WO2023051521A1 - 人工瓣膜置换系统 - Google Patents

人工瓣膜置换系统 Download PDF

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Publication number
WO2023051521A1
WO2023051521A1 PCT/CN2022/121698 CN2022121698W WO2023051521A1 WO 2023051521 A1 WO2023051521 A1 WO 2023051521A1 CN 2022121698 W CN2022121698 W CN 2022121698W WO 2023051521 A1 WO2023051521 A1 WO 2023051521A1
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WO
WIPO (PCT)
Prior art keywords
valve
clamping
hoop
leaflet
support
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/CN2022/121698
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English (en)
French (fr)
Inventor
吕世文
陈志�
陈进雄
张善冬
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.)
Jenscare Scientific Co Ltd
Original Assignee
Jenscare Scientific Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Jenscare Scientific Co Ltd filed Critical Jenscare Scientific Co Ltd
Priority to JP2024517046A priority Critical patent/JP7717410B2/ja
Priority to US18/695,351 priority patent/US20260041549A1/en
Priority to CA3231651A priority patent/CA3231651A1/en
Priority to EP22874906.5A priority patent/EP4385460A4/en
Publication of WO2023051521A1 publication Critical patent/WO2023051521A1/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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • 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
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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

Definitions

  • the application relates to the field of medical devices, in particular to an artificial valve replacement system.
  • both the mitral valve and the tricuspid valve have a special physiological structure, which makes it very difficult to accurately position and fix the product.
  • the specific anatomical position of the mitral valve in the heart and its complex anatomical structure bring great challenges to mitral valve replacement surgery.
  • the technique of locking the prosthesis of the mitral valve/tricuspid valve in the heart through surgery often utilizes the radial support force of the stent on the atrioventricular valve ring.
  • the disadvantage of this technique is that it is easy to cause compression on the tissue around the valve annulus, and it is easy to cause the impact of the stent and the compressed tissue on the outflow tract. From the perspective of the long-term use of the replacement valve, as the patient's use time goes by after the operation, the regurgitation will decrease, the ventricular and atrial pressure will decrease, and the heart structure will be reconstructed. The larger size of the stent will affect the reduction of the size of the valve ring. Affecting the internal structures of the heart is clearly an unwanted result.
  • the locking technology can also be fixed at the leaflet by pre-implanting a docking device at the valve leaflet, and stretching the bracket inside the docking device.
  • Patent CN109789019A describes a heart valve docking coil and system from Edwards Lifesciences. In this patent publication, the leaflet and stent are tightly clamped together by wrapping the docking device on the outside of the leaflet. The superiority of this stent fixation method is outstanding, but the large anterior leaflet is hooped on the stent, which does not solve the problem of blocking the blood flow of the left outflow tract.
  • mitral valve replacement prosthesis currently has at least the following technical pain points: 1. After the prosthesis is replaced, the anterior valve leaflet will block the left ventricular outflow tract; internal structure, leading to a large number of complications; the industry urgently needs a new transcatheter heart valve replacement system to solve the above and other technical problems.
  • the present application provides an artificial valve replacement system.
  • the main purpose of this application is to overcome some problems and deficiencies of the related art.
  • an artificial valve replacement system comprising: a valve support, a valve clamping and fixing device cooperating with the valve support, and the valve clamping and fixing device is configured to clamp a native valve leaflet A clamping mechanism and a hoop, the hoop is configured on the clamping mechanism; wherein, the clamping device is configured to be able to present a first form and a second form, and the second form is in After the first form; wherein, when the valve clamping device is in the first form, the valve clamping mechanism is configured to capture and clamp the native valve leaflet; wherein, after the valve support is radially expanded, The valve clamping and fixing device is in the second configuration, and the radial expansion of the valve support causes the hoop member to drive the native valve leaflets to move upwards and tighten the valve support.
  • the distal end of the valve clamping mechanism is detachably connected, and when the valve clamping device is in the first state, the valve leaflets around the valve clamping mechanism can realize automatic opening and closing, when the valve The stent enters the valve clamping mechanism, the distal end of the valve clamping mechanism is disassembled, and the valve support is in a state of radial expansion, and the radial expansion of the valve support causes the hoop to drive the native valve leaflet upward Position and tighten the valve stent.
  • the radial expansion of the valve support drives the clamping mechanism, the hoop member, the native valve leaflet and the chord
  • the hoop is at least partly displaced upwards and drives the native valve leaflet and chordae to be pulled upwards, and the hoop tightens the valve support, and at this time, the valve clamping and fixing device is in the second configuration.
  • the valve clamping mechanism clamps part of the native valve leaflets, and in the second form, the native valve leaflets around the valve clamping mechanism are driven by the hoop and shift up.
  • the hoop member is a closed-loop structure, and the hoop member passes through the flap clamping mechanism.
  • the hoop is connected to the flap clamping mechanism to form a closed-loop structure, the hoop is two segments of wire or wire, and both ends of the hoop are fixed to the flap clamping mechanism connect.
  • the hoop member and the valve clamping mechanism include at least two connection points, and the heights of the connection points between the hoop member and the valve clamping mechanism are different.
  • the heights of the connection points of the hoop on the valve clamping mechanism are different, specifically, the hoop is The height of the front leaflet area is greater than the height of the hoop in the rear leaflet area, which can not only significantly lift the front leaflet, avoid blocking the outflow tract of the left ventricle, but also avoid the impact of the hoop on the rear leaflet.
  • the chordae in the lobe area are stretched to protect the chordae.
  • the flap clamping mechanism includes a plurality of clamping members, and the heights of the connection points between the hoop member and each of the clamping members are different, so that in the second form, the The hoop part is in a wave-shaped form; or, in the second form, the height of the hoop part in the area of the front leaflet is higher than the height of the hoop part in the area of the rear leaflet; this can make the front lobe
  • the leaflets are lifted to a higher position to avoid obstruction of the LV outflow tract by the anterior leaflet after replacement.
  • the position of the connection point between the hoop and the clamping mechanism should not be too high, for example, the connection point is located in the two-thirds of the proximal end of the native valve leaflet, which can effectively prevent the hoop from being too high. Pull tendon tissue.
