CN210114539U

CN210114539U - Artificial chordae tendineae implantation system with detection device

Info

Publication number: CN210114539U
Application number: CN201721470629.8U
Authority: CN
Inventors: 张庭超; 张伟伟; 周春远
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2017-11-07
Filing date: 2017-11-07
Publication date: 2020-02-28
Anticipated expiration: 2027-11-07

Abstract

The utility model discloses a take detecting device's artifical chordae tendineae implantation system, including clamping device, piercing depth, pusher and detecting device, pusher includes the propelling movement pipe, clamping device is including holding the centre gripping push rod of artifical chordae tendineae and being used for cooperating the distal end chuck and the near-end chuck of centre gripping leaflet, detecting device includes an at least probe, the dress is worn in the propelling movement pipe to the probe activity, the clamping face of near-end chuck or distal end chuck is equipped with the probe export, the clamping face of the distal end chuck or the near-end chuck that corresponds is equipped with and accepts the chamber with the probe that the probe export is relative, when distal end chuck and near-end chuck are closed, the distal end of probe stretches out from the probe export and accepts in the chamber is accepted in the probe. The utility model discloses a mechanical structure's detection device can detect whether the leaflet is by the centre gripping between distal end chuck and near-end chuck fast, accurately, simple structure, and is easy and simple to handle, and the operation risk is low, and has reduced the manufacturing cost of apparatus, alleviates patient's economic burden.

Description

Artificial chordae tendineae implantation system with detection device

Technical Field

The utility model belongs to the technical field of medical instrument, a repair heart valve defect's apparatus is related to, especially relate to a take detecting device's artifical chordae tendineae implantation system.

Background

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. Referring to fig. 1, a normal, healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the chordae tendineae or papillary muscles are diseased, such as the chordae tendineae of the posterior leaflet shown in fig. 2, and the mitral valve fails to return to the closed state as it would if it were in the normal state when the left ventricle were in the contracted state, the momentum of the blood flow may further cause the leaflets to fall into the left atrium, causing blood backflow.

At present, the mode of implanting artificial chordae tendineae in a surgical operation is generally adopted to treat chordae tendineae lesion, invasive thoracotomy technology is adopted, and general anesthesia and moderate low-temperature extracorporeal circulation are carried out as auxiliary support. The surgical operation has the defects of complex operation process, high operation cost, high wound degree of patients, high complication risk, long hospitalization time, pain in the recovery process of the patients and the like.

The existing instrument for implanting the artificial chordae tendineae in a minimally invasive mode clamps valve leaflets through a capture device, judges the clamping effect through a capture verification system and then implants the artificial chordae tendineae. The principle of the capture verification system is that the optical fiber is used for judging whether the valve leaflet is clamped or not by utilizing different colors generated when the optical fiber meets the valve leaflet and blood, after the valve leaflet is clamped, the optical fiber is transmitted to a valve leaflet clamping surface of the capture device, optical signals such as reflection and refraction can be generated after the optical fiber meets the valve leaflet or the blood, and the signals are detected by the other optical fiber wire. This instrument is implanted to artifical chordae tendineae uses optic fibre to intervene in the treatment apparatus, leads to the apparatus structure complicated, and optic fibre need be along with the apparatus body gets into the patient internal, increases the operation risk. In addition, the capture verification system is also provided with a capture verification monitor, so that the structure of the instrument is complicated, the production process is complex, and the production cost and the operation cost are high.

SUMMERY OF THE UTILITY MODEL

The to-be-solved technical problem of the utility model lies in, to the above-mentioned defect among the prior art, provide a take detecting device's artifical chordae tendineae implantation system, stretch into patient's thorax at it, with the accurate, the centre gripping effect of judging the leaflet effectively of the detecting device of leaflet centre gripping back accessible mechanical type to help the operator to judge whether can implant artifical chordae tendineae.

The utility model provides a technical scheme that its technical problem adopted is:

the artificial chordae tendineae implantation system with the detection device comprises a clamping device, a puncture device, a pushing device and the detection device, wherein the pushing device comprises a pushing conduit. 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 distal end chuck is disposed at a distal end of the clamping push rod. The proximal collet is disposed at a distal end of the pusher catheter. The puncture device and the clamping push rod are respectively movably arranged in the pushing guide pipe in a penetrating way. The detection device comprises at least one probe. The probe is movably arranged in the pushing guide pipe in a penetrating mode. The clamping surface of the near-end chuck or the far-end chuck is provided with a probe outlet, and the corresponding clamping surface of the far-end chuck or the near-end chuck is provided with a probe accommodating cavity opposite to the probe outlet. When the far-end chuck and the near-end chuck are closed, the far end of the probe extends out of the probe outlet and is contained in the probe containing cavity. Therefore, when the valve leaflet is not clamped or the clamping position is deviated, the proximal clamping head and the distal clamping head can be closed, and the distal end of the probe can be pushed into the probe accommodating cavity from the probe outlet; when the valve leaf is clamped, the valve leaf covers the probe outlet, the probe can not enter the probe containing cavity smoothly, and therefore the clamping effect of the valve leaf is indicated.

In the artificial chordae implantation system, preferably, the axial length of the probe is greater than the axial length of the push catheter.

In the artificial chordae tendineae implantation system, preferably, the probe comprises a probe body with a certain length, and the probe body is of a solid or hollow structure.

In the artificial chordae implantation system, it is preferable that the hardness of the distal end portion of the probe body is less than or equal to the hardness of the proximal end portion of the probe body.

In the artificial chordae tendineae implantation system, the probe preferably further comprises a probe head arranged at the distal end of the probe main body, the probe head and the probe main body are integrally formed or fixedly connected, and the fixed connection is selected from detachable connection or non-detachable fixed connection.

In the artificial chordae tendineae implantation system, preferably, the outer surface of the probe is smooth, the probe is a solid or hollow structure, and the shape of the probe is at least one selected from conical, truncated, cylindrical, spherical or hemispherical.

In the artificial chordae implantation system, the number of the probes is preferably two.

In the artificial chordae tendineae implantation system, preferably, the two probes are arranged in parallel and the distal ends of the two probes are connected.

In the artificial chordae implantation system, preferably, the detection device further comprises a detection handle arranged at the proximal end of the probe. The probe handle and the probe are integrally formed or fixedly connected, and the fixed connection is selected from detachable connection or non-detachable fixed connection.

