CN109806029B - Artificial chordae tendineae implanting system with negative pressure device - Google Patents

Abstract

The invention discloses an artificial chordae implantation system with a negative pressure device, which comprises a clamping device, a puncture device, a pushing device and the negative pressure device, wherein the pushing device comprises a pushing catheter, the puncture device and the clamping device are respectively and movably arranged in the pushing catheter in a penetrating manner, the clamping device is internally provided with an artificial chordae, the negative pressure device comprises at least one vacuum tube axially penetrating through the pushing catheter and a vacuum pump hermetically connected with the near end of the vacuum tube, and the vacuum pump sucks valve leaflets through the vacuum tube. According to the artificial chordae tendineae implantation system, after the valve leaflet is clamped by the far-end chuck and the near-end chuck, an operator can quickly and accurately judge the clamping effect of the valve leaflet through whether the vacuum pump can attract the valve leaflet or not, so that the operator is helped to judge whether the artificial chordae tendineae can be implanted or not, the safety and effectiveness of instruments are improved, and the success rate of an operation is improved.

Description

Artificial chordae tendineae implanting system with negative pressure device

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 an artificial chordae tendineae implantation system with a negative pressure device.

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. Rupture of the mitral chordae tendineae typically manifests as acute severe asthma, left heart failure such as dyspnea, pulmonary edema, and partially progressive chronic heart failure. 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.

There is an apparatus for implanting artificial chordae tendineae in a minimally invasive manner, which first clamps the valve leaflets with a clamping device and then implants the artificial chordae tendineae. However, after the instrument is inserted into the patient's chest, the operator cannot tell whether the leaflets are effectively clamped in the clamping device, such as when the operator is directly implanting artificial chordae tendineae, which can lead to surgical failure.

Disclosure of Invention

The present invention is directed to overcoming the above-mentioned problems of the prior art and providing an artificial chordae implantation system for indicating the clamped state of the leaflets.

The technical scheme adopted by the invention for solving the technical problems is as follows:

the artificial chordae tendineae implantation system with the negative pressure device comprises a clamping device, a puncture device, a pushing device and the negative pressure device, wherein the pushing device comprises a pushing conduit, the puncture device and the clamping device are movably arranged in the pushing conduit in a penetrating mode respectively, and the clamping device accommodates the artificial chordae tendineae. The negative pressure device comprises at least one vacuum tube axially penetrating through the pushing catheter and a vacuum pump hermetically connected with the near end of the vacuum tube, and the vacuum pump sucks the valve leaflets through the vacuum tube. Thus, after the valve leaflet is clamped by the distal end clamp and the proximal end clamp, the operator can judge the clamping effect of the valve leaflet according to whether the vacuum pump can suck the valve leaflet or not.

In the artificial chordae implantation system, preferably, the axial direction of the vacuum tube is parallel to the axial direction of the push catheter.

In the artificial chordae tendineae implantation system, the diameter of the distal opening of the vacuum tube is preferably larger than the diameter of the rest of the vacuum tube.

In the artificial chordae tendineae implantation system, preferably, a flat suction cup is arranged at the far end of the vacuum tube, the suction cup is made of a biocompatible material, and the diameter of the suction cup is larger than that of the opening at the far end of the vacuum tube.

In the artificial chordae implantation system, preferably, the artificial chordae includes a flexible chordae body having a first end and a second end opposite to each other, and the first end and/or the second end is/are connected with a fixing member for non-detachable fixed connection or detachable fixed connection with the puncture device.

The system is implanted to artifical chordae tendineae, prefer the cover is equipped with anti-skidding piece on the chordae tendineae main part, anti-skidding piece is equipped with the binding face with the laminating of leaflet, anti-skidding piece is followed the axial slip of chordae tendineae main part.

In the artificial chordae tendineae implanting system, preferably, 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 the valve leaflets in a matching mode, the near-end chuck is arranged at the far end of the pushing catheter, and the far-end chuck is arranged at the far end of the clamping push rod.

In the artificial chordae implantation system, an artificial chordae channel is preferably arranged in the clamping push rod along the axial direction, an artificial chordae accommodating cavity is arranged in the far-end chuck, the far end of the artificial chordae accommodating cavity is communicated with the far-end chuck, the artificial chordae channel is communicated with the artificial chordae accommodating cavity, and the artificial chordae is accommodated in the artificial chordae channel and the artificial chordae accommodating cavity.

