CN109893297B - Artificial chordae tendineae implantation system with clamping auxiliary device - Google Patents
Artificial chordae tendineae implantation system with clamping auxiliary device Download PDFInfo
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- CN109893297B CN109893297B CN201711288779.1A CN201711288779A CN109893297B CN 109893297 B CN109893297 B CN 109893297B CN 201711288779 A CN201711288779 A CN 201711288779A CN 109893297 B CN109893297 B CN 109893297B
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Abstract
The invention discloses an artificial chordae tendineae implantation system with a clamping auxiliary device, which comprises a push catheter, a clamping device, a puncture device and the clamping auxiliary device, wherein the clamping device comprises a clamping push rod containing the artificial chordae tendineae, a far-end chuck and a near-end chuck which are used for matching with and clamping valve leaflets, and the puncture device comprises a puncture push rod and a puncture needle head arranged at the far end of the puncture push rod. The clamping auxiliary device comprises a clamping auxiliary arm movably arranged in the push catheter in a penetrating way and a clamping auxiliary piece arranged at the far end of the clamping auxiliary arm, and the clamping auxiliary arm pushes the clamping auxiliary piece to extend out of the far end of the artificial chordae tendineae implantation system and then is matched with the clamping device to clamp the valve leaflet. In the artificial chordae tendineae implantation system, the clamping auxiliary component can be supported on the lower surface of the valve leaflet to assist the clamping device in stabilizing the pulsating valve leaflet, improve the clamping stability and prevent the valve leaflet from slipping from the clamping device.
Description
Technical Field
The invention belongs to the technical field of medical instruments, relates to an instrument for repairing heart valve defects, and particularly relates to an 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.
Even if a few of the chordae tendineae are broken, the tension of other chordae tendineae can be increased to cause the rupture of new chordae tendineae. 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.
An existing instrument for implanting the artificial chordae tendineae in a minimally invasive mode clamps and fixes the valve leaflets through a clamping device, and then a puncture needle is combined with the artificial chordae tendineae and pulls the artificial chordae tendineae to fix the valve leaflets to ventricular walls. However, since the leaflets are always in a pulsating state and the surfaces of the leaflets are smooth tissues, it is difficult for the clamping device to successfully clamp the leaflets quickly, and even if the leaflets are clamped, the leaflets can fall off from the clamping device, so that the operation time is prolonged and even the operation fails. Moreover, after the valve leaflets are captured, if the clamping position is found to be not ideal, the operator needs to finely adjust the clamping device, and the valve leaflets are easy to slip out of the clamping device, so that the operation time is prolonged and even the operation fails.
Disclosure of Invention
The present invention is directed to solve the above-mentioned problems of the prior art, and an object of the present invention is to provide an artificial chordae tendineae implantation system with a clamping auxiliary device, which can rapidly clamp a leaflet, improve the stability of clamping the leaflet, and prevent the leaflet from slipping out of the clamping device.
The technical scheme adopted by the invention for solving the technical problems is as follows:
an artificial chordae tendineae implantation system with a clamping auxiliary device comprises a pushing catheter, a clamping device, a puncture device and a clamping auxiliary device. The clamping device comprises a clamping push rod containing the artificial chordae tendineae, and a far-end chuck and a near-end chuck which are used for matching and clamping the valve leaflets. The puncture device comprises at least one puncture push rod and a puncture needle head arranged at the far end of the puncture push rod. The clamping push rod and the puncture push rod are movably arranged in the pushing guide pipe in a penetrating mode respectively. The piercing needle has a tapered distal end and a hook-shaped body. The clamping auxiliary device comprises a clamping auxiliary arm movably arranged in the push catheter in a penetrating mode and a clamping auxiliary piece arranged at the far end of the clamping auxiliary arm. The clamping auxiliary arm pushes the clamping auxiliary piece to extend out from the far end of the pushing conduit or the far end of the near-end chuck, and the clamping auxiliary piece is matched with the clamping device to clamp the valve leaflets. Therefore, the clamping auxiliary component can be supported on the lower surface of the valve leaflet to assist the clamping device to stabilize the pulsating valve leaflet and prevent the valve leaflet from slipping from the clamping device.
In the artificial chordae implantation system, it is preferable that the clamping aid is made of an elastic and/or flexible material.
In the artificial chordae implantation system, it is preferable that the holding aid is made of an X-ray opaque material.
In the artificial chordae tendineae implantation system, preferably, the clamping auxiliary member is a rod-shaped structure formed by at least one support rod, and the rod-shaped structure and the clamping auxiliary arm are accommodated in the pushing conduit together;
or the clamping auxiliary part is a deformation structure formed by a plurality of support rods, the deformation structure is at least one of a bifurcation structure, an umbrella-shaped structure, a closed structure, a sheet structure, a net structure or a disc structure, and the deformation structure and the clamping auxiliary arm are contained in the push conduit together after being contracted and deformed.
In the artificial chordae tendineae implantation system, the clamping auxiliary arm is preferably a hard rod-shaped or tubular structure;
or the clamping auxiliary arm comprises an elastic and/or flexible auxiliary arm main body and a hard support body arranged outside and/or inside the auxiliary arm main body.
