CN111265340A - Tissue clamping device and clamp main body thereof - Google Patents

Tissue clamping device and clamp main body thereof Download PDF

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Publication number
CN111265340A
CN111265340A CN202010243522.XA CN202010243522A CN111265340A CN 111265340 A CN111265340 A CN 111265340A CN 202010243522 A CN202010243522 A CN 202010243522A CN 111265340 A CN111265340 A CN 111265340A
Authority
CN
China
Prior art keywords
clip
arm
gripping device
tissue
clamping
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010243522.XA
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Chinese (zh)
Inventor
肖振昕
虞奇峰
其他发明人请求不公开姓名
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Shanghai Newmed Medical Co Ltd
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Shanghai Newmed Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Newmed Medical Co Ltd filed Critical Shanghai Newmed Medical Co Ltd
Priority to CN202010243522.XA priority Critical patent/CN111265340A/en
Publication of CN111265340A publication Critical patent/CN111265340A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

Abstract

The application discloses tissue clamping device and clip main part thereof, tissue clamping device's clip main part include the outer arm lock of arm lock and second in supporting part, first interior arm lock, first outer arm lock, the second, one side of supporting part with first interior arm lock with first outer arm lock can buckle in proper order and link to each other, the opposite side of supporting part with in the second the arm lock with the outer arm lock of second can buckle in proper order and link to each other, the clip main part is the integrated into one piece structure.

Description

Tissue clamping device and clamp main body thereof
Technical Field
The application relates to the field of medical supplies, in particular to a tissue clamping device and a clamp body thereof.
Background
In surgical repair of body tissue, it is often necessary to clamp and secure the tissue by means of a tissue clamping device. For example, in the treatment of mitral regurgitation, a more common cardiac disorder, the mitral valve is located between the left atrium and the left ventricle, and during left ventricular contraction, the mitral valve acts as a check valve to tightly close the atrioventricular orifice and prevent blood from flowing back from the left ventricle into the left atrium. However, when the mitral valve is diseased, it may happen that the mitral valve is difficult to close completely when the left ventricle contracts, so that the left atrium receives a large amount of blood backflow, which may cause a sharp rise in left atrium and pulmonary venous pressure, increase in left ventricle diastolic volume load, further cause a series of pathological changes such as left ventricle enlargement, pulmonary hypertension, and the like, and finally cause clinical manifestations such as heart failure, arrhythmia, and the like, and may be life-threatening in severe cases. In the operation of treating mitral valve regurgitation, the opposite sides of the mitral valve can be clamped by one tissue clamping device, so that a large hole is changed into two small holes between the valves of the mitral valve, the regurgitation area is reduced, the occurrence of the mitral valve regurgitation is effectively prevented, and the tissue clamping device can also be suitable for the tricuspid valve of the heart, and the effect of reducing the regurgitation area is achieved by clamping the valve leaflets on two sides. The clamp body is an important part for clamping tissues, and the clamping of the tissues is realized by the tissue clamping device assisted by the opening and closing of the clamping arms of the clamp body.
Disclosure of Invention
One of the embodiments of the application provides a tissue clamping device's clip main part, the clip main part includes the outer arm lock of arm lock and second in supporting part, first interior arm lock, first outer arm lock, the second, one side of supporting part with first interior arm lock with first outer arm lock is consecutive can buckle and link to each other, the opposite side of supporting part with in the second the arm lock with the outer arm lock of second is consecutive can buckle and link to each other, the clip main part is the integrated into one piece structure.
One of the embodiments of the present application provides a tissue gripping device comprising a clip body according to any of the embodiments of the present application.
Drawings
The present application will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:
FIG. 1 is a schematic structural view of a tissue gripping device according to some embodiments of the present application;
FIG. 2 is a schematic structural view of a tissue gripping device shown in a collapsed state according to some embodiments of the present application;
FIG. 3 is a top view of a tissue gripping device according to some embodiments of the present application;
FIG. 4 is a schematic structural view of a clip body of a tissue gripping device in a closed condition according to some embodiments of the present application;
FIG. 5 is a schematic structural view of the open state of the clip body of the tissue gripping device according to some embodiments of the present application;
FIG. 6 is a schematic structural view of another open state of the clip body of the tissue gripping device according to some embodiments of the present application;
FIG. 7 is a schematic illustration of the attachment of a clip body to a clip for tissue gripping according to some embodiments of the present application;
FIG. 8 is a front view schematic of an S-bar bend configuration of a clip body of a tissue gripping device according to some embodiments of the present application;
FIG. 9 is a schematic illustration of a side view of an S-bar bend configuration of a clip body of a tissue gripping device according to some embodiments of the present application;
FIG. 10 is a schematic view of the S-bar bent configuration of the clip body of the tissue gripping device shown in some embodiments of the present application;
FIG. 11 is a schematic illustration of a waisted configuration of a clip body of a tissue gripping device according to some embodiments of the present application;
FIG. 12 is a schematic structural view of a clip body of a tissue gripping device according to some embodiments of the present application;
FIG. 13 is a side view of a clip body of the tissue gripping device of FIG. 12 according to some embodiments of the present application;
FIG. 14 is a schematic view of a clip body of a tissue gripping device according to further embodiments of the present application;
FIG. 15 is a schematic structural view of a clip body of a tissue gripping device according to further embodiments of the present application;
FIG. 16 is a schematic view of the connection of the clip body to the barb clip of the tissue gripping device according to some embodiments of the present application;
FIG. 17 is a schematic illustration of an integrally formed barbed clip for a tissue gripping device according to some embodiments of the present application;
FIG. 18 is a schematic view of an integrally formed structure of a barbed clip of the tissue gripping device according to further embodiments of the present application;
FIG. 19 is a schematic illustration of a tissue gripping device according to some embodiments of the present application showing a barb of the barb clip removably attached to the gripping portion;
FIG. 20 is a schematic illustration of the configuration of barbs of a barbed clip of the tissue gripping device according to some embodiments of the present application;
FIG. 21 is a schematic diagram illustrating the configuration of barbs in a barbed clip of a tissue gripping device according to other embodiments of the present application;
FIG. 22 is a schematic view of a cut shape of a barbed clip of the tissue gripping device according to some embodiments of the present application;
FIG. 23 is a schematic illustration of a barbed clip of the tissue gripping device according to some embodiments of the present application;
FIG. 24 is a schematic view of a barbed clip of a tissue gripping device according to further embodiments of the present application;
FIG. 25 is a schematic view of the structure of the inner clamping arms of the tissue gripping device according to some embodiments of the present application;
FIG. 26 is a schematic view of the connection of the barbed clip, the inner clip arms, and the securing ring of the tissue gripping device according to some embodiments of the present application;
FIG. 27 is a schematic view of a barbed clip of a tissue gripping device integrally formed with a clip body according to some embodiments of the present application;
FIG. 28 is a schematic structural view of a locking mechanism of the tissue gripping device according to some embodiments of the present application;
FIG. 29 is a schematic structural view of a tissue gripping device having a locking mechanism according to some embodiments of the present application;
FIG. 30 is a schematic view of a locking tab of a locking tube of a locking mechanism of a tissue gripping device shown in accordance with some embodiments of the present application in a retracted state;
FIG. 31 is a schematic structural view of the locking tabs of the locking tube of the locking mechanism of the tissue gripping device shown in accordance with some embodiments of the present application in an open state;
FIG. 32 is a schematic structural view of a tissue gripping device according to some embodiments of the present application with the locking mechanism unlocked;
FIG. 33 is a schematic structural view of a tissue gripping device according to some embodiments of the present application with the locking mechanism locked;
FIG. 34 is a schematic view of a resilient support of a tissue gripping device according to some embodiments of the present application;
FIG. 35 is a schematic view of a resilient support of a tissue gripping device according to further embodiments of the present application;
FIG. 36 is a schematic structural view of a resilient support of the tissue gripping device according to further embodiments of the present application;
FIG. 37 is a schematic diagram of a resilient support of a tissue gripping device according to further embodiments of the present application;
FIG. 38 is a top view of the resilient mount of FIG. 37 shown in accordance with some embodiments of the present application;
FIG. 39 is a schematic illustration of the resilient frame of FIG. 37 after heat treatment in accordance with certain embodiments of the present application;
FIG. 40 is a schematic structural view of a first connector of the tissue gripping device according to some embodiments of the present application;
FIG. 41 is a schematic view of the connection of a first connector of the tissue gripping device to the clip body according to some embodiments of the present application;
FIG. 42 is a schematic view of the attachment of the clip body to the delivery member of the tissue gripping device according to some embodiments of the present application;
FIG. 43 is a schematic structural view of a second connector of the tissue gripping device according to some embodiments of the present application;
FIG. 44 is a schematic view of the attachment of a clip body to a second connector according to some embodiments of the present application;
FIG. 45 is a schematic structural view of a second connector of the tissue gripping device according to another embodiment of the present application;
FIG. 46 is a schematic view of the attachment of a clip body to a second connector according to another embodiment of the present application.
