WO2020119462A1 - 分离式释放的主动脉瓣膜支架 - Google Patents

分离式释放的主动脉瓣膜支架 Download PDF

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Publication number
WO2020119462A1
WO2020119462A1 PCT/CN2019/121427 CN2019121427W WO2020119462A1 WO 2020119462 A1 WO2020119462 A1 WO 2020119462A1 CN 2019121427 W CN2019121427 W CN 2019121427W WO 2020119462 A1 WO2020119462 A1 WO 2020119462A1
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WIPO (PCT)
Prior art keywords
valve
section
aortic valve
sewing section
guiding device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2019/121427
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English (en)
French (fr)
Inventor
李毅斌
郑玲和
吕世文
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ningbo Jenscare Biotechnology Co Ltd
Original Assignee
Ningbo Jenscare Biotechnology Co Ltd
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Publication date
Application filed by Ningbo Jenscare Biotechnology Co Ltd filed Critical Ningbo Jenscare Biotechnology Co Ltd
Priority to EP19895646.8A priority Critical patent/EP3895661A4/en
Priority to US17/312,733 priority patent/US11864994B2/en
Publication of WO2020119462A1 publication Critical patent/WO2020119462A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2/2409—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
    • A61F2/2412—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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0083—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the present application belongs to the field of medical devices, and relates to a separate release aortic valve stent.
  • Aortic valve stenosis is mainly caused by sequelae of rheumatic fever, congenital aortic valve structural abnormalities or senile aortic valve calcification.
  • the patients are asymptomatic during the compensatory period.
  • Most patients with severe aortic valve stenosis have symptoms of burnout, dyspnea (labor or paroxysmal), angina, dizziness or syncope, and even sudden death.
  • Aortic valve regurgitation is when the aortic valve opens when the ventricle contracts, the blood flow in the left ventricle enters the aorta and shoots toward the whole body, and is closed when the ventricle is dilated, preventing the blood from flowing back into the left ventricle if the aorta occurs.
  • the aortic valve cannot be closed tightly during diastole, causing blood to flow back into the left ventricle from the aorta.
  • aortic valve replacement In the treatment of aortic valve diseases, surgical valve replacement is the traditional effective treatment. However, patients with this type of disease are mostly elderly and have multiple organ diseases, and their physical conditions are difficult to undergo surgical operations, making them clinically hopeless patients. In addition, the cause of degenerative aortic valve disease is still not very clear, the etiology cannot be treated, there is no effective method to curb its development, and the drug treatment effect is not good. The ideal treatment for aortic valve disease should both improve the patient's symptoms and prolong their lifespan. Early percutaneous aortic valve balloon angioplasty was used to treat aortic valve stenosis, but both single-center data and multi-center registration data have found that its long-term effect is not good.
  • TAVR autologous aortic valve insufficiency
  • the main reason is that accurate positioning and precise release of stent valves are the most critical technical points in TAVR surgery.
  • the aortic valve has openings for the left and right coronary arteries, and the valve is adjacent to the mitral valve. If the positioning and release are not accurate, fatal complications such as coronary occlusion or massive mitral regurgitation may occur.
  • Traditional TAVR devices whether SAPIEN or CoreValve, are mainly used in patients with severe aortic valve stenosis, and are not suitable for patients with aortic valve regurgitation. In the traditional technology, the device design for patients with aortic valve regurgitation
  • the patents CN201520325599.6 and CN201511017536.5 describe a double-ring aortic valve stent, that is, a W-shaped ring-shaped fixing ring is added to the main body stent, and the three feet of the fixing ring are used to fix the three aorta sinus ,
  • the ring-shaped fixed ring is connected to the main body bracket with three nickel-titanium alloy wires.
  • the nickel-titanium alloy wire is V-shaped, and its V-shaped bend corresponds to the V-shaped bend of the fixing ring.
  • the V-shaped nickel-titanium alloy wire can be stretched into a straight line, so that the positional relationship between the fixing ring and the bracket becomes an up-down relationship.
  • the main problems of this design are: 1) the ring-shaped fixation ring is difficult to operate its alignment aortic sinus after release, and the adjustability is poor; 2) once the ring-shaped fixation ring is released from the sheath, it is stuck in the valve sinus and cannot be re-entered.
  • Surgical risk is high; 3) The ring-shaped fixed ring is not constrained, which makes it very easy to bounce in the delivery sheath, and often does not fully achieve the alignment with the autologous valve after jumping out, which makes adjustment difficult; 4) After the valve is completely released, Autologous valve leaflets still have the risk of blocking the coronary arteries against the aortic sinus wall; 5) The coaxiality of the movement of the upper and lower stents is poor, and it is easy to dislocate and interfere.
  • Patent CN201610029112.9 describes a catheter-delivered aortic valve device. Similar to the above, the upper end of the main body stent forms a three-valve upper bell mouth structure, and the lower side of the main body stent is also provided with positioning for positioning The ring, the positioning ring and the main body bracket are connected with a positioning wire.
  • the main problems of this design are: 1) it is difficult to operate its alignment aortic sinus after the positioning ring is released, and the adjustability is poor; 2) even if it is already aligned with the aortic sinus, the positioning ring will be very easily affected by the impact of blood flow Rushing out of the sinus, causing the end of the positioning ring clip to not touch the bottom of the valve sinus; 3) After the valve is fully released, the autologous valve leaflet still has the risk of blocking the coronary artery against the aortic sinus wall; 4) The same movement of the upper and lower stents Poor axiality, easy to misplace interference.
  • the traditional technology has been able to partially take care of the self-valve leaflet clamping member and the reduced delivery catheter.
  • the traditional technology has a positioning ring that cannot be controlledly released, has poor coaxiality, and is difficult to adjust and fix after release.
  • the risk of clogging the coronary opening requires a valve replacement device that simultaneously solves the above problems.
  • the purpose of this application is to overcome the traditional technical limitations.
  • the traditionally separated aortic valve stent cannot effectively control the position of the main body stent and the positioning member, cannot effectively avoid coronary artery blockage, and cannot re-enter after the clamping member is completely released Sheath and other issues, developed a new type of separate release aortic valve stent.
  • a separate-release aortic valve stent includes a valve sewing section, a positioning member and an artificial valve, the artificial valve is connected to the valve sewing section, the valve sewing section and the positioning member are Two independent members are connected by a guide device, the positioning component can be released before the valve sewing section, the valve sewing section is provided with a sliding connection structure, and one end of the guide device is connected to the On the positioning member, the other end of the guide device passes through the sliding connection structure and is connected to the positioning member, and the valve sewing section can slide along the guide device.
