CN113413240A - Multidimensional fixed heart valve prosthesis - Google Patents
Multidimensional fixed heart valve prosthesis Download PDFInfo
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- CN113413240A CN113413240A CN202010894373.3A CN202010894373A CN113413240A CN 113413240 A CN113413240 A CN 113413240A CN 202010894373 A CN202010894373 A CN 202010894373A CN 113413240 A CN113413240 A CN 113413240A
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- valve
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- atrium
- heart
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 25
- 238000004873 anchoring Methods 0.000 claims abstract description 156
- 210000002837 heart atrium Anatomy 0.000 claims abstract description 57
- 230000007246 mechanism Effects 0.000 claims abstract description 51
- 238000009958 sewing Methods 0.000 claims abstract description 26
- 230000001746 atrial effect Effects 0.000 claims description 42
- 210000005003 heart tissue Anatomy 0.000 claims description 29
- 210000001519 tissue Anatomy 0.000 claims description 24
- 239000012528 membrane Substances 0.000 claims description 5
- 238000005452 bending Methods 0.000 claims description 4
- 230000001737 promoting effect Effects 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 12
- 230000002457 bidirectional effect Effects 0.000 abstract description 2
- 210000004115 mitral valve Anatomy 0.000 description 22
- 206010027727 Mitral valve incompetence Diseases 0.000 description 12
- 230000008901 benefit Effects 0.000 description 10
- 208000016569 congenital mitral valve insufficiency Diseases 0.000 description 9
- 208000005907 mitral valve insufficiency Diseases 0.000 description 9
- 238000013461 design Methods 0.000 description 7
- 210000003484 anatomy Anatomy 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- -1 polytetrafluoroethylene Polymers 0.000 description 6
- 230000002265 prevention Effects 0.000 description 6
- 125000006850 spacer group Chemical group 0.000 description 5
- 239000007943 implant Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 210000003540 papillary muscle Anatomy 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000002861 ventricular Effects 0.000 description 3
- 229920004934 Dacron® Polymers 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 210000003698 chordae tendineae Anatomy 0.000 description 2
- 210000003748 coronary sinus Anatomy 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 230000003412 degenerative effect Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000002651 drug therapy Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 210000005246 left atrium Anatomy 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 210000005036 nerve Anatomy 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 210000005245 right atrium Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 206010003658 Atrial Fibrillation Diseases 0.000 description 1
- 206010049694 Left Ventricular Dysfunction Diseases 0.000 description 1
- 206010024119 Left ventricular failure Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004971 interatrial septum Anatomy 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 208000002815 pulmonary hypertension Diseases 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 210000005241 right ventricle Anatomy 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
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- 230000000638 stimulation Effects 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/2466—Delivery devices therefor
Abstract
The invention relates to the field of medical equipment, in particular to a multi-dimensional fixed heart valve prosthesis, which comprises a support and a valve, wherein the support comprises a valve sewing section and an atrium section, the valve is fixedly connected to the valve sewing section, the valve sewing section is matched and connected with the atrium section, a valve leaf clamping piece is arranged on the valve sewing section, an anti-falling anchoring mechanism is arranged on the atrium section, after the heart valve prosthesis is released, the valve leaf clamping piece is matched and connected with a front valve leaf of a patient, and the anti-falling anchoring mechanism penetrates through the atrium section and is fixedly connected with a back valve tissue of the patient; arranging a bidirectional anchoring device at the posterior valve region so as to fix the posterior valve region of the patient; the combination of the two makes the valve prosthesis have multi-dimensional anchoring force, and ensures the anchoring effect of the valve prosthesis in the heart.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a heart valve prosthesis fixed in multiple dimensions.
Background
The mitral valve has a complex anatomy, including the leaflets, annulus, chordae tendinae, and papillary muscles, which play important roles in maintaining the function of the right and left ventricles, respectively. Any disease that affects the structural integrity and proper functioning of the leaflets, annulus, chordae tendineae, papillary muscles and left ventricle may lead to severe mitral insufficiency (MR), which may cause left ventricular failure, pulmonary hypertension, atrial fibrillation, stroke and death. According to recent epidemiological survey data in western developed countries such as the united states, the leading type of valvular disease in the elderly population older than 65 years is mitral regurgitation. Currently, although there is no authoritative epidemiological survey data in China, the number of mitral regurgitation patients in China is indisputably huge as the population ages. Mitral insufficiency can be divided into degenerative MR and functional MR, the degenerative MR being caused by pathological changes in 1 or more of the leaflets, annulus, chordae tendineae, and papillary muscles; functional MR is usually left ventricular dysfunction, such as annular enlargement, but the mitral valve is usually normal.