In the artificial chordae tendineae implantation system, preferably, an auxiliary arm accommodating cavity is axially arranged in the pushing catheter, and an included angle between 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 artificial chordae implantation system, preferably, the proximal end chuck is arranged at the distal end of the pushing catheter, the distal end chuck is arranged at the distal end of the clamping push rod, an artificial chordae accommodating cavity is arranged in the distal end chuck, and the artificial chordae accommodating cavity is communicated with the inner cavity of the clamping push rod.
In the artificial chordae implantation system, a puncture channel is preferably arranged in the far-end chuck along the axial direction, the far end of the puncture channel penetrates through the artificial chordae accommodating cavity, and the puncture needle head hooks the artificial chordae after penetrating out of the puncture channel; or the artificial chordae accommodating cavity is communicated to the clamping surface of the far-end chuck, and the puncture needle head hooks the artificial chordae after penetrating out of the clamping surface of the near-end chuck.
In the artificial chordae implantation system, preferably, the artificial chordae is a closed loop structure with two ends connected.
The artificial chordae tendineae implantation system is preferably provided with an anti-slip piece, the anti-slip piece is provided with a binding surface attached to the valve leaflet, the anti-slip piece is provided with at least two through holes, two ends of the artificial chordae tendineae respectively penetrate through the different through holes and then are connected, and the anti-slip piece is contained in the clamping push rod or the far-end chuck.
Compared with the prior art, the artificial chordae tendineae implantation system with the clamping auxiliary device has the following beneficial effects:
set up centre gripping auxiliary device in artifical chordae tendineae implantation system, after the leaflet was held by distal end chuck and near-end chuck, centre gripping auxiliary arm promoted the centre gripping auxiliary member and stretches out from propelling movement pipe distal end or near-end chuck distal end, and the centre gripping auxiliary member supports at the lower surface of leaflet, holds up the leaflet to the atrium side, and then reduces leaflet amplitude of motion, assists clamping device to stabilize the leaflet of beating. Moreover, after the auxiliary clamping device is supported on the lower surface of the valve leaflet, if an operator finds that the clamping position is not ideal, the clamping device can be finely adjusted, and in the fine adjustment process, the supporting function of the auxiliary clamping device can prevent the valve leaflet from slipping out of the clamping device.
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 an artificial chordae tendineae in the artificial chordae tendineae implantation system according to the first embodiment of the invention;
figure 4 is a schematic structural view of an artificial chordae implantation system according to a first embodiment of the invention;
figure 5 is an exploded view of an artificial chordae implantation system according to a first embodiment of the invention;
fig. 6 is a schematic view of the artificial chordae tendineae implantation system with the clamping device disengaged according to the first embodiment of the present invention;
fig. 7a is a schematic structural view of a puncture device in the artificial chordae implantation system according to the first embodiment of the present invention;
FIG. 7b is an enlarged partial view of the piercing needle of FIG. 7 a;
fig. 8 is a schematic view of the distal collet of the artificial chordae implantation system according to the first embodiment of the present invention;
FIG. 9 is a schematic view of the clamping aid extending from the distal end of the push catheter in the artificial chordae implantation system in accordance with the first embodiment of the present invention;
figure 10 is a radial cross-sectional view of a pusher catheter in an artificial chordae implantation system in accordance with a first embodiment of the invention;
fig. 11 is a schematic view of the clamping aid of fig. 9 supported on the lower surface of the leaflets;
figure 12 is an axial cross-sectional view of the distal end of a pusher catheter in an artificial chordae implantation system in accordance with a first embodiment of the invention;
FIG. 13 is an axial cross-sectional view of another embodiment of the distal end of the pusher catheter;
fig. 14 is a schematic structural view of a clamping auxiliary device in the artificial chordae implantation system according to the first embodiment of the present invention;
FIG. 15 is a schematic structural view of another embodiment of a grip assist apparatus;
FIG. 16 is a schematic structural view of another embodiment of a grip assist apparatus;
fig. 17 to 24 are schematic views illustrating a process of implanting an artificial chordae using the artificial chordae implanting system according to the first embodiment of the invention;
fig. 25 and 26 are schematic structural views of different embodiments of the clamping auxiliary device in the artificial chordae implantation system according to the second embodiment of the present invention;
figures 27a-27c are schematic views of different embodiments of a clamping assist device in a system for implanting artificial chordae tendineae according to a third embodiment of the present invention;
fig. 28a and 28b are schematic views illustrating the use of a third embodiment of the invention, wherein fig. 28a is a schematic view of the clamping assist device extending from the distal end of the pusher catheter, and fig. 28b is a schematic view of the clamping assist device supported on the lower surface of the leaflets;
FIG. 29 is a schematic view of another embodiment of a grip assist device.
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.
Hereinafter, a position close to the operator is defined as a proximal end, and a position far from the operator is defined as a distal end.
