CN114041903A - Repair device for preventing mitral valve regurgitation - Google Patents
Repair device for preventing mitral valve regurgitation Download PDFInfo
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- CN114041903A CN114041903A CN202111403260.XA CN202111403260A CN114041903A CN 114041903 A CN114041903 A CN 114041903A CN 202111403260 A CN202111403260 A CN 202111403260A CN 114041903 A CN114041903 A CN 114041903A
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- fixing part
- flow
- rod piece
- valve
- prosthetic device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
Abstract
The present invention provides a prosthetic device for preventing mitral regurgitation for use in surgically preventing valve regurgitation in a patient's heart. It is characterized by comprising a bracket and a flow resisting part, wherein the bracket comprises: the first fixing part is annular, a micro-thorn mechanism is arranged on the outer side of the first fixing part, and the flow choking part is arranged on the first fixing part. The second fixing part is spiral and made of shape memory metal wire materials, and is used for being stretched at one end and then shuttled between adjacent chordae tendineae of the heart of a patient in the operation process, and the second fixing part is wound on the adjacent chordae tendineae after external force is removed. And the connecting parts are respectively connected with the first fixing part and the second fixing part. The connecting part is provided with a support rod and a connecting rod. The supporting rod is strip-shaped, and two ends of the supporting rod are respectively connected to the first fixing part. The connecting rod piece is strip-shaped, one end of the connecting rod piece is connected to the middle of the supporting rod piece, and the other end of the connecting rod piece is connected to the other end of the second fixing portion.
Description
Technical Field
The present invention relates to a prosthetic device for preventing mitral regurgitation.
Background
Mitral regurgitation, left ventricular ejection of blood can occur through two pathways, the aortic and mitral valves. The greater the systemic afterload (i.e. blood pressure) the greater the reflux fraction. Chronic mitral regurgitation, passive expansion of the left atrium without significant pressure increase prevents early shortness of breath (which is very common in mitral stenosis), however, chronic increase in left ventricular preload causes dysfunction of left ventricular dilation and contraction, typically with a later onset of symptoms than mitral stenosis. Acute mitral regurgitation, of course, is immediately symptomatic in that the left atrial pressure rises suddenly without compliance. Mild mitral regurgitation has no obvious clinical symptoms, but when severe regurgitation is treated surgically.
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.
Patents US2009105751a1, CN101902975 describe a device for repairing a valve leaflet in a beating heart of a patient, which comprises a handle assembly, a capture assembly and a needle, wherein the valve leaflet is captured by the capture assembly, and the needle passes through the valve leaflet to limit the movement of the prolapsed valve leaflet so as to achieve the effect of preventing regurgitation, but the technique is operationally required to grasp the moving valve leaflet, is difficult and long in operation, and is easy to tear the autologous valve leaflet.
Patent US20130023985 describes an implant, implant system and method for treating valve insufficiency and other valve diseases, the implant comprising an auxiliary leaflet coaptation, the length of the upper portion of the leaflet coaptation fitting against the native annulus portion being 25-35mm, equal to the distance between the first and second coaptation interfaces, the length of the upper portion of the leaflet coaptation to the lower portion being 50-60mm, and optionally anchoring means provided on the leaflet coaptation, in another claim, in addition to defining the length of the upper portion to conform to the native annulus portion to be 25-35mm, defining the height of the leaflet coaptation portion perpendicular to the annulus to be 35-45mm, defining the height of the ventricular uncoaptation portion perpendicular to the annulus to be 25-35mm, and defining the radius of curvature of the coaptation portion to be within 35-45 mm. The system has length limitation for the upper part fitting the native valve ring part, is only suitable for the whole repair of mitral valve anterior valve or posterior valve prolapse and the whole leaflet prolapse repair of partial tricuspid valve, and shows that the lower length of the conjugant covers at least most leaflets, and the combination part has specific radian requirement. This technique does not accommodate the prolapse of a small valve or the repair of a smaller valve, such as the aortic valve, while sacrificing the remaining properly functioning valves in the repair of an incompetent site. In summary, the disadvantages include: first, it is explicitly stated that the length of the upper part of the coaptation body is equal to the distance between the first and second coaptation junctions, and thus is only suitable for the overall repair of the leaflets, the repair area including both the leaflet prolapse site and the leaflet normal site; second, the valve annulus lengths of individuals vary widely, the distance between the first and second junctional junctions is unpredictable prior to actual surgery, and it is difficult to precisely match product designs; thirdly, the shape of the conjugant part is cone-shaped, which strives to match the cone shape of the human valve leaflet, and the complete matching is difficult because of the difference of human bodies; fourth, the design is not suitable for repair in conjunction with leaflet prolapse.
