CN112618106A - Artificial valve leaflet device capable of being freely assembled and using method thereof - Google Patents

Artificial valve leaflet device capable of being freely assembled and using method thereof Download PDF

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Publication number
CN112618106A
CN112618106A CN202110022164.4A CN202110022164A CN112618106A CN 112618106 A CN112618106 A CN 112618106A CN 202110022164 A CN202110022164 A CN 202110022164A CN 112618106 A CN112618106 A CN 112618106A
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CN
China
Prior art keywords
leaflet
valve leaflet
artificial
valve
freely
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Pending
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CN202110022164.4A
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Chinese (zh)
Inventor
梁玉晨
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Qichen Shanghai Medical Equipment Co ltd
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Qichen Shanghai Medical Equipment Co ltd
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Publication date
Application filed by Qichen Shanghai Medical Equipment Co ltd filed Critical Qichen Shanghai Medical Equipment Co ltd
Priority to CN202110022164.4A priority Critical patent/CN112618106A/en
Publication of CN112618106A publication Critical patent/CN112618106A/en
Pending legal-status Critical Current

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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
    • A61F2/2463—Implants forming part of the valve leaflets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to the technical field of medical instruments, in particular to an artificial valve leaflet device capable of being freely assembled and a using method thereof, which comprises a single valve leaflet, a bracket, a sewing film and a fixing piece, wherein the single valve leaflet is used for being attached to a native valve leaflet or the root of the native valve leaflet; the bracket is connected to the end of the single valve leaf and used for extending the single valve leaf; the sewing film is sewn on the surface of the bracket; the fixing piece is a gasket sewed by a suture and/or an anchoring structure and is used for attaching and fixing the artificial valve leaflet device to the native valve leaflet. According to the freely assembled artificial valve leaflet device and the using method thereof, the artificial valve leaflet device is transported to the position of the native valve through the conveying device, can be used for backflow caused by reasons such as incomplete closure of the native valve and the like, is simple in structure, reduces the treatment cost of a patient, and meanwhile, the structural formula of the single valve leaflet is convenient for operation and is suitable for freely assembling and selecting different heart valve leaflets.

