Medical puncture system
By designing an integrated medical puncture system, the existing system's complex and time-consuming operation in Mini-PCNL surgery is solved, and the safety and efficiency of the surgery are improved.
Patent Information
- Application Number
- CN202380059614.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-08-16
- Filing Date
- 2023-08-15
- Publication Date
- 2025-03-28
AI Technical Summary
Existing medical puncture systems require multiple different devices when performing Mini-PCNL surgery, resulting in complex, time-consuming and increased patient burden.
An integrated medical puncture system is designed, including a rod unit, a dilator unit and a puncture needle unit, which are connected by a grip section and can be operated in a specific sequence, ensuring the safety and smoothness of each process step.
The system allows minimally invasive surgery to be performed through a unique overall tool system, reducing the number of times surgeons switch between different devices, improving the safety and efficiency of the surgery and reducing the burden on patients.
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Figure CN119730801A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a medical puncture system for performing puncture on a patient having 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 nephrolithotomy (Mini-PCNL). Background Art
[0002] Mini-PCNL is a urological surgical procedure for removing kidney stones. Although the procedure is gentle and has few complications due to the miniaturization of the instruments, it requires some work steps to perform, which must also be performed in part under X-ray and ultrasound examinations.
[0003] First, in the case of an ultrasound examination, the hollow system of the kidney is punctured with the aid of a fine needle. Subsequently, in the case of an X-ray examination, a guide wire is inserted into the puncture needle and the needle is pulled back, and then the puncture channel is expanded with the aid of a dilator inserted onto the guide wire so that the so-called Amplatz sheath can then be introduced via the dilator. After the dilator is removed, a special endoscope, the so-called nephroscope, is pushed forward into the hollow system of the kidney via the Amplatz sheath. The laser fiber used to crush kidney stones is guided through the working channel of the nephroscope. The resulting stone fragments are then flushed out by a permanent flushing flow in the hollow system of the kidney between the Amplatz sheath and the nephroscope. Therefore, when Mini-PCNL is conventionally performed, a plurality of different instruments are required, which must be provided separately and used in sequence.
[0004] A puncture needle system for puncturing an organ, in particular a kidney, is known from DE 10 2009 060 921 A1, which contains an optical device in the puncture needle tip. The known puncture needle system is designed only for a relatively small inner cavity of a working rod, which follows from the fact that the outer diameter of the working rod should be relatively small (less than 6 Fr) and further enlargement of the passage opening should be avoided. Therefore, only a relatively small inner cavity can be used to perform the work. If the diameter of the working rod is not sufficient to accommodate a device for mechanical lithotripsy or for breaking up stones, for example, which works with the aid of laser energy, then in the known puncture needle system, the working rod must first be pulled out of the passage, a guide wire inserted and a larger working rod with an obturator introduced along the guide wire in order to enlarge the passage.
[0005] This approach is relatively time-consuming, requires the surgeon to work very carefully, and is associated with an increased burden on the patient. Summary of the invention
[0006] The object underlying the present invention is to specify an improved puncture system which avoids the above-explained disadvantages and correspondingly improves the safety of the medical operation.
[0007] The object is achieved by a medical puncture system for performing puncture on a patient, the medical puncture system having a rod unit, a dilator unit and a puncture needle unit, the medical puncture system having the following features:
[0008] a) the shaft unit has an outer tubular body with an inner working cavity and a first grip section, which is configured for manual operation of the shaft unit and is connected to the outer tubular body at a section remote from the patient,
[0009] b) the dilator unit has an inner tubular body with an inner puncture lumen and a second grip section, which is configured for manual operation 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,
[0010] c) The puncture needle unit has a puncture needle and a third grip section, which is configured for manual operation 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.
[0011] The puncture system according to the invention allows for minimally invasive surgery, in particular Mini-PCNL, to be performed with a single overall tool system, in which all necessary elements are integrated, and the surgeon does not have to use additional instruments or switch between individual instruments. The surgeon can perform a complete puncture smoothly and with little stress on the patient, until the outer tubular body with a relatively large lumen is precisely placed. The medical puncture system supports the surgeon in this regard with its structural features in terms of safe, error-free and smooth work.
[0012] The outer tubular body can be dimensioned so that the device for breaking up the stone and aspirating the stone fragments can be guided through it. The outer tubular body can be designed as an Amplatz sheath, for example. The required widening of the puncture site can be performed in one operation by means of an integrated dilator.
[0013] The terms "puncture" and "perforation" are to be understood in the medical sense. "Puncture" means inserting a puncture needle into a hollow body, so that the puncture needle penetrates the sheath of the hollow body to be punctured.
[0014] The portion at the far (distal) end of the puncture device and thus near the punctured area of the patient from the user's perspective is regarded as a section of the puncture system that is close to the patient. Correspondingly, the section away from the patient is arranged at the proximal end of the puncture system from the user's perspective, that is, farther away from the punctured area of the patient. If the word "or" is used below, it means a feasible alternative, but the combination consisting of features or manifestations separated by "or" is also clearly feasible in principle. In the sense of the present invention, the indefinite term "one" should not be understood as a numeral. That is to say, for example, if a "component" is mentioned, this should be interpreted in the sense of "at least one component".
