Medical puncture system

Abstract

The invention relates to a medical puncture system for carrying out a puncture on a patient, the system comprising the features of claim 1. The medical puncture system can in principle be used for punctures of any kind. The medical puncture system is especially suitable for carrying out minimally invasive percutaneous nephrolitholapaxy (mini-PCNL).

Description

[0001] Medical puncture system

[0002] The invention relates to a medical puncture system for performing a puncture on a patient, having the features of claim 1. The medical puncture system can generally be used for all types of punctures. The medical puncture system is particularly suitable for performing minimally invasive percutaneous nephrolitholapaxy (mini-PCNL).

[0003] Mini-PCNL is a urological-surgical procedure for the removal of kidney stones. Although it is gentle and low-complication due to instrument miniaturization, several steps are required, some of which must be performed under radiological and sonographic guidance.

[0004] First, under ultrasound guidance, the renal sac is punctured with a thin needle. Under X-ray control, a guidewire is inserted over the needle and withdrawn. A dilator threaded over the guidewire is then used to widen the puncture channel. This allows an Amplatz sheath to be inserted through the dilator. After the dilator is removed, a specialized endoscope, called a nephroscope, is advanced through this Amplatz sheath into the renal sac. A laser fiber, used for lithotripsy of kidney stones, is passed through the nephroscope's working channel. The resulting stone fragments are then flushed out by the constant flow of irrigation in the renal sac between the Amplatz sheath and the nephroscope.This conventional mini-PCNL procedure requires several different instruments, which must be prepared separately and inserted one after the other. DE 10 2009 060 921 A1 discloses a puncture needle system for puncturing an organ, particularly a kidney, which incorporates an optical system in the puncture needle tip. This known puncture needle system is only designed for relatively small inner lumens of the working shaft. This is due to 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. Therefore, only a relatively small inner lumen is available for performing the procedure.If the diameter of the working shaft is not sufficient to accommodate a device for disintegrating the stone, which is used for example for mechanical lithotripsy or works with laser energy, the working shaft of the known puncture needle system must first be withdrawn from the canal, a guide wire inserted and a larger working shaft with an obturator for bougienage of the access inserted along this guide wire.

[0005] Such a procedure is relatively time-consuming, requires very careful work from the surgeon and is associated with increased stress for the patient.

[0006] The invention is based on the object of providing an improved puncture system which avoids the disadvantages explained above and accordingly improves the safety of the medical procedure.

[0007] This object is achieved by a medical puncture system with a shaft unit, a dilator unit, and a puncture needle unit for performing a puncture on a patient, having the following features: a) the shaft unit has an outer tubular body with an inner working lumen and a first handle section which is configured for manual handling of the shaft unit and is connected to the outer tubular body at a section remote from the patient, b) the dilator unit has an inner tubular body with an inner puncture lumen and a second handle section which is configured for manual handling of the dilator unit and is connected to the inner tubular body at a section remote from the patient, wherein the inner tubular body can be guided through the working lumen of the outer tubular body, c) the puncture needle unit has a puncture needle and a third handle section,which is designed for manual handling of the puncture needle unit and is connected to the puncture needle at a section remote from the patient, wherein the puncture needle can be guided through the puncture lumen of the inner tubular body.

[0008] The puncture system according to the invention allows the performance of minimally invasive procedures, in particular a mini-PCNL, with a single, integral tool system in which all necessary elements are integrated, eliminating the need for the surgeon to resort to additional instruments or switch between individual instruments. The surgeon can perform the entire puncture, including the precise placement of the comparatively large-bore outer tube-shaped body, quickly and with minimal stress on the patient. The medical puncture system supports the surgeon with its design features, ensuring safe, error-free, and rapid work.

[0009] The outer tubular body can be dimensioned such that a device for disintegrating the stone and suctioning the stone fragments can be inserted through this outer tubular body. The outer tubular body can be designed, for example, as an Amplatz shaft. The integrated dilator allows the necessary dilation of the puncture site to be performed in a single operation.

[0010] The terms "puncturing" and "puncture" are to be understood in the medical sense. "Puncture" 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.

