CN111110312A - Device for tissue clamping and use method thereof - Google Patents

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a device for clamping tissues and a using method thereof, wherein the device comprises a handle, an inner tube, an inner clamp, an outer tube seat, an outer tube, a sleeve, an outer clamp and a releasing mechanism; the outer pipe is connected with the sleeve and the outer pipe seat; the outer clip is provided with an outer clip seat and an outer clip sheet, and the outer clip sheet is driven by the sleeve opening to clip; the inner pipe penetrates through the outer pipe seat, the outer pipe, the sleeve and the outer clamp seat in sequence and is sleeved in the outer pipe, and the inner pipe is connected with the inner clamp and the handle; the inner clamp is provided with an inner clamping seat and an inner clamping piece, the inner clamping seat drives the outer clamping seat to move when abutting against the outer clamping seat, and the inner clamping piece and the outer clamping piece are assembled into a clamp when abutting against each other; the releasing mechanism is sleeved at the joint of the front end of the outer pipe and the sleeve and used for locking or unlocking the connection of the outer pipe and the sleeve. The device for clamping the tissue and the using method thereof can be operated more conveniently, accurately and safely, reduce the operation requirements on a doctor, and simultaneously, if the clamping position of the mitral valve leaflet is not good, the clamping can be repeated and the operation and the release can be performed again.

Description

Device for tissue clamping and use method thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a device for clamping tissues and a using method thereof.

Background

The valvular heart disease is one of the most common heart diseases in China, wherein the valvular damage is mainly caused by rheumatic fever; with the development of aging population in recent years, valve degeneration (including calcification, mucus degeneration and the like) and metabolic disorder valve damage are increasing in China. Mitral regurgitation is characterized by the retrograde flow of blood from the left ventricle to the left atrium of the heart through an incompetent mitral valve. During the normal systolic cycle, the mitral valve acts as a check valve preventing the backflow of oxygenated blood into the left atrium, so that the oxygenated blood is pumped through the aortic valve to the aorta and then throughout the body. Mitral regurgitation can significantly reduce the pumping efficiency of the heart, placing the patient at risk for severe, progressive heart failure. The most common treatment for mitral regurgitation relies on valve replacement or repair, including leaflet and annulus remodeling, the latter commonly referred to as annuloplasty. Although all of these techniques are very effective, patient recovery is slow because they rely on an open chest, which is a major surgical trauma. In recent years, Mitraclip of yapei corporation, a valve-clamping device for percutaneous venous access, has also appeared internationally, but the complicated operation thereof has caused troubles to doctors. Patent document CN107595435A discloses a valve clamping device, which comprises a first clamping part, a second clamping part and a connecting part, wherein the first clamping part has at least two first clamping arms, the second clamping part has a corresponding number of second clamping arms, each first clamping arm and the corresponding second clamping arm can be combined into a group of clamps, but the operation is not convenient and fast, the release is not stable, and the success rate of the operation is affected.

In view of the above-mentioned shortcomings of the prior art, there is a need for a new device system and method that provides a quick, stable, convenient and quick handling system and method that addresses the valve clamping process.

Disclosure of Invention

In view of the above-described deficiencies in the prior art, the present invention provides a device for tissue clamping and method of use thereof.

In order to achieve the purpose, the invention adopts the following technical scheme:

a device for clamping tissues comprises 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 pipe is connected with the sleeve, and the rear end of the outer pipe is connected with the outer pipe seat; the outer clamp is provided with an outer clamp seat and two outer clamping sheets which are positioned on the outer clamp seat and are in an opening shape, the outer clamp seat is sleeved in the sleeve, and the two outer clamping sheets are leaked out of one end of the sleeve opening, so that the outer clamp seat can move in the sleeve along the sleeve direction, and the sleeve opening drives the outer clamping sheets to clamp; the inner pipe penetrates through the outer pipe seat, the outer pipe, the sleeve and the outer clamping seat in sequence and is sleeved in the outer pipe, the front end of the inner pipe is connected with the inner clamp, and the rear end of the inner pipe is connected with the handle, so that the handle drives the inner pipe and the inner clamp to move in the outer pipe in sequence along the direction of the outer pipe; the inner clamp is provided with an inner clamping seat and two inner clamping pieces which are positioned on the inner clamping seat and are in an opening shape, the inner clamping seat is provided with a propping bulge so as to drive the outer clamping seat to move when the inner clamping seat props against the outer clamping seat, and the inner clamping pieces are matched with the outer clamping pieces so as to be combined into a clamp when the inner clamping pieces and the outer clamping pieces prop against each other; the release mechanism is sleeved at the joint of the front end of the outer pipe and the sleeve and used for locking or unlocking the connection of the outer pipe and the sleeve.