  • the hoop member when the valve clamping device is in the second configuration, the hoop member is located between the chordae tendineae and the native valve leaflet, and the valve support is radially expanded such that the hoop member is at least partially It is displaced upwards and pulls the native valve leaflets and chordae upward.
  • the hoop is tied to the outer periphery of the clamping mechanism in a tensioned state, and the native valve leaflet is pulled upward by the hoop , and the native valve leaflets are folded back to at least partially overlap themselves.
  • the hoop member also hoops the valve clip mechanism and the native valve leaflets around the outer periphery of the valve support.
  • the valve support gradually expands radially from the non-radially expanded state, and gradually expands the clip valve Fixing device, so that the hoop member is gradually expanded from a relaxed state and tensioned, thereby gradually pulling the chordae and the clamped native valve leaflet, and tightening the valve support and the valve clamping mechanism .
  • the valve clamping mechanism moves toward the atrium, so that part of the native valve leaflet and chordae are folded back in the gap formed by the valve clamping mechanism. Between the valve leaflet accommodating cavity and/or the lower part of the native valve ring and the hoop.
  • one end of the valve clamping mechanism abuts against the root of the clamped native valve leaflet.
  • the valve clamping device includes a single clamping valve member, an atrium support segment (after the valve clamping device is installed in place, the atrial support segment is located in the atrium and provides support), a ventricular segment, and a hoop,
  • the hoops are respectively connected with the valve clip and the ventricular segment, and, on a section parallel to the central axis of the clip valve fixing device, the hoops are inclined; more specifically, the The height of the connection between the hoop and the clip is higher than the height of the region of the clip; when used for mitral valve treatment, the clip is used to clamp the front leaflet, and , the hoop can significantly pull the anterior valve leaflet and related chordae.
  • the flap clamping mechanism includes a first clamping half body and a second clamping half body, the first clamping half body and the second clamping half body are detachably connected, or the first clamping half body and the second clamping half body are detachably connected.
  • the clamping half and the second clamping half are two independent components separate from each other; and the first clamping half and the second clamping half are configured to respectively capture and clamp different native valve leaflets, and
  • the perimeter of the closed loop formed by the hoop is slightly smaller than the perimeter of the radially expanded valve support in place.
  • the first clamping half body and the second clamping half body together form a substantially sleeve-shaped structure under the restraint state of the clamping valve fixing device, and the substantially sleeve-shaped structure is sleeved on
  • the inner core tube is covered on the outer periphery by the outer sheath tube.
  • the first clamping half body and the second clamping half body have complementary shapes, and are snap-connected detachably in a constrained state of the clamping flap fixing device.
  • the first clamping half has a first support section, a first detachable fitting section extending from the first support section, and a first detachable fitting section further extending from the first detachable fitting section.
  • the first clamping section is provided with a first jaw on the first supporting section; and the second clamping half has a second supporting section, and the second detachable fitting extending from the second supporting section segment, and a second clamping segment further extending downward from the first detachable fitting segment, and a second jaw is provided on the second supporting segment.
  • the first clamping half body and the second clamping half body respectively include a leaflet catcher and a valve pressing member, and the hoop member is connected to one end of the leaflet catcher.
  • the first jaw and the second jaw are provided with teeth, and the teeth can define the relative positions between the first clamping half body, the second clamping half body and the native leaflet, the The teeth are configured for gripping and securing the clamped native valve leaflets.
  • the teeth can be barbs or other structures that can be locked with the valve leaflet, so that the first clamping half body and the second clamping half body can firmly bite the native valve leaflet.
  • its teeth can be respectively provided at one end of the first clamping half and the second clamping half, and the teeth can "pin" the native valve leaflet to prevent the first clamping half and the second clamping half from Slippage occurred after the native valve leaflet was clamped by the holding half.
  • the first clamping segment is connected to the first detachable fitting segment through an elastic segment, and the first jaw is connected to the first support segment through an elastic segment; and the second The clamping section is connected with the second detachable matching section through the elastic segment, and the second jaw is connected with the second support segment through the elastic segment.
  • said first clamping half is integrally formed and said second clamping half is integrally formed.
  • both the first clamping half and the second clamping half consist of a shape memory alloy.
  • both the first clamping half body and the second clamping half body are configured to respectively form a leaflet accommodating cavity, when the first clamping half body and the second clamping half body capture And when clamping the autologous valve leaflet, part of the autologous valve leaflet is folded back in the valve leaflet accommodating cavity.
  • the native valve leaflet when the first clamping half body and the second clamping half body are opened to capture the native valve leaflet, the native valve leaflet is located at the opening angle of the first clamping half body and the second clamping half body.
  • the delivery system can be operated to move the entire clamping valve fixing device upward toward the atrium, so that part of the native valve leaflet is folded between the first clamping half body and the second clamping half body, specifically Said that the tip part of the native valve leaflet is folded in the valve leaflet accommodating cavity, which can effectively shorten the length of the native valve leaflet and prevent it from blocking the left ventricular outflow tract.
  • the valve support can also be provided with a positioning ring to be positioned in the atrium, the positioning ring is configured to adapt to the shape of the physiological structure of the native valve annulus, and the positioning ring is provided with an auxiliary fixing ring. pole.
  • the number of the auxiliary fixing rods is three or four, which can not only play a strong supporting role, but also avoid excessive pulling on the original annulus and reduce the number of implants.
  • the positioning ring is provided with a flexible sealing membrane, and after the valve support is installed in place, the sealing membrane adheres to the atrial tissue.
  • the valve support is provided with barbs for auxiliary fixation, and the barbs are arranged on the positioning ring.
  • the valve support is provided with a fixed clamp, and, in the second configuration, the fixed clamp clamps the native valve leaflet so that the native valve leaflet is clamped on the valve support between the fixed clips.
  • the artificial valve replacement system further includes an inner core tube and an outer sheath tube; A constrained state between the sheaths; and in the constrained state, the clamping valve fixation device cannot clamp the native valve leaflet.
  • an inner core tube is also included; and the valve support can enter and reach the middle area of the valve clamping mechanism along the inner core tube.
  • the first clamping half body and the second clamping half body are detachably connected, the inner core tube is provided with an enlarged end, the first clamping half body is provided with a first detachable fitting section, and the second clamping half body is provided with a first detachable fitting section.
