CN113768660A - Prosthetic heart valve and prosthetic heart valve system - Google Patents
Prosthetic heart valve and prosthetic heart valve system Download PDFInfo
- Publication number
- CN113768660A CN113768660A CN202010523677.9A CN202010523677A CN113768660A CN 113768660 A CN113768660 A CN 113768660A CN 202010523677 A CN202010523677 A CN 202010523677A CN 113768660 A CN113768660 A CN 113768660A
- Authority
- CN
- China
- Prior art keywords
- valve
- heart valve
- prosthetic heart
- valve frame
- cells
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 210000003709 heart valve Anatomy 0.000 title claims abstract description 59
- 239000008280 blood Substances 0.000 abstract description 8
- 210000004369 blood Anatomy 0.000 abstract description 8
- 230000006835 compression Effects 0.000 abstract description 8
- 238000007906 compression Methods 0.000 abstract description 8
- 230000009471 action Effects 0.000 abstract description 4
- 208000007536 Thrombosis Diseases 0.000 abstract description 3
- 102000004169 proteins and genes Human genes 0.000 abstract description 3
- 108090000623 proteins and genes Proteins 0.000 abstract description 3
- 210000001519 tissue Anatomy 0.000 description 10
- 230000037303 wrinkles Effects 0.000 description 10
- 239000000463 material Substances 0.000 description 8
- 230000000903 blocking effect Effects 0.000 description 4
- 210000003516 pericardium Anatomy 0.000 description 4
- 229920000139 polyethylene terephthalate Polymers 0.000 description 4
- 239000005020 polyethylene terephthalate Substances 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 238000009958 sewing Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- -1 Polyethylene Terephthalate Polymers 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 230000004323 axial length Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 238000009998 heat setting Methods 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 210000004115 mitral valve Anatomy 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
Images
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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (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
The invention relates to a heart valve prosthesis and a heart valve prosthesis system, wherein the heart valve prosthesis comprises a valve frame and at least one protruding structure, the protruding structure comprises a protruding part, the protruding part is arranged on the valve frame and protrudes towards the outer side of the valve frame, and the protruding part is constructed to form folds when being radially compressed. After the artificial heart valve is implanted into a human body, the bulge part in the bulge structure is correspondingly contacted with the autologous valve ring, the bulge part can generate radial compression action on the bulge part by the autologous valve ring, folds formed by the bulge part are contacted with the autologous valve ring, contact points between the bulge part and the inner wall of the autologous valve ring can be increased, adherence can be improved, the size of a gap formed between the bulge part and the autologous valve ring is reduced, the flow rate of blood flowing through the gap can be reduced, protein in the blood is deposited at the gap to form thrombus to seal the gap, and further the valve periphery leakage is prevented.
Description
Technical Field
The invention relates to the field of interventional medical devices, in particular to a prosthetic heart valve and a prosthetic heart valve system.
Background
Heart valve disease has become one of the most common cardiovascular diseases today, and while thousands of patients worldwide can benefit from surgical valve replacement surgery every year, a large number of patients are still not amenable to surgical treatment due to advanced, and numerous complications of valve disease.
The above disadvantages can be overcome by intervention of artificial valve operation. In 2002, the Cribier et al implant the stent with the artificial valve into the diseased aortic valve position of the human body, so that the hemodynamics of the postoperative patient is obviously improved, and the life quality is improved. In recent years, with the continuous improvement of interventional instruments and the accumulation of related experience, interventional heart valve stents are beginning to be applied to cases where surgery is not appropriate, such as aortic valves, pulmonary valves, mitral valves, tricuspid valves, and the like.
As shown in fig. 1, the conventional prosthetic heart valve 10 includes a valve frame 11 and an outer skirt 13 covering the valve frame 11. In order to adapt to the physiological shape of the native valve annulus (the native valve annulus is approximately circular), the portion of the valve frame 11 contacting the native valve annulus is set in a cylindrical state. The valve frame 11 is made of a material with shape memory, so that the valve frame 11 has self-expansion property, and the valve frame 11 is self-expanded and unfolded after being released from the sheath. The valve frame 11 has a plurality of meshes for easy packing into the sheath after compression.