[0015] The present invention also provides an improved system in the sense of a general puncture system. In principle, it is also possible to advantageously puncture all body cavities and body spaces and all anatomical and pathological structures to be punctured and to perform corresponding operations using the puncture system according to the invention.
[0016] In principle, the components of the improved puncture system can also be used in combination with all known intervention, puncture and catheter systems or also as a stand-alone product.
[0017] The term “puncture system” shall be retained hereinafter, but has a broad meaning in the sense of a general puncture system, with which not only PCNL can be performed.
[0018] In principle, with the aid of the puncture system according to the invention, surgery can be performed in and at all body cavities and spaces and all anatomical and pathological structures, for example the trachea, pleural cavity, abdominal cavity and pelvic cavity, stomach, intestines, gallbladder, bladder and subarachnoid space. In addition, pathological structures in and on the patient, such as abscesses, can be intervened.
[0019] In the following, the term "patient" includes all living beings of all age groups and sexes. Application in the technical field and in and at all objects and structures is also clearly possible, for example in and at reservoirs, containers, cavities, expandable materials and in and at pump systems, hose systems, tube systems and port systems.
[0020] All components described can be used once or several times at a puncture system or also independently of such a puncture system at / in other products or completely independently. Different features of different components can also be combined freely, and features of certain components can also be used at other components without this having to be explicitly mentioned. In principle, all components and features can be used both inside and outside the patient.
[0021] The puncture system according to the invention is characterized in that it combines all necessary components for performing PCNL, in particular Mini-PCNL, into one device. All components are connected to one another at the gripping area and can be disconnected from one another. The user can only operate the connection and disconnection steps at the gripping area in a specific sequence. This ensures a safe sequence of the individual process steps, thereby preventing the risk of accidental misoperation of the individual components.
[0022] Here, the first grip section, the second grip section and the third grip section are each shaped in a particularly grip-friendly manner, i.e., in an ergonomic manner, so that they support simple and safe gripping by the user. This has the advantage that the user does not have to grip individual parts of the puncture system at locations that are not originally provided for this purpose, such as at the Luer / Lock connector, but rather a defined grip section is provided, which, due to its grip-friendly shape, visually stands out from other parts of the puncture system and is thus easily perceived by the user as a grip section. This also promotes intuitive working with the puncture system according to the invention.
[0023] The first gripping section, the second gripping section and / or the third gripping section may have, for example, a hyperboloid shape. For example, the curvature of the hyperboloid shape of the second gripping section may be smaller than the curvature of the first gripping section and / or the third gripping section. The first gripping section, the second gripping section and / or the third gripping section may also be configured as other rotationally symmetrical bodies. Grooves and / or protrusions or other surface structured portions may also be present on the outer surface of the first gripping section, the second gripping section and / or the third gripping section to increase gripping properties.
[0024] Individual or all gripping sections can at least partially consist of a material that increases the frictional resistance or be coated with at least one such material. This prevents an undesired slipping of the user's fingers. The gripping area can also consist entirely or partially of an elastomer, such as rubber or silicone, or any other material that is softer than the other materials of the puncture system, for example.
[0025] Individual or all grip sections can also consist of at least one material having an antimicrobial effect or be coated with at least one such material.
[0026] Individual or all grip sections can also consist of at least one material having particularly hydrophobic properties or be coated with at least one such material. Properties in the sense of the lotus effect or properties similar to the lotus effect are also conceivable.
[0027] A single or all gripping sections can be designed at least partially in a color different from the other components of the puncture system, for example green, yellow or red. In particular, the gripping sections can be designed in different colors. This should remind the user of the colors of traffic lights and can indicate the sequence of operating steps. Additionally, the sequence of operating steps can be indicated by numbering or generally by markings, such as the numbering or other markings of the gripping sections. Special patterns in the gripping area, such as cross-shaped or arrow-shaped patterns, are also feasible.
[0028] However, it is also conceivable to design those areas of the puncture system at least partially in red or another eye-catching color which must not be touched in order to prevent contamination by bacteria, for example.
[0029] The color "yellow" is also conceivable, at least partially, in areas that should not be touched, but whose touching is still possible in special cases. Then, the color "green" can be used for areas that are allowed to be touched.
[0030] However, in particular highly luminescent or fluorescent colors are also conceivable.
[0031] It is also conceivable that individual or all gripping areas are first covered by an adhesive structure, such as a film, which can be removed before, during or after the puncture process. The features described for the gripping area can also be implemented individually or in combination at one or more other components of the puncture system.
[0032] In another advantageous embodiment, the puncture system is partially, mostly or completely transparent so that the fluid / urine / blood flow can be directly identified. As long as the material properties allow, the puncture needle can also be transparent.
[0033] According to an advantageous design of the present invention, the first gripping section can be releasably coupled to the second gripping section by form fit via at least one form-fitting coupling element, and / or the second gripping section can be releasably coupled to the third gripping section by form fit via at least one form-fitting coupling element. This has the following advantages: On the one hand, the first gripping section can be reliably coupled to the second gripping section, but the first gripping section can also be disengaged from the second gripping section when necessary, so that the corresponding subunit of the puncture system can be removed after the working section of performing puncture on the patient. Similarly, the second gripping section can be reliably coupled to the third gripping section, but can also be disengaged from the third gripping section when necessary.
