Myocardial biopsy forceps

Abstract

The invention relates to a pair of myocardial biopsy forceps, which comprises a sleeve assembly, a catheter, a handle assembly, a transmission part and a negative pressure adsorption assembly, the near end of the catheter is connected with the handle assembly, the far end of the catheter is connected with the sleeve assembly, a rotary cutter is arranged in the sleeve assembly in a sliding mode, and the rotary cutter is a hollow tubular cutter; a transmission part is arranged in the catheter, the near end of the transmission part is connected with the negative pressure adsorption assembly, the far end of the transmission part is connected with the rotary cutter, and the transmission part is used for driving the rotary cutter to stretch out of the sleeve assembly and rotationally cut myocardial tissue; an adsorption tube is arranged in the transmission part, the negative pressure adsorption assembly is communicated with the near end of the adsorption tube, and the far end of the adsorption tube is communicated with an inner cavity of the rotary cutter, so that negative pressure adsorption positioning is carried out on the myocardial tissue before rotary cutting and in the rotary cutting process, and the tissue is kept tensioned. According to the myocardial biopsy forceps, myocardial tissue is positioned and tensioned in advance through the negative pressure adsorption assembly, crossing of passive clamping orientation and active adsorption is achieved, and the problems that in the heart beating environment, biopsy forceps are prone to slipping off, and sampling and positioning are difficult are effectively solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a myocardial biopsy forceps. BACKGROUND

[0002] Myocardial biopsy forceps is a medical device specially used for percutaneous endomyocardial biopsy (EMB), mainly used for obtaining a small piece of myocardial tissue sample from the inner wall of the heart (usually the right ventricle or left ventricle) for pathological examination. During use, medical personnel usually use the transjugular or femoral vein approach to send the biopsy forceps into the right ventricle under X-ray fluoroscopy (sometimes combined with ultrasound guidance), and occasionally through the arterial path to enter the left ventricle for sampling.

[0003] Chinese patent document CN120477835B discloses a rotary cutting type myocardial biopsy forceps, which comprises a sleeve assembly, a catheter, a handle assembly, a push-pull ring and a rotary cutting knife located inside the sleeve assembly. The distal end of the handle assembly is connected to the proximal end of the catheter, and the distal end of the catheter is connected to the sleeve assembly. The sleeve assembly includes a sleeve body and a sealing assembly arranged at the open end of the sleeve body. The proximal end of the sleeve body is connected to the catheter, and the rotary cutting knife is slidingly arranged inside the sleeve body. A first driving member is arranged inside the catheter, and the handle assembly is drivingly connected to the rotary cutting knife through the first driving member to drive the rotary cutting knife to extend out of the sleeve body and cut the myocardial tissue. The first driving member is a transmission member, the push-pull ring is connected to one end of the transmission member, and the other end of the transmission member is connected to the rotary cutting knife. The rotary cutting knife is a hollow tubular cutter in the shape of a circle or a polygon. The rotary cutting type myocardial biopsy forceps has the following defects: (1) the rotary cutting type myocardial biopsy forceps only relies on the push-in rotary cutting knife for sampling, and the myocardial tissue may be difficult to enter the inside of the knife pipe due to wetness and smoothness or heart beating; (2) although there is a sealing assembly outside, it is not absolutely reliable to rely on negative pressure and friction force to retain the myocardial cell sample during the process of retracting the rotary cutting knife into the sleeve.

[0004] Therefore, there is an urgent need to provide a myocardial biopsy forceps capable of stable sampling. SUMMARY

[0005] (I) Technical problems to be solved

[0006] In view of the above-mentioned defects and shortcomings of the prior art, the present application provides a myocardial biopsy forceps, which solves the technical problem of the rotary cutting type myocardial biopsy forceps that the rotary cutting knife is difficult to stably sample due to wetness and smoothness of the myocardial tissue or heart beating.

