CN113855333A - Split type valve support reaches intervention mitral valve replacement system including it - Google Patents
Split type valve support reaches intervention mitral valve replacement system including it Download PDFInfo
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- CN113855333A CN113855333A CN202111211090.5A CN202111211090A CN113855333A CN 113855333 A CN113855333 A CN 113855333A CN 202111211090 A CN202111211090 A CN 202111211090A CN 113855333 A CN113855333 A CN 113855333A
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- frame
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- shaped
- mitral valve
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- 210000004115 mitral valve Anatomy 0.000 title claims abstract description 101
- 229910052751 metal Inorganic materials 0.000 claims abstract description 89
- 239000002184 metal Substances 0.000 claims abstract description 89
- 210000005240 left ventricle Anatomy 0.000 claims abstract description 29
- 210000005246 left atrium Anatomy 0.000 claims abstract description 17
- 238000011161 development Methods 0.000 claims description 16
- 239000000463 material Substances 0.000 claims description 12
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 11
- 239000004744 fabric Substances 0.000 claims description 10
- QNRATNLHPGXHMA-XZHTYLCXSA-N (r)-(6-ethoxyquinolin-4-yl)-[(2s,4s,5r)-5-ethyl-1-azabicyclo[2.2.2]octan-2-yl]methanol;hydrochloride Chemical compound Cl.C([C@H]([C@H](C1)CC)C2)CN1[C@@H]2[C@H](O)C1=CC=NC2=CC=C(OCC)C=C21 QNRATNLHPGXHMA-XZHTYLCXSA-N 0.000 claims description 6
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 claims description 6
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 claims description 6
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 claims description 6
- 238000012800 visualization Methods 0.000 claims description 6
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 4
- 238000003466 welding Methods 0.000 claims description 4
- 238000002513 implantation Methods 0.000 description 9
- 230000017531 blood circulation Effects 0.000 description 8
- 230000000694 effects Effects 0.000 description 8
- 238000000034 method Methods 0.000 description 8
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 6
- 230000002861 ventricular Effects 0.000 description 6
- 238000013461 design Methods 0.000 description 5
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 4
- 239000000956 alloy Substances 0.000 description 4
- 230000008602 contraction Effects 0.000 description 4
- 210000001105 femoral artery Anatomy 0.000 description 4
- 229910000684 Cobalt-chrome Inorganic materials 0.000 description 2
- 229920004934 Dacron® Polymers 0.000 description 2
- 206010027727 Mitral valve incompetence Diseases 0.000 description 2
- 206010067171 Regurgitation Diseases 0.000 description 2
- 239000010952 cobalt-chrome Substances 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000010247 heart contraction Effects 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
- 210000003492 pulmonary vein Anatomy 0.000 description 2
- 238000007142 ring opening reaction Methods 0.000 description 2
- 241001391944 Commicarpus scandens Species 0.000 description 1
- 208000011682 Mitral valve disease Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
Images
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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
- 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
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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
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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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
- 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
- A61F2/2442—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
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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
- 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
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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
- 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
- A61F2/2466—Delivery devices therefor
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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
- 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
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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
- 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
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a split-type valve stent and an interventional mitral valve replacement system comprising the same. The split valve support comprises an outer frame and an inner frame which is arranged inside the outer frame and matched with the outer frame; the outer frame comprises a cylindrical outer metal frame with a kidney-shaped section, one end of the outer metal frame is outwards folded along the circumferential direction to form a support ring, and at least one hook is arranged at the kidney-shaped recess at the other end of the outer metal frame; the inner frame comprises a cylindrical inner metal frame with a kidney-shaped section, two X-shaped crossed connecting wires are arranged at one end of the inner metal frame, and the interface of the end of the inner metal frame is cut into a shape of 8 by the two connecting wires; the outer frame is under the expansion form, and the one side that is provided with the support ring is detained in the valve ring of left atrium one side in reverse, and the one side that is provided with the crotch stretches into the left ventricle, the inner frame is under the expansion form, and the one side that is not provided with the connecting wire is towards the left atrium, and the one side that is provided with the connecting wire stretches into the left ventricle.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a split type valve stent and an interventional mitral valve replacement system comprising the same.
Background
Mitral regurgitation is the most common disease of mitral valve, and the treatment method for patients with mitral regurgitation usually includes two methods, namely repair and replacement, and repair is the first choice and the best method, but when the repair method is not enough to achieve the treatment effect, mitral valve replacement is still needed, and if the patient cannot perform surgery again under the condition of the patient, Transcatheter Mitral Valve Replacement (TMVR) is needed.
