CN110269725B - Artificial chordae tendineae capable of being developed - Google Patents

Abstract

The invention discloses a developable artificial chordae tendineae, which comprises a flexible chordae tendineae main body, wherein the chordae tendineae main body comprises a flexible inner core with certain axial length, at least one developing piece for displaying the position of the artificial chordae tendineae is arranged on the inner core, and the developing piece is made of a material which is not transparent to X rays. The artificial chordae tendineae can quickly and accurately judge whether the implantation position is reasonable or not in the operation process and prevent the artificial chordae tendineae from being twisted due to too long artificial chordae tendineae or preventing the artificial chordae tendineae from being too short and excessively pulling the valve leaflets in the operation process.

Description

Artificial chordae tendineae capable of being developed

Technical Field

The invention belongs to the field of medical appliances, relates to an appliance for repairing heart valve defects, and particularly relates to a visualized artificial chordae tendineae.

Background

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), and 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 when the left ventricle is in the contracted state, the momentum of the blood flow may further cause the leaflets to drop into the left atrium, causing blood backflow.

Currently, surgical or minimally invasive methods are usually used to implant artificial chordae tendineae, which are usually sutures made of polymer materials. However, during the operation, when the suture as the artificial chordae enters the human body, the operator cannot visually see the position and shape of the artificial chordae, cannot judge whether the implantation position is reasonable, and may cause tangling due to too long artificial chordae or excessive pulling of the leaflets due to too short artificial chordae during the operation. In addition, since a plurality of artificial chordae need to be implanted on the valve leaflet, the artificial chordae implanted first may affect the implantation process of the artificial chordae implanted later, which may increase the difficulty of the operation and increase the operation time.

Disclosure of Invention

The present invention is directed to solve the above-mentioned problems of the prior art, and an object of the present invention is to provide a visualized artificial chordae tendineae, which can more quickly and accurately determine whether the implantation position is reasonable during the operation and prevent the artificial chordae tendineae from being twisted too long or excessively pulling the valve leaflets due to too short artificial chordae tendineae during the operation.

The artificial chordae tendineae are particularly suitable for implanting a plurality of chordae tendineae, when implanting a second and later artificial chordae tendineae, an operator can see the position and the shape of the implanted artificial chordae tendineae, and by taking the position and the shape as reference, the ideal position of the implanted artificial chordae tendineae is referred and positioned, so that the position deviation of the implanted artificial chordae tendineae is avoided, the operation difficulty is reduced, the operation time is shortened, and the operation success rate is improved.

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

a developable artificial chordae comprising a flexible chordae body comprising a flexible inner core of axial length, said inner core being provided with at least one visualization member for displaying the position of the artificial chordae, said visualization member being at least partially made of a material that is opaque to X-rays.

Further, in the developable artificial chordae tendineae, it is preferable that the development member is a dot structure having a certain area, and at least one of the development members of the dot structure is disposed in the middle or at an end of the inner core.

Further, in the developable artificial chordae tendineae, preferably, the developing members are arranged at intervals along the axial direction of the inner core, and the developing members are distributed from one end of the inner core to the other end of the inner core.

Further, in the developable artificial chordae, it is preferable that the development member is a linear structure, a belt-like structure, or a ring-like structure having a certain axial length; the developing piece at least extends from one end of the inner core to the other end; or the developing member is disposed at least at the center or the end of the inner core.

Further, in the developable artificial chordae, it is preferable that the development member is disposed on the outer surface of the inner core or inside the inner core; or the developing member is twisted with the core.

Further, in the developable artificial chordae, it is preferable that the inner core is entirely a development member.

Further, in the developable artificial chordae, preferably, the chordae main body further comprises an outer layer body sleeved outside the inner core.

Further, in the developable artificial chordae, preferably, the inner core is made of polyethylene terephthalate, polypropylene, polylactic acid, polytetrafluoroethylene or expanded polytetrafluoroethylene, and the outer layer is made of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, nylon, polypropylene, polyethylene, high-density polyethylene or polyurethane.

Further, in the developable artificial chordae tendineae, it is preferable that a reinforcing member for increasing strength of the inner core is provided outside and/or inside the inner core, and hardness of the reinforcing member is greater than that of the inner core.

Further, in the developable artificial chordae, it is preferable that the reinforcing member is a linear structure, a ribbon-like structure or a rod-like structure wound around the outer surface of the inner core or disposed in the inner core;

or the reinforcing piece is a linear structure or a belt-shaped structure twisted with the inner core;

or the reinforcing piece is a tubular structure sleeved outside the inner core.

