CN117045393A - Anchoring device for prosthetic heart valve and prosthetic heart valve system - Google Patents
Anchoring device for prosthetic heart valve and prosthetic heart valve system Download PDFInfo
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- CN117045393A CN117045393A CN202210487344.4A CN202210487344A CN117045393A CN 117045393 A CN117045393 A CN 117045393A CN 202210487344 A CN202210487344 A CN 202210487344A CN 117045393 A CN117045393 A CN 117045393A
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- anchoring
- anchoring device
- heart valve
- wire
- prosthetic heart
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- 238000004873 anchoring Methods 0.000 title claims abstract description 293
- 210000003709 heart valve Anatomy 0.000 title claims abstract description 132
- 230000007704 transition Effects 0.000 claims abstract description 5
- 230000000149 penetrating effect Effects 0.000 claims abstract description 4
- 238000002513 implantation Methods 0.000 abstract description 39
- 210000005240 left ventricle Anatomy 0.000 description 26
- 239000000463 material Substances 0.000 description 18
- 210000003698 chordae tendineae Anatomy 0.000 description 12
- 238000000034 method Methods 0.000 description 10
- 210000004115 mitral valve Anatomy 0.000 description 10
- 230000008569 process Effects 0.000 description 5
- 208000007536 Thrombosis Diseases 0.000 description 4
- 238000013461 design Methods 0.000 description 4
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- 230000002980 postoperative effect Effects 0.000 description 2
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- 210000005241 right ventricle Anatomy 0.000 description 2
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides an anchoring device of a prosthetic heart valve and a prosthetic heart valve system, wherein the anchoring device comprises an anchoring structure and a guiding structure; the anchoring structure comprises an elastic wire and a containing part; the accommodating part is connected with the elastic wire and is arranged along the extending direction of the elastic wire; the guide structure comprises a guide wire which is axially arranged in the accommodating part in a penetrating way; the guide wire can extend out of the accommodating part from the distal end of the accommodating part and is used for moving along the cavity wall of the preset cavity to form a release track; the anchoring structure is configured to follow the release trajectory formed by the guidewire to transition from a contracted state to an expanded state. The prosthetic heart valve system includes an anchoring device and a prosthetic heart valve for receipt in the anchoring device. According to the invention, the anchoring device can accurately encircle the native valve leaflet under the guidance of the guide wire, so that the implantation steps of the anchoring device are simplified, and the implantation difficulty is reduced.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to an anchoring device of a prosthetic heart valve and a prosthetic heart valve system.
Background
Transcatheter mitral valve replacement surgery (TMVR) is a method of using a catheter to intervene, compressing a prosthetic heart valve in vitro to a delivery system, delivering the prosthetic heart valve to the mitral valve annulus of a human body, and releasing and fixing the prosthetic heart valve at the mitral valve annulus to replace native valve leaflets. Compared with the surgical operation, the mitral valve replacement operation does not need an external circulation auxiliary device, has small wound and quick recovery of patients, can obviously improve the hemodynamic index of the postoperative patients, has smaller wound when being implanted through the atrial septum path of the femoral vein relative to the apical path, and has wider audience.
Although mitral valve replacement techniques have evolved rapidly, there are still limitations to the manner in which prosthetic heart valves can be anchored. Traditional anchoring methods are mainly to fix the prosthetic heart valve by designing anchoring thorns to grasp native valve leaflets or by over-sizing the prosthetic heart valve. Both of these anchoring means are prone to damage to the native valve leaflet or compression of the native annulus tissue, thereby adversely affecting patient recovery.
The prior art also adopts the design that the anchoring device is separated from the artificial heart valve, for example, the artificial heart valve consists of an anchoring ring and a valve main body, the design that the anchoring ring is separated from the valve main body can effectively avoid the compression of the native valve ring, the native valve is not easy to damage, and meanwhile, the size of each part of the conveying system is reduced, so that the movement of the conveying system in the body is more facilitated. In this manner, the anchoring ring is delivered separately from the valve body. Wherein the process of releasing the anchoring ring by the anchoring ring delivery system is complicated, firstly the anchoring ring delivery system needs to release the rope loop structure in the heart to catch the end of the guide wire so that the guide wire forms a guide coil, and then the anchoring ring can be implanted along the guide coil. At the same time, the end of the anchoring ring is also specially designed with a butt-joint fastening device, so that the anchoring ring has a closed ring structure. In addition, when the artificial heart valve is in a kidney-shaped structure (i.e., convex at both ends and concave in the middle), in order to achieve the desired anchoring effect, the mutual positions of the artificial heart valve and the anchoring ring need to be adjusted multiple times, so that the anchoring ring is just clamped into the concave of the artificial heart valve, the difficulty and complexity of the implantation operation of the artificial heart valve are increased, the operation proficiency of an operator is high, and meanwhile, the health of a patient is adversely affected due to the overlong operation time.
Disclosure of Invention
The invention aims to provide an anchoring device of a prosthetic heart valve and a prosthetic heart valve system, which can enable the anchoring device to accurately encircle a native valve leaflet under the guidance of a guide wire, so that the implantation step of the anchoring device can be simplified, and the implantation difficulty can be reduced.
To achieve at least one of the above objects, the present invention provides an anchoring device for a prosthetic heart valve, the anchoring device having a contracted state and an expanded state and being switchable between the contracted state and the expanded state;
the anchoring device comprises an anchoring structure and a guiding structure; the anchoring structure comprises an elastic wire and a containing part; the accommodating part is connected with the elastic wire and is arranged along the extending direction of the elastic wire; the guide structure comprises a guide wire which is axially arranged in the accommodating part in a penetrating way;
the guide wire can extend out of the accommodating part from the distal end of the accommodating part and is used for moving along the cavity wall of the preset cavity to form a release track;
the anchoring structure is configured to follow the release trajectory formed by the guidewire to transition from the contracted state to the expanded state.
Optionally, the accommodating portion has a cavity extending therethrough in an axial direction thereof, and the guide wire is disposed in the cavity.
Optionally, the elastic wire is disposed outside the accommodating portion, the accommodating portion is composed of a cavity tube, the cavity tube and the elastic wire are disposed in parallel, and the guide wire is disposed in the cavity of the cavity tube.
