CN109833117B - Bilateral artificial chordae tendineae implantation system - Google Patents

Bilateral artificial chordae tendineae implantation system Download PDF

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Publication number
CN109833117B
CN109833117B CN201711214263.2A CN201711214263A CN109833117B CN 109833117 B CN109833117 B CN 109833117B CN 201711214263 A CN201711214263 A CN 201711214263A CN 109833117 B CN109833117 B CN 109833117B
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China
Prior art keywords
clamping
artificial chordae
bilateral
chordae
implantation system
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CN201711214263.2A
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CN109833117A (en
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张庭超
张伟伟
潘湘斌
孟旭
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Hangzhou Valgen Medtech Co Ltd
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Hangzhou Valgen Medtech Co Ltd
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Priority to CN201711214263.2A priority Critical patent/CN109833117B/en
Priority to PCT/CN2018/102166 priority patent/WO2019105073A1/en
Publication of CN109833117A publication Critical patent/CN109833117A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Abstract

The invention discloses a bilateral artificial chordae tendineae implantation system, which comprises a clamping device, a puncture device and a pushing device, wherein the pushing device comprises a pushing catheter, the clamping device comprises a clamping push rod, a far-end chuck and a near-end chuck, the far-end chuck and the near-end chuck are used for clamping valve leaflets in a matching mode, the near-end chuck is arranged at the far end of the pushing catheter, the far-end chuck is arranged at the far end of the clamping push rod, the clamping push rod is movably arranged on the approximate central shaft of the pushing catheter, the puncture device comprises at least one pair of puncture push rods and puncture needle heads respectively arranged at the far ends of the puncture push rods, and the puncture push rods are movably arranged. The bilateral artificial chordae tendineae implanting system can clamp the anterior leaflet and the posterior leaflet of the mitral valve at the same time, and then implant the artificial chordae tendineae in the anterior leaflet and the posterior leaflet of the mitral valve at the same time, thereby greatly shortening the operation time and improving the operation efficiency.

Description

Bilateral artificial chordae tendineae implantation system
Technical Field
The invention belongs to the technical field of medical instruments, relates to an instrument for repairing a heart valve defect, and particularly relates to a bilateral artificial chordae tendineae implantation system.
Background
The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. Referring to fig. 1, a normal, healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the chordae tendineae or papillary muscles are diseased, such as the chordae tendineae of the posterior leaflet shown in fig. 2, and the mitral valve fails to return to the closed state as it would if it were in the normal state when the left ventricle were in the contracted state, the momentum of the blood flow may further cause the leaflets to fall into the left atrium, causing blood backflow.
At present, the mode of implanting artificial chordae tendineae in a surgical operation is generally adopted to treat chordae tendineae lesion, invasive thoracotomy technology is adopted, and general anesthesia and moderate low-temperature extracorporeal circulation are carried out as auxiliary support. The surgical operation has the defects of complex operation process, high operation cost, high wound degree of patients, high complication risk, long hospitalization time, pain in the recovery process of the patients and the like.
Another treatment is the implantation of artificial chordae tendineae in a minimally invasive manner. In the prior art, an instrument for implanting an artificial chordae tendineae in a minimally invasive manner comprises a handle assembly, a capture assembly, a needle and other assemblies; after the valve leaflets are captured by the closable capture assembly, the valve leaflets are punctured by the needle and then the artificial chordae tendineae are hooked. The instrument can only implant the artificial chordae tendineae at one side of the anterior leaflet or the posterior leaflet of the mitral valve in each operation, and the operation efficiency is low and the operation time is long.
Disclosure of Invention
The present invention is directed to solve the above-mentioned problems of the prior art, and provides a bilateral artificial chordae implantation system capable of implanting artificial chordae tendineae in the anterior leaflet and the posterior leaflet of the mitral valve at the same time, improving the operation efficiency, and saving the operation time.
The technical scheme adopted by the invention for solving the technical problems is as follows:
the bilateral artificial chordae tendineae implanting system comprises a clamping device, a puncturing device and a pushing device. The pushing device comprises a pushing catheter. The pushing catheter is provided with a plurality of through inner cavities along the axial direction. The clamping device comprises a clamping push rod, a far-end chuck and a near-end chuck, wherein the far-end chuck and the near-end chuck are used for cooperatively clamping the valve leaflets. The proximal collet is disposed at a distal end of the pusher catheter. The distal end chuck is disposed at a distal end of the clamping push rod. The clamping push rod is movably arranged at the position of the central shaft of the pushing conduit in a penetrating way. The puncture device comprises at least one pair of puncture push rods and puncture needle heads respectively arranged at the far ends of the puncture push rods. The puncture push rod is movably arranged in the pushing guide pipe in a penetrating way and is symmetrically arranged relative to the clamping push rod. Therefore, the clamping device of the bilateral artificial chordae tendineae implantation system can simultaneously clamp the anterior leaflet and the posterior leaflet of the mitral valve, and then at least one pair of puncture push rods positioned at two sides of the clamping push rods drives the puncture needle heads to respectively puncture the anterior leaflet and the posterior leaflet of the mitral valve, thereby realizing the implantation of the artificial chordae tendineae at two sides.
In the bilateral artificial chordae tendineae implantation system, the distal end of the puncture needle is preferably a straight tip with a conical shape.
In the bilateral artificial chordae tendineae implantation system, the diameter of the push catheter is preferably in the range of 10mm to 12 mm.
In the bilateral artificial chordae implantation system, it is preferable that the bilateral artificial chordae implantation system further includes at least one pair of artificial chordae. Each artificial chordae tendineae comprises a section of flexible chordae body. The tendon body has opposing first and second ends. The first end and/or the second end is connected with a fixing piece. The fixing piece is used for being fixedly connected with the puncture needle head in an unremovable mode or fixedly connected with the puncture needle head in a detachable mode.
In the bilateral artificial chordae implantation system, preferably, the chordae body is accommodated in the clamping push rod and the distal collet. The fixing pieces are accommodated in the far-end chuck, and the near end of each fixing piece corresponds to one puncture needle head respectively.
In the bilateral artificial chordae implantation system, an artificial chordae channel is preferably arranged in the clamping push rod along the axial direction, an artificial chordae housing cavity is arranged in the far-end chuck, and the artificial chordae housing cavity penetrates through to the near-end surface of the far-end chuck. The artificial chordae channel is communicated with the artificial chordae accommodating cavity, and the chordae body is accommodated in the artificial chordae channel and the artificial chordae accommodating cavity.
In the bilateral artificial chordae tendineae implanting system, preferably, a fixing cavity for accommodating the fixing piece is arranged on the proximal end face of the distal clamping head. The fixed cavity is axially communicated with the artificial chordae tendineae accommodating cavity.
In the bilateral artificial chordae tendineae implantation system, preferably, the shape of the fixed cavity is matched with that of the fixed part, and the diameter of an inscribed circle of the fixed cavity is larger than that of an circumscribed circle of the artificial chordae tendineae accommodating cavity.
In the bilateral artificial chordae implantation system, preferably, the chordae main body is further sleeved with an anti-slip piece. The anti-skidding piece is provided with a binding face which is attached to the valve leaflet, and the anti-skidding piece slides along the axial direction of the tendon main body.
In the bilateral artificial chordae tendineae implanting system, preferably, an artificial chordae tendineae accommodating cavity is arranged in the far-end chuck, a fixing cavity for accommodating the fixing piece and an accommodating groove for accommodating the anti-slip piece are arranged on the clamping surface of the far-end chuck, the accommodating groove is radially communicated with the artificial chordae tendineae accommodating cavity, and the accommodating groove is radially communicated with the fixing cavity.
In the bilateral artificial chordae implantation system, preferably, the bilateral artificial chordae implantation system further comprises a clamping assistance device. The clamping auxiliary device comprises at least two clamping auxiliary arms movably penetrating in the push guide pipe and clamping auxiliary pieces respectively arranged at the far ends of the clamping auxiliary arms. The at least two clamping auxiliary arms are symmetrically arranged relative to the clamping push rod. The clamping aid is made of an elastic and/or flexible material. The clamping auxiliary arm pushes the clamping auxiliary piece connected with the clamping auxiliary arm to penetrate out of the far end of the pushing guide pipe or the far end of the clamping device, and the clamping auxiliary piece and the clamping device are matched to clamp the valve leaflets.