Furthermore, in the developable artificial chordae tendineae, preferably, the developable artificial chordae tendineae further include a fixing element arranged at least one end of the chordae tendineae main body, and a puncture connecting element for non-detachably fixedly connecting or detachably fixedly connecting with a puncture needle head is arranged on one side of the fixing element, which faces away from the chordae tendineae main body.

Furthermore, in the developable artificial chordae tendineae, preferably, the fixing member is provided with an accommodating cavity for accommodating the puncture needle head, the puncture connecting member is a thread, an adhesive layer, a rough surface or at least one groove or hole arranged on the side wall of the accommodating cavity, and the groove or hole and the puncture needle head form interference fit, buckle connection or key connection.

Further, in the developable artificial chordae tendineae, preferably, the developable artificial chordae tendineae further include an anti-slip member sleeved on the chordae main body, and the anti-slip member slides along the axial direction of the chordae main body.

Further, in the developable artificial chordae tendineae, preferably, at least one through hole is provided on the anti-slip member, and each chordae tendineae main body passes through only one through hole;

or the antiskid piece is provided with at least two through holes, and two ends of the tendon main body respectively penetrate through the different through holes.

Further, in the developable artificial chordae tendineae, preferably, the anti-slip member is provided with an abutting surface abutting against the valve leaflet.

Compared with the prior art, the invention at least has the following beneficial effects:

the main structure inner core of the artificial chordae tendineae is provided with the developing element made of developing material which does not transmit X-rays, therefore, after the artificial chordae tendineae enter the body of a patient, an operator can quickly and accurately observe the position of the artificial chordae tendineae, thereby judging whether the implantation position is reasonable or not and preventing the artificial chordae tendineae from being twisted due to too long artificial chordae tendineae or excessively pulling the valve leaflets due to too short artificial chordae tendineae in the operation process.

In addition, when the second and later artificial chordae tendineae are implanted, the operator can see the position and the shape of the earlier implanted artificial chordae tendineae, and the position and the shape are taken as reference to refer to and position the ideal position of the later implanted artificial chordae tendineae, so that the position deviation of the later implanted artificial chordae tendineae is avoided, the operation difficulty is reduced, the operation time is shortened, and the operation success rate is improved.

Drawings

The invention will be further described with reference to the following drawings and examples, in which:

FIG. 1 is a schematic illustration of normal chordae tendineae in a heart;

figure 2 is a schematic illustration of chordae rupture in the heart;

fig. 3 is a schematic structural view of an artificial chorda tendinea according to a first embodiment of the invention;

FIGS. 4 to 8 are schematic structural views of different embodiments of a developing member according to a first embodiment of the present invention;

fig. 9 to 11 are schematic structural views of different embodiments of the reinforcing member according to the first embodiment of the present invention;

fig. 12 is a schematic structural view of an artificial chorda tendineae according to a second embodiment of the invention;

fig. 13 is a schematic structural view of another embodiment of the artificial chordae tendineae according to the second embodiment of the present invention;

FIG. 14 is a schematic view of a mounting member and a piercing needle of a second embodiment of the present invention;

fig. 15 to 17 are schematic structural views of different embodiments of artificial chordae tendineae according to a third embodiment of the present invention;

fig. 18 to 21 are schematic structural diagrams of each step of the artificial chordae tendineae implantation process according to the third embodiment of the invention.

Detailed Description

For a more clear understanding of the technical features, objects, and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

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

Example one

As shown in fig. 3, the developableartificial chordae 100 of the first embodiment includes aflexible chordae body 110. Thechordae body 110 comprises a flexibleinner core 111 having an axial length, theinner core 111 being provided with avisualization member 113 for displaying the position of the artificial chordae, thevisualization member 113 being at least partially made of a material that is opaque to X-rays.

Thechordae body 110 is for implantation into the heart to replace diseased chordae within the heart. According to different implantation operation modes, the morphological structure of the artificial chordae tendineae after being implanted into a human body has two modes: one is to implant the artificial tendon in the form of a U-shaped suture into the body, as shown in fig. 3, and the implanted artificial tendon is U-shaped, i.e., the middle of the suture before implantation remains inside the patient after implantation, and the two ends of the suture before implantation are withdrawn outside the patient after implantation, and the U-shaped portion remaining inside the patient serves as the artificial tendon. The other mode is as follows: the artificial chordae tendineae are in the same shape before and after implantation, and are all in the form of linear suture lines, the length of the suture lines is cut according to the physiological structure of the patient after implantation, and the suture lines remained in the body of the patient are used as the artificial chordae tendineae.