[0007] (II) Technical solutions

[0008] In order to achieve the above-mentioned purposes, the main technical solutions adopted by the present application include:

[0009] The embodiment of the present application provides a myocardial biopsy forceps, which comprises a sleeve assembly, a catheter, a handle assembly, a rotary cutter, a transmission member and a negative pressure suction assembly.

[0010] The proximal end of the catheter is connected with the handle assembly, and the distal end is connected with the sleeve assembly.

[0011] The rotary cutter is slidably arranged in the sleeve assembly, and the rotary cutter is a hollow tubular structure.

[0012] The transmission member is arranged in the catheter, the proximal end of the transmission member is connected with the negative pressure suction assembly, and the distal end is connected with the rotary cutter, so that the rotary cutter is driven to extend or retract relative to the sleeve assembly and rotate to cut.

[0013] The transmission member is coaxially arranged with a suction tube, the distal end of the suction tube is communicated with the inner cavity of the rotary cutter, and the proximal end is communicated with the negative pressure suction assembly, so that negative pressure is generated in the inner cavity of the rotary cutter to suck myocardial tissue.

[0014] Optionally, the negative pressure suction assembly comprises a negative pressure generator and a connecting interface.

[0015] The negative pressure generator is a medical electric negative pressure pump or a vacuum syringe with a locking mechanism, and the negative pressure generator is in airtight connection with the proximal end of the suction tube through the connecting interface.

[0016] Optionally, a fluid control valve group is arranged on a fluid path between the negative pressure suction assembly and the rotary cutter, and the fluid control valve group comprises:

[0017] A one-way check valve configured to allow fluid to flow from the rotary cutter to the negative pressure suction assembly and cut off reverse flow; and / or,

[0018] A manual pressure relief valve configured to communicate the atmosphere with the fluid path in an open state to release negative pressure.

[0019] Optionally, a flow safety control unit is further arranged in the fluid path between the negative pressure suction assembly and the rotary cutter, and the flow safety control unit is at least one of the following structures:

[0020] A microporous flow restrictor, which is a sheet arranged on the cross section of the flow path, and a throttle hole is arranged in the center of the sheet;

[0021] A liquid-encountering self-sealing filter element, which is configured to be breathable in a dry state and to close the pores to cut off the negative pressure flow path after contacting liquid.

[0022] Optionally, the rotary cutter is in a hollow cylindrical tube shape, and a plurality of cutting teeth are circumferentially spaced apart on a distal end face of the rotary cutter, and the plurality of cutting teeth extend in a continuous wavy shape in a circumferential direction to form a crown-shaped wavy blade.

[0023] An edge bevel of the crown-shaped wavy blade is formed on an outer wall side of the rotary cutter, and an inner wall surface of the rotary cutter remains flat and smooth.

[0024] Optionally, a plurality of barb structures are provided on the inner wall surface of the rotary cutter, and tips of the barb structures point to a proximal end direction.

[0025] The barb structures are configured to elastically fit the inner wall surface when the myocardial tissue enters the rotary cutter, and the barb structures can be opened to hold the myocardial tissue when the myocardial tissue has a tendency to slide out.

[0026] Optionally, the barb structures are scale-shaped elastic barbs formed by laser cutting and inwardly bending the tube wall of the rotary cutter, or formed by an elastic metal bushing embedded in the rotary cutter.

[0027] Optionally, the sleeve assembly includes a sleeve body and a closure assembly.

[0028] A distal end of the sleeve body has an open mouth, and the closure assembly is arranged at the open mouth.

[0029] The closure assembly includes a tubular base made of a shape memory alloy, and a distal end of the tubular base is circumferentially divided to form a plurality of radially openable and closable support petals.

[0030] An outer peripheral surface of the support petals is covered with an elastic sealing film, the elastic sealing film is attached to the support petals and extends to cover a gap region between adjacent two support petals.

[0031] When the support petals are in a closed state, the elastic sealing film forms a closed pouch structure under the driving of the support petals.

[0032] Optionally, the elastic sealing film forms a web-shaped connecting portion at a gap between adjacent support petals, and the web-shaped connecting portion is configured to be in an elastic stretching state when the support petals are opened, and to assist in closing and sealing by using a retraction force when the support petals are closed.

