WO2022022574A1 - Valvule prothétique - Google Patents
Valvule prothétique Download PDFInfo
- Publication number
- WO2022022574A1 WO2022022574A1 PCT/CN2021/108949 CN2021108949W WO2022022574A1 WO 2022022574 A1 WO2022022574 A1 WO 2022022574A1 CN 2021108949 W CN2021108949 W CN 2021108949W WO 2022022574 A1 WO2022022574 A1 WO 2022022574A1
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- WO
- WIPO (PCT)
- Prior art keywords
- segment
- prosthetic valve
- mesh
- grid
- valve according
- Prior art date
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Classifications
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- 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
-
- 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
Definitions
- the present invention relates to the technical field of artificial prosthesis devices, in particular, to an artificial valve.
- the natural heart valves (aortic, pulmonary, tricuspid and mitral) play a very important role in ensuring the supply of blood to the body.
- Prosthetic valves are used to treat valvular heart disease.
- the artificial valve is used to replace the natural valve.
- the tricuspid valve annulus is a "D"-shaped structure, and there is a coronary sinus between the inferior vena cava and the tricuspid valve orifice, accurate circumferential positioning is particularly important for the prosthetic valve for tricuspid valve replacement; and, While ensuring the accurate positioning of the valve, it is also an essential requirement for the tricuspid valve to effectively avoid the coronary sinus and fix it firmly.
- the main purpose of the present invention is to provide a tricuspid valve valve, the distal developing point can solve the problem of inaccurate circumferential positioning of the tricuspid valve valve in the prior art; On the other hand, the valve is fixed. At the same time, the valve's own gap design can avoid blocking the coronary sinus after implantation and ensure the normal function of the valve.
- the present invention provides an artificial valve, comprising: a stent, the stent includes a first grid segment, a second grid segment and a limit segment that are connected to each other, and the second grid segment is located between the first grid segment and the limit segment.
- the second grid segment is surrounded by a barrel-shaped structure, the diameter of the first grid segment increases from the direction close to the second grid segment to the direction away from the second grid segment, and the first grid segment has an avoidance gap, and the limit segment has an outward
- the sealing film the sealing film is arranged on the support; the valve leaflet, the valve leaflet is arranged on the second grid segment, so that the flow direction of the fluid is from the first grid segment to the limit segment.
- the limiting segment is connected to the second grid segment, the limiting segment is at least one "U"-shaped structure, the middle of the limiting segment extends toward the first grid segment, and the two ends of the "U"-shaped structure are respectively connected to the second grid segment.
- Mesh segments are connected.
- the limiting segment is a plurality of "U"-shaped structures, and the plurality of "U"-shaped structures are evenly distributed at the first end of the second grid segment.
- the first grid segment is a bell mouth structure, and the first grid segment is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.
- the avoidance gap of the first grid segment is a fan-shaped structure.
- the bracket further includes a plurality of connecting ears, and the plurality of connecting ears are arranged on the first end of the first mesh segment.
- the stent is made by a cutting process or a weaving process.
- bracket further includes barbs connected to the second mesh segment and extending in a direction away from the central axis of the second mesh segment.
- the barbs extend obliquely toward the direction of the first mesh segment.
- the angle between the barbs and the outer side wall of the second grid segment is between 10 degrees and 80 degrees, and the length of the barbs is 1 mm to 10 mm.
- the artificial valve further includes a developing part, and the developing part is arranged on the stent.
- the developing component is located at the apex of the outward flange of the limiting section, and the developing component on at least one apex is different from other apexes, and can be used to distinguish the circumferential positioning of the valve.
- the first mesh segment is provided with a sealing film, the first mesh segment has an avoidance notch, and the developing member is arranged corresponding to the avoidance notch.
- cross section of the second mesh segment is "D" shaped.
- the vertices of the outward flanging of the limiting segment are respectively provided with three developing points, wherein the avoiding gap of the first mesh segment is provided with three developing points at the developing points of the vertices of the flanging corresponding to the axial direction, Easy to show location. As shown in the figure, the number of developing points is different at the three developing places.
- the artificial valve is delivered to the right ventricle beyond the target position by the delivery device, and the limit segment is first released.
- the "D"-shaped structure after valve release can correspond to the "D"-shaped annulus of the tricuspid valve.
- the flanging of the limiting segment will interact with the native valve leaflets or chordae tendineae to form a blocking limit.
