used to charge the battery 126. According to this embodiment, the implantable lubrication system 120 further comprises a second unit 122, which in turn contains a battery 126 and a reservoir 1108 for the fluid. Lubricating fluid 128 is pumped from reservoir 1108 through first block 121 by means of a pumping device, through channel 1106 and into the area of the hip joint, where it helps lubricate the surfaces of the hip joint or the artificial contact surfaces of the implantable medical device. The lubricating fluid is preferably a biocompatible lubricating fluid, such as hyaluronic acid.

In FIG. 30 shows an implantable lubrication system adapted to be used with any medical device disclosed herein, according to an embodiment in which the implantable lubrication system is a circulating lubrication system comprising one inlet 130 in a lubricated joint and one outlet 131. Preferably, this system is a continuous lubrication system in which a pump element 123 continuously circulates a lubricating fluid 128 inside a basin hip.

[076] In FIG. 31 shows an implantable lubricating system for circulatory lubrication, adapted for use with any medical device disclosed herein, the lubricating system further comprising a filter element 132 for filtering the lubricating fluid. The filter is self-cleaning, and the filtered substance is discharged through the waste channel 133 into the human abdomen or into a container attached to the waste channel 133. By filtering the lubricant fluid 128, the circulating lubricant system can operate for extended periods of time without the need for any surgical procedures.

In FIG. 32 shows the lubricating fluid of FIG. 29, when lubricating an implantable medical device containing an artificial contact surface 45 by a lubricating fluid 128.

In FIG. 33 shows a lubrication system that can be configured to be used in combination with any medical device disclosed herein, according to yet another embodiment, wherein the lubrication system comprises a unit 1310 comprising a tap needle 1311 attached to a work system for operating said tap needles 1311. The needle is configured to penetrate a self-sealing membrane 1314 located in the pelvic bone 9 for introducing a lubricating fluid into the hip joint. Channel 1106 is configured to supply a lubricating fluid from the inlet channel and / or from an additional reservoir, which can be implanted subcutaneously or in the body cavity, into block 1310.

[077] In FIG. 33b, the lubrication system is shown in a position in which the outlet needle 1311 is in an advanced position by means of a working device enabling the outlet needle 1311 to operate. The needle penetrates through the self-sealing membrane 1314 and is in a position in which the introduction of lubricating fluid is possible. In FIG. 34 shows a system for treating a disease comprising a unit 10 of the present invention located in a patient’s abdominal cavity. The implanted energy conversion device 1002 is configured to supply energy to the energy-consuming components of the installation via the power supply line 1003. An external energy transfer device 1004 for non-invasively providing power to the installation 10 transmits energy via at least one wireless energy signal. An implanted energy conversion device 1002 converts energy from a wireless energy signal into electrical energy supplied by power supply line 1003.

The implanted energy conversion device 1002 may also contain other components, such as: a coil for receiving and / or transmitting signals and energy, an antenna for receiving and / or transmitting signals, a microcontroller, a charge control unit, optionally containing an energy storage device, such as a capacitor at least one sensor, such as a temperature sensor, a pressure sensor, a position sensor, a motion sensor, etc., a transceiver, an engine, optionally comprising an engine controller, a pump, and other details to control the operation of a medical implant.

[078] The wireless energy signal may comprise a wave signal selected from the following group: a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal , An RF signal, an X-ray signal, and a gamma radiation signal. In another embodiment, the wireless energy signal may comprise an electric or magnetic field or a combined electric and magnetic field.

A device for transmitting wireless energy 1004 may transmit a carrier signal for transmitting a wireless energy signal. Such a carrier signal may comprise digital, analog, or a combination of digital or analog signals. In this case, the wireless energy signal comprises an analog or digital signal or a combination of an analog and digital signal.

In general, the energy converting apparatus 1002 is configured to convert the first form wireless energy transmitted by the energy transmitting apparatus 1004 to second form energy, which is usually different from first form energy. The implanted device 10 can operate under the influence of energy of the second form. The energy converting apparatus 1002 can directly provide the installation with power in the form of second-form energy, as the first-form energy transmitted by the energy transmitting apparatus 1004 is converted into the second-form energy by the energy converting apparatus 1002. The system may also comprise an implantable battery, wherein second-form energy is used to charge the battery at least partially.

[079] In another embodiment, the wireless energy transmitted by the power transfer device 1004 can be used to directly power the installation as wireless energy is transmitted by the power transfer device 1004. If the system contains an operating device for ensuring the operation of the installation, as described below, the wireless energy transmitted by the energy transfer device 1004 can be used to directly supply power to the operating device to generate kinetic energy for the operation of the installation.

The wireless energy of the first form may contain sound waves, and the device 1002 for converting energy may contain a piezoelectric element for converting sound waves into electrical energy. The energy of the second form may comprise electrical energy in the form of direct current or pulsating direct current, or a combination of direct current and pulsating direct current, or alternating current, or a combination of direct and alternating current. Typically, an installation contains electrical components powered by electrical energy. Other implantable electrical system components may be at least one voltage level protective device and / or at least one DC protective device connected to the electrical components of the installation.

[080] If necessary, one of the energy of the first form and the second form may contain magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy or thermal energy. Preferably, one of the energy of the first form and the second form is non-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy transfer device can be controlled from outside the patient’s body to release electromagnetic wireless energy, which is used to operate the unit. In another embodiment, the device for transmitting energy is controlled from outside the patient’s body to release non-magnetic wireless energy, which is used to ensure the operation of the installation.

The external power transmission device 1004 also includes a wireless remote control having an external signal transmitter for transmitting a wireless control signal for non-invasively controlling the installation. An implanted signal receiver, which can be integrated into the implanted device 1002 for energy conversion or can be performed separately from it, receives a control signal.

[081] The wireless control signal may comprise a signal modulated in frequency, amplitude, phase, or a combination of these options. In another embodiment, the wireless control signal comprises an analog or digital signal or a combination of an analog and digital signal. In another embodiment, the wireless control signal comprises an electric or magnetic field or a combined electric and magnetic field.

The wireless remote control may transmit a carrier signal to carry the wireless control signal. Such a carrier signal may comprise digital, analog, or a combination of digital or analog signals. If the control signal contains an analog or digital signal or a combination of an analog and digital signal, the wireless remote control preferably transmits an electromagnetic carrier wave signal to carry the digital or analog control signal.