Description

Artificial valve leaflet device capable of being freely assembled and using method thereof
Technical Field
The invention relates to the technical field of medical instruments, in particular to an artificial valve leaflet device capable of being freely assembled and a using method thereof.
Background
Heart valves are divided into two groups, atrioventricular (mitral, tricuspid) and semilunar (aortic, pulmonary) valves, according to their respective morphology and function. Between the right atrium and the right ventricle is the tricuspid valve, between the right ventricle and the pulmonary artery is the pulmonary valve, between the left atrium and the left ventricle is the mitral valve, and between the left ventricle and the aorta is the aortic valve. The heart valve is like a one-way valve, controls the direction and flow of blood, and causes regurgitation when the structure is damaged, and the regurgitation is divided into primary regurgitation and secondary regurgitation according to the etiology, wherein the primary regurgitation is caused by the structural damage of the heart valve, and the secondary regurgitation is caused by the increase of the systolic pressure and the diastolic pressure of the ventricles, the enlargement of the ventricles and the enlargement of the valve annulus which cause the relative insufficiency of the leaflets. The conventional treatment scheme in the prior art is surgical valve replacement, and for example, patent document CN212089843U discloses a prosthetic heart valve, which includes a stent, a spacer, valve leaflets, a suture film and a suture thread; the stent is of a multi-layer reticular structure, and comprises a blood flow inflow end and a blood flow outflow end and is used for propping and connecting the original heart valve; the gasket is arranged at the blood flow outflow end of the bracket; the valve leaflet is arranged inside the blood outflow end of the support and is used for replacing the original heart valve; the suture films are arranged on the inner side and the outer side of the blood flow inflow end of the stent and are used for preventing paravalvular leakage; the bracket is provided with a suture hole; the valve leaf penetrates through the stitching hole and is stitched with the gasket, and the support and the valve leaf are stitched by a stitching film through a stitching line to form a heart valve prosthesis structure. The surgical trauma, risks, and long-term and expensive rehabilitation treatments after surgery of existing surgical valve replacements make a large number of patients reluctant to undergo surgery.
In view of the above technical problems, it is desirable to improve.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a freely assembled artificial valve leaflet device and a using method thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
a freely assemblable artificial leaflet device comprising a single leaflet for fitting on or at the root of a native leaflet, a stent, a suture film, and a fixture; the bracket is connected to the end of the single valve leaf and used for extending the single valve leaf; the sewing film is sewn on the surface of the bracket; the fixing piece is a gasket sewed by a suture and/or an anchoring structure and is used for attaching and fixing the artificial valve leaflet device to the native valve leaflet.
Preferably, the stent is a diamond grid structure and is formed by one or more of cutting, welding and weaving.
Preferably, the wall thickness of the bracket is 0.05-1 mm; the height of the bracket is 3-20 mm; the width of the support is 0.05-1 mm.
Preferably, the thickness of the single-piece valve leaflet is 0.05-0.1mm, and the material of the single-piece valve leaflet is one or a combination of more of bovine pericardium, porcine pericardium and porcine heart valve.
Preferably, the thickness of the sewing film is 0.01-1mm, and the sewing film is made of one or a combination of more of PET, polyurethane, PTFE and e-PTFE.
Preferably, the suture thread is made of one or more of PET, PTFE, PE, catgut, chemically synthesized PGA and pure natural collagen.
Preferably, the gasket is made of one or a combination of more of polyurethane, PET and PTFE.
Preferably, the anchoring structure material is one or a combination of more of a polymer material and a metal material.
Preferably, the anchoring structure is a helical anchor.
A method of using a freely assemblable prosthetic leaflet device, comprising the steps of:
s1, the artificial valve leaflet device is collected into the conveying device and conveyed to the target native valve leaflet position through the conveying device;
s2, releasing the artificial valve leaflet device to the target native valve leaflet through the delivery device;
s3, attaching and fixing the artificial valve leaflet device to the target native valve leaflet through a fixing piece;
and S4, removing the conveying device.
Compared with the prior art, the freely-assembled artificial valve leaflet device and the using method thereof are transported to the native valve position through the conveying device, can be used for regurgitation caused by reasons such as incomplete closure of the native valve and the like, have simple structure, reduce the treatment cost of patients, and meanwhile, the structural formula of the single valve leaflet is convenient for the operation and is suitable for the free assembly selection of different heart valve leaflets.
Drawings
Fig. 1 is a structural view of a single-piece leaflet and stent portion of a freely assemblable prosthetic leaflet device according to a first embodiment of the present invention;
fig. 2 is a schematic view illustrating an overall structure of a freely assemblable artificial leaflet device according to a first embodiment of the present invention;
fig. 3 is a schematic view illustrating an implantation completion state of the freely assemblable artificial leaflet device according to the first embodiment of the present invention;
fig. 4 is a structural view illustrating an anchoring structure of a freely assemblable artificial leaflet device according to a second embodiment of the present invention;
fig. 5 is a schematic view illustrating an implantation completion state of the freely assemblable artificial leaflet device according to the second embodiment of the present invention;
fig. 6 is an enlarged schematic view of an implantation completion state of the freely assemblable artificial leaflet device of the second embodiment of the present invention;
wherein: 1. the artificial heart valve comprises a single valve leaf, 2 parts of a bracket, 3 parts of a sewing membrane, 4 parts of a gasket, 5 parts of a sewing line and 6 parts of an anchoring structure.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.
The first embodiment is as follows:
as shown in fig. 1 to 3, the freely assemblable artificial leaflet device of this embodiment is used for regurgitation caused by valve insufficiency, is released by a delivery system, and is fixed with the native leaflets by the fixing members.
The single-piece valve leaflet is used for being attached to a native valve leaflet or the root of the native valve leaflet; the bracket is connected to the end part of the single valve leaflet and is used for extending the single valve leaflet, and the bracket of the embodiment extends to cover the upper surface of the native valve leaflet; the sewing film is sewed and covered on the surface of the bracket; form the laminating through mounting and native valve leaf and fix, guarantee that artifical valve leaf can not take place to shift under the blood flow strikes, select for use the sutural gasket of suture for the mounting of this example of reduce cost.
The stent is of a rhombic grid structure, the stent is more firm when being covered with a sewing film, the sewing film is prevented from falling off, the contact area with valve leaflets is increased, and the stent is formed by one or more modes of cutting, welding and weaving; the wall thickness of the bracket is 0.05-1mm, the height of the bracket is 3-20mm, the rod width of the bracket is 0.05-1mm, the rod width refers to the width of the rod forming the bracket, the size of the bracket under the size is more suitable for production and use, and the size is preferably selected according to the native valve leaflet injury of a patient and the heart pressure environment.
The material of the single valve leaf is selected from one or a plurality of bovine pericardium, porcine pericardium and porcine heart valve; the thickness of the single-piece valve leaflet is designed to be 0.05-0.1mm, and is preferably selected according to the damage condition of the native valve leaflet of a patient.
The material of the sewing film is one or a combination of more of PET, polyurethane, PTFE and e-PTFE, preferably PET; the thickness of the suture film is 0.01-1mm, and is preferably selected according to the damage condition of the native valve leaflet of the patient.
The suture thread is made of one or more of PET, PTFE, PE, catgut, chemically synthesized PGA and pure natural collagen, preferably PTFE; the gasket is made of one or a combination of polyurethane, PET and PTFE. The gasket is sewed on the upper part and the lower part of the artificial valve leaflet through a suture line so as to realize the joint between the valve leaflets.
Accordingly, the present embodiment also provides a method for using a freely assemblable artificial leaflet device, comprising the steps of:
s1, the artificial valve leaflet device is collected into the conveying device and conveyed to the target native valve leaflet position through the conveying device;
s2, releasing the artificial valve leaflet device to the target native valve leaflet through the delivery device;
s3, sewing the shim on the upper part and the lower part of the artificial valve leaflet through a sewing thread, and attaching and fixing the artificial valve leaflet device on the target native valve leaflet;
and S4, removing the conveying device.
The artificial valve leaflet device capable of being freely assembled can be used for regurgitation caused by incomplete closing of the valve, the valve leaflets are released through the delivery system and are fixed with the native valve leaflets through the sewing films and the sewing threads, time and labor are saved, and meanwhile, the structural formula of the single valve leaflet is convenient for the operation and is suitable for the free assembly selection of different heart valve leaflets.
Example two:
as shown in fig. 4 to 6, the freely-assemblable artificial leaflet device of the present embodiment differs from that of the first embodiment in that:
the fixing piece adopts an anchoring structure, the anchoring piece is anchored and fixed by a more time-saving and labor-saving anchoring piece, the anchoring piece is preferably an anchoring piece with a spiral structure, the diameter of a thread is 0.1-3mm, the height of the thread is 0.5-10mm, the anchoring piece can be arranged according to actual requirements, and the anchoring structure is made of one or more of high polymer materials and metal materials. Furthermore, the fixing piece can be a combination of a pad sewed by a suture line and an anchoring structure, so that the stability is enhanced, and the fixing piece is suitable for patients with larger heart pressure environment.
The stent of the first embodiment extends to cover the upper surface of the native valve leaflet, and the stent of the first embodiment extends to wrap the whole native valve leaflet, so that the stent is more suitable for patients with serious damage to the native valve leaflet.
Accordingly, the present embodiment also provides a method for using a freely assemblable artificial leaflet device, comprising the steps of:
s1, the artificial valve leaflet device is collected into the conveying device and conveyed to the target native valve leaflet position through the conveying device;
s2, releasing the artificial valve leaflet device to the target native valve leaflet through the delivery device;
s3, attaching and fixing the artificial valve leaflet device to the target native valve leaflet through spiral puncture of the anchoring piece;
and S4, removing the conveying device.
Other structures refer to the first embodiment.
The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.

