CN211934429U

CN211934429U - Suture length adjustment system

Info

Publication number: CN211934429U
Application number: CN201922486663.XU
Authority: CN
Inventors: 郭荣辉; 谢琦宗
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2020-11-17
Anticipated expiration: 2029-12-30

Abstract

The utility model provides a suture length adjustment system, including implant and the device of sunkening cord, the device of sunkening cord includes: the hollow bending adjusting device is parallelly and movably arranged on the wire feeder and the wire grabbing device in the bending adjusting device in a penetrating manner; the far end of the wire feeder extends out of the far end of the bending adjusting device and surrounds the suture, and the wire grabbing device extends out of the far end of the bending adjusting device and overlaps the far end of the wire feeder to surround the suture; the thread catcher is received in the inner cavity of the bending device and drives the distal end of the thread feeder to fold, the folded thread feeder pulls the suture, and the implant is conveyed along the folded thread feeder and receives the part of the suture pulled by the thread feeder. The utility model provides a pair of suture length adjustment system realizes regulating and controlling the length of implanting the internal suture of patient, weakens or eliminates because the suture relaxs the long-term problem that leads to, and suture length adjustment system's accommodate mode is little to the damage of suture simultaneously, improves the suture life-span, reduces the operation risk.

Description

Suture length adjustment system

Technical Field

The utility model belongs to the field of medical equipment, concretely relates to suture length adjustment system.

Background

Mitral insufficiency is one of the most common heart valve diseases at present, and the main causes are rheumatic heart disease, mitral valve myxoid degeneration, ischemic heart disease, cardiomyopathy and the like, which cause the lesions of valve rings, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, and the valve leaflets of the mitral valve cannot be completely closed.

Surgery is an effective method for treating mitral insufficiency, but the surgery causes great trauma to human bodies, and has more complications and higher mortality rate for elderly patients and patients with more complications.

At present, minimally invasive interventional surgery is the more preferable choice for most heart diseases, and the main interventional therapy modes include artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve rim-to-rim repair and the like. Wherein implantation of the artificial chordae tendineae X over the leaflets is effective in treating mitral insufficiency caused by chordae rupture, leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure, as shown in fig. 1. However, as shown in fig. 2, after the artificial chordae X is implanted for a period of time, the artificial chordae X is in a loose state due to the change of the heart volume and other factors, and the length of the artificial chordae X is often required to be adjusted again to avoid the abnormal function of the heart valve. In addition, in mitral or tricuspid annuloplasty, the artificial chordae are often used to tighten the size of the annulus and then to fix the artificial chordae. However, the artificial chordae may also be in a relaxed state for a period of time after the annuloplasty, requiring adjustment of the artificial chordae length.

The artificial chordae tendineae length adjusting device of the prior art has the following defects: the implant needs to clamp the artificial chordae tendineae to realize regulation and control, in order to improve the clamping force of the implant, the parts of the implant in contact with the artificial chordae tendineae have higher connection strength, and the implant is usually made of rigid materials, so that under a long-term implantation state, the damage of the implant to the artificial chordae tendineae is larger, and the safety and the reliability are poorer.

SUMMERY OF THE UTILITY MODEL

The utility model provides a suture length adjustment system regulates and control the length of implanting the internal suture of patient, avoids because the suture relaxs the long-term problem that leads to, and suture length adjustment system's regulative mode is little to the damage of suture simultaneously, improves the suture life-span, reduces the operation risk. Therefore, the utility model discloses a suture length adjustment system is particularly useful for adjusting the artificial chordae tendineae length of implanting heart valve, weakens or eliminates because the valve regurgitation scheduling problem that the artificial chordae tendineae relaxes and leads to avoid damaging the artificial chordae tendineae, improve artificial chordae tendineae life, safe and reliable.

The utility model provides a pair of suture length adjustment system, including implant and thread burying device, the thread burying device includes:

the hollow bending adjusting device is parallelly and movably arranged on the wire feeder and the wire grabbing device in the bending adjusting device in a penetrating manner;

the distal end of the wire feeder extends out of the distal end of the bending adjusting device and surrounds the suture, and the wire grabbing device extends out of the distal end of the bending adjusting device and overlaps the distal end of the wire feeder to surround the suture; the thread grabbing device is accommodated in the inner cavity of the bending adjusting device and drives the far end of the thread feeding device to fold, the folded thread feeding device pulls the suture, and the implant is conveyed along the folded thread feeding device and accommodates the part of the suture pulled by the thread feeding device.

The embodiment of the utility model provides a suture length adjustment system, through with the wire feeder and grab the line ware and wear to locate adjustable return bend parallelly, the distal end overlap joint of wire feeder and the distal end overlap joint of grabbing the line ware and surround the suture, the distal end of wire feeder is turned back and is worn out and transfer the device of bending under the drive of grabbing the line ware, and the implant can be followed folding wire feeder and removed near the suture and accept the suture quilt the tractive part of wire feeder makes the length of suture shorten to suitable length.

