CN216702724U

CN216702724U - Valve leaflet anchoring piece and artificial chordae tendineae repairing device

Info

Publication number: CN216702724U
Application number: CN202023267271.3U
Authority: CN
Inventors: 郭扬
Original assignee: Hangzhou Duanyou Medical Technology Co ltd
Current assignee: Hangzhou Duanyou Medical Technology Co ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2022-06-10
Anticipated expiration: 2030-12-30

Abstract

The utility model relates to the field of medical instruments, in particular to a valve leaflet anchoring piece and an artificial chordae tendineae repairing device, wherein the valve leaflet anchoring piece comprises a base and a fluke, wherein a fluke positioning hole and a chordae tendineae positioning hole are formed in the base, and the fluke positioning hole is matched with the fluke; the artificial chordae tendineae repair device comprises the leaflet anchor, the artificial chordae tendineae and the papillary muscle anchor, wherein one end of the artificial chordae tendineae is connected with the chordae tendineae positioning hole, and the other end of the artificial chordae tendineae is connected with the papillary muscle anchor. The valve leaflet anchoring piece adopts the bar material to manufacture the base of the valve leaflet anchoring piece, adopts the metal wire to manufacture the fluke, has good molding stability and is not easy to break; the small-size valve leaflet anchoring piece can be realized by combining the bar base and the metal wire anchor fluke, and the process is simple, easy to process and low in cost; the valve leaflet anchoring part has the advantages of large number of flukes, small damage to the native valve leaflets, uniform stress on the valve leaflets and good anchoring performance.

Description

Valve leaflet anchoring piece and artificial chordae tendineae repairing device

Technical Field

The utility model relates to the field of medical instruments, in particular to a valve leaflet anchoring piece and an artificial chordae tendineae repairing device.

Background

The mitral valve is a complex tissue structure between the Left Atrium (LA) and the Left Ventricle (LV), and is composed of a mitral annulus, a mitral anterior leaflet, a mitral posterior leaflet, mitral chordae tendineae, and papillary muscles. The mitral valve ensures that blood can only flow from the left atrium to the left ventricle and not vice versa. A normal, healthy mitral valve has a plurality of chordae tendineae connected at one end to the leaflet edges and at the other end to papillary muscles located in the ventricular wall. When the left ventricle is in diastole, the anterior leaflet and the posterior leaflet of the mitral valve are opened, the chordae tendineae are in a relaxed state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in the systole, the anterior and posterior mitral valve coaptate under the action of blood pressure, meanwhile, due to the pulling action of chordae tendinae, the valve leaflet can not overturn to the atrium side due to the blood pressure, and under the combined action of the valve leaflet and chordae tendineae, the blood flow channel between LA and LV is closed, and blood can only flow from the left ventricle to the aorta through the aortic valve (AV for short) and is sent to all organs of the whole body. When the chordae tendineae or papillary muscles are diseased or impacted by external force, part of the chordae tendineae is often elongated or broken, and when the left ventricle contracts, the valve leaflets are overturned to one side of the atrium under the action of blood pressure due to the fact that the chordae tendineae are lost to be pulled, so that the valve leaflets cannot be closely involuted, and blood backflow is generated, namely mitral regurgitation. When acute severe mitral regurgitation occurs (such as tendon cable breakage caused by external force such as impact), hemodynamics is changed sharply, a large amount of arterial blood flows back to the left atrium, so that pulmonary congestion is caused, capillary pressure rises sharply, acute pulmonary edema occurs, severe clinical symptoms such as dyspnea and hemoptysis occur, and patients die if not immediately subjected to clinical intervention. If only a single tendon is broken to generate mild-moderate mitral regurgitation, clinical symptoms of a patient cannot be immediately caused due to the compensatory function of the heart, but the increased tension of other tendons can generate new tendon breakage, the pressure of the left atrium rises, the left atrium and the mitral valve annulus gradually expand to increase the regurgitation degree, the left ventricular preload is increased, the left ventricular dilatation and contraction dysfunction is caused, the left heart failure occurs, the whole heart failure is often caused, and the life health of the patient is seriously threatened. 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. It follows that mitral valve chordae tendineae elongation or rupture has a great impact on human health and requires clinical intervention.

