DE102022120628A1 - Medical puncture system - Google Patents

Abstract

The invention relates to a medical puncture system for performing a puncture on a patient with the features of claim 1. The medical puncture system can in principle be used for all types of punctures. The medical puncture system is particularly suitable for performing minimally invasive percutaneous nephrolitholapaxy (mini-PCNL).

Description

The invention relates to a medical puncture system for performing a puncture on a patient with the features of claim 1. The medical puncture system can in principle be used for all types of punctures. The medical puncture system is particularly suitable for performing minimally invasive percutaneous nephrolitholapaxy (mini-PCNL).

Mini-PCNL is a urological-surgical procedure for the removal of kidney stones. Although it is gentle and has few complications due to the miniaturization of the instruments, several work steps are required to carry it out, some of which also have to be carried out under X-ray and sonographic control.

First, the hollow system of the kidney is punctured with a thin needle under ultrasound control. Under X-ray control, after inserting a guide wire over the needle and retracting it with a dilator threaded over the guide wire, the puncture channel is widened so that a so-called Amplatz shaft can then be inserted via the dilator. After the dilator has been removed, a specialized endoscope, a so-called nephroscope, is advanced into the hollow system of the kidney via this shaft. A laser fiber is passed through the working channel of the nephroscope and is used for lithotripsy of kidney stones. The resulting stone fragments are then flushed out by the permanent rinsing flow in the hollow system of the kidney between the Amplatz shaft and the nephroscope. This conventional implementation of a mini-PCNL requires several different instruments that must be provided separately and used one after the other.

From the DE 10 2009 060 921 A1 a puncture needle system for puncturing an organ, in particular a kidney, is known, which includes optics in the puncture needle tip. The known puncture needle system is only designed for relatively small inner lumens of the working shaft, which results from the fact that the outer diameter of the working shaft should be relatively small (less than 6 Fr) and further bulging of the access opening should be avoided. This means that only a relatively small inner lumen is available to carry out the work. If the diameter of the working shaft is not sufficient to accommodate a device for disintegration of the stone, which is used, for example, for mechanical lithotripsy or works with laser energy, in the known puncture needle system the working shaft must first be pulled out of the canal, a guide wire inserted and along it Guide wire, a larger working shaft with an obturator can be inserted to bougien the access.

Such a procedure is relatively time-consuming, requires very careful work by the surgeon and is associated with increased stress on the patient.

The invention is based on the object of specifying an improved puncture system which avoids the previously explained disadvantages and accordingly improves the safety of the medical procedure.

1. a) die Schafteinheit hat einen äußeren tubusförmigen Körper mit einem inneren Arbeitslumen und einen ersten Griffabschnitt, der zum manuellen Handhaben der Schafteinheit eingerichtet ist und an einem patientenfernen Abschnitt mit dem äußeren tubusförmigen Körper verbunden ist,
2. b) die Dilatatoreinheit hat einen inneren tubusförmigen Körper mit einem inneren Punktionslumen und einen zweiten Griffabschnitt, der zum manuellen Handhaben der Dilatatoreinheit eingerichtet ist und an einem patientenfernen Abschnitt mit dem inneren tubusförmigen Körper verbunden ist, wobei der innere tubusförmige Körper durch das Arbeitslumen des äußeren tubusförmigen Körpers führbar ist,
3. c) die Punktionsnadeleinheit hat eine Punktionsnadel und einen dritten Griffabschnitt, der zum manuellen Handhaben der Punktionsnadeleinheit eingerichtet ist und an einem patientenfernen Abschnitt mit der Punktionsnadel verbunden ist, wobei die Punktionsnadel durch das Punktionslumen des inneren tubusförmigen Körpers führbar ist.

This task is solved by a medical puncture system with a shaft unit, a dilator unit and a puncture needle unit for performing a puncture on a patient, with the following features:

1. a) the shaft unit has an outer tubular body with an inner working lumen and a first handle section which is set up for manual handling of the shaft unit and is connected to the outer tubular body at a section remote from the patient,
2. b) the dilator unit has an inner tubular body with an inner puncture lumen and a second handle section which is set up for manual handling of the dilator unit and is connected to the inner tubular body at a section remote from the patient, the inner tubular body passing through the working lumen of the outer tubular body can be guided,
3. c) the puncture needle unit has a puncture needle and a third handle section, which is set up for manual handling of the puncture needle unit and is connected to the puncture needle at a section remote from the patient, the puncture needle being able to be guided through the puncture lumen of the inner tubular body.

The puncture system according to the invention allows minimally invasive procedures to be carried out, in particular a mini-PCNL, with a single, integral tool system in which all the necessary elements are integrated and the surgeon does not have to resort to additional instruments or change between individual instruments. The surgeon can carry out the complete puncture up to the precise positioning of the comparatively large-lumen outer tubular body quickly and with little impact Carry out patient treatment. The medical puncture system supports the surgeon with its design features in terms of safe, error-free and quick work.