Patent US20130325110a1 describes a method of treating mitral and tricuspid regurgitation by delivering a leaflet closing prosthesis without beating, the method comprising anchoring a ventricular anchor from the atrium through the native valve to the right ventricle, delivering and adjusting the position of the prosthesis at the tricuspid annulus using a catheter until regurgitation is reduced, securing the catheter relative to the flexible track and to the inferior vena cava. Although the position of the prosthesis can be adjusted by the delivery method to adapt to different reflux positions and have certain pathological adaptability, the position of the prosthesis at the fixed position of the inferior vena cava is far away from the valve ring position, so that the prosthesis is easily unstable to fix and can be displaced after the fixation is finished.
Disclosure of Invention
In order to solve the problems, the invention provides a repair device for preventing mitral regurgitation, which adopts the following technical scheme:
the present invention provides a prosthetic device for preventing mitral regurgitation for use in surgically preventing valve regurgitation in a patient's heart. It is characterized by comprising a bracket and a flow resisting part, wherein the bracket comprises: the first fixing part is annular, a micro-thorn mechanism is arranged on the outer side of the first fixing part, and the flow choking part is arranged on the first fixing part. The second fixing part is spiral and made of shape memory metal wire materials, and is used for being stretched at one end and then shuttled between adjacent chordae tendineae of the heart of a patient in the operation process, and the second fixing part is wound on the adjacent chordae tendineae after external force is removed. And the connecting parts are respectively connected with the first fixing part and the second fixing part. The connecting part is provided with a support rod and a connecting rod. The supporting rod is strip-shaped, and two ends of the supporting rod are respectively connected to the first fixing part. The connecting rod piece is strip-shaped, one end of the connecting rod piece is connected to the middle of the supporting rod piece, and the other end of the connecting rod piece is connected to the other end of the second fixing portion.
The repair device for preventing mitral regurgitation provided by the invention can also have the technical characteristics that the second fixing part is covered by the protective film.
The present invention provides a prosthetic device for preventing mitral regurgitation that may also have the technical feature that the resistive flow component has a width that is two-thirds of the deployed width of a single native leaflet of a patient's heart.
The repair device for preventing mitral valve regurgitation provided by the invention can also have the technical characteristics that the flow resisting part is a single piece, a plurality of pieces, a cylinder, a column or a balloon, or the flow resisting part is a combination of the single piece and the plurality of pieces, or the flow resisting part is a combination of the single piece and the cylinder, or the flow resisting part is a combination of the single piece and the column, or the flow resisting part is a combination of the single piece and the balloon.
The present invention provides a prosthetic device for preventing mitral regurgitation that may also have the technical feature wherein the flow-impeding component is a lattice structure.
The repair device for preventing mitral valve regurgitation provided by the invention can also have the technical characteristics that the flow resisting part is a high polymer material sheet or an animal-derived material sheet, and when the flow resisting part is the high polymer material sheet or the animal-derived material sheet, the holes are formed in the flow resisting part.
Action and Effect of the invention
According to the repair device for preventing mitral valve regurgitation, firstly, the repair device reserves the movement functions of the autologous valve leaflets and the valve leaflets, prevents the prolapsed valve leaflets from overturning through the flow blocking parts, thereby achieving the purpose of preventing the valve regurgitation, and has the advantages of less implants, good hemodynamics and the like.
Secondly, after the chordae tendineae are wound by the second fixing part, on one hand, the fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.
Finally, the invention provides a valve repair device with simpler structure and smaller volume, which can be percutaneously inserted and implanted through apex of heart minimally invasive, and simultaneously, the maximum width of the flow resisting part adopted by the invention is the design of the maximum width 2/3 of the expansion of a single self-valve leaflet, so that the valve repair device has better tissue compliance, reduces the possibility of damaging the valve leaflet, and is particularly suitable for repairing the prolapse of the combined valve leaflet.