In FIG. 35 shows the system of FIG. 34 in a more general block diagram showing the installation 10, a device 1002 for powering the installation 10 via the power supply line 1003, and an external device 1004 for transmitting energy. The skin of the patient 1005, shown generally as a vertical line, separates the internal components within the patient to the right of the line from the external components to the left of the line.

[082] In FIG. 36 shows an embodiment of the invention identical to the embodiment of FIG. 35 except that a reversible device in the form of an electric switch 1006 operating, for example, from polarized energy, is additionally implanted in the patient to reverse the installation 10. When the switch is powered by polarized energy, the wireless remote control of the external power transmission device 1004 transmits a wireless signal carrying polarized energy, and the implanted device 1002 for converting energy converts wireless polarized energy into polarized first current for operating the electric switch 1006. When the polarity of the current is shifted by the implanted device 1002 for converting energy, electrical switch 1006 reverses the function performed by installing 10.

In FIG. 37 shows an embodiment of the invention identical to the embodiment of FIG. 35 with the exception that the working device 1007 implanted in the patient to ensure the operation of the installation 10 is located between the implanted device 1002 for converting energy and the installation 10. The specified working device can be made in the form of a motor 1007, such as an electric servomotor. The engine 1007 is powered by energy received from the implanted device 1002 for converting energy as the remote control transfers the external device 1004 for transmitting wireless signal energy to the receiver of the implanted device 1002 for converting energy.

[083] FIG. 38 shows an embodiment of the invention identical to the embodiment of FIG. 35 except that it also comprises a working device implanted in a patient in the form of an assembly 1008 comprising an engine / pump unit 1009 and a fluid reservoir 1010. In this case, the installation 10 operates hydraulically, i.e. the hydraulic fluid is pumped through the engine / pump unit 1009 from the fluid reservoir 1010 through the channel 1011 to the installation 10 to ensure the operation of the installation 10, and to return the installation to its original position, the hydraulic fluid is pumped back from the installation 109 to the installation 10 reservoir 1010 for the fluid. An implanted energy conversion device 1002 converts wireless energy into current, such as polarized current, to power an engine / pump unit 1009 via an electrical power supply line 1012. Instead of a hydraulically driven installation 10, it is also provided that the working device comprises a pneumatic working device. In this case, the hydraulic fluid may be compressed air used for adjustment, and an air chamber is provided in place of the fluid reservoir.

In all of the above embodiments, the energy conversion device 1002 may include a rechargeable battery, such as a battery or capacitor, charged with wireless energy and supplying energy to any energy-consuming part of the system.

In yet another embodiment, the above-described wireless remote control can be replaced by manual control of any implanted part for contacting the patient’s hand most likely indirectly, for example by means of a push button located under the skin.

[084] In FIG. 39 shows an embodiment of the invention comprising an external wireless remote control power transmission device 1004, an installation 10, in this case hydraulically operated, and an implanted energy conversion device 1002, as well as a hydraulic fluid reservoir 1013, an engine / pump unit 1009 and a reversing device in the form of a hydraulic device for shifting the valve 1014, all of which are implanted in a patient. Naturally, hydraulic operation can be easily performed by simply changing the direction of pumping, and thus the hydraulic valve may not be used. The remote control may be a device separated from an external device for transmitting energy or included in the specified device. The engine of the engine / pump unit 1009 is an electric motor. Under the influence of the control signal from the wireless remote control of the external energy transfer device 1004, the implanted energy conversion device 1002 supplies the engine / pump unit 1009 with energy derived from the energy transferred by the control signal, whereby the engine / pump unit 1009 distributes the hydraulic fluid between the tank 1013 of hydraulic fluid and installation 10. Remote control of an external power transmission device 1004 controls a hydraulic device a valve shifting valve 1014 for shifting the direction of the hydraulic fluid flow between one direction in which the fluid is pumped by the engine / pump unit 1009 from the hydraulic fluid reservoir 1013 to the installation 10 to ensure its operation and the opposite direction in which the fluid the medium is pumped back from the installation 10 to the hydraulic fluid reservoir 1013 by the engine / pump unit 1009 to return the installation to its original position.

[085] In FIG. 40 shows an embodiment of the invention, comprising an external wireless remote control power transmission device 1004, an installation 10, an implanted energy conversion device 1002, an implanted internal control unit 1015 controlled by wireless remote control of an external power transmission device 1004, an implanted battery 1016 and implanted capacitor 1017. The internal control unit 1015 provides the accumulation of electrical energy received from the implant a power conversion device 1002 in the battery 1016 supplying energy to the installation 10. Under the influence of the control signal from the wireless remote control of the external power transmission device 1004, the internal control unit 1015 extracts electrical energy from the battery 1016 and transfers it via transmission lines 1018 and 1019 , or directly transfers electrical energy from an implanted device 1002 for converting energy through transmission line 1020, a stabilizing capacitor 1017 ektrichesky current lines 1021 and 1019 to operate the transmission unit 10.

The internal control unit is preferably made programmable from outside the human body. In a preferred embodiment, the internal control unit is programmed to adjust the setting 10 in accordance with the programmed mode of operation or to input from any sensor that determines any possible physical parameter of the patient or any functional parameter of the system.

[086] According to an alternative embodiment, the capacitor 1017 in the embodiment of FIG. 40, 10 can not be performed. According to another alternative, the battery 1016 in this embodiment may not be performed.

In FIG. 41 shows an embodiment of the invention identical to the embodiment of FIG. 35 except that the battery 1022 for supplying energy for the operation of the installation 10 and the electrical switch 1023 for switching the operation of the installation 10 is also implanted in the patient. The electric switch 1023 can be controlled by remote control, and its operation can be provided by the energy supplied by the implanted device 1002 to convert energy to switch from an off mode in which the battery 1022 is not used to an on mode in which the battery 1022 supplies energy for operation installation 10.

In FIG. 42 shows an embodiment of the invention identical to the embodiment of FIG. 41 except that the internal control unit 1015 controlled by the wireless remote control of the external power transfer device 1004 is also implanted in a patient. In this case, the electric switch 1023 is powered by the energy supplied by the implanted energy converting device 1002 for switching from an off mode in which the wireless remote control cannot control the internal control unit 1015 and the battery is not used, into the standby mode in which the remote control can control the internal control unit 1015 to release electric energy from the battery 1022 to ensure the operation of the installation 10.