[0033] A thickness of the web-shaped connecting portion is greater than a thickness of the elastic sealing film attached to the surface of the support petals.

[0034] Optionally, the handle assembly includes:

[0035] a handle body fixedly connected to the catheter;

[0036] A closed sliding sleeve is provided outside the handle body;

[0037] A traction component, one end of which is connected to the closed sliding sleeve and the other end of which is connected to the closed assembly, is used to drive the closed assembly to generate axial displacement in order to control the opening and closing of the support petals.

[0038] (III) Beneficial Effects

[0039] The beneficial effects of this invention are as follows: The myocardial biopsy forceps of this invention, by employing a negative pressure adsorption component and an adsorption tube inserted into the transmission component, and connecting the distal end of the adsorption tube to the inner cavity of the hollow rotary cutter, can actively adsorb myocardial tissue before and during the rotary cutting action, compared to the prior art which relies solely on mechanical propulsion for passive rotary cutting. This effectively solves the problems of easy slippage of the blade and difficulty in positioning under conditions of heartbeat and slippery tissue, achieving a leap from passive clamping to active capture, and ultimately significantly improving the success rate of myocardial tissue sampling.

[0040] The myocardial biopsy forceps of the present invention, by employing a fluid control valve assembly and a flow safety control unit, can prevent external gas or backflow liquid from accidentally entering the ventricle, compared to direct connection to a negative pressure source. The flow safety control unit can limit the maximum suction force, thus achieving the technical effect of ensuring effective sampling while effectively maintaining surgical safety and preventing air embolism or ventricular wall damage.

[0041] The myocardial biopsy forceps of the present invention, due to the barb structure pointing proximally on the inner wall of the rotary cutter, can conform to the myocardial tissue after it enters and open and hold it when the tissue slides out, in accordance with the principle of physical barbs, compared with the smooth inner wall of the blade tube in the prior art. This achieves the technical effect of forming a pneumatic and mechanical double locking with negative pressure adsorption, preventing the tissue sample from accidentally slipping out during the blade withdrawal process.

[0042] The myocardial biopsy forceps of the present invention, by employing an elastic sealing membrane attached to a shape memory alloy support flap and covering its gap, can form a continuous, seamless, pouch-like closed space when the tip is closed, compared to the existing technology that relies solely on the assembly and sealing of metal flaps. This physically and completely blocks the path of leakage of tiny tissue fragments and blood, thereby eliminating the risk of iatrogenic vascular embolism caused by sample detachment and significantly improving the safety of interventional procedures. Attached Figure Description

[0043] Figure 1 This is a front view schematic diagram of Embodiment 1 of the myocardial biopsy forceps of the present invention;

[0044] Figure 2 for Figure 1A schematic diagram of the internal structure of the sleeve assembly of the myocardial biopsy forceps, wherein the sealing component is located inside the sleeve body and is in a deformed state;

[0045] Figure 3 for Figure 2 A top view of the closure assembly of the myocardial biopsy forceps in a deformed state, wherein the closure assembly includes a first tube segment and a second tube segment;

[0046] Figure 4 for Figure 3 A side view of the enclosed component, in which the second pipe segment is divided into two supporting lobes along the circumferential direction;

[0047] Figure 5 for Figure 4 A top view of the enclosed component in its initial state;

[0048] Figure 6 for Figure 3 Another side view of the closed component, in which the second tube segment is divided into three supporting petal structures along the circumference;

[0049] Figure 7 for Figure 1 A schematic diagram of the internal structure of the handle assembly of the myocardial biopsy forceps;

[0050] Figure 8 This is a schematic front view of the negative pressure adsorption assembly, transmission component, and rotary cutter of Embodiment 1 of the myocardial biopsy forceps of the present invention.