Themain body 110 is fixed between the leaflets and the ventricular wall (or papillary muscles) to replace the diseased chordae, maintaining the tension between the leaflets and the ventricular wall. Theflexible tendon body 110 means that it can be bent at will, is inelastic, and cannot be elongated in the axial direction. The cross-section of thetendon body 110 may be any suitable shape, such as circular, elliptical, rectangular, square, etc., preferably circular or elliptical, and when the cross-section of thetendon body 110 is rectangular, thetendon body 110 resembles a flat ribbon. Theentire tendon body 110 may have the same cross-sectional shape at different locations or may have different shapes at different locations. Thetendon bodies 110 in this embodiment have the same cross-sectional shape, for example, thetendon bodies 110 are linear structures with a circular cross-section. It will be appreciated that in other embodiments, at least a portion of thetendon body 110 may have different shapes, such as: themain tendon 110 has a flat band-like structure in one portion and a linear structure in the other portion. In some embodiments, the outer diameter of thetendon body 110 ranges from 0.1mm to 1.0mm, preferably 0.20mm to 0.35 mm. Theentire chordae body 110 may have the same diameter. It is understood that in other embodiments, at least a portion of thetendon body 110 can have a different diameter.

As shown in fig. 4, the tendonmain body 110 includes a flexibleinner core 111 having a certain axial length, and theinner core 111 may be a solid or hollow wire-like structure or may be formed by twisting a plurality of solid or hollow filaments, and the number of the filaments ranges from 2 to 10. In this embodiment, theinner core 111 is preferably formed by twisting 3 e-PTFE threads.

The material used forinner core 111 should have a certain flexibility, a certain strength to withstand the tension between the pulsating valve leaflets and the ventricular wall or papillary muscles, and fatigue resistance to maintain its physical properties in the human body for a long period of time, and to withstand tensile strength. Theinner core 111 is made of a biocompatible polymer material, such as polyethylene terephthalate (PET), polypropylene (PP), polylactic acid (PLLA), Polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (e-PTFE), preferably e-PTFE.

As shown in fig. 5 to 8 are further embodiments: themain body 110 of the tendon rope is provided with anouter layer 112 outside theinner core 111 in addition to theinner core 111. Theouter layer body 112 is of a tubular structure, theinner core 111 is arranged in a tubular inner cavity of theouter layer body 112 in a penetrating mode, the mutual position relation between theinner core 111 and theouter layer body 112 is not limited, namely, the outer layer body and the outer layer body can be in clearance fit or gapless fit, preferably gapless fit, so that the mutual positions of theouter layer body 112 and theinner core 111 are very clear, and the developingpiece 113 arranged on theinner core 111 can accurately display the position of the whole tendonmain body 110.

Theouter layer 112 has a cross-sectional shape that matches the cross-sectional shape of the tendonmain body 110 described above. Can be circular, elliptical, rectangular, square or other tubular cross-sectional configurations. Theouter layer body 112 is made of a polymer material compatible with the human body or a relatively soft metal material, and preferably a polymer material. Theouter layer body 112 and theinner core 111 may be made of the same or different materials. Specifically, theouter layer 112 is made of polytetrafluoroethylene (abbreviated as PTFE), expanded polytetrafluoroethylene (abbreviated as e-PTFE), polyester (abbreviated as Dacron), nylon, polypropylene (abbreviated as PP), polyethylene (abbreviated as PE), high density polyethylene (abbreviated as HDPE), or polyurethane (abbreviated as PU), and in this embodiment, theouter layer 112 is made of e-PTFE.

