Biopsy Needle with Renal Capsular Hemostasis Module

Abstract

The invention relates to a biopsy needle system containing a capsular hemostasis module for reducing the risk of post-biopsy bleeding in renal biopsy procedures. The system comprises a biopsy needle for obtaining a sample from renal tissue, a capsular hemostasis module positioned at the renal capsule level, a hemostatic agent delivery lumen, and outlet channels for distributing the hemostatic agent to the capsular puncture site. The capsular hemostasis module is structured to remain fixed at the renal capsule level, independent of the sampling movement of the biopsy needle. Following the collection of the biopsy sample, the biocompatible hemostatic agent is delivered through the lumen to the capsular hemostasis module without fully withdrawing the biopsy needle and distributed in a controlled manner around the capsular entry site. In the preferred application, the module includes an annular distribution chamber and multiple outlet openings connected to this chamber for the circumferential distribution of the hemostatic agent.Thus, instead of applying the hemostatic material over a wide area along the renal parenchyma, the aim is to apply it locally and in a controlled manner to the area where the biopsy needle passes the renal capsule.

Description

TARIFF Biopsy Needle with Renal Capsular Hemostasis Module Technical Area The invention relates to medical devices used in percutaneous renal biopsy procedures. More specifically, the invention enables biopsy5, which allows for the collection of samples from renal tissue. A sampling agent works in conjunction with a local hemostatic agent at the biopsy entry point. a biopsy with a capsular hemostasis module that allows for material application It relates to the needle system. State of the Art Percutaneous renal biopsy is used in the diagnosis of kidney diseases through histopathological analysis.10 It is an invasive procedure commonly used for evaluation purposes. The procedure During the biopsy, the biopsy needle passes through the skin, soft tissues, and renal capsule to the cortical area. A tissue sample is taken. The entry point created by the biopsy needle is specifically designed for the renal capsule. and can create a bleeding focus at the level of subcapsular vascular structures. In standard biopsy devices, tissue samples are usually collected using a spring mechanism or semi-spring mechanism. The sample is taken using an automated sampling element. Bleeding control is performed during the process. subsequently, external pressure, observation, or, if deemed necessary, insertion into the entry tract. This can be achieved through methods such as the placement of hemostatic material. Additionally... A coaxial sheath or a separate lumen is used in biopsies or similar percutaneous procedures. 20 that allows the delivery of coagulant or biocompatible filler material through it These systems are also known. However, a significant portion of known systems use hemostatic material. along a specific length of the biopsy tract or into the organ parenchyma It focuses on releasing the amount of hemostatic material. In this approach, the amount and The distribution area may increase, especially with hemostatic application to the renal capsule25 It can be difficult to focus on the puncture site. On the other hand, with a sampling element that moves when the biopsy needle is fired Displacement of the hemostasis element also occurs at the capsule level, predetermined This can make it difficult to protect the point of entry. Purpose of the Invention30 The aim of the invention is to create a biopsy sampling element independent of forward and backward movement. capsular hemostasis that can maintain its position at the renal capsule level By providing the module, it allows hemostatic material to penetrate deep into the biopsy tract. instead of being distributed widely, it is applied locally around the biopsy entry site in the renal capsule. and to enable its controlled transmission.35 Another objective of the invention is to create a central passage located within the capsular hemostasis module. thanks to which the biopsy sample can move freely in and out while providing this, the module in question is at the capsule level depending on the external pin or sheath. The main goal is to keep it stable. 1 Another purpose of the invention is to allow the delivery of hemostatic material through one or more exit orifices. a flow pathway that allows distribution to the area around the capsular puncture The goal is to create a hemostatic agent in the lumen, capsular area. In a preferred application, the hemostatic agent opens the lumen, capsular area. Fluid is distributed through an annular distribution chamber located within the hemostasis module. is connected and the room in question has the material on the distal contact surface of the module or5 It distributes this to multiple outlet openings located around the surface. Explanation of the Figures Figure 1: Overview of the biopsy needle system containing the capsular hemostasis module. appearance. Figure 2: Enlarged view of the distal portion of the capsular hemostasis module.10 Figure 3A: Capsular hemostasis module positioned at the renal capsule level. state. Figure 3B: Center of the capsular hemostasis module of the biopsy sampling element. The state in which it progresses through the passage and extends into the renal tissue. Figure 3C: Biopsy sampling element returned and capsular hemostasis15 The state in which the module maintains its position at capsule level. Figure 3D: Output of hemostatic material in the capsular hemostasis module. The state in which the contents are distributed around the capsular entry area through the openings. Figure 4: Cross-sectional view of the capsular hemostasis module. Figure 5: View of the distal contact surface of the capsular hemostasis module.20 Figure 6: Lateral view of the capsular hemostasis module. Explanation of References in Figures 1: Biopsy device body 2: Biopsy ignition element 3: Hemostasis activation element25 4: Hemostatic agent inlet connection. 5: External pin or sheath 6: Capsular hemostasis module 7: Biopsy sampling element 8: Hemostatic agent lumen30 9: Hemostatic agent exit opening 10: Annular distribution chamber 11: Distal capsular contact surface 12: Central Gateway 13: Echogenic signal element35 2 14: Axial positioning and locking element 15: One-way valve or pressure limiting element 16: Renal capsule 17: Renal cortex 18: Capsular puncture site5 Description of the Invention The subject of the invention is a biopsy needle system, a biopsy device body (1), biopsy firing element (2), optional hemostasis activation element (3), hemostatic agent input connection (4), external needle or sheath (5), capsular hemostasis module (6), biopsy sampling element (7), hemostatic agent lumen (8) and at least one hemostatic agent10 It includes an outlet opening (9). Biopsy sampling element (7) is placed longitudinally inside the external needle or sheath (5). It is positioned so that it can move back and forth along the axis. Biopsy Sampling element (7), spring mechanism for taking tissue sample, mechanical triggering, semi-automatic triggering or similar movement mechanism15 It can be operated. The invention relates to a specific biopsy gun or a specific sampling needle. It is not limited by its diameter. Capsular hemostasis module (6), in the distal part of the external needle or sheath (5) It is positioned inside the