CN114681151A - Suture length adjusting system capable of being adjusted quantitatively - Google Patents

Abstract

The present invention provides a quantitatively adjustable suture length adjustment system, comprising an adjustment component, the adjustment component includes a first adjustment member and a second adjustment member axially movably connected to the first adjustment member, the The first adjusting member is provided with a first positioning portion, and the second adjusting member is provided with a second positioning portion corresponding to the first positioning portion. The suture is passed between the first adjustment piece and the second adjustment piece, and the second adjustment piece moves distally in the axial direction relative to the first adjustment piece to push the suture so that the suture is pushed up. The length of the suture between the first adjusting member and the second adjusting member increases until the first positioning portion and the second positioning portion are matched, thereby restricting the second adjusting member relative to each other The first adjustment member moves. The suture length adjustment system has simple structure and convenient operation, can realize quantitative adjustment of the suture length, and does not apply a fixed pressure to the suture during the adjustment process, which is beneficial to avoid suture damage.

Description

Quantitatively adjustable suture length adjustment system

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a quantitatively adjustable suture length adjustment system.

Background technique

Mitral valve insufficiency is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, mitral valve myxoid degeneration, cardiac ischemic disease, cardiomyopathy, etc. The leaflets, chordae tendineae, and papillary muscles develop lesions that prevent the mitral valve leaflets from closing completely.

Surgery is an effective method for the treatment of mitral regurgitation, but due to the large trauma to the human body, the elderly patients and patients with more comorbidities have more complications and higher mortality.

At present, minimally invasive interventional surgery is the better choice for most heart diseases. The main interventional treatment methods include artificial chordae tendineae implantation, mitral annuloplasty and mitral valve edge-to-edge repair. Among them, the implantation of artificial chordae tendineae on the valve leaflets can effectively treat mitral valve insufficiency caused by rupture of the chordae tendineae, valve leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure. However, after the artificial chordae are implanted for a period of time, due to changes in cardiac capacity and other factors, the implanted artificial chordae will be in a relaxed state, and it is often necessary to adjust the length of the artificial chordae again to shorten the effective length of the artificial chordae to reduce Avoid abnormal heart valve function.

In the prior art, an artificial tendon chord length adjustment device is disclosed. First, the artificial tendon chord is captured by hooks, the artificial tendon chord is stretched by means of equipment, and the length of the artificial tendon chord is determined by the stretching amount. fixed to achieve the control effect. The main defects of this technology are: 1. The control device is too complicated and the operation is difficult; 2. The extrusion force of the clip is easy to cause damage to the artificial chordae tendineae; 3. The quantitative control cannot be performed, and the control amount is unstable. These problems will lead to the risk of surgical failure or ineffective regulation in the regulation of artificial chordae tendineae.

SUMMARY OF THE INVENTION

In order to solve the above technical problems, the present invention provides a quantitatively adjustable suture length adjustment system, which has simple structure and convenient operation, can realize quantitative adjustment of the suture length, and can avoid suture damage during the adjustment process.

The quantitatively adjustable suture length adjustment system provided by the present invention includes an adjustment assembly, the adjustment assembly includes a first adjustment member and a second adjustment member axially movably connected to the first adjustment member, the first adjustment member An adjusting member is provided with a first positioning portion, and the second adjusting member is provided with a second positioning portion corresponding to the first positioning portion; the suture is passed between the first adjusting member and the second adjusting member , the second adjusting member moves distally in the axial direction relative to the first adjusting member to push the suture, so that the suture between the first adjusting member and the second adjusting member The length increases until the first positioning part is adapted to the second positioning part, so as to limit the relative movement between the second adjusting member and the first adjusting member.

In the quantitatively adjustable suture length adjustment system provided by the present invention, after the suture is passed between the first adjustment member and the second adjustment member, the second adjustment member moves to the distal end in the axial direction relative to the first adjustment member to Push the suture to increase the length of the suture between the first adjusting member and the second adjusting member to adjust the suture, and by controlling the movement of the second adjusting member relative to the first adjusting member, the seam can be realized. Quantitative adjustment of the thread length, the whole system has a simple structure and is easy to operate; in addition, in the process of adjusting the suture, the second adjusting member does not exert a fixed pressure on the suture, which is beneficial to avoid damage to the suture; After the quantitative adjustment is completed, the cooperation between the first positioning part and the second positioning part can restrict the movement of the second adjustment member relative to the first adjustment member, thereby preventing the suture from loosening.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

FIG. 1 is a schematic diagram of the overall structure of a quantitatively adjustable suture length adjustment system provided by an embodiment of the present invention.

FIG. 2 is a schematic three-dimensional structure diagram of the adjusting assembly and the conveying assembly shown in FIG. 1 .

3 is a partial axial cross-sectional view of the adjusting assembly and the conveying assembly shown in FIG. 2 , wherein the second limiting member is accommodated in the second accommodating cavity and corresponds to the position of the second positioning portion.

FIG. 4 is a schematic view of the second adjusting member shown in FIG. 3 moving distally in the axial direction relative to the first adjusting member until the first positioning portion is matched with the second positioning portion.

FIG. 5 is a schematic diagram of a suture that is pushed through between the first adjusting member and the second adjusting member shown in FIG. 4 .

FIG. 6 is a schematic three-dimensional structural diagram of the adjustment assembly shown in FIG. 4 .

FIG. 7 is an axial cross-sectional view of the adjustment assembly shown in FIG. 6 .

FIG. 8 is a schematic three-dimensional structural diagram of the first regulating member shown in FIG. 6 .

FIG. 9 is a proximal front view of the first adjustment member shown in FIG. 8 .

FIG. 10 is a schematic structural diagram of the second adjusting member shown in FIG. 6 .

FIG. 11 is a right side view of the second adjusting member shown in FIG. 10 .

FIG. 12 is a schematic view of the structure of the release member shown in FIG. 3 .

FIG. 13 is an axial cross-sectional view of the release member shown in FIG. 12 .

FIG. 14 is a distal elevational view of the release member shown in FIG. 12 .

FIG. 15 is a schematic three-dimensional structural diagram of the first limiting member shown in FIG. 3 .