[087] In FIG. 43 shows an embodiment of the invention identical to the embodiment of FIG. 42, except that the battery 1016 is replaced by the battery 1022, and the implanted components are otherwise connected. In this case, the battery 1016 stores energy from the implanted device 1002 for converting energy. Under the influence of the control signal from the wireless remote control of the external power transfer device 1004, the internal control unit 1015 controls the electric switch 1023 to switch from the off mode in which the battery 1016 is not used to the on mode in which the battery 1016 supplies energy for operation of the installation 10 The battery can be replaced with a capacitor or made in combination with it.

In FIG. 44 shows an embodiment of the invention identical to the embodiment of FIG. 43, except that the battery 1022 is also implanted in the patient and the implanted components are otherwise connected. Under the influence of the control signal from the wireless remote control of the external power transfer device 1004, the internal control unit 1015 controls the battery 1016 to deliver energy to ensure the operation of the electric switch 1023 to switch it from the off mode, in which the battery 1022 is not used, to the on mode, which battery 1022 supplies electrical energy for the operation of the installation 10.

In another embodiment, the operation of the electric switch 1023 can be carried out by means of the energy supplied by the battery 1016 to switch from an off mode in which the wireless remote control cannot control the battery 1022 to supply electrical energy, and is not used, in standby mode in which the wireless remote the control can control the battery 1022 for supplying electrical energy to ensure the operation of the installation 10.

[088] It should be understood that switch 1023 and all other switches in a given application should be interpreted in the broadest sense. This means a transistor, a microprocessor control unit, a main control unit, a specialized integrated circuit, a programmable gate array, a digital-to-analog converter, or any other electronic component or circuit capable of turning the power on and off. Preferably, the switch is controlled from outside the body, or in another embodiment, by means of an implanted internal control unit.

In FIG. 45 shows an embodiment of the invention identical to the embodiment of FIG. 41 except that the engine 1007, a mechanical reversing device in the form of a gearbox 1024 and an internal control unit 1015 for controlling the gearbox 1024 are also implanted in a patient. The internal control unit 1015 controls the gearbox 1024 to reverse the function performed by the installation 10 (performed mechanically). An even simpler option is electronic switching of the engine direction. The gearbox, understood in its broadest sense, can be a servo-driven design that saves power for the device to work in favor of a longer working step.

[089] In FIG. 46 shows an embodiment of the invention identical to the embodiment of FIG. 52, except that the implanted components are otherwise connected. Thus, in this case, the internal control unit 1015 is powered by a battery 1022, while the battery 1016, preferably a capacitor, actuates an electric switch 1023 to switch to on mode. When the electric switch 1023 is in the on mode, the internal control unit 1015 can control the battery 1022 to supply (or not supply) energy to ensure operation of the installation 10.

In FIG. 47 schematically shows possible combinations of implanted plant components to achieve various communication options. Essentially, an apparatus 10, an internal control unit 1015, an engine or pump unit 1009, and an external power transmission device 1004 comprising an external wireless remote control are configured. According to the above description, the wireless remote control transmits a control signal received by the internal control unit 1015, which in turn controls the various implanted components of the installation.

A feedback device, preferably comprising a sensor or measuring device 1025, can be implanted in a patient to determine the physical parameter of the patient. The physical parameter may be at least one parameter selected from the group consisting of pressure, volume, diameter, extension, elongation, extension, movement, flexion, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, palpitations and breathing. The sensor may detect any of the above physical parameters. For example, the sensor may be a pressure or motor activity sensor. In another embodiment, the sensor 1025 may be configured to determine a functional parameter. The functional parameter may be associated with the transfer of energy to charge the implanted energy source and may contain at least one parameter selected from the group consisting of; electricity, any electrical parameter, pressure, volume, diameter, tension, elongation, extension, movement, bending, elasticity, temperature and current.

[090] Feedback data may be sent to an internal control unit or to an external control unit, preferably via an internal control unit. Feedback data can be sent from the body through an energy transfer system or a separate communication system with a receiver and transmitters. The internal control unit 1015 or, in another embodiment, the external wireless remote control of the external power transmission device 1004 may control the installation 10 under the influence of signals from the sensor 1025. The transceiver may be combined with the sensor 1025 to send information about the determined physical parameter to the external wireless remote control. The wireless remote control may comprise a signal transmitter or transceiver, and the internal control unit 1015 may comprise a signal receiver or transceiver. In another embodiment, the wireless remote control may comprise a signal receiver or transceiver, and the internal control unit 1015 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send information or data related to the installation 10, from the inside of the patient’s body beyond.

In the case where the engine / pump unit 1009 and the battery 1022 for supplying the engine / pump unit 1099 have been implanted, information related to charging the battery 1022 may be transmitted as feedback data. More precisely, when charging the battery or the battery with energy, feedback data relating to the indicated charging process is sent, and the power supply is changed accordingly.

[091] FIG. 48 shows an alternative embodiment in which the adjustment of the apparatus 10 is carried out from outside the patient’s body. The system 1000 comprises a battery 1022 connected to the installation 10 via a subcutaneous placed electrical switch 1026. Thus, the adjustment of the installation 10 is carried out non-invasively by manually pressing the subcutaneous placed switch, whereby the installation 10 is turned on and off. You need to understand that the shown embodiment is simplified, and additional components, such as an internal control unit or any other part disclosed in this application, can be added to the system. Two subcutaneous placed switches may also be used. In a preferred embodiment, a single implanted switch sends information to the internal control unit to perform some predetermined action, and when the patient presses the switch again, the opposite action is performed.

In FIG. 49 shows an alternative embodiment in which system 1000 comprises a hydraulic fluid reservoir 1013 hydraulically coupled to a plant. Non-invasive adjustment is carried out by manually pressing the hydraulic reservoir connected to the installation. In another embodiment, the hydraulic fluid reservoir 1013 is configured to operate with an inlet for introducing a hydraulic fluid, preferably for calibrating it.

[092] The system may include an external data transmitter and an implantable internal data transmitter associated with an external data transmitter. An internal transmitter supplies data related to the installation or patient, an external data transmitter and / or an external data transmitter supplies data to an internal data transmitter.