Example one
As shown in fig. 3-24, an artificial chordae implantation system with a clamping assist device is used to implant an artificial chordae 100 into a patient to replace diseased or broken chordae in the patient's heart. The artificial chordae tendineae implanting system comprises a clamping device 300, a puncturing device 400, a pushing device 200 and a clamping auxiliary device 500. The pusher device 200 includes a pusher catheter 210. The clamping device 300 includes a clamping push rod 330 that houses the artificial chordae tendineae 100, and a distal collet 310 and a proximal collet 320 for cooperatively clamping the leaflets. The puncture device 400 includes a puncture push rod 420 and a puncture needle 410 disposed at a distal end of the puncture push rod 420. The holding push rod 330 and the puncturing push rod 420 are movably inserted into the pushing catheter 210, respectively. The piercing needle 410 has a tapered distal end and a hook-like body. The grasping aid 500 includes a grasping aid arm 520 movably inserted into the pushing catheter 210 and a grasping aid 510 provided at a distal end of the grasping aid arm 520. The grasping aid arm 520 pushes the grasping aid 510 distally out of the delivery catheter 210 or the proximal collet 320, and the grasping aid 510 cooperates with the grasping device 300 to grasp the leaflets.
As shown in fig. 3, the artificial chordae 100 has a length and flexibility. The artificial chordae 100 is flexible, meaning that it is free of tension in the axial direction and can be bent at will. The artificial chorda 100 is made of a biocompatible polymer material or a relatively soft metal material. The artificial chorda tendineae 100 of this embodiment is a flexible wire made of PTFE, and both ends of the flexible wire are connected by knotting, gluing, or the like to form a closed loop structure. Therefore, after the puncture needle 410 punctures the valve leaflet and hooks the artificial chordae tendineae 100, one end of the annular structure can be pulled to the near end, the annular structure penetrates the valve leaflet and then is fixed on mastoid muscle or ventricular wall, the other end of the annular structure is left on the upper surface of the valve leaflet, so that the tension between the valve leaflet and the ventricular wall is maintained, and meanwhile, two chordae tendineae are implanted between the valve leaflet and the ventricular wall, and the operation efficiency and effect are improved.
The artificial chordae tendineae 100 are provided with a slip prevention part 130, the slip prevention part 130 is provided with at least two through holes 131, and two ends of the artificial chordae tendineae 100 are respectively fixed together by knotting after passing through different through holes 131 to form a closed loop structure. Thus, the anti-slip members 130 can slide on the artificial chordae 100 without falling off. The anti-slip element 130 is accommodated in the clamping push rod 330, after the puncture needle 410 punctures the valve leaflet and hooks the artificial chordae tendineae 100, the anti-slip element 130 is brought to the puncture point by the puncture device 400 through the clamping push rod 330 and the distal collet 310, the anti-slip element 130 and the artificial chordae tendineae 100 are jointly fixed on the valve leaflet, and the anti-slip element 130 is padded between the artificial chordae tendineae 100 and the upper surface of the valve leaflet, so that the point contact between the artificial chordae tendineae 100 and the valve leaflet is increased to surface contact, and the risk that the artificial chordae tendineae 100.
In order to distribute the force of the artificial chordae 100 to the leaflets as much as possible to the contact surfaces between the slip-resistant member 130 and the leaflets, the slip-resistant member 130 needs to be fitted to the leaflets as much as possible, and therefore the slip-resistant member 130 has a fitting surface 132 that fits to the leaflets. The anti-slip member 130 is not limited in specific structure except for the abutting surface 132, and may be, for example, a sheet having a certain area, a disc, a sphere or other irregular shape, preferably a sheet. The anti-slip member 130 may be a non-porous structure, a net structure, a bar grid structure, or the like. The anti-slip members 130 may be made of an elastic material or a non-elastic material and should be biocompatible. 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 structure or a double disc structure is similar to the stopper of the prior art and will not be described 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. The anti-slip member 130 of this embodiment is an elastic pad made of silicone.
As shown in fig. 4-6, the main structure of the pushing device 200 is a pushing catheter 210. The pusher catheter 210 is a tubular body having an axial length or a rod-shaped body having an inner lumen. The pusher catheter 210 has a plurality of spaced apart axial lumens. The push catheter 210 may be a multi-lumen tube formed integrally, or may be an integral structure formed by multiple tubes sleeved and fixed together. 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) or a metallic material (e.g., stainless steel or nitinol). 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.
As shown in fig. 7a, the puncture device 400 includes at least one puncture push rod 420 and a puncture needle 410 disposed at a distal end of the puncture push rod 420. The puncture needle 410 is used to puncture the leaflets and to hook the artificial chordae 100, pulling the artificial chordae 100 proximally. As shown in fig. 7b, the piercing needle 410 has a tapered distal end and a hook-like body. The hook-shaped main body is used for hooking the artificial chordae tendineae 100, and the puncture point formed on the valve leaflet by the conical distal end is small, so that the postoperative healing of a patient is facilitated. In this embodiment, the number of the puncture push rods 420 is one. In order to ensure the connection effectiveness between the puncture device 400 and the artificial chordae tendineae 100, the number of the puncture push rods 420 may be two or more.
The proximal end of the puncture push rod 420 penetrates out of the proximal end of the push catheter 210 and then is provided with the third handle 401, so that the puncture push rod 420 can be driven to move along the axial direction of the push catheter 210 by operating the axial movement of the third handle 401, and the puncture needle head 410 is driven to puncture towards the distal end or withdraw towards the proximal end.