[0051] Figure 9 for Figure 8 A schematic diagram of the transmission components and the internal structure of the rotary cutter in the process;

[0052] Figure 10 This is a top view of the sealing component of the myocardial biopsy forceps embodiment 2 of the present invention in a deformed state, wherein the sealing component includes a first tube segment and a second tube segment, and an elastic sealing membrane is sleeved around the second tube segment;

[0053] Figure 11 for Figure 10 A side view of the enclosed component, in which the second pipe segment is divided into two supporting lobes along the circumferential direction;

[0054] Figure 12 for Figure 10 Another side view of the closed component shows that the second tube segment is divided into three supporting lobes along the circumference.

[0055] [Explanation of Labels in the Attached Image]

[0056] 1: Sleeve assembly; 2: Guide tube; 3: Handle assembly; 31: Handle body; 32: Operating ring; 34: Sealing sleeve; 35: Knurled high-head screw; 4: Sleeve body; 41: Inner cylinder; 42: Outer cylinder; 43: Compression spring; 5: Rotary cutter; 6: Sealing assembly; 61: First pipe section; 62: Second pipe section; 63: Sealing pliers head; 7: Transmission component; 8: Traction wire; 9: Adsorption tube; 10: Negative pressure adsorption assembly; 11: Cutting teeth; 12: Barbed structure; 13: Elastic sealing membrane. Detailed Implementation

[0057] To better explain and facilitate understanding of the present invention, a detailed description of the invention is provided below with reference to the accompanying drawings and specific embodiments. In this description, the side of the rotary myocardial biopsy forceps closest to the operator is defined as "proximal," and the side closest to the patient is defined as "distal."

[0058] Example 1:

[0059] Please refer to Figures 1 to 9 This embodiment provides a myocardial biopsy forceps, a sleeve assembly 1, a catheter 2, a handle assembly 3, a rotary cutter 5, a transmission component 7, a traction wire 8, an adsorption tube 9, and a negative pressure adsorption assembly 10.

[0060] The proximal end of catheter 2 is connected to handle assembly 3, and the distal end of catheter 2 is connected to sleeve assembly 1. A rotary cutter 5 is slidably disposed within sleeve assembly 1. A transmission component 7 passes through catheter 2 and is driven by the rotary cutter 5 to extend or retract relative to sleeve assembly 1 and perform rotary cutting. An adsorption tube 9 is coaxially disposed within transmission component 7. The distal end of adsorption tube 9 communicates with the inner cavity of rotary cutter 5, and the proximal end of adsorption tube 9 communicates with negative pressure adsorption assembly 10. This allows negative pressure to be generated within the inner cavity of rotary cutter 5 to adsorb myocardial tissue, achieving active adsorption and positioning of the target tissue before and during rotary cutting while maintaining tissue tension.

[0061] The negative pressure adsorption assembly 10 may include a negative pressure generator and a connection interface. The negative pressure generator may be a medical electric negative pressure pump or a vacuum injector with a locking mechanism. The connection interface is used to achieve an airtight connection with the proximal end of the adsorption tube 9. It should be noted that the connection interface is preferably a Luer connector. The vacuum injector with a locking mechanism generates negative pressure inside the syringe by pulling the plunger, thereby drawing liquid or gas into the syringe. The locking mechanism's function is to fix the plunger in place after it is pulled to the desired position, preventing the plunger from retracting and maintaining the vacuum state inside the syringe. Figure 2 As shown, the sleeve assembly 1 includes a sleeve body 4 and a sealing component 6. The proximal end of the sleeve body 4 is connected to the catheter 2, and its distal end forms an open opening; the sealing component 6 is disposed at the distal open opening of the sleeve body 4 and is used to selectively seal the open opening after sampling to reduce the risk of tissue sample or debris shedding.

[0062] Preferably, the sleeve body 4 includes an inner cylinder 41 and an outer cylinder 42 sleeved around the inner cylinder 41. The inner cylinder 41 is used to guide and accommodate the rotary cutter 5. The outer wall surface of the inner cylinder 41 and the inner wall surface of the outer cylinder 42 enclose an annular space, and the sealing component 6 is at least partially located within this annular space to achieve the opening and closing sealing function without significantly increasing the distal outer diameter.

