CN113855332A - Integrated surgical mitral valve replacement system - Google Patents
Integrated surgical mitral valve replacement system Download PDFInfo
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- CN113855332A CN113855332A CN202111209190.4A CN202111209190A CN113855332A CN 113855332 A CN113855332 A CN 113855332A CN 202111209190 A CN202111209190 A CN 202111209190A CN 113855332 A CN113855332 A CN 113855332A
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- valve
- mitral valve
- replacement system
- surgical mitral
- saddle
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- 210000004115 mitral valve Anatomy 0.000 title claims abstract description 64
- 239000004744 fabric Substances 0.000 claims abstract description 11
- 239000007779 soft material Substances 0.000 claims abstract description 11
- 229910052751 metal Inorganic materials 0.000 claims description 16
- 239000002184 metal Substances 0.000 claims description 16
- 238000003780 insertion Methods 0.000 claims description 11
- 230000037431 insertion Effects 0.000 claims description 11
- 229910000990 Ni alloy Inorganic materials 0.000 claims description 9
- SZMZREIADCOWQA-UHFFFAOYSA-N chromium cobalt nickel Chemical compound [Cr].[Co].[Ni] SZMZREIADCOWQA-UHFFFAOYSA-N 0.000 claims description 9
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 9
- 239000011248 coating agent Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 claims description 7
- 238000005452 bending Methods 0.000 claims description 6
- 239000010935 stainless steel Substances 0.000 claims description 6
- 229910001220 stainless steel Inorganic materials 0.000 claims description 6
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 3
- 229920004934 Dacron® Polymers 0.000 claims 2
- 229920001296 polysiloxane Polymers 0.000 claims 1
- 230000017531 blood circulation Effects 0.000 abstract description 6
- 230000002861 ventricular Effects 0.000 abstract description 6
- 230000000903 blocking effect Effects 0.000 abstract description 5
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 230000001225 therapeutic effect Effects 0.000 abstract description 2
- 230000000694 effects Effects 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 229920004933 Terylene® Polymers 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 206010027727 Mitral valve incompetence Diseases 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 238000004873 anchoring Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 239000000741 silica gel Substances 0.000 description 2
- 229910002027 silica gel Inorganic materials 0.000 description 2
- 241001391944 Commicarpus scandens Species 0.000 description 1
- 241000446313 Lamella Species 0.000 description 1
- 208000011682 Mitral valve disease Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 208000016569 congenital mitral valve insufficiency Diseases 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 210000005240 left ventricle Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 208000005907 mitral valve insufficiency Diseases 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000004804 winding Methods 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
-
- 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
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A61F2/2448—D-shaped rings
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
Abstract
The present invention provides an integrated surgical mitral valve replacement system, comprising an outer stent and at least two surgical mitral valves disposed within the outer stent; the outer layer support is a saddle-shaped structure support with a D-shaped section, and the edge of the outer layer support is coated with a soft material layer; the surgical mitral valve comprises a valve seat, a valve frame and at least three biological tissue valve leaflets attached to the valve frame, wherein the valve seat, the valve leaflets and the valve frame are connected through a fabric layer coated on the valve frame. The integrated surgical mitral valve replacement system is beneficial to avoiding blocking the ventricular outflow tract and reducing the risk of being wound by chordae tendinae, the opening and closing of the system are not interfered by factors except blood flow, the requirement of a human body is met, and the overall therapeutic effect can be better.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to an integrated surgical mitral valve replacement system.
Background
Mitral regurgitation is the most common disease of mitral valve, and the treatment methods for patients with mitral regurgitation usually include two methods, namely repair and replacement, and repair is the first choice and the best method, but actually many dysfunctional valves cannot achieve the treatment effect by adopting the repair method, and at the moment, Mitral Valve Replacement (MVR) is needed.
CN109009569A discloses a prosthetic valve intervention replacement device for mitral insufficiency, which comprises a support and prosthetic valve leaflets, wherein the lower edge of the support is a cone-shaped structure with a "D" cross section, a plurality of stopping cables are arranged in the support, and the lower edge is connected with the prosthetic valve leaflets and can move along with the movement of the natural valve leaflets of a patient. The intervention replacement device does not influence the functions of a left ventricular outflow tract and an aortic valve, retains the functions of the natural valve leaflet of the mitral valve, drives the artificial valve leaflet and the natural valve leaflet to move in the same direction through natural blood flow, and can completely close the artificial valve leaflet in a contraction period to prevent the mitral valve from flowing backwards.