The utility model provides a suture length adjustment system is particularly useful for adjusting the artificial chordae tendineae length of implanting heart valve, for example shorten artificial chordae tendineae length in order to increase the tension between leaflet and the papillary muscle, perhaps tighten up annulus size etc. weaken or eliminate the mitral valve regurgitation scheduling problem once more that leads to because the suture is lax, suture length adjustment system passes through flexible line feeder tractive artificial chordae tendineae simultaneously, it is little to the damage of artificial chordae tendineae, improve artificial chordae tendineae life-span, safety and reliability, fatigue performance is better.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.

FIG. 1 is a schematic view of a prior art mitral valve implanted artificial chordae tendineae;

FIG. 2 is a schematic representation of a prior art prosthetic chordae tendineae slack for implantation in a mitral valve;

fig. 3 is a schematic structural diagram of a suture length adjustment system according to an embodiment of the present invention;

FIG. 4 is a schematic structural view of the bend adjusting device in FIG. 3;

figure 5a is a front view of the thread burial device of figure 3;

figure 5b is a partial cross-sectional view of the thread burial device of figure 3;

figure 5c is a side view of the thread burial device of figure 3;

FIG. 6 is a schematic view of the catgut embedding device of FIG. 3 shown in an arcuate shape around the artificial chordae tendineae;

FIG. 7 is a schematic view of the wire feeder of FIG. 3 pulling the artificial chordae tendineae;

FIG. 8a is a schematic view of the implant of FIG. 3 being delivered along a wire feeder and receiving an artificial chordae tendineae;

FIG. 8b is another angular schematic of FIG. 8 a;

FIG. 8c is a cross-sectional view at another angle of FIG. 8 a;

FIG. 9 is a schematic structural view of the preformed tube of FIG. 3;

fig. 10 is a schematic structural view of the wire feeder in fig. 3;

fig. 11 is a schematic structural view of the wire grabber of fig. 3;

FIG. 12 is a schematic view of the catgut embedding device of FIG. 3 shown in an arcuate shape around the artificial chordae tendineae;

FIG. 13 is a schematic structural view of the implant device of FIG. 3;

figure 14 is a schematic view of the implant device of figure 13 interacting with an artificial chordae tendineae;

FIG. 15a is a schematic structural view of the implant of FIG. 13;

FIG. 15b is another angular configuration of the implant of FIG. 13;

FIG. 15c is a cross-sectional view of the implant of FIG. 13;

figure 16a is a cross-sectional view of the implant receiving portion of figure 14 with micro-manipulation of the artificial chordae tendineae;

figure 16b is a cross-sectional view of the implant receiving portion of artificial chordae tendineae of figure 14 to achieve mesoscopic control;

figure 16c is a cross-sectional view of the implant receiving portion of figure 14 with multiple modulation of the artificial chordae tendineae;

FIG. 17 is a schematic structural view of another embodiment of an implant;

FIG. 18 is a schematic view of the implant of FIG. 17 being delivered along a wire feeder and receiving a portion of an artificial chordae tendineae;

FIG. 19 is a schematic view of the suture length adjustment system of FIG. 3 entering adjacent to an artificial chordae tendineae;

figure 20 is a schematic view of the implant of figure 3 secured to an artificial chordae tendineae, fully adjusted.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. The embodiments of the present invention can be combined with each other appropriately.

In the field of interventional medical device technology, a position close to an operator is generally defined as a proximal end, and a position far away from the operator is defined as a distal end, which will not be described in detail later.

Referring to fig. 3, fig. 3 is a suture length adjusting system for adjusting the length of a suture according to an embodiment of the present invention. The suture is a medical grade suture, such as a PET suture or a PTFE suture. In the present embodiment, the PTFE suture is used as the artificial chordae tendineae, and the PTFE suture is implanted into the leaflets of the mitral valve.

Referring to fig. 3, a suture length adjustment system 1000 includes a thread burial device 2000 and an implant device 3000.

Referring to fig. 3, the thread burying device 2000 includes a bending device 100, a thread feeder 300 and a thread catcher 400.

Referring to fig. 4, the bending apparatus 100 is a hollow structure. The bending adjusting device 100 comprises an adjustable bent pipe 11 and a bending adjusting handle 12. The adjustable elbow 11 is a hollow pipe structure. An adjustable elbow handle 12 is attached to the proximal end of the adjustable elbow 11. The bending control member on the bending control handle 12 can control the bending of the adjustable bent pipe 11 and adjust the bending degree of the adjustable bent pipe 11.

Referring to fig. 5a, 5b and 5c, the wire feeder 300 and the wire gripper 400 are axially and movably inserted into the bending apparatus 100 in parallel. Specifically, the wire feeder 300 and the wire gripper 400 are axially and movably inserted into the inner cavity of the bending adjusting device 100 in parallel. It should be noted that, in the following description, if not specifically stated, the term "along the axial direction" refers to the axial direction of the bending adjustment device 100.