Mitral regurgitation due to the presence of lesions or broken chordae can often be treated by medication, surgery or intervention. The pharmaceutical means (such as blood pressure reduction, diuresis, etc.) is symptomatic treatment, which can only alleviate clinical symptoms, but cannot solve the problem at all. Cardiac surgery is still currently the gold standard of clinical treatment for moderate to severe mitral regurgitation. The heart surgery needs general anesthesia and thoracotomy, and the direct-view operation is carried out under the condition of cardiac arrest by means of extracorporeal circulation, so that the operation process is complex, the patient has high risk of trauma and complications, the hospitalization recovery time is long, and the heart surgery is not suitable for high-risk patients with low cardiac function, multiple complications, high age and the like.

The artificial chordae repair operation is to implant an artificial chordae repair device in a minimally invasive way to repair the mitral valve. The device is characterized in that the operation is completed under the condition that the heart does not stop jumping, and the artificial chordae repair device can be accurately implanted in the operation by means of the navigation function of modern imaging equipment such as three-dimensional ultrasound and radiography. The device shortens the operation time, reduces the degree of trauma, and reduces the operation difficulty and the operation risk. The artificial chordae tendineae repair device generally comprises a conveying system and two parts of artificial chordae tendineae, wherein after the artificial chordae tendineae are implanted into a human body, one end of the artificial chordae tendineae is connected with valve leaflets, and the other end of the artificial chordae tendineae is connected with papillary muscles, so that anchoring is realized. In the prior art, a valve leaflet anchoring member is a metal pipe cut into an anchor claw shape, and the valve leaflet anchoring member has the following problems that 1, the plastic anchor claw is cut, has larger plastic strain and is easy to break; 2. the leaflet anchors are small size parts, but the tube cutting needs to consider the problem of coaxiality, and the smaller the tube diameter is, the more difficult the realization is. Therefore, the cutting type fluke has complex process, high processing cost and certain limitation on the diameter; 3. the use of cutting techniques to make flukes has certain limitations on the number of flukes, as the greater the number of flukes, the more difficult the process can be. The anchor flukes are small in number, local gripping force of the anchor flukes on native valve leaflets of anchoring points is too large, the native valve leaflets are easily damaged, and the valve leaflets can be torn in serious cases.

SUMMERY OF THE UTILITY MODEL

In view of the above-mentioned drawbacks of the prior art, it is an object of the present invention to provide a leaflet anchor and artificial chordae repair device that solve the problems of the prior art.

In order to achieve the above and other related objects, the present invention provides a leaflet anchor comprising a base and a fluke, wherein the base is provided with fluke positioning holes and tendon positioning holes, and the fluke positioning holes are adapted to the fluke.

The utility model also provides an artificial chordae tendineae repair device, which comprises the leaflet anchor, the artificial chordae tendineae and the papillary muscle anchor, wherein one end of the artificial chordae tendineae is connected with the chordae tendineae positioning hole, and the other end of the artificial chordae tendineae is connected with the papillary muscle anchor.

As described above, the leaflet anchor and artificial chordae repair device according to the present invention have the following advantageous effects:

1. the base of the valve leaflet anchoring part is made of the bar material, the fluke is made of the metal wire, and the metal wire has good shaping stability and is not easy to break.

2. The small-size valve leaflet anchoring piece can be realized by adopting the combination of the bar base and the metal wire anchor fluke, and the small-size valve leaflet anchoring piece has the advantages of simple process, easy processing and low cost.

3. The valve leaflet anchoring part has the advantages of large number of flukes, small damage to the native valve leaflets, uniform stress on the valve leaflets and good anchoring performance.