Referring again to fig. 4 to 8, theinner core 111 is provided with avisualization member 113 for displaying the position of the artificial chordae tendineae, and thevisualization member 113 is at least partially made of a material that is not transparent to X-rays. The developingmember 113 may directly use a related art metal developing dot or developing ring (for example, a developing dot or developing ring made of tantalum, platinum or gold); or by applying a developer to thecore 111. Among the prior art, after artifical chordae tendineae get into the patient internal, can not require the position of the lower mode visual display artifical chordae tendineae of rank through operations such as X ray, lead to operation cost to increase, the operation degree of difficulty increases, and operation time increases. According to the invention, the developingmember 113 is arranged on theinner core 111, so that an operator can quickly and accurately observe the position of the artificial chordae tendineae through X-rays, thereby judging whether the implantation position is reasonable or not, and preventing the artificial chordae tendineae from being twisted due to too long artificial chordae tendineae or preventing the artificial chordae tendineae from being excessively pulled to valve leaflets due to too short artificial chordae tendineae in the operation process. And when implanting the second and later artificial chordae tendineae, the operator can see the position and form of the first implanted artificial chordae tendineae, and with the position as a reference, refer to and position the ideal position of the later implanted artificial chordae tendineae, so as to avoid the position deviation of the later implanted artificial chordae tendineae, thereby reducing the operation cost and difficulty, shortening the operation time and improving the operation success rate.

As shown in fig. 5, the first embodiment of the developingmember 113 is: thecore 111 is integrally formed with the developingmember 113, i.e., the developer is applied to thecore 111 so that theentire core 111 can have a developing function. Developers include, but are not limited to, iopromide, iohexol, sodium diatrizoate, iopamidol, iomeprol, iopentol, ioversol, iotrolan, or iodixanol. The application may be carried out by immersing each of the fine wires in the developer individually, or by immersing theentire core 111 formed by twisting a plurality of fine wires in the developer. It will be appreciated that in other embodiments, the developer may also be applied to theinner core 111 by coating, spraying, or drop coating.

As shown in fig. 6, the second embodiment of the developingmember 113 is: the developingmember 113 has a dot structure having a certain area. The dot-shaped developingmember 113 is embedded in the wall surface of theinner core 111, or the developer is applied to different positions of theinner core 111 by coating, spraying or dripping, etc. to form the dot-shaped developingmember 113, or the dot-shaped developingmember 113 may be formed on theinner core 111 by other methods, which will not be described herein again. In order to display the position of the tendinous process, thedisplay 113 with a dot structure is arranged on theinner core 111 differently according to the different implantation operation methods and the different morphological structures of the artificial chorda after being implanted into the human body: for the artificial chordae tendineae in a U-shaped configuration, at least one developingmember 113 in a dot-shaped configuration is disposed in the middle of theinner core 111; for the artificial chordae tendineae in a straight configuration, at least one developingmember 113 in a dot configuration is provided at an end of theinner core 111, preferably at both ends. In a more preferred embodiment, the developingmembers 113 are arranged at intervals along the axial direction of theinner core 111, that is, the developingmembers 113 are arranged at intervals or continuously in a dot-like structure on theinner core 111 of the entire chordae tendineae, and the developingmembers 113 are distributed dispersedly from one end of theinner core 111 to the other end of theinner core 111. The point-shaped structure of the developingmember 113 displays the shape, position and length of the entire chordae tendineae under the X-ray, which is convenient for the operation.

The third embodiment of the developingmember 113 is: the developingmember 113 has a linear structure, a belt-like structure, or a ring-like structure having a certain axial length. When the developingmember 113 has a ring-shaped structure, it is similar to a developing ring pressed on a medical balloon catheter, and will not be described herein.

The position of thevisualization member 113 is related to the implantation procedure: when the developingmember 113 is disposed on at least one end of theinner core 111, it is suitable for a linear artificial chordae tendineae implantation manner; when the developingmember 113 is disposed at the center of theinner core 111, which is suitable for a surgical manner when a U-shaped suture is implanted, the middle portion of the tendonmain body 110 with the developingmember 113 is left in the body to indicate a position, and both ends are left outside the body.

The developingmember 113 having a linear structure or a belt-like structure may be provided on the outer surface of the inner core or inside the inner core, or may be twisted together with theinner core 111. For example, as shown in fig. 7, thedeveloper 113 is wrapped or sleeved around the outer surface of theinner core 111; as shown in fig. 4 or 8, the developingmember 113 is twisted with theinner core 111 to form an integral body.

As shown in fig. 9 to 11, in order to reinforce the strength of theartificial tendon 100, the tendonmain body 110 further includes a reinforcingmember 114 provided outside and/or inside theinner core 111, the reinforcingmember 114 is made of a polymer material or a metal material, and the hardness of the reinforcingmember 114 is greater than that of theinner core 111.

