JP2007518460A - Needleless syringes and ampoules for intradermal, subcutaneous and intramuscular injection - Google Patents

Abstract

A needleless hypodermic syringe comprising a manually operable elongated housing, an impact impact injection mechanism in the housing, suction force generating means provided in the housing and cooperating with the impact impact injection mechanism, and safety At least one jet orifice capable of cooperating with the interlock mechanism, the impact impact injection mechanism and the suction force generating means, and allowing the drug to be injected into the skin surface in response to an impact applied to the drug by the impact impact injection mechanism. A needleless syringe comprising two drug-containing ampoules and means for receiving and holding the ampule on the syringe in communication with the impact impact injection mechanism and in communication with the suction force generating means. The needleless syringe discharges the drug from the ampoule with a jet flow at a speed sufficient to penetrate the held skin tissue pressed against the orifice by the suction force generating means, and based on the position and angle of the jet orifice. The drug is injected intradermally, subcutaneously or intramuscularly.

Description

  The present invention provides intradermal (ID), subcutaneous (SUB-Q) and intramuscular (IM) injections into human or animal tissue by means of a narrow high pressure liquid jet stream at a rate sufficient to penetrate the recipient tissue. A needleless impact impact syringe that can be made and a single use disposable fillable or filled ampoule for the syringe.

  Current state-of-the-art attempts to inject drugs subcutaneously include the difficulties associated with precise positioning of the skin relative to the jet opening of the syringe, and the jet pressure versus skin penetration when making an injection perpendicular to the skin surface. It has only limited success because it cannot be accurately controlled. In addition, current systems lack precise control of repetitive injection speeds and repeatability due to mechanical tolerances in the pressure / force generator used. Some current devices have safety issues due to the lack of safety interlocks to prevent the device from being activated when not in proper contact with the skin, and are associated with the device structure A catastrophic failure, partly due to the lack of pressure control, could be seen in the syringe body.

  Of particular note is the ability to administer drugs to Langerhans cells in the skin. Langerhans cells are dendritic cells that are normally present in the upper spinous layer of the skin. These cells are known to participate in the immune response of the skin and migrate from the skin to the lymph nodes. They have a receptor common to macrophages and function as antigen-presenting cells for T and B lymphocytes. Langerhans cells are capable of fixing and processing skin antigens and are therefore immune cells that first arrive at the site of inflammation. For this reason, Langerhans cells are particularly important in immune system research related to facilitating vaccine development and treatment for autoimmune disease and rejection prevention therapy.

  Needleless syringes have been used as a substitute for needled hypodermic syringes for injecting drugs, vaccines, local anesthetics and other fluids into human or animal tissue. The drug is expelled at a high rate so that it first penetrates the epidermis and then enters the target tissue. An alternative method is to push the discharge nozzle onto the skin and inject fluid through the epidermis at high pressure. Such prior art devices are unable to cope with this jetting action and the flow control variables after penetrating the skin, resulting in low-level and painful injections. They are also inferior in terms of the ability to provide the force necessary to penetrate the stratum corneum, generally limiting the delivery of the drug to the intradermal portion, particularly the upper layers of the skin.

  Prior art devices typically use a spring loaded piston pump to draw fluid from the tank. At the end of the piston retraction stroke, the piston is disengaged from the retraction mechanism, reversing the direction, thereby pressurizing the fluid for ejection from the delivery nozzle. In some devices, fluid is contained in adjacent receptacles or containers within the device, and fluid is supplied into the nozzle under pressure and discharged through the delivery nozzle under pressure. In another prior art device, the piston is advanced with a discharge stroke by a gas or electric motor instead of a spring. In most of these devices, the discharge orifice must be firmly placed on the skin and the nozzle must be in direct contact with the epidermis. In order to make a suitable contact, the operator pushes the orifice firmly into the epidermis at an angle perpendicular to the skin surface, usually perpendicular to the skin plane, thereby stretching the epidermis at the point of contact, This increases the ability of the injection to penetrate the stretched tissue at the point of contact. However, pushing the orifice into the epidermis is a variable that depends on the operator of the device and the ability of the recipient to withstand the device being pressed against living tissue.

  In general, the use of existing devices results in drug loss at the entry point of the nozzle, resulting in poor injection due to movement of the recipient or lack of operator experience, and the drug is placed at the proper depth and layer of tissue. Injections to disperse in will be received at an angle that either does not penetrate or is excessively penetrated. In addition, premature manipulation and relative movement between the epidermis and the orifice, which can cause skin tears during injection, are common, resulting in pain and poor drug delivery to the recipient. In other cases, the epidermis deforms away from the orifice and the injection solution leaks from the entry point. In some cases, the device attempts to stretch the epidermis by deforming it above the discharge orifice. In all of these conditions, the success of the injection procedure relies on the ability of the operator to perform stably when using the device to allow for acceptable ejection and epidermal penetration.

  Various methods have been proposed to solve these problems. For example, there are powered syringes, sensing / control devices with compressed gas cylinders to enhance their performance, and electric syringes, which are heavy and cumbersome and are disturbed by variations in gas supply, pressure, and leakage. Often.

  Depending on the need for drug delivery and the skill of the operator, ensure that there are problems with using these devices, for example, accurately measuring and managing the administered drug, and that the syringe has delivered the correct amount of drug to the appropriate tissue. There was a need. The following patents attempt to address these known problems with varying degrees of success, and some proposed methods are as follows.

  U.S. Pat. No. 3,859,996 (Mizzy) discloses a controlled leak method that ensures that the syringe orifice is accurately placed on the subject's skin at the required pressure and in an accurate posture relative to the skin. Yes. When the installation conditions are met, the control leak is sealed by the contact pressure on the subject's skin and the pressure in the syringe control circuit rises until the pressure sensing pilot valve opens, which causes the high pressure gas to push the piston forward, Allow the drug to be injected. This use of valves and the use of pressure gas complicates the manufacture and use of the device and is not applicable to the present invention.

  International publications WO 82/02835 (Cohen) and European Patent Publication No. 347190 (Finger) disclose a method of improving the seal between the orifice and the skin and preventing relative movement therebetween. This method uses a vacuum device to suck the epidermis directly and firmly onto the discharge orifice. In order to suck the epidermis into the orifice, the discharge orifice is positioned perpendicular to the skin surface. This method and syringe mechanism for injecting drug into the skin is different and is not applicable to the present invention because of its unique ampoule structure.

  U.S. Pat. No. 3,859,996 (Mizzy) is further a pressure sensing sleeve on a syringe placed over the subject until a proper contact pressure between the orifice and the skin is achieved. Disclosed is a pressure sensing sleeve that prevents actuation of the syringe. The basic purpose is to stretch the epidermis above the discharge orifice and apply the pressurized drug at a rate higher than the rate at which the epidermis deforms and leaves the orifice. The method of stretching the skin over the orifice in this way is completely different from the present invention, together with the arrangement of the mechanism, and is not applied to the present invention.

  U.S. Pat. No. 5,480,381 (T. Weston) discloses a means of pressurizing a drug at a rate fast enough to puncture the epidermis before it has deformed and leaves the orifice. Yes. In addition, the device directly senses that the pressure of the discharge orifice on the subject's epidermis is a predetermined value that allows operation of the syringe. The device provides a mechanical ordering based on a cam and cam follower mechanism and includes a chamber with a liquid outlet for dispensing liquid and an impact member for ejecting liquid. Sequencing and camming are driven by an electric motor gearbox and, with camming and sequencing and adjustable pressure sensing, do not apply to the present invention.

U.S. Pat. No. 5,891,086 (T. Weston) is pre-filled with a pressurized gas that applies a constant force to the impact member to strike the cartridge components and deliver a single dose of drug. A needleless syringe is described that includes a chamber. This device includes an adjustment knob that sets the dose and impact gap and utilizes direct contact pressure sensing to initiate an injection. The use of contact pressure sensing in this way, the need for constant adjustment, and the use of pressurized gas to perform the injection process do not apply to the present invention.

U.S. Pat.No. 3,859,996 International Publication WO82 / 02835 European Patent Publication No. 347190 U.S. Patent No. 5,480,381 U.S. Patent No. 5,891,086

  Current state-of-the-art attempts to inject drugs subcutaneously include the difficulties associated with accurate positioning of the skin with respect to the jet opening of the syringe, and jet pressure versus skin penetration when making an injection perpendicular to the skin surface It has only limited success because it cannot be controlled accurately. In addition, current systems lack accurate control and repeatability of injection jet velocity due to mechanical tolerances in the pressure / force generator used. Some current devices have safety issues due to the absence of safety interlocks to prevent the device from being accidentally activated when it is not in proper contact with the skin, and the device structure There was a catastrophic failure in the syringe body, partly due to the lack of accurate pressure control associated with.

  The present invention overcomes these disadvantages by the combination of a syringe and an ampoule used with the syringe. An ampoule is a part that holds the drug to be injected and works with both the syringe and the patient's skin surface, thereby applying the suction generated by the syringe to draw the skin tightly and make an appropriate injection. As such, ampoules are an important component of the system. Since the release of the interlock needs to generate a full suction force in a system that cannot be achieved without the ampoule, the ampoule is further linked with a syringe to properly activate the safety interlock. The ampoule and syringe combination of the present invention makes it possible to achieve needleless injection of the drug into the skin, subcutaneously and intramuscularly at any angle to the skin surface. Furthermore, the ampoule and syringe combination of the present invention can achieve the shallow intradermal injection necessary to accurately and reliably administer drugs to Langerhans cells in the upper spinous layer of the skin.

  Accordingly, the present invention provides a manually operable elongated housing, an impact impact injection mechanism in the housing, a suction force generating means in the housing that cooperates with the impact impact injection mechanism, a safety interlock mechanism, and an impact. At least one drug-containing ampoule capable of cooperating with the impact injection mechanism and the suction force generating means, and having a jet orifice, and in response to an impact applied to the drug by the impact impact injection mechanism, the drug is passed through the jet orifice. A needleless syringe comprising a drug containing ampoule that allows injection into a surface, and means for receiving and holding the ampoule on the syringe in communication with the suction force generating means while being aligned with the impact impact injection mechanism The skin held against the orifice by the suction force generating means With a jet stream at a velocity sufficient to penetrate the tissue, the drug is ejected from the ampoule and is injected intradermally, subcutaneously or intramuscularly based on the position and angle of the jet orifice. A needleless syringe is provided.

  The present invention further includes an ampoule for a needleless syringe comprising an elongate body having a front end, a rear end, a generally flat upper surface, and a lower surface having a downward offset between the front and rear ends. Because of this offset, a forward-facing step surface is provided, and a horizontal inner hole in the main body extends from the rear end of the main body to a point substantially adjacent to the step surface, and the inner hole opens at the rear end. In the inner hole, a sealed plunger adapted to be pushed by an impact impact injection mechanism is arranged, the inner hole further comprising a jet orifice penetrating the step surface, whereby the inner hole is An amplifier capable of holding a certain amount of medicine that can be injected into the skin surface pressed against the orifice as the plunger is pushed forward in the inner hole by the impact impact injection mechanism. To provide.

