CN117338358A

CN117338358A - Suture tightening device and method

Info

Publication number: CN117338358A
Application number: CN202311351312.2A
Authority: CN
Inventors: 章仕忠; 李升清; 裴世宁; 邰平; 韦家威; 李志刚; 王国辉
Original assignee: Nanjing Sealmed Medical Technology Co ltd
Current assignee: Nanjing Sealmed Medical Technology Co ltd
Priority date: 2023-10-18
Filing date: 2023-10-18
Publication date: 2024-01-05
Anticipated expiration: 2043-10-18
Also published as: CN117338358B

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a suture tightening device and a suture tightening method. In the suture tightening device, the suture is provided with a suture end and a hanging end, the suture end penetrates through the tissue in the body to be sutured, and a slipknot is arranged between the suture end and the hanging end; the suture cinching device includes a sheath and a cutting assembly; the sheath tube is used for abutting the slipknot, so that the slipknot slides towards the suture end and forms a fixed knot at a position close to the sutured internal tissue; the cutting assembly is used to sever the suture at the overhanging end of the suture. The suture tightening device disclosed by the invention is beneficial to solving or improving the problem that thrombus is easy to generate when suture tightening is realized through the indwelling plug after suture is adopted in the prior art.

Description

Suture tightening device and method

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a suture tightening device and a suture tightening method.

Background

The left and right heart rooms of the normal heart are completely isolated by the room septum, and when the secondary septum fails to cover the secondary orifice, the most typical secondary atrial septal defect is formed; however, when the two membranes that make up the atrial septum are not fused together, an patent foramen ovale is formed.

The current clinical application of patent foramen ovale treatment is widely represented by Amplatzer, which comprises an integrated left disc surface, right disc surface and waist connecting piece. The left disc surface, the right disc surface and the waist connecting piece of the plugging device are all rigidly connected to form an integral structure. The principle is that the plugging device with elastic characteristics is compressed into a structure with smaller size, the plugging device is conveyed to an unclosed position through a catheter, the elastic plugging device is self-expanded and restored to a preset shape, a left disc surface and a right disc surface are respectively clung to the atrial wall at two sides of an oval foramen, and the left disc surface and the right disc surface are tightly clamped with the edges of a primary septum and a secondary septum together to block blood flow. In addition, there are also currently ways to suture the primary and secondary septa with sutures, thereby cinching the sutures to close the foramen ovale, blocking blood flow, as shown in fig. 1-2.

If the occluder is used for treating patent foramen ovale, the main material of the occluder metal disc is nickel-titanium alloy memory metal coated with a polyester film, and the patent foramen ovale has individual differences in size, so that the situation of incomplete adaptation of the occluder can occur in practical application; in addition, if the patient subsequently requires secondary treatment of other structural heart diseases, once the occluder is placed, the patient cannot perform the operation of atrial septum penetration, impeding subsequent treatment.

If the foramen ovale is closed by suturing the primary and secondary septa, the prior art discloses a solution in which a plug (for achieving tightening of the suture) is left in the right atrium after suturing is completed, as shown in fig. 3-4. The suture is pressed by the plug to close the oval hole, the size of the plug is relatively large, and thrombus is easy to form; the process of placing and locking the plug in the right atrium is relatively complex, and the function implementation requirement is relatively high.

Accordingly, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.

Disclosure of Invention

The invention aims to provide a suture tightening device and a suture tightening method, which are used for solving or improving at least one of the problems that the operation is complex, the requirement on the instrument is high, the volume of an indwelling plug is large and thrombus is easy to generate when the suture is tightened through the indwelling plug after the internal tissue is sutured in the prior art.

In order to achieve the above object, the present invention provides the following technical solutions: a suture cinching device having a suture end and a depending end, the suture end extending through tissue in a body being sutured, a slip knot disposed between the suture end and the depending end; the suture cinching device includes a sheath and a cutting assembly; the sheath tube is used for abutting the slipknot, so that the slipknot slides towards the suture end and forms a fixed knot at a position close to the sutured internal tissue; the cutting assembly is used to sever the suture at the overhanging end of the suture.

Preferably, the cutting tube is slidably assembled in the sheath tube, one end of the cutting tube, which is close to the slipknot, is provided with a first through hole, and the tube wall of the cutting tube is provided with a second through hole; a third through hole is formed in the wall of the sheath tube; the first through hole, the second through hole and the third through hole are communicated to form a suture channel which allows the overhanging end of the suture to pass through, and a cutting edge is arranged at the second through hole.