Referring again to fig. 4-6, the gripping device 300 includes a gripping push rod 330, a distal collet 310, and a proximal collet 320. The holding push rod 330 is movably inserted into 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 holding push 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. 6, at which time the distal end of the instrument can be fine-tuned to allow the valve leaflet to enter between the distal collet 310 and the proximal collet 320, and then the second handle 301 is withdrawn proximally to drive the holding push rod 330 to move proximally, so that the distal collet 310 is close to the proximal collet 320 to form a holding state as shown in fig. 4, at which time the valve leaflet is held and fixed by the holding 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.
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 in close contact with each other and have a large leaflet contact area, respectively. Preferably, both clamping surfaces are obliquely disposed, i.e., the clamping surfaces are angled less than 90 degrees from the axial direction of the pusher conduit 210. 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 enhancer is preferably at least one of a protrusion, a ridge, a groove, or a depression, and the grip surface of the distal collet 310 is configured with grip enhancers having a shape that matches the shape of the grip 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.
The clamping push rod 330 is a tubular or hollow rod with a certain axial length, preferably oval or circular in cross section. An artificial chordae passage 331 is axially provided in the clamping push rod 330. An artificial tendon-receiving cavity 315 is formed in the distal collet 310 and is communicated with the artificial tendon channel 331, the artificial tendon-receiving cavity 315 is U-shaped or V-shaped, two ends of the artificial tendon-receiving cavity 315 are respectively communicated with the artificial tendon channel 331, and the artificial tendon 100 is received in the artificial tendon channel 331 and the artificial tendon-receiving cavity 315 (as shown in fig. 8). The distal chuck 310 is provided with a puncture channel 334 along the axial direction, the distal end of the puncture channel 334 penetrates through the artificial chordae accommodating cavity 315, so that the puncture needle 410 can advance distally along the puncture channel 334 until the artificial chordae 100 is hooked, and then the puncture push rod 420 is retracted proximally, so as to drive the puncture needle 410, the artificial chordae 100 and the anti-slip element 130 to be pulled out from the clamping surface of the distal chuck 310 simultaneously until the puncture needle 410 and the artificial chordae 100 jointly pass through the valve leaflet, and the anti-slip element 130 is attached to the upper surface of the valve leaflet. It is understood that the artificial chordae receiving cavity 315 may also extend through the clamping surface of the distal collet 310, and that the puncture channel 334 need not be provided in the distal collet 310, and the puncture needle 410 may also grasp the artificial chordae 100.
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, has increased the friction damage to the tissue, the problem of blood leakage appears simultaneously, has increased the risk that the patient produced postoperative complication. The present embodiment, however, places and secures the artificial chordae inside the device, avoiding the aforementioned problems.
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 edges of the valve leaflets, so that artificial gaps are formed between the valve edges of the valve leaflets, the valve edges cannot be combined, the mitral valve regurgitation is caused, and the operation effect is not ideal. The artificial chordae implantation system provided by the embodiment has the advantages that the distance between each artificial chordae and the edge of each valve leaflet is basically consistent, the folding of the edge of each valve leaflet can be effectively avoided, and the operation effect is improved.
Referring again to fig. 5 and 6, to further enhance clamping, a clamping aid 500 is also provided in the artificial chordae implantation system of the present invention, the clamping aid 500 comprising a clamping aid 510 and a clamping aid arm 520. To facilitate pushing, a fourth handle 501 may also be provided at the proximal end of the grip assist arm 520.
The push catheter 210 is provided with an auxiliary arm accommodation chamber 250 in the axial direction, that is, one of the plurality of inner chambers of the push catheter 210 is selected as the auxiliary arm accommodation chamber 250. Prior to piercing, both grip assist 510 and grip assist arm 520 are received in assist arm receiving cavity 250. As shown in FIG. 9, an opening 260 is formed on the gripping surface of the proximal collet 320, the sidewall of the push catheter 210 or the sidewall of the proximal collet 320, the opening 260 is connected to the auxiliary arm receiving chamber 250, and when the operator pushes the fourth handle 501 distally, the auxiliary gripping arm 520 is driven to push the auxiliary gripping member 510 to protrude from the opening 260.
Referring to fig. 10, the holding push rod 330 and the puncturing push rod 420 are jointly inserted into the pushing catheter 210, and the axial directions of the holding push rod 330 and the puncturing push rod 420 are both parallel to the axial direction of the pushing catheter 210. The grip push rod 330 is disposed at one side of the push catheter 210, and the puncture push rod 420 is disposed at the other side of the push catheter 210. In order to reduce the patient's trauma and the size of the cardiac incision of the patient, the overall outer diameter of the pusher catheter 210 should be minimized, and therefore the auxiliary arm housing 250 is preferably provided between the grip pusher housing 280 and the puncture pusher housing 270.
As shown in fig. 11, during puncturing, the holding rod 330 contacts with the leaflet edge, and the distal collet 310 and the proximal collet 320 can only hold a portion of the leaflet, and at this time, in order to keep the pulsating leaflet as stable as possible and facilitate puncturing, a supporting force needs to be provided on the other side of the leaflet opposite to the leaflet edge, so that a certain angle needs to be formed between the holding auxiliary device 510 and the push catheter 210, and the holding auxiliary device can be supported on the lower surface of the leaflet on the side opposite to the leaflet edge. Accordingly, the angle between the distal end of the auxiliary arm receiving chamber 250 and the axial direction of the push catheter 210 is in the range of 120 ° and 150 °.