At present, the treatment methods of MR mainly include drug therapy, surgery and interventional therapy. Drug therapy only improves the symptoms of the patient and does not prolong the survival time of the patient. Surgery, mainly valve repair or valve replacement, is recognized as the first treatment for mitral regurgitation and has been shown to alleviate symptoms and prolong the life of the patient. However, for many high-risk patients of advanced age with multiple system diseases, the surgical risk is high and the survival benefit is low, and according to the european data, the surgical success rate of such patients is only 50%, and the surgical success rate of patients with severe functional MR is as low as 16%. Thus, transcatheter interventional mitral valve repair and replacement theoretically could benefit high-risk patients who lose surgical opportunity. Interventional procedures are performed by loading a prosthetic implant extracorporeally onto a delivery system, delivering it along a vascular path or puncture the apex of the heart to the mitral annulus, and then releasing and securing it to replace, in whole or in part, the function of the native valve. Currently, intervention treatment of mitral valve has become one of the hot spots of research in related fields, and many products are under development. However, the development of a mitral valve intervention device faces a number of special difficulties due to the problems of the complexity of the mitral valve itself and the surrounding structures.
Patent CN201880035165.9 discloses a minimally invasive implantable device and mitral valve implant system, comprising a device (10) with an annuloplasty ring (11), wherein the annuloplasty ring (11): -having at least one tissue anchor (15); -deformable between a delivery configuration (57), in which the annuloplasty ring (11) is compressed to size and inserted in the left atrium (12), and an open configuration (X), in which the annuloplasty ring (11) is expanded to its original initial shape (58) to affect and fixate at the anatomical opening (9); -a generally annular shape with an inner layer for stabilization and at least one outer envelope through which at least one artificial thread (33) is drawn; and-having a circular ring (27), said circular ring (27); -having an anterior portion (20) engaging a tissue anchor site (24) of an anterior side (31) of the mitral valve annulus (13) of the anterior leaflet (16), and-having a posterior portion (21) engaging a tissue anchor site (24) of a posterior side (32) of the mitral valve annulus (13) of the posterior leaflet (17) providing the tissue anchor site (24) of the annuloplasty ring (11) with at least one tissue anchor line (33) from at least one tissue anchor (15); wherein the tissue anchors (15) are positionable around the mitral valve annulus (13) and each tissue anchor (15) implanted on the mitral valve annulus (13) is provided with a tissue anchor line (33) to secure the annuloplasty ring (11) to the tissue anchors (15). The technical scheme has the defects that: according to the physiological anatomy structure of the mitral valve, the anterior valve area of the mitral valve is close to the aortic area, so that when the puncture is performed on the anterior valve area, the operation difficulty is very high, the aortic valve area of a patient is easy to puncture, the blood vessel wall of the anterior valve area is very thin, and the puncture is easy to tear, so that the operation failure is caused; in addition, if only the posterior valve area is fixed by needle insertion, the fixing effect is not ideal, and the anterior valve area of the prosthesis can be separated, so that the prosthesis fixing fails.
Patent CN201410478565.0 discloses a prosthetic device for implantation in the area of the native mitral valve of the heart, said native mitral valve having a native annulus and anterior and posterior native valve leaflets, said prosthetic device comprising: a radially compressible and self-expandable spacer configured for placement between the anterior and posterior native valve leaflets, wherein the spacer does not allow blood to flow through the spacer; a first ventricular anchor extending from the spacer and configured for placement behind the anterior native valve leaflet; a second ventricular anchor extending from the spacer and configured for placement behind the native valve leaflet. This design utilizes first ventricle anchor and second ventricle anchor to fix anterior valve leaflet and posterior valve leaflet, respectively, in the patient's heart, and the technical defect of this scheme lies in: according to the physiological anatomy structure of the mitral valve, the length of the posterior valve leaflet of the patient is very short, the second ventricular anchor cannot effectively clamp and fix the posterior valve leaflet, meanwhile, in the actual operation process, the difficulty of clamping and anchoring is very large due to the very short length of the posterior valve leaflet, a large amount of operation time is consumed, the extension of the operation time is extremely unfavorable for the postoperative recovery of the patient, and the complication of the operation can be caused.