CN113180889A discloses a mitral valve replacement device and its using method, wherein the device involved comprises a stent for supporting artificial valve leaflets and anchors for anchoring the artificial valve leaflets to native valve leaflets, the stent is connected with a suture film by a suture thread, the stent is in a "D" type structure and is jointed with the native valve; the artificial valve leaflet is fixedly connected with the bracket, and the anchoring piece is used for jointing the artificial valve leaflet with the native valve leaflet; according to the invention, the artificial valve leaflet device with the support is conveyed to the native valve position through the conveying device, so that the regurgitation of the valve caused by incomplete closure and calcification is effectively avoided; can also be used for replacing native valves, has the effect of reducing the volume of the ventricles, improves the cardiac function and has important clinical significance.
As indicated above, MVR currently uses mitral valve products that are typically single-valved, regardless of the implant modality. The interventional mitral valve mainly comprises a memory alloy framework, biological tissue valve leaflets and fabric partially coated on metal, and the size of the mitral valve is larger, so that the size of a corresponding interventional mitral valve product is also larger. The metal frame adopted by the product is very light and thin, but the metal frame has larger size, so that the metal frame bears more stress, has insufficient durability and is easy to break or break down. In addition, the intervention mitral valve has a large size, so the intervention mitral valve has a large depth into the left ventricle part and is easy to be wound with chordae tendineae, thereby affecting the normal work and even causing the failure.
Disclosure of Invention
In view of the deficiencies of the prior art, it is an object of the present invention to provide an integrated surgical mitral valve replacement system. The integrated surgical mitral valve replacement system is beneficial to avoiding blocking the ventricular outflow tract and reducing the risk of being wound by chordae tendinae, the opening and closing of the system are not interfered by factors except blood flow, the requirement of a human body is met, and the overall therapeutic effect can be better.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present disclosure provides an integrated surgical mitral valve replacement system comprising an outer housing and at least two surgical mitral valves disposed within the outer housing;
the outer layer support is a saddle-shaped structure support with a D-shaped section, and the edge of the outer layer support is coated with a soft material layer;
the surgical mitral valve comprises a valve seat, a valve frame and at least three biological tissue valve leaflets attached to the valve frame, wherein the valve seat, the valve leaflets and the valve frame are connected through a fabric layer coated on the valve frame.
In the invention, the integrated surgical bivalve mitral valve is provided to replace a single implanted mitral valve, the valve is integrally D-shaped and more conforms to the natural shape of the mitral valve, and the D-shaped straight edge design can avoid blocking the ventricular outflow tract. The sum of the opening areas of the two smaller valves is slightly smaller than that of the single-valve mitral valve with the same specification, but the D-shaped design supports the opening and closing without being interfered by factors except blood flow, so that the requirement of a human body can be met, and a better treatment effect can be achieved overall. In particular, the integrated surgical mitral valve outer frame is D-shaped as a whole, and is closer to the shape of the native mitral valve, and the annular part combined with the valve ring is saddle-shaped and is more tightly attached to the native valve ring.
Preferably, both longitudinal ends of the outer layer bracket are bent upwards, and both transverse ends of the outer layer bracket are bent downwards to form a crossed double-arch curved surface structure.
Preferably, the radian of the upward bending is 120-180 °, for example, 120 °, 130 °, 140 °, 150 °, 160 °, 170 °, 180 °, and the like.
Preferably, the downward bending radian is 120-180 degrees, such as 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180 degrees and the like.
Preferably, the saddle-shaped structural support is a closed metal support integrally formed by a front saddle bridge, a saddle and a rear saddle bridge, the front saddle bridge is on one side of a D-shaped curved edge, and the rear saddle bridge is on one side of a D-shaped straight edge.
Preferably, the rear saddle bridge has a greater height than the front saddle bridge.
Preferably, the rear saddle bridge has a protrusion height of 5 to 10mm, for example, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc., and the front saddle bridge has a protrusion height of 1 to 5mm, for example, 1mm, 2mm, 3mm, 4mm, 5mm, etc.