The syringe of the present invention uses a single use disposable drug ampoule that is configured to provide a contact surface with the activation device, thereby easily loading the drug manually or mechanically from a multiple ampoule delivery device. And precisely positioning and sealing the structure of the activation device to inject the drug intradermally, subcutaneously or intramuscularly. The ampoule further includes a mechanism that induces a vacuum to stretch the skin and hold the skin in precise alignment with the jet orifice during a short injection. Ampoule orifices have different offset variations with ID, SUB-Q injection or IM injection. Ampoules and syringes can also be adapted to different drug viscosities as required by different types of drugs, including providing multiple orifices in ampoules for higher doses or wider patterns of injection. Adjusted. The syringe of the present invention is manually, pneumatically and / or electrically or electromagnetically actuated to provide an interface mechanism for attaching an ampoule, and when performing an activation process, the impact force causes the drug to be applied to the skin surface. On the other hand, a mechanism is provided that enables injection at an arbitrary angle between horizontal and vertical and at a skew angle. In addition, the activation device provides a safety interlock mechanism that prevents the impact force from being accidentally activated except when the ampoule is properly interfaced to the skin surface. The syringe provides the operator with a comfortable and lightweight device. Thereby, the operator can quickly and easily load the ampoule, properly position the ampoule on the skin surface, actuate the impact force, inject the medicament and reset the activation device.

  In the present invention, a pre-measured quantity of fluid drug is sufficiently thin enough to penetrate tissue of both a person and animal undergoing treatment or vaccination at any angle between horizontal and vertical. A needle-free ampoule is provided that ejects with a jet.

  The present invention relates to a single use disposable drug ampoule having the ability to generate a vacuum prior to injecting the drug into the tissue, thereby stretching and properly holding the skin, manually, pneumatically and / or electrically. Or an electromagnetically actuated activation syringe. Ampoules and syringes are truly unmatched structures made of materials currently used in the medical world and configured to minimize labor and be easy to handle and operate. The size and shape chosen also minimizes weight. The visibility of the operation, along with age, hand size, hand strength, skin type and thickness, was also a very important consideration.

  The subject of the present invention provides a method and mechanism comprising a disposable fillable or filled ampoule and a manual or automated actuating device, intradermal (ID), subcutaneous (SUB-Q) or intramuscular. (IM) To provide any novel needleless syringe for injection. There are many advantages obtained by the present invention. In particular, the injection uses horizontal impact impact jet pressure, so it spreads the particles over a larger area than when using a needled syringe, reduces local pressure in the tissue, and from the opening in the tissue. Eliminate fluid leakage, thereby reducing the likelihood of spreading infection. The device allows injection at any angle and sideways from horizontal to vertical with respect to the ampoule centerline, depending on the individual conditions such as medication and injection site. A unique feature of the present invention is that the drug is delivered from the ampoule holding it with a known controlled impact impact force.

  A further new technique of the present invention is a method of stretching the skin, which increases permeability and thus reduces the amount of energy required to inject fluid into tissue and from horizontal to vertical and / or lateral. A method of injecting fluid into the skin in a direction so that the positioning of the tissue for intradermal, subcutaneous or intramuscular injection can be controlled. It is also important to introduce a safety mechanism built into the syringe that prevents it from operating until the skin is properly positioned.

  The ampoule, in conjunction with the syringe, allows loading by hand or mechanical means, and is a vacuum generated by the operation of the syringe that stretches the skin and aligns precisely with the jet orifice during short injection times It has a mechanism for generating a vacuum that keeps it in the closed state. The activation device provides an interface or abutment mechanism for attaching the ampoule, which provides the impact impact force necessary to inject the drug when performing the activation process. Each ampoule body has a see-through window with a scale on the outside in order to display the amount of medicine contained in the ampoule.

  In the second embodiment of the present invention, the syringe operates in the same manner as the first embodiment, except that certain functions and sequence execution components utilize external air pressure for operation. The handle has been replaced by a finger operated trigger and the return mechanism is all pneumatic. Alternatively, pneumatic operation can be performed using an electronic solenoid powered by a battery pack that may be part of the syringe or separate. The ampoule structure of both embodiments is the same, and the attachment method of the ampoule structure to the syringe and the filling method of the ampoule structure are the same. Since each syringe embodiment uses the same ampoule, each comprises means for performing either intradermal (ID), subcutaneous (SUB-Q) or intramuscular (IM) injection.

  Another embodiment of the present invention provides a syringe adapted to receive a multiple ampule assembly and a multiple ampule assembly for the syringe. The syringe components and operation are similar to those of the other embodiments, with the exception that the front end of the syringe has been modified to receive a rotatable multiple ampoule assembly, A plurality of ampoules are disposed within the cylindrical cartridge. The cartridge is rotatable at the front end of the syringe so that each ampule of the cartridge can be aligned with the suction and injection means of the syringe.

  The present invention is also a needleless syringe, wherein the ampoule further comprises at least one suction port that vertically penetrates the body from the top surface to the bottom surface at a point in front of the step surface, the suction port comprising a suction port In fluid communication with the force generating means, so that prior to injection, the suction force generated by the suction force generating means is applied to the skin surface through the port, attracting the skin surface to the lower surface of the ampoule and the jet orifice; Can stretch the skin, improve the porosity of the skin relative to the drug jet, and direct the drug jet intradermally, subcutaneously or intramuscularly depending on the angle and placement of the orifice.

  The present invention still further provides a needleless syringe comprising a syringe assembly and at least one drug-containing ampoule that can be removably attached to the syringe assembly, the syringe assembly having a manually operable elongated housing. The housing is a body portion that houses the mechanical impact impact means, the mechanical impact impact means being capable of linearly reciprocating between the injection preparation position and the injection position within the housing, and a drive A compressible drive spring disposed concentrically along the rear portion of the rod, constrained between a fixed abutment in the housing and a protrusion at a position approximately midway between the drive rods, thereby A compressible drive spring, which is compressed by a backward displacement of the drive rod, and a protrusion. A latch mechanism for releasably holding the drive rod in the injection ready position where the spring is compressed, a release means for releasing the latch mechanism when attempting to inject, and an injection preparation means cooperating with the drive rod A needleless syringe is provided comprising a body portion having a drive rod that is pushed backward to be placed in an injection ready position, thereby compressing the spring and engaging the latch mechanism. The needleless syringe further includes a detent means adapted to removably receive at least one ampoule and detent means for releasably securing the ampoule to the syringe assembly when the impact impact mechanism is in the injection ready position. And wherein the at least one ampoule comprises a body having a front end, a rear end, a substantially flat upper surface, and a stepped lower surface provided with a front-facing step surface, the body at the rear end Behind the step surface is a horizontally disposed generally cylindrical drug chamber that opens and narrows toward the jet orifice in the step surface, the size and position of the chamber being fixed to the syringe assembly When the latch mechanism is released, the front end of the drive rod is received, and the chamber has a means for holding the drug in the chamber. And further includes a sealing plunger that is adapted to be engaged by the drive rod when the latching mechanism is released so that the drive rod moves forward in a horizontally disposed chamber. A nose front portion that pushes forward and pushes the drug under pressure through a jet orifice into the skin surface that was pressed against the ampoule.

  The needleless syringe of the present invention comprises at least one suction port disposed vertically through the ampoule body in front of the jet orifice, suction force generating means disposed in the body portion of the housing, and in the housing and nose portion. A suction conduit for fluidly communicating between the suction force generating means and the at least one suction port, thereby transmitting the suction force generated by the suction force generating means to at least one suction port of the ampoule And the suction force serves to attract the skin surface to the ampoule and orifice prior to injection. To increase the suction of the skin surface against the ampoule, and preferably for intradermal injection, the skin surface is lifted slightly above the height of the jet orifice, thereby forming an injection path into the spinous layer of the skin For this reason, it is preferred that the lower surface of the ampoule that surrounds the suction port is concave, thereby forming a slight depression that draws the skin by suction.

  The syringe does not contact the skin tissue surrounding the injection, but all materials are currently used in the medical community and are compatible with all current disinfection methods, so if desired, the syringe can be used for disinfection. Can be immersed in alcohol.

    The present invention uses a vacuum to stretch the recipient's skin, thereby increasing the permeability of the skin to injection, thereby reducing the amount of energy required to inject the drug into the skin tissue. The present invention relates to a device and method for needleless jet injection of a drug from a fillable or filled ampoule into the skin of a human or animal. The vacuum is further used to position the skin to be suitable for drug injection.

  The method uses a device to inject a pre-measured quantity of fluid drug by a high-pressure jet stream at a sufficient speed that can penetrate the human or animal epidermis, and the orifice of a disposable ampoule to the epidermis. Depending on the offset and angle and the impact impact force, the drug is administered intradermally, subcutaneously or intramuscularly. Another new aspect of the method is that the drug is injected into the skin from a single use ampoule horizontally or at any other desired angle to spread the particles over a wider range when using a needle syringe. There is.

  This method reduces local pressure in the skin tissue during injection, thereby reducing local pain, minimizing tissue damage, eliminating fluid leakage from the injection opening, and spreading infection A safety device is provided to reduce the possibility while preventing erroneous operation of the syringe.

  The syringe assembly 20 shown in FIG. 1 includes a molded housing 21 that houses a syringe mechanism that is actuated by a release button 23. By the operation of the syringe 20, the medicine 31 contained in the ampule 25 shown in FIG. 2 is dispersed or delivered. The ampoule 25 is fixed to the syringe 21 by a holding clamp 22 attached to the front end portion of the syringe 20 and an insert fairing 74 attached to the lower side of the syringe 20 at the other end portion of the ampoule 25. In the main embodiment of the syringe 20, it is manually operated and ready to deliver the drug by rotating the handle 30 about the shaft 56. The handle includes a hand grip 29 that is shaped to be easy to operate. The handle 30 rotates at the handle pivot 24.