[0034] According to an advantageous design of the present invention, when the first grip section, the second grip section and the third grip section are coupled to each other via a shape-fitting coupling element, the first grip section, the second grip section and the third grip section form a uniform grip section for holding and manually operating the puncture system. The uniform grip section formed in the described manner forms a kind of handle of the puncture system. The first grip section, the second grip section and the third grip section can respectively form subsections of such a handle. The uniform grip section can be uniformly configured in the following sense, for example: the first grip section transitions to the second grip section without a perceptible transition section or with a gentle transition section. In addition, the second grip section can transition to the third grip section without a perceptible transition section or with a gentle transition section. Here, the first grip section can be directly adjacent to the second grip section. The second grip section can be directly adjacent to the third grip section.
[0035] According to an advantageous design scheme of the present invention, it is proposed that the second gripping section coupled to the first gripping section by a form fit can be disengaged from the first gripping section by a rotational movement relative to the first gripping section, and / or the third gripping section coupled to the second gripping section by a form fit can be disengaged from the second gripping section by a rotational movement relative to the second gripping section. In the described manner, an accidental disengagement of one gripping section from another gripping section is avoided. In order to disengage, the user must perform a limited rotational movement of a gripping section relative to an adjacent gripping section. The rotational movement required to disengage one gripping section from another gripping section can be, for example, a rotation within an angle range of 90 to 180 degrees. In particular, in order to achieve a form-fitting coupling, a thread can be avoided, which has the following advantages: in order to disengage one gripping section from another gripping section, multiple rotations are not required, i.e., rotation at an angle of more than 360 degrees is not required.
[0036] The second grip section can be disengaged from the first grip section, for example, by a rotational movement relative to the first grip section about the longitudinal axis. The form-fitting coupling between the first grip section and the second grip section can be designed in the manner of a bayonet connection. The third grip section can be disengaged from the second grip section by a rotational movement relative to the second grip section about the longitudinal axis. The form-fitting coupling between the second grip section and the third grip section can be designed in the manner of a bayonet connection.
[0037] According to an advantageous design of the present invention, the puncture needle can be longitudinally displaced relative to the inner tubular body, wherein the puncture needle unit can be removed from the dilator unit in a direction away from the end of the puncture system close to the patient. In order to remove the puncture needle unit, the form-fitting coupling between the second grip section and the third grip section should first be cancelled.
[0038] According to an advantageous design of the invention, the inner tubular body can be longitudinally displaced relative to the outer tubular body, wherein the dilator unit can be removed from the rod unit in a direction away from the end of the puncture system close to the patient. To remove the dilator unit, the form-fitting coupling between the first grip section and the second grip section should first be cancelled.
[0039] In this advantageous design, for example, puncture can be performed so that the puncture needle is first guided forward only with its tip to the desired position inside the patient's body. The shape-fitting coupling between the second grip section and the third grip section is then released. Now, the still connected unit consisting of the expander unit and the rod unit can be pushed forward. The unit is guided on the puncture needle here. Therefore, the puncture needle acts like a guide wire. Here, the opening is widened by the expander unit so that the rod unit can also be pushed forward together. If the unit consisting of the expander unit and the rod unit is placed at the correct position, the puncture needle unit can be removed, that is, the puncture needle unit is pulled out of the inner tubular body. Then, the shape-fitting coupling between the first grip section and the second grip section can be released, and the rod unit can be pushed forward and placed at the correct position. Subsequently, the expander unit can be removed by pulling the expander unit out of the outer tubular body. Therefore, only the rod unit of the outer tubular body with a relatively large inner cavity remains at the patient. For example, a lithotripter may be introduced directly through the outer tubular body.
[0040] According to an advantageous design of the present invention, the puncture system has a locking mechanism, which ensures that the dilator unit can only be removed from the rod unit when the third grip section is decoupled from the second grip section and / or the puncture needle unit is removed from the dilator unit. This supports the surgeon in a safe working manner. Due to its structure, the puncture system prevents the dilator unit from being pulled out incorrectly together with the puncture needle unit or the rod unit from being pushed forward without the dilator unit.
[0041] According to an advantageous design of the present invention, the form-fitting coupling between the first grip section and the second grip section is locked via a locking mechanism, wherein the locking mechanism has a locked state and an unlocked state, wherein in the locked state, the first grip section is prevented from being disengaged from the second grip section, and in the unlocked state, the first grip section and the second grip section are released from being disengaged. This allows the locking mechanism to be structurally simple while being functionally reliable. In particular, the locking mechanism can be implemented by purely mechanical co-acting devices.
[0042] According to an advantageous design of the present invention, the puncture needle unit has at least one locking element that locks the locking mechanism in a locked state, and prevents the locking mechanism from switching to an unlocked state by means of the locking element. The locking element can, for example, extend from the third grip section in the direction toward the first grip section and extend mostly or completely through the inner chamber of the second grip section in the longitudinal direction.
[0043] According to an advantageous design of the present invention, at least when the puncture needle is guided through the puncture lumen of the inner tubular body, the third gripping section is arranged farther away from the end of the puncture system close to the patient than the second gripping section.
[0044] According to an advantageous design of the present invention, at least when the inner tubular body is guided through the working cavity of the outer tubular body, the second gripping section is arranged farther away from the end of the puncture system close to the patient than the first gripping section.