At present, the mitral valve through a catheter is designed into a single valve, and mainly comprises a memory alloy frame, biological tissue valve leaflets attached to the memory alloy frame, and fabric partially covering metal, and the size of the mitral valve is large, so that the corresponding interventional mitral valve product is also large in size, and the turning part is difficult to operate, so that the metal frame adopted by the product is very light and thin, but the metal frame is large in size, so that the stress borne by the metal frame is large, the durability is insufficient, and the metal frame is easy to break or break. 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.
CN212522085U discloses a mitral valve stent, comprising: the inner support is internally connected with the artificial biological valve leaf; the outer bracket is connected and sleeved outside the inner bracket; the skirt edge is wrapped and connected on the inner support; the upper end and/or the lower end of the combination of the inner support and the skirt edge are/is provided with hollows; the utility model discloses a mitral valve support, be the fretwork when the upper end of the combination of inner support and shirt rim, can be used for guaranteeing unobstructed of the pulmonary vein export blood flow of left atrium, move down the inner support, when making the upper end of inner support not more than the valve ring, the part of the lower extreme protrusion outer support after inner support and the shirt rim combination this moment will block left ventricle outflow tract, lower extreme design after combining inner support and shirt rim is the fretwork, can be used to ensure unobstructed of left ventricle outflow tract, consider unobstructed and the pulmonary vein export blood flow of left atrium of guarantee left ventricle outflow tract unobstructed simultaneously unobstructed, can avoid the blood flow to be obstructed, more be applicable to through pipe mitral valve replacement.
CN113349987A discloses a mitral valve intervention valve and delivery system, wherein the intervention valve includes a valve frame, a valve skirt and valve leaflets, the valve skirt is fixedly covered on the inner wall of the valve frame, the valve leaflets are connected to the valve skirt, and in the opened state of the valve frame, an eversion structure is formed at one end of the valve frame. The intervention valve further comprises an adjusting structure, one end of the adjusting structure is fixed on the valve frame or the valve skirt, and the other end of the adjusting structure is an operating end and used for adjusting the implantation position of the mitral valve intervention valve through external force traction. It can be further adjusted the implantation state through adjusting the structure after implanting to the position of implanting of guaranteeing to intervene the valve can effectively match with the valve ring, prevents that the perivalvular from leaking. In addition, the operation end of adjusting the structure can be fixed in the apex of the heart to can produce the effect of holding down all the time to intervene the valve, and structure such as cooperation barb guarantees to intervene the reliable cooperation of valve and valve ring, avoids intervene the valve to the direction drunkenness of atrium and to lose efficacy with the valve ring cooperation and lead to the valve to leak all around.
Based on the above research, it can be seen that the valve stent, as a device commonly used in TMVR, can provide positioning and support for TMVR, achieving the effect of treating MR. However, valve stents are at risk of shifting and fail to meet the subsequent TMVR techniques. Therefore, it is of great practical significance to find a valve stent which provides a good positioning and fixing base for the intervention of mitral valve implantation.
Disclosure of Invention
In view of the deficiencies of the prior art, it is an object of the present invention to provide a split-type valve stent and an interventional mitral valve replacement system including the same. The split valve stent sequentially implants components from femoral artery or apex of heart to a target position through a catheter, after combination and fixation, a good positioning and fixing foundation is provided for the implantation of an interventional mitral valve, in addition, the size of the implanted interventional mitral valve is smaller due to the double-valve design, the sum of effective opening areas can meet the requirements of a human body, and the operation is easier.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the invention provides a split-type valve stent, which comprises an outer frame and an inner frame which is arranged inside the outer frame and matched with the outer frame;
the outer frame comprises a cylindrical outer metal frame with a kidney-shaped section, one end of the outer metal frame is outwards folded along the circumferential direction to form a support ring, and at least one hook is arranged at the kidney-shaped recess at the other end of the outer metal frame;
the inner frame comprises a cylindrical inner metal frame with a kidney-shaped section, two X-shaped crossed connecting wires are arranged at one end of the inner metal frame, and the interface of the end of the inner metal frame is cut into a shape of 8 by the two connecting wires;
the outer frame is under the expansion form, and the one side that is provided with the support ring is detained in the valve ring of left atrium one side in reverse, and the one side that is provided with the crotch stretches into the left ventricle, the inner frame is under the expansion form, and the one side that is not provided with the connecting wire is towards the left atrium, and the one side that is provided with the connecting wire stretches into the left ventricle.