  The syringe housing 21 includes an access panel 27 and an end cap 28 to facilitate assembly and maintenance of the mechanism within the housing 21. FIG. 3 shows a cross-sectional view of the syringe 20 before actuating the mechanism for injection. This mechanism within the housing 21 includes a piston 35 adapted to generate a vacuum to stretch the recipient's skin at the injection site immediately prior to injection, and a release for pressure delivery of the drug into the skin tissue. Mechanism. The mechanism within the housing 21 of the syringe 20 also has a compression drive spring 42 that provides a force to push one end of the drive rod 43 into the ampoule 25 containing the medicament. The other end of the drive rod 43 is provided with a retaining ring 59 that cooperates with means for locking the drive rod 43 in a state in which the compression drive spring 42 is compressed. The protruding ring 120 located approximately in the middle along the drive rod 43 is provided with a surface on the drive rod 43 for pressing the compression drive spring 42. The other end of the compression drive spring 42 abuts on the annular surface 123 at the end of the drive spring chamber 128 in the housing 21. In order to eject the medicine 31 from the ampoule 25, the mechanism of the syringe 20 moves to the position shown in FIG. 4 by turning the handle 30 and waits, thereby pulling the slide frame 45 forward via the extension link 40. As a result, the drive rod latch 48 engages with the retaining ring 59 on the end of the drive rod 43 around which the compression drive spring is wound. When the slide frame 45 is pulled forward by the link 40 attached to the handle 30, the upper surface of the latch 48 slides along the spring ramp 50 and pivots downward to engage the front surface of the retaining ring 59. . The drive rod latch 48 is preloaded to the release position by a torsion spring 53 located on the rotation axis of the latch 48 and the side frame 45. When the latch 48 comes into contact with the spring ramp 50, the latch 48 is pushed down against the load of the torsion spring and moves to the locked position where it engages with the drive rod retaining ring 59. The spring ramp 50 is preferably held in the housing 21 by two pins 51. The drive rod latch 48 is supported by the slide frame 45, rotates around the pin joint 52 in the upright support portion of the slide frame 45, and is held in the slide frame by a horizontal pin 58 that also holds the connector link 47. . The slide frame 45 has a horizontal lower leg portion that is guided by sliding in the machining groove 122 in the housing 21. An end pivot point 60 for pivotally attaching the extension link 40 is provided on the horizontal lower leg portion of the slide frame 45. By rotating the handle 30 returning to the starting position shown in FIG. 3, the drive rod 45 is pushed backward, and the spring 42 is compressed between the annular surface 123 and the protruding ring 120. When the handle 30 is rotated fully back to the starting position, the spring 42 is fully compressed and the protruding ring 120 engages the release catch teeth 79 depending from the underside of the release catch 44. The drive rod 43 holds the spring 42 and the drive rod 43 in a compressed position ready to push the drug 31 out of the ampoule 25 and release it. To move the slide frame 45 in this manner with the link 40 attached to both the slide frame 45 and the handle 30, the link 40 rotates about the pivot 41 on the handle and the pivot 60 on the slide frame.

  The handle 30 itself is attached to the syringe assembly housing 21 and rotates about the pivot 24. The syringe handle 30 attached to the outside of the housing 21 has two legs shaped to straddle the housing 21, each leg being attached to the pivot point 24 on each side of the housing structure by a retaining pin 58. Yes. The free end of the syringe handle 31 is formed or shaped to provide a finger hook or hand grip 29. In order to provide sufficient leverage to compress the drive rod compression spring 42, the handle 30 is extended in length. The extension link 40 can rotate about its handle attachment point 41, and when the handle 30 is rotated, the extension link 40 can also rotate. By similarly pivoting the pin joint 60 to the slide frame 45, the extension link 40 pivots relative to the slide frame 45 so that when the handle 30 is rotated downward or upward, the extension link 40 is moved to the slide frame 45. Push or pull 45.

  In addition to pulling the drive rod 43 against the compression spring 42, the slide frame 45 has a second function. In order to ensure good contact between the ampoule 25 and the recipient's skin during drug injection, the syringe 20 creates a vacuum at this point of contact between the ampoule 25 and the recipient's skin. In order to generate this vacuum, a second connector link 47 that extends rearward from the latch 48 and engages with the vacuum piston 35 at the rear of the housing 21 is attached to the slide frame 45. As the slide frame 45 moves rearward, the compression spring 42 is compressed, and the drive rod 43 is pulled to the injection preparation position. At the same time, the connector link 47 attached to the upright support portion of the slide frame 45 at one end and attached to the pin joint 51 by the fastening pin 58 at the other end is attached to the piston extension 46 by the rod latch pivot pin 54. The piston 35 is pulled backward in the cylinder 123 milled at the rear part of the housing 21. The piston 35 generates a vacuum for the syringe 20 when applied to the recipient's skin, thereby stretching the skin tightly against the suction port 63 in the ampoule 25, thereby injecting the drug. The exit orifice 66 can be accurately positioned to do this. In addition, the vacuum system is provided with a safety device to prevent accidental operation of the syringe 20 if a good vacuum seal of the ampoule 25 to the skin is not initially obtained. The safety device includes a small interlocking piston rod 36 that is adapted to engage and disengage the release latch 44 in response to the vacuum generated by the piston 35. The interlock piston rod 36 reciprocates in the channel 125, and a small piston 126 located in a small cylinder 127 communicating with the cylinder 123 of the vacuum piston 35 is provided at the rear end thereof. The piston 35 is provided with an O-ring seal 34 that allows the piston to reliably generate a vacuum in the cylinder 123 to actuate the small interlock piston rod 36. The generated vacuum acts on the small piston 126, whereby the small interlock piston rod 36 takes a position to engage or disengage from the release arm 55, thereby locking the arm in the non-release position. Or unlock the arm in the release position. Release arm 55 can pivot between two operating positions about pivot pin 54, which is associated with syringe housing structure 21 and attached to the locked position by torsion spring 33 on pivot pin 54. It is energized.

  A pair of connector links 47 straddle the vacuum piston 35 and are connected to the vacuum piston by a piston extension 46. The vacuum piston 35 is driven by the movement of the slide frame 45, and the generated vacuum reaches the ampoule 25 through the suction tube 71. To release the drive rod 43, the syringe includes a release button 23 that rotates the release arm 55 about the pivot pin 54 when pressed. Since the release arm 55 is engaged with the release catch 44, when the release arm 55 rotates downward, the release catch 44 rotates upward to release the drive rod 43, and then the drive rod is driven to the drive spring 42. , So that the front end of the drive rod 43 enters the ampoule 25. The release catch 44 rotates around the latch pin 58 against the torsion spring 53. The release button 23 is mounted within the structure of the syringe housing 21, so that when pressed inward, it contacts the release arm 55 and acts as a cam, causing the release arm 55 to rotate downward, thereby The release catch 44 that locks the compression spring 42 in its load compression position is raised. The release button 23 is held in the syringe housing 21 flush with the outer surface of the housing and retained in the housing structure with a retaining snap ring 32 to prevent false actuation until required by the actuation procedure. . As described above, the release catch 44 includes a torsion spring 53 that holds the release latch 44 in the locked position in a tensioned state, thereby holding the drive rod 43 against the compression spring 42 in the compressed state. . The inclined end face of the release catch 44 comprises means for contacting the corresponding inclined end face of the release arm 55 so that the release catch 44 is provided by a latch pin 58 when the release arm 55 is depressed by the button 23 during the release function. It pivots upward about the pivot point and engages the housing 21 structure.

  FIG. 4 shows a cross-sectional view of the syringe 20 after the handle 30 has been rotated away from the housing after drug injection. In order to ensure that the drive rod latch 48 always engages the drive rod retaining ring 59, the spring ramp 50 pushes the drive rod latch downward, thereby engaging and locking onto the protruding retaining ring 59. To do. The spring lamp is held by two roll pins 51. In order to ensure that the drive rod latch 48 is released at the end of the stroke of the slide frame 45, a torsion spring 53 held by the pin 58 and driving the latch about the pivot pin 52 to the release position is provided to the latch 48. Is provided. In order to obtain a vacuum, the piston 35 has an annular O-ring seal 34 that is received in an annular groove on the surface of the piston 35 and abuts against the wall of the cylinder 123. The vacuum generated by the piston 35 is transmitted to the ampoule 25 by the suction passage 73 and the vacuum tube 71, and the vacuum tube is provided with a seal 70 at the junction with the ampoule 25 to effectively inject the drug by the syringe. In addition, the suction function of the skin at the ampoule contact position is surely obtained. When the lower surface of the syringe release button 23 is pressed, the release arm 55 is moved downward by a cam operation to press the release latch 44 upward. The release arm 55 rotates around the pivot point 57 and holds the pin 54 and the torsion spring 33.

  To ensure that the release arm cannot be accidentally rotated by someone pressing button 23 before it is needed, and so that the recipient's skin contacts ampoule 25 and is ready for injection. Therefore, the syringe 20 includes a locking mechanism that prevents the drive rod 43 from being released inadvertently. When the handle 30 is rotated, the vacuum piston 35 in the cylinder 123 moves to generate a vacuum or pressure that presses the small piston 126. As a result, the interlock piston rod 36 reciprocates between the locked position and the unlocked position. . The pressure generated in the cylinder 123 by the piston 35 when the handle 30 is rotated downward, thereby engaging the drive rod latch 48 with the retaining ring 59 causes the interlock piston rod 36 to move forward and to the release arm 55. Press to the locked position. Conversely, when the handle 30 is rotated upward, the piston 35 moves backward in the cylinder 123, and when the ampoule 25 is applied to the skin, it acts on the small piston 126 to move the interlock piston rod 26. Pull backwards, thereby creating a vacuum sufficient to unlock the release arm 55. Until complete suction is provided to the system, the interlock piston rod 36 is interlocked to the release arm 55 by engaging the corresponding interlock hole 80 in the release arm 55 at the end of the rod 36. In this state, when the button 23 is pressed, the release arm 55 cannot rotate away from the engaged state with the protruding ring 120, so that the spring 42 pulls the drive rod 43 into the ampoule 25. It is prevented from moving inward and the medicine cannot be discharged. An O-ring 37 is provided on the small piston 126 on the interlock piston rod 36, thereby maintaining a vacuum between the large piston 35 and the interlock piston rod 36. In order to send a vacuum from the cylinder 123 to the ampoule 25 in the space between the two sealed pistons, a suction port A38 is provided as shown in FIG. In order to prevent the interlock piston rod 36 from moving too far and to hold the interlock piston rod in a position suitable for vacuum operation, the interlock piston rod 36 is engaged by a retaining ring 39 in the small cylinder 127. Is done. In order to prevent the large drive compression spring 42 from pressing the drive rod 43 hard against the end stopper and damaging the ampoule 25, the drive rod 43 is a cushion washer at the end of the drive spring chamber 128 when released. 75 hits the bottom. FIG. 4 also shows a surface 69 in contact with the skin of the recipient who is injecting the drug. The ampoule 25 is disposable and can be easily loaded into the syringe assembly by rotating a holding clamp 22 secured with a detent 26 on the housing 21 of the syringe assembly. FIG. 5 is an end view showing the syringe assembly and end cap 28 with mounting screw 76. FIG. 6 is a cross-sectional view of the housing 21 and shows two legs of the slide frame 45 when the slide frame 45 straddles the vacuum piston 35.

  FIG. 7 is a cross-sectional view of the housing, showing the path and passage through the suction manifold 72. The manifold suction passage 73 provides the vacuum necessary to pull the interlock piston rod 36 from the release arm 55 with a small inflow vacuum in order to move the piston rod 36 into the syringe assembly 20. The suction manifold system is machined in the housing structure, receives vacuum pressure from the vacuum piston 35, leads to the interlock piston chamber 127 through a suction passage 73 that opens into the structure in the vacuum piston chamber 123, and is linked to the ampule 25. The vacuum port 129 is designed to guide the vacuum to the suction tube 71 and the suction passage is sequentially opened and closed according to the position of the interlock piston 126, and the suction force from the machining suction passage in the structure to the suction port in the ampule 25 And a pair of suction tubes guided to 63.