  • the positioning member is provided with an anchoring segment and a clamping segment, the clamping segment is connected to the anchoring segment, and one end of the guiding device is connected to the clamping segment, so The other end of the guide device passes through the sliding connection structure and is connected to the anchoring section.
  • the valve sewing section can slide along the guide device by using the sliding connection structure.
  • the clamping section is located at the proximal end of the anchoring section and is an integral member with the anchoring section.
  • the anchoring section is a grid-like structure or a wavy structure.
  • the surface of the anchoring section is covered with a film or braid.
  • the clamping section has three claw members, and the claw members are U-shaped or V-shaped structures.
  • the end of the claw member is configured to be inward toward the axis of the clamping section, the outer contour of the valve sewing section is provided with a depression, and the valve sewing section After being completely released, the recess matches the inner folded structure of the claw member.
  • the native valve leaflet is located between the claw member and the valve sewing section.
  • the guiding device is a flexible linear structure or a ribbon structure. In an embodiment, the guiding device is a plurality of flexible wires.
  • the guiding device is located between the positioning member and the valve sewing section.
  • the guiding device rides on the free edge of the native valve leaflet.
  • the self-valve leaflets are straddled and pulled down by the guiding device to ensure that the coronary artery opening cannot be blocked.
  • the axial relative position of the valve sewing section and the positioning member is limited by the length of the guide device.
  • valve sewing section and the positioning member are located at different positions in the delivery sheath after being compressed.
  • the sliding connection structure is a hole. In an embodiment, the sliding connection structure and the valve sewing section are an integrated structure. In one embodiment, the sliding connection structure is located at a proximal portion of the valve sewing section.
  • a connection point of the guiding device and the anchoring section is located on a distal portion of the anchoring section.
  • a plurality of sliding connection structures are provided on the valve sewing section.
  • the valve support further includes an auxiliary guiding device, one end of the auxiliary guiding device is connected to the anchoring section, and the other end of the auxiliary guiding device is connected to the valve sewing Paragraph.
  • the clamping section is located in the sinus of the autologous valve after the release, and the anchoring section is at least partially located in the blood vessel after the release.
  • a seal is provided at the proximal end of the valve sewing section.
  • the seal prevents blood from passing through the valve sewing section and The gap between autologous tissues.
  • the seal is a discontinuous band structure. In one embodiment, when the detachable aortic valve stent is implanted, the lower part of the claw member corresponds to the discontinuity of the seal member.
  • the distal end of the anchoring section is provided with a matching structure
  • the proximal end of the valve sewing section is provided with a connecting structure, which is compressed and loaded in the delivery sheath
  • the coordination structure is mutually constrained.
  • connection structure is a rod and the mating structure is a hole.
  • the connection structure passes through the mating structure.
  • a limited position hole is provided on the connection structure.
  • the connecting structure is a coil
  • the matching structure is a hole
  • the connecting structure is provided with a groove
  • the mating structure is provided with a protrusion
  • the groove and the protrusion match each other.
  • this application provides a guiding device between the positioning member and the main valve, the guiding device plays at least four main functions: 1) The valve sewing section can be guided along the The device slides to the specified position. This movement mode can greatly enhance the coaxiality between the valve sewing section and the positioning component, to avoid interference and misalignment between the two during the mutual movement process; 2) The alignment of the main valve and the positioning component And during the release process, the guide device rides on the free edge of the native autologous leaflet, which can effectively limit the free edge activity of the autologous leaflet.
  • the guiding device After the full release, it automatically reduces the height of the free edge of the autologous leaflet to avoid blocking the coronary artery
  • the opening also enhances the anchoring effect; 3) assists in achieving a controlled release of the positioning component; 4) the guiding device also plays a role in limiting the relative position of the main valve and the positioning component, which is convenient for the doctor to operate.
  • the clamping segment in the present application is first positioned in the sinus of the autologous aorta, and then the anchoring segment is at least partially located in the blood vessel and is fixed by the ascending aorta.
  • the advantage of this design is to ensure that the positioning member will not fall off after release, giving the subsequent main body valve enough time to release.
  • the sealing member in this application is a discontinuous band structure.
  • the lower part of the claw member corresponds to the discontinuity of the sealing member, that is, the seal
  • the continuous part of the piece corresponds to the junction of the autologous valve leaflets.
  • the targeted local sealing technology can effectively reduce the diameter of the delivery sheath while ensuring the effect of reducing paravalvular leakage.
  • the position where the clamping section and the valve sewing section of this application are in contact is a matching concave and convex profile.
  • the advantage of this design is that it is convenient for the positioning and fixing of the positioning component and the main valve, which is beneficial to anchoring and reduction. Valvular leak.
  • FIGS. 1A and 1B are schematic diagrams of an embodiment of the present application.
  • FIG. 1C is a schematic structural diagram of a positioning component in this application.
  • 1D and 1E are cut views of the aortic valve stent of the present application.
  • 2A-2C are schematic diagrams of the motion trajectories of the valve sewing section, positioning member and guide device in the present application.
  • 2D is a schematic diagram of an embodiment of a positioning component in this application.
  • 3A-3D are schematic diagrams of the mating structure and connection structure in this application.
  • FIG. 3E is a schematic diagram of an embodiment of a fitting structure and a connecting structure in this application.
  • 4A-4L are schematic diagrams of the operation steps of this application.
  • 5A and 5B are schematic diagrams of another implementation manner in this application.
  • FIG. 6A is a schematic diagram of another implementation manner in the present application.
  • 6B is a schematic diagram of an embodiment of a seal.
  • 6C is a schematic diagram of another embodiment of a valve sewing section and a positioning component of the present application.
  • 6D is a schematic diagram of another implementation manner in this application.
  • the distal end mentioned in this application refers to the end far from the apex of the heart, and the proximal end refers to the end close to the apex of the heart.
  • a separate-release aortic valve stent 100 includes a valve sewing section 110, a positioning member 120, and an artificial valve 130, the artificial valve 130 is connected to On the valve sewing section 110, the valve sewing section 110 and the positioning member 120 are two independent members and connected by a guide device 140, so that the valve sewing section 110 and the positioning member 120 are After compression, it is located in different positions of the delivery sheath, which plays the role of reducing the diameter of the delivery sheath.