In the invention, the split type interventional bivalve mitral valve device consists of an outer frame and an inner frame matched with the outer frame from outside to inside, wherein the outer frame is made of memory metal, after the outer frame is expanded, one end which is turned over (namely one end of the outer metal frame is turned outwards along the circumferential direction to form a support ring) can be reversely buckled on the valve ring at one side of the left atrium, the other side metal frame part extends into the left ventricle, and the cross section of the valve ring opening is overlooked from the inflow side of the mitral valve to be kidney-shaped (which can be observed by overlooking). The inner frame can also be called as a connecting frame, is connected with the outer frame and is used for supporting and fixing a subsequently implanted intervention mitral valve, the shape of the cylindrical frame part of the inner frame is consistent with that of the metal frame part of the outer frame extending into the left ventricle, and the outer side of the frame is provided with a part of barbs facing the left atrium side for increasing friction and preventing falling off; two metal wires extending from one end of the outflow side of the mitral valve are intersected in an X shape to divide the section of the orifice of the valve at the outflow side into 8 shapes, thereby providing a good positioning and fixing foundation for the subsequent implantation of the interventional mitral valve.
Preferably, the material of the outer frame is memory metal, preferably nickel-titanium alloy.
The invention can adjust the size of the outer frame and the inner frame at will by adopting the memory alloy material, the frame is always in the contraction device in the process of implanting the frame, and the frame is released after reaching the target position, and the bracket can be quickly expanded from the contraction state to abut against the ventricular wall.
Preferably, the outer frame is a hollow-out net structure, preferably a honeycomb-shaped regular hexagonal hollow-out net structure.
Preferably, in the outer frame, the outward-folding forming support ring is in a plane structure or a saddle-shaped structure.
Preferably, in the outer frame, an included angle between the everted support ring and the cylindrical outer metal frame is 90-160 degrees, and may be 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees and the like, for example.
Preferably, in the outer frame, the width of the support ring is 4-10 mm, and may be 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc.
Preferably, the radian of the inner concavity of the outer frame is 100-160 degrees, and the radian can be 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees and the like.
Preferably, in the outer frame, the hook is arranged at the intersection of two regular hexagons at the other end of the outer metal frame, is concave along with the concave side of the kidney shape, and is bent towards one side of the support ring.
Preferably, the outer frame is provided with at least one development site, preferably 2-10, and may be, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.
Preferably, in the outer frame, the visualization point is arranged on a side of the outer frame extending into the left ventricle.
Preferably, the number of the developing points arranged in the outer frame is 4, two developing points are arranged on the inward concave side and two developing points are arranged on the outward convex side of the tubular outer metal frame with the kidney-shaped section.
Preferably, the material of the outer frame development point comprises platinum-iridium alloy and/or tantalum metal.
Preferably, the part of the inner frame where the two connecting wires intersect in the X shape is a welding section, and the length of the welding section is 1-3mm, and may be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, etc.
Preferably, the material of the connecting wire is memory metal, preferably nickel-titanium alloy.
Preferably, the inner metal frame is a hollow mesh structure, preferably a rhombic hollow mesh structure.
Preferably, at least one barb type anchor is obliquely arranged on the outer peripheral surface of the inner metal frame.
Preferably, in the inner frame, the overhead anchor is provided at the apex of the diamond-shaped mesh structure, and only one overhead anchor is provided at the apex of the interconnected diamond-shaped mesh structure.
Preferably, in the inner frame, the barb type anchor is spike-shaped and is disposed obliquely upward toward the left atrium side.
Preferably, the angle of inclination of the barb anchor is 70-90 °, for example, 70 °, 75 °, 80 °, 85 °, 90 °, and the like.
Preferably, the length of the barb anchor is 5-8mm, and may be, for example, 5mm, 5.5mm, 6mm, 6.5mm, 7mm, 7.5mm, 8mm, or the like.
Preferably, the inner frame is provided with at least one development site corresponding to the position of the outer metal frame, preferably 2-10, and may for example be 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.
Preferably, the visualization point is provided on the side of the inner frame that protrudes into the left ventricle.
Preferably, the number of the developing points arranged in the inner frame is 4, two developing points are arranged on the inward concave side and two developing points are arranged on the outward convex side of the tubular inner metal frame with the kidney-shaped cross section.