  The sequence for actuating the syringe 20 begins by squeezing the handle 30 with the ampoule 25 not loaded. As a result, the drive rod is pulled back and latched in the injection ready position, and the compression drive spring 42 is compressed between the protruding ring 120 and the annular abutment surface 124 at the rear end of the spring chamber 128. The drive rod latch 48 captures and pulls back the drive rod 43 but is spring biased upward and away from the drive rod 43 so that when in the fully forward position for the spring ramp 50, the drive rod 43 is It just takes the gripping position. When the drive rod 43 is released, when the handle 30 is squeezed, the latch 48 catches the lip of the drive rod retaining ring 59 and pulls the drive rod 43 back. For this purpose, a notch 125 is provided under the latch 48. Preferably, a small concave recess is provided in the front surface of the drive rod retaining ring 59 to engage the notch 125 of the drive rod latch 48 and hold the notch in place while squeezing the handle 30. The drive rod 43 is fully retracted, the protruding ring 120 is engaged with the release catch 44, and when the drive rod 43 is released, the drive rod latch 48 is disengaged from the holding ring 59 to release the holding ring 59. Rotate upward by the torsion spring 53.

  With the drive rod spring 42 compressed, the ampoule 25 is slid into place, the ampoule holding clamp 22 is tightened, thereby lifting the ampoule 25 and against the seal 70 at the bottom of the syringe nose, and the ampoule locking tab 61 Is engaged with the syringe structure. The syringe 20 is then placed with the ampoule 25 in place on the patient's skin and the handle 30 is extended. Hold the handle again. Because the drive rod 43 has already returned to the injection ready position, the drive rod retaining ring 59 is not in a position to be captured by the drive rod latch 48 when the handle 30 is extended and then squeezed again. When the handle 30 is squeezed twice, the vacuum piston 35 generates a vacuum in the cylinder 123, which is transmitted to the suction port 63 in the ampoule 25 by the suction passage 73 and the suction tube 71. This vacuum stretches the skin tightly against the ampoule 25, and when a good seal is obtained against the skin, retracts the interlock piston rod 36 from the interlock hole 80 in the release arm 55, thereby providing The button 23 is released so that it can operate. With the handle 30 held firmly, the release button 23 is pressed, whereby the release arm 55 is moved downward by a cam operation, so that the release catch 44 rises and separates from the protruding ring 120. The spring 42 can push the drive rod 43 into the ampoule 25 and provide the force necessary to eject the drug 31 from the ampoule 25 through the orifice 66. The button is then released and the handle 30 is returned to the extended position so that the vacuum is lost and the syringe can be pulled away from the skin. At the same time, the interlock piston rod 36 is pushed forward to re-engage with the interlock hole 80 in the release arm 55, and the syringe 20 is locked to prevent accidental operation. Returning to the starting position of the actuation sequence, the handle can be squeezed, thereby latching and pulling back the drive rod 43 so that the used ampoule can be released and replaced with a filled one.

  A second embodiment of the syringe assembly is shown in cross-section in FIGS. For convenience and avoidance of confusion, wherever functions and operations overlap, i.e., are repeated, similar parts are designated with the same reference numerals. The main difference between the two embodiments is that in the above embodiment, manual operation by rotation of the manually operated handle 30 is used, whereas this embodiment has an external air supply power for a part of its function. Is to use. As described above, the first embodiment utilizes the manual extension and retraction of the handle, thereby actuating the large piston 35 to generate a vacuum and using that vacuum to the recipient. Ensure that the skin is in direct contact with the injection orifice 66 of the syringe. This manual mechanism also activates means for preventing accidental actuation of the syringe, and means for compressing the impact or compression drive spring 42 into the locked position, which is released by the operator depressing the activation button 23. Prepare to be able to do it. In this second embodiment of the invention, an external source of pressurized air activates and deactivates the mechanical action that prepares the drive spring 42 and drive rod 43 for injection, the mechanical action that generates a vacuum, and the locking safety mechanism. Means are provided to cause the mechanical action to occur to occur automatically in response to movement of the trigger assembly 89. Vacuum assist is achieved by actuation of valve 100 controlled by trigger assembly 89. By moving the trigger in one direction, the valve opens, thereby causing pressure to move to the large return piston 83 in the extension housing 102 at the rear end of the syringe housing 21, which pulls back on the vacuum piston 35, thereby creating a vacuum. And the same mechanism achieved by the previous handle movement can be initiated, and the connection between the return piston 83 and the vacuum piston 35 is effected by a connecting rod 82 that penetrates the end wall of the extension housing 102. Is called. By operating the trigger in the reverse direction, the external pressure supply source is closed, and as a result, the vacuum assist function performed by the return piston 83 is stopped. 8 and 9 show the two positions during the injection operation of this new embodiment. This embodiment of a needleless jet injector utilizes external air pressure to provide actuation and continuous operation of the syringe components. The syringe 20 opens and closes the air supply valve 100 in the syringe 20 and opens and closes an external supply air pressure from an external source that flows into the large return piston 83 connected to the vacuum piston 35 by a connecting rod 82 via a fitting 49. In order to perform the movement, a trigger assembly 89 operated by an operator's finger is provided. The vacuum piston 35 functions as described in connection with the previous embodiment and provides a vacuum for the interlocking function of the release button 23 and release catch 44 to initiate drug injection. The vacuum piston 35 is moved by the return piston 83, thereby creating a vacuum at the contact surface between the recipient's skin and the ampoule 25 containing the drug. The syringe operator's finger activates the trigger assembly 89 by applying a pulling movement to move the trigger 89 upward toward the syringe activation frame 87, which causes the trigger assembly 89 to push the push rod 90. Valve 100 is actuated and air pressure continues to flow from the external air source through source fitting 49 to the syringe. The push rod 90 moves back and forth in a machined support fitting 95 attached to the underside of the syringe assembly and is held in the support fitting 95 by a threaded bush 105 at the end adjacent to the trigger 89, the bushing supporting Means are provided for sealing and holding the air pressure within the fitting 95. An O-ring seal 92 is captured between the bushing 105 and the support fitting 95 to seal around the pushrod 90 at a location where the pushrod 90 passes through the bushing 105 and contacts the trigger assembly 89. A similar O-ring seal 92 seals around the push rod 90 at the other end adjacent the valve 100 and seals the support fitting 95. The valve 100 is used to reciprocate in response to the back-and-forth movement of the push rod 90 and to continuously flow air pressure from the air supply source through the two lateral pressure ports 91 into the valve cavity 130. The valve 100 opens and closes a passage for inflow pressure to move to the syringe assembly. The valve is sealed with an O-ring 101 in one direction and sealed with the aforementioned O-ring 92 in the opposite direction. The push rod 90 is machined with an undercut 131 that allows air to flow into the valve 100 and subsequently allows the air to pass upward to reach the syringe 20 or the valve 100 and The seal prevents air flow. The position of the valve 100 is controlled by the position of the valve retracted into the trigger assembly 89. When the trigger assembly 89 is not actuated, the valve 100 is positioned in the air shut-off or closed position by the compression spring 99 captured by the spring retaining plug 98 threaded into the support fitting 95. When the valve 100 is in the shut-off or closed position, any air pressure that accumulates on the opposite side of the valve during injection is exhausted from the return spring cavity through the pressure vent hole 97. An O-ring seal 96 is installed in the interface air passage 132 joint between the support fitting 95 and the extension housing 102 attached to the syringe assembly. The air passage 132 transfers compressed air from the valve 100 to the extension housing 102, thereby driving a large return piston 83 that is connected to the vacuum piston 35 by a connecting rod 82. The air pressure behind the return piston 83 pulls the connecting rod 82 and subsequently moves the slide frame 45, thereby achieving the action that the handle had done in the syringe assembly described above. The return piston 83 has an O-ring 84 for sealing the piston, and a compression spring 85 for the return function of the return piston 83 located between the return piston 83 and the spring holding cap 94. The compression spring 85 is captured in the return piston pocket 133 and in the pocket 134 of the spring retaining cap 94. Air trapped between the holding cap 94 and the return piston 83 is discharged from the cavity through the air vent hole 97. The holding cap 94 is attached to the end of the extension housing 102 with a set screw 86. Air pressure entering the pressure side of the return piston 83 enters a port 135 that is machined into the extension housing 102 and connected to the air passage 132. The plug 93 closes the end of the port 135 and enters the vacuum piston cylinder 123. The extension housing 102 is provided with an O-ring seal 81 that seals pressure around the connecting rod 82 and prevents air from entering the vacuum piston cylinder 123.

  In the embodiment of the manually operated syringe 20, the drive rod 43 is a single piece, but in this embodiment, the drive rod 43 is divided into two sections: a drive rod portion 43 ′ and a drive rod portion 43 ″. The rear portion, ie, the drive rod 43 ', includes a retaining ring 95 and a drive cylinder 78 at the front end of the retaining ring 95 and the drive rod portion 43'. And a compression drive spring 42 that surrounds the shaft between them, remote from the drive cylinder 78 is a drive rod forward portion 43 ", which is the ampoule 25 when an injection is performed. Get inside. To ensure that the drive rod portion 43 "is not overly impacted on the ampoule plunger 65 when driven by the large drive spring 42 and does not cause problems when injecting fluid. In addition, a small compression spring 77 is installed between the rear end of the drive rod front portion 43 ″ and the drive cylinder 78. This compression spring 77 ensures that the end of the drive rod portion 43 "is always in contact with the ampule plunger 65 before and during the injection, so that when operating the syringe, the drive rod portion 43" and the ampule plunger A strong impact between 65 is avoided. When the release catch 44 is rotated and placed in the release position and the release catch tooth 79 releases the engagement from the drive cylinder 78 to release the drive spring 42, the compression spring 77 absorbs the initial impact. As a result, the force applied by the drive rod portion 43 "to the ampoule piston 65 is constant, and the drug fluid is pushed out of the ampoule 65 with the rapid high energy provided by the large drive spring 42. This two-part alternative The example drive rod 43 can also be applied to the manual syringe embodiment described above, Figures 10A and 10B show a connection that connects an external air source to the syringe and the associated manifold in the air passage in the syringe. FIG.

  In a further alternative, the functions of the pneumatic system described above may be achieved by an electronic solenoid or similar electrical or electromagnetic device powered by a battery or other power source. In such an alternative, the solenoid is mounted in place of the pneumatic piston 83 in the extension housing 102 and the solenoid plunger is mounted on the connecting rod 82. A battery pack providing power to the solenoid may be provided in place of the support fitting 95 under the housing 21 and via a switch actuated by the trigger assembly 89 or a switch located anywhere on the housing 21. The solenoid may be electrically connected. Such alternative operational steps are the same as the pneumatic embodiment described herein.

  The preferred embodiment of the syringe employs a mechanical compression spring mechanism and a latch mechanism to provide the driving force for the impact impact mechanism, but to provide a pneumatically or electrically actuated syringe as a whole. Certainly falls within the scope of the present invention. In such variations, the compression drive spring mechanism and the mechanical actuation preparation and latch mechanism are replaced by equivalent pneumatic and electrical, electronic or electromagnetic actuators to drive both the drive rod 43 and the vacuum piston 35. It is done.