Optionally, the elastic wire is disposed outside the accommodating portion, and the accommodating portion is composed of a plurality of accommodating structures arranged at intervals along the extending direction of the elastic wire;
each containing structure is provided with at least one through hole, the through holes of all the containing structures define at least one cavity, and the guide wire sequentially passes through a row of the through holes along the extending direction of the elastic wire.
Optionally, the elastic wire is disposed inside the accommodating portion, the accommodating portion has at least two cavities extending through along an axial direction of the accommodating portion, and the elastic wire and the guide wire are disposed in the two cavities of the accommodating portion respectively.
Optionally, the guide wire is configured to be able to increase the diameter of the anchoring structure, and/or the anchoring device further comprises a reducing wire arranged in the receiving portion for increasing the radius of curvature of the receiving portion and increasing the diameter of the anchoring structure.
Optionally, the elastic wire is disposed outside the accommodating portion, and the guide wire and the reducing wire are respectively disposed in the same cavity or two cavities in the accommodating portion; or the elastic wire is arranged in the accommodating part, and the elastic wire, the guide wire and the reducing wire are respectively arranged in the three cavities of the accommodating part.
Optionally, the stiffness of the reducing wire is greater than 0.1 times the stiffness of the elastic wire.
Optionally, a distal end portion of the cavity in the accommodating portion for accommodating the reducing wire is sealed, and the shape of the distal end portion is spherical, conical or elliptical.
Optionally, the anchoring device in the expanded state is a coiled structure; wherein in the expanded state the anchoring device has an anchoring segment surrounding a native valve She Yong, the anchoring segment having at least one turn of a coil, the anchoring device further having a grasping segment axially connected to the anchoring segment; the curvature radius of the grabbing section is larger than that of the anchoring section, so that the anchoring device moves along the cavity wall of the preset cavity and expands and forms when being implanted.
To achieve the above object, the present invention also provides a prosthetic heart valve system comprising a prosthetic heart valve and an anchoring device of any one of the prosthetic heart valves for being received in the anchoring device.
In the anchoring device of the artificial heart valve and the artificial heart valve system provided by the invention, the anchoring device has a contracted state and an expanded state and can be switched between the contracted state and the expanded state; the anchoring device comprises an anchoring structure and a guiding structure; the anchoring structure comprises an elastic wire and a containing part; the accommodating part is connected with the elastic wire and is arranged along the extending direction of the elastic wire; the guide structure comprises a guide wire which is axially arranged in the accommodating part in a penetrating way; the guide wire can extend out of the accommodating part from the distal end of the accommodating part and is used for moving along the cavity wall of the preset cavity to form a release track; the anchoring structure is configured to follow the release trajectory formed by the guidewire to transition from the contracted state to the expanded state. So configured, since the anchoring device has been pre-molded into a particular configuration (e.g., a coiled configuration or a loop configuration) prior to implantation, implantation of the anchoring device within the predetermined chamber may be accomplished by allowing the anchoring structure (including the elastic wire and the receiving portion) to gradually follow the guide wire along the lumen wall of the predetermined chamber and allowing the anchoring device to expand around the native valve leaflet upon gradual release. Then, the anchoring device does not need a rope sleeve structure to capture the guide wire when being implanted, so that the implantation process of the anchoring device can be simplified, the implantation difficulty of the anchoring device is reduced, the success rate of implantation of the artificial heart valve can be improved, and the reliability and convenience of the artificial heart valve operation can be improved.
The anchoring structure preferably has an anchoring section which can be connected to the anchoring section by means of an interference fit between the inner chamber and the prosthetic heart valve and which exerts an anchoring force on the prosthetic heart valve. The anchoring device preferably also has a reducing wire or guide wire which is capable of increasing the diameter of the anchoring structure. After implantation of the anchoring device, the guide wire and/or the reducing wire is withdrawn, and the anchoring device may return to the smaller diameter at the predetermined setting and around the native valve leaflet. After implantation of the prosthetic heart valve, the anchoring means may adapt to the outer contour of the prosthetic heart valve, such that the prosthetic heart valve may be secured in a predetermined subject by the anchoring means.
Drawings
FIG. 1 is a schematic view of an anchoring device according to an embodiment of the present invention, wherein the accommodating portion is composed of a cavity tube, and the cavity tube has a cavity;
FIG. 2 is a schematic structural view of an anchoring device according to an embodiment of the present invention, wherein the accommodating portion is composed of a cavity tube, and the cavity tube has two cavities;
FIG. 3 is a schematic view of the usage of the anchoring device according to the first embodiment of the present invention;
FIG. 4 is a schematic view of the use of the artificial heart valve system according to the first embodiment of the invention;
FIG. 5 is a schematic view of an anchoring device according to a second embodiment of the present invention;
fig. 6 is a schematic structural view of an anchoring device according to a third embodiment of the present invention.
In the figure: an anchoring device 1; an elastic thread 11; a housing portion 12; a cavity 121; a cavity tube 122; a receiving structure 123; a through hole 124; a guide wire 13; a lumen 14; an anchor section 15; a gripping section 16; native valve leaflets 21; chordae tendineae 22; a prosthetic heart valve 3; an outflow section 31; an annulus segment 32; a flange section 33; a delivery sheath 4.
Detailed Description
The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.
The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
As used in this specification, the term "proximal" generally refers to the end that is proximal to the operator; the term "distal" is opposite "proximal" and generally refers to the end that is distal from the operator. As used in this specification, the term "radial" refers to a direction parallel to the native annulus, i.e. radial of the native annulus, after implantation of the anchoring device or prosthetic heart valve system into the heart; the term "axial" refers to the direction perpendicular to the native annulus, i.e. the axial direction of the native annulus, after implantation of the anchoring device or prosthetic heart valve system in the heart. Herein, the predetermined object refers to a body in which a prosthetic heart valve needs to be implanted, and the predetermined object generally refers to the heart of a human body; the predetermined chamber refers to a chamber in the heart that is capable of receiving and securing an anchoring structure, such as the left ventricle or the right ventricle.
The invention will be described in detail below with reference to the drawings and the preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict. In the following description, the left ventricle is illustrated as the predetermined chamber, but a person skilled in the art should be able to modify the following description to obtain an implementation when the predetermined chamber is the right ventricle.
Example 1
As shown in fig. 1 to 4, a preferred embodiment of the present invention provides a prosthetic heart valve system comprising an anchoring device 1 and a prosthetic heart valve 3, the prosthetic heart valve 3 being for being accommodated in the anchoring device 1. In this embodiment, the expanded anchoring device 1 is of coiled construction (including a helical coil) and has an annular lumen 14, and the prosthetic heart valve 3 is adapted to be received in the lumen 14 of the anchoring device 1.
