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CN113545890B - Novel transcatheter mitral valve - Google Patents

Novel transcatheter mitral valve Download PDF

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Publication number
CN113545890B
CN113545890B CN202110767007.6A CN202110767007A CN113545890B CN 113545890 B CN113545890 B CN 113545890B CN 202110767007 A CN202110767007 A CN 202110767007A CN 113545890 B CN113545890 B CN 113545890B
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Prior art keywords
main body
mitral valve
connecting rod
cylindrical main
cylindrical body
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CN202110767007.6A
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CN113545890A (en
Inventor
潘湘斌
朱达
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Fuwai Yunnan Cardiovascular Hospital
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Fuwai Yunnan Cardiovascular Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition

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  • 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 belongs to the technical field of medical instruments, particularly relates to the technical field of medical instruments for implanting a transcatheter heart valve, and particularly relates to a novel transcatheter mitral valve. The blood transfusion device comprises a blood inflow end and a blood outflow end, and comprises an inner support, wherein the inner support comprises a first cylindrical main body and a connecting rod, the first cylindrical main body is fixedly connected with the connecting rod, and the connecting rod is arranged on the outer ring of the first cylindrical main body; the inner support is used for connecting the artificial valve leaflet; the outer support comprises a second cylindrical main body and a connecting arm, the second cylindrical main body is fixedly connected with the connecting arm, and the connecting arm is arranged at the far end of the second cylindrical main body; the outer bracket is used for being fixedly arranged on the mitral valve annulus; the connecting rod is fixedly connected with the blood outflow end of the connecting arm.