  In an overall pneumatic alternative, the chamber in which the drive rod latch 48 operates to engage the retaining ring 59 on the end of the drive rod 43 forms a pneumatically actuated piston to which the drive rod 43 is attached. It can be deformed to form a pneumatic cylinder with the retaining ring 59 deformed in this way. By creating an appropriate passage, a pneumatic fluid, such as compressed air, is directed to either side of the piston in response to proper valve actuation, thereby causing the pneumatic piston and drive rod 43 to reciprocate. Furthermore, means for adjusting the air pressure may be provided, whereby the driving force on the plunger 65 of the drive rod 43 for intradermal, subcutaneous or intramuscular injection can be adjusted.

  In a fully electrically operated syringe, it is easy to replace the drive spring 42 with an electronic or electromagnetic actuator such as a push-pull solenoid and the drive rod 43 forms a reciprocating core. In this modification, the drive of the solenoid results in a reciprocating motion of the drive rod 43. The drive force generated by the solenoid is adjusted for intradermal, subcutaneous or intramuscular injection by means of a variable force solenoid and appropriate voltage regulation means.

  Considering now ampule 25, it holds the drug to be injected and pulls the skin firmly in order to properly inject, so that the suction generated by the syringe is applied to the skin and interacts with the syringe. In part, it is a key component of the syringe device of the present invention. In addition, to release the interlock, the ampoule 25 is associated with the syringe so that a complete suction force that cannot be achieved without the ampoule 25 must be established on the system, thereby ensuring safety in the syringe. Proper interlocking devices to function properly. The combination of the ampoule 25 and syringe 20 of the present invention makes it possible to achieve needle-free injection of a drug intradermally, subcutaneously or intramuscularly at any angle with respect to the surface of the skin.

  A basic disposable drug-filled ampoule according to the present invention is shown in FIGS. 11, 12 and 13 and provides a drug container and means for attaching to a syringe and associated with a vacuum system. Ampoule body 67 is preferably made of plastic, glass, or equivalent material suitable for medical use, or a combination thereof, and is provided with a cylindrical or other shaped hole chamber 62 that contains the drug. A dose scale 141 is provided on the ampoule 25 side of the chamber 62 to indicate the amount of drug in the chamber 62. An exit orifice 66 is provided at the front end portion of the inner hole chamber 62, while the rear end portion of the chamber 62 is closed by an inner ampoule plunger seal 65 that holds a medicine in the chamber. The plunger seal 65 is contacted by the drive rod 43 when the syringe is actuated and pushed forward in the chamber 62 to eject the drug through the orifice 66.

  The shape of the ampoule 25 is important for the syringe system to function properly, particularly to achieve intradermal injection. From this point of view, the main body 67 of the ampoule 25 is configured such that the nose portion 136 is thinner than the inner hole chamber portion 137, and as a result, as shown in FIGS. A vertical offset 138, that is, a step surface is generated. This offset 138 effectively forms a pocket 139 in front of the orifice 66 and allows the skin surface to be easily pulled into the pocket by suction from the syringe applied via the suction port 63. In addition, the lower surface offset 138 allows an ampoule to be formed for intradermal, intramuscular, or subcutaneous injection, which remains in the same position of the bore chamber 62 relative to the upper surface of the body 67. It can be used with the same syringe 20 by simply changing the thickness of the 67 nose portions 136. Thus, an ampoule with a thin nose portion 136 has a larger offset 138 so that the effective height of the chamber 62 is higher and is more suitable for subcutaneous or intramuscular injection. On the other hand, an ampoule with a thicker nose has a smaller offset 138 and is suitable for intradermal injection. In this way, the drive rod 43 of the syringe and the plunger seal 65 in the bore chamber 62 are always at the same relative height so that different ampoules can be used with the same syringe. This relationship compares FIG. 24, which shows an ampoule 25 with a thick nose portion 136 being used for intradermal injection, and FIG. 26, which shows an ampoule 25 with a thin nose portion 138 being used for subcutaneous injection. Will become clear.

  In yet another embodiment, the underside of the ampoule that closely surrounds the lower end of the suction port 36 may be formed with a recess or well 140 with the end of the suction port 63 located deepest. preferable. The well 140 improves the suction effect on the skin and helps to lift the skin into the pocket 139. This is particularly advantageous in the case of intradermal injection. In an ampoule having a single suction port 63, the well 140 is preferably circular, and in an ampoule having two or more suction ports 63, a separate well 140 can be formed in each port 63. Or, as shown in FIG. 12, a single well 140 can be formed that encloses all ports 63 therein.

  FIG. 12 shows a plan view of an ampoule 25 having two suction ports 63 and a single well 140 surrounding both ports. FIG. 13 is a longitudinal cross-sectional view of an ampoule 25 with a chamber 62, which reduces the fluid resistance when the ampoule 25 receives an impact driving force from the spring-loaded drive rod 43 of the syringe 20. The ampoule 25 is provided with a precise throat by having a chamber 62 with a contour 68 on its inner surface to help accelerate. By reducing the fluid resistance in this way, the acceleration of the piston 65 is increased, and as a result, the relative force of the compression drive spring 42 causes the pressure to rise faster and the drug to be injected faster. Accordingly, the drug 31 is delivered from the ampoule 25 by a known controlled impact driving force.

  In addition to the offset 138 difference resulting from the relative thickness of the nose portion 136 of the ampoule body 67, the location and location of the orifice 66 centerline relative to the lower surface 69 of the vacuum port 63 is further intradermal, subcutaneous, or intramuscular. It can be changed by further adjusting the ampoule for injection. Thereby also the drug is injected through the skin of the human or animal to a predetermined depth of the skin layer 64, either laterally or obliquely, horizontally or vertically, or at varying angles ranging between horizontal and vertical. The dispersion of the drug during injection can be controlled by changing the angle of the orifice 66 relative to the vacuum port horizontal plane 69 and the ampoule centerline. In addition, multiple orifices can be provided so that larger dose injections and wider injection patterns can be easily performed. As described above, the ampoule 25 has a locking tab 61 at each end for engaging and latching the syringe 20. This locking tab 61 also correctly positions and holds the ampoule 25 on the syringe 20 so that the suction port 63 is correctly engaged with the vacuum suction tube 71 and the drive rod 43 is aligned with the chamber 62 and the plunger 65. To do. To inject the drug into the recipient's skin 64, the surface of the ampoule and the suction port 71 are used to ensure suction through the port 63 so that the skin 64 between the ports 63 stretches to the recipient's skin 64. The connection surface between the two is sealed by a vacuum port seal 70.

  In addition to being pre-filled, ampule 25 may be filled with drug 31 from an external source using adapter assembly 103 shown in FIG. The ampoule 25 is held and sealed to fill the drug through a rubber seal 104 in the adapter that allows the ampoule 25 to be filled. The adapter 103 includes means for receiving and holding the ampoule 25 so that the orifice 66 is aligned with the passageway 115 via the rubber seal 104. Standard Luer connector 142 provides a means for attaching a filled syringe.

  Another embodiment of an ampoule provided with means for directly filling the inner hole chamber 62 with a medicine is shown in FIGS. In this embodiment, the ampoule is provided with a filling port 143 on the upper surface of the ampoule 25 and is closed by a rubber stopper 106 that can be resealed.

  FIG. 16 shows an unfilled ampoule 25 in which a filling port 143 is connected to the bore chamber 62 by a passage 115. Plug 118 closes orifice 66 and protective covers 107 and 108 maintain the surface and interior of the ampoule in a sterile condition.

  FIG. 17 shows the operation of filling the ampule of this embodiment. During this operation, the probe 111 of the nozzle 110 is inserted into the filling port 143 of the ampoule 25 via the stopper 106. The nozzle 110 is located on the flat top surface 114 of the ampoule 25 and includes a shoulder stopper 116 that accurately positions the probe 11 to fill the drug. The air must first be exhausted from the ampoule passage 115 and the space 113 in the ampoule 25. This is accomplished by using the syringe 109 and its retraction handle 112 to aspirate air prior to filling the ampoule 25 with drug. By removing the probe 11, the plug 106 is resealed, whereby the vacuum passage 115 and the space 113 can be sealed. The new syringe 109 containing the medicine or the probe 111 of the nozzle 110 of the original syringe 109 containing the medicine again is reinserted through the stopper 106, and the above-mentioned syringe is inserted into the ampule 25 after the air is exhausted. Used to fill drugs. The pressure of the medicine injected into the space 113 through the probe 11 and the passage 115 presses the plunger 65 backward in the inner hole chamber 62.

  FIG. 18 shows the means for plugging the ampoule orifice 66 with the plug 118 when filling the medicament. The plug 118 includes an enlarged head 119 having a capture pad 117 that seals against the surface of the ampoule 25 and facilitates removal to prevent the plug 118 from being sucked into the orifice 66, and has a protective double outer. The cover 121 functions as a means for preventing the plug 118 from being pushed out of the orifice 66 during filling. All other openings in ampoule 25 are protected by protective covers 107 and 108 to keep ampule 25 completely sterile and to remove and discard ampoule orifice plug 118 when protective cover 108 is removed. , Whereby the protective covers 107 and 108 preferably include tabs that can be gripped to facilitate removal of the shield from the ampoule 25.

  Referring to the drawings, in the preferred embodiment of the present invention shown in FIGS. 1 and 2, the outer container of a needleless syringe is shown in a plan view and a side view, respectively. The syringe assembly 20 includes a housing 21 that holds the components of the syringe assembly that are actuated by an external handle 30 and a release button 23 shown in plan view. FIG. 2 illustrates means for mounting a drug-filled ampoule 25 in the syringe 20 and includes an access panel 27, end cap 28, and insert fair as a detachable unit for syringe assembly and inspection. A ring 74 is provided.

  FIGS. 3 and 4 respectively show a syringe assembly that shows that the handle 30 is in both the upper and lower rotational positions and, as a result, the positions that all components stored in the housing 21 should take. FIG. This embodiment includes the use of a single filled ampoule 25 and shows the ampoule being held in the syringe assembly. Ampoule 25 has a protruding tab 61 that engages a notch cavity in insert fairing 74 at one end and is positioned relative to the nose of housing 21 by retaining clamp 22 at the other end. Pressed and held, this holding clamp pivots outward away from the ampoule 25 so that the ampoule 25 can be removed and replaced after the ampoule 25 has been used. Ampoule 25 has at least one vacuum suction port 63 associated with injection into the recipient's skin. By placing the ampoule 25 in the syringe 20, the ampoule 25 is positioned under or against the seal 70. This seal is used to seal between the ampoule 25 and the pair of suction tubes 71 so that the ampoule vacuum port 63 is in a vacuum state. The suction tube 71 communicates with a manifold 72 machined in the housing 21 at both ends thereof. The ampoule holding clamp 22 is held in the ampoule holding position by a detent protrusion on the holding clamp, and this detent protrusion engages with a small pocket in the housing 21, and when the holding clamp 22 is in the ampoule holding position, Fit into this pocket to hold it securely. When releasing the clamp 22, the clamp is rotated around the upper detent pocket to remove the ampoule.