After the artificial heart valve 10 is implanted into a human body, the valve frame 11 is unfolded under the self-expansion force, due to the mesh openings on the valve frame 11, the material of the valve frame 11 is not continuous in the 360-degree circumferential direction, further, only a plurality of supporting points 111 of the valve frame 11 are used for radially supporting the outer skirt 13, and the unfolded outer skirt 13 is only contacted with the inner wall of the autologous valve annulus at the positions of the supporting points 111. Since the native valve annulus is substantially circular in shape, the outer skirt 13 forms a chord of the circle, and very severe paravalvular leakage exists between the outer skirt 13 and the native valve annulus.
Disclosure of Invention
Based on this, there is a need for a prosthetic heart valve, which at least solves the problem of perivalvular leakage easily occurring after the prosthetic heart valve is implanted in the prior art.
In one embodiment, a prosthetic heart valve is provided, including a valve frame and at least one protruding structure, the protruding structure including a protrusion, the protrusion being disposed on the valve frame and protruding outward of the valve frame, the protrusion being configured to form a pleat when radially compressed.
In one embodiment, the number of the convex structures is multiple, and the convex parts of the convex structures can move independently under the action of external radial force.
In one embodiment, the valve frame is provided with meshes, the bulges protrude out of the meshes, and the bulges cover the outer sides of the meshes protruded by the bulges.
In one embodiment, the prosthetic heart valve further comprises an outer skirt, the outer skirt covers the outer side surface of the valve frame, and at least part of the outer skirt protrudes out of the outer side surface of the valve frame to form a protruding part.
In one embodiment, the outer skirt is at least partially connected with the valve frame, the part of the outer skirt connected with the valve frame is a connecting part, and two adjacent bulges are connected through the connecting part.
In one embodiment, the valve frame comprises a plurality of circles of annular grid structures which are axially connected, the protruding structure comprises an elastic part, one end of the elastic part is connected with the annular grid structures, the other end of the elastic part extends to the outer side of the valve frame to abut against the inner side face of the protruding part, the elastic part is connected with the protruding part, and the elastic part can elastically deform inwards when being compressed in the radial direction.
In one embodiment, the annular grid structure comprises a plurality of unit cells, the unit cells are annularly connected to form the annular grid structure, the elastic element is connected with the axial end parts of the unit cells, and the orthographic projection of the unit cells surrounds the orthographic projection of the elastic element in a projection plane parallel to the central axis plane of the annular grid structure.
In one embodiment, the number of the protruding structures is multiple, wherein at least one protruding structure comprises a plurality of elastic members, one part of the elastic members is connected with the near end of the unit cell, the other part of the elastic members is connected with the far end of the unit cell, and when the elastic members are in a compressed state, the axial distance is reserved between the elastic members connected with the near end of the unit cell and the elastic members connected with the far end of the unit cell.
In one embodiment, the number of the protruding structures is multiple, wherein at least one protruding structure comprises a plurality of elastic members, one part of the elastic members is connected with the near end of the unit cell, the other part of the elastic members is connected with the far end of the unit cell, and when the unit cell is in a compressed state, the elastic members connected with the near end of the unit cell and the elastic members connected with the far end of the unit cell have circumferential spacing and do not have axial spacing.
In one embodiment, a prosthetic heart valve system is also provided, the prosthetic heart valve system including a delivery apparatus releasably coupled to the prosthetic heart valve, and the prosthetic heart valve described above.
The bulge of foretell artificial heart valve implantation outwards bulges in the lateral surface of valve frame, the bulge is constructed and can forms the fold when receiving radial compression, after artificial heart valve implantation human body, bulge and autologous valve ring in the bulge structure correspond the contact, because the external diameter of bulge is greater than the internal diameter of autologous valve ring in the artificial heart valve, the bulge can receive autologous valve ring to its radial compression effect that produces, the fold that the bulge formed contacts with autologous valve ring, can increase the contact point of bulge and autologous valve ring inner wall, adherence can improve, and reduce the size of the clearance that forms between bulge and the autologous valve ring, can reduce the velocity of flow that blood flows through this clearance, protein in the blood deposits and forms the thrombus in clearance department can carry out the shutoff to the clearance, and then prevent the valve periphery and leak.
Drawings
Fig. 1 is a state diagram of a prior art prosthetic heart valve implantation.
Fig. 2 is a perspective view of a prosthetic heart valve according to a first embodiment of the present invention.