Description of reference numerals: 100-clamp body, 200-first connecting piece, 300-second connecting piece, 400-clamping piece, 500-locking mechanism, 600-brake bar, 700-elastic support, 800-disengaging piece, 110-supporting part, 120-first inner clamping arm, 121-clamping hole, 122-fixing groove, 125-through hole, 130-second inner clamping arm, 140-first outer clamping arm, 150-second outer clamping arm, 160-first bending structure, 170-second bending structure, 202-mounting bayonet, 204-through hole, 206-convex block, 302-connecting hole, 304-mounting hole, 306-convex block, 410-first clamping piece, 420-second clamping piece, 430-fixing part, 440-clamping part, 450-barb, 451-clamping ring, 452-through hole, 460-fixing ring, 510-locking tube, 520-locking piece, 530-sleeve, 511-locking fin, 710-first support rod, 712-first arc section, 714-second arc section, 716-third arc section, 720-second support rod, 730-first mounting part, 740-second mounting part, 750-first connecting part, 760-second connecting part, 810-main body, 820-first connecting piece, 830-second connecting piece, 840-fixing support rod, 910-S rod bending structure, 920-waist bending structure, 911-straight rod, 912-bending rod, 913-connecting rod and 930-through hole.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.
On the contrary, this application is intended to cover any alternatives, modifications, equivalents, and alternatives that may be included within the spirit and scope of the application as defined by the appended claims. Furthermore, in the following detailed description of the present application, certain specific details are set forth in order to provide a better understanding of the present application. It will be apparent to one skilled in the art that the present application may be practiced without these specific details.
The embodiment of the application relates to a tissue clamping device, an inner clamping arm of a clamp main body of the tissue clamping device can be opened or closed relatively, and the clamping of tissues can be realized after the tissue clamping device is matched with a clamping piece. The tissue clamping device may be suitable for various applications, for example, it may be used for clamping tissues such as heart valves (e.g. mitral valve, tricuspid valve) or blood vessel valves, and may reach a predetermined position through various paths during the process of clamping tissues, which is not limited in this application.
FIG. 1 is a schematic structural view of a tissue gripping device according to some embodiments of the present application; FIG. 2 is a schematic structural view of a tissue gripping device shown in a collapsed state according to some embodiments of the present application; FIG. 3 is a top view of a tissue gripping device according to some embodiments of the present application; FIG. 4 is a schematic structural view of a clip body of a tissue gripping device in a closed condition according to some embodiments of the present application; FIG. 5 is a schematic structural view of the open state of the clip body of the tissue gripping device according to some embodiments of the present application; FIG. 6 is a schematic structural view of another open state of the clip body of the tissue gripping device according to some embodiments of the present application; FIG. 7 is a schematic illustration of the attachment of a clip body to a clip for tissue gripping according to some embodiments of the present application. The clip body for a tissue gripping device according to the embodiment of the present application will be described in detail below with reference to fig. 1 to 7. It should be noted that the following examples are only for explaining the present application and do not constitute a limitation to the present application.
In an embodiment of the present application, as shown in fig. 1-7, a tissue gripping device may include a clip body 100, a first connector 200, a second connector 300, and a clip 400. The clip body 100 may include a support 110, a first inner clip arm 120, a first outer clip arm 140, a second inner clip arm 130, and a second outer clip arm 150, wherein one side of the support 110 may be sequentially connected with the first inner clip arm 120 and the first outer clip arm 140 in a bendable manner, and the other side of the support 110 may be sequentially connected with the second inner clip arm 130 and the second outer clip arm 150 in a bendable manner. The bendable connection of the support 110 and the first inner clip arm 120 and the bendable connection of the support 110 and the second inner clip arm 130 can be understood as follows: the connection between the first inner clip arm 120 and the support 110 and the connection between the second inner clip arm 130 and the support 110 may be bent, the first inner clip arm 120 and the second inner clip arm 130 may be bent and relatively folded with respect to the support 110, and the first inner clip arm 120 and the second inner clip arm 130 may also be bent and relatively opened away from the support 110. The bendable connection of the first inner clamping arm 120 and the first outer clamping arm 140 and the bendable connection of the second inner clamping arm 130 and the second outer clamping arm 150 can be understood as follows: the joint of the first inner clamping arm 120 and the first outer clamping arm 140 and the joint of the second inner clamping arm 130 and the second outer clamping arm 150 can be bent, the included angle between the first inner clamping arm 120 and the first outer clamping arm 140 can be changed, and the included angle between the second inner clamping arm 130 and the second outer clamping arm 150 can be changed. In some embodiments, the number of the inner and outer clamping arms may be increased as required, for example, a third inner clamping arm, a fourth inner clamping arm, a third outer clamping arm and a fourth outer clamping arm may also be included, and the support portion 110 may be sequentially connected with the third inner clamping arm and the third outer clamping arm, and the support portion 110 may be sequentially connected with the fourth inner clamping arm and the fourth outer clamping arm.
In some embodiments, the clip body 100 can be a one-piece structure. Specifically, in the production manufacturing process of the clip body 100, the clip body 100 may be made by cutting (e.g., laser cutting) using a metal tube. In alternative embodiments, the clip body 100 may also be made using a woven wire. The clip body 100 can be connected between the first connector 200 and the second connector 300, and the relative movement of the first connector 200 and the second connector 300 can drive the first inner clip arm 120 and the second inner clip arm 130 to open or close relatively. The state in which the first inner clip arm 120 and the second inner clip arm 130 are relatively closed is shown in fig. 4. The relative opening angle of the first inner clamping arm 120 and the second inner clamping arm 130 can be any angle, such as 40 °, 90 °, 120 °, 180 °, 270 °, 350 °, 360 °, and the like. For example, fig. 5 shows a state in which the first inner clamp arm 120 and the second inner clamp arm 130 are relatively opened by 180 °; fig. 6 shows a state in which the first inner clip arm 120 and the second inner clip arm 130 are relatively opened by approximately 360 °. In some embodiments, as shown in fig. 1-2, one end (shown upper end) of the support portion 110 is connected (e.g., fixedly connected) to the first connector 200, and one end (shown lower end) of the first outer clamp arm 140 and one end (shown lower end) of the second outer clamp arm 150 are respectively connected (e.g., fixedly connected) to the second connector 300. With this arrangement, the second link 300 can move relative to the support 110 when the second link 300 moves relative to the first link 200. When the second connector 300 is away from the support 110, the first outer clamping arm 140 and the second outer clamping arm 150 can respectively pull the first inner clamping arm 120 and the second inner clamping arm 130 to be relatively opened by being driven by the second connector 300. In some embodiments, in order to allow a greater angular range of opening of the first and second inner clamp arms 120 and 130, an end of the first outer clamp arm 140 and an end of the second outer clamp arm 150 may be flexibly connected to the second connector 300.
In some embodiments, as shown in fig. 7, clip 400 may include a first clip 410 disposed on first inner clip arm 120 and a second clip 420 disposed on second inner clip arm 130, first clip 410 and second clip 420 being openable with respect to first inner clip arm 120 and second inner clip arm 130, respectively, and enabling tissue to be clamped between first clip 410 and first inner clip arm 120 and between second clip 420 and second inner clip arm 130. In some embodiments, the clip 400 may be a barbed clip. In some embodiments, the clip 400 may also be other types of clips. For example, the side of the clip 400 facing the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130) may be provided with barbs and/or protrusions, etc.
In some embodiments, the tissue gripping device may further comprise a first control mechanism for controlling the movement of the second connector 300 relative to the first connector 200 to control the relative closing or opening of the first inner clip arm 120 and the second inner clip arm 130. The first control mechanism may include a brake lever 600, the brake lever 600 can pass through the support portion 110 and be detachably connected (e.g., screwed) to the second connector 300, and the brake lever 600 can push and pull the second connector 300 to move relative to the first connector 200. In some embodiments, the tissue gripping device may further include a second control mechanism for controlling the opening or closing of first jaw 410 and second jaw 420 relative to first inner clip arm 120 and second inner clip arm 130, respectively. The second control mechanism may include a first pull cable connected to the first jaw 410 and a second pull cable connected to the second jaw 420. For example, a first pull cable may be coupled to a through hole of the open end of the first jaw 410 and a second pull cable may be coupled to a through hole of the open end of the second jaw 420. First clip 410 and second clip 420 may be preformed with a spring back force toward first inner clip arm 120 and second inner clip arm 130, respectively. When the first traction cable and/or the second traction cable is pulled, the first clamping piece and/or the second clamping piece can be opened relative to the first inner clamping arm 120 and the second inner clamping arm 130 under the pulling force of the traction cable; when the first pull cable and/or the second pull cable are released, the first clip 410 may be urged toward the first inner clip arm 120 by a resilient force, and/or the second clip 420 may be urged toward the second inner clip arm 130 by a resilient force.