Preferably, the release mechanism comprises a release pipe and a release pipe seat, the front end of the release pipe is provided with an inner cavity and a boss, the sleeve is embedded in the inner cavity, the outer side of the sleeve is provided with a convex wall with a groove, and the convex wall with the groove is matched with the boss to form a rotary clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe and used for rotating the release pipe.

As a preferred scheme, the release pipe seat is also provided with an emptying port for emptying in an operation, and the other end of the release pipe seat is provided with a sealing element; and a luer is arranged at the tail end of the outer tube base.

Preferably, the diameter of the inner tube is 0.5-2.5mm, the diameter of the outer tube is 2.6-5mm, and the opening angle of the two outer clamping sheets is 100-160 degrees.

Preferably, the diameter of the sleeve pipe is smaller than that of the outer pipe so that the sleeve is inserted into the outer pipe, and a limiting step is arranged inside the outer pipe and used for abutting against the bottom of the sleeve.

As a preferred scheme, the front end of the outer pipe is also provided with a limiting groove, the sleeve is provided with a limiting protrusion, and the limiting groove is matched with the limiting protrusion to limit the sleeve to move along the circumferential direction of the outer pipe.

Preferably, the wall of the sleeve is provided with a plurality of holes for accelerating endothelialization of the sleeve implantation.

As the preferred scheme, the side of the abutting face of the inner clamping piece and the side of the abutting face of the outer clamping piece are respectively provided with clamping teeth, and the bottom end of the outer side of the outer clamping piece is also provided with a clamping protrusion.

As the preferred scheme, the end part of the pipe orifice of the inner cavity of the sleeve is provided with an internal thread, and the outer side of the outer clamping seat is provided with an external thread matched with the internal thread.

A method of using a device for tissue clamping, comprising the steps of:

s1, conveying a device for clamping tissues to a heart valve, controlling an inner tube to move back and forth through a handle, and adjusting the position of an inner clamp to enable an outer clamping piece and the inner clamping piece to be respectively positioned at the inner side and the outer side of a prolapsed valve leaf;

s2, drawing the handle to retract the inner clamp and the outer clamp into the sleeve to clamp the valve;

s3, the connection between the inner pipe and the inner clamp is released, the release mechanism is adjusted, the connection between the outer pipe and the sleeve is unlocked, and the sleeve and the inner clamp and the outer clamp are released

Compared with the prior art, the invention has the beneficial effects that:

the device for clamping tissues and the using method thereof can be operated more conveniently, accurately and safely, and the operating requirements on doctors are reduced. Meanwhile, if the clamping position of the mitral valve leaflets is not good, the mitral valve leaflets can be repeatedly clamped and then released.

Drawings

FIG. 1 is a schematic view of the overall structure of a first embodiment of the device for tissue clamping and its method of use according to the present invention;

FIG. 2 is a schematic view of the overall cross-sectional structure of a first embodiment of the device for tissue clamping and method of use of the device of the present invention;

FIG. 3 is a schematic view of a first embodiment of the device for tissue clamping and method of use of the device of the invention in an intraoperative use;

FIG. 4 is a schematic view of the device for tissue clamping and method of use of the device of the present invention after the inner and outer clamps have been released;

FIG. 5 is a schematic view of the outer tube of the first embodiment of the device for tissue clamping and method of use of the invention;