Description

Novel transcatheter mitral valve
Technical Field
The invention belongs to the technical field of medical instruments, particularly relates to the technical field of medical instruments for implanting a transcatheter heart valve, and particularly relates to a novel transcatheter mitral valve.
Background
Transcatheter Valve Replacement (TVR) is a minimally invasive Valve Replacement operation, which means that an assembled Valve is placed into a Valve through a catheter to replace the original Valve, and the Valve Replacement is functionally completed, wherein the specific implantation process of the TVR is as follows: the TVR has become a main treatment means for patients with valvular stenosis, which cannot be tolerated by surgical operations or high risk of surgical operations, such as valvular stenosis, by compressing the prosthetic valve into a transcatheter delivery system, delivering the valve to the valve root through a peripheral blood vessel (such as femoral artery, femoral vein, subclavian artery, moving abdominal aorta, etc.) or apex of heart using the delivery system, releasing the valve, fixing the valve in the annulus, and replacing the native valve with the prosthetic valve.
At present, the design of sharp barbs of a valve design is used for fixing the valve, for example, a patent (CN 110575286A) discloses an external cardiac valve stent and a prosthetic cardiac valve, the external cardiac valve stent comprises a mesh-tube-shaped external stent body, the external stent body is provided with a blood outflow end and a blood inflow end, the blood outflow end is of a wave structure, one or more wave crests in the wave structure are bent into the external stent body at intervals to form a bent part, the unbent wave crests are connected with outward barbs or outward barbs at intervals, the invention designs a wave structure on the blood outflow end of the external stent body, the wave crests in the wave structure are bent inward at intervals, an outflow end port formed by the inward bent wave crest is deviated to a mitral valve posterior leaflet, and the inward bent wave crest is connected with the internal stent, the valve is attached to prevent the outflow tract from being obstructed while ensuring good fixation. The method is characterized in that: including a net pipy outer support body, the outer support body has a blood outflow end and a blood inflow end, the blood outflow end is wave structure, just one or more crests at every interval in the wave structure to this internal one or more crests of buckling of outer support form the portion of bending, do not buckle all be connected with outside barb or interval connection have outside barb on the crest. However, when the valve device is implanted, the unbent wave crests are connected with outward barbs or are connected with outward barbs at intervals, which are prone to damage to the left ventricular wall or blood vessels of the heart and cause complications.
Disclosure of Invention
In view of the above, the present invention provides a novel transcatheter mitral valve comprising a blood inflow end and a blood outflow end, including
The inner support comprises a first cylindrical main body and a connecting rod, the first cylindrical main body is fixedly connected with the connecting rod, and the connecting rod is arranged on the outer ring of the first cylindrical main body; the inner support is used for connecting the artificial valve leaflet;
the outer support comprises a second cylindrical main body and a connecting arm, the second cylindrical main body is fixedly connected with the connecting arm, and the connecting arm is arranged at the far end of the second cylindrical main body; the outer bracket is used for being fixedly arranged on the mitral valve annulus;
the connecting rod is fixedly connected with the blood outflow end of the connecting arm.
Preferably, the connecting arm extends from a connection point with the second cylindrical body to a position between a center direction of the second cylindrical body and a blood outflow end direction.
In a preferred embodiment, the first cylindrical body and the connection bar are fixedly connected to each other at a blood inflow end, and a connection portion between the connection bar and the first cylindrical body is made of an elastic material.
In a preferred embodiment, the first cylindrical body and the connection rod are fixedly connected to each other at a blood inflow end, and a connection portion between the connection rod and the first cylindrical body is formed in a "P" shape.
In a preferred embodiment, the first cylindrical body and the connection bar are fixedly connected to each other at a blood inflow end, and a connection portion between the connection bar and the first cylindrical body is formed in an "L" shape.
In a preferred embodiment, an expansion ring is fixedly attached to the second tubular body at the blood inflow end, and the diameter of the edge of the expansion ring is larger than the diameter of the second tubular body.
As a preferred technical scheme, the side wall of the second cylindrical main body is provided with fish-scale protrusions, the fish-scale protrusions are arranged in one layer or multiple layers in the axial direction of the second cylindrical main body, and the fish-scale protrusions are uniformly distributed on one circumference of the second cylindrical main body.
As a preferable technical solution, the direction of the scale-shaped protrusion is between the direction of the blood inflow end and the direction perpendicular to the surface of the second cylindrical main body.
As a preferable technical scheme, the fish-scale bulges are shaped like an n shape and/or an omega shape.
As a preferred technical solution, the inner stent and the outer stent are configured as a self-expanding metal stent or a balloon-expandable metal stent.
Has the beneficial effects that:
the invention provides a novel transcatheter mitral valve, which comprises an inner stent and an outer stent. The outer bracket is provided with a fish-scale protrusion part and a sealing skirt and is used for fixing the outer bracket on the mitral valve annulus and preventing the valve periphery from leaking; the inner support is used for fixing valve leaflets and is used as a functional core of the transcatheter artificial heart valve; the outer support and the inner support are obliquely linked up and down to form a complete valve.
The outer stent of the novel transcatheter mitral valve is provided with a fish scale-shaped protruding part, and the shape of the fish scale-shaped protruding part is n or omega or other similar shapes which are different from sharp barbs; the stent has a plurality of layers of fish-scale-shaped protrusions at the periphery; the stent has a plurality of fish-scale protrusions in the circumferential direction, and may be single-layered or multi-layered in the valve height direction. The fish-scaled protrusions of the stent, protruding from the contour of the outer stent, have a height and/or inclination for anchoring the mitral valve in the vicinity of the annulus.