Preferably, the material of the inner frame development point comprises platinum-iridium alloy and/or tantalum metal.
In a second aspect, the present invention provides an interventional mitral valve replacement system comprising a split-valve stent according to the first aspect and at least two interventional mitral valves.
Preferably, the interventional mitral valve comprises a strut frame, wherein an annular flanging structure is arranged on the edge of one side of the strut frame, is arranged on the outflow side of the valve implanted in the body, and reversely buckles the split valve support from one side of the left ventricle; and at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric.
In the invention, the annular flanging structure is arranged on the edge of at least one side of the strut frame, so that the traditional mode of obliquely arranging an anchor at the periphery of a metal frame is replaced, the firmness of intervention in the mitral valve can be further improved, and the problem of valve falling and displacement caused by overhigh pressure on the outflow side of the closed mitral valve during heart contraction is prevented. And the interventional mitral valve can be sequentially implanted into two interventional mitral valves with smaller sizes through a catheter when TMVR is needed due to poor annuloplasty ring repair effect, so that a single larger interventional mitral valve is replaced, and due to the smaller size, the metal frame can be firmer than the single interventional mitral valve, the part entering the left ventricle is less than the single interventional mitral valve, the sum of the opening areas of the two smaller valves can be ensured to meet the requirement of a human body, and a better treatment effect can be achieved.
In the invention, the valve outflow side refers to the side from which blood flows out of the valve, and the metal frame at the end is provided with an annular flanging structure which can be used for reversely buckling the valve bracket from the left ventricle side so as to prevent the valve from falling and shifting caused by the pressure on the closed mitral valve outflow side during the heart contraction.
Preferably, in the interventional mitral valve, the annular cuff structure is a metal ring with an arc.
Preferably, the metal ring is made of nickel-titanium alloy and/or cobalt-chromium alloy.
Preferably, the flanging radian of the metal ring is 50-80 degrees, and the flanging radian can be 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees and the like.
Preferably, the inner diameter of the metal ring is the same as the inner diameter of the strut frame, and the outer diameter of the metal ring is 21-27mm, for example, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, etc.
Preferably, in the interventional mitral valve, the annular flange structure is a flange-like structure and is connected with the edge of the strut frame in an interference fit manner.
Preferably, the interventional mitral valve has a dilation pattern that includes bulbing or self-dilation.
Preferably, the interventional mitral valve is expanded in a ball-expanding manner, the strut frame is made of cobalt-chromium metal, and the size of the stent can be adjusted at will so that the stent is released after reaching a target position and is quickly expanded to abut against the ventricular wall.
Preferably, the interventional mitral valve is self-expandable, and the strut frame is made of a memory alloy material, preferably nitinol, and the size of the stent can be adjusted at will so that the stent is released after reaching the target position, and is rapidly expanded to abut against the ventricular wall.
Preferably, in the interventional mitral valve, the strut frame is a straight cylindrical metal frame having a continuous mesh structure.
Preferably, in the interventional mitral valve, the inner diameter of the strut frame is 18-24mm, such as 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, etc., and the height of the strut frame is 12-15mm, such as 12mm, 13mm, 14mm, 15mm, etc.
Preferably, in the interventional mitral valve, the lattice structure is a diamond-shaped lattice.
Preferably, in the interventional mitral valve, the area of the diamond-shaped mesh is 15-45mm2For example, it may be 15mm2、20mm2、25mm2、30mm2、35mm2、40mm2、45mm2And the like.
The invention designs the grid shape of the metal frame intervening in the mitral valve into a continuous rhombic net structure with proper size so as to improve the strength and the supporting force of the inner layer bracket and avoid the fracture of the inner layer bracket caused by insufficient strength and supporting force.
Preferably, in the interventional mitral valve, the fabric comprises dacron and/or PTFE.
Preferably, the fabric is wrapped inside the strut frame in the interventional mitral valve.
Preferably, in the interventional mitral valve, the thickness of the fabric is 0.1-0.5mm, and may be, for example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, and the like.
Preferably, in the intervention mitral valve, the edges of the valve leaflets are sequentially butted and folded to form a plane, and a small hole is formed in the center of the folded valve structure.
Preferably, in the interventional mitral valve, the aperture of the small hole is 1.5mm or less, and may be, for example, 1.5mm, 1.2mm, 1.0mm, 0.8mm, 0.5mm, 0.1mm, or the like.
In the present invention, the leaflet structure of the intervening mitral valve is effective in preventing regurgitation.