As shown in fig. 9, a first embodiment of the reinforcingmember 114 is: the reinforcingmember 114 is at least one of a wire-like structure, a ribbon-like structure, and a rod-like structure having a certain hardness, which is wound around the outer surface of theinner core 111 or is inserted into an inner cavity provided in the axial direction of theinner core 111.

As shown in fig. 10, a second embodiment of the reinforcingmember 114 is: the reinforcingmember 114 is a linear structure or a ribbon structure twisted with thecore 111; that is, the reinforcingmember 114 is an elongated rod-like structure, a thread-like structure, or a ribbon-like structure made of a material having high hardness, and is twisted together with the thin wire that makes up thecore 111.

As shown in fig. 11, a third embodiment of the reinforcingmember 114 is: the reinforcingmember 114 is a tubular structure sleeved outside theinner core 111, that is, the reinforcingmember 114 may also be a prefabricated tubular structure directly sleeved on the outer surface of theinner core 111.

Compared with the prior art, the artificial chordae tendineae of the embodiment have at least the following beneficial effects:

(1) the inner core is provided with a developing component made of developing materials which do not transmit X-rays, therefore, after the artificial chordae tendineae enter the body of a patient, an operator can quickly and accurately observe the positions of the artificial chordae tendineae, thereby judging whether the implantation positions are reasonable or not, and preventing the artificial chordae tendineae from being twisted too long or preventing the artificial chordae tendineae from being excessively pulled and valve leaflets caused by too short in the operation process.

(2) When the second and later artificial chordae are implanted, the operator can see the position and the shape of the implanted artificial chordae, and the operator can refer to and position the ideal position of the implanted artificial chordae to avoid the position deviation of the implanted artificial chordae, thereby reducing the operation difficulty, shortening the operation time and improving the operation success rate.

Example two

The structure of the artificial chordae tendineae of the second embodiment is substantially the same as that of the artificial chordae tendineae of the first embodiment, and comprises a flexible chordae tendineaemain body 110, the chordae tendineaemain body 110 comprises aninner core 111 and preferably further comprises anouter layer body 112 covering theinner core 111, and theinner core 111 is provided with avisualization member 113 for displaying the position of the artificial chordae tendineae in operation. The difference is that the artificial chordae tendineae of the second embodiment further include a fixingmember 120 disposed at least one end of the chordaemain body 110.

Referring specifically to fig. 12 and 13, thetendon body 110 has opposing first and second ends. Afastener 120 is attached to the first end and/or the second end. The side of the fixingmember 120 facing away from themain body 110 is provided with a puncture connecting member for forming an undetachable fixed connection or a detachable fixed connection with the puncture needle head.

The first and second ends of thetendon body 110 do not differ in direction, importance, etc. The fixingmember 120 may be provided at one end of the tendonmain body 110 as shown in fig. 12, or may be provided at both ends of the tendonmain body 110 as shown in fig. 13. In this embodiment, the fixingmember 120 is preferably disposed at the first end and the second end of the tendonmain body 110. The tendonmain body 110 and the fixingmember 120 are fixedly connected, and the fixing connection mode may adopt various fixing modes such as knotting, winding, welding, bonding, clamping and the like, which is not limited in the present invention. For example, one end of themain body 110 may be tied out of the fixingmember 120 to form a larger diameter wire loop, or the end may be welded to a larger diameter round ball, or a positioning rod may be provided at the end.

It can be understood that when thefastener 120 is disposed at the first end of the tendonmain body 110, since the second end of the tendonmain body 110 is not provided with thefastener 120, the second end should have a diameter larger than that of the tendonmain body 110 by knotting, winding, or providing a ball end, a disk end, or the like, so as to fix the second end of the tendonmain body 110 to the upper surface of the leaflet.

In order to facilitate the connection with thepuncture needle 410, the fixingelement 120 is provided with a puncture connecting element for non-detachably fixedly connecting or detachably fixedly connecting with thepuncture needle 410, and the shape of the fixingelement 120 is matched with different connecting modes. The exterior of the fixingmember 120 is generally cylindrical, and the cross-sectional shape may be various shapes such as a circle, an ellipse, a polygon, and the like, preferably a circle or an ellipse. The fixingmember 120 is provided with anaccommodating cavity 121 for accommodating thepuncture needle 410, and the puncture connecting member is a thread, an adhesive layer, a rough surface, or at least one groove or hole arranged on the side wall of theaccommodating cavity 121, and the groove or hole and thepuncture needle 410 form an interference fit, a snap connection, or a key connection.