Referring to fig. 6, the distal end of the wire feeder 300 extends out of the distal end of the bending device 100 and surrounds the artificial chordae tendineae X. The distal end of the wire gripper 400 protrudes from the distal end of the bending device 100 and overlaps the distal end of the wire feeder 300 to enclose the artificial chordae tendineae X. Specifically, when the distal end of the bending device 100 is located near the artificial chordae tendineae X, the distal end of the wire feeder 300 gradually protrudes from the distal end of the bending device 100 and extends along the circumferential direction of the artificial chordae tendineae X, so that the wire feeder 300 surrounds the circumferential side of the artificial chordae tendineae X. The sequence of the distal end of the wire feeder 300 and the distal end of the wire grabber 400 extending out of the distal end of the bending device 100 is not limited in this embodiment. In one embodiment, the distal end of the wire feeder 300 first extends beyond the distal end of the bend adjusting device 100, and then the distal end of the wire gripper 400 gradually approaches the distal end of the wire feeder 300 and overlaps the distal end of the wire feeder 300. In another embodiment, the distal end of the wire grabber 400 first extends out of the distal end of the bend adjusting device 100, and then the distal end of the wire feeder 300 gradually approaches the distal end of the wire grabber 400 and overlaps the distal end of the wire grabber 400. In other embodiments, the wire feeder 300 and the wire gripper 400 may extend out of the distal end of the bend adjusting device 100 at the same time and overlap.

After the distal end of the wire grabber 400 is overlapped with the distal end of the wire feeder 300, the wire grabber 400 and the wire feeder 300 enclose the artificial chordae tendineae X.

In this embodiment, the wire feeder 300 is made of a flexible material, and the distal end of the wire feeder 300 is hung on the wire gripper 400, so that the wire gripper 400 can pull the wire feeder 300 to move.

Referring to fig. 7, the thread catcher 400 is retracted into the inner cavity of the bend adjusting device and drives the distal end of the thread feeder 300 to fold, and the folded thread feeder 300 pulls the artificial chordae tendineae X. That is, when the distal end of the wire feeder 300 is received into the inner cavity of the bending apparatus 100 along with the wire gripper 400, the wire feeder 300 folds and pulls the artificial chordae X due to the blockage of the artificial chordae X. Specifically, the distal end of the wire feeder 300 is driven by the wire grabber 400 to move from the distal end to the proximal end, and due to the blocking of the artificial chordae tendineae X, the wire feeder 300 is led to pass through the inner cavity of the bending adjustment device 100 in a U-shaped or folded manner until the distal end of the wire feeder 300 passes through the proximal end of the bending adjustment device 100. Optionally, the proximal end of the wire feeder 300 is disposed outside the proximal end of the bend adjusting device 100. At this time, the opposite ends of the wire feeder 300 are both disposed outside the proximal end of the bending device 100, and are both free ends.

Referring to fig. 3, an implant device 3000 includes a push rod 500 and an implant 600. Referring to fig. 8a to 8c, the implant 600 is moved along the folded wire feeder 300 to the vicinity of the artificial chordae X by the push rod 500 and receives a portion of the artificial chordae X pulled by the wire feeder 300. Specifically, the folded wire feeder 300 forms a moving slide rail of the implant 600, the implant 600 moves from the proximal end of the bending device 100 to the distal end of the bending device 100 along the folded wire feeder 300 under the action of the push rod 500, and moves out from the distal end of the bending device 100, and the implant 600 accommodates a part of the artificial chordae tendineae X pulled by the wire feeder 300 under the further pushing of the push rod 500 to shorten the length of the artificial chordae tendineae X.

At this time, the operator can observe the regurgitation degree of the mitral valve according to medical images such as ultrasound, thereby judging the length of the artificial chordae tendineae X that needs to be shortened, and adjusting the length of the artificial chordae tendineae X contained in the implant 600, so that the length of the artificial chordae tendineae X is shortened to a suitable length, and at this time, the pulling force between the valve leaflets and the ventricular wall is moderate, and the mitral valve regurgitation disappears or reaches the slightest state.

According to the suture length adjusting system 1000 provided by the embodiment, the wire feeder 300 and the wire gripper 400 are parallelly inserted into the bending adjusting device 100, the distal end of the wire feeder 300 is overlapped with the distal end of the wire gripper 400 and surrounds the artificial chordae tendineae X, the distal end of the wire feeder 300 is folded back and penetrates out of the bending adjusting device 100 under the driving of the wire gripper 400, the implant 600 can move to the vicinity of the artificial chordae tendineae X along the folded wire feeder 300 and accommodate the part of the artificial chordae tendineae X drawn by the wire feeder 300, so that the length of the artificial chordae tendineae X is shortened to a proper length, the problems of mitral valve regurgitation again and the like caused by the loose artificial chordae tendineae X are weakened or eliminated, meanwhile, the damage to the artificial chordae tendineae X by the adjusting mode of the suture length adjusting system is small, the service life of the artificial chorda.

The adjustable bending pipe 11 of the bending adjusting device 100 is described in detail below with reference to the accompanying drawings.

