CN111067666B - Transcatheter valve replacement system - Google Patents
Transcatheter valve replacement system Download PDFInfo
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- CN111067666B CN111067666B CN201911299162.9A CN201911299162A CN111067666B CN 111067666 B CN111067666 B CN 111067666B CN 201911299162 A CN201911299162 A CN 201911299162A CN 111067666 B CN111067666 B CN 111067666B
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- catheter
- valve replacement
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
Abstract
The application relates to a transcatheter valve replacement system, which comprises a valve replacement prosthesis, a delivery catheter, a control handle and an anchoring device, wherein the valve replacement prosthesis comprises a valve support, an artificial valve leaflet and a self-adaptive film-covered support, the artificial valve leaflet is arranged in the valve support, the self-adaptive film-covered support is connected to the periphery of the valve support, an anchored unit is arranged on the valve replacement prosthesis, the anchored unit is fixed on the heart tissue through an anchoring device, the anchoring device is arranged in a delivery catheter, the anchoring device comprises an anchoring needle, an anchoring needle catheter, an anchoring needle pushing rod and a controllable guiding device, the anchoring needle is preloaded in the distal end of the anchoring needle catheter, the distal end part of the anchoring needle catheter is of a bendable structure, one end of the controllable guiding device is detachably connected with the anchored unit, and the controllable guiding device can control the distal part of the anchoring needle catheter to form a fixed bending angle along the radial direction and enable the distal end of the anchoring needle catheter to be abutted against the anchored unit.
Description
Technical Field
The present invention relates to a medical device, and more particularly to a transcatheter valve replacement system.
Background
Minimally invasive transcatheter treatment of cardiovascular diseases is becoming the main treatment means, such as coronary stents, heart valves, occluders, great vessel stents and other cardiovascular implantation devices, the implantation device needs to be delivered to the expected ideal position of the human body through a delivery device, and the implantation device needs to be fixed after reaching the target position, wherein the fixation of the heart valve prosthesis is particularly important. In the prior art, the aortic valve and the pulmonary valve are fixed mainly by radial supporting force of a valve support, and the valve support is provided with clamping pieces or bulges, depressions and the like which are fixed by using the shapes and characteristics of anatomical structures; the fixation of the mitral valve and the tricuspid valve is mainly added with auxiliary fixing devices such as barbs, valve leaflet clamping pieces, valve annulus clamping devices, apical fixation lines, fixation rods and the like on the basis of radial supporting force. However, because the anatomical structures of the mitral valve and the tricuspid valve are complex, the fixation problem cannot be well solved only by radial support of the valve stent and other auxiliary fixation devices, on one hand, the valve has a large influence on the autologous valve annulus, and the diastolic and systolic motion of the heart is blocked; on the other hand, for minimally invasive transcatheter products, it is difficult to provide an effective, relatively flexible structure on the implantation instrument for securing the prosthesis to the target site, limited by the diameter of the catheter and the performance of the catheter.
The anchoring member described in patent CN 105101911 a, arranged around the valve support and comprising an outwardly facing fixation portion having an engagement surface configured to engage tissue at an implantation site against the native annulus, the fixation portion having a first cross-sectional shape in an unbiased condition and being deformable to a second cross-sectional shape to adapt to the shape of the tissue at the implantation site in a deployed state. Although the fixing part of the anchoring part has a shape adapted to the tissue at the implantation site, the valve needs to be fixed by the anchoring part, because the atrioventricular valve, especially the mitral valve, implanted into the heart is subjected to a large blood flow impact force when the valve is closed, and the native valve annulus is soft and large in size, the anchoring part still needs to have a proper radial supporting force on the native valve annulus to provide a sufficient anchoring force and a leakage-proof effect, so that the valve still has a certain influence on the diastolic and systolic movement, and the implantation effect of the valve is still to be researched.
The repair system for the prevention of valvular regurgitation with an anchoring device described in patent CN201410316922.3, said anchor release device comprising a delivery tube and a pusher, said anchor release device being detachably connected to said fixation unit, a distal portion of said anchor release device having a preset shape such that the distal portion of said delivery tube can be bent in whole or in part so as to tighten the most distal end of said delivery tube against said fixation unit or against the native tissue before said anchor is moved. In the scheme, the detachable connection operation of the anchoring piece releasing device and the fixing unit is complex, the precision requirement is high, the pre-installation difficulty is high, and after the sheath is retracted, the stress at the detachable connection part is large, so that an implantation instrument and the anchoring piece releasing device are easily damaged; before anchoring, the bend of the conveying pipe needs to be fixed by a supporting structure, otherwise, the far end of the conveying pipe is difficult to abut against a fixing unit, and in the processes of sheathing up and sheathing down, because the length of the conveying pipe is changed, before anchoring, a gap may exist between the far end of the conveying pipe and the fixing unit, the abutting is not firm, the anchoring effect is affected, and the operation risk is high; for an implantation instrument needing multi-point fixation, the scheme needs to be simultaneously provided with a plurality of conveying pipes, the structure is complex, and the diameter of a conveying conduit is large; the anchoring operation is finished, and the anchoring operation can not be carried out again, so that the operation risk is high.
Accordingly, those skilled in the art have endeavored to develop a valve replacement system suitable for use with an atrioventricular valve that addresses two of the following problems: 1. the valve prosthesis is effectively fixed under the condition of not influencing the motion of the heart; 2. the valve is fixed by the delivery catheter which has simple structure, effective operation and high safety.
Disclosure of Invention
In view of the above-mentioned deficiencies of the prior art, the present invention provides a transcatheter valve replacement system in which the valve prosthesis is not effectively secured by radial bracing but is anchored; the delivery catheter has simple structure, accurate positioning and convenient operation, and can safely and reliably anchor the valve on the heart tissue.