Specifically, the attachment between the securingelement 120 and the piercingneedle 410 may be provided in a variety of ways, such as, for example, by threading, bonding, friction coupling via a roughened surface, interference fit, or snap fit. In this embodiment, a snap connection is adopted, specifically, a groove or a hole is arranged on the inner surface of the fixingmember 120 to serve as a puncture connector, and the puncture connector is clamped with a protrusion or aconvex edge 411 arranged on thepuncture needle head 410 to form a non-detachable or detachable fixed connection. As shown in fig. 14, threegrooves 125 are radially formed on theinner surface 121 of the fixingmember 120 as piercing connectors, and are engaged with and engaged with theconvex edges 411 of the piercingneedle 410. The threegrooves 125 can ensure the stability of the connection between the fixingmember 120 and thepuncture needle 410, reduce the swing amplitude of thepuncture 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 thepuncture needle 410.

Compared with the prior art, the artificial chordae tendineae of the embodiment have at least the following beneficial effects:

at least one end in the two ends of the tendonmain body 110 is provided with a fixingpart 120 used for being connected with a puncture needle head, and a detachable or non-detachable fixed connection is formed between the puncture connecting part arranged on the fixingpart 120 and thepuncture needle head 410, therefore, although thepuncture needle head 410 is not in direct contact with the tendonmain body 100, after thepuncture needle head 410 is connected with the fixingpart 120, the tendonmain body 100, the fixingpart 120 and thepuncture needle head 410 are sequentially connected, the connection effectiveness is improved, and the risk that the tendon main body falls off from thepuncture needle head 410 can be effectively avoided.

EXAMPLE III

The third embodiment of the artificial chordae tendineae has substantially the same structure as the second embodiment of the artificial chordae tendineae, except that the developable artificial chordae tendineae further includes aslip prevention member 130 fitted over the chordaemain body 110.

As shown in fig. 15 to 17, in order to change the point contact between theartificial chordae 100 and the leaflets to surface contact, thereby reducing the risk of theartificial chordae 100 tearing the leaflets, a slip-preventingelement 130 is fitted over thechordae body 110, and the slip-preventingelement 130 can slide axially along thechordae body 110. Since theanti-slip element 130 is pre-disposed on themain chordae tendineae 110, after thepuncture needle 410 punctures the valve leaflet and is fixedly connected with themain chordae tendineae 110, theanti-slip element 130 can be brought to the puncture point and fixed on the valve leaflet together with themain chordae tendineae 110.

The arrangement of theanti-slip members 130 on theartificial chorda 100 is as follows: as shown in fig. 15, the first embodiment is: each tendonmain body 110 is provided with anon-slip member 130, thenon-slip member 130 is provided with at least one throughhole 131, one end of each tendonmain body 110 is connected with the fixingmember 120 after passing through only one throughhole 131, and the other end without the fixingmember 120 is knotted or provided with a spherical end, a disc-shaped end or the like, so that the diameter of the other end is larger than that of the throughhole 131 of thenon-slip member 130. As shown in fig. 16, in the second embodiment, at least two throughholes 131 are formed in theanti-slip member 130, and the first end and the second end of onetendon body 110 are respectively connected to the fixingmember 120 after passing through different throughholes 131; as shown in fig. 17, another way is to provide at least two throughholes 131 on theanti-skid device 130, and each tendonmain body 110 passes through a different throughhole 131, i.e. a plurality of tendonmain bodies 110 share oneanti-skid device 130.

In order to distribute the force of themain chordae 110 on the leaflets as much as possible to the contact surfaces between theanti-slip element 130 and the leaflets, theanti-slip element 130 needs to be in close contact with the leaflets as much as possible, so that theanti-slip element 130 is provided with acontact surface 132 in close contact with the leaflets. Theanti-slip member 130 is not limited to the specific structure except for theabutting surface 132, and can have various structures: 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. Theanti-slip member 130 may be a non-porous structure, a net structure, a bar-grid structure, etc. Theanti-slip member 130 should be made of a biocompatible material, and may be made of an elastic material or a non-elastic material. Specifically, theanti-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 theanti-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, theanti-slip member 130 having a disc-like structure or a double disc-like structure should be made of a shape memory material.