Compared with the prior art, the invention has the following beneficial effects:
the invention provides a split type interventional bivalve mitral valve device, wherein components are implanted into a target position from a femoral artery or an apex of the heart in sequence through a catheter, and after combination and fixation, a good positioning and fixing foundation is provided for the implantation of the interventional mitral valve.
Drawings
FIG. 1 is a schematic structural diagram of a split-type valve stent provided by the invention, which comprises an outer frame;
FIG. 2 is a top view of a split-type valve stent provided by the present invention including an outer frame;
FIG. 3 is a side view of a split-type valve stent provided by the present invention including an outer frame;
wherein 11 is an outer metal frame, 12 is a support ring, 13 is a hook, and 14 is an outer frame developing point.
FIG. 4 is a schematic structural diagram of a split-type valve stent provided by the invention, which comprises an inner frame;
FIG. 5 is a top view of a split-type valve stent provided by the present invention including an inner frame;
FIG. 6 is a side view of a split-valve stent including an inner frame provided by the present invention;
wherein 21 is an inner metal frame, 22 is a connecting wire, 23 is an inverted hook type anchor, and 24 is an inner frame developing point.
FIG. 7 is a schematic structural view of an interventional mitral valve replacement system provided by the present invention;
wherein, 1 is the outer frame, 2 is the inner frame, and 3 is the intervention mitral valve.
FIG. 8 is a schematic view of the structure of an interventional mitral valve provided by the present invention;
wherein 31 is a strut frame, 32 is an annular flanging structure, and 33 is a biological tissue valve leaflet.
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 a split-type valve stent comprising an outer frame 1 (as shown in fig. 1, 2, and 3) and a matching inner frame 2 (as shown in fig. 4, 5, and 6) disposed inside the outer frame.
As shown in fig. 1 to 3, the outer frame 1 includes a cylindrical outer metal frame 11 having a kidney-shaped cross section, one end of the outer metal frame 11 is folded outward in the circumferential direction to form a support ring 12, and at least one hook 13 is provided in a kidney-shaped recess at the other end of the outer metal frame 11.
As shown in fig. 4 to 6, the inner frame 2 includes a cylindrical inner metal frame 21 having a kidney-shaped cross section, one end of the inner metal frame 21 is provided with two connecting wires 22 intersecting in an X-shape, and the two connecting wires 22 cut the interface of the one end of the inner metal frame into a figure 8.
The outer frame 1 is in a unfolding state, one side provided with the support ring 12 is reversely buckled with an annulus on one side of the left atrium, one side provided with the hook 13 extends into the left ventricle, one side provided with no connecting wire faces the left atrium, and one side provided with the connecting wire 22 extends into the left ventricle.
It should be noted that, as shown in fig. 1, the split type interventional bivalve mitral valve device of the present invention is composed of an outer frame 1 and an inner frame 2 matched with the outer frame from outside to inside; after the outer frame 1 is self-expanded, one end of the folded outer frame (i.e. one end of the outer metal frame is folded outwards along the circumferential direction to form a support ring) can be reversely buckled on the valve ring on one side of the left atrium, the other side of the metal frame extends into the left ventricle, and the cross section of the valve ring opening is in a kidney shape when viewed from the inflow side of the mitral valve (i.e. the side where blood flows from the valve) in a top view (as the top view provided by fig. 2, the kidney-shaped cross section at the center can be directly observed). In particular, the kidney-shaped concave design can well reduce the tilting effect of the stent to the outflow tract. The hook 13 can hook the valve leaf on one side of the outflow channel and is concave along with the support.
It should be noted that, as shown in fig. 4, the inner frame 2 may also be referred to as a connecting frame, which connects the outer frame 1 and is used for supporting and fixing the subsequently implanted interventional mitral valve 3, a cylindrical frame portion (inner metal frame 21) of the connecting frame is consistent with a shape of a metal frame portion of the outer frame extending into the left ventricle (can be embedded into the outer frame in a matching manner), two metal wires extending from one end of the valve outflow side (i.e. the side from which blood flows out of the valve) of the inner frame 1 intersect in an X shape, so as to divide the orifice cross section of the valve on the outflow side into 8 shapes, thereby providing a good positioning and fixing base for the subsequent implantation of the interventional mitral valve 3.
Further, the material of the outer frame 1 is a memory metal, preferably a nickel-titanium alloy.