Preferably, the saddle is provided with at least two insertion holes matching the surgical mitral valve.
Preferably, the insertion hole has a circular shape.
Preferably, the diameter of the insertion hole is 17 to 25mm, and may be, for example, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, or the like.
Preferably, the material of the outer layer bracket is metal, preferably cobalt-chromium-nickel alloy.
Preferably, the soft material layer is made of silica gel and/or terylene.
Preferably, the thickness of the soft material layer coating is 2 to 5mm, for example, 2mm, 3mm, 4mm, 5mm, etc., and the width of the edge coating is 3 to 8mm, for example, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, etc.
Preferably, the frame of the valve seat is a hollow cylindrical ring, the outer diameter of the cylindrical ring is matched with an insertion hole formed in the saddle, and the inner diameter of the cylindrical ring is 17-25 mm, and may be 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm and the like.
Preferably, the top end of the valve seat is a curved surface matched with a double-arch curved surface formed by the outer-layer support, and the bottom end of the valve seat is of a continuous U-shaped concave structure.
Preferably, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm, for example, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm and the like.
Preferably, the number of the continuous U-shaped concave structures is at least three.
Preferably, the number of the continuous U-shaped concave structures is three, and the included angle between the center lines of two adjacent flap ridges is 120 degrees.
Preferably, the valve seat is made of any one or a combination of at least two of PET, cobalt-chromium-nickel alloy and stainless steel.
Preferably, the petal frame is a continuous U-shaped concave structure wound by at least one metal sheet.
Preferably, the width of the metal sheet is 0.5 to 1mm, and may be, for example, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, or the like.
Preferably, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm, for example, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm and the like.
Preferably, the valve frame is an integrally formed closed structure.
Preferably, the number of the continuous U-shaped concave structures is three, and the included angle between the center lines of two adjacent flap ridges is 120 degrees.
Preferably, the valve frame is made of any one or a combination of at least two of nickel-titanium alloy, cobalt-chromium-nickel alloy and stainless steel.
Preferably, the valve leaflets are of cambered surface sheet structures, the edges of one section of the valve leaflets are sequentially butted and folded to form a valve structure, a small hole is formed in the center of the folded valve structure, and the convex surface of each valve leaflet faces the same side.
Preferably, the fabric layer is made of terylene and/or PTFE;
preferably, the thickness of the fabric layer coating is 0.2-1 mm, such as 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 1mm, etc.
Compared with the prior art, the invention has the following beneficial effects:
(1) the invention provides an integrated surgical bivalve mitral valve outer frame which is D-shaped as a whole and is more similar to the shape of a self-body mitral valve, and an annular part combined with an annulus is saddle-shaped and is more tightly attached to the self-body annulus;
(2) the invention provides an integrated surgical bivalve mitral valve, which replaces the implantation of a single mitral valve, the whole valve is D-shaped and more conforms to the natural shape of the mitral valve, and the design of a D-shaped straight edge can avoid blocking the ventricular outflow tract;
(3) compared with the opening area of a single-valve mitral valve with the same specification, the sum of the opening areas of the two smaller valves provided by the invention is slightly smaller, but the D-shaped design supports the opening and closing without being interfered by factors except blood flow, so that the requirement of a human body can be met, and a better treatment effect can be achieved overall.
Drawings
FIG. 1 is an assembled block diagram of an integrated surgical mitral valve replacement system provided by the present invention;
wherein, 1 is an outer layer bracket, 2 is a surgical mitral valve, and 3 is a soft material layer.
FIG. 2 is a schematic structural diagram of an outer stent provided by the present invention;
FIG. 3 is a top view of an outer stent provided by the present invention;
FIG. 4 is a front view of an outer stent provided by the present invention;
FIG. 5 is a right side view of an outer stent provided by the present invention;
wherein 11 is a front saddle bridge, 12 is a saddle, and 13 is a rear saddle bridge.
FIG. 6 is a schematic structural view of a surgical mitral valve provided in accordance with the present invention;
wherein 21 is a valve seat, 22 is a valve frame, and 23 is a valve leaf.
Fig. 7 is a schematic structural view of a petal seat provided by the present invention;
FIG. 8 is a top view of a petal seat provided by the present invention;
fig. 9 is a right side view of a valve seat provided by the present invention.