In the bilateral artificial chordae tendineae implanting system, preferably, an auxiliary arm accommodating cavity is axially arranged in the pushing catheter, and an included angle between the axial direction of the distal end part of the auxiliary arm accommodating cavity and the axial direction of the pushing catheter ranges from 120 degrees to 150 degrees.
In the bilateral artificial chordae implantation system, it is preferable that the clamping aid is made of an X-ray opaque material.
Compared with the prior art, the bilateral artificial chordae tendineae implantation system has the following beneficial effects: the centre gripping push rod sets up in the approximate center pin department of propelling movement pipe, and at least a pair of puncture push rod sets up in the propelling movement pipe and sets up about the centre gripping push rod symmetry, consequently can centre gripping mitral valve's anterior leaflet and posterior leaflet simultaneously through the relative motion between near-end chuck and the distal end chuck, and then implants artificial chordae tendineae in mitral valve's anterior leaflet and posterior leaflet simultaneously, shortens operation time greatly, improves operation efficiency.
Drawings
The invention will be further described with reference to the accompanying drawings and examples, in which:
FIG. 1 is a schematic view of normal chordae tendineae in a heart;
figure 2 is a schematic illustration of chordae rupture in the heart;
fig. 3 is a schematic structural view of a bilateral artificial chordae implantation system according to a first embodiment of the invention;
FIG. 4 is a schematic view of the clamping device closed in the bilateral artificial chordae implantation system of FIG. 3;
fig. 5 is a schematic view of the artificial chordae in the bilateral artificial chordae implantation system of fig. 3;
figure 6 is a schematic structural view of another embodiment of an artificial chordae tendineae;
figure 7 is a schematic structural view of another embodiment of an artificial chordae tendineae;
FIG. 8 is a schematic view of the fastener attached to the puncture needle in the double-sided artificial chordae implantation system of FIG. 3;
FIG. 9 is a schematic view of the clamping push rod and distal collet of the bilateral artificial chordae implantation system of FIG. 3;
FIG. 10 is a schematic view of the configuration of the proximal face of the distal collet of FIG. 9;
FIG. 11 is a sectional view A-A of FIG. 10;
12a-12c are schematic views of another embodiment of the proximal face of the distal collet, wherein FIG. 12a is a schematic view of the structure of the proximal face of the distal collet, FIG. 12B is a cross-sectional view A-A of FIG. 12a, and FIG. 12c is a cross-sectional view B-B of FIG. 12 a;
figure 13 is an exploded view of a bilateral artificial chordae implantation system according to a second embodiment of the invention;
figure 14 is a radial cross-sectional view of the push catheter in the bilateral artificial chordae implantation system of figure 13;
figure 15 is a schematic view of the proximal face of the distal collet in the bilateral artificial chordae implantation system of figure 13;
FIG. 16 is a sectional view A-A of FIG. 15;
FIG. 17 is a cross-sectional view B-B of FIG. 10;
figure 18 is an exploded view of a bilateral artificial chordae implantation system according to a third embodiment of the present invention;
figure 19 is an axial cross-sectional view of the pusher catheter in the bilateral artificial chordae implantation system of figure 18;
figures 20 and 21 are schematic views of the bilateral artificial chordae implantation system of figure 18 with the clamping aid extending from the opening;
figure 22 is a schematic view of the clamping aid and clamping aid arm of the bilateral artificial chordae implantation system of figure 18;
FIG. 23 is a schematic structural view of another embodiment of a grip assist apparatus;
FIG. 24 is a schematic structural view of another embodiment of a grip assist apparatus;
FIG. 25 is a schematic structural view of another embodiment of a grip assist apparatus;
fig. 26 to 32 are schematic views showing a process of implanting an artificial chordae using the artificial chordae implanting system according to the third embodiment of the present invention.
Detailed Description
For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.
For convenience of description, the proximal orientation is defined as the proximal end, and the distal orientation is defined as the distal end.
Example one
As shown in fig. 3-12, the bilateral artificial chordae implantation system of the present invention is used to implant artificial chordae 100 into a patient's heart to replace diseased chordae of the anterior and posterior leaflets of the mitral valve. The bilateral artificial chordae implantation system includes a holding device 300, a puncturing device 400, and a pushing device 200. The pusher device 200 includes a pusher catheter 210. The push catheter 210 has a plurality of lumens formed therethrough in the axial direction. The gripping device 300 includes a gripping push rod 330 and a distal collet 310 and a proximal collet 320 for cooperatively gripping the valve leaflets. A proximal collet 320 is disposed at the distal end of the pusher catheter 210 and a distal collet 310 is disposed at the distal end of the gripping pusher 330. The holding push rod 330 is movably inserted into the substantially central axis of the push catheter 210. The puncture device 400 includes at least a pair of puncture push rods 420 and puncture needles 410 respectively disposed at distal ends of the puncture push rods 420. The puncture push rod 420 is movably inserted into the push catheter 210 and is symmetrically arranged with respect to the holding push rod 330. Therefore, the clamping device 300 of the bilateral artificial chordae tendineae implantation system of the present invention can simultaneously clamp the anterior leaflet and the posterior leaflet of the mitral valve, and then the puncture needle 410 is driven by at least one pair of puncture push rods 420 located at both sides of the clamping push rod 330 to respectively puncture the anterior leaflet and the posterior leaflet of the mitral valve, thereby achieving bilateral artificial chordae tendineae implantation.
The bilateral artificial chordae implantation system of the first embodiment includes a pair of artificial chordae 100. Each artificial tendon 100 includes a flexible tendon body 110. The chordae body 110 is for implantation within the heart to replace diseased chordae within the heart. The tendon body 110 has opposing first and second ends. A fastener 120 is attached to the first end and/or the second end. The holder 120 is adapted to be non-removably secured or removably secured to the puncturing device 400.
The chordae body 110 may be secured between the leaflets and the ventricular wall (or papillary muscles) to replace diseased chordae to maintain tension between the leaflets and the ventricular wall. The cord body 110 is flexible in the sense that it can be bent at will without stretching in the axial direction, typically the cord body 110 takes the form of a flexible wire. The material of the tendon main body 110 may be a polymer material compatible with the human body or a relatively soft metal material. Preferably a polymer material such as PTFE.
The first and second ends of the tendon body 110 do not differ in direction, importance, etc. The fixing member 120 may be provided only at one end of the tendon main body 110 as shown in fig. 5, or may be provided at both ends of the tendon main body 110 as shown in fig. 6. The fixing member 120 is provided only at the first end of the tendon main body 110 in this embodiment. The tendon main body 110 and the fixing member 120 may be fixedly connected by knotting, winding, welding, bonding, or clipping. For example, one end of the main body 110 of the tendon can be passed through the fixing member 120 and then knotted to form a coil with a larger diameter; or welding the tail end into a round ball with a larger diameter; or the tail end is provided with a positioning rod, the axial direction of the positioning rod in the natural state is different from the axial direction of the tendon main body 110 and the fixing piece 120, after one end of the positioning rod and the tendon main body 110 passes through the fixing piece 120, the positioning rod returns to the natural state and can be clamped on the back surface of the fixing piece 120, and therefore one end of the tendon main body 110 is fixed on the fixing piece 120. As shown in fig. 5, since the second end of the chordae main body 110 is not provided with the fixing member 120, the diameter of the second end should be made larger than that of the chordae main body 110 by knotting, winding, or providing a bulbous end, a disc-shaped end, etc. in order to fix the second end of the chordae main body 110 to the upper surface of the leaflet.
The holder 120 is designed to form a detachable or non-detachable fixed connection with the puncture needle 410 of the puncture device 400, and is shaped to fit different connection methods. The exterior of the fixing member 120 is generally cylindrical, and the cross-sectional shape may be circular, elliptical, polygonal, etc., and is preferably circular or elliptical.
