CN115089345B - Artificial valve fixing device and artificial valve fixing device conveying system - Google Patents
Artificial valve fixing device and artificial valve fixing device conveying system Download PDFInfo
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- CN115089345B CN115089345B CN202210626240.7A CN202210626240A CN115089345B CN 115089345 B CN115089345 B CN 115089345B CN 202210626240 A CN202210626240 A CN 202210626240A CN 115089345 B CN115089345 B CN 115089345B
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a prosthetic valve fixing device and a prosthetic valve fixing device conveying system, which comprise a fixing frame, wherein the fixing frame is elastic, a clamping cavity is formed on the fixing frame, and a plurality of first clamping arms and second clamping arms are formed on the fixing frame; a first clamping surface is formed on the first clamping arm, the first clamping surface faces the second clamping arm, a second clamping surface is formed on the second clamping arm, the second clamping surface faces the first clamping arm, and the first clamping surface and the second clamping surface are close to each other; be equipped with anchor assembly on the first arm lock, anchor assembly orientation the second arm lock, or all be equipped with on first arm lock and the second arm lock anchor assembly on the first arm lock is towards the second arm lock anchor assembly on the second arm lock is towards first arm lock. The valve can improve the connection stability of the artificial valve ring and the valve sinus, and prevent the whole artificial valve from shifting and losing the effect caused by the shifting of the artificial valve ring.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a prosthetic valve fixing device and a prosthetic valve fixing device conveying system.
Background
The aortic valve regurgitation of the heart is mainly caused by deformation, thickening, calcification and limited movement of the aortic valve leaflets due to various reasons, so that the valves are insufficiently closed, and ejected blood flows back to the left ventricle; this results in a reduction in effective stroke volume due to blood backflow, known as aortic insufficiency, which is mostly combined with varying degrees of aortic stenosis. The most frequent causes of aortic insufficiency are rheumatic valvular heart diseases, and bacterial endocarditis, marfan's syndrome, congenital aortic valve malformations, aortic dissection aneurysms and the like are also common causes which can cause aortic insufficiency clinically.
At present, the treatment mode of aortic valve regurgitation is mainly realized by implanting a prosthetic valve to replace a native valve, and because aortic valve regurgitation and aortic valve leaflets are calcified differently, if an anchoring mechanism is not arranged on a valve support, the valve support is easy to displace. The current common mode mainly comprises two modes of arranging an anchoring mechanism on a valve support or adopting a split type implantation mode, implanting an annulus firstly, implanting a prosthetic valve, and utilizing the annulus to clamp a native valve leaflet and the prosthetic valve (the native valve leaflet is positioned between the annulus and the prosthetic valve). The split type implantation mode has the advantage of firmer fixation, and the artificial valve does not need to be in direct contact with the valve ring, so that the conduction block caused by excessive radial force is avoided.
However, the connection between the existing valve ring and the artificial valve is smooth, so that the valve ring can still be displaced under the scouring of blood after clamping the native valve leaflets. Does not facilitate a secure connection between the annulus and the sinus valve.
Disclosure of Invention
The invention aims to provide a prosthetic valve fixing device and a prosthetic valve fixing device conveying system, which can improve the connection stability of a prosthetic valve ring and a valve sinus and prevent the integral displacement and the failure of the prosthetic valve caused by the displacement of the prosthetic valve ring.
The technical scheme for achieving the purpose comprises the following steps.
The invention provides a fixing device for a prosthetic valve, which comprises a fixing frame, wherein the fixing frame is elastic, a clamping cavity is formed on the fixing frame, and a plurality of first clamping arms and second clamping arms are formed on the fixing frame;
a first clamping surface is formed on the first clamping arm, the first clamping surface faces the second clamping arm, a second clamping surface is formed on the second clamping arm, the second clamping surface faces the first clamping arm, and the first clamping surface and the second clamping surface are close to each other;
be equipped with anchor assembly on the first arm lock, anchor assembly orientation second arm lock, or all be equipped with on first arm lock and the second arm lock anchor assembly orientation second arm lock is faced to anchor assembly on the first arm lock anchor assembly orientation on the second arm lock first arm lock.
In some embodiments, a supporting arm is formed on the fixing frame, a first connecting arm and a second connecting arm are arranged on the supporting arm, the first connecting arm is connected with the first clamping arm, the second connecting arm is connected with the second clamping arm, and the anchoring part is formed on the first connecting arm and/or the second connecting arm.