In the artificial chordae tendineae implantation system, a probe channel, a clamping push rod channel and a puncture push rod channel are preferably arranged in the push catheter along the axial direction. The probe channel is arranged between the clamping push rod channel and the puncture push rod channel, and the distance between the probe channel and the clamping push rod channel is smaller than the distance between the probe channel and the puncture push rod channel.

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.

In the artificial chordae implantation system, preferably, the chordae main body is accommodated in the clamping push rod and the distal end chuck, the fixing piece is accommodated in the distal end chuck, and the proximal end of the fixing piece corresponds to the distal end of the puncture device.

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 artificial chordae accommodating cavity runs through to the clamping surface of the far-end chuck, the artificial chordae channel is communicated with the artificial chordae accommodating cavity, and the chordae body is accommodated in the artificial chordae channel and the artificial chordae accommodating cavity.

In the artificial chordae tendineae implantation system, preferably, a fixing cavity for accommodating the fixing piece is arranged on 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 tendineae implantation system, preferably, the shape of the fixed cavity is matched with that of the fixed part, and the diameter of an inscribed circle of the fixed cavity is larger than that of an circumscribed circle of the artificial chordae tendineae accommodating cavity.

The system is implanted to artifical chordae tendineae, prefer still to overlap on the chordae tendineae main part and be equipped with anti-skidding piece, 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 implantation system, a through hole is preferably arranged on the anti-slip member, and the chordae main body passes through the through hole;

or the anti-skid piece is provided with at least two through holes, and the first end and the second end of the tendon main body respectively penetrate through the different through holes;

or the anti-skid piece is provided with at least two through holes, and the at least two tendon main bodies respectively penetrate through the different through holes.

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

In the artificial chordae implantation system, preferably, the artificial chordae implantation system further comprises a clamping auxiliary device; the clamping auxiliary device comprises at least one clamping auxiliary arm movably penetrating in the push conduit and a clamping auxiliary piece arranged at the far end of the clamping auxiliary arm; the clamping aid is made of an elastic and/or flexible material; the clamping auxiliary arm pushes the clamping auxiliary piece connected with the clamping auxiliary arm to penetrate out of the far end of the pushing guide pipe or the far end of the clamping device, and the clamping auxiliary piece and the clamping device are matched to clamp the valve leaflets.

In the artificial chordae tendineae implantation system, preferably, an auxiliary arm accommodating cavity is axially arranged in the pushing catheter, and an included angle between the axial direction of the distal end part of the auxiliary arm accommodating cavity and the axial direction of the pushing catheter ranges from 120 degrees to 150 degrees.

In the artificial chordae implantation system, it is preferable that the holding aid is made of an X-ray opaque material.

Compared with the prior art, the artificial chordae tendineae implantation system with the detection device of the utility model has the following beneficial effects at least:

the utility model discloses a detection device includes that at least one wears the probe of dress in the propelling movement pipe, can be accurate, instruct leaflet centre gripping effect effectively through mechanical structure's probe, and detection device such as instrument simple structure, convenient operation avoid using optic fibre and optical display has reduced patient's operation risk, and instrument low in production cost, alleviates patient's economic burden.

Drawings

The invention will be further explained with reference to the drawings and examples, wherein:

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 an exploded view of an artificial chordae implantation system with a detection device according to a first embodiment of the present invention;

fig. 4 is a schematic structural view of an artificial chordae tendineae in the artificial chordae tendineae implantation system according to the first embodiment;

figure 5 is a schematic structural view of another embodiment of an artificial chordae tendineae;

figure 6 is a schematic structural view of another embodiment of an artificial chordae tendineae;

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

FIG. 8 is a schematic view of the first embodiment of an artificial chordae implantation system with a fixture attached to the needle;

fig. 9 is a schematic structural view of the clamping push rod and the distal collet in the artificial chordae implantation system according to the first embodiment;

fig. 10 is a schematic view of the artificial chordae implantation system of the first embodiment with the clamping device being open;

fig. 11 is a schematic view showing a closed clamping device in the artificial chordae implantation system according to the first embodiment;

figure 12 is a schematic view of the gripping surface of the distal collet of the artificial chordae implantation system of the first embodiment;

FIG. 13 is a cross-sectional view B-B of FIG. 12;

fig. 14 is a schematic view of the clamping assistance device in the artificial chordae implantation system according to the first embodiment;

figure 15 is an axial cross-sectional view of the distal end of the pusher catheter of the artificial chordae implantation system of the first embodiment;

FIG. 16 is a schematic view of the clamp assist arm pushing clamp assist of FIG. 14;

fig. 17 is a schematic view of the structure of the clamping aid of fig. 14 supporting a leaflet;

FIG. 18 is an axial cross-sectional view of another embodiment of the distal end of the pusher catheter;

FIGS. 19a and 19b are schematic structural views of different embodiments of the clamping assist device;

FIGS. 20 a-20 c are schematic structural views of various embodiments of a grip assist device;

FIG. 21 is a schematic structural view of a different embodiment of a grip assist device;

fig. 22 is a schematic structural view of a detecting device in the artificial chordae implantation system according to the first embodiment;

FIG. 23 is a schematic view of the sonde of FIG. 22 mounted through a pusher catheter;

figure 24 is a radial cross-sectional view of a pusher catheter in the artificial chordae implantation system of the first embodiment;

FIG. 25 is a schematic structural view of another embodiment of a probe device;

fig. 26 to 36 are schematic views illustrating a process of implanting an artificial chordae using the artificial chordae implanting system of the first embodiment;

fig. 37 is a schematic structural view of a detecting device in the artificial chordae tendineae implanting system with the detecting device according to the second embodiment of the present invention;

FIG. 38 is a schematic view showing the structure of the probe unit and the holding unit of the second embodiment inserted in the pusher catheter;

FIG. 39 is a schematic view showing the structure in which the distal end of the probe device according to the second embodiment is protruded from the holding surface of the proximal collet;

fig. 40 is a schematic process diagram of the artificial chordae implantation system of the second embodiment for chordae implantation;

fig. 41 is a schematic structural view of a detecting device, a clamping push rod and a distal chuck in the artificial chordae implantation system with a detecting device according to the third embodiment of the present invention;

fig. 42 is a schematic structural view of the pusher catheter and the proximal collet of the third embodiment.

Detailed Description

In order to clearly understand the technical features, objects, and effects of the present invention, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

For convenience of description, a position close to the operator is hereinafter defined as a proximal end, and a position far from the operator is hereinafter defined as a distal end.