Preferably, the cutting assembly further comprises a cutting button and a connecting rod, and the connecting rod is respectively connected with the cutting button and the cutting tube; the suture cinching device also includes a handle coupled to the sheath, the cutting button slidably mounted to the handle, the cutting button adapted to adjust the sliding movement of the cutting tube in the axial direction.

Preferably, a cutting groove is formed in the handle, and the cutting button penetrates through the cutting groove; one end of the cutting button, which is far away from the cutting pipe, is connected with the handle through an elastic piece; the resilient member is compressed in response to displacement of the cutting button in a direction away from the fixed knot.

Preferably, one end of the sheath tube, which is close to the handle, is provided with a connecting sleeve, and the inner wall of the connecting sleeve is provided with a rotation stopping groove and a back stopping groove; the handle is close to the one end of sheath pipe is equipped with and ends the rotating muscle and setting element, end the rotating muscle with end the groove looks adaptation that changes, setting element with end the groove looks adaptation that returns.

Preferably, the suture tightening device further comprises a stay wire assembly, wherein the stay wire assembly comprises a stay wire coil, a stay wire and a stay wire sleeve which are sequentially connected; the pull loop is used for capturing the overhanging end of the suture; the stay wire penetrates through the suture channel and is used for guiding the hanging end of the suture to enter the suture channel and penetrate out of the third through hole; the stay wire sleeve is used for being held by hand.

Preferably, the suture includes a first suture and a second suture, and the slip knot is formed by tying the second suture around the first suture.

Preferably, a surgical clamp is also included for clamping the overhanging end of the second suture to maintain the second suture stationary until the slip knot reaches a set position.

The invention also provides a suture tightening method, which adopts the following technical scheme: the suture tightening method adopts the suture tightening device to tighten the suture, and comprises the following steps: (1) tying a slipknot on the suture; (2) Abutting the sheath against the slip knot, sliding the slip knot toward the suture end of the suture, and forming a fixed knot at a location proximal to the tissue being sutured; (3) The suture is severed at the overhanging end of the suture using a cutting assembly.

Preferably, the method further comprises the following steps: the step (2) is preceded by the step of inserting the overhanging end of the suture into the suture channel and out of the third through-hole.

The beneficial effects are that:

the suture tightening device can enable the slipknot to slide towards the suture end of the suture and form a fixed knot at a position close to the tissue in the suture body by arranging the slipknot and the sheath tube which is abutted with the slipknot on the suture, thereby tightening the suture (closing between the tissues to be sutured). The volume of the fixation knot (formed by tying the suture) is significantly reduced relative to prior art plugs which are left in the body after cinching the suture; the suture is easy to generate thrombus when the suture is tightened through the indwelling plug after the suture is adopted in the prior art.

The suture cinching device of the present invention may be used to cinch at least a patent foramen ovale suture.

The suture tightening device of the invention is simple and convenient to operate and convenient to control, and can conveniently cut the suture after the fixed knot is formed, reduce the suture left in the body and withdraw the sheath tube from the body.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. Wherein:

FIG. 1 is a schematic diagram showing a state of stitching of a primary septum and a secondary septum by a suture in the prior art;

FIG. 2 is a schematic view showing a state of sewing the primary septum and the secondary septum by a suture according to the prior art;

FIG. 3 is a schematic view showing the suture of FIG. 1 being cinched by an indwelling plug (the foramen ovale between the primary and secondary compartments should be closed with the suture fully cinched);

FIG. 4 is a schematic view showing the suture of FIG. 2 being cinched by an indwelling plug (the foramen ovale between the primary and secondary compartments should be closed with the suture fully cinched);

FIG. 5 is a schematic view of the overall structure of a suture cinching device according to one embodiment of the present invention;

FIG. 6 is a schematic view of the cross-sectional structure in the direction A-A of FIG. 5 (cut button not shown);

FIG. 7 is a schematic view of a cutting assembly according to an embodiment of the present invention at different viewing angles;

FIG. 8 is a schematic view of a sheath according to an embodiment of the present invention;

FIG. 9 is a schematic view of the left handle shell according to one embodiment of the present invention from different viewing angles;