  • the holding half is provided with a second detachable fitting section; and, the first detachable fitting section and the second detachable fitting section are detachably connected through the inner core tube; and the enlarged end is generally cylindrical in shape,
  • the first detachable matching section and the second detachable matching section can be fitted together to form a similar snap connection, and then the enlarged end is inserted into the middle of the first detachable matching section and the second detachable matching section to form a detachable Disassemble the connection; when the enlarged end is withdrawn from the middle of the first detachable fitting section and the second detachable fitting section, the valve support provides radial expansion force for the first clamping half body and the second clamping half body, making it Complete disassembly and separation.
  • the enlarged end is withdrawn from the proximal end relative to the valve clamping mechanism, so as to realize disassembly and separation from the valve clamping mechanism.
  • valve stent may be a ball-expandable stent or a self-expanding stent.
  • the hoop member is generally in the shape of a strip, a wire or a hemp rope.
  • the covering film on the outer periphery of the hoop member can increase the frictional force with the native valve leaflet.
  • an artificial valve replacement system including: a clamping valve fixing device, comprising a generally sleeve-shaped structure formed by a first clamping half body and a second clamping half body in a constrained state The clamping mechanism of the valve, and the hoop part that is tied to the distal end of the clamping mechanism and constitutes a closed loop around the clamping mechanism; the inner core tube; the outer sheath tube; and the radially expandable tubular valve support, wherein, in the constrained state of the clamping valve fixing device, the valve clamping mechanism is sleeved on the inner core tube and is constrained in the outer sheath tube; wherein, in the first In the configuration, the first clamping half body and the second clamping half body are exposed from the outer sheath tube and deformed to the configurations capable of clamping the native leaflets respectively, and the hoop member is in a relaxed state; wherein , in the second form of the clamping valve fixing device, the valve support
  • the native valve leaflet in the first configuration, maintains a partial opening and closing function; and, in the second configuration, at least part of the native valve leaflet is folded.
  • the artificial valve replacement system further includes a positioning ring, and the positioning ring is configured to have a shape adapted to the physiological structure of the native valve ring.
  • the positioning ring is integrated with the flap fixing device.
  • a method for operating an artificial valve replacement system including: operating the outer sheath of the artificial valve replacement system to enter the surgical site; The proximal end is gradually withdrawn to gradually expose the clamping mechanism in the constrained state in the outer sheath, and gradually release the valve clamping mechanism made of shape memory alloy along with the withdrawal of the outer sheath.
  • the first clamping half and the second clamping half are gradually deformed to each capture and clamp the corresponding native valve leaflet; the outer sheath is completely withdrawn from the surgical site, and the inner core tube is retained In situ; operate the valve stent delivery device to enter the tubular valve stent along the inner core tube and arrive between the first clamping half body and the second clamping half body of the valve clamping mechanism, and withdraw the valve support The inner core tube; radially expanding the valve support, and thereby radially expanding the valve clamping mechanism, thereby expanding and tensioning the hoop member tied on the outer periphery of the valve clamping mechanism, wherein the The unfolding and tensioning of the hoop gradually pulls the chordae and the native valve leaflet along the axial direction of the valve support until the hoop tightens the valve support and the clamping mechanism, and Ultimately, lifting and folding back of the native valve leaflets is achieved; and withdrawing the valve stent delivery device.
  • an artificial valve replacement system including: a valve support; and a valve clamping device, the valve clamping device includes a valve clamping mechanism and a hoop, and the hoop is configured on the valve clamping mechanism Above; wherein, the clamping valve fixation device has a first form and a second form; when the valve clamping fixation device is in the first form, the valve clamping mechanism is configured to be pre-fixed in the middle of the native valve by clamping a partial native valve leaflet In the region, the hoop is in a relaxed state, and the native valve leaflet can maintain the function of partial opening and closing; when the clamping device is in the second state, the valve support radially expands and drives the clamping mechanism and the hoop to expand synchronously, and the hoop
  • the components gradually lift the chordae, autogenous valve leaflets and adjacent tissues, and finally realize the folding back of the autologous valve leaflets.
  • the hoop pulls the autogenous valve leaflet and chordae to displace in the direction of the connection point between the hoop and the clamping mechanism and drives part of the autogenous
  • the leaflets are folded back; finally, the hoop part fixes part of the leaflets, chordae, and clamping mechanism on the outer periphery of the valve support.
  • the valve clamping mechanism moves toward the atrium so that part of the native valve leaflet and chordae are folded back inside the valve clamping mechanism and/or below the native valve annulus Between the hoop and the hoop, the height of the valve leaflet can be lifted to avoid obstruction of the left ventricular outflow tract.
  • first clamping half body and the second clamping half body are detachably connected; and, the first clamping half body and the second clamping half body can capture and clamp different native leaflets respectively.
  • first clamping half body and the second clamping half body are two independent components, and are axially arranged in the outer sheath, and the first clamping half body and the second clamping half body can be independent of each other. Captures and holds different native valve leaflets.
  • valve clipping mechanism is used to capture and clamp the native valve leaflet to achieve a similar "marginal alignment" "edge” repair can effectively reduce valve regurgitation.
  • the native valve can still work normally, buying more time for the operation and effectively reducing complications; at the same time, the valve stent can be along the inner core
  • the tube smoothly reaches the middle area of the clamping mechanism, the positioning is accurate and the operation is more convenient.
  • the direction of the connection point between the parts and the clamping mechanism is displaced and the autogenous valve leaflets are lifted upwards, which avoids the obstruction of the left ventricular outflow tract by the autologous valve leaflets after replacement; finally, the hoop parts will part of the autologous valve leaflets, chordae tendineae and clipping valves.
  • the mechanism ring is fixed on the outer periphery of the valve stent, and its anchoring method can avoid radially supporting the native valve ring, avoiding adverse effects on the shape of the native valve, and at the same time solves the two major problems in the treatment of mitral valve replacement in related technologies Pain points with good clinical significance.
  • the hoop only plays the role of fixing the valve support, but cannot solve the blocking effect of the native valve leaflet on the left ventricular outflow tract.