The procedure for implanting the artificial chordae tendineae of the third embodiment is used as an example to illustrate the procedure of using the developable artificial chordae tendineae of the present invention:

as shown in fig. 18 and 19, during the operation, the operator drives thepuncture needle 410 through thevalve leaflet 900, so that thepuncture needle 410 and the fixingelement 120 of theartificial chordae tendineae 100 can form a firm fixed connection. Then, the operator can withdraw thepuncture push rod 210 and thepuncture needle 410 disposed at the distal end of thepuncture push rod 210, so as to drive the fixingmember 120 of theartificial chordae tendineae 100 and the chordaemain body 110 connected to the fixingmember 120 to sequentially pass through thevalve leaflet 900, theanti-slip member 130 is also pulled to thevalve leaflet 900, the abutting surface (i.e., the lower surface) of theanti-slip member 130 contacts with the upper surface of thevalve leaflet 900, and simultaneously, part of the chordae tendineaemain body 110 presses the upper surface of theanti-slip member 130 to abut against the valve leaflet 900 (as shown in fig. 20), at this time, the point contact between theartificial chordae tendineae 100 and thevalve leaflet 900 is converted into the surface contact between theanti-slip member 130 and thevalve leaflet 900, which can effectively reduce the risk of tearing of thevalve leaflet 900. Then, the operator can observe theartificial chordae 100 by X-ray, select an appropriate fixing point and implantation length, adjust the length of thechordae body 110 left in the heart, and fix both ends of thechordae body 110 on the ventricular wall, respectively, thereby completing implantation of the artificial chordae 100 (as shown in fig. 21).

Compared with the prior art, the embodiment has at least the following beneficial effects:

set up anti-skidding piece in the chordae tendineae main part of artifical chordae tendineae, can change the point contact between artifical chordae tendineae and the leaflet into the face contact between anti-skidding piece and the leaflet, effectively reduce the tearing risk of leaflet caused by the cutting of artifical chordae tendineae.

It is understood that in the third embodiment, the implantation process is described by taking the example of the use of the developable artificial chordae tendineae for the transapical minimally invasive chordae implantation, and the developable artificial chordae tendineae of the present invention can also be used in the conventional thoracotomy.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (9)

1. The developable artificial chordae tendineae comprises a flexible chordae tendineae main body and is characterized in that the chordae tendineae main body is U-shaped, one part of the chordae tendineae main body is a flat belt-shaped structure, and the other part of the chordae tendineae main body is a linear structure; the tendon main body comprises a flexible inner core with a certain axial length, the structure of the inner core is a solid or hollow linear structure or is formed by twisting a plurality of solid or hollow thin lines, at least one developing piece used for displaying the position of the artificial tendon is arranged on the inner core, at least part of the developing piece is made of a material which does not transmit X rays, the inner core is provided with a reinforcing piece used for improving the strength of the inner core, the hardness of the reinforcing piece is greater than that of the inner core, and the reinforcing piece is a rod-shaped structure, a linear structure or a belt-shaped structure twisted together with the inner core and the developing piece.

2. The developable artificial chordae according to claim 1, wherein the developer is a wire or ribbon like structure having an axial length.

3. The developable artificial chordae of claim 1, wherein the chordae body further comprises an outer layer surrounding the inner core.

4. The developable artificial chordae tendineae of claim 3, wherein the inner core is made of polyethylene terephthalate, polypropylene, polylactic acid, polytetrafluoroethylene, or expanded polytetrafluoroethylene and the outer layer is made of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, nylon, polypropylene, polyethylene, or polyurethane.

5. The developable artificial chordae according to any one of claims 1 to 4, further comprising a fixing element disposed at least one end of the chordae body, wherein a puncture connecting element for non-detachably or detachably fixedly connecting with a puncture needle head is disposed at a side of the fixing element facing away from the chordae body.

6. The developable artificial chordae tendineae of claim 5, wherein the fixture has a cavity for receiving a puncture needle, and the puncture connector is a thread, an adhesive layer, a roughened surface, or at least one groove or hole on a sidewall of the cavity, the groove or hole forming an interference fit or snap connection with the puncture needle.

7. The developable artificial chordae according to any one of claims 1 to 4, further comprising a slip-preventing member fitted over the chordae body, said slip-preventing member sliding in the axial direction of the chordae body.

8. The developable artificial chordae according to claim 7, wherein the anti-slip member is provided with at least one through hole, each chordae body passing through only one of the through holes;

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

9. The developable artificial chordae of claim 8, wherein the slip resistant member has an abutment surface that abuts the leaflet.

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