CN113545892A - Valve prosthesis capable of effectively improving perivalvular leakage - Google Patents

Valve prosthesis capable of effectively improving perivalvular leakage Download PDF

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Publication number
CN113545892A
CN113545892A CN202110864529.8A CN202110864529A CN113545892A CN 113545892 A CN113545892 A CN 113545892A CN 202110864529 A CN202110864529 A CN 202110864529A CN 113545892 A CN113545892 A CN 113545892A
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CN
China
Prior art keywords
leakage
valve
stent
valve prosthesis
skirt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202110864529.8A
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Chinese (zh)
Inventor
王焱
王斌
陈翔
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Xiamen University Affiliated Cardiovascular Hospital
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Xiamen University Affiliated Cardiovascular Hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Xiamen University Affiliated Cardiovascular Hospital filed Critical Xiamen University Affiliated Cardiovascular Hospital
Priority to CN202110864529.8A priority Critical patent/CN113545892A/en
Publication of CN113545892A publication Critical patent/CN113545892A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • A61F2/2418Scaffolds therefor, e.g. support stents

Abstract

The invention belongs to the technical field of medical instruments, particularly relates to the field of A61F2/24, and particularly relates to a valve prosthesis capable of effectively improving paravalvular leakage. The invention provides a valve prosthesis capable of effectively improving perivalvular leakage, which is characterized by comprising a bracket, wherein the bracket is of a hollow annular structure; a prosthetic leaflet fixedly disposed within the stent ring structure; a leakage prevention ring disposed around an outer periphery thereof; the prosthetic valve leaflet and the leakage-proof ring are respectively and fixedly connected with the bracket. The attaching skirt edge can effectively attach the native leaflets, so that after the valve prosthesis is implanted, a gap is reduced between the leakage-proof ring and heart tissue, and the attaching skirt edge can also attach the native leaflets in a clinging manner when the valve is opened and closed, so that perivalvular leakage is avoided.

