CN212730074U - Implant, assembly for forming implant and interventional artificial chordae repair device - Google Patents

Abstract

The present application relates to the field of medical devices, and in particular to an implant comprising an artificial chordae tendineae and papillary anchoring elements, the artificial chordae tendineae comprising an artificial chordae tendineae body and a self-tightening structure for anchoring leaflets formed at one end of the artificial chordae tendineae body, the other end of the artificial chordae tendineae body being connected to the papillary anchoring elements, and an assembly for forming an implant and an interventional artificial chordae tendineae repair device. The utility model provides an implant has optimized the fixed mode of leaflet of artifical chordae tendineae prosthesis, can accomplish the fixed of artifical chordae tendineae and leaflet through intervene operation, need not to open the chest, the operation wound is little, the patient resumes soon. The self-tightening knot cannot be displaced, so that the friction between the knot and the valve leaflet is reduced, the anchoring wound surface is small, the damage to the native valve leaflet is small, the anchoring effect is good, and the backflow treatment effect is stable; meanwhile, the rapid endothelialization of the implant is facilitated, the endothelialization effect is better, and the anatomical form of the valve leaflet is not changed.

Description

Implant, assembly for forming implant and interventional artificial chordae repair device

Technical Field

The utility model relates to the field of medical equipment, especially, relate to an implant and be used for forming the subassembly of implant and intervene artifical chordae tendineae prosthetic devices.

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 can ensure that blood can only flow from the left atrium to the left ventricle and can not flow reversely. 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 rapidly, a large amount of arterial blood flows back to the left atrium, so that pulmonary congestion is caused, capillary pressure is increased rapidly, acute pulmonary edema occurs, severe clinical symptoms such as dyspnea and hemoptysis occur, and patients can die if not immediately perform 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 injury 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, advanced age and other surgical operations.

The interventional operation is completed by puncturing, sending the instrument into the heart through peripheral blood vessels under the navigation of modern imaging equipment such as three-dimensional ultrasound and radiography and under the condition that the heart does not beat, so that the trauma degree and the complication risk are greatly reduced, and the interventional operation is the only treatment mode for surgical high-risk patients. Interventional prosthetic chordae repair devices generally consist of two parts, a delivery system and an implant comprising prosthetic chordae, leaflet anchoring elements and papillary muscle anchoring elements, the prosthetic chordae prosthesis being delivered from the delivery system into the heart, the leaflet anchoring elements connecting the leaflets and the papillary muscle anchoring elements connecting the papillary muscles to replace extended or broken native chordae tendineae and eliminate or reduce mitral regurgitation. The artificial chordae tendineae can only be effectively treated if they are securely and reliably connected to the leaflets and papillary muscles. Because papillary muscles belong to a ventricular trabecular system and have a relatively thick and compact structure, the fixation modes (such as spiral screwing, barb anchoring and the like) in the ventricles of the existing various interventional instruments can ensure firm anchoring. The difficulty in realizing the connecting technology of the artificial chordae tendineae and the valve leaflets is greater, and the two main aspects are as follows: firstly, the fixing firmness is ensured. In order to avoid thrombus generated in the heart by the artificial chordae tendineae prosthesis, the conventional artificial chordae tendineae are made of Polytetrafluoroethylene (PTFE) or Expanded Polytetrafluoroethylene (EPTFE), and the two materials have excellent lubricating property and are not easy to firmly knot; secondly, tearing the valve leaf. The leaflets of the mitral valve are formed by a spongy atrium layer and a fibrous ventricle layer, the thickness of the leaflets is 1-4mm, the strength is low, large local stress is generated under the traction action of the chordae tendineae, the leaflets are easy to tear, and further the artificial chordae tendineae fall off and lose the treatment effect. In the prior art, the main methods for anchoring the valve leaflets are known as a metal fluke, a wire knot and a gasket fixing method. For example, a metal anchor claw designed by Cardiomech corporation has a high surgical risk in such an anchoring mode, on one hand, the wound surface caused by puncturing and grasping the valve leaflet by the anchor claw is large, so that acute perforation of the valve leaflet is easily caused, and on the other hand, metal allergy or immune reaction may be caused after the metal piece is implanted. Other problems may also arise, such as additional loading of the leaflets to alter leaflet surface morphology, affecting hemodynamics, etc., while the metal flukes are not conducive to tissue growth and do not form endothelialization in a short period of time.