[0011] The section of parts of the puncture system closest to the patient is those parts which, from the user's perspective, are located at the far (distal) end of the puncture system and thus close to the punctured area of ​​the patient. Accordingly, sections far from the patient are located at the proximal end of the puncture system from the user's perspective, i.e. further away from the punctured area of ​​the patient. When 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. Therefore, if, for example, a component is mentioned, this is to be interpreted in the sense of "at least one component".

[0012] The invention also provides an improved system in the sense of a general puncture system. In principle, the puncture system according to the invention also makes it possible to advantageously puncture all body cavities and interbody spaces, as well as all anatomical and pathological structures that are to be punctured, and to perform corresponding procedures.

[0013] In principle, components of the improved puncture system can also be combined with all known intervention, puncture and catheter systems or used as standalone products.

[0014] 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 a PCNL can be performed.

[0015] With the puncture system according to the invention, interventions can be performed in and on all body cavities and interbody spaces, as well as on all anatomical and pathological structures, for example, the trachea, pleural space, abdominal and pelvic cavity, stomach, intestine, gallbladder, urinary bladder, and cerebrospinal fluid space. In addition, interventions can be performed on pathological structures such as abscesses in and on the patient.

[0016] The term “patient” in the following includes all living beings of all ages and genders. Applications are also explicitly possible 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 pump, hose, tube and port systems. All components described can be used once or multiple times on a puncture system or independently of such a system 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. All components and features can basically be used inside and outside of a patient.

[0017] The puncture system according to the invention is characterized by the fact that it combines all the necessary components for performing a PCNL, especially a mini-PCNL, into a single instrument. All components are connected to each other at the handle and can be detached from each other. The user can only perform the connection and detachment steps at the handle in a specific sequence. This ensures a safe sequence of the individual process steps and thus prevents the risk of accidental misoperation of the individual components.

[0018] The first, second, and third handle sections are each ergonomically designed to facilitate easy and secure gripping by the user. This has the advantage that the user does not have to grasp the individual parts of the puncture system at locations not intended for this purpose, such as Luer / Lock connectors, but rather has defined handle sections available. Their ergonomic design visually distinguishes them from other parts of the puncture system and thus makes them easily recognizable as handle sections by the user. This also promotes intuitive operation of the puncture system according to the invention.

[0019] The first, second and / or third grip section can, for example, have a hyperboloid shape. For example, the curvature of the hyperboloid shape of the second grip section can be less than the curvature of the first and / or third grip section. The first, second and / or third grip section can also be designed as another rotationally symmetrical body. Grooves and / or knobs or another surface structure can also be present on the outer surface of the first, second and / or third grip section to increase grip. Individual or all grip sections can be made at least partially of a material or can be coated with at least one such material that increases frictional resistance. This prevents the user's fingers from accidentally slipping. The grip area can also be made entirely or partially of an elastomer, e.g.Rubber or silicone, or any other material that is softer than the other material of the puncture system.

[0020] Individual or all handle sections may also consist of at least one antimicrobial material or be coated with at least one such material.

[0021] Individual or all handle sections can also be made of or coated with at least one material that exhibits particularly hydrophobic properties. Properties similar to or reminiscent of a lotus effect are also conceivable.

[0022] Individual or all handle sections can be designed, at least in part, in a different color than the other components of the puncture system, e.g., 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 operating steps. Additionally, the sequence of operating steps can be indicated by numbering or general labeling, e.g., numbering or other labeling of the handle sections. Special patterns in the handle area are also possible, e.g., cross- or arrow-like patterns.

[0023] 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.

[0024] It's also conceivable to use the color "yellow" at least partially in areas that shouldn't be touched, but where touching is still possible in special situations. The color "green" can then be used for areas that may be touched.

[0025] Particularly conceivable are highly luminous or fluorescent colors. 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 procedure. The features explained for the handle sections can also be implemented individually or in combination on one or more other components of the puncture system.

[0026] In a further advantageous embodiment, the puncture system is partially, predominantly, or completely transparent so that fluid / urine / blood flow can be directly detected. The puncture needle can also be transparent, provided the material properties allow it.