Description

Valve prosthesis capable of effectively improving perivalvular leakage
Technical Field
The invention belongs to the technical field of medical instruments, particularly relates to the field of A61F2/24, and particularly relates to a valve prosthesis capable of effectively improving paravalvular leakage.
Background
Tricuspid valve regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement and tricuspid valve annular dilation, and is clinically commonly represented by the causes of the tricuspid valve regurgitation (left heart failure, pulmonary hypertension and the like), and the symptoms of right heart failure such as tricuspid valve regurgitation, hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but surgical treatment is required when there is severe regurgitation. Traditional treatment approaches for mitral and tricuspid valve disease include medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. Many patients do not tolerate the enormous surgical risk and can only remain indefinitely at risk for death. With the first report of aortic valve intervention replacement, many companies have done a lot of work on interventional aortic valve technology, and the technology is mature. However, there remains a significant gap in the industry in the interventional treatment of atrioventricular valves. Although a few products currently exist for the interventional treatment of atrioventricular valves for transcatheter valvuloplasty and repair, no mature product is yet internationally available for transcatheter valve replacement.
Patent CN201710675846.9 discloses a valved stent replacement valve suitable for mitral and tricuspid valves of the heart, the valved stent replacement valve for the heart of a patient comprises an implantable valve stent, the implantable valve stent supports a cloth-like structure; the implantable valve stent comprises N support members, an upper end positioning member and a lower end member; each of the support members includes upper and lower vertical portions connected by a bent connection portion; the upper end positioning component comprises an upper layer structure and a lower layer structure, the upper layer structure consists of N metal arches, the lower layer structure consists of N hooks, the N metal arches connect the upper ends of every two supporting components together, and each hook extends downwards from the upper end of the supporting component; the lower end part comprises a metal net which is connected with the lower vertical parts of all the supporting parts and is cylindrical; the cloth-shaped structure comprises an upper end part and a cylindrical lower end part, the upper end part covers the metal arch and is supported by the metal arch, the lower end part radially covers the inside of the metal net and is supported by the metal net, and a one-way valve is arranged in the lower end part and allows blood to descend and prevents blood from ascending; fixation of the implantable valve stent within the heart is achieved by locking the heart tissue between the metal arch and the hooks. The disadvantages of this design are: the position of the valve prosthesis at the valve is not provided with an effective leakage-proof structure, and the shaking of the valve prosthesis after implantation can not be avoided, so that the risk of leakage around the valve is large.
Patent CN201911299162.9 discloses a radial catheter valve replacement system, wherein a leaflet lift stop device 1030 is disposed on the outer side of the valve stent 1010 or the adaptive stent-graft 1020 near the native leaflet site, preferably on the outer peripheral surfaces of the valve stent 1010 and the adaptive stent-graft 1020, when the valve replacement prosthesis 1000 is pre-assembled, the leaflet lift stop device 1030 is pre-assembled inside the delivery catheter 1600 in a manner of turning towards the distal end, when the leaflet lift stop device 1030 is implanted, the control handle 1500 is operated to position the valve replacement prosthesis when the leaflet lift stop device 1030 is released from the delivery catheter 1600 to turn over more than 90 °, the native leaflet 0040 is lifted by the leaflet lift stop device 1030, and after implantation, the leaflet lift stop device 1030 holds the leaflet native 0040 to assist in fixing the valve replacement prosthesis. The disadvantages of this design are: the self-body valve leaflet is tightly attached to the self-adaptive film covering support when being clamped by the valve leaflet lifting blocking device, and the self-adaptive film covering support has strong flexibility and can adapt to the movement of heart tissue to be always attached to the heart tissue, so that the self-body valve leaflet is easy to displace along with the movement of the self-adaptive film covering support when the self-adaptive film covering and the valve leaflet lifting device are matched to clamp the self-body valve leaflet, and the clamping effect of the self-body valve leaflet is not strong.
Therefore, those skilled in the art have endeavored to develop a valve prosthesis effective in improving paravalvular leakage, mainly solving the following problems: how to effectively improve the problem of perivalvular leakage after the valve prosthesis is implanted.
Disclosure of Invention
In view of the above problems, the present invention provides a valve prosthesis capable of effectively improving paravalvular leakage, which is characterized by comprising
The bracket is arranged into a hollow annular structure;
a prosthetic leaflet fixedly disposed within the stent ring structure;
a leakage prevention ring disposed around an outer periphery thereof;
the prosthetic valve leaflet and the leakage-proof ring are respectively and fixedly connected with the bracket.
As a preferred technical scheme, a fitting skirt is arranged at the distal end of the leakage-proof ring, the distal end of the fitting skirt is fixedly connected with the leakage-proof ring, and the proximal end of the fitting skirt extends to point to the support; when the valve prosthesis is implanted, the leakage-proof ring is attached to the native valve ring, and the attaching skirt is attached to the native leaflets.
As a preferred aspect, the conformable skirt includes a fixed end that is secured to the distal end of the leak-proof ring and is positioned in the inflow tract of the native valve, and a free end that is positioned in the outflow tract of the native valve.
As a preferable mode, the free end is closer to the holder than the fixing section in a radial direction of the holder, and the attachment skirt has a tendency to be away from the holder as a whole.
As a preferred technical scheme, the attaching skirt edge is of an annular structure, and the attaching skirt edge is continuously and uninterruptedly arranged along the periphery of the leakage-proof ring.
Preferably, the length of the attached skirt does not exceed the length of the native leaflets.
As a preferable technical scheme, the attaching skirt is made of TPU materials.