  • the positioning member 120 is released before the valve sewing section 110, and a sliding connection structure 111 is provided on the valve sewing section 110, and one end of the guiding device 140 is connected to the positioning member 120.
  • the other end of the guide device 140 passes through the sliding connection structure 111 and is connected to the positioning member 120.
  • the valve sewing section 110 can slide along the guide device 140.
  • the positioning member 120 is provided with an anchoring segment 121 and a clamping segment 122, the clamping segment 122 is located at the proximal end of the anchoring segment 121, and the distal end of the clamping segment 122 is The proximal end of the anchoring section 121 is connected.
  • the clamping section 122 and the anchoring section 121 are an integral member.
  • One end 1401 of the guiding device 140 is connected to the clamping section 122, and the other end 1402 of the guiding device 140 passes through the sliding connection structure 111 and is connected to the anchoring section 121.
  • the valve sewing section 110 can slide along the guiding device 140.
  • the clamping section 122 is equally divided along the circumferential direction with three claw members 1221 (1221a, 1221b, 1221c).
  • the claw members are U-shaped or V-shaped structures for matching three aortic sinus physiological structures. After being released, the claw 1221 reaches the back of the autologous valve leaflet and the sinus floor of the aortic valve to complete the positioning.
  • the guiding device 140 is a flexible linear structure. In one embodiment, the guiding device 140 is three flexible threads. In other embodiments, more flexible threads may be used to connect the valve to be sewn.
  • the segment 110 and the positioning member 120 achieve a better stable positioning effect, but more flexible wires may increase the pushing resistance.
  • FIG. 1D shows the cutting structure of the positioning member 120 and FIG. 1E shows the cutting structure of the valve sewing section 110.
  • the guiding device 140 is located between the positioning member 120 and the valve sewing section 110, so that the guiding device 140 can be avoided to the greatest extent.
  • the artificial valve 130 sutured in the valve sewing section 110 is damaged, and it can provide the possibility of subsequently suppressing the free edge of the autogenous valve leaflet.
  • three sliding connection structures 111 are provided on the proximal portion of the valve sewing section 110, and the sliding connection structures 111 are holes.
  • the sliding connection structure 111 and the valve sewing section 110 are an integrated structure. After the valve sewing section 110 is completely released, the guide device 140 rides on the free edge of the native valve leaflet 180.
  • the axial relative position of the valve sewing section 110 and the positioning member 120 is limited by the length of the guide device 140.
  • the anchoring section 121 is a grid-like structure, and the surface of the anchoring section 121 is covered with a membrane or braid 160 for avoiding vascular dissection.
  • the anchoring section 121 is a wave-shaped structure (not shown).
  • connection point of the guiding device 140 and the anchoring section 121 is located on the distal end portion of the anchoring section 121, and the valve sewing section 110 and the positioning member 120 are located on the delivery sheath after being compressed
  • the guiding device 140 can assist the positioning member 120 to re-insert into the sheath after being released, especially when most of the anchoring section 121 is released and can be re-inserted into the sheath. Choosing to retract and release the positioning member 120 greatly improves the success rate of the operation.
  • the guiding device of the present application has at least four main functions: 1) The valve sewing section can slide along the guiding device to a specified position, such a movement method It can greatly enhance the coaxiality between the sewed section of the valve and the positioning component, to avoid interference and misalignment between the two during the mutual movement process; 2) During the alignment and release of the main valve and the positioning component, the guide device rides On the free edge of the native autologous leaflet, it can effectively limit the free edge activity of the autologous leaflet, and when fully released, it automatically reduces the height of the free edge of the autologous leaflet, avoids covering the coronary opening, and enhances the anchoring effect; 3 ) Auxiliary realization of the controlled release of the positioning component; 4) The guiding device also plays a role in limiting the relative position of the main body valve and the positioning component, which is convenient for the doctor to operate.
  • the distal end of the anchoring section 121 is provided with a fitting structure 1210, and the proximal end of the valve sewing section 110 is provided with a connecting structure 1101.
  • the connection structure 1101 and the mating structure 1210 restrain each other.
  • the connection structure 1101 is a rod, and the mating structure 1210 is a hole.
  • the connecting structure 1101 passes through Cross the mating structure 1210.
  • the connecting structure 1101 is provided with a limit hole 1102.
  • the connecting structure 1101 passes through the fitting structure 1210 Afterwards, the limiting hole 1102 is penetrated by the limiting wire 1103. Only when the limiting wire 1103 is pulled away, the connecting structure 1101 can be withdrawn from the fitting structure 1210.
  • a controllable release of the positioning member 120 is achieved to prevent the positioning member 120 from bouncing out of the delivery sheath during the release process and affecting implantation
  • it is easy to control and adjust the angle and position of the clamping section 122 and at the same time, it can re-insert the sheath after the positioning member 120 is completely released, reducing the risk of surgery.
  • connection structure 1101 is a coil
  • fitting structure 1210 is a hole.
  • the connection structure 1101 After passing through the fitting structure 1210, the limiting wire 1103 passes through.
  • valve stent 100 can be delivered and released through the following steps:
  • valve holder 100 is compressed and loaded in a delivery sheath 170, and the valve sewing section 110 is located at the distal end of the positioning member 120, with the assistance of an imaging device ,
  • the implant is delivered to the patient's lesion through the femoral artery or similar artery approach;
  • the positioning member 120 can be re-entered into the sheath, re-released or evacuated from the human body, the risk of surgery is greatly reduced ;
  • the guide tip is closed with the sheath again.
  • Such an operation can help to compress the delivery sheath 170 of the valve sewing section 110 to better pass the autologous leaflet. Pushing the delivery sheath along the guide device 140 until it is limited by the length of the guide device 140, at this time the native valve leaflet 180 is straddled and depressed by the guide device 140;
  • valve stent 100 can also be delivered and released through the apex, transatrial septum puncture, etc. The operation steps are similar to the above and will not be repeated here.
  • a separate-release aortic valve stent 200 includes a valve sewing section 210, a positioning member 220, and an artificial valve (not shown).
  • the artificial valve is connected to On the valve sewing section 210, the valve sewing section 210 and the positioning member 220 are two independent members and are connected by a guide device 240, and the guide device 240 is a belt-shaped structure.
  • the valve stent 200 further includes an auxiliary guiding device 250.
  • the auxiliary guiding device 250 is a wire, and one end 2501 of the auxiliary guiding device 250 is connected to the anchoring section 221 On the other hand, the other end 2502 of the auxiliary guiding device 250 is connected to the valve sewing section 210.