FIG. 10 is a schematic view of the right housing of the handle according to one embodiment of the present invention from different viewing angles;

FIG. 11 is a schematic view of a cable assembly according to an embodiment of the present invention;

FIG. 12 is a schematic view of a suture cinching device in a first use configuration and an enlarged view at I according to one embodiment of the present invention;

FIG. 13 is a schematic view of a suture cinching device according to one embodiment of the present invention in a second use configuration;

FIG. 14 is a schematic view of a suture cinching device according to one embodiment of the present invention in a third use configuration;

FIG. 15 is a schematic view of a suture cinching device in a fourth use configuration and an enlarged view at II according to one embodiment of the present invention;

FIG. 16 is a schematic view of a suture cinching device in a fifth use configuration and an enlarged view at III according to one embodiment of the present invention;

FIG. 17 is a schematic view of a suture cinching device in a sixth use configuration and an enlarged view at IV according to one embodiment of the present invention;

FIG. 18 is a schematic view of a suture cinching device according to one embodiment of the present invention in a seventh use configuration.

Reference numerals:

1-a handle; 2-a cutting assembly; 3-sheath; 4-a pull wire assembly; 11-left shell; 111-mounting holes; 112-left cut groove; 113-left positioning piece; 12-right shell; 121-mounting posts; 122-right cut groove; 123-right positioning piece; 124-anti-rotation ribs;

21-cutting the tube; 211-a first through hole; 212-a second via; 213-cutting edge; 22-connecting rods; 23-a support; 24-a cutting button; 25-an elastic member;

31-a third through hole; 32-connecting sleeve; 321-a rotation stopping groove; 322-a backstop groove;

41-a stay wire sleeve; 411-card strip; 42-drawing wire; 43-pull coil;

51-slipknots; 52-fixing the knot; 61-a first suture; 62-second suture.

Detailed Description

The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the invention, fall within the scope of protection of the invention.

The present invention will be described in detail with reference to examples. It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other.

In the description of the present invention, it should be understood that references to orientation descriptions such as upper, lower, front, rear, left, right, etc. are based on the orientation or positional relationship shown in the drawings, are merely for convenience of description of the present invention and to simplify the description, and do not indicate or imply that the apparatus or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the present invention.

In the description of the present invention, a number means one or more, a number means two or more, and greater than, less than, exceeding, etc. are understood to not include the present number, and above, below, within, etc. are understood to include the present number. The description of the first and second is for the purpose of distinguishing between technical features only and should not be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may explicitly or implicitly include one or more features.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the term "connected" should be construed broadly, and for example, it may be a fixed connection or an active connection, or it may be a detachable connection or a non-detachable connection, or it may be an integral connection; may be mechanically connected, may be electrically connected, or may be in communication with each other; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements, indirect communication or interaction relationship between the two elements.

The end of the suture tightening device close to the operator is a proximal end and the end far away from the operator is a distal end during the use process.

The invention provides a suture tightening device, which aims at least one of the problems of complex operation, high requirement on instruments and large volume of an indwelling plug and easy thrombus generation when the suture is tightened by adopting a mode of indwelling the plug after the suture is adopted to suture in vivo tissues (such as a primary septum and a secondary septum).

As shown in fig. 5 to 6, in the suture tightening device according to the embodiment of the present invention, the suture has a suture end and a hanging end, the suture end penetrates the tissue to be sutured, and a slipknot 51 is provided between the suture end and the hanging end; the suture cinching device includes a sheath 3 and a cutting assembly 2; the sheath 3 is used for abutting against the slipknot 51, so that the slipknot 51 slides towards the suture end and a fixed knot 52 is formed at a position close to the sutured body tissue; the cutting assembly 2 is used to sever the suture at the overhanging end of the suture.

Wherein, the suture end in the "suture end penetrating the sutured body tissue" means a portion on the suture that contacts the sutured tissue before or after tightening the suture; "slipknot" is understood in the present invention as a knot body that can be slipped over a suture (preferably, the inner diameter of the distal end port of the sheath 3 is smaller than the knot body size of the slipknot 51, so as to avoid that the knot body of the slipknot 51 enters the sheath 3 when the sheath 3 applies a pushing force for distal slipping to the slipknot 51, which affects the effect of slipping of the slipknot 51 to the suture end); "near the tissue of the body to be sutured" means at or near the site of contact with the tissue of the body to be sutured (i.e., the present invention does not require that the slipknot 51 must be moved to the site of contact with the tissue of the body to be sutured; the movable distance of the slipknot 51 is designed according to actual needs, so that tightening of the suture can be achieved); the fixed knot means that the knot body is in a state of being relatively fixed and incapable of sliding on the suture at will, and can effectively keep the suture in a tightened state; the "sutured body tissue" may be a primary septum, a secondary septum, and a body tissue similar to the primary septum, the secondary septum.