FIG. 3 is a schematic cross-sectional view of a heart valve prosthesis according to a first embodiment of the present invention
Fig. 4 is a perspective view of the flap frame and the elastic member in the first embodiment of the present invention.
Fig. 5 is a perspective view of the annular lattice structure and the elastic member in the first embodiment of the present invention.
Fig. 6 is a schematic structural view of the projection structure and the unit cell in a compressed state according to the first embodiment of the present invention.
Fig. 7 is a schematic sectional view along a-a of fig. 6.
FIG. 8 is a perspective view of a leaflet of the first embodiment of the invention
Fig. 9 is a schematic view of a second embodiment of the present invention showing a structure in which the projection structure and the unit cell are in a compressed state.
Fig. 10 is a schematic sectional structure view along B-B of fig. 9.
Fig. 11 is a schematic structural view of a third embodiment of the present invention with a projection structure and a unit cell in a compressed state.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
The axial direction refers to the direction parallel to the connecting line of the center of the far end and the center of the near end of the medical instrument; the radial direction means a direction perpendicular to the axial direction.
After the prosthetic heart valve is implanted in a human body, blood flow flows along the axial direction of the prosthetic heart valve, defining a flow of blood from the proximal end of the prosthetic heart valve to the distal end of the prosthetic heart valve.
First embodiment
Referring to fig. 2 and 3, an embodiment of the invention provides a prosthetic heart valve 30, which includes a valve frame 31, at least one protrusion structure 33, an inner skirt 35, and a valve leaflet 37.
The inner skirt 35 is fixed to the frame of the cell 312 by sewing, and the inner skirt 35 is located inside the valve frame 31, and the inner skirt 35 may be a flow blocking member made of flow blocking materials such as PET (Polyethylene Terephthalate), PTFE (polytetrafluoroethylene), and the like.
The profile of the distal end of the inner skirt 35 is trimmed according to the profile of the distal end of the valve frame 31, and the profile of the proximal end of the inner skirt 35 may be trimmed according to the profile of the proximal end of the valve frame 31 or may be a plain end.
Referring to fig. 4 and 5, the valve frame 31 is made of a material with shape memory, the valve frame 31 includes a plurality of circles of axially connected annular grid structures 311, and a plurality of meshes 313 are formed on the annular grid structures 311 of the valve frame 31. When the valve frame 31 is subjected to radial compression force, the valve frame can contract inwards and deform to a compression state; after the radial compression force is removed, the valve frame 31 can be restored to its natural state under the action of its own expansion force. The valve frame 31 has an outer diameter larger than the inner diameter of the native valve annulus 21 in the natural state.
The annular grid structure 311 includes a plurality of unit cells 312, the unit cells 312 are connected in an annular manner (i.e., connected in a circumferential direction) to form a complete annular grid structure 311, the unit cells 312 may be rhombus, rectangle, or other closed polygonal frames, and the through holes surrounded by the frames of the unit cells 312 are the above-mentioned mesh holes 313. The number of the unit cells 312 in the annular grid structure 311 may be 6 to 18, the number of the unit cells 312 in the annular grid structure 311 of the present embodiment is 12, and the shape of the unit cells 312 is a diamond shape. When the valve frame 31 is manufactured, the valve frame 31 can be processed by performing laser cutting on the shape memory alloy tube (such as a nickel-titanium alloy tube) and then performing heat setting and other processes, so that the structure of the valve frame 31 meets expectations.
The convex structure 33 is arranged on the valve frame 31, the convex structure 33 is arranged at the proximal end of the valve frame 31, and after the artificial heart valve 30 is implanted, the convex structure 33 is abutted against the native valve annulus 21. Of course, in other embodiments, the protruding structure 33 may be disposed at other positions of the valve frame 31, such as the middle or the distal end of the valve frame 31, as long as the protruding structure 33 abuts against the native annulus 21 after the prosthetic heart valve 30 is implanted.
In one embodiment, the number of the protruding structures 33 is multiple, each protruding structure 33 is arranged along the circumferential direction, and the number of the protruding structures 33 may be 6-18. In this embodiment, the number of the protruding structures 33 is the same as the number of the cells 312 in a single annular grid structure 311, the protruding structures 33 are connected to the cells 312 in a one-to-one correspondence, the number of the protruding structures 33 is 12, and each protruding structure 33 is disposed on the same annular grid structure 311 (i.e., on the same circumference). Of course, in other embodiments, the number of the convex structures 33 may be only one.