Example one

As shown in fig. 3 to 36, an artificial chordae implantation system with a detection device is used for implanting artificial chordae into a patient to replace diseased or broken chordae inside the heart of the patient. The artificial chordae tendineae implanting system comprises a holding device 300, a puncturing device 400, a pushing device 200 and a detecting device 600. 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 distal collet 310 is disposed at the distal end of the gripping push rod 330. A proximal collet 320 is disposed at the distal end of the pusher catheter 210. The puncture device 400 and the holding push rod 330 are movably inserted into the push catheter 210, respectively. The probing apparatus 600 includes at least one probe 610, and the probe 610 is movably inserted into the pushing catheter 210. The proximal chuck 320 has a probe outlet 321 on a clamping surface thereof, and the corresponding distal chuck 310 has a probe receiving cavity 316 opposite the probe outlet 321 for receiving the distal end of the probe 610. when the proximal chuck 320 is closed with the distal handpiece 310, the distal end of the probe 610 extends from the probe outlet 321 and is received in the probe receiving cavity 316. Thus, in the absence of a leaflet between the proximal collet 320 and the distal collet 310, the two may be fully closed and the distal end of the probe 610 may be pushed into the probe receptacle 316. After the push catheter 210 is inserted into the thoracic cavity of the patient, after the operator clamps the valve leaflets by the distal collet 310 and the proximal collet 320 of the clamping device 300, if the distal end of the probe 610 can be pushed into the probe accommodating cavity 316, it indicates that the probe 610 is not blocked by the valve leaflets, the valve leaflets are not clamped or the clamped position is deviated, the clamping effect is not ideal, and the instrument position needs to be adjusted to clamp again; if the distal end of the probe 610 cannot be advanced into the probe-receiving cavity 316, indicating that the distal end of the probe 610 is obstructed by the leaflets, the leaflet grip is better and the operator can perform leaflet penetration and implant the artificial chordae tendineae.

As shown in fig. 4-7, the artificial chordae implantation system of the first embodiment includes an artificial chordae 100. The artificial chordae 100 includes a length of flexible chordae body 110. The chordae body 110 is for implantation within the heart to replace diseased chordae within the heart. The tendon body 110 has opposing first and second ends. A fastener 120 is attached to the first end and/or the second end. The holder 120 is adapted to be non-removably secured or removably secured to the puncturing device 400.

The main body 110 is fixed to the leaflets at one end and can be fixed to the ventricular wall or papillary muscles at the other end to replace the diseased chordae tendineae and maintain 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 polymer material.

The fixing member 120 may be provided at both ends of the tendon main body 110 as shown in fig. 4, or may be provided at one end of the tendon main body 110 as shown in fig. 5. The number of the artificial chordae 100 may be one, or two or more as shown in fig. 6. The tendon main body 110 and the fixing member 120 are fixedly connected, and the fixing connection mode can be knotting, winding, welding, bonding, clamping and the like. For example, one end of the tendon main body 110 may be tied to form a coil with a larger diameter after penetrating through the fixing element 120, or the end may be welded to a round ball with a larger diameter, or a positioning rod may be further disposed at the end, an axial direction of the positioning rod in a natural state is not coaxial with an axial direction of the tendon main body 110 and the fixing element 120, and after the positioning rod and one end of the tendon main body 110 penetrate through the fixing element 120, the positioning rod returns to the natural state, and may be clamped on the back surface of the fixing element 120, so that one end of the tendon main body 110 is fixed on the fixing element 120. When the fixing member 120 is 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 member 120, the second end should have a diameter larger than that of the tendon main body 110 by knotting, winding, or providing a bulbous end, a disc-shaped end, etc., as shown in fig. 7, 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. 4).

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. 8, three grooves 125 are radially formed on the inner surface 121 of the fixing member 120, and are engaged with the protruding rim 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. 4 to 7, in order to increase the point contact between the artificial chordae 100 and the valve leaflet to surface contact, thereby effectively reducing the risk of the artificial chordae 100 tearing the valve leaflet, it is preferable that the chordae body 110 is sleeved with a slip prevention element 130, and the slip prevention element 130 can slide 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. 4, in one mode, at least two through holes 131 are formed in the anti-slip member 130, and the first end and the second end of one tendon main body 110 are respectively connected to the fixing member 120 after passing through different through holes 131; as shown in fig. 6, another way is to provide at least two through holes 131 on the anti-skid device 130, and each tendon main body 110 passes through a different through hole 131, that is, a plurality of tendon main bodies 110 share one anti-skid device 130; as shown in fig. 7, 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 provide the other end without the fixing member 120 with a diameter larger than the diameter of the through hole 131 on the non-slip member 130 by knotting or providing a ball-shaped end, a disk-shaped end, etc. 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 specific structure of the anti-slip member 130 is not limited except for the abutting surface 132, and various structures are possible: for example, the shape may be a sheet, a disk or a sphere having a certain area, or even an irregular shape, preferably a sheet. The anti-slip member 130 may be a non-porous structure, a net structure, a bar-grid structure, etc. The anti-slip member 130 should be made of a biocompatible material, and may be made of an elastic material or a non-elastic material. Specifically, the anti-slip member 130 is selected from at least one of an elastic pad, a heart patch, a felt sheet, a mesh structure, a disc structure, or a double disc structure. The structure of the anti-slip member 130 having a disc-like structure or a double disc-like structure is similar to the stopper in the prior art, and will not be described in detail herein. Preferably, in order to reduce the overall size of the instrument, the anti-slip member 130 having a disc-like structure or a double disc-like structure should be made of a shape memory material.

As shown in FIG. 3, 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 push catheter 210 may be made of a biocompatible polymer material (e.g., polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile butadiene styrene ABS, nylon elastomer Pebax, or polyurethane PU), a metal 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 and 8, a puncture device 400 is inserted into a lumen of the pusher catheter 210. 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 puncture needle 410 may be connected to the fixing member 120 of the artificial chordae 100 after puncturing the leaflets to pull the chordae body 110 proximally. The distal end of piercing needle 410 is tapered with a straight tip to facilitate piercing the leaflets and reducing the diameter of the puncture site it forms on the leaflets. Adopt the syringe needle that has hook-like head end among the prior art to pass the valve leaflet to collude the stylolite as artifical 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.