[0045] According to an advantageous design of the present invention, the inner tubular body has an expansion section in the area close to the patient, which is tapered at the outer circumference toward the end of the puncture system close to the patient. The expansion section can be directly connected to the hollow cylindrical part of the inner tubular body, for example. The expansion section can have an outer contour that is linearly, incrementally or incrementally ramped. Here, the difference between the outer diameters of the inner tubular body and the outer tubular body is relatively small, for example less than 50% of the outer diameter of the inner tubular body.
[0046] According to an advantageous design of the present invention, the puncture needle is configured as a hollow needle and has an opening in the region of the third gripping section through which liquid can be conducted from the region of the puncture needle close to the patient through the puncture needle to the outside. This has the advantage that it is possible to check whether the puncture is correctly performed and whether the puncture needle tip is correctly placed based on the liquid flowing out of the opening. For example, a hose connector, such as a Luer lock connector, can be provided at the opening.
[0047] The puncture needle may have a pointed tip at the end close to the patient, for example a tip in the form of a conical shape or an inclined abrasive blade.
[0048] The material for the puncture needle can be a metallic material, in particular stainless steel or in principle a metal alloy. However, the puncture needle can also be made of a plastic material. The puncture needle can also be made entirely or partially of lightweight construction or of at least one material that is resorbable / dissolves easily in urine, blood, infusion solutions or other fluids, such as sugar or salt, for example in the region of the puncture tip. Magnesium can also be used. The puncture needle can also be advantageously improved by means of at least one sensor, for example in the region of the puncture tip.
[0049] According to an advantageous design of the present invention, the puncture needle has at least one optical device at least in the area close to the patient, by which light can be radiated toward the patient and / or an image can be recorded. The optical device can be coupled to a display device, for example, which is arranged separately from the puncture system or is also fastened to the puncture system. For example, the image information recorded by the optical device can be reproduced on the display device. In this way, the surgeon can visually check whether the puncture is performed correctly and whether the puncture needle tip is correctly placed.
[0050] It is also conceivable that a commercially available smartphone or similar device that communicates with other components of the optical device and / or puncture system can be used as a display device. Here, for example, communication can also be carried out wirelessly via waves / electromagnetic fields.
[0051] The optical device can have, for example, an electric light source, an optical fiber and / or a camera. If the puncture needle is designed as a hollow needle, the optical device can be arranged, for example, in the inner cavity of the puncture needle.
[0052] According to an advantageous design, at least one optical device completely closes the inner cavity of the puncture needle in the area close to the patient, and the puncture needle has one or more lateral openings behind the closed area when viewed from the end of the puncture needle close to the patient. This has the following advantages: although the area of the puncture needle is closed by the optical device, liquid can be conducted from the area of the puncture needle close to the patient through the puncture needle to the third grip section and in particular to its opening through the lateral openings behind it.
[0053] According to an advantageous design, the optical device is detachably coupled to the puncture needle, particularly in a form-fitting manner. Thus, the optical device can be removed from the puncture needle, and, for example, a guide wire can be introduced through the inner cavity of the puncture needle.
[0054] According to an advantageous design of the present invention, at least when the first grip section, the second grip section and the third grip section are coupled to each other via a form-fitting coupling element, the inner tubular body protrudes from the outer tubular body at the end facing away from the patient. The end of the inner tubular body facing away from the patient extends to the interior of the second grip section.
[0055] According to an advantageous design of the present invention, at least when the first grip section, the second grip section and the third grip section are coupled to each other via a form-fitting coupling element, the inner tubular body extends out of the outer tubular body at the end close to the patient. Here, the inner tubular body can extend out of the outer tubular body by at least the length of the expansion section.
[0056] According to an advantageous design of the present invention, at least when the first grip section, the second grip section and the third grip section are coupled to each other via a form-fitting coupling element, the puncture needle protrudes from the inner tubular body at the end facing away from the patient. The end of the puncture needle facing away from the patient here extends to the interior of the third grip section.
[0057] According to an advantageous design of the present invention, at least when the first grip section, the second grip section and the third grip section are coupled to each other via a shape-fitting coupling element, the puncture needle extends from the inner tubular body at the end close to the patient. In this way, a medical puncture system in a basic state in which the puncture system can be delivered, for example, by the manufacturer can be used directly as an integrated tool to perform the entire puncture process. The puncture system does not have to be specially prepared by the user. On the contrary, the puncture system can be directly guided to the desired position in the patient's body with the tip of the puncture needle facing forward. This can be additionally checked and visualized, for example, by ultrasound or radiological monitoring. Then, if the puncture needle is correctly placed, the various parts of the puncture system can be moved or removed in sequence as previously described, until only the rod unit is left at the patient in the end. For example, the length of the part of the puncture needle extending from the third grip section can be at least 1.5 times the length of the part of the outer tubular body extending from the first grip section.
[0058] In this way, the puncture system according to the invention allows an all-in-one puncture and, accordingly, an optimized workflow for nephrolithotomy. The surgeon does not have to switch between different instruments.
[0059] According to an advantageous design of the present invention, the puncture needle protrudes from the inner tubular body at the end close 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 is particularly applicable in the following operating state of the medical puncture system: in the operating state, for example, when the first grip section, the second grip section and the third grip section are coupled to each other via a shape-fitting coupling element, the rod unit, the dilator unit and the puncture needle unit are assembled to each other. Thereby, the puncture needle protrudes relatively far from the outer tubular body with its puncture needle tip, which is conducive to the implementation of Mini-PCNL.