The anchoring device 1 has a contracted state and an expanded state and is switchable between said contracted state and said expanded state. The contracted state generally refers to a state in which the anchoring device 1 is in the delivery sheath 4, and in the delivery sheath 4, the anchoring device 1 is deformed and compressed; the expanded state refers to a state when the anchoring device 1 is not constrained or separated from the delivery sheath 4, and at this time, the anchoring device 1 is formed by self-expansion.
The anchoring device 1 comprises an anchoring structure comprising an elastic wire 11 and a receiving portion 12. The accommodating portion 12 is connected to the elastic wire 11 and is provided along the extending direction of the elastic wire 11. The elastic wire 11 may be provided inside or outside the accommodating portion 12; as in the first embodiment, the elastic wire 11 is disposed outside the accommodating portion 12.
The anchoring device 1 further comprises a guide structure comprising a guide wire 13, the guide wire 13 being arranged axially through the receiving portion 12. The guide wire 13 is capable of extending from the distal end of the accommodating portion 12 out of the accommodating portion 12 and is used to move along the wall of the left ventricle (predetermined chamber) to form a release trajectory; the anchoring structure (comprising the elastic wire 11 and the receiving portion 12) is adapted to follow the release trajectory formed by the guide wire 13 to switch from the contracted state to the expanded state.
So configured, since the anchoring device 1 has been pre-shaped to a specific configuration prior to implantation, the anchoring structure (the elastic wire 11 and the receiving portion 12) can be allowed to gradually follow the guide wire 13 along the wall of the left ventricle when the anchoring device 1 is implanted, eventually allowing the anchoring device 1 to be expanded around the native valve leaflet 21 upon gradual release, thereby allowing implantation of the anchoring device 1 within the predetermined lumen. By the arrangement, the anchoring device 1 does not need a rope sleeve structure to catch the guide wire when being implanted, the implantation process of the anchoring device 1 can be simplified, the implantation difficulty of the anchoring device 1 is reduced, the success rate of implantation of the artificial heart valve 3 can be improved, and the reliability and convenience of the operation of the artificial heart valve 3 can be improved.
In the present embodiment, the accommodating portion 12 has a cavity 121 extending therethrough in the axial direction thereof, and the guide wire 13 is disposed in the cavity 121 of the accommodating portion 12.
The accommodating portion 12 may be a continuous and continuous structure, or may be a plurality of intermittently arranged structures. As shown in fig. 1, the receiving portion 12 is a continuously extending tube having a length equal to or different from that of the elastic wire 11. Preferably, the distal end of the accommodating portion 12 is correspondingly disposed at the distal end of the elastic wire 11, and the proximal end of the accommodating portion 12 is correspondingly disposed at the proximal end of the elastic wire 11.
Referring to fig. 3, in one embodiment, the maximum outer diameter of the anchoring device 1 after expansion is smaller than the inner diameter of the area where the anchoring device 1 contacts the left ventricle, so that the anchoring device 1 can be fixed in position on the native valve leaflet 21 by the prosthetic heart valve 3. So set up, anchor 1 need not to anchor thorn, also need not to fix through prosthetic heart valve 3's oversize, therefore can not cause the damage of native valve leaflet 21 or to the oppression of native valve annulus tissue, and the operation damage is little, more is favorable to patient's postoperative rehabilitation.
Further, the elastic wire 11 is made of an elastic material, preferably a super elastic material and/or a material having a shape memory function, or other materials having a strong elastic deformability, so as to ensure that the elastic wire 11 can be elastically deformed to a greater extent in the axial, radial or circumferential directions. The elastic material for producing the elastic yarn 11 is not limited in the present application, and any elastic material may be used as long as it is a metal material or a polymer material capable of elastically deforming. For example, the elastic wire 11 may be made of one or a combination of stainless steel, titanium alloy and nickel-titanium alloy, and the material of the elastic wire 11 may also be made of a polymer material, such as nylon material, polyester fiber, and the like. Furthermore, each elastic filament 11 may be made from a combination of one or more materials, for example, segments of different kinds of materials may be interconnected to form the elastic filament 11. The elastic wire 11 may be a solid or hollow structure as long as it can provide a sufficiently strong supporting force. Meanwhile, the cross-sectional shape of the elastic wire 11 is not limited, such as a circular shape, a ring shape or a rectangular shape, or may be a variable diameter or a variable cross-section design, that is, the cross-sections of the elastic wire 11 at different positions are different in size or shape, so as to meet the design requirements of the anchoring device 1.
The elastic thread 11 may be previously shaped into a specific shape such as a spiral shape. Stretching the elastic wire 11 in the extending direction (i.e., the length direction) and placing in the delivery sheath 4 in a compressed state (see fig. 3); when the anchoring device 1 is disengaged from the distal end of the delivery sheath 4, the elastic wire 11 can return to its original shape (i.e., helical shape).
In this embodiment, the elastic wire 11 is pre-shaped into a spiral shape, and when the anchoring device 1 is released, the elastic wire 11 may return to the spiral shape during the gradual removal of the delivery sheath 4, so that the anchoring device 1 can form a spiral shape and anchor in place of the native valve leaflet 21 after expansion.
The present application is not limited to the material for preparing the guide wire 13, and the guide wire 13 is required to have sufficient rigidity and softness so as to be capable of extending out of the distal end of the receiving portion 12 without damaging the wall of the predetermined chamber, and for example, a conventional green guide wire or loach guide wire or the like may be used as the guide wire 13 in the present application.
Taking mitral valve replacement as an example, after implantation in the body, the prosthetic heart valve 3 is partially received in the annular lumen 14 and the anchoring device 1 is positioned and secured at the mitral valve annulus by expansion or configuration of the prosthetic heart valve 3.