The distal end of the piercing needle 410 is provided with at least one tooth or at least one bead for forming an interference fit or snap-fit connection with the mount 120. It is understood that in other embodiments, the puncture needle 410 may be fixedly connected with the fixing member 120 of the artificial chordae 100 in a non-detachable or detachable manner by means of screw thread, adhesive, friction connection, or the like. The puncture needle 410 is connected with a puncture push rod 420 at the proximal end, and the puncture push rod 420 is movably arranged in the inner cavity of the pushing catheter 210 in a penetrating way. The proximal end of penetrating push rod 420 extends out of the proximal end of pusher catheter 210 and is connected to third handle 401. Therefore, the axial movement of the third handle 401 can drive the puncture push rod 420 to move along the axial direction of the pushing catheter 210, and further drive the puncture needle 410 to puncture distally or withdraw proximally. After the valve leaflet is clamped by the clamping device 300, the puncture needle 410 can be driven by the third handle 401 to puncture the valve leaflet and be connected with the fixing element 120 of the artificial chordae tendineae 100, and the puncture needle 410 and the artificial chordae tendineae 100 are connected into a whole through the fixing element 120. The probability of hooking the artificial chordae tendineae by the needle head with the hook-shaped head end in the prior art is low, so that the success rate of the operation is low, and the operation time is prolonged; and after the needle hooks the artificial chordae tendineae, because the needle is connected with the artificial chordae tendineae only through weak friction, in the process of withdrawing the needle, the artificial chordae tendineae are easy to fall off from the needle due to the blood flow scouring of a patient or the action of an operator, so that the operation failure is caused, and the operation time is prolonged. 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 to fig. 3 and 9-11, the clamping device 300 includes a clamping pusher 330, a distal collet 310, and a proximal collet 320. 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. 10, 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 clamping state as shown in fig. 11. 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 directly as the proximal collet 320 to 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 end face of the rod acting as the grasping face 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 as gripping enhancements, respectively, and when the distal collet 310 and the proximal collet 320 are closed, there is no gap therebetween.

Referring to fig. 9, 12 and 13, the clamping push rod 330 is a tubular body or a hollow rod body with a certain axial length, the cross section is preferably elliptical or circular, and an artificial chordae channel 331 is axially disposed in the clamping push rod 330. Two artificial chordae accommodating cavities 315 are formed in the distal collet 310 and are communicated with the artificial chordae passage 331, and the two artificial chordae accommodating cavities 315 are respectively communicated with the clamping surface of the distal collet 310. The tendon body 110 of the artificial tendon 100 is received in the artificial tendon channel 331 and the artificial tendon receiving cavity 315.

The clamping surface of the distal collet 310 defines two fixing cavities 313 for receiving the two fixing members 120 of the artificial chordae 100, respectively. 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 chorda 100 are respectively received in the distal collet 310, and the proximal end of each fixing element 120 corresponds to one puncture needle 410 respectively.

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.

Because the anti-slip member 130 is further disposed on the artificial tendon 100, the holding surface of the distal collet 310 is provided with a receiving groove 314 for receiving the anti-slip member 130. The accommodating grooves 314 are respectively communicated with the two artificial chordae accommodating cavities 315 in the radial direction. Therefore, after the two puncture needle heads 410 respectively puncture the anterior leaflet and the posterior leaflet of the mitral valve and are respectively connected with one fixing element 120, the two puncture needle heads 410 and the fixing 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 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 used for fixing the fixing member 120 of the artificial chordae tendineae 100 in the fixing cavity 313 and enabling the fixing member 120 to be smoothly pulled out from the fixing cavity 313 after being pulled by 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 main body 110 and the anti-slip member 130 smoothly out of the clamping surface of the distal collet 310, the fixing cavity 313 and the receiving groove 314 are in radial communication. Preferably, the width D3 of the communication part between the fixing cavity 313 and the receiving groove 314 is 20% -50% of D1, which is set for the purpose of: if D3 is too large, the securing member 120 of the artificial chordae 100 may not be securely held within the securing cavity 313 of the distal collet 310 and may easily slip out of the securing cavity 313, directly resulting in failure of the instrument; if D3 is too small, after the puncture needle 410 is connected to the fixing member 120 of the artificial chordae 100, the fixing member 120 cannot be smoothly pulled out of the fixing cavity 313, resulting in a failed operation.

As shown in fig. 14, in order to further enhance the clamping, a clamping auxiliary device 500 is further provided in the artificial chordae implantation system, the clamping auxiliary device 500 comprising a clamping auxiliary arm 520 movably threaded in the push catheter 210 and a clamping auxiliary element 510 provided at a distal end of the clamping auxiliary arm 520. To facilitate pushing, a fourth handle 501 may also be provided at the proximal end of the grip assist arm 520.

As shown in fig. 15, an auxiliary arm housing chamber 250 is provided in the push catheter 210 in the axial direction. Prior to piercing, both grip assist 510 and grip assist arm 520 are received in assist arm receiving cavity 250. An opening 260 is formed on the grasping face of the proximal collet 320, the sidewall of the push catheter 210, or the sidewall of the proximal collet 320, the opening 260 is communicated with the auxiliary arm receiving cavity 250, when the operator pushes the fourth handle 501 distally, the grasping auxiliary arm 520 can be driven to push the grasping auxiliary element 510 to pass through the opening 260 (as shown in fig. 16), so as to support the lower surface of the valve leaflet, stabilize the pulsating valve leaflet, reduce the amplitude of the movement of the valve leaflet, and cooperate with the grasping device 300 to grasp and fix the valve leaflet (as shown in fig. 17).

One embodiment of the auxiliary arm receiving cavity 250 is that 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 axial direction of the distal end portion of the auxiliary arm receiving cavity 250 and the axial direction of the push catheter 210 is in the range of 120 ° -150 °, which is because the holding push rod 330 contacts the edge of the leaflet before puncturing, 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 stable as much as possible and facilitate puncturing, a supporting force needs to be provided on the other side of each leaflet opposite to the edge, so that the holding auxiliary element 510 and the push catheter 210 need to have an included angle to support the lower surface of the other side of each leaflet opposite to the leaflet edge, and the included angle between the holding auxiliary element 510 and the push catheter 210 is substantially equal to the included angle α between the axial direction of the distal end portion of the auxiliary arm receiving cavity 250 and the axial direction of the push catheter 210.

As shown in fig. 18, another embodiment of the auxiliary arm receiving cavity 250 is: the auxiliary arm receiving cavity 250 includes a distal cavity 251 and a proximal cavity 252, the proximal cavity 252 is substantially parallel to the axial direction of the pusher catheter 210, and the included angle γ between the distal cavity 251 and the proximal cavity 252 is in the range of 120 ° -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.