As a preferred technical solution, the leakage-proof ring comprises an adaptive component, a clamping structure and a reinforcing structure; the adaptive component is arranged at the far end of the bracket; the reinforcing structure is disposed between the proximal end and the distal end of the stent, and the clamping structure is disposed at the proximal end of the stent.
As a preferred technical solution, the adaptive component is configured as a structure extending at the distal end of the stent in a direction away from the stent; the outer diameter of the reinforcing structure is smaller than the maximum outer diameter of the adaptive component.
As a preferable technical solution, the cross-sectional pattern of the clamping structure is arranged in a V shape, one end of the V-shaped structure of the clamping structure is fixed with the bracket, and the other end of the V-shaped structure of the clamping structure is aligned with the reinforcing structure in the axial direction of the bracket; the V-shaped structure of the clamping structure is opened towards the far end.
Has the advantages that:
1. compared with the prior art, the attaching skirt edge can effectively attach the native leaflets, so that after the valve prosthesis is implanted, a gap is reduced between the leakage-proof ring and heart tissue, and the attaching skirt edge can also be attached to the native leaflets during the opening and closing actions of the valve, so that the perivalvular leakage is avoided;
2. the self-adaptive valve leaflet is characterized in that the self-adaptive valve leaflet is clamped between the clamping mechanism and the reinforcing structure, and the self-adaptive valve leaflet is fixed on the clamping mechanism.
Drawings
Fig. 1 is a schematic view of the overall structure of the valve prosthesis of the present invention.
Fig. 2 is a schematic view of the structure of the present invention after implantation.
Fig. 3 is a partially enlarged schematic view of fig. 2.
The self-adaptive valve comprises a support 1, a prosthetic valve leaflet 2, a leakage-proof ring 3, a self-adaptive component 31, a clamping mechanism 32, a reinforcing structure 33, a fitting skirt edge 4, a fixed end 41 and a free end 42.
Detailed Description
The proximal end is defined herein as the end proximal to the apex of the heart and the distal end is defined herein as the end distal to the apex of the heart.
A valve prosthesis effective in improving paravalvular leakage as shown in figures 1, 2 and 3 comprises
The support 1 is a hollow annular structure;
the prosthetic valve leaflet 2 is fixedly arranged inside the annular structure of the stent 1;
a leakage preventing ring 3, the leakage preventing ring 3 being circumferentially disposed between the two;
the prosthetic valve leaflet 2 and the leakage-proof ring 3 are respectively fixedly connected with the bracket 1.
In some preferred embodiments, the distal end of the leakage-proof ring 3 is provided with an attaching skirt 4, the distal end of the attaching skirt 4 is fixedly connected with the leakage-proof ring 3, and the proximal end of the attaching skirt 4 extends towards the stent 1; when the valve prosthesis is implanted, the leakage-proof ring 3 is attached to the native valve annulus, and the attaching skirt 4 is attached to the native leaflets. Due to the opening and closing of the valve, a gap may be formed between the leakage-proof ring 3 and the valve ring, and the attaching skirt 4 can be tightly attached to the native leaflets, so that the paravalvular leakage can be effectively improved, as shown in fig. 2 and 3.
In some preferred embodiments, the conformable skirt 4 includes a fixed end 41 and a free end 42, the fixed end 41 being fixed to the distal end of the containment ring 3 and located in the inflow tract of the native valve, and the free end 42 being located in the outflow tract of the native valve.
In some preferred embodiments, the free end 42 is closer to the stent 1 than the fixing section in the radial direction of the stent 1, and the whole of the attaching skirt 4 has a tendency to be away from the stent 1.
In some preferred embodiments, the attaching skirt 4 is provided in an annular structure, and the attaching skirt 4 is continuously and uninterruptedly provided along the periphery of the leakage preventing ring 3.
In some preferred embodiments, the length of the conformable skirt 4 does not exceed the length of the native leaflets.
In some preferred embodiments, the conformable skirt 4 is made of TPU material. The membrane made of TPU material is very soft and has very strong fitting performance, and when the valve prosthesis is implanted, the membrane can be tightly fitted with the native leaflet, so that the perivalvular leakage caused by the gap between the native leaflet and the leakage-proof ring 3 is avoided.
In some preferred embodiments, the containment ring 3 comprises an adaptive part 31, a gripping structure 32 and a reinforcing structure 33; the adaptive part 31 is arranged at the far end of the bracket 1; the reinforcing structure 33 is disposed between the proximal and distal ends of the stent 1, and the gripping structure 32 is disposed at the proximal end of the stent 1.
In some preferred embodiments, the adaptive member 31 is provided as a structure extending in a direction away from the stent 1 at the distal end of the stent 1; the outer diameter of the reinforcing structure 33 is smaller than the maximum outer diameter of the adaptive member 31.
In some preferred embodiments, the cross-sectional pattern of the clamping structure 32 is arranged in a V shape, one end of the V-shaped structure of the clamping structure 32 is fixed to the stent 1, and the other end of the V-shaped structure of the clamping structure 32 is aligned with the reinforcing structure 33 in the axial direction of the stent 1; the V-shaped structure of the gripping structure 32 opens distally.
In some preferred embodiments, the region of the reinforcing structure 33 has a rigidity greater than that of the rest of the containment ring 3.
The working principle is as follows: the valve prosthesis capable of effectively improving the perivalvular leakage is arranged in a heart valve ring and used for treating the tricuspid valve regurgitation as a replacement valve, the reinforcing structure is arranged on the clamping area of the valve prosthesis, so that the rigidity strength of the clamping area is greater than that of the attaching area, and the clamping area cannot be influenced by the movement of the self-adaptive component for attaching the heart tissue to randomly deviate after the autologous valve leaflet is clamped between the clamping mechanism and the reinforcing structure due to the fact that the clamping mechanism and the reinforcing structure have rigidity, so that the autologous valve leaflet has a good clamping effect, and the valve prosthesis can be stably fixed in the heart. The attaching skirt edge can effectively attach the native leaflets, so that after the valve prosthesis is implanted, a gap is reduced between the leakage-proof ring and heart tissue, and the attaching skirt edge can also attach the native leaflets in a clinging manner when the valve is opened and closed, so that perivalvular leakage is avoided.