By providing the slipknot 51 on the suture and using the sheath 3 which can be abutted against the slipknot 51, the slipknot 51 can be slid toward the suture end of the suture, and the fixing knot 52 can be formed at a position close to the tissue in the body to be sutured, thereby achieving tightening of the suture. The significantly reduced volume of fixation knot 52 (formed by tying a knot with a suture) relative to prior art plugs that reside within the body after cinching the suture (as shown in fig. 3-4) helps to solve or ameliorate the problem of the excessive volume of plugs that reside within the body and are prone to thrombus when the suture is used. The suture cinching device of the present invention may be used at least to cinch a suture of a patent foramen ovale (the application of the suture cinching device of the present invention is not limited to cinching a suture of a patent foramen ovale) to effect closure of a patent foramen ovale. In addition, the suture cinching device of the present invention is simple and easy to operate and easy to control, and allows the suture to be severed using the cutting assembly 2 after the knot 52 is formed, reducing the amount of suture left in the body, and withdrawing the sheath 3 from the body.

In the preferred embodiment of the suture cinching device of the present invention, as shown in FIGS. 7-8, the cutting assembly 2 includes a cutting tube 21, the cutting tube 21 is slidably mounted within a sheath 3 (the sheath 3 has an inner lumen and the distal end of the sheath 3 has a hole for allowing the suture to pass therethrough), the end of the cutting tube 21 adjacent to the slip knot 51 has a first through hole 211, and the wall of the cutting tube 21 is provided with a second through hole 212; the wall of the sheath tube 3 is provided with a third through hole 31; the first through hole 211, the second through hole 212 and the third through hole 31 are communicated to form a suture passage allowing the overhanging end of the suture to pass through (the knot body of the slipknot 51 is preferably sized so as not to enter the suture passage), and a cutting edge 213 is provided at the second through hole 212 (the cutting edge 213 is used for cutting the suture). The suture channel is arranged, so that the overhanging end of the suture can enter the cutting tube 21 after passing through the first through hole 211 and the second through hole 212 in sequence and can be penetrated out of the third through hole 31 (the overhanging end of the suture penetrated out of the third through hole 31 can be held by a hand or clamped by an instrument, and matched with the sheath tube 3, so that the suture is tightened); further, the sheath 3 can be conveniently brought into contact with the slipknot 51 (preferably, in this state, the cutting edge 213 is not in contact with the suture), and a force is applied to the slipknot 51 to slide the slipknot 51 in the direction of the tissue (e.g., secondary and primary septum) to be sutured. By providing the cutting edge 213 at the second through-hole 212 (e.g., at the inner wall of the second through-hole 212, or at a localized location within the inner wall of the second through-hole), the suture at the proximal end of the fixation knot 52 can be conveniently severed by adjusting the relative position and relationship of the second through-hole 212 to the suture after the fixation knot 52 is formed. Specifically, after the anchor knot 52 is formed, the suture thread (depending end) at the proximal end of the anchor knot 52 is placed in tension by the operation of the depending end of the suture thread passing through the third through hole 31, and the cutting blade 213 is moved in a direction approaching the suture thread (suture thread passing through the third through hole 31), so that the suture thread can be cut when the cutting blade 213 contacts the suture thread.

Preferably, the cutting tube 21 is made of stainless steel. More preferably, the cut tube 21 is a stainless steel tube having an inner diameter of 0.40mm to 0.45mm (e.g., 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44mm, or 0.45 mm), and a wall thickness of 0.03 to 0.05mm (e.g., 0.03mm, 0.04mm, or 0.05 mm).