Fig. 10 is a schematic structural view of a petal frame provided by the present invention;
fig. 11 is a top view of a petal rack provided by the present invention;
fig. 12 is a front view of a petal rack provided by the present invention.
Fig. 13 is a schematic structural view of a leaflet provided by the present invention.
Detailed Description
It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.
It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.
The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.
In one embodiment, the present invention provides an integrated surgical mitral valve replacement system, as shown in fig. 1, comprising an outer stent 1 and at least two surgical mitral valves 2 disposed within the outer stent 1.
As shown in fig. 1, the outer layer bracket 1 is a saddle-shaped bracket with a D-shaped cross section, and the edge of the outer layer bracket 1 is covered with a soft material layer 3.
As shown in fig. 6, the surgical mitral valve includes a valve seat 21, a valve frame 22, and at least three biological tissue leaflets 23 attached to the valve frame, which are connected by a fabric layer coated on the valve frame.
In the invention, the integrated surgical bivalve mitral valve is provided to replace a single implanted mitral valve, the valve is integrally D-shaped and more conforms to the natural shape of the mitral valve, and the D-shaped straight edge design can avoid blocking the ventricular outflow tract. The sum of the opening areas of the two smaller valves is slightly smaller than that of the single-valve mitral valve with the same specification, but the D-shaped design supports the opening and closing without being interfered by factors except blood flow, so that the requirement of a human body can be met, and a better treatment effect can be achieved overall. In particular, the integrated surgical mitral valve outer frame is D-shaped as a whole, and is closer to the shape of the native mitral valve, and the annular part combined with the valve ring is saddle-shaped and is more tightly attached to the native valve ring.
Further, as shown in fig. 2, fig. 3, fig. 4, and fig. 5, the outer layer stent provided by the present invention has longitudinal ends bent upward and transverse ends bent downward to form a crossed double-arch curved surface structure.
It should be noted that as shown in fig. 3, the longitudinal direction refers to the y-axis direction shown in the drawings and the transverse direction refers to the x-axis direction shown in the drawings, which are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation and be operated, and thus should not be construed as limiting the present invention.
Preferably, the radian of the upward bending is 120-180 degrees.
Preferably, the downward bending radian is 120-180 degrees.
Further, as shown in fig. 2, 3, 4 and 5, the structure of the outer layer support provided by the invention is schematically illustrated, the saddle-shaped structure support is a closed metal support formed by integrally forming a front saddle bridge 11, a saddle 12 and a rear saddle bridge 13, the front saddle bridge 11 is on the side of a curved edge of a D shape, and the rear saddle bridge 13 is on the side of a straight edge of the D shape.
It should be noted that, as shown in fig. 3, the front saddle bridge 11 is the curved side of the D-shape, projecting outward, and the rear saddle bridge 13 is the straight side of the D-shape, and the references to "front saddle bridge" and "rear saddle bridge" are only for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention.
Further, the height h of the rear saddle bridge 3 is set2Is greater than the height h of the front saddle bridge 11。
It should be noted that, as shown in fig. 4, the rear saddle bridge 3 is clearly visible from a front view, which means that the height of the projection of the rear saddle bridge 3 is greater than that of the front saddle bridge 1, so that it can be seen from this angle.
Further, fig. 5 is a right side view of the outer layer bracket provided by the present invention, as shown in fig. 5, the height h of the protrusion of the rear saddle bridge25-10 mm, the height h of the front saddle bridge1Is 1-5 mm.
Further, at least two insertion holes matching the surgical mitral valve are provided on the saddle 12.
Further, the shape of the insertion hole is circular.
Preferably, the diameter of the embedding hole is 17-25 mm (OD).
It should be noted that, as shown in fig. 3, the saddle 12 is provided with two circular insertion holes having a certain diameter to match the surgical mitral valve, but the shape is not limited to a circle, i.e., the insertion holes are matched in shape and size to the surgical mitral valve, and the number is not limited to two. It can be understood that the number of surgical mitral valves implanted into the outer stent can be appropriately adjusted according to the actual situation in the present invention.
Further, the outer layer bracket is made of metal, preferably cobalt-chromium-nickel alloy.
Further, the soft material layer 3 is made of silica gel and/or terylene.
