Artificial chordae tendineae length adjustment system

Abstract

The present invention provides an artificial chordae tendineae length adjustment system, comprising an implant and a wire embedding device. The wire embedding device includes: a hollow bending adjustment device, a wire feeder and a wire gripper that are arranged in parallel and movably penetrate through the bending adjustment device; the distal end of the wire feeder extends out of the distal end of the bending adjustment device and surrounds the artificial chordae tendineae, and the wire gripper extends out of the distal end of the bending adjustment device and picks up the distal end of the wire feeder to surround the artificial chordae tendineae; the wire gripper is received into the inner cavity of the bending adjustment device and drives the distal end of the wire feeder to fold, and the folded wire feeder pulls the artificial chordae tendineae, and the implant is conveyed along the folded wire feeder and houses the part of the artificial chordae tendineae pulled by the wire feeder. The artificial chordae tendineae length adjustment system provided by the present invention can adjust the length of the artificial chordae tendineae implanted in a patient, weaken or eliminate the long-term problems caused by the relaxation of the artificial chordae tendineae. At the same time, the adjustment method of the artificial chordae tendineae length adjustment system causes little damage to the artificial chordae tendineae, improves the service life of the artificial chordae tendineae, and reduces the surgical risk.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to an artificial chordae tendineae length adjustment system. Background Art

[0002] Mitral insufficiency is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, mitral mucoid degeneration, cardiac ischemic disease, myocardial lesions, etc., which lead to lesions in the annulus fibrosus, valve leaflets, chordae tendineae, and papillary muscles in the mitral valve structure, resulting in incomplete closure of the valve leaflets of the mitral valve.

[0003] Surgical operation is an effective method for treating mitral insufficiency. However, due to the large trauma caused by the operation to the human body, for elderly patients and patients with multiple complications, there are more complications and a higher mortality rate.

[0004] Now, minimally invasive interventional surgery is a better choice for most heart diseases. The main interventional treatment methods include artificial chordae tendineae implantation, mitral annuloplasty, and mitral edge-to-edge repair. Among them, implanting artificial chordae tendineae X on the valve leaflets can effectively treat mitral insufficiency caused by chordae tendineae rupture, valve leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure, as Figure 1 shown. However, as Figure 2 shown, after implanting artificial chordae tendineae X for a period of time, due to changes in factors such as cardiac volume, the artificial chordae tendineae X is in a relaxed state, and it is often necessary to readjust the length of the artificial chordae tendineae X to avoid abnormal heart valve function. In addition, in mitral or tricuspid annuloplasty, artificial chordae tendineae are often used to tighten the annulus size and then fix the artificial chordae tendineae. However, after a period of time after annuloplasty, the artificial chordae tendineae may also be in a relaxed state, and it is necessary to adjust the length of the artificial chordae tendineae.

[0005] The existing artificial chordae tendineae length adjustment devices have the following defects: the implant needs to clamp the artificial chordae tendineae to achieve regulation. In order to improve the clamping force of the implant, the components of the implant in contact with the artificial chordae tendineae need to have a high connection strength. The implant is usually made of rigid materials. Therefore, in the long-term implanted state, the implant causes greater damage to the artificial chordae tendineae, and the safety and reliability are poor. Summary of the Invention

[0006] The present invention provides an artificial chordae tendineae length adjustment system for regulating the length of artificial chordae tendineae implanted in a patient, avoiding long-term problems caused by the relaxation of artificial chordae tendineae. At the same time, the adjustment method of the artificial chordae tendineae length adjustment system causes little damage to the artificial chordae tendineae, improves the service life of the artificial chordae tendineae, and reduces the surgical risk. Therefore, the artificial chordae tendineae length adjustment system of the present invention is particularly suitable for adjusting the length of artificial chordae tendineae implanted in heart valves, weakening or eliminating problems such as valve regurgitation caused by the relaxation of artificial chordae tendineae, avoiding damage to the artificial chordae tendineae, improving the service life of the artificial chordae tendineae, and being safe and reliable.

[0007] The artificial chordae tendineae length adjustment system provided by the present invention includes an implant and an embedding device, and the embedding device includes:

[0008] A hollow bending adjustment device, a wire feeder and a wire gripper that are parallel and movably disposed in the bending adjustment device;

[0009] The distal end of the wire feeder extends out of the distal end of the bending adjustment device and surrounds the artificial chordae tendineae, and the wire gripper extends out of the distal end of the bending adjustment device and overlaps the distal end of the wire feeder to surround the artificial chordae tendineae; the wire gripper retracts into the inner cavity of the bending adjustment device and drives the distal end of the wire feeder to fold, and the folded wire feeder pulls the artificial chordae tendineae, and the implant is transported along the folded wire feeder and houses the part of the artificial chordae tendineae pulled by the wire feeder.

[0010] The artificial chordae tendineae length adjustment system provided by the embodiment of the present invention passes the wire feeder and the wire gripper through the adjustable bending tube in parallel. The distal ends of the wire feeder and the wire gripper overlap and surround the artificial chordae tendineae. The distal end of the wire feeder folds back and passes through the bending adjustment device under the drive of the wire gripper. The implant can move along the folded wire feeder to the vicinity of the artificial chordae tendineae and house the part of the artificial chordae tendineae pulled by the wire feeder, so that the length of the artificial chordae tendineae is shortened to a suitable length.