[0063] like Figures 3 to 6 As shown, the sealing assembly 6 includes a first tube segment 61 and a second tube segment 62. The distal end of the first tube segment 61 is connected to the proximal end of the second tube segment 62. The second tube segment 62 is made of shape memory alloy and is divided circumferentially to form at least two radially openable support lobes, the distal end of each support lobe forming a sealing jaw 63. The second tube segment 62 has an initial shape and a deformed state: in the initial shape, the distal end of the second tube segment 62 expands radially outward, causing the sealing jaw 63 to open, thereby opening the distal opening of the inner cylinder 41, facilitating the extension of the rotary cutter 5 for sampling; when the second tube segment 62 enters the constrained area of ​​the outer cylinder 42 under axial traction, the second tube segment 62 is restricted by the inner wall of the outer cylinder 42 and switches from the initial shape to the deformed state, its distal end contracts radially inward, causing each sealing jaw 63 to close and form a sealing structure at the distal end to close the distal opening of the inner cylinder 41.

[0064] In a preferred embodiment, the second pipe segment 62 is circumferentially divided into two support flap structures, each support flap forming a semi-circular closed clamp head 63 at its distal end (see reference). Figure 4 , Figure 5 In another preferred embodiment, the second pipe segment 62 is divided circumferentially into three supporting petal structures (see reference). Figure 6 This allows for a more uniform circumferential fit and sealing effect. Of course, the invention is not limited to this; the second pipe segment 62 can also be divided circumferentially into four, five, or more supporting petal structures.

[0065] like Figure 7 As shown, the handle assembly 3 includes a handle body 31, an operating ring 32, and a closed sliding sleeve 34. The handle body 31 is fixedly connected to the guide tube 2, and the operating ring 32 is disposed on the handle body 31 for the operator to hold and operate stably; the closed sliding sleeve 34 is slidably sleeved on the outside of the handle body 31.

[0066] One end of the traction wire 8 is connected to the closed sliding sleeve 34, and the other end is connected to the closed assembly 6 (preferably connected to the first pipe section 61), which is used to drive the closed assembly 6 to generate axial displacement, thereby controlling the second pipe section 62 to achieve radial opening and closing within the constraint area of ​​the outer cylinder 42.

[0067] Preferably, such as Figure 2As shown, a compression spring 43 is provided in the annular space of the sleeve body 4. The compression spring 43 is used to apply force to the distal end to push the sealing component 6 to reset, so that the sealing component 6 tends to open when the traction is released.

[0068] Preferably, such as Figure 7 As shown, a knurled high-head screw 35 is provided on the closed slide sleeve 34, and a positioning hole is provided on the handle body 31. The knurled high-head screw 35 can be screwed into the threaded hole on the closed slide sleeve 34, and can be selectively inserted into the positioning hole to axially position the closed slide sleeve 34 and maintain the closed state.

[0069] like Figure 9 As shown, the rotary cutter 5 is a hollow tubular tool. Preferably, the distal end face of the rotary cutter 5 is provided with a plurality of cutting teeth 11 spaced apart circumferentially, and the plurality of cutting teeth 11 extend in a continuous wavy shape along the circumferential direction to form a crown-shaped wavy blade. The beveled edge of the crown-shaped wavy blade is preferably formed on the outer wall side of the rotary cutter 5 to improve cutting efficiency and reduce internal cavity resistance, and the inner wall surface of the rotary cutter 5 is kept relatively flat and smooth to facilitate the entry of myocardial tissue.

[0070] It should be noted that the advantage of using a crown-shaped wavy blade lies in its crests and troughs. The troughs provide an entry channel for myocardial tissue. When the distal end of the rotary cutter 5 contacts the myocardial tissue, even before rotation, the protruding parts of the myocardial tissue are embedded in the troughs under negative pressure. This increases the contact area between the blade and the myocardial tissue, providing initial anti-slip positioning. The crests of the crown-shaped wavy blade penetrate the tissue first, transforming surface-contact cutting into point-contact puncture and cutting. This significantly reduces the axial thrust and rotational torque required for rotary cutting, reducing mechanical pressure on the heart wall and lowering the risk of perforation.