FIG. 16 is an axial cross-sectional view of the first limiting member shown in FIG. 15 .

FIG. 17 is a front view of the distal end of the first stopper shown in FIG. 15 .

FIG. 18 is a schematic three-dimensional structural diagram of the connecting shaft shown in FIG. 3 .

FIG. 19 is a schematic three-dimensional structural diagram of the connecting shaft, the disengaging piece, the second limiting piece and the connecting piece shown in FIG. 3 .

FIG. 20 is an axial cross-sectional view of the connecting shaft, the releasing member, the second limiting member and the connecting piece shown in FIG. 19 .

Figures 21 to 23 are schematic diagrams of the use process of the quantitatively adjustable suture length adjustment system provided by the present invention.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Furthermore, the following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the invention may be practiced. Directional terms mentioned in the present invention, such as "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., only Reference is made to the directions of the accompanying drawings, therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be configured in a specific orientation and operation, and therefore should not be construed as limiting the present invention.

It should be noted that, in order to describe the structure of the quantitatively adjustable suture length adjustment system more clearly, the defined terms "proximal end" and "distal end" described in the specification of the present invention are conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; Defined as the axial direction; the circumferential direction is the direction around the axis of a cylinder, tube and other objects (perpendicular to the axis and perpendicular to the radius of the section); the radial direction is the direction along the diameter or radius. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments, and should not be construed as limiting the present invention.

Please refer to FIG. 1 to FIG. 5 together, the present invention provides a quantitatively adjustable suture length adjustment system 1, including an adjustment assembly 20, the adjustment assembly 20 includes a first adjustment member 21 and is axially movably connected to the first adjustment member 21. The second adjusting member 22 of the adjusting member 21 , wherein the first adjusting member 21 is provided with a first positioning portion 211 , and the second adjusting member 22 is provided with a second positioning portion 221 corresponding to the first positioning portion 211 . The suture 2 is passed between the first adjustment member 21 and the second adjustment member 22, and the second adjustment member 22 moves distally relative to the first adjustment member 21 in the axial direction to push the suture 2, so that the first adjustment member The length of the suture 2 between the 21 and the second adjusting member 22 is increased until the first positioning portion 211 and the second positioning portion 221 are matched, so as to limit the relative movement between the second adjusting member 22 and the first adjusting member 21 . It can be understood that, when the second adjusting member 22 moves to the distal end in the axial direction relative to the first adjusting member 21 by different distances, the distance at which the suture 2 is pushed up is also different, and thus the adjusted length of the suture 2 is different. Specifically, as shown in FIG. 5 , after the suture 2 is pushed up by the second adjustment member 22 , the suture 2 between the first adjustment member 21 and the second adjustment member 22 is bent into an inverted U shape or a “ji” shape , the adjusted length H of the suture 2 is approximately equal to twice the length h of the suture 2 located on each side of the second adjusting member 2 along the radial direction of the first adjusting member 21, that is, H and h satisfy the relationship: H=2h, wherein the length h of the suture 2 on each side of the second adjusting member 2 along the radial direction of the first adjusting member 21 is the axially distal end of the second adjusting member 22 relative to the first adjusting member 21 Therefore, by controlling the movement amount of the second adjusting member 22 relative to the first adjusting member 21, the quantitative adjustment of the length of the suture 2 can be realized.

In the quantitatively adjustable suture length adjusting system 1 provided by the present invention, after the suture 2 is passed between the first adjusting member 21 and the second adjusting member 22, the second adjusting member 22 is axially relative to the first adjusting member 21. Move to the distal end to push the suture 2, thereby increasing the length of the suture 2 between the first adjustment piece 21 and the second adjustment piece 22 to adjust the suture 2, and by controlling the second adjustment piece 22 relative to each other The amount of movement of the first adjusting member 21 can realize the quantitative adjustment of the length of the suture 2. The structure of the whole system is simple and the operation is convenient; 2. Applying a fixed pressure is beneficial to avoid damage to the suture 2; in addition, after the quantitative adjustment of the suture 2 is completed, the cooperation of the first positioning part 211 and the second positioning part 221 can limit the second adjustment member 22 relative to the first adjustment member 21 move, thereby preventing suture 2 from loosening.

It should be noted that the suture 2 can be a suture used as an artificial tendon, such as e-PTFE suture or PET suture, and the second adjusting member 22 pushes the suture 2 to adjust the length of the suture 2, that is, The effective length of the artificial chordae tendineae is adjusted. After the quantitative adjustment of the suture 2 is completed, the adjustment component 20 is clamped on the suture 2 and placed in the human body as an implant. In order to ensure the safety of implantation, the first adjustment member 21 and the second adjustment member 22 can be made of metal materials or polymer materials with good biocompatibility, such as stainless steel or PEEK. The first adjustment member 21 and the second adjustment member The material of 22 may be the same or different.

As shown in FIG. 1 , the suture length adjustment system 1 further includes a delivery component 40 connected to the proximal end of the adjustment component 20 and a handle component 60 connected to the proximal end of the delivery component 40 , wherein the delivery component 40 is used for delivery adjustment The assembly 20 is placed inside the human body and controls the relative movement between the first adjusting member 21 and the second adjusting member 22 , and the handle assembly 60 is used for the operator to control the delivery assembly 40 outside the body.

Specifically, please refer to FIG. 6 to FIG. 8 together, the first adjusting member 21 is a hollow substantially cylindrical body, and is provided with a first receiving cavity 212 extending in the axial direction. The first receiving cavity 212 at least penetrates the first adjusting member 21 , so that the second adjusting member 22 is axially slidably inserted into the first accommodating cavity 212 from the proximal end of the first adjusting member 21 . Preferably, in this embodiment, the first accommodating cavity 212 passes through the distal end surface of the first adjusting member 21 together, which is beneficial to reduce the weight of the first adjusting member 21; in addition, the first accommodating cavity 212 passes through the first adjusting member The distal end surface of 21 enables the second adjustment member 22 to move distally relative to the first adjustment member 21 in the axial direction until the distal end of the second adjustment member 22 protrudes from the distal end of the first adjustment member 21, which is beneficial to increase the first adjustment member 21. The distance that the second adjusting member 22 moves to the distal end in the axial direction relative to the first adjusting member 21 increases the length H of the suture 2 to be adjusted. Of course, in other embodiments, the first accommodating cavity 212 may not pass through the distal end surface of the first regulating member 21 , as long as the depth of the first accommodating cavity 212 along the axial direction of the first regulating member 21 is sufficient to provide the second regulating member 22 mobile space.