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 an implant, an assembly for forming an implant and an interventional artificial chordae repair device, for solving the problems of the prior art.

To achieve the above and other related objects, a first aspect of the present application provides an implant including an artificial chordae tendineae body and a papillary muscle anchoring element, and an anchoring leaflet self-tightening structure formed at one end of the artificial chordae tendineae body, the other end of the artificial chordae tendineae body being connected to the papillary muscle anchoring element.

The self-tightening structure for anchoring the valve leaflet comprises a self-tightening line knot and a valve leaflet anchoring ring, wherein the valve leaflet anchoring ring is closed and locked at the self-tightening line knot.

The self-tightening knot is selected from a brink knot, a rope knot, a double-sleeve knot and a plain knot.

Preferably, the implant further comprises a shim through which the leaflet anchoring ring extends. The shim comprises a first shim and/or a second shim, and the leaflet anchoring ring is matched with the first shim and/or the second shim and locked through the self-tightening line knot to form a leaflet anchoring structure.

The papillary muscle anchoring element is in a spiral shape and is provided with a barbed column shape or a ship-like anchor shape.

A second aspect of the application provides an assembly for forming the implant, the assembly comprising an artificial chordae tendineae line comprising a connecting section for guiding, an artificial chordae body section and a line section for forming a self-tightening structure, the artificial chordae tendineae line being adapted to form an artificial chordae tendineae in the implant, optionally the assembly further comprising a spacer.

The free end of the connecting section for guiding is provided with a magnetic block, a tenon-and-mortise structure or a buckle structure; preferably, the guide connecting section may be cut out.

The artificial chordae tendineae body is selected from wires.

The third aspect of the application provides an intervene artifical chordae tendineae prosthetic devices, prosthetic devices includes the subassembly, connect seal wire and conveying system, connect in the seal wire locates conveying system, conveying system is equipped with the adaptation artifical chordae tendineae line body's in the subassembly passageway.

Preferably, the connecting guidewire is selected from a group consisting of wires. Furthermore, when the artificial chordae tendineae repairing device is implanted, the connecting guide wire is detachably connected with the connecting section for guiding.

Preferably, the conveying system comprises a first chuck and a second chuck, the first chuck is internally provided with a U-shaped channel, the second chuck is provided with a central channel, a first side wall channel and a second side wall channel, one end of the first side wall channel and one end of the second side wall channel are both communicated with the central channel, and in a use state, the other end of the first side wall channel and the other end of the second side wall channel are respectively aligned with two openings of the U-shaped channel.

Preferably, intervene artifical chordae tendineae prosthetic devices still includes supplementary connecting seal wire and auxiliary connecting wire, supplementary connecting seal wire can be dismantled with the guide and be connected, in the U type passageway was located to auxiliary connecting wire, one end can be dismantled with the guide and be connected with connecting segment and/or supplementary connecting seal wire, and the other end can be dismantled with connecting the seal wire and be connected.

As mentioned above, the implant, the assembly and the interventional artificial chordae repair device of the present application have the following advantages:

1) the valve leaflet fixing mode of the artificial chordae tendineae prosthesis is optimized, the mode replaces a surgical thoracotomy, the fixation of the artificial chordae tendineae and the valve leaflets is completed in an intervention mode, and the trauma of the operation to an organism is reduced.

2) Can realize metal-free implantation without causing metal allergy or immunoreaction.

3) The self-tightening knot is different from a movable knot in the mode of anchoring the valve leaflet, the self-tightening knot cannot shift after being fixed, the friction between the knot and the valve leaflet is reduced, the anchoring wound surface is small, the damage to the native valve leaflet is small, the valve leaflet is not easy to tear, the fixation is firm, the anchoring effect is good, and the backflow treatment effect is stable; meanwhile, the self-tightening wire knot has small damage to the native valve leaflet relative to the metal fluke, is favorable for the rapid endothelialization of the implant, has better endothelialization effect, and can not change the anatomical form of the valve leaflet.

