WO2021143622A1

WO2021143622A1 - Tissue clipping device and use method therefor

Info

Publication number: WO2021143622A1
Application number: PCT/CN2021/070878
Authority: WO
Inventors: 陈大凯
Original assignee: 科凯(南通)生命科学有限公司
Priority date: 2020-01-14
Filing date: 2021-01-08
Publication date: 2021-07-22
Also published as: DE112021000533T5; CN111110312A

Abstract

A tissue clipping device and a use method therefor, comprising a handle, an inner tube, an inner clip, an outer tube base, an outer tube, a sleeve, an outer clip, and a release mechanism. The outer tube is connected to the sleeve and the outer tube base; the outer clip is provided with an outer clip base and outer clip pieces, and clipping of the outer clip pieces is driven by a sleeve opening; the inner tube penetrates through the outer tube base, the outer tube, and the sleeve, sequentially, the outer clip base is sleeved in the outer tube, and the inner tube is connected to the inner clip and the handle; the inner clip is provided with an inner clip base and inner clip pieces, and the inner clip base abuts against the outer clip base to drive the outer clip base to move, and the inner clip pieces abut against the outer clip pieces to be combined into a clip; the release mechanism is sleeved at a position where a front end of the outer tube and the sleeve are connected, and is used for locking or unlocking the connection between the outer tube and the sleeve. By means of the tissue clipping device and the use method therefor in the present invention, the operation can be performed more conveniently, accurately, and safely, and operation requirements for a doctor are reduced. Moreover, if a mitral valve leaflet clipping position is not good, repeated clipping and release can be performed.

Description

Device for tissue clamping and its use method

Technical field

The invention belongs to the technical field of medical devices, and specifically relates to a device for tissue clamping and a method of use thereof.

Background technique

Heart valvular disease is one of the most common heart diseases in my country, among which valve damage is mainly caused by rheumatic fever; in recent years, with the development of the aging population, valve degeneration (including calcification and mucous degeneration) and metabolic disorders valves Damage is also increasing in our country. The characteristic of mitral regurgitation is the retrograde flow of blood from the left ventricle of the heart to the left atrium through the malfunctioning mitral valve. During the normal systolic cycle, the mitral valve acts as a check valve to prevent oxygenated blood from flowing back into the left atrium, so that oxygenated blood is pumped through the aortic valve to the aorta and then to the whole body. Mitral regurgitation can significantly reduce the pumping efficiency of the heart, thereby putting the patient at severe and progressive risk of heart failure. The most common treatment of mitral regurgitation relies on valve replacement or repair, including leaflet and annulus remodeling, the latter of which is generally called valvuloplasty. Although all these techniques are very effective, because they rely on thoracotomy, the surgical trauma is large and the patient recovers slowly. In recent years, Abbott’s Mitraclip, a valve clamping device through percutaneous venous intervention, has also appeared internationally, but its complicated operation has brought trouble to doctors. Patent documents such as the patent document with publication number CN107595435A disclose a valve clamp, including a first clamping part, a second clamping part, and a connecting part. The first clamping part has at least two first clamping parts. The second clamping member has a corresponding number of second clamping arms, and each of the first clamping arms and its corresponding second clamping arm can be combined into a set of clamps, but its operation is not Convenient and unstable release, which affects the success rate of surgery.

In view of the above-mentioned shortcomings of the existing related technologies, a new device system and method is needed.

Summary of the invention

Based on the above-mentioned shortcomings in the prior art, the present invention provides a device for tissue splicing and a method of use thereof.