It should be noted that the invention can adjust the size of the outer frame and the inner frame at will by adopting the memory alloy material, the frame is always in the contraction device in the implantation process, and when the frame is released after reaching the target position, the bracket can be quickly opened from the contraction state to prop against the ventricular wall.
Further, the outer frame 1 has a hollow-out mesh structure, preferably a honeycomb-shaped regular hexagonal hollow-out mesh structure.
Further, the everting forming support ring 12 is of a planar or saddle-shaped configuration.
Furthermore, the included angle between the everted support ring 12 and the cylindrical outer metal frame is 90-160 degrees.
Further, the width of the support ring 12 is 4-10 mm.
Furthermore, the radian of the inner recess of the outer frame 1 is 100-160 degrees.
Further, the hook 13 is arranged at the intersection of two regular hexagons at the other end of the outer metal frame 11, is concave with the side of the kidney-shaped recess, and is bent toward the side of the support ring 12.
As a preferred solution of the invention, the outer frame is provided with at least one development site 14, preferably 2-10.
Further, the visualization point 14 is disposed on a side of the outer frame 1 that protrudes into the left ventricle.
Further, as shown in fig. 1 to 3, the number of the developing points 14 provided in the outer frame 1 is 4, and two are provided on the concave side and two are provided on the convex side of the cylindrical outer metal frame 11 having a kidney-shaped cross section.
It should be noted that, as shown in fig. 1 to fig. 3, the positions of the development points 14 are based on the orientations or positional relationships shown in the drawings, and only for the convenience of describing the present invention and simplifying the description, 4 development points are provided, as long as two of the front and rear are satisfied, so as to facilitate the positioning direction of the barb D-type anchor bracket, rather than indicating or suggesting that the device or element to be referred must have a specific orientation.
Further, the material of the outer frame development point 14 includes platinum-iridium alloy and/or tantalum metal.
Further, in the inner frame 2, the portion where the two connecting wires 22 intersect in the X shape is a welded section having a length of 1 to 3 mm.
Further, the connecting wire 22 is made of memory metal, preferably nitinol.
Further, the inner metal frame 21 is a hollow mesh structure, preferably a rhombic hollow mesh structure.
Further, at least one barb type anchor 23 is obliquely arranged on the outer peripheral surface of the inner metal frame 21.
Further, the barb type anchors 23 are disposed at the vertexes of the diamond-shaped mesh structure, and only one barb type anchor 23 is disposed at the vertexes of the diamond-shaped mesh structure connected with each other.
Further, the barb type anchor 23 is spike-shaped and is disposed obliquely upward toward the left atrium side.
Further, the angle of inclination of the barb anchor 23 is 70-90 °.
Further, the length of the barb type anchor 23 is 5-8 mm.
Further, the inner frame 2 is provided with at least one developing point 24 corresponding to the position of the outer metal frame, preferably 2-10.
Further, the visualization point 24 is provided on the side of the inner frame 2 that protrudes into the left ventricle.
Further, as shown in fig. 4 to 6, the number of the developing points 24 provided in the inner frame 2 is 4, and two are provided on the inner concave side and two are provided on the outer convex side of the tubular inner metal frame 21 having the kidney-shaped cross section.
It should be noted that, as shown in fig. 4 to 6, the positions of the inner frame development points 24 are based on the orientation or positional relationship shown in the drawings, and only for convenience of describing the present invention and simplifying the description, 4 development points are provided as long as two development points are satisfied, and the corresponding positioning with the outer frame development points is satisfied, rather than indicating or suggesting that the designated device or component must have a specific orientation.
Further, the material of the inner frame development point 24 includes platinum-iridium alloy and/or tantalum metal.
In another embodiment, the present invention provides an interventional mitral valve replacement system, which is configured as shown in fig. 7, and comprises the split-type valve stent and at least two interventional mitral valves 3, wherein the split-type valve stent comprises an outer frame 1 and a matching inner frame 2 disposed inside the outer frame.
Further, the structure of the intervention mitral valve 3 is as shown in fig. 8, the intervention mitral valve 3 includes a pillar frame 31, an annular flange structure 32 is arranged on an edge of one side of the pillar frame 31, the annular flange structure 32 is arranged on a valve outflow side after being implanted in a body, and the split-type valve stent is buckled from a left ventricle side; at least three biological tissue valve leaflets 33 are arranged inside the strut frame 31, and the valve leaflets 33 are connected with the strut frame 31 through fabric.