In FIG. 50 schematically shows the layout of a system configured to send data from within the patient’s body beyond its boundaries to transmit feedback data associated with at least one functional parameter of the installation or system or associated with the physical parameter of the patient to ensure that the exact amount of energy is delivered to the implanted an internal power receiver 1002 connected to the implanted energy-consuming components of the installation 10. Such a power receiver 1002 may include a power source and / or a device for converting energy. Briefly, wireless energy is transmitted from an external energy source 1004a located outside the patient, and received through an internal energy receiver 1002 located inside the patient. The internal energy receiver is configured to directly or indirectly supply the energy-consuming components of the installation 10 with the energy received by the switch 1026. The energy balance between the energy received by the internal energy receiver 1002 and the energy used by the installation 10 is determined, and the transmission of wireless energy is further controlled based on the determined energy balance. Thus, the energy balance provides an accurate indication of the required amount of energy, sufficient for the proper operation of the installation 10, but without causing an undesirable increase in temperature.

[093] FIG. 50, the patient’s skin is indicated by a vertical line 1005. In this embodiment, the energy receiver comprises an energy converting device 1002 located inside the patient, preferably not deep under the patient’s skin 1005. In general, an implanted energy converting device 1002 can be placed in the abdominal cavity, chest, muscle fascia (eg, in the wall of the abdominal cavity), under the skin, or in any other suitable place. The implanted energy conversion device 1002 is configured to receive wireless energy E transmitted from an external energy source 1004a located in an external energy transfer device 1004 located outside the patient’s skin 1005 in the vicinity of the implanted energy conversion device 1002.

It is well known in the art that wireless energy E can generally be transmitted by any suitable transdermal energy transfer device, such as a device comprising a primary coil made in an external energy source 1004a and located adjacent to it a secondary coil made in an implanted device 1002 for energy conversion. When an electric current is passed through the primary coil, energy in the form of voltage is induced in the secondary coil, which can be used to power the implanted energy-consuming components of the installation, for example, after accumulating incoming energy in an implanted energy source, such as a battery or capacitor. However, the present invention as a whole is not limited to any specific energy transfer method, transdermal energy transfer devices, or energy sources, and any type of wireless energy can be used.

[094] The amount of energy received by the implanted energy receiver can be compared with the energy used by the implanted components of the installation. The term "used energy" in this case also includes the energy accumulated by the implanted components of the installation. The control device comprises an external control unit 1004b controlling an external energy source 1004a based on a certain energy balance in order to control the amount of energy transmitted. To ensure the transfer of the proper amount of energy, the energy balance and the required amount of energy are determined by means of a sensing device comprising an implanted internal control unit 1015 connected between the switch 1026 and the installation 10. The internal control unit 1015 can thus be made with the possibility of obtaining various measurements carried out by appropriate sensors and other similar devices (not shown), measuring some characteristics of the installation 10, some Zoom reflecting the required amount of energy needed for proper operation of the unit 10. In addition, also by means of appropriate measuring devices or sensors may be identified current status of the patient in order to provide parameters reflecting the patient's state. Therefore, such characteristics and / or parameters may be related to the current state of the installation 10, for example, power consumption, operation mode and temperature, as well as to the state of the patient, which is indicated by parameters such as; body temperature, blood pressure, palpitations, and breathing. Other types of physical parameters of the patient and the functional parameters of the device are described in other publications.

[095] In addition, the energy source in the form of a battery 1016 can, if necessary, be connected to an implanted device 1002 for converting energy by means of a control unit 1015 to accumulate the obtained energy for subsequent use by the installation 10. Additionally or in another embodiment, the characteristics can also be measured specified battery, also reflecting the required amount of energy. The battery can be replaced by a battery, and the measured characteristics can be related to the current state of the battery and any electrical parameter, such as power consumption, voltage, temperature, etc. It must be understood that in order to ensure sufficient voltage and current for installation 10, and also to avoid overheating, the battery must be optimally charged by obtaining the proper amount of energy, i.e. not too much and not too little from the implanted energy conversion device 1002. The battery may also be a capacitor with appropriate characteristics.

For example, the characteristics of the battery can be regularly measured to determine the current state of the battery, and this information can then be stored as status information in the respective storage means in the internal control unit 1015. Thus, when performing new measurements, the accumulated battery status information can be properly updated. In this case, the state of the battery can be “calibrated” by transferring the proper amount of energy to maintain the battery in optimal condition.

[096] Thus, the internal control unit 1015 of the determining device is configured to determine the energy balance and / or the current required amount of energy (energy per unit time or accumulated energy) based on measurements made by the above sensors or measuring devices of the installation 10, or the patient or an implanted energy source, if one is used, or any combination of the above elements. The internal control unit 1015 is also connected to the internal signal transmitter 1027, configured to transmit a control signal reflecting the determined amount of energy to an external signal receiver 1004 connected to the external control unit 1004b. Then, the amount of energy transmitted from the external energy source 1004a can be adjusted under the influence of the received control signal.

In another embodiment, the detection device may comprise an external control unit 1004b. In this embodiment, the sensor measurements can be transferred directly to the external control unit 1004b, wherein the energy balance and / or the current required amount of energy can be determined by the external control unit 1004b, thereby integrating the above function of the internal control unit 1015 into the external control unit 1004b. In this case, the internal control unit 1015 can be omitted, and the sensor measurements are supplied directly to the internal signal transmitter 1027, which sends the measurements to the external signal receiver 1004 and to the external control unit 1004b. Then, the energy balance and the current required amount of energy can be determined by the external control unit 1004b based on the indicated sensor measurements.

[097] Thus, in the present solution according to the arrangement of FIG. 50 use feedback including data indicating the energy required, which is a more efficient solution than previous solutions, since it is based on the actual use of energy compared to the energy received, for example, regarding the amount of energy, the difference in energy or the rate of energy production compared to the rate of energy use of the implanted energy-consuming components of the installation. The installation can use the energy received for consumption or for energy storage in an implanted energy source, etc. The various parameters described above are used when appropriate and necessary, and then used as a tool to determine the actual energy balance. However, these parameters may also be necessary to perform any actions carried out in the patient’s body for specific control of the installation.

The internal signal transmitter 1027 and the external signal receiver 1004 may be configured as separate units using suitable signal transmission means, such as radio signals, infrared or ultrasonic signals. In another embodiment, the internal signal transmitter 1027 and the external signal receiver 1004 may be integrated in the implanted energy conversion device 1002 and an external energy source 1004a, respectively, for transmitting control signals in the opposite direction with respect to energy transfer, using essentially the same transmission method . The control signals can be modulated in frequency, phase or amplitude.