[0027] 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 means of a form-fitting connection via at least one form-fitting coupling element and / or the second handle section can be releasably coupled to the third handle section by means of a form-fitting connection via at least one form-fitting coupling element. This has the advantage that the first handle section can be reliably coupled to the second handle section, but can also be detached therefrom if necessary, so that after performing a working section of a puncture on the patient, the corresponding sub-unit 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 therefrom if necessary.

[0028] According to an advantageous embodiment of the invention, the first, second, and third handle sections form a homogeneous handle section for gripping and manually handling the puncture system when coupled to one another via the form-fitting 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 subsections of such a handle. The homogeneous handle section can, for example, be homogeneous in the sense that the first handle section transitions into the second handle section without a noticeable transition or with a smooth transition. Furthermore, the second handle section can transition into the third handle section without a noticeable transition or with a smooth transition. The first handle section can be directly adjacent to the second handle section.The second handle section can be directly adjacent to the third handle section.

[0029] 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 therefrom 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 therefrom by a rotational movement relative to the second handle section. In this way, accidental release of one handle section from the other handle section is reliably prevented. To release, the user must perform a defined rotational movement of one handle section relative to the adjacent handle section. The rotational movement required to release one handle section from the other handle section can, for example, be a rotation in an angular range of 90 to 180 degrees.In particular, a thread can be avoided for the realization of the positive coupling, which has the advantage that no multiple rotations, i.e. by an angle of more than 360 degrees, are required to release one handle section from the other handle section.

[0030] The second handle section can be released from the first handle section, for example, by rotating it around its 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 by rotating it around its longitudinal axis. The positive coupling between the second and third handle sections can be designed in the manner of a bayonet connection.

[0031] According to an advantageous embodiment of the invention, the puncture needle is longitudinally displaceable relative to the inner tubular body, wherein the puncture needle unit is removable from the dilator unit in a direction away from the end of the puncture system closest to the patient. To remove the puncture needle unit, the positive coupling between the second and the third handle section must first be released. According to an advantageous embodiment of the invention, the inner tubular body is longitudinally displaceable relative to the outer tubular body, wherein the dilator unit is removable from the shaft unit in a direction away from the end of the puncture system closest to the patient. To remove the dilator unit, the positive coupling between the first and the second handle section must first be released.

[0032] With such an advantageous embodiment, for example, 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. The positive coupling between the second and third handle sections is then released. The unit consisting of the dilator unit and the shaft unit, which is still connected, can now be pushed forward. It is guided over the puncture needle. The puncture needle thus acts like a guide wire. The dilator unit widens the opening so that the shaft unit can also be pushed forward. Once the unit consisting of the dilator unit and the shaft unit has been positioned in the correct position, the puncture needle unit can be removed, i.e. the puncture needle unit is pulled out of the inner tube-shaped body.The positive coupling between the first and second handle sections can then be released, allowing the shaft unit to be advanced and positioned correctly. The dilator unit can then be removed by pulling it out of the outer tubular body. Thus, only the shaft unit with the relatively large-lumen outer tubular body remains on the patient. A lithotripter, for example, can be inserted directly through this outer tubular body.

[0033] According to an advantageous embodiment of the invention, the puncture system is provided with a safety mechanism that 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 is removed from the dilator unit. This supports the surgeon in working safely. Due to its design, the puncture system prevents the dilator unit from being mistakenly 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, the positive coupling between the first and second handle sections is secured via the locking mechanism, wherein the locking mechanism has a locked and an unlocked state. In the locked state, detachment of the first handle section from the second handle section is prevented, and in the unlocked state, detachment of the first handle section from the second handle section is permitted. This allows for a structurally simple implementation of the locking mechanism while simultaneously ensuring reliable function. In particular, the locking mechanism can be implemented using purely mechanically interacting components.

[0034] According to an advantageous embodiment of the invention, the puncture needle unit has at least one locking element that blocks the locking mechanism in the locked state, preventing the locking mechanism from being transferred to the unlocked state. The locking element can, for example, protrude from the third handle section toward the first handle section and extend longitudinally predominantly or completely through an inner chamber of the second handle section.

[0035] 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 closest to the patient than the second handle section, at least when the puncture needle is guided through the puncture lumen of the inner tubular body.

[0036] 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 closest to 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.