  • the function of the auxiliary guiding device 250 is to together with the guiding device 240, so that the valve sewing section 210 and the positioning member 220 can be positioned more stably. Since the connection parts at both ends of the auxiliary guiding device 250 are not consistent with the guiding device 240, the length of the auxiliary guiding device 250 needs to be carefully designed according to the length of the guiding device 240.
  • the distal end of the anchoring section 221 is provided with a fitting structure 2210, and the proximal end of the valve sewing section 210 is provided with a connecting structure 2101.
  • the connecting structure 2101 and the fitting structure 2210 are loaded in the delivery sheath under compression Mutual restraint.
  • the connecting structure 2101 is provided with a groove 2104
  • the mating structure 2210 is provided with a protrusion 2211
  • the groove 2104 and the protrusion 2211 match each other.
  • a separate-release aortic valve stent 300 includes a valve sewing section 310, a positioning member 320, and an artificial valve 330.
  • the artificial valve 330 is connected to the On the valve sewing section 310, the valve sewing section 310 and the positioning member 320 are two independent members and are connected by a guide device 340.
  • the positioning member 320 is released before the valve sewing section 310, and the positioning member 320 is provided with an anchoring section 321 and a clamping section 322, and the clamping section 322 has three claw members 3221.
  • the valve sewing section 310 is provided with a sliding connection structure 311, one end 3401 of the guide device 340 is connected to the hole 3222 at the bottom end of the claw member 3221, and the other end 3402 of the guide device 340 is removed from the
  • the sliding connection structure 311 is connected to the anchoring section 321 after passing through, and the valve sewing section 310 can slide along the guiding device 340.
  • a seal 370 is arranged at the proximal end of the valve sewing section 310. When the valve stent 300 is implanted, the seal 370 prevents blood from passing through the valve sewing section and the body Gap between organizations.
  • the seal 370 is a discontinuous band structure.
  • the lower part of the claw member 3221 (3221a, 3221b, 3221c) corresponds to the discontinuity of the seal 370, that is, the continuous place of the seal corresponds to the junction of the autologous valve leaflets, so
  • the targeted local sealing technology can effectively reduce the diameter of the delivery sheath while ensuring the effect of reducing paravalvular leakage.
  • the end of the claw member 3221 is configured to be inward toward the axis of the clamping section 322.
  • the outer contour of the valve sewing section 310 is provided with a recess 3105. After the valve sewing section 310 is completely released, the recess 3105 matches the structure of the claw member 3221. The advantage of this design is that it is convenient for the positioning and fixing of the positioning component and the main valve, which is beneficial for anchoring and reducing paravalvular leakage.