[0060] According to an advantageous design of the present invention, the puncture needle is at least 1.5 times or at least twice as long as the outer tubular body.
[0061] According to an advantageous design of the present invention, the puncture system is configured to perform minimally invasive percutaneous nephrolithotomy (Mini-PCNL). Likewise, the puncture system is equally and advantageously applicable to similar minimally invasive surgeries, in particular endoscopic surgeries. Other possible application areas may be, for example, general surgery, pediatric surgery, visceral surgery, trauma surgery and orthopedic surgery, spinal surgery and gynecology. It is also conceivable to use it in the field of thoracic surgery within the scope of video-assisted thoracic surgery (VATS). Other possible application areas may also be veterinary medicine. Application feasibility in non-medical fields is also conceivable, for example, application feasibility at and in pump and hose systems.
[0062] According to an advantageous design of the present invention, the outer tubular body is adjustable in length and / or has at least one expected breaking site for selectively shortening the outer tubular body and / or is slotted in the longitudinal direction from the end away from the patient. This has the following advantages: during the operation, the outer tubular body can be directly matched to the specific characteristics of the operation and the patient in terms of its length, that is, the outer tubular body can be shortened to the desired length. This can optimize the flushing flow and improve the flushing of stone fragments, and avoid the outer tubular body from protruding unnecessarily far from the patient, which will make the execution of the operation difficult. For example, the outer tubular body can be slotted in a section of 10% to 50% of the total length from the end away from the patient. Similarly, the first gripping section can be slotted so that the gripping section can also be separated due to the slotted embodiment. If there is an expected breaking site, the expected breaking site can be arranged at equal or unequal spacings from each other on the longitudinal extension of the outer tubular body, for example, at a spacing of at least 1 cm.
[0063] In another independent aspect, the invention relates to an external tubular body in the form of an Amplatz sheath for performing percutaneous nephrolithotomy, wherein the Amplatz sheath has a plurality of incisions distributed over its longitudinal extension and surrounding the circumference, through which the intended breaking sites are formed, in order to selectively shorten the Amplatz sheath at the corresponding sites selected by the user. The advantages previously described can also be achieved thereby. The Amplatz sheath can have one or more of the previously mentioned features of the external tubular body.
[0064] It is also possible to shorten the Amplatz sheath with the aid of a tool during nephrolithotomy, i.e. when the Amplatz sheath is already placed on the patient. This is particularly advantageous if the outer tubular body is designed as an Amplatz sheath for percutaneous nephrolithotomy. A tube cutter can be used as a tool, especially when the material of the outer tubular body is relatively hard. If a softer material is involved, it can also be cut with scissors, for example. The described method is also possible if the Amplatz sheath is not designed with the expected breaking site described previously.
[0065] In this regard, the present invention also relates to a method for adjusting the length of an Amplatz sheath for performing percutaneous nephrolithotomy, wherein the Amplatz sheath is shortened to a desired extent before or during percutaneous nephrolithotomy on a patient, for example by splitting a section of the Amplatz sheath with the aid of a tool and / or disconnecting a section of the Amplatz sheath using at least one expected breaking site. BRIEF DESCRIPTION OF THE DRAWINGS
[0066] The present invention will be described in detail below based on embodiments using the accompanying drawings.
[0067] The accompanying drawings show:
[0068] Figure 1 A medical puncture system is shown in a stereoscopic view.
[0069] Figure 2 Show according to Figure 1 A partial enlarged view of the area close to the patient of the medical puncture system, Figure 3 The various structural units of the medical puncture system are shown.
[0070] Figure 4 The partially cutaway perspective view shows a grip section of a medical puncture system.
[0071] Figure 5 In the side view, the Figure 4 The grip section,
[0072] Figure 6 Shown according to Figure 5 A sectional view of the section plane BB is shown in FIG.
[0073] Figure 7 Shown according to Figure 5 A cross-sectional view of the section plane AA is shown in FIG.
[0074] Figure 8 Shows something like Figure 4 Another partial cross-sectional view,
[0075] Fig. 9 In the side view, the Figure 8 The grip section,
[0076] Fig.10 Shown according to Fig. 9 A sectional view of the section plane DD is shown in FIG.
[0077] Fig.11 Shown according to Fig. 9 A cross-sectional view of the section plane CC shown in FIG.
[0078] Fig.12 Shows something like Figure 4 Another partial cross-sectional view,
[0079] Fig.13 In the side view, the Fig.12 The grip section,
[0080] Fig.14 Shown according to Fig.13 A cross-sectional view of the section plane EE is shown in FIG.
[0081] Fig.15 shows an image reproduction unit,
[0082] Figure 16-Figure 19 Shows the steps in executing Mini-PCNL.
[0083] Fig. 20 Another embodiment of the rod unit is shown in a side view.
[0084] Fig.21 In the front view of the first grip section, the Fig. 20 The rod unit,
[0085] Fig. 22 Show according to Fig. 20 A modified form of the rod element,
[0086] Fig.23 Show according to Fig. 22 The placement of the rod unit on the patient,
[0087] Figure 24-28 A rod element with the expected fracture site is shown.