[0011] The artificial chordae tendineae length adjustment system provided by the present invention is particularly suitable for adjusting the length of artificial chordae tendineae implanted in heart valves. For example, shortening the length of artificial chordae tendineae to increase the tension between the valve leaflets and the papillary muscles, or tightening the valve annulus size, etc., weakening or eliminating problems such as mitral valve re-regurgitation caused by the relaxation of artificial chordae tendineae. At the same time, the artificial chordae tendineae length adjustment system pulls the artificial chordae tendineae through a flexible wire feeder, causes little damage to the artificial chordae tendineae, improves the service life of the artificial chordae tendineae, is safe and reliable, and has good fatigue performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the embodiments will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can be obtained based on these drawings.

[0013] Figure 1 is a schematic structural diagram of an artificial chordae tendineae implanted in the mitral valve in the prior art;

[0014] Figure 2 is a schematic structural diagram of the relaxation of an artificial chordae tendineae implanted in the mitral valve in the prior art;

[0015] Figure 3 is a schematic structural diagram of an artificial chordae tendineae length adjustment system provided by an embodiment of the present invention;

[0016] Figure 4 is Figure 3 a schematic structural diagram of the bending adjustment device in;

[0017] Figure 5a is Figure 3 a front view of the wire embedding device in;

[0018] Figure 5b is Figure 3 a partial cross-sectional view of the wire embedding device in;

[0019] Figure 5c is Figure 3 a side view of the wire embedding device in;

[0020] Figure 6 is Figure 3 a schematic diagram of the wire embedding device in an arc shape around the artificial chordae tendineae;

[0021] Figure 7 is Figure 3 a schematic diagram of the wire feeder pulling the artificial chordae tendineae in;

[0022] Figure 8a is Figure 3 a schematic diagram of the implant being conveyed along the wire feeder and accommodating the artificial chordae tendineae in;

[0023] Figure 8b is Figure 8a another angle schematic diagram of;

[0024] Figure 8c is Figure 8a another angle cross-sectional view of;

[0025] Figure 9 is Figure 3 a schematic structural diagram of the preformed tube in;

[0026] Figure 10 is Figure 3 a schematic structural diagram of the wire feeder in

[0027] Figure 11 is Figure 3 a schematic structural diagram of the wire gripper in

[0028] Figure 12 is Figure 3 a schematic diagram showing that the wire embedding device is arc-shaped around the artificial chord tendineae in

[0029] Figure 13 is Figure 3 a schematic structural diagram of the implantation device in

[0030] Figure 14 is Figure 13 a schematic diagram showing the interaction between the implantation device and the artificial chord tendineae in

[0031] Figure 15a is Figure 13 a schematic structural diagram of the implant in

[0032] Figure 15b is Figure 13 a schematic structural diagram of the implant from another angle in

[0033] Figure 15c is Figure 13 a cross-sectional view of the implant in

[0034] Figure 16a is Figure 14 a cross-sectional view showing that the implant accommodates part of the artificial chord tendineae to achieve micro-regulation in

[0035] Figure 16b is Figure 14 a cross-sectional view showing that the implant accommodates part of the artificial chord tendineae to achieve medium-regulation in

[0036] Figure 16c is Figure 14 a cross-sectional view showing that the implant accommodates part of the artificial chord tendineae to achieve multi-regulation in

[0037] Figure 17 is a schematic structural diagram of another implementation of the implant;

[0038] Figure 18 is Figure 17 a schematic diagram showing that the implant is transported along the wire feeder and accommodates part of the artificial chord tendineae in

[0039] Figure 19 is Figure 3 a schematic diagram showing that the artificial chord tendineae length adjustment system enters the vicinity of the artificial chord tendineae in

[0040] Figure 20 Yes Figure 3 Schematic diagram of the implant fixation in the artificial chordae tendineae and full regulation. Specific implementation mode

[0041] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with 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, rather than all the embodiments. The embodiments listed in the present invention can be appropriately combined with each other.

[0042] In the technical field of interventional medical devices, the orientation close to the operator is generally defined as the proximal end, and the orientation far from the operator is defined as the distal end, which will not be elaborated hereinafter.

[0043] Please refer to Figure 3 , Figure 3 An artificial chordae tendineae length adjustment system provided by an embodiment of the present invention is used to adjust the length of the artificial chordae tendineae. The artificial chordae tendineae is a medical-grade suture, such as a PET suture or a PTFE suture. In this embodiment, a PTFE suture is used as the artificial chordae tendineae, and the scenario of implanting the PTFE suture into the valve leaf of the mitral valve is taken as an example for illustration.

[0044] Please refer to Figure 3 , the artificial chordae tendineae length adjustment system 1000 includes an embedding device 2000 and an implanting device 3000.

[0045] Please refer to Figure 3 , the embedding device 2000 includes a bending adjustment device 100, a wire feeder 300 and a wire gripper 400.

[0046] Please refer to Figure 4 , the bending adjustment device 100 has a hollow structure. The bending adjustment device 100 includes an adjustable bending tube 11 and a bending adjustment handle 12. The adjustable bending tube 11 is a hollow tube structure. The bending adjustment handle 12 is connected to the proximal end of the adjustable bending tube 11. The bending control member on the bending adjustment handle 12 can control the bending of the adjustable bending tube 11 and adjust the bending degree of the adjustable bending tube 11.