  • valve sewing section 310 is provided with a sliding connection structure 311, and the connection point between the guiding device 340 and the positioning member 320 is in contact with the claw piece 3221. Arranged staggered in the axis direction, the valve sewing section 310 can slide along the guide device 340.

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Abstract

一种分离式释放的主动脉瓣膜支架（100，200，300），包括瓣膜缝制段（110，210，310）、定位部件（120，220，320）和人工瓣膜（130，330），人工瓣膜（130，330）被连接在瓣膜缝制段（110，210，310）上，瓣膜缝制段（110，210，310）与定位部件（120，220，320）为两个独立构件并通过导引装置（140，240，340）连接，定位部件（120，220，320）先于瓣膜缝制段（110，210，310）释放，瓣膜缝制段（110，210，310）上设置有滑动连接结构（111，311），导引装置（140，240，340）的一端连接在定位部件（120，220，320）上，导引装置（140，240，340）的另一端从滑动连接结构（111，311）中穿过后连接在定位部件（120，220，320）上，瓣膜缝制段（110，210，310）能够沿导引装置（140，240，340）滑动；可有效控制主体支架和定位件的位置、有效避免冠脉堵塞。

Description

分离式释放的主动脉瓣膜支架
相关申请
本申请要求2018年12月14日申请的，申请号为201811530921.3，名称为“一种分离式释放的主动脉瓣膜支架”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请属于医疗器械领域，涉及到一种分离式释放的主动脉瓣膜支架。
背景技术
主动脉瓣狭窄主要由风湿热的后遗症、先天性主动脉瓣结构异常或老年性主动脉瓣钙化所致。患者在代偿期无症状，主动脉瓣重度狭窄的患者大多有倦怠、呼吸困难(劳力性或阵发性)、心绞痛、眩晕或晕厥的症状，甚至会突然死亡。
主动脉瓣返流即主动脉瓣在心室收缩时开放，左心室内的血流进入主动脉射向全身，在心室舒张时候关闭，阻止主动脉内的血液返流回左心室，若发生主动脉瓣关闭不全时，在心脏舒张期主动脉瓣不能关闭严密，造成血液从主动脉逆流入左心室。
在主动脉瓣膜疾病的治疗方面，外科手术瓣膜置换术是传统的有效治疗方法。可是这类疾病的患者多系高龄，同时有多器官疾病，身体条件难以接受外科手术，成为临床治疗无望的患者。此外，退化性主动脉瓣膜疾病的病因仍不十分清楚，无法进行病因治疗，也无有效的方法遏制其发展，药物治疗效果不佳。理想的治疗主动脉瓣疾病的措施应既能改善患者的症状又能延长其寿命。早年开展的经皮主动脉瓣球囊成型术曾被用来治疗主动脉瓣狭窄，但无论是单中心的数据还是多中心的注册资料均发现其长期效果不佳。在国内，外科瓣膜置换术仍是一种主要的治疗选择。近年来，国内外一些学者开展了经皮主动脉瓣膜置换的基础和临床研究，并取得到一些突破性的进展。为需要外科瓣膜置换的高危老年性主动脉瓣退行性患者，提供了一种有效的治疗方法。2002年，Cribier等成功进行了经导管主动脉瓣膜置换术(Transcatheter Aortic Valve Replacement，TAVR)，迄今为止，全球已经完成超过5万例TAVR手术，世界各地的研究均表明：对于无法进行外科换瓣或外科换瓣存在高风险的患者，这项技术是安全有效的。尽管进行TAVR手术的多为高风险患者，但术后30天存活率高于90％，TAVR术后患者血流动力学指标得到明显改善。
但目前自体主动脉瓣关闭不全仍然被列为TAVR术的禁忌症。主要原因在于，支架瓣 膜的准确定位和精确释放是TAVR手术中最为关键的技术点。主动脉瓣上有左右冠状动脉的开口，瓣下毗邻二尖瓣，如果定位释放不准确，则可能出现冠脉堵塞或二尖瓣大量反流等致命的并发症。传统的TAVR器械无论是SAPIEN或者是CoreValve均主要用于严重主动脉瓣狭窄患者，并不合适用于主动脉瓣反流患者。传统技术中，针对主动脉瓣反流患者的器械设计
已经取得一定共识，例如国外的JenaValve、Acurate，国内的J-Valve，均是采用类似自体瓣叶夹持件的结构，用于定位主动脉瓣的三个窦，这样有利于支架的准确定位植入。但是，以上器械目前仍多从经心尖入路，对患者创伤仍较大，不能算是严格意义上的经皮植入。针对如何兼顾自体瓣叶夹持件和鞘管过大的问题，国内学者和工程师们作出了一些概念上的尝试。
专利CN201520325599.6和CN201511017536.5中描述了一款双环主动脉瓣膜支架，即在主体支架外加上一个W形的环形固定环，固定环的三个底脚用于固定在主动脉三个窦内，环形固定环用三个镍钛合金丝与主体支架连接。镍钛合金丝呈V形，其V形弯折与固定环V形弯折相对应。V形的镍钛合金丝能够拉伸为一字，使得固定环和支架的位置关系由内外关系成为上下关系。该设计的主要问题在于：1)环形固定环在释放后难以操作其对位主动脉窦，可调整性差；2)环形固定环一旦释放出鞘即卡在瓣膜窦部，无法进行重入鞘，手术风险大；3)环形固定环并未设置约束，导致其极容易在输送鞘管中弹跳，往往跳出后并不能完全实现与自体瓣膜的对中，加重调整难度；4)瓣膜完全释放后，自体瓣叶仍旧有贴靠主动脉窦壁堵塞冠脉的风险；5)上下支架运动的同轴性差，容易错位干涉。
专利CN201610029112.9中描述了一种经导管输送的主动脉瓣膜装置，与上述类似，其主体支架的上端形成呈三瓣型式的上喇叭口结构，主体支架的下侧还设置有用于定位的定位环，定位环与主体支架用定位线连接。该设计的主要问题在于：1)定位环释放后难以操作其对位主动脉窦，可调整性差；2)哪怕是已经对准主动脉窦，由于血流的冲击力，定位环将非常容易被冲出窦部，导致定位环夹子的端部无法抵触在瓣窦底部；3)瓣膜完全释放后，自体瓣叶仍旧有贴靠主动脉窦壁堵塞冠脉的风险；4)上下支架运动的同轴性差，容易错位干涉。
综上所述，传统技术已经能够部分兼顾自体瓣叶夹持件和缩小输送导管，然而传统技术均存在定位环无法可控释放，同轴性差，释放后难以调整和固定，以及自体瓣叶容易堵塞冠脉开口的风险，亟需一种同时解决以上问题的瓣膜置换装置。
发明内容
本申请的目的是克服传统的技术限制，针对传统分离式释放的主动脉瓣膜支架无法有效控制主体支架和定位件的位置、无法有效避免冠脉堵塞，以及无法在完全释放夹持件后重新入鞘等问题，开发了一种新型的分离式释放的主动脉瓣膜支架。
本申请的目的是通过以下技术方案实现的：