It should be noted that the inner contour of the first accommodating cavity 212 is substantially the same as the outer contour of the second regulating member 22 , so that the second regulating member 22 can be movably accommodated in the first accommodating cavity 212 .

Please refer to FIGS. 7 to 10 together. A pair of guide sliding surfaces 213 are oppositely disposed on the inner wall of the first accommodating cavity 212 , and the first positioning portion 211 includes at least one locking groove formed on at least one sliding guide surface 213 . The locking groove The second adjusting member 22 includes a pair of outer wall surfaces 222 corresponding to the pair of guide sliding surfaces 213 one-to-one, and the second positioning portion 221 includes an elastic clip disposed on at least one outer wall surface 222. The elastic hook is snapped into a corresponding one of the locking grooves to stop the relative movement between the second adjusting member 22 and the first adjusting member 21 . Preferably, in this embodiment, the guide sliding surface 213 and its corresponding outer wall surface 222 are both arc surfaces. The sliding contact of the 222 is smoother. Of course, in other embodiments, the guide sliding surface 213 and its corresponding outer wall surface 222 may also be flat surfaces.

In this embodiment, the pair of guide sliding surfaces 213 are both provided with the latching grooves, and the pair of outer wall surfaces 222 are both provided with the elastic latching hooks, so that the two opposite sides of the second adjusting member 22 can pass through the latching grooves. The elastic hooks are snapped into the corresponding slots to limit the relative movement between the first regulating member 21 and the second regulating member 22 , and the reliability is higher.

Among the pair of guide sliding surfaces 213 , the slot on one of the guide sliding surfaces 213 may or may not correspond to the position of the slot on the other guide sliding surface 213 , that is, the slot on one of the guide sliding surfaces 213 may or may not correspond. The position of the locking groove in the axial direction of the first adjusting member 21 is the same as or different from the position of the locking groove on the other guide sliding surface 213 in the axial direction of the first adjusting member 21 . In this embodiment, the positions of the respective card slots of the pair of guide sliding surfaces 213 correspond to each other.

In this embodiment, the number of said card slots on each guide sliding surface 213 is one. It can be understood that, when the number of the card slots on each guide sliding surface 213 is one, the elastic hooks on the outer wall surface 222 corresponding to the guide sliding surface 213 can only be locked into the one card slot to prevent the sliding movement. The relative movement between the first adjusting member 21 and the second adjusting member 22 is restricted, that is, the distance that the second adjusting member 22 moves to the distal end relative to the first adjusting member 21 in the axial direction is a fixed value, and the suture 2 The length H that can be quantitatively adjusted is unique. Optionally, in other embodiments, the card grooves on each guide sliding surface 213 may be provided in a plurality (ie, two or more), and the plurality of card grooves are arranged along the length of the first adjusting member 21 . Axially distributed on the sliding guide surface 213 , the elastic hooks on the outer wall surface 212 corresponding to the sliding sliding surface 213 provided with the plurality of locking grooves can be engaged with the elastic hooks at different axial positions of the first adjusting member 21 . In one of the said card slots, there are multiple distances that the second adjusting member 22 moves to the distal end relative to the first adjusting member 21 in the axial direction, so that the length H of the suture 2 that can be adjusted quantitatively has multiple values It is beneficial to enhance the applicable range of the suture length adjustment system 1 , and the opening of a plurality of the card slots is also beneficial to reduce the weight of the first adjustment member 21 .

Wherein, each of the card slots can extend along the radial direction of the first adjusting member 21 to penetrate through the outer wall of the first adjusting member 21 or not pass through the outer wall of the first adjusting member 21, preferably through the outer wall of the first adjusting member 21, there are It is beneficial to reduce the weight of the first adjusting member 21 more.

It should be noted that, in this embodiment, the spacing direction of the pair of guide sliding surfaces 213 is defined as the first direction, and the distance between the inner wall of the first accommodating cavity 212 and the second adjusting member 22 is substantially perpendicular to the first direction. A gap is provided in the second direction of the direction, and the gap is used for accommodating the suture 2 between the inner wall of the first receiving cavity 212 and the second adjusting member 22 , so as to prevent the suture 2 from being squeezed and damaged. Specifically, please refer to FIG. 5 , FIG. 6 and FIG. 9 together. In this embodiment, the inner wall of each side of the first accommodating cavity 212 in the second direction is respectively provided with a first adjusting member penetrating through the axial direction. 21, the depth of the groove (that is, the dimension along the second direction) is not less than the diameter of the suture 2, when the second adjusting member 22 is accommodated in the first accommodation cavity 212 and pushes the suture 2 , the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first accommodating cavity 212 is accommodated in the groove, so that the suture 2 can be prevented from being squeezed and damaged. In other embodiments, the groove may also be opened on the outer wall of each side of the second adjusting member 22 in the second direction, or each side of the first accommodating cavity 212 in the second direction The inner wall of the second regulating member 22 and the outer wall of each side of the second regulating member 22 in the second direction are respectively provided with grooves correspondingly to accommodate the gap between the outer wall of the second regulating member 22 and the inner wall of the first accommodating cavity 212 Thread 2 can also avoid crushing damage to suture 2.