Disclosure of Invention
The invention aims to provide a multi-dimensionally fixed heart valve prosthesis, which has the following advantages: arranging a valve leaflet clamping piece in the front valve area by utilizing the physiological anatomical structure of the heart, wherein the valve leaflet clamping piece is used for fixing the front valve; arranging a bidirectional anchoring device at the posterior valve region so as to fix the posterior valve region of the patient; the combination of the two makes the valve prosthesis have multi-dimensional anchoring force, and ensures the anchoring effect of the valve prosthesis in the heart.
In order to solve the technical problem, the invention is solved by the following technical scheme: a multi-dimensional fixed heart valve prosthesis comprises a support and a valve, wherein the support comprises a valve sewing section and an atrium section, the valve is fixedly connected to the valve sewing section, the valve sewing section is matched and connected with the atrium section, a valve leaf clamping piece is arranged on the valve sewing section, a separation-preventing anchoring mechanism is arranged on the atrium section, when the heart valve prosthesis is released, the valve leaf clamping piece is matched and connected with a front valve leaf of a patient, the separation-preventing anchoring mechanism penetrates through the atrium section and is fixedly connected with a back valve tissue of the patient or the separation-preventing anchoring mechanism penetrates through the atrium section and is fixedly connected with a back valve tissue of the patient and a tissue of a junction area of the back valve and the front valve.
The invention can be further realized by the following technical scheme:
preferably, the anti-dropping anchoring mechanism comprises an anchor and an anti-dropping piece, one end of the anchor is fixedly connected with one end of the anti-dropping piece, the other end of the anchor penetrates through the atrium section to be connected with the heart tissue in a matched mode, and the other end of the anti-dropping piece penetrates through the atrium section to be folded back and form two or more connecting points with the atrium section.
Preferably, heart valve prosthesis still includes anticreep anchoring mechanism pusher, anticreep anchoring mechanism pusher includes conveying pipe and push rod, the push rod with anticreep anchoring mechanism is set up in the conveying pipe, when the push rod promotes anticreep anchoring mechanism, the other end of anchor passes the atrium section and is connected with heart tissue cooperation, when further promoting the push rod, the other end of anticreep spare passes turn back behind the atrium section and with the atrium section forms two or more tie points, anticreep spare restriction the anchor breaks away from the atrium section.
Preferably, the length of the anchor is greater than the length of the release prevention member.
Preferably, the anchor and the anti-slip element each have a predetermined shape.
Preferably, the anchors are one or more arcuate anchoring needles.
More preferably, the anchor may be one or more helically configured anchoring needles.
Preferably, the anti-slip means is one or more arcuate anchoring needles.
More preferably, the anti-slip means may be one or more anchoring needles of helical configuration.
More preferably, when the anchor is one or more arc-shaped anchoring needles, the anti-dropping member may be one or more arc-shaped anchoring needles.
More preferably, when the anchor is one or more arc-shaped anchor needles, the anti-slip member may be one or more anchor needles of a helical structure.
More preferably, when the anchor may be one or more anchor needles of helical structure, the anti-slip member may be one or more arc-shaped anchor needles.
More preferably, when the anchor may be one or more helical anchoring needles, the anti-slip member may be one or more helical anchoring needles.
Preferably, the atrial segment is covered with a membrane, and the membrane material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or an animal-derived material.
Preferably, one end of the push rod is detachably connected with the anti-drop anchoring mechanism.
More preferably, the other end of the anchor passes through the atrial segment, the heart tissue and then is connected to the sewing segment.
Preferably, the other end of the release element is passed through the atrial segment, the heart tissue, and finally attached to the atrial segment.
Preferably, the anti-drop anchoring mechanism further comprises a limiting member, and one end of the anchoring member and one end of the anti-drop member are respectively and fixedly connected with the limiting member.
Preferably, the end part of the other end of the anchor is provided with a barb structure or the anchor is uniformly provided with micro-barbs.
Preferably, the end part of the other end of the anti-falling part is provided with a barb structure or the anti-falling part is uniformly provided with micro-barbs.
Preferably, the leaflet clipping member comprises a fixed end and a free end, the fixed end is connected with the valve sewing section in a matching way, the free end extends from the fixed end to the proximal end, and extends to the distal end after passing through the first bending point to form a leaflet holding cavity, and the native leaflets are folded and clipped in the leaflet holding cavity when the leaflet clipping member is completely released.