In the artificial chordae tendineae implantation system, preferably, a fixing cavity is formed in the clamping surface of the far-end chuck, and the fixing cavity is axially communicated with the artificial chordae tendineae accommodating cavity.

In the artificial chordae implantation system, preferably, the diameter of an inscribed circle of the fixing cavity is larger than the diameter of an circumscribed circle of the artificial chordae accommodating cavity.

In the artificial chordae tendineae implantation system, preferably, the clamping surface of the distal end chuck is provided with an anti-slip part accommodating groove, the anti-slip part accommodating groove is radially communicated with the artificial chordae tendineae accommodating cavity, and the anti-slip part accommodating groove is radially communicated with the fixed cavity.

In the artificial chordae tendineae implanting system, preferably, the push conduit is provided with a puncture push rod channel, a clamping push rod channel and a vacuum channel which are separated from each other along the axial direction, and the vacuum channel is positioned between the puncture push rod channel and the clamping push rod channel.

In the artificial chordae tendineae implantation system, preferably, a vacuum tube outlet communicated with the vacuum tube channel is arranged on the clamping surface of the near-end clamping head, and the far end of the vacuum tube extends out of the vacuum tube outlet.

Compared with the prior art, the artificial chordae tendineae implantation system with the negative pressure device has the following beneficial effects:

the artificial chordae tendineae implantation system is provided with the negative pressure device, after the valve leaflets are clamped by the far-end chuck and the near-end chuck, an operator can quickly and accurately judge the clamping effect of the valve leaflets through whether the vacuum pump can attract the valve leaflets or not, so that whether the artificial chordae tendineae can be implanted or not is judged, the safety and the effectiveness of instruments are improved, and the success rate of surgery and the efficiency of surgery are improved.

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;

figure 3 is a schematic structural view of an artificial chordae implantation system with a negative pressure device according to one embodiment of the present invention;

figure 4 is a schematic view of the clamping device closed in the artificial chordae implantation system of figure 3;

figure 5 is an exploded view of the artificial chordae implantation system of figure 3;

fig. 6 is a schematic view of the artificial chordae tendineae in the artificial chordae implantation system of fig. 3;

figure 7 is a schematic structural view of another embodiment of an artificial chordae tendineae;

figure 8 is a schematic structural view of another embodiment of an artificial chordae tendineae;

figure 9 is a schematic structural view of another embodiment of an artificial chordae tendineae;

FIG. 10 is a schematic view of the attachment of the securing element to the puncture needle in the artificial chordae implantation system of FIG. 3;

figure 11 is a schematic view of the gripping surface of the distal collet of the artificial chordae implantation system of figure 3;

FIG. 12 is a cross-sectional view B-B of FIG. 11;

figure 13 is a radial cross-sectional view of the push catheter in the artificial chordae implantation system of figure 3;

fig. 14 a-14 c are schematic views of the vacuum device attracting the leaflets of the artificial chordae implantation system of fig. 3, wherein fig. 14a is a schematic view of the leaflets not covering the vacuum tube outlet, fig. 14b is a schematic view of the leaflets only partially covering the vacuum tube outlet, fig. 14c is a schematic view of the leaflets fully covering the vacuum tube outlet, the vacuum device attracting the leaflets;

figure 15 is an axial cross-sectional view of the distal end of the push catheter in the artificial chordae implantation system of figure 3;

FIG. 16 is a schematic structural view of another embodiment of a negative pressure device;

FIG. 17 is an enlarged view of a portion of FIG. 16 at M;

fig. 18-24 are schematic views of a process for implanting an artificial chordae using the artificial chordae implantation system of fig. 3.

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.

In the field of interventional medical device technology, a position close to the operator is generally defined as proximal and a position far from the operator as distal.

As shown in fig. 3-24, an artificial chordae implantation system for implanting an artificial chordae 100 into a patient to replace diseased or broken chordae within the heart of the patient. The artificial chordae tendineae implanting system comprises a clamping device 300, a puncturing device 400, a pushing device 200 and a negative pressure device 500. The pusher device 200 includes a pusher catheter 210. The puncture device 400 and the holding device 300 are movably inserted into the pusher catheter 210, respectively. The holder 300 accommodates the artificial chorda tendineae 100 therein. The negative pressure device 500 comprises at least one vacuum tube 510 axially penetrating the push catheter 210 and a vacuum pump 520 hermetically connected to the proximal end of the vacuum tube 510, wherein the vacuum pump 520 sucks the valve leaflets through the vacuum tube 510.