  In order to eject the drug fluid 31 from the ampoule 25, the drive rod 43 moves in a bore hole provided in the structure of the housing 21 and drives the chamber opening in the ampoule 25 with which the plunger 65 is in contact. Thereby, fluid is pushed out of the ampoule 25 through the orifice 66 in a pressurized state. The drive rod 43 is driven into the ampoule 25 by a large compression drive spring 42 to apply a load to the protruding ring 120 of the drive rod 43 and to apply a load to the abutment surface 124 of the housing structure at the opposite end. To compress the drive spring 42, the syringe assembly is pivoted about the pivot 24 which is provided and provided with a handle across the assembly. When the handle 30 is rotated upward toward the housing 21, the compression spring 42 is compressed and held in the preload compression position by the release catch 44 and rotates around the pin 58 including the torsion spring 53. As the protruding drive rod ring 120 passes by the side of the tooth 79 of the release catch 44, the torsion spring 53 preloads the release catch 44 downward to immediately latch the drive rod 43.

  In order to compress the compression spring 42 surrounding the drive rod 43, the drive rod 43 also has a retaining ring 59 in a position where its rear end terminates, which is driven by the drive rod latch 48 and In response to the upward rotation, the drive rod 43 is pulled to compress the compression spring 42. To accomplish this compression and preloading of the compression spring 42 as the handle 30 rotates upwardly, the handle 30 is connected to a link 40, which connects the pivot points 41 and 60 to each other. It is connected to a slide frame 45 that slides in a groove that is provided at the end and machined in the housing 21. The slide frame 45 is moved horizontally in the groove by the handle 30 pushing the link 40, and then the link moves the slide frame 45. 3 and 4 show two positions of the slide frame 45 and the handle 30. FIG. An upright leg portion of the slide frame 45 is attached to a drive rod latch 48, and the drive rod 43 and the compression spring 42 are pulled using the drive rod latch, and the compression load energy is accumulated. The drive rod latch 48 rotates about a pivot point pin 52 that holds and engages the connecting link 47 and torsion spring 53. The drive rod latch 48 is biased upward and placed in the unlatched position by a torsion spring to ensure that the drive rod 43 is released when the syringe 20 is activated.

  In order to ensure that the drive rod latch 48 rotates downward against the torsion spring load, the drive rod latch 48 is guided downward to a latch lock position by a ramp 50. The ramp 50 is held in the housing structure 21 by two roll pins 51, and the ramp 50 is sloped to match the angled end portion of the drive rod latch 48. In order to pull back, capture and hold the drive rod retaining ring 59, the drive rod latch 48 has a protruding hook surface on the opposite side. The drive rod retaining ring 59 preferably has a concave recess in the front surface to ensure that the protruding hook of the drive rod latch 48 is engaged while the handle 30 is grasped and the drive rod 43 is pulled back. To do. When the release catch 44 is released, the compression spring 42 drives the drive rod 43 into the ampoule 25 and ejects fluid from the orifice 66 in the ampoule 25. In order to minimize the impact noise of the drive rod protruding ring 120 and the compression spring 42 that strike the end stopper, a plastic or rubber washer 75 is provided on the front side of the drive rod protruding ring to weaken the impact. Yes.

  A connection link 47 connected to the slide frame 45 is connected to the pin 54 at the other end, and engages with an extension 46 of the piston 35 that provides a vacuum to the ampoule vacuum port 63. When the slide frame 45 moves horizontally in a groove machined in the housing structure, the connecting link 47 moves the piston inward and outward in the cylinder 123. In order to create a vacuum behind the piston 35, the piston 35 has an O-ring seal 34. As shown in FIG. 7, the generated vacuum is sent to the suction tube 71 through the suction passage 73 in the structural manifold 72 and subsequently to the vacuum port 63 in the ampoule 25. The vacuum generated by the movement of the piston 35 causes the interlock piston rod 36 to retract. The interlock piston rod includes means for locking and unlocking the release arm 55. When it is necessary to interlock, two vacuum port openings in the manifold 72 cycle the interlock piston rod 36 back and forth. The interlock piston 126 is provided with an O-ring seal 37 and a holding ring 39. The holding ring controls the movement stroke length of the interlock piston and accommodates the interlock piston in its own cylinder 127.

  The interlock piston rod 36 extends into the release arm 55 to lock and retracts from the release arm 55 to unlock. The release arm 55 pivots about a pivot pin 54 that has a torsion spring 33 that positions the arm 55 for engagement with the piston rod 36. When the release arm 55 is in the horizontal position, the release arm 55 is stationary on the bottom surface of the release button 23 as a result of the load by the torsion spring 53, and this release button is held in the housing 21 by the snap ring 32. When the operator depresses the release button 23, the release button depresses the release arm 55 and rotates it, and then the release arm drives the release catch 44 upward to release the engagement with the drive rod 43. The drive rod is then pushed into the ampoule 25 by the compression spring 42 and injects the drug into the recipient's skin tissue.

  The ampoule 25 is shown in the side view of FIG. 11, and FIG. 12 is a plan view of the ampule 25. Ampoule 25 is manufactured from one or more of various plastics, glass, or equivalent medical device specification materials. Ampoule 25 has at least one vacuum port 63 that is used in positioning, stretching and holding the recipient's skin 64. Ampoule 25 further includes at least two locking tabs 61 and an inner cylinder bore chamber 62 for receiving a prefilled medicine. A dose scale is provided on the outer surface of the ampoule 25 adjacent to the inner bore chamber 62. An ampoule plunger 65 shown in FIG. 11 is accommodated in the inner hole chamber 62, captures and accommodates the drug in the inner hole chamber 62, and transmits the force of the drive rod 43 to the drug, thereby passing through the orifice 66. A drug is ejected from the ampoule 25. In order to enhance the injection process, the bore chamber 62 is preferably shaped to have a contour indicated by the numeral 68. Ampoule 25 and syringe 20 use the vacuum generated by syringe 20 to stretch and properly hold the recipient's skin so that ampoule 25 can inject the drug into the skin. Unique in respect. Stretching the skin increases the permeability, thereby reducing the amount of energy required to inject fluid into the tissue. By injecting the drug horizontally to the skin, the tissue positioning can be controlled for ID injection, Sub-Q injection and IM injection. Inner bore 62 and orifice 66 are designed to accelerate the fluid with minimal drag by improved throat profile 68. In order to minimize turbulence and the resulting resistance, the size and length of the ampoule bore is optimized, thereby reducing the energy required to penetrate pain and skin tissue. This process of injecting the drug fluid into the tissue diffuses the drug particles over a wider area than when using a needled syringe, reduces the local pressure in the tissue and from the injection opening in the tissue. Fluid leakage, thereby reducing the possibility of spreading the infection.

  A further embodiment of the present invention is shown in FIG. 19, which shows a side view of the syringe 20 of the present invention, adapted to receive and attach a multiple ampoule assembly 200. FIG. The function, operation and internal components of the syringe 20 are the same as those described above in the single ampoule embodiment above, except for the ampoule, the ampoule attachment to the syringe 20 and the ampoule replacement method. FIG. 12 is a cross-sectional view of a multiple ampoule syringe assembly comprising components of a manual embodiment single ampoule syringe. Similarly, the air driven embodiment may be modified to accept multiple ampoule assemblies 200. The mechanical operation of the hand-operated syringe and air-driven syringe 20 is the same as described herein above, and their description is not necessary unless a clear understanding of the multiple ampoule embodiment is required. Do not repeat.

  As shown in FIGS. 21 and 22, a multiple ampoule syringe housing 201 includes a rotatable multiple unit cartridge 205 that is molded into a plurality of drug fillings formed in a cylinder 222 of plastic or similar material. A used ampoule 25 is accommodated. As shown in FIGS. 20 and 21, the cylinder 222 can rotate around the central shaft 206. The cylinder 222 is manually rotated by a rotation knob 208 that is rotatably attached to the end of the shaft 206. A cartridge 205 containing ampoule 25 is secured to shaft 206 by sleeve 209, thereby providing a means to rotate and position ampoule 25 for injecting fluid. A positioning detent 207 is provided in the syringe housing 21 and is positioned and detented in a series of pockets 204 in the rim of the cartridge 205. Further, a similar detent 214 in the syringe housing 21 engages an annular groove 213 adjacent the end of the shaft 206 to capture and hold the plurality of unit assemblies 200 on the end of the syringe 20. Detents 207 and 214 are preferably ball 215 and spring 216 mechanisms as shown, but other detent mechanisms that provide similar functions may be used.

  The rotation knob 208 is fixed and held on the sleeve 209 by the knob capturing pin 223 so that when the knob is rotated, the cartridge 205 in the housing 201 is rotated about the shaft 206 but not the shaft 206 itself. A sleeve 209 attached to the knob 208 is keyed in the cartridge 205, rotates the cartridge to various ampoule positions, and the positioning detent 207 engages the pocket 204 to be in that position, driving the ampoule 25. Hold the rod 43 in alignment.

  Within the multi-unit 200 cartridge 205, each ampoule 25 includes preferably two but at least one set of vacuum ports 203 and an internal cylinder bore chamber 62 for containing prefilled medication. It is out. Similar to the single ampoule embodiment, each ampoule 25 of the multiple units 200 has a dose scale on its outer surface. Each ampoule 25 accommodates an ampoule plunger 212 in its inner hole chamber 62, and this ampoule plunger captures and accommodates the drug. Similarly, the lumen chamber 62 is the same as the contour shape, size, length and configuration shown in the single ampoule embodiment above, and therefore the injection procedure, injection method and result of the injection are the same.

  The multi-unit assembly 200 includes a similar suction tube 210 and a seal 211 for abutting each ampoule that is positioned for injecting fluid. The stepped surface of the cartridge sleeve 209 depresses the suction tube 210, thereby improving the sealing of the abutment surface by the seal 211 between the suction tube 210 and the ampoule 25. The suction tube 210 is coupled to the syringe manifold system in the same manner as the previously described embodiment.

  On the outer surface of the multi-unit housing 201 is a window 221 through which the state of the various ampoules 25 in the cartridge 205 can be seen by the electronic cord 219 and the serial number 222. This data provides information about the drug and dose used, the date and time of filling, the name of the supplier's laboratory, etc., and / or other relevant information. As with the single ampule, each of the multiple ampules can be protected by a removable tab 220 prior to use.

  In use, the multi-unit ampoule assembly 200 pre-filled with the desired drug in the ampoule 25 is selected, and the detent 214 engages the groove 213 at the end of the shaft 206, thereby causing the multi-unit assembly 200. Is mounted on the syringe 21 by inserting the end of the shaft 206 into the bottomed shaft receiving hole 218 drilled in the end of the syringe housing 21 until it is held in place. The engagement of the detent 214 and the groove 213 is strong enough to hold the multi-unit assembly 200 in place so that it is not accidentally displaced, but is easy to replace the multi-unit assembly 200 with another assembly 200. It is not so strong that it cannot be removed. By placing the multi-unit assembly 200 in place, the ampoule is in place and the knob 208 is rotated to operate the syringe as described above. To prepare a syringe for the next injection using the same multiple unit assembly 200, the syringe is ready again as described above, the drive rod is withdrawn from the used ampoule 25 and the knob 208 is rotated. Just place the next ampoule in place. When all the ampoules in the multiple units are used up or if a different multiple unit is desired, the housing 201 of the multiple units 200 is grasped and pulled out of the syringe.