Referring again to fig. 14, the clamping aid 510 is supported on the leaflet lower surface and cooperates with the clamping device 300 to clamp the leaflets. The clamping aid 510 is made of a resilient and/or flexible material to accommodate the anatomy of the leaflets and the amplitude of motion of the leaflets and avoid damage to the leaflets. The elastic material is preferably a shape memory material. The clamping aid 510 may be made of a metallic material, a polymeric material, or a metal-polymer composite. The clamping aid 510 in this embodiment is a support rod. 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 supporting rod can be regular round or oval, crescent, semicircle, polygon and the like. The holding auxiliary 510 is smooth in shape, and the distal end forms a smooth round head by laser spot welding without defects such as burrs, edges or edges and corners. In this embodiment, the clamping aid 510 is made of elastic nitinol with a shape memory and is circular in cross-section.

The clamp assist arm 520 is rod-shaped or tubular with an axial length and a stiffness or rigidity to provide support and pushability. The auxiliary holding arm 520 may be made of a single-layer or multi-layer composite structure metal rod or a polymer rod, and may be made of a single wire or a plurality of wires. The cross-section of the grasping auxiliary arm 520 may be a regular circle or an ellipse, a crescent, a semicircle, a polygon, or a ring, etc. The grasping auxiliary arm 520 may be made of a metal material, a polymer material, or a metal-polymer composite material. In this embodiment, the auxiliary holding arm 520 is made of an elastic material having a memory function, and has a circular cross section.

The support of the auxiliary holding arm 520 and the flexibility of the auxiliary holding member 510 can be achieved by using different materials for the auxiliary holding member 510 and the auxiliary holding arm 520. That is, the grip auxiliary arm 520 is made of a hard material; the clamping aid 510 is made of a resilient and/or flexible material. It is understood that the clamping auxiliary arm 520 and the clamping auxiliary member 510 may be made of the same material, and then a material with higher hardness may be added outside or inside the clamping auxiliary arm 520 to serve as a reinforcing tube or a stiffening wire to ensure the support of the clamping auxiliary arm 520.

The clamping aid 510 is made of an X-ray opaque material. In the prior art, before the clamping device clamps the valve leaflet, the relative position between the instrument and the valve leaflet cannot be judged in a mode with a low operation requirement level such as X-ray, the clamping device can be moved to a proper position only by relying on accurate ultrasonic guidance, the beating state of the valve leaflet is observed by ultrasonic, and when the valve leaflet beats to be close to the clamping device, the relative motion between the far-end chuck and the near-end chuck is rapidly driven to clamp the valve leaflet. Ultrasound has high requirements for the operating technique of doctors and the analysis capability of heart ultrasound images, which leads to increased operation cost, increased operation difficulty and increased operation time. In this embodiment, the auxiliary clamping member 510 is made of a non-transparent material, and after the auxiliary clamping member 510 contacts the valve leaflet, the flexible and/or elastic auxiliary clamping member 510 swings correspondingly along with the movement range of the valve leaflet, so that before the valve leaflet is clamped by the clamping device 300, an operator can quickly and accurately judge the position of the valve leaflet through X-rays, thereby quickly and accurately operating the clamping device 300 to clamp the valve leaflet, reducing the cost and difficulty of the operation, shortening the operation time, and improving the success rate of the operation.

It is understood that in other embodiments, the clamping aid 510 may also be a deformed structure composed of a plurality of support rods in order to enhance the strength of the clamping aid 500. The deformed structure is contracted and deformed, and then is accommodated in the push catheter 210 together with the holding auxiliary arm 520. As shown in fig. 19a, the deformation structure is an open-type branched structure or an umbrella-shaped structure formed by a plurality of support rods, and the included angle phi between the branched structures is less than or equal to 150 degrees. To facilitate being pushed through the pusher catheter 210, the clamping aid 510 has a compressed state and an extended state in its natural state. When the clamping auxiliary member 510 is in a compressed state, it can be accommodated in the auxiliary arm accommodating cavity 250 of the pushing catheter 210 and pushed; when the grasping aid 510 extends from the grasping surface of the proximal collet 320, the sidewall of the pusher catheter 210, or the opening 260 in the sidewall of the proximal collet 320, it transitions to an extended state and can support the lower surface of the leaflets to stabilize the beating leaflets. The contact surface of the clamping auxiliary 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.

It will also be appreciated that in other embodiments, the ends of the grasping aid 510 in a bifurcated or umbrella-like configuration may be rolled proximally of the grasping aid arms 520, with a plurality of grasping aids 510 forming a recessed area, as shown in fig. 19 b. 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.

Referring to fig. 20 a-20 c, it is also understood that in other embodiments, the deformation structure may be a closed loop structure formed by a plurality of support rods, and the closed loop structure may be circular, diamond-shaped, oval-shaped, pear-shaped, polygonal, or other irregular shapes that may form a closed structure. Referring to fig. 21, it can be further 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 loop structure to improve the stability of the closed loop structure and further enhance the supporting force of the clamping auxiliary 510 on the valve leaflets. It will also be appreciated that in other embodiments, when a plurality of support rods and connecting rods are provided in a closed loop structure, the closed loop structure may also form a sheet-like structure or a net-like structure. It will also be appreciated that in other embodiments, the mesh structure may be heat-set to form a stretch-deformable disc-like structure (similar to the single-disc occluders of the prior art), and the disc-like structure may be further heat-set to form a columnar, nested, flattened, etc. structure. If the grasping aid 510 is made of a shape memory material, it can be received in the auxiliary arm receiving cavity 250 of the pusher catheter 210 and delivered, and then extended through the opening 260, returning to its natural, deployed state, contacting the lower surface of the leaflets and providing support to the leaflets.

As shown in fig. 22-23, the probe 600 is used to detect whether a leaflet is clamped between the distal collet 310 and the proximal collet 320. The probing apparatus 600 includes at least one probe 610. In this embodiment, the detecting device 600 includes two probes 610, the two probes 610 are arranged in parallel, and the distances between the two probes 610 and the clamping push rod 330 are substantially equal.