As shown in fig. 6-9, artificial chordae 100 includes a length of flexible chordae body 110. 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 main body 110 is fixed between the leaflets and the ventricular wall (or papillary muscles) to replace the diseased chordae, maintaining the 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, and is preferably a PTFE polymer material.

The first and second ends of the tendon body 110 do not differ in direction, importance, etc. The fixing member 120 may be provided at both ends of the tendon main body 110 as shown in fig. 6, or may be provided only at one end of the tendon main body 110 as shown in fig. 7. The number of the artificial chordae 100 may be one, or two or more as shown in fig. 8. The tendon main body 110 and the fixing member 120 are fixedly connected by knotting, winding, welding, bonding, clamping and the like. For example, one end of the main body 110 may be tied out of the fixing element 120 to form a larger diameter wire loop, or the end may be welded to a larger diameter round ball, or a positioning rod may be provided at the end that is not coaxial with the fixing element 120. When the fixing pieces 120 are provided only at the first end of the tendon main body 110, since the second end of the tendon main body 110 is not provided with the fixing pieces 120, the second end should have a diameter larger than that of the tendon main body 110 by knotting, winding, providing a bulbous end, a disc-shaped end, or a positioning rod, etc., as shown in fig. 9, in order to fix the second end of the tendon main body 110 to the upper surface of the leaflet. In this embodiment, it is preferable that the number of the artificial chordae 100 is one, and the fixing members 120 are disposed at the first and second ends of the chordae body 110 (as shown in fig. 6).

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. In this embodiment, a snap connection is adopted, specifically, a groove or a hole is formed on the inner surface of the fixing member 120, and the groove or the hole is engaged with a protrusion or a protruding edge formed on the puncture needle 410 to form a non-detachable or detachable fixed connection. As shown in fig. 10, the inner surface 121 of the fixing member 120 is radially provided with three grooves 125, which are engaged with the ledge 411 of the puncture needle 410. 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.

As shown in fig. 6, 8 and 9, in order to increase the point contact between the artificial chordae 100 and the leaflet to surface contact, thereby reducing the risk of the artificial chordae 100 tearing the leaflet, it is preferable that the chordae body 110 be sleeved with a slip prevention element 130, and the slip prevention element 130 can slide axially along 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 anti-slip means 130 are arranged on the artificial chordae 100 in the following manner: as shown in fig. 6, in one mode, at least two through holes 131 are formed in the anti-slip member 130, and a first end and a second end of one tendon main body 110 respectively pass through different through holes 131 and then are respectively connected to the fixing member 120; another way is that the anti-skid device 130 is provided with at least two through holes 131, and one end of each tendon main body 110 passes through different through holes 131, that is, a plurality of tendon main bodies 110 share one anti-skid device 130; as shown in fig. 8 and 9, a third way is to provide a non-slip member 130 on each tendon main body 110, provide a through hole 131 on the non-slip member 130, connect one end of the tendon main body 110 with the fixing member 120 after passing through the through hole 131, and enable the diameter of the other end to be larger than the diameter of the through hole 131 on the non-slip member 130 by knotting or providing a spherical end, a disc-shaped end, a positioning rod, etc. on the other end without the fixing member 120. In this embodiment, two through holes 131 are formed in the anti-slip member 130, and the first end and the second end of the tendon main body 110 are respectively connected to one of the fixing members 120 after passing through one of the through holes 131.

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 anti-slip member 130 is not limited in specific structure except for the abutting surface 132, and may be, for example, a sheet, a disc 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. 3-5, 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 is preferably axially disposed with a plurality of lumens therethrough spaced from one another. 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.

Referring to fig. 3-5 and 10, the pusher catheter 210 has a lumen through which the puncture device 400 is inserted. 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 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. In this embodiment, the number of the puncture push rods 420 is two.

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 110 proximally. 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 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 chordal tendineae, then withdraw the syringe needle and drive artifical chordal tendineae and pass the valve leaflet, fix the one end of artifical chordal 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 risk that postoperative valve leaflet was torn. 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 artificial chordae implantation system of this embodiment forms a single puncture site on each leaflet ranging from 0.3mm to 1.5mm in diameter, and further, the diameter of the puncture site can be controlled to be about 0.7mm by selecting an appropriate shape and diameter of the puncture needle 410.