  • the valve clip mechanism Anchored on the native valve leaflet first the connection point between the hoop and the clamping mechanism is higher than the connection between the tip of the native valve leaflet and the chordal tissue, and the length of the hoop is fixed. When the diameter of the valve stent When it expands, the hoop moves upward toward the connection point with the clamping mechanism.
  • the hoop uses the connection point as a fulcrum and pulls the chord tendon to further drive the autogenous valve leaflet upward, finally making the hoop
  • the hoop can tighten the valve support to prevent it from radially supporting the native valve ring, and at the same time, it can effectively prevent the native valve leaflets from blocking the outflow tract, which has good clinical significance.
  • one end of the first clamping half body and one end of the second clamping half body are provided with valve leaflet accommodation chambers, so that the valve clamping mechanism can catch and clamp When holding the valve leaflet, part of the autogenous valve leaflet can be folded back in the valve leaflet accommodation cavity. After folding back, the length of the leaflet is shortened, which effectively avoids the obstruction of the left ventricular outflow tract and reduces the impact of the original valve leaflet tissue on the blood after replacement. Especially when used for mitral valve replacement, it is very suitable for the physiological characteristics of the long anterior leaflet of the mitral valve and has good clinical significance.
  • the positioning ring provides the locking force at the annulus or atrium for the clamping mechanism, so that the first clamping half body and the second clamping half body are capturing And after the valve leaflets are clamped and the valve support has not yet entered the release position, the valve clamping mechanism can be well kept in the position in the heart, preventing the valve clamping mechanism from slipping.
  • the inner core tube can not only control the disassembly and connection of the valve clamping mechanism, but also serve as a guide route for the valve support to enter the valve clamping mechanism, so that it can greatly shorten the operation time
  • the enlarged end only needs to be withdrawn from the middle of the first detachable fitting section and the second detachable fitting section, and the valve stent is in the process of gradually expanding radially to restore the functional form for the first clamping half and
  • the second clamping half provides radial expansion force to complete disassembly and separation; the structure is simple to assemble and the disassembly operation is also very convenient, which is beneficial to the development of clinical operations and has good clinical significance.
  • the height of the connection point of the hoop on the flap mechanism is different. Specifically, the height of the hoop in the front leaflet area is greater than that of the hoop in the rear The height of the leaflet area can not only significantly lift the front leaflet, avoid blocking the outflow tract of the left ventricle, but also prevent the hoop from excessively pulling the chord tendon in the rear leaflet area to protect the chord tendon tissue.
  • FIGS. 1a-1c are schematic diagrams of the structure of a valve support, a clip valve fixing device and a hoop according to an embodiment of the present application.
  • FIGS. 2a-2j are schematic diagrams showing the details and working principles of a valve clip fixation device according to an embodiment of the present application.
  • Figures 3a-3d show a hoop according to another embodiment of the present application.
  • 4a-4d are schematic diagrams of the process of the outer sheath entering the heart according to an embodiment of the present application.
  • 5a-5k are schematic diagrams of the process of valve clamping and fixing device, hoop member and valve support cooperating to complete valve replacement according to an embodiment of the present application.
  • Figures 6a-6c show an implementation manner of setting a positioning ring according to an embodiment of the present application.
  • FIG. 7a-7h are schematic views of the working principle of the positioning ring according to an embodiment of the present application.
  • Figure 8a shows a positioning ring according to another embodiment of the present application.
  • FIGS. 9a-9d show schematic diagrams of a balloon-expandable stent according to another embodiment of the present application.
  • FIGS 10a and 10b show schematic diagrams according to another embodiment of the present application.
  • Fig. 11a and Fig. 11b show schematic diagrams according to another embodiment of the present application.
  • FIGS 13a and 13b show schematic diagrams according to another embodiment of the present application.
  • proximal end refers to the end close to the operator
  • distal end refers to the end away from the operator
  • an artificial valve replacement system may include a valve support 1 and a clamp valve fixed together with the valve support 1 device 2.
  • the valve clamping and fixing device 2 may include a valve clamping mechanism 21 and a hoop member 3, and the hoop member 3 is arranged on the valve clamping mechanism 21, as shown in FIGS. 1a-1b.
  • the flap mechanism 21 can be composed of two halves made of a shape memory alloy, namely, a first clamping half 211 and a second clamping half 212. .
  • the first clamping half body 211 and the second clamping half body 212 can be integrally formed as shown in FIG. 4, and is tightly sheathed and constrained within the tube 6 by an outer sheath tube 6, as shown in Figs. 2a-2b.
  • the first clamping half body 211 and the second clamping half body 212 can capture and clamp different native valve leaflets respectively, as shown in FIGS. 1 b and 2 c .
  • the first clamping half body 211 and the second clamping half body 212 are all provided with teeth 213, and its teeth 213 can bite and fix the first clamping half body 211, the second clamping half body 212 and the self body leaflet.
  • the relative position between leaflets is shown in Fig. 2e-2g.
  • the teeth 213 may be tines, columella, barbs or other structures that can fix the valve leaflets, so that the first clamping half body 211 and the second clamping half body 212 can firmly bite the native valve leaflets.
  • first clamping half body 211 and one end of the second clamping half body 212 are provided with a leaflet accommodating chamber 214, when the first clamping half body 211 and the second clamping half body 212 capture and clamp the body When the leaflet is removed, part of the autologous leaflet is folded back in the leaflet accommodation cavity 214, as shown in Figures 1b and 2g.
  • the connection can be separated from each other when a force is applied, for example, when the enlarged end 41 of the inner core tube 4 is pulled away from the mating part and the valve stent 1 is stretched from the mating (eg fitting) part.
  • the first clamping half body 211 may have a first supporting section 2112, a first detachable matching section 2111 extending from the first supporting section 2112 and integrated therewith, and a first detachable matching section 2111 extending from the first supporting section 2112.
  • Section 2111 is integrally further extended downward by a first clamping section 2113 .
  • a first clamping jaw 2130 with teeth 213 may be formed on the main body of the first supporting section 2112 through laser cutting and still integrally connected with the elastic section 2131 .
  • the first clamping section 2113 is integrally connected with the first detachable matching section 2111 through the elastic section 2110 similarly.