Furthermore, the thickness of the soft material layer 3 coating is 2-5 mm, and the width of the edge coating is 3-8 mm.
Further, the frame of lamella seat is hollow cylinder ring, the external diameter of cylinder ring and the embedding hole phase-match that sets up on the saddle, the internal diameter of cylinder ring is 17 ~ 25 mm.
Further, fig. 7, 8, and 9 are schematic diagrams of various angles of the structure of the flap seat provided by the present invention, as shown in fig. 7-9, the top end of the flap seat 21 is a curved surface matched with the double-bow-shaped curved surface formed by the outer layer support, the bottom end is a continuous U-shaped concave structure, and the whole frame is a hollow cylindrical ring.
It should be noted that, as shown in fig. 7, 8 and 9, the top end of the valve seat 21 refers to one end of the curved ring, the bottom end of the valve seat 21 refers to one end of the continuous U-shaped concave structure, and the "top end" and "bottom end" are only used for convenience of describing and simplifying the present invention, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.
Further, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm.
Further, the number of the continuous U-shaped concave structures is at least three.
Further, the number of the continuous U-shaped concave structures is three, and the included angle between the center lines of two adjacent petal ridges is 120 degrees.
Further, the valve seat is made of any one or a combination of at least two of PET, cobalt-chromium-nickel alloy and stainless steel.
Further, fig. 10, fig. 11, and fig. 12 are schematic diagrams of various angles of the structure of the petal seat provided by the present invention, and as shown in fig. 10 to 12, the petal frame 22 is a continuous U-shaped concave structure formed by winding at least one metal sheet.
Further, the width of the metal sheet is 0.5-1 mm.
Further, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm.
Further, the valve frame 22 is an integrally formed closed structure.
Further, the number of the continuous U-shaped concave structures is three, and the included angle between the center lines of two adjacent petal ridges is 120 degrees.
Further, the valve frame 22 is made of any one or a combination of at least two of nickel-titanium alloy, cobalt-chromium-nickel alloy, and stainless steel.
Further, fig. 13 is a schematic structural view of the leaflet provided by the present invention, the leaflet 13 is a cambered sheet-shaped structure, the edges of one section of the leaflet 13 are sequentially butted and folded to form a valve structure, a small hole is formed in the center of the folded valve structure, and the convex surface of each leaflet 13 faces to the same side.
Further, the fabric layer is made of terylene and/or PTFE.
Preferably, the thickness of the fabric layer coating is 0.2-1 mm.
The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.
Claims (10)
1. An integrated surgical mitral valve replacement system comprising an outer stent and at least two surgical mitral valves disposed within the outer stent;
the outer layer support is a saddle-shaped structure support with a D-shaped section, and the edge of the outer layer support is coated with a soft material layer;
the surgical mitral valve comprises a valve seat, a valve frame and at least three biological tissue valve leaflets attached to the valve frame, wherein the valve seat, the valve leaflets and the valve frame are connected through a fabric layer coated on the valve frame.
2. The integrated surgical mitral valve replacement system of claim 1, wherein the outer stent has longitudinal ends that curve upward and transverse ends that curve downward to form an intersecting double-arcuate curved structure;
preferably, the radian of the upward bending is 120-180 degrees;
preferably, the downward bending radian is 120-180 degrees.
3. The integrated surgical mitral valve replacement system of claim 1 or 2, wherein the saddle-shaped structural support is a closed metal support integrally formed by a front saddle bridge, a saddle, and a rear saddle bridge, the front saddle bridge being on one side of the curved side of the D-shape, the rear saddle bridge being on one side of the straight side of the D-shape;
preferably, the height of the rear saddle bridge is greater than the height of the front saddle bridge;
preferably, the height of the bulge of the rear saddle bridge is 5-10 mm, and the height of the bulge of the front saddle bridge is 1-5 mm;
preferably, the saddle is provided with at least two insertion holes matched with the surgical mitral valve;
preferably, the insertion hole is circular in shape;
preferably, the diameter of the embedding hole is 17-25 mm.
4. An integrated surgical mitral valve replacement system according to any of claims 1-3, wherein the outer stent is made of a metal, preferably cobalt-chromium-nickel alloy.
5. The integrated surgical mitral valve replacement system of any one of claims 1-4, wherein the soft material layer is made of silicone and/or dacron.