Drawings

Fig. 1 shows a schematic view of an implant according to the present application.

Fig. 2 shows a schematic diagram of four self-tightening knots of the present application, in the order of a double noose (fig. 2a), a knot at the end of the rope (fig. 2b), a knot at the flat (fig. 2c), and a knot at the brink (fig. 2 d).

Fig. 3 shows a schematic view of three structures of the papillary muscle anchoring elements of the present application, in the order of a helical structure (fig. 3a), a barbed structure (fig. 3b), and a boat-like anchor structure (fig. 3 c).

Fig. 4 is a schematic view of the interventional artificial chordae repair device of the present application.

Figures 5a-5e are schematic illustrations showing steps of use of the interventional artificial chordae repair device of the present application.

Figure 6 shows another schematic view of the interventional artificial chordae repair device of the present application.

Figure 7 shows a schematic representation of the steps of use of the interventional artificial chordae repair device of figure 6.

Figure 8 is a schematic view showing the steps of the interventional artificial chordae repair device of the present application in use.

Description of the element reference numerals

1 Artificial chordae tendineae

11 artificial chordae tendineae body

Self-tightening structure for 12-leaf valve

121 self-tightening knot

122 leaflet anchoring ring

Papillary muscle anchoring element

3 shim

31 first shim

32 second gasket

41 connecting guide wire

42 auxiliary connection guide wire

43 auxiliary connecting line

431 first connection end

432 second connection end

5 conveying system

51 first chuck

511U-shaped channel

52 second chuck

521 center channel

522 first sidewall passage

523 second sidewall passage

6 valve leaf

Detailed Description

The following description of the embodiments of the present application is provided for illustrative purposes, and other advantages and capabilities of the present application will become apparent to those skilled in the art from the present disclosure.

Please refer to fig. 1 to 8. 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 understanding and reading the contents disclosed in the specification, and are not used for limiting the conditions that the present application can implement, so 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 technical content disclosed in the present application without affecting the efficacy and the achievable purpose of the present application. 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 application, and changes or modifications in the relative relationship may be made without substantial technical changes.

As shown in fig. 1, a first aspect of the present application provides an implant comprising an artificial chordae 1 and a papillary muscle anchoring element 2, the artificial chordae 1 comprising an artificial chordae body 11 and a self-tightening structure 12 for anchoring leaflets formed at one end of the artificial chordae body 11, the other end of the artificial chordae body 11 being connected to the papillary muscle anchoring element 2.

The leaflet-anchoring self-tightening structure 12 includes a self-tightening knot 121 and a leaflet anchoring ring 122, and the leaflet anchoring ring 122 is closed and locked at the self-tightening knot.

As shown in fig. 2, the self-tightening knot 121 is a knot that can be tightened by tightening one end of a thread. The self-tightening knot 121 is selected from the group consisting of a double hitch knot (fig. 2a), a knot of a string (fig. 2b), a knot of a plain (fig. 2c), and a knot of a brinell (fig. 2 d). The self-tightening knot 121 is preferably a knot. The knot tying method is simple, rapid and easy to realize.

The self-tightening knot 121 can lock the knot when one end of the thread is tightened by different winding modes of the thread.

The self-tightening knot 121 and the leaflet anchoring ring 122 may be integrated with the artificial chordae body 11, may be connected three separate structures, or may be integrated with the artificial chordae body 11 and the leaflet anchoring ring 122, and the self-tightening knot is formed by using a single suture to lock the leaflet anchoring ring 122.

In a preferred embodiment, the self-tightening knot 121 and the leaflet anchoring ring 122 are integral with the artificial chordae body 11. The artificial chordae 1 is wound into knots, so that excessive sutures are prevented from being used in the body, the control is easy, the loosening of the sutures is avoided, and the operation speed can be increased.

In the embodiment shown in fig. 1, the implant further comprises a shim through which the leaflet anchoring ring 122 extends from the shim 3.