As shown in FIG. 8 , in this embodiment, the outer wall of the first adjusting member 21 is provided with a first slot 214 from the proximal end surface that communicates with the first receiving cavity 212 . The first slot 214 is axially extended, and the positions of the first slot 214 and the slot on the inner wall of the first accommodating cavity 212 in the circumferential direction of the first adjusting member 21 are staggered from each other. The first slot 214 is used for the thread 2 to pass in and out. When the second adjusting member 22 pushes the thread 2, the first slot 214 can prevent the thread 2 from moving in the radial direction of the first adjusting member 21 , to prevent the suture 2 from being separated from the first adjusting member 21 and the second adjusting member 22 . Optionally, as shown in FIGS. 6 and 7 , in this embodiment, at least one hollow hole 216 is further opened on the outer wall of the first adjusting member 21 to further reduce the weight of the first adjusting member 21 . The extending direction of each hollow hole 216 may be the same or different from the extending direction of the slot of the first adjusting member 21 , and each hollow hole 216 may or may not be communicated with the first receiving cavity 212 . In this embodiment, each hollow hole 216 extends in the same direction as the card slot and communicates with the first receiving cavity 212 , so that the hollow hole 216 can also function as the card slot.

Further, please refer to FIG. 3 , FIG. 7 and FIG. 8 together. In this embodiment, the first adjusting member 21 defines at least one threaded hole extending in the axial direction from the proximal end face of the first receiving cavity 212 . For detachable connection with the distal end of the drive rod 45 in the delivery assembly 40. The driving rod 45 is used to transport the first regulating member 21 , and its axial movement can drive the first regulating member 21 to move in the axial direction, thereby driving the axial movement between the first regulating member 21 and the second regulating member 22 . The relative movement is to realize the hooking and pushing of the suture 2, thereby realizing the quantitative adjustment of the length of the suture 2; moreover, after the quantitative adjustment of the length of the suture 2 is completed, the driving rod 45 can be disassembled and separated from the first adjusting member 21 , so that the first regulating member 21 is indwelled in the human body.

Please refer to FIG. 7 , FIG. 10 and FIG. 11 together, the second adjusting member 22 is a hollow block and is provided with a second accommodating cavity 223 extending in the axial direction. The second accommodating cavity 223 at least penetrates through the second adjusting member 22, and at least one outer wall surface 222 of the second adjusting member 22 is provided with an opening 224 in the proximal end region that communicates with the second receiving cavity 223, and the second positioning portion 221 (ie, the elastic hook) is provided on the Opening 224. In this embodiment, two outer wall surfaces 222 on opposite sides of the second adjusting member 22 respectively define an opening 224 , and each opening 224 is provided with the elastic hook.

Specifically, as shown in FIG. 11 , in this embodiment, the elastic hook includes an elastic piece and a buckle connected to the proximal end of the elastic piece, and the distal end of the elastic piece is connected to the distal edge of the opening 224 , so The buckle includes a stop surface facing the proximal end of the second adjusting member 22 and an inclined plane facing the outer side of the second adjusting member 22 and the distal end of the second adjusting member 22 . Wherein, the elastic sheet is made of elastic material to ensure its elastic deformation ability. It should be noted that, in this embodiment, in the initial state, the elastic hook of the second adjusting member 22 is located outside the distal end of the first adjusting member 21 , and the second adjusting member 22 is axially relative to the first adjusting member 21 . When moving to the distal end, the elastic hook first abuts against the proximal end surface of the first adjusting member 21, and at this time, the inner wall of the edge of the first receiving cavity 212 near the port will push against the inclined plane of the hook, Forcing the proximal end of the elastic piece to bend toward the second accommodating cavity 223 , so that the second adjusting member 22 can move to the distal end in the axial direction relative to the first adjusting member 21 until the elastic hook is accommodated in the first accommodating cavity 212 ; When the second adjusting member 22 continues to move distally in the axial direction relative to the first adjusting member 21 until the buckle corresponds to the position of the slot of the first adjusting member 21, the inner wall of the first receiving cavity 212 is no longer Pushing the buckle, the elastic piece recovers and deforms so that the buckle is inserted into the corresponding slot; it can be understood that under the reaction of the pushed suture 2, the second adjusting member 22 exists Relative to the tendency of the first adjusting member 21 to move proximally in the axial direction, the stop surface of the buckle abuts against the groove surface of the locking groove, which can restrict the second adjusting member 22 relative to the first adjusting member 21 along the axis Move proximally to prevent suture 2 from loosening.

As shown in FIG. 10 , in this embodiment, a radial groove 225 is formed on the distal end surface of the second adjusting member 22 corresponding to the first slot 214 of the first adjusting member 21 , and both ends of the radial groove 225 respectively penetrate through the first groove 214 of the first adjusting member 21 . On the outer walls of the second adjustment piece 22 , the radial grooves 225 are used to accommodate and pass the suture 2 located at the distal end of the second adjustment piece 22 . Preferably, the radial grooves 225 are rounded to ensure smoothness of the radial grooves 225 and avoid damage to the suture 2 .

Further, please refer to FIG. 3 , FIG. 6 and FIG. 10 together. In this embodiment, the proximal end of the second adjusting member 22 is provided with a first connecting portion 226, which is used for the distal end of the conveying member 43 in the conveying assembly 40. Detachable connection at the end. The conveying member 43 is used for conveying the second adjusting member 22 and for restricting the axial position of the second adjusting member 22 to be fixed when the driving rod 45 drives the first adjusting member 21 to move in the axial direction, so that the first adjusting member 21 and the A relative movement in the axial direction can occur between the two adjusting members 22, so as to realize the hooking and pushing of the suture 2, thereby realizing the quantitative adjustment of the length of the suture 2; The conveying member 43 can be disassembled and separated from the second regulating member 22 , so that the second regulating member 22 can be indwelled in the human body together with the first regulating member 21 .

Specifically, as shown in FIG. 6 , in this embodiment, the first connecting portion 226 is a pair of first barbs disposed at the proximal end of the second adjusting member 22 , the pair of first barbs and the second adjusting The outer wall surface 222 of one side of the piece 22 is integrally connected, and each of the first barbs has a first joint surface. It should be noted that when the second adjusting member 22 is accommodated in the first accommodating cavity 212 , the first connecting portion 226 is located outside the distal end of the first adjusting member 21 .

Referring to FIG. 3 , the conveying assembly 40 includes the aforementioned conveying member 43 and the driving member 45 . The conveying member 43 and the driving member 45 are flexible rods, flexible tubes or flexible steel cables with a certain axial length, certain support and bendability, and are both made of metal materials or polymer materials with good biocompatibility. Metal materials such as stainless steel are preferable. In this embodiment, the conveying member 43 is a stainless steel cable, and the driving rod 45 is a rod body made of stainless steel. The driving rod 45 is screwed to the first adjusting member 21 .