In a preferred embodiment of the suture cinching device of the present invention, as shown in FIG. 7, the cutting assembly 2 further includes a cutting button 24 and a connecting rod 22, the connecting rod 22 being connected to the cutting button 24 and the cutting tube 21, respectively (the cutting button 24, connecting rod 22 and cutting tube 21 being disposed in sequence from the proximal end to the distal end); the suture cinching device further includes a handle 1 (handle 1 has a hollow interior) with the handle 1 attached to the sheath 3, a cutting button 24 slidably mounted to the handle 1, the cutting button 24 being adapted to adjust the sliding movement of the cutting tube 21 in the axial direction (to facilitate severing of the suture after the fixation knot 52 is formed). Wherein, the handle 1 is arranged so that an operator can conveniently realize the control of the sheath tube 3 through the operation of the handle 1; the arrangement of the cutting button 24 and the connecting rod 22 (preferably, the distal end of the connecting rod 22 has better flexibility with respect to the cutting tube 21) allows control of the cutting tube 21 by operation of the cutting button 24, and thus cutting of the suture according to the actual situation.

In the preferred embodiment of the suture cinching device of the present invention, as seen in FIGS. 9-10, the handle 1 is provided with a cutting slot through which the cutting button 24 is disposed; the end of the cutting button 24 remote from the cutting tube 21 is connected to the handle 1 (e.g., the inner wall of the handle 1) through an elastic member 25; in response to displacement of the cutting button 24 in a direction away from the fixed knot 52, the elastic member 25 is compressed (the cutting edge comes into contact with the suture, cutting the suture). The above arrangement allows the cutting assembly 2 to self-reset after being forced to slide along the axial direction of the cutting tube 21. Specifically, in practice, after the anchor 52 is formed, the suture may be severed by sliding the cutting button 24 proximally (when the elastic member 25 is compressed) to bring the cutting edge 213 of the cutting tube 21 into contact with the suture at the proximal end of the anchor 52 (the suture at the depending end). Thereafter, the elastic member 25 is restored without manipulation, and the cutting tube 21 is moved distally to the pre-stressed position. Preferably, the cutting button 24 is connected to the connecting rod 22 by a support 23, the cutting button 24 being arranged between the proximal and distal faces of the support 23, the proximal face of the support 23 being spaced from the proximal face of the handle 1; the elastic piece 25 is a spring, and the spring is sleeved on the outer wall of the supporting piece 23 at the proximal end of the cutting button 24; in the axial direction of the cutting tube 21, one end of the spring is connected to the cutting button 24 and the other end is connected to the handle 1.

In the preferred embodiment of the suture tightening device of the present invention, as shown in fig. 8-10, one end of the sheath tube 3, which is close to the handle 1, is provided with a connecting sleeve 32, and the inner wall of the connecting sleeve 32 is provided with a rotation stopping groove 321 and a back stopping groove 322; the handle 1 is close to sheath 3's one end is equipped with and ends the muscle 124 and the setting element that end, ends the muscle 124 and ends the adaptation of changeing groove 321, and the setting element is with stopping groove 322 looks adaptation. The assembly of the handle 1 and the sheath 3 can be conveniently realized by adapting the rotation stopping groove on the connecting sleeve 32 to the rotation stopping rib 124 on the handle 1 (the far end of the handle 1) (for example, the rotation stopping rib and the handle can be in interference fit), adapting the rotation stopping groove 322 on the connecting sleeve 32 to the positioning piece on the handle 1 (for example, the rotation stopping groove 322 on the connecting sleeve 32 is formed by enabling the positioning piece on the handle 1 to enter the rotation stopping groove 321 of the connecting sleeve 32 and the rotation stopping rib 124 on the handle 1 to enter the rotation stopping groove 321 of the connecting sleeve 32 when the assembly is finished, and the first through hole 211, the second through hole 212 and the third through hole 31 are communicated after the assembly is finished, so that a suture passage allowing a suture to pass can be formed.

Preferably, the positioning sleeve is disposed along the circumferential direction of the connecting sleeve 32, and the rotation stopping groove 321 is disposed in a direction parallel to the axis of the connecting sleeve 32.

In a preferred embodiment of the suture cinching device of the present invention, as seen in FIG. 11, the suture cinching device further includes a cinch assembly 4, the cinch assembly 4 including a cinch ring 43, a cinch wire 42, and a cinch sleeve 41 that are connected in sequence; the pull coil 43 is used to capture the overhanging end of the suture (i.e., the overhanging end of the suture is threaded through the pull coil 43); a pull wire 42 is disposed through the suture channel for guiding the overhanging end of the suture into the suture channel and out of the third through hole 31; the stay wire sheath 41 is for hand holding (to facilitate pulling of the stay wire 42).