In one embodiment, the spacer 3 comprises a first spacer 31 and/or a second spacer 32, and the leaflet anchoring ring 122 is mated with the first spacer 31 and/or the second spacer 32 and locked via the self-tightening knot 121 to form a leaflet anchoring structure.

In one embodiment, the first gasket 31 is a thin sheet structure. The thickness of the first gasket 31 is 0.1 to 2mm, preferably 0.3 to 1 mm.

The shape of the first gasket 31 may be selected from the group consisting of polygonal, circular, and elliptical shapes, and preferably quadrangular and elliptical shapes. When the first gasket 31 has a quadrangular shape, the quadrangular shape has a length of 1 to 10mm, preferably 2 to 4mm, and a width of 1 to 4mm, preferably 1 to 2 mm. When the shape of the first gasket 31 is an ellipse, the major axis of the ellipse is 1 to 10mm, preferably 2 to 4mm, and the minor axis is 1 to 4mm, preferably 1 to 2 mm.

The second gasket 32 is of a sheet structure. The second gasket 32 has a thickness of 0.1 to 2mm, preferably 0.3 to 1 mm.

The shape of the second pad 32 can be selected from polygonal, circular and oval, preferably quadrilateral and oval.

When the second gasket 32 has a quadrangular shape, the quadrangular shape has a length of 1 to 10mm, preferably 2 to 4mm, and a width of 1 to 4mm, preferably 1 to 2 mm. When the second gasket 32 has an elliptical shape, the major axis of the elliptical shape is 1 to 10mm, preferably 2 to 4mm, and the minor axis thereof is 1 to 4mm, preferably 1 to 2 mm.

The first gasket 31 and the second gasket 32 may be made of Polytetrafluoroethylene (PTFE), Expanded Polytetrafluoroethylene (EPTFE), polyethylene terephthalate (PET), polyester, felt, or a mesh-type metal wire. The material of the first gasket 31 is preferably expanded polytetrafluoroethylene or polyethylene terephthalate.

The first gasket 31 and the second gasket 32 may have the same structure, shape and material, or may be different from each other, and they may be used alone or in combination. The first shim 31 and the second shim 32 have the functions of reducing local traction stress of the valve leaflet, accelerating endothelialization and increasing anchoring stability.

As shown in fig. 3, the papillary muscle anchoring element 2 is selected from the group consisting of a helix (fig. 3a), a barb (fig. 3b), a boat-like anchor structure (fig. 3 c). The papillary muscle anchoring elements 2 may be embedded in the myocardial tissue as a fixation mechanism for the artificial chordae tendineae 1 to the myocardium.

A second aspect of the present application provides an assembly for forming the implant, the assembly comprising an artificial chordae tendineae line comprising a connecting section for guiding, an artificial chordae body section and a line section for forming a self-tightening structure, the artificial chordae tendineae line being adapted to form an artificial chordae 1 in the implant, and a papillary anchoring element 2.

In particular, the assembly further comprises a shim, the leaflet anchoring ring 122 penetrating the shim 3.

At least one gasket is arranged. In one embodiment, the spacer 3 comprises a first spacer 31 and a second spacer 32, and the leaflet anchor ring 122 is mated with the first spacer 31 and the second spacer 32 and locked by the self-tightening knot 121 to form a leaflet anchor structure.

The artificial chordae tendineae body is selected from wires. Specifically, the wire meets the requirements of YY 0167-2020 standard.

Generally, the diameter specification of the wire rod can be selected from 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.

Preferably, the guiding connecting section is used for assisting in guiding the artificial chordae main body section and the self-tightening structure forming line section to move during conveying, and the guiding connecting section is cut off and does not remain in the body after assisting. Preferably, the guiding connecting section can realize DSA developing, and optionally, a developer can be added to the guiding connecting section, or a developing wire can be wound, or a developing material, such as gold, platinum, PtW alloy, tantalum or PtIr alloy and the like, can be adopted for the detachably connected connecting connector. The boundaries of the above sections are not clearly divided, and the guiding connecting section has a guiding function, the self-tightening structure forming line section corresponds to the line section of the self-tightening structure 12 for anchoring the valve leaflets formed in the implant, and the artificial chordae body section corresponds to the line section of the artificial chordae body in the implant.