Claims (10)

1. A valve prosthesis capable of effectively improving paravalvular leakage is characterized by comprising
The support (1), the support (1) is set to be a hollow annular structure;
the prosthetic valve leaflet (2), the prosthetic valve leaflet (2) is fixedly arranged inside the annular structure of the bracket (1);
a leakage-proof ring (3), the leakage-proof ring (3) being circumferentially arranged between the two rings;
the prosthetic valve leaflet (2) and the leakage-proof ring (3) are respectively fixedly connected with the bracket (1).
2. The valve prosthesis capable of effectively improving paravalvular leakage according to claim 1, wherein the distal end of the leakage-proof ring (3) is provided with an attaching skirt (4), the distal end of the attaching skirt (4) is fixedly connected with the leakage-proof ring (3), and the proximal end of the attaching skirt (4) extends towards the stent (1); when the valve prosthesis is implanted, the leakage-proof ring (3) is attached to the native valve annulus, and the attaching skirt (4) is attached to the native leaflets.
3. The valve prosthesis effective in improving paravalvular leakage according to claim 2, wherein said conformable skirt (4) comprises a fixed end (41) and a free end (42), said fixed end (41) being fixed at the distal end of said leakage prevention ring (3) and located in the inflow tract of the native valve, and said free end (42) being located in the outflow tract of the native valve.
4. Valve prosthesis effective in improving paravalvular leakage according to claim 3, characterized in that said free end (42) is closer to said stent (1) than said fixed section in the radial direction of said stent (1), said conforming skirt (4) having overall a tendency to move away from said stent (1).
5. The valve prosthesis capable of effectively improving paravalvular leakage according to claim 2, wherein said attaching skirt (4) is provided in an annular structure, and said attaching skirt (4) is continuously and uninterruptedly provided along the periphery of said leakage-proof ring (3).
6. The valve prosthesis effective in improving paravalvular leakage according to claim 1, wherein said conformable skirt (4) has a length not exceeding the length of the native leaflets.
7. The valve prosthesis effective in improving paravalvular leakage according to claim 1, wherein said conformable skirt (4) is made of TPU material.
8. The valve prosthesis effective in improving paravalvular leakage according to claim 1, wherein said leakage-proof ring (3) comprises an adaptive component (31), a clamping structure (32) and a reinforcing structure (33); the adaptive component (31) is arranged at the far end of the bracket (1); the reinforcing structure (33) is arranged between the proximal end and the distal end of the stent (1), and the clamping structure (32) is arranged at the proximal end of the stent (1).
9. The valve prosthesis capable of effectively improving paravalvular leakage according to claim 8, wherein the adaptive component (31) is provided in a structure extending in a direction away from the stent (1) at the distal end of the stent (1); the outer diameter of the reinforcing structure (33) is smaller than the maximum outer diameter of the adaptive part (31).
10. The valve prosthesis capable of effectively improving paravalvular leakage according to claim 9, wherein the cross-sectional pattern of the clamping structure (32) is arranged in a V shape, one end of the V-shaped structure of the clamping structure (32) is fixed with the stent (1), and the other end of the V-shaped structure of the clamping structure (32) is aligned with the reinforcing structure (33) in the axial direction of the stent (1); the V-shaped structure of the clamping structure (32) opens towards the distal end.
CN202110864529.8A 2021-07-29 2021-07-29 Valve prosthesis capable of effectively improving perivalvular leakage Pending CN113545892A (en)