Preferably, the pull wire sleeve 41 is also provided with a clamping strip 411, so that the pull wire sleeve is conveniently connected with the sheath tube 3 through the clamping strip 411 (the clamping strip 411 clamps the sheath tube 3; the clamping strip 411 can be connected with the sheath tube 3 in a detachable manner); the distal end of the pull coil 43 has a clip (which may be in a clip-like configuration) for facilitating the clipping of the suture.

More preferably, the pull coil 43 may be made of a stainless steel wire of 0.1mm-0.15mm (e.g., 0.1mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm or 0.15 mm), and the pull coil 43 has a hollow ring shape so as to perform a function of capturing a suture.

In a preferred embodiment of the suture cinching device of the present invention, as shown in FIG. 12, the suture includes a first suture 61 and a second suture 62, and the slip knot 51 is formed by tying the second suture 62 around the first suture 61. Wherein, the first suture 61 and the second suture 62 may be two sutures which have no connection relationship with each other (as shown in fig. 1, the first suture 61 is arranged to penetrate through the secondary space, the second suture 62 is arranged to penetrate through the primary space; but after the first suture 61 and the second suture 62 are tightened, the suturing of tissues can be realized); alternatively, the first suture 61 and the second suture 62 are attached at the distal end of the body tissue being sutured (e.g., the first suture 61 and the second suture 62 are integrally provided; as shown in FIG. 2).

In a preferred embodiment of the suture cinching device of the present invention, a surgical clamp (not shown) is also included for grasping the depending end of the second suture 62 to maintain the second suture 62 stationary until the slip knot 51 reaches the set position (forming a fixed knot 52). Specifically, before the slipknot 51 reaches the set position, the hanging end of the first suture 61 is pulled by the operator, the sheath 3 abuts against the knot body of the slipknot 51, and the slipknot 51 is pushed distally. When the slipknot 51 is pushed to the suture (near the tissue being sutured), the second suture 62 is pulled by hand, at which point the knot is locked at the suture (forming the securing knot 52) and remains stationary.

In the preferred embodiment of the suture cinching device of the present invention, as shown in FIGS. 9-10, handle 1 is comprised of left housing 11 and right housing 12, which are connected by an interference fit with mounting post 121 through mounting hole 111; the left shell 11 is provided with a left cutting groove 112, the right shell 12 is provided with a right cutting groove 122, the left cutting groove 112 and the right cutting groove 122 are symmetrically arranged, the left shell 11 and the right shell 12 are matched to form a handle 1 to form a cutting groove, and the contour of the cutting groove is matched with the cutting button 21 of the cutting assembly 2; the far end of the left shell 11 is provided with a left positioning piece 113, the far end of the right shell 12 is provided with a right positioning piece 123, and after the left positioning piece 113 and the right positioning piece 123 are combined (the left shell 11 and the right shell 12 are assembled), a positioning piece which is matched with a retaining groove 322 of a connecting sleeve 31 of the sheath tube 3 is formed; the anti-rotation rib 124 designed on the right shell 12 is in contact limit with the anti-rotation groove 321 of the connecting sleeve 31.

As shown in fig. 7, the cutting assembly 2 is composed of a cutting button 24, a support 23 connected to the cutting button, a connection rod 22 provided at a distal end of the support 23, and a cutting tube 21 connected to a distal end of the connection rod 22. Wherein, the outer wall of the supporting piece 23 positioned at the proximal end of the cutting button 24 is sleeved with an elastic piece 25 (the elastic piece 25 is a spring, the inner diameter of the spring is matched with the outer diameter of the supporting piece 23 at the corresponding position), the distal end of the elastic piece 25 is connected with the cutting button 24 or the supporting piece 23, and the proximal end of the elastic piece 25 can be abutted against the inner wall of the handle 1; the two ends of the cutting button 24 protrude from the left cutting groove 112 and the right cutting groove 122, respectively; the center of the far end of the supporting piece 23 is provided with a mounting hole which is connected with the near end of the connecting rod 22 through glue; the distal outer diameter of the connecting rod 22 is adapted to the proximal inner diameter of the cutting tube 21 (so as to achieve connection of the connecting rod 22 and the cutting tube 21); the cutting tube 21 may be made of stainless steel having an inner diameter of 0.40mm to 0.45mm (e.g., 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44mm, or 0.45 mm), a wall thickness of 0.03mm to 0.05mm (e.g., 0.03mm, 0.04mm, or 0.05 mm), and an outer diameter of the cutting tube 21 and the connecting rod 22 after being connected by glue is the same as a proximal outer diameter of the cutting tube 21; the distal end of the cutting tube 21 has a first through hole 211, the center of the cutting tube is designed with a second through hole 212, and a cutting edge 213 is arranged at the second through hole 212 for cutting the suture (the suture in the invention can be selected from 4-0 polypropylene suture).