FIG. 6 is a schematic cross-sectional view of a release tube of a first embodiment of the device for tissue clamping and method of use of the device of the invention;

FIG. 7 is a schematic view of a cannula configuration of a first embodiment of the device for tissue clamping and method of use of the invention;

FIG. 8 is a schematic view of the outer clamping portion leaflet closed configuration of a first embodiment of the device and method for using the same for tissue clamping of the present invention;

FIG. 9 is a schematic view of the closed inner leaflet clip structure of the first embodiment of the tissue fastening device and method of use of the device;

wherein: 1. a handle; 2. an inner tube; 3. an outer tube seat; 4. an outer tube; 401. a limiting groove; 402. a limiting step; 5. releasing the tube seal; 6. releasing the tube seat; 7. a release tube; 701. a boss; 702. an inner cavity; 8. a sleeve; 801. a limiting bulge; 802. a convex wall with a groove; 803. a hole; 9. an outer clamp; 901. an outer clip; 902. an outer holder; 10. internal clamping; 101. an inner clip; 102. an inner clamping seat.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention, the following description will explain the embodiments of the present invention with reference to the accompanying drawings. It is obvious that the drawings in the following description are only examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

The first embodiment is as follows:

referring to fig. 1, the device system and method for tissue clamping of the present embodiment includes ahandle 1, aninner tube 2, anouter tube holder 3, anouter tube 4, a release mechanism, asleeve 8, anouter clamp 9, and aninner clamp 10. The front section of theinner tube 2 is connected with theinner clip 10, and the rear end is connected with thehandle 1. The 4 anterior segments of outer tube link to each other withsleeve pipe 8, and the rear end links to each other withouter tube base 3, and 7 anterior segmentinner chambers 702 of release pipe haveboss 701, fixsleeve pipe 8 onouter tube 4, and release mechanism releases, andsleeve pipe 8 just can follow and drop onouter tube 4. Throughhandle 1 controlinner tube 2 back-and-forth movement, adjust the position ofinterior clamp 10, make its clamp close the valve leaf of prolapse, if the position is improper, still can repeat the adjustment, after suitable, withinterior clamp 10 andouter clamp 9income sleeve pipe 8 in, untieinner tube 2 and the connection ofinterior clamp 10, then adjustment release mechanism releasessleeve pipe 8 and interiorouter clamp 9, accomplishes fast and stable operation, easy operation is convenient.