Compared with the prior art, the invention has the advantages that:
1. the invention skillfully utilizes the physiological anatomical structure of the heart, utilizes the characteristics that the vascular wall of the anterior valve area of the mitral valve is very thin and is close to the aortic area, and the anterior valve leaflet is longer, and is provided with the leaflet clamping piece to fold the leaflet of the anterior valve and realize the anchoring of the anterior valve area; the posterior valve leaflet of the mitral valve is not suitable for anchoring the folding of the leaflet due to short length, and is very suitable for needle insertion anchoring because the tissue thickness of the posterior valve area of the mitral valve is large, so that an anti-drop anchoring mechanism is designed in the posterior valve area to anchor the posterior valve area; the perfect combination of the two anchoring modes ensures that the valve prosthesis has multi-dimensional anchoring force and ensures the anchoring effect of the valve prosthesis in the heart;
2. the anchoring component of the invention is connected with the heart tissue in a matching way through the atrium section, so that the bracket is fixed in the heart, and the anti-falling component finally forms 2 connecting points with the atrium section after passing through the atrium section; the anti-drop device is characterized in that only one connecting point is arranged between the anchoring piece and the atrium section all the time, so that only one force point is arranged on the atrium section of the anchoring piece, when the support is impacted by blood flow, the anchoring piece is easy to drop out of the atrium section, and the support loses a fixed point;
3. the length of the anchoring element is greater than that of the anti-slip element, so that the design has the advantages that: the anchoring piece fixes the bracket and the tissue, the anti-drop piece penetrates through the atrial section and is finally connected with the atrial section, so that the anti-drop anchoring mechanism is locked on the atrial section, and the length of the anti-drop piece is shorter, therefore, the anti-drop piece cannot hook or press heart tissues such as nerve bundles, coronary sinus and the like in the anchoring/locking process, and the condition that the heart tissues are damaged or torn is avoided; meanwhile, the shorter anti-falling part has smaller moment, is less prone to deformation and pull-off, and can enable the anti-falling anchoring mechanism and the atrium section to be locked more stably; (ii) a
4. One end of the push rod is detachably connected with the anti-falling anchoring mechanism, and after the push rod pushes and anchors the anti-falling anchoring mechanism to a target position, the push rod can withdraw from a human body, so that implants are greatly reduced, contact and stimulation to atria are reduced, and the human body can be conveniently withdrawn by a conveying system;
5. the anchors of the present invention are designed to pass through the atrial segment, through the heart tissue and attach to the sewn segment of the valve, and are designed to: both ends of the anchoring part are connected with the bracket, so that the anchoring part and the bracket are connected into a whole, the anchoring part is not easy to loosen relative to the bracket after being implanted, and the anchoring part is prevented from being pulled off or separated from the atrium segment;
6. the anti-dropping part penetrates through the atrial section and the cardiac tissue and is finally connected with the atrial section, and the design has the advantages that: the anti-falling part needs to penetrate through heart tissues and then is finally connected with the atrial section, so that the anti-falling part is locked at the atrial section and simultaneously connected with part of the heart tissues, and the anchoring effect of the anti-falling part is further strengthened;
7. in the invention, barb structures are arranged at the other end of the anchoring piece and the other end of the anti-falling piece or micro-barb structures are uniformly distributed on the anchoring piece and the anti-falling piece, so that the design has the advantages of further increasing the anchoring effect of the anti-falling anchoring mechanism and more effectively avoiding the situation that the anti-falling anchoring mechanism is pulled off or separated from the atrium section
8. The free end of the leaflet holder of the present invention forms a leaflet receiving cavity, which is designed to aim at: the native valve leaflet can fill the space of the valve leaflet containing cavity after being folded, so that the anchoring force of the valve leaflet clamping piece is larger, and the anchoring effect is better.
Drawings
Fig. 1 is a schematic view of a heart valve prosthesis of the present invention through an atrioventricular valve.
FIG. 2 is a schematic view of the sheath retraction of the present invention.
Fig. 3a to 3e are schematic views illustrating the fixation of the anterior valve tissue by the leaflet clipping device of the present invention.
FIGS. 4a to 4g are schematic views illustrating the fixation of the valve tissue by the anti-detachment anchoring mechanism according to the present invention; fig. 4g is a top view of the anti-drop anchoring mechanism after completion of fixation.
FIGS. 5 a-5 c are schematic views showing the fixation completed after implantation in accordance with the present invention; fig. 5b is a partial enlarged view of fig. 5a, and fig. 5c is another embodiment.