[0037] According to an advantageous embodiment of the invention, the inner tubular body has a dilatation section in a region near the patient, which tapers on the outer circumference toward the end of the puncture system near the patient. The dilatation section can, for example, directly adjoin a hollow-cylindrical part of the inner tubular body. The dilatation section can, for example, 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., less than 50% of the outer diameter of the inner tubular body.

[0038] According to an advantageous embodiment of the invention, the puncture needle is designed as a hollow needle and has an opening in the area of ​​the third handle section through which fluid can be directed from the area of ​​the puncture needle closest to the patient through the puncture needle to the outside. This has the advantage that the correct puncture procedure and the correct placement of the puncture needle tip can be verified based on the fluids escaping from the opening. A hose connection, such as a Luer-Lock connector, can be provided at the opening.

[0039] The puncture needle may have a point at the end closest to the patient, e.g., in a conical shape or in the form of a bevel.

[0040] Materials for the puncture needle can be metal, particularly stainless steel, or generally metal alloys. However, the puncture needle can also be made of a plastic material. It can also be entirely or partially lightweight or made of at least one absorbable material that is easily soluble in urine, blood, infusion solutions, or other fluids, e.g., a sugar or a salt, e.g., 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, e.g., in the area of ​​the puncture tip.

[0041] According to an advantageous embodiment of the invention, the puncture needle has at least one optical component, at least in the area near the patient, through which light can be emitted toward the patient and / or images can be captured. The optical component can, for example, be coupled to a display device arranged separately from the puncture system or attached to the puncture system. Image information captured by the optical component, for example, can be displayed on the display device. In this way, the surgeon can visually verify the correct puncture procedure and the correct placement of the puncture needle tip.

[0042] It is also conceivable that a standard smartphone or similar device could 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, for example, via waves / electromagnetic fields.

[0043] The optical component can, for example, comprise 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, for example, be arranged in the inner lumen of the puncture needle.

[0044] According to an advantageous embodiment, the at least one optical component completely closes the inner lumen of the puncture needle in the patient-proximal region, and the puncture needle has one or more lateral openings behind this closure point, as seen from the end of the puncture needle closest to the patient. This has the advantage that, despite the area of ​​the puncture needle closed by the optical component, the fluid can be guided through the lateral openings located behind it from the area of ​​the puncture needle closest to the patient through the puncture needle to the third handle section, and in particular to its opening.

[0045] According to an advantageous embodiment, the optical component is detachably coupled to the puncture needle, in particular, positively coupled to the puncture needle. The optical component can thus be removed from the puncture needle and, for example, a guide wire can be inserted through the inner lumen of the puncture needle.

[0046] According to an advantageous embodiment of the invention, 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.

[0047] According to an advantageous embodiment of the invention, the inner tubular body protrudes from the outer tubular body at the end closest to 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 by at least the length of the dilatation section.

[0048] According to an advantageous embodiment of the invention, 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.

[0049] According to an advantageous embodiment of the invention, the puncture needle protrudes from the inner tubular body at the end closest to 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 its basic state—in which the puncture system may, for example, be delivered by the manufacturer—can be used directly as an integrated tool for carrying out the entire puncture procedure. The user does not need to make any special preparations to the puncture system. Rather, the puncture system can be guided directly, with the tip of the puncture needle leading, to the desired location inside the patient's body. This can be additionally verified and visualized, for example, by an ultrasound examination or radiological monitoring.Once the puncture needle is correctly positioned, the individual parts of the puncture system can be moved or removed one after the other, as previously explained, 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 the length of the part of the outer tubular body protruding from the first handle section.

[0050] In this way, the puncture system according to the invention enables a kind of all-in-one puncture and thus an optimized workflow for nephrolitholapaxy. The surgeon does not have to switch between different instruments.

[0051] According to an advantageous embodiment of the invention, the puncture needle protrudes from the inner tubular body at the end closest to the patient with a free length that is at least 30% of the length of the outer tubular body, in particular at least 50% or 70% of the length of the outer tubular body. This applies in particular in an operating state of the medical puncture system in which the shaft unit, the dilator unit and the puncture needle unit are assembled together, e.g. when the first, second and third handle sections are coupled together via the form-fitting coupling elements. The puncture needle with its puncture needle tip thus protrudes relatively far from the outer tubular body, which is advantageous for performing a mini-PCNL.