[0071] More preferably, the inner wall surface of the rotary cutter 5 is provided with multiple barbed structures 12, the tips of which point towards the proximal end. The barbed structures 12 are configured such that when myocardial tissue enters the inner cavity of the rotary cutter 5 under negative pressure, the barbed structures 12 can elastically conform to the inner wall surface of the rotary cutter 5; when the myocardial tissue tends to slip out, the barbed structures 12 can open to hold the myocardial tissue, thereby achieving dual retention of the myocardial tissue sample together with negative pressure adsorption.

[0072] The barb structure 12 can be a scale-like elastic barb, formed by laser cutting and inward bending of the tube wall of the rotary cutter 5, or formed by an elastic metal bushing embedded in the rotary cutter 5. Specifically, laser cutting refers to using femtosecond laser cutting technology to perform a semi-penetrating cut on the tube wall, or cutting out tongue-like pieces and then bending them inward. Embedded elastic metal bushing refers to using a tube-in-tube structure, where the inner layer is a bushing with stamped barbs made of thin sheet rolled up and pressed into the outer hollow tubular cutter with an interference fit.

[0073] To balance sampling effectiveness and clinical safety, preferably, a fluid control valve assembly (not shown) is installed in the fluid path between the negative pressure adsorption component 10 and the rotary cutter 5. The fluid control valve assembly may include:

[0074] A one-way check valve is configured to allow fluid to flow from the rotary cutter 5 side to the negative pressure adsorption assembly 10 side and to block reverse flow, thereby reducing the risk of backflow or accidental entry; and / or,

[0075] A manual pressure relief valve is configured to connect the atmosphere to the fluid path when open, so that the operator can quickly relieve the negative pressure when needed, avoid excessive adsorption, or facilitate the release of the sample.

[0076] More preferably, a flow safety control unit (not shown) is also provided in the fluid path to limit maximum suction or provide automatic protection upon contact with liquid. The flow safety control unit may include a microporous flow restrictor and a liquid-reactive self-sealing filter element.

[0077] The micro-orifice flow limiter is a thin sheet placed on the cross-section of the flow path, with a throttling orifice in the center of the sheet to limit the flow rate and the rate of negative pressure rise; the sheet is preferably a stainless steel sheet with laser-drilled holes.

[0078] The liquid-reactive self-sealing filter element is designed to be breathable in a dry state and to close its pores upon contact with liquid to cut off the negative pressure flow path. This automatically blocks the suction pathway when blood or liquid enters, improving safety. The preferred material for the liquid-reactive self-sealing filter element is a porous polymer matrix, which has air-repellent and hydrophilic properties or contains water-swellable materials.

[0079] The process of using the myocardial biopsy forceps in this embodiment may include the following steps:

[0080] Step S1: Establish an access via peripheral blood vessels, and under image guidance, insert catheter 2 and sleeve assembly 1 into the target heart chamber, and bring the distal end of sleeve assembly 1 close to the sampling site.

[0081] Step S2: Push the closing sleeve 34 to the far end to release or reduce the traction force on the traction wire 8. Under the action of the compression spring 43, the closing component 6 is reset and in the open state, thereby opening the far end opening of the inner cylinder 41.

[0082] Step S3: The transmission component 7 drives the rotary cutter 5 to extend to the distal end relative to the sleeve assembly 1 and contact the target myocardial tissue. Then, the negative pressure adsorption assembly 10 is activated (and the negative pressure is adjusted / released through the valve group when necessary) to form a negative pressure in the inner cavity of the rotary cutter 5, so as to suck up and locate the target myocardial tissue.