In some embodiments, one side of the support 110 is connected to the first inner clip arm 120 by a first bending structure 160, and the other side of the support 110 is connected to the second inner clip arm 130 by a first bending structure 160. The first bending structure 160 may be an S-bar bending structure 910 or a waist-reducing bending structure 920. The first inner clamping arm 120 is connected to the first outer clamping arm 140 via a second bending structure 170, and the second inner clamping arm 130 is connected to the second outer clamping arm 150 via a second bending structure 170. The second bending structure 170 may be an S-bar bending structure 910 or a waist-reducing bending structure 920. The first bending structure 160 and the second bending structure 170 enable both to realize bending by themselves due to their own structural characteristics and/or material characteristics. The specific structures of the first bending structure 160 and the second bending structure 170 may be the same or different. For example, when the first bending structure 160 is an S-bar bending structure 910, the second bending structure 170 may be the S-bar bending structure 910, or a waist-reducing bending structure 920. Both the S-bar bending structure 910 and the waist-reducing bending structure 920 may be heat treated. The S-bar bending structure 910 and the waist-thinning bending structure 920 are easy to be deformed by heat treatment, and can enable stress at the bending part to be shared uniformly, and are not easy to break after being bent for multiple times, so that the service life of the clip main body 100 can be prolonged.
FIG. 8 is a front view of an S-bar bend configuration of a clip body of a tissue gripping device according to some embodiments of the present application. FIG. 9 is a side view schematic of an S-bar bend configuration of a clip body of a tissue gripping device according to some embodiments of the present application. FIG. 10 is a schematic view of the bent state of the S-bar bend configuration of the clip body of the tissue gripping device according to some embodiments of the present application. As shown in fig. 8-10, the S-bar bent structure 910 can be understood as a bendable bar structure similar to an "S" shape. In some embodiments, the S-bar bending structure 910 may include at least three straight bars 911 and two curved bars 912, wherein the three straight bars 911 are parallel to each other and the three straight bars 911 are connected end to end by the two curved bars 912. In the S-bar bent structure 910 shown in fig. 8-9, a single row (e.g., the following row in fig. 8) of S-bar bent structures 910 may include 7 segments of straight bars 911 and 6 segments of bent bars 912, the 7 segments of straight bars 911 being parallel to each other and connected end to end by the 6 segments of bent bars 912. In some embodiments, the number of straight bars 911 and curved bars 912 of the S-bar bent structure 910 may be other numbers. Fig. 10 shows the S-bar bent structure 910 when bent, and fig. 8-9 show the S-bar bent structure 910 when not bent, as shown in fig. 10, when the S-bar bent structure 910 is bent, the straight bars 911 still remain relatively parallel, and the S-bar bent structure 910 is bent at the bent bars 912. With this arrangement, the S-bar bending structure 910 can be more easily bent. In some embodiments, the S-bar bent structures 910 can be arranged in multiple rows (e.g., 2 rows, 3 rows, etc.), as shown in FIG. 8, i.e., including two upper and lower rows of S-bar bent structures 910. The S-bar bending structures 910 are arranged in multiple rows, so that the S-bar bending structures 910 are more stable when bent, for example, side bending and/or twisting between the multiple straight bars 911 can be avoided when bent. In some embodiments, when the S-bar bending structures 910 are arranged in multiple rows, the bending bars 912 of two adjacent rows of S-bar bending structures 910 can be connected by a connecting bar 913 (as shown in FIG. 8). By arranging the connecting rods 913 to connect two adjacent rows of the S-rod bending structures 910, the stability of the S-rod bending structures 910 during bending can be effectively improved. In some embodiments, the S-bar bent structure 910 may be cut from a sheet or tube of shape memory alloy. The heat-treated and shaped S-bar bent structure 910 may have a pre-formed resilience. The S-bar bending structure 910 is easy to bend, and has good resilience and superior fatigue resistance.
FIG. 11 is a schematic illustration of a waisted configuration of a clip body of a tissue gripping device according to some embodiments of the present application. As shown in fig. 11, the first inner clip arm 120 and the first outer clip arm 140 may be connected by a waist-bending structure 920. The waist-reducing bending structure 920 can be understood as a bendable rod-shaped structure with a width at the middle part smaller than the widths at the two ends. The middle width of bending the structure 920 through setting up thin waist is less than the both ends width, can make the middle part of bending the structure 920 of thin waist change in buckling. The waist-reducing bending structure 920 may be cut from a plate or tube of shape memory alloy. The waist-reducing bent structure 920 after heat treatment and shaping can have a pre-fabricated resilience. In some alternative embodiments, the waist-reducing bending structure 920 can also be understood as a bendable structure (as shown in the second bending structure 170 of fig. 15) having a smaller cross-sectional area at the middle portion than at the two ends.
FIG. 12 is a schematic structural view of a clip body of a tissue gripping device according to some embodiments of the present application; FIG. 13 is a side view of a clip body of the tissue gripping device of FIG. 12 according to some embodiments of the present application; FIG. 14 is a schematic view of a clip body of a tissue gripping device according to further embodiments of the present application; FIG. 15 is a schematic view of a clip body of a tissue gripping device according to further embodiments of the present application. In some embodiments, as shown in fig. 12-15, the support 110 may be a mesh structure. The mesh structure may include one or more of a diamond mesh, a circular mesh, a rectangular mesh, a square mesh, a triangular mesh, or a regular polygonal mesh. In some embodiments, the mesh structure can determine the stiffness of the support 110, and one skilled in the art can design the size and shape of the mesh according to the stiffness requirement of the support 110. For example, when the support 110 needs to be hard, triangular meshes may be selected or the meshes may be set small, and when the support 110 needs to be soft, regular polygonal meshes may be selected or the meshes may be set large. The heat treated support may also be made resilient by providing the support 110 as a lattice structure to facilitate passage through the delivery tube when delivering the tissue gripping device. In addition, the lattice-structured support 110 can effectively fill the space between the first inner clip arm 120 and the second inner clip arm 130, and can prevent the formation of thrombus after the tissue is clamped by the tissue clamping device.
In some embodiments, the cross-sectional shape of the support portion 110 may be circular or elliptical, and the cross-sectional area of the middle portion of the support portion 110 may be larger than the cross-sectional areas of both ends thereof. Wherein the cross-section is a plane perpendicular to the brake lever 600. For example, the shape of the support 110 may be approximately spherical or ellipsoidal. By such a design, possible benefits include, but are not limited to: so that the supporting part 110 does not easily damage the tissue; the tissue clamping device is convenient to convey to the tissue to be clamped through the pipe fitting of the conveying system; can form effective support for the clamped tissue. In some embodiments, the support 110 may also be pear-shaped, cylindrical, etc. Those skilled in the art can determine the shape of the support portion 110 of the clip body 100 to be different according to the specific condition of the tissue to be clipped (such as the shape of the coaptation edge of the mitral valve leaflet), so that the shape of the support portion 110 can be more suitable for the shape of the tissue (such as the coaptation edge of the mitral valve leaflet), and the clipping effect is better.
In some embodiments, as shown in fig. 12 and 14, the first and second outer clamp arms 140 and 150 may include a plurality of through holes 930 formed therein, the plurality of through holes 930 being configured to assist in deforming the first and second outer clamp arms 140 and 150 during the heat treatment process. In some embodiments, each through-hole may extend along a width direction of the first and second outer clamp arms 140 and 150, and a plurality of through-holes may be arranged at intervals along a length direction of the first and second outer clamp arms 140 and 150. In alternative embodiments, the plurality of through holes 930 may have other shapes and/or other arrangements. For example, the plurality of through holes 930 may be square holes, circular holes, polygonal holes, or the like. For another example, the plurality of through holes 930 may be arranged in a plurality of rows along the width direction of the first and second outer clamp arms 140 and 150. In some embodiments, when the first inner clamping arm 120 and the second inner clamping arm 130 are closed, in order to enable the first outer clamping arm 140 and the second outer clamping arm 150 to perform a better wrapping function on the support portion 110, the first inner clamping arm 120 and the second inner clamping arm 130, the first outer clamping arm 140 and the second outer clamping arm 150 may be bent and deformed into a circular arc shape along the length direction after the heat treatment (as shown in fig. 4 to 5).