[0047] Please refer to Figure 5a , Figure 5b and Figure 5c , the wire feeder 300 and the wire gripper 400 are arranged in parallel along the axis and movably penetrate through the bending adjustment device 100. Specifically, the wire feeder 300 and the wire gripper 400 are arranged in parallel along the axis and movably penetrate through the inner cavity of the bending adjustment device 100. It should be noted that in the subsequent description, unless otherwise specified, "along the axis" refers to the axis of the bending adjustment device 100.

[0048] Please refer to Figure 6, the distal end of the wire feeder 300 extends beyond the distal end of the bending adjustment device 100 and surrounds the artificial chord X. The distal end of the wire gripper 400 extends beyond the distal end of the bending adjustment device 100 and overlaps with the distal end of the wire feeder 300 to surround the artificial chord X. Specifically, when the distal end of the bending adjustment device 100 is near the artificial chord X, the distal end of the wire feeder 300 gradually extends beyond the distal end of the bending adjustment device 100 and extends circumferentially along the artificial chord X, so that the wire feeder 300 surrounds the circumferential side of the artificial chord X. In this embodiment, the sequence of the distal end of the wire feeder 300 and the distal end of the wire gripper 400 extending beyond the distal end of the bending adjustment device 100 is not limited. In one embodiment, the distal end of the wire feeder 300 first extends beyond the distal end of the bending adjustment device 100, and then the distal end of the wire gripper 400 gradually approaches the distal end of the wire feeder 300 and overlaps with the distal end of the wire feeder 300. In another embodiment, the distal end of the wire gripper 400 first extends beyond the distal end of the bending adjustment device 100, and then the distal end of the wire feeder 300 gradually approaches the distal end of the wire gripper 400 and overlaps with the distal end of the wire gripper 400. In other embodiments, the wire feeder 300 and the wire gripper 400 can extend beyond the distal end of the bending adjustment device 100 simultaneously and overlap with each other.

[0049] After the distal end of the wire gripper 400 overlaps with the distal end of the wire feeder 300, the wire gripper 400 and the wire feeder 300 surround the artificial chord X.

[0050] 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.

[0051] Please refer to Figure 7 , the wire gripper 400 is received into the inner cavity of the bending adjustment device and drives the distal end of the wire feeder 300 to fold, and the folded wire feeder 300 pulls the artificial chord X. That is, when the distal end of the wire feeder 300 is received into the inner cavity of the bending adjustment device 100 along with the wire gripper 400, the wire feeder 300 is folded due to the obstruction of the artificial chord X and pulls the artificial chord X. Specifically, the distal end of the wire feeder 300 moves from the distal end to the proximal end under the drive of the wire gripper 400. Due to the obstruction of the artificial chord X, the wire feeder 300 passes back into the inner cavity of the bending adjustment device 100 in a U-shaped or folded form until the distal end of the wire feeder 300 passes out of the proximal end of the bending adjustment device 100. Optionally, the proximal end of the wire feeder 300 is provided outside the proximal end of the bending adjustment device 100. At this time, both opposite ends of the wire feeder 300 are provided outside the proximal end of the bending adjustment device 100 and are both free ends.

[0052] Please refer to Figure 3 , the implantation device 3000 includes a push rod 500 and an implant 600. Please refer to in combination Figures 8a to 8c, the implant 600 moves along the folded wire feeder 300 under the action of the push rod 500 to near the artificial chordae tendineae X and houses the part of the artificial chordae tendineae X pulled by the wire feeder 300. Specifically, the folded wire feeder 300 forms a moving slide rail for the implant 600. The implant 600 moves from the proximal end of the bending adjustment device 100 along the folded wire feeder 300 to the distal end of the bending adjustment device 100 under the action of the push rod 500, and moves out from the distal end of the bending adjustment device 100. The implant 600 houses the part of the artificial chordae tendineae X pulled by the wire feeder 300 under the further push of the push rod 500 to shorten the length of the artificial chordae tendineae X.

[0053] At this time, the operator can observe the degree of mitral regurgitation according to medical images such as ultrasound, so as to judge the length that the artificial chordae tendineae X needs to be shortened, and adjust the length of the artificial chordae tendineae X housed in the implant 600, so that the length of the artificial chordae tendineae X is shortened to a suitable length. At this time, the pulling force between the valve leaf and the ventricular wall is moderate, and the mitral regurgitation disappears or reaches the mildest state.

[0054] The artificial chordae tendineae length adjustment system 1000 provided in this embodiment passes the wire feeder 300 and the wire gripper 400 through the bending adjustment device 100 in parallel. The distal ends of the wire feeder 300 and the wire gripper 400 overlap and surround the artificial chordae tendineae X. The distal end of the wire feeder 300 folds back and passes out of the bending adjustment device 100 driven by the wire gripper 400. The implant 600 can move along the folded wire feeder 300 to near the artificial chordae tendineae X and house the part of the artificial chordae tendineae X pulled by the wire feeder 300, so that the length of the artificial chordae tendineae X is shortened to a suitable length, weakening or eliminating problems such as mitral regurgitation caused by the relaxation of the artificial chordae tendineae X. At the same time, the adjustment method of the artificial chordae tendineae length adjustment system has little damage to the artificial chordae tendineae X, improves the service life of the artificial chordae tendineae X, and reduces the surgical risk.

[0055] The following specifically describes the adjustable bending tube 11 of the bending adjustment device 100 with reference to the accompanying drawings.