The outer support and the inner support of the novel transcatheter mitral valve form a complete valve by adopting an up-and-down inclined link, the inclined link is provided with a plurality of links on the circumference, the link shape can be an elastic link with the shapes of L, p and the like, and the outer support is prevented from obviously working along with the cardiac cycle or influencing the valve leaflets of the inner support.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and those skilled in the art can obtain other drawings based on the drawings without inventive labor.
FIG. 1 is a schematic structural view of a novel transcatheter mitral valve;
FIG. 2 is a design of a novel transcatheter mitral valve outer frame with 2 layers of "n" shaped fish-scale protrusions;
FIG. 3 is a design of a novel transcatheter mitral valve outer frame with 1 layer of "n" shaped and 1 layer of "omega" shaped fish-scaled protrusions;
FIG. 4 is a design of a novel transcatheter mitral valve inner frame designed as a "p" type angled connection;
FIG. 5 shows an "L" shaped angled connection of the novel transcatheter mitral valve stent according to an embodiment of the present invention;
wherein: 1-inner support, 11-first cylindrical main body, 12-connecting rod, 2-outer support, 21-second cylindrical main body, 22-connecting arm, 23-expanding ring and 24-fish scale bulge.
Detailed Description
A novel transcatheter mitral valve comprises a blood inflow end and a blood outflow end, including
The inner support 1 comprises a first cylindrical main body 11 and a connecting rod 12, wherein the first cylindrical main body 11 is fixedly connected with the connecting rod 12, and the connecting rod 12 is arranged on the outer ring of the first cylindrical main body 11; the inner support 1 is used for connecting the artificial valve leaflet;
the external bracket 2 comprises a second cylindrical main body 21 and a connecting arm 22, wherein the second cylindrical main body 21 is fixedly connected with the connecting arm 22, and the connecting arm 22 is arranged at the far end of the second cylindrical main body 21; the outer bracket 2 is used for being fixedly arranged on the mitral valve annulus;
the connecting rod 12 is fixedly connected with the connecting arm 22 at the blood outflow end.
In some preferred embodiments, the connecting arm 22 extends from a connection point with the second cylindrical body 21 to a position between a center direction of the second cylindrical body 21 and a blood outflow end direction.
In some preferred embodiments, the first cylindrical body 11 and the connection rod 12 are fixedly connected at the blood inflow end, and the connection portion of the connection rod 12 and the first cylindrical body 11 is made of an elastic material.
The connecting part of the connecting rod 12 and the first cylindrical main body 11 is made of elastic material, so that the influence of the deformation of the outer bracket on the inner bracket is absorbed, and the contraction of the connecting rod is used for replacing the contraction of the first cylindrical main body. Thereby ensuring that the first cylindrical main body does not deform as much as possible, and avoiding the outer stent from obviously working along with the cardiac cycle or influencing the valve leaflets of the inner stent.
In some preferred embodiments, the first cylindrical body 11 and the connection rod 12 are fixedly connected at the blood inflow end, and the connection portion of the connection rod 12 and the first cylindrical body 11 is provided in a "P" shape.
The connecting part is set to be in a P shape, so that the connecting rod and the first cylindrical main body are separated in force transmission, deformation pressure brought by the outer support is completely absorbed by the connecting rod, the first cylindrical main body is prevented from deforming as much as possible, and the outer support is prevented from obviously working along with a cardiac cycle or influencing the valve blades of the inner support.
In some preferred embodiments, the first cylindrical body 11 and the connection rod 12 are fixedly connected at the blood inflow end, and the connection portion of the connection rod 12 and the first cylindrical body 11 is formed in an "L" shape.
In some preferred embodiments, an expansion ring 23 is fixedly connected to the second cylindrical body 21 at the blood inflow end, and the diameter of the edge of the expansion ring 23 is larger than that of the second cylindrical body 21.
The expanding ring is arranged on one side of the valve ring facing to the atrium, so that the valve is ensured to be fixed, and the valve ring is prevented from being washed away from a target position in blood flow.
In some preferred embodiments, the side wall of the second cylindrical body 21 is provided with scale-shaped protrusions 24, the scale-shaped protrusions 24 are arranged in one or more layers in the axial direction of the second cylindrical body 21, and one layer of the scale-shaped protrusions 24 is uniformly distributed on one circumference of the second cylindrical body 21.
In some preferred embodiments, the fish-scale protrusions 24 are oriented between the direction of the blood inflow end and the direction perpendicular to the surface of the second cylindrical body 21.
In some preferred embodiments, the fish-scale protrusions 24 are shaped as "n" and/or "Ω".
The fish scale-shaped convex part is different from a sharp barb in the shape of n or omega or other similar shapes; the stent has a plurality of layers of fish-scale-shaped protrusions at the periphery; the stent has a plurality of fish-scale-like projections in the circumferential direction, and may be single-layered or multi-layered in the valve height direction. The support has a fish-scale protrusion, protruding out of the contour of the outer support, with a certain height and/or inclination for anchoring the mitral valve in the vicinity of the annulus.
The fish scale-shaped bulges are used for stably fixing the outer support in the valve ring, the sharp thorn design is avoided, the valve ring is prevented from being damaged by the sharp thorn structure, and the expansion ring is designed, so that the fixing effect is ensured by utilizing the space difference of the atria and the ventricles.
In some preferred embodiments, the inner stent 1 and the outer stent 2 are provided as self-expanding metal stents or balloon-expanding metal stents.
The working principle is as follows: the invention provides a novel transcatheter mitral valve, which comprises an inner stent and an outer stent. The outer bracket is provided with a fish-scale protrusion part and a sealing skirt and is used for fixing the outer bracket on the mitral valve annulus and preventing the valve periphery from leaking; the inner support is used for fixing valve leaflets and is used as a functional core of the transcatheter artificial heart valve; the outer support and the inner support are obliquely linked up and down to form a complete valve. The design of the outer valve support has larger fit area with the native body wall of the native mitral valve, thereby avoiding the problem of complications such as wall damage and coronary artery stabbing caused by the stimulation of the left ventricular wall by the sharp shape after the outer valve support is fitted with the mitral valve ring, and reducing the transient reaction of the human body caused by the stimulation of tissues implanted by mitral valve instruments.