Fig. 6 a-6 n are schematic views of various embodiments of the anchor structure of the present invention.
Fig. 7a and 7b are schematic views of various embodiments of the anchor micro-piercing arrangement of the present invention.
FIGS. 8 a-8 d are schematic illustrations of various embodiments of atrial segments of the present invention.
The names of the parts indicated by the numbers in the drawings are as follows: 1-stent, 11-valve sewing section, 12-atrium section, 2-valve leaflet holder, 3-anti-drop anchoring mechanism, 31-anchor, 32-anti-drop, 33-anti-drop anchoring mechanism pushing device, 331-conveying conduit, 332-push rod, 34-limiting piece, 21-fixed end, 22-free end and 23-valve leaflet containing cavity.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
The proximal end of the present invention refers to the end near the apex of the heart, and the distal end refers to the end away from the apex of the heart.
The specific embodiment is as follows:
as shown in fig. 1, a multi-dimensionally fixed heart valve prosthesis comprises a stent 1 and a valve (not shown). As shown in fig. 5a, the stent 1 comprises a valve sewing section 11 and an atrium section 12, the valve (not shown) is fixedly connected to the valve sewing section 11, the valve sewing section 11 is connected with the atrium section 12 in a matching way, as shown in fig. 3a to 3e, the valve sewing section 11 is provided with a valve leaflet clamping piece 2, and the valve leaflet clamping piece 2 is connected with the front valve leaflet of the patient in a matching way; as shown in fig. 4g, the atrium section 12 is provided with a retaining-off anchoring mechanism 3, the retaining-off anchoring mechanism 3 passes through the atrium section 12 and is fixedly connected with the tissue of the patient's back valve or the retaining-off anchoring mechanism 3 passes through the atrium section 12 and is fixedly connected with the tissue of the patient's back valve tissue and the tissue of the junction area of the back valve and the front valve; anti-detachment anchoring mechanism 3 comprises anchoring element 31 and anti-detachment element 32, one end of anchoring element 31 is fixedly connected with one end of anti-detachment element 32, the other end of anchoring element 31 passes through atrial segment 12 to be connected with heart tissue in a matching mode, the other end of anti-detachment element 32 passes through atrial segment 12 to be connected with atrial segment 12 in a matching mode, and anti-detachment element 32 limits anchoring element 31 to be detached from atrial segment 12; the valve leaflet holding member 2 comprises a fixed end 21 and a free end 22, the fixed end 21 is connected with the valve sewing section 11 in a matching way, the free end 22 extends from the fixed end 21 to the proximal end, passes through a first bending point and extends to the distal end to form a valve leaflet accommodating cavity 23, and the native valve leaflets are folded and held in the valve leaflet accommodating cavity 23 when the valve leaflet holding member 2 is completely released; according to the physiological anatomical structure of the heart, the characteristics that the blood vessel wall of the anterior valve region of the mitral valve is thin and is close to the aortic region, and meanwhile, the anterior valve leaflet is long are utilized, the leaflet clamping piece 2 is arranged, the leaflet of the anterior valve is folded, and the anchoring of the anterior valve region is realized; the posterior valve leaflet of the mitral valve is not suitable for anchoring the folding of the leaflet due to short length, and the anti-drop anchoring mechanism 3 is designed in the posterior valve area for anchoring the posterior valve area because the tissue thickness of the posterior valve area of the mitral valve is large and is very suitable for needle insertion and anchoring; the perfect combination of the two anchoring modes ensures that the valve prosthesis has multi-dimensional anchoring force and ensures the anchoring effect of the valve prosthesis in the heart.
The components and connection of the components of the reversible curved valve delivery system of the present invention will be described in detail with reference to the accompanying drawings;
in this embodiment, the heart valve prosthesis further includes an anti-detachment mechanism pushing device 33, as shown in fig. 4a to 4f, the anti-detachment mechanism pushing device 33 includes a delivery conduit 331 and a pushing rod 332, the pushing rod 332 and the anti-detachment mechanism 3 are disposed in the delivery conduit 331, when the pushing rod 332 pushes the anti-detachment mechanism 3, the other end of the anchor 31 passes through the atrial segment 12 to be connected with the heart tissue in a matching manner, when the pushing rod 332 is further pushed, the other end of the anti-detachment element 32 passes through the atrial segment 12 to finally form 2 connection points (as shown in fig. 5 b) with the atrial segment 12, and the anti-detachment element 32 restricts the anchor 31 from the atrial segment 12.