The connecting section for guiding, the artificial chordae body section and the line section for forming the self-tightening structure can be different line sections of one wire rod, also can be three wire rods, and also can be two wire rods, at the moment, the connecting section for guiding and the artificial chordae body section are one wire rod, and the line section for forming the self-tightening structure is the other wire rod. Of course, other combinations are possible as long as the implant can be formed.

As shown in fig. 3, the papillary muscle anchoring element 2 is selected from the group consisting of a helix (fig. 3a), a barb (fig. 3b), a boat-like anchor structure (fig. 3 c). The papillary muscle anchoring elements 2 may be embedded in the myocardial tissue as a fixation mechanism for the artificial chordae tendineae 1 to the myocardium.

As shown in fig. 4, a third aspect of the present application provides an interventional artificial chordae repair device comprising an implant, a connecting guidewire 41 and a delivery system 5, said connecting guidewire 41 being provided within the delivery system 5, said delivery system 5 being provided with a channel adapted to the artificial chordae body in said assembly.

In one embodiment, the connecting guidewire 41 is selected from a metal wire. Preferably, it is selected from the group consisting of wires that are elastic and have good support properties. The connecting guide wire 41 has a diameter of 0.2 to 1.5mm, preferably 0.5 to 1.0 mm. The connecting wire 41 may be a single strand, a mandrel with an inner spring and an outer spring, and preferably a single strand. The metal wire can be made of nickel-titanium alloy, stainless steel and titanium alloy, and preferably, the metal wire is made of nickel-titanium alloy. The tip of the connecting wire 41 is in the shape of a sharp needle.

Further, when the interventional artificial chordae repair device is implanted, the connecting guide wire 41 is detachably connected with the free end of the connecting section for guiding. The detachable connection mode can be a buckle, a magnetic attraction, a mortise and tenon joint, a coupling and the like, and the application is not specially limited.

In the embodiment shown in fig. 4, the conveying system 5 includes a first chuck 51 and a second chuck 52, the first chuck 51 is provided with a U-shaped channel 511 therein, the second chuck 52 is provided with a central channel 521, a first side wall channel 522 and a second side wall channel 523, one end of the first side wall channel 522 and one end of the second side wall channel 523 are communicated with the central channel 521, and in a use state, the other end of the first side wall channel 522 and the other end of the second side wall channel 523 are respectively aligned with two openings of the U-shaped channel 511.

Preferably, in the use state, the first clip 51 and the second clip 52 are respectively disposed at the same position on both sides of the leaflet 6, i.e. the first clip 51 and the second clip 52 can be aligned apart from the leaflet 6.

Specifically, the first and second jaws 51 and 52 are relatively movable and grip the leaflets when they are brought into close proximity.

Specifically, when the first chuck 51 and the second chuck 52 are close to each other, after one end of the first sidewall passage 522 and one end of the second sidewall passage 523 are aligned with two openings of the U-shaped pipe 511, the connecting wire 41 may pass through the second spacer 32, the leaflet 6, and the first spacer 31 and then enter the U-shaped pipe 511.

Before the interventional artificial chordae repair device is used, the first shim 31 is preset between the U-shaped channel 511 and the valve leaflet in the first clamping head 51, the second shim 32 is preset between the central channel 521, the first side wall channel 522 or the second side wall channel 523 and the valve leaflet in the second clamping head 52, and the connecting guide wire 41 is preset in the central channel 521; obliquely inserting the preset connecting guide wire 41 into the first sidewall passage 522; the self-tightening knot 121 is wrapped around the connecting guidewire 41 and the connecting segment is disposed in the second sidewall channel 523. The interventional artificial chordae repair device is used to form the implant.