The protruding structure 33 in this embodiment is substantially in the shape of a quadrangular pyramid, the protruding structure 33 includes a protruding portion 331 and an elastic member 335, the protruding portion 331 is located outside the elastic member 335, and the protruding portion 331 forms an outer contour of the protruding structure 33.
The protruding portion 331 is disposed on the valve frame 31, the protruding portion 331 can be disposed on the outer side surface or the inner side surface of the valve frame 31, the protruding portion 331 protrudes toward the outer side of the valve frame 31, and the protruding portion 331 in this embodiment is disposed on the outer side surface of the valve frame 31. Referring to fig. 6 and 7, the protrusions 331 are configured to form pleats 332 when radially compressed. When the prosthetic heart valve 30 is implanted in a human body, the protrusion 33 abuts against the native valve annulus 21, and the protrusion 331 of the protrusion 33 abuts against the native valve annulus 21. Because the outer diameter of the convex part 331 of the artificial heart valve 30 is larger than the inner diameter of the autologous valve annulus 21, the convex part 331 can be compressed radially by the autologous valve annulus 21, the folds 332 formed by the convex part 331 are contacted with the autologous valve annulus 21, the contact point of the convex part 331 and the inner wall of the autologous valve annulus 21 can be increased, and the adherence can be improved. Compared with the prior art, the size of the gap formed between the convex part 331 and the autologous valve ring 21 can be reduced, so that the flow velocity of blood at the gap can be reduced, and the gap can be blocked by depositing nutrient substances such as protein in the blood and forming thrombus at the gap, thereby preventing paravalvular leakage.
When the radial external force acts, the protrusions 331 of the protrusion structures 33 can move independently, so that the adjacent protrusions 331 can be prevented from being linked with each other, even if a certain protrusion 331 is not radially compressed, the protrusion 331 cannot be linked with the adjacent protrusion 331, and further the protrusion 331 which is not radially compressed drives the adjacent protrusion 331 to radially expand relative to the outer surface of the valve frame 31, so that the protrusion 331 is better attached to the tissue wall of the autologous valve annulus 21.
The number of the protruding portions 331 may be 6-18, in this embodiment, each protruding structure 33 includes one protruding portion 331, the number of the protruding portions 331 is the same as the number of the unit cells 312, and the number of the protruding portions 331 is 12.
The bulge 331 protrudes out of the mesh 313, the bulge 331 covers the outside of the mesh 313 protruded by the bulge, when the bulge 33 is pressed inward in the radial direction, the fold 332 formed by compressing the bulge 331 is accommodated in the mesh 313, so that the outer side surface of the bulge 331 after compression deformation is consistent with the outer side surface of the valve frame 31, a gap between the artificial heart valve 30 and the tissue wall of the autologous valve annulus 21 can be avoided, and further the perivalvular leakage is prevented. In contrast, when the prosthetic heart valve 30 is implanted, the tissue wall of the native valve annulus 21 compresses the protrusion 331 in the radial direction, and if the outer side surface of the protrusion 331 protrudes outward from the outer side surface of the valve frame 31, a gap is formed between the valve frame 31 and the tissue wall of the native valve annulus 21, which may result in perivalvular leakage. Note that the outer side surface of the wrinkle 332 is an arc surface where the outermost portion (e.g., the portion indicated by the outer tip in fig. 7) is located. Note also that the outer side surface of the substance attached to the substrate has the same outer surface as the substrate, for example, if a film structure is attached to the outer surface of the valve frame 31, the film structure has an attachment portion attached to the valve frame 31, and the outer surface of the attachment portion can be regarded as the same as the outer surface of the valve frame 31.
The prosthetic heart valve 30 also includes an outer skirt 34, and the outer skirt 34 may be a flow blocking member made of a flow blocking material such as PET, PTFE, or the like. In this embodiment, the outer skirt 34 is made of PET, the outer skirt 34 covers the outer side of the valve frame 31, and at least a portion of the outer skirt 34 protrudes out of the outer side of the valve frame 31 to form the protruding portion 331. The outer skirt 34 is at least partially connected to the valve frame 31, the connecting portion 341 of the outer skirt 34 to the valve frame 31, and any two adjacent protrusions 331 are connected by the connecting portion 341. The connection portion 341 may be connected to the valve frame 31 by a suture 336 so that the connection portion 341 is attached to the valve frame 31. The connection portion 341 may space the two adjacent protrusions 331 so that radial movements of the two adjacent protrusions 331 do not interlock with each other. It is to be noted that the suture in this embodiment is not shown in fig. 2 and 3, but only in fig. 6.