[0056] Specifically, please refer to Figure 4, the adjustable bent tube 11 is a multi-layer tubular structure. At least one adjustable bending section 110 is provided at the distal end of the adjustable bent tube 11. The multi-layer tubular structure of the adjustable bent tube 11 includes an inner membrane 111, a reinforcing tube 112 sleeved on the inner membrane 111, and an outer tube 113 sleeved on the reinforcing tube 112. In this embodiment, the inner membrane 111 is a flexible tube made of a flexible material such as polytetrafluoroethylene (PTFE). The reinforcing tube 112 is preferably a metal braided mesh structure. The reinforcing tube 112 has a certain stiffness and can be bent axially, thereby providing radial and axial support forces for the adjustable bent tube 11, avoiding torsional deformation of the tube body in the radial direction, improving the torsion control of the adjustable bent tube 11, and at the same time not affecting the bending of each adjustable bending section 110 on the adjustable bent tube 11. The outer tube 113 is made of a material such as block polyether amide resin (PEBAX) with excellent biocompatibility and a certain hardness. And, the hardness of the part of the outer tube 113 corresponding to the adjustable bending section 110 at the distal end is less than the hardness of other parts of the outer tube 113, so that the adjustable bending section 110 of the adjustable bent tube 11 is more likely to bend. In this embodiment, the inner membrane 111, the reinforcing tube 112, and the outer tube 113 are formed together by hot melt compounding to form at least one delivery cavity that completely penetrates from the proximal end to the distal end. The wire feeder 300 and the wire gripper 400 are movably inserted into the delivery cavity.

[0057] Please refer to Figure 4 , the bending adjustment device 100 further includes a traction member 13. Specifically, the traction member 13 is located between the inner membrane 111 and the reinforcing tube 112. The traction member 13 includes a traction wire 131 and an anchor ring 132. The anchor ring 132 is fixedly sleeved on the distal end of the adjustable bending section 110. In this embodiment, the anchor ring 132 is sleeved on the inner membrane 111 at the position corresponding to the adjustable bending section 110. The traction wire 131 is embedded in the tube wall of the adjustable bent tube 11 and is arranged along the axial direction of the adjustable bent tube 11. The distal end of the traction wire 131 is connected to the anchor ring 132 on the adjustable bending section 110, and the proximal end of the traction wire 131 passes through the tube wall at the proximal end of the adjustable bent tube 11 and is connected to the bending adjustment handle 12. By pulling the traction wire 131 with the bending adjustment handle 12, the corresponding adjustable bending section 110 is controlled to bend. In this embodiment, the number of adjustable bending sections 110 is two, and the number of traction members 13 is also two. Each traction member 13 pulls one adjustable bending section 110.

[0058] The anchor ring 132 can be made of a biocompatible metal material or a polymer material. In this embodiment, the anchor ring 132 is made of SUS304 stainless steel. The connection method between the traction wire 131 and the anchor ring 132 includes but is not limited to bonding, welding, hot melting, knotting and other methods, which are not limited here.

[0059] By setting the distal end of the adjustable bent tube 11 of the bending adjustment device 100 to be bendable, it is convenient for the adjustable bent tube 11 to enter the bending path, so as to convey the wire feeder 300 to the artificial tendon cord X.

[0060] Please refer to Figure 3 , the buried wire device 2000 further includes a pre-shaped tube 200. Please refer to Figure 9 , at least one arc-shaped bending section 210 is provided at the distal end of the pre-shaped tube 200. In this embodiment, in order to facilitate passing through the mitral valve, one arc-shaped bending section 210 is provided at the distal end of the pre-shaped tube 200. In other embodiments, in order to adapt to the physiological and anatomical structures of different use sites, 2 or more bending sections may be provided at the distal end of the pre-shaped tube 200, and multiple bending sections may be located in different planes.

[0061] Please refer to Figure 3 , the pre-shaped tube 200 is axially movably inserted into the adjustable bending tube 11. The wire feeder 300 is axially movably inserted into the pre-shaped tube 200. The pre-shaped tube 200 and the wire gripper 400 are movably inserted into the adjustable bending tube 11 of the bending device 100 in parallel.

[0062] Please refer to Figure 9 , the pre-shaped tube 200 is processed by heat setting or other means, and at least one arc-shaped bending section 210 is machined at the distal end of the pre-shaped tube 200. The distal end of the pre-shaped tube 200 is in an arc-shaped bent state in the natural state (without the action of external force). Please refer to Figure 3 , when the pre-shaped tube 200 is arranged inside the adjustable bending tube 11, the pre-shaped tube 200 is constrained to a straight state by the inner wall of the adjustable bending tube 11. Please refer to Figure 6 , when the distal end of the pre-shaped tube 200 extends out of the distal end of the adjustable bending tube 11, the distal end of the pre-shaped tube 200 rebounds and forms an arc around the artificial tendon cord X when it extends out of the adjustable bending tube 11. The wire feeder 300 is movably inserted into the pre-shaped tube 200. Therefore, as the pre-shaped tube 200 surrounds the artificial tendon cord X, and the distal end of the wire feeder 300 extends out of the distal end of the pre-shaped tube 200.