As shown in fig. 5a-5e, the method of forming the implant includes the steps of:

1) as in fig. 5a, a partial segment of the artificial chordae tendineae is wound around the connecting guidewire 41; when the first chuck 51 and the second chuck 52 are clamped, and the opening of the first sidewall passage 522 and the opening of the second sidewall passage 523 are respectively aligned with the two openings of the U-shaped passage 511, the connecting guide wire 41 is pushed in the direction of the arrow shown in the figure to sequentially penetrate through the second spacer 32, the valve leaflet 6 and the first spacer 31 and enter the U-shaped passage 511;

2) as shown in fig. 5b, the connecting wire 41 is pushed further in the direction of the arrow, and the connecting wire 41 enters the U-shaped channel 511 and is connected to the guiding connecting segment; optionally, the connecting guide wire 41 sequentially penetrates through the first spacer 31, the valve leaflet 6 and the second spacer 3 in the U-shaped channel 511 and then is connected with the guiding connecting section;

3) as shown in fig. 5c, the connecting guide wire 41 is retracted along the arrow direction, and the connecting guide wire 41 drives the connecting section for guiding, the main section of artificial chordae tendineae, and the line section for forming the self-tightening structure to sequentially pass through the second spacer 32, the leaflet 6, and the first spacer 31, and then the line section for forming the self-tightening structure forms the leaflet anchoring ring 122 in a closed loop at the self-tightening line junction;

4) as shown in fig. 5d, the connecting guide wire 41 is withdrawn continuously, so that the artificial tendon cable body forms a self-tightening knot 121;

5) as shown in fig. 5e, the first and second jaws 51 and 52 are removed, and the self-tightening knot 121 is tightened;

6) the artificial chordae tendineae line body penetrates through the papillary muscle anchoring element 2 to be movably connected with the papillary muscle anchoring element 2, the length of the artificial chordae tendineae body is adjusted, the connecting section for guiding is cut off, and the artificial chordae tendineae body is fixedly connected with the papillary muscle anchoring element 2 to form the implant.

In the embodiment shown in fig. 6, the interventional artificial chordae repair device further comprises an auxiliary connecting guide wire 42 and an auxiliary connecting wire 43, the auxiliary connecting guide wire 42 is detachably connected with the guiding connecting segment, the auxiliary connecting wire 43 is arranged in the U-shaped channel 511, one end of the auxiliary connecting wire is detachably connected with the guiding connecting segment and/or the auxiliary connecting guide wire 42, and the other end of the auxiliary connecting wire is detachably connected with the connecting guide wire 41. The placement of the auxiliary connecting wire 42 and the auxiliary connecting wire 43 allows for a more rapid completion of the implantation.

The detachable connection is selected from the modes of buckles, magnetic attraction, mortise and tenon joints, coupling and the like. The auxiliary connecting guide wire 42 is used for guiding the self-tightening structure forming wire segment and the artificial tendon body segment into the U-shaped channel 511 through the guiding connecting segment connected with one end.

As shown in fig. 6, the auxiliary connecting wire 43 includes a first connecting end 431 and a second connecting end 432, and when the auxiliary connecting wire is implanted, the first connecting end 431 is connected to the connecting wire 41, and the second connecting end 432 is connected to one end of the auxiliary connecting wire 42. Preferably, the connection between the first connection end 431 and the connection guide wire 41 and the connection between the second connection end 432 and the auxiliary connection guide wire 42 are all detachable connections. The auxiliary connecting wire 43 is used to help the connecting wire 41 to connect with the connecting section for guiding. The auxiliary connecting line 43 is detachably connected to the guiding connecting segment. The detachable connection is selected from the modes of buckles, magnetic attraction, mortise and tenon joints, coupling and the like. The auxiliary connecting line 43 can realize the development under DSA, and a developer can be added to the auxiliary connecting line 43, or a metal wire can be wound, or a metal material can be adopted for the connecting structure at the two ends of the auxiliary connecting line 43.

Before the interventional artificial chordae tendineae repair device is used, the connecting guide wire 41 and the auxiliary connecting guide wire 42 are preset in the central channel 521; the auxiliary connection line 43 is preset in the U-shaped channel 511.