Claims (9)

1. A novel transcatheter mitral valve, which comprises a blood inflow end and a blood outflow end, and is characterized by comprising
The inner support (1) comprises a first cylindrical main body (11) and a connecting rod (12), the first cylindrical main body (11) is fixedly connected with the connecting rod (12), and the connecting rod (12) is arranged on the outer ring of the first cylindrical main body (11); the inner support (1) is used for connecting the artificial valve leaf;
the outer support (2) comprises a second cylindrical main body (21) and a connecting arm (22), the second cylindrical main body (21) is fixedly connected with the connecting arm (22), and the connecting arm (22) is arranged at the far end of the second cylindrical main body (21); the outer bracket (2) is used for being fixedly arranged on a mitral valve annulus;
the blood outlet end of the connecting rod (12) is fixedly connected with the blood outlet end of the connecting arm (22), the first cylindrical main body (11) is fixedly connected with the connecting rod (12) at the blood inlet end, and the connecting part of the connecting rod (12) and the first cylindrical main body (11) is made of elastic materials.
2. A novel transcatheter mitral valve according to claim 1, wherein the connecting arms (22) extend from a connection point with the second cylindrical body (21) in a direction between a central direction of the second cylindrical body (21) and a direction of a blood outflow end.
3. The new transcatheter mitral valve according to claim 1, wherein the first cylindrical body (11) and the connecting rod (12) are fixedly connected at the blood inflow end, and the connecting site of the connecting rod (12) and the first cylindrical body (11) is arranged in a "P" shape.
4. The new transcatheter mitral valve according to claim 1, wherein the first cylindrical body (11) and the connecting rod (12) are fixedly connected at a blood inflow end, and a connection site of the connecting rod (12) and the first cylindrical body (11) is provided in an "L" shape.
5. The novel transcatheter mitral valve according to claim 1, wherein the second cylindrical body (21) has a stent ring (23) fixedly attached at a blood inflow end, the stent ring (23) having an edge diameter greater than a diameter of the second cylindrical body (21).
6. A new type of transcatheter mitral valve according to claim 1, wherein the second cylindrical body (21) is provided with scale-like protrusions (24) on the side wall, the scale-like protrusions (24) being arranged in one or more layers in the axial direction of the second cylindrical body (21), a layer of the scale-like protrusions (24) being evenly distributed on one circumference of the second cylindrical body (21).
7. The new transcatheter mitral valve according to claim 6, wherein the direction of the fish-scale protrusions (24) is between the direction of the blood inflow end and the direction perpendicular to the surface of the second cylindrical body (21).
8. A novel transcatheter mitral valve according to claim 6 or 7, characterized in that the fish squamous bulge (24) is shaped as an "n" and/or an "Ω".
9. The new transcatheter mitral valve according to claim 1, wherein the inner stent (1) and the outer stent (2) are provided as self-expanding metal stents or balloon-expanding metal stents.
CN202110767007.6A 2021-07-07 2021-07-07 Novel transcatheter mitral valve Active CN113545890B (en)

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CN202110767007.6A CN113545890B (en) 2021-07-07 2021-07-07 Novel transcatheter mitral valve

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Application Number Priority Date Filing Date Title
CN202110767007.6A CN113545890B (en) 2021-07-07 2021-07-07 Novel transcatheter mitral valve

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CN113545890B true CN113545890B (en) 2022-07-15

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117653418B (en) * 2023-12-14 2024-07-05 鑫依医疗科技(北京)有限公司 Prosthetic heart valve prosthesis

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103889369A (en) * 2011-10-19 2014-06-25 托尔福公司 Devices, systems and methods for heart valve replacement
CN106175987A (en) * 2016-08-31 2016-12-07 上海纽脉医疗科技有限公司 Cardiac valve prosthesis
CN109394393A (en) * 2017-08-18 2019-03-01 上海微创心通医疗科技有限公司 Heart valve prosthesis
CN208799371U (en) * 2017-08-18 2019-04-30 上海微创心通医疗科技有限公司 Heart valve prosthesis
CN111655201A (en) * 2018-02-15 2020-09-11 医疗系统公司 Stent and replacement heart valve prosthesis with improved fixation features

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102016111103A1 (en) * 2016-06-17 2017-12-21 Biotronik Ag Heart valve prosthesis with outer apron

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103889369A (en) * 2011-10-19 2014-06-25 托尔福公司 Devices, systems and methods for heart valve replacement
CN106175987A (en) * 2016-08-31 2016-12-07 上海纽脉医疗科技有限公司 Cardiac valve prosthesis
CN109394393A (en) * 2017-08-18 2019-03-01 上海微创心通医疗科技有限公司 Heart valve prosthesis
CN208799371U (en) * 2017-08-18 2019-04-30 上海微创心通医疗科技有限公司 Heart valve prosthesis
CN111655201A (en) * 2018-02-15 2020-09-11 医疗系统公司 Stent and replacement heart valve prosthesis with improved fixation features

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