The outer tubular body can be dimensioned in such a way that
a device for disintegration of the stone and suction of the stone fragments can be carried out through this outer tubular body. The outer tubular body can be designed, for example, as an Amplatz shaft. Thanks to the integrated dilator, the necessary expansion of the puncture site can be carried out in one operation.

The terms “puncture” and “puncture” are to be understood in a medical sense. “Puncturing” refers to the insertion of a puncture needle into the hollow body in such a way that the puncture needle penetrates the shell of the hollow body to be punctured.

Parts of parts of the puncture system that are close to the patient are those parts that, from the user's perspective, are arranged at the distant (distal) end of the puncture system and thus in the vicinity of the patient's punctured area. Accordingly, sections remote from the patient are arranged at the proximal end of the puncture system from the user's perspective, i.e. h further away from the patient's punctured area. If the word “or” is used below, possible alternatives are shown, but combinations of the features or characteristics separated by “or” are also explicitly possible. For the purposes of the present invention, the indefinite term “a” is not to be understood as a numeral. For example, if we are talking about a component, this should be interpreted in the sense of “at least one component”.

The invention also provides an improved system in the sense of a general puncture system. In principle, with the puncture system according to the invention, it is also possible to advantageously puncture all body cavities and interbody spaces and all anatomical and pathological structures that are to be punctured and to carry out corresponding interventions.

Components of the improved puncture system can in principle be combined with all known intervention, puncture and catheter systems or used as independent products.

The term “puncture system” will be retained in the following, but has a broader meaning in the sense of a general puncture system with which not only PCNL can be carried out.

With the puncture system according to the invention, interventions can basically be carried out in and on all body cavities and interbody spaces and all anatomical and pathological structures, examples of which include the trachea, pleural space, abdominal and pelvic space, stomach, intestines, gallbladder, urinary bladder and cerebrospinal fluid space. In addition, interventions can be made on pathological structures such as abscesses in and on the patient.

The term “patient” includes all living beings of all ages and genders. Applications in technical areas and in and on all objects and structures, e.g. in and on reservoirs, containers, cavities, expandable materials and in and on pumps, hoses, pipes and port systems, are also explicitly possible.

All components described can be used one or more times on a puncture system or independently of one on/in other products or completely independently. Various features of different components can also be freely combined and features of certain components can also be used on other components without this being explicitly mentioned. In principle, all components and features can be used inside and outside of a patient.

The puncture system according to the invention is characterized in that it combines all the necessary components for carrying out a PCNL, in particular mini-PCNL, into one instrument. All components are connected to each other at the handle area and can be detached from each other. The user can only operate the connection and release steps in a certain sequence on the handle area. This ensures a safe sequence of the individual process steps and thus prevents the risk of accidental incorrect operation of the individual components.

The first, second and third handle sections are each shaped to be particularly easy to grip, ie ergonomically shaped, so that they support easy and safe gripping by the user. This has the advantage that the user does not have to place the individual parts of the puncture system in places that are not actually intended for this purpose, such as: B. on Luer/Lock connections, but has defined handle sections available, which stand out visually from other parts of the puncture system due to their easy-to-grip design Users can therefore easily perceive them as handle sections. This also promotes intuitive working with the puncture system according to the invention.

The first, second and/or third handle sections can have a hyperboloid shape, for example. For example, the curvature of the hyperboloid shape of the second handle section can be less than the curvature of the first and/or third handle sections. The first, second and/or third handle section can also be designed as another rotationally symmetrical body. On the outer surface of the first, second and/or third handle section, grooves and/or knobs or another surface structure can also be present to increase the grip.

Individual or all handle sections can at least partially consist of or be coated with a material that increases the frictional resistance. This prevents the user's fingers from accidentally slipping. The grip area can also be completely or partially z. B. made of an elastomer, e.g. B. rubber or silicone, or made of any other material that is softer than the other material of the puncture system.

Individual or all handle sections can also consist of at least one antimicrobial material or be coated with at least one.

Individual or all handle sections can also consist of or be coated with at least one material that has particularly hydrophobic properties. Properties in the sense of or similar to a lotus effect are also conceivable.

Individual or all handle sections can at least partially be designed in a different color than the other components of the puncture system, for example in green, yellow or red. In particular, the handle sections can be designed in different colors. This is intended to remind the user of the colors of a traffic light and can indicate the sequence of the operating steps. In addition, the sequence of the operating steps can be identified by numbering or generally a label, for example numbering or other labeling of the handle sections. Special patterns in the handle area are also possible, e.g. cross- or arrow-like patterns.

However, it is also conceivable that areas of the puncture system that must not be touched, for example to prevent contamination with germs, are at least partially designed in red or another conspicuous color.

The color “yellow” is also conceivable, at least partially in areas that should not be touched, but which can still be touched in special situations. The color “green” can then be used for areas that can be touched.

Strongly bright or fluorescent colors are also particularly conceivable.

It is also conceivable that individual or all handle sections are initially covered by an adhesive structure, e.g. a film, which can be removed before, during or after the puncture process. The features explained for the handle sections can be implemented individually or in combination on one or more other components of the puncture system.