The attachment between the securing element 120 and the piercing needle 410 may be by a variety of means, such as a threaded connection, an adhesive connection, a friction connection through a roughened surface, an interference fit, or a snap-fit connection. As shown in fig. 8, in this embodiment, a snap connection is adopted, specifically, three grooves or holes 125 are radially arranged on the inner surface of the fixing member 120, and are engaged with and clamped between the protruding edge 411 or the protrusion arranged on the puncture needle 410 to form a fixed connection. The three grooves 125 can ensure the stability of the connection between the fixing member 120 and the puncture needle 410, reduce the swing amplitude of the puncture needle 410 after the connection, and also avoid the increase of the diameter of the puncture point due to the additional increase of the diameter of the puncture needle 410.
Referring to fig. 5 and 6, in order to increase the point contact between the artificial chordae 100 and the valve leaflet to surface contact, thereby reducing the risk of the artificial chordae 100 tearing the valve leaflet, it is preferable that the chordae body 110 is sleeved with a slip prevention element 130, and the slip prevention element 130 can slide along the axial direction of the chordae body 110. Since the anti-slip element 130 is pre-arranged on the main body 110 of the chordae tendineae, after the puncture needle 410 punctures the leaflet and is fixedly connected with the main body 110 of the chordae tendineae, the anti-slip element 130 can be brought to the puncture point and fixed on the leaflet together with the main body 110 of the chordae tendineae. The concrete arrangement mode of the anti-skid member 130 on the artificial chordae tendineae 100 is as follows: the anti-slip member 130 is provided with a through hole 131, and the tendon main body 110 passes through the through hole 131. The number of the through holes 131 is related to the fixing manner of the anti-slip member 130. One way is to provide the anti-slip member 130 with a through hole 131, and the main body 110 of the tendon is passed through the through hole 131 (as shown in fig. 5). Alternatively, the anti-slip device 130 is provided with at least two through holes 131, and the first end and the second end of one of the tendon main bodies 110 are respectively inserted through different through holes 131 (as shown in fig. 6). In order to prevent the anti-slip member 130 from falling off the artificial chordae 100, the diameter of the through hole 131 is smaller than that of the fixing member 120, and the second end of the chordae body 110, where the fixing member 120 is not provided, should be formed by knotting, or providing a ball-shaped end, a disc-shaped end, etc. such that the diameter of the second end is larger than that of the through hole 131 of the anti-slip member 130 (as shown in fig. 5).
In order to distribute the force of the main body 110 to the leaflets as much as possible to the contact surfaces between the anti-slip elements 130 and the leaflets, the anti-slip elements 130 need to be attached to the leaflets as much as possible, so that the anti-slip elements 130 have attachment surfaces 132 attached to the leaflets. The specific structure of the anti-slip member 130 is not limited except for the abutting surface 132, and various structures are possible: for example, the shape may be a sheet, a disk or a sphere having a certain area, or even an irregular shape, preferably a sheet. The anti-slip member 130 may be a non-porous structure, a net structure, a bar-grid structure, etc. The anti-slip member 130 should be made of a biocompatible material, and may be made of an elastic material or a non-elastic material. Specifically, the anti-slip member 130 is selected from at least one of an elastic pad, a heart patch, a felt sheet, a mesh structure, a disc structure, or a double disc structure. The structure of the anti-slip member 130 having a disc-like structure or a double disc-like structure is similar to the stopper in the prior art, and will not be described in detail herein. Preferably, in order to reduce the overall size of the instrument, the anti-slip member 130 having a disc-like structure or a double disc-like structure should be made of a shape memory material.
As shown in fig. 7, the anti-slip member 130 may not be provided on the main body 110, and the main body 110 may be fixed between the leaflet and ventricular wall or papillary muscle to replace the diseased chordae tendineae as long as the fixing member 120 is fixedly connected to the puncture needle 410.
Referring again to fig. 3 and 4, the main structure of the pushing device 200 is a pushing catheter 210. The pusher catheter 210 is a tubular or rod-shaped body having an axial length, preferably circular in cross-section, with a diameter in the range of 10mm to 12 mm. The pusher catheter 210 has a plurality of spaced through lumens disposed axially therethrough. The push catheter 210 may be a multi-lumen tube formed integrally, or the outer tube and the inner tube may be fixed together to form the push catheter 210 of an integral structure. The pusher catheter 210 may be made of a biocompatible polymeric material (e.g., polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile butadiene styrene ABS, nylon elastomer Pebax, or polyurethane PU), a metallic material (e.g., stainless steel or nitinol), or a metal-polymer composite. The proximal end of the pusher catheter 210 is provided with a first handle 201 for manipulating the pusher catheter 210 to be pushed distally or retracted proximally.
The puncture device 400 is movably inserted into the lumen of the pusher catheter 210. In order to achieve bilateral artificial chordae tendineae implantation of the anterior and posterior leaflets of the mitral valve, the puncture device 400 includes at least a pair of puncture push rods 420 and puncture needles 410 respectively disposed at distal ends of the puncture push rods 420. Each piercing push rod 420 has a certain axial length, and the two piercing push rods 420 are symmetrically disposed about the grip push rod 330 (i.e., the central axis of the pusher catheter 210). The puncture needle 410 may be connected to the fixing member 120 of the artificial chordae 100 after puncturing the leaflet to pull the chordae body 100 proximally.
The distal end of piercing needle 410 is tapered with a straight tip to facilitate piercing the leaflets and reducing the diameter of the puncture site it forms on the leaflets. Adopt the syringe needle that has hook-like head end among the prior art to pass the valve leaflet to collude the stylolite as artifical chordae tendineae, then withdraw the syringe needle and drive artifical chordae tendineae and pass the valve leaflet, fix artifical chordae tendineae on the ventricular wall again, the puncture point that this kind of syringe needle that has hook-like head end formed on the valve leaflet is bigger than normal, and is great to the valve leaflet damage, not only influences the process that patient's postoperative resumes, still can increase the valve leaflet and be torn the risk. And the conical straight tip forms a small puncture point on the valve leaflet, which is beneficial to the postoperative healing of a patient. The double-sided artificial chordae implantation system of the present embodiment forms a single puncture point on each leaflet ranging from 0.3mm to 1.5mm in diameter, and further, the diameter of the puncture point can be controlled to be about 0.7mm by selecting an appropriate shape and diameter of the puncture needle 410.
The distal end of the piercing needle 410 is provided with at least one tooth or at least one ring of ledges 411 for forming an interference fit or snap connection with the fixture 120. It is understood that in other embodiments, the puncture needle 410 may be fixedly connected with the fixing member 120 of the artificial chordae 100 in a non-detachable or detachable manner by means of screw thread, adhesive, friction connection, or the like. The puncture needle 410 is connected with a puncture push rod 420 at the proximal end, and the puncture push rod 420 is movably arranged in the inner cavity of the pushing catheter 210 in a penetrating way. The proximal end of penetrating push rod 420 extends out of the proximal end of pusher catheter 210 and is connected to third handle 401. Therefore, the axial movement of the third handle 401 can drive the puncture push rod 420 to move along the axial direction of the pushing catheter 210, and further drive the puncture needle 410 to puncture distally or withdraw proximally. After the valve leaflet is clamped by the clamping device 300, the puncture needle 410 can be driven by the third handle 401 to puncture the valve leaflet and be connected with the fixing element 120 of the artificial chordae tendineae 100, and the puncture needle 410 and the artificial chordae tendineae 100 are connected into a whole through the fixing element 120. The probability of hooking the artificial chordae tendineae by the needle head with the hook-shaped head end in the prior art is low, so that the success rate of the operation is low, and the operation time is prolonged; and after the needle hooks the artificial chordae tendineae, because the needle is connected with the artificial chordae tendineae only through weak friction, in the process of withdrawing the needle, the artificial chordae tendineae are easy to fall off from the needle due to the blood flow scouring of a patient or the action of an operator, the operation time is prolonged, and even operation failure is caused. The puncture needle 410 of the present embodiment is stably and reliably connected to the main body 110 of the artificial chordae tendineae 100 by the fixing element 120, so that the artificial chordae tendineae 100 are not easily separated from the puncture needle 410, and the operator can conveniently and quickly pull one end or both ends of the artificial chordae tendineae 100 connected to the fixing element 120 to a predetermined position of the ventricular wall or the papillary muscle.