Specifically, the front end of the outer tube 4 is connected with the sleeve 8, the rear end of the outer tube is connected with the outer tube base 3 through a threaded connection mode or an adhesive fixation mode and the like, the diameter of the sleeve 8 is smaller than that of the outer tube 4 so that the sleeve 8 is inserted into the outer tube 4, a limiting step 402 is arranged inside the outer tube 4, the limiting step 402 abuts against the bottom of the sleeve 8, a limiting groove 401 is further arranged at the front end of the outer tube 4, the sleeve 8 is provided with a limiting protrusion 801, and the limiting groove 401 and the limiting protrusion 801 are matched to limit the sleeve 8 to move circumferentially along; the outer clamp 9 is provided with an outer clamp holder 902 and two outer clamping pieces 901 which are positioned on the outer clamp holder 902 and are in an open shape, the outer clamp holder 902 is sleeved in the sleeve 8, and the two outer clamping pieces 901 are leaked out of one end of the opening of the sleeve 8, so that the outer clamp holder 902 can move in the sleeve 8 along the direction of the sleeve 8 and can be driven by the opening of the sleeve 8 to clamp the outer clamping pieces, the end part of the opening of the inner cavity of the sleeve 8 is provided with an internal thread, the outer side of the outer clamp holder 902 is provided with an external thread matched with the internal thread, the outer clamp holder 902 can be screwed into the thread part of the sleeve 8 to prevent the outer clamp holder 902 from moving freely when the device is not used, the bottom end of the outer side of the outer clamping piece 901 is also provided with a clamping bulge, and when the outer clamping; the inner tube 2 sequentially penetrates through the outer tube seat 3, the outer tube 4, the sleeve 8 and the outer clamping seat 902 and is sleeved in the outer tube 4, the front end of the inner tube 2 is connected with the inner clamping seat 102 through threads, and the rear end of the inner tube 2 is connected with the handle 1 through threads, glue, fixation and other modes, so that the handle 1 sequentially drives the inner tube 2 and the inner clamp 10 to move in the outer tube 4 along the direction of the outer tube 4; the inner clamp 10 is provided with an inner clamp seat 102 and two inner clamping pieces 101 which are positioned on the inner clamp seat 102 and are in an opening shape, the inner clamp seat 102 is provided with a propping bulge so as to drive the outer clamp seat 902 to move along the pipe direction of the sleeve 8 when the inner clamp seat 102 props against the outer clamp seat 902, the outer clamp seat 902 is also internally provided with a square, triangular, special-shaped and other non-circular groove, the shape of the propping bulge inserted into the groove end is matched with that of the groove, so that the inner clamp seat 102 can also drive the outer clamp seat 902 to rotate and move along the circumferential direction of the sleeve 8; the inner clamping piece 101 is matched with the outer clamping piece 901, so that the inner clamping piece 101 and the outer clamping piece 901 are combined into a clamp when abutting against each other, the inner clamping piece 101 and the outer clamping piece 901 are both arc-shaped, and barb-shaped clamping teeth are respectively arranged on the abutting surface sides to strengthen the clamping force; the releasing mechanism is sleeved at the joint of the front end of the outer pipe 4 and the sleeve 8 and used for locking or unlocking the connection of the outer pipe 4 and the sleeve 8, the releasing mechanism comprises a releasing pipe 7 and a releasing pipe seat 6, the front end of the releasing pipe 7 is provided with an inner cavity 702 and a boss 701, the sleeve 8 is embedded in the inner cavity 702, a convex wall 802 with a groove is arranged on the outer side of the sleeve 8, the convex wall 802 with the groove is matched with the boss 701 to form a rotary clamping structure, specifically, the boss 701 can penetrate through the groove of the convex wall 802 with the groove and can be movably clamped at the convex wall in a rotating mode at the concave wall, and when the boss 701 rotates to the position overlapped with the groove again, the; one end of the release pipe seat 6 is fixedly connected with the rear end of the release pipe 7 through threads or glue, and the release pipe seat 6 is rotated by being held by a hand to drive the release pipe 7 to rotate; the release pipe seat 6 is also provided with an evacuation port for evacuation in operation, the other end of the release pipe seat 6 is provided with a sealing element, the sealing element can be a sealing screw, a sealing gasket and other devices capable of enhancing evacuation tightness, the release mechanism can also be a clamping piece with two semi-circles clamped mutually, the bottom end of the clamping piece can be opened to release the connection of the unlocking sleeve 8 and the outer pipe 4, or the sleeve 8 is provided with an L-shaped groove, the release pipe 7 is provided with a protrusion matched with the L-shaped groove to be rotationally clamped and connected to complete locking or unlocking and the like, and the specific structure of the release; the tail end of the outer tube seat 3 is designed by luer standard threads, so that standard luer instruments can be conveniently connected, and the functionality is enhanced.