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CN202110864529.8A CN113545892A (en) 2021-07-29 2021-07-29 Valve prosthesis capable of effectively improving perivalvular leakage

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Application Number Priority Date Filing Date Title
CN202110864529.8A CN113545892A (en) 2021-07-29 2021-07-29 Valve prosthesis capable of effectively improving perivalvular leakage

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115089345A (en) * 2022-06-02 2022-09-23 北京市普惠生物医学工程有限公司 Artificial valve fixing device, artificial valve fixing device conveying system and artificial valve fixing device conveying method

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140296969A1 (en) * 2013-04-02 2014-10-02 Tendyne Holdlings, Inc. Anterior Leaflet Clip Device for Prosthetic Mitral Valve
US20150094802A1 (en) * 2012-02-28 2015-04-02 Mvalve Technologies Ltd. Single-ring cardiac valve support
CN106456328A (en) * 2014-05-19 2017-02-22 爱德华兹生命科学卡迪尔克有限责任公司 Replacement mitral valve with annular flap
US20170216024A1 (en) * 2014-08-03 2017-08-03 Mvalve Technologies Ltd. Sealing elements for intracardiac devices
CN209377809U (en) * 2018-10-15 2019-09-13 上海微创心通医疗科技有限公司 A kind of heart valve prosthesis prosthese and its bracket
CN111970995A (en) * 2018-02-28 2020-11-20 爱德华兹生命科学公司 Prosthetic mitral valve with improved anchor and seal

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150094802A1 (en) * 2012-02-28 2015-04-02 Mvalve Technologies Ltd. Single-ring cardiac valve support
US20140296969A1 (en) * 2013-04-02 2014-10-02 Tendyne Holdlings, Inc. Anterior Leaflet Clip Device for Prosthetic Mitral Valve
CN106456328A (en) * 2014-05-19 2017-02-22 爱德华兹生命科学卡迪尔克有限责任公司 Replacement mitral valve with annular flap
US20170216024A1 (en) * 2014-08-03 2017-08-03 Mvalve Technologies Ltd. Sealing elements for intracardiac devices
CN111970995A (en) * 2018-02-28 2020-11-20 爱德华兹生命科学公司 Prosthetic mitral valve with improved anchor and seal
CN209377809U (en) * 2018-10-15 2019-09-13 上海微创心通医疗科技有限公司 A kind of heart valve prosthesis prosthese and its bracket

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115089345A (en) * 2022-06-02 2022-09-23 北京市普惠生物医学工程有限公司 Artificial valve fixing device, artificial valve fixing device conveying system and artificial valve fixing device conveying method

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