- the delivery device then releases the second mesh segment, which increases in diameter and has barbs and is caught in the tricuspid annulus.
- the above structure enables the artificial valve to have a better fixation effect at the tricuspid valve.
- the technical scheme of the present invention effectively solves the problems of the adaptability and circumferential positioning of the artificial valve and human organs.
- Figures 1A and 1B show schematic front views of an embodiment of a prosthetic valve according to the present invention
- Figure 2 shows a schematic top view of the prosthetic valve of Figure 1;
- FIG. 3 shows a schematic top view of the artificial valve according to another embodiment of the artificial valve of the present invention.
- Figure 4 shows a schematic front view of the stent of the prosthetic valve of Figure 1;
- FIG. 5 shows a schematic top view of the bracket of FIG. 4.
- FIG. 6 shows a schematic structural diagram of another embodiment of the stent of the artificial valve of the present invention.
- FIG. 7 shows a schematic diagram of the implantation of a prosthetic valve in a human body according to the present disclosure
- FIG. 8 shows a schematic diagram of an exemplary delivery tool for implanting a prosthetic valve according to the present disclosure.
- Figure 9 shows a schematic diagram of the release of the limiting segment during implantation of the prosthetic valve.
- bracket 11, first mesh segment; 12, second mesh segment; 13, limit segment; 131, "U"-shaped structure; 14, barb; 15, connecting ear; 20, sealing membrane; 30, flap Leaf; 40, developing parts; 50, avoiding the gap.
- proximal refers to the direction near or close to the operator, eg, a doctor, nurse, or other medical personnel
- distal or distal refers to the direction away from the proximal or proximal end or the direction close to the patient or prosthesis implanter.
- upstream refers to the direction from which the fluid originates and “downstream” refers to the fluid direction of flow.
- the artificial valve of this embodiment includes: a stent 10 and a valve leaflet 30 .
- the bracket 10 includes a first grid segment 11, a second grid segment 12 and a limiting segment 13 which are connected in the axial direction X, the second grid segment 12 is located between the first grid segment 11 and the limiting segment 13, and the second grid segment 12 is located between the first grid segment 11 and the limiting segment 13.
- the limiting segment 13 has outward flanges.
- the leaflets 30 are arranged on the second mesh segment 12 so that the flow direction of the fluid is from the first mesh segment 11 to the limiting segment 13 .
- the stent 10 is formed by a laser using a nickel-titanium tube, and the first mesh segment 11 , the second mesh segment 12 and the limiting segment 13 are integrally formed.
- the present disclosure is not limited to this, but the first The one mesh segment, the second mesh segment, and the stop segment may be formed separately and joined together, eg, by laser welding, gluing, or the like.
- the size of the stent 10 is determined according to the size of the anatomical structure of the body part to be implanted.
- the maximum dimension D1 of the cross-section of the first mesh segment 11 is in the range of 40-70 mm
- the cross-section of the second mesh segment is the largest
- the dimension D2 is in the range of 20-50mm
- the maximum dimension D3 of the cross-section of the limiting section is in the range of 25-60mm.
- the entire height H1 of the stent 10 is in the range of 20-40 mm
- the height H2 of the second grid segment is in the range of 10-20 mm, so as not to hinder the normal opening and closing of the valve leaflets.
- a sealing membrane 20 is provided on the first mesh segment 11 and/or the second mesh segment 12 to prevent paravalvular leakage when the prosthetic valve is implanted into the human body.
- the sealing membrane 20 may be formed using materials derived from animals such as bovine pericardium, porcine pericardium, etc., but the present disclosure is not limited thereto, and other suitable biocompatible synthetic materials may be used.
- the sealing film 20 may be sutured to the first mesh segment 11 and the second mesh segment 12 by stitches, however, the present disclosure is not limited thereto, and other methods that can be conceived by those skilled in the art can be adopted, for example, Welding, bonding, rivets, etc.
- the limiting segment 13 is connected to the second grid segment 12 , and the limiting segment 13 includes at least one inverted “U”-shaped structure 131 .
- the vertex of the structure 131 extends toward the direction of the first mesh segment 11 .