[098] Thus, feedback data can be transmitted through a separate communication system containing receivers and transmitters, or can be integrated into the power system. According to the present invention, such embedded feedback data and the energy system comprises an implantable internal energy receiver for receiving wireless energy, the energy receiver having a first internal coil, a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, wherein energy has a second external coil and a second electronic circuit connected to the second coil. The second external coil of the power transmitter transmits wireless energy received by the first coil of the power receiver. The system further comprises a power switch for turning on and off the connection of the first internal coil and the first electronic circuit so that the external energy transmitter receives feedback data related to charging the first coil, in the form of fluctuations in the load resistance of the second external coil, when the power switch turns on or turns off the connection of the first internal coil and the first electronic circuit. When performing the system in the arrangement of FIG. 50, the switch 1026 is separate from the internal control unit 1015 and is controlled by it or integrated into the internal control unit 1015. You must understand that the switch 1026 should be interpreted in the broadest sense. This means a transistor, a microprocessor control unit, a main control unit, a specialized integrated circuit, a programmable gate array, a digital-to-analog converter, or any other electronic component or circuit capable of turning the power on and off.

[099] In conclusion, the power supply arrangement of FIG. 50 may operate essentially as follows. First, the energy balance is determined by the internal control unit 1015 of the determination device. A control signal reflecting the required amount of energy is also generated by the internal control unit 1015, and the control signal is transmitted from the internal signal transmitter 1027 to the external signal receiver 1004. In another embodiment, the energy balance may be determined by the external control unit 1004b, depending on the method of implementation as described above. In this case, the control signal may contain measurement results from various sensors. Then, the amount of energy released from the external energy source 1004a can be adjusted by the external control unit 1004b based on the determined energy balance, for example, under the influence of the received control signal. This process can be periodically repeated at regular intervals during the current energy transfer, or can be carried out on a substantially continuous basis during the energy transfer.

The amount of energy transferred can usually be adjusted by adjusting various transmission parameters in the internal energy source 1004a, such as voltage, current, amplitude, wave frequency, and pulse characteristics.

[100] This system can also be used to obtain information on the connection coefficients between the coils in the transdermal energy transfer system, even for the purpose of calibrating the system to determine the optimal location of the external coil relative to the internal coil and to optimize the energy transfer. In this case, the amount of energy transferred is simply compared with the amount of energy received. For example, when moving an external coil, the coupling coefficient can change, and accurately displayed movements can help you find the location of the external coil that is optimal for energy transfer. Preferably, the external coil is configured to calibrate the amount of energy transferred to obtain feedback data in the sensing device to achieve the maximum coupling coefficient.

The indicated connection coefficient data can also be used as feedback data for energy transfer. In such a case, the energy system according to the present invention comprises an implantable internal energy receiver for receiving wireless energy having a first internal coil, a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy having a second external coil and second electronic circuit connected to the second coil. The second external coil of the power transmitter transmits the wireless energy received by the first coil of the power receiver. This system further comprises a feedback device for reporting data on the amount of energy received in the first coil as feedback data, the second electronic circuit comprising a sensing device for receiving feedback data and for comparing the amount of energy transmitted by the second coil with feedback data related to the amount of energy received in the first coil, in order to obtain the connection coefficient between the first and second coils. The energy transmitter can adjust the transmitted energy under the influence of the received connection coefficient.

[101] Referring to FIG. 51, although wireless power transmission for the operation of the installation is disclosed in the above description in order to provide non-invasive control, it should be understood that the installation can also operate using wired energy. A similar example is shown in FIG. 51, where an external switch 1026 is connected between an external power source 1004a and an operating device, such as an electric motor 1007, that provides operation of the unit 10. An external control unit 1004b controls the operation of the external switch 1026 to ensure the proper operation of the unit 10.

In FIG. 52, various embodiments of the methods for supplying and using the energy received by the installation 10 are shown. Similar to the example of claim 50, the internal energy receiver 1002 receives wireless energy E from an external energy source 1004a controlled by the transmission control unit 1004b. The internal energy receiver 1002 may include a constant voltage circuit, marked as a dotted block "constant V" in the drawing, for supplying energy to the installation 10 at a constant voltage. The internal energy receiver 1002 may also comprise a direct current circuit, marked as a dashed block “constant C” in the drawing, for supplying energy to the installation 10 at constant current.

[102] Installation 10 includes an energy-consuming part 10a, which may be an engine, pump, restriction device or any other device for use in medicine, for the implementation of the electrical work which requires energy. Installation 10 may also include an energy storage device 10b for storing energy supplied from the internal energy receiver 1002. Thus, the supplied energy can be directly consumed by the energy consuming part 10a, or it can be stored in the energy storage device 10b, or it can be partially consumed and partially stored. Installation 10 may also comprise an energy stabilization unit 10c for stabilizing energy supplied from the internal energy receiver 1002. Thus, energy can be supplied in an irregular manner such that it may be necessary to stabilize the energy before consumption or storage. The energy supplied from the internal energy receiver 1002 can also be accumulated and / or stabilized by a separate energy stabilization unit 1028 located outside the installation 10 before consumption and / or accumulation by the installation 10. In another embodiment, the energy stabilization unit 1028 can be integrated into internal energy receiver 1002. In any case, the energy stabilization unit 1028 may comprise a constant voltage circuit and / or a constant current circuit.

[103] It should be noted that in FIG. 50 and FIG. 52, some possible but non-limiting embodiments are shown with respect to the arrangement and interconnection of the various functional components and elements shown. However, it will be apparent to one skilled in the art that many variations and modifications can be made within the scope of the present invention.

In FIG. 53 schematically shows a diagram for measuring an energy balance for one of the proposed configurations of a wireless energy transmission control system, or an energy balance control system. The system has an output signal with a centered value of 2.5 V, which is directly proportional to the energy imbalance. The derivative of this signal indicates whether the value is increasing or decreasing, and how quickly this change occurs. If the amount of energy received is lower than the amount of energy used by the implanted components of the installation, a larger amount of energy is transferred, thus being charged to the energy source. The output signal from the circuit is usually fed to an analog-to-digital converter and converted to digital format. Digital data can then be sent to an external device for transmitting energy, which allows the device to adjust the level of transmitted energy. In another embodiment, a fully analog system can be used in which comparators are used to compare the energy balance level with certain maximum and minimum thresholds and send data to an external device for energy transfer if the balance goes beyond the window minimum / maximum.