一种分离式释放的主动脉瓣膜支架，包括瓣膜缝制段、定位部件和人工瓣膜，所述人工瓣膜被连接在所述瓣膜缝制段上，所述瓣膜缝制段与所述定位部件为两个独立构件并通过导引装置连接，所述定位部件能够先于所述瓣膜缝制段释放，所述瓣膜缝制段上设置有滑动连接结构，所述导引装置的一端连接在所述定位部件上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述定位部件上，所述瓣膜缝制段能够沿所述导引装置滑动。
本申请的目的还可以通过以下技术方案进一步实现：
在一实施例中，所述定位部件设置有锚定段和夹持段，所述夹持段与所述锚定段连接，所述导引装置的一端连接在所述夹持段上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述锚定段上，所述瓣膜缝制段利用所述滑动连接结构能够沿所述导引装置滑动。
在一实施例中，所述夹持段位于所述锚定段的近端，并且与所述锚定段为一体构件。
在一实施例中，所述锚定段为网格状结构或波浪形结构。在一实施例中所述锚定段的表面覆盖有膜或者编织物。
在一实施例中，所述夹持段具有三个爪件，所述爪件为U形或者V形结构。
在一实施例中，所述爪件的端部被设置为向所述夹持段的轴线方向内拢的结构，所述瓣膜缝制段的外轮廓上设置有凹陷，所述瓣膜缝制段完全释放后，所述凹陷与所述爪件的内拢的结构相匹配。
在一实施例中，所述瓣膜缝制段完全释放后自体瓣叶位于在所述爪件与所述瓣膜缝制段之间。
在一实施例中，所述导引装置为柔性线状结构或者带状结构。在一实施例中，所述导引装置为多根柔性线。
在一实施例中，所述导引装置位于所述定位部件与所述瓣膜缝制段之间。
在一实施例中，所述瓣膜缝制段完全释放后，所述导引装置骑跨在自体瓣叶的游离缘上。在一实施例中，所述自体瓣叶被所述导引装置骑跨并拉低，确保能够不堵塞冠脉开口。
在一实施例中，所述瓣膜缝制段与所述定位部件的轴向相对位置由所述导引装置的长 度所限位。
在一实施例中，所述瓣膜缝制段与所述定位部件被压缩后位于输送鞘管的不同位置。
在一实施例中，所述滑动连接结构为孔。在一实施例中，所述滑动连接结构与所述瓣膜缝制段为一体结构。在一实施例中所述滑动连接结构位于所述瓣膜缝制段的近端部分。
在一实施例中，所述导引装置与所述锚定段的连接点位于所述锚定段的远端部分上。
在一实施例中，在所述瓣膜缝制段上设置有多个所述滑动连接结构。
在一实施例中，所述瓣膜支架还包括辅助导引装置，所述辅助导引装置的一端连接在所述锚定段上，所述辅助导引装置的另一端连接在所述瓣膜缝制段上。
在一实施例中，所述夹持段释放后位于自体瓣膜窦部，所述锚定段释放后至少部分位于血管内。
在一实施例中，所述瓣膜缝制段的近端配置有密封件，当所述分离式释放的主动脉瓣膜支架被植入时，所述密封件阻止血液通过所述瓣膜缝制段与自体组织之间的间隙。
在一实施例中，所述密封件为不连续的带状结构。在一实施例中，当所述分离式释放的主动脉瓣膜支架被植入时，所述爪件的下方对应所述密封件的不连续处。
在一实施例中，所述锚定段的远端设置有配合结构，所述瓣膜缝制段的近端设置有连接结构，当被压缩装载在输送鞘管中时所述连接结构和所述配合结构相互约束。
在一实施例中，所述连接结构为杆，所述配合结构为孔，当所述瓣膜支架被压缩装载在输送鞘管中时，所述连接结构穿过所述配合结构。在一实施例中，在所述连接结构上设置有限位孔，当所述瓣膜支架被压缩装载在输送鞘管中时，所述连接结构穿过所述配合结构后，限位丝穿过所述限位孔。
在一实施例中，所述连接结构为线圈，所述配合结构为孔，当所述瓣膜支架被压缩装载在输送鞘管中时，所述连接结构穿过所述配合结构后，限位丝穿过所述线圈。
在一实施例中，所述连接结构上设置有凹槽，所述配合结构上设置有凸起，所述凹槽和所述凸起相互匹配。
同传统技术相比，本申请的优点在于：
1、区别于传统技术，本申请在定位部件和主体瓣膜之间设置有导引装置，所述导引装置至少起到四个主要作用：1)所述瓣膜缝制段能够沿所述导引装置滑动到达指定位置，这样的移动方式能够大大增强瓣膜缝制段和定位部件之间的同轴性，避免两者在相互运动过程产生干涉和错位；2)在主体瓣膜与定位部件的对位及释放过程中，导引装置骑跨在原生自体瓣叶的游离缘上，能够有效限制自体瓣叶的游离缘活动，完全释放后更是自动压低自体瓣叶的游离缘高度，避免遮挡冠脉开口，同时增强了锚定效果；3)辅助实现所述 定位部件的可控释放；4)导引装置还起到对主体瓣膜与定位部件相对位置的限位作用，便于医生操作。
2、区别于传统技术的固定方式，本申请中所述夹持段释放后首先定位在自体主动脉窦部，然后所述锚定段释放后至少部分位于血管内，利用升主动脉进行固定，这样设计的好处在于确保定位部件在释放后不会脱落，给予后续的主体瓣膜释放充足的时间。
3、通过所述瓣膜缝制段和所述定位部件间的相互约束，实现所述定位部件的可控释放，避免所述定位部件在释放过程中从输送鞘管中弹跳而影响植入效果，便于控制和调整所述夹持段的角度和位置，同时能够在所述定位部件完全释放后重新入鞘，降低手术风险。相比于传统技术中分别对瓣膜主体和定位部件进行控制，这样的相互约束能够最大限度减少鞘管尺寸。
4、区别于传统技术，本申请中所述密封件为不连续的带状结构，当所述瓣膜支架被植入时，所述爪件的下方对应所述密封件的不连续处，即密封件的连续处对应自体瓣叶的交界处，针对性的局部封堵技术在确保减少瓣周漏效果的同时，有效降低输送鞘管的直径。
5、区别于传统技术，本申请夹持段与瓣膜缝制段接触的部位为相配合的凹凸轮廓，这样设计的好处在于方便定位部件和主体瓣膜的对位和固定，有利于锚定和减少瓣周漏。
附图说明
为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。
图1A和图1B为本申请一种实施方式的示意图。
图1C为本申请中定位部件的结构示意图。
图1D和图1E为本申请的主动脉瓣膜支架切割图。
图2A-图2C为本申请中瓣膜缝制段、定位部件以及导引装置的运动轨迹示意图。
图2D为本申请中定位部件的一种实施方式的示意图。
图3A-图3D为本申请中配合结构和连接结构的示意图。
图3E为本申请中配合结构和连接结构的一种实施方式的示意图。
图4A-图4L为本申请操作步骤的示意图。
图5A和图5B为本申请中另外一种实施方式的示意图。
图6A为本申请中另外一种实施方式的示意图。
图6B为密封件的一种实施方式的示意图。
图6C为本申请瓣膜缝制段与定位部件的另外一种实施方式的示意图。
图6D为本申请中另外一种实施方式的示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本申请所述的远端是指远离心尖的一端，所述的近端是指接近心尖的一端。
具体实施例一：