biopsy sampling element (7). Module (6) It includes a central passage (12) that allows passage. Capsular hemostasis module20 (6) is directly dependent on the firing motion of the biopsy sampling element (7). It is associated with an external needle or sheath (5) in such a way that it will not be possible to perform a biopsy. The sampling element (7) moves into the renal cortex (17) and returns to the capsular The hemostasis module (6) can maintain its position at the level of the renal capsule (16). Contact with the renal capsule (16) on the distal side of the capsular hemostasis module (6)25 There is a distal capsular contact surface (11) structured in such a way as to make contact. Distal capsular contact surface (11) flat, slightly concave, elastically compatible or with renal surface It could be in another geometric structure that would increase the contact area. Preferred In one of the applications, the contact surface (11) is the convex surface of the kidney. It is concave in shape to conform to its geometry.30 Hemostatic agent inlet connection (4), a syringe, cartridge, pump or other It can be designed to be connected to a fluid supply source. Inlet connection (4) The hemostatic agent lumen (8) extends between the capsular hemostasis module (6) and the capsule hemostasis module. The lumen of the hemostatic agent (8) is inside the wall of the external needle or sheath (5), on its outer surface. a separate microcatheter extending as an adjacent separate channel or together with an external needle35 It can be created in this way. 3 In the preferred application, the lumen of the hemostatic agent (8), the module of capsular hemostasis (6) is fluid-connected with the annular distribution chamber (10) inside. Annular distribution chamber (10) distributes the incoming hemostatic material circumferentially and multiple Hemostatic agent is delivered to the exit opening (9). Exit openings (9) are distal capsular contact. on the surface (11), at the circumferential edge of the contact surface or one of these regions5 It can be found in combination. Hemostatic agent exit openings (9), capsular puncture of hemostatic material circumferential, radial, oblique or directed distribution around the region (18) They can be positioned to provide the following: the number, diameter, angles, and annularity of the outlet openings. geometry of the distribution chamber (10); viscosity of the material to be applied, target10 It can be adjusted according to volume and device diameter. In one application of the invention, the capsular hemostasis module (6), external needle or sheath (5) It is fixed in a predetermined position. In another application... The module (6) can move axially with limited range along the outer pin or sheath (5) and Axial positioning and locking at the position requested by the operator15 It can be fixed with element (14). Thus, different patient anatomies and different entry points The capsular contact point is adjustable for their depth. Visualization of the capsular hemostasis module (6) at the renal capsule (16) level an echogenic marker element on or near the module to facilitate (13) can be found. Echogenic marker element (13) clearly detects ultrasound waves.20 reflecting surface irregularities, micronotch, coating or similar structure It may include. Thus, before the operator fires the biopsy sampling element (7) position of the capsular hemostasis module (6) relative to the renal capsule by ultrasonography can verify. On the hemostatic agent lumen (8) or on the hemostatic agent inlet connection (4)25 A one-way valve or pressure limiting element (15) may be present. The said element (15), to reduce backflow, limit involuntary material outflow or a specific It can be used to allow flow after the threshold pressure. Outlet openings (9), also injection to reduce the risk of occlusion during tissue advancement It can be covered with a flexible membrane that opens under pressure.30 In one application, the hemostasis activation element (3) is derived from the biopsy firing element. (2) are placed separately. Hemostasis activation element (3), biopsy The mechanical or sampling element (7) will become active after firing. It can be used in conjunction with an electronic locking system. This feature is not mandatory. The hemostatic agent is connected to a35 connection (4) directly to the hemostatic agent inlet port. It can also be administered via syringe or controlled pump. Capsular hemostasis module (6), external needle as a permanent part of the biopsy device or can be manufactured integrated with the sheath (5), a standard or special biopsy needle. It can also be produced in the form of a detachable adapter that can be attached to it. Detachable In practice, interchangeable internal adapters suitable for different biopsy needle diameters or 40 Connecting rings can be used. 4 Hemostatic material; fluid, suspension, gel precursor or during injection. Another biocompatible material that can flow might be an example of absorbable gelatin. base materials, hemostatic systems containing fibrin or thrombin, collagen derivatives, polysaccharide-based materials, hydrogel-forming systems, and the like. Biocompatible hemostatic materials can be used. The scope of protection of the invention is specified. It is not limited to a single composition of hemostatic materials. During use, external needle or sheath (5) renal capsule (16) under ultrasonography guidance is advanced to the level and the capsular hemostasis module (6) distal capsular contact The surface (11) is positioned so that it contacts the renal capsule. Biopsy Sampling element (7) proceeds through the central passage (12) from the renal cortex (17) tissue10 It takes the sample and returns. During this movement, the capsular hemostasis module (6) is external. The position of the needle or sheath (5) at the level of the renal capsule is mainly based on It protects. After tissue sample collection, external needle or sheath (5) and capsular hemostasis Before the module (6) is completely withdrawn, hemostatic material is introduced.15 It is delivered from the connection (4). The material is delivered through the annular lumen (8) of the hemostatic agent. from there to the distribution room (10) and from there to the exit openings (9) to the capsule It is distributed locally around the puncture site (18). Then the system returns It can be withdrawn. The technical approach of the invention requires that the hemostatic material must necessarily pass through the entire biopsy tract. without requiring it to be left along its entire length, the material on the renal capsule It relies on directing the needle to the puncture site. However, if needed... In addition to capsular application, the same device also injects material into a short section of the tract. Additional outlets allowing for emission, or a separate lumen, may also be included. How the Invention Can Be Applied to Industry25 The invention relates to a medical device containing disposable or reusable components. It can be produced in the form of an external needle or sheath (5), biopsy sampling element (7) and Capsular hemostasis module (6) medical use suitable metal, polymer or thereof They can be produced from combinations of these. Fluid delivery components can be sterilized or It can be manufactured as a single-use system. The system is used in renal biopsy procedures.30 Different needle diameters suitable for use under ultrasound guidance. It can be generated in various sampling lengths.