In some of the embodiments, the anchor is bent and includes a main body and a barb, and a limiting clip groove is formed between the barb and the main body.
In some embodiments, the mount is an integrally formed ring, a plurality of closed frame bodies are formed on the mount, each frame body includes a first clamping arm and a second clamping arm, the top portions of the first clamping arm and the second clamping arm are elastically connected, the support arm is arranged on the frame body, the bottom portion of the support arm is provided with a first connecting arm, the first connecting arm is connected with the first clamping arm, the top portion of the support arm is provided with a second connecting arm, the second connecting arm faces the second clamping arm and is bent, the second connecting arm is connected with the second clamping arm, and an arc-shaped rod is formed between the two frame bodies.
The invention also provides a conveying system of the artificial valve fixing device, which comprises the artificial valve fixing device and a conveying sheath pipe, wherein a conveying guide pipe is arranged in the conveying sheath pipe, the end part of the conveying guide pipe is provided with the fixing frame, the conveying guide pipe is provided with a locking mechanism, and the locking mechanism is connected with the top and the bottom of the fixing frame.
In some of these embodiments, the delivery catheter comprises an outer catheter having a middle catheter disposed therein and an inner catheter disposed therein, the middle catheter slidably engaging the outer catheter and the inner catheter slidably engaging the middle catheter.
In some of these embodiments, the locking mechanism includes a first locking member that fits over the middle catheter and a second locking member that fits over the inner catheter.
In some embodiments, a plurality of first protrusions are disposed on the first locking member, a plurality of second protrusions are disposed on the second locking member, a plurality of first fasteners engaged with the first protrusions are disposed at the top end of the fixing frame, and a second fastener engaged with the second protrusions is disposed at the bottom end of the first clip arm.
In some embodiments, a supporting arm is formed on the fixing frame, a plurality of connecting buckles are arranged on the supporting arm, and the top ends of the connecting buckles are bent towards the clamping cavity.
The invention also provides a method for conveying the artificial valve fixing device, which comprises the following steps:
the delivery sheath enters the aorta, the delivery catheter pushes the fixing frame out of the delivery sheath, and the fixing frame is unfolded;
the delivery conduit presses the fixing frame against the aortic sinus, the bottom of the fixing frame is separated from the delivery conduit, and the first clamping arm and the second clamping arm of the fixing frame are matched to clamp the native valve leaflets;
the top of the mount is detached from the delivery catheter, and the delivery sheath and delivery catheter are withdrawn from the aorta.
The artificial valve fixing device provided by the invention is used for clamping an artificial valve by forming the clamping cavity on the elastic fixing frame, the first clamping arm and the second clamping arm are formed on the fixing frame, the first clamping surface is formed on the first clamping arm, the second clamping surface is formed on the second clamping arm, the first clamping surface and the second clamping surface are close to each other, when the device is used, the first clamping surface and the second clamping surface clamp native valve leaflets on aortic sinus through tensioning of the first clamping arm and the second clamping arm, and the anchoring piece is inserted into the native valve leaflets when the first clamping surface and the second clamping surface clamp the native valve leaflets on the aortic sinus, so that the stability of clamping the native valve leaflets is further improved, the connection stability of the fixing frame on the aortic valve sinus is improved, the situation that the fixing frame and the artificial valve in the clamping cavity are integrally displaced and lose the function is avoided.
The artificial valve fixing device provided by the invention has the advantages that the anchoring piece is arranged to be bent and comprises the main body and the barb, the limiting clamping groove is formed between the barb and the main body, after the anchoring piece is inserted into the native valve leaflet, the end part of the barb extends from one side to the other side of the native valve leaflet, at the moment, if the barb is to be separated from the inserting direction, the other end part of the barb is inserted from the other side of the native valve leaflet, and part of the native valve leaflet is clamped in the limiting clamping groove, so that the barb cannot be separated from the native valve leaflet, and the connection stability of the anchoring piece and the native valve leaflet is improved.