  • the whole of the first clamping half body 211 can be made of memory alloy, and the elastic segment 2131 and the elastic segment 2110 have the structure of diamond wave, S bar or thin straight bar as shown in the figure, so that they are easy to elastically deform, for example, easy to straighten to Loaded preoperatively within an outer sheath 6 (eg, as shown in Figures 2b and 2e), and easily bendable to fold back the leaflets during and after surgery (as shown in Figures 2j-3d and described in detail below ).
  • the second clamping half body 212 can have a second support section 2122, a second detachable mating section 2121 extending from the second support section 2122 and integral with it, and The detachable matching section 2121 integrally extends downwards to a second clamping section 2123 .
  • a second clamping jaw 2133 with teeth 213 may be formed on the body of the second support section 2122 through laser cutting and integrally connected with the elastic section 2132 .
  • the second clamping section 2123 is integrally connected with the second detachable matching section 2121 through the elastic section 2120 .
  • the second clamping half body 212 can be made of a shape memory alloy as a whole, and the elastic segment 2132 and the elastic segment 2120 have the structure of a diamond wave, an S rod or a thin straight rod as shown in the figure, so that they are easy to elastically deform, for example, easy to straighten and Loaded preoperatively within an outer sheath 6 (eg, as shown in Figures 2b and 2e), and easily bendable to fold back the leaflets during and after surgery (as shown in Figures 2j-3d and detailed below. described).
  • the first clamping half body 211 integrally formed by the first supporting section 2112, the first detachable matching section 2111 and the first clamping section 2113, and the second supporting section 2122, the second detachable
  • the second clamping half body 212 which is integrally formed by the detachable matching section 2121 and the second clamping section 2123, is sleeved on the inner core tube 4 in a sleeve-like structure and is loaded into the outer sheath tube 6, wherein the first can
  • the two protrusions 2115 of the detachable fitting section 2111 and the two complementary shaped recesses 2125 of the second detachable fitting section 2121 are correspondingly engaged (or fitted) together to fix and hold the first clamping half.
  • the body 211 and the second clamping half body 212 constitute a sleeve-like structure. At this time, the enlarged end 41 of the inner core tube 4 has penetrated into the sleeve formed by the first detachable matching section 2111 and the second detachable matching section 2121. Inside the barrel (as shown in Figure 2a-2b).
  • the outer sheath 6 is withdrawn proximally (that is, in the direction of the straight arrow shown in FIG. 2c) to be exposed (released) earlier.
  • the first clamping section 2113 and the second clamping section 2123 and the first detachable matching section 2111 and the second detachable matching section 2121 are exposed and released, and by virtue of its own shape memory effect (elastic segment) from the previous straight, with the first and second support segments 2112, 2122 In a substantially straight state, they are bent upwards (indicated by the curved arrows in FIG.
  • first clamping jaw 2130 and the second clamping jaw 2133 each rely on its own shape memory effect (elastic segment) from the state of being respectively embedded in the first and second support segments 2112, 2122 and conforming to its overall shape, through its own shape memory effect (elastic segment).
  • the elastic segment deforms and bends downward (as shown by the curved arrow in FIG. 2f ), and presses against the corresponding first clamping segment 2113 and second clamping segment 2123 , as shown in FIGS. 2h-2i.
  • the native valve leaflet that was previously caught and attached to the first clamping section 2113 is clamped between the first jaw 2130 and the first clamping section 2113 and is held by the first clamping jaw 2130.
  • the teeth 213 on the clamping jaws 2130 are bitten and fixed; the autologous valve leaflets that were caught and attached to the second clamping section 2123 before are clamped between the second clamping jaws 2133 and the second clamping section 2123 and are held
  • the teeth 213 on the second jaw 2133 bite and fix it, as shown in Fig. 2j.
  • the flap mechanism 21 is in the capture state, and an expandable channel 215 is formed between the first support section 2112 and the second support section 2122, as shown in FIG. Space.
  • valve stent 1 After the valve stent 1 is carried by the valve stent delivery device 7 (for example, FIG. 5c ), it enters along the path of the inner core tube 4, wraps around the first and second support segments 2112, 2122 and enters the expandable channel 215 (FIG. 5e ), the enlarged end 41 of the inner core tube 4 is retracted to separate from the clamping mechanism 21 (Fig. The body 211 is further separated from the second clamping half 212 (Fig. 5g-5h).
  • the hoop member 3 is generally made of a linear or strip-shaped flexible member, such as passing through the perforations (Figure 2c-2d) on the ends of the first clamping section 2113 and the second clamping section 2123, and forming a A closed loop or loop that can constrain the position (ie, radial expansion) of the first clamping segment 2113 and the second clamping segment 2123 .
  • the circumference of the hoop member 3 in a fully expanded state is generally set to be smaller than the circumference of the cross-sectional circle of the fully expanded (expanded) valve stent 1 .
  • the hoop 3 also clamps the autogenous valve ring in the middle and tightly hoops it, as shown in the figure 2j and Figs. 5i-5j), and constrain the valve stent 1 to prevent its overexpansion to be larger than the size of the native valve annulus and cause damage.
  • valve support 1 in the process of the radial expansion of the valve support 1 in place and recovery to the functional form, the valve support 1 is tightly bound by the hoop 3 tethered on the clamping mechanism 21 that clamps the native valve leaflet. Due to the radial support thereof, the valve support 1 is indirectly fixed on the native leaflet tissue through the hoop 3 .
  • the hoop member 3 as a whole may be a flexible ring or ring, for example, a ring or ring that may be formed of generally flexible strips, wires, wires, twisted wires or ropes.
  • the outer periphery of the hoop member 3 may also be covered with a membrane, which can increase the friction between the hoop and the native leaflet.
  • the hoop piece 3 may be a closed-loop structure, or the hoop piece 3 cooperates with the flap mechanism 21 to form a closed-loop structure. After the flap mechanism 21 captures the native valve leaflet, the hoop member 3 is located on the periphery of the native valve leaflet and surrounds the native valve leaflet (as shown in Figure 2j and Figures 5i-5j).
  • the valve stent 1 can also be, for example, a self-expanding mesh stent, and its shape is, for example, a cylindrical structure that can be expanded and fixed in place when it reaches the surgical site.