The axial length of the stylet 610 is preferably greater than the axial length of the pusher catheter 210. The stylet 610 is movably mounted in the stylet channel 270 of the pusher catheter 210. To facilitate manipulation, the proximal end of the probe 610 is attached to a probe handle 601. The probe handle 601 and the probe 610 may be integrally formed or fixedly connected, and the fixed connection is detachable connection such as screw connection and clamping connection, or non-detachable fixed connection such as welding and bonding. The gripping surface of the proximal collet 320 is provided with a probe outlet 321 to facilitate the distal end of the probe 610 to protrude therefrom. The corresponding gripping surface of the distal collet 310 defines a probe receiving cavity 316 (shown in FIG. 9) opposite the probe outlet 321 for receiving the distal end of the probe 610. When the proximal and

distal jaws

320, 310 are closed, the distal end of the probe 610 extends from the probe outlet 321 and is received in the probe receiving cavity 316

As shown in fig. 24, the pusher catheter 210 has a probe channel 270, a holding pusher channel 280, and a piercing pusher channel 290 formed therein in the axial direction. The holding push rod 330 is inserted into the holding push rod channel 280 of the pushing catheter 210, and the puncturing push rod 420 is inserted into the puncturing push rod channel 290 of the pushing catheter 210, so as to ensure that 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 clamping pusher channel 280 is disposed on one side of the pusher catheter 210 and two piercing pusher channels 290 are disposed on the other side of the pusher catheter 210. The probe channel 270 is disposed between the clamping pusher channel 280 and the piercing pusher channel 290, and the distance between the probe channel 270 and the clamping pusher channel 280 is less than the distance between the probe channel 270 and the piercing pusher channel 290. It is understood that when the auxiliary arm receiving cavity 250 is further provided in the push catheter 210, the auxiliary arm receiving cavity 250 is disposed between the clamping push rod channel 280 and the piercing push rod channel 290, the probe channel 270 is disposed between the clamping push rod channel 280 and the auxiliary arm receiving cavity 250, and the distance between the probe channel 270 and the clamping push rod channel 280 is smaller than the distance between the probe channel 270 and the piercing push rod channel 290.

When the proximal collet 320 and the distal collet 310 are closed, if the valve leaflet is clamped between the proximal collet 320 and the distal collet 310 and the edge of the valve leaflet contacts the clamping push rod 330, the distal end of the probe 610 is blocked by the valve leaflet after passing through the clamping surface of the proximal collet 320 and cannot advance further distally, which indicates that the valve leaflet can be better clamped and can be punctured. In addition, when the distal end of the probe 610 is blocked by the leaflet and cannot enter the probe receiving cavity, the relative fixation between the leaflet edge and the main body 110 of the chordae tendineae is also shown, which improves the therapeutic effect of the artificial chordae tendineae implantation. Therefore, the clamping effect of the valve leaflets can be effectively detected through the probe of the mechanical structure, and the instrument has a simple structure and is convenient to operate.

The probe 610 includes a probe body having a length, which may be a solid or hollow structure. The cross section of the probe body may be regular circle, or ellipse, crescent, semicircle, polygon, etc., preferably circle. The probe body may be made of a metallic material, a polymer material, or a metal-polymer material. For example, the probe body can be a solid rod-shaped or hollow tubular 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 distal portion of the probe body has a hardness less than or equal to a hardness of the proximal portion of the probe body. Preferably, the distal portion of the probe body has a hardness less than that of the proximal portion of the probe body. That is, the distal portion of the probe body is preferably flexible or resilient to avoid puncture or damage to the leaflets, and the proximal portion of the probe body is preferably a structure having a degree of stiffness or rigidity to provide support and pushability.

The distal portion and the proximal portion of the probe body may be integrally formed or may be separately processed and then connected together by welding, bonding, sleeving, screwing or interference fit, which are common technical means in the art, that is, the proximal support and the distal flexibility of the probe body may be achieved by using different materials to respectively manufacture the proximal portion and the distal portion of the probe body. It is understood that, in other embodiments, the whole rod body or the tube body may be made of a softer material, and then the outer tube with higher hardness is sleeved on the outer surface of the proximal end portion of the rod body or the tube body to serve as a reinforcing tube to improve the proximal end support of the probe body; the heat shrinkable tube can also be used as a reinforcing tube to be wrapped on the flexible rod body or the near end part of the tube body, and then the heat shrinkable tube is heated to be wrapped on the outer surface of the near end part after being shrunk so as to improve the near end support of the probe body. It can also be understood that, for a rod body or a tube body formed by winding a single wire or a plurality of wires, a thermoplastic elastomer such as Pebax, nylon and the like can be wrapped on the outer surface of the proximal end part of the rod body or the tube body, and then the rod body or the tube body is heated to melt the thermoplastic elastomer, and then the thermoplastic elastomer is wrapped on the outer surface and simultaneously permeates into gaps among a plurality of wires or a single wire, so as to improve the proximal end support performance of the probe body.

It will be appreciated that in other embodiments, the probe 610 may further include a probe head disposed at the distal end of the probe body, the probe head and the probe body being integrally formed or fixedly connected, and the fixed connection being selected from a detachable connection or a non-detachable fixed connection. The tip at the distal end of the probe 610 is preferably smooth on the outside surface to avoid damage to the leaflets, e.g., a smooth rounded tip can be formed by laser spot welding, without burrs, edges, corners, etc. The probe can be a solid or hollow structure, but for the convenience of pushing, the shape of the probe is selected from at least one of a cone, a table, a cylinder, a sphere or a hemisphere. The probe may be made of a metallic material, a polymeric material, or a metal-polymeric material.

It is also understood that in other embodiments, the probing apparatus 600 may include only one probe 610, and may also include a plurality of probes 610 (e.g., three probes as shown in fig. 25). The plurality of probes 610 may be commonly inserted into one lumen of the pusher catheter 210, i.e., the pusher catheter 210 has only one probe channel 270, or may be inserted into different lumens of the pusher catheter 210, i.e., the pusher catheter 210 has a plurality of probe channels 270.