It should be noted that, as shown in fig. 8, the metal frame at the end of the inflow side of the valve (i.e. the side from which blood flows in) may be optionally provided with an annular flange structure 32, which can be used to buckle the valve holder from the left atrium side to the opposite direction, so as to prevent the valve from being displaced toward the left ventricle due to the pressure generated when blood flows in from the open mitral valve to the side during diastole. And the interventional mitral valve can be sequentially implanted into two interventional mitral valves with smaller sizes through a catheter when TMVR is needed due to poor annuloplasty ring repair effect, so that a single larger interventional mitral valve is replaced, and due to the smaller size, the metal frame can be firmer than the single interventional mitral valve, the part entering the left ventricle is less than the single interventional mitral valve, the sum of the opening areas of the two smaller valves can be ensured to meet the requirement of a human body, and a better treatment effect can be achieved.
Further, in the interventional mitral valve 3, the annular cuff structure 32 is a metal ring with a curvature.
Further, in the interventional mitral valve 3, the material of the metal ring is nickel-titanium alloy and/or cobalt-chromium alloy.
Further, in the interventional mitral valve 3, the arc of the flanging of the metal ring is 50-80 °.
Further, in the interventional mitral valve 3, the inner diameter of the metal ring is the same as the inner diameter of the strut frame, and the outer diameter of the metal ring is 21-27 mm.
Further, in the interventional mitral valve 3, the annular flange structure is a flange-like structure and is connected with the edge of the strut frame in an interference fit manner.
Further, in the interventional mitral valve 3, the interventional mitral valve has an expansion pattern including a balloon expansion or a self-expansion.
Furthermore, in the intervention mitral valve 3, the intervention mitral valve is expanded in a ball-expanding manner, the strut frame is made of cobalt-chromium metal, and the size of the stent can be adjusted at will, so that the stent is released after reaching the target position and is quickly expanded to abut against the ventricular wall.
Further, in the intervention mitral valve 3, the intervention mitral valve is self-expandable, the strut frame is made of a memory alloy material, preferably nitinol, and the size of the stent can be adjusted at will so that the stent is released after reaching the target position, and is rapidly expanded to abut against the ventricular wall.
Further, in the interventional mitral valve 3, the strut frame 31 is a straight cylindrical metal frame having a continuous mesh structure.
Further, in the interventional mitral valve 3, the inner diameter of the strut frame 31 is 18-24mm, and the height of the strut frame is 12-15 mm.
Further, in the interventional mitral valve 3, the lattice structure is a diamond-shaped lattice.
Further, in the interventional mitral valve 3, the area of the diamond-shaped mesh is 15-45mm2。
The invention designs the grid shape of the metal frame intervening in the mitral valve into a continuous rhombic net structure with proper size so as to improve the strength and the supporting force of the inner layer bracket and avoid the fracture of the inner layer bracket caused by insufficient strength and supporting force.
Further, in the interventional mitral valve 3, the fabric comprises dacron and/or PTFE.
Further, in the intervening mitral valve 3, the fabric is wrapped inside the strut frame.
Further, in the interventional mitral valve 3, the thickness of the fabric is 0.1-0.5 mm.
Further, in the intervention mitral valve 3, the edges of the valve leaflets are sequentially butted and folded to form a plane, and a small hole is formed in the center of the folded valve structure.
Further, in the interventional mitral valve 3, the aperture of the small hole is 1.5mm or less.
In the present invention, the leaflet structure of the intervening mitral valve is effective in preventing regurgitation.
In another embodiment, the present invention provides a method of implanting an interventional mitral valve replacement system, comprising the steps of:
(1) implanting an outer frame from a femoral artery or apical approach to a target location via a catheter;
(2) the developing points are positioned in an auxiliary mode through four pairs of developing points arranged on the outer frame and the inner frame, and the inner frame is implanted;
(3) after combined fixation, the interventional mitral valve is finally implanted.
It should be noted that, the present invention aims to provide a split-type interventional bivalve mitral valve device, wherein components are sequentially implanted from a femoral artery or an apex of the heart to a target position through a catheter, and after the components are combined and fixed, a good positioning and fixing basis is provided for the interventional mitral valve implantation.