  • the valve support 1 can also be provided with a positioning ring 11 that will be positioned in the atrium during the operation, and the positioning ring 11 is configured to adapt to the shape of the physiological structure of the native valve ring.
  • the positioning ring 11 can be covered with a film to avoid paravalvular leakage.
  • the flap clamping device 2 can take on the first shape and the second shape.
  • the valve clamping mechanism 21 is configured to be pre-fixed on, for example, the middle area of the native valve by clamping a part of the native valve leaflet. At this time, the hoop member 3 is not clamping the valve The relaxed configuration of scaffold 1. At this time, the native valve leaflet can maintain the function of partial opening and closing.
  • valve support 1 When the valve clip fixing device 2 is in the second form, the valve support 1 radially expands and drives the valve clip mechanism 21 and the hoop 3 to expand synchronously and is finally tightly held by the hoop 3.
  • the hoop Part 3 is located between the native valve leaflet and the chordal tissue, and is gradually pulled upwards (for example, as shown by the upward arrow in Figure 5h) and hoops the native valve leaflet and adjacent tissues, driving the clamped native valve leaflet to be lifted upward and gradually turn back.
  • the clamping member 3 pulls the hooped native valve leaflet and chordae upward to the clamping member 3 and the clamping mechanism. 21
  • the connecting point is displaced in the direction and drives the autogenous valve leaflet to fold back; finally, the hoop member 3 fixes part of the autologous valve leaflet, chordae tendineae, and valve clamping mechanism 21 on the outer periphery of the valve support 1, as shown in Figure 1c for example.
  • valve clamping mechanism 21 when the valve clamping mechanism 21 captures and clamps the native valve leaflet, the valve clamping mechanism 21 moves toward the atrium; Cooperate and pull back part of the native valve leaflet while pulling upward to raise the position of the valve leaflet and avoid blocking the left ventricular outflow tract.
  • traditional replacement would make the obstruction of the left ventricular outflow tract by the anterior native leaflet very obvious.
  • Using this solution can effectively reduce the impact of the original autologous valve leaflet tissue on blood flow after replacement, because the autologous valve leaflet tissue is not only partially folded back to reduce the risk of flow obstruction, but also by means of the radial expansion of the valve stent 1. Being pulled upward reduces its potential to obstruct LV outflow tract blood flow.
  • An exemplary operation process of the first embodiment for repairing the mitral valve is as follows.
  • valve support delivery device 7 After that, operate the valve support delivery device 7 to enter the heart along the path of the inner core tube 4, as shown in Figure 5c-5e;
  • the inner core tube 4 (such as withdrawing) makes it disassembled and separated from the clamping mechanism 21, as shown in Figures 5f and 5g; after that, the valve support delivery device 7 is further operated to gradually release the valve support 1, and the valve support 1 radially expands and recovers. functional form;
  • the radial expansion of the valve support 1 makes the first clamping half body 211 and the second clamping half body 212 of the valve clamping mechanism 21 move further in the direction shown by the curved arrow in FIG. 3 a to approach or even abut against On the periphery of the valve support 1, the clamped leaflets are thus partially folded back; the further radial expansion of the valve support 1 makes it expand outward and is supported on the hoop member 3 tightened by the periphery of the valve support 1, and After returning to the functional form and being anchored in the heart, the native valve leaflet is clamped between the hoop 3 and the valve support 1, and then the valve support delivery device 7 can be withdrawn from the body, as shown in Figures 5h-5k.
  • Embodiment 2 is generally the same as Embodiment 1, except that the valve clamping mechanism 21 in this embodiment also includes a positioning ring 5, and the positioning ring 5 can provide anchoring for the valve clamping mechanism 21 at the annulus or atrium.
  • the valve clamping mechanism 21 can be well kept in the heart. position, to prevent the flap clamping mechanism 21 from falling off, as shown in Figures 6a-6c.
  • the valve clamping and fixing device 2 may include a valve clamping mechanism 21 and a hoop 3 , and the hoop 3 may be configured on the valve clamping mechanism 21 .
  • a positioning ring 5 is also provided, and the positioning ring 5 can be configured to adapt to the shape of the physiological structure of the annulus; wherein, the clamping valve fixing device 2 can have a first form and a second form; when the clamping valve fixing device 2 is in the In the first form, the valve clamping mechanism 21 can be configured to be pre-fixed on, for example, the middle area of the native valve by clamping a partial native valve leaflet, the hoop member 3 can be in a relaxed state, and the native valve leaflet can maintain a partial opening and closing position.
  • the positioning ring 5 is located in the atrium; when the valve clamping device 2 is in the second form, the valve support 1 can radially expand and drive the valve clamping mechanism 21 and the hoop part 3 to unfold synchronously, and the hoop part 3 can be gradually pulled The autogenous valve leaflet and adjacent tissue, and finally realize the folding back of the autologous valve leaflet.
  • the positioning ring 5 can be composed of a radial rod-shaped support 51, which can effectively prevent the valve stent from shaking left and right, and help reduce or avoid the occurrence of paravalvular leakage.
  • the rod-shaped support 51 can include two main supports 511 and at least one auxiliary support 512. One end of the rod-shaped support 51 can be fixedly connected to the body of the positioning ring as a fixed end, and the other end of the rod-shaped support 51 is free.
  • a flexible skirt 52 can be provided between adjacent rod-shaped supports 51, and when the positioning ring 5 is fully released, it can adapt to a closed-loop structure such as a D-shaped structure, and the connection line at the free end of the main support 511 can form The straight section of the D-shaped structure is provided, and the free end of the auxiliary support 512 can be located on the arc section of the D-shaped structure, as shown in FIG. 6c for example.
  • the artificial valve replacement system may further include a capture control part 22, a disassembly control part 23, and a positioning ring control part 24; wherein the disassembly control part 23 can control the first clamping half body 211 and the second clamping half body The disassembly of the body 212 separates.
  • the first clamping half body 211 and the second clamping half body 212 are loaded into the outer sheath tube 6 in a state of being engaged with each other and straightened.
  • the clip valve fixing device 2 is in For example, when the central region of the native valve needs to capture the native valve leaflet, the outer sheath of the outer sheath tube 6 is withdrawn to the proximal end, and the further manipulation of the capture control member 2 can make the distal end of the first clamping half body 211 and the second clamping half The distal end of the body 212 is released to return to the preset configuration, and the valve clamping device 2 is in the first configuration.