The purpose of the invention is realized by the following technical scheme:
a transcatheter valve replacement system comprises a valve replacement prosthesis, a delivery catheter and a control handle, wherein the proximal end of the delivery catheter is connected with the control handle, the valve replacement prosthesis comprises a valve support, an artificial valve leaflet and an adaptive tectorial membrane support, the artificial valve leaflet is arranged in the valve support, the adaptive tectorial membrane support comprises an adaptive expansion support and a tectorial membrane, the adaptive tectorial membrane support is connected at the periphery of the valve support, the adaptive tectorial membrane support can adapt to the movement of heart tissue and fit the heart tissue,
one end of the self-adaptive covered stent is fixedly connected with one end of the valve stent, a gap is arranged between the other end of the self-adaptive covered stent and the other end of the valve stent, and the gap is covered by a flexible film;
the transcatheter valve replacement system further comprises a leaflet lift stop device and an anchoring device, wherein an anchored unit is arranged on the valve replacement prosthesis, the anchored unit is fixed on heart tissue through the anchoring device, the leaflet lift stop device is arranged outside the valve stent or the adaptive covered stent, when the valve replacement prosthesis is pre-assembled, the leaflet lift stop device is pre-assembled inside the delivery catheter in a mode of turning towards the far end, the anchoring device is arranged in the delivery catheter, the anchoring device comprises an anchoring needle, an anchoring needle catheter, an anchoring needle pushing rod and a controllable guiding device, the anchoring needle is pre-assembled in the far end of the anchoring needle catheter, the far end part of the anchoring needle pushing rod is pre-assembled in the lumen of the anchoring needle catheter, and the far end part of the anchoring needle catheter is of a bendable structure, the proximal end of the anchoring needle catheter is connected with the control handle, one end of the controllable guiding device is detachably connected with the anchored unit, and the controllable guiding device can control the distal end part of the anchoring needle catheter to form a fixed bending angle along the radial direction and enable the distal end of the anchoring needle catheter to be attached to the anchored unit.
The purpose of the invention can be further realized by the following technical scheme:
preferably, one part of the adaptive covered stent is abutted against and connected with one end of the valve stent, and the other part of the adaptive covered stent forms the gap with the valve stent.
Preferably, the part of the adaptive covered stent fixedly connected with the valve stent is circular, the middle part of the adaptive covered stent is D-shaped, and the part of the adaptive covered stent in contact with the atrial tissue is elliptical or elliptical-like. The whole body of the self-adaptive covered stent is attached to heart tissues, so that the self-adaptive covered stent has a leakage-proof effect while the heart movement is not influenced, and has a similar effect with a leakage-proof ring.
Preferably, the self-adaptive film-coated stent is woven by silk materials.
More preferably, the self-adaptive covered stent and the leaflet lifting and blocking device are of an integrated structure.
Preferably, the controllable guiding device comprises a guiding element and a limiting wire, the limiting wire is detachably connected to the anchored unit, the proximal end of the limiting wire is connected with the control handle, the guiding element is arranged at the distal end of the anchoring needle catheter, the limiting wire penetrates through the guiding element when being preassembled, and when the control handle is operated to enable the anchoring needle catheter to move axially and distally, under the cooperation of the limiting wire and the guiding element, the distal end part of the anchoring needle catheter is bent and deformed so as to realize angle change, so that the distal end of the anchoring needle catheter is abutted with the anchored unit.
More preferably, the controllable guiding device further comprises a control rod, a connecting hole is formed in the anchored unit, a locking hole is formed in the distal end of the limiting wire, when the valve stent is preassembled, the locking hole penetrates through the connecting hole, the distal end of the control rod is inserted into the locking hole, when the control handle is operated to enable the limiting wire to be tensioned and locked, the valve stent is connected with the limiting wire, the control rod and the anchoring needle catheter, the relative positions of the valve stent and the limiting wire are fixed, and when the control rod is operated to move axially to enable the distal end of the control rod to be separated from the locking hole, the valve stent and the limiting wire are separated.
More preferably, the guide member is provided with a guide hole, and when the stopper is preassembled, the distal end of the stopper wire firstly passes through the guide hole and then passes through the connection hole.
More preferably, the distal end of the control rod is provided with an anti-falling end, and the anti-falling end is of an inverted cone structure, a Y-shaped structure, a wave structure or a compressible round structure.
More preferably, the locking hole is a compressible round hole or a U-shaped hole formed by winding a plurality of wires back.
More preferably, the guide member is of one-piece construction with the anchor catheter.
More preferably, the guide is movably connected with the control rod.
Preferably, the transcatheter valve replacement system further comprises a valve stent detachable device, wherein the valve stent detachable device comprises a release control member and a connecting member, the release control member is of a rod-shaped or wire structure, the distal end of the connecting member is provided with an annular structure, the proximal end of the valve replacement prosthesis is provided with a release connecting hole, when pre-assembly is performed, the release connecting hole firstly passes through the annular structure, and the distal end of the control rod is inserted into the release connecting hole.
Compared with the prior art, the invention has the advantages that:
1. the size of the valve replacement prosthesis is not designed according to the size of an atrioventricular valve ring, but is designed according to the size smaller than the size of a self valve ring on the basis of ensuring the effective valve opening area of the valve replacement prosthesis, and the valve replacement prosthesis is fixed on heart tissues through the anchoring device, so that the defect that other international products rely on the radial supporting force of the valve prosthesis to fix the valve prosthesis is overcome.
2. The periphery of the valve replacement prosthesis is designed with the flexible wide self-adaptive covered stent so as to be attached to the front and rear valve leaves of the self-body valve and the atrial wall, adhesion is formed in the future, leakage around the valve can be effectively prevented, and contraction of the ventricle is not hindered.