[0083] Step S4: The transmission component 7 drives the rotary cutter 5 to rotate relative to the sleeve assembly 1 and cuts the myocardial tissue to complete the sampling; under the action of negative pressure adsorption and barbed structure 12, the sample is kept in the inner cavity of the rotary cutter 5.

[0084] Step S5: Manipulate the transmission component 7 to retract the rotary cutter 5 into the sleeve body 4; then pull the closing sleeve 34 to allow the closing component 6 to enter the constraint area of ​​the outer cylinder 42 and close and seal the open end of the inner cylinder 41.

[0085] Step S6: Keep the instrument closed and process the sample; if necessary, open the manual pressure relief valve to release the negative pressure so that the sample can be released or the instrument can be cleaned.

[0086] Example 2:

[0087] Please refer to Figure 10 , Figure 11 and Figure 12 This embodiment provides another myocardial biopsy forceps. Compared with embodiment 1, the difference in this embodiment is that the sealing component 6 is provided with an elastic sealing membrane 13 on the outer periphery of the supporting valve to further improve the continuity and reliability of the closure and sealing. The remaining structures and connections, the rotary cutting sampling mechanism and the negative pressure adsorption structure are the same as those in embodiment 1, and will not be described again here.

[0088] In this embodiment, the outer peripheral surface of each support petal formed by the circumferential division of the second segment 62 of the sealing component 6 is covered with an elastic sealing film 13. The elastic sealing film 13 is attached to the outer surface of the support petal and extends to cover the gap area between two adjacent support petals.

[0089] When the supporting flap contracts radially inward and is in a closed state under the constraint of the outer cylinder 42, the elastic sealing membrane 13 forms a closed sac structure under the action of the supporting flap, thereby providing a continuous sealing interface outside the closed metal flap and reducing the possibility of leakage of tiny tissue debris or blood from the flap gap.

[0090] Furthermore, the elastic sealing membrane 13 forms a web-like connection at the gap between adjacent support petals. The web-like connection is in an elastically stretched state when the support petals are open, and uses the recoil force to assist in the closure and sealing when the support petals are closed, which also helps to reduce the risk of human tissue fibers getting stuck in the metal gap.

[0091] Preferably, the thickness of the webbed connection is greater than the thickness of the elastic sealing membrane 13 attached to the surface of the support petals, so as to improve the tear resistance and fatigue resistance of the gap coverage area.

[0092] Furthermore, the elastic sealing membrane 13 is preferably made of medical-grade polyurethane or silicone rubber, which has a high elongation.

[0093] The above are merely preferred embodiments of the present invention. For those skilled in the art, various modifications or substitutions can be made to the above structure and its connection methods without departing from the concept of the present invention, and all such modifications or substitutions should fall within the protection scope of the present invention.

Claims

1. A myocardial biopsy forceps, characterized by: The application relates to a medical device for myocardial tissue sampling, comprising: a sleeve assembly (1), a catheter (2), a handle assembly (3), a rotary cutter (5), a transmission member (7) and a negative pressure suction assembly (10); a proximal end of the catheter (2) is connected with the handle assembly (3), and a distal end of the catheter (2) is connected with the sleeve assembly (1); the rotary cutter (5) is slidingly arranged in the sleeve assembly (1), and the rotary cutter (5) is a hollow tubular structure; the transmission member (7) is arranged in the catheter (2), a proximal end of the transmission member (7) is connected with the negative pressure suction assembly (10), and a distal end of the transmission member (7) is connected with the rotary cutter (5) and used for driving the rotary cutter (5) to extend or retract relative to the sleeve assembly (1) and to rotate and cut; a suction pipe (9) is coaxially arranged in the transmission member (7), a distal end of the suction pipe (9) is communicated with an inner cavity of the rotary cutter (5), and a proximal end of the suction pipe (9) is communicated with the negative pressure suction assembly (10) and is configured to generate negative pressure in the inner cavity of the rotary cutter (5) so as to suck myocardial tissue.