In a further advantageous embodiment, the puncture system is designed to be partially, predominantly or completely transparent so that fluid/urine/blood flows can be recognized directly. The puncture needle can also be designed to be transparent, provided the material properties allow it.

According to an advantageous embodiment of the invention, it is provided that the first handle section can be releasably coupled to the second handle section by positive locking via at least one positive coupling element and/or the second handle section can be releasably coupled to the third handle section by positive locking via at least one positive coupling element. This has the advantage that, on the one hand, the first handle section can be reliably coupled to the second handle section, but it can also be detached from it if necessary, so that after carrying out a working section of a puncture on the patient, the corresponding subunit of the puncture system can be removed. Likewise, the second handle section can be reliably coupled to the third handle section, but can also be detached from it if necessary.

According to an advantageous embodiment of the invention, it is provided that the first, second and third handle sections form a homogeneous handle section for gripping and manually handling the puncture system when they are coupled to one another via the positive coupling elements. The homogeneous handle section formed in this way forms a type of handle of the puncture system. The first, second and third handle sections can each form part of such a handle. The homogeneous handle section can, for example, be designed to be homogeneous in the sense that the first handle section merges into the second handle section without a noticeable transition or with a gentle transition. In addition, the second handle section can merge into the third handle section without a noticeable transition or with a gentle transition. The first handle section can directly adjoin the second handle section. The second handle section can directly adjoin the third handle section.

According to an advantageous embodiment of the invention, it is provided that the second handle section, which is positively coupled to the first handle section, can be released from it by a rotational movement relative to the first handle section and/or the third handle section, which is positively coupled to the second handle section, can be released by a rotational movement relative to the second Handle section can be detached from it. In this way, accidental detachment of one handle section from the other handle section is reliably avoided. To release, the user must perform a defined rotational movement of a handle section relative to the adjacent handle section. The rotational movement required to release one handle section from the other handle section can, for. B. be a rotation in an angular range of 90 to 180 degrees. In particular, a thread can be avoided to realize the positive coupling, which has the advantage that there is no need to turn one handle section several times from the other handle section, i.e. H. an angle of more than 360 degrees is required.

The second handle section can be released from the first handle section relative to the first handle section, for example, by a rotational movement about the longitudinal axis. The positive coupling between the first and second handle sections can be designed in the manner of a bayonet connection. The third handle section can be released from the second handle section relative to the second handle section by a rotational movement about the longitudinal axis. The positive coupling between the second and third handle sections can be designed in the manner of a bayonet connection.

According to an advantageous embodiment of the invention, it is provided that the puncture needle is longitudinally displaceable relative to the inner tubular body, the puncture needle unit being removable from the dilator unit in a direction facing away from the end of the puncture system near the patient. To remove the puncture needle unit, the positive coupling between the second and third handle sections must first be removed.

According to an advantageous embodiment of the invention, it is provided that the inner tubular body is longitudinally displaceable relative to the outer tubular body, the dilator unit being removable from the shaft unit in a direction facing away from the end of the puncture system near the patient. To remove the dilator unit, the positive coupling between the first and second handle sections must first be removed.

With such an advantageous embodiment, e.g. B. the puncture can be carried out in such a way that initially only the puncture needle is guided with its tip first to the desired position inside the patient's body. Then the positive coupling between the second and third handle sections is released. Now the still connected unit consisting of the dilator unit and the shaft unit can be pushed forward. It is guided over the puncture needle. The puncture needle therefore acts like a guide wire. The opening is widened by the dilator unit so that the shaft unit can also be advanced. Once the unit consisting of the dilator unit and the shaft unit is placed in the correct place, the puncture needle unit can be removed, i.e. H. the puncture needle unit is pulled out of the inner tubular body. Then the positive coupling between the first and second handle sections can be released and the shaft unit can be advanced and placed in the correct location. The dilator unit can then be removed by pulling it out of the outer tubular body. This means that only the shaft unit with the relatively large outer tubular body remains on the patient. A lithotripter, for example, can be guided directly through this outer tubular body.

According to an advantageous embodiment of the invention, it is provided that the puncture system has a safety mechanism which ensures that the dilator unit can only be removed from the shaft unit when the third handle section is decoupled from the second handle section and/or the puncture needle unit has been removed from the dilator unit is. This supports the surgeon in working safely. Due to its design, the puncture system prevents the dilator unit from being incorrectly pulled out together with the puncture needle unit or the shaft unit from being advanced without the dilator unit.

According to an advantageous embodiment of the invention, it is provided that the positive coupling between the first and the second handle section is secured via the securing mechanism, the securing mechanism having a secured and an unlocked state has, wherein in the secured state a release of the first handle section from the second handle section is prevented and in the unlocked state a release of the first handle section from the second handle section is enabled. This allows the safety mechanism to be implemented in a structurally simple manner while at the same time functioning reliably. In particular, the security mechanism can be implemented by components that interact with one another purely mechanically.