Specifically, referring to fig. 4, the adjustable bent pipe 11 has a multi-layer tubular structure. The distal end of the adjustable elbow 11 is provided with at least one adjustable elbow section 110. The multi-layered tubular structure of the adjustable elbow 11 includes an inner membrane 111, an enhanced tube 112 sleeved on the inner membrane 111, and an outer tube 113 sleeved on the enhanced tube 112. In this embodiment, the inner membrane 111 is a flexible tube made of a flexible material such as Polytetrafluoroethylene (PTFE). The reinforcement tube 112 is preferably a metal braided mesh structure. The reinforcing tube 112 has a certain rigidity and can be bent in the axial direction, so as to provide radial and axial supporting force for the adjustable bent tube 11, avoid the twisting deformation of the tube body in the radial direction, improve the twisting control performance of the adjustable bent tube 11, and simultaneously, not affect the bending of each adjustable bent segment 110 on the adjustable bent tube 11. The outer tube 113 is made of a material having excellent biocompatibility and a certain hardness, such as block polyether amide resin (PEBAX). Moreover, the hardness of the portion of the outer tube 113 corresponding to the distal adjustable bending section 110 is lower than the hardness of the other portions of the outer tube 113, so that the adjustable bending section 110 of the adjustable bending tube 11 is easier to bend. In this embodiment, the inner tube 111, the reinforcing tube 112, and the outer tube 113 are formed by heat fusion, and at least one delivery lumen is formed from the proximal end to the distal end. The wire feeder 300 and the wire gripper 400 are movably arranged through the conveying cavity.

Referring to fig. 4, the bend-adjusting apparatus 100 further includes a pulling member 13. In particular, the traction means 13 are located between the inner membrane 111 and the reinforcement tube 112. The tractor 13 includes a tractor wire 131 and an anchor ring 132. An anchoring ring 132 is fixedly secured to the distal end of the adjustable bend section 110. In this embodiment, the anchoring ring 132 is sleeved on the inner membrane 111 at a position corresponding to the adjustable bending section 110. The drawing wire 131 is embedded in the wall of the adjustable elbow 11 and is arranged along the axial direction of the adjustable elbow 11. The distal end of the pull wire 131 is connected to the anchoring ring 132 on the adjustable bending section 110, the proximal end of the pull wire 131 penetrates out of the tube wall of the proximal end of the adjustable bending tube 11 and is connected to the bending adjusting handle 12, and the corresponding adjustable bending section 110 is controlled to bend by pulling the pull wire 131 through the bending adjusting handle 12. In this embodiment, the number of the adjustable bending sections 110 is two, and the number of the pulling members 13 is also two. Each pulling member 13 pulls on one adjustable bending section 110.

The anchoring ring 132 may be made of a biocompatible metallic material or a polymeric material. In this embodiment, the anchor ring 132 is made of SUS304 stainless steel. The means for connecting the traction wire 131 to the anchoring ring 132 includes, but is not limited to, bonding, welding, heat fusing, knotting, etc., and is not limited thereto.

The distal end of the adjustable elbow 11 through the setting of the adjustable elbow device 100 is bendable so that the adjustable elbow 11 can enter the bending path to convey the wire feeder 300 to the artificial chordae tendineae X.

Referring to fig. 3, the catgut embedding device 2000 further includes a pre-shaping tube 200. Referring to fig. 9, the distal end of the sizing tube 200 is provided with at least one curved bending section 210. In this embodiment, the distal end of the sizing tube 200 is provided with an arcuate bend section 210 to facilitate passage through the mitral valve. In other embodiments, the distal end of the pre-shaped tube 200 may also be provided with 2 or more than 2 curved segments, and the multiple curved segments may lie in different planes, in order to accommodate the physiological anatomy of different sites of use.

Referring to fig. 3, the preformed pipe 200 is movably inserted into the adjustable bent pipe 11 along the axial direction. The wire feeder 300 is movably inserted into the pre-shaping pipe 200 in the axial direction. The pre-shaping pipe 200 and the wire grabbing device 400 are movably inserted into the adjustable bent pipe 11 of the bending adjusting device 100 in parallel.

Referring to fig. 9, the pre-shaped tube 200 is heat-set or the like to form at least one curved bent section 210 at the distal end of the pre-shaped tube 200. The distal end of the sizing tube 200 is in an arc-shaped bent state in a natural state (without the influence of external force). Referring to fig. 3, when the pre-shaped pipe 200 is disposed in the adjustable bent pipe 11, the pre-shaped pipe 200 is constrained to be in a straight state by the inner wall of the adjustable bent pipe 11. Referring to fig. 6, when the sizing tube 200 extends out of the distal end of the adjustable elbow 11, the distal end of the sizing tube 200 rebounds to form an arc around the artificial chordae tendineae X when extending out of the adjustable elbow 11. The wire feeder 300 is movably threaded in the sizing tube 200, so that the sizing tube 200 surrounds the artificial chordae tendineae X, and the distal end of the wire feeder 300 extends out of the distal end of the sizing tube 200.