[0052] According to an advantageous embodiment of the invention, the puncture needle is at least 1.5 times or at least twice as long as the outer tubular body,

[0053] According to an advantageous embodiment of the invention, the puncture system is designed to perform minimally invasive percutaneous nephrolitholapaxy (mini-PCNL). Likewise, the puncture system is equally advantageously suited for comparable minimally invasive procedures, in particular endoscopic procedures. Possible further areas of application may include, for example, general surgery, pediatric surgery, visceral surgery, trauma surgery and orthopedics, spinal surgery, and gynecology. Application in the field of thoracic surgery as part of video-assisted thoracoscopy (VATS) is also conceivable. Possible further areas of application may also include veterinary medicine. Applications in non-medical fields are also conceivable, e.g., on and in pump and tube systems.According to an advantageous embodiment of the invention, the outer tubular body is adjustable in length and / or has at least one predetermined breaking point for optionally shortening the outer tubular body and / or is slit 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 directly during the operation to specific characteristics of the operation and the patient, i.e. it can be shortened to a desired length. This allows the irrigation flow to be optimized and the flushing out of stone fragments to be improved, and it prevents the outer tubular body from protruding unnecessarily far from the patient, which would complicate the procedure.For example, the outer tubular body can be slit over a section of 10 to 50% of its total length from the end remote from the patient. The first handle section can also be slit, so that the handle section can also be split due to the slit design. If predetermined breaking points are present, these can be arranged at equal or unequal distances from one another along the length of the outer tubular body, for example, at intervals of at least 1 cm.

[0054] In a further, independent aspect, the invention relates to an outer tubular body in the form of an Amplatz shaft for performing percutaneous nephrolitholapaxy. The Amplatz shaft has a plurality of circumferentially extending notches distributed along its length, forming predetermined breaking points for selectively shortening the Amplatz shaft at a location selected by the user. This also allows the previously explained advantages to be realized. The Amplatz shaft can have one or more of the aforementioned features of the outer tubular body.

[0055] It is also possible to shorten the Amplatz stem using a tool while performing nephrolitholapaxy, i.e., when it is already in place on the patient. This is particularly advantageous if the outer tubular body is designed as an Amplatz stem for performing percutaneous nephrolitholapaxy. A tube cutter, for example, can be used as a tool, particularly if the outer tubular body is made of a relatively hard material. If the material is softer, scissors, for example, can also be used to cut it. This procedure is also possible if the Amplatz stem is designed without the predetermined breaking points described above.

[0056] In this respect, the invention also relates to a method for adjusting the length of an Amplatz shaft for performing a percutaneous nephrolitholapaxy, in which the Amplatz shaft is shortened to a desired length before or during the performance of the percutaneous nephrolitholapaxy on the patient, for example by cutting off a piece of the Amplatz shaft using a tool and / or breaking off a piece of the Amplatz shaft using at least one predetermined breaking point.

[0057] The invention is explained in more detail below using exemplary embodiments and drawings.

[0058] It shows

[0059] Figure 1 shows a medical puncture system in perspective view,

[0060] Figure 2 is an enlarged detail of the patient-near area of ​​the medical puncture system according to Figure 1,

[0061] Figure 3 individual components of the medical puncture system,

[0062] Figure 4 shows the handle section of the medical puncture system in a partially sectioned perspective view,

[0063] Figure 5 shows the handle section according to Figure 4 in side view,

[0064] Figure 6 is a sectional view along the section plane BB shown in Fig. 5,

[0065] Figure 7 is a sectional view along the section plane AA shown in Fig. 5,

[0066] Figure 8 is another partial sectional view analogous to Figure 4,

[0067] Figure 9 shows a handle section according to Figure 8 in side view,

[0068] Figure 10 is a sectional view according to the section plane DD shown in Fig. 9,

[0069] Figure 11 is a sectional view along the section plane CC shown in Fig. 9,

[0070] Figure 12 is another partial sectional view analogous to Figure 4,

[0071] Figure 13 shows the handle section according to Figure 12 in side view,

[0072] Figure 14 is a sectional view according to the section plane EE shown in Figure 13, Figure 15 is an image display unit,

[0073] Fig. 16-19 Steps in performing a mini-PCNL,

[0074] Figure 20 shows a further embodiment of a shaft unit in side view, Figure 21 shows the shaft unit according to Figure 20 in a front view of the first handle section,

[0075] Figure 22 shows the shaft unit according to Figure 20 in a modified form,

[0076] Figure 23 shows the placement of the shaft unit according to Figure 22 on the patient, Fig. 24-28 a shaft unit with predetermined breaking points,

[0077] Fig. 29-33 a shortened tubular body with a closing body.