After the valve leaflet is clamped by the clamping device 300, the puncture needle 410 is driven by the third handle 401 to puncture the valve leaflet and is 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, and the operation time is prolonged or 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.

Referring also to fig. 3-5, the gripping device 300 includes a gripping push rod 330, and a distal collet 310 and a proximal collet 320 for cooperatively gripping the leaflets. The holding push rod 330 is movably inserted into an inner cavity of the pusher 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, at this time, a leaflet receiving space is formed between the distal collet 310 and the proximal collet 320, and after the leaflet is inserted into the leaflet receiving space by the distal end of the fine tuning instrument, the second handle 301 is withdrawn proximally to drive the clamping pushing rod 330 to move proximally, so that the distal collet 310 is close to the proximal collet 320 to form a closed state as shown in fig. 4. At this time, the leaflet is 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.

It will also be appreciated that in other embodiments, the separately provided proximal collet 320 may be eliminated and the distal end of the pusher catheter 210 may be used as the proximal collet 320 and cooperate with the distal collet 310 to grip the leaflets. In such an embodiment, the pusher catheter 210 is preferably a rod with multiple partitioned lumens, with the distal surface of the rod acting as a grasping surface for the leaflets.

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, e.g., they may be disposed obliquely, i.e., at an acute angle of less than 90 degrees to the axial direction of the pusher catheter 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 body or a hollow rod body with a certain axial length, the cross section is preferably oval or circular, and an artificial chordae tendineae channel is arranged in the clamping push rod 330 along the axial direction. Two artificial chordae receiving cavities 315 are formed in the distal collet 310 and communicate with the artificial chordae passage, the two artificial chordae receiving cavities 315 each penetrating to a clamping surface of the distal collet 310 (i.e., a proximal surface of the distal collet 310). The tendon body 110 of the artificial tendon 100 is received in the artificial tendon channel and the artificial tendon receiving cavity 315.

Referring to fig. 11 and 12, the clamping surface of the distal collet 310 defines two fixing cavities 313 for respectively receiving the two fixing members 120 of the artificial chordae 100. Each fixation cavity 313 is in axial communication with one artificial chordae containment cavity 315. The positions of the two fixed cavities 313 correspond to the positions of the two puncture needles 410, respectively. Thus, the two fixing elements 120 of the artificial chordae tendineae 100 are respectively received in the distal collet 310, and the proximal end of each fixing element 120 corresponds to a respective puncture needle 410.

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. While the present embodiment places and secures the artificial chordae 100 inside the instrument, the aforementioned problems are avoided. 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 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 member 130 is further disposed on the artificial tendon 100, the clamping surface of the distal collet 310 is provided with an anti-slip member receiving groove 314 for receiving the anti-slip member 130. The anti-slip member receiving groove 314 is in radial communication with the two artificial chordae tendineae receiving cavities 315, respectively. 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 elements 120, the chordae main bodies 110 and the anti-slip elements 130 respectively connected with the two puncture needle heads 410 can be driven to be sequentially pulled out from the clamping surface of the distal chuck 310 by respectively withdrawing the two puncture push rods 420 towards the proximal ends until the puncture needle heads 410, the fixing elements 120 and the chordae main bodies 110 sequentially penetrate through the leaflets, and the anti-slip elements 130 are attached to the upper surfaces of the leaflets.

The fixing cavity 313 and the anti-slip element receiving groove 314 are configured 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 main body 110 does not contact the valve leaflet alone at the moment when the valve leaflet is separated from the clamping device 300 and resumes beating when the distal collet 310 and the proximal collet 320 are changed from the closed state to the open state, thereby preventing the linear cutting effect of the main body 110 from damaging the beating valve leaflet.

The fixing cavity 313 is sized to secure the fixing member 120 of the artificial chorda 100 in the fixing cavity 313 and to be smoothly pulled out of the fixing cavity 313 when 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 tendineae 100 cannot pass through the artificial chordae housing 315, so that the puncture needle 410 cannot pull the artificial chordae tendineae 100 out of the holding surface of the holding plunger 330 after connecting with the fixing element 120 of the artificial chordae tendineae 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 tendon body 110 and the cleat 130 smoothly out of the clamping surface of the distal collet 310, the fixing cavity 313 and the cleat receiving groove 314 are in radial communication. Preferably, the width D3 of the communication portion between the fixing cavity 313 and the cleat 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.