The clamping device 300 may simultaneously clamp the anterior and posterior leaflets of the mitral valve. The clamping device 300 includes a clamping push rod 330, a distal collet 310, and a proximal collet 320. The holding push rod 330 is movably inserted into the substantially central axis of the push catheter 210. A proximal collet 320 is disposed at the distal end of the pusher catheter 210. The distal collet 310 is disposed at the distal end of the gripping push rod 330. The proximal end of the gripping push rod 330 passes out of the proximal end of the pusher catheter 210 and is provided with a second handle 301. Thus, the second handle 301 is pushed distally to drive the clamping pushing rod 330 to move distally, so that the distal collet 310 is away from the proximal collet 320 to form an open state as shown in fig. 3, and a hollow cylindrical leaflet receiving space is formed between the distal collet 310 and the proximal collet 320 to simultaneously receive the anterior leaflet and the posterior leaflet of the mitral valve. The operator can adjust the distal end of the device to simultaneously enter the anterior leaflet and the posterior leaflet of the mitral valve into the leaflet receiving space between the distal collet 310 and the proximal collet 320, and then withdraw the second handle 301 proximally, which moves the clamping rod 330 proximally, so that the distal collet 310 approaches the proximal collet 320 to form a clamped state as shown in fig. 4, in which both the anterior leaflet and the posterior leaflet of the mitral valve are clamped and fixed by the clamping device 300. The shape of the proximal collet 320 and the distal collet 310 should match the shape of the pusher catheter 210, and the distal collet 310 and the proximal collet 320 should form a smooth exterior whole when closed to facilitate pushing and reduce trauma to the patient's wound. It will be appreciated that the aforementioned distally advancing of the second handle 301 to move the distal collet 310 away from the proximal collet 320 may also be achieved by proximally retracting the first handle 201 and advancing the catheter 210; proximal withdrawal of the second handle 301 to bring the distal collet 310 into proximity with the proximal collet 320 may also be achieved by distally advancing the first handle 201 and the pusher catheter 210.
To improve the stability of the clamping, the clamping surface of the proximal collet 320 (i.e., the distal surface of the proximal collet 320) and the clamping surface of the distal collet 310 (i.e., the proximal surface of the distal collet 310) should be flush with each other and have a larger leaflet contact area, respectively. The proximal face of the distal collet 310 acts as a gripping face for contact with the leaflets, preferably being provided as a conical surface projecting proximally from the distal end; while the distal face of the proximal collet 320, which serves as a gripping face for contact with the valve leaflets, is preferably provided as a conical surface that is concave from the distal end to the proximal end and is shaped to mate with the conical surface of the proximal face of the distal collet 310. In addition, a grip enhancing member for enhancing a grip force is provided on the grip surface of the distal collet 310 and/or the proximal collet 320. The grip-enhancing members are preferably at least one of protrusions, ridges, grooves or dimples, and the shape of the grip-enhancing members provided on the proximal face (i.e., gripping surface) of the distal collet 310 should be interfitted with the shape of the grip-enhancing members provided on the distal face (i.e., gripping surface) of the proximal collet 320 such that there is no gap between the closed distal collet 310 and the proximal collet 320. In this embodiment, the gripping surface of the distal collet 310 and the gripping surface of the proximal collet 320 are provided with a plurality of parallel ribs, respectively, as gripping enhancements, and when the distal collet 310 and the proximal collet 320 are closed, there is no gap therebetween.
As shown in fig. 9, the clamping push rod 330 is a tubular body or a hollow rod body with a certain axial length, the cross section is preferably oval or circular, and an artificial chordae passage 331 is axially provided in the clamping push rod 330. As shown in fig. 10-11, two artificial chordae receiving chambers 315 and 315 ' are provided in the distal collet 310, each communicating with the artificial chordae passage 331, the artificial chordae receiving chambers 315 and 315 ' each extending through to the proximal end surface of the distal collet 310, and the artificial chordae receiving chambers 315 and 315 ' are symmetrically disposed about the gripping push rod 330 (i.e., the central axis of the pusher catheter 210). That is, the distal end of the artificial chordae passage 331 is bifurcated into a Y-shape, with the two branches of the Y-shape bifurcated serving as artificial chordae housing cavities 315 and 315', respectively. The tendon main body 110 of one artificial tendon 100 is received in the artificial tendon channel 331 and the artificial tendon housing cavity 315, and the tendon main body 110 of the other artificial tendon 100 is received in the artificial tendon channel 331 and the artificial tendon housing cavity 315'.
The proximal end face of the distal collet 310 is provided with two fixation cavities 313 and 313 'for receiving the fixation elements 120 of the two artificial chordae tendineae 100, respectively, and the fixation cavities 313 and 313' are symmetrically arranged with respect to the gripping push rod 330 (i.e., the central axis of the pusher catheter 210). The fixing cavity 313 is axially communicated with the artificial chordae accommodating cavity 315; the fixing cavity 313 'is axially communicated with the artificial chordae accommodating cavity 315'. The positions of the two fixed cavities 313 and 313' correspond to the positions of the two piercing needles 420, respectively. Thus, the two fixing elements 120 of the two artificial chordae tendineae 100 are respectively accommodated in the distal collet 310, and the proximal end of each fixing element 120 corresponds to one puncture needle 410 respectively. Preferably, the proximal face of the distal collet 310 is elliptical and both fixation lumens 313 and 313' are located on the major axis of the ellipse to accommodate the shape of the mitral valve when the leaflets close.
It is understood that in other embodiments, the fixing cavities 313 and 313 'may be located at other positions of the ellipse, as long as the two fixing cavities 313 and 313' are symmetrically arranged, as shown in fig. 12a-12 c.
The prior art exposes artifical chorda tendineae outside the apparatus for the apparatus surface is not smooth, when leading to the apparatus to get into the human body, becomes the friction damage to the tissue, appears leaking blood simultaneously, has increased the risk that the patient produced postoperative complication. The fixation lumen 313 of this embodiment allows the artificial chorda 100 to be placed and secured inside the device, avoiding the problems described above. In addition, in the prior art, the artificial chordae tendineae implanted in a manner of combining the U-shaped ring sleeve with the hook-shaped needle can cause the fold of the valve edge of the valve leaflet, so that the artificial gap is formed at the position of the valve leaflet, the involution edge cannot be formed, the mitral valve regurgitation is easy to cause, and the operation effect is not ideal. In the bilateral artificial chordae implantation system provided by the embodiment, the distance between the fixing cavity 313 and the clamping push rod 330 is the distance between the implanted artificial chordae and the edge of the valve leaflet, so that the folding of the edge of the valve leaflet can be effectively avoided, and the operation effect can be enhanced.
Since the anti-slip members 130 are further provided on the artificial chordae tendineae 100, the proximal end surface of the distal collet 310 is provided with two receiving grooves 314 and 314 'for receiving the anti-slip members 130 of the two artificial chordae tendineae 100, respectively, and the receiving grooves 314 and 314' are symmetrically arranged with respect to the holding push rod 330 (i.e., the central axis of the pusher catheter 210). The accommodating groove 314 is in radial communication with the artificial chordae accommodating cavity 315, and the accommodating groove 314 'is in radial communication with the artificial chordae accommodating cavity 315'. The containing groove 314 is communicated with the fixing cavity 313 in the radial direction. The containing groove 314 'is communicated with the fixing cavity 313' in the radial direction. Therefore, after the two puncture needle heads 410 respectively puncture the anterior leaflet and the posterior leaflet of the mitral valve and are respectively connected with one fixing element 120, the two puncture needle heads 410 and the fixing element 120, the chordae main body 110 and the anti-slip element 130 which are respectively connected with the two puncture needle heads are driven to be sequentially pulled out from the proximal end surface of the distal chuck 310 by respectively withdrawing the pair of puncture push rods 420 towards the proximal end until the puncture needle head 410, the fixing element 120 and the chordae main body 110 on one side sequentially pass through the anterior leaflet of the mitral valve, the anti-slip element 130 is attached to the upper surface of the anterior leaflet of the mitral valve, the puncture needle head 410, the fixing element 120 and the chordae main body 110 on the other side sequentially pass through the posterior leaflet of the mitral valve, and the anti-slip element 130 is attached to the upper surface of the posterior leaflet of the mitral valve, thereby completing.