Referring to fig. 12, which shows an embodiment of the auxiliary arm receiving cavity 250, the auxiliary arm receiving cavity 250 is a substantially straight cavity, the entire auxiliary arm receiving cavity 250 is obliquely disposed in the push catheter 210, and the included angle α between the distal end of the auxiliary arm receiving cavity 250 and the axial direction of the push catheter 210 is in the range of 120-.
Referring to fig. 13, another embodiment of the auxiliary arm receiving cavity 250 is shown, wherein the auxiliary arm receiving cavity 250 comprises a distal cavity 251 and a proximal cavity 252, the proximal cavity 252 is substantially parallel to the axial direction of the pushing catheter 210, and the included angle γ between the distal cavity 251 and the proximal cavity 252 is in the range of 120 ° and 150 °. As long as the smooth transition between the distal cavity 251 and the proximal cavity 252 is ensured without affecting the smooth passage of the auxiliary holding arm 520 in the auxiliary arm receiving cavity 250.
The shape of the auxiliary arm receiving cavity 250 matches the shape of the auxiliary clamping arm 520, and the cross section can be circular or elliptical, crescent, semicircle, polygon and other suitable shapes, and is preferably circular or elliptical without edges and corners.
The auxiliary clamping device 500 includes an auxiliary clamping arm 520 and an auxiliary clamping member 510 disposed at a distal end of the auxiliary clamping arm 520. 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. For example, a metallic material, a polymeric material, or a metal-polymer composite material may be selected. The elastic material is preferably a shape memory material.
As shown in fig. 14-15, the clamping auxiliary member 510 in this embodiment is a rod-shaped structure formed by at least one support rod. The rod-like structure is housed in the pusher catheter 210 together with the holding sub-arm 520. The holding aid 510 in fig. 14 is a rod-shaped structure formed by one support rod, and the holding aid 510 in fig. 15 is a rod-shaped structure formed by two support rods arranged in parallel. The supporting rod 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 support rod can be regular circle or ellipse, crescent, semicircle, polygon and the like, and is preferably circle. The holding aid 510 is preferably made of an elastic material with a memory function, and the holding aid 510 is smooth as a whole, and the distal end can be formed into a smooth round head by laser spot welding without defects such as burrs, edges, corners and the like. The diameter of the gripping aid 510 of the rod-like structure should be larger than the diameter of the gripping aid arms 520 to provide stable support for the leaflets. As shown in fig. 11, after the clamping auxiliary element 510 is pushed out from the distal end of the pushing catheter 210 or the proximal end of the collet 320, the clamping auxiliary element 510 is supported on the lower surface of the valve leaflet, and the elastic or flexible clamping auxiliary element 510 can conform to the movement range of the valve leaflet and will not cause perforation or puncture of the valve leaflet due to too hard.
The auxiliary clamping arm 520 is a rod with an axial length, can be a metal rod or a polymer rod with a single-layer or multi-layer composite structure and a hollow or solid structure, and can also be formed by winding a single wire or a plurality of wires. For example, the auxiliary gripping arm 520 in fig. 14 is a single rod, and the auxiliary gripping arm 520 in fig. 15 is two parallel rod bodies. The cross-section of the auxiliary gripping arm 520 may be a regular circle or an oval, crescent, semicircle, polygon, ring, etc., preferably a circle. The grasping auxiliary arm 520 is preferably made of a material with a memory function, and may be made of a metal material, a polymer material, or a metal-polymer composite material. Clamping secondary arm 520 is preloaded into secondary arm receiving chamber 250 of pusher catheter 210. The auxiliary holding arm 520 has a certain hardness or rigidity to provide support and pushing capability, i.e. to support the auxiliary holding member 510, and to move the fourth handle 501 to drive the entire auxiliary holding device 500 to move distally or retract proximally.
The auxiliary clamping member 510 and the auxiliary clamping arm 520 may be integrally formed, or may be fixedly connected together by non-detachable or detachable means. The non-detachable fixing means that the auxiliary clamping arm 520 and the auxiliary clamping member 510 are separately processed and then fixedly connected together by welding, bonding, or the like. The detachable fixation means that the auxiliary clamping arm 520 and the auxiliary clamping member 510 are respectively and separately processed and then fixedly connected together in the form of socket joint, threaded connection, interference fit, etc. The above connection method is conventional technology and will not be described herein.
The grip assistant 510 and the grip assistant arm 520 may be separately formed using different materials. That is, the grip assisting arm 520 is a rigid rod-like or tubular structure; the clamping aid 510 is made of a resilient and/or flexible material.