In another embodiment, the other end of the detachment prevention element 32 is folded back through the atrial segment 12 and forms 3 connection points with the atrial segment 12 (as shown in fig. 5 c), and the detachment prevention element 32 restricts detachment of the anchor element 31 from the atrial segment 12.
In the present embodiment, the length of the anchor member 31 is greater than the length of the detachment prevention member 32; the advantages of such a design are: the anchoring piece fixes the bracket 1 and the tissue, the anti-falling piece 32 penetrates through the atrium section 12 and is finally connected with the atrium section 12, so that the anti-falling anchoring mechanism 3 is locked on the atrium section 12, and the length of the anti-falling piece is short, so that the anti-falling piece cannot hook or press heart tissues such as nerve bundles, coronary sinus and the like in the anchoring/locking process, and the condition that the heart tissues are damaged or torn is avoided; meanwhile, the moment of the shorter anti-falling piece 32 is smaller, so that the anti-falling piece is less prone to deformation and pull-off, and the anti-falling anchoring mechanism 3 and the atrium section 12 can be locked more stably; the anchoring element 31 and the anti-detachment element 32 each have a predetermined shape.
In this embodiment, the anchoring elements 31 are one or more arcuate anchoring needles; alternatively, the anchoring element 31 may be one or more anchoring needles of helical configuration, as shown in fig. 6 a-6 f.
In this embodiment, the anti-slip member 32 is one or more arc-shaped anchoring needles; alternatively, the release preventing member 32 may be one or more anchoring needles in a helical configuration, as shown in fig. 6 a-6 f.
In some preferred embodiments, when the anchoring member 31 is one or more arc-shaped anchoring needles, the anti-slip member 32 may be one or more arc-shaped anchoring needles, as shown in fig. 6a to 6 f.
In some preferred embodiments, when the anchoring element 31 is one or more arc-shaped anchoring needles, the anti-slip element 32 may be one or more anchoring needles with a spiral structure, as shown in fig. 6a to 6 f.
In some preferred embodiments, while the anchoring element 31 may be one or more anchoring needles with a helical structure, the anti-slip element 32 may be one or more anchoring needles with an arc shape, as shown in fig. 6a to 6 f.
In some preferred embodiments, while the anchoring element 31 may be one or more helically configured anchoring needles, the retaining element 32 may be one or more helically configured anchoring needles, as shown in fig. 6 a-6 f.
In some preferred embodiments, the shape of the other end of the anchor 31 may be a helical structure; similarly, the other end of the anti-slip element 32 may also be in a spiral structure, as shown in fig. 6g, when the other end of the anti-slip element 32 is in a spiral structure, the anti-slip element 32 and the anchoring area form 4 connection points, which further ensures that the anti-slip element 32 does not separate from the anchoring area 12, and further ensures that the anti-slip element 32 can disperse/resolve the impact force to the 4 force points when the valve prosthesis 1 is impacted by blood flow, so as to reduce the force applied to the anchor 31, so that the anti-slip anchoring mechanism 2 is locked on the anchoring area 12, and the anchor 31 is prevented from loosening relative to the anchoring area 12 and separating from the anchoring area 12.
In some preferred embodiments, anti-slip anchor mechanism 2 is further provided with a connecting section, as shown in fig. 6h, the connecting section is provided in an arc structure, one end of anchor 31 is connected with the connecting section, and one end of anti-slip element 32 is connected with the connecting section.
In some preferred embodiments, as shown in fig. 6i and 6j, the anchoring element 31 and the anti-detachment element 32 each have a preset shape; when the anchoring member 31 is one or more arc-shaped anchoring needles, the detachment prevention member 32 may be one or more arc-shaped anchoring needles.
In some preferred embodiments, as shown in fig. 6k, when the anchoring element 31 is one or more arc-shaped anchoring needles, the anti-slip element 32 may be one or more anchoring needles with a helical structure.
In some preferred embodiments, as shown in fig. 6l, while the anchoring element 31 may be one or more anchoring needles with a helical structure, the anti-slip element 32 may be one or more arc-shaped anchoring needles.
In some preferred embodiments, as shown in fig. 6m and 6n, while the anchoring element 31 may be one or more helically configured anchoring needles, the anti-slip element 32 may be one or more helically configured anchoring needles.
In this embodiment, the atrial segment 12 is covered with a membrane, and the membrane material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron, or an animal-derived material.