In order to achieve the above-mentioned purpose of the invention, the present invention adopts the following technical solutions:

A device for tissue clamping, including a handle, an inner tube, an inner clamp, an outer tube seat, an outer tube, a sleeve, an outer clamp, and a release mechanism; the front end of the outer tube is connected with the sleeve, and the rear end is connected with the outer tube Seat connection; the outer clip has an outer clip seat and two open-shaped outer clips located on the outer clip seat, the outer clip seat is sleeved in the casing and the two outer clips leak out of one end of the casing mouth, So that the outer clamp seat can move in the casing along the direction of the sleeve, the outer clamp is driven by the sleeve mouth to clamp; the inner tube passes through the outer tube seat, the outer tube, the sleeve, and the outer clamp seat is sleeved in the outer tube in turn , The front end of the inner tube is connected with the inner clip, and the rear end is connected with the handle, so that the handle drives the inner tube and the inner clip to move in the outer tube along the direction of the outer tube in turn; the inner clip has an inner clip seat and two pieces located on the inner clip seat The upper is an open-shaped inner clip, the inner clip seat has abutting protrusions, so that when the inner clip seat is in contact with the outer clip seat, the outer clip seat is driven to move, and the inner clip is matched with the outer clip. The inner clip piece and the outer clip piece are combined to form a clamp when they are in conflict; the release mechanism is sleeved at the connection between the front end of the outer tube and the sleeve, and is used to lock or unlock the connection between the outer tube and the sleeve.

As a preferred solution, the release mechanism includes a release tube and a release tube seat, the front end of the release tube has an inner cavity and a boss, the sleeve is embedded in the inner cavity and the outer side is provided with a grooved convex wall, the belt The groove convex wall is matched with the boss to form a rotating clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe for rotating the release pipe.

As a preferred solution, the release tube socket is further provided with an emptying port for surgical emptying, the other end of the release tube socket is provided with a sealing element; the end of the outer tube socket is provided with a luer interface.

As a preferred solution, the diameter of the inner tube is 0.5-2.5 mm, the diameter of the outer tube is 2.6-5 mm, and the opening angle of the two outer clips is 100-160 degrees.

As a preferred solution, the diameter of the casing tube is smaller than the diameter of the outer tube so that the casing can be inserted into the outer tube, and the outer tube has a limiting step inside, and the limiting step is used to abut the bottom of the casing.

As a preferred solution, the front end of the outer tube further has a limiting groove, the sleeve has a limiting protrusion, and the limiting groove and the limiting protrusion are matched to restrict the sleeve from moving in the circumferential direction of the outer tube.

As a preferred solution, a number of holes are provided on the sleeve wall of the sleeve for accelerating endothelialization of the sleeve implantation.

As a preferred solution, the abutting surface sides of the inner clip and the outer clip are respectively provided with clamping teeth, and the outer bottom end of the outer clip is also provided with a clamping protrusion.

As a preferred solution, the end of the mouth of the inner cavity of the sleeve is provided with an internal thread, and the outer side of the outer clamp seat is provided with an external thread adapted to the internal thread.

A method for using a device for tissue clamping is implemented by a device for tissue clamping, and includes the following steps:

S1. Send the device for tissue clamping to the heart valve, control the inner tube to move back and forth through the handle, and adjust the position of the inner clip so that the positions of the outer clip and the inner clip are located on the inner and outer sides of the prolapsed valve leaflet;

S2. Twitch the handle to collect the inner clip and the outer clip into the sleeve and clamp the valve;

S3. Unlock the connection between the inner tube and the inner clamp, adjust the release mechanism, unlock the connection between the outer tube and the sleeve, and release the sleeve and the inner and outer clamps.

Compared with the prior art, the present invention has the following beneficial effects:

The device for tissue clamping and its use method of the present invention can be operated more conveniently, accurately and safely, and the operation requirements for doctors are reduced. At the same time, if the clamping position of the mitral valve leaflets is not good, the clamping can be repeated, and then the operation is released.