- the limiting segment 13 includes a ring surrounded by a plurality of inverted U-shaped structures 131 , and the position between the two U-shaped structures of the ring is connected to the second mesh segment 12 through a connecting rod (not marked), and the U
- the diameter size of the ring enclosed by the type structure is larger than the size of the second mesh segment 12 , so that the limiting segment 13 constitutes the flange of the second mesh segment 12 .
- the "U"-shaped structure 131 is easy to set and process, and the "U"-shaped structure 131 is a smooth transition, so that it will not cause damage to the organs of the body.
- the bending part of the "U"-shaped structure 131 is an arc-shaped transition, which not only ensures that the stress of the stent 10 will not be concentrated, nor will it damage the organs and tissues of the body.
- the artificial valve of this embodiment can be used to replace the mitral valve or the tricuspid valve of the human body.
- the present disclosure is not limited thereto, and the limiting segment 13 may also include a "V"-shaped structure, or a wave-shaped structure.
- the limiting section may pass through the connecting rod at both ends of the “U”-shaped structure or at approximately the middle position between two adjacent U-shaped structures (not identified) are respectively connected to the second grid segments 12 .
- the above structure is compact and easy to use.
- the limiting segment 13 , the second grid segment 12 and the first grid segment 11 can be laser cut by a pipe material, so that the connection between the first grid segment 11 , the second grid segment 12 and the limiting segment 13 has a smooth transition.
- the same product can also be made by wire weaving.
- the limiting segment 13 includes a plurality of “U”-shaped structures, and the multiple “U”-shaped structures are preferably evenly distributed around the circumferential direction of the second mesh segment 12 . This ensures that the artificial valve is relatively balanced when it interacts with the body tissue.
- multiple "U”-shaped structures can be arranged at intervals, or the ends of adjacent "U”-shaped structures can be connected at the same connection point, so that multiple "U"-shaped structures are composed of
- the limiting section 13 is a wavy structure.
- the limiting segment includes three "U"-shaped structures, three leaflets 30, and the three leaflets 30 are arranged in a one-to-one correspondence with the three "U"-shaped structures, that is, when viewed in the axial direction , each of which includes a U-shaped structure in the sectors covered by the three leaflets 30 .
- the above structure further ensures that the installation of the artificial valve is relatively stable. Taking the tricuspid valve as an example, the three "U"-shaped structures can contact the valve leaflets or myocardial tissue for positioning and fixation; then the second grid and the first grid are released, and the valve is stuck at the tricuspid valve.
- the blood flows from the right atrium through the artificial valve into the right ventricle; when the heart contracts, the blood pressure closes the artificial valve, giving the valve pressure to the atrium, and the three "U"-shaped structures interact with the tissue to provide a reaction force to fix the valve. in the tricuspid valve position.
- the first mesh segment 11 is a bell-shaped structure.
- the first mesh segment 11 is a bell-shaped structure, on the one hand, it ensures that the first mesh segment 11 forms a limit to another angle of the artificial valve, that is, the artificial valve will not fall into the ventricle from the installation position, and on the other hand, due to the first mesh A sealing membrane 20 is installed on the grid segment 11 and/or the second grid segment.
- FIG. 7 when the first grid segment 11 and the second grid segment 12 fit with the body tissue, paravalvular leakage can be avoided.
- the first grid segment 11 is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.
- the first mesh segment 11 is provided with an avoidance gap
- the avoidance gap is a fan-shaped structure.
- the avoidance gap can be formed by a petal-shaped support bar without a coating, so that the avoidance gap has connecting ribs, and the connecting ribs are connected to the support bars on both sides of the avoidance gap.
- the present disclosure is not limited to this, and the avoidance gap may not be provided with connecting ribs, as shown in FIG. 3 .
- the bracket 10 further includes a plurality of connecting ears 15 , and the plurality of connecting ears 15 are arranged on the first end of the first mesh segment 11 .
- the provision of the connecting ears 15 facilitates the connection of the prosthetic valve to the delivery device.
- the connecting ears 15 may be provided with connecting holes.
- One end of the first grid segment 11 with a smaller diameter is connected to the second grid segment 12 .
- the second mesh segment 12 is substantially barrel-shaped, which need not have a circular cross-section, and its size and cross-sectional shape can be determined according to the site to be implanted.
- the second mesh segment 12 comprises two rings connected to each other in the axial direction (the height direction of the pages of Figures 1 and 4), wherein each ring comprises a plurality of wave shapes, the waves of the first ring The wave crests of the shape are connected with the wave troughs of the second ring through connecting rods, and each wave shape is formed into a zigzag shape.