According to an advantageous embodiment of the invention, it is provided that the puncture needle unit has at least one securing element which blocks the securing mechanism in the secured state and which prevents the securing mechanism from being transferred into the unlocked state. The securing element can, for example, protrude from the third handle section in the direction of the first handle section and extend in the longitudinal direction predominantly or completely through an inner chamber of the second handle section.

According to an advantageous embodiment of the invention, it is provided that the third handle section is arranged further from the end of the puncture system near the patient than the second handle section, at least when the puncture needle is guided through the puncture lumen of the inner tubular body.

According to an advantageous embodiment of the invention, it is provided that the second handle section is arranged further from the end of the puncture system near the patient than the first handle section, at least when the inner tubular body is guided through the working lumen of the outer tubular body.

According to an advantageous embodiment of the invention, it is provided that the inner tubular body has a dilatation section in an area close to the patient, which tapers on the outer circumference towards the end of the puncture system close to the patient. The dilation section can, for example, connect directly to a hollow cylindrical part of the inner tubular body. The dilation section can e.g. B. have a linear, progressive or degressive ramp-shaped outer contour. The difference between the outer diameters of the inner tubular body and the outer tubular body is relatively small, e.g. B. less than 50% of the outer diameter of the inner tubular body.

According to an advantageous embodiment of the invention, it is provided that the puncture needle is designed as a hollow needle and in the area of the third handle section there is an opening through which liquid can be directed outwards from the area of the puncture needle near the patient through the puncture needle. This has the advantage that the correct puncture process and the correct placement of the puncture needle tip can be checked based on liquids emerging from the opening. For example, there can be a hose connection at the opening, for example a Luer lock connection.

The puncture needle can have a tip at the end near the patient, e.g. B. in a conical shape or in the form of an oblique cut.

Materials for the puncture needle can be metal materials, in particular stainless steel or generally metal alloys. The puncture needle can also consist of a plastic material. It can also be made entirely or partially of lightweight construction or made of at least one absorbable material that is easily soluble in urine, blood, infusion solutions or other fluids, for example a sugar or a salt, for example in the area of the puncture tip. Magnesium can also be used. Likewise, the puncture needle can advantageously be further developed with at least one sensor, for example in the area of the puncture tip.

According to an advantageous embodiment of the invention, it is provided that the puncture needle has at least one optical component, at least in the area close to the patient, through which light can be emitted towards the patient and/or images can be recorded. The optical component can, for example, be coupled to a display device arranged separately from the puncture system or attached to the puncture system. For example, image information recorded by the optical component can be displayed on the display device. In this way, the surgeon can visually check that the puncture is performed correctly and that the puncture needle tip is correctly placed.

It is also conceivable that a commercially available smartphone or a similar device can be used as the display device, which communicates with the optical component and/or with other components of the puncture system. Communication can also take place wirelessly via waves/electromagnetic fields, for example.

The optical component can have, for example, an electrical light source, an optical fiber and/or a camera. If the puncture needle is designed as a hollow needle, the optical component can be arranged, for example, in the inner lumen of the puncture needle.

According to an advantageous embodiment, it is provided that the at least one optical component in the area near the patient completely closes the inner lumen of the puncture needle and, viewed from the end of the puncture needle near the patient, the puncture needle has one or more lateral openings behind this closure point. This has the advantage that, despite the area of the puncture needle closed by the optical component, the liquid can be guided from the area of the puncture needle near the patient through the puncture needle to the third handle section and in particular to its opening through the side openings behind it.

According to an advantageous embodiment of the invention, it is provided that the inner tubular body protrudes from the outer tubular body at the end remote from the patient, at least when the first, second and third handle sections are coupled to one another via the positive coupling elements. The end of the inner tubular body remote from the patient extends into the interior of the second handle section.

According to an advantageous embodiment of the invention, it is provided that the inner tubular body protrudes from the outer tubular body at the end near the patient, at least when the first, second and third handle sections are coupled to one another via the positive coupling elements. The inner tubular body can protrude from the outer tubular body at least by the length of the dilation section.

According to an advantageous embodiment of the invention, it is provided that the puncture needle protrudes from the inner tubular body at the end remote from the patient, at least when the first, second and third handle sections are coupled to one another via the positive coupling elements. The end of the puncture needle remote from the patient extends into the interior of the third handle section.

According to an advantageous embodiment of the invention, it is provided that the puncture needle protrudes from the inner tubular body at the end near the patient, at least when the first, second and third handle sections are coupled to one another via the positive coupling elements. In this way, the medical puncture system in the basic state, in which the puncture system can be delivered by the manufacturer, for example, can be used directly as an integrated tool for carrying out the entire puncture process. The user does not need to make any special preparations for the puncture system. Rather, the puncture system can be guided directly with the tip of the puncture needle first to the desired location inside the patient's body. This can be additionally checked and visualized, for example, through an ultrasound examination or radiological monitoring. If the puncture needle is correctly placed, the individual parts of the puncture system can then be moved or removed one after the other, as explained above, until ultimately only the shaft unit remains on the patient. The length of the part of the puncture needle protruding from the third handle section can, for example, be at least 1.5 times as large as the length of the part of the outer tubular body which protrudes from the first handle section.