Furthermore, thehandle 1 is made of high polymer materials such as PP, ABS and metal materials, and the structure is not limited, so that the operation is convenient; the diameter of theinner tube 2 is preferably 0.5-2.5mm, the diameter of theouter tube 4 is 2.6-5mm, and the material is stainless steel tube or high polymer material (such as PP, ABS, PE, etc.), and the material is stainless steel or nickel titanium, etc. for operation. The front end is connected with the inner clamp 10 through screw threads, the rear end and the handle 1 can be fixed through rivets by inserting the screw threads and the holes in the front and the back, and can be disassembled on site; the outer tube seat 3 is made of high polymer materials such as PP, ABS and the like, the release tube sealing element 5 is a device which is matched with a seal screw and a release tube seat 6 into a whole and is made of high polymer materials and metal materials, a sealing gasket is additionally arranged below the seal screw, the release tube 7 is made of high polymer materials and metal materials such as PP, ABS, PE, stainless steel and the like, the sleeve 8 is made of high polymer materials, metal materials or alloy materials, the number of the limiting bulges 801 of the sleeve 8 can be 1 or more, preferably 2-3, the positions of the limiting bulges 801 and the limiting grooves 401 can be interchanged corresponding to the number of the limiting grooves 401 of the adapting sleeve 8, the length of the sleeve 8 inserted into the outer tube 4 is preferably 1-3mm, the sleeve 8 with the groove convex wall 802 is in an outer ring shape, the width of the outer ring is 0.5-2mm, the number of the grooves is preferably 2-3, the, the wall of the sleeve 8 is provided with a plurality of holes 803, so that the endothelialization process after the sleeve is implanted into a human body is accelerated; the outer clip 9 is made of nickel titanium, the two clamping pieces are arc-shaped, and after heat treatment, the angle of the two clamping pieces reaches 100 degrees and 160 degrees, so that the mitral valve leaflets can be conveniently captured; the inner clip 10 is made of nickel titanium, the two clamping pieces are arc-shaped and matched with the outer clip 9, and a row of barbed clamping teeth are arranged at the front ends of the two clamping pieces of the inner clip 10, and can penetrate into the valve leaflets after the outer clip 9 is clamped, so that the inner clip 9 and the outer clip 9 can be prevented from falling off after clamping the valve leaflets.

A method of using a device for tissue clamping, comprising the steps of:

s1, delivering a device for tissue clamping to the heart valve, such as: the device is sent to a ventricular valve from the apex of the heart through an operation, theinner tube 2 is controlled by thehandle 1 to move back and forth, and the position of theinner clip 10 is adjusted, so that theouter clip 901 and theinner clip 101 are respectively positioned at the inner side and the outer side of the prolapsed valve leaf;

s2, thehandle 1 is drawn to enable theinner clamp 10 and theouter clamp 9 to be retracted into thesleeve 8, and a valve is clamped; certainly, before use, thehandle 1 is rotated to sequentially drive theinner tube 2, theinner clamping base 102 and theouter clamping base 902 to enable theouter clamping base 902 to be separated from the threaded area of thesleeve 8, then thehandle 1 is drawn to sequentially drive theinner tube 2 and theinner clamping base 102, theinner clamping base 102 drives theouter clamping base 902 to be accommodated in thesleeve 8, the opening of thesleeve 8 is used for accommodating theinner clamp 10 and clamping sheets to clamp the leaves to be clamped, meanwhile, if the clamping position of the mitral valve is not good, clamping can be repeated, and finally, the clamping bulge at the bottom end of the outer side of theouter clamping sheet 901 is clamped into the opening of thesleeve 8 to stabilize the clamping action;

s3, theinner tube 2 is driven to rotate through therotating handle 1, the threaded connection between theinner tube 2 and theinner clamp 10 is unfastened, the releasing mechanism is adjusted, namely the releasingtube seat 6 is rotated to drive the releasingtube 7 to rotate, when theboss 701 of the releasingtube 7 is overlapped with the groove of theconvex wall 802 with the groove of thesleeve 8, the releasingtube 7 is pulled out to unlock the connection between theouter tube 4 and thesleeve 8, thesleeve 8 and the inner andouter clamps 9 are released, and the operation is completed.

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 conveyor system, and the "front end" refers to the end away from the operator of the conveyor system.

While embodiments of the present invention have been described with reference to repairing mitral valve regurgitation, it will be appreciated by those skilled in the art that the disclosed prosthetic mitral valve regurgitation may be used in addition to other prosthetic mitral valve regurgitations or to deliver other devices for placement into the corresponding body locations. The present invention is not limited to one means for repairing mitral valve regurgitation.

It should be noted that the above-mentioned only illustrates the preferred embodiments and principles of the present invention, and that those skilled in the art will be able to make modifications to the embodiments based on the idea of the present invention, and that such modifications should be considered as the protection scope of the present invention.