In some embodiments, the clip body 100 can be a one-piece structure made of a shape memory alloy tube that is cut and heat set. The shape memory alloy may include nickel titanium alloy or cobalt chromium alloy, etc. FIG. 13 is a side view of the clip body of the tissue gripping device of FIG. 12. As can be seen from fig. 13, the clamp body of fig. 12 is a tube integrally cut and formed structure. The cutting mode of the pipe can comprise laser cutting, water cutting and the like. Similarly, FIGS. 14-15 are schematic views of the clip body being integrally formed. In addition to the integrally formed clip body 100 shown in fig. 12-15, various portions (e.g., the support portion, the first bending structure 160, the second bending structure 170, the first outer clip arm 140, the second outer clip arm 150, etc.) may be deformed during the heat treatment of the clip body 100. For example, both ends of the supporting part 110 are inwardly gathered during the heat treatment, so that the sectional area of the central portion of the supporting part is greater than the sectional areas of both ends thereof. Also for example, the first and second outer clamp arms 140 and 150 are bent into a circular arc shape and the first and second bending structures 160 and 170 are bent during the heat treatment. When the clip main body 100 is heat-treated, each portion of the clip main body 100 may be deformed by a mold. The shape memory alloy can remember the shape after heat treatment setting (such as the shape shown in fig. 4), and when the tissue is clamped, the clip body 100 will have a restoring force to return to the original shape to clamp the tissue. It is noted that the clip body 100 shown in fig. 1-7 is merely used to illustrate the general shape of the clip body 100 and does not mean that the final shape of the clip body conforms to that shown in fig. 1-7. For example, on the basis of the clip main body 100 shown in fig. 1 to 7, the supporting portion 110 of the clip main body 100 may be a grid structure, and the first bending structure 160 and the second bending structure 170 may be an S-bar bending structure 910 or a waist-reducing bending structure 920.
In some embodiments, clip 400 may include a first clip 410 disposed on first inner clip arm 120 and a second clip 420 disposed on second inner clip arm 130, and first clip 410 may be identical to second clip 420. Specifically, the clip 400 may include a fixing portion 430 and a clamping portion 440, and the fixing portion 430 and the clamping portion 440 may be connected by a bending portion. In some embodiments, clip 400 may be a barbed clip that may include a retention portion 430, a gripping portion 440, and barbs 450. One end of the clamping portion 440 may be connected to one end of the fixing portion 430 by a bending portion, and the other end of the clamping portion 440 may be provided with a barb 450. FIG. 16 is a schematic view of the connection of the clip body to the barb clip of the tissue gripping device according to some embodiments of the present application. As shown in fig. 16, barbs 450 may be located on a side of the clamping portion 440 of the clip 400 (e.g., first clip 410 or second clip 420) that faces toward the inner clip arm (e.g., first inner clip arm 120 or second inner clip arm 130). Fixing portion 430 may be used to fix clip 400 (e.g., first clip 410 or second clip 420) to an inner clip arm (e.g., first inner clip arm 120 or second inner clip arm 130). Clamping portion 440 may be configured to cooperate with an inner clamp arm (e.g., first inner clamp arm 120 or second inner clamp arm 130) to clamp tissue. One end of the fixing portion 430 and one end of the clamping portion 440 may be connected by a bending portion, so that the clip 400 (e.g., the first clip 410 or the second clip 420) can be opened and closed relative to the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130). The barbs 450 can effectively prevent tissue from escaping from between the clip 400 and the inner clip arms, which can make the tissue clamping device more stable in clamping the tissue.
In some embodiments, the bend may be an S-bar bend 910 (as shown in FIGS. 19 and 22-24). The S-bar bending structure 910 is easy to deform by heat treatment, and can enable stress at the bending position to be shared uniformly, and is not easy to break after being bent for multiple times. In addition, the bending part is set as the S-bar bending structure 910, so that the clip 400 can be smoothly bent and is not easily broken in the bending process. In some embodiments, the S-bar bending structure 910 may include at least three straight bars 911 and two curved bars 912, wherein the three straight bars 911 are parallel to each other and the three straight bars 911 are connected end to end by the two curved bars 912. For more details on the S-bar bent structure 910, reference may be made to FIGS. 8-10 and their associated descriptions.
In some embodiments, the securing portion 430, the gripping portion 440, and the barb 450 may be an integrally formed structure. Specifically, the fixing portion 430, the clamping portion 440 and the barb 450 may be integrally formed by cutting (e.g., laser cutting) a plate or a tube. Through the integrated into one piece of fixed part 430, clamping part 440 and barb 450, can be so that barb clip stable in structure, each part is connected reliably and be convenient for manufacturing. In some embodiments, barbs 450 may include multiple barbed strips, such as 3, 4, 5, 7, 10, etc. The plurality of barbed strips can be arranged in a row or a plurality of rows. The outer wall of the thorn strip can be a plane or an arc surface. FIG. 17 is a schematic illustration of an integrally formed barbed clip for a tissue gripping device according to some embodiments of the present application. In some embodiments, at least one stab strip may be connected to the other end of the clamping portion 440 via the S-bar bend 910. Preferably, as shown in fig. 17, all of the barbed strips may be connected to the other end of the clamping portion 440 by the S-bar bending structure 910. The design of the S-bar bending structure 910 can facilitate bending of the barbed strip during the heat treatment process, such as bending the barbed strip at 90 degrees to the clamping portion 440. FIG. 18 is a schematic view of an integrally formed barbed clip for a tissue gripping device according to other embodiments of the present application. In some embodiments, as shown in fig. 18, at least one (e.g., all) of the stab strips may have a through-hole 452 formed therein. In some embodiments, the through-hole 452 may extend through the stab strip along a thickness direction of the stab strip. The number of the through holes on each pricking strip can be one or more. The shape of the through-hole may include a thorn shape, a square shape, a circular shape, a triangular shape, etc. Preferably, each of the stab strips may comprise a through hole 452, and the shape of the through hole is similar to the shape of the stab strip. In the production and manufacturing process of the barb clamp piece, the design of the through hole can facilitate the bending and forming of the barb strip in the heat treatment process. In some alternative embodiments, the through holes on the barbed strips may also penetrate along other directions (e.g., the width direction of the barbed strips).
In some embodiments, the barb 450 may be removably attached to the other end of the gripping portion 440. The skilled person can choose whether to attach the barb 450 to the gripping part 440 or what kind of barb 450 to attach to the gripping part 440 according to the actual need. FIG. 19 is a schematic illustration of a tissue gripping device according to some embodiments of the present application showing a barb of the barb clip removably attached to the gripping portion; FIG. 20 is a schematic illustration of the configuration of barbs of a barbed clip of the tissue gripping device according to some embodiments of the present application; fig. 21 is a schematic diagram of the configuration of barbs of a barbed clip of a tissue gripping device according to other embodiments of the present application. As shown in fig. 19 to 21, the other end of the clamping portion 440 may include a catching groove, and the barb 450 may include a snap ring 451, and the snap ring 451 may be caught to the catching groove. By such an arrangement, the barb 450 can be easily and securely attached to the gripping portion 440. In addition, the barb 450 and the clamping portion 440 are detachably connected, so that the problem that the barb is difficult to bend in the heat treatment process can be avoided. In some embodiments, the snap ring 451 may be made of an elastic material or a super-elastic metal (e.g., nitinol) to facilitate the fitting of the snap ring 451 to the snap groove. In some embodiments, as shown in fig. 20-21, the opposing sides of the snap ring 451 can be straight or curved to accommodate different types of grips 440 (e.g., grips cut from sheet material or grips cut from tubing). In some embodiments, the number, shape, and arrangement of the barbs 450 can be adjusted based on the application (e.g., the nature of the tissue to be held).
In some embodiments, the fixing portion 430 and the clamping portion 440 may be an integrally formed structure made of shape memory alloy through cutting and heat treatment setting. The shape memory alloy may include nickel titanium alloy or cobalt chromium alloy, etc. FIG. 22 is a schematic view of a cut shape of a barbed clip of the tissue gripping device according to some embodiments of the present application; FIG. 23 is a schematic illustration of a barbed clip of the tissue gripping device according to some embodiments of the present application; fig. 24 is a schematic view of a barbed clip of a tissue gripping device according to further embodiments of the present application. As shown in fig. 22, the barbed clip may be integrally cut from a shape memory alloy sheet material. As shown in fig. 23 and 24, the fixing portion 430 and the clamping portion 440 of the integrally cut barb clip after heat treatment and shaping may be at a certain angle, and at this time, the bending portion will have a pre-fabricated resilience. By such a design, the gripping force of the barbed clip and the inner clip arm (e.g., first inner clip arm 120 or second inner clip arm 130) on tissue may be increased. It should be noted that the fixing portion 430 and the clamping portion 440 are at an angle, which means that the fixing portion 430 is not parallel to the clamping portion 440. Preferably, after heat treatment setting, the fixing portion 430 may be bent into the inner hole of the clamping portion 440 (as shown in fig. 23-24), that is, the fixing portion 430 is turned over by an angle greater than 180 ° relative to the clamping portion 440 during the heat treatment. In some embodiments, the angle between the fixing portion 430 and the clamping portion 440 can be determined by one skilled in the art according to the desired clamping force, the size of the tissue clamping device, and the like, for example, when the fixing portion 430 is bent into the inner hole of the clamping portion 440, the angle between the fixing portion 430 and the clamping portion 440 can be designed to be 15 °, 20 °, 30 °, and the like.