[104] The circuit shown schematically in FIG. 53 reflects the implementation of a circuit for a system transferring energy to the implanted energy components of a device according to the present invention from outside the patient’s body through inductive energy transfer. An inductive energy transfer system typically uses an external transmitting coil and an internal receiving coil. The receiving coil L1 is shown in the circuit of FIG. 36; transmitting parts of the system are not shown.

The implementation of the general concept of energy balance and the method of transmitting information to an external energy transmitter can be performed in many different ways. The circuit of FIG. 53 and the above method of evaluating and transmitting data should be considered only as examples of the implementation of the control system.

DETAILED DESCRIPTION OF THE SCHEME

[105] In FIG. 53 characters Y1, Y2, Y3, etc. control points are indicated on the diagram. The components in the diagram and their respective values are values suitable for this particular embodiment, which is only one of an infinite number of possible configurations.

The energy receiving coil L1 receives energy to power the circuit. In this particular case, energy is transferred to the implanted components at a frequency of 25 kHz. The output signal of the energy balance is at the control point Y1.

It will be apparent to those skilled in the art that the above embodiments of the system can be combined in a variety of different ways. For example, the electrical switch 1006 of FIG. 36 may be used in any of the embodiments of FIG. 39-45, the hydraulic valve shifter 1014 of FIG. 39 may be used in the embodiment of FIG. 38, and gearbox 1024 may be used in the embodiment of FIG. 37. It should be noted that the switch can be literally any electronic circuit or component.

In the embodiments described in accordance with FIG. 50, 52, and 53, a method and system for controlling the transfer of wireless energy to implantable energy-consuming components of an electrical installation is disclosed. The specified method and system are defined below in general terms.

[106] Thus, a method for controlling the transmission of wireless energy supplied to the implantable energy-consuming components of the above installation is proposed. Wireless energy E is transmitted from an external energy source located outside the patient, and is obtained by means of an internal energy receiver located inside the patient and connected to the implanted energy-consuming components of the device for directly or indirectly supplying it with the received energy. The energy balance between the energy received by the internal energy receiver and the energy used for the installation is determined. The transmission of wireless energy E from an external energy source is then controlled based on a specific energy balance.

Wireless energy can be transferred inductively from the primary coil in an external energy source to a second coil in an internal energy receiver. A change in the energy balance can be detected in order to control the transfer of wireless energy based on the detected change in the energy balance. A difference can also be detected between the energy received by the internal energy receiver and the energy used for the medical device in order to control the transmission of wireless energy based on the detected energy difference.

[107] When controlling the transfer of energy, the amount of transmitted wireless energy can be reduced if the detected change in energy balance indicates an increase, or vice versa. A decrease / increase in energy transfer may also correspond to a detected rate of change.

The amount of wireless energy transmitted can also be reduced if the detected energy difference indicates that the energy received is greater than the energy used, or vice versa. The decrease / increase in energy transfer in this case may correspond to the magnitude of the detected energy difference.

According to the above description, the energy used for the medical device can be consumed to operate the medical device and / or stored in at least one energy storage device of the medical device.

After the electrical and / or physical parameters of the medical device and / or the physical parameters of the patient are determined, energy can be transferred for consumption and storage in accordance with the transmission rate per unit time determined on the basis of these parameters. The total amount of energy transferred can also be determined based on these parameters.

[108] If a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and / or accumulated, and the detected difference is related to the time integral of at least one measured electrical parameter associated with said energy balance, an integral is defined for the monitored voltage and / or current strength associated with the energy balance.

If the time derivative of the measured electrical parameter associated with the amount of energy consumed and / or stored is determined, the derivative for the monitored voltage and / or current associated with the energy balance can be determined.

The transmission of wireless energy from an external energy source can be controlled by applying electric pulses to an external energy source from a first electrical circuit to transmit wireless energy, the electric pulses having leading and trailing edges, varying the length of the first time intervals between successive leading and trailing edges of the electrical pulses and / or the duration of the second time intervals between successive trailing and leading edges of electrical imp pulses and transmission of wireless energy, and the transmitted wireless energy generated from electrical pulses has a varying power depending on the duration of the first and / or second time intervals.

[109] In this case, the frequency of the electrical pulses may be substantially constant when the first and / or second time intervals vary. When electrical impulses are applied, they can remain unchanged, with the exception of varying first and / or second time intervals. The amplitude of the electrical impulses can be essentially unchanged when the first and / or second time intervals vary. In addition, electrical pulses can vary by varying only the duration of the first time intervals between successive leading and trailing edges of the electrical pulses.

A chain of at least two electrical pulses can be applied in a row, and when applying a pulse train, a pulse train having a first electric pulse at the beginning of the pulse train and having a second electric pulse at the end of the pulse train, at least two pulse trains can be applied in a row wherein the duration of the second time intervals between successive trailing edges of the second electrical pulse in the first chain of pulses and the leading edges of the first electrical pulse The second pulse train varies.

[110] When electrical pulses are applied, they can have a substantially constant current strength and a substantially constant voltage. Electrical pulses may also have a substantially constant current and a substantially constant voltage. In addition, electrical pulses can also have a substantially constant frequency. Electrical pulses in a pulse train can also have a substantially constant frequency.

The circuit formed by the first electrical circuit and an external energy source may have a first characteristic time span or a first time constant, and when the transmitted energy is varied effectively, said frequency time span may be within the first characteristic time span or a time constant, or may be shorter.

Also proposed is a system comprising the above-described installation for controlling the transmission of wireless energy supplied to the implantable energy-consuming components of the installation. In its broadest sense, the system comprises a control device for controlling the transfer of wireless energy from the device for transmitting energy, and an implantable internal energy receiver for receiving the transmitted wireless energy, connected to the implantable energy-consuming components of the installation for directly or indirectly supplying it with the received energy.

[111] The system also includes a determining device configured to determine an energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy-consuming components of the installation, the control device controlling the transmission of wireless energy from an external device for transmitting energy based on the energy balance defined by the definitive device.

In one embodiment, the at least one battery may be configured as part of a power conversion device 1002 or replace it to supply energy to a facility 10 via an energy supply line. In one embodiment, the battery is not rechargeable. In another embodiment, the battery is rechargeable.