The fixing cavity and the receiving groove can be arranged to pull the main body 110 and the anti-slip element 130 to the valve leaflet without loosening the distal collet 310 and the proximal collet 320, so that the valve leaflet is separated from the clamping device 300 and recovers pulsation when the distal collet 310 and the proximal collet 320 are changed from the closed state to the open state, the main body 110 does not contact with the valve leaflet independently, and the linear cutting effect of the main body 110 is prevented from damaging the pulsating valve leaflet.
The dimensions of the fixing cavity 313, the accommodating groove 314, and the artificial tendon accommodating cavity 315 on the side of the clamping rod 330 will be described below. The fixing cavity 313 is sized such that the fixing member 120 of the artificial chorda tendineae 100 can be fixed in the fixing cavity 313 and smoothly pulled out from the fixing cavity 313 after the fixing member 120 is pulled by an external force. Therefore, the shape of the fixing cavity 313 matches the shape of the fixing member 120, and the diameter of the inscribed circle of the fixing cavity 313 is larger than the diameter of the circumscribed circle of the artificial chordae accommodating cavity 315. Preferably, the ratio of the diameter of the circumscribed circle of the artificial chordae accommodating cavity 315 to the diameter of the inscribed circle of the fixing cavity 313 is (0.2-0.4): 1. when the cross sections of the fixing cavity 313 and the artificial chordae accommodating cavity 315 are both circular, the diameter of the inscribed circle of the fixing cavity 313 is the diameter of the circular cross section of the fixing cavity 313, and the diameter of the circumscribed circle of the artificial chordae accommodating cavity 315 is the diameter of the circular cross section of the artificial chordae accommodating cavity 315. In this embodiment, the fixing cavity 313 is circular in cross-section with a diameter D1, the artificial chordae housing cavity 315 is circular in cross-section with a diameter D2, and D2 is 30% of D1. The purpose of this is: if D2 is too large, when the puncture needle 410 is pushed by the puncture push rod 420 to engage with the fixing element 120 of the artificial chordae tendineae 100, due to the pushing force of the puncture push rod 420 towards the distal end, the fixing element 120 may slip out of the fixing cavity 313 into the artificial chordae tendineae receiving cavity 315, so that the puncture needle 410 and the fixing element 120 of the artificial chordae tendineae 100 cannot be successfully connected at one time, thereby prolonging the operation time; if D2 is too small, the main body 110 of the artificial chordae 100 cannot pass through the artificial chordae housing 315, so that the puncture needle 410 cannot pull the artificial chordae 100 out of the holding surface of the distal clamp 310 after connecting to the fixing element 120 of the artificial chordae 100. It is understood that, in other embodiments, the cross-sections of the fixing cavity 313 and the artificial chordae receiving cavity 315 may also be in other shapes, such as an ellipse, a triangle, a quadrangle, a polygon, etc., as long as the shape of the fixing cavity 313 matches the shape of the fixing element 120, and the shape of the artificial chordae receiving cavity 315 does not affect the smooth passing of the chordae body 110 therein.
In order to pull the main body 110 and the anti-slip member 130 smoothly out of the clamping surface of the distal collet 310, the fixing cavity 313 and the receiving groove 314 are in radial communication. Preferably, the width D3 of the communication part between the fixing cavity 313 and the receiving groove 314 is 20% -50% of D1, which is set for the purpose of: if D3 is too large, the securing member 120 of the artificial chordae 100 may not be securely held within the securing cavity 313 of the distal collet 310 and may easily slip out of the securing cavity 313, directly resulting in failure of the instrument; if D3 is too small, after the puncture needle 410 is connected to the fixing member 120 of the artificial chordae 100, the fixing member 120 cannot be smoothly pulled out of the fixing cavity 313, resulting in a failed operation.
It can be understood that the dimensions of the fixing cavity 313 ', the accommodating groove 314 ' and the artificial chordae accommodating cavity 315 ' on the other side of the clamping push rod 330 are identical to those of the fixing cavity 313, the accommodating groove 314 and the artificial chordae accommodating cavity 315, and thus the detailed description is omitted.
Compared with the prior art, the bilateral artificial chordae tendineae implanting system provided by the embodiment has at least the following beneficial effects:
(1) the puncture needle head adopts a conical structure with a straight pointed end, the diameter of the puncture needle head is smaller, a puncture point formed on the valve leaflet is smaller, the damage to the valve leaflet is reduced, and the postoperative healing process of a patient is accelerated;
(2) the puncture needle head and the fixing piece of the artificial chordae tendineae are positioned through the clamping device, so that the matching probability of the puncture needle head and the fixing piece of the artificial chordae tendineae can be effectively improved, and the operation time is shortened;
(3) the puncture needle head and the artificial chordae tendineae can form stable and reliable indirect connection, so that the artificial chordae tendineae is not easy to separate from the puncture needle head, and the artificial chordae tendineae can be conveniently and quickly pulled to a fixed position;
(4) the centre gripping push rod sets up in the approximate center pin department of propelling movement pipe, and at least a pair of puncture push rod is the symmetry setting about the centre gripping push rod, and anterior leaflet and the posterior leaflet of mitral valve are held simultaneously in the relative motion between accessible near-end chuck and the distal end chuck, and then implant artifical chordae tendineae in anterior leaflet and the posterior leaflet of mitral valve simultaneously, shorten operation time greatly, improve operation efficiency.
Example two
The structure of the double-sided artificial chordae implantation system of the second embodiment is substantially the same as that of the double-sided artificial chordae implantation system of the first embodiment, except that in the double-sided artificial chordae implantation system of the second embodiment, the puncturing device comprises two pairs of puncturing push rods and puncturing needles respectively arranged at the distal ends of the puncturing push rods, and the structure of the artificial chordae is different from that of the artificial chordae of the first embodiment.
Specifically, as shown in fig. 13, in the double-sided artificial chordae tendineae implantation system of the second embodiment, the puncturing device 400 includes two pairs of puncturing push rods 420 and a puncturing needle 410 disposed at a distal end of each puncturing push rod 420. The two artificial chordae tendineae 100 are respectively accommodated in the clamping push rod 330, and each artificial chordae tendineae 100 takes the form of fig. 6, that is, the fixing members 120 are disposed at both ends of the chordae main body 110.
Referring to fig. 14, four puncture push rod channels 202 are provided in the pushing catheter 210, and one puncture push rod 420 is movably inserted into each puncture push rod channel 202. Thus, two puncture push rods 420 are provided as one pair on one side of the pusher catheter 210 (hereinafter referred to as "first side"), and the other two puncture push rods 420 are provided as another pair on the other side of the pusher catheter 210 opposite to the first side (hereinafter referred to as "second side"), and the two puncture push rods 420 in each pair are disposed symmetrically with respect to the central axis of the pusher catheter 210. For ease of operation, the proximal ends of both piercing push rods 420 in each pair are connected to the same handle 401.
The holding push rod 330 is movably inserted into the holding push rod channel 203 of the pusher catheter 210 and is positioned at a substantially central axis, whereby the four piercing push rods 420 are symmetrically disposed about the holding push rod 330. An artificial chordae passage 331 is axially disposed within the clamping push rod 330. Both artificial chordae 100 are received in artificial chordae channels 331 that grip the push rod 330. Four fasteners 120 are disposed in distal cartridge 310 and correspond to four piercing needles 410 at the distal end of four piercing push rods 420, respectively.