2. The myocardial biopsy forceps according to claim 1, wherein: the negative pressure suction assembly (10) comprises a negative pressure generator and a connecting interface; the negative pressure generator is a medical electric negative pressure pump or a vacuum syringe with a locking mechanism, and the negative pressure generator is in airtight connection with the proximal end of the suction pipe (9) through the connecting interface.

3. The myocardial biopsy forceps according to claim 2, wherein: a fluid control valve group is arranged on a fluid path between the negative pressure suction assembly (10) and the rotary cutter (5), and the fluid control valve group comprises: a one-way check valve configured to allow fluid to flow from the rotary cutter (5) to the negative pressure suction assembly (10) and to cut off reverse flow; and / or a manual pressure relief valve configured to communicate the atmosphere with the fluid path in an open state to release negative pressure.

4. The myocardial biopsy forceps according to claim 2, wherein: a flow safety control unit is further arranged in the fluid path between the negative pressure suction assembly (10) and the rotary cutter (5), and the flow safety control unit is at least one of the following structures: a microporous flow restrictor which is a sheet arranged on a flow path section, and a throttling hole is arranged in the center of the sheet; a liquid-encountering self-sealing filter element which is configured to be breathable in a dry state and to close pores to cut off the negative pressure flow path after contacting liquid.

5. The myocardial biopsy forceps according to claim 1, wherein: the rotary cutter (5) is a hollow cylindrical pipe, a plurality of cutting teeth (11) are arranged on a distal end surface of the rotary cutter (5) in a circumferential direction, the plurality of cutting teeth (11) extend in a continuous wave shape in the circumferential direction, and a crown-shaped wave blade is formed; an edge bevel of the crown-shaped wave blade is formed on a side of an outer wall of the rotary cutter (5), and an inner wall surface of the rotary cutter (5) remains flat and smooth.

6. The myocardial biopsy forceps according to claim 5, wherein: a plurality of barb structures (12) are arranged on the inner wall surface of the rotary cutter (5), and the barb structures (12) are pointed towards a proximal end direction; the barb structures (12) are configured to be elastically attached to the inner wall surface when myocardial tissue enters the rotary cutter (5); when the myocardial tissue has a sliding-out tendency, the barb structures (12) can be opened to hold the myocardial tissue.

7. The myocardial biopsy forceps according to claim 6, wherein: The barb structure (12) is a scale-shaped elastic barb formed by laser cutting and inwardly bending the tube wall of the rotary cutter (5), or formed by an elastic metal bush embedded in the rotary cutter (5).

8. The myocardial biopsy forceps according to any one of claims 1 to 7, wherein: The sleeve assembly (1) comprises a sleeve body (4) and a closure assembly (6); The distal end of the sleeve body (4) has an open mouth, and the closure assembly (6) is arranged at the open mouth; The closure assembly (6) comprises a tubular base body made of shape memory alloy, and the distal end of the tubular base body is circumferentially divided to form a plurality of radially openable and closable support petals; An elastic sealing film (13) is arranged on the outer circumferential surface of the support petals, and the elastic sealing film (13) is attached to the support petals and extends to cover the gap region between adjacent two support petals; When the support petals are in the closed state, the elastic sealing film (13) forms a closed pouch structure under the driving of the support petals.

9. The myocardial biopsy forceps according to claim 8, wherein: The elastic sealing film (13) forms a web-shaped connecting part at the gap between adjacent support petals, and the web-shaped connecting part is configured to be in an elastic stretching state when the support petals are opened and to assist the closure and sealing by using the retraction force when the support petals are closed. The thickness of the web-shaped connecting part is greater than the thickness of the elastic sealing film (13) attached to the surface of the support petals.

10. The myocardial biopsy forceps according to claim 8, wherein: The handle assembly (3) comprises: A handle body (31) fixedly connected with the catheter (2); A closure sliding sleeve (34) slidingly sleeved outside the handle body (31); A traction member (8) having one end connected with the closure sliding sleeve (34) and the other end connected with the closure assembly (6), for driving the closure assembly (6) to produce axial displacement to control the opening and closing of the support petals.

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