[0063] Please refer to Figure 9, the length of the pre-shaped tube 200 is greater than or equal to 1100 mm so that it can be delivered to the left ventricle via the femoral artery. The outer diameter of the pre-shaped tube 200 is ≤ 2 mm, preferably 1.5 mm, to reduce the damage to the patient. The curved section 210 at the distal end of the pre-shaped tube 200 is preferably semi-circular, and the bending radius of the curved section 210 ranges from 5 mm to 9 mm. If the bending radius is too small, it is not conducive to surrounding the artificial chordae tendineae X; if the bending radius is too large, it is easy to interfere with the myocardial wall or the natural chordae tendineae, affecting the surgical operation. The bending radius of the curved section 210 is preferably 5 mm, so that the distal end of the pre-shaped tube 200 can automatically enter the preset wire gripper 400 when the distal end of the pre-shaped tube 200 rebounds after extending out of the arc-shaped curved section 210. The pre-shaped tube 200 can be a metal tube, such as a nitinol tube; it can also be a single-layer plastic tube, such as a nylon tube or a PA tube; it can also be a multi-layer composite tube, such as an outer membrane of block polyether amide resin (Pebax), a middle layer of metal braided mesh, and an inner membrane of polytetrafluoroethylene (PTFE).

[0064] Further, please refer to Figure 6 , the wire gripper 400 is located on the inner curved side of the curved section 210 of the pre-shaped tube 200, so that the curved section 210 of the pre-shaped tube 200 surrounds the artificial chordae tendineae X from a more distal position relative to the wire gripper 400 after extending out of the distal end of the adjustable bending tube 11, and the wire gripper 400 surrounds the artificial chordae tendineae X from the relatively proximal side after extending out of the distal end of the adjustable bending tube 11 until the distal end of the wire gripper 400 overlaps with the distal end of the pre-shaped 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 overlaps with the distal end of the wire feeder 300 and drives the distal end of the wire feeder 300 to fold back into the bending device 100.

[0065] The adjustment process of the artificial chordae tendineae length adjustment system 1000 provided in this embodiment can be as follows: after the distal end of the pre-shaped tube 200 is pushed out of the distal end of the adjustable bending tube 11, it rebounds to form an arc to wrap the artificial chordae tendineae X, the wire gripper 400 is pushed to form an overlap with the pre-shaped tube 200, and then the wire feeder 300 is passed through the pre-shaped tube 200 until the distal end of the wire feeder 300 enters the wire gripper 400. Then, the wire gripper 400 picks up the wire feeder 300 and pulls the distal end of the wire feeder 300 out from the proximal end of the bending device 100. At this time, the wire feeder 300 is in a U shape and is connected to the artificial chordae tendineae X. Then, the implant 600 is pushed along the U-shaped wire feeder 300 through the implant device 3000 until it contacts the artificial chordae tendineae X until the artificial chordae tendineae X is bent in the implant 600 of the implant device 3000, thereby shortening the effective length of the artificial chordae tendineae X and regulating the artificial chordae tendineae X.

[0066] Please refer to Figure 10, the wire feeder 300 includes a wire guiding wire 310, a connecting sleeve 320 connected to the proximal end of the wire guiding wire 310, and at least one pulling wire 330 connected to the connecting sleeve 320. The wire guiding wire 310 adopts a pigtail wire, and a soft pigtail section is arranged at the distal end so as to be captured by the wire gripper 400. The softness of the wire guiding wire 310 is greater than that of the pulling wire 330, so that the wire guiding wire 310 can be more easily hung on the distal end of the wire gripper 400, which is beneficial to the wire guiding wire 310 to be lapped on the distal end of the wire gripper 400. The proximal end of the wire guiding wire 310 is crimped to the distal end of the connecting sleeve 320. The connecting sleeve 320 is selected as a metal tube, preferably a stainless steel tube. The distal end of the pulling wire 330 is crimped to the connecting sleeve 320. The proximal end of the pulling wire 330 is a free end and extends out of the proximal end of the bending adjustment device 100.

[0067] Further, the length of the pulling wire 330 is greater than or equal to twice the length of the wire guiding wire 310. For example, the length of the wire guiding wire 310 ≥ 1100 mm, and the length of the pulling wire 330 ≥ 2200 mm, so that the pulling wire 330 can be connected to the artificial tendon cord X in a U shape, and the two free ends of the pulling wire 330 can extend outside the patient's body. The pulling wire 330 adopts a medical-grade suture, preferably a polyethylene terephthalate (PET) suture.

[0068] Further, the pulling wire 330 is made of a flexible material, and the pulling wire 330 pulls the artificial tendon cord X in a U shape in the implant 600. After the wire gripper 400 pulls the wire guiding wire 310 back into the bending adjustment device 100, the pulling wire 330 pulls the artificial tendon cord X. When the adjustment process is completed and the implant 600 is implanted on the artificial tendon cord, the flexible pulling wire 330 pulls the artificial tendon cord X, which can reduce the wear on the artificial tendon cord X and avoid the damage to the artificial tendon cord by the rigid implant in the prior art. Therefore, the safety and fatigue performance are better.

[0069] Please refer to Figure 11 , the wire gripper 400 includes a control rod 430 having a certain axial length and a capture ring 410 provided at the distal end of the control rod 430. The distal end of the control rod 430 and the capture ring 410 extend out of the distal end of the bending adjustment device 100. The capture 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 adjustment device 100 under the action of the capture ring 410.

[0070] Further, the capture ring 410 is made of a flexible material. Please refer to Figure 6 and Figure 12When the distal end of the control rod 430 and the catching ring 410 extend from the distal end of the bending device 100, the distal end of the control rod 430 and / or the catching ring 410 bends toward the distal end of the wire feeder 300 to catch the distal end of the predetermined forming tube 200 or the distal end of the wire feeder 300.