  • the outer sheath of the outer sheath tube 6 continues to withdraw to the proximal end so that the clamping valve fixing device 2 is completely When exposed, the positioning ring control member 24 is manipulated to release the positioning ring 5 and return to the preset shape.
  • the positioning ring 5 can conform to the uneven contour of the patient's own valve annulus and does not limit the systolic function of the atrium.
  • first clamping half body 211 and the second clamping half body 212 can be two independent components, and are respectively fixedly connected with the positioning ring 5, as shown in FIG. 7e, the first clamping half body Both the 211 and the second clamping half 212 can be made of metal memory alloy material, such as nickel-titanium alloy, for example.
  • the positioning ring 5 has a preset shape, and the positioning ring 5 can be in a grid-like or "Z"-shaped structure or a wave-like structure, as shown in Figure 6b, such a structure allows the positioning ring 5 to perform Larger scale sizing while still being within the range of elastic deformation.
  • the positioning ring 5 and the flap mechanism 21 may be of an integral structure, as shown in FIG. 8 a , or may be of a split structure.
  • the positioning ring 5 can be made of a metal memory alloy material, such as nickel-titanium alloy; and the positioning ring 5 can be covered with a film.
  • valve stent delivery device 7 Operate the valve stent delivery device 7 to make it enter the heart along the path of the inner core tube 4, and when the valve stent 1 enters the middle area of the clamping mechanism 21, manipulate the disassembly control member 23 to make the first clamping half body 211 and the second clamping half 212 are separated from each other, as shown in FIG. 7h; the valve stent delivery device 7 is further operated to gradually release the valve stent 1, and the valve stent 1 expands radially and restores the preset shape.
  • valve support 1 makes the first clamping half body 211 and the second clamping half body 212 of the valve clamping mechanism 21 abut against the outer periphery of the valve support 1, further radial expansion makes it support the hoop member 3 and Return to the preset shape and be anchored in the heart, the native valve leaflet is clamped between the hoop 3 and the valve support 1, and then the valve support delivery device 7 is withdrawn from the body.
  • Embodiment 3 is basically the same as Embodiment 1, except that the valve stent 1 in this embodiment is a balloon-expandable stent.
  • the valve support 1 can be a ball-expanded valve, as shown in Figs. 9a-9d.
  • the valve clamping mechanism 21 captures and clamps the native leaflet, the valve clamping mechanism 21 moves toward the atrium.
  • the valve support 1 is in the middle area of the clamping mechanism 21, for example, the valve support 1 can be released and radially expanded to return to the functional form, and the valve support 1 and the hoop 3 can cooperate to gradually increase part of the native valve leaflets.
  • the native valve leaflet can be pulled upwards and folded back while pulling upwards (for example, as shown by the upward arrow in Figure 5h), thereby further widening the left ventricular outflow tract And reduce the risk of obstruction of the left ventricular outflow tract by the native valve leaflet.
  • the traditional replacement will make the obstruction of the left ventricular outflow tract by the anterior native valve leaflet very obvious, while the axial height of the balloon-expandable stent is shorter, After the stent is implanted, the influence of blood flow on the left ventricular outflow tract can be further reduced.
  • Embodiment 4 is basically the same as Embodiment 3, except that in this embodiment, the height of the connection point between the hoop member 3 and the valve clamping mechanism 21 is different, so that the hoop member 3 is targeted to the native valve leaflet. Lifting, as shown in Figures 10a and 10b.
  • the height of the connection point between the hoop 3 and the clamp mechanism 21 is different. Specifically, in the area of the anterior leaflet, the hoop 3 and the clip The connection point of the flap mechanism 21 is higher than the connection point in the area of the posterior leaflet.
  • the advantage of this design is that: according to the physiological and anatomical structure, the length of the anterior valve leaflet is relatively long, and after the replacement, the anterior valve leaflet can easily block the left ventricular outflow tract. The connection position of the valve clamp mechanism 21 is relatively high.
  • the hoop member 3 can lift the front leaflet more to ensure that the front leaflet will not affect the left ventricular outflow tract, and the rear leaflet area, the hoop
  • the pulling range of the part 3 is small, which can avoid the excessive pulling of the hoop part 3 on the chorda tendon tissue, and is beneficial to protect the tissue.
  • Embodiment 5 is generally the same as Embodiment 1, except that the flap mechanism 21 in this embodiment includes a plurality of clamping members 25, and the connection between the hoop 3 and each of the clamping members 25 The heights of the dots are different, as shown in Fig. 11a and Fig. 11b, so that in the second configuration, the hoop member 3 is in a wavy configuration.
  • the flap clamping mechanism 21 includes a plurality of clamping members 25, and the heights of the connection points between the hoop 3 and each of the clamping members 25 are different, so that in the second form Next, the hoop member 3 is in a wave shape.
  • connection position of the clamping member 25 and the hoop 3 is higher than the connection position of the clamping member 25 and the hoop 3 in the rear leaflet area.
  • the purpose of this design is: According to the physiological and anatomical structure, the length of the anterior valve leaflet is relatively long, and after the replacement, the anterior valve leaflet can easily block the left ventricular outflow tract. The position is higher, and in the second form, the hoop 3 can lift the front leaflet more to ensure that the anterior leaflet will not affect the left ventricular outflow tract, while the pulling range of the hoop 3 in the rear leaflet area Smaller, this can avoid the excessive pulling of the hoop part 3 to the chord tissue, which is beneficial to protect the tissue.
  • Embodiment 6 is generally the same as Embodiment 1, the difference is that in this embodiment, the valve support 1 is provided with a fixed clip 9, which is used to clamp the native valve leaflet, and has a certain effect.
  • the anchoring effect can also increase the degree of fit between the valve leaflet and the valve support 1, thereby playing a good role in preventing leakage.
  • valve support 1 is provided with a fixing clip 9, and, in the second configuration, the fixing clip 9 clamps the native valve leaflet so that the native valve leaflet is clamped Between the valve support 1 and the fixing clip 9, as shown in Figs. 12a-12c.