The artificial valve fixing device provided by the invention is characterized in that a plurality of frame bodies are formed by arranging a fixing frame in an integrally formed annular shape, the frame bodies are connected through arc-shaped rods, each frame body comprises a first clamping arm and a second clamping arm, a supporting arm is arranged in each frame body, a first connecting arm connected with the first clamping arm is arranged at the bottom of each supporting arm, and a first connecting arm connected with the second clamping arm after being bent towards the second clamping arm is arranged at the top of each supporting arm; when processing, only need process a plurality of interconnect's framework on the cylinder, process out the support arm in the framework, then buckle the framework and can form first arm lock and the second arm lock that draws close each other, make the second linking arm at support arm top buckle simultaneously when the framework is buckled, can effectively reduce the manufacturing degree of difficulty and the manufacturing cost of mount.
According to the conveying system provided by the invention, the conveying guide pipe is arranged in the conveying sheath pipe, the end part of the conveying guide pipe is provided with the fixing frame and the locking mechanisms connected with the top and the bottom of the fixing frame, and the connecting stability of the fixing frame and the conveying guide pipe is improved by utilizing the locking mechanisms.
According to the conveying system provided by the invention, the locking mechanism is arranged to comprise the outer layer conduit, the middle layer conduit arranged in the outer layer conduit and the inner layer conduit arranged in the middle layer conduit, the first locking piece connected with the top of the fixing frame is arranged on the middle layer conduit, the second locking piece connected with the bottom of the fixing frame is arranged on the inner layer conduit, when the conveying conduit feeds the fixing frame into the aortic valve sinus, the second convex block on the second locking piece and the second buckling piece at the bottom end of the first clamping arm can be unlocked by utilizing the relative sliding of the inner layer conduit and the middle layer conduit, the first clamping arm is elastically reset, the valve leaf is clamped by the second clamping arm, then the connection of the first buckling piece at the top of the fixing frame and the first convex block on the first locking piece is unlocked by utilizing the relative sliding of the middle layer conduit and the outer layer conduit or the middle layer conduit and the inner layer conduit, the conveying conduit is separated from the fixing frame, so that the conveying sheath conduit is evacuated from the aorta, and the releasing convenience of the fixing frame is improved.
According to the conveying system provided by the invention, the plurality of connecting buckles bent towards the clamping cavity are arranged on the supporting arm, and when the artificial valve is clamped in the clamping cavity, the connecting buckles are buckled on the valve frame of the artificial valve, so that the connecting stability of the artificial valve is improved.
Drawings
FIG. 1 is a front view of an unlocked state of the prosthetic valve fixation device of the present invention;
FIG. 2 is a top view of the prosthetic valve fixation device of the present invention in an unlocked state;
FIG. 3 is a perspective view of the prosthetic valve fixation device of the present invention in an unlocked state;
FIG. 4 is a front view of the prosthetic valve fixation device of the present invention in a locked state;
FIG. 5 is a top view of the prosthetic valve fixation device of the present invention in a locked state;
FIG. 6 is a perspective view of the prosthetic valve fixation device of the present invention in a locked state;
FIG. 7 is a schematic view of the delivery system of the present invention entering the aorta;
FIG. 8 is a schematic view of the mechanism of the present invention with the prosthetic valve fixation device extended from the delivery system;
FIG. 9 is a schematic view of the prosthetic valve fixation device of the present invention deployed within the aorta;
FIG. 10 is an enlarged partial view of portion A of FIG. 9 of the present invention;
FIG. 11 is a schematic view of the prosthetic valve attachment device of the present invention pressed against the aortic sinus;
FIG. 12 is an enlarged partial view of portion B of FIG. 11 in accordance with the present invention;
FIG. 13 is a schematic structural view of a portion of the prosthetic valve fixation device and delivery system of the present invention;
FIG. 14 is a schematic view of the prosthetic valve fixation device of the present invention fully unlocked with the delivery system;
FIG. 15 is an enlarged partial view of portion C of FIG. 14 of the present invention;
FIG. 16 is a schematic view of the prosthetic valve of the present invention implanted in the aorta;
FIG. 17 is a schematic view of the present invention with a prosthetic valve secured to a prosthetic valve securing device;
FIG. 18 is an enlarged partial view of section D of FIG. 17 in accordance with the present invention;
FIG. 19 is an initial state view of the prosthetic valve fixation device of the present invention;
FIG. 20 is the expanded state of FIG. 19 of the present invention;
FIG. 21 is a schematic view of the present invention shown in FIG. 20 after folding;
fig. 22 is a developed state diagram of fig. 21 of the present invention.