[0071] For details, please refer to Figure 11 , the control rod 430 is connected to the capture ring 410 through the locking sleeve 420. The capture ring 410 is a flexible structure, which is formed into a ring by winding at least one flexible wire or flexible line, and then its two free ends are inserted into the inner cavity of the locking sleeve 420 and crimped. Flexible wires or flexible lines include but are not limited to nickel-titanium wires, stainless steel wires, or medical-grade sutures. The diameter of the capture ring 410 can be greater than 20 mm to facilitate the capture of the distal end of the predetermined 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 a solid rod or hollow tube made of metal or polymer material, such as stainless steel wire, poly-ether-ether-ketone (PEEK) tube, etc.

[0072] The structure of the implant device 3000 is described below with reference to the accompanying drawings.

[0073] See also Figure 13 , the distal end of the push rod 500 abuts against the proximal end of the implant 600. Figure 14 The implant 600 is transported along the wire feeder 300 under the push of the push rod 500 until the part of the artificial chord X pulled by the wire feeder 300 is accommodated in the inner cavity of the implant 600 to shorten the length of the artificial chord X and regulate the artificial chord X.

[0074] In one embodiment, see Figure 15a , Figure 15b and Figure 15c The implant 600 is a hollow smooth cylinder. The proximal end of the implant 600 is provided with a first through hole 61 and a second through hole 62 spaced apart in parallel along the axial direction. The distal end of the implant 600 has a receiving groove 63 connected to the first through hole 61 and the second through hole 62. The inner diameter of the receiving groove 63 is larger than the inner diameter of the first through hole 61 and the inner diameter of the second through hole 62. Figure 16a , Figure 16b and Figure 16c The first through hole 61 and the second through hole 62 are both used to receive and pass the wire feeder 300. The receiving groove 63 is used to receive the portion of the artificial tendon X pulled by the wire feeder 300.

[0075] Specifically, the two free ends of the wire feeder 300 are respectively passed through the first through hole 61 and the second through hole 62 from the receiving groove 63. The push rod 500 pushes the implant 600, and slides the implant 600 along the folded wire feeder 300 to the artificial chord X until the part of the artificial chord X pulled by the wire feeder 300 is received in the receiving groove 63. At this time, the part of the artificial chord X that needs to be shortened is received in the receiving groove 63 to adjust the artificial chord X to a suitable length.

[0076] Please refer to Figure 16a 、 Figure 16b and Figure 16c , by adjusting the tightening degree of the pulling wire 330 of the wire feeder 300, multi-level regulation of the artificial chord X can be achieved. Within the axial distance L of the receiving groove 63, by adjusting the tightening degree of the pulling wire 330, the distances at which the bent section of the artificial chord X enters the inner cavity of the implant 520 are Y1, Y2, and Y3 respectively, and multi-level regulation of micro, medium, and large amounts of the artificial chord X can be achieved. It can be understood that only the distances Y1, Y2, and Y3 are taken as examples here, and the distance at which the bent section of the artificial chord X enters the inner cavity of the implant 520 is not specifically limited, as long as it is less than the axial distance L of the receiving groove 63. Therefore, stepless regulation of the artificial chord X can be achieved in this embodiment.

[0077] The implant 600 is made of implant-grade materials, such as poly-ether-ether-ketone (PEEK) or stainless steel. The push rod 500 is a hollow tube, such as a nitinol tube, a poly-ether-ether-ketone (PEEK) tube, etc.

[0078] In another embodiment, please refer to Figure 17 and Figure 18 , a hollow portion 74 is provided on the outer peripheral surface of the implant 700. The hollow portion 74 radially communicates the first through hole 71, the second through hole 72, and the receiving groove 73 along the implant 700.

[0079] The implant 700 provided in this embodiment has a hollow structure in the circumferential direction, thereby reducing the weight of the implant 700, reducing the burden on the artificial chord X, and further reducing the postoperative risk; in addition, the hollow structure is also more conducive to the endothelialization of the implant 700 and more conducive to the postoperative recovery of the patient.

[0080] The following describes the usage process of the artificial chord length adjustment system 1000 of the present invention for adjusting the length of the artificial chord X implanted in the mitral valve.

[0081] The first step: After making a small incision through femoral artery puncture, a puncture guide wire (not shown in the figure) is sent from the femoral artery - abdominal aorta - thoracic aorta - aortic arch to the left ventricle to establish a track from outside the body to inside the body.

[0082] In the second step, please refer to Figure 19 , and feed the adjustable bending tube 11 along the puncture guide wire until the distal end of the adjustable bending tube 11 enters the left ventricle and reaches near the artificial chord X, then withdraw the puncture guide wire.

[0083] In the third step, please refer to Figure 6 , the pre-shaped tube 200 and the wire gripper 400 are installed in parallel in the adjustable bending tube 11 of the bending adjustment device 100, and the wire gripper 400 is located on the inner bending side of the bending section 210 of the pre-shaped tube 200 (please refer to Figure 9 in combination), so as to ensure that the distal end of the wire gripper 400 is on the same side as the distal end of the bent pre-shaped tube 200 after being sent out, which is convenient for capturing the artificial chord X.