[0078] With reference to Figures 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 connected to the inner tubular body 2. The shaft unit 14 has an outer tubular body 3 and a first handle section 4 connected to it. The puncture needle 1 can be sharpened in the region A closest to the patient, i.e., at the end, i.e., have a puncture needle tip. The puncture needle 1 can be designed as a hollow needle. In this case, an optical system 7 can be arranged within the puncture needle.The optics 7 can be guided outward through the puncture needle 1 and through the third handle section 6 via an electrical cable 8 or light guide and connected to an image display unit. At the end remote from the patient, the puncture needle unit 12 can have an anti-kink device 11, e.g., behind the third handle section 6, 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 located behind the optics 7 when viewed from the end of the puncture needle 1 closest to the patient. Bodily 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., with a Luer connector, in order to guide the fluids taken up through the side openings 9 to the outside for collection and / or analysis.

[0079] In the dilator unit 13, it can be seen that the outer tubular body 2 has a dilation section 25 at the end closest to the patient. In the delivery state, which is shown in Figure 1, as seen from the end A closest to the patient, the second handle section is located behind the first handle section and the third handle section is located behind the second handle section 5. The inner tubular body 2 protrudes from the outer tubular body 3 at the end closest to the patient, at least by the length of the dilation section 25. Furthermore, the puncture needle 1 protrudes from the inner tubular body 2 at the end closest to the patient by a considerably longer amount, for example by at least 1.5 times the length of the inner tubular body.

[0080] Figures 4 to 14 are intended to explain the release of the handle sections 4, 5, 6 from one another and the sequence of this release determined by the locking mechanism.

[0081] In the starting position (Fig. 4), all handle sections 4, 5, and 6 are positively connected to one another. The connections can only be released by rotating the dilator unit 13 in the region of the second handle section 5. The shaft unit 14 is positively connected to the dilator unit 13 in the region of the second handle section 5 by a positive-locking 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 an Amplatz shaft groove 17 on the first handle section 4 and thereby prevents any possible rotating movement of the first handle section 4 relative to the second handle section 5. This ensures that the shaft unit 14 cannot be detached from the dilator unit 13 and advanced as long as this is blocked by the securing element.

[0082] 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.

[0083] 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 in the distal region for better ultrasound visibility, e.g. sandblasting, coating, etc. Fig. 17 shows the position of the puncture needle in the hollow system 21 of the kidney 22. In this position, an additional visual inspection is now carried out. In addition, urine is taken in through the side openings 9 in the distal region of the puncture needle 1 and released again through a passage opening 10 in the third handle section 6. This passage opening 10 can have a standardized connection, e.g. Luer-Lock connection, through which, for example, contrast medium can be administered via syringes or tubes.

[0084] 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. Fig. 9 shows the illustration when the dilator unit 13 is rotated by 90°. The sectional view C in Fig. 11 shows the open position. In this position, the dilator unit 13 is released 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 until it passes over the optics 7. Once the dilator unit 13 has reached the position shown in Fig. 18, the puncture needle unit 12 is removed.

[0085] The dilator unit 13 is then rotated further until a noticeable stop is reached. The sectional view EE in Fig. 14 shows the open position. In this position, the shaft unit 14 is released by the dilator groove 19 and can be detached from the dilator unit. The shaft unit 14 is then advanced axially over the dilator unit 13 into the hollow system 21 of the kidney 22. Once the shaft unit 14 is correctly positioned, the dilator unit 13 is subsequently removed.