The number of the driving rods 45 is equal to the number of the threaded holes. In this embodiment, the first adjusting member 21 is provided with a pair of the threaded holes, and there are two driving rods 45 correspondingly. The movement of the adjusting member 21 in the axial direction is stable, and the rotation of the first adjusting member 21 can be prevented during the moving process.

Please refer to FIGS. 3 , 12 to 14 together. In this embodiment, the delivery assembly 40 further includes a release member 47 detachably connected to the distal end of the delivery member 43 , and the release member 47 is used to be detachable from the second adjustment member 22 connect. That is to say, in this embodiment, the distal end of the conveying member 43 is detachably connected to the second adjusting member 22 through the disengaging member 47 .

Specifically, as shown in FIG. 12 to FIG. 14 , in this embodiment, the release member 47 has a substantially block-like structure, which includes a waist-shaped stop portion 472 at the distal end, and a stop portion 472 connected to the distal end of the stop portion 472 . The embedded portion 474 and a pair of second barbs disposed at the distal end of the stop portion 472 , the pair of second barbs are respectively located on opposite sides of the embedded portion 474 , and the pair of second barbs are used for connecting with the embedded portion 474 . The pair of first barbs at the proximal end of the second adjustment member 22 are detachably connected. Wherein, each of the second barbs has a second binding surface adapted to the first binding surface of the first barb, and both the first binding surface and the second binding surface have a certain curvature S-shaped surface, and the curvature of the two are adapted. It can be understood that the axial movement of the conveying member 43 can drive the release member 47 to move axially relative to the second adjusting member 22 , so that the second connecting portion 476 and the first connecting portion 226 are detachably connected or separated. When the first barb of the first connecting portion 226 and the second barb of the second connecting portion 476 are in a connected state, the conveying member 43 can be used to convey the second adjusting member 22 and the shaft for restricting the second adjusting member 22 to the location. It should be noted that, in this embodiment, when the first barb and the second barb are in a connected state, the stopper portion 472 of the release member 47 stops at the proximal end of the first barb, and releases the The insert portion 474 of the piece 47 is inserted between the pair of first barbs.

The release member 47 is also made of a metal material or polymer material with good biocompatibility, preferably a metal material such as stainless steel.

Further, please refer to FIG. 2 , FIG. 3 , and FIGS. 15 to 17 together. In this embodiment, the delivery assembly 40 further includes an outer sheath tube 49 and a first limiting member 41 connected to the distal end of the outer sheath tube 49 , The outer sheath tube 49 is a hollow tube body for the conveying member 43 and the driving member 45 to move through. The first limiting member 41 is used to limit the first connecting portion 226 of the second adjusting member 22 and the second connecting portion of the disengaging member 47 . 476's breakaway. Wherein, the outer sheath tube 49 and the first limiting member 41 can be made of metal materials or polymer materials with good biocompatibility, preferably metal materials such as stainless steel.

Specifically, as shown in FIGS. 2 and 3 , in this embodiment, the first limiting member 41 includes a main body portion 414 with a columnar structure and a socket portion 415 connected to the proximal end of the main body portion 414 , and the socket portion 415 is hollow The distal end of the outer sheath tube 49 is fixedly connected to the socket portion 415 of the first limiting member 41 by any means such as clamping, bonding or welding. Wherein, the main body portion 414 and the socket portion 415 may be integrally formed, or may be formed separately and fixedly connected by any method such as laser welding, gluing, or clamping, preferably laser welding.

Please refer to FIG. 3 , FIG. 16 and FIG. 17 together, the main body portion 414 defines a limiting groove 410 from the distal surface, and the bottom surface of the limiting groove 410 defines a first through hole 411 extending in the axial direction for the conveying member 43 to pass through. Through the distal end, the main body portion 414 further defines at least one second through hole 412 extending in the axial direction on one side of the limiting groove 410 for the distal end of the at least one driving member 45 to pass through. In this embodiment, the number of the second through holes 412 and the number of the driving members 45 are both set to two.

There is a radial distance between the axis of the limiting slot 410 and the axis of the first limiting member 41 , that is, the limiting slot 410 is eccentrically disposed at the distal end of the main body portion 414 of the first limiting member 41 . It should be noted that, in this embodiment, the shape of the limiting groove 410 is adapted to the shape of the release member 47. When the outer sheath tube 49 moves in the axial direction, the first limiting member 41 moves in the axial direction, so that the second limiting member 41 moves in the axial direction. When the connecting portion of the first connecting portion 226 of the adjusting member 22 and the second connecting portion 476 of the disengaging member 47 is accommodated or moved out of the limiting groove 410, the connection or separation of the first connecting portion 226 and the second connecting portion 476 can be realized. That is, the connection or separation of the second adjusting member 22 and the disengaging member 47 is realized.

As shown in FIG. 16 , in this embodiment, the edge of the main body portion 414 is further protruded with a truncate 416 on the edge of the distal surface. The circumferential direction of the first limiting member 41 extends for one circle. As shown in FIG. 3 , in this embodiment, under the driving of the driving rod 45 , the first regulating member 21 moves proximally relative to the second regulating member 22 in the axial direction to abut against the main body of the first limiting member 41 . 414 Distal face. Among them, it can be understood that the convex trough 416 has a certain height along the axial direction of the first limiting member 41, and after the suture 2 is passed through the first slot 14 of the first adjusting member 21, the first adjusting member During the axial movement of 21 relative to the second adjusting member 22 toward the proximal end, the proximal end of the first adjusting member 21 will gradually penetrate into the space surrounded by the convex truncate 416 until the proximal end surface of the first adjusting member 21 abuts against the proximal end of the first adjusting member 21. The distal end surface of the main body portion 414, that is to say, the protruding trough 416 can gradually enclose the proximal end portion of the first adjusting member 21 extending a certain distance from the proximal end to the distal end, thereby, can enclose the first adjusting member 21 against contact. The gap between the proximal end surface of the first adjusting member 21 and the distal end surface of the main body portion 414 before pressing against the main body portion 414 prevents the gap from hanging on the human tissue and avoids damage to the human tissue. Preferably, in this embodiment, a second slot 417 is formed on the protruding turret 416 corresponding to the first slot 214 of the first adjusting member 21 , so that when the first adjusting member 21 abuts against the distal end surface of the main body portion 414 , the first slot 214 and the second slot 417 together form a through hole for accommodating the suture 2 hooked by the first adjusting member 21 .