[0084] In the fourth step, send the pre-shaped tube 200 and the wire gripper 400 along the adjustable bending tube 11 of the bending adjustment device 100 to near the artificial chord X, and control the distance within the spherical area with a radius of 5 mm from the artificial chord X;

[0085] In the fifth step, pass the pre-shaped tube 200 out of the inner cavity of the adjustable bending tube 11 of the bending adjustment device 100. Due to its own shaping characteristics, the pre-shaped tube 200 returns to its original state, and the distal end of the pre-shaped tube 200 crosses over the artificial chord X and wraps the artificial chord X in an arc; during this process, when the distance that the pre-shaped tube 200 passes out of the distal end of the adjustable bending tube 11 is less than 5 mm, it basically moves straight forward to a distance, and continue to feed the pre-shaped tube 200 until the distal end of the pre-shaped tube 200 gradually bends and moves away and can bypass the artificial chord X. During this process, the operator can pull the pre-shaped tube 200 while using ultrasound to judge whether the artificial chord X is captured by the arc-shaped bending section 210 of the pre-shaped tube 200. If the bending section 210 of the pre-shaped tube 200 fails to capture the artificial chord X successfully, withdraw the bending section 210 of the pre-shaped tube 200 into the bending adjustment device 100, repeat the capture process to capture the artificial chord X until it is confirmed to be captured;

[0086] In the sixth step, when the artificial chord X is captured by the bending section 210 of the pre-shaped tube 200, the wire gripper 400 and the control rod 430 of the wire gripper 400 (please refer to Figure 11 in combination) are basically parallel to the straight section of the pre-shaped tube 200. Push the control rod 430 of the wire gripper 400 to make the distal end of the wire gripper 400 pass out of the inner cavity of the bending adjustment device 100, and the capture loop 410 approaches the distal end of the pre-shaped tube 200. Then continue to push the capture loop 410 forward, and the distal end of the pre-shaped tube 200 can be sleeved into the capture loop 410 to realize the overlap of the distal end of the pre-shaped tube 200 and the distal end of the wire gripper 400. After that, the wire feeding guide wire 310 (please refer to Figure 10)It is pushed out from the distal end of the pre-shaped tube 200, and the distal end of the wire feeding guide wire 310 also enters the capture loop 410. Then, the pre-shaped tube 200 is withdrawn from the bending adjustment device 100. At this time, the wire feeding guide wire 310 is sleeved in the capture loop 410.

[0087] Step 7, please refer to Figure 7 , retract the control rod 430 to drive the capture loop 410 to retract until the capture loop 410 retracts into the adjustable bending tube 11 (please refer to Figure 3 ) The distal end of the wire feeding guide wire 310 is blocked by the distal end face of the adjustable bending tube 11, so that the distal end of the wire feeding guide wire 310 is connected to the capture loop 410 in a U shape. Relying on the deformation of the capture loop 410 in the adjustable bending tube 11, the wire feeding guide wire 310 can be pulled proximally and pulled out from the proximal end of the bending adjustment device 100, so as to pull the end of the pulling wire 330 connected to the connecting sleeve 320 to the proximal end and pull it out from the proximal end of the bending adjustment device 100. At this time, the pulling wire 330 is connected to the artificial chord X in a U shape, as Figure 8a shown.

[0088] Step 8, please refer to Figure 16a , pass the two free ends of the U-shaped pulling wire 330 (labeled 300 in the figure) through the receiving grooves 63 at the distal end of the implant 600 and through the first through hole 61 and the second through hole 62 respectively, and pass through the inner cavity of the push rod 500 (please refer to Figure 14 ) and extend to the outside of the proximal end of the push rod 500. Then push the push rod 500 so that the distal end of the push rod 500 fits against the proximal end of the implant 600, and then drive the implant 600 to enter the patient's body along the pulling wire 330 until the implant 600 reaches near the artificial chord X; tighten the pulling wire 330 to pull part of the artificial chord X into the implant 600, and the artificial chord X is pulled to form a U-shaped bend in the large cavity at the distal end of the implant 600, thereby changing the effective length of the artificial chord X and realizing the regulation of the artificial chord X.

[0089] Step 9, please refer to Figure 20 , withdraw the push rod 500, tighten the U-shaped pulling wire 330 and tie a knot and fix it outside the implant 600 to lock the effective length of the adjusted artificial chord X, cut off the excess pulling wire 330, complete the regulation process of the artificial chord X, and relieve or treat mitral regurgitation.

[0090] The push rod 500, the wire embedding device 2000 and the adjustable bending tube 11 in the present invention are all made of flexible and bendable materials to reduce the damage to the artificial chord X and avoid damaging human tissues or natural chords. For example, metal tubes such as thinner stainless steel tubes are used, and polymer tubes such as PEEK tubes with thinner wall thickness are used. The outer diameters of the materials of the wire embedding device 2000, the push rod 500 and the adjustable bending tube 11 are small, so the tissue damage is small and the passability in blood vessels is also good.