As shown in fig. 8, the proximal end of the sheath 3 is provided with a connecting sleeve 32, which are connected by glue. The anti-return groove 322 is matched with a positioning piece (formed by assembling the left positioning piece 113 and the right positioning piece 123), and an anti-rotation groove 321 designed in the connecting sleeve 32 is in contact limit with an anti-rotation rib 124 on the handle 1; a third through hole 31 is designed on the tube wall of the sheath tube 3 at a position close to the distal end (the sheath tube 3 is hollow, and the distal end is provided with an opening, the opening is at least provided with a size allowing the first suture 61 and the second suture 62 to pass through), and the third through hole 31 is used for installing the pull ring 43 of the pull wire assembly 4 and passing a suture (a 4-0 polypropylene suture can be adopted) when the product is used (a suture channel allowing the suture to pass through is formed after the first through hole 211, the second through hole 212 and the third through hole 31 are communicated).

As shown in fig. 11, the wire assembly 4 is composed of a wire sleeve 41, a wire coil 43, and a wire 43. The clamping strip 411 designed by the stay wire sleeve 41 clamps the sheath tube 32; the pull coil 42 is made of stainless steel wire having a diameter of 0.1mm-0.15mm (e.g., 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, or 0.15 mm); the pull wire 42 may be disposed through the suture channel such that the pull wire 42 may function to guide the overhanging end of the suture into and out of the suture channel.

The invention also provides a suture tightening method, which adopts the suture tightening device to tighten the suture and comprises the following steps: (1) tying a slipknot 51 over the suture; (2) The sheath 3 is abutted against the slipknot 51, the slipknot 51 is slid toward the suture end of the suture, and a fixed knot 52 is formed at a position close to the tissue in the body to be sutured; (3) The suture is severed at the depending end of the suture using the cutting assembly 2.

In a preferred embodiment of the suture cinching method of the present invention, the method further comprises the steps of: prior to step (2), the step of passing the overhanging end of the suture into the suture channel and out of the third through hole 31 is also included.

In a preferred embodiment of the suture cinching method of the present invention, the suture is severed by sliding the cutting button 24 proximally, with the cutting edge 213 at the second through hole 212 exerting a force on the suture.

In a preferred embodiment of the suture cinching method of the present invention, it includes the steps of:

step one: after passing the suture (4-0 polypropylene suture) through the secondary/primary septum, respectively, as shown in fig. 2, the primary septum suture (i.e., the suture that passes through the primary septum; i.e., the second suture 62) is tied around the secondary septum suture (i.e., the suture that passes through the secondary septum; i.e., the first suture 61) to form a knot (slip knot 51), as shown in fig. 12.

Step two: the two ends of the knotted suture are placed in the pull coil 43 (the suture is made to penetrate the pull coil 43), and the pull sleeve 41 is pulled back to the proximal end, so that the ends of the suture (4-0 polypropylene suture) are driven to sequentially pass through the sheath 3, the first through hole 211, the inner cavity of the cutting tube 21, the second through hole 212 and the third through hole 31, as shown in fig. 13 to 14.

Step three: the primary suture is then clamped using the forceps, i.e., the primary suture (i.e., the coiled suture; i.e., the second suture 62) is held stationary, the secondary suture (i.e., the first suture 61) is pulled by one hand, the sheath 3 is pushed distally by one hand, and the knot (slip knot 51) is then held against the distal end of the sheath 3, as shown in fig. 15; continuing to advance the sheath 3 distally, the fisher knot (slip knot 51) will be pushed to the suture (near the primary and secondary). The advanced position is fed back by the radiopaque stainless steel cutting tube 21 (the sheath 3 and the like in the suture tightening device of the present invention may be made of a radiopaque material).