Description of the reference numerals:
10. a fixed mount; 11. a first clamp arm; 12. a second clamp arm; 103. a frame body; 104. a support arm; 1041. a first connecting arm; 1042. a second connecting arm; 1043. a first fastener; 1044. a connecting rod; 105. an arc-shaped rod; 106. a second fastener; 107. connecting buckles; 108. a clamping cavity;
20. an anchoring member; 201. a main body; 202. a barb; 203. a limiting clamp groove;
30. a delivery sheath; 301. a delivery catheter; 3011. an outer conduit; 3012. a middle layer conduit; 3013. an inner conduit; 302. a first locking member; 3021. a first bump; 303. a second locking member; 3031. a second bump;
40. the valve sinus; 401. native valve leaflets; 50. a prosthetic valve; 501. a flap frame; 60. a second sheath.
Detailed Description
In order that the invention may be readily understood, specific embodiments thereof will be described in more detail below with reference to the accompanying drawings.
As used herein, unless otherwise specified or defined, "first, \ 8230," is used merely to distinguish between names, and does not denote a particular quantity or order.
As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items, unless specified or otherwise defined.
It should be noted that "fixed to" or "connected to" in this document may be directly fixed to or connected to one element or may be indirectly fixed to or connected to one element.
As shown in fig. 1 to 3, the artificial valve fixing device includes a fixing frame 10, the fixing frame 10 is elastic, a clamping cavity 108 for clamping the artificial valve 50 is formed on the fixing frame 10, a first clamping arm 11 and a second clamping arm 12 are formed on the fixing frame 10, a first clamping surface facing the second clamping arm 12 is formed on the first clamping arm 11, a second clamping surface facing the first clamping arm 11 is formed on the second clamping arm 12, the first clamping surface and the second clamping surface are close to each other, the first clamping arm 11 and the second clamping arm 12 are used for being fixed on the aortic valve sinus 40 when in use, and clamping the native valve leaflet 401 through the first clamping surface and the second clamping surface.
The first clamping arm 11 and the second clamping arm 12 are arc-shaped and are used for matching with the aortic sinus 40.
The fixing frame 10 is provided with a supporting arm 104, the supporting arm 104 is provided with a first connecting arm 1041 and a second connecting arm 1042, the first connecting arm 1041 is located at the bottom of the supporting arm 104 and connected with the first clamping arm 11, and the second connecting arm 1042 is located at the top of the supporting arm 104 and is bent towards the second clamping arm 12 and connected with the second clamping arm 12.
The first connecting arm 1041 or the second connecting arm 1042 is provided with an anchor 20, or the first connecting arm 1041 or the second connecting arm 1042 is provided with an anchor 20, the anchor 20 arranged on the first connecting arm 1041 faces the second connecting arm 1042 and the second clamping arm 12, and the anchor 20 arranged on the second connecting arm 1042 faces the first connecting arm 1041 and the first clamping arm 11.
The anchor 20 is bent and comprises a main body 201 and a barb 202, and a limited clamping groove 203 is formed between the barb 202 and the main body 201. When the fixing frame is used, the first clamping arm 11 and the second clamping arm 12 clamp the native valve leaflet 401, the barb 202 and the end of the main body 201 are inserted into the native valve leaflet 401, and the other end of the barb 202 is buckled on the native valve leaflet 401 in the direction opposite to the insertion direction of the anchor 20, so that a part of the native valve leaflet 401 is contained in the limiting clamping groove 203, the anchor 20 cannot be separated from the native valve leaflet 401 under the blocking of the barb 202, and the connection stability of the fixing frame 10 and the native valve leaflet 401 is improved.
The fixing frame 10 is an integrally formed annular arrangement and comprises a plurality of frame bodies 103 connected with each other, an arc-shaped rod 105 is formed between the frame bodies 103 to connect the frame bodies 103, the frame bodies 103 comprise a first clamping arm 11 and a second clamping arm 12, and the top of the first clamping arm 11 is elastically connected with the top of the second clamping arm 12, and the supporting arm 104 is arranged in the frame body 103. When machining, only a plurality of interconnected frame bodies 103 need to be machined on the cylinder, the supporting arm 104 is machined in the frame body 103, then the frame body 103 is bent to form a first clamping arm 11 and a second clamping arm 12 which are close to each other, and when the frame body 103 is bent, the second connecting arm 1042 at the top of the supporting arm 104 is bent, so that the manufacturing difficulty and the manufacturing cost of the fixing frame 10 can be effectively reduced.