Drawings

Fig. 1 shows a schematic view of a leaflet anchor of the present invention.

Figure 2 shows a schematic view of the artificial chordae repair device of the utility model.

In fig. 3 a to c are shown schematic views of different papillary anchors of the utility model.

Figures 4 a to f show a schematic representation of the method of use of the artificial chordae repair device of the utility model.

Description of the element reference numerals

11 base

111 fluke positioning hole

112 chordae tendineae positioning holes

12 anchor fluke

2 Artificial chordae tendineae

3 papillary muscle anchor

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure of the present invention.

Please refer to fig. 1 to 4. It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.

As shown in the drawings, the present invention provides a leaflet anchor comprising a base 11 and a fluke 12, wherein the base 11 is provided with a fluke positioning hole 111 and a chordae tendineae positioning hole 112, and the fluke positioning hole 111 is adapted to the fluke 12.

The base 11 has the functions of reducing local traction stress of the valve leaflet, accelerating endothelialization and increasing anchoring stability.

Generally, the base 11 is made of a biocompatible metal material. Such as shape memory alloys, nitinol, titanium alloys, cobalt chromium alloys, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium. In a preferred embodiment, the base 11 is made of a shape memory alloy.

The base 11 is axisymmetric or centrosymmetric in itself. The base 11 is selected from a bar. Generally, the shape of the base 11 is selected from cylindrical or prismatic. The cylindrical shape may be a cylinder or an elliptic cylinder. The prism shape may be a triangular prism, a quadrangular prism or other prisms. Preferably, the base 11 is cylindrical in shape. The cylindrical shape prevents the corners from locally stressing the leaflets.

In one embodiment, fluke-locating holes 111 are provided in the edge of base 11.

One or more fluke positioning holes 111 may be provided. In a preferred embodiment, there are a plurality of fluke-positioning holes 111. Such as 2, 3, 4 or more. When the plurality of fluke positioning holes 111 are provided, the fluke positioning holes 111 are distributed axisymmetrically or centrosymmetrically. The symmetrical distribution is more beneficial to the dispersion of the anchoring force, and the tearing of local valve leaflets caused by overlarge stress is prevented.

In one embodiment, the tendon positioning holes 112 are provided on a central axis of the base 11. The traction force of the chordae tendineae to the base 11 in all directions can be ensured to be the same, thereby avoiding the local traction stress of the base 11 to the valve leaflets from being overlarge.

One or more of the tendon positioning holes 112 may be provided. In one embodiment, one of the tendon positioning holes 112 is provided.

The tendon positioning holes 112 are through holes or blind holes.

The material of the fluke 12 is selected from metal wires. In one embodiment, the wire is nickel titanium.

The number of flukes 12 matches the number of fluke positioning holes 111. The fluke 12 is welded with the fluke positioning hole 111 or the fluke 12 is riveted, pressed and fixed in the fluke positioning hole 111.

The utility model also provides an artificial chordae tendineae repair device, which comprises the leaflet anchor, the artificial chordae tendineae 2 and the papillary muscle anchor 3, wherein one end of the artificial chordae tendineae 2 is connected with the chordae tendineae positioning hole 112, and the other end is connected with the papillary muscle anchor 3.

The artificial chordae 2 act to pull the native leaflets and prevent them from prolapsing or turning to the side of the left atrium.

The artificial chordae 2 is selected from a wire. Specifically, the wire meets the requirements of YY 0167-2020 standard.

Typically, the wire has a diameter selected from the group consisting of 5-0, 4-0, 3-0, 2-0/T, and 2-0. The diameter of the wire is preferably 3-0, 2-0. Clinical data indicate that 3-0, 2-0 diameter wires are closer to the usage requirements of chordae tendineae.

The structure of the wire may be a single or multi-strand weave. The structure of the wire is preferably single stranded. The structure of the single strands is more stable and the multiple strands run the risk of being drawn, twisted or twisted.