Step four: when the knot is pushed to the suture (near the tissue being sutured), the primary septal suture (the suture held stationary by the original forceps; i.e., the second suture 62) is pulled by hand, at which point the knot is locked at the suture (forming the fixation knot 52) and held stationary, as shown in fig. 16.

Step five: the sheath 3 is held stationary, at which time the cutting button 24 is pulled proximally (the cutting button 24 may be wrench-like) to a limit, the elastic member 25 is compressed, the cutting edge of the cutting edge 213 at the second through hole 212 of the cutting tube 21 is brought into contact with a suture (e.g., a 4-0 polypropylene suture may be used), and the suture contact force is cut off, as shown in fig. 17. The cutting button 24 is released and the cutting assembly 2 is reset under the action of the spring.

Step six: finally, the sheath tube 3 is withdrawn, and the beaten and locked fisher knots suture and lock the primary septum/secondary septum, and the patent foramen ovale is closed, as shown in figure 18.

The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A suture cinching device characterized in that the suture has a suture end and a hanging end, the suture end extending through tissue in the body being sutured, a slip knot being disposed between the suture end and the hanging end;

the suture cinching device includes a sheath and a cutting assembly;

the sheath tube is used for abutting the slipknot, so that the slipknot slides towards the suture end and forms a fixed knot at a position close to the sutured internal tissue;

the cutting assembly is used to sever the suture at the overhanging end of the suture.

2. The suture cinching device of claim 1, wherein the cutting assembly includes a cutting tube slidably mounted within the sheath, the cutting tube having a first through hole at an end thereof adjacent the slip knot and a second through hole in a wall thereof; a third through hole is formed in the wall of the sheath tube;

the first through hole, the second through hole and the third through hole are communicated to form a suture channel which allows the overhanging end of the suture to pass through, and a cutting edge is arranged at the second through hole.

3. The suture cinching device of claim 2, wherein the cutting assembly further includes a cutting button and a connecting rod that is connected to the cutting button and cutting tube, respectively;

the suture cinching device also includes a handle coupled to the sheath, the cutting button slidably mounted to the handle, the cutting button adapted to adjust the sliding movement of the cutting tube in the axial direction.

4. A suture cinching device according to claim 3, wherein the handle is provided with a cutting slot through which the cutting button is disposed;

one end of the cutting button, which is far away from the cutting pipe, is connected with the handle through an elastic piece;

the resilient member is compressed in response to displacement of the cutting button in a direction away from the fixed knot.

5. A suture cinching device according to claim 3 wherein a sleeve is provided at one end of the sheath adjacent the handle, the inner wall of the sleeve being provided with a rotation stop groove and a backstop groove;

the handle is close to the one end of sheath pipe is equipped with and ends the rotating muscle and setting element, end the rotating muscle with end the groove looks adaptation that changes, setting element with end the groove looks adaptation that returns.

6. The suture cinching device of claim 2, further comprising a cinch assembly comprising a cinch coil, a cinch wire, and a cinch sleeve connected in sequence;

the pull loop is used for capturing the overhanging end of the suture; the stay wire penetrates through the suture channel and is used for guiding the hanging end of the suture to enter the suture channel and penetrate out of the third through hole; the stay wire sleeve is used for being held by hand.

7. A suture cinching device according to any one of claims 1 to 6 wherein the suture includes a first suture and a second suture, the slip knot being formed by tying the second suture around the first suture.

8. The suture cinching device of claim 7, further comprising a surgical clamp for clamping a depending end of the second suture to maintain the second suture stationary until the slip knot reaches a set position.

9. Suture cinching method, characterized in that the cinching of a suture is achieved with a suture cinching device according to any of claims 1-8, comprising the steps of:

(1) Tying a slipknot on the suture;

(2) Abutting the sheath against the slip knot, sliding the slip knot toward the suture end of the suture, and forming a fixed knot at a location proximal to the tissue being sutured;

(3) The suture is severed at the overhanging end of the suture using a cutting assembly.

10. The suture cinching method according to claim 9, further comprising the steps of: the step (2) is preceded by the step of inserting the overhanging end of the suture into the suture channel and out of the third through-hole.