Further, please refer to FIG. 3 , in order to prevent the suture 2 from being passed through the first slot 214 (that is, when the suture 2 is not hooked by the first adjusting member 21 ), the second adjusting member 22 is relatively early relative to the first adjusting member 21 . The adjusting member 21 is moved to the distal end in the axial direction to be accommodated in the first accommodating cavity 212, and the elastic hooks are locked into the corresponding slots. 43 The second limiting member 42 at the distal end, the conveying member 43 is also used to drive the second limiting member 42 to move to the distal end in the axial direction until the second limiting member 42 is accommodated in the second accommodating cavity 223 and is connected with the second limiting member 42. The positions of the elastic hooks correspond to the positions of the elastic hooks, so as to prevent the elastic hooks from bending toward the second accommodating cavity 223 , so that the elastic hooks are moved to the distal end in the axial direction relative to the first adjustment member 21 when the second adjusting member 22 It can be stopped at the proximal port of the first accommodating cavity 212 , thereby preventing the second adjusting member 22 from being accommodated in the first accommodating cavity 212 prematurely.

Specifically, please refer to FIG. 3 , FIG. 13 , and FIGS. 18 to 20 together. In this embodiment, the distal end of the conveying member 43 is fixedly provided with a connecting shaft 46 , and the releasing member 47 corresponds to the first passage of the first limiting member 41 . The hole 411 is also provided with a third through hole 478 (as shown in FIG. 13 ) that penetrates through the axial direction and is provided with an internal thread. The end protrudes from the distal end of the releasing member 47 , and the second limiting member 42 is fixedly arranged at the distal end of the connecting shaft 46 .

As shown in FIG. 18 , in this embodiment, the connecting shaft 46 includes a proximal shaft section 462 , an intermediate shaft section 464 and a distal shaft section 466 that are connected in sequence from the proximal end to the distal end, and the diameters of the three are successively reduced, wherein , the proximal shaft segment 462 is provided with a through hole from the proximal end face along the axial direction for connecting the distal end of the conveying member 43 , and the intermediate shaft segment 464 is provided with an internal thread adapted to the third through hole 478 of the disengaging member 47 External thread. As shown in FIGS. 19 and 20 , in this embodiment, the second limiting member 42 is a block-shaped washer with a connecting hole, and the second limiting member 42 is sleeved on the distal shaft section 466 of the connecting shaft 46 . , and the proximal end surface of the second limiting member 42 abuts on the shoulder between the intermediate shaft section 464 and the distal shaft section 466 of the connecting shaft 46 , and the outer contour of the second limiting member 42 is in contact with the second accommodating cavity. The inner contour of 223 is adapted to facilitate insertion into the proximal end of the second accommodating cavity 223 to stop the elastic hook. In this embodiment, the distal end of the second limiting member 42 is further provided with a connecting piece 48 , the connecting piece 48 is provided with a through hole in the axial direction, and the connecting piece 48 is sleeved on the distal shaft section 466 of the connecting shaft 46 and located at the At the distal end of the second limiting member 42 , the connecting piece 48 is fixedly connected with the connecting shaft 46 , so that the second limiting member 42 is fixed on the connecting shaft 46 . In other embodiments, the second limiting member 42 may be directly and fixedly connected with the connecting shaft 46 , and the connecting shaft 46 may be integrated with the conveying member 43 . Wherein, the second limiting member 42 , the connecting shaft 46 and the connecting piece 48 may be made of metal materials or polymer materials with good biocompatibility, preferably metal materials such as stainless steel. The connection between the connecting shaft 46 and the conveying member 43 and the connection between the connecting piece 48 and the connecting shaft 46 can be connected by any method such as laser welding, gluing, clamping, interference, etc., preferably laser welding.

Please refer to FIG. 3 and FIG. 4 together. In this embodiment, the second connecting portion 476 of the release member 47 is fitted with the first connecting portion 226 of the second adjusting member 22 and placed on the limit of the first limiting member 41 . In the groove 410, when the conveying member 43 is rotated, the rotation of the conveying member 43 drives the connecting shaft 46 to rotate. Under the restriction of the limiting groove 410, the disengaging member 47 will not rotate, so that the connecting shaft 46 and the disengaging member 47 are threaded to move. The connecting shaft 46 moves axially relative to the release member 47 and drives the second limiting member 42 to move axially. Therefore, when the second limiting member 42 moves to the distal end to be accommodated in the proximal end of the second accommodating cavity 223 of the second adjusting member 22 and corresponds to the position of the elastic hook, the second limiting member The outer side of 42 abuts on the side of the elastic hook facing the second accommodating cavity 223 , which restricts the bending deformation of the elastic hook toward the second accommodating cavity 223 . When the first adjusting member 21 is driven by the driving member 45 When moving downward and proximally, the proximal port of the first receiving cavity 212 of the first adjusting member 21 presses the inclined plane of the elastic hook. The elastic hook cannot be elastically deformed, the elastic hook cannot be inserted into the slot of the first adjusting member 21, and the second adjusting member 22 cannot be completely accommodated in the first accommodating cavity 212; when the conveying member 43 is controlled to drive the second limit After the moving member 42 moves proximally to the inner cavity of the second receiving cavity 223 of the second adjusting member 22, the elastic hook of the second adjusting member 22 restores the ability of elastic deformation. 21 continues to move toward the proximal end, and the proximal portion of the first receiving cavity 2122 of the first adjusting member 21 squeezes the inclined plane of the elastic hook, the elastic hook is bent toward the second receiving cavity 223, and the first adjusting member 21 can move towards the proximal end relative to the second adjusting member 22, so that the second adjusting member 22 is completely accommodated in the first accommodating cavity 212 until the elastic hook is snapped into the corresponding slot, thereby restricting the first adjusting member The axial movement between 21 and the second adjusting member 22 locks the first adjusting member 21 and the second adjusting member 22 together.