Claims (10)

1. A device for clamping tissues 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 pipe is connected with the sleeve, and the rear end of the outer pipe is connected with the outer pipe seat; the outer clamp is provided with an outer clamp seat and two outer clamping sheets which are positioned on the outer clamp seat and are in an opening shape, the outer clamp seat is sleeved in the sleeve, and the two outer clamping sheets are leaked out of one end of the sleeve opening, so that the outer clamp seat can move in the sleeve along the sleeve direction, and the sleeve opening drives the outer clamping sheets to clamp; the inner pipe penetrates through the outer pipe seat, the outer pipe, the sleeve and the outer clamping seat in sequence and is sleeved in the outer pipe, the front end of the inner pipe is connected with the inner clamp, and the rear end of the inner pipe is connected with the handle, so that the handle drives the inner pipe and the inner clamp to move in the outer pipe in sequence along the direction of the outer pipe; the inner clamp is provided with an inner clamping seat and two inner clamping pieces which are positioned on the inner clamping seat and are in an opening shape, the inner clamping seat is provided with a propping bulge so as to drive the outer clamping seat to move when the inner clamping seat props against the outer clamping seat, and the inner clamping pieces are matched with the outer clamping pieces so as to be combined into a clamp when the inner clamping pieces and the outer clamping pieces prop against each other; the release mechanism is sleeved at the joint of the front end of the outer pipe and the sleeve and used for locking or unlocking the connection of the outer pipe and the sleeve.

2. The device for tissue clamping of claim 1, wherein the release mechanism comprises a release tube and a release tube seat, the front end of the release tube is provided with an inner cavity and a boss, the sleeve is embedded in the inner cavity and provided with a convex wall with a groove on the outer side, and the convex wall with the groove is matched with the boss to form a rotary clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe and used for rotating the release pipe.

3. The device for tissue clamping of claim 2 wherein said release tube holder is further provided with a drain for surgical drainage, said release tube holder being provided at the other end with a seal; and a luer is arranged at the tail end of the outer tube base.

4. The device as claimed in claim 2, wherein the inner tube has a diameter of 0.5-2.5mm, the outer tube has a diameter of 2.6-5mm, and the two outer clips have an opening angle of 100-160 degrees.

5. A device for tissue clamping according to claim 1, wherein the cannula has a smaller diameter than the outer tube so that the cannula can be inserted into the outer tube, the outer tube having a stop step inside, the stop step being adapted to abut against the bottom of the cannula.

6. The device for tissue clamping of claim 5, wherein the outer tube further comprises a limiting groove at the front end, the sleeve comprises a limiting protrusion, and the limiting groove and the limiting protrusion are adapted to limit the sleeve from moving along the circumference of the outer tube.

7. A device for tissue clamping according to claim 1, wherein said sleeve has a plurality of holes in the wall of the sleeve for accelerating endothelialization of the sleeve implant.

8. The tissue clamping device of claim 1, wherein the abutting surfaces of the inner clamping piece and the outer clamping piece are respectively provided with clamping teeth, and the bottom end of the outer side of the outer clamping piece is further provided with a clamping protrusion.

9. The device for tissue clamping as claimed in claim 1, wherein the end of the lumen of the cannula is provided with an internal thread, and the outer side of the outer clamping seat is provided with an external thread matched with the internal thread.

10. A method of using a device for tissue clamping, comprising the steps of:

s1, conveying a device for clamping tissues to a heart valve, controlling an inner tube to move back and forth through a handle, and adjusting the position of an inner clamp to enable an outer clamping piece and the inner clamping piece to be respectively positioned at the inner side and the outer side of a prolapsed valve leaf;

s2, drawing the handle to retract the inner clamp and the outer clamp into the sleeve to clamp the valve;

s3, the connection between the inner pipe and the inner clamp is released, the release mechanism is adjusted, the connection between the outer pipe and the sleeve is unlocked, and the sleeve and the inner clamp and the outer clamp are released.

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