The material of the wire rod can be selected from Polytetrafluoroethylene (PTFE), Expanded Polytetrafluoroethylene (EPTFE), polyethylene terephthalate (PET), ultrahigh molecular weight polyethylene (UHMWPE), mulberry silk, nylon, cotton and the like. The material of the wire is preferably Polytetrafluoroethylene (PTFE) or Expanded Polytetrafluoroethylene (EPTFE). The present application is not limited to this.

As shown in fig. 3, the papillary anchors 3 are selected from the group consisting of spirals (a in fig. 3), barbs (b in fig. 3) or boat-like anchor structures (c in fig. 3). The papillary muscle anchoring piece 3 can be embedded into myocardial tissue after being implanted into a body and is used as a fixing mechanism for connecting the artificial chordae tendineae 2 with the myocardium.

The artificial chordae tendineae repair device of the utility model may be implanted transapically or via the interatrial septum approach, preferably via the interatrial septum approach. The prior art delivery system and the chordae cutting device are required to be implanted in cooperation with each other.

The use method of the artificial chordae tendineae repair device comprises the following steps: placing the artificial chordae repair device in a delivery system from the interatrial septum through a common sheath into the atrium (a in fig. 4); the pushing and conveying system finishes the grabbing of the valve leaflet by the valve leaflet anchoring part under the assistance of the ultrasonic and DSA medical imaging equipment (b in figure 4); the conveying system is pulled back to withdraw the artificial chordae tendineae 2 (c in fig. 4); anchoring the papillary anchors 3 to the left ventricular myocardium by the delivery system (d in fig. 4); the length of the artificial chordae tendineae 2 is adjusted by the aid of the ultrasonic images by retracting the conveying system, the appropriate length of the artificial chordae tendineae 2 is found, no reflux is ensured, and the length of the artificial chordae tendineae 2 is locked by a chordae fixing device in the conveying system (e in fig. 4). And (3) cutting the redundant length of the artificial chordae tendineae 2 by using a chordae tendineae cutting device, withdrawing the conveying system and completing the operation. The final state of the implant in the heart is shown in fig. 4 f.

In conclusion, the present invention effectively overcomes various disadvantages of the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the utility model. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. A leaflet anchor, characterized in that the leaflet anchor comprises a base (11) and a fluke (12), wherein the base (11) is provided with fluke positioning holes (111) and tendon positioning holes (112), and the fluke positioning holes (111) are matched with the fluke (12).

2. The leaflet anchor of claim 1, where the base (11) is itself axisymmetric or centrosymmetric.

3. The leaflet anchor of claim 1, where the base (11) is selected from a bar, or where the shape of the base (11) is selected from a cylinder or a prism.

4. The leaflet anchor of claim 1, where the fluke positioning hole (111) is provided at an edge of the base (11) or where the chordae positioning hole (112) is provided on a central axis of the base (11).

5. The leaflet anchor of claim 1, where the fluke-positioning hole (111) is provided with one or more; when the fluke positioning holes (111) are provided in plurality, the fluke positioning holes (111) are distributed in axial symmetry or in central symmetry.

6. The leaflet anchor of claim 1, where the fluke (12) is made of a material selected from the group consisting of wires.

7. The leaflet anchor of claim 1, where the fluke (12) is welded or riveted to a fluke-positioning hole (111).

8. An artificial chordae repair device comprising a leaflet anchor according to any of claims 1-7, an artificial chordae (2) and a papillary anchor (3), the artificial chordae (2) being connected at one end to a chordae positioning hole (112) and at one end to the papillary anchor (3).

9. The artificial chordae repair device according to claim 8, wherein the artificial chordae (2) is selected from wires.

10. The artificial chordae repair device according to claim 8, wherein the papillary anchors (3) are selected from a spiral structure, a barbed structure or a boat-like anchor structure.