  Although the principles of the invention have been described above in conjunction with specific methods and apparatus, the specification is illustrative only and embodies the spirit of the invention and can be devised by those skilled in the art in many other configurations. It should be clearly understood that it falls within the scope of the claims set forth in the claims.

It is a top view of the needleless syringe of the present invention. It is a side view of the needleless syringe comprised manually. FIG. 3 is a longitudinal sectional view of the syringe of FIG. 2 before injection. It is sectional drawing after the injection of the syringe of FIG. FIG. 3 is a view of the end cap of the needleless syringe of FIG. 2. FIG. 3 is a vertical sectional view of a vacuum piston portion of the syringe of FIG. 2. FIG. 3 is a longitudinal cross-sectional view of the suction manifold portion of the syringe of FIG. FIG. 6 is a longitudinal cross-sectional view before injection of a variation of a syringe configured to be operated by air pressure. It is a longitudinal cross-sectional view after the injection of the said modification of the syringe comprised so that it might be operated with an air pressure. It is a side view of the return piston housing of the modification of the syringe of FIG. FIG. 9 is an end view of a return piston housing of a variation of the syringe of FIG. 1 is a side view of an ampoule according to the present invention. 1 is a plan view of an ampoule according to the present invention. FIG. 12 is a longitudinal sectional view of the ampoule of FIG. 11. It is the figure of the ampule in the adapter for filling. FIG. 6 is a plan view of a variation of an ampoule according to the present invention having a stopper for filling via a hypodermic syringe. FIG. 16 is a longitudinal cross-sectional view showing the ampule of FIG. 15 with a protective cover in place. FIG. 16 is a longitudinal cross-sectional view of the ampoule of FIG. 15 during filling. FIG. 16 is a longitudinal cross-sectional view of the ampoule of FIG. 15 filled with drug and sealed for use. It is a side view of a multiple ampoule unit syringe. FIG. 20 is a longitudinal cross-sectional view of the multiple ampoule unit syringe of FIG. 19. FIG. 20 is a detailed cross-sectional view of the front end of the multiple ampoule unit syringe of FIG. 19. FIG. 20 is a vertical cross-sectional view showing the vacuum port portion of the ampoule assembly of the multiple ampoule unit syringe of FIG. FIG. 3 is a view of an ampoule assembly showing adjacent ampoules. It is a figure which shows the ampule for intradermal injection in use. It is an enlarged view of intradermal injection. It is a figure which shows the ampule for subcutaneous injection in use. It is an enlarged view of subcutaneous injection.

Explanation of symbols

20 Syringe assembly 21 Housing 22 Retaining clamp 23 Release button 24 Pivot 25 Ampoule 26 Detent 27 Access panel 28 End cap 29 Hand grip 30 Handle 31 Drug 32 Snap ring 33 Torsion spring 34 Seal 35 Vacuum piston 36 Interlock piston rod 37 O-ring 38 Suction port A
39 retaining ring 40 extension link 41 pivot 42 compression drive spring 43 drive rod 44 release catch 45 slide frame 46 extension 47 connector link 48 drive rod latch 49 external air supply fitting 50 ramp 51 roll pin 52 pivot 53 torsion spring 54 pivot pin 55 Release arm 56 Shaft 57 Pivot 58 Pin 59 Retaining ring 60 Pivot 61 Locking tab 62 Cylinder bore 63 Suction port 64 Skin 65 Ampoule plunger 66 Exit orifice 67 Ampoule body 68 Contour 69 Vacuum port surface 70 Vacuum port seal 71 Suction tube 72 Suction manifold 73 Suction Passage 74 Insert fairing 75 Cushion washer 76 Screw 77 Compression spring 78 Drive cylinder 79 Release cylinder C-tooth 80 Interlock hole 81 O-ring 82 Connecting rod 83 Return piston 84 O-ring 85 Compression spring 86 Set screw 87 Actuating frame 88 Pin 89 Trigger assembly 90 Push rod 91 Pressure port 92 O-ring 93 Plug 94 Spring retaining cap 95 Support fitting 96 O-ring 97 Pressure release 98 Spring holding plug 99 Compression spring 100 Valve 101 O-ring 102 Extension housing 103 Luer adapter 104 Rubber seal 105 Sleeve 106 Stopper 107 Pull-out protective shield 108 Pull-out protective shield 109 Syringe 110 Nozzle 111 Probe 112 Pull-in handle 113 Vacuum Space 114 Flat Surface 115 Path 116 Shoulder Stopper 117 Capture Pad 118 Ampoule Orifice Plug 119 Expanding Head 120 Projection Ring 121 Protective outer double cover 122 Side frame groove 123 Cylinder 124 Annular contact surface 125 Channel 126 Small piston 127 Small cylinder 128 Drive spring chamber 129 Vacuum port 130 Valve recess 131 Undercut 132 Air passage 133 Return piston pocket 134 Holding cap Pocket 135 Port 136 Ampoule nose part 137 Ampoule inner chamber part 138 Offset 139 Pocket 140 Recess 141 Dose scale 142 Luer connector 143 Filling port 200 Multiple ampoule assembly 201 Housing 202 Multiple unit cylinder 203 Vacuum port 204 Detent pocket 205 Multiple unit cartridge 206 Shaft 207 Positioning detent 208 Rotation knob 209 Sleeve 210 Multiple units Pull tube 211 suction tube seal 212 more units ampoule plunger 213 annular groove 214 detent 215 ball 216 spring 217 detent 218 shaft receiving hole 219 Electronic identification code 220 detachable tabs 221 window 222 serial number 223 capture pin

Claims (29)