In some embodiments, as shown in FIG. 16, the inner clamp arm (e.g., first inner clamp arm 120 or second inner clamp arm 130) may have a through-hole 125 for receiving the barb 450. In some embodiments, the number of through holes 125 may be equal to the number of stab strips (e.g., 4 each). In some embodiments, the number of through holes 125 may also be unequal to the number of stab strips. For example, the through hole may be a hole extending in the width direction of the inner clip arm, which hole is capable of accommodating all the barbed strips. Through set up through-hole 125 on the arm lock including, when the barb clamping piece was closed, in the through-hole 125 of arm lock in the barb 450 can just in time be inserted, can make the barb clamping piece press from both sides and get the tissue more convenient like this, also more firm to the clamp of tissue after pressing from both sides and getting the tissue.
FIG. 25 is a schematic view of the structure of the inner clamping arms of the tissue gripping device according to some embodiments of the present application; FIG. 26 is a schematic view of the connection of the barbed clip, the inner clip arms, and the securing ring of the tissue gripping device according to some embodiments of the present application. In some embodiments, as shown in fig. 25 and 26, the inner clip arms (e.g., the first inner clip arm 120 or the second inner clip arm 130, the first inner clip arm 120 is an example) may be provided with a clip hole 121 for matching with a fixing portion 430 of the barbed clip, and the fixing portion 430 can be inserted into the clip hole 121. Specifically, the shape of the card hole 121 may be identical to the shape of the fixing portion 430. In some embodiments, the first inner clip arm 120 and the second inner clip arm 130 can further include a fixing groove 122, and the tissue holding device can further include a fixing ring 460, wherein the fixing ring 460 can be engaged with the fixing groove 122 to limit the fixing portion 430 from being disengaged from the engaging hole 121. Specifically, the fixing grooves 122 may be symmetrically disposed at both sides in the width direction of the inner clip arm (as shown in fig. 25). In an actual installation process, when the clip body 100 is an integrally formed structure, the fixing ring 460 may be sleeved on the first inner clip arm 120 and the second inner clip arm 130 through the first outer clip arm 150 and the second outer clip arm 160, respectively. The retaining ring 460 may be made of an elastic material or a superelastic alloy (e.g., nitinol). The barb clip can be conveniently and firmly installed by the cooperation of the clip hole 121 and the fixing portion 430 and the cooperation of the fixing groove 122 and the fixing ring 460. In some alternative embodiments, after the fixing portion 430 is inserted into the card hole 121, the fixing portion 430 may be directly fixed in the card hole 121 by bonding or welding (e.g., laser welding) or the like (e.g., gluing or welding along a gap between the fixing portion 430 and the card hole 121). In other embodiments, the barb clip can be attached to the inner clip arm by bonding, welding, riveting, threading, snapping, or the like.
In some embodiments, the retention portion 430 and the gripping portion 440 of the barbed clip may be integrally formed with the clip body 100. FIG. 27 is a schematic view of a barbed clip of a tissue gripping device integrally formed with a clip body according to some embodiments of the present application. In the embodiment shown in fig. 27, the retention portion 430, the gripping portion 440, and the barb 450 of the barb clip may all be integrally formed with the clip body 100. Specifically, when the clip body 100 is cut, the shape of the clamping portion 440 and the barb 450 of the barb clip can be cut on the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130) of the clip body 100, and one end of the cut clamping portion 440 is still connected to the inner clip arm (at this time, one end of the fixing portion 430 of the barb clip is also still connected to the inner clip arm). In some embodiments, after the grip portion 440 and the barb 450 are integrally cut, the barb 450 may be bent by heat treatment. In some alternative embodiments, the clip portion 440 may be cut only in the inner clip arm, and a barb may be installed at the other end of the cut clip portion 440. The barb clamping piece and the inner clamping arm can be more reliably connected through the integral molding of all or part of the barb clamping piece and the inner clamping arm, and the clamping stability of the tissue clamping device is favorably improved; meanwhile, the assembling process of the tissue clamping device can be simplified, and the production efficiency is improved.
In some embodiments, the tissue gripping device may include a locking mechanism 500. FIG. 28 is a schematic structural view of a locking mechanism of the tissue gripping device according to some embodiments of the present application; FIG. 29 is a schematic structural view of a tissue gripping device having a locking mechanism according to some embodiments of the present application. As shown in fig. 28 and 29, the locking mechanism 500 may include a locking tube 510 and a locking member 520, and one end (e.g., the lower end) of the locking tube 510 may be fixedly connected to the second connecting member 300. The outer wall of the locking tube 510 may be provided with locking tabs 511, the locking tabs 511 being capable of serving to limit the opening of the clip body. FIG. 30 is a schematic structural view of a locking tab of a tissue gripping device shown in a retracted state according to some embodiments of the present application; FIG. 31 is a schematic view of a tissue gripping device with locking tabs in an open position according to some embodiments of the present application. As shown in fig. 30-31, the locking tabs 511 are switchable between a retracted state and an extended state. The opening of the locking tab 511 when it is opened faces the second connector 300. The locking tabs 511 are open by default when not pressed by external force. In some embodiments, the locking member 520 may be fixedly coupled to the supporting portion 110 of the clip body. For example, the locking member 520 may be secured within the interior cavity of the support portion 110 by gluing, welding (e.g., laser welding), or the like. Locking tab 511 is capable of limiting the opening of the clip body (i.e., the relative opening of first and second inner clip arms 120, 130) by limiting the movement of locking member 520. As shown in FIG. 28, when the locking member 520 moves away from the second linkage 300, the flared locking tabs 511 can abut against the locking member 520 to limit the movement of the locking member 520. In alternative embodiments, the locking tabs 511 may also limit the opening of the clip body by limiting movement of other portions of the clip body (e.g., the support portion 110). For example, the flared locking tabs 511 may bear directly against the support 110.
In some embodiments, locking mechanism 500 may cooperate with a first control mechanism for controlling the relative closing or opening of first inner clamp arm 120 and second inner clamp arm 130 to limit the relative opening of first inner clamp arm 120 and second inner clamp arm 130. Specifically, the other end (the upper end as shown in fig. 28) of the locking tube 510 can be detachably connected to the brake lever 600, the brake lever 600 can control the second connecting member 300 to move relative to the first connecting member 200 through the locking tube 510, and the locking fin 511 can limit the relative movement between the locking member 520 (or the supporting portion 110) and the locking tube 510 (or the second connecting member 300), so as to limit the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130. Through setting up locking mechanism 500, the holding state that keeps that tissue clamping device can be stable after accomplishing the centre gripping to the tissue can effectively avoid tissue clamping device to open because of receiving the blood flow impact. It will be appreciated that locking tab 511 may be used to limit the relative opening of first inner clamp arm 120 and second inner clamp arm 130 without limiting the closing of first inner clamp arm 120 and second inner clamp arm 130.
In some embodiments, locking mechanism 500 may further include a sleeve 530, sleeve 530 being capable of fitting over locking tube 510 and allowing retraction of locking tabs 511. Specifically, when the locking tabs 511 are positioned within the sleeve 530, the locking tabs 511 are forced to retract, and when the locking tabs 511 are exposed outside of the sleeve 530, the locking tabs 511 automatically open. In some embodiments, the brake bar 600 of the tissue gripping device can be fixedly attached (e.g., welded, glued, threaded, etc.) to the sleeve 530, and the brake bar 600 can be removably attached (e.g., threaded) to the locking tube 510. When the brake lever 600 is connected to the locking tube 510, the sleeve 530 enables the locking tab 511 to retract; when the brake lever 600 is disengaged from the locking tube 510, the sleeve 530 releases the action on the locking tabs 511 and the locking tabs 511 are spread apart. As shown in fig. 32 and 33, fig. 32 is a schematic view of the structure when the locking tab 511 is retracted and the locking mechanism 500 is unlocked, and fig. 33 is a schematic view of the structure when the locking tab 511 is expanded and the locking mechanism 500 is locked. In the embodiment of fig. 32-33, the inner bore diameter of the locking member 520 is larger than the outer diameter of the sleeve 530, and the expanded locking tabs 511 cannot pass through the inner bore of the locking member 520. When the brake lever 600 is connected to the locking tube 510, the sleeve 530 covers the locking fin 511 of the locking tube 510, the locking member 520 can slide freely on the locking tube 510 and the sleeve 530, and the tissue holding device can perform the holding operation of the tissue in this state. When the tissue clamping device has finished clamping the tissue, the detent lever 600 and the sleeve 530 can be removed, and the sleeve 530 releases the action of the locking tab 511, so that the locking tab 511 originally located in the sleeve 530 is exposed out of the sleeve 530 and opened, and the locking tab 511 can restrict the movement of the locking member 520 to restrict the opening of the clip body.