The top of the supporting arm 104 is provided with a first fastener 1043 for connecting with a conveying system, and the bottom of the first clamping arm 11 is provided with a second fastener 106 for connecting with the conveying system.
The first clamping arm 11 is provided with at least one connecting buckle 107 for connecting with the artificial valve 50 installed in the clamping cavity 108, and the connecting buckle 107 bends towards the clamping cavity 108.
As shown in fig. 19 to 20, the frame body 103 is ring-shaped in an initial state, the supporting arm 104 is disposed inside the frame body 103, the first connecting arm 1041 is disposed on two sides of a top portion of the supporting arm 104, the second connecting arm 1042 is disposed on two sides of a bottom portion of the supporting arm 104, the first connecting arm 1041 is connected to the top portion of the frame body 103, and the second connecting arm 1042 is connected to the bottom portion of the frame body 103.
The anchoring member 20 is disposed on the top of the second connecting arm 1042, the first fastener 1043 is disposed on the bottom of the supporting arm 104, the anchoring member 20 is disposed on the top of the supporting arm 104, and the anchoring member 20 may also be disposed on the first connecting arm 1041.
A connecting rod 1044 is arranged at the bottom of the supporting arm 104, and the first fastening piece 1043 is arranged at the bottom end of the connecting rod 1044.
The second fastening member 106 is disposed at the top of the frame 103, and at least one connection buckle 107 is disposed at the bottom of the first connection arm 1041.
The structure of the fixing frame 10 shown in fig. 21 to 22 is formed by bending the fixing frame 10 shown in fig. 19 and 20, specifically, bending the frame 103 at a position above the arc rod 105 to form the first clamping arm 11 and the second clamping arm 12 which are close to each other, so that the supporting arm 104 is bent due to the bending of the frame 103, the first connecting arm 1041 is bent on the second connecting arm 1042 along with the supporting wall, at this time, the position of the first buckle 1043 in situ at the bottom of the supporting arm 104 and the position of the anchor 20 in situ at the top of the supporting arm 104 are reversed, and the connecting buckle 107 is located at the top end of the first connecting arm 1041 at this time.
As shown in fig. 4 to 6 and fig. 9, the present embodiment further provides a delivery system of a prosthetic valve fixing device, including the above prosthetic valve fixing device and a delivery sheath 30, a delivery catheter 301 is disposed in the delivery sheath 30, the end of the delivery catheter 301 is provided with the fixing frame 10, in an initial state, the delivery catheter 301 and the fixing frame 10 are both accommodated in the delivery sheath 30, and the fixing frame 10 abuts against the inner wall of the delivery sheath 30.
The conveying conduit 301 comprises an outer conduit 3011, a middle conduit 3012 is arranged in the outer conduit 3011, an inner conduit 3013 is arranged in the middle conduit 3012, the inner conduit 3013 is in sliding fit with the middle conduit 3012, and the middle conduit 3012 is in sliding fit with the outer conduit 3011 or the inner conduit 3013.
Be equipped with locking mechanism on conveying pipe 301, locking mechanism includes first retaining member 302 and second retaining member 303, first retaining member 302 is located on the middle level pipe 3012 be equipped with a plurality of first lugs 3021 on the first retaining member 302, at the support arm 104 top first lock 1043 orientation the centre gripping cavity 108 buckle and detain in the first lug 3021, with first retaining member 302 is connected be equipped with a plurality of second lugs 3031 on the second retaining member 303, first arm lock 11 orientation the centre gripping cavity 108 is buckled, and second lock 106 bottom first arm lock 11 detains in the second lug 3031, with second retaining member 303 is connected.
The locking mechanism is used for improving the connection stability of the fixing frame 10 and the conveying conduit 301, the inner conduit 3013 and the middle conduit 3012 are relatively slid to unlock the second lug 3031 on the second locking member 303 and the second fastener 106 at the bottom end of the first clamping arm 11, the first clamping arm 11 elastically resets and clamps the native valve leaflet 401 with the second clamping arm 12, then the middle conduit 3012 and the outer conduit 3011 or the middle conduit 3012 and the inner conduit 3013 are relatively slid to unlock the connection of the first fastener 1043 at the top of the fixing frame 10 and the first lug 3021 on the first locking member 302, and the conveying conduit 301 is separated from the fixing frame 10, so that the conveying sheath 30 is separated from the aorta, and the release convenience of the fixing frame 10 is improved.