Referring again to fig. 3-5, to indicate the clamping effect of the clamping device 300 on the valve leaflets, a negative pressure device 500 is also provided in the artificial chordae implantation system of the present invention. The negative pressure device 500 includes at least one vacuum tube 510 axially penetrating the push catheter 210 and a vacuum pump 520 sealingly connected to a proximal end of the vacuum tube 510. The vacuum tube 510 and the vacuum pump 520 are connected together by means of adhesion, welding, screw connection, etc. which are commonly used in the art, and the two are hermetically connected to ensure the air tightness of the device. The pushing conduit 210 is provided with a vacuum tube passage 290 along the axial direction, a vacuum tube 510 is inserted into the vacuum tube passage 290, the clamping surface of the proximal clamping head 320 is provided with a vacuum tube outlet 321 communicated with the vacuum tube passage 290, and the distal end of the vacuum tube 510 extends out of the vacuum tube outlet 321.

The vacuum tube 510 can be movably inserted into the vacuum tube channel 290, and the vacuum tube 510 and the vacuum tube channel 290 can be fixed together by means of adhesion, screw connection, and other technical means commonly used in the art. It is understood that in other embodiments, the vacuum tube 510 and the vacuum tube channel 290 may be a unitary structure, i.e., a lumen of the pusher catheter 210 is used as the vacuum tube 510, and the proximal end of the vacuum tube 510 is hermetically connected to the vacuum pump 520, i.e., the valve leaflets may be sucked by negative pressure.

The vacuum tube 510 is made of a flexible biocompatible material, such as a single-layer tube made of PTFE or silicone; it may be a multi-layer composite pipe body made of various materials, for example, an innermost layer made of PTFE material, a woven mesh or spring made of metal material as a middle layer, and an outermost layer made of Pebax or nylon. The cross-section of the vacuum tube 510 may be circular or elliptical, crescent, semi-circular or polygonal, and preferably circular or elliptical without corners.

The length of the vacuum tube 510 is greater than or equal to 220 cm. Thus, in an operating room environment, the vacuum pump 520 may be placed outside of the sterile field, thereby eliminating the need to sterilize the vacuum pump 520, thereby reducing the cost of producing the instruments.

The vacuum tube 510 may be shipped and sterilized, packaged and transported together by the manufacturer in the pusher catheter 210, or the vacuum tube 510 may be packaged and transported separately from the pusher catheter 210 and inserted into the pusher catheter 210 by the operator after sterilization before surgery.

It will also be appreciated that in other embodiments, the vacuum tube 510 may be movably connected to the vacuum pump 520 by a sealed connector (not shown) since sterilization of the vacuum pump 520 may not be necessary. At the time of shipment, the connection between the vacuum tube 510 and the vacuum pump 520 is released, the vacuum tube 510 is sterilized and packaged, and the vacuum pump 520 may be packaged separately without being strictly sterilized. Before use, the vacuum tube 510 placed in the sterile field and the vacuum pump 520 placed outside the sterile field can be connected together by a sealed connector by an operator and then used.

The specific type and model of the vacuum pump 520 are not limited, and any device or equipment that can extract vacuum by mechanical, physical, chemical or physicochemical methods to the closed environment can be used, and preferably a medical pressure pump, a medical balloon pressure pump and a medical syringe.

Referring to fig. 13, the pusher catheter 210 has a piercing pusher channel 270, a clamping pusher channel 280, and a vacuum tube channel 290 disposed therein along the axial direction. The clamping push rod 330 is movably inserted in the clamping push rod channel 280, the puncturing push rod 420 is movably inserted in the puncturing push rod channel 270, and the axial directions of the clamping push rod 330, the puncturing push rod 420 and the vacuum tube 510 are all parallel to the axial direction of the pushing catheter 210. The clamping pusher channel 280 is disposed on one side of the pusher catheter 210 and the two piercing pusher channels 270 are disposed on the other side of the pusher catheter 210. To minimize patient trauma, reduce the patient's cardiac incision, and minimize the overall outer diameter of the pusher catheter 210, the vacuum tube channel 290 is preferably disposed between the clamping pusher rod channel 280 and the piercing pusher rod channel 270.