Referring to FIG. 1 , in this embodiment, in order to facilitate the operator to manipulate the delivery component 40 in vitro, the quantitatively adjustable suture length adjustment system 1 further includes a handle component 60 connected to the proximal end of the delivery component 40 . Specifically, as shown in FIG. 1 , the handle assembly 60 includes a first knob 61 , a second knob 62 , a third knob 63 and a housing 64 , the housing 64 is fixedly connected to the proximal end of the outer sheath 49 , and the first knob 61 At the proximal end of the housing 64 , the second knob 62 is arranged in the middle of the housing 64 , and the third housing 63 is arranged at the distal end of the housing 64 .

As shown in FIG. 2 , in this embodiment, the proximal ends of the conveying member 43 and the driving member 45 respectively protrude from the proximal end of the outer sheath tube 49 and extend into the housing 64 , and then connect with the corresponding knobs. Specifically, in this embodiment, the first knob 61 is connected to the proximal end of the driving member 45 to control the axial movement of the driving member 45, thereby driving the first adjusting member 21 to open and close relative to the second adjusting member 22; The second knob 62 is connected with the proximal end of the driving member 45 for controlling the rotation of the driving member 45, thereby realizing the separation of the driving member 45 from the first adjusting member 21; the third knob 63 is connected with the proximal end of the conveying member 43, used for The movement of the conveying member 43 in the axial direction is controlled, and the rotation of the conveying member 43 is controlled to drive the movement of the second limiting member 42 in the axial direction. Among them, it should be noted that the connection between the first knob 61 and the second knob 62 and the driving member 45, and the connection between the third knob 63 and the conveying member 43 are all realized by means of the prior art, which will not be repeated here. .

Please refer to FIGS. 3 , 4 and 21 to 23 together. In the following, taking the suture 2 as an artificial chordae tendinea implanted in the human body as an example, the use process of the suture length adjustment system 1 provided in this embodiment is described with reference to the accompanying drawings. illustrate.

Step 1: As shown in Figure 21, the adjustment component 20 at the distal end of the suture length adjustment system 1 is delivered to the artificial chordae tendineae through a guide device such as an adjustable sheath or a pre-shaped catheter (not shown in the figure). near suture 2.

Step 2: As shown in FIG. 22 , the first knob 61 of the handle assembly 60 controls the driving member 45 to move distally in the axial direction, and the driving member 45 drives the first adjusting member 21 to move to the distal end, so that the first adjusting member 21 is opened relative to the second adjusting member 22 and hooks the suture 2 . At this time, the suture 2 is passed through the first slot 214 of the first adjusting member 2 .

Step 3: Use the medical imaging device to observe whether the first adjusting member 21 has successfully hooked the suture 2. When it is observed that the suture 2 has been successfully hooked, the third knob 63 of the handle assembly 60 is used to control the rotation of the conveying member 43 to convey the suture 2. The second limiting member 42 is rotated relative to the releasing member 47 to drive the second limiting member 42 to move proximally to the proximal end of the second receiving cavity 223 of the second adjusting member 22, so that the second limiting member 42 does not limit the elastic hook deformability.

Step 4: As shown in Figures 4 and 23, the first knob 61 is then used to control the driving member 45 to move proximally in the axial direction to drive the first regulating member 21 to move proximally, so that the second regulating member 22 is accommodated in the In the first accommodating cavity 212, the distal end of the second adjusting member 22 pushes against the suture 2, so that the suture 2 is bent into an inverted U shape, and the adjustment of the suture 2 is completed, that is, the effective length of the artificial chordae tendineae is reduced, so that the original The loose artificial chordae tendineae are adjusted and re-tensioned. At this time, the elastic hooks of the second adjusting member 22 are locked into the locking grooves of the first adjusting member 21, thereby restricting the axial movement between the first adjusting member 21 and the second adjusting member 22, preventing the Adjusted suture 2 is loose.

Step 5: Control the rotation of the driving member 45 through the second knob 62 of the handle assembly 60 to release the connection between the driving member 45 and the first regulating member 21, so that the first regulating member 21 and the driving member 45 are separated; 63 Control the conveying member 43 to move to the distal end in the axial direction, and the conveying member 43 drives the disengaging member 47 to move to the distal end to move out of the limiting groove 410 of the first limiting member 41 to release the first connection to the second regulating member 22 The connection between the part 216 and the second connecting part 476 of the disengaging member 47 makes the second adjusting member 22 separate from the disengaging member 47 , and at this time, the adjusting assembly 20 and the conveying assembly 60 are completely disengaged.

Step 6: The delivery assembly 60 and the guide device are withdrawn from the human body, and the adjustment assembly 20 is placed in the patient's body as an implant and connected to the suture 2 to complete the adjustment of the suture 2 .

During the adjustment process of the suture 2, the effective length of the suture 2 can be adjusted only by controlling the corresponding rotation, which is convenient to operate and saves time; Adjustment, there is almost no damage to the suture 2, and the safety of the instrument is high; in addition, by controlling the movement amount of the second adjusting member 22 relative to the first adjusting member 21, and then controlling the moving distance of the second adjusting member 22 to push the suture 2, The quantitative adjustment of the length of the suture 2 can be realized.

The above are the implementations of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present invention, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of the present invention.

Claims (17)

1. A quantitatively adjustable suture length adjustment system comprising an adjustment assembly, the adjustment assembly comprising:

the first adjusting piece is provided with a first positioning part; and

the second adjusting piece is axially movably connected with the first adjusting piece, and a second positioning part is arranged corresponding to the first positioning part;

the suture passes through the first adjusting piece and the second adjusting piece, the second adjusting piece moves relative to the first adjusting piece along the axial direction to the far end to push the suture, the length of the suture between the first adjusting piece and the second adjusting piece is increased until the first positioning part is matched with the second positioning part, and therefore the relative movement between the second adjusting piece and the first adjusting piece is limited.