As shown in fig. 15 to 17, the distal collet 310 is provided with four artificial chordae housing cavities 315 each penetrating to the clamping surface of the distal collet 310, and the four artificial chordae housing cavities 315 are symmetrically disposed with respect to the clamping push rod 330 (i.e., the central axis of the pushing catheter 210), that is, two artificial chordae housing cavities 315 are provided on one side (hereinafter, referred to as "first side") of the distal collet 310 as a pair, and the other two artificial chordae housing cavities are provided on the other side (hereinafter, referred to as "second side") of the distal collet 310 opposite to the first side as another pair. The distal end of each artificial chordae accommodating cavity 315 is in axial communication with one of the fixation cavities 313, the ratio of the diameter D2 of each artificial chordae accommodating cavity 315 to the diameter D1 of the fixation cavity 313 to which it is connected being in the range (0.2-0.4): 1.
the two fixed chambers 313 on the first side communicate radially with each other, and the two fixed chambers 313 on the second side communicate radially with each other. The two artificial chordae housing cavities 315 on the first side are in radial communication with each other, and the two artificial chordae housing cavities 315 on the second side are in radial communication with each other. The main body 110 of one artificial tendon 100 is received in the artificial tendon channel 331 and the two artificial tendon receiving cavities 315 on the first side of the distal collet 310, and the main body 110 of the other artificial tendon 100 is received in the artificial tendon channel 331 and the two artificial tendon receiving cavities 315 on the second side of the distal collet 310. That is, the first end and the second end of each tendon main body 110 respectively penetrate through the artificial tendon channel 331 and then respectively penetrate through the two artificial tendon receiving cavities 315 located on the same side of the distal collet 310, and are respectively connected to one fixing member 120 accommodated in the fixing cavity 313.
Therefore, when the operator pushes the four puncture push rods 420 towards the distal end, respectively, and the four puncture needles 410 at the distal ends of the four puncture push rods 420 puncture the anterior leaflet and the posterior leaflet of the mitral valve, respectively, the two puncture needles 410 at the first side are connected to the two fasteners 120 at the first side, respectively, the two puncture needles 410 at the second side are connected to the two fasteners 120 at the second side, respectively, so that the tendon main body 110, the two fasteners 120 and the two puncture needles 410 at the two ends of the tendon main body 110 form a U-shaped structure, the other tendon main body 110, the two fasteners 120 and the two puncture needles 410 at the two ends of the tendon main body 110 also form a U-shaped structure, and then the operator withdraws the four puncture push rods 420 towards the proximal end to drive the two tendon main bodies 110 to be withdrawn from the proximal end surface of the distal collet 310, respectively, and a portion of the two tendon main bodies 110 are attached to the upper surfaces of the anterior leaflet and the posterior leaflet of the mitral valve, the remaining portion of the chordae body 110 then follows the anchors 120 and the piercing needle 410 through the anterior and posterior leaflet, respectively, until it reaches a predetermined location of the ventricular wall or papillary muscle. Therefore, the bilateral artificial chordae implantation system of the present embodiment can implant four artificial chordae 100 between the anterior leaflet and the posterior leaflet of the mitral valve and the ventricular wall or papillary muscle, respectively, quickly and conveniently, and avoid the leaflet damage caused by the vertical cutting effect of the chordae main body 110 on the leaflets.
The artificial chorda 100 in this embodiment is also provided with a slip stop 130. Referring again to fig. 6, the sheet-shaped anti-slip member 130 is provided with at least two through holes 131, and the first end and the second end of the tendon body 110 of one artificial tendon 100 are connected to one of the fixing members 120 after passing through one of the through holes 131 of the anti-slip member 130, respectively. Thus, before puncturing, the tendon main body 110 and the anti-slip member 130 form a closed state in a ring shape. After puncturing, the anti-slip member 130, the tendon main body 110, the two fixing members 120 and the two puncturing needles 410 form an open loop U-shaped state. And the main body 110 of the chordae tendineae presses the anti-slip element 130 to make the anti-slip element 130 cling to the upper surface of the valve leaflet, the relative positions between the main body 110 of the chordae tendineae and the anti-slip element 130 and the valve leaflet are basically fixed, and the valve leaflet is prevented from being torn caused by the implanted main body 110 of the chordae tendineae.
Referring again to fig. 15-17, the proximal surface of the distal collet 310 further defines two receiving slots 314 for receiving the anti-slip members 130, wherein the two receiving slots 314 are symmetrically disposed about the clamping push rod 330 (i.e., the central axis of the pusher catheter 210). The two fixing cavities 313 on the first side of the distal collet 310 are in radial communication with the receiving grooves 314 on the side, and the two fixing cavities 313 on the second side of the distal collet 310 are in radial communication with the receiving grooves 314 on the side. Thus, after puncturing, the main body 110, the two securing members 120 and the anti-slip member 130 on the same side can be pulled out of the proximal surface of the distal collet 310. Preferably, the width D3 of the communication part between the fixing cavity 313 and the receiving groove 314 at each side is 20% -50% of the diameter D1 of the fixing cavity 313.
Compared with the prior art, the bilateral artificial chordae tendineae implanting system of the embodiment has at least the following beneficial effects:
(1) a plurality of artificial chordae tendineae can be implanted into the anterior leaflet and the posterior leaflet of the mitral valve at the same time, so that the operation efficiency is improved;
(2) the point contact between the artificial chordae tendineae and the valve leaflets can be increased to surface contact through the anti-slip piece, the tail ends of the artificial chordae tendineae can be prevented from falling off from the anti-slip piece and the valve leaflets, and the operation effect can be maintained more effectively;
(3) the chordae main part is hugged closely the anti-skidding piece to the upper surface of leaflet, and the chordae main part and the fixed mode between anti-skidding piece and the leaflet is comparatively firm reliable, effectively avoids the risk that the leaflet tears or chordae main part and anti-skidding piece drop from the leaflet surface, and the operation effect is better.
EXAMPLE III
The third bilateral artificial chordae implantation system has substantially the same structure as the second bilateral artificial chordae implantation system, except that a clamping assistance device is further included.
Specifically, referring to fig. 18, the bilateral artificial chordae implantation system includes a clamping device 300, a puncture device 400, a pushing device 200, and a clamping assist device 500. The gripping pusher 330 of the gripping apparatus 300 is located at the substantially central axis of the pusher conduit 210. The grasping aid 500 includes at least one pair of grasping aid arms 520 movably inserted into the pushing catheter 210 and grasping aid members 510 respectively provided at distal ends of the grasping aid arms 520. Each pair of clamp assist arms 520 is symmetrically disposed about the clamp push rod 330 (i.e., the central axis of the pusher catheter 210). To facilitate pushing, a fourth handle 501 may also be provided at the proximal end of the grip assist arm 520. In this embodiment, a pair of auxiliary gripping arms 520 are provided, two auxiliary gripping arms 520 are movably inserted into the pushing catheter 210 and are symmetrically arranged with respect to the gripping pusher 330, and a distal end of each auxiliary gripping arm 520 is provided with an auxiliary gripping member 510.
As shown in fig. 19 to 21, an auxiliary arm housing chamber 250 is provided in the push catheter 210 in the axial direction. Prior to piercing, both grip assist 510 and grip assist arm 520 are received in assist arm receiving cavity 250. An opening 260 is formed on the distal end surface of the proximal collet 320, the side wall of the push catheter 210, or the side wall of the proximal collet 320, and the opening 260 communicates with the auxiliary arm receiving chamber 250. When the operator pushes the fourth handle 501 distally, the grasping aid arms 520 can be actuated to push the grasping aid 510 out of the opening 260, thereby supporting the lower surface of the leaflet, stabilizing the beating leaflet, reducing the amplitude of motion of the leaflet, and engaging the grasping device 300 to grasp and hold the leaflet.
Preferably, the included angle between the axial direction of the distal end portion of the auxiliary arm receiving cavity 250 and the axial direction of the pushing catheter 210 is in the range of 120 ° and 150 °. The reason for this is that before puncturing, the holding push rod 330 contacts with the leaflet edge, the distal collet 310 and the proximal collet 320 can only hold part of the leaflets, and at this time, in order to keep the pulsating leaflets stable as much as possible and facilitate puncturing, a supporting force needs to be provided on the other side of each leaflet opposite to the edge, so that a certain angle needs to be formed between the holding auxiliary member 510 and the push catheter 210, and the holding auxiliary member can be supported on the lower surface of the other side of each leaflet opposite to the leaflet edge.