It is understood that in other embodiments, the vacuum tube 510 and the push catheter 210 may be coaxially disposed, i.e., the vacuum tube channel 290 through which the vacuum tube 510 is threaded is disposed at a substantially central axis of the push catheter 210. It will also be appreciated that in other embodiments, the axial direction of the vacuum tube 510 may not be parallel to the axial direction of the pusher catheter 210, for example, the vacuum tube channel 290 may be disposed anywhere in the pusher catheter 210, and the axial direction of the vacuum tube channel 290 may be at an angle to the axial direction of the pusher catheter 210, so long as the vacuum tube outlet 321 is disposed on the gripping surface of the proximal collet 320 and communicates with the distal end of the vacuum tube 510, thereby generating vacuum suction on the leaflets.

In the prior art, when inserting artificial chordae tendineae implantation system into the patient, the doctor observes the leaflet position with the help of equipment such as supersound, and then after operation clamping device 300 centre gripping leaflet, can't directly perceivedly judge whether the centre gripping effect of leaflet is ideal, if directly implant artificial chordae tendineae, probably lead to the operation failure. In the artificial chordae implantation system of the present embodiment, the negative pressure device 500 has the function of indicating the clamping effect of the valve leaflets. Referring to fig. 14a to 14c, after the leaflet is clamped, the vacuum pump 520 is turned on, so that negative pressure is generated in the vacuum tube 510, the negative pressure is transmitted to the vacuum tube outlet 321 on the clamping surface of the proximal chuck 320 through the vacuum tube 510, if the leaflet cannot completely cover the vacuum tube outlet 321, the negative pressure in the vacuum tube 510 cannot be maintained, the leaflet cannot be sucked, and the vacuum tube 510 has blood backflow, which indicates that the leaflet has poor clamping effect and needs to be regulated by the clamping device 300 for re-clamping; if the valve leaflet can completely cover the vacuum tube outlet 321, the negative pressure can be kept stable, the valve leaflet is subjected to vacuum suction and has no blood backflow, which indicates that the valve leaflet has good clamping effect, and an operator can continue subsequent operation to implant the artificial chordae tendineae.

In addition, the negative pressure device 500 has the functions of assisting the clamping device 300, stabilizing the valve leaflet, and improving the clamping force. During puncturing, the holding push rod 330 contacts with the edge of the valve leaflet, the distal collet 310 and the proximal collet 320 can only hold part of the valve leaflet, the negative pressure in the vacuum tube 510 can make the valve leaflet tightly attached to the holding surface of the proximal collet 320, the valve leaflet is subjected to vacuum suction, the movement amplitude is reduced, and therefore the negative pressure device 500 can assist the proximal collet 320 and the distal collet 310 in holding the valve leaflet, and the pulsating valve leaflet is kept stable and convenient for puncturing.

It will be appreciated that in order to prevent excessive blood aspiration into the vacuum tube 510 from affecting the patient after the negative pressure device 500 is opened, the negative pressure device 500 further comprises a return tube (not shown) for directing blood back flow, a proximal end of the return tube being in selective communication with a proximal end of the vacuum tube 510 via an openable valve, and a distal end of the return tube being insertable into and in communication with the chest cavity of the patient. Thus, blood drawn through the vacuum tube 510 may be re-expelled through the return tube into the patient's chest cavity to reduce the patient's loss of blood flow. The structure of the return tube and the valve and the connection way with the vacuum tube 510 can be a biocompatible tube, a valve body and a connection way commonly used by those skilled in the art, and are not described herein again. It should be noted that, because the return tube is added, after the artificial chordae implantation system of the present invention is inserted into the chest of the patient, the operator may first start the vacuum pump 520 of the negative pressure device 500, stabilize the pulsating valve leaflet by suction, then drive the clamping device 300 to clamp the valve leaflet, puncture and implant the artificial chordae, during this process, since the blood sucked by the vacuum tube 510 may flow into the patient again through the return tube, the adverse effect on the patient may be avoided.

Referring to fig. 15, in order to enhance the vacuum suction force, the contact area between the distal opening of the vacuum tube 510 and the valve leaflets should be increased. Thus, the diameter at the distal opening of the vacuum tube 510 is larger than the diameter of the rest of the vacuum tube 510.