- each wave shape can also be formed with a rounded transition. U-shaped or otherwise.
- the second mesh segment 12 includes two wavy rings, however, the present disclosure is not limited thereto, and may also include one or more rings.
- the leaflets 30 are connected in the second mesh segment 12, and in the embodiment shown in FIG. 1, three leaflets 30 are included, however, the present disclosure is not so limited, and Implantation site and other factors, two leaflets or four leaflets, or even more leaflets 30 may be employed.
- the leaflets 30 are formed from animal derived materials such as porcine pericardium, bovine pericardium, however, the present disclosure is not so limited and other biocompatible synthetic materials may be employed.
- the leaflets 30 may be sutured to the sealing membrane 20 and the second mesh segment 12 using sutures (not shown), as shown by the thick solid lines in FIG. 1 , but the present disclosure is not so limited, and adhesives may be used , welding, rivets and other methods. As shown in FIG. 1, the leaflet 30 includes arcuate edges sutured to the second mesh segment 12 and the sealing membrane 20, and includes a free edge. When the leaflet 30 is implanted in place, as shown in FIG.
- each leaflet 30 is pushed apart, allowing blood to flow through, and when the blood flow in the opposite direction passes, blood fills each leaflet 30, Thereby, the free edge portions of the three leaflets are abutted and closed.
- the stent 10 further includes barbs 14 connected to the second mesh segment 12 and extending in a direction away from the central axis of the second mesh segment 12 , pointing toward the first mesh segment 12 .
- the second mesh segment 12 is provided with barbs 14, which can penetrate into the tissue around the native valve for fixing.
- the angle between the barbs 14 and the central axis of the second grid segment 12 is 10 degrees to 80 degrees, preferably 60 degrees.
- the length of the barbs 14 is between 1 mm and 10 mm.
- the structure of the multiple barbs 14 makes the artificial valve and the body tissue more focal points, and the fixation of the artificial valve is more stable.
- the number of barbs 14 is three groups or a multiple of three groups.
- the length of the barbs 14 is 1 mm to 10 mm.
- the length of the barbs 14 is 3 mm.
- the artificial valve further includes a developing member 40 , and the developing member 40 is arranged on the limiting section 13 of the stent 10 .
- the provision of the developing member 40 facilitates circumferential positioning.
- the developing member 40 can be a metal with good developability, such as platinum, gold or platinum-iridium alloy. After the artificial valve enters the body, with the aid of the developing device, the developing component 40 can be clearly displayed on the screen of the device, which helps the valve to be clearly positioned.
- the developing member 40 is located at the distal apex of the “U”-shaped structure of the limiting segment, and at least one of the “U”-shaped structures has a developing member.
- the developing member 40 may be at a plurality of vertices of the "U"-shaped structure, but the developing member on at least one vertex is different from other vertexes, and can distinguish the circumferential direction of the prosthetic valve. Valve positioning is more accurate when multiple "U"-shaped structures have developing points. In FIG.
- each vertex has a different number of developing components, 1, 2, and 3, respectively, and the vertices can be distinguished from each other.
- the sheath tube is released from the distal end of the valve, the circumferential position of the valve can be confirmed according to different developing components.
- the "D"-shaped structure valve corresponds to the "D"-shaped anatomical structure of the human body. fully released.
- the implantation method of the artificial valve according to the present disclosure will be described below with reference to FIGS. 7 to 9 .
- the artificial valve is formed by using a memory alloy to automatically restore the set shape when released as an example. description, but the present disclosure is not limited thereto, and the valve can also be opened by means of a balloon or the like.
- the delivery device 100 includes a handle 110 and a catheter 120, the distal portion of the catheter 120 includes a receiving space in which the compressed prosthetic valve is placed, and the catheter 120 includes an outer tube and an inner tube, which are manipulated by The handle 110 can move the outer tube relative to the inner tube to release the prosthetic valve.
- the artificial valve is firstly reduced in diameter to a size that can be accommodated in the accommodating space, and the connecting ears of the first mesh segment are connected with the corresponding connecting mechanism on the inner tube of the delivery device, and the outer tube is moved to reduce the diameter
- the prosthetic valve is enclosed in the containment space.