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. The split type valve support is characterized by comprising an outer frame and an inner frame which is arranged inside the outer frame and matched with the outer frame;
the outer frame comprises a cylindrical outer metal frame with a kidney-shaped section, one end of the outer metal frame is outwards folded along the circumferential direction to form a support ring, and at least one hook is arranged at the kidney-shaped recess at the other end of the outer metal frame;
the inner frame comprises a cylindrical inner metal frame with a kidney-shaped section, two X-shaped crossed connecting wires are arranged at one end of the inner metal frame, and the interface of the end of the inner metal frame is cut into a shape of 8 by the two connecting wires;
the outer frame is under the expansion form, and the one side that is provided with the support ring is detained in the valve ring of left atrium one side in reverse, and the one side that is provided with the crotch stretches into the left ventricle, the inner frame is under the expansion form, and the one side that is not provided with the connecting wire is towards the left atrium, and the one side that is provided with the connecting wire stretches into the left ventricle.
2. The split-type valve stent of claim 1, wherein the outer frame is made of memory metal, preferably nitinol;
preferably, the outer frame is a hollow-out net structure, preferably a honeycomb-shaped regular hexagonal hollow-out net structure.
3. The split-type valve stent of claim 1 or 2, wherein the outer folds form the support ring in a planar structure or a saddle-shaped structure;
preferably, the included angle between the support ring after being turned outwards and the cylindrical outer metal frame is 90-160 degrees;
preferably, the width of the support ring is 4-10 mm.
4. The split-type valve stent of any one of claims 1 to 3, wherein the radian of the inner concavity of the outer frame is 100 to 160 °;
preferably, the hook is arranged at the intersection of two regular hexagons at the other end of the outer metal frame, is concave along with one side of the kidney-shaped recess, and is bent towards one side of the support ring;
preferably, the outer frame is provided with at least 1 development site, preferably 2-10;
preferably, the developing point is arranged on one side of the outer frame extending into the left ventricle;
preferably, the number of the developing points arranged in the outer frame is 4, two developing points are arranged on the inward concave side and two developing points are arranged on the outward convex side of the cylindrical outer metal frame with the kidney-shaped section;
preferably, the material of the outer frame development point comprises platinum-iridium alloy and/or tantalum metal.
5. The split-type valve stent of any one of claims 1 to 4, wherein the X-shaped intersection part of the two connecting wires is a welding section, and the length of the welding section is 1-3 mm;
preferably, the material of the connecting wire is memory metal, preferably nickel-titanium alloy.
6. The split-type valve stent according to any one of claims 1 to 5, wherein the material of the inner frame is a memory metal, preferably a nickel-titanium alloy;
preferably, the inner frame is a hollow mesh structure, preferably a diamond-shaped hollow mesh structure.
7. The split-type valve stent of any one of claims 1 to 6, wherein the outer circumferential surface of the inner metal frame is obliquely provided with at least one barb-type anchor;
preferably, the overhead hook type anchors are arranged at the vertexes of the rhombic net structures, and only one overhead hook type anchor is arranged at the vertexes of the rhombic net structures connected with each other;
preferably, the barb type anchor is spike-shaped and is arranged obliquely upwards towards one side of the left atrium;
preferably, the angle of inclination of the barb anchor is 70-90 °;
preferably, the length of the barb anchor is 5-8 mm.
8. Split valve stent according to any one of claims 1 to 7, wherein the inner frame is provided with at least one visualization point corresponding to the position of the outer metal frame, preferably 2 to 10;
preferably, the visualization point is arranged on the side of the inner frame that protrudes into the left ventricle;
preferably, the number of the developing points arranged in the inner frame is 4, two developing points are arranged on the inward concave side and two developing points are arranged on the outward convex side of the tubular inner metal frame with the kidney-shaped cross section;
preferably, the material of the inner frame development point comprises platinum-iridium alloy and/or tantalum metal.
9. An interventional mitral valve replacement system comprising the split valve stent of any one of claims 1-8 and at least two interventional mitral valves.
10. The interventional mitral valve replacement system of claim 9, wherein the interventional mitral valve comprises a strut frame, and an annular flange structure is arranged on an edge of one side of the strut frame, and is arranged on an outflow side of the valve implanted in a body to reversely buckle the split-type valve stent from a left ventricle side; and at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric.
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| CN202111211090.5A CN113855333A (en) | 2021-10-18 | 2021-10-18 | Split type valve support reaches intervention mitral valve replacement system including it |
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| CN202111211090.5A CN113855333A (en) | 2021-10-18 | 2021-10-18 | Split type valve support reaches intervention mitral valve replacement system including it |
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Cited By (1)
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| CN115770126A (en) * | 2023-02-10 | 2023-03-10 | 上海欣吉特生物科技有限公司 | Support for fixing artificial valve and fixing method thereof |
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