[0086] Figure 15 shows, by way of example, an image display unit 20 that can be connected to the electrical cable 8 or the optical fibers. The image display unit 20 can, for example, have an image display device (monitor), an interface, and a dimmer. As mentioned, an optic 7 or, more generally, at least one optical component is located at the distal region of the puncture needle 1. This optic can be designed as a small camera with an integrated light unit, via which the area near the puncture is visually recorded by the user. The puncture system can be connected, for example, to the image display unit 20 via a cable 8 near the user. The cable 8 can be centrally routed from the third handle section 6 so that the puncture system can be rotated easily and 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 visually monitored.The X-ray exposure for patients and staff is also reduced and may even be eliminated completely.

[0087] Optimum rinsing properties can be achieved by keeping the shaft length of the outer tubular body 3 as short as possible. This can be achieved 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 enable a predetermined breaking point so that the shaft can be split if necessary, thus enabling an improved flow length. The illustrations in Fig. 22 and Fig. 23 show the outer tubular body with the split end remote from the patient. In addition, a circumferential predetermined breaking point 26 can be provided, for example at the end of the longitudinal notch 24, at which the split parts of the shaft can be broken off.

[0088] Another possible design is a length-adjustable outer tubular body with assembled tube sections. In the area of ​​the outer tubular body away from the patient, the individual tube sections have screw connections. The shaft length can be shortened by loosening the screw connections of the individual tube sections.

[0089] A further embodiment is an outer tubular body 3 with a plurality of predetermined breaking points 26 running around the circumference, as shown in Figures 24 to 28. A specific longitudinal section of the outer tubular body 3 can, for example, be provided with a plurality of such predetermined breaking points 26 arranged at equal or unequal distances from one another, for example at intervals of 1 cm. The predetermined breaking points 26 can, for example, be designed as circumferential depressions (grooves) formed on the outer side, with different profile cross-sections of the depressions being conceivable. Figure 26 shows a predetermined breaking point 26 with a rectangular cross-section, Figure 27 a predetermined breaking point 26 with a triangular cross-section, and Figure 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 predetermined breaking point 26 when the outer tubular body 3 is placed on the patient.

[0090] Figures 29 and 30 show the outer tubular body 3 according to Figures 24 to 28 in a form shortened at a predetermined breaking point 26. In addition, a closure body 27 is attached to the location where the outer tubular body 3 is shortened at a predetermined breaking point. In principle, the shortened outer tubular body 3 can continue to be used without such a closure body. However, by attaching the closure body 27, the exposed predetermined breaking point can be covered. Furthermore, the closure body 27 may, if necessary, allow for better manual operation of the remaining part of the outer tubular body 3.

[0091] It can be seen that the closing body 27 can have a funnel shape, at least in an inner hollow region. In an end region of the closing body 27, which can be placed externally on the end section of the outer tubular body 3, the closing body 27 can have a fastening element 28. The fastening element 28 can be designed, in particular, to engage in a notch-shaped predetermined breaking point 26 in order 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 displaced.

[0092] It is also conceivable to shorten the outer tubular body by means of a telescopic device.

[0093] 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.

[0094] According to an advantageous embodiment of the invention, the outer tubular body can also be made of plastic or at least one metallic material or a corresponding alloy, or can be coated with at least one such material over part, the majority, or the entire length. Furthermore, the outer tubular body can be constructed in two parts, made of plastic and metal.

[0095] According to an advantageous embodiment, the inner tubular body and / or the outer tubular body can have a conical or curved tip.

[0096] List of reference symbols

[0097] 1 puncture needle

[0098] 2 Inner tubular body (e.g. dilator)

[0099] 3 Outer tubular body (e.g. Amplatz stem)

[0100] 4 First grip section (e.g. Amplatz grip)

[0101] 5 Second handle section (e.g. dilator handle)

[0102] 6 Third handle section (e.g. puncture needle handle)

[0103] 7 Optics

[0104] 8 cables / optical fibers

[0105] 9 needle side openings

[0106] 10 Opening with Luer connection if necessary

[0107] 11 kink protection

[0108] 12 Puncture needle unit

[0109] 13 Dilator unit

[0110] 14 Shaft unit

[0111] 15 Securing element

[0112] 16 Amplatz Bridge

[0113] 17 Amplatz shaft groove

[0114] 18 Dilator bar

[0115] 19 Dilator groove

[0116] 20 Image display unit (interface, dimmer, monitor)