- the prosthetic valve is delivered to the target location, for example, the right ventricle, through the delivery device, first by manipulating the handle, such as turning the handle, to move the outer tube proximally relative to the inner tube, thereby releasing the limiting segment, as shown in Figure 9,
- the conveyor is rotated as a whole to adjust the circumferential direction of the artificial valve, so that the "D"-shaped structure after the valve is released can correspond to the "D"-shaped annulus of the tricuspid valve.
- the inverted U-shaped structure of the limiting segment 13 will be in contact with the native valve leaflet 20 or the chordae tendineae to form a blocking limit.
- Manipulation of the handle of the delivery device is then continued to release the second mesh segment, which has an increased diameter jamming the tricuspid annulus and, where present, the barbs 14 piercing into the surrounding musculature.
- the above structure enables the artificial valve to have a better fixation effect at the tricuspid valve.
- the technical scheme of the present invention effectively solves the problems of the adaptability and circumferential positioning of the artificial valve and human organs.
- the avoidance gap can avoid the location of the coronary sinus ostium, and also ensure that the atrioventricular node is not compressed, and the blood flow from the coronary sinus will not be blocked to the right atrium.
- the first mesh segment 11 may be of regular shape, such as mesh, or may be of irregular shape. Also, the first mesh segment 11 has an escape gap.
- the avoidance gap can effectively avoid the coronary venous orifice, and the developing member 40 is arranged corresponding to the valve leaflet, so that the position of the developing member 40 can determine whether the position of the valve leaflet is properly placed.
- the cross-section of the second mesh segment 12 is “D”-shaped, including a D-shaped straight segment and an arc-shaped segment.
- the first mesh When viewed along the axial direction, the first mesh The avoidance gap of the grid segment is set at the connection between the straight segment and the arc segment of the "D" shape.
- the valve is "D" shaped, and the three valve leaflets 30 do not have to be exactly the same, and the shape of the valve leaflet on the straight side is different from the shape of the valve leaflet on the curved side.
- the barbs 14 By arranging the barbs 14 on the outer side wall of the stent 10, especially on the second mesh segment, when the heart valve (artificial valve) is released to the target position, it can penetrate into the tissue around the valve, thereby enhancing the fixation. effect. After the heart valve is released, the barbs 14 penetrate into the valve annulus of the human body, and are not easily displaced.
- the developing member may be provided only on the vertex corresponding to the D-shaped straight segment leading to the U-shaped structure, whereby the circumferential positioning of the prosthetic valve can be determined by the developing member during implantation .
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic 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
La présente invention concerne une valvule prothétique comprenant : une endoprothèse(10), l'endoprothèse (10) comprenant une première section de grille (11), une seconde section de grille (12) et une section de limitation (13) qui sont reliées l'une à l'autre, la seconde section de grille (12) étant située entre la première section de grille (11) et la section de limitation (13), la seconde section de grille (12) formant une structure en forme de tonneau d'une manière fermée, le diamètre de la première section de grille (11) augmentant dans la direction allant d'une position proche de la seconde section de grille (12) à une position éloignée de la seconde section de grille (12), et la section de limitation (13) ayant un bord orienté vers l'extérieur ; une membrane d'étanchéité (20), la membrane d'étanchéité (20) étant disposée sur l'endoprothèse (10) ; et un feuillet de valvule (30), le feuillet de valvule (30) étant disposé sur la seconde section de grille de façon à faire s'écouler un fluide dans la direction allant de la première section de grille (11) à la section de limitation (13). La valvule prothétique résout efficacement les problèmes du positionnement et de la fixation circonférentiels d'une valvule tricuspide d'intervention existante.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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CN202021521065.8 | 2020-07-28 | ||
CN202010738991.9 | 2020-07-28 | ||
CN202021521065.8U CN213963771U (zh) | 2020-07-28 | 2020-07-28 | 人工瓣膜 |
CN202010738991.9A CN113995554A (zh) | 2020-07-28 | 2020-07-28 | 人工瓣膜 |
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WO2022022574A1 true WO2022022574A1 (fr) | 2022-02-03 |
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PCT/CN2021/108949 WO2022022574A1 (fr) | 2020-07-28 | 2021-07-28 | Valvule prothétique |
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Cited By (1)
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CN114886615B (zh) * | 2022-05-09 | 2024-03-26 | 上海纽脉医疗科技股份有限公司 | 人工瓣膜及经导管人工瓣膜置换系统 |
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