如图1A-图1E所示，作为一种实施方式，一种分离式释放的主动脉瓣膜支架100，包括瓣膜缝制段110、定位部件120和人工瓣膜130，所述人工瓣膜130被连接在所述瓣膜缝制段110上，所述瓣膜缝制段110与所述定位部件120为两个独立构件并通过导引装置140连接，使得所述瓣膜缝制段110与所述定位部件120被压缩后位于输送鞘管的不同位置，起到缩小输送鞘管直径的作用。所述定位部件120先于所述瓣膜缝制段110释放，所述瓣膜缝制段110上设置有滑动连接结构111，所述导引装置140的一端连接在所述定位部件120上，所述导引装置140的另一端穿过所述滑动连接结构111后连接在所述定位部件120上，所述瓣膜缝制段110能够沿所述导引装置140滑动。在一个实施方式中，所述定位部件120设置有锚定段121和夹持段122，所述夹持段122位于所述锚定段121的近端，所述夹持段122的远端与所述锚定段121的近端连接，在此实施例中所述夹持段122与所述锚定段121为一体构件。所述导引装置140的一端1401连接在所述夹持段122上，所述导引装置140的另一端1402从所述滑动连接结构111中穿过后连接在所述锚定段121上，所述瓣膜缝制段110能够沿所述导引装置140滑动。所述夹持段122沿周向等分配备有三个爪件1221(1221a、1221b、1221c)，所述爪件为U形或者V形结构，用以配合三个主动脉窦生理结构，所述爪件1221在释放后到达自体瓣叶的背后和主动脉瓣窦底，以完成定位。所述导引装置140为柔性线状结构，在一个实施方式中，所述导引装置140为三根柔性线，在其它的实施方式中也可以采用更多的柔性线来连接所述瓣膜缝制段110与所述 定位部件120，以达到更好的稳定定位作用，但更多的柔性线可能会增加推送阻力。图1D示出了定位部件120的切割结构，图1E示出了瓣膜缝制段110的切割结构。
如图2A-图2C所示，作为一种实施方式，所述导引装置140位于所述定位部件120与所述瓣膜缝制段110之间，这样能够最大限度避免所述导引装置140在滑动过程中损伤缝合在所述瓣膜缝制段110内的所述人工瓣膜130，而且能够为后续压低自体瓣叶游离缘提供可能。具体的，在所述瓣膜缝制段110的近端部分设置有三个所述滑动连接结构111，所述滑动连接结构111为孔。在一实施例中，所述滑动连接结构111与所述瓣膜缝制段110为一体结构。所述瓣膜缝制段110完全释放后，所述导引装置140骑跨在自体瓣叶180的游离缘上。所述瓣膜缝制段110与所述定位部件120的轴向相对位置由所述导引装置140的长度所限位，实际上，通过调整所述导引装置140的长度，能够实现当所述瓣膜缝制段110被限位在患者瓣环位置的同时，所述自体瓣叶180被所述导引装置140骑跨并拉低，确保不堵塞冠脉开口。另一方面，如图2D所示，所述锚定段121为网格状结构，所述锚定段121的表面覆盖有膜或者编织物160用于避免血管夹层。在另一个实施方式中，所述锚定段121为波浪形结构(未示出)。所述导引装置140与所述锚定段121的连接点位于所述锚定段121的远端部分上，所述瓣膜缝制段110与所述定位部件120被压缩后位于输送鞘管的不同位置，所述导引装置140能够辅助所述定位部件120在释放后重新入鞘，尤其是当所述锚定段121的绝大部分被释放后能够重新入鞘，医生将视定位效果可选择重新回撤和释放所述定位部件120，极大提高手术成功率。综上所述，区别于传统技术，本申请的所述导引装置至少起到四个主要作用：1)所述瓣膜缝制段能够沿所述导引装置滑动到达指定位置，这样的移动方式能够大大增强瓣膜缝制段和定位部件之间的同轴性，避免两者在相互运动过程产生干涉和错位；2)在主体瓣膜与定位部件的对位及释放过程中，导引装置骑跨在原生自体瓣叶的游离缘上，能够有效限制自体瓣叶的游离缘活动，完全释放后更是自动压低自体瓣叶的游离缘高度，避免遮挡冠脉开口，同时增强了锚定效果；3)辅助实现所述定位部件的可控释放；4)导引装置还起到对主体瓣膜与定位部件相对位置的限位作用，便于医生操作。
如图3A所示，所述锚定段121的远端设置有配合结构1210，所述瓣膜缝制段110的近端设置有连接结构1101，当被压缩装载在输送鞘管中时，所述连接结构1101和所述配合结构1210相互约束。如图3B所示，作为一种实施方式，所述连接结构1101为杆，所述配合结构1210为孔，当所述瓣膜支架100被压缩装载在输送鞘管中时，所述连接结构1101穿过所述配合结构1210。如图3C和图3D所示，所述连接结构1101上设置了限位孔1102，当所述瓣膜支架100被压缩装载在输送鞘管中时，所述连接结构1101穿过所述配合 结构1210后，所述限位孔1102中被限位丝1103穿过，只有抽离所述限位丝1103，所述连接结构1101才能从所述配合结构1210中撤出。通过所述瓣膜缝制段110和所述定位部件120间的相互约束，实现所述定位部件120的可控释放，避免所述定位部件120在释放过程中从输送鞘管中弹跳而影响植入效果，便于控制和调整所述夹持段122的角度和位置，同时能够在所述定位部件120完全释放后重新入鞘，降低手术风险。相比于传统技术中分别对瓣膜主体和定位部件进行控制，这样的相互约束能够最大限度减少鞘管尺寸。作为另一种实施方式，如图3E所示，所述连接结构1101为线圈，所述配合结构1210为孔，当所述瓣膜支架100被压缩装载在输送鞘管中时，所述连接结构1101穿过所述配合结构1210后被限位丝1103穿过。
为了更好地阐明本实施方案，所述瓣膜支架100可以通过以下操作步骤进行输送及释放：
(1)如图4A和图4B所示，将所述瓣膜支架100压缩装载在输送鞘管170内，所述瓣膜缝制段110位于所述定位部件120的远端，在影像设备的辅助下，将植入物经股动脉或类似动脉途径入路输送至患者病变部位；
(2)如图4C和图4D所示，逐步释放所述夹持段122直至所有所述爪件1221张开角度，所述夹持段122释放后位于自体瓣膜窦部，此时所述锚定段121仍被压缩在输送鞘管内；
(3)如图4E和图4F所示，调整所述爪件1221的角度和位置，到达自体瓣叶的背后和主动脉瓣窦底后，逐步释放所述锚定段121，所述锚定段121被释放后至少部分位于血管内提供锚定力，由于所述瓣膜缝制段110和所述定位部件120间的相互约束，所述锚定段121并不会弹跳，而且这种利用升主动脉进行固定的方式，所述定位部件120在完全释放后并不会因血流冲刷而移位脱落，给予后续的主体瓣膜释放充足的时间。更重要的是，若医生不满意所述定位部件120的位置，在所述导引装置140的辅助下，可重新将所述定位部件120收入鞘中，重新释放或者撤离人体，手术风险大大降低；
(4)如图4G和图4H所示，在确定位置后，抽离所述限位丝1103，所述连接结构1101从所述配合结构1210中撤出，所述锚定段121被完全释放锚定在升主动脉内；
(5)如图4I和图4J所示，将导引Tip头重新与鞘管合拢，这样的操作可帮助压缩着所述瓣膜缝制段110的输送鞘管170更好地通过自体瓣叶。沿着所述导引装置140推动输送鞘管直至被所述导引装置140的长度所限位，此时自体瓣叶180被所述导引装置140骑跨并压低；
(6)如图4K和图4L所示，逐步释放所述瓣膜缝制段110直至其完全释放，所述瓣 膜缝制段110完全释放后，自体瓣叶维持被压低的形态位于所述爪件1221与所述瓣膜缝制段110之间；
(7)撤离输送导管。
所述瓣膜支架100还可以经心尖、经房间隔穿刺等途径进行输送及释放，操作步骤与上文类似，不再赘述。
具体实施例二：
如图5A所示，作为另一种实施方式，一种分离式释放的主动脉瓣膜支架200，包括瓣膜缝制段210、定位部件220和人工瓣膜(未显示)，所述人工瓣膜被连接在所述瓣膜缝制段210上，所述瓣膜缝制段210与所述定位部件220为两个独立构件并通过导引装置240连接，所述导引装置240为带状结构。与具体实施例一区别在于，所述瓣膜支架200还包括辅助导引装置250，具体的，辅助导引装置250为线，所述辅助导引装置250的一端2501连接在所述锚定段221上，所述辅助导引装置250的另一端2502连接在所述瓣膜缝制段210上。所述辅助导引装置250的作用在于连同所述导引装置240，使得所述瓣膜缝制段210和所述定位部件220能够更好地稳定定位。由于所述辅助导引装置250两端的连接部位与所述导引装置240的不尽一致，因此所述辅助导引装置250的长度需要根据所述导引装置240的长度精心设计。