  • the position of the fixing clip 9 does not overlap with the flap clamping mechanism 21 .
  • Embodiment 7 is generally the same as Embodiment 1, the difference is that in this embodiment, the clip valve fixing device 2 has only a single clip valve part 10, and one side of the hoop part 3 is connected with the clip part 10, and the part of the clip part 3 The other side is connected to the ventricular segment 102 .
  • the clamping valve fixing device 2 includes a single clamping valve member 10, an atrium support segment 101, a ventricular segment 102 and a hoop 3, wherein the hoop 3 is connected to the valve clamping member 10 respectively. It is connected with the ventricular segment 102, and, on a section parallel to the central axis of the clamp valve fixing device 2, the hoop member 3 is inclined; The supporting force is provided, the valve clip 10 is connected with the ventricular segment 102 and is located on one side of the front leaflet, the hoop 3 is connected with the clip 10, and the clip 3 is connected with the rear valve leaflet The ventricular segments 102 in the area are fixedly connected, so that the hoop member 3 is inclined in a section parallel to the central axis of the valve clip fixing device 2 , as shown in FIGS. 13 a and 13 b .
  • the valve clamp 10 is used to clamp the front leaflet, and the height of the hoop 3 at the area of the valve clamp 10 is higher than that of the hoop 3 at the rear leaflet.
  • the height of the region; the purpose of this design is: after the valve clamping device 2 is installed in place, it can lift up the anterior valve leaflet and related chordal tissue in a targeted manner, so as to avoid affecting the left ventricular outflow tract. In the leaf area, the hoop 3 will not obviously pull the chordae and posterior valve leaflets, reducing the impact on the original tissue.
  • Embodiment 7 the relevant structure and concept of Embodiment 7 are similar to Embodiment 1, so the description will not be repeated here.

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Abstract

一种人工瓣膜置换系统，抱箍件(3)至少部分被配置在夹瓣机构(21)上，夹瓣固定装置(2)被构造为能够呈现第一形态和第二形态，第二形态出现在第一形态后，当夹瓣固定装置(2)处于第一形态时，夹瓣机构(21)被构造成可捕捉和夹持自体瓣叶，瓣膜支架(1)径向扩张后，夹瓣固定装置(2)处于第二形态。

Description

人工瓣膜置换系统
相关申请的交叉引用：本申请要求了2021年9月30日提交的，专利申请号为202111164164.4的专利申请作为优先权，该申请所公开的内容在此参考引入。
技术领域
本申请涉及医疗器械领域，具体涉及人工瓣膜置换系统。
背景技术
从心脏结构来看，无论是二尖瓣还是三尖瓣，均具有特殊的生理结构，造成产品准确定位和固定非常困难。尤其是，二尖瓣在心内的特定解剖位置及其复杂的解剖结构，给二尖瓣置换手术带来极大的挑战。
相关技术中，通过手术将二尖瓣/三尖瓣的假体在心内锁定的技术，常利用支架对房室瓣环的径向支撑力。这种技术的缺点在于，容易对瓣环周围组织造成压迫，并且容易导致支架和压迫组织对流出道产生影响。从置换瓣膜的长期使用影响来看，随着手术后患者使用时间的推移，返流会减少，心室心房压下降，心脏结构进行重建，较大尺寸规格的支架会影响瓣环尺寸的缩小，从而影响心脏的内部结构，这显然是不想要的结果。
除此之外，锁定的技术也可通过预先在瓣叶处植入一个对接装置，通过支架在该对接装置内部撑开来固定在瓣叶处。专利CN109789019A描述了Edwards Lifesciences公司的一种心脏瓣膜对接线圈和系统。在该专利公开中，通过将对接装置缠绕在瓣叶外侧，将瓣叶和支架紧紧箍在一起。这种支架固定的方式优越性很突出，但是前叶较大箍在支架上，对左流出道血流得阻挡并未解决。
综上所述，二尖瓣置换假体目前至少存在如下技术痛点：1.假体置换后，前瓣叶会遮挡左室流出道；2.大规格的支架径向支撑自体瓣环会影响心脏内部结构，导致出现大量并发症；业内亟需一种新的经导管心脏瓣膜置换系统，来解决以上的和其它的技术问题。
发明内容
根据本申请的各种实施例，本申请提供了一种人工瓣膜置换系统。本申请的主要目的是克服相关技术的一些问题和不足。
根据本申请的一方面，公开了一种人工瓣膜置换系统，包括：瓣膜支架、与所述瓣膜支架协同操作的夹瓣固定装置，所述夹瓣固定装置被构造成用来夹持自体瓣叶的夹瓣机构和抱箍件，所述抱箍件被配置在所述夹瓣机构上；其中，所述夹瓣固定装置被构造为能够呈现第一形态和第二形态，且第二形态在第一形态后；其中，当所述夹瓣固定装置处于第一形态时，所述夹瓣机构被构造成可捕捉和夹持所述自体瓣叶；其中，所述瓣膜支架径向扩张后，所述夹瓣固定装置处于第二形态，所述瓣膜支架的径向扩张导致所述抱箍件带动自体瓣叶向上移位并箍紧所述瓣膜支架。
根据一实施例，所述夹瓣机构的远端可拆卸连接，并且，所述夹瓣固定装置在第一形态下，所述夹瓣机构周边的瓣叶可实现自主开闭，当所述瓣膜支架进入所述夹瓣机构内，所述夹瓣机构远端被拆卸，所述瓣膜支架处于径向扩张的状态，所述瓣膜支架的径向扩张导致所述抱箍件带动自体瓣叶向上移位并箍紧所述瓣膜支架。
根据一实施例，所述瓣膜支架径向扩张后，其中，所述瓣膜支架的径向扩张带动所述夹瓣机构、所述抱箍件、自体瓣叶和腱索联动，其中，所述抱箍件至少部分被向上移位并带动自体瓣叶和腱索向上提拉，并且所述抱箍件箍紧所述瓣膜支架，此时所述夹瓣固定装置处于第二形态。
根据一实施例，在所述第一形态下，所述夹瓣机构夹持部分自体瓣叶，在所述第二形态下，所述夹瓣机构周边的自体瓣叶被所述抱箍件带动并向上移位。