It will be appreciated that in other embodiments, the distal end of the vacuum tube 510 may also be provided with a flat suction cup 540, as shown in fig. 16 and 17, in order to further increase the suction of the leaflet by the negative pressure device 500. To ensure safety, the suction cup is preferably made of a biocompatible material. The diameter of the suction cup 540 is larger than the diameter of the distal opening of the vacuum tube 510 and smaller than the diameter of the vacuum tube outlet 321 to increase the contact area and improve the vacuum suction force.

It is understood that, in other embodiments, in order to enhance the suction force to the valve leaflet, a plurality of vacuum tube channels 290 separated from each other may be further disposed in the push catheter 210, at least one vacuum tube 510 penetrates each vacuum tube channel 290, a vacuum pump 520 may be connected to a proximal end of each vacuum tube 510, or the proximal ends of the vacuum tubes 510 are connected to the same vacuum pump 520 through a joint, and the same vacuum pump 520 sucks different portions of the lower surface of the valve leaflet through the vacuum tubes 510, so as to further increase the vacuum suction force to the valve leaflet by the negative pressure device 500, and increase the clamping effect.

The use of the artificial chordae tendineae implantation system with a negative pressure device provided by the invention is described by taking the chordae tendineae implantation clamped by the posterior leaflet of the mitral valve as an example:

the first step is as follows: referring to fig. 18, the artificial chordae implant system is advanced into the left ventricle, and continued to be advanced until the distal collet 310 and the proximal collet 320 are both within the left atrium;

the second step is that: referring to fig. 19, the pushing catheter 220 is withdrawn proximally or the holding push rod 330 is pushed distally, such that the proximal collet 320 at the distal end of the pushing catheter 220 is separated from the distal collet 310 at the distal end of the holding push rod 330, and a leaflet receiving space is formed between the proximal collet 320 and the distal collet 310;

the third step: referring to fig. 20, keeping the relative position between the first handle 201 and the second handle 301 unchanged, the whole instrument is slowly moved proximally until the leaflets enter the leaflet containing space formed between the proximal collet 320 and the distal collet 310 and the leaflet edges contact the clamping push rod 330, at which time the second handle 301 is withdrawn proximally, driving the distal collet 310 toward the proximal collet 320 until the two close and the leaflets are clamped;

the fourth step: the vacuum pump 520 of the negative pressure device 500 is turned on, the vacuum pump 520 generates vacuum suction force to the valve leaflet through the vacuum tube 510, and at this time, the negative pressure device 500 has an indication effect of the clamping effect of the valve leaflet: if the leaflets do not completely cover the vacuum tube outlet 321 on the clamping surface of the proximal clamp 320 (as shown in fig. 14a and 14 b), the vacuum suction cannot be maintained and blood is sucked out, indicating that the leaflets are poorly clamped and need to be re-clamped; if the leaflets completely cover the vacuum tube outlets 321 (as shown in fig. 14 c), the vacuum suction can be maintained unchanged, which indicates that the leaflets are clamped well and the operator can perform subsequent operations; the vacuum suction force generated by the vacuum pump 520 can assist the clamping device 300 in stabilizing the pulsating valve leaflets, so that the clamping effect of the clamping device 300 on the valve leaflets is enhanced, the subsequent implantation operation is facilitated, and the valve leaflets can be effectively prevented from slipping from the clamping device 300;

the fifth step: referring to fig. 21a, the third handle 401 is pushed distally, and the two puncture needles 410 are driven to move distally along the axial direction of the push catheter 210, i.e. the puncture needles 410 move toward the distal collet 310, until the two puncture needles 410 pass through the valve leaflets and form a fixed connection with the two fixing elements 120 of the artificial chordae 100 (as shown in fig. 21 b);

and a sixth step: referring to fig. 22, the third handle 401 is withdrawn, so that the puncture needle 410 drives the fixing member 120 of the artificial chordae tendineae 100 and the main body 110 of the chordae tendineae connected to the fixing member 120 to sequentially pass through the valve leaflet, the anti-slip member 130 is also pulled out from the clamping surface of the distal collet 310, the abutment surface 132 (i.e., the lower surface) of the anti-slip member 130 contacts with the upper surface of the valve leaflet, and simultaneously part of the main body 110 of the chordae tendineae presses the upper surface of the anti-slip member 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 anti;

the seventh step: the third handle 401 is further withdrawn until the fixture 120 is withdrawn from the proximal end of the delivery catheter 210, the vacuum pump 520 is turned off to remove the vacuum suction to the leaflets by the negative pressure, then the first handle 201 is operated to separate the proximal collet 320 and the distal collet 310, the leaflets are returned to the pulsatile state, and then the entire artificial chordae implant system is withdrawn, and the length of the chordae body 110 remaining in the heart is adjusted to fix the two ends of the chordae body 110 to the ventricular wall, respectively (as shown in fig. 24).