Referring to fig. 6 to 7 again, in the present embodiment, each of the protrusion structures 33 includes a plurality of elastic members 335, and the elastic members 335 and the protruding portions 331 are disposed in a one-to-one correspondence. Of course, in other embodiments, the number of the elastic members 335 in each of the protruding structures 33 may be multiple, for example, the number of the elastic members 335 in each of the protruding structures 33 is two, three or more. In addition, in other embodiments, the number of the elastic members 335 in one part of the protruding structure 33 may be one, and the number of the elastic members 335 in another part of the protruding structure 33 may be multiple, and the "multiple" may be two or more.
One end of the elastic member 335 is connected to the annular mesh structure 311, the other end of the elastic member 335 extends to the outside of the valve frame 31 and abuts against the inner side surface of the protrusion 331, the elastic member 335 can be connected to the protrusion 331 through a suture 337, the elastic member 335 can elastically deform inward when being radially compressed, the elastic member 335 can provide elastic force, when the protrusion 331 is radially compressed and deformed inward and forms a wrinkle 332, the elastic member 335 elastically deforms in the radial direction, so that the elastic member 335 guides the protrusion 331 to be radially compressed, the protrusion 331 is prevented from greatly swinging in the circumferential direction during deformation, the protrusion 331 is ensured to deform in the radial direction, the protrusion 331 is further enabled to form a uniform wrinkle 332 in the circumferential direction, and a large gap between a local area of the outer skirt 332 and a tissue wall due to non-uniform wrinkle 332 can be avoided. And, the elastic force provided by the elastic member 335 can also make the protrusion 331 closely fit with the tissue wall of the native valve annulus 21.
The elastic member 335 is connected to an axial end (i.e., a proximal end or a distal end) of the unit cell 312, in this embodiment, the elastic member 335 is connected to the distal end of the unit cell 312, and in other embodiments, the elastic member 335 may be connected to the proximal end of the unit cell 312. In a projection plane parallel to a central axis plane of the annular grid structure 311, an orthographic projection of the unit cell 312 surrounds an orthographic projection of the elastic member 335, so that when the elastic member 335 is subjected to a radial compressive force, the elastic member can be elastically deformed to be located in a mesh 313 surrounded by the annular grid structure 311, and then a wrinkle 332 formed by the bulge 331 can be brought into the mesh 313 of the unit cell 312, a frame of the unit cell 312 presses the wrinkle 332, so that the wrinkle 332 is more compact, and the function of preventing the leakage around the valve is achieved. Under the co-extrusion action of the elastic element 335 and the tissue wall of the native valve annulus 21, the outer side surface of the wrinkle 332 and the outer side surface of the valve frame 31 can be located on the same peripheral surface, that is, the wrinkle 332 and the valve frame 31 have the same outer side surface, so that a gap between the tissue wall of the native valve annulus 21 and the valve frame 31 or the wrinkle 332 can be avoided, and the valve periphery leakage can be prevented.
Referring to fig. 8, the number of the leaflets 37 is 3, the structure and shape of each leaflet 37 are the same, and the leaflets 37 are connected end to end and uniformly distributed on the inner side of the valve frame 31. The leaflet 37 has a fixed edge 371 and a free edge 373, wherein the fixed edge 371 is fixed to the distal ends of the inner skirt 35 and the valve frame 31 by sewing, the free edge 373 is not fixed by sewing and can be opened and closed angularly, and the leaflet 37 mainly functions as a one-way valve to allow blood to flow from the proximal end to the distal end and prevent blood from flowing from the distal end to the proximal end. The material of the valve leaflet 37 is a biological tissue material, such as porcine pericardium, bovine pericardium, equine pericardium, ovine pericardium, porcine heart valve, etc., and may also be a polymer material and a tissue engineering material.