The following description will be made of the implementation of the artificial chordae implantation system with a detecting device according to the present embodiment, taking the chordae implantation clamped by the posterior leaflet of the mitral valve as an example:

the first step is as follows: referring to fig. 26, 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. 27, the pushing catheter 210 is withdrawn proximally or the clamping pusher 330 is pushed distally, so that the proximal collet 320 is separated from the distal collet 310, and a leaflet receiving space is formed between the proximal collet 320 and the distal collet 310;

the third step: referring to fig. 28, the fourth handle 501 is pushed distally, the fourth handle 501 drives the auxiliary clamping arm 520 to push the auxiliary clamping element 510 out of the opening 260, at this time, the auxiliary clamping element 510 is supported on the lower surface of the leaflet to stabilize the pulsating leaflet, the relative positions of the first handle 201, the second handle 301 and the fourth handle 501 are kept unchanged, the whole instrument is slowly moved proximally until the leaflet enters the leaflet holding space formed between the proximal collet 320 and the distal collet 310, and the auxiliary clamping element 510 can provide a certain supporting force for the leaflet;

the fourth step: referring to fig. 29 and 30, 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: keeping the first handle 201 at a constant position, pushing the probe handle 601 distally, driving the stylet 610 to move distally along the axial direction of the pusher catheter 210; as shown in fig. 31a or fig. 31b, if the leaflet is poorly held, i.e. the leaflet does not completely cover the probe opening 321 on the holding surface of the proximal collet 320, the distal end of the probe 610 can extend from the probe opening 321 into the probe-receiving cavity 316 of the distal collet 310, and the second to fourth steps are repeated to re-hold the leaflet; if the leaflet is well clamped, i.e., the leaflet completely covers the probe opening 321 on the clamping surface of the proximal collet 320, the distal end of the probe 610 cannot protrude from the probe opening 321 and enter the probe-receiving cavity 316 of the distal collet 310, as shown in fig. 31c, a subsequent operation can be performed.

And a sixth step: as shown in fig. 32, pushing the third handle 401 distally, drives the puncture needle 410 to move distally until the puncture needle 410 passes through the valve leaflet, as shown in fig. 33a, and forms a fixed connection with the fixing element 120 of the artificial chordae 100, as shown in fig. 33 b;

the seventh step: referring to fig. 34, 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 (i.e., the lower surface) of the anti-slip member 130 is in contact 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. 35), at this time, the point contact between the artificial chordae tendineae 100 and the valve leaflet is converted into the surface contact between the;

eighth step: the third handle 401 is further withdrawn until the fixing member 120 is withdrawn from the proximal end of the pushing catheter 210, and then the fourth handle 501 is withdrawn, so that the holding auxiliary member 510 is withdrawn into the auxiliary arm accommodating chamber 250, the entire artificial chordae implantation system is withdrawn, the length of the main chordae 110 remaining in the heart is adjusted, and both ends of the main chordae 110 are fixed to the ventricular wall of the heart, respectively, thereby completing the artificial chordae implantation (as shown in fig. 36).

In the fourth step, if the operator finds that the valve leaflet is not effectively clamped, the relative positions of the distal collet 310 and the proximal collet 320 can be fine-tuned to generate a certain distance therebetween, the relative position between the clamping rod 330 and the valve leaflet is adjusted, the clamping device 300 is operated again to clamp the valve leaflet, and the fifth step of the surgical operation is performed. During the adjustment process, the leaflet is prevented from slipping out of the holding device 300 because the holding assistance device 500 under the leaflet has a certain supporting effect on the leaflet.

Example two

The artificial chordae implantation system with the probe according to the second embodiment has substantially the same structure as the artificial chordae implantation system according to the first embodiment, except that the two probes 610 of the probe 600 are arranged side by side and the distal ends of the two probes 610 are connected in the artificial chordae implantation system according to the second embodiment.

Referring to fig. 37-39, the distal ends of the probes 610 have some elasticity/flexibility and are connected together by a connecting rod 620. When the probe handle 601 is retracted, the connecting rod 620 rests on the gripping surface of the proximal collet 320. The clamping surface of the proximal collet 320 is preferably provided with a groove 323 for receiving the connecting rod 620, and the groove 323 should be in communication with the probe passage 270. Accordingly, the clamping surface of the distal collet 310 is also provided with a connecting rod receiving groove 322 for receiving the connecting rod 620, and the connecting rod receiving groove 322 is respectively communicated with the two probe receiving cavities 316. When the probing handle 601 of the probing device 600 is pushed to the distal end, the distal ends of the two probes 610 and the connecting rod 620 extend out of the proximal collet 320 and enter the connecting rod receiving slot 322 and the probe receiving cavity 316 of the distal collet 310; when the probing handle 601 is retracted proximally, the distal ends of the two probes 610 and the connecting rod 620 are withdrawn from the distal collet 310, the distal ends of the probes 610 are received in the probe channel 270 in the pusher catheter 210, and the connecting rod 620 is received on or in the groove 323 of the clamping surface of the proximal collet 320.

In this embodiment, the increased contact area between the distal end of the detection device 600 and the leaflet is particularly useful for detecting irregular leaflet shapes. For example, as shown in fig. 40, since the shape of the edge of the leaflet is irregular, even though the leaflet is effectively clamped by the clamping device 300, the leaflet may not cover the probe outlet 321 of the proximal clamp 320, and the distal ends of the two probes 610 of the embodiment are connected together by the connecting rod 620, so that the contact area between the distal end of the detecting device 600 and the leaflet is increased, the leaflet can be detected to be clamped, and the operator can be instructed to perform leaflet puncture and implantation of the artificial chordae tendineae.

The use method of the artificial chordae implantation system of the present embodiment is substantially the same as that of the artificial chordae implantation system of the first embodiment, and is not repeated herein.

EXAMPLE III

The artificial chordae implantation system with the probe device according to the third embodiment has substantially the same structure as the artificial chordae implantation system according to the first embodiment, except that the probe 610 of the probe device 600 is movably inserted into the holding push rod 330 in the artificial chordae implantation system according to the third embodiment.

Specifically, referring to fig. 41 and 42, the stylet 610 is inserted through the clamping push rod 330 and the clamping push rod 330 is inserted through the pusher catheter 210, i.e., the stylet 610 is also located within the lumen of the clamping push rod 330. The stylet 610 is bent distally and then bent proximally and received in the distal collet 310. The gripping surface of the distal cartridge 310 defines a probe outlet 318 and the gripping surface of the corresponding proximal cartridge 320 defines a probe receiving cavity 324 opposite the probe outlet 318.

A curved stylet ramp 319 is provided in the distal collet 310, with one end of the stylet ramp 319 connected to a stylet channel 332 in the clamping push rod 330 and the other end extending through to the stylet outlet 318 on the clamping face of the distal collet 310. The probe 610 extends through the probe passage 332 and the probe bend 319, which hold the push rod 330. The distal end of the probe 610 has flexibility and toughness, and can be naturally kept straight, and can be bent under pressure and moved in the axial direction in a curve. It is understood that in other embodiments, the probe channel 332 need not be separately provided, but rather the lumen holding the push rod 330 can be used directly as the probe channel 332.