In particular, the manner in which the anchoring device 1 is fixed is related to the structure of the prosthetic heart valve 3. The prosthetic heart valve 3 may take on existing construction and in particular may comprise an outflow section 31 and an annular section 32 connected to each other, and in some cases a flange section 33 to enhance the anchoring effect of the prosthetic heart valve 3 and to prevent paravalvular leakage. The outflow section 31, the annular section 32 and the flange section 33 are axially connected in sequence, and after the artificial heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annular section 32. When the artificial heart valve 3 is in the structure with the convex middle concave (i.e. the kidney-shaped structure), the artificial heart valve 3 can not compress the anchoring device 1 when being expanded, and the anchoring device 1 is abutted against the annular segment 32 of the artificial heart valve and can be clamped in the concave part through the outflow segment 31 and the flange segment 33 of the artificial heart valve 3. If the artificial heart valve 3 is cylindrical or conical, the anchoring device 1 can be pressed at the annular part through the expansion of the artificial heart valve 3, at this time, the anchoring device 1 can adapt to the external contour of the expanded artificial heart valve 3 when being stressed and deformed so as to apply an anchoring force to the artificial heart valve 3, and after the anchoring force is applied, the artificial heart valve 3 and the anchoring device 1 are mutually and fixedly connected in a sealing way.
More specifically, referring to fig. 1 and 3, the anchoring device 1 may be placed in the delivery sheath 4 and moved with the delivery sheath 4 to the mitral valve annulus position, after which the anchoring device 1 may be gradually moved out of the delivery sheath 4 and released in the left ventricle under the pushing of the delivery system. Specifically, the anchoring device 1 may first extend the distal end of the guide wire 13 beyond the distal end of the accommodating portion 12 and move a distance along the wall of the left ventricle (refer to fig. 3) during implantation, and then stop the movement of the guide wire 13 and move the elastic wire 11 and the accommodating portion 12 along the movement track (release track) of the guide wire 13. When the distal ends of the elastic wire 11 and the receiving portion 12 approach the distal end position of the guide wire 13, the movement of the elastic wire 11 and the receiving portion 12 is stopped, and the distal end of the guide wire 13 is again moved along the wall of the left ventricle, so reciprocally until the anchoring device 1 is completely released and can be expanded around the native valve leaflet 21 of the predetermined subject to complete the implantation of the anchoring device 1. After the anchoring device 1 is fully expanded, the anchoring device 1 can be positioned around the native valve leaflet 21 of the predetermined subject, and the anchoring device 1 can be secured at the native annulus with the prosthetic heart valve 3. Preferably, the proximal end of the receiving portion 12 is proximal to the proximal end of the elastic wire 11; the distal end of the receiving portion 12 is close to the distal end of the elastic wire 11. By "proximal" is meant that the proximal end of the receiving portion 12 does not exceed the proximal end of the elastic wire 11, and the proximal ends of the two may or may not be aligned, and similarly, that the distal end of the receiving portion 12 does not exceed the distal end of the elastic wire 11, and the distal ends of the two may or may not be aligned.
It is understood that the delivery system refers to a delivery system of the anchoring device 1 or the prosthetic heart valve 3, i.e. to a device capable of moving within a predetermined object carrying the compressed anchoring device 1 or prosthetic heart valve 3.
Preferably, the outer diameter of the expanded artificial heart valve 3 is larger than the inner diameter of the expanded artificial heart valve 1, so that after the artificial heart valve 3 is implanted, the anchoring device 1 can be stressed and deformed after the artificial heart valve 3 is expanded, the elastic wire 11 has elasticity, the anchoring device 1 can be self-adaptive to the outer contour of the artificial heart valve 3 when being stressed and deformed, and the anchoring force can be applied to the artificial heart valve 3 through the interference fit between the anchoring device 1 and the artificial heart valve 3, so that the artificial heart valve 3 can be more firmly connected with the anchoring device 1, and the anchoring force for anchoring the artificial heart valve 3 in a preset object can be provided through the anchoring device 1, so that the artificial heart valve 3 is fixed at the original valve 21, even if the artificial heart valve 3 is fixed in the preset object through the anchoring device 1.
Referring to fig. 1, in one embodiment, the elastic wire 11 is disposed outside the accommodating portion 12, the accommodating portion 12 is composed of a cavity tube 122, the cavity tube 122 is disposed parallel to the elastic wire 11, the accommodating portion 12 has a cavity 121, and the guide wire 13 is disposed in the cavity 121 of the cavity tube 122. Preferably, the proximal end of the cavity 121 corresponds to the proximal end of the elastic wire 11, and the distal end of the cavity 121 corresponds to the distal end of the elastic wire 11. The shape of the cavity 121 is not limited in the present application, and the cross-sectional shape of the cavity 121 in the axial direction may be circular, elliptical, square, or the like, preferably circular or elliptical, to facilitate the movement of the guide wire 13 in the cavity 121.
In this embodiment, the length of the elastic wire 11 is the same as that of the cavity tube 122, and the positions of the elastic wire 11 and the cavity tube 122 correspond to each other and can be sewn, bonded or otherwise connected at the positions where they are in contact.
The material of the cavity tube 122 is not limited in the present application. For example, the hollow tube 122 may be made of a polymer material such as low-strength polyethylene, PU, polytetrafluoroethylene, or the like.
In an embodiment, the anchoring device 1 further comprises a reducing wire (not shown) provided in the receiving portion 12 for increasing the radius of curvature of the receiving portion 12, thereby increasing the diameter of the entire anchoring structure. The reducing wire may be an unbent wire or a bent wire with a larger radius of curvature. When the diameter-variable wire is inserted into the cavity 121 of the accommodating portion 12, the diameter-variable wire can increase the radius of curvature of each portion of the anchoring device 1, so that the anchoring device 1 can always move along the wall of the left ventricle after being released, and can grasp all the native tissues such as the native valve leaflet 21 and the chordae tendineae 22. After the complete implantation of the anchoring device 1, the guide wire 13 and the reducing wire are withdrawn, and the anchoring device 1 is able to resume the smaller diameter spiral shape at the time of the pre-shaping, against the native valve leaflet 21, so as to facilitate the adaptation of the anchoring device 1 to the outer contour of the prosthetic heart valve 3 and to provide an anchoring force for the prosthetic heart valve 3. It should be noted that, when the anchoring device 1 passes through the middle of the chordae tendineae 22, that is, the anchoring device 1 cannot accommodate the native valve leaflet 21 and the chordae tendineae 22 in the inner cavity 14, since a portion of the chordae tendineae 22 tissue is located outside the anchoring device 1 at this time, the prosthetic heart valve 3 cannot be closely attached to a portion of the native valve leaflet 21 after implantation, which may cause the generation of paravalvular leakage and may cause failure of the operation of the prosthetic heart valve 3.