As shown in fig. 7, the method of forming the implant includes the steps of:

1) as shown in fig. 7a, a partial segment of the artificial chordae tendineae is wound around the connecting guidewire 41; when the first chuck 51 and the second chuck 52 are clamped, the opening of the first sidewall passage 522 and the opening of the second sidewall passage 523 are aligned with the two openings of the U-shaped passage 511, respectively, and then the connecting wire 41 is pushed in the direction of the arrow shown in the figure into the U-shaped passage 511 to be connected with the second connecting end 432; meanwhile, the auxiliary connecting wire 42 is pushed in the direction of the arrow shown in the figure to enter the U-shaped channel 511 and then to be connected with the first connecting end 431, and at this time, the guide connecting segment is carried by the auxiliary connecting wire 42 and enters the U-shaped channel 511 and is connected with the first connecting end 431. Optionally, the connecting wire 41 and the auxiliary connecting wire 42 penetrate through the second spacer 32, the leaflet 6, and the first spacer 31 in sequence and then enter the U-shaped channel 511.

2) As shown in fig. 7b, when the linking guide wire 41 and the auxiliary linking guide wire 42 are retracted in the direction of the arrow shown in the figure, the auxiliary linking guide wire 42 is disengaged from the second linking end 432, and the second linking end 432 is detachably connected to the guiding linking segment.

3) As shown in fig. 7c, the auxiliary connecting guide wire 42 is retracted along the arrow direction, the auxiliary connecting guide wire 42 is withdrawn and is not used, the connecting guide wire 41 is retracted, the connecting guide wire 41 drives the auxiliary connecting wire 43 to move, the auxiliary connecting wire 43 drives the connecting section for guiding, the artificial tendon body section and the line section for forming the self-tightening structure to move, and the line section for forming the self-tightening structure forms the leaflet anchoring ring 122 in a closed loop at the self-tightening line junction. Optionally, the auxiliary connection line 43 drives the guiding connection segment, the artificial chordae main body segment, and the self-tightening structure forming line segment to move sequentially through the first spacer 31, the leaflet 6, and the second spacer 32.

4) The connecting guide wire 41 is continuously withdrawn, and the guide connecting segment and the artificial chordae tendineae body segment penetrate through the self-tightening wire knot 121.

5) The first and second chucks 51 and 52 are taken out, and the self-tightening knot 121 is tightened;

6) the artificial chordae tendineae line body penetrates through the papillary muscle anchoring element 2 to be movably connected with the papillary muscle anchoring element 2, the length of the artificial chordae tendineae body is adjusted, and after the connecting section for guiding is cut off, the artificial chordae tendineae body is fixedly connected with the papillary muscle anchoring element 2.

As shown in fig. 8, the steps of the interventional artificial chordae repair device when in use are as follows: the delivery system 5 is advanced from the interatrial septum through the common sheath into the atrium (fig. 8 a); a push delivery system 5 to complete leaflet clipping with the assistance of ultrasound and DSA medical imaging equipment (fig. 8 b); the release liner 3 and the leaflet are retracted with the self-tightening structure 12, the delivery system 5, the artificial chordae 1 (fig. 8 c); anchoring the papillary muscle anchoring elements 2 to the left ventricular myocardium by the delivery system 5 (fig. 8 d); the delivery system 5 is withdrawn, with the papillary anchoring elements 2 connected to one end of the guiding connection, and the artificial chordae tendineae length is adjusted by ultrasound image assistance, ensuring no regurgitation (fig. 8 e). After the adjustment of the length, the connecting segments for guiding are cut off and the final state of the implant in the heart is shown in fig. 8 f.

The implant or the interventional artificial chordae repair device can be used for fixing the artificial chordae and the valve leaflets in an interventional mode, thoracotomy is not needed, surgical trauma is small, and recovery of a patient is fast. And the fixation is firm, the valve leaf is not easy to tear, and meanwhile, the rapid endothelialization of the implant is facilitated, and the healing of the wound surface is facilitated.

In summary, the present application effectively overcomes various disadvantages of the prior art and has a high industrial utility value.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. 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 concepts disclosed in the present application shall be covered by the claims of the present application.