In some embodiments, the brake lever 600 and the locking tube 510 may be connected by threads. For example, an external thread may be disposed on one end of the brake lever 600 connected to the locking tube 510, an internal thread may be correspondingly disposed on the locking tube 510, and the sleeve 530 is sleeved outside the brake lever 600 and can cover the external thread of the brake lever 600. With this arrangement, the brake lever 600 can be easily disengaged from the locking tube 510. In other embodiments, the brake lever 600 and the locking tube 510 can be detachably connected by means of a snap connection.
In some embodiments, the locking tab 511 may include at least two pieces, and the at least two pieces of locking tab 511 are symmetrically arranged on the outer wall of the locking tube 510 at the same distance as the second connector 300. Note that the number of the locking tabs 511 may be 2, 3, 4, or the like. 2 or 4 locking tabs 511 may be disposed axisymmetrically (or centrosymmetrically) on the outer wall of the locking tube 510, and 3 locking tabs 511 may be disposed centrosymmetrically (e.g., 120 degrees apart) on the outer wall of the locking tube 510. The movement of the locking member 520 is limited by the at least two symmetrically arranged locking tabs 511, so that each locking tab 511 can be uniformly stressed, thereby improving the stability of the locking mechanism 500 and prolonging the service life of the locking mechanism 500.
In some embodiments, the locking tab 511 may include at least two pieces, and the at least two pieces of locking tab 511 may be disposed on an outer wall of the locking tube 510 at different distances from the second connector 300; the at least two locking tabs 511 are capable of limiting the opening of the clip body 100 when the clip body is at different opening and closing angles (e.g., the first inner clip arm 120 and the second inner clip arm 130 are relatively opened to different angles). It can be understood that when the first inner clamping arm 120 and the second inner clamping arm 130 are opened to different angles, the distance between the locking member 520 and the second connecting member 300 is different, and therefore, the locking tab 511, which is at a different distance from the second connecting member 300, is required to abut against the locking member 520 to limit the movement of the locking member 520 (the supporting portion 110) relative to the second connecting member 300. In the actual operation process, due to the difference of pathological conditions and physiological structures of different patients or the difference of clamped tissues, the opening and closing angles of the clamp body 100 of the tissue clamping device after clamping and furling the tissues can be different, and through the arrangement, the tissue clamping device with the locking mechanism 500 can be suitable for different patients or different tissues.
In some embodiments, the locking tube 510 and the locking tab 511 may be a unitary structure. For example, the locking tube 510 with the locking tab 511 may be formed by cutting (e.g., laser cutting) a cut out with a tube. In some embodiments, the locking tube 510 and locking tabs 511 may be integrally formed structures of shape memory alloy that are cut and heat set. The shape memory alloy may be a nickel titanium alloy or a cobalt chromium alloy, or the like. After the shape memory alloy tube is cut to form the locking tabs 511 on the locking tube 510, the junction of the locking tabs 511 and the locking tube 510 is heat-set so that the locking tabs 511 are flared outwardly. After heat treatment setting, the connection of locking tabs 511 to locking tube 510 will have a pre-determined spring-back force that will ensure that locking tabs 511 will automatically open when exposed outside of sleeve 530. In some alternative embodiments, the locking tube 510 and locking tab 511 may also be two pieces that are connected to each other. For example, the locking tab 511 may be a resilient tab that may be affixed to the locking tube by gluing, welding (e.g., laser welding), or the like.
In some embodiments, the tissue gripping device may comprise a resilient mount 700. FIGS. 34-37 are schematic illustrations of the construction of the flexible support of the tissue gripping device according to various embodiments of the present application. As shown in fig. 34-37, the resilient mount 700 may include a first strut 710, a second strut 720, a first mounting portion 730, and a second mounting portion 740. One end of the first and second struts 710 and 720 may be connected to the first mounting portion 730, and the other end of the first and second struts 710 and 720 may be connected to the second mounting portion 740. In the embodiment of the present application, the elastic bracket 700 is an integrally formed structure. That is, the first rod 710, the second rod 720, the first mounting portion 730 and the second mounting portion 740 are integrally formed. The elastic support 700 is stable in structure, all the parts are connected reliably, and the production and the manufacture are simple and convenient. In some embodiments, as shown in fig. 1, the first mounting portion 730 and the second mounting portion 740 of the elastic bracket 700 may be fixedly coupled with the second connector 300. That is, both ends of the first and second struts 710 and 720 are fixed to the second connector 300. The first supporting rod 710 of the elastic bracket 700 can be abutted against the joint of the first inner clamping arm 120 and the first outer clamping arm 140; the second rod 720 of the elastic bracket 700 can be abutted against the joint of the second inner clamping arm 130 and the second outer clamping arm 150. For example, as shown in fig. 1, a first strut 710 may be held internally between the first inner and outer clamp arms 120, 140, and a second strut 720 may be held internally between the second inner and outer clamp arms 130, 150. In some embodiments, when the first strut 710 or the second strut 720 is abutted between the inner clamping arm and the outer clamping arm, the first strut 710 or the second strut 720 can be further fixedly connected with the joint of the inner clamping arm and the outer clamping arm by means of gluing, laser welding or wire-wound connection. In some alternative embodiments, first strut 710 may abut the outside of first outer clamp arm 140 and second strut 720 may abut the outside of second outer clamp arm 150. For example, the middle portion of the first strut 710 may be fixedly attached to the outer side of the first outer clamp arm (e.g., glued, laser welded, or wire wound, etc.), and the second strut 720 may be fixedly attached to the outer side of the second outer clamp arm 150. Through setting up elastic support 700, can increase the area that tissue clamping device is used for catching the tissue, and elastic support 700 has better supporting effect to the tissue to improve tissue clamping device's stability. Meanwhile, the elastic support 100 has a good tightening effect, so that the elastic force of the elastic support 700 can make the clamping force on the tissue greater after the first inner clamp arm 120 and the second inner clamp arm 130 are folded. In addition, the amount of spring force provided by the flexible mount 700 to the tissue gripping device can be adjusted (e.g., by adjusting the width of the first bar 710 and/or the second bar 720) based on the tissue gripping requirements of different tissues or different patients, such that the tissue gripping device using the flexible mount 700 can be adapted to different tissues or different patients.
In some embodiments, as shown in fig. 34, the middle portions of the first and second struts 710, 720 may include a first arc segment 712, a second arc segment 714, and a third arc segment 716, respectively, connected in series; the second arc segment 714 is convex in the opposite direction to the first and third arc segments 712, 716. Wherein the second circular arc segment 714 may be convex toward the second connector 300, and the first circular arc segment 712 and the third circular arc segment 716 may be convex toward a direction away from the second connector 300. When the elastic bracket 700 is assembled with the clip body 100, the second arc sections 714 of the first and second struts 710 and 720 are located between the first inner and outer clamp arms 120 and 140 and between the second inner and outer clamp arms 130 and 150. By such a design, the first and second struts 710 and 720 can better wrap around the support portion 110 to better cover the tissue.
In some embodiments, as shown in fig. 35, the first and second struts 710, 720 may have a width. For example, the width of the first and second struts 710, 720 may be greater than a set threshold. The set threshold may be 2, 3, or 4 times the thickness of the struts (e.g., first strut 710 and second strut 720), etc. In some embodiments, the width of the first and second struts 710, 720 can be positively correlated to the spring force provided by the resilient mount 700 to the tissue gripping device. It will be appreciated that, to the extent the wider the width of the first and second struts 710, 720, the greater the spring force provided by the resilient mount 700 to the tissue gripping device, and the greater the tissue gripping force provided by the tissue gripping device. In some embodiments, different widths of the flexible stent 700 may be selected for use according to the gripping requirements of different tissues or tissues of different patients. In some embodiments, the width of the segments of the first strut 710 and the second strut 720 can be different to further adjust the spring force provided by the resilient mount 700 to the tissue gripping device.