In this way, the puncture system according to the invention allows a type of all-in-one puncture and accordingly an optimized workflow for nephrolitholapaxy. The surgeon does not have to switch between different instruments.

According to an advantageous embodiment of the invention, it is provided that the puncture system is set up to carry out a minimally invasive percutaneous nephrolitholapaxy (mini-PCNL). The puncture system is also just as advantageous for comparable minimally invasive procedures, especially for endoscopic procedures.

According to an advantageous embodiment of the invention, it is provided that the outer tubular body is adjustable in length and/or has at least one predetermined breaking point for selectively shortening the outer tubular body and/or is designed to be slotted in the longitudinal direction from the end remote from the patient. This has the advantage that the length of the outer tubular body can be adapted to specific characteristics of the operation and the patient directly while an operation is being carried out, i.e. it can be shortened to a desired length. This can optimize the irrigation flow and improve the flushing out of stone fragments and prevent the outer tubular body from protruding unnecessarily far from the patient, which would make it more difficult to carry out procedures. For example, the outer tubular body can be slotted from the end remote from the patient over a section of 10 to 50% of the total length. Likewise, the first handle section can be designed to be slotted, so that the handle section can also be divided due to the slotted design. If predetermined breaking points are present, these can be arranged at equal or unequal distances from one another over the longitudinal extent of the outer tubular body, for example at intervals of at least 1 cm.

In a further, independent aspect, the invention relates to an outer tubular body in the form of an Amplatz shaft for carrying out a percutaneous nephrolitholapaxy, the Amplatz shaft having a plurality of circumferential notches distributed over its longitudinal extent, through which predetermined breaking points for selectively shortening the Amplatz shaft at a respective one User selected location are formed. The previously explained advantages can also be realized in this way. The Amplatz shaft can have one or more of the aforementioned features of the outer tubular body.

It is also possible to remove the Amplatz shaft while performing nephrolitholapaxy, i.e. H. If this is already applied to the patient, it can be shortened using a tool. This is particularly advantageous if the outer tubular body is designed as a socket for carrying out percutaneous nephrolitholapaxy. A pipe cutter, for example, can be used as a tool, especially if the material of the outer tubular body is relatively hard. If the material is softer, scissors can also be used to cut it off. This procedure is also possible if the Amplatz shaft is designed without the previously explained predetermined breaking points.

In this respect, the invention also relates to a method for adjusting the length of an Amplatz shaft for carrying out a percutaneous nephrolitholapaxy, in which the Amplatz shaft is shortened to a desired dimension before or during the performance of the percutaneous nephrolitholapaxy on the patient, for example by removing a piece of the Amplatz shaft using a Tool is separated and / or a piece of the Amplatz shaft is broken off using at least one predetermined breaking point.

The invention is explained in more detail below using exemplary embodiments using drawings.

• 1 ein medizinisches Punktionssystem in perspektivischer Ansicht,
• 2 eine Ausschnittsvergrößerung des patientennahen Bereichs des medizinischen Punktionssystems gemäß 1,
• 3 einzelne Baueinheiten des medizinischen Punktionssystems,
• 4 den Griffabschnitt des medizinischen Punktionssystems in teilweise geschnittener perspektivischer Ansicht,
• 5 den Griffabschnitt gemäß 4 in Seitenansicht,
• 6 eine Schnittansicht gemäß der in 5 dargestellten Schnittebene B-B,
• 7 eine Schnittansicht gemäß der in 5 dargestellten Schnittebene A-A,
• 8 eine weitere teilweise Schnittansicht analog zu 4,
• 9 ein Griffabschnitt gemäß 8 in Seitenansicht,
• 10 eine Schnittansicht gemäß der in 9 dargestellten Schnittebene D-D,
• 11 eine Schnittansicht gemäß der in 9 dargestellten Schnittebene C-C,
• 12 eine weitere teilweise Schnittansicht analog zu 4,
• 13 den Griffabschnitt gemäß 12 in Seitenansicht,
• 14 eine Schnittansicht gemäß der in 13 dargestellten Schnittebene E-E,
• 15 eine Bildwiedergabeeinheit,
• 16-19 Schritte bei der Durchführung einer Mini-PCNL,
• 20 eine weitere Ausführungsform einer Schafteinheit in Seitenansicht,
• 21 die Schafteinheit gemäß 20 in einer Frontansicht des ersten Griffabschnitts,
• 22 die Schafteinheit gemäß 20 in modifizierter Form,
• 23 die Platzierung der Schafteinheit gemäß 22 am Patienten,
• 24-28 eine Schafteinheit mit Sollbruchstellen,
• 29-33 ein gekürzter tubusförmiger Körper mit einem Abschlusskörper.