Description of the drawings

Figure 1 is a schematic diagram of the overall structure of the device for tissue clamping according to the first embodiment of the present invention;

2 is a schematic diagram of the overall cross-sectional structure of the device for tissue splicing according to the first embodiment of the present invention;

Fig. 3 is a schematic diagram of the operating state of the device for tissue clamping according to the first embodiment of the present invention;

4 is a schematic diagram of the internal and external clamps of the device for tissue clamping according to the first embodiment of the present invention after being released;

Fig. 5 is a schematic diagram of the outer tube structure of the device for tissue splicing according to the first embodiment of the present invention;

6 is a schematic diagram of a cross-sectional structure of the release tube of the device for tissue clamping according to the first embodiment of the present invention;

Figure 7 is a schematic diagram of the sleeve structure of the device for tissue clamping according to the first embodiment of the present invention;

Fig. 8 is a schematic structural view of the valve leaflets of the outer clamping part of the device for tissue clamping according to the first embodiment of the present invention;

9 is a schematic structural view of the valve leaflets of the inner clamping part of the device for tissue clamping according to the first embodiment of the present invention;

Among them: 1. Handle; 2. Inner tube; 3. Outer tube seat; 4. Outer tube; 401. Limit groove; 402. Limit step; 5. Release tube seal; 6. Release tube seat; 7. Release tube; 701. Boss; 702. Inner cavity; 8. Casing; 801. Limiting protrusion; 802. Convex wall with groove; 803. Hole; 9. Outer clip; 901. Outer clip; 902. Outer clamp seat; 10. Inner clamp; 101. Inner clamp piece; 102. Inner clamp seat.

Detailed ways

In order to explain the embodiments of the present invention more clearly, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings in the following description are only embodiments of the present invention. For those of ordinary skill in the art, without creative work, other drawings can be obtained based on these drawings, and others can be obtained.的实施方式。

Example one:

As shown in Figures 1-9, a device system and method for tissue clamping of this embodiment includes a handle 1, an inner tube 2, an outer tube seat 3, an outer tube 4, a release mechanism, and a sleeve 8 , Outer clip 9, inner clip 10. The front section of the inner tube 2 is connected with the inner clip 10, and the rear end is connected with the handle 1. The front section of the outer tube 4 is connected with the sleeve 8, and the rear end is connected with the outer tube socket 3. The inner cavity 702 of the front section of the release tube 7 has a boss 701. The sleeve 8 is fixed on the outer tube 4, and the release mechanism is released. Fall off from the outer tube 4. Control the inner tube 2 to move back and forth through the handle 1, adjust the position of the inner clip 10 to clamp the prolapsed valve leaflet. If the position is not suitable, you can repeat the adjustment. When appropriate, the inner clip 10 and the outer clip 9 are collected. Inside the casing 8, untie the connection between the inner tube 2 and the inner clip 10, and then adjust the release mechanism to release the casing 8 and the inner and outer clips 9 to complete a quick and stable operation, which is simple and convenient.