It is understood that in other embodiments, the auxiliary clamping arm 520 may also include a resilient and/or flexible auxiliary arm body 521, and a rigid support 522 (as shown in fig. 16) disposed inside and/or outside the auxiliary arm body 521. The support body 522 is used to support the auxiliary arm main body 521. The support body 522 may be nested or juxtaposed with the auxiliary arm main body 521. Firstly, a whole rod body or a pipe body made of a soft material is used as the clamping auxiliary piece 510 and the auxiliary arm main body 521 in the clamping auxiliary device 500, and then an inner pipe with higher hardness is arranged in an inner cavity of the auxiliary arm main body 521 in a penetrating manner, or an outer pipe with higher hardness is sleeved or arranged in parallel on the outer surface of part of the auxiliary arm main body 521 as a support body 522 to improve the support performance of the clamping auxiliary arm 520 at the proximal end; the support body 522 can also be made of a heat shrinkable tube and is wrapped on the outer surface of the soft auxiliary arm body 521, and then the heat shrinkable tube is heated to shrink and is wrapped on the outer surface of the auxiliary arm body 521 to improve the support performance. It can also be understood that, for the auxiliary arm main body 521 formed by winding a single wire or a plurality of wires, the thermoplastic elastomer such as Pebax may be wrapped on a part of the outer surface of the auxiliary arm main body 521, and then heated to melt the thermoplastic elastomer and wrap the thermoplastic elastomer on the outer surface while penetrating into the plurality of wires or the gaps between the single wires (i.e., the support body 522 is disposed outside and inside the auxiliary arm main body 521), so as to improve the support performance of the auxiliary arm main body 521.
The holding aid 510 is preferably 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 on the operating technique of doctors and the analysis capability of heart ultrasound images, which leads to increased operation difficulty and increased operation time, thereby increasing the risk of complications of patients. After the clamping auxiliary part 510 of this embodiment contacts with the valve leaflet, the clamping auxiliary part can produce corresponding swing along with the activity range of valve leaflet, therefore before clamping device grasps the valve leaflet, the operator can judge the position of valve leaflet through X ray accurately fast to operate clamping device with the centre gripping valve leaflet fast accurately, shorten operation time, improve the operation success rate.
Taking the chordae tendineae implantation clamped by the posterior leaflet of the mitral valve as an example, the implementation process of the artificial chordae tendineae implantation system provided by the embodiment is described as follows:
the first step is as follows: referring to fig. 17, the distal clip 310 and the proximal clip 320 of the artificial chordae implant system are advanced into the left atrium;
the second step is that: referring to fig. 18, the pusher catheter 210 is withdrawn proximally or the clamping pusher 330 is pushed distally such that the proximal collet 320 separates from the distal collet 310, forming a leaflet receiving space therebetween;
the third step: referring to fig. 19, pushing the fourth handle 501 distally, the fourth handle 501 drives the grasping aid arm 520 to push the grasping aid 510 out of the opening 260, where the grasping aid 510 rests on the leaflet undersurface to help stabilize the beating leaflet; keeping the relative positions of the first handle 201, the second handle 301 and the fourth handle 501 unchanged, moving the whole instrument proximally slowly until the valve leaflet enters the leaflet containing space between the proximal collet 320 and the distal collet 310, and the clamping auxiliary element 510 can provide a certain supporting force for the valve leaflet;
the fourth step: referring to fig. 20, the distal end of the artificial chordae implantation system is moved slightly until the leaflet edge contacts the clamping push rod 330, whereupon the second handle 301 is withdrawn proximally, driving the distal collet 310 towards the proximal collet 320 until the two close and the leaflet is clamped;
the fifth step: referring to fig. 21, pushing the third handle 401 distally drives the tapered distal end of the piercing needle 410 to pierce the leaflet 900, and the hooked body of the piercing needle 410 grabs the artificial chordae tendineae 100;
and a sixth step: referring to fig. 22, withdrawing the third handle 401, so that the puncture needle 410 drives the artificial chordae tendineae 100 to move proximally through the valve leaflet, the sliding prevention element 130 is also pulled out by the clamping push rod 330 and the distal collet 310, the abutment surface (i.e., the lower surface) of the sliding prevention element 130 contacts with the upper surface of the valve leaflet, and simultaneously part of the artificial chordae tendineae 100 presses the upper surface of the sliding prevention element 130 to abut against the valve leaflet (as shown in fig. 23), at this time, the point contact between the artificial chordae tendineae 100 and the valve leaflet is converted into the surface contact between the sliding prevention element 130 and the valve leaflet, which can effectively reduce the risk of the valve leaflet;
the seventh step: withdrawing the fourth handle 501, withdrawing the clamping auxiliary member 510 into the auxiliary arm accommodating cavity 250, withdrawing the entire artificial chordae implantation system, adjusting the length of the artificial chordae 100 left in the heart, and fixing one end of the closed structure of the artificial chordae 100 to the ventricular wall (as shown in fig. 24), thereby completing the artificial chordae implantation.
In the fourth step, after the valve leaflet is clamped by the clamping device 300, if the clamping position is found to be not ideal, the relative positions of the distal collet 310 and the proximal collet 320 can be finely adjusted to generate a certain distance therebetween, and then the valve leaflet is clamped again; during fine adjustment, the leaflet is prevented from slipping out of the holding device 300 because the holding assist device 500 under the leaflet has a certain supporting effect on the leaflet.
Example two
The artificial chordae implantation system of the present embodiment has substantially the same structure as the artificial chordae implantation system of the first embodiment, except that: in this embodiment, the clamping auxiliary member 510 is a deformed structure formed by a plurality of support rods, and the deformed structure is accommodated in the push conduit 210 together with the clamping auxiliary arm 520 after being contracted and deformed.