3. The valve leaflet lifting blocking device is used for assisting in fixing, so that the valve replacement prosthesis is fixed more stably.
4. The transcatheter valve replacement system has the advantages of simple structure and convenient operation, and one limiting wire in the controllable guiding device can play a plurality of roles of guiding, bending adjustment, positioning, traction, disassembly and the like, namely:
the limiting wire is used as a guide rail and can guide and limit the anchoring needle catheter to move along a specific direction, so that the implementation has the advantages that: on one hand, the requirement on the position of the anchoring needle catheter is reduced during preassembly, the loading difficulty is low, the anchoring needle catheter is movably connected with the limiting wire, internal stress does not exist among all parts during loading, and the damage to a product is small; on the other hand, if the anchoring position or the anchoring effect is not ideal, the anchoring needle catheter can be withdrawn from the delivery catheter and then reloaded with the anchoring needle, and then the anchoring operation is carried out along the limiting wire again, so that the operation risk is greatly avoided.
The limiting wire is used as a bend adjusting line to change the distal end part of the anchoring needle catheter from an initial straight line state to a fixed bend angle state, so that the needle outlet direction is changed, the expected anchoring position is realized, and the structure of the conveying device is simplified.
The limiting wire is used as a positioning wire and is connected with a specific position on the implantation instrument, so that the relative position of the needle outlet of the anchoring needle catheter and the anchored unit can be accurately positioned, and accurate anchoring is realized.
The limiting wire is used as a traction wire, when the needle is inserted, the anchoring needle catheter is pulled to counteract the reaction force of the anchoring needle and the anchored unit, so that the anchoring needle catheter is tightly attached to the anchored unit before the anchoring needle is anchored, and the anchoring needle can safely and effectively fix the anchored area and the tissue.
The limiting wire is used as a detachable wire and can be separated from the implantation instrument after the anchoring operation is finished.
Drawings
Fig. 1a is a schematic view of the anatomy of the right heart and fig. 1b is a schematic view of the valve replacement prosthesis of the present invention implanted in the heart.
Fig. 2a is a schematic structural view of one embodiment of the valve replacement prosthesis of the present invention, and fig. 2b is a top view of the valve replacement prosthesis shown in fig. 2 a.
Fig. 2c is a schematic structural view of another embodiment of the valve replacement prosthesis of the present invention, and fig. 2d is a top view of the valve replacement prosthesis shown in fig. 2 c.
Fig. 3 is a schematic structural view of a transcatheter valve replacement system of the present invention.
Fig. 4-6 are schematic views of the operation of the transcatheter valve replacement system of the present invention.
Fig. 7a to 7e are schematic structural views of various embodiments of anchored units provided on the valve stent of the present invention.
Fig. 8a and 8b are schematic structural views of different embodiments of the anchoring needle of the present invention.
Fig. 9a and 9b are schematic structural views of different embodiments of the anchoring needle pushing rod of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.
The proximal end of the invention refers to the end close to the control handle or operator, and the distal end refers to the end far away from the control handle or operator.
This example takes a transcatheter tricuspid valve replacement as an example, as shown in fig. 1a, fig. 1a shows the main anatomical structures of the right heart, including right atrium 0010, right ventricle 0020, ventricular septum 0030, native leaflets 0040, tricuspid annulus 0050, chordae tendineae 0060, and papillary muscles 0070, and in the case of severe insufficiency in the tricuspid valve, the tricuspid annulus 0050 is significantly enlarged in most patients. The valve replacement prosthesis of the present invention is implanted into a patient's heart by way of a transcatheter, primarily to replace the function of the tricuspid valve. As shown in fig. 1b, the present application implants a valve replacement prosthesis 1000 to a target site via a transcatheter valve replacement system.
As shown in fig. 2a and 3, a transcatheter valve replacement system includes a valve replacement prosthesis 1000, a delivery catheter 1600, and a control handle 1500, the proximal end of the delivery catheter 1600 being coupled to the control handle 1500. The valve replacement prosthesis comprises a valve support 1010, a prosthetic valve leaflet 1105 and an adaptive covered support 1020, wherein the prosthetic valve leaflet 1105 is arranged in the valve support 1010, the adaptive covered support 1020 comprises a self-expanding support and a covering film, the adaptive covered support 1020 is connected to the periphery of the valve support 1010, the adaptive covered support 1020 can adapt to the movement of the heart tissue to be attached to the heart tissue, one end of the adaptive covered support 1020 is fixedly connected with one end of the valve support 1010, and a gap is arranged between the other end of the adaptive covered support 1020 and the other end of the valve support 1010 and covered by a flexible film; the transcatheter valve replacement system further includes a leaflet lift stop device 1030 and an anchoring device, an anchored unit 1102 is disposed on the valve replacement prosthesis, the anchored unit 1102 is secured to cardiac tissue by the anchoring device, the leaflet lift stop device 1030 is disposed outside the valve stent 1010 or the adaptive stent graft 1020, the leaflet lift stop device 1030 is preloaded inside the delivery catheter 1600 in a distally-flipped form when the valve replacement prosthesis 1010 is preloaded, the anchoring device is disposed within the delivery catheter 1600, the anchoring device includes an anchoring needle 0100, an anchoring needle catheter 1300, an anchoring needle pusher rod 1800, and a controllable guiding device, the anchoring needle 0100 is preloaded within the distal end of the anchoring needle catheter 1300, a distal portion of the anchoring needle pusher rod 1800 is preloaded within the lumen of the anchoring needle catheter 1300, as shown in fig. 5, the distal portion of the anchoring catheter 1300 is a bendable structure 1301, the proximal end of the anchoring catheter 1300 is connected to the control handle 1500, one end of the controllable guiding device is detachably connected to the anchored unit 1102, and the controllable guiding device can control the distal portion of the anchoring catheter 1300 to form a fixed bend angle in the radial direction and make the distal end of the anchoring catheter 1300 abut against the anchored unit 1102.