Specifically, the front end of the outer tube 4 is connected with the sleeve 8, and the rear end is connected with the outer tube base 3 by threaded connection or adhesive fixation. The diameter of the sleeve 8 is smaller than the diameter of the outer tube 4 so that the sleeve 8 can be inserted into the outer tube. Tube 4, the outer tube 4 has a limiting step 402 inside, the limiting step 402 abuts the bottom of the sleeve 8, the front end of the outer tube 4 also has a limiting groove 401, the sleeve 8 has a limiting protrusion 801, a limiting recess The groove 401 is matched with the limiting protrusion 801 to restrict the sleeve 8 from moving in the circumferential direction of the outer tube 4; the outer clamp 9 has an outer clamp seat 902 and two outer clamp pieces 901 which are open on the outer clamp seat 902, The clamp seat 902 is sleeved in the sleeve 8 and the two outer clamp pieces 901 leak out from one end of the sleeve 8 port, so that the outer clamp seat 902 can move in the sleeve 8 along the direction of the sleeve 8 and is driven by the sleeve 8 port. The external clamp is clamped, the end of the inner cavity of the sleeve 8 is provided with internal threads, and the outside of the outer clamp seat 902 is provided with external threads that match the internal threads. When the device is not in use, the outer clamp seat 902 can be clamped first. Screw into the thread of the sleeve 8 to avoid arbitrary movement of the outer clamp seat 902. The outer bottom end of the outer clamp 901 is also provided with a clamping protrusion. When the outer clamp 901 is closed, the clamping protrusion is clamped on the inner cavity port of the sleeve 8 The inner tube 2 penetrates through the outer tube socket 3, the outer tube 4, the sleeve 8, and the outer clamp seat 902 in sequence, and is sleeved in the outer tube 4, and the front end of the inner tube 2 is connected with the inner clamp seat 102 through threads. The rear end and the handle 1 are connected by threaded connection or adhesive fixation, so that the handle 1 drives the inner tube 2 and the inner clip 10 to move in the outer tube 4 along the direction of the outer tube 4; the inner clip 10 has an inner clip seat 102 and two The inner clip 101 is located on the inner clip seat 102 in an open shape. The inner clip seat 102 has abutting protrusions so that when the inner clip seat 102 is in contact with the outer clip seat 902, the outer clip seat 902 is driven to move along the tube direction of the sleeve 8 , The outer clamp seat 902 is also provided with non-circular grooves such as square, triangle, special-shaped, etc., and the shape of the groove end is inserted into the groove against the front end of the protrusion to match the groove, so that the inner clamp seat 102 can also drive the outer clamp seat 902 rotates along the circumferential direction of the sleeve 8; the inner clip 101 is adapted to the outer clip 901, so that the inner clip 101 and the outer clip 901 are combined to form a fixture when the inner clip 101 and the outer clip 901 collide, and the inner clip 101 and the outer clip 901 are both It is arc-shaped, and the side of the contact surface is respectively provided with barbed gripping teeth to strengthen the clamping force; the release mechanism is sleeved at the connection between the front end of the outer tube 4 and the sleeve 8 to lock or unlock the outer tube 4 and the sleeve 8 Connection, the release mechanism includes a release tube 7, a release tube seat 6. The front end of the release tube 7 has an inner cavity 702 and a boss 701. The sleeve 8 is embedded in the inner cavity 702 and the outer side is provided with a grooved convex wall 802 with grooves. The convex wall 802 is adapted to the boss 701 to form a rotary clamping structure. Specifically, the boss 701 can pass through the groove of the grooved convex wall 802 and rotate and move at the concave wall to be clamped at the convex wall. When the table 701 rotates to the position where it overlaps with the groove again, it can pass through the groove and detach from the clamping; one end of the release pipe socket 6 is connected with the rear end of the release pipe 7 by screwing or glueing, and is used to hold the rotating release pipe socket 6 Drive the release tube 7 to rotate; the release tube seat 6 is also provided with an emptying port for surgical discharge The other end of the release tube socket 6 is provided with a sealing element. The sealing element can be a sealing screw, a gasket, etc., which can enhance the drainage and sealing performance. Of course, the release mechanism can also be two semicircular clamps sandwiching each other. The bottom end of the sheet can be opened to release and unlock the connection between the sleeve 8 and the outer tube 4, or the sleeve 8 has an L-shaped groove, and the release tube 7 has a protrusion that is adapted to the L-shaped groove to complete the locking or unlocking, etc. The specific structure of the release mechanism is not limited; the end of the outer tube base 3 is designed with a standard Luer interface thread, which can be easily connected to standard Luer interface devices and enhance functionality.