[0091] An artificial chordae tendineae length adjustment system 1000 provided by the present invention passes a wire feeder 300 through a pre-shaped tube 200, and the pre-shaped tube 200 and a wire gripper 400 are jointly passed through an adjustable bending tube 11. After the pre-shaped tube 200 is pushed out from the adjustable bending tube 11, it forms an arc to wrap the artificial chordae tendineae X. The wire feeder 300 passes through the pre-shaped tube 200, and the distal end of the wire feeder 300 enters the wire gripper 400. The wire gripper 400 pulls out one end of the wire feeder 300. At this time, the wire feeder 300 is U-shaped and connected to the artificial chordae tendineae X. The implant 600 passes through the U-shaped wire feeder 300 and is pushed by the push rod 500 to contact the artificial chordae tendineae X. The artificial chordae tendineae X is bent by relying on the implant 600, thereby shortening the effective length of the artificial chordae tendineae X and regulating the artificial chordae tendineae X. Through a minimally invasive method, the artificial chordae tendineae X implanted in the mitral valve is regulated to weaken or eliminate the secondary mitral regurgitation caused by the relaxation of the artificial chordae tendineae X. Compared with the prior art, it has at least the following beneficial effects: The artificial chordae tendineae length adjustment system 1000 is a flexible system, which is more suitable for remote intervention, causes less damage to the human body, and reduces the surgical risk; The artificial chordae tendineae X is pulled by the flexible pulling wire 330, causing less long-term damage to the artificial chordae tendineae X and improving the effective life of the artificial chordae tendineae X.

[0092] The above are some embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and retouches can be made, and these improvements and retouches are also regarded as the protection scope of the present invention.

Claims

1. An artificial chordae tendineae length adjustment system, characterized in that, Comprising an implant, a wire embedding device and a push rod, the wire embedding device includes: A hollow bending adjustment device, A pre-shaped tube, at least one arc-shaped bending section being provided at the distal end of the pre-shaped tube; the pre-shaped tube is movably inserted into the bending adjustment device; A wire feeder, the wire feeder is movably inserted into the pre-shaped tube, the distal end of the wire feeder extends out of the distal end of the pre-shaped tube and surrounds the artificial tendon cord, and the wire feeder is made of a flexible material; A wire gripper, running parallel to the pre-shaped tube and movably inserted into the bending adjustment device; the wire gripper extends out of the distal end of the bending adjustment device and overlaps the distal end of the wire feeder to surround the artificial tendon cord; the wire gripper retracts into the inner cavity of the bending adjustment device and drives the distal end of the wire feeder to fold, and the folded wire feeder pulls the artificial tendon cord; The implant is conveyed along the folded wire feeder and houses the part of the artificial tendon cord pulled by the wire feeder; at the proximal end of the implant, a first through hole and a second through hole are arranged in parallel at intervals along the axis, and at the distal end of the implant, there is a receiving groove communicating with the first through hole and the second through hole; both the first through hole and the second through hole are used to house and pass through the wire feeder, and the receiving groove is used to house the part of the artificial tendon cord pulled by the wire feeder; The distal end of the push rod abuts against the proximal end of the implant, and the implant is conveyed along the wire feeder under the pushing of the push rod until the part of the artificial tendon cord pulled by the wire feeder is housed in the inner cavity of the implant.

2. The artificial chordae tendineae length adjustment system according to claim 1, characterized in that The pre-shaped tube extends out of the distal end of the bending adjustment device and surrounds the artificial tendon cord in an arc shape.

3. The artificial chordae tendineae length adjustment system according to claim 2, characterized in that, The length of the pre-shaped tube is greater than or equal to 1100 mm, and the bending radius range of the bending section is 5 mm to 9 mm.

4. The artificial chordae tendineae length adjustment system according to claim 2, characterized in that, The wire gripper is located on the inner bending side of the bending section of the pre-shaped tube.

5. The artificial chordae tendineae length adjustment system according to claim 1, wherein The wire feeder includes a wire guiding wire and a pulling wire connected to the proximal end of the wire guiding wire, the softness of the wire guiding wire is greater than that of the pulling wire, and the proximal end of the pulling wire is a free end and extends out of the proximal end of the bending adjustment device.

6. The artificial chordae tendineae length adjustment system according to claim 5, characterized in that, The length of the pulling wire is greater than or equal to twice the length of the wire guiding wire.

7. The artificial chordae tendineae length adjustment system according to claim 5, characterized in that, The pulling wire is made of a flexible material, and the pulling wire pulls the artificial tendon cord in a U shape in the implant.

8. The artificial chordae tendineae length adjustment system according to claim 1, characterized in that The wire gripper includes a control rod and a grasping ring provided at the distal end of the control rod, the distal end of the control rod and the grasping ring extend out of the distal end of the bending adjustment device, and the grasping ring is used to connect the distal end of the wire feeder so that the distal end of the wire feeder is retracted into the bending adjustment device under the action of the grasping ring.

9. The artificial chordae tendineae length adjustment system according to claim 8, wherein, The grasping ring is made of a flexible material, and when the distal end of the control rod and the grasping ring extend out of the distal end of the bending adjustment device, the distal end of the control rod and the grasping ring bend towards the distal end of the wire feeder.

10. The artificial chordae tendineae length adjustment system according to claim 1, characterized in that, The bending adjustment device includes an adjustable bending tube and a traction wire embedded in the tube wall of the adjustable bending tube, the adjustable bending tube has an adjustable bending section, the distal end of the traction wire is connected to the adjustable bending section of the adjustable bending tube, and the proximal end of the traction wire passes through the tube wall at the proximal end of the adjustable bending tube.

11. The artificial chordae tendineae length adjustment system according to claim 1, characterized in that, A hollowed-out portion is provided on the outer peripheral surface of the implant, and the hollowed-out portion radially communicates with the first through hole, the second through hole and the receiving groove along the implant.

12. The artificial chordae tendineae length adjustment system according to claim 1, characterized in that Both the push rod and the wire embedding device are made of flexible and bendable materials.

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