Naturally, battery power can be placed remotely or can be integrated into the device.

[112] In addition, the system may contain any of the following elements:

- A primary coil in an external energy source, configured to inductively transfer energy to a second coil in an internal energy receiver.

- The detection device is configured to detect changes in the energy balance, and the control device controls the transmission of wireless energy based on the detected changes in the energy balance.

- The detection device is configured to detect differences between the energy received by the internal energy receiver and the energy used for the implantable energy-consuming components of the installation, and the control device controls the transmission of wireless energy based on the detected energy difference.

- The control device controls an external device for energy transfer in order to reduce the amount of transmitted wireless energy, if the detected change in the energy balance indicates an increase in the energy balance, or vice versa, moreover, a decrease / increase in the transmitted energy corresponds to the detected rate of change.

- The control device controls an external device for energy transfer in order to reduce the amount of transmitted wireless energy, if the detected energy difference indicates that the received energy is more than used, or vice versa, and the decrease / increase in energy transfer corresponds to the magnitude of the detected energy difference.

- The energy used for the installation is consumed to ensure the operation of the installation and / or is stored in at least one energy storage device of the installation.

- After the electrical and / or physical parameters of the installation and / or physical parameters of the patient are determined, the device for transmitting energy transfers energy for consumption and accumulation in accordance with the transmission rate per unit time determined by the determining device based on these parameters.

[113] The determination device also determines the total amount of energy transferred based on the specified parameters.

- If there is a difference between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and / or accumulated, and the detected difference is related to the time integral of at least one measured electrical parameter associated with the specified energy balance, the determining device determines the integral for the monitored voltage and / or amperage associated with the energy balance.

- If the time derivative of the measured electrical parameter associated with the amount of energy consumed and / or stored is determined, the determining device determines the derivative for the monitored voltage and / or current strength associated with the energy balance.

- The device for transmitting energy contains a coil located outside the human body, and an electrical circuit is made to power the external coil with electrical pulses for transmitting wireless energy. Electrical pulses have leading and trailing edges, and the electrical circuit is configured to vary the first time intervals between successive leading and trailing edges and / or second time intervals between successive trailing and leading edges of electrical pulses in order to vary the power of the transmitted wireless energy.

[114] As a result, the power receiver receiving the transmitted wireless energy has a varying power.

- The electrical circuit is configured to deliver electrical pulses that remain unchanged, with the exception of varying first and / or second time intervals.

- The electrical circuit has a time constant and is configured to vary the first and second time intervals only within the first time constant, as a result of which, varying the duration of the first and / or second time periods, the power transmitted through the coil varies.

- The electrical circuit is configured to deliver electrical pulses that vary only by varying the duration of the first time intervals between successive leading and trailing edges of the electrical pulses.

- The electrical circuit is configured to supply a chain of at least two electrical pulses in a row, said circuit having a first electrical pulse at the beginning of the pulse chain and a second electrical pulse at the end of the pulse chain, and is the duration of the second time intervals between successive trailing edges of the second electrical pulse in the first pulse chain and the leading edge of the first electric pulse of the second pulse chain is varied by the first electrical circuit s.

- The electrical circuit is configured to provide electrical pulses in the form of pulses having a substantially constant height and / or amplitude and / or intensity and / or voltage and / or current and / or frequency.

- The electrical circuit has a time constant and is configured to vary the first and second time periods only within the first time constant, as a result of which, when varying the duration of the first and / or second time periods, the power transmitted through the first coil varies.

- The electrical circuit is configured to provide electrical pulses with varying the duration of the first and / or second time intervals only within the range including the first time constant, or having values relatively close to the first time constant, compared with the value of the first time constant.

[115] In FIG. 54-57 are shown in more detail flow charts of four different methods of hydraulically or pneumatically feeding an implanted device according to the present invention.

In FIG. 54 shows the above system. The system includes an implanted installation 10 and, also, a separate regulatory tank 1013, a one-way pump 1009 and an alternating valve 1014.

In FIG. 55 shows a plant 10 and a fluid reservoir 1013. By moving the wall of the regulatory tank or changing its size in another way, the installation can be adjusted without using any valve, providing free passage of fluid at any time by moving the wall of the tank.

In FIG. 56 shows a plant 10, a two-way pump 1009, and a control tank 1013.

[116] FIG. 57 is a block diagram of a reverse servo motor system with a first closed system controlling a second closed system. The servo-motor system comprises a regulatory reservoir 1013 and a servo-motor reservoir 1050. The servo-motor reservoir 1050 mechanically controls the implanted plant 10 by means of a mechanical connection 1054. The apparatus has an expandable / contractible cavity.

The cavity is preferably expanded or contracted due to the supply of hydraulic fluid from a larger adjustable reservoir 1052 in fluid communication with the installation 10. In another embodiment, the cavity contains a compressible gas that can be compressed or expanded under the control of a servo motor tank 1050.

Servo motor tank 1050 can also be made as part of the installation itself.

[117] In one embodiment, the regulatory reservoir is placed under the skin of the patient, and his work is done by pressing the outer surface of the reservoir with a finger. This system is shown in FIG. 58a-s. In FIG. 58a, a flexible subcutaneous regulatory reservoir 1013 is shown connected to a convex servo motor reservoir 1050 via a channel 1011. Said corrugated servo motor reservoir 1050 is housed in a flexible apparatus 10. In the position of FIG. 58a, the servo motor tank 1050 contains a minimum amount of fluid, and most of the fluid is located in the regulator tank 1013. Due to the mechanical connection between the servo motor tank 1050 and the installation 10, the external shape of the installation 10 is compressed, i.e. it occupies a volume less than its maximum volume. The indicated maximum volume is shown in dotted lines in the drawing.

In FIG. 58b shows a position in which a user, such as the patient in whom the installation is implanted, pushes the regulator reservoir 1013 so that the fluid contained therein flows over the channel 1011 into the servomotor reservoir 1050, which expands in the longitudinal direction due to its corrugated shape . The specified expansion, in turn, leads to the expansion of the installation 10 so that it occupies its maximum volume, thereby stretching the wall of the stomach (not shown) with which it is in contact.

[118] The control tank 1013 is preferably provided with means 1013a to maintain its shape after compression. These means, according to the schematic drawing in the drawing, thus keep the installation 10 in the extended state when the user releases the regulatory tank. Thus, the regulatory reservoir essentially acts as a switch that turns the system on and off.