A manually operable elongated housing;
An impact impact injection mechanism in the housing;
A suction force generating means in the housing and cooperating with the impact impact injection mechanism;
A safety interlock mechanism;
It is possible to cooperate with the impact impact injection mechanism and the suction force generating means, and has at least one jet orifice. The drug is passed through the jet orifice in response to an impact applied to the drug by the impact impact injection mechanism. An ampule containing an injectable drug that can be injected into the
Means for aligning with the impact impact injection mechanism and for receiving and holding the ampoule on the syringe in communication with the suction force generating means;
Thereby, the medicine is ejected from the ampule with a jet flow at a speed sufficient to penetrate the skin tissue held against the orifice by the suction force generating means, and the position and angle of the jet orifice. The needleless syringe is configured to inject the drug into the skin, subcutaneously or intramuscularly based on the force generated by the impact shock injection mechanism.   The ampoule includes an elongated body having a front end portion, a rear end portion, a substantially flat upper surface, and a lower surface having a downward offset between the front end portion and the rear end portion. A horizontal inner hole in the main body extends from the rear end portion of the main body to a point substantially adjacent to the stepped surface, the inner hole opens at the rear end portion, A sealing plunger is disposed therein, and the inner hole further includes at least one jet orifice extending through the stepped surface, whereby the inner hole is inserted into the plunger by the impact impact injection mechanism. The medicine according to claim 1, which can hold a certain amount of medicine that can be injected into a skin surface pressed against the orifice and held in response to being pushed forward in the inner hole. Syringe.   The ampoule further includes at least one suction port extending vertically from the upper surface to the lower surface at a point in front of the step surface, the suction port being in fluid communication with the suction force generating means. A suction force generated by the suction force generating means can be applied to the skin surface through the port prior to injection of the medicament, whereby the skin surface is applied to the ampule in the ampoule. The needleless syringe of claim 2, wherein the needleless syringe is attracted to a lower surface and the jet orifice. The impact shock injection mechanism is
The ampoule is capable of linearly reciprocating between an injection preparation position and an injection position within the housing and moving from the injection preparation position to the injection position to contact and push the plunger. A drive rod having a front portion adapted to protrude from the housing into an inner bore;
A compressible drive spring disposed concentrically along a rear portion of the drive rod between a fixed abutment and a protrusion at a substantially intermediate position along the drive rod;
A releasable latch mechanism adapted to engage the protrusion and to hold the drive rod in the injection ready position by the compressed spring;
An injection preparation mechanism adapted to pull the drive rod back and place it in the preparation position for injection;
Accordingly, by activating the injection preparation mechanism, the drive rod is pulled in the housing to compress the drive spring between the fixed contact portion and the protrusion, and the latch mechanism is By positioning the drive rod to engage a protrusion, thereby holding the drive rod in the ready position for injection and releasing the latch mechanism; The compression of the spring is released, thereby pushing the drive rod forward to engage the plunger in the ampoule and driving the plunger toward the drug, thereby causing the drug to move through the orifice. The needleless syringe according to claim 3, wherein the needleless syringe is pushed out and injected into the skin surface.   The suction force generating means is a reciprocating piston disposed in a cylinder in the housing and mechanically connected to the injection preparation mechanism, whereby the drive rod is prepared for injection at the same time. A piston that generates a suction force behind the piston by moving in the cylinder, and means for fluid communication between the cylinder and the ampoule, thereby transmitting the suction force from the cylinder to the ampoule suction port The needleless syringe according to claim 4, comprising:   The safety interlock mechanism is a reciprocating rod capable of responding to the suction force, and is engaged with the latch mechanism according to an insufficient suction force applied to the skin surface through the ampoule suction port. A reciprocating rod adapted to engage, whereby the latch mechanism releases the drive rod and the drive spring from the injection ready position when the ampoule is not in safe contact with the skin surface The needleless syringe of claim 5, wherein the needleless syringe is disabled from operating.   Further comprising a concave recess in the lower surface of the ampoule that surrounds and is concentric with the suction port, thereby applying the suction force generated by the suction force generating means to the skin surface through the port 4. A needleless syringe according to claim 3, wherein the needleless syringe is capable of pulling the skin surface against the lower surface of the ampoule and pulling it into the recess and pressing it against the jet orifice prior to injection of the medicament.   The jet orifice is positioned horizontally in the step surface adjacent its upper end and along the centerline of the bore, whereby the ampoule is adapted for intradermal injection of a drug. 7. The needleless syringe according to 7.   8. The jet orifice according to claim 7, wherein the jet orifice is located in the stepped surface at a downward angle with respect to a centerline of the bore so that the ampoule is adapted for subcutaneous or intramuscular injection of a drug. Needleless syringe.   The ampoule is two suction ports that are laterally spaced on both sides of the center line of the ampoule and that vertically extends the body from the upper surface to the lower surface at a point in front of the step surface. Two suction ports that extend and are in fluid communication with the suction force generating means, and a concave recess in the lower surface surrounding the lower end of the suction port, thereby generating the suction force A suction force generated by the means can be applied to the skin surface via the port, thereby pulling the skin surface into the depression and attracting the lower surface of the ampoule prior to the injection of the drug. The needleless syringe according to claim 2, wherein the needleless syringe is pressed against the jet orifice. A syringe assembly and at least one drug-containing ampoule that is removably attachable to the syringe assembly, the syringe assembly having a manually operable elongated housing, the housing comprising:
A body portion for accommodating mechanical impact impact means, wherein the drive rod is capable of linearly reciprocating between the injection preparation position and the injection position within the housing, and is concentric along the rear portion of the drive rod; A compressible drive spring disposed in the housing, constrained between a fixed abutment in the housing and a protrusion at a position approximately midway between the drive rods, whereby the drive rod is displaced backwards A compressible drive spring that is compressed by, a latch mechanism that cooperates with the protrusion to releasably hold the drive rod in an injection ready position where the spring is compressed, and to try to inject Sometimes releasing means for releasing the latch mechanism and the drive rod, and pushes the drive rod backward to place it in the injection ready position. Thereby, a body portion and a injection preparation means for engaging the latch mechanism while compressing the spring,
A nose front portion adapted to removably receive the at least one ampoule and comprising detent means for releasably securing the ampoule to the syringe assembly when the impact impact mechanism is in the injection ready position; The at least one ampoule includes a main body having a front end, a rear end, a substantially flat upper surface, and a stepped lower surface provided with a front-facing step surface, and the main body includes the rear end. A substantially cylindrical drug chamber disposed horizontally at the end of the step surface and narrowing toward at least one jet orifice in the step surface, the size and position of the chamber being the ampule Receives the front end of the drive rod when the latch mechanism is released and is secured to the syringe assembly And the chamber further contains a sealing plunger that provides a means for retaining the drug in the chamber, such that the plunger is engaged by the drive rod when the latch mechanism is released. The drive rod pushes the plunger forward in the chamber to push the drug in a pressurized state through the jet orifice into the skin surface held against the ampoule. A needleless syringe comprising a front portion.   And at least one suction port disposed vertically through the ampoule body in front of the jet orifice, suction force generating means disposed in the body portion of the housing, and in the housing and the nose portion. And a suction conduit arranged in fluid communication between the suction force generation means and the at least one suction port, whereby the suction force generated by the suction force generation means is applied to the at least one suction port of the ampoule. The needleless syringe of claim 11, wherein the needle force is transmitted and the suction force attracts the skin surface to the ampoule and the orifice prior to injection.   The suction force generating means comprises a piston capable of reciprocating movement within a cylinder in the housing, the piston being connected to the injection preparation means and operable to generate the suction force. 12. The needleless syringe according to 12.   And further comprising an interlock actuated by a suction force adapted to lock the latch mechanism so as not to operate inadvertently in response to an insufficient suction force applied to the skin surface. Comprising a piston operating in a cylinder adjacent to the force generating means and fluidly connected by said suction conduit, said piston having a longitudinally protruding locking rod, said locking rod being spaced apart from said piston Having one end and engaged with the latch mechanism when the interlock is in the locked position and disengaged from the latch mechanism when sufficient suction is applied to the skin through the ampoule, The drive rod and the spring are released from the injection ready position, whereby the driver Brod is also driven when engaging said plunger of the ampoule chamber moves forward, needle-free syringe according to claim 13.   The injection preparation means includes a handle pivotally attached to the housing, a slide frame in the housing that is mechanically coupled to the handle and thereby reciprocates within the housing when the handle rotates. It is attached to the slide frame and engages with the drive rod when the handle is rotated away from the housing, and the compression drive spring of the compression drive spring when the handle is rotated toward the housing. The drive rod is pulled backward against the force, and the latch mechanism is biased to disengage from the drive rod by engagement, the slide frame, and the suction A mechanical link between the piston of the force generating means and the piston The needleless syringe according to claim 14, wherein the needle moves in the cylinder when the handle rotates, and generates a suction force on the ampoule when the handle rotates toward the housing. .   The injection preparation means is mechanically connected to the pneumatically actuated piston in the housing, by means of a pneumatically actuated piston in the housing, a compressed air source, an air conduit, a trigger operated valve, and A slide frame that reciprocates within the housing when the piston is activated, and is attached to the slide frame and engages the drive rod when the pneumatically actuated piston is driven in a first direction. The drive rod is pulled backward against the force of the compression drive spring when the pneumatically actuated piston is driven in the second direction, and is engaged with the drive rod by the engagement of the latch mechanism. Drive rod latch urged so as to be released, slide frame and suction force generating means A mechanical link disposed between the piston, the suction piston moves in the suction piston cylinder when the pneumatic piston is activated, and the pneumatic piston 15. A needleless syringe according to claim 14, wherein said ampule generates a suction force when driven in said second direction.   Further comprising a concave recess in the lower surface of the ampoule that surrounds and is concentric with the suction port, thereby applying the suction force generated by the suction force generating means to the skin surface through the port 14. A needleless syringe according to claim 13, wherein the needleless syringe is capable of pulling the skin surface against the lower surface of the ampoule and retracting into the recess and pressing against the jet orifice prior to injection of the medicament.   The jet orifice is positioned horizontally in the step surface adjacent its upper end and along the centerline of the bore, whereby the ampoule is adapted for intradermal injection of a drug. 17. A needleless syringe according to item 17.   18. The jet orifice according to claim 17, wherein the jet orifice is located in the stepped surface at a downward angle with respect to a centerline of the inner bore so that the ampoule is adapted for subcutaneous or intramuscular injection of a drug. Needleless syringe.   The ampoule is two suction ports that are laterally spaced on both sides of the center line of the ampoule and that vertically extends the body from the upper surface to the lower surface at a point in front of the step surface. Two suction ports that extend and are in fluid communication with the suction force generating means, and a concave recess in the lower surface surrounding the lower end of the suction port, thereby generating the suction force A suction force generated by the means can be applied to the skin surface via the port, thereby pulling the skin surface into the depression and attracting the lower surface of the ampoule prior to the injection of the drug. The needleless syringe according to claim 11, wherein the needleless syringe is pressed against the jet orifice.   The at least one ampoule comprises a multiple ampoule assembly comprising a plurality of identical ampules disposed about and parallel to a central shaft within the cylindrical assembly, the cylindrical assembly comprising a An ampoule can be rotated about the shaft to sequentially align the drive rod and the suction conduit, the nose forward portion of the housing having a socket for receiving the central shaft therein, the socket and The shaft has cooperating detent means for removably securing the multiple ampoule assembly to the syringe housing, and the nose portion accurately and sequentially aligns each of the ampules with the drive rod and the suction conduit. In order to ensure that the ampule Having cooperable with detent means, needle-free syringe according to claim 14.   The at least one ampoule further comprises a filling port disposed on the top surface of the body, the filling port being in fluid communication with the front end of the chamber and a filling syringe for injecting medication into the chamber A self-sealing plug disposed in the conduit for receiving a needle or probe, wherein the ampoule includes a detachable plug that temporarily closes the jet orifice during filling, and the filling port, the detachable The needleless syringe according to claim 14, further comprising a removable plug and a removable protective seal covering the open rear end of the chamber.   The injection preparation means is mechanically coupled to the solenoid within the housing and electrically actuated solenoid, power supply, electrical circuit, trigger actuated switch, and within the housing, whereby the solenoid is activated. A slide frame that reciprocates within the housing, and is attached to the slide frame, and engages with the drive rod when the solenoid is driven in the first direction, and the solenoid is in the second direction. A drive rod latch that pulls the drive rod backward against the force of the compression drive spring when driven, and is biased to disengage from the drive rod by engagement of the latch mechanism And between the slide frame and the piston of the suction force generating means Comprising a mechanical link, whereby the suction piston moves in the suction piston cylinder when the solenoid is actuated and when the pneumatically actuated piston is driven in the second direction The needleless syringe according to claim 14, wherein a suction force is generated in the ampoule.   The drive rod is divided into two sections: a rear section coaxial with the compression drive spring and a front section adapted to enter the ampoule, and the front section and the rear by shock absorbing means. The sections are integrated so that the shock absorbing means operates to absorb the initial impact shock when the drive spring is released, so that the impact of the drive rod on the ampoule plunger is reduced. 15. A needleless syringe according to claim 14, which is smooth and constant.   The drive rod is divided into two sections: a rear section coaxial with the compression drive spring and a front section adapted to enter the ampoule, and the front section and the rear by means of shock absorption. The sections are integrated so that the shock absorbing means operates to absorb the initial impact shock when the drive spring is released, so that the impact of the drive rod on the ampoule plunger is reduced. A needleless syringe according to claim 4 which is smooth and constant. The impact shock injection mechanism is
It is possible to reciprocate linearly between the injection preparation position and the injection position within the housing, and the movement from the injection preparation position to the injection position causes the plunger to contact and drive the plunger from the housing. A drive rod having a front portion adapted to project into the ampoule bore;
Pneumatic means for reciprocating the drive rod between the injection preparation position and the injection position;
Comprising manually operated valve means for activating the pneumatic means,
A first actuation of the pneumatic means causes the drive rod to be pulled backwards within the housing, thereby allowing an ampoule to be attached to the syringe, and a second actuation of the pneumatic means. The drive rod is pulled forward, thereby engaging the plunger with the ampoule and pushing the plunger against the drug, whereby the drug is pushed through the orifice and onto the skin surface. 4. The needleless syringe according to claim 3, which is injected. The impact shock injection mechanism is
The plunger is capable of linearly reciprocating between the injection preparation position and the injection position within the housing and moving from the injection preparation position to the injection position to contact and drive the plunger from the housing. A drive rod having a front portion adapted to project into the ampoule bore;
Solenoid means for reciprocating the drive rod between the injection preparation position and the injection position;
Comprising manually operated switch means for actuating the solenoid means,
A first actuation of the solenoid means causes the drive rod to be pulled rearwardly within the housing, thereby allowing an ampoule to be attached to the syringe, and a second actuation of the solenoid means causes the A drive rod is pulled forward, thereby engaging the plunger with the ampoule and pushing the plunger against the drug so that the drug is pushed through the orifice and injected into the skin surface. The needleless syringe according to claim 3.   The injection preparation mechanism includes a pneumatically actuated piston, and a slide frame in the housing mechanically connected to the pneumatically actuated piston for reciprocating in the housing by pneumatic actuation of the pneumatically actuated piston. , Valve means for directing pneumatic fluid to the pneumatically actuated piston, and the piston is engaged with the drive rod upon activation, and is disengaged from the drive rod by engagement of a releasable latch mechanism A drive rod latch attached to the slide frame that is urged to move, and a mechanical link between the pneumatically operated piston and the suction force generating means, wherein the suction force generating means is the pneumatically operated piston The needleless syringe of claim 6, wherein the needleless syringe is activated when activated. The injection preparation mechanism includes an electrically operated push-pull solenoid having a reciprocating core, and a slide frame in the housing mechanically connected to the reciprocating core so that the solenoid reciprocates within the housing by operation. And a power supply, switch means for connecting the power supply and the solenoid to be operable to actuate the solenoid, and attached to the slide frame and engaged with the drive rod by actuation of the solenoid A drive rod latch that is biased to disengage from the drive rod by engagement of the releasable latch mechanism, and a mechanical disposed between the solenoid and the suction force generating means A link, whereby the suction when the solenoid is actuated. Force generating means is activated, the needle-free syringe according to claim 6.

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