Show it

• 1 a medical puncture system in a perspective view,
• 2 an enlargement of the area of the medical puncture system close to the patient 1 ,
• 3 individual structural units of the medical puncture system,
• 4 the handle section of the medical puncture system in a partially sectioned perspective view,
• 5 the handle section accordingly 4 in side view,
• 6 a sectional view according to in 5 illustrated section plane BB,
• 7 a sectional view according to in 5 shown section plane AA,
• 8th another partial sectional view analogous to 4 ,
• 9 a handle section according to 8th in side view,
• 10 a sectional view according to in 9 illustrated section plane DD,
• 11 a sectional view according to in 9 shown section plane CC,
• 12 another partial sectional view analogous to 4 ,
• 13 the handle section accordingly 12 in side view,
• 14 a sectional view according to in 13 illustrated section plane EE,
• 15 an image display unit,
• 16-19 Steps in conducting a mini PCNL,
• 20 another embodiment of a shaft unit in side view,
• 21 the shaft unit accordingly 20 in a front view of the first handle section,
• 22 the shaft unit accordingly 20 in modified form,
• 23 the placement of the shaft unit accordingly 22 on the patient,
• 24-28 a shaft unit with predetermined breaking points,
• 29-33 a shortened tubular body with a final body.

With reference to the 1 to 3 The basic structure of the medical puncture system is first explained. The medical puncture system is essentially made up of three structural units, namely a shaft unit 14, a dilator unit 13 and a puncture needle unit 12. The puncture needle unit 12 has a puncture needle 1 and a third handle section 6 connected to the puncture needle 1. The dilator unit 13 has an inner tubular body 2 and a second handle section 5, which is connected to the inner tubular body 2. The shaft unit 14 has an outer tubular body 3 and a first handle section 4 connected thereto. The puncture needle 1 can be placed in the patient near area A, ie at the end, be sharpened, ie have a puncture needle tip. The puncture needle 1 can be designed as a hollow needle. In this case, optics 7 can be arranged within the puncture needle. The optics 7 can be guided outwards via an electrical cable 8 or light guide through the puncture needle 1 and through the third handle section 6 and connected to an image display unit. At the end remote from the patient, the puncture needle unit 12, e.g. B. behind the third handle section 6, have a kink protection 11, which prevents the electrical cable 8 or the light guide from kinking. In addition, the puncture needle 1 can have one or more side openings 9, which are arranged behind the optics 7 when viewed from the end of the puncture needle 1 near the patient. Body fluids can enter the interior of the puncture needle 1 through the side openings 9. The puncture needle unit 12 can, for example, have an opening 10 in the area of the third handle section 6, e.g. B. with a Luer connection in order to direct and collect and/or analyze the liquids received via the side openings 9 to the outside.

In the dilator unit 13 it can be seen that the outer tubular body 2 has a dilation section 25 at the end near the patient. In the delivery condition, which is in the 1 is shown, viewed from the end A near the patient, the second handle section is located behind the first handle section and the third handle section is behind the second handle section 5. The inner tubular body 2 protrudes from the outer tubular body 3 at the end close to the patient, at least by the length of the Dilation section 25. Furthermore, the puncture needle 1 protrudes much longer from the inner tubular body 2 at the end near the patient, for example by at least 1.5 times the length of the inner tubular body.

Based on 4 to 14 The release of the handle sections 4, 5, 6 from each other and the sequence of this release determined by the safety mechanism will be explained.

In the starting position 4 all handle sections 4, 5, 6 are positively connected to one another. The connections can only be released by rotating the dilator unit 13 in the area of the second handle section 5. The shaft unit 14 is positively connected to the dilator unit 13 in the area of the second handle section 5 by a positive coupling element in the form of an Amplatz web 16, which is located on the first handle section 4. A securing element in the form of a puncture needle lock 15 on the third handle section 6 engages in a space shaft groove 17 on the first handle section 4 and thereby prevents a possible rotating movement of the first handle section 4 relative to the second handle section 5. This ensures that the shaft unit 14 does not can be released and advanced from the dilator unit 13 as long as this is blocked by the securing element.

The sequence of the individual process steps is made easier for the user by clear labeling and/or markings, e.g. arrows, numbering, on the individual handle sections 4, 5, 6.

In the puncture system according to the invention, the skin 23 is first punctured, for example under ultrasound monitoring. The puncture needle 1 can have a special surface structure on the distal area for better ultrasound visibility, for example sandblasting, coating, etc. 17 shows the position of the puncture needle in the hollow system 21 of the kidney 22. An additional optical check is now carried out in this position. In addition, urine is absorbed via the side openings 9 on the distal region of the puncture needle 1 and released again via a passage opening 10 on the third handle section 6. This passage opening 10 can have a standardized connection, for example a Luer lock connection, through which, for example, contrast medium can be administered via syringes or tubes.

When the puncture needle tip is correctly positioned in the hollow system 21 of the kidney 22, the dilator unit 13 is rotated until it reaches a noticeable stop. 9 shows the illustration when the dilator unit 13 is rotated by 90°. The sectional view C 11 shows the open position. The dilator unit 13 is released in this position by the dilator groove 19 and can now be detached from the puncture needle unit 12. The dilator unit 13 is then advanced axially together with the shaft unit 14 over the puncture needle 1 to over the optics 7. When the dilator unit 13 has reached the position according to 18 the puncture needle unit 12 is removed.