Referring to FIG. 9, the length of the pre-shaped tube 200 is greater than or equal to 1100mm so that it can be delivered to the left ventricle via the femoral artery. The outer diameter of the pre-shaped tube 200 is less than or equal to 2mm, preferably 1.5mm, to reduce injury to the patient. The curved section 210 of the distal end of the sizing tube 200 is preferably semi-circular and the curved section 210 has a radius of curvature in the range of 5mm to 9 mm. If the bending radius is too small, the artificial chordae tendineae X are not favorably surrounded; if the bending radius is too large, the surgical instrument is easily interfered with the myocardial wall or the natural chordae tendineae, and the surgical operation is affected. The bend radius of the curved segment 210 is preferably 5mm so that the distal end of the sizing tube 200 can enter the self-entry sizing gripper 400 when the protruding curved segment 210 rebounds. The pre-shaped tube 200 may be a metal tube, such as a nickel titanium tube; or a single-layer plastic pipe, such as a nylon pipe PA pipe; it can also be a multilayer composite tube, such as outer membrane block polyether amide resin (Pebax), middle layer metal woven mesh, inner membrane 111 Polytetrafluoroethylene (PTFE).

Further, referring to fig. 6, the wire grabber 400 is located at the inward bending side of the bent section 210 of the pre-shaping tube 200, so that the bent section 210 of the pre-shaping tube 200 extends out of the distal end of the adjustable bent tube 11 and surrounds the artificial chordae tendineae X from the farther end relative to the wire grabber 400, and the wire grabber 400 surrounds the artificial chordae tendineae X from the opposite proximal end side after extending out of the distal end of the adjustable bent tube 11 until the distal end of the wire grabber 400 overlaps the distal end of the pre-shaping tube 200. After the wire feeder 300 extends out of the distal end of the pre-shaped tube 200, the distal end of the wire gripper 400 is overlapped with the distal end of the wire feeder 300 and drives the distal end of the wire feeder 300 back into the bend adjusting device 100.

The adjustment process of the suture length adjustment system 1000 provided by the present embodiment may be: after the distal end of the pre-shaping tube 200 is pushed out from the distal end of the adjustable bent tube 11, the distal end of the pre-shaping tube 200 rebounds to form an arc wrapping artificial tendon X, the pushing wire gripper 400 is overlapped with the pre-shaping tube 200, the wire feeder 300 penetrates out of the pre-shaping tube 200 until the distal end of the wire feeder 300 enters the wire gripper 400, then the wire feeder 300 is overlapped with the wire gripper 400, the distal end of the wire feeder 300 is pulled out of the proximal end of the bending adjusting device 100, at the moment, the wire feeder 300 is in a U shape and is connected with the artificial tendon X, then the implant 600 is pushed along the U-shaped wire feeder 300 by the implanting device 3000 to be in contact with the artificial tendon X until the artificial tendon X is bent in the implant 600 of the implanting device 3000, so that the effective length of the artificial tendon X is shortened, and the artificial tendon X is adjusted and controlled.

Referring to fig. 10, the wire feeder 300 includes a wire feeding guide wire 310, a connection sleeve 320 connected to a proximal end of the wire feeding guide wire 310, and at least one pulling wire 330 connected to the connection sleeve 320. The wire feeding guide wire 310 is a pigtail guide wire, and a soft pigtail section is arranged at the far end so as to be caught by the wire catcher 400. The softness of the wire feeding guide wire 310 is greater than that of the pulling wire 330, so that the wire feeding guide wire 310 can be hung at the distal end of the wire grabbing device 400 more easily, and the wire feeding guide wire 310 can be lapped on the distal end of the wire grabbing device 400 conveniently. The proximal end of the wire feeding guide wire 310 is pressed against the distal end of the connecting sleeve 320. The connecting sleeve 320 is made of a metal pipe, preferably a stainless steel pipe. The distal end of the pull wire 330 is crimped to the coupling sleeve 320. The proximal end of the pulling wire 330 is a free end and extends out of the proximal end of the bend adjusting device 100.

Further, the length of the pull wire 330 is greater than or equal to twice the length of the wire feed guide wire 310. For example, the length of the wire feeding guide wire 310 is more than or equal to 1100mm, and the length of the pulling wire 330 is more than or equal to 2200mm, so that the pulling wire 330 can be connected with the artificial chordae tendineae X in a U shape, and two free ends of the pulling wire 330 can extend out of the patient. The pull wire 330 is a medical grade suture, preferably Polyethylene terephthalate (PET) suture.

Further, the pulling wire 330 is made of a flexible material, and the pulling wire 330 pulls the artificial chordae tendineae X in a U-shape in the implant 600. After the wire grabber 400 pulls the wire feeding guide wire 310 back into the bending apparatus 100, the pulling wire 330 pulls the artificial chordae tendineae X. When the regulation and control process is completed, the implant 600 is implanted on the artificial chordae tendineae, the flexible pulling wire 330 pulls the artificial chordae tendineae X, the abrasion to the artificial chordae tendineae X can be reduced, the damage of the rigid implant in the prior art to the artificial chordae tendineae is avoided, and therefore the safety and the fatigue performance are good.

Referring to fig. 11, the wire grabber 400 includes a control rod 430 having an axial length and a grab ring 410 disposed at a distal end of the control rod 430. The distal end of the control rod 430 and the catching ring 410 extend out of the distal end of the bend adjusting device 100. The catching ring 410 is used to connect the distal end of the wire feeder 300, so that the distal end of the wire feeder 300 is received into the bending device 100 by the catching ring 410.