Specifically, the deformation structure is an open-type branched structure or an umbrella-shaped structure composed of a plurality of support rods. The clamping auxiliary member 510 has a compressed state in which the clamping auxiliary member 510 can be pushed in the auxiliary arm receiving cavity 250 of the push guide tube 210 and an extended state in a natural state; when the auxiliary clamping element 510 extends out of the opening 260, it is converted into an extended state, and can be supported on the lower surface of the valve leaflet to stabilize the valve leaflet and facilitate puncturing. The contact surface of the clamping auxiliary member 510 with a larger diameter and the valve leaflet is the plane where the clamping auxiliary member 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.
As shown in FIG. 25, the holding aid 510 is composed of two support rods, the angle between the two support rods
In the range of 20 deg. -150 deg., preferably 60 deg. -90 deg., to provide stable support and not interfere with the proximal retraction of the gripping aid 510 into the pusher catheter 210. The struts are flexible and resilient, such that the struts can be folded and received in the lumen of the pusher catheter 210, and when extended out of the opening 260, the struts return to a bifurcated configuration having an angle to support the leaflets.
In use, the bifurcated structure is first retracted into the pusher catheter 210, the auxiliary grasping arm 520 is received in the auxiliary arm receiving cavity 250 of the pusher catheter 210, and the proximal end thereof protrudes out of the proximal end of the pusher catheter 210 and is connected to the fourth handle 501. Pushing the fourth handle 501 distally, the grasping aid 510 extends out of the opening 260, transitioning into a natural state of extension (i.e., returning to a bifurcated configuration) due to its own flexibility and/or elasticity, resting on the lower surface of the leaflets; when the fourth handle 501 is retracted proximally, the two support struts of the bifurcated structure are closed and the entire bifurcated structure is pulled back into the secondary arm receiving cavity 250 of the pusher catheter 210. The grasping auxiliary arm 520 and the grasping auxiliary member 510 may be integrally formed as a single structure, or may be separately formed and then assembled together.
It is understood that in other embodiments, at least two auxiliary gripping arms 520 may be commonly inserted into an auxiliary arm receiving cavity 250 of the pushing catheter 210, and a support rod may be provided at the distal end of each auxiliary gripping arm 520 to serve as the auxiliary gripping member 510. Therefore, the clamping auxiliary members 510 penetrate through the same opening 260 and form a certain included angle with each other to form a bifurcated structure or an umbrella-shaped structure, and are supported on the lower surface of the valve leaflet to provide more effective support. In this embodiment, the plurality of auxiliary gripping arms 520 may be fixed to each other by a stopper such as a ferrule or an outer sleeve, or may be fixed to each other without a stopper, and the radial displacement between the plurality of auxiliary gripping arms 520 may be limited only by the wall surface of the auxiliary arm receiving cavity 250. In addition, the operator can control the axial movement of each auxiliary clamping arm 520 individually to adjust the relative position between each auxiliary clamping element 510 and the leaflet, so as to adapt to leaflet structures of different shapes, thereby achieving better supporting effect. It is further understood that in other embodiments, the clamping aids 510 can also protrude through different openings 260, and the clamping aids 510 are also angled to form a bifurcated structure or an umbrella-shaped structure.
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. 26. 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.
EXAMPLE III
The artificial chordae implantation system of this embodiment is substantially the same as the artificial chordae implantation system of the second embodiment, except that the clamping assist element 510 at the distal end of the clamping assist arm 520 is a closed structure formed by a plurality of support rods, and the closed structure may be circular, diamond-shaped, oval-shaped, pear-shaped, polygonal, or other irregular shapes that form a closed structure, as shown in fig. 27a-27 c. As shown in fig. 28a and 28b, the grasping aid 510, after extending from the distal end of the push catheter 210, has a larger contact area with the leaflet 600, and thus better supports the leaflet 600.
It is understood that in other embodiments, at least one flexible and/or elastic connecting rod 511 can be disposed between the support rods of the closed structure to improve the stability of the closed structure itself and further enhance the supporting force of the clamping auxiliary member 510 to the valve leaflets, as shown in fig. 29.
It will also be appreciated that in other embodiments, the closed structure may also form a sheet-like structure or a net-like structure when a plurality of support bars and connecting bars are provided in the closed 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. So long as the grasping aid 510 is made of a shape memory material, it can be delivered through the auxiliary arm receiving cavity 250 in the pusher catheter 210 and extend through the opening 260, returning to its natural, deployed state, resting against the lower surface of the leaflets.
In summary, in the artificial chordae implantation system with the auxiliary clamping device of the present invention, by adding the auxiliary clamping device to the artificial chordae implantation system, after the leaflet is clamped by the distal end clamp and the proximal end clamp, the auxiliary clamping device can be supported on the lower surface of the leaflet to lift the leaflet toward the atrium side, thereby reducing the moving amplitude of the leaflet and assisting the clamping device in stabilizing the beating leaflet. And, if the operator finds that the clamping position is not ideal, the clamping device can be fine-tuned, and the support of the clamping aid prevents the leaflet from slipping out of the clamping device during the fine-tuning process.