Second embodiment
The number of the projection structures 43 in the second embodiment is plural, wherein at least one projection structure 43 includes plural elastic members 435, and a part of the plural elastic members 435 of the projection structure 43 is connected to the proximal end of the unit cell, and another part of the plural elastic members 435 is connected to the distal end of the unit cell. In the compressed state, the resilient members 435 associated with the proximal ends of the cells are axially spaced from the resilient members 435 associated with the distal ends of the cells such that the raised structures 43 are radially compressed and may create circumferentially extending corrugations.
The number of the elastic members 435 of each projection structure 43 is illustrated as two. Specifically, referring to fig. 9 and 10, in the present embodiment, the number of the elastic members 435 of each protruding structure 43 is two. Of course, in other embodiments, the number of the elastic members 435 of only the partially protruding structure 43 may be two. In addition, in other embodiments, the number of "plurality of elastic members 435" may be 3, 4, or more.
In this embodiment, in one of the convex structures 43, one of the elastic members 435 is connected to the proximal end of the cell, the other elastic member 435 is connected to the distal end of the cell, the two elastic members 435 are axially opposite, and in a compressed state, there is an axial gap between the two elastic members 435, the convex structure can not only form an axial fold 432a, but also form a circumferentially extending fold 432b at the axial gap, and the extending direction of the fold 432b is perpendicular to the blood flow direction, which is beneficial for preventing the paravalvular leakage of the heart valve prosthesis 30. In addition, the extra folds 432a and 432b added on the outer side surface of the valve frame 31 can also increase the stress points of the prosthetic heart valve 30, so as to increase the radial supporting force and stability of the prosthetic heart valve 30.
In the natural state, the opening angle formed by the tangent of the elastic member 435 and the axis of the valve frame ranges from 15 ° to 60 °, and the opening angle in this embodiment is 30 °.
Third embodiment
The third embodiment differs from the second embodiment in that the raised structures 53 may create curved, extending corrugations 532 in the compressed state with circumferential spacing between the resilient members 535 associated with the proximal ends of the cells 312 and the resilient members 535 associated with the distal ends of the cells 312 and no axial gap between the resilient members 535. It should be noted that the two elastic members 535 do not have axial clearance, which means that the free end of one elastic member 535 is located within the axial length of the other elastic member 535.
Referring to fig. 11, in the present embodiment, the sum of the lengths of the two elastic members 535 is greater than the axial length of the mesh 313, so that the two elastic members 535 have no axial gap, the ends of the two elastic members 535 are disposed away from each other, and when in a compressed state, the convex structures 53 can form a curve-extending fold 532 between the two elastic members 535, and the curve-extending fold 532 is beneficial to the prosthetic heart valve 30 to prevent paravalvular leakage.
Fourth embodiment
The present embodiment also provides a prosthetic heart valve system including a transporter (not shown) releasably coupled to the prosthetic heart valve 30, and the prosthetic heart valve 30 described above.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. A prosthetic heart valve, comprising a valve frame and at least one raised structure, the raised structure comprising a projection, the projection being located on the valve frame, and projecting outward of the valve frame, the projection being configured to form a pleat when radially compressed.
2. The prosthetic heart valve of claim 1, wherein the number of raised structures is a plurality, the projections of each raised structure being independently movable when subjected to a radially external force.
3. The prosthetic heart valve of claim 1, wherein the valve frame has a mesh formed thereon, the protrusion protruding outside the mesh and covering the outside of the mesh that is protruded therefrom.
4. The prosthetic heart valve of claim 1, further comprising an outer skirt covering an outer side of the valve frame, the outer skirt at least partially protruding from the outer side of the valve frame to form the protrusion.
5. The prosthetic heart valve of claim 4, wherein the outer skirt is at least partially connected to the valve frame, and the portion of the outer skirt connected to the valve frame is a connecting portion, and two adjacent protrusions are connected by the connecting portion.
6. The prosthetic heart valve of claim 1, wherein the valve frame comprises a plurality of axially connected rings of lattice structures, the protrusion structure further comprises an elastic member, one end of the elastic member is connected to the ring lattice structure, the other end of the elastic member extends to the outside of the valve frame to abut against the inner side of the protrusion, the elastic member is connected to the protrusion, and the elastic member is elastically deformable inward when being radially compressed.
7. The prosthetic heart valve of claim 6, wherein the annular lattice structure comprises a plurality of unit cells annularly connected to form the annular lattice structure, the resilient member being connected to axial ends of the unit cells, an orthographic projection of the unit cells encompassing an orthographic projection of the resilient member in a plane of projection parallel to a central axis plane of the annular lattice structure.