6. The integrated surgical mitral valve replacement system of any one of claims 1-5, wherein the soft material layer wrap has a thickness of 2-5 mm and an edge wrap width of 3-8 mm.
7. The integrated surgical mitral valve replacement system of any one of claims 1 to 6, wherein the frame of the valve seat is a hollow cylindrical ring having an outer diameter matching an insertion hole provided on the saddle, and an inner diameter of 17 to 25 mm;
preferably, the top end of the valve seat is a curved surface matched with a double-arch curved surface formed by the outer-layer bracket, and the bottom end of the valve seat is of a continuous U-shaped sunken structure;
preferably, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm;
preferably, the number of the continuous U-shaped concave structures is at least three;
preferably, the number of the continuous U-shaped concave structures is three, and the included angle between the central lines of two adjacent petal ridges is 120 degrees;
preferably, the valve seat is made of any one or a combination of at least two of PET, cobalt-chromium-nickel alloy and stainless steel.
8. The integrated surgical mitral valve replacement system of any of claims 1-7, wherein the valve frame is a continuous U-shaped concave structure wound from at least one sheet of metal;
preferably, the width of the metal sheet is 0.5-1 mm;
preferably, the depths of the continuous U-shaped concave structures are respectively and independently 8-15 mm;
preferably, the valve frame is an integrally formed closed structure;
preferably, the number of the continuous U-shaped concave structures is three, and the included angle between the central lines of two adjacent petal ridges is 120 degrees;
preferably, the valve frame is made of any one or a combination of at least two of nickel-titanium alloy, cobalt-chromium-nickel alloy and stainless steel.
9. The integrated surgical mitral valve replacement system of any one of claims 1-8, wherein the leaflets are in the shape of curved sheets, the edges of a segment of the leaflets are sequentially butted together to form a valve structure, the center of the valve structure after being butted together forms a small hole, and the convex surface of each leaflet faces the same side.
10. The integrated surgical mitral valve replacement system of any of claims 1-9, wherein the fabric layer is made of dacron and/or PTFE;
preferably, the thickness of the fabric layer coating is 0.2-1 mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111209190.4A CN113855332A (en) | 2021-10-18 | 2021-10-18 | Integrated surgical mitral valve replacement system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111209190.4A CN113855332A (en) | 2021-10-18 | 2021-10-18 | Integrated surgical mitral valve replacement system |
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| CN113855332A true CN113855332A (en) | 2021-12-31 |
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| US20080154359A1 (en) * | 2001-11-01 | 2008-06-26 | Salgo Ivan S | Non-planar cardiac vascular support prosthesis |
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| CN102105101A (en) * | 2008-05-09 | 2011-06-22 | 爱德华兹生命科学公司 | Degenerative valvular disease specific annuloplasty rings |
| CN105764447A (en) * | 2013-12-11 | 2016-07-13 | 雪松-西奈医学中心 | Methods, devices and systems for transcatheter mitral valve replacement in a double-orifice mitral valve |
| US20190029815A1 (en) * | 2017-07-27 | 2019-01-31 | Kar Health, LLC | Transcatheter Mitral Valve Prosthesis |
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2021
- 2021-10-18 CN CN202111209190.4A patent/CN113855332A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080154359A1 (en) * | 2001-11-01 | 2008-06-26 | Salgo Ivan S | Non-planar cardiac vascular support prosthesis |
| CN101217920A (en) * | 2005-07-13 | 2008-07-09 | 爱德华兹生命科学公司 | Prosthetic mitral heart valve having a contoured sewing ring |
| US20090259292A1 (en) * | 2008-04-08 | 2009-10-15 | Medtronic, Inc. | Multiple Orifice Implantable Heart Valve and Methods of Implantation |
| CN102105101A (en) * | 2008-05-09 | 2011-06-22 | 爱德华兹生命科学公司 | Degenerative valvular disease specific annuloplasty rings |
| CN105764447A (en) * | 2013-12-11 | 2016-07-13 | 雪松-西奈医学中心 | Methods, devices and systems for transcatheter mitral valve replacement in a double-orifice mitral valve |
| US20190029815A1 (en) * | 2017-07-27 | 2019-01-31 | Kar Health, LLC | Transcatheter Mitral Valve Prosthesis |
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