Drawings
FIG. 1 is a schematic three-dimensional view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention;
FIG. 2 is an elevation view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention;
FIG. 3 is a schematic illustration of a bracket assembly according to an embodiment of the invention;
FIG. 4 is a schematic view of the connection between the connecting portion and the second fixing portion according to the embodiment of the present invention;
fig. 5 is a schematic structural diagram of a second fixing portion in the embodiment of the invention.
Detailed Description
In order to make the technical means, the original characteristics, the achieved objects and the effects of the present invention easily understood, a prosthetic device for preventing mitral regurgitation of the present invention will be described in detail with reference to the accompanying drawings.
< example >
FIG. 1 is a schematic three-dimensional view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention; fig. 2 is an elevation view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention.
As shown in fig. 1 and 2, a prosthetic device 01 for preventing mitral regurgitation includes a stent 1 and an obstructing member 2.
Fig. 3 is a schematic view of a bracket component in an embodiment of the invention.
As shown in fig. 3, the bracket 1 includes a first fixing portion 11, a second fixing portion 13, and a connecting portion 12.
The first fixing portion 11 is annular, the first fixing portion 11 is disposed in the atrium, and a micro-puncture mechanism 111 is provided on the outside. When the prosthetic device 01 is implanted, the micro-puncture structure 111 is punctured into the autologous valve annulus tissue; the micro-thorn structure 111 helps the first fixing part 11 to be anchored at the autologous valve annulus, so as to avoid the deviation of the repair device 01 after being implanted and ensure the repair effect.
The connecting portions 12 connect the first fixing portion 11 and the second fixing portion 13, respectively.
The connecting portion has a support link 121 and a connecting link 122.
The supporting rod 121 is strip-shaped, and two ends of the supporting rod are respectively connected to the first fixing portion 11. When the prosthetic device 01 is implanted, the support rod member 121 is positioned at the septal valve junction; the support rod member 121 is located at the valve partition junction, so that the repair device 01 can be prevented from affecting the operation of the native valve leaflets, and meanwhile, the repair device 01 can be prevented from swinging towards the atrium by the flow blocking part 2.
The connecting rod 122 is in a strip shape, one end of the connecting rod is connected to the middle of the supporting rod 121, and the other end of the connecting rod is connected to the other end of the second fixing portion 13.
FIG. 4 is a schematic view of the connection between the connecting portion and the second fixing portion according to the embodiment of the present invention; fig. 5 is a schematic structural diagram of a second fixing portion in the embodiment of the invention.
As shown in fig. 4 and 5, the second fixing portion 13 has a spiral shape, and the second fixing portion 13 has a preset spiral shape. When preassembling, the second fixing portion 13 is straightened to be in a linear state. On one hand, fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.
The second fixing portion 13 is made of shape memory metal wire material. The shape memory metal wire is further provided with a protective film 131 on the periphery, the protective film 131 can effectively prevent the tissue from being damaged, meanwhile, the protective film 131 can prevent the second fixing portion 13 from rubbing with the chordae tendineae, and the second fixing portion 13 can be restored to a preset shape according to a preset path during shuttling. For being shuttled between adjacent chordae tendineae of the patient's heart by one end being straightened and wrapped around the adjacent chordae tendineae upon removal of external force during a procedure.
The choke part 2 is provided on the first fixing portion 11.
The flow resisting part 2 is a single piece, a plurality of pieces, a cylinder, a column or a balloon, or the flow resisting part 2 is a combination of a single piece and a plurality of pieces, or the flow resisting part 2 is a combination of a single piece and a cylinder, or the flow resisting part 2 is a combination of a single piece and a column, or the flow resisting part 2 is a combination of a single piece and a balloon.
The flow resisting part 2 is of a grid structure, or the flow resisting part 2 is a high polymer material sheet or an animal-derived material sheet, and when the flow resisting part 2 is the high polymer material sheet or the animal-derived material sheet, holes are formed in the flow resisting part 2.
The flow resisting part 2 is positioned between the patient's autologous valve leaflets in a free state, the maximum width of the flow resisting part 2 is smaller than the maximum width of the single autologous valve leaflet, and preferentially, the maximum width of the flow resisting part 2 is 2/3 of the maximum width of the single autologous valve leaflet.
After the prosthetic device 01 is implanted into the heart, along with the impact of blood flow, the flow blocking part 2 is opened along with the impact, and when the native valve is in the closed state, the flow blocking part 2 is located in the middle area of the native valve, and the flow blocking part 2 can avoid the gap between adjacent valve leaflets, so that the problem of paravalvular leakage is well prevented.