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 (10)
1. Artificial chordae tendineae implanting system with clamping auxiliary device comprises a pushing guide pipe, a clamping device, a puncturing device and a clamping auxiliary device, wherein the clamping device comprises a clamping push rod containing the artificial chordae tendineae and a far-end chuck and a near-end chuck used for matching with clamping valve leaflets, the puncturing device comprises at least one puncturing push rod and a puncturing needle head arranged at the far end of the puncturing push rod, and the artificial chordae tendineae implanting system is characterized in that: the clamping auxiliary device comprises a clamping auxiliary arm movably arranged in the push catheter in a penetrating mode and a clamping auxiliary piece arranged at the far end of the clamping auxiliary arm, the clamping auxiliary arm pushes the clamping auxiliary piece to extend out of the far end of the push catheter or the far end of the near-end chuck, and the clamping auxiliary piece and the clamping device are matched to clamp the valve leaflet.
2. The artificial chordae implantation system of claim 1, wherein the clamping aid is made of a resilient and/or flexible material.
3. The artificial chordae implantation system of claim 2, wherein the clamping aid is made of an X-ray opaque material.
4. The artificial chordae implantation system of claim 1, wherein the clamping aid is a rod-like structure comprised of at least one support rod, the rod-like structure being housed in the push catheter with the clamping aid arm;
or the clamping auxiliary part is a deformation structure formed by a plurality of support rods, the deformation structure is at least one of a bifurcation structure, an umbrella-shaped structure, a closed structure, a sheet structure, a net structure or a disc structure, and the deformation structure and the clamping auxiliary arm are contained in the push conduit together after being contracted and deformed.
5. The artificial chordae implantation system of claim 1, wherein the clamping assist arm is a rigid rod or tubular structure;
or the clamping auxiliary arm comprises an elastic and/or flexible auxiliary arm main body and a hard support body arranged outside and/or inside the auxiliary arm main body.
6. The artificial chordae implantation system of claim 1, wherein an auxiliary arm receiving cavity is axially disposed within the push catheter, a distal end of the auxiliary arm receiving cavity being angled in a range of 120 ° and 150 ° from the axial direction of the push catheter.
7. The artificial chordae implantation system of claim 1, wherein the proximal collet is disposed at a distal end of the pusher catheter, the distal collet is disposed at a distal end of the clamping push rod, and an artificial chordae receiving cavity is disposed in the distal collet and is in communication with an inner cavity of the clamping push rod.
8. The artificial chordae implantation system of claim 7, wherein a puncture channel is axially disposed in the distal collet, a distal end of the puncture channel extends through the artificial chordae housing cavity, and the puncture needle extends out of the puncture channel and grabs the artificial chordae;
or the artificial chordae accommodating cavity is communicated to the clamping surface of the far-end chuck, and the puncture needle head hooks the artificial chordae after penetrating out of the clamping surface of the near-end chuck.
9. The artificial chordae implantation system of claim 1, wherein the artificial chordae is a closed loop structure connected at both ends.
10. The system of claim 9, wherein the artificial chordae tendineae are provided with a slip prevention member, the slip prevention member has a contact surface contacting with the valve leaflet, the slip prevention member is provided with at least two through holes, two ends of the artificial chordae tendineae are connected after passing through different through holes, respectively, and the slip prevention member is received in the clamping push rod or the distal collet.
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| CN110313947B (en) * | 2018-03-28 | 2024-07-02 | 杭州德晋医疗科技有限公司 | Heart valve repair system |
| CN110151360B (en) * | 2019-06-20 | 2023-08-29 | 苏州汇禾医疗科技有限公司 | Auxiliary supporting structure |
| CN110353821B (en) * | 2019-06-20 | 2023-08-01 | 上海汇禾医疗科技股份有限公司 | Clamping device and clamping assembly |
| WO2021109616A1 (en) * | 2019-12-06 | 2021-06-10 | 杭州德晋医疗科技有限公司 | Valve suture device and valve repair suture device |
| CN112914635B (en) * | 2019-12-06 | 2024-09-20 | 杭州德晋医疗科技有限公司 | Valve suture device and valve repair suture device |
| CN112773561B (en) * | 2020-01-23 | 2024-10-11 | 北京领健医疗科技有限公司 | Valve repair instrument |
| CN111467081A (en) * | 2020-03-30 | 2020-07-31 | 科凯(南通)生命科学有限公司 | Multi-point fixed artificial chordae tendineae implanting device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6358277B1 (en) * | 2000-06-21 | 2002-03-19 | The International Heart Institute Of Montana Foundation | Atrio-ventricular valvular device |
| AU2003247526A1 (en) * | 2002-06-12 | 2003-12-31 | Mitral Interventions, Inc. | Method and apparatus for tissue connection |
| WO2011034973A2 (en) * | 2005-02-07 | 2011-03-24 | Abbott Vascular | Methods, systems and devices for cardiac valve repair |
| WO2009052528A2 (en) * | 2007-10-18 | 2009-04-23 | Neochord Inc. | Minimially invasive repair of a valve leaflet in a beating heart |
| US8968393B2 (en) * | 2008-02-28 | 2015-03-03 | Medtronic, Inc. | System and method for percutaneous mitral valve repair |
| JP6600558B2 (en) * | 2013-01-25 | 2019-10-30 | メドテンシア インターナショナル エルティーディー オーワイ | Device, medical system and method for collection of chordae and / or leaflets |
| CN104523353B (en) * | 2014-12-24 | 2016-10-12 | 金仕生物科技（常熟）有限公司 | Artificial mitral valve valve valve holder |
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