The present application may use a metal wire, a metal tube, a polymer wire, or the like as the reducing wire, and the reducing wire may be provided as one or a combination of a plurality of stainless steel wires, titanium alloy wires, and nickel-titanium alloy wires, for example.
Preferably, the stiffness of the reducing wire is greater than 0.1 times that of the elastic wire 11, so that the curvature radius of each part of the anchoring device 1 is greater than the inner diameter of the left ventricle, thereby better ensuring that the anchoring device 1 can always move along the cavity wall of the left ventricle after being released and can grasp all the native tissues such as the native valve leaflets 21, the chordae tendineae 22 and the like.
In other embodiments, the guide wire 13 is configured to increase the diameter of the anchoring structure, for example by using a stiffer material for the guide wire 13 or increasing the wall thickness of the material from which the guide wire 13 is made, so that the guide wire 13 has sufficient strength, in which case the reducing wire may not be provided. The stronger guide wire 13 also increases the radius of curvature of the receiving portion 12 and thus the diameter of the entire anchoring structure, so that the anchoring device 1 can always move along the wall of the left ventricle after release.
In one embodiment, the guide wire 13 and the reducing wire are respectively arranged in the same cavity 121 or in both cavities 121 in the receiving portion 12. In the present embodiment, the guide wire 13 and the reducing wire are disposed in the same cavity 121 or two different cavities 121 in the cavity tube 122, respectively.
In other embodiments, as shown in fig. 2, one cavity tube 122 may further have two cavities 121, and the guide wire 13 and the reducing wire are respectively inserted into the two cavities 121 of the cavity tube 122. The two cavities 121 of the cavity tube 122 may be provided independently or may communicate with each other. The two cavities 121 are preferably arranged independently so that the guide wire 13 is not disturbed by the reducing wire when it is moved.
In other embodiments, the accommodating portion 12 includes two cavity tubes 122, the two cavity tubes 122 are disposed parallel to the elastic wire 11, each cavity tube 122 has one cavity 121, and the guide wire 13 and the reducing wire may be respectively disposed in the cavities 121 of the different cavity tubes 122. The placement positions of the elastic wire 11 and the cavity tubes 122 are not limited in the present application, and in an embodiment, the two cavity tubes 122 may be connected to the elastic wire 11 separately, for example, the two cavity tubes 122 may be disposed on two sides of the elastic wire 11. In another embodiment, two cavity tubes 122 are connected to each other, and only one cavity tube 122 is connected to the elastic wire 11, for example, the elastic wire 11 and one cavity tube 122 may be disposed on both sides of the other cavity tube 122. In a further embodiment, each cavity tube 122 is connected to the elastic wire 11 and the other cavity tube 122, respectively, i.e. the elastic wire 11 and the two cavity tubes 122 form a triangle-like structure, which reduces the cross-sectional size of the anchoring device 1 for facilitating the transport of the transport system. It should be understood that in the two cavity tubes 122 described above, the material, size, and strength of each cavity tube 122 may be the same or different.
Preferably, the distal end of the cavity 121 in the receiving portion 12 for receiving the reducing wire is provided with a seal, which reduces the resistance of the reducing wire to entering or exiting the delivery system and also reduces the risk of thrombosis at the distal end of the anchoring device 1. In this embodiment, all of the cavity tubes 122 containing the reducing wires are provided in contact with the distal end of the left ventricle in a sealed manner, for example, a silicone gasket may be placed on the distal end of the cavity tube 121 to seal the distal end of the anchoring device 1.
More preferably, the shape of the distal end of the cavity 121 for receiving the reducing wire in the receiving portion 12 is spherical, conical, elliptical or sphere-like, which on the one hand reduces the risk of thrombosis associated with the implantation of the anchoring device 1; on the other hand, the distal end of the anchoring device 1 may be allowed to transition smoothly to prevent the distal end of the anchoring device 1 from scratching the myocardial wall or apex.
Further, the anchoring device 1 in the expanded state is a coiled structure, such as a helical coil. In the expanded state, the anchoring structure has an anchoring section 15 for encircling the native valve leaflet 21, the anchoring section 15 having at least one turn, where the number of turns is the number of turns the anchoring section 15 is wound around when pre-shaped. Preferably 2 turns, which allows the anchoring segment 15 to have a sufficient anchoring force for the prosthetic heart valve 3 and to deform to adapt to the outer contour of the prosthetic heart valve 3 when the prosthetic heart valve 3 expands, so that anchoring of the prosthetic heart valve 3 can be achieved by the anchoring device 1.
To enable the anchoring device 1 to encircle the native valve leaflet 21, the inner diameter of the anchoring section 15 (i.e. the largest diameter of the lumen 14 in the anchoring device 1) generally corresponds to the size of the native valve leaflet 21, as in the present embodiment the inner contour of the anchoring section 15 has a radius of 5 mm-20 mm, and the adapted anchoring device 1 may be selected for different patients. The shape of the anchoring section 15 is not limited in the present application, and preferably, the shape of the outer contour of the anchoring section 15 after expansion corresponds to the shape of the inner contour of the native valve leaflet 21, so as to achieve better anchoring, for example, the shape of the anchoring section 15 after expansion may be circular, circular arc, oval, or the like.
In one embodiment, the anchor segment 15 may be wound from a material of the elastic wire 11 and a material of the hollow tube 122. In another embodiment, the anchoring section 15 may be formed by connecting two or more elastic wires 11 of materials and two or more hollow tubes 122 of materials in sections, for example, the elastic wires 11 of different kinds of materials may be connected to each other, the hollow tubes 122 of different kinds of materials may be connected to each other, and then the elastic wires 11 and the hollow tubes 122 may be connected to each other in the radial direction to form the anchoring section 15.
To increase the friction of the anchoring section 15 during anchoring, i.e. to further increase the anchoring effect of the anchoring device 1 in the heart, a high friction coefficient coating may be applied to the surface of the anchoring section 15. The Gao Maca coefficient cover may be a combination of one or more of polyethylene and PET materials.
Referring to fig. 1 and 3, in the expanded state, the anchoring structure preferably further has a grasping section 16 axially connected to the anchoring section 15, the grasping section 16 having a radius of curvature greater than that of the anchoring section 15 so that the anchoring structure moves along the wall of the left ventricle and expands to shape when implanted. Due to the large radius of the grasping section 16, the grasping section 16 is allowed to always abut against the lumen wall of the left ventricle when the anchoring device 1 is released within the delivery sheath 4, so that the anchoring device 1 can grasp all of the native tissue, such as native valve leaflets 21 and chordae tendineae 22, and will contain the native tissue, such as native valve leaflets 21 and chordae tendineae 22, inside the lumen 14 (i.e., around all of the native valve leaflets 21 and chordae tendineae 22) when the anchoring device 1 is moved.