As shown in fig. 7 to 15, the present embodiment further provides a method for delivering a prosthetic valve fixing device into an aortic valve sinus 40 by the delivery system, comprising the steps of:
the delivery sheath 30 into the aorta;
the conveying conduit 301 pushes the fixing frame 10 out of the conveying conduit 301, and the fixing frame 10 is elastically reset and unfolded in the aorta;
the conveying conduit 301 is rotated to search the position of the valve sinus 40, the fixing frame 10 is conveyed into the aortic valve sinus 40 through the conveying conduit 301, and the first clamping arm 11 and the second clamping arm 12 of the fixing frame 10 are pressed against the valve sinus 40 under the action of the conveying conduit 301;
the outer layer conduit 3011 and the middle layer conduit 3012 of the delivery conduit 301 are fixed in position, the inner layer conduit 3013 slides downwards or pulls upwards relative to the middle layer conduit 3012, so that the second projection 3031 is separated from the second fastener 106, the first clamping arm 11 is unlocked, the first clamping arm 11 elastically resets to be matched with the first clamping arm 11 to clamp the native valve leaflet 401, and the anchor 20 on the connecting arm penetrates into the native valve leaflet 401;
the position of the outer conduit 3011 of the delivery catheter 301, or the outer conduit 3011 and the inner conduit 3013 is fixed, the middle conduit 3012 slides downwards or pulls upwards relative to the outer conduit 3011 and the inner conduit 3013, so that the first bump 3021 is separated from the first fastener 1043, and the fixing frame 10 is completely separated from the delivery catheter 301;
the delivery catheter 301 is withdrawn from the aorta by the delivery sheath 30.
In the present embodiment, the displacement direction of the inner layer conduit 3013 and the middle layer conduit 3012 when unlocking with the fixing frame 10 is the same as or opposite to the orientation direction of the first bump 3021 and the second bump 3031, and the unlocking force is relatively small when the orientation direction is the same, so that the unlocking is relatively easy, and when the orientation direction is opposite, the unlocking force required to solve the problem is relatively large, and the unlocking is relatively difficult.
As shown in fig. 16 to 18, further comprising the step of implanting the prosthetic valve 50:
the prosthetic valve 50 enters the aorta under delivery of the second sheath 60;
the second sheath 60 feeds the artificial valve 50 into the clamping cavity 108 of the fixing frame 10;
when the artificial valve 50 is unfolded, the valve frame 501 of the artificial valve 50 butts against the first clamping arm 11 of the fixing frame 10;
the connecting buckle 107 on the first clamping arm 11 is buckled into the grid of the valve frame 501;
the first sheath is separated from the prosthetic valve 50 and withdrawn from the aorta.
According to the fixing device, the conveying system and the conveying method for the artificial valve 50 provided by the embodiment, the first clamping arm 11 and the second clamping arm 12 are formed on the fixing frame 10, when the fixing frame is used, the first clamping arm 11 and the second clamping arm 12 are tensioned, so that the first clamping surface and the second clamping surface clamp the native valve leaflet 401 on the aortic valve sinus 40, and the anchoring part 20 arranged on the first clamping arm 11 or the first clamping arm 11 and the second clamping arm 12 is used for pricking the native valve leaflet 401 in the native valve leaflet when the first clamping surface and the second clamping surface clamp the native valve leaflet 401 on the aortic valve sinus 40, so that the clamping stability of the native valve leaflet 401 is further improved, the connection stability of the fixing frame 10 on the aortic valve sinus 40 is improved, and the fixing frame 10 and the artificial valve 50 in the clamping cavity 108 are prevented from shifting integrally and losing the function.
The above examples are not intended to be exhaustive list based on the present invention, and there may be many other embodiments other than those listed. Any alterations and modifications without departing from the spirit of the invention are within the scope of the invention.