A method of using a prosthetic device 01 for preventing mitral regurgitation in this embodiment is as follows: when preassembling, the second fixing portion 13 is straightened to be in a linear state. When the prosthetic device 01 is implanted, the second fixing part 13 is shuttled between adjacent chordae tendineae of the heart of the patient by being straightened at one end and wound around the adjacent chordae tendineae after the external force is removed, and the micro-barbed structure 111 of the first fixing part 11 is inserted into the native annulus tissue and is fixed in position. And the choke part 2 is opened along with the impact of the blood flow, when the native valve is in a closed state, the choke part 2 is positioned in the middle area of the native valve, and the mitral valve is prevented from regurgitating.
Examples effects and effects
According to the prosthetic devices for preventing mitral regurgitation provided by the embodiment, firstly, the motion functions of the autologous valve leaflets and the valve leaflets are kept, and the prolapsed valve leaflets are prevented from overturning through the flow blocking parts, so that the aim of preventing the valve regurgitation is fulfilled.
Secondly, after the chordae tendineae are wound by the second fixing part, on one hand, the fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.
Finally, the embodiment provides a valve repair device with a simpler structure and a smaller volume, the valve repair device can be percutaneously inserted and can be implanted through apical minimally invasive surgery, and meanwhile, the maximum width of the flow blocking part adopted by the invention is the maximum width 2/3 of the expansion of the single self-valve leaflet, so that the valve repair device has better tissue compliance, reduces the possibility of damaging the valve leaflet, and is particularly suitable for repairing the prolapse of the combined valve leaflet.
The above-described embodiments are merely illustrative of specific embodiments of the present invention, and the present invention is not limited to the description of the above-described embodiments.
Claims (6)
1. A prosthetic device for preventing mitral regurgitation for use in surgically inhibiting valve regurgitation in a patient's heart, comprising a stent and flow-obstructing components,
wherein, the support includes:
the first fixing part is annular, a micro-thorn mechanism is arranged on the outer side of the first fixing part, and the flow choking part is arranged on the first fixing part;
a second fixing part in a spiral shape, made of a shape memory metal wire material, for being shuttled between adjacent chordae tendineae of the heart of the patient through one end of the second fixing part being straightened and wound around the adjacent chordae tendineae after external force is removed during an operation;
a connecting part respectively connecting the first fixing part and the second fixing part,
the connecting part is provided with a supporting rod piece and a connecting rod piece,
the supporting rod piece is strip-shaped, two ends of the supporting rod piece are respectively connected to the first fixing part,
the connecting rod piece is strip-shaped, one end of the connecting rod piece is connected to the middle of the supporting rod piece, and the other end of the connecting rod piece is connected to the other end of the second fixing portion.
2. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein:
wherein the second fixing portion is covered with a protective film.
3. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein:
wherein the flow-impeding component width is two-thirds of a single native leaflet deployment width of the patient's heart.
4. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein:
the flow resisting part is a single piece, a plurality of pieces, a cylinder, a column or a balloon, or the flow resisting part is a combination of the single piece and the plurality of pieces, or the flow resisting part is a combination of the single piece and the cylinder, or the flow resisting part is a combination of the single piece and the balloon.
5. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein:
wherein the flow resisting parts are of a grid structure.
6. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein:
wherein, the choked flow part is made of high molecular material or animal source material, and the choked flow part is provided with holes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111403260.XA CN114041903A (en) | 2021-11-24 | 2021-11-24 | Repair device for preventing mitral valve regurgitation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111403260.XA CN114041903A (en) | 2021-11-24 | 2021-11-24 | Repair device for preventing mitral valve regurgitation |
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| Publication Number | Publication Date |
|---|---|
| CN114041903A true CN114041903A (en) | 2022-02-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111403260.XA Pending CN114041903A (en) | 2021-11-24 | 2021-11-24 | Repair device for preventing mitral valve regurgitation |
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| CN (1) | CN114041903A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116965976A (en) * | 2023-09-11 | 2023-10-31 | 上海傲流医疗科技有限公司 | Valve gap filling and repairing device |
-
2021
- 2021-11-24 CN CN202111403260.XA patent/CN114041903A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116965976A (en) * | 2023-09-11 | 2023-10-31 | 上海傲流医疗科技有限公司 | Valve gap filling and repairing device |
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