[0088] Figure 29-Figure 33 A shortened tubular body with a closed body is shown. DETAILED DESCRIPTION
[0089] Reference Figures 1 to 3First, the basic structure of the medical puncture system is explained. The medical puncture system is basically constructed of three structural units, namely, a rod 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 gripping section 6 connected to the puncture needle 1. The dilator unit 13 has an inner tubular body 2 and a second gripping section 5 connected to the inner tubular body 2. The rod unit 14 has an outer tubular body 3 and a first gripping section 4 connected to the outer tubular body. The puncture needle 1 can be sharpened at the area A close to the patient, that is, at the end, that is, it can have a puncture needle tip. The puncture needle 1 can be configured as a hollow needle. In the described case, an optical device 7 can be arranged in the puncture needle. The optical device 7 can be guided outward through the puncture needle 1 and through the third gripping section 6 via an electrical cable 8 or an optical conductor and connected to the image reproduction unit. At the end facing away from the patient, the puncture needle unit 12 can have a kink protection 11, for example behind the third grip section 6, by which the cable 8 or the optical conductor is prevented from being bent. In addition, the puncture needle 1 can have one or more side openings 9, which are arranged behind the optical device 7 when viewed from the end of the puncture needle 1 close to the patient. Body fluid can enter the interior of the puncture needle 1 through the side openings 9. The puncture needle unit 12 can have an opening 10, for example an opening with a Luer connector, in the region of the third grip section 6, so that the liquid absorbed via the side openings 9 can be conducted to the outside and collected and / or analyzed.
[0090] In the case of the dilator unit 13, it can be seen that the outer tubular body 2 has a dilation section 25 at the end close to the patient. Figure 1 In the delivery state shown in FIG, the second gripping section is behind the first gripping section, and the third gripping section is behind the second gripping section 5, as viewed from the end A close to the patient. 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 expansion section 25. In addition, the puncture needle 1 protrudes substantially longer from the inner tubular body 2 at the end close to the patient, for example by at least 1.5 times the length of the inner tubular body.
[0091] according to Figures 4 to 14 , the separation of the grip sections 4 , 5 , 6 from one another and the sequence of the separation determined by the locking mechanism shall be explained.
[0092] exist Figure 4In the initial position, all gripping sections 4, 5, 6 are connected to each other in a form-fitting manner. The connection can only be disconnected by rotating the expander unit 13 in the area of the second gripping section 5. The rod unit 14 is connected to the expander unit 13 in the area of the second gripping section 5 in a form-fitting manner via a form-fitting coupling element in the form of an Amplatz tab 16 located at the first gripping section 4. The locking element in the form of a puncture needle stop 15 at the third gripping section 6 engages in the Amplatz sheath groove 17 at the first gripping section 4, thereby preventing possible rotational movement of the first gripping section 4 relative to the second gripping section 5. This ensures that the rod unit 14 cannot be disconnected from the expander unit 13 and pushed forward as long as it is blocked by the locking element.
[0093] The sequence of the individual process steps is explained to the user by clear markings and / or symbols, such as arrows, numbers, etc., on the individual grip sections 4 , 5 , 6 .
[0094] In the puncture system according to the invention, puncture is first performed, for example under ultrasound monitoring, through the skin 23. For better ultrasound visibility, the puncture needle 1 can have a special surface structure at the distal end region, such as sandblasting, coating, etc. Fig.17 The position of the puncture needle in the hollow system 21 of the kidney 22 is shown. In this position, an optical examination is now additionally performed. In addition, urine is absorbed via the side opening 9 at the distal end region of the puncture needle 1 and discharged again via the through-opening 10 at the third grip section 6. The through-opening 10 can have a standard connection, such as a Luer lock, via which, for example, a contrast medium can be administered, for example, via a syringe or a hose.
[0095] When the puncture needle tip is in the correct position in the hollow system 21 of the kidney 22 , the dilator unit 13 is rotated until a perceptible stop is reached. Fig. 9 The illustration shows the expander unit 13 when it is rotated by 90°. Fig.11 The sectional view C shows the open position. In this position, the dilator unit 13 is released by the dilator slot 19 and can now be detached from the puncture needle unit 12. Subsequently, the dilator unit 13 is pushed forward axially on the puncture needle 1 together with the rod unit 14 until it reaches the optical device 7. Fig.18 When the dilator unit 13 reaches the position reached, the puncture needle unit 12 is removed.
[0096] Subsequently, the spreader unit 13 is rotated further until a perceptible stop is reached. Fig.14The section EE in FIG. 1 shows the open position. In this position, the rod unit 14 is released by the dilator slot 19 and can be disengaged from the dilator unit. Subsequently, the rod unit 14 is pushed forward axially on the dilator unit 13 into the hollow system 21 of the kidney 22. Subsequently, when the position of the rod unit 14 is correct, the dilator unit 13 is removed.
[0097] Fig.15 An image reproduction unit 20 which can be connected to an electrical cable 8 or an optical conductor is shown by way of example. The image reproduction unit 20 can have, for example, an image display device (monitor), an interface and a dimmer. As mentioned, at the distal end region of the puncture needle 1 there is an optical device 7 or generally at least one optical device, which can be designed as a small camera and an integrated light unit, via which the area close to the puncture is visually detected by the user. The puncture system can be connected to the image reproduction unit 20, for example, via a cable 8 close to the user. The cable 8 can here be led out centrally from the third grip section 6 so that the puncture system can be rotated without problems and can be operated with both hands.