Further, the catching ring 410 is made of a flexible material. Referring to fig. 6 and 12, when the distal end of the control rod 430 and the capture ring 410 extend from the distal end of the bend adjustment device 100, the distal end of the control rod 430 and/or the capture ring 410 are bent toward the distal end of the wire feeder 300 to capture the distal end of the predetermined tube 200 or the distal end of the wire feeder 300.

Specifically, referring to fig. 11, the lever 430 is connected to the capture ring 410 by a locking sleeve 420. The catching ring 410 is a flexible structure, and after being wound into a ring shape by at least one flexible wire or flexible thread, two free ends thereof are inserted into the inner cavity of the locking sleeve 420 and are pressed. Flexible wires or wires include, but are not limited to, nickel titanium wires, stainless steel wires, or medical grade sutures, etc. The capture ring 410 may be greater than 20mm in diameter to facilitate capture of the distal end of the sizing tube 200 or the distal end of the wire feeder 300. The locking sleeve 420 is a rigid structure made of metal, such as a stainless steel sleeve. The control rod 430 is made of a solid rod or a hollow tube made of metal or polymer material, such as stainless steel wire, poly-ether-ketone (PEEK) tube, etc.

The structure of the implant device 3000 is illustrated in the following description with reference to the drawings.

Referring to fig. 13, the distal end of the push rod 500 abuts the proximal end of the implant 600. Referring to fig. 14, the implant 600 is conveyed along the wire feeder 300 by the pushing of the push rod 500 until a part of the artificial chordae tendineae X pulled by the wire feeder 300 is accommodated in the inner cavity of the implant 600, so as to shorten the length of the artificial chordae tendineae X and regulate the artificial chordae tendineae X.

In one embodiment, referring to fig. 15a, 15b and 15c, implant 600 is a hollow smooth cylinder. The proximal end of the implant 600 is axially provided with a first through hole 61 and a second through hole 62 which are spaced apart. The distal end of the implant 600 has a receiving groove 63 communicating with the first through hole 61 and the second through hole 62. The inner diameters of the receiving grooves 63 are larger than the inner diameters of the first through hole 61 and the second through hole 62, respectively. Referring to fig. 16a, 16b and 16c, the first through hole 61 and the second through hole 62 are both used for receiving and passing through the wire feeder 300. The accommodating groove 63 is used for accommodating the part of the artificial chordae tendineae X pulled by the wire feeder 300.

Specifically, two free ends of the wire feeder 300 are respectively inserted into the first through hole 61 and the second through hole 62 from the accommodating groove 63, the push rod 500 pushes the implant 600, the implant 600 slides to the artificial tendon X along the folded wire feeder 300 until a part of the artificial tendon X pulled by the wire feeder 300 is accommodated in the accommodating groove 63, and a part of the artificial tendon X to be shortened is accommodated in the accommodating groove 63, so as to adjust and control the artificial tendon X to a proper length.

Referring to fig. 16a, 16b and 16c, the artificial chordae X can be adjusted in multiple stages by adjusting the tightening degree of the pull wire 330 of the wire feeder 300, and the distances from the bent segment of the artificial chordae X into the inner cavity of the implant 520 are respectively Y1, Y2 and Y3 by adjusting the tightening degree of the pull wire 330 within the axial distance L of the accommodating groove 63, so that the artificial chordae X can be adjusted in multiple stages of trace, medium and large quantities. It should be understood that, the distances Y1, Y2 and Y3 are only taken as examples, and the distance of the bent segment of the artificial chordae tendineae X entering the inner cavity of the implant 520 is not particularly limited as long as the distance is less than the axial distance L of the receiving groove 63, so that the present embodiment can realize stepless adjustment and control of the artificial chordae tendineae X.

Implant 600 is made of an implant grade material such as poly-ether-ether-ketone (PEEK) or stainless steel. The push rod 500 is a hollow tube, such as a nickel titanium tube, a poly-ether-ketone (PEEK) tube, or the like.

In another embodiment, referring to fig. 17 and 18, a hollow portion 74 is disposed on the outer peripheral surface of the implant 700. The hollow portion 74 is communicated with the first through hole 71, the second through hole 72 and the receiving groove 73 along the radial direction of the implant 700.

The implant 700 provided by the embodiment adopts a hollow structure in the circumferential direction, so that the weight of the implant 700 is reduced, the burden of the artificial chordae tendineae X is reduced, and the risk after operation is reduced; in addition, the hollowed-out structure is more beneficial to endothelialization of the implant 700 and postoperative recovery of a patient.

The use of the suture length adjustment system 1000 of the present invention to adjust the length of the artificial chordae tendineae X implanted in the mitral valve is described below.

The first step is as follows: after a small incision is made by femoral artery puncture, a puncture guide wire (not shown) is delivered to the left ventricle through the femoral-abdominal-thoracic-aortic arch, establishing an orbit from outside the body to inside the body.

Secondly, referring to fig. 19, the adjustable bent tube 11 is fed along the puncture guide wire until the distal end of the adjustable bent tube 11 enters the left ventricle and reaches the vicinity of the artificial chordae tendineae X, and the puncture guide wire is removed.