Further, the handle 1 can be made of polymer materials such as PP, ABS, and metal materials. The structure is not limited and easy to operate; the diameter of the inner tube 2 is preferably 0.5-2.5mm, and the material of the outer tube 4 is selected for use in surgical operations. High polymer materials (such as PP, ABS, PE, etc.) or metal materials such as stainless steel, nickel-titanium, etc., with a diameter of 2.6-5mm. The front end and the inner clamp 10 are connected by threads, the rear end and the handle 1 can be fixed with positive and negative threads, holes are inserted with rivets, and can be disassembled on site; the outer tube base 3 is made of polymer materials, such as PP, ABS, etc., and the release tube is sealed The part 5 selects the sealing screw and the release tube base 6 as an integrated device, the material is polymer material, metal material, and the sealing gasket is added under the sealing screw, and the release tube 7 is made of polymer material and metal material, such as PP, ABS, PE and Stainless steel, etc. The casing 8 is made of polymer materials, metal materials or alloy materials. The limiting protrusion 801 of the casing 8 can be one or more, preferably 2-3, corresponding to the limit of the adapting casing 8. The number of grooves 401, the position of the limiting protrusion 801 and the limiting groove 401 can be interchanged, the length of the sleeve 8 inserted into the outer tube 4 is preferably 1-3mm, and the sleeve 8 with grooves and convex walls 802 is the outer ring The outer ring is 0.5-2mm wide, the number of grooves is preferably 2-3, and the number of bosses 701 of the release tube 7 is adapted to the number of holes 803 on the wall of the sleeve 8 to accelerate the endothelialization process after implantation in the human body; The outer clip 9 is made of nickel-titanium material, and the two clips are arc-shaped. After heat treatment, the angle of the two clips reaches 100-160 degrees, which is convenient for capturing the mitral valve leaflets; the inner clip 10 is made of nickel-titanium material, two The clip piece is arc-shaped and matches the outer clip 9. There is a row of barbed teeth on the front ends of the two clips of the inner clip 10. After the outer clip 9 is clamped, it can penetrate into the valve leaflets to prevent The inner and outer clips 9 clamp the valve leaflets and fall off.

A method of using a device for tissue clamping includes the following steps:

S1. Send the device for tissue clamping to the heart valve, for example, send the device from the apex of the heart to the ventricular valve by surgery, control the inner tube 2 to move back and forth through the handle 1, and adjust the position of the inner clip 10 to make the outer The position of the clip 901 and the inner clip 101 are respectively located on the inner and outer sides of the prolapsed valve leaflet;

S2. Twitch the handle 1 to collect the inner clip 10 and the outer clip 9 into the sleeve 8 to clamp the valve; of course, before use, rotate the handle 1 to drive the inner tube 2, the inner clip seat 102, and the outer clip seat 902 in turn to make the outer clip seat. 902 separates from the threaded area of the casing 8, and then pulls the handle 1 to drive the inner tube 2 and the inner clamp seat 102 in turn, the inner clamp seat 102 drives the outer clamp seat 902 into the sleeve 8, and the sleeve 8 ports close the inner clamp 10 and the outer clamp 9 Thereby clamping the valve leaflets to be clamped, and at the same time, if the mitral valve leaflets are not well clamped, the clamping can be repeated, and finally the clamping protrusion on the outer bottom end of the outer clamping piece 901 is clamped into the 8 port of the sleeve. Firm clamping action;

S3. Drive the inner tube 2 to rotate by rotating the handle 1, untie the threaded connection between the inner tube 2 and the inner clamp 10, and adjust the release mechanism, that is, rotating the release tube seat 6 drives the release tube 7 to rotate, when the boss 701 of the release tube 7 is connected to When the grooves of the grooved convex wall 802 of the sleeve 8 overlap, the release tube 7 is pulled out to unlock the connection between the outer tube 4 and the sleeve 8, and the sleeve 8 and the inner and outer clamps 9 are released to complete the operation.

It should be understood that in the description of the embodiments of the present invention, the "rear end" refers to the end close to the operator of the conveying system, and the "front end" refers to the end leaving the operator of the conveying system.

The embodiments of the present invention are described in terms of repairing mitral valve regurgitation. Those skilled in the art can understand that the repairing mitral valve regurgitation disclosed in the present invention can also be used for other devices or to deliver other devices. To the corresponding position of the body. The present invention is not limited to one method for repairing mitral valve regurgitation.

It should be noted that the above is only a detailed description of the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the ideas provided by the present invention, there will be changes in specific implementations. These changes should also be regarded as the protection scope of the present invention.