8. The prosthetic heart valve of claim 6, wherein the number of raised structures is a plurality, wherein at least one of the raised structures comprises a plurality of resilient members, wherein a portion of the resilient members of the plurality of resilient members are connected to the proximal ends of the cells and another portion of the resilient members are connected to the distal ends of the cells, and wherein in a compressed state, the resilient members connected to the proximal ends of the cells are axially spaced from the resilient members connected to the distal ends of the cells.
9. The prosthetic heart valve of claim 6, wherein the number of raised structures is a plurality, wherein at least one of the raised structures comprises a plurality of resilient members, wherein a portion of the plurality of resilient members are connected to the proximal ends of the cells and another portion of the plurality of resilient members are connected to the distal ends of the cells, and wherein in a compressed state the resilient members connected to the proximal ends of the cells are circumferentially spaced from and axially spaced from the resilient members connected to the distal ends of the cells.
10. A prosthetic heart valve system, comprising a delivery device and a prosthetic heart valve according to any one of claims 1 to 9, the delivery device being releasably connectable to the prosthetic heart valve.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010523677.9A CN113768660A (en) | 2020-06-10 | 2020-06-10 | Prosthetic heart valve and prosthetic heart valve system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010523677.9A CN113768660A (en) | 2020-06-10 | 2020-06-10 | Prosthetic heart valve and prosthetic heart valve system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113768660A true CN113768660A (en) | 2021-12-10 |
Family
ID=78834583
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010523677.9A Pending CN113768660A (en) | 2020-06-10 | 2020-06-10 | Prosthetic heart valve and prosthetic heart valve system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113768660A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114081677A (en) * | 2021-11-16 | 2022-02-25 | 上海臻亿医疗科技有限公司 | Artificial heart valve |
| WO2024141005A1 (en) * | 2022-12-30 | 2024-07-04 | 元心科技(深圳)有限公司 | Prosthetic heart valve |
Citations (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130018458A1 (en) * | 2011-07-15 | 2013-01-17 | Edwards Lifesciences Corporation | Perivalvular sealing for transcatheter heart valve |
| US20140222144A1 (en) * | 2013-02-01 | 2014-08-07 | Medtronic CV Luxembourg S.a.r.l | Anti-Paravalvular Leakage Component for a Transcatheter Valve Prosthesis |
| US20140236287A1 (en) * | 2013-02-21 | 2014-08-21 | Medtronic, Inc. | Transcatheter Valve Prosthesis and a Concurrently Delivered Sealing Component |
| US20140277427A1 (en) * | 2013-03-14 | 2014-09-18 | Cardiaq Valve Technologies, Inc. | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
| WO2014164832A1 (en) * | 2013-03-12 | 2014-10-09 | Edwards Lifesciences Corporation | Rapidly deployable surgical heart valves |
| US20150005863A1 (en) * | 2013-06-26 | 2015-01-01 | St. Jude Medical, Cardiology Division, Inc. | Puckering Seal for Reduced Paravalvular Leakage |
| CN105188609A (en) * | 2013-03-15 | 2015-12-23 | 西美蒂斯股份公司 | Improvements relating to transcatheter stent-valves |
| US20160030170A1 (en) * | 2013-03-12 | 2016-02-04 | St. Jude Medical, Cardiology Division, Inc. | Self-actuating sealing portions for a paravalvular leak protection |
| CN108601656A (en) * | 2016-02-12 | 2018-09-28 | 爱德华兹生命科学公司 | Prosthetic heart valve with Multi-layer sealing component |
| US20190046314A1 (en) * | 2017-08-11 | 2019-02-14 | Edwards Lifesciences Corporation | Sealing element for prosthetic heart valve |
| CN109419572A (en) * | 2017-09-04 | 2019-03-05 | 杭州启明医疗器械股份有限公司 | A kind of anti-week leakage holder device and processing method, skirt corrugation method, heart valve with overlay film |