Of course, if the guide wire 13 has sufficient strength or if the anchoring device 1 comprises said reducing wire, the anchoring device 1 may reduce the initial radius of curvature of the gripping section 16 or make the radius of curvature of the gripping section 16 the same as the radius of curvature of the anchoring section 15, in which case the gripping section 16 will not float inside the left ventricle after implantation of the anchoring device 1, thereby facilitating a long-term implantation of the anchoring device 1 in the human body.
In order to enable the gripping section 16 to be moved along the wall of the left ventricle at all times during the movement, the radius of curvature of the gripping section 16 generally corresponds to the size of the left ventricle, i.e. the radius of the expanded outer contour of the gripping section 16 corresponds to the radius of the inner contour of the left ventricle, and the adapted anchoring device 1 can be selected according to the individual patient, so that the anchoring device 1 can be moved against the wall of the left ventricle without being inserted into the myocardial wall more easily.
The shape of the grabbing section 16 is not limited in the present application, and the grabbing section 16 may have a circular arc structure or a coil structure. When the grabbing section 16 is in an arc structure, the grabbing section 16 can be formed by single arc or multiple arc connection, and the length of the arc can be set according to the requirement. Wherein, the curvature radius of each arc section in the multiple arc sections forming the grabbing section 16 is 10 mm-30 mm, so that the anchoring device 1 is better assisted to grab all the structures of the native valve leaflets 21, the chordae tendineae 22 and the like. When the grasping section 16 is a coil structure, the number of turns of the coil structure is not more than 2 turns, so that the grasping section 16 can be easily deformed to change the moving direction when moving.
To reduce friction during movement of the gripping section 16, i.e. to further reduce the resistance during movement of the gripping section 16, the surface of the gripping section 16 may be coated with a coating having a low coefficient of friction. The low friction coating may be one or a combination of polytetrafluoroethylene or velvet cloth.
In one example, the anchoring section 15 and the gripping section 16 may be made of different elastic wires 11 and hollow tubes 122, respectively, and the anchoring section 15 and the gripping section 16 may be connected to each other to form the anchoring device 1, i.e. the anchoring section 15 and the gripping section 16 may be formed separately and then connected to each other. In other examples, the anchoring section 15 and the gripping section 16 may be formed by winding an elastic wire 11 and a hollow tube 122 connected to each other in sequence to form the integrated anchoring device 1.
< example two >
The same parts as those of the first embodiment will not be described in detail, and the differences will be described below, but the same points will be referred to in the first embodiment.
Unlike the first embodiment, in the present embodiment, the accommodating portion 12 includes a plurality of accommodating structures 123 arranged at intervals along the extending direction of the elastic wire 11; each containing structure 123 has at least one through hole 124, the through holes 124 of all containing structures 123 defining at least one cavity 121, the guide wire 13 passing through a row of through holes 124 in succession along the extension direction of the elastic wire 11.
Referring to fig. 5, each receiving structure 123 includes a circular ring connected to the elastic wire 11, each circular ring having a through hole 124, a row of through holes 124 on the axis of the elastic wire 11 forms a cavity 121, and the guide wire 13 passes through one of the cavities 121, that is, the guide wire 13 sequentially passes through all the rows of through holes 124 formed by the circular rings, thereby reducing the risk of thrombus that may be caused by the cavity tube 122.
It should be appreciated that the accommodating structure 123 is not limited to a circular ring, and the accommodating structure 123 need only include at least one through hole 124, and the specific structure of the accommodating structure 123 is not limited in the present application. The number of the accommodating structures 123 is not limited in the present application, and the number of the accommodating structures 123 may be set as needed. The connection manner of the receiving structure 123 and the elastic wire 11 is not limited in the present application, and the receiving structure 123 may be connected to the elastic wire 11 by welding, sewing or bonding.
When the anchoring device 1 comprises said reducing wires, each containing structure 123 has at least two through holes 124 arranged side by side in the radial direction of the elastic wire 11, the through holes 124 of all containing structures 123 defining at least two cavities 121, the guide wire 13 passing sequentially through one row of through holes 124 in the direction of extension of the elastic wire 11, said reducing wire passing sequentially through the other row of through holes 124 in the direction of extension of the elastic wire 11. In a specific embodiment, each accommodating structure 123 includes two rings disposed side by side and connected to the elastic wire 11, each ring has a through hole 124, two cavities 121 are formed by two rows of through holes 124 of the rings on the axis of the elastic wire 11, and the guide wire 13 and the reducing wire respectively pass through the two rows of through holes 124 of the rings, so as to realize threading of the guide wire 13 and the reducing wire in the accommodating portion 12.
Example III
The same parts as those of the first embodiment will not be described in detail, and the differences will be described below, but the same points will be referred to in the first embodiment.
Unlike the first embodiment, in this embodiment, the elastic wire 11 is disposed inside the accommodating portion 12, and at least two cavities 121 of the accommodating portion 12 extend through axially along the accommodating portion, and the elastic wire 11 and the guide wire 13 are respectively disposed in the two cavities 121 of the accommodating portion 12. Wherein the elastic wire 11 and the guide wire 13 may be inserted into any one of the cavities 121 of the accommodating portion 12.
In one embodiment, the accommodating portion 12 is formed by a cavity tube 122, and the cavity tube 122 is disposed parallel to the elastic wire 11; the cavity tube 122 has two cavities 121, and the elastic wire 11 and the guide wire 13 are respectively disposed in the two cavities 121 of the cavity tube 122.
Referring to fig. 6, when the anchoring device 1 includes the variable diameter wire, the cavity tube 122 of the anchoring device 1 may have three cavities 121, and the elastic wire 11, the guide wire 13 and the variable diameter wire are respectively penetrated in the three cavities 121 of the receiving portion 12. In the present embodiment, the elastic wire 11, the guide wire 13 and the reducing wire are respectively inserted into three cavities 121 of the cavity tube 122. The elastic wire 11, the reducing wire, and the guide wire 13 may be inserted into any one of the cavities 121 of the accommodating portion 12. The three cavities 121 may be provided independently or may communicate with each other. Preferably, the three cavities 121 are arranged independently so that the guide wire 13 is not disturbed by the elastic wire 11 and the reducing wire when moving.