The dilator unit 13 is then rotated further until a noticeable stop is reached. The sectional view EE in 14 shows the open position. The shaft unit 14 is released in this position by the dilator groove 19 and can be detached from the dilator unit. The shaft unit 14 is then advanced axially via the dilator unit 13 into the hollow system 21 of the kidney 22. If the shaft unit 14 is in the correct position, the dilator unit 13 is then removed.

The 15 shows an example of an image display unit 20 which is connected to the electrical cable 8 or the light guide can be connected. The image display unit 20 can z. B. have an image display device (monitor), an interface and a dimmer. As mentioned, there is an optics 7 on the distal area of the puncture needle 1, which can be designed as a small camera and an integrated light unit, via which the area near the puncture can be visually recorded by the user. The puncture system can be connected, for example, to the image display unit 20 via a cable 8 close to the user. The cable 8 can be led out centrally from the third handle section 6 so that the puncture system can be rotated without any problems and can be operated with both hands.

With the puncture system according to the invention, a guide wire is no longer required since the position of the puncture needle with tip can be checked optically. The X-ray exposure for patients and staff is also reduced and may even be eliminated altogether.

Optimal rinsing properties can be achieved by making the shaft length of the outer tubular body 3 as short as possible. This can be implemented by individually adjusting the shaft length. According to an advantageous embodiment of the invention, the outer tubular body 3 can be formed with notches 24 at the end remote from the patient. The notches 24 run axially outside the outer tubular body 3 with a defined notch length. The notches allow for a predetermined breaking point so that if necessary the shaft can be split open to allow for improved flow length. The representations 22 and 23 show the outer tubular body with a split end remote from the patient. In addition, for example at the end of the longitudinal notch 24, there can be a circumferential predetermined breaking point 26 at which the split parts of the shaft can be broken off.

Another possible embodiment is a length-adjustable outer tubular body with assembled tubular parts. In the area of the outer tubular body that is remote from the patient, the individual tube parts have screw connections. The shaft length can be shortened by loosening the screw connection of the individual pipe parts.

Another embodiment is an outer tubular body 3 with several predetermined breaking points 26 surrounding the circumference, as in the 24 to 28 shown. A specific longitudinal section of the outer tubular body 3 can, for example, be provided with several such predetermined breaking points 26, which are arranged at equal or unequal distances from one another, for example at intervals of 1 cm. The predetermined breaking points 26 can be designed, for example, as circumferential depressions (grooves) formed on the outside, with different profile cross sections of the depressions being conceivable. The 26 shows a predetermined breaking point 26 with a rectangular cross section 27 a predetermined breaking point 26 with a triangular cross section and the 28 a predetermined breaking point 26 with a semicircular cross section. The shaft length of the outer tubular body 3 can be shortened by breaking it off at the desired breaking point 26 when the outer tubular body 3 is placed on the patient.

The 29 and 30 show the outer tubular body 3 according to 24 to 28 in a form shortened at a predetermined breaking point 26. In addition, at the point where the outer tubular body 3 is shortened at a predetermined breaking point, a closing body 27 is placed there. In principle, the shortened outer tubular body 3 can continue to be used without such a closing body. However, by placing the closing body 27, the exposed predetermined breaking point can be covered. In addition, with the closing body 27, better manual operation can be carried out on the remaining part of the outer tubular body 3.

It can be seen that the end body 27 can have a funnel shape, at least in an inner hollow area. In an end region of the closure body 27, which can be placed on the outside of the end section of the outer tubular body 3, the closure body 27 can have a fastening element 28. The fastening element 28 can in particular be designed to engage in a notch-shaped predetermined breaking point 26 in order in this way to form a positive coupling of the closing body 27 with the outer tubular body 3. For example, the fastening element 28 can be designed as a displaceably arranged fastening clip, which then engages in a notch-shaped predetermined breaking point 26 when moved.

Shortening the outer tubular body using a telescopic device is also conceivable.

According to an advantageous embodiment of the invention, the inner tubular body and/or the outer tubular body can consist of at least one hydrophilic material and/or be coated with at least one hydrophilic material.

According to an advantageous embodiment of the invention, the outer tubular body can also be made of plastic or at least one metal chemical material or a corresponding alloy or be coated with at least one such material over a partial length, the majority or the entire length. Furthermore, the outer tubular body can be designed in two parts made of plastic and metal.

According to an advantageous embodiment, the inner tubular body and/or the outer tubular body can have a conical or curved tip.