As shown in fig. 2a and 2b, the valve replacement prosthesis 1000 includes a valve stent 1010, a prosthetic leaflet 1105, and an adaptive stent graft 1020. The valve support 1010 comprises a valve leaflet sewing section and a connecting section 1012, the valve support 1010 is a barrel-shaped mesh structure made of nickel-titanium alloy materials, the main body part is the valve leaflet sewing section, the artificial valve leaflet 1105 is fixedly connected to the valve leaflet sewing section, and the near end of the valve support 1010 is the connecting section 1012 for detachable connection with a delivery catheter; the size of the valve stent 1010 is not designed according to the size of an atrioventricular valve annulus, but is designed according to the size smaller than the size of a native valve annulus on the basis of ensuring the effective valve opening area of the valve replacement prosthesis, so that the defect that other international products rely on the radial supporting force of the valve prosthesis to fix the valve replacement prosthesis is overcome.
As shown in fig. 2c and 2d, the adaptive stent graft 1020 is attached to the periphery of the valve stent 1010, the adaptive stent graft 1020 can adapt to the movement of the heart tissue and always fit the heart tissue, the distal end of the adaptive stent graft 1020 is attached to and fixed to the distal end of the valve stent 1010, a gap 1021 is provided between the proximal end of the adaptive stent graft 1020 and the proximal end of the valve stent 1010, the gap 1021 extends from the proximal end of the adaptive stent graft 1020 to the connection point of the distal end and the valve stent 1010, the gap 1021 is free connected by a flexible membrane 1022, in one embodiment, a part of the adaptive stent graft 1020 is attached to and connected to one end of the valve stent 1010, a gap 1021 is formed between another part of the adaptive stent graft 1020 and the valve stent 1010, the part of the distal end of the adaptive stent graft 1020 attached to and fixed to the valve stent 1010 is circular, the middle portion of the adaptive stent graft 1020 is D-shaped and the portion of the proximal end of the adaptive stent graft 1020 that contacts the atrial tissue is elliptical or elliptical-like. In a preferred embodiment, the self-expanding stent of the adaptive stent graft 1020 is integrally woven from a wire, and the stent graft is made of a flexible polymer material such as PTFE film or polyester film. As shown in fig. 2D, the two convex portions 1023 of the middle D-shaped portion of the adaptive stent graft 1020 are located at the boundary portion of the native valve leaflet, which can significantly improve the perivalvular regurgitation. The periphery of the valve replacement prosthesis 1000 is provided with the flexible wide self-adaptive covered stent 1020, so that the valve replacement prosthesis can be conveniently attached to the front and back valve leaflets and the atrial wall of a self body, adhesion is formed in the future, the valve replacement prosthesis can effectively prevent the leakage around the valve and does not hinder the contraction of the ventricle.
As shown in fig. 1b and fig. 2a, the anchored unit 1102 is fixed on the ventricular septum 0030 by the anchoring needle 0100, so that the valve prosthesis 1000 is mainly fixed on the heart tissue by the anchoring needle 0100, the disadvantage of supporting the annulus-fixed valve replacement prosthesis by the radial supporting force of the valve stent 1010 is avoided, and the leaflet lift stopper 1030 plays a role of auxiliary fixation, so that the fixation of the valve replacement prosthesis is more stable. In one embodiment, the anchored unit 1102 is attached to the distal end of the valve stent 1010. In another embodiment, the anchored unit 1102 is attached to the distal end of the adaptive stent graft 1020. In a preferred embodiment, the anchored unit 1102 is a unitary structure with the valve stent 1010 or the adaptive stent graft 1020.
The leaflet lift and stop device 1030 is arranged on the outer side of the valve support 1010 or the adaptive covered support 1020 close to the autologous leaflet site, preferably on the outer peripheral surface of the valve support 1010 and the adaptive covered support 1020, when the valve replacement prosthesis 1000 is preassembled, the leaflet lift and stop device 1030 is preassembled inside the conveying catheter 1600 in a mode of turning towards the far end, when the leaflet lift and stop device 1030 is implanted, the control handle 1500 is operated to position the valve replacement prosthesis when the leaflet lift and stop device is released from the conveying catheter 1600 to the position of turning over more than 90 degrees, the autologous leaflets 0040 are lifted through the leaflet lift and stop device 1030, after implantation, the leaflet lift and stop device 1030 clamps the autologous leaflets 0040 to assist the fixation of the valve replacement prosthesis, and in one embodiment, the leaflet lift and stop device 1030 is integrally woven by shape memory alloy wires. In a preferred embodiment, the adaptive stent graft 1020 is a unitary structure with the leaflet lift stop device 1030.
As shown in FIG. 3, the controllable guiding device comprises a guiding element 1700 and a limiting wire 1200, wherein the limiting wire 1200 is detachably connected to the anchored unit 1102, the proximal end of the limiting wire 1200 is connected with a first control element 1510 on the control handle 1500, and the first control element 1510 can axially move and be fixed at a stopping position when the control handle 1500 is operated. Spacing silk 1200 is flexible line, is made by macromolecular material or metal silk thread, has certain intensity and toughness, can provide the great fixed power of intensity when taut and realize the connection of relevant subassembly, because spacing silk 1200 is softer when loosening does not influence the position of other subassemblies. The guide member 1700 is disposed at the distal end of the anchoring catheter 1300, and when the guide member 1700 is pre-assembled, the stop wire 1200 passes through the guide member 1700, and when the control handle 1500 is operated to move the anchoring catheter 1300 axially to the distal end, the anchoring catheter 1300 moves along the stop wire 1200 under the cooperation of the stop wire 1200 and the guide member 1700, and the distal end portion of the anchoring catheter 1300 is gradually bent and deformed to realize an angular change, so that the distal end of the anchoring catheter 1300 abuts against the anchored unit 1102.