Preferably, the distal end portion for accommodating the elastic wire 11 and the distal end portion for accommodating the reducing wire in the accommodating portion 12 are both sealed, for example, a silicone pad may be disposed at the distal end of the cavity 121 accommodating the elastic wire 11 and the distal end of the cavity 121 accommodating the reducing wire, so that the distal ends of the rest of the cavities 121 of the anchoring device 1 except the cavity 121 accommodating the guide wire 13 are sealed, thereby reducing the risk of thrombus at the distal end of the anchoring device 1.
To increase the smoothness of the movement of the anchoring device 1 within the left ventricle, the end of the distal end of the anchoring device 1 (i.e. the distal end of the gripping section 16) is shaped as a perforated sphere, cone, oval or sphere-like structure. Wherein a cavity 121 for accommodating the guide wire 13 is penetrated in the through hole of the distal end of the anchoring device 1.
For any of the above embodiments, in a non-limiting operation, taking mitral valve replacement as an example, the implantation procedure of the anchoring device 1 and prosthetic heart valve 3 is:
referring to fig. 3 and 4, in combination with fig. 2, the anchoring device 1 is retracted within the delivery sheath 4, the delivery sheath 4 may be advanced into the left ventricle via the aorta, atrium, or other route, and the anchoring device 1 may then be advanced to the sheath orifice of the delivery sheath 4 and release of the anchoring device 1 may begin in the left ventricle. First, the gripping section 16 of the anchoring device 1 is pushed out of the delivery sheath 4. Specifically, the distal end of the guide wire 13 is pushed out of the accommodating portion 12, the guide wire 13 can move along the wall of the left ventricle, after the guide wire 13 moves a small distance, the guide wire 13 stops moving, and then the elastic wire 11 and the accommodating portion 12 are pushed and the elastic wire 11 and the accommodating portion 12 move along the extending direction of the guide wire 13 until the distal end of the elastic wire 11 and the distal end of the accommodating portion 12 approach the distal end position of the guide wire 13. The guide wire 13 is then pushed again and the elastic wire 11, the receiving portion 12 and the guide wire 13 repeat the above-described movement process until the anchoring device 1 is detached from the delivery sheath 4. During the release of the anchoring device 1, since the distal end of the guide wire 13 is soft and does not damage the native tissue, when the moving position of the guide wire 13 or the receiving portion 12 is separated from the wall of the left ventricle, the guide wire 13 or the receiving portion 12 may be withdrawn slightly and pushed again, so that the distal end of the guide wire 13 can be pushed along the wall of the left ventricle and the anchoring section 15 can be moved along the wall of the predetermined chamber all the time under the guidance of the grasping section 16 so as to be able to encircle all the native tissue such as the native valve leaflets 21 and chordae tendineae 22. After confirming that the anchoring device 1 has been completely detached from the delivery sheath 4 and is able to encircle the native valve leaflet 21, the guide wire 13 and the reducing wire are withdrawn and the anchoring device 1 is allowed to resume its smaller diameter at the time of pre-shaping and encircle the native valve leaflet 21 and chordae tendineae 22. The delivery system is then kept in position with the anchoring device 1 and implantation of the prosthetic heart valve 3 is initiated.
The prosthetic heart valve 3 is used to replace and substitute a native mitral valve. The prosthetic heart valve 3 may enter the atrium via the inferior vena cava or other route and cross the native leaflets 21 into the lumen 14 of the anchoring device 1; the artificial heart valve 3 is released and expanded along the radial direction, the artificial heart valve 3 can be expanded by balloon disposable ball expansion or adopting self-expanding sheath and the like, during the expansion, the anchoring section 15 in the anchoring device 1 can generate elastic deformation or plastic deformation, the shape of the annular section 32 in the artificial heart valve 3 can be self-adapted when the anchoring section 15 is deformed, and the anchoring section 15 is fully fixedly connected and sealed with the annular section 32, so that the anchoring device 1 and the artificial heart valve 3 are fixedly connected into a whole. The anchoring section 15 is capable of applying an anchoring force to the expanded prosthetic heart valve 3 to effect anchoring of the prosthetic heart valve 3 at the native leaflet 21 site.
As shown in fig. 4, taking the kidney-shaped prosthetic heart valve 3 as an example, the prosthetic heart valve 3 includes an outflow section 31, an annular section 32 and a flange section 33 which are axially connected in order, and after the prosthetic heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annular section 32. The prosthetic heart valve 3 is implanted with care being taken with respect to the anchoring device 1 so that the anchoring device 1 is positioned at the annulus segment 32 of the prosthetic heart valve 3 and so that the anchoring device 1 encircles and abuts the native leaflets 21, whereupon the expanded prosthetic heart valve 3 provides anchoring force to the anchoring device 1 within the predetermined object. At the same time, the outflow section 31 and the flange section 33 with larger radii can limit the annular section 32 of the prosthetic heart valve 3 in the axial direction, even if the annular section 32 can only be located at the location of the anchoring device 1, so that it is ensured that the prosthetic heart valve 3 cannot move in the axial direction after implantation. After the prosthetic heart valve 3 has been fully expanded, the operator can withdraw the delivery system by confirming that the prosthetic heart valve 3 and the anchoring device 1 have been firmly implanted in a predetermined position, thereby completing the implantation procedure of the prosthetic heart valve 3 and the anchoring device 1.
It should also be appreciated that the prosthetic heart valve system provided by embodiments of the present invention may include the anchoring device 1 provided in any of the embodiments.
In summary, the anchoring device 1 provided by the invention comprises an anchoring structure and a guiding structure, wherein the anchoring structure comprises an elastic wire 11 and a containing part 12, the guiding structure comprises a guiding wire 13, and since the anchoring device 1 is pre-shaped into a specific structure before implantation, the anchoring structure can gradually follow the guiding wire 13 to move along the cavity wall of a preset cavity when the anchoring device 1 is implanted, and the anchoring device 1 can be expanded and molded around the native valve leaflet 21 when gradually released, so that the implantation of the anchoring device 1 in the preset cavity can be realized. The anchoring device 1 does not need a rope sleeve structure to capture the guide wire 13 during implantation, so that the implantation process of the anchoring device 1 can be simplified, the implantation difficulty of the anchoring device 1 can be reduced, the success rate of implantation of the artificial heart valve 3 can be improved, and the reliability and convenience of the operation of the artificial heart valve 3 can be improved.