2. The quantitatively adjustable suture length adjustment system of claim 1, wherein the first adjustment member is hollow and is provided with a first receiving cavity in an axial direction, the first receiving cavity extending at least through a proximal end face of the first adjustment member; the second adjusting piece is inserted into the first accommodating cavity from the proximal end of the first adjusting piece in an axial sliding manner.

3. The suture length adjustment system capable of quantitative adjustment according to claim 2, wherein the inner wall of the first housing cavity is provided with a pair of slide guiding surfaces, and the first positioning portion comprises at least one slot opened on at least one slide guiding surface, and the slot extends along the radial direction of the first adjusting member;

the second adjusting part comprises a pair of outer wall surfaces in one-to-one correspondence with the pair of guide sliding surfaces, the second positioning part comprises an elastic clamping hook arranged on at least one of the outer wall surfaces, and the elastic clamping hook is clamped into the corresponding clamping groove to stop the relative movement between the second adjusting part and the first adjusting part.

4. The quantitatively adjustable suture length adjustment system of claim 3, wherein the direction of separation of the pair of slide guide surfaces is a first direction, and a gap is provided between the inner wall of the first receiving cavity and the second adjustment member in a second direction, the second direction being substantially perpendicular to the first direction.

5. The suture length adjustment system capable of quantitative adjustment according to claim 3, wherein the second adjustment member is hollow and is provided with a second receiving cavity along an axial direction, the second receiving cavity at least penetrates through a proximal end face of the second adjustment member, at least one outer wall face of the second adjustment member is provided with an opening communicated with the second receiving cavity at a proximal end region, and the elastic hook is arranged at the opening.

6. The quantitatively adjustable suture length adjustment system of any one of claims 1 to 5, further comprising a delivery assembly, a distal end of which is detachably connected to the adjustment assembly, the delivery assembly being adapted to deliver the adjustment assembly and to control the relative movement between the first and second adjustment members.

7. The quantitatively adjustable suture length adjustment system of claim 6, wherein the delivery assembly includes a delivery member and at least one drive member; the far end of the conveying piece is detachably connected with the second adjusting piece and is used for conveying the second adjusting piece and limiting the axial position of the second adjusting piece; the far end of the driving piece is detachably connected with the first adjusting piece and is used for conveying the first adjusting piece and driving the first adjusting piece and the second adjusting piece to move relatively.

8. The quantitatively adjustable suture length adjustment system of claim 7, wherein the delivery assembly further comprises a release member removably attached to the distal end of the delivery member, the proximal end of the second adjustment member being provided with a first attachment portion and the distal end of the release member being provided with a second attachment portion, the first attachment portion being removably attached to the second attachment portion.

9. The quantitatively adjustable suture length adjusting system according to claim 8, wherein the delivery assembly further comprises an outer sheath and a first retaining member attached to the distal end of the outer sheath, the first retaining member defining a retaining groove from a distal end surface, a bottom surface of the retaining groove defining a first through-hole extending in the axial direction for the distal end of the delivery member to pass through, the first retaining member further defining at least one second through-hole extending in the axial direction on a side of the retaining groove for the distal end of at least one of the driving members to pass through;

the conveying piece and at least one driving piece are movably arranged in the outer sheath tube in a penetrating way;

the sheath tube drives the first limiting part to move axially, so that the connecting part of the first connecting part and the second connecting part is accommodated in or moved out of the limiting groove, and the second adjusting part is connected with or separated from the releasing part.

10. The quantitatively adjustable suture length adjustment system of claim 9, wherein a radial gap is provided between the axis of the stop slot and the axis of the first stop member, the stop slot being eccentrically disposed at the distal end of the first stop member.

11. The quantitatively adjustable suture length adjustment system according to claim 10, wherein the first stop member is provided with rafters at the edges of the distal end face, the rafters extending circumferentially of the first stop member; the first adjusting piece moves to the near end along the axial direction relative to the second adjusting piece to abut against the far end face of the first limiting piece, and the protrusion surrounds the near end portion of the first adjusting piece.

12. The quantitatively adjustable suture length adjusting system according to claim 11, wherein the outer wall of the first adjusting member is provided with a first slot communicating with the first receiving cavity from a proximal end face, and the protrusion is provided with a second slot corresponding to the first slot;

when the first adjusting piece abuts against the far end face of the first limiting piece, the first open groove and the second open groove form a through hole together.

13. The quantitatively adjustable suture length adjusting system according to claim 9, wherein the releasing member is provided with a third through hole which is axially through and provided with an internal thread, corresponding to the first through hole, and the delivery member is screw-coupled to the releasing member and has a distal end protruding from a distal end of the releasing member;

the conveying assembly further comprises a second limiting part connected to the far end of the conveying part, and the conveying part is further used for driving the second limiting part to move towards the far end along the axial direction until the second limiting part is contained in the second containing cavity and corresponds to the position of the elastic clamping hook so as to stop the elastic clamping hook from bending towards the second containing cavity.

14. The quantitatively adjustable suture length adjustment system of claim 7, wherein the distal end portion of the drive member is externally threaded; the first adjusting piece is provided with threaded holes extending along the axial direction from the proximal end face to one side of the first accommodating cavity, the number of the threaded holes corresponds to that of the driving piece, and the internal threads of the threaded holes are matched with the external threads of the driving piece.

15. The quantitatively adjustable suture length adjustment system of claim 3, wherein the outer wall of the first adjustment member is open from a proximal end face with a first slot communicating with the first receiving cavity, the first slot extending substantially in an axial direction of the first adjustment member;

the positions of the first open groove and the clamping groove in the circumferential direction of the first adjusting piece are staggered.

16. The quantitatively adjustable suture length adjustment system of claim 15, wherein the distal end face of the second adjustment member opens into a radial slot corresponding to the first slot, both ends of the radial slot penetrating through the outer wall of the second adjustment member, respectively.

17. The suture length adjustment system capable of quantitative adjustment according to claim 3, wherein the outer wall of the first adjustment member is provided with at least one hollow hole, and the extending direction of the hollow hole is the same as or different from the extending direction of the clamping groove.

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