In some embodiments, as shown in fig. 36, one end of the first and second struts 710 and 720 may be connected to the first mounting portion 730 by an S-bar bent structure 910; the other ends of the first and second struts 710 and 720 may be connected to the second mounting portion 740 by an S-bar bent structure 910. The S-bar bending structure 910 may at least include three sections of straight bars 911 and two sections of curved bars 912, where the three sections of straight bars 911 are parallel to each other and the three sections of straight bars 911 are connected end to end through the two sections of curved bars 912. For more details on the S-bar bent structure 910, reference may be made to FIGS. 8-10 and their associated descriptions. The elastic bracket 700 (e.g., the end of the strut) can be easily changed in shape during heat treatment by providing an S-bar bent structure at the end of the strut to be connected to the mounting portion.
In some embodiments, as shown in fig. 37, one end of the first and second struts 710 and 720 may be connected to the first mounting portion 730 by a first connection 750; the other ends of the first and second struts 710 and 720 may be connected to the second mounting portion 740 by a second connection portion 760; the first and second connection portions 750 and 760 may be provided with through holes. The number of the through holes may include one or more. The shape of the through hole may include, but is not limited to, a long stripe, a square, a circle, a rectangle, and the like. The elastic bracket 700 (e.g., the distal end of the strut) can be easily changed in shape during heat treatment by providing through holes in the first and second connection portions 750 and 760.
In some embodiments, the elastic support 700 may be an integrally formed structure made of shape memory alloy tube material through cutting and heat setting. The shape memory alloy may be a nickel titanium alloy or a cobalt chromium alloy, or the like. Preferably, the material of the elastic stent 700 may be a super-elastic metal (e.g., nitinol). FIG. 38 is a top view of the resilient mount of FIG. 33 shown in accordance with some embodiments of the present application. As can be seen in fig. 38, the elastic stent 700 in fig. 37 is cut from a shape memory alloy tube. Similarly, the elastic stent 700 shown in fig. 34-36 can also be integrally cut from a shape memory alloy tube. After the elastic stent 700 is cut from the shape memory alloy tube, the elastic stent 700 may be further heat treated. FIG. 39 is a schematic representation of the resilient frame of FIG. 37 after heat treatment according to some embodiments of the present application. As shown in fig. 39, the heat-treated and shaped first and second mounting portions 730 and 740 may be folded to facilitate mounting the elastic bracket 700 on the second connector 300. Meanwhile, the first strut 710 and the second strut 720 after heat treatment have a pre-fabricated resilience. After the elastic bracket 700 is mounted on the second connector 300 and assembled with the clip body 100, when the first and second inner clip arms 120 and 130 clip and close tissue, the pre-formed resilience of the first and second struts 710 and 720 can further cause the first and second inner clip arms 120 and 130 to clip tissue, thereby making the tissue clipping device more stable.
FIG. 40 is a schematic structural view of a first connector of the tissue gripping device according to some embodiments of the present application; FIG. 41 is a schematic view of the connection of a first connector of the tissue gripping device to the clip body according to some embodiments of the present application. As shown in fig. 40 to 41, the first connector 200 may be provided therein with a mounting notch 202, and one end (an upper end as shown in fig. 41) of the support portion 110 of the clip body 100 may be inserted into and fixed to the mounting notch 202. In addition, the first connector 200 may be provided with a through hole 204 through which the brake lever 600 passes. The sidewall of the first connector 200 may be provided with a protrusion 206 for the transfer connector 800 to be engaged. In some embodiments, after one end of the supporting portion 110 is inserted into the mounting bayonet 202, the supporting portion 110 may be fixedly connected to the first connector 200 by a pin. In some embodiments, after the one end of the supporting portion 110 is inserted into the mounting bayonet 202, the supporting portion 110 may be fixedly connected to the first connector 200 by gluing, welding, or the like.
FIG. 42 is a schematic view of a tissue gripping device coupled to a delivery assembly according to some embodiments of the present application. As shown in FIGS. 2 and 42, the first connector 200 can be connected to the delivery connector 800 of the delivery assembly such that the tissue gripping device can be delivered to a predetermined location by the delivery assembly. After the tissue is clamped by the tissue gripping device, delivery connector 800 of the delivery assembly can be disengaged from the tissue gripping device to allow the delivery assembly to be withdrawn, leaving the tissue gripping device in the body.
As shown in fig. 42, the delivery connector 800 may include a main body 810, a first connector piece 820, and a second connector piece 830. Wherein, the connection positions of the first connection piece 820 and the second connection piece 830 and the main body 810 can have a pre-made resilience force, and the pre-made resilience force can enable the first connection piece 820 and the second connection piece 830 to automatically open in a natural state. The middle portions of the first connecting piece 820 and the second connecting piece 830 may further be provided with a fixing strut 840, the fixing strut 840 is perpendicular to the first connecting piece 820 and the second connecting piece 830, and a suspended end of the fixing strut 840 is provided with a through hole for the brake lever 600 to pass through. As shown in FIGS. 2 and 42, when the delivery connector 800 is connected to the first connector 200 of the tissue gripping device, the first connector 820 and the second connector 830 are folded toward each other and engage with the protrusions 206 of the first connector 200, respectively. The brake lever 600 can then be passed through the through-holes in the fixing strut 840 connected to the first connecting piece 820 and the second connecting piece 830, and the brake lever 600 will limit the opening of the first connecting piece 820 and the second connecting piece 830. When it is desired to disengage the delivery assembly from the tissue gripping device, the brake lever 600 can be first disengaged from the tissue gripping device and the brake lever 600 can be withdrawn such that the brake lever 600 disengages from the through-holes in the fixation struts 840 associated with the first connector tab 820 and the second connector tab 830, such that the first connector tab 820 and the second connector tab 830 automatically open and disengage from the tab 206 on the first connector 200. In some embodiments, the delivery connector 800 may be a one-piece structure made of shape memory alloy tubing that is cut and heat set. Specifically, during the heat treatment process, the first connecting piece 820 and the second connecting piece 830 of the conveying connector 800 may be bent with respect to the main body 810 so that the joints of the first connecting piece 820 and the second connecting piece 830 with the main body 810 have a pre-fabricated resilience. In addition, the fixing bar 840 may be bent perpendicular to the first connecting piece 820 or the second connecting piece 830 during the heat treatment.
FIG. 43 is a schematic structural view of a second connector of the tissue gripping device according to some embodiments of the present application; FIG. 44 is a schematic view of the attachment of a clip body to a second connector according to some embodiments of the present application; FIG. 45 is a schematic structural view of a second connector of the tissue gripping device according to another embodiment of the present application; FIG. 46 is a schematic view of the attachment of a clip body to a second connector according to another embodiment of the present application. As shown in fig. 43-46, the second connector 300 may be provided at the center thereof with a coupling hole 302 (e.g., a threaded hole) for detachable coupling with the brake lever 600. In some embodiments, as shown in fig. 43-44, mounting holes 304 for mounting the first and second outer clamp arms 140 and 150 and the first and second mounting portions 730 and 740 of the elastic bracket 700 may be provided around the coupling holes. As shown in fig. 44, one end (lower end) of the first outer clip arm 140 can be inserted into one of the mounting holes 304 of the second connector 300 and fixedly connected to the second connector 300. In addition, one end of the second outer clamping arm 150 can also be inserted into the other mounting hole 304 of the second connector 300 and fixedly connected with the second connector 300. The manner of fixedly connecting one end of the first outer clamping arm 140 and one end of the second outer clamping arm 150 to the second connector 300 may include gluing, welding, clamping, etc. from the inside or bottom end (lower end shown) of the mounting hole 304. In some embodiments, as shown in fig. 45-46, the second connector 300 may have a protrusion 306 on a sidewall thereof for mounting the first and second outer clamp arms 140 and 150 and the first and second mounts 730 and 740 of the resilient mount 700. As shown in fig. 46, one end (lower end) of the first outer clamping arm 140 can be engaged with one of the protrusions 306 of the second connector 300 and fixedly connected with the second connector. The manner of fixedly connecting one end of the first outer clamping arm 140 to the second connector 300 may include gluing, welding, etc. In some embodiments, after the four protrusions 306 on the sidewall of the second connector 300 are completely engaged with the first and second outer clamp arms 140 and 150 and the first and second mounting portions 730 and 740 of the elastic bracket 700, a fixing sleeve may be sleeved on the exterior of the second connector 300, so as to effectively prevent the components from being disengaged from the protrusions 306. Wherein, the fixing sleeve can be fixedly connected with the second connector 300 by welding, gluing, etc. In some alternative embodiments, when the tissue gripping device comprises the locking mechanism 500, a connecting hole fixedly connected with the locking tube may be provided on the center of the second connector 300.