| CN111050700A (en) * | 2017-09-08 | 2020-04-21 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
| CN111132635A (en) * | 2017-08-17 | 2020-05-08 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
| CN111163727A (en) * | 2017-08-03 | 2020-05-15 | 卡迪尔维尔福股份有限公司 | Artificial heart valve |
-
2020
- 2020-06-10 CN CN202010523677.9A patent/CN113768660A/en active Pending
Patent Citations (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130018458A1 (en) * | 2011-07-15 | 2013-01-17 | Edwards Lifesciences Corporation | Perivalvular sealing for transcatheter heart valve |
| US20140222144A1 (en) * | 2013-02-01 | 2014-08-07 | Medtronic CV Luxembourg S.a.r.l | Anti-Paravalvular Leakage Component for a Transcatheter Valve Prosthesis |
| US20140236287A1 (en) * | 2013-02-21 | 2014-08-21 | Medtronic, Inc. | Transcatheter Valve Prosthesis and a Concurrently Delivered Sealing Component |
| WO2014164832A1 (en) * | 2013-03-12 | 2014-10-09 | Edwards Lifesciences Corporation | Rapidly deployable surgical heart valves |
| US20160030170A1 (en) * | 2013-03-12 | 2016-02-04 | St. Jude Medical, Cardiology Division, Inc. | Self-actuating sealing portions for a paravalvular leak protection |
| US20140277427A1 (en) * | 2013-03-14 | 2014-09-18 | Cardiaq Valve Technologies, Inc. | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
| CN105188609A (en) * | 2013-03-15 | 2015-12-23 | 西美蒂斯股份公司 | Improvements relating to transcatheter stent-valves |
| US20150005863A1 (en) * | 2013-06-26 | 2015-01-01 | St. Jude Medical, Cardiology Division, Inc. | Puckering Seal for Reduced Paravalvular Leakage |
| CN108601656A (en) * | 2016-02-12 | 2018-09-28 | 爱德华兹生命科学公司 | Prosthetic heart valve with Multi-layer sealing component |
| CN111163727A (en) * | 2017-08-03 | 2020-05-15 | 卡迪尔维尔福股份有限公司 | Artificial heart valve |
| US20190046314A1 (en) * | 2017-08-11 | 2019-02-14 | Edwards Lifesciences Corporation | Sealing element for prosthetic heart valve |
| CN111132635A (en) * | 2017-08-17 | 2020-05-08 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
| CN109419572A (en) * | 2017-09-04 | 2019-03-05 | 杭州启明医疗器械股份有限公司 | A kind of anti-week leakage holder device and processing method, skirt corrugation method, heart valve with overlay film |
| CN111050700A (en) * | 2017-09-08 | 2020-04-21 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114081677A (en) * | 2021-11-16 | 2022-02-25 | 上海臻亿医疗科技有限公司 | Artificial heart valve |
| WO2023087817A1 (en) * | 2021-11-16 | 2023-05-25 | 上海臻亿医疗科技有限公司 | Prosthetic heart valve |
| WO2024141005A1 (en) * | 2022-12-30 | 2024-07-04 | 元心科技(深圳)有限公司 | Prosthetic heart valve |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11696826B2 (en) | Low profile transcatheter heart valve | |
| US11464629B2 (en) | Atrial pocket closures for prosthetic heart valves | |
| EP2079400B1 (en) | Sutureless heart valve attachment | |
| US10537424B2 (en) | Paravalvular leak protection | |
| CN112351751B (en) | artificial heart valve | |
| US20200085573A1 (en) | Valve anchor and installation method | |
| US6045576A (en) | Sewing ring having increased annular coaptation | |
| US8062359B2 (en) | Highly flexible heart valve connecting band | |
| US11202708B2 (en) | Segmented, growth-accommodating, artificial valve | |
| CN113768660A (en) | Prosthetic heart valve and prosthetic heart valve system | |
| US20240358501A1 (en) | Prosthetic cardiac valve delivery devices, systems, and methods | |
| WO2023144673A1 (en) | Valve skirts for prosthetic devices |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20231221 Address after: 518000 1604, Xianjian technology building, No. 22, Keji South 12th Road, gaoxinyuan community, Yuehai street, Nanshan District, Shenzhen, Guangdong Province Applicant after: Shenzhen Jianxin Medical Technology Co.,Ltd. Address before: 518000 1st-5th Floor of Saiba Research Building, Langshan Second Road, North District of Nanshan High-tech Industrial Park, Shenzhen City, Guangdong Province Applicant before: LIFETECH SCIENTIFIC (SHENZHEN) Co.,Ltd. |
|
| TA01 | Transfer of patent application right |