[0117] 21 Hollow system

[0118] 22 Kidney

[0119] 23 Skin

[0120] 24 notch

[0121] 25 Dilation section

[0122] 26 Predetermined breaking point

[0123] 27 closing bodies

[0124] 28 Fastening element

Claims

Patent claims 1. A medical puncture system comprising a shaft unit (14), a dilator unit (13), and a puncture needle unit (12) for performing a puncture on a patient, comprising the following features: a) the shaft unit (14) has an outer tubular body (3) with an inner working lumen and a first handle portion (4) configured for manual handling of the shaft unit (14) and connected to the outer tubular body (3) at a portion remote from the patient; b) the dilator unit (13) has an inner tubular body (2) with an inner puncture lumen and a second handle portion (5) configured for manual handling of the dilator unit (13) and connected to the inner tubular body (2) at a portion remote from the patient; the inner tubular body (2) being guideable 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 portion (6) which is designed for manual handling of the puncture needle unit (12) and is connected to the puncture needle (1) at a portion remote from the patient, wherein the puncture needle (1) can be guided through the puncture lumen of the inner tubular body (2).

2. Medical puncture system according to claim 1, characterized in that the first handle section (4) can be releasably coupled to the second handle section (5) by means of a form-fitting connection via at least one form-fitting coupling element and / or the second handle section (5) can be releasably coupled to the third handle section (6) by means of a form-fitting connection via at least one form-fitting coupling element. Medical puncture system according to claim 2, characterized in that the first, second, and third handle sections (4, 5, 6) form a homogeneous handle section for gripping and manually handling the puncture system when coupled to one another via the positive-locking coupling elements. Medical puncture system according to claim 2 or 3, characterized in that the second handle section (5), which is positively coupled to the first handle section (4), can be released therefrom by a rotational movement relative to the first handle section (4), and / or the third handle section (6), which is positively coupled to the second handle section (5), can be released therefrom by a rotational movement relative to the second handle section (5).A 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), wherein the puncture needle unit (12) is removable from the dilator unit (13) in a direction away from the end of the puncture system closest to the patient. A 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), wherein the dilator unit (13) is removable from the shaft unit (14) in a direction away from the end of the puncture system closest to the patient.Medical puncture system according to 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). A medical puncture system according to claim 7, characterized in that the positive coupling between the first and second handle sections (4, 5) is secured via the securing mechanism, wherein the securing mechanism has a secured and an unlocked state, wherein in the secured state, detachment of the first handle section (4) from the second handle section (5) is prevented, and in the unlocked state, detachment of the first handle section (4) from the second handle section (5) is permitted. A medical puncture system according to claim 8, characterized in that the puncture needle unit (12) has at least one securing element (15) that blocks the securing mechanism in the secured state and prevents the securing mechanism from being transferred to 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 a region near the patient, which dilatation section tapers on the outer circumference towards the end of the puncture system near the patient. Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1) is designed as a hollow needle and an opening is present in the region of the third handle section (6) through which fluid can be guided from the region of the puncture needle (1) near the patient through the puncture needle (1) to the outside. Medical puncture system according to one of the preceding claims, characterized in that the puncture needle (1), at least in the region near the patient, has at least one optical component (7) through which light can be emitted towards the patient and / or images can be taken.Medical puncture system according to claim 12, characterized in that the optical component (7) is detachably and / or positively coupled to the puncture needle. 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 closest to the patient, at least when the first, second, and third handle sections (4, 5, 6) are coupled to one another via the positive coupling elements. 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 closest to the patient, at least when the first, second, and third handle sections (4, 5, 6) are coupled to one another via the positive coupling elements. Medical puncture system according to one of the preceding claims, characterized in that the puncture system is designed to perform 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 body (3) and / or is slit in the longitudinal direction from the end remote from the patient. Amplatz shaft for performing percutaneous nephrolitholapaxy, characterized in that the Amplatz shaft has a plurality of circumferentially extending notches (24) distributed along its longitudinal extent, forming predetermined breaking points (26) for selectively shortening the Amplatz shaft at a location selected by the user.

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