In some embodiments, the tissue gripping device may be controlled by a control handle that may be coupled to the tissue gripping device via a delivery assembly. Specifically, the control handle can comprise a brake lever control mechanism and a clamping piece control mechanism. A brake lever control mechanism can be used to control the extension and rotation of brake lever 600. A clip control mechanism may be used to control the opening and closing of first clip 410 and second clip 420 relative to first inner clip arm 120 and second inner clip arm 130, respectively.
In some embodiments, methods of using the tissue gripping devices of the present application may comprise the steps of:
(1) delivering the tissue gripping device to a predetermined location via a delivery assembly;
(2) the second connecting piece 300 is controlled by the brake lever 600 to move relative to the first connecting piece 200, so that the first inner and outer arms 120 and the second inner clamping arm 130 are relatively opened to a proper angle;
(3) controlling the first and second jaws 410, 420 to open and close relative to the first and second inner clamp arms 120, 130, respectively (e.g., via first and second pull cables) such that tissue is clamped between the first jaw 410 and the first inner clamp arm 120 and between the second jaw 420 and the second inner clamp arm 130;
(4) controlling the second connector 300 to move relative to the first connector 200, so that the first inner clamping arm 120 and the second inner clamping arm 130 are relatively closed;
(5) the brake lever 600 and thus the delivery assembly are controlled to disengage from the tissue gripping device. Now if the tissue gripping device includes locking mechanism 500, locking tabs 511 on locking tube 510 will be opened outwardly to limit the relative opening of first inner clip arm 120 and second inner clip arm 130.
For example, when treating mitral regurgitation by clamping the mitral valve with the tissue clamping device, the tissue clamping device can be delivered to the mitral valve via the left atrium, and then the second connector 300 is controlled by the brake lever 600 to move relative to the first connector 200, so that the first inner clamping arm 120 and the second inner clamping arm 130 of the clamp body 100 are opened to a proper angle (e.g., 120 °, 150 °, 180 °, etc.); and controls first and second jaws 410 and 420 to open relative to first and second inner clamp arms 120 and 130, respectively. Further adjusting the position of the tissue gripping device such that the first and second inner clip arms 120, 130 are located on the left ventricular side of the mitral valve and such that the first and second inner clip arms 120, 130 capture the mitral valve; subsequently controlling first and second jaws 410, 420 to close relative to first and second inner clamp arms 120, 130, respectively, to enable the mitral valve to be clamped between first inner clamp arm 120 and first jaw 410 and between second inner clamp arm 130 and second jaw 420; then, the first inner clamping arm 120 and the second inner clamping arm 130 of the clamp main body 100 are controlled to be folded by the brake lever 600, the operation of clamping the mitral valve by the tissue clamping device is completed, and the mitral valve is changed from a big hole into two small holes. Then the brake bar 600 and the delivery assembly are controlled to be separated from the tissue clamping device, so that the brake bar 600 and the delivery assembly can be removed from the human body. In addition, when the tissue clamping device has the locking mechanism 500, after the brake lever 600 is disengaged from the locking tube 510, the locking fin 511 of the locking mechanism 500 automatically opens to restrict the opening of the first inner clip arm 120 and the second inner clip arm 130 of the clip body 100, so that the tissue clamping device can be prevented from being disengaged from the mitral valve due to impact of blood flow or the like.
The benefits that may be provided by the tissue gripping devices disclosed herein include, but are not limited to: (1) one or more components of the tissue clamping device can be of an integrally formed structure, so that the tissue clamping device is stable in structure, reliable in connection and simple and convenient to produce and manufacture; (2) the inner clamping arms of the clamp main body of the tissue clamping device can be flexibly folded or unfolded through the bendable connection of the inner clamping arms and the supporting part and the bendable connection of the inner clamping arms and the outer clamping arms, so that the tissue can be captured and clamped better; (3) through the ingenious design of the bending structure, the related parts can be easily subjected to heat treatment and deform, and the stable bending effect among the parts can be realized; (4) by arranging the barb clamping piece, the tissue can be prevented from falling out from the space between the clamping piece and the inner clamping arm, so that the clamping stability of the tissue clamping device is improved; (5) the locking mechanism can limit the opening of the inner clamping arm of the tissue clamping device after the tissue clamping device clamps the tissue, so that the tissue clamping device clamps the tissue more stably; (6) through setting up elastic support, not only can make the tissue more easily catch by arm in first arm lock and the second, can also protect the tissue to improve the stability of organizing the clamping device centre gripping. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.
The present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed.

Claims (10)

1. The utility model provides a tissue clamping device's clip main part, a serial communication port, the clip main part includes the outer arm lock of arm lock and second in supporting part, first interior arm lock, first outer arm lock, the second, one side of supporting part with first interior arm lock with first outer arm lock is consecutive can buckle and link to each other, the opposite side of supporting part with in the second the arm lock with the outer arm lock of second is consecutive can buckle and link to each other, the clip main part is the integrated into one piece structure.
2. The clip body of a tissue gripping device of claim 1, wherein one side of the support portion is connected to the first inner clip arm by a first bend; the other side of the supporting part is connected with the second inner clamping arm through a first bending structure;
the first inner clamping arm is connected with the first outer clamping arm through a second bending structure; the second inner clamping arm is connected with the second outer clamping arm through a second bending structure.
3. The clip body of a tissue gripping device of claim 2, wherein the first fold is an S-bar fold or a loin fold;
the second bending structure is an S-rod bending structure or a waist-thinning bending structure.
4. The clip body of a tissue gripping device of claim 3, wherein the S-bar bent structure comprises at least three sections of straight bars and two sections of bent bars, the three sections of straight bars being parallel to each other and the three sections of straight bars being connected end to end by the two sections of bent bars.
5. The clip body of a tissue gripping device of claim 1, wherein the support portion is a lattice structure; the mesh structure comprises a diamond mesh, a circular mesh, a rectangular mesh, a square mesh, a triangular mesh or a regular polygonal mesh.
6. The clip body of a tissue gripping device of claim 1, wherein the cross-sectional shape of the support portion is circular or elliptical;
the cross-sectional area of the middle part of the supporting part is larger than the cross-sectional areas of the two ends of the supporting part.
7. The clip body of the tissue gripping device of claim 1, wherein the first inner clip arm and the second inner clip arm include integrally cut barbed clips thereon.
8. The clip body of the tissue gripping device of claim 1, wherein the first and second outer clip arms include a plurality of through-holes therein, the plurality of through-holes being configured to assist in deforming the first and second outer clip arms during thermal processing.
9. The clip body of a tissue gripping device of claim 1, wherein the clip body is a one-piece structure of shape memory alloy tubing cut and heat set.
10. A tissue gripping device comprising the clip body of any one of claims 1-9.
CN202010243522.XA 2020-03-31 2020-03-31 Tissue clamping device and clamp main body thereof Pending CN111265340A (en)

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Application Number Priority Date Filing Date Title
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112402061A (en) * 2020-12-07 2021-02-26 科凯(南通)生命科学有限公司 Braided mesh valve repair clamp
CN113331996A (en) * 2021-05-25 2021-09-03 北京领健医疗科技有限公司 Anchoring clamp and valve closing instrument using same
WO2021196580A1 (en) * 2020-03-31 2021-10-07 Shanghai Newmed Medical Co., Ltd. Tissue clamping devices
WO2022052506A1 (en) * 2020-09-10 2022-03-17 Shanghai Newmed Medical Co., Ltd. Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device
CN114431903A (en) * 2020-11-03 2022-05-06 深圳市健心医疗科技有限公司 Tissue closure device
WO2022160524A1 (en) * 2021-01-27 2022-08-04 Shanghai Newmed Medical Co., Ltd. Tissue clamping devices and tissue repair devices

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021196580A1 (en) * 2020-03-31 2021-10-07 Shanghai Newmed Medical Co., Ltd. Tissue clamping devices
WO2022052506A1 (en) * 2020-09-10 2022-03-17 Shanghai Newmed Medical Co., Ltd. Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device
CN114431903A (en) * 2020-11-03 2022-05-06 深圳市健心医疗科技有限公司 Tissue closure device
CN112402061A (en) * 2020-12-07 2021-02-26 科凯(南通)生命科学有限公司 Braided mesh valve repair clamp
CN112402061B (en) * 2020-12-07 2022-02-22 科凯(南通)生命科学有限公司 Braided mesh valve repair clamp
WO2022160524A1 (en) * 2021-01-27 2022-08-04 Shanghai Newmed Medical Co., Ltd. Tissue clamping devices and tissue repair devices
CN113331996A (en) * 2021-05-25 2021-09-03 北京领健医疗科技有限公司 Anchoring clamp and valve closing instrument using same

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