The probing device 600 of the artificial chordae implantation system of the present embodiment is used as follows: after the valve leaflet is clamped, the axial movement of the probe 610 is driven by moving the detection handle 601, the distal end part of the probe 610 is bent along the shape of the curved probe curve 319 when passing through the curved probe curve 319, and continues to advance, if the distal end of the probe 610 can enter the probe accommodating cavity 324 on the clamping surface of the proximal clamping head 320 through the probe outlet 318 on the clamping surface of the distal clamping head 310, which indicates that the clamping effect of the valve leaflet is poor, and the clamping position needs to be adjusted for reclamping; if the distal end of the probe 610 is not able to enter the probe-receiving cavity 324 from the probe outlet 318 by actuation of the probe handle 601, indicating that the leaflet has completely or nearly completely filled the leaflet-receiving space between the proximal clip 320 and the distal clip 310, the leaflet will be better gripped and the insertion of the artificial chordae tendineae can be performed.

To sum up, the utility model discloses a take detecting device's artifical chordae tendineae implantation system adopts mechanical form's probe as detecting device for apparatus simple structure has reduced the operation risk, and manufacturing cost is lower, alleviates patient's economic burden.

The above description is only exemplary of the present invention and should not be taken as limiting the scope of the present invention, as any modifications, equivalents, improvements and the like made within the spirit and principles of the present invention are intended to be included within the scope of the present invention.

Claims

1. The artificial chordae tendineae implantation system with the detection device comprises a clamping device, a puncture device, a pushing device and the detection device, wherein the pushing device comprises a pushing catheter, and is characterized in that the clamping device comprises a clamping push rod containing the artificial chordae tendineae, a far-end chuck and a near-end chuck, the far-end chuck and the near-end chuck are used for being matched with and clamping valve leaflets, the far-end chuck is arranged at the far end of the clamping push rod, the near-end chuck is arranged at the far end of the pushing catheter, the puncture device and the clamping push rod are respectively and movably arranged in the pushing catheter in a penetrating mode, the detection device comprises at least one probe, the probe is movably arranged in the pushing catheter in a penetrating mode, a probe outlet is arranged on a clamping surface of the near-end chuck or the far-end chuck, a probe containing cavity opposite to the probe outlet is arranged on a clamping surface of the far, when the far-end chuck and the near-end chuck are closed, the far end of the probe extends out of the probe outlet and is contained in the probe containing cavity.

2. The artificial chordae implantation system of claim 1, wherein an axial length of the stylet is greater than an axial length of the push catheter.

3. The artificial chordae implantation system of claim 1, wherein the probe comprises a probe body having a length, the probe body being a solid or hollow structure.

4. The artificial chordae implantation system of claim 3, wherein a hardness of a distal portion of the probe body is less than or equal to a hardness of a proximal portion of the probe body.

5. The system of claim 3, wherein the stylet further comprises a probe head at the distal end of the stylet body, the probe head being integrally formed with the stylet body or fixedly attached thereto, the fixed attachment being selected from a detachable attachment or a non-detachable fixed attachment.

6. The artificial chordae implantation system of claim 5, wherein the outer surface of the probe is smooth, the probe is a solid or hollow structure, and the shape of the probe is selected from at least one of conical, truncated, cylindrical, spherical, or hemispherical.

7. The artificial chordae implantation system of claim 1, wherein the number of probes is two.

8. The artificial chordae implantation system of claim 7, wherein the two probes are juxtaposed and the distal ends of the two probes are connected.

9. The system of claim 1, wherein the probing device further comprises a probing handle disposed at the proximal end of the probe, the probing handle and the probe being integrally formed or fixedly attached, the fixed attachment being selected from a detachable attachment and a non-detachable fixed attachment.

10. The system of claim 1, wherein the push catheter has a probe channel, a clamping push rod channel, and a puncturing push rod channel disposed therein along an axial direction, the probe channel is disposed between the clamping push rod channel and the puncturing push rod channel, and a distance between the probe channel and the clamping push rod channel is smaller than a distance between the probe channel and the puncturing push rod channel.

11. 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.

12. The artificial chordae implantation system of claim 11, wherein the chordae body is received in the clamping push rod and the distal collet, the fixation element is received in the distal collet, and a proximal end of the fixation element corresponds to a distal end of the puncture device.

13. The artificial chordae implantation system of claim 12, wherein an artificial chordae channel is axially disposed in the clamping push rod, an artificial chordae housing cavity is disposed in the distal collet, the artificial chordae housing cavity extends through to the clamping surface of the distal collet, the artificial chordae channel communicates with the artificial chordae housing cavity, and the chordae body is housed in the artificial chordae channel and the artificial chordae housing cavity.

14. The artificial chordae implantation system of claim 13, wherein the gripping surface of the distal collet defines a fixation cavity for receiving the fixation element, the fixation cavity in axial communication with the artificial chordae receiving cavity.

15. The artificial chordae implantation system of claim 14, wherein the fixation lumen has a shape that matches a shape of the fixation element and the diameter of an inscribed circle of the fixation lumen is larger than the diameter of a circumscribed circle of the artificial chordae housing lumen.

16. The artificial chordae implantation system according to any of the claims 11-15, wherein the main body is further provided with a slip prevention element, said slip prevention element having an abutment surface for abutment with the leaflets, said slip prevention element sliding along the axial direction of the main body.

17. The artificial chordae implantation system of claim 16, wherein the slip resistant member has a through hole through which the main body of the chordae passes;

18. The artificial chordae implantation system of claim 14, wherein the gripping surface of the distal collet defines a channel for receiving a slip prevention member, the channel being in radial communication with the artificial chordae receiving cavity and the channel being in radial communication with the fixation cavity.

19. The artificial chordae implantation system of claim 1, further comprising a clamping assist device; the clamping auxiliary device comprises at least one clamping auxiliary arm movably penetrating in the push catheter and a clamping auxiliary piece arranged at the far end of the clamping auxiliary arm; the clamping aid is made of an elastic and/or flexible material; the clamping auxiliary arm pushes the clamping auxiliary piece connected with the clamping auxiliary arm to penetrate out of the far end of the pushing guide pipe or the far end of the clamping device, and the clamping auxiliary piece and the clamping device are matched to clamp the valve leaflets.

20. The artificial chordae implantation system of claim 19, wherein an auxiliary arm receiving cavity is axially disposed within the push catheter, an angle between an axial direction of a distal end of the auxiliary arm receiving cavity and an axial direction of the push catheter being in a range of 120 ° -150 °.

21. The artificial chordae implantation system of claim 19, wherein the clamping aid is made of an X-ray opaque material.