As shown in fig. 22-23, the gripping aid 510 is supported on the lower surface of the leaflet and cooperates with the gripping device 300 to grip the leaflet. The clamping aid 510 is made of a resilient and/or flexible material to accommodate the anatomy of the leaflets and the amplitude of motion of the leaflets and avoid damage to the leaflets. The elastic material is preferably a shape memory material. The clamping aid 510 may be made of a metallic material, a polymeric material, or a metal-polymer composite. The holding aid 510 in this embodiment is a rod-shaped body. The rod-shaped body can be a solid or hollow structure with a single-layer or multi-layer composite structure, and can also be formed by winding a single wire or a plurality of wires. The cross section of the rod-shaped body can be regular circle or ellipse, crescent, semicircle, polygon and the like. The holding auxiliary 510 is smooth in shape, and the distal end forms a smooth round head by laser spot welding without defects such as burrs, edges or edges and corners. In this embodiment, the clamping aid 510 is made of elastic nitinol with a shape memory and is circular in cross-section.
The clamp assist arm 520 is rod-shaped or tubular with an axial length and a stiffness or rigidity to provide support and pushability. The auxiliary holding arm 520 may be made of a single-layer or multi-layer composite structure metal rod or a polymer rod, and may be made of a single wire or a plurality of wires. The cross-section of the grasping auxiliary arm 520 may be a regular circle or an ellipse, a crescent, a semicircle, a polygon, or a ring, etc. The grasping auxiliary arm 520 may be made of a metal material, a polymer material, or a metal-polymer composite material. In this embodiment, the auxiliary holding arm 520 is made of an elastic material having a memory function and has a circular cross section.
The support of the auxiliary holding arm 520 and the flexibility of the auxiliary holding member 510 can be achieved by using different materials for the auxiliary holding member 510 and the auxiliary holding arm 520. That is, the grip auxiliary arm 520 is made of a hard material; the clamping aid 510 is made of a resilient and/or flexible material. It is understood that the clamping auxiliary arm 520 and the clamping auxiliary member 510 may be made of the same material, and then a material with higher hardness may be added outside and/or inside the clamping auxiliary arm 520 to serve as a reinforcing tube or a stiffening wire to ensure the support of the clamping auxiliary arm 520. As shown in fig. 23, the grasping auxiliary arm 520 is composed of a relatively soft inner tube 521 and a relatively hard outer tube 522.
Preferably, the clamping aid 510 is made of an X-ray opaque material. In the prior art, before the clamping device clamps the valve leaflet, the relative position between the instrument and the valve leaflet cannot be judged in a mode with a low operation requirement level such as X-ray, the clamping device can be moved to a proper position only by relying on accurate ultrasonic guidance, the beating state of the valve leaflet is observed by ultrasonic, and when the valve leaflet beats to be close to the clamping device, the relative motion between the far-end chuck and the near-end chuck is rapidly driven to clamp the valve leaflet. Ultrasound has high requirements for the operating technique of doctors and the analysis capability of heart ultrasound images, which leads to increased operation cost, increased operation difficulty and increased operation time. Because the auxiliary clamping member 510 of the present embodiment is made of a non-transparent material, after the auxiliary clamping member 510 contacts the valve leaflet, the flexible and/or elastic auxiliary clamping member 510 swings correspondingly along with the movement range of the valve leaflet, so that before the valve leaflet is clamped by the clamping device 300, an operator can quickly and accurately judge the position of the valve leaflet by using X-rays, thereby quickly and accurately operating the clamping device 300 to clamp the valve leaflet, reducing the cost and difficulty of the operation, shortening the operation time, and improving the success rate of the operation.
It is understood that in other embodiments, the clamping aid 510 may also be a deformed structure made up of a plurality of rod-shaped bodies in order to enhance the strength of the clamping aid 500. The deformed structure is contracted and deformed, and then is accommodated in the push catheter 210 together with the holding auxiliary arm 520. For example, the deformation structure is an open-type bifurcated structure or an umbrella-type structure formed by a plurality of rod-shaped bodies. To facilitate being pushed through the pusher catheter 210, the clamping aid 510 has a compressed state and an extended state in its natural state. When the clamping auxiliary member 510 is in a compressed state, it can be accommodated in the auxiliary arm accommodating cavity 250 of the pushing catheter 210 and pushed; when the grasping aid 510 extends from the grasping surface of the proximal collet 320, the sidewall of the pusher catheter 210, or the opening 260 in the sidewall of the proximal collet 320, it transitions to an extended state and can support the lower surface of the leaflets to stabilize the beating leaflets. The contact surface of the clamping auxiliary part 510 with a larger diameter and the valve leaflet is the plane where the clamping auxiliary part 510 is located, so that the contact area between the clamping auxiliary device 500 and the valve leaflet is larger, the valve leaflet can be better attached, and the support of the clamping auxiliary device 500 to the valve leaflet is improved.
It will also be appreciated that in other embodiments, the ends of the gripping aids 510 in a bifurcated or umbrella-like configuration may be rolled proximally of the gripping aid arms 520, with a plurality of gripping aids 510 forming a recessed area, as shown in FIG. 24. At this time, since the end of each of the holding aids 510 is turned inward and directed toward the proximal end of the holding aid arm 520, the end of the support rod of the holding aid 510 can be prevented from stabbing the leaflets or the ventricular wall.
It will also be appreciated that in other embodiments, the deformation structure may be a closed loop structure formed by a plurality of support rods, and the closed loop structure may be circular, diamond-shaped, oval, pear-shaped, polygonal, or other irregular shapes that may form a closed structure, as shown in fig. 25. It will also be appreciated that in other embodiments, at least one flexible and/or elastic connecting rod may be disposed between the support rods of the closed loop structure to improve the stability of the closed loop structure and further enhance the supporting force of the clamping auxiliary 510 on the valve leaflets. It will also be appreciated that in other embodiments, when a plurality of support rods and connecting rods are provided in a closed loop structure, the closed loop structure may also form a sheet-like structure or a net-like structure. It will also be appreciated that in other embodiments, the mesh structure may be heat-set to form a stretch-deformable disc-like structure (similar to the single-disc occluders of the prior art), and the disc-like structure may be further heat-set to form a columnar, nested, flattened, etc. structure. If the grasping aid 510 is made of a shape memory material, it can be received in the auxiliary arm receiving cavity 250 of the pusher catheter 210 and delivered, and then extended through the opening 260, returning to its natural, deployed state, contacting the lower surface of the leaflets and providing support to the leaflets.