As shown in fig. 4b, one end of the push rod 332 is detachably connected to the anti-drop anchoring mechanism 3; specifically, one end of the push rod 332 is movably connected to the stopper 34 (by using a known technique, such as a rope loop, a slipknot, etc.), and after the anchoring effect of the anti-drop anchoring mechanism 3 is confirmed to be ideal, the anti-drop anchoring mechanism pushing device 33 (including the delivery catheter 331 and the push rod 332) can be withdrawn from the human body by removing the movable connection, which is advantageous in that the volume of the implant can be reduced, and the risk of thrombosis can be reduced.
In this embodiment, the other end of the anchoring member 31 passes through the atrial segment 12 and the cardiac tissue and then is connected to the valve sewing segment 11; more preferably, the other end of the anchoring element 31 passes through the atrium section 12, the heart tissue, behind the valve sewing section 11 and between the artificial valve and the valve sewing section 11, and the other end of the release preventing element 32 passes through the atrium section 12, behind the heart tissue, and finally connects with the atrium section 12, as shown in fig. 8 a; the advantages of such a design are: the anti-falling part 32 needs to penetrate through the heart tissue and then is finally connected with the atrium section 12, so that the anti-falling part 32 is locked on the atrium section 12 and is connected with part of the heart tissue, and the anchoring effect of the anti-falling part 32 is further strengthened; meanwhile, both ends of the anchoring member 31 are connected with the stent 1, so that the anchoring member 31 and the stent 1 are connected into a whole, and the anchoring member 31 is not easy to loosen relative to the stent 1 after being implanted, thereby avoiding the situation that the anchoring member 31 is pulled off or separated from the atrial segment 12.
In another embodiment, as shown in fig. 8b, the other end of the anchoring element 31 passes through the atrial segment 12 and the heart tissue and then is connected to the sewing segment 11; the other end of the release element 32 passes through the atrial segment 12 and eventually connects to the atrial segment 12 and forms 2 connection points with the atrial segment 12.
In another embodiment, as shown in FIG. 8c, the other end of anchoring elements 31 are connected to the patient's heart tissue through atrial segment 12; the other end of the release element 32, after passing through the atrial segment 12, the heart tissue, eventually connects to the atrial segment 12 and forms 2 connection points with the atrial segment 12.
In another embodiment, as shown in FIG. 8d, the other end of anchoring elements 31 are connected to the patient's heart tissue through atrial segment 12; the other end of the release element 32 passes through the atrial segment 12 and eventually connects to the atrial segment 12 and forms 2 connection points with the atrial segment 12.
In this embodiment, the end of the other end of the anchor 31 is provided with a barb structure or the anchor 31 is uniformly provided with micro-barbs, as shown in fig. 7a and 7 b; the anchoring effect of anchoring elements 31 can be further increased and pulling/detachment of anchoring elements 31 from atrial segment 12 can be more effectively avoided.
In this embodiment, the end of the other end of the anti-falling part 32 is provided with a barb structure or the anti-falling part 32 is uniformly provided with micro-barbs, as shown in fig. 7a and 7 b; the advantages of such a design are: the locking effect of the detachment prevention member 32 can be further increased to more effectively prevent the anchoring member 31 from being pulled out/detached from the atrial segment 12.
The working process steps of the invention are as follows (refer to the attached drawings):
1. the delivery catheter 331 with the heart valve prosthesis is passed from the right atrium into through the interatrial septum into the left atrium;
2. withdrawing the sheath such that the free end 22 of the leaflet clip 2 extends proximally from the fixed end 21 thereof past the first bending point and distally to form a leaflet receiving cavity 23, the native leaflets being folded and held within the leaflet receiving cavity 23 when the leaflet clip 2 is fully released;
3. the outer sheath is withdrawn continuously, the valve prosthesis is released completely, and then the anti-dropping anchoring mechanism pushing device 33 is operated to fix the anti-dropping anchoring mechanism 3 in the valve area at the right atrium, specifically, when the push rod 332 pushes the anti-dropping anchoring mechanism 3, the other end of the anchoring element 31 firstly passes through the atrium section 12 to be connected with the heart tissue in a matched manner, and when the push rod 332 is further pushed, the other end of the anti-dropping element 32 passes through the atrium section 12 to be finally connected with the atrium section 12 in a matched manner;
4. withdrawing the delivery catheter 331 from the body;
the above description is only a preferred embodiment of the present invention, and for those skilled in the art, the present invention should not be limited by the description of the present invention, which should be interpreted as a limitation.