Claims (8)
1. The artificial valve fixing device is characterized by comprising a fixing frame, wherein the fixing frame is elastic, a clamping cavity is formed on the fixing frame, and a plurality of first clamping arms and second clamping arms are formed on the fixing frame;
a first clamping surface is formed on the first clamping arm, the first clamping surface faces the second clamping arm, a second clamping surface is formed on the second clamping arm, the second clamping surface faces the first clamping arm, and the first clamping surface and the second clamping surface are close to each other;
the first clamping arm is provided with an anchoring part, the anchoring part faces the second clamping arm, or the first clamping arm and the second clamping arm are both provided with the anchoring part, the anchoring part on the first clamping arm faces the second clamping arm, and the anchoring part on the second clamping arm faces the first clamping arm;
the fixing frame is in an integrally formed annular shape, a plurality of closed frame bodies are formed on the fixing frame, each frame body comprises a first clamping arm and a second clamping arm, and the tops of the first clamping arms and the second clamping arms are elastically connected;
be equipped with the support arm in the framework, be equipped with first linking arm in the bottom of support arm, first linking arm with first arm lock is connected, is equipped with the second linking arm at the top of support arm, second linking arm orientation the second arm lock is buckled, just the second linking arm with the second arm lock is connected, two be formed with the arc pole between the framework.
2. The prosthetic valve fixation device according to claim 1, wherein the support arm is formed on the fixation frame, the first connection arm and the second connection arm are provided on the support arm, the first connection arm is connected to the first clamp arm, the second connection arm is connected to the second clamp arm, and the anchor is formed on the first connection arm and/or the second connection arm.
3. The prosthetic valve fixation device of any one of claims 1 or 2, wherein the anchor is bent and comprises a main body and a barb, and a limiting clip groove is formed between the barb and the main body.
4. The delivery system of the prosthetic valve fixing device, comprising the prosthetic valve fixing device of any one of claims 1 to 3 and a delivery sheath, wherein a delivery catheter is arranged in the delivery sheath, the fixing frame is arranged at the end of the delivery catheter, and a locking mechanism is arranged on the delivery catheter and connected with the top and the bottom of the fixing frame.
5. The delivery system of claim 4, wherein the delivery catheter comprises an outer catheter, a middle catheter disposed within the outer catheter, and an inner catheter disposed within the middle catheter, the middle catheter slidably engaging the outer catheter, the inner catheter slidably engaging the middle catheter.
6. The delivery system of claim 5, wherein said locking mechanism comprises a first locking member and a second locking member, said first locking member being disposed over said middle catheter and said second locking member being disposed over said inner catheter.
7. The transport system of claim 6 wherein a plurality of first projections are provided on said first retaining member, a plurality of second projections are provided on said second retaining member, a plurality of first fasteners are provided at the top end of the mounting bracket for engaging said first projections, and a second fastener is provided at the bottom end of said first clip arm for engaging said second projections.
8. The conveying system as claimed in any one of claims 4 to 7, wherein a support arm is formed on the fixing frame, a plurality of connecting buckles are provided on the support arm, and top ends of the connecting buckles are bent toward the holding cavity.
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CN202210626240.7A CN115089345B (en) | 2022-06-02 | 2022-06-02 | Artificial valve fixing device and artificial valve fixing device conveying system |
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CN202210626240.7A CN115089345B (en) | 2022-06-02 | 2022-06-02 | Artificial valve fixing device and artificial valve fixing device conveying system |
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CN115089345B true CN115089345B (en) | 2023-04-14 |
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Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
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US7896915B2 (en) * | 2007-04-13 | 2011-03-01 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
WO2018178967A1 (en) * | 2017-03-27 | 2018-10-04 | Truleaf Medical Ltd. | Invertible valve support frame for use with prosthetic heart valve apparatus |
KR20230066375A (en) * | 2020-08-28 | 2023-05-15 | 아이엔큐비8 메디컬 테크놀로지스 엘엘씨 | artificial heart valve |
CN214967151U (en) * | 2021-03-19 | 2021-12-03 | 宁波健世科技股份有限公司 | Valve prosthesis with reinforcing structure |
CN215458984U (en) * | 2021-04-30 | 2022-01-11 | 沛嘉医疗科技(苏州)有限公司 | Valve stent and prosthetic valve assembly |
CN113545892A (en) * | 2021-07-29 | 2021-10-26 | 厦门大学附属心血管病医院 | Valve prosthesis capable of effectively improving perivalvular leakage |
CN216318216U (en) * | 2021-09-03 | 2022-04-19 | 梅举 | Clamping and positioning device for interventional valve and artificial valve system |
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