The anchoring structure of the prosthetic heart valve provided by the invention is preferably provided with an anchoring section 15, wherein the anchoring section 15 can realize the connection of the prosthetic heart valve 3 and the anchoring section 15 through interference fit between the inner cavity 14 and the prosthetic heart valve 3, and the anchoring force is applied to the prosthetic heart valve 3. The anchoring device 1 preferably also has a reducing or guiding wire capable of increasing the diameter of the anchoring structure, and after implantation of the anchoring device 1 the guiding wire 13 and/or the reducing wire is withdrawn, the anchoring device 1 may return to the smaller diameter at the time of the pre-shaping and encircle the native valve leaflet 21. After implantation of the prosthetic heart valve 3, the anchoring device 1 may adapt to the outer contour of the prosthetic heart valve 3, such that the prosthetic heart valve 3 may be secured in a predetermined object by the anchoring device 1.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.
Claims (11)
1. An anchoring device for a prosthetic heart valve, the anchoring device having a contracted state and an expanded state and being switchable between the contracted state and the expanded state;
the anchoring device comprises an anchoring structure and a guiding structure; the anchoring structure comprises an elastic wire and a containing part; the accommodating part is connected with the elastic wire and is arranged along the extending direction of the elastic wire; the guide structure comprises a guide wire which is axially arranged in the accommodating part in a penetrating way;
the guide wire can extend out of the accommodating part from the distal end of the accommodating part and is used for moving along the cavity wall of the preset cavity to form a release track;
the anchoring structure is configured to follow the release trajectory formed by the guidewire to transition from the contracted state to the expanded state.
2. The anchoring device of a prosthetic heart valve of claim 1, wherein the receiving portion has a cavity extending axially therethrough, the guide wire being disposed in the cavity.
3. The anchoring device of a prosthetic heart valve of claim 2, wherein the elastic wire is disposed outside of the receiving portion, the receiving portion being comprised of a hollow tube disposed parallel to the elastic wire, the guide wire being disposed in the cavity of the hollow tube.
4. The anchoring device of a prosthetic heart valve of claim 2, wherein the elastic wire is disposed outside of the receiving portion, the receiving portion being comprised of a plurality of receiving structures spaced apart along an extension direction of the elastic wire;
each containing structure is provided with at least one through hole, the through holes of all the containing structures define at least one cavity, and the guide wire sequentially passes through a row of the through holes along the extending direction of the elastic wire.
5. The anchoring device of a prosthetic heart valve according to claim 2, wherein said elastic wire is disposed inside said housing portion having at least two of said cavities extending axially therethrough, said elastic wire and said guide wire being disposed in respective ones of said cavities of said housing portion.
6. The anchoring device of a prosthetic heart valve of claim 2, wherein the guide wire is configured to increase a diameter of the anchoring structure, and/or further comprising a variable diameter wire disposed in the receiving portion for increasing a radius of curvature of the receiving portion to increase a diameter of the anchoring structure.
7. The anchoring device of a prosthetic heart valve of claim 6, wherein the elastic wire is disposed outside of the receptacle, the guide wire and the reducing wire being disposed in the same or both of the cavities in the receptacle, respectively; or the elastic wire is arranged in the accommodating part, and the elastic wire, the guide wire and the reducing wire are respectively arranged in the three cavities of the accommodating part.
8. The anchoring device of a prosthetic heart valve of claim 6 or 7, wherein the stiffness of the reducing wire is greater than 0.1 times the stiffness of the elastic wire.
9. The anchoring device of a prosthetic heart valve according to claim 6 or 7, wherein a distal end of the cavity in the receiving portion for receiving the reducing wire is sealingly arranged, the distal end being spherical, conical or elliptical in shape.
10. The anchoring device for a prosthetic heart valve of claim 1, wherein the anchoring device in the expanded state is a coiled structure;
wherein in the expanded state, the anchoring structure has an anchoring segment surrounding a native valve She Yong, the anchoring segment having at least one turn of a coil, the anchoring structure further having a grasping segment axially connected to the anchoring segment; the curvature radius of the grabbing section is larger than that of the anchoring section, so that the anchoring structure moves along the cavity wall of the preset cavity and expands and forms when being implanted.
11. A prosthetic heart valve system comprising a prosthetic heart valve and an anchoring device for the prosthetic heart valve of any one of claims 1-10, the prosthetic heart valve being for receipt in the anchoring device.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210487344.4A CN117045393A (en) | 2022-05-06 | 2022-05-06 | Anchoring device for prosthetic heart valve and prosthetic heart valve system |
| PCT/CN2023/075329 WO2023213106A1 (en) | 2022-05-06 | 2023-02-10 | Anchoring device of artificial heart valve and artificial heart valve system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210487344.4A CN117045393A (en) | 2022-05-06 | 2022-05-06 | Anchoring device for prosthetic heart valve and prosthetic heart valve system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117045393A true CN117045393A (en) | 2023-11-14 |
Family
ID=88646206
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210487344.4A Pending CN117045393A (en) | 2022-05-06 | 2022-05-06 | Anchoring device for prosthetic heart valve and prosthetic heart valve system |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN117045393A (en) |
| WO (1) | WO2023213106A1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2809263B1 (en) * | 2012-01-31 | 2017-08-23 | Mitral Valve Technologies Sàrl | Mitral valve docking devices, systems |
| CR20190069A (en) * | 2016-08-26 | 2019-05-14 | Edwards Lifesciences Corp | Heart valve docking coils and systems |
| CA3115714A1 (en) * | 2018-10-19 | 2020-04-23 | Shifamed Holdings, Llc | Adjustable medical device |
| CN112315626A (en) * | 2020-11-06 | 2021-02-05 | 上海纽脉医疗科技有限公司 | Artificial heart valve and medical device |
| CN113303947A (en) * | 2021-06-17 | 2021-08-27 | 上海臻亿医疗科技有限公司 | Anchoring device for heart valve |
-
2022
- 2022-05-06 CN CN202210487344.4A patent/CN117045393A/en active Pending
-
2023
- 2023-02-10 WO PCT/CN2023/075329 patent/WO2023213106A1/en unknown
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| Publication number | Publication date |
|---|---|
| WO2023213106A1 (en) | 2023-11-09 |
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