To sum up, the artificial chordae tendineae implantation system of the invention adds a negative pressure device with the function of indicating the clamping effect of the valve leaflet in the artificial chordae tendineae implantation system, after the valve leaflet is clamped, the negative pressure generated by a vacuum pump is transmitted to the outlet of a vacuum tube on the clamping surface of a near-end chuck through the vacuum tube, if the valve leaflet can not completely cover the outlet of the vacuum tube, the negative pressure in the vacuum tube can not be maintained, which indicates that the clamping effect of the valve leaflet is poor, and the clamping device needs to be adjusted to clamp again; if the valve leaf can completely cover the vacuum tube outlet at this moment, the negative pressure can be kept stable, which shows that the valve leaf has good clamping effect and can continue the follow-up puncture operation.

In addition, after the valve leaflet is clamped by the far-end chuck and the near-end chuck, the negative pressure device can generate certain vacuum suction force on the valve leaflet so as to reduce the moving amplitude of the valve leaflet, assist the clamping device to stabilize the pulsating valve leaflet and prevent the valve leaflet from slipping from the clamping device.

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 (11)

1. Take negative pressure device's artifical chorda tendineae implantation system, including clamping device, piercing depth, pusher and negative pressure device, pusher includes the propelling movement pipe, piercing depth with clamping device wears the dress movably respectively in the propelling movement pipe, the artifical chorda tendineae has been held to the clamping device, its characterized in that: the clamping device is used for clamping the valve leaflets, the negative pressure device is used for indicating the clamping effect of the clamping device on the valve leaflets, the negative pressure device comprises at least one vacuum tube axially penetrating through the pushing catheter and a vacuum pump hermetically connected with the proximal end of the vacuum tube, and the vacuum pump sucks the valve leaflets through the vacuum tube;

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 clamping valve leaflets in a matched mode;

the push conduit is internally provided with a puncture push rod channel, a clamping push rod channel and a vacuum tube channel which are separated from each other along the axial direction, and the vacuum tube channel is positioned between the puncture push rod channel and the clamping push rod channel.

2. The artificial chordae implantation system of claim 1, wherein an axial direction of the vacuum tube is parallel to an axial direction of the push catheter.

3. The artificial chordae implantation system of claim 1, wherein the diameter at the distal opening of the vacuum tube is greater than the diameter of the remainder of the vacuum tube.

4. The artificial chordae implantation system of claim 3, wherein the distal end of the vacuum tube is provided with a flat suction cup, the suction cup being made of a biocompatible material, the diameter of the suction cup being larger than the diameter at the distal opening of the vacuum tube.

5. The artificial chordae implantation system of claim 1, wherein the artificial chordae comprises a length of flexible chordae body having opposite first and second ends, a fixation element being attached to the first and/or second ends for non-removable or removable fixation connection with the puncture device.

6. The artificial chordae implantation system of claim 5, wherein the main body is provided 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.

7. The system of claim 1, wherein an artificial chordae channel is axially disposed within the clamping push rod, an artificial chordae housing cavity is disposed within the distal collet, a distal end of the artificial chordae housing cavity extends through the distal collet, the artificial chordae channel is in communication with the artificial chordae housing cavity, and the artificial chordae is housed within the artificial chordae channel and the artificial chordae housing cavity.

8. The artificial chordae implantation system of claim 7, wherein the gripping surface of the distal collet defines a fixation cavity in axial communication with the artificial chordae receiving cavity.

9. The artificial chordae implantation system of claim 8, wherein the diameter of the inscribed circle of the fixation lumen is larger than the diameter of the circumscribed circle of the artificial chordae housing lumen.

10. The artificial chordae implantation system of claim 8, wherein the gripping surface of the distal collet defines a slip resistant receptacle in radial communication with the artificial chordae receiving cavity and in radial communication with the fixation cavity.

11. The artificial chordae implantation system of claim 1, wherein the clamping surface of the proximal clamp is provided with a vacuum tube outlet in communication with the vacuum tube channel, the distal end of the vacuum tube extending from the vacuum tube outlet.

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