Claims

REQUESTS 1. The invention relates to obtaining percutaneous samples from renal tissue and to the biopsy entry site. It is a biopsy needle system for delivering hemostatic agent; its characteristic feature is an external needle. or sheath (5), axially moving inside the external pin or sheath (5). a biopsy sampling element (7) that can be made, distal of the external needle or sheath (5)5 positioned independently of the biopsy sampling element (7) in the section, a distal capsular contact surface (11) to make contact with the renal capsule and biopsy containing a central gateway (12) that allows passage of the sampling element (7). Capsular hemostasis module (6), from a hemostatic agent inlet connection (4) The hemostatic agent lumen (8) extending to the capsular hemostasis module (6) and the aforementioned10 It must contain at least one hemostatic agent outlet opening (9) in connection with the lumen (8) and the capsular hemostasis module (6), biopsy sampling element (7) advanced and renal capsule together with external needle or sheath (5) during back sampling movement It is structured in a way that will allow it to maintain its position at that level.

2. Biopsy needle system according to claim 1, its feature is capsular hemostasis module (6)15 an annular distribution with fluid connection to the lumen (8) of the hemostatic agent within it It is that there is room (10).

3. Biopsy needle system according to Claim 2, characterized by its annular distribution chamber. (10), multiple distributed around the periphery of the capsular hemostasis module (6) The hemostatic agent outlet is connected to the fluid via the (9) opening.20 4. Biopsy needle system according to any of the items 1-3, and its characteristics are: hemostatic agent exit openings (9) on the distal capsular contact surface (11) and / or its location at the circumferential edge of this surface and the center of the hemostatic material to distribute in circumferential, radial or oblique direction around the passage (12) It is the direction.25 5. Biopsy needle system according to any of requests 1-4, its characteristic is; distal To increase the contact area of ​​the capsular contact surface (11) with the renal surface, concave or it has an adaptable geometry.

6. Biopsy needle system according to any of the requests 1-5, its characteristic is; capsular Position of the hemostasis module (6) relative to the renal capsule under ultrasonography30 It contains at least one echogenic marker element (13) which facilitates its identification.

7. Biopsy needle system according to any of claims 1-6, characterized by its capsular nature. axial position of the hemostasis module (6) on the external pin or sheath (5) an axial sensor that allows adjustment and locking in the selected position. It includes a positioning and locking element (14).35 8. Biopsy needle system according to any of the items 1-7, and its characteristics are: on the hemostatic agent inlet connection (4) and / or hemostatic agent lumen (8) a one-way valve or pressure limiter that restricts backflow or unintended flow It contains element (15). 6 9. Biopsy needle system according to any of the requests 1-8; its characteristic is; biopsy a separate hemostasis activation element (3) and biopsy from the firing element (2) before firing of the sampling element (7) hemostasis activation element (3) It includes a locking scheme that restricts its activation.

10. Biopsy needle system according to any of claims 1-9, and its characteristic is; capsular5 The hemostasis module (6) is detachably connected to the external pin or sheath (5) and one that includes at least one adapter structure to accommodate different biopsy needle diameters It is a module. 7

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