An alternative embodiment of hydraulic or pneumatic operation is described below with reference to FIG. 59 and 60a-s. The block diagram of FIG. 59 comprises a first closed system controlling a second closed system. The first system comprises a control tank 1013 and a servo motor tank 1050. The servo motor tank 1050 mechanically controls the larger adjustable tank 1052 by means of a mechanical connection 1054. The implanted device 10, having an expandable / contracted cavity, is in turn controlled by a larger adjustable tank 1052 by supplying a hydraulic fluid from a larger, adjustable reservoir 1052 in fluid communication with installation 10.

[119] An example of this embodiment is described below with reference to FIG. 60a-s. As in the previous embodiment, the regulatory reservoir is placed under the skin of the patient, and his work is carried out by pressing on the outer surface of the reservoir by means of a finger. The control tank 1013 is in fluid communication with the corrugated servo motor tank 1050 via channel 1011. In the first closed system 1013, 1011, 1050 of FIG. 60a, the servo motor tank 1050 contains a minimum amount of fluid, and most of the fluid is located in the control tank 1013.

The servo motor tank 1050 is mechanically connected to a larger adjustable tank 1052, in this example also having a corrugated shape, but having a larger diameter than the servo motor tank 1050. The larger adjustable tank 1052 is in fluid connection with the installation 10. This means that when the user clicks on the regulatory tank 1013, thereby pushing the fluid from the regulatory tank 1013 into the servo motor tank 1050, the expansion of the servo motor tank 1050 allows it to be pushed out больш a larger volume of fluid from a larger adjustable reservoir 1052 to unit 10. In other words, in this reversible servo mechanism, a small volume in the control reservoir compresses with greater force, resulting in a larger total area moving with less force per unit area.

[120] As in the previous embodiment described above with reference to FIG. 58a-c, the control tank 1013 is preferably provided with means 1013a to maintain its shape after compression. These means, according to the schematic drawing in the drawing, thus keep the installation 10 in the extended state when the user releases the regulatory tank. Thus, the regulatory reservoir essentially acts as a switch that turns the system on and off.

Although the various parts described above in the drawings are located at specific locations, it should be understood that these locations may vary depending on the application.

Used in any of the embodiments disclosed herein, the lubricating fluid is preferably a biocompatible lubricating fluid simulating a synovial fluid of a natural hip joint. In one embodiment, the lubricating fluid is hyaluronic acid.

[121] In all of the above embodiments, it is assumed that the execution of the channel is excluded, and the channel or channels are in direct connection with the tank or inlet channel. It should be noted that any implementation option or part of an implementation option, as well as any method or part of the method can be combined in any way. All the above examples should be considered as part of the general description, as a result of which they can generally be combined in any way. It should be noted that the description as a whole must be considered as a description of the installation and method.

Various of the above features of the invention can be combined in any way, if the specified combination does not contain obvious contradictions. The present invention will be described in detail below with reference to preferred embodiments and with reference to the accompanying drawings. In the same way, individual features of various embodiments may be combined or interchangeable if said combination or replacement does not contradict the overall function of the device.

Claims (25)

1. An implantable lubricant device for lubricating a joint of a patient, being a human or a mammal, by adding a lubricating fluid containing: an implantable reservoir configured to replenish and store the lubricating fluid, and - an implantable replenishing inlet channel connected to said implantable reservoir configured to replenish to replenish said implantable reservoir configured to replenish with lubricating fluid, - an implantable infusion needle connected in fluid to the specified implantable reservoir, made with the possibility of replenishment, - and the specified implantable infusion needle is made for longitudinal displacement and has a tip having an outlet channel for the delivery of fluid, and - an implantable drive unit connected to an implantable infusion needle and configured to advance and retract the tip of the implantable infusion needle to introduce the specified lubricating fluid into the region of the specified joint. 2. The implantable lubricant device according to claim 1, wherein said implantable infusion needle is closed at the distal end and has a lateral outlet channel for delivery of the lubricating fluid. 3. The implantable lubricant device according to claim 1, wherein said implantable infusion needle is configured to pass into fibrous tissue. 4. The implantable lubricant device according to claim 1, wherein said implantable reservoir configured to replenish has an adjustable volume. 5. The implantable lubricant device according to claim 1, wherein said implantable replenishing inlet duct comprises a self-sealing membrane. 6. The implantable lubricant device according to claim 1, further comprising an implantable pump for pumping said lubricating fluid from said implantable reservoir toward said implantable infusion needle. 7. The implantable lubricant device according to claim 6, wherein said implantable pump is a motor driven pump. 8. The implantable lubricant device according to claim 6, wherein said implantable pump comprises an automatically controlled engine configured to pump from time to time a certain volume of said lubricating fluid towards said implantable infusion needle. 9. The implantable lubricant device according to claim 6, wherein said implantable pump comprises a movable wall. 10. The implantable lubricant device according to claim 1, wherein the components of said implantable lubricant device are contained within a common housing. 11. The implantable lubricating device according to claim 4, in which the specified implantable reservoir, made with the possibility of replenishment, contains a flexible part of the wall. 12. The implantable lubricant device according to claim 1, comprising a system for manually and non-invasively controlling an implantable lubricant device comprising an implantable switch. 13. The implantable lubricant device according to claim 1, comprising a system for manually and non-invasively controlling an implantable lubricant device having a wireless remote control. 14. The implantable lubricant device according to claim 1, comprising a system for manually and non-invasively controlling an implantable lubricant device comprising a hydraulic reservoir configured to be manually pressed. 15. The implantable lubricant device according to claim 1, containing an internal energy source for powering the implantable energy-consuming components of the implantable lubricant device. 16. The implantable lubricant device according to claim 1, comprising an internal energy receiver configured to provide non-invasive and wireless power using an energy transfer device outside the patient’s body. 17. The implantable lubricant device according to claim 1, comprising at least one sensor for measuring at least one physical parameter of the patient. 18. The implantable lubricant device according to claim 1, comprising at least one sensor for measuring at least one functional parameter related to the implantable lubricant device. 19. The implantable lubricant device according to claim 18, in which at least one functional parameter is associated with the transfer of energy to charge an internal energy source. 20. The implantable lubricant device according to claim 1, comprising a feedback device for sending feedback data from within the patient’s body to at least an external control unit located outside the patient’s body.

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