In one embodiment, as shown in FIG. 4, the end of the anchor catheter 1300 is fixedly attached to the guide 1700 by interference fit or welding or gluing, and the proximal end of the anchor catheter 1300 is attached to the third control 1530 on the control handle 1500. The third control 1530 can move the anchor catheter 1300 in an axial direction when the control handle 1500 is operated. One, two or more guide holes 1701 are formed in the guide member 1700, and the stopper wire 1200 is detachably coupled to the anchored-unit 1102 through the guide holes 1701. The guide 1700 has certain strength and is made of a metal material or a high polymer material with higher hardness, and the surface of the guide 1700 is mechanically polished to be smooth without sharp edges so as to prevent tissues from being punctured; in a preferred embodiment, the guide 1700 is integrally formed with the anchor catheter 1300. The distal end part of the anchoring needle catheter 1300 is of a bendable structure and is a slit cutting tube which is made by removing partial materials of a catheter-grade nickel-titanium tube or a stainless steel metal tube with good elasticity through laser engraving, a slit is not arranged at the head of the slit cutting tube with the length of 2-10mm, the head of the anchoring needle 0100 is prevented from being clamped when the anchoring needle is withdrawn, the slit cutting tube has certain strength, and the wall thickness is more than 0.1 mm.
As shown in fig. 5, the controllable guiding device further includes a control rod 1400, a connection hole 1110 is provided on the anchored unit 1102, a locking hole 1210 is provided at the distal end of the limiting wire 1200, and the locking hole 1210 is a compressible round hole or a U-shaped hole formed by winding a plurality of wires back. In one embodiment, the position-limiting wire 1200 and the locking hole 1210 are of an integral structure, or the position-limiting wire 1200 is folded in half at the end to form a u-shaped locking hole 1210, or the position-limiting wire 1200 is folded in half and wound and woven to form a circular locking hole. The locking apertures 1210 are flexible, compressible structures that facilitate quick and safe withdrawal from the attachment apertures 1110 without affecting the position of the valve replacement prosthesis 1000. When preassembling, after the locking hole 1210 passes through the connecting hole 1110, the distal end of the control rod 1400 is inserted into the locking hole 1210, and when the control handle 1500 is operated to make the limiting wire 1200 tensioned and locked, the connection among the valve stent 1010, the limiting wire 1200, the control rod 1400 and the anchoring catheter 1300 is formed, so that the positions among the valve stent 1010, the limiting wire 1200, the control rod 1400 and the anchoring catheter 1300 are relatively fixed, as shown in fig. 6, when the control rod 1400 is operated to axially move to make the distal end of the control rod 1400 disengage from the locking hole 1210, the valve replacement prosthesis 1010 and the limiting wire 1200 are disengaged. In one embodiment, the guide member 1700 is fixedly attached to the distal end of the control rod 1400, the guide member 1700 is provided with a guide hole 1701, and when pre-assembled, the distal end of the stop wire 1200 is inserted through the guide hole 1701 and then through the coupling hole 1110, and in a preferred embodiment, the guide member 1700 is movably coupled to the anchoring catheter 1300. The proximal end of the control rod 1400 is connected to a second control 1520 of the control handle 1500. The control rod 1400 is a thin rod made of metal or memory alloy material, has certain toughness, and is not easy to deform when moving in a short distance. The distal end of the control rod 1400 is provided with an anti-slip end 1410, and the anti-slip end 1410 has an inverted cone structure, a Y-shaped structure, a wave structure, a compressible circular structure, or the like, so as to prevent the distal end of the control rod 1400 from being unintentionally separated from the locking hole 1210.
As shown in FIG. 5, the transcatheter valve replacement system further comprises a valve stent detachable device, the valve stent detachable device comprises a release control part 1910 and a connecting part 1900, the release control part 1910 is in a rod-shaped or wire structure, the distal end of the connecting part 1900 is provided with a ring-shaped structure, a release connecting hole is arranged at the proximal end of the connecting section 1012 of the valve stent 1010, the ring-shaped structure at the distal end of the connecting part 1900 passes through the release connecting hole when pre-assembling, and the distal end of the release control rod 1910 is inserted into the ring-shaped structure.
In one embodiment, the valve replacement prosthesis 1000 is provided with the connection holes 1110, and the connection holes 1110 may be disposed at the end of the valve replacement prosthesis 1000, or may be disposed at other positions of the valve replacement prosthesis 1000, which has a wide application range.
In one embodiment, as shown in fig. 7a and 7b, a support frame 1100 is disposed on the distal end of the valve stent 1010, and the support frame 1100 is a compressible structure such as a V-shape or a diamond shape, and has a certain strength and rigidity. The supporting framework 1100 is provided with connecting holes 1110 and 1111, the connecting holes 1110 and 1111 are of circular ring structures, and the connecting holes 1110 and 1111 and the supporting framework 1100 are integrally manufactured by laser cutting and heat treatment setting of a nickel-titanium tube. An anchored unit 1102 is arranged in a space surrounded by the supporting framework 1100, the anchored unit 1102 is a polymer braided fabric, the edge of the anchored unit 1102 is fixed with the supporting framework 1100 by a suture, in a preferred embodiment, the anchored unit 1102 is made of PTFE material and is fixed on the supporting framework 1100 through sintering, and as another preferred embodiment, the anchored unit 1102 is a net structure formed between a metal wire and the supporting framework 1100. In another embodiment, the anchored unit 1102 is a unitary structure with the valve stent 1010 and the support frame 1100 is a unitary structure with the valve stent 1010. In one embodiment, the anchored unit 1102 is a flexible member, one end of which is connected to the implantation instrument 1000, and a supporting framework is disposed on the anchored unit 1102, and the supporting framework is a mesh structure formed by winding a metal wire. In another embodiment, the anchored unit 1102 is a flexible member, one end of which is connected to the implantation instrument 1000, and a supporting framework is disposed on the anchored unit 1102, and the supporting framework is a polymer braided fabric. In another embodiment, the anchored element 1102 is a stiff stent made of wire. In another embodiment, the anchored unit 1102 is a support rod. In one embodiment, the anchored unit 1102 may be a triangular structure, a circular shape, an isosceles trapezoid shape, or a rectangular shape, as shown in fig. 7b-7 e.