Claims

A device for tissue clamping, which is characterized by comprising a handle, an inner tube, an inner clamp, an outer tube seat, an outer tube, a sleeve, an outer clamp, and a release mechanism; the front end of the outer tube is connected with the sleeve, and the rear The end is connected to the outer tube seat; the outer clip has an outer clip seat and two open-shaped outer clips on the outer clip seat, the outer clip seat is sleeved in the sleeve and the two outer clips leak out of the sleeve One end of the nozzle so that the outer clamp can move in the casing along the direction of the sleeve, and the outer clamp is driven by the sleeve to be clamped; the inner tube passes through the outer tube socket, the outer tube, the sleeve, and the outer clamp sleeve in turn Set in the outer tube, the front end of the inner tube is connected with the inner clip, and the rear end is connected with the handle, so that the handle drives the inner tube and the inner clip to move in the outer tube in the direction of the outer tube in turn; the inner clip has an inner clip seat and two pieces An open inner clip located on the inner clip seat, the inner clip seat has abutting protrusions, so that when the inner clip seat is in contact with the outer clip seat, the outer clip seat is driven to move, and the inner clip is opposite to the outer clip seat. It is adapted so that the inner clip piece and the outer clip piece are combined to form a clamp when they collide; the release mechanism is sleeved at the connection between the front end of the outer tube and the sleeve, and is used to lock or unlock the connection between the outer tube and the sleeve.
The device for tissue clamping according to claim 1, wherein the release mechanism comprises a release tube and a release tube seat, the front end of the release tube has an inner cavity and a boss, and the sleeve is embedded It is arranged in the inner cavity and is provided with a grooved convex wall on the outside, and the grooved convex wall is matched with the boss to form a rotating clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe for rotating Release the tube.
The device for tissue clamping according to claim 2, wherein the release tube socket is further provided with an emptying port for surgical emptying, and the other end of the release tube socket is provided with a seal Pieces; The end of the outer tube seat is provided with a Luer interface.
The device for tissue clamping according to claim 2, wherein the diameter of the inner tube is 0.5-2.5mm, the diameter of the outer tube is 2.6-5mm, and the two outer clips have openings. The angle is 100-160 degrees.
The device for tissue clamping according to claim 1, wherein the diameter of the cannula tube is smaller than the diameter of the outer tube so that the cannula can be inserted into the outer tube, and the outer tube has a limiting step inside. , The limit step is used to abut the bottom of the casing.
The device for tissue clamping according to claim 5, wherein the front end of the outer tube further has a limiting groove, the sleeve has a limiting protrusion, and the limiting groove is connected to The limiting protrusion is adapted to restrict the sleeve from moving in the circumferential direction of the outer tube.
The device for tissue clamping according to claim 1, characterized in that a number of holes are provided on the sleeve wall of the sleeve for accelerating the endothelialization of the sleeve implantation.
The device for tissue clamping according to claim 1, wherein the abutting surface side of the inner clip and the outer clip are respectively provided with clamping teeth, and the outer bottom end of the outer clip is also provided with Snap protrusion.
The device for tissue clamping according to claim 1, wherein the end of the inner cavity of the sleeve is provided with an internal thread, and the outer side of the outer clamp seat is provided with an internal thread that is compatible with the internal thread. External thread.
A method for using a device for tissue clamping is implemented by the device for tissue clamping according to any one of claims 1-9, and is characterized in that it comprises the following steps:

S1. Send the device for tissue clamping to the heart valve, control the inner tube to move back and forth through the handle, and adjust the position of the inner clip so that the positions of the outer clip and the inner clip are located on the inner and outer sides of the prolapsed valve leaflet;

S2. Twitch the handle to collect the inner clip and the outer clip into the sleeve and clamp the valve;

S3. Unlock the connection between the inner tube and the inner clamp, adjust the release mechanism, unlock the connection between the outer tube and the sleeve, and release the sleeve and the inner and outer clamps.