Reference symbol list

1

puncture needle

2

Internal tubular body (e.g. dilator)

3

Outer tubular body (e.g. Amplatz shaft)

4

First handle section (e.g. Amplatz handle)

5

Second handle section (e.g. dilator handle)

6

Third handle section (e.g. puncture needle handle)

7

optics

8th

Cable/light guide

9

Needle side openings

10

Opening with Luer connection if necessary

11

Anti-kink protection

12

Puncture needle unit

13

Dilator unit

14

shaft unit

15

Security element

16

Amplatz footbridge

17

Amplatz shaft groove

18

Dilator bar

19

Dilator groove

20

Image display unit (interface, dimmer, monitor)

21

Hollow system

22

kidney

23

skin

24

score

25

Dilatation section

26

Predetermined breaking point

27

Final body

28

fastener

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 102009060921 A1 [0004]

Claims (17)

Medical puncture system with a shaft unit (14), a dilator unit (13) and a puncture needle unit (12) for performing a puncture on a patient, with the following features: a) the shaft unit (14) has an outer tubular body (3) with an inner working lumen and a first handle section (4), which is set up for manual handling of the shaft unit (14) and is connected to the outer tubular body (3 ) connected is, b) the dilator unit (13) has an inner tubular body (2) with an inner puncture lumen and a second handle section (5), which is set up for manual handling of the dilator unit (13) and is connected to the inner tubular body (2 ) is connected, the inner tubular body (2) being able to be guided through the working lumen of the outer tubular body (3), c) the puncture needle unit (12) has a puncture needle (1) and a third handle section (6), which is set up for manual handling of the puncture needle unit (12) and is connected to the puncture needle (1) at a section remote from the patent, the puncture needle ( 1) can be guided through the puncture lumen of the inner tubular body (2). Medical puncture system Claim 1 , characterized in that the first handle section (4) can be releasably coupled to the second handle section (5) via at least one positive coupling element and/or the second handle section (5) can be releasably coupled to the third handle section (6) via at least one positive coupling element. can be releasably coupled by positive locking. Medical puncture system Claim 2 , characterized in that the first, second and third handle sections (4, 5, 6) form a homogeneous handle section for gripping and manual handling of the puncture system when they are coupled to one another via the positive coupling elements. Medical puncture system Claim 2 or 3 , characterized in that the second handle section (5) coupled by positive locking to the first handle section (4) can be released from it by a rotational movement relative to the first handle section (4) and / or the third coupled by positive locking with the second handle section (5). Handle section (6) can be released from it by a rotational movement relative to the second handle section (5). Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1) is longitudinally displaceable relative to the inner tubular body (2), the puncture needle unit (12) being removable from the dilator unit (13) in a direction facing away from the end of the puncture system near the patient is. Medical puncture system according to one of the preceding claims, characterized in that the inner tubular body (2) is longitudinally displaceable relative to the outer tubular body (3), the dilator unit (13) facing away from the shaft unit (14) in a direction facing away from the end of the puncture system near the patient ) is removable. Medical puncture system Claim 6 , characterized in that the puncture system has a safety mechanism which ensures that the dilator unit (13) can only be removed from the shaft unit (14) when the third handle section (6) is decoupled from the second handle section (5) and / or the puncture needle unit (12) is removed from the dilator unit (13). Medical puncture system Claim 7 , characterized in that the positive coupling between the first and the second handle section (4, 5) is secured via the securing mechanism, the securing mechanism having a secured and an unlocked state, with the first handle section (4) being released from the in the secured state second handle section (5) is prevented and in the unlocked state the first handle section (4) can be released from the second handle section (5). Medical puncture system Claim 8 , characterized in that the puncture needle unit (12) has at least one securing element (15) which blocks the securing mechanism in the secured state and which prevents the securing mechanism from being transferred into the unlocked state. Medical puncture system according to one of the preceding claims, characterized in that the inner tubular body (2) has a dilatation section (25) in an area close to the patient, which tapers on the outer circumference towards the end of the puncture system close to the patient. Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1) is a hollow needle is formed and in the area of the third handle section (6) there is an opening through which liquid can be directed outwards from the area of the puncture needle (1) near the patient through the puncture needle (1). Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1) has at least one optical component, at least in the area close to the patient, through which light can be emitted towards the patient and/or images can be recorded. Medical puncture system according to one of the preceding claims, characterized in that the inner tubular body (2) protrudes from the outer tubular body (3) at the end near the patient, at least when the first, second and third handle sections (4, 5, 6) extend beyond the positive coupling elements are coupled to each other. Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1) protrudes from the inner tubular body (2) at the end near the patient, at least when the first, second and third handle sections (4, 5, 6) over the positive coupling elements are coupled with each other. Medical puncture system according to one of the preceding claims, characterized in that the puncture system is set up to carry out a minimally invasive percutaneous nephrolitholapaxy (Mini-PCNL). Medical puncture system according to one of the preceding claims, characterized in that the outer tubular body (3) is adjustable in length and/or has at least one predetermined breaking point (26) for selectively shortening the outer tubular (3) body and/or in the longitudinal direction from the end remote from the patient is slotted. Amplatz shaft for carrying out a percutaneous nephrolitholapaxy, characterized in that the Amplatz shaft has several circumferential notches (24) distributed over its longitudinal extent, through which predetermined breaking points (26) are formed for optionally shortening the Amplatz shaft at a respective point selected by the user.

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