When preassembling, the far end of the limiting wire 1200 is detachably connected to the connecting hole of the supporting framework 1100, the limiting wire 1200 is a flexible wire and is made of high polymer materials or metal wire wires, the limiting wire has certain strength and toughness, connection with high strength can be formed when tensioning is conducted, the positions of other components are not affected due to softness when loosening is conducted, and the near end of the limiting wire 1200 is connected with the first control 1510 on the control handle 1500.
As shown in fig. 8a and 8b, the anchor needle 0100 includes at least one curved needle 0101 and a curved needle fixing end 0102, the curved needle 0101 has a predetermined shape, the distal end of the curved needle 0101 extends in the radial direction to form a curved section 0104 in an unstressed state, the anchor needle 0100 can be deformed and installed in the lumen of the anchor needle catheter 1300 when pre-installed, the anchor needle 0100 can recover the predetermined shape when released from the anchor needle catheter 1300, the curved needle 0101 is a nickel-titanium alloy wire heat-treated and shaped into the curved section 0104, the head is a sharpened structure, as an embodiment, a small curved angle 0105 opposite to the bending direction of the curved section 0104 is disposed at a distance of 0.5-2mm from the end of the curved section 0104, and the small curved angle 0105 is disposed to facilitate deeper insertion of the anchor needle 0100 into tissue when being pushed out from the anchor needle catheter 1300. The fixed end 0102 is a proximal end fixing part of the curved needle 0101 and can be formed by welding or winding a twist from the proximal end of the curved needle. As a preferred embodiment, a fixing member 0112 is disposed outside the fixing end 0102, and in one embodiment, as shown in fig. 8a, the fixing member 0112 is a metal annular sleeve with a length of 0.5-3mm and an inner diameter closely contacting the fixing end 0102; in another embodiment, as shown in fig. 8b, the fixing member 0112 is a spiral fastener, and the spiral fastener is formed by annularly winding a metal wire along the axial direction close to the fixing end 0102. As shown in fig. 8a, in a preferred embodiment, the anchor needle 0100 further includes a curved needle connection end 0103, the curved needle connection end 0103 is a connection portion between the anchor needle 0100 and the anchor needle pushing rod 1800, and is used for controlling the movement of the anchor needle 0100, and as an embodiment, the curved needle connection end 0103 is a circular ring structure formed by bending the proximal end of the curved needle 0101.
The anchor needle push rod 1800 is used to push the anchor needle 0100 out of the anchor needle guide 1300, and has strength and toughness such that the distal end portion of the anchor needle push rod 1800 can be deformed to conform to the curvature of the distal end portion of the anchor needle guide 1300. As an embodiment, as shown in fig. 9a, the anchoring needle pushing rod 1800 is a thin rod or a wire-like structure made of metal or memory alloy material, and a distal end 1820 of the anchoring needle pushing rod 1800 is provided with a fixing hook 1824 for detachably connecting with the connecting end 0103 of the anchoring needle 0100, so as to limit the movement of the anchoring needle 0100 and increase the product safety. As another embodiment, as shown in fig. 9b, the anchoring needle pushing rod 1800 is made of a stainless steel tube, the distal portion of the anchoring needle pushing rod 1800 is provided with a cutting slit, which can conform to the bending deformation of the distal portion of the anchoring needle catheter 1300, a pulling wire 1810 is arranged in the lumen of the anchoring needle pushing rod 1800, the pulling wire 1810 passes through the connecting end 0103 of the anchoring needle 0100, and then is folded back to pass through the anchoring needle pushing rod 1800 and extend out of the body, and the proximal end of the pulling wire 1810 is free, which can be manually controlled. In a preferred embodiment, the distal end of the needle pushing rod 1800 is provided with a flexible segment 1806, and the connecting end 0103 of the needle 0100 is partially located in the area defined by the flexible segment 1806, so as to facilitate the retrieval of the needle 0100 into the inside of the needle guide 1300.
The distal end parts of the anchoring needle 0100 and the anchoring needle push rod 1800 are pre-installed in the lumen of the anchoring needle catheter 1300 respectively, and the distal head of the anchoring needle 0100 is at a certain distance, preferably within 0.5mm-5mm, from the distal end of the anchoring needle catheter 1300, so that the distal end of the anchoring needle 0100 is prevented from being exposed out of the anchoring needle catheter 1300 due to movement of the anchoring needle catheter 1300 during sheath retracting and releasing, and the needle inserting effect is prevented from being influenced; the proximal end of anchor needle push rod 1800 is connected to fourth control 1540 of control handle 1500.