所述锚定段221的远端设置有配合结构2210，所述瓣膜缝制段210的近端设置有连接结构2101，所述连接结构2101和所述配合结构2210在压缩装载在输送鞘管中时相互约束。作为一种实施方式，如图5B所示，所述连接结构2101上设置有凹槽2104，所述配合结构2210上设置有凸起2211，所述凹槽2104和所述凸起2211相互匹配。
具体实施例三：
如图6A所示，作为另一种实施方式，一种分离式释放的主动脉瓣膜支架300，包括瓣膜缝制段310、定位部件320和人工瓣膜330，所述人工瓣膜330被连接在所述瓣膜缝制段310上，所述瓣膜缝制段310与所述定位部件320为两个独立构件并通过导引装置340连接。所述定位部件320先于所述瓣膜缝制段310释放，所述定位部件320设置有锚定段321和夹持段322，所述夹持段322具有三个爪件3221。所述瓣膜缝制段310上设置有滑动连接结构311，所述导引装置340的一端3401连接在所述爪件3221底端的孔3222上，所述导引装置340的另一端3402从所述滑动连接结构311中穿过后连接在所述锚定段321上，所述瓣膜缝制段310能够沿所述导引装置340滑动。与之前实施例不同在于，所述瓣膜缝制段310的近端配置有密封件370，当所述瓣膜支架300被植入时，所述密封件370阻止血液通过所述瓣膜缝制段与自体组织之间的间隙。由于自体瓣叶的辅助防漏作用，自 体瓣叶的瓣叶交界区域最容易产生反流，作为一种实施方式，如图6B所示，所述密封件370为不连续的带状结构，当所述瓣膜支架300被植入时，所述爪件3221(3221a、3221b、3221c)的下方对应所述密封件370的不连续处，即密封件的连续处对应自体瓣叶的交界处，如此针对性的局部封堵技术在确保减少瓣周漏效果的同时，有效降低输送鞘管的直径。
如图6C所示，所述爪件3221的端部被设置为向所述夹持段322的轴线方向内拢的结构。在一实施例中，所述瓣膜缝制段310的外轮廓上设置有凹陷3105，所述瓣膜缝制段310完全释放后，所述凹陷3105与所述爪件3221内拢的结构相匹配，这样设计的好处在于方便定位部件和主体瓣膜的对位和固定，有利于锚定和减少瓣周漏。
如图6D所示，作为另外一种实施方式，所述瓣膜缝制段310上设置有滑动连接结构311，所述导引装置340与所述定位部件320的连接点与所述爪件3221在轴线方向上错开布置，所述瓣膜缝制段310能够沿所述导引装置340滑动。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (17)

  1. 一种分离式释放的主动脉瓣膜支架，其特征在于，包括瓣膜缝制段、定位部件和人工瓣膜，所述人工瓣膜被连接在所述瓣膜缝制段上，所述瓣膜缝制段与所述定位部件为两个独立构件并通过导引装置连接，所述定位部件能够先于所述瓣膜缝制段释放，所述瓣膜缝制段上设置有滑动连接结构，所述导引装置的一端连接在所述定位部件上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述定位部件上，所述瓣膜缝制段能够沿所述导引装置滑动。
  2. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述定位部件设置有锚定段和夹持段，所述夹持段与所述锚定段连接，所述导引装置的一端连接在所述夹持段上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述锚定段上，所述瓣膜缝制段通过所述滑动连接结构能够沿所述导引装置滑动。
  3. 如权利要求2所述的分离式释放的主动脉瓣膜支架，其特征在于，所述夹持段具有爪件，所述爪件的端部被设置为向所述夹持段的轴线方向内拢的结构，所述瓣膜缝制段的外轮廓上设置有凹陷，所述瓣膜缝制段完全释放后，所述凹陷与所述爪件的内拢的结构相匹配。
  4. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述导引装置为柔性线状结构或者带状结构。
  5. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述导引装置位于所述定位部件与所述瓣膜缝制段之间。
  6. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述瓣膜缝制段完全释放后，所述导引装置骑跨在自体瓣叶的游离缘上。
  7. 如权利要求6所述的分离式释放的主动脉瓣膜支架，其特征在于，所述自体瓣叶被所述导引装置骑跨并拉低。
  8. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述瓣膜缝制段与所述定位部件的轴向相对位置由所述导引装置的长度所限位。
  9. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述瓣膜缝制段与所述定位部件被压缩后位于输送鞘管的不同位置。
  10. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述滑动连接结构位于所述瓣膜缝制段的近端部分，所述导引装置与所述锚定段的连接点位于所述锚定段的远端部分上。
  11. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述分离式释放的主动脉瓣膜支架还包括辅助导引装置，所述辅助导引装置的一端连接在所述锚定段上，所述辅助导引装置的另一端连接在所述瓣膜缝制段上。
  12. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述瓣膜缝制段的近端配置有密封件。
  13. 如权利要求12所述的分离式释放的主动脉瓣膜支架，其特征在于，所述密封件为不连续的带状结构。
  14. 如权利要求1所述的分离式释放的主动脉瓣膜支架，其特征在于，所述锚定段的远端设置有配合结构，所述瓣膜缝制段的近端设置有连接结构，当被压缩装载在输送鞘管中时所述连接结构和所述配合结构相互约束。
  15. 如权利要求14所述的分离式释放的主动脉瓣膜支架，其特征在于，所述连接结构为杆，所述配合结构为孔，当所述分离式释放的主动脉瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构。
  16. 如权利要求15所述的分离式释放的主动脉瓣膜支架，其特征在于，在所述连接结构上设置有限位孔，当所述分离式释放的主动脉瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构，限位丝穿过所述限位孔。
  17. 如权利要求14所述的分离式释放的主动脉瓣膜支架，其特征在于，所述连接结构为线圈，所述配合结构为孔，当所述分离式释放的主动脉瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构，限位丝穿过所述线圈。
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