The following describes an implementation of the bilateral artificial chordae tendineae implantation system provided in this embodiment, taking a bilateral artificial chordae tendineae implantation method in which the anterior leaflet and the posterior leaflet of the mitral valve are clamped at the same time as an example:
first, referring to fig. 26, a bilateral prosthetic chordae implantation system is advanced through the mitral valve into the left ventricle;
secondly, referring to fig. 27, the bilateral artificial chordae tendineae implantation system is continuously advanced until the distal collet 310 and the proximal collet 320 are both located in the left atrium, the second handle 301 is pushed to the distal end, the second handle 301 drives the holding push rod 330 to move distally relative to the push catheter 210, the distal collet 310 located at the distal end of the holding push rod 330 is separated from the proximal collet 320 located at the distal end of the push catheter 210, and at this time, a hollow cylindrical leaflet containing space is formed between the proximal collet 320 and the distal collet 310;
third, referring to fig. 28, the fourth handle 501 is pushed to the distal end, the fourth handle 501 drives the auxiliary clamping arm 520 to push the auxiliary clamping element 510 out of the opening 260, at this time, the two auxiliary clamping elements 510 are respectively supported on the lower surfaces of the anterior leaflet and the posterior leaflet of the mitral valve to assist in stabilizing the pulsating leaflet, the relative position between the first handle 201 and the second handle 301 is kept unchanged, the whole apparatus is slowly moved to the proximal end until the anterior leaflet and the posterior leaflet of the mitral valve both enter the leaflet holding space between the proximal collet 320 and the distal collet 310, at this time, the two auxiliary clamping elements 510 can respectively provide a certain supporting force for the anterior leaflet and the posterior leaflet of the mitral valve;
fourthly, referring to fig. 29, the distal end of the bilateral artificial chordae tendineae implantation system is finely adjusted until the edges of the anterior leaflet and the posterior leaflet of the mitral valve are both in contact with the clamping push rod 330, at which time the second handle 301 is withdrawn proximally, driving the distal collet 310 towards the proximal collet 320 until both are closed and both the anterior leaflet and the posterior leaflet of the mitral valve are clamped;
fifthly, pushing the third handle 401 to the far end, and driving the four puncture needles 410 to move towards the far end chuck 310 along the axial direction of the push catheter 210 respectively until the four puncture needles 410 pass through the anterior leaflet and the posterior leaflet of the mitral valve respectively and form a fixed connection with the four fixing elements 120 arranged in the far end chuck 310 respectively;
sixthly, referring to fig. 30, the third handle 401 is withdrawn, so that the puncture needle 410 drives the fixing element 120 and the main body 110 of the tendon connected to the fixing element 120 to pass through the valve leaflets in sequence, the anti-slip elements 130 are also pulled out from the proximal end surface of the distal collet 310, the abutting surfaces (i.e., the lower surfaces) of the two anti-slip elements 130 are respectively in contact with the upper surfaces of the anterior leaflet and the posterior leaflet of the mitral valve, and simultaneously, each main body 110 of the tendon presses the upper surfaces of the two anti-slip elements 130 to respectively abut the anterior leaflet and the posterior leaflet of the mitral valve (as shown in fig. 31), at this time, the point contact between the artificial tendon 100 and the valve leaflets is converted into the surface contact between the anti-slip elements 130 and the valve leaflets, which can effectively reduce;
seventhly, referring to fig. 31, the third handle 401 is continuously withdrawn until the fixing member 120 is withdrawn from the proximal end of the push catheter 210, the fourth handle 501 is withdrawn, the clamping auxiliary member 510 is withdrawn into the auxiliary arm receiving cavity 250, the entire bilateral artificial chordae implantation system is withdrawn, the length of the chordae main body 110 remaining in the heart is adjusted, and both ends of the chordae main body 110 are fixed at predetermined positions of the ventricular wall or the papillary muscle, respectively, as shown in fig. 32, thereby completing the bilateral artificial chordae implantation of the anterior leaflet and the posterior leaflet of the mitral valve.
In the fourth step, if the operator finds that the valve leaflet is not effectively clamped, the relative positions of the distal collet 310 and the proximal collet 320 can be fine-tuned to generate a certain distance therebetween, the relative position between the clamping rod 330 and the valve leaflet is adjusted, the clamping device 300 is operated again to clamp the valve leaflet, and the fifth step of the surgical operation is performed. During the adjustment process, the leaflet is prevented from slipping out of the holding device 300 because the holding assistance device 500 under the leaflet has a certain supporting effect on the leaflet.
In summary, in the bilateral artificial chordae tendineae implanting system of the present invention, the clamping push rod is disposed at the substantially central axis of the pushing catheter, and the at least one pair of puncturing push rods are disposed in the pushing catheter and symmetrically disposed with respect to the clamping push rod, so that the anterior leaflet and the posterior leaflet of the mitral valve can be clamped simultaneously by the relative movement between the proximal collet and the distal collet, and then the artificial chordae tendineae are implanted at the anterior leaflet and the posterior leaflet of the mitral valve, thereby greatly shortening the operation time and improving the operation efficiency.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (12)

1. The bilateral artificial chordae tendineae implanting system comprises a clamping device, a puncturing device and a pushing device, wherein the pushing device comprises a pushing catheter, the pushing catheter is provided with a plurality of through inner cavities along the axial direction, the clamping device comprises a clamping push rod, a far-end chuck and a near-end chuck, the far-end chuck and the near-end chuck are used for clamping valve leaflets in a matching mode, the near-end chuck is arranged at the far end of the pushing catheter, the far-end chuck is arranged at the far end of the clamping push rod, the system is characterized in that the clamping push rod is movably arranged at the approximate central shaft of the pushing catheter in a penetrating mode, the puncturing device comprises at least one pair of puncturing push rods and puncturing needles respectively arranged at the far ends of the puncturing push rods, the puncturing push rods are movably arranged in the pushing catheter in a penetrating mode and are symmetrically arranged relative to the clamping push rods, and clamping surfaces of the, the clamping surface of the far-end chuck is a conical surface which is convex from the far end to the near end, and the clamping surface of the near-end chuck is a conical surface which is concave from the far end to the near end;
the bilateral artificial chordae implantation system further comprises at least one pair of artificial chordae, each artificial chordae comprises a chordae main body with flexibility, the chordae main body is provided with a first end and a second end which are opposite to each other, the first end and/or the second end is connected with a fixing piece, and the fixing piece is used for being fixedly connected with the puncture needle head in an undetachable mode or in a detachable mode.
2. The bilateral artificial chordae implantation system of claim 1, wherein the distal end of the puncture needle is a straight tip that is tapered.
3. The bilateral artificial chordae implantation system of claim 1, wherein the push catheter has a diameter in the range of 10mm to 12 mm.
4. The bilateral artificial chordae implantation system of claim 1, wherein the chordae body is received in the clamping push rod and the distal collet, the fixation elements are received in the distal collet, and a proximal end of each fixation element corresponds to a respective one of the puncture needles.
5. The bilateral artificial chordae implantation system of claim 4, wherein the clamping push rod is axially provided with an artificial chordae channel therein, the distal collet is provided with an artificial chordae housing cavity therein, the artificial chordae housing cavity extends through to a proximal end face of the distal collet, the artificial chordae channel is in communication with the artificial chordae housing cavity, and the chordae body is housed in the artificial chordae channel and the artificial chordae housing cavity.
6. The bilateral artificial chordae implantation system of claim 5, wherein the proximal face of the distal collet defines a fixation cavity for receiving the fixation element, the fixation cavity in axial communication with the artificial chordae receiving cavity.
7. The bilateral artificial chordae implantation system of claim 6, wherein the fixation cavity has a shape that matches a shape of the fixation element and the diameter of an inscribed circle of the fixation cavity is larger than the diameter of a circumscribed circle of the artificial chordae housing cavity.
8. The bilateral artificial chordae implantation system of claim 1, wherein the main body is further sleeved with a slip prevention element, the slip prevention element is provided with an abutting surface abutting against the valve leaflet, and the slip prevention element slides along the axial direction of the main body.
9. The bilateral artificial chordae implantation system of claim 8, wherein the distal collet has an artificial chordae receiving cavity therein, the gripping surface of the distal collet has a fixation cavity for receiving the fixation element and a receiving slot for receiving the anti-slip element, the receiving slot is in radial communication with the artificial chordae receiving cavity, and the receiving slot is in radial communication with the fixation cavity.
10. The bilateral artificial chordae implantation system of claim 1, further comprising a clamping assist device; the clamping auxiliary device comprises at least two clamping auxiliary arms movably penetrating in the push conduit and clamping auxiliary pieces respectively arranged at the far ends of the clamping auxiliary arms; the at least two clamping auxiliary arms are symmetrically arranged relative to the clamping push rod; the clamping aid is made of an elastic and/or flexible material; the clamping auxiliary arm pushes the clamping auxiliary piece connected with the clamping auxiliary arm to penetrate out of the far end of the pushing guide pipe or the far end of the clamping device, and the clamping auxiliary piece and the clamping device are matched to clamp the valve leaflets.
11. The bilateral artificial chordae implantation system of claim 10, wherein the push catheter has an auxiliary arm receiving cavity disposed therein in an axial direction, the auxiliary arm receiving cavity having a distal end portion with an included angle in the range of 120 ° and 150 ° with respect to the axial direction of the push catheter.
12. The bilateral artificial chordae implantation system of claim 10, wherein the clamping aid is made of an X-ray opaque material.
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