[0098] In the puncture system according to the invention, a guide wire is no longer needed, because the position of the puncture needle with the tip can be checked optically. Thus, the X-ray burden on the patient and the staff is also smaller and may be completely eliminated.
[0099] Optimal flushing properties can be achieved by a rod length of the outer tubular body 3 that is as short as possible. This can be achieved by individualizing the rod length. According to an advantageous embodiment of the invention, the outer tubular body 3 can be formed with a cutout 24 at the end facing away from the patient. The cutout 24 extends axially outside the outer tubular body 3 with a defined cutout length. The cutout can achieve a desired breaking point, so that the rod can be split if necessary, so that an improved flow-through length can thus be achieved. Fig. 22 and Fig.23 The outer tubular body is shown with a split end facing away from the patient. In addition, for example at the end of the longitudinally extending cutout 24 there can be a circumferential intended breaking point 26 at which the split part of the rod can be broken off.
[0100] Another possible embodiment is an outer tubular body with an adjustable length of assembled tube parts. In the region of the outer tubular body away from the patient, the individual tube parts have a threaded connection. The rod length can be shortened by disconnecting the threaded connection of the individual tube parts.
[0101] Another embodiment is an outer tubular body 3 having a plurality of intended breaking sites 26 circumferentially arranged, such as in Figure 24 to Figure 28As shown in . A specific longitudinal section of the outer tubular body 3 can be provided with a plurality of such expected breaking points 26, for example, which are arranged at equal or unequal distances from each other, for example at a distance of 1 cm. The expected breaking points 26 can be designed, for example, as circumferential recesses (grooves) formed on the outside, wherein different profile cross sections of the recesses are conceivable. Fig.26 The expected fracture site 26 is shown with a rectangular cross section, Fig. 27 The expected fracture site 26 is shown to have a triangular cross-section, and Fig.28 An expected breaking site 26 with a semicircular cross section is shown. If the outer tubular body 3 is placed on a patient, the rod length of the outer tubular body 3 can be shortened by breaking at the desired expected breaking site 26.
[0102] Fig.29 and Fig.30 The basis for the shortening at the expected fracture site 26 is shown in the form of Figure 24 to Figure 28 In addition, a closing body 27 is arranged at the part where the outer tubular body 3 is shortened at the expected breaking part. In principle, the shortened outer tubular body 3 can also continue to be used without such a closing body. However, the exposed expected breaking part can be covered by arranging the closing body 27. In addition, the remaining part of the outer tubular body 3 can be better manually operated with the help of the closing body 27 when necessary.
[0103] It can be seen that the closing body 27 can have a funnel shape at least in the inner hollow area. In the end area 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 for engaging in the notch-shaped expected breaking site 26, so as to form a positive coupling of the closing body 27 to the outer tubular body 3 in the described manner. For example, the fastening element 28 can be designed as a movably arranged fastening clip, which then engages in the notch-shaped expected breaking site 26 by movement.
[0104] It is also conceivable to shorten the outer tubular body by means of a telescoping device.
[0105] According to an advantageous configuration of the present invention, the inner tubular body and / or the outer tubular body may be formed of at least one hydrophilic material and / or may be coated with at least one hydrophilic material.
[0106] According to an advantageous design of the present invention, the outer tubular body can also be made of plastics or at least one metallic material or corresponding alloy, or on part length, most length or whole length, use at least one such material coating. In addition, the outer tubular body can be designed in two parts of plastics and metal.
[0107] According to an advantageous design, the inner tubular body and / or the outer tubular body may have a conical or curved tip.
[0108] Reference numerals list
[0109] 1. Puncture needle
[0110] 2 Internal tubular body (e.g. dilator)
[0111] 3 External tubular body (eg Amplatz sheath)
[0112] 4 First grip section (e.g. Amplatz grip)
[0113] 5. Second gripping section (e.g., dilator gripping section)
[0114] 6. Third grip section (e.g., puncture needle grip)
[0115] 7 Optical Devices
[0116] 8 Cables / optical conductors
[0117] 9-pin side opening
[0118] 10 Opening for Luer fitting if necessary
[0119] 11 Bending protection piece
[0120] 12 Needle Unit
[0121] 13 Expander unit
[0122] 14 Rod elements
[0123] 15 Locking element
[0124] 16 Amplatz patch
[0125] 17 Amplatz sheath slot
[0126] 18 Expander tab
[0127] 19 Expander slot
[0128] 20 Image reproduction unit (interface, dimmer, monitor)
[0129] 21 Hollow System
[0130] 22 Kidney
[0131] 23 Skin
[0132] 24 Incision
[0133] 25 Expansion section
[0134] 26 Expected fracture site
[0135] 27 closed body
[0136] 28 Fastening elements
Claims
1. A medical puncture system for performing puncture on a patient, the medical puncture system comprising a rod unit (14), a dilator unit (13) and a puncture needle unit (12), the medical puncture system having the following features: a) the rod unit (14) comprises an outer tubular body (3) with an inner working cavity and a first gripping section (4), wherein the first gripping section is configured to manually operate the rod unit (14) and is connected to the outer tubular body (3) at a section away from the patient, b) the dilator unit (13) comprises an inner tubular body (2) with an inner puncture cavity and a second gripping section (5), the second gripping section being configured for manually operating the dilator unit (13) and being connected to the inner tubular body (2) at a section remote from the patient, wherein the inner tubular body (2) can be guided through the working cavity of the outer tubular body (3), c) The puncture needle unit (12) has a puncture needle (1) and a third gripping section (6), wherein the third gripping section is configured to manually operate the puncture needle unit (12) and is connected to the puncture needle (1) at a section away from the patient, wherein the puncture needle (1) can be guided through the puncture cavity of the inner tubular body (2).