Claims (10)
1. A multi-dimensionally fixed heart valve prosthesis comprising a stent and a valve, characterized in that: the support comprises a valve sewing section and an atrium section, wherein the valve is fixedly connected to the valve sewing section, the valve sewing section is connected with the atrium section in a matched mode, a valve leaflet clamping piece is arranged on the valve sewing section, an anti-drop anchoring mechanism is arranged on the atrium section, when the heart valve prosthesis is released, the valve leaflet clamping piece is connected with a front valve leaflet of a patient in a matched mode, and the anti-drop anchoring mechanism penetrates through the atrium section and is fixedly connected with a back valve tissue of the patient.
2. A multi-dimensional fixed heart valve prosthesis as claimed in claim 1, wherein: the anti-falling anchoring mechanism comprises an anchoring piece and an anti-falling piece, one end of the anchoring piece is fixedly connected with one end of the anti-falling piece, the other end of the anchoring piece penetrates through the atrium section to be connected with heart tissues in a matched mode, and the other end of the anti-falling piece penetrates through the atrium section to be folded back and form two or more connection points with the atrium section.
3. A multi-dimensional fixed heart valve prosthesis as claimed in claim 2, wherein: heart valve prosthesis still includes anticreep anchoring mechanism pusher, anticreep anchoring mechanism pusher is including carrying pipe and push rod, the push rod with anticreep anchoring mechanism is set up in carrying the pipe, works as the push rod promotes during anticreep anchoring mechanism, the other end of anchor passes the atrium section and is connected with heart tissue cooperation, when further promoting during the push rod, the other end of anticreep spare passes turn back behind the atrium section and with the atrium section forms two or more tie points, the restriction of anticreep spare the anchor breaks away from the atrium section.
4. A multi-dimensional fixed heart valve prosthesis as claimed in claim 2, wherein: the length of the anchor is greater than the length of the anti-slip member.
5. A multi-dimensional fixed heart valve prosthesis as claimed in claim 2, wherein: the anchor is one or more arc-shaped anchor needles, and the anti-falling part is one or more arc-shaped anchor needles.
6. A multi-dimensional fixed heart valve prosthesis as claimed in claim 3, wherein: one end of the push rod is detachably connected with the anti-falling anchoring mechanism.
7. A multi-dimensional fixed heart valve prosthesis as claimed in claim 2, wherein: the other end of the anchoring piece penetrates through the atrium section and the heart tissue and then is connected with the valve sewing section, and the other end of the anti-release piece penetrates through the atrium section and the heart tissue and then is finally connected with the atrium section.
8. A multi-dimensional fixed heart valve prosthesis as claimed in claim 1, wherein: the atrial segment is covered with a membrane.
9. A multi-dimensional fixed heart valve prosthesis as claimed in claim 2, wherein: the anti-drop anchoring mechanism further comprises a limiting part, and one end of the anchoring part and one end of the anti-drop part are respectively and fixedly connected with the limiting part.
10. A multi-dimensional fixed heart valve prosthesis as claimed in claim 1, wherein: the valve leaflet clamping piece comprises a fixed end and a free end, the fixed end is connected with the valve sewing section in a matched mode, the free end extends from the fixed end to the near end, the free end extends to the far end after passing through a first bending point to form a valve leaflet containing cavity, and when the valve leaflet clamping piece is completely released, a native valve leaflet is folded and clamped in the valve leaflet containing cavity.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010894373.3A CN113413240A (en) | 2020-08-31 | 2020-08-31 | Multidimensional fixed heart valve prosthesis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010894373.3A CN113413240A (en) | 2020-08-31 | 2020-08-31 | Multidimensional fixed heart valve prosthesis |
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| CN113413240A true CN113413240A (en) | 2021-09-21 |
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| CN202010894373.3A Pending CN113413240A (en) | 2020-08-31 | 2020-08-31 | Multidimensional fixed heart valve prosthesis |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022042478A1 (en) * | 2020-08-31 | 2022-03-03 | 宁波健世生物科技有限公司 | Anti-detachment anchoring mechanism applied to implanted prosthesis |
-
2020
- 2020-08-31 CN CN202010894373.3A patent/CN113413240A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022042478A1 (en) * | 2020-08-31 | 2022-03-03 | 宁波健世生物科技有限公司 | Anti-detachment anchoring mechanism applied to implanted prosthesis |
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