As shown in fig. 3, when preassembling, the locking hole 1210 at the distal end of the retaining wire 1200 first passes through the guiding hole 1701 of the guiding element 1700 and then passes through the connecting hole 1110, and then the distal end of the control rod 1400 is inserted into the locking hole 1210, so that the retaining wire 1200 forms a detachable connection with the valve replacement prosthesis 1000, the control rod 1400 and the retaining element 1700. During loading, the limiting wire 1200 has a large mobility, so that the operation is convenient, and the loading difficulty of the valve replacement prosthesis 1000 is reduced; and after being loaded to the delivery catheter 1600, the valve replacement prosthesis 1000 is movably connected with the controllable guiding device, and each part has proper mobility, so that the internal stress is reduced, and the product is not easily damaged. The guide member 1700 can slide along the stop wire 1200, and the anchoring needle catheter 1300 is located below the valve replacement prosthesis 1000 and is staggered with the main body part of the valve replacement prosthesis 1000, so that on one hand, the damage to the valve replacement prosthesis 1000, especially the artificial valve leaflet 1105 can be reduced during loading and sheathing, on the other hand, the diameter of the delivery catheter 1600 can be greatly reduced, the performance of the delivery device can be improved, and especially the subversive effect on the surgical access can be realized, for example, the heart apex or atrial access in the prior art is changed into the vascular access with smaller trauma, the damage to the patient during puncture access is reduced, the surgical risk is reduced, and the safety of the product is improved.
As shown in fig. 4 and 5, in the operation, the valve replacement prosthesis 1000 and the anchoring device are released from the delivery catheter 1600 to the initial position, when the control handle 1500 is operated to move the third control member 1530 to move the anchoring catheter 1300 distally along the retaining wire 1200 under the guidance of the guide member 1700, the distal end portion of the anchoring catheter 1300 is bent and deformed, the distal end of the anchoring catheter 1300 pushes the anchored unit 1102 of the valve replacement prosthesis 1000 to expand radially, the control handle 1500 is operated to move the first control member 1510 proximally, so that the retaining wire 1200 is tensioned and locked, the anchored unit 1102 of the valve replacement prosthesis 1000 is tightly connected with the retaining wire 1200, the control rod 1400 and the anchoring catheter 1300, so that the positions thereof are fixed relative to each other, the distal end portion of the anchoring catheter 1300 forms a fixed bend 1301, and the distal ends of the control rod 1400 and the anchoring catheter 1300 are respectively tightly attached to the anchored unit 1102 of the valve replacement prosthesis 1000, and at both ends of the linking hole 1110, the end of the guide 1700 is located at a distance from the distal end of the locking hole 1210 that is approximately equal to the length of the linking hole 1110, the anchored unit 1102 of the valve replacement device 1000 forms a tight fit with the control rod 1400 and the anchoring catheter 1300, and the anchored unit 1102 has no space for movement relative to the control rod 1400 and the anchoring catheter 1300.
As shown in fig. 6, when the control handle 1500 is operated to move the second control 1520 in the axial direction, the distal end of the control rod 1400 is disengaged from the locking hole 1210, and is withdrawn from the locking hole 1210, and the connection between the anchored unit 1102 of the valve replacement prosthesis 1000 and the stop wire 1200, the control rod 1400 and the anchoring catheter 1300 is disengaged, so as to complete the release of the valve replacement prosthesis 1000.
In this process, the limiting wire 1200 has the following functions:
the first, limiting wire 1200 acts as a guide to guide and limit the movement of the anchor catheter 1300 in a specific direction, which is advantageous: on one hand, the requirement on the position of the anchoring needle catheter 1300 is reduced during preassembly, the loading difficulty is low, the anchoring needle catheter 1300 is movably connected with the limiting wire 1200, internal stress does not exist among all parts during loading, and the damage to a product is small; on the other hand, if the anchoring position or anchoring effect is not ideal, the anchoring needle catheter 1300 can be withdrawn from the delivery catheter 1600, reloaded, and then the anchoring operation can be performed again along the stop wire 1200, thereby greatly avoiding the operation risk.
Secondly, the limiting wire 1200 is used as a bend adjusting wire to change the distal end part of the anchoring needle catheter 1300 from an initial straight state to a fixed bend state, so that the needle outlet direction is changed, the expected anchoring position is realized, and the structure of the delivery device is simplified.
And thirdly, the limiting wire 1200 is used as a positioning wire and connected with a specific position on the valve replacement prosthesis 1000, so that the relative position of the needle outlet of the anchoring needle catheter 1300 and the anchored unit 1102 can be accurately positioned, and accurate anchoring can be realized.
Fourth, the position-limiting wire 1200 is used as a pulling wire to counteract the reaction force between the anchor needle 0100 and the anchored unit 1102 during the needle insertion operation, so as to ensure that the anchor needle catheter 1300 is tightly attached to the anchored unit 1102 before the anchor needle 0100 is anchored, thereby ensuring that the anchor needle can safely and effectively fix the anchored unit 1102 to the tissue.
Fifth, the stop wire 1200 serves as a detachable wire that can be detached from the valve replacement prosthesis after the procedure is completed.
In addition, as shown in fig. 7a, two connection holes 1110 and 1111 are formed in the supporting frame 1100, and two stopper wires 1200 and 1201 are inserted through the connection holes 1110 and 1111, respectively. The distal end of the anchoring catheter 1300 is connected to the retaining wire 1200 and the retaining wire 1201 simultaneously, when the retaining wires are tightened, the distal head of the anchoring catheter 1300 can be self-positioned to the middle of the anchored unit 1102 under the action of the guide 1700, the influence of the supporting framework 1100 and the detachable points on the orifice of the anchoring catheter is reduced, in a preferred embodiment, one anchoring catheter can be connected to two or more retaining wires simultaneously, and the outlet position of the end of the anchoring catheter is automatically positioned by controlling the lengths of different retaining wires. When the needle pushing rod 1800 pushes the anchoring needle 0100 to move distally, the anchoring needle 0100 is gradually released from the outlet of the needle guide 1300, and the needle tip of the anchoring needle 0100 penetrates through the anchored unit 1102, then penetrates into the tissue and restores the preset shape, so that the anchoring needle 0100 fixes the anchored unit 1102 of the valve replacement prosthesis 1000 to the target tissue.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.