2. The medical puncture system according to claim 1, characterized in that: The first grip section (4) can be detachably coupled to the second grip section (5) by means of a form fit via at least one form-fitting coupling element, and / or the second grip section (5) can be detachably coupled to the third grip section (6) by means of a form fit via at least one form-fitting coupling element.
3. The medical puncture system according to claim 2, characterized in that: When the first, second and third gripping sections are coupled to one another via the form-fitting coupling element, the first, second and third gripping sections (4, 5, 6) form a uniform gripping section for gripping and manually operating the puncture system.
4. The medical puncture system according to claim 2 or 3, characterized in that: The second grip section (5) coupled to the first grip section (4) by a form fit can be disengaged from the first grip section by a rotational movement relative to the first grip section (4), and / or the third grip section (6) coupled to the second grip section (5) by a form fit can be disengaged from the second grip section by a rotational movement relative to the second grip section (5).
5. The medical puncture system according to any one of the preceding claims, characterized in that: The puncture needle (1) is longitudinally movable relative to the inner tubular body (2), wherein the puncture needle unit (12) can be removed from the dilator unit (13) in a direction away from the end of the puncture system close to the patient.
6. The medical puncture system according to any one of the preceding claims, characterized in that: The inner tubular body (2) is longitudinally movable relative to the outer tubular body (3), wherein the dilator unit (13) can be removed from the rod unit (14) in a direction away from the end of the puncture system close to the patient.
7. The medical puncture system according to claim 6, characterized in that: The puncture system has a locking mechanism, which ensures that the dilator unit (13) can only be removed from the rod unit (14) when the third grip section (6) is decoupled from the second grip section (5) and / or the puncture needle unit (12) is removed from the dilator unit (13).
8. The medical puncture system according to claim 7, characterized in that: The shape-fitting coupling between the first grip section (4, 5) and the second grip section (4, 5) is locked via the locking mechanism, wherein the locking mechanism has a locked state and an unlocked state, wherein in the locked state, the first grip section (4) is prevented from disengaging from the second grip section (5), and in the unlocked state, the first grip section (4) and the second grip section (5) are released from disengagement.
9. The medical puncture system according to claim 8, characterized in that: The puncture needle unit (12) has at least one locking element (15) which blocks the locking mechanism in the locked state and prevents the locking mechanism from switching to the unlocked state.
10. The medical puncture system according to any one of the preceding claims, characterized in that: The inner tubular body (2) has a widened section (25) in the area close to the patient, which is tapered at the outer circumference toward the end of the puncture system close to the patient.
11. The medical puncture system according to any one of the preceding claims, characterized in that: The puncture needle (1) is designed as a hollow needle and, in the region of the third grip section (6), there is an opening through which a liquid can be conducted from the region of the puncture needle (1) close to the patient through the puncture needle (1) to the outside.
12. The medical puncture system according to any one of the preceding claims, characterized in that: The puncture needle (1) has at least one optical device (7) at least in a region close to the patient, by means of which light can be radiated toward the patient and / or images can be recorded.
13. The medical puncture system according to claim 12, characterized in that: The optical device (7) is coupled to the puncture needle in a detachable and / or form-fitting manner.
14. The medical puncture system according to any one of the preceding claims, characterized in that: At least when the first, second and third gripping sections (4, 5, 6) are coupled to one another via the form-fitting coupling element, the inner tubular body (2) protrudes from the outer tubular body (3) at the end close to the patient.
15. The medical puncture system according to any one of the preceding claims, characterized in that: At least when the first, second and third gripping sections (4, 5, 6) are coupled to one another via the form-fitting coupling element, the puncture needle (1) protrudes from the inner tubular body (2) at the end close to the patient.
16. The medical puncture system according to any one of the preceding claims, characterized in that: The puncture system is configured to perform minimally invasive percutaneous nephrolithotomy (Mini-PCNL).
17. The medical puncture system according to any one of the preceding claims, characterized in that: The outer tubular body (3) is adjustable in length and / or has at least one intended breaking point (26) for selectively shortening the outer tubular body (3) and / or is slotted in the longitudinal direction starting from the end remote from the patient.
18. An Amplatz sheath for performing percutaneous nephrolithotomy, characterized in that: The Amplatz sheath has a plurality of circumferentially surrounding cutouts (24) distributed over the longitudinal extension of the Amplatz sheath, through which intended breaking sites (26) are formed in order to selectively shorten the Amplatz sheath at corresponding sites selected by a user.
Citation Information
Patent Citations
Puncture needle system
DE102009060921A1
Cited By
Percutaneous kidney puncture device
CN120154398A
A percutaneous nephrostomy device
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