Claims (19)

1. An implant, characterized in that it comprises an artificial chordae (1) and a papillary muscle anchoring element (2), said artificial chordae (1) comprising an artificial chordae body (11) and a self-tightening structure (12) for anchoring leaflets formed at one end of said artificial chordae body (11), the other end of said artificial chordae body (11) being connected to the papillary muscle anchoring element (2).

2. The implant of claim 1, wherein the leaflet-anchoring self-tightening structure (12) comprises a self-tightening knot (121) and a leaflet-anchoring ring (122), the leaflet-anchoring ring (122) closing and locking at the self-tightening knot.

3. Implant according to claim 2, characterized in that the self-tightening knot (121) is selected from the group consisting of a burlin knot, a knot of a knot.

4. Implant according to claim 2, characterized in that it further comprises a shim (3), the leaflet anchoring ring (122) extending through the shim (3).

5. Implant according to claim 4, characterized in that the spacer comprises a first spacer (31) and/or a second spacer (32), the leaflet anchoring ring (122) cooperating with the first spacer (31) and/or the second spacer (32) and being locked into a leaflet anchoring structure via the self-tightening wire bonds (121).

6. Implant according to claim 1, characterized in that the papillary anchoring elements (2) are helical, cylindrical or boat-like anchors provided with barbs.

7. An assembly for forming an implant according to any one of claims 1 to 6, characterized in that it comprises an artificial chordae tendineae line, comprising a connecting section for guiding, a body section for artificial chordae tendineae and a line section for forming a self-tightening structure, and a papillary anchoring element (2), said artificial chordae tendineae line being suitable for forming an artificial chordae tendineae (1) in an implant according to any one of claims 1 to 6.

8. The assembly of claim 7, further comprising a gasket.

9. The assembly of claim 7, wherein the artificial chordae are selected from wires.

10. The assembly of claim 8, wherein at least one of said spacers is provided.

11. Assembly according to claim 8, characterized in that the shims comprise a first shim (31) and a second shim (32).

12. Assembly according to claim 7, wherein the papillary muscle anchoring element (2) is in the shape of a helix, a cylinder provided with barbs or a boat-like anchor.

13. The assembly of claim 7, wherein the free end of the guiding connecting section is provided with a magnet, a mortise and tenon structure or a buckle structure.

14. The assembly of claim 7, wherein the guide connector segments are sheared away after the implant is formed.

15. An interventional artificial chordae repair device, characterized in that the repair device comprises an assembly according to any of claims 7-14, a connecting guide wire (41) and a delivery system (5), the connecting guide wire (41) being arranged in the delivery system (5), the delivery system (5) being provided with a channel adapted to an artificial chordae body in the assembly.

16. The interventional artificial chordae repair device of claim 15, wherein the connecting guidewire (41) is selected from a group consisting of a wire; the connecting guide wire (41) is detachably connected with the free end of the connecting section for guiding.

17. The interventional artificial chordae tendineae repair device of claim 15, wherein the delivery system (5) comprises a first collet (51) and a second collet (52), the first collet (51) is provided with a U-shaped channel (511), the second collet (52) is provided with a central channel (521), a first side wall channel (522) and a second side wall channel (523), one end of the first side wall channel (522) and one end of the second side wall channel (523) are both communicated with the central channel (521), and in the use state, the other end of the first side wall channel (522) and the other end of the second side wall channel (523) are respectively aligned with two openings of the U-shaped channel (511).

18. The interventional artificial chordae repair device of claim 17, further comprising an auxiliary connecting guide wire (42) and an auxiliary connecting wire (43), wherein the auxiliary connecting guide wire (42) is detachably connected to the guiding connecting section, the auxiliary connecting wire (43) is disposed in the U-shaped channel (511), one end of the auxiliary connecting wire is detachably connected to the guiding connecting section and/or the auxiliary connecting guide wire (42), and the other end of the auxiliary connecting wire is detachably connected to the connecting guide wire (41).

19. The interventional artificial chordae repair device of claim 16 or 18, wherein the detachable connection is selected from a magnetically attractive connection, a mortise and tenon connection, or a snap-fit connection.

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