Third, referring to fig. 6, the pre-shaping tube 200 and the wire grabber 400 are parallelly inserted into the adjustable bending tube 11 of the bending apparatus 100, and the wire grabber 400 is located at the inward-bending side of the bending section 210 (see fig. 9) of the pre-shaping tube 200, so as to ensure that the wire grabber 400 is at the same side as the distal end of the bent pre-shaping tube 200 after being delivered, thereby facilitating the grabbing of the artificial chordae tendineae X.

Fourthly, the pre-sizing pipe 200 and the thread grabbing device 400 are conveyed to the position near the artificial chordae tendineae X along the adjustable bent pipe 11 of the bending adjusting device 100, and the distance is controlled in a spherical area within 5mm of the radius of the artificial chordae tendineae X;

fifthly, the pre-shaping pipe 200 penetrates out of the inner cavity of the adjustable bent pipe 11 of the bending adjusting device 100, the pre-shaping pipe 200 restores the original state due to the shaping characteristics of the pre-shaping pipe, and the far end of the pre-shaping pipe 200 passes over the artificial chordae tendineae X and wraps the artificial chordae tendineae X in an arc shape; in the process, when the pre-shaping tube 200 penetrates out of the far end of the adjustable bent tube 11 by a distance less than 5mm, the pre-shaping tube 200 is basically kept moving linearly to the far end, the pre-shaping tube 200 is conveyed continuously until the far end of the pre-shaping tube 200 is gradually bent to the far end and can bypass the artificial chordae tendineae X, in the process, an operator can pull the pre-shaping tube 200 and judge whether the artificial chordae tendineae X are caught by the arc-shaped bent section 210 of the pre-shaping tube 200 by ultrasonic waves, if the bent section 210 of the pre-shaping tube 200 does not catch the artificial chordae tendineae X successfully, the bent section 210 of the pre-shaping tube 200 is withdrawn to the bending adjusting and shaping device 100, and the catching process is repeated to catch the artificial chordae tendineae X;

sixthly, after the artificial chordae tendineae X are caught by the curved section 210 of the pre-shaping tube 200, the wire grabber 400 and the control rod 430 (see fig. 11) of the wire grabber 400 are substantially parallel to the straight section of the pre-shaping tube 200, the distal end of the wire grabber 400 is pushed out of the inner cavity of the curve adjusting device 100 by pushing the control rod 430 of the wire grabber 400, the catching ring 410 approaches the distal end of the pre-shaping tube 200, then the catching ring 410 is pushed forward continuously, that is, the distal end of the pre-shaping tube 200 can be captured in the catching ring 410, the distal end of the pre-shaping tube 200 is overlapped with the distal end of the wire grabber 400, then the wire feeding 310 (see fig. 10) can be pushed out of the distal end of the pre-shaping tube 200, the distal end of the wire feeding 310 also enters the catching ring 410, the pre-shaping tube 200 is withdrawn from the curve adjusting device 100, and the wire feeding 310 is captured in the catching ring 410.

Seventhly, referring to fig. 7, the control rod 430 is retracted to drive the catching ring 410 to retract until the catching ring 410 retracts into the adjustable bent tube 11 (see fig. 3 in combination), the distal end of the wire feeding guide wire 310 is blocked by the distal end surface of the adjustable bent tube 11, so that the distal end of the wire feeding guide wire 310 is connected to the catching ring 410 in a U shape, and the wire feeding guide wire 310 can be pulled to the proximal end and pulled out from the proximal end of the bending apparatus 100 by the deformation of the catching ring 410 in the adjustable bent tube 11, so that the end of the pull wire 330 abutting against the connecting sleeve 320 is pulled to the proximal end and pulled out from the proximal end of the bending apparatus 100, and at this time, the pull wire 330 is connected to the artificial tendon X in a U shape, as shown in fig. 8 a.

Eighthly, referring to fig. 16a, the two free ends of the U-shaped pulling wire 330 (marked as 300 in the figure) pass through the first through hole 61 and the second through hole 62 respectively via the receiving slot 63 at the distal end of the implant 600, pass through the inner cavity of the push rod 500 (see fig. 14) and extend to the outside of the proximal end of the push rod 500, and then push the push rod 500, so that the distal end of the push rod 500 is attached to the proximal end of the implant 600, thereby driving the implant 600 to enter the patient along the pulling wire 330 until the implant 600 reaches the vicinity of the artificial chordae tendinae X; the artificial chordae X is partially pulled into the implant 600 by the pulling wire 330, and the artificial chordae X is pulled into the large cavity at the distal end of the implant 600 to form a U-shaped bend, thereby changing the effective length of the artificial chordae X and realizing the regulation and control of the artificial chordae X.

Ninth, referring to fig. 20, the push rod 500 is withdrawn, the U-shaped pulling wire 330 is tightened and tied outside the implant 600 to fix, so as to lock the effective length of the adjusted artificial chordae tendineae X, cut off the extra pulling wire 330, complete the artificial chordae tendineae X adjustment process, and alleviate or treat mitral regurgitation.

The utility model provides a push rod 500, buried line device 2000 and adjustable return bend 11 all adopt flexibility, flexible material to make to reduce the damage to artifical chordae tendineae X, and avoid damaging human tissue or natural chordae tendineae, for example adopt metal pipes such as thin stainless steel pipe, polymer pipes such as the thin PEEK pipe of wall thickness. The thread embedding device 2000, the push rod 500 and the adjustable elbow 11 are made of materials with small outer diameters, so that the thread embedding device has small damage to tissues and good trafficability in blood vessels.