Claims (10)

1. A freely assembled artificial valve leaflet device is characterized by comprising a single valve leaflet, a bracket, a sewing film and a fixing piece, wherein the single valve leaflet is used for being attached to a native valve leaflet or a native valve leaflet root; the bracket is connected to the end of the single valve leaf and used for extending the single valve leaf; the sewing film is sewn on the surface of the bracket; the fixing piece is a gasket sewed by a suture and/or an anchoring structure and is used for attaching and fixing the artificial valve leaflet device to the native valve leaflet.
2. The freely assemblable prosthetic leaflet device of claim 1, wherein the stent is a diamond-shaped lattice structure formed by one or more of cutting, welding, and weaving.
3. The freely assemblable artificial leaflet device of claim 2, wherein the stent has a wall thickness of 0.05-1 mm; the height of the bracket is 3-20 mm; the width of the support is 0.05-1 mm.
4. The freely assemblable artificial leaflet device of claim 3, wherein the single leaflet has a thickness of 0.05-0.1mm and is made of one or more of bovine pericardium, porcine pericardium and porcine heart valve.
5. The freely assemblable artificial leaflet device of claim 4, wherein the thickness of the suture film is 0.01-1mm, and the material of the suture film is one or more of PET, polyurethane, PTFE, and e-PTFE.
6. The freely assemblable prosthetic leaflet device of claim 1, wherein the suture material is one or more of PET, PTFE, PE, catgut, chemically synthesized PGA, and pure native collagen.
7. The freely assemblable prosthetic valve leaflet device of claim 6, wherein the spacer is made of one or more of polyurethane, PET, and PTFE.
8. The freely assemblable prosthetic leaflet device of claim 1, wherein the anchoring structural material is one or more of polymeric material, metallic material, or a combination thereof.
9. The freely assemblable prosthetic leaflet device of claim 8, wherein the anchoring structure is a helical anchor.
10. The use of a freely assemblable artificial leaflet device as set forth in any one of claims 1 to 9, which comprises the steps of:
s1, the artificial valve leaflet device is collected into the conveying device and conveyed to the target native valve leaflet position through the conveying device;
s2, releasing the artificial valve leaflet device to the target native valve leaflet through the delivery device;
s3, attaching and fixing the artificial valve leaflet device to the target native valve leaflet through a fixing piece;
and S4, removing the conveying device.
CN202110022164.4A 2021-01-08 2021-01-08 Artificial valve leaflet device capable of being freely assembled and using method thereof Pending CN112618106A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110022164.4A CN112618106A (en) 2021-01-08 2021-01-08 Artificial valve leaflet device capable of being freely assembled and using method thereof

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Application Number Priority Date Filing Date Title
CN202110022164.4A CN112618106A (en) 2021-01-08 2021-01-08 Artificial valve leaflet device capable of being freely assembled and using method thereof

Publications (1)

Publication Number Publication Date
CN112618106A true CN112618106A (en) 2021-04-09

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CN202110022164.4A Pending CN112618106A (en) 2021-01-08 2021-01-08 Artificial valve leaflet device capable of being freely assembled and using method thereof

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113198045A (en) * 2021-04-29 2021-08-03 武汉纺织大学 Fitting type biological valve and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113198045A (en) * 2021-04-29 2021-08-03 武汉纺织大学 Fitting type biological valve and preparation method thereof

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