Claims (10)
1. A transcatheter valve replacement system, comprising a valve replacement prosthesis, a delivery catheter and a control handle, a proximal end of the delivery catheter being connected to the control handle, the valve replacement prosthesis comprising a valve stent, a prosthetic leaflet, and an adaptive stent graft, the prosthetic leaflet being disposed within the valve stent, the adaptive stent graft comprising a self-expanding stent graft and a stent graft, the adaptive stent graft being connected at a periphery of the valve stent, the adaptive stent graft being conformable to heart tissue, the transcatheter valve replacement system characterized in that:
one end of the self-adaptive covered stent is fixedly connected with one end of the valve stent, a gap is arranged between the other end of the self-adaptive covered stent and the other end of the valve stent, and the gap is covered by a flexible film;
the transcatheter valve replacement system further comprises a leaflet lift stop device and an anchoring device, wherein an anchored unit is arranged on the valve replacement prosthesis, the anchored unit is fixed on heart tissue through the anchoring device, the leaflet lift stop device is arranged outside the valve stent or the adaptive covered stent, when the valve replacement prosthesis is pre-assembled, the leaflet lift stop device is pre-assembled inside the delivery catheter in a form of turning towards the far end, the anchoring device is arranged in the delivery catheter, the anchoring device comprises an anchoring needle, an anchoring needle catheter, an anchoring needle pushing rod and a controllable guiding device, the anchoring needle is pre-assembled in the far end of the anchoring needle catheter, the far end part of the anchoring needle pushing rod is pre-assembled in the lumen of the anchoring needle catheter, and the far end part of the anchoring needle catheter is of a bendable structure, the proximal end of the anchoring needle catheter is connected with the control handle, one end of the controllable guiding device is detachably connected with the anchored unit, and the controllable guiding device can control the distal end part of the anchoring needle catheter to form a fixed bending angle along the radial direction and enable the distal end of the anchoring needle catheter to be attached to the anchored unit.
2. The transcatheter valve replacement system of claim 1, wherein a portion of the adaptive stent-graft abuts and is attached to an end of the valve stent, and another portion of the adaptive stent-graft forms the gap with the valve stent.
3. The transcatheter valve replacement system of claim 1, wherein the portion of the adaptive stent graft fixedly attached to the valve stent is circular, the middle portion of the adaptive stent graft is D-shaped, and the portion of the adaptive stent graft in contact with atrial tissue is elliptical or quasi-elliptical.
4. The transcatheter valve replacement system of claim 1, wherein the controllable guiding device comprises a guide element and a stop wire, the stop wire is detachably connected to the anchored unit, a proximal end of the stop wire is connected to the control handle, the guide element is disposed at the distal end of the anchoring catheter, the stop wire passes through the guide element when pre-installed, and when the control handle is operated to move the anchoring catheter axially distally, a distal portion of the anchoring catheter is bent and deformed to effect the angular change in cooperation with the stop wire and the guide element such that the distal end of the anchoring catheter abuts the anchored unit.
5. The transcatheter valve replacement system of claim 4, wherein the controllable guiding device further comprises a control rod, the anchored unit is provided with a connecting hole, the distal end of the retaining wire is provided with a locking hole, when pre-assembled, the distal end of the control rod is inserted into the locking hole after the locking hole passes through the connecting hole, when the control handle is operated to enable the retaining wire to be tensioned and locked, the valve stent is connected with the retaining wire, the control rod and the anchoring catheter so that the relative positions of the valve stent and the retaining wire are fixed, and when the control rod is operated to axially move to enable the distal end of the control rod to be separated from the locking hole, the valve stent and the retaining wire are separated.
6. The transcatheter valve replacement system of claim 5, wherein a guide hole is provided in the guide member, and when pre-assembled, the distal end of the retention wire passes through the guide hole before passing through the attachment hole.
7. The transcatheter valve replacement system of claim 5, wherein the distal end of the control rod is provided with an anti-slip end, the anti-slip end being an inverted cone structure, a Y-shaped structure, a wave structure, or a compressible round structure.
8. The transcatheter valve replacement system of claim 5, wherein the locking hole is a compressible round hole or a U-shaped hole formed by a plurality of wires wound back.
9. The transcatheter valve replacement system of claim 4, wherein the guide is an integrally formed structure with the anchoring catheter.
10. The transcatheter valve replacement system of claim 5, further comprising a valve stent detachment device, wherein the valve stent detachment device comprises a release control member and a connecting member, wherein the release control member is in a rod-type or wire-type configuration, wherein a distal end of the connecting member is provided with a ring-shaped configuration, wherein a proximal end of the valve replacement prosthesis is provided with release attachment holes, and wherein the release attachment holes are pre-installed by first passing through the ring-shaped configuration and inserting a distal end of the control rod into the release attachment holes.
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| CN201911299162.9A CN111067666B (en) | 2019-12-17 | 2019-12-17 | Transcatheter valve replacement system |
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| CN201911299162.9A CN111067666B (en) | 2019-12-17 | 2019-12-17 | Transcatheter valve replacement system |
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| CN107890382A (en) * | 2017-12-20 | 2018-04-10 | 乐普（北京）医疗器械股份有限公司 | It can position recyclable through conduit implanted aorta petal film device |
| WO2019136294A1 (en) * | 2018-01-07 | 2019-07-11 | Suzhou Jiecheng Medical Technology Co., Ltd. | Prosthetic heart valve delivery system |
| CN108904100B (en) * | 2018-06-22 | 2021-01-19 | 宁波健世生物科技有限公司 | Implanting instrument for preventing valve regurgitation and conveying system thereof |
| CN109199641B (en) * | 2018-10-24 | 2021-04-23 | 宁波健世生物科技有限公司 | Artificial valve prosthesis with fixing piece |
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2019
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