The utility model provides a pair of suture length adjustment system 1000, through wearing the dress with wire feeder 300 in the preformed tube 200 in advance, to wear the dress in adjustable return bend 11 with grabbing line ware 400 jointly in advance the preformed tube 200, after preset tube 200 released from adjustable return bend 11, form arc parcel artifical tendon X, wear out from preset tube 200 wire feeder 300, wire feeder 300's distal end gets into in grabbing line ware 400, grab line ware 400 pulls out wire feeder 300 one end, wire feeder 300 is the U type and is connected with artifical tendon X this moment, implant 600 passes U type wire feeder 300, the propelling movement is to contacting with artifical tendon X under push rod 500's effect, rely on implant 600 to buckle artifical tendon X, thereby shorten artifical tendon X's effective length, regulate and control artifical tendon X. The artificial chordae tendineae X implanted in the mitral valve are regulated in a minimally invasive mode, and the secondary mitral regurgitation caused by the relaxation of the artificial chordae tendineae X is weakened or eliminated. Compared with the prior art, the method has the following beneficial effects: the suture length adjusting system 1000 is a flexible system, is suitable for remote intervention, has small damage to a human body and reduces operation risk; the artificial chordae tendineae X are pulled through the flexible pulling lines 330, so that the artificial chordae tendineae X are less damaged for a long time, and the service life of the artificial chordae tendineae X is prolonged.

The foregoing are some embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principle of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims

1. A suture length adjustment system comprising an implant and a thread burial device, the thread burial device comprising:

2. The suture length adjustment system of claim 1, wherein the thread embedding device further comprises a pre-shaped tube, a distal end of the pre-shaped tube being provided with at least one curved segment, the pre-shaped tube being movably threaded in the bending adjustment device, the thread feeder being movably threaded in the pre-shaped tube;

the pre-shaping tube extends out of the far end of the bending adjusting device and surrounds the suture in an arc shape, and the wire feeder extends out of the far end of the pre-shaping tube.

3. The suture length adjustment system of claim 2, wherein the pre-shaped tube length is greater than or equal to 1100mm and the curved segment has a radius of curvature in the range of 5mm to 9 mm.

4. The suture length adjustment system of claim 2, wherein the grasper is located on an inturned side of the curved segment of the sizing tube.

5. The suture length adjustment system of claim 1, wherein the wire feeder comprises a wire feeding guide wire and a pulling wire connected to a proximal end of the wire feeding guide wire, wherein the wire feeding guide wire has a greater flexibility than the pulling wire, and wherein the proximal end of the pulling wire is free and extends beyond the proximal end of the bend adjustment device.

6. The suture length adjustment system of claim 5, wherein the pull wire has a length greater than or equal to two times a length of the wire feed guide wire.

7. The suture length adjustment system of claim 5, wherein the pull wire is made of a flexible material that pulls the suture in a U-shape within the implant.

8. The suture length adjustment system of claim 1, wherein the suture grabber comprises a control rod and a catching ring disposed at a distal end of the control rod, the distal end of the control rod and the catching ring extending beyond a distal end of the bend adjustment device, the catching ring adapted to engage the distal end of the suture feeder such that the distal end of the suture feeder is received into the bend adjustment device by the catching ring.

9. The suture length adjustment system of claim 8, wherein the capture ring is made of a flexible material, and wherein the distal end of the control rod and the capture ring bend toward the distal end of the wire feeder when the distal end of the control rod and the capture ring extend from the distal end of the bend adjustment device.

10. The suture length adjustment system of claim 1, wherein the bending adjustment device comprises an adjustable elbow and a pull wire embedded in a wall of the adjustable elbow, the adjustable elbow having an adjustable bending section, a distal end of the pull wire being connected to the adjustable bending section of the adjustable elbow, and a proximal end of the pull wire extending out of the wall of the proximal end of the adjustable elbow.

11. The suture length adjustment system of claim 1, further comprising a push rod, a distal end of the push rod abutting a proximal end of the implant, the implant being delivered along the wire feeder under the push of the push rod until a portion of the suture pulled by the wire feeder is received within a lumen of the implant.

12. The suture length adjustment system of claim 11, wherein the proximal end of the implant is axially juxtaposed with first and second spaced apart through holes, and the distal end of the implant has a receiving channel in communication with the first and second through holes; the first through hole and the second through hole are used for accommodating and passing through the thread feeder, and the accommodating groove is used for accommodating the part of the suture pulled by the thread feeder.

13. The suture length adjustment system of claim 12, wherein a hollow portion is disposed on an outer circumferential surface of the implant, and the hollow portion communicates with the first through hole, the second through hole, and the receiving groove along a radial direction of the implant.

14. The suture length adjustment system of claim 11, wherein the push rod and the catgut embedding device are both made of a flexible, bendable material.

15. The suture length adjustment system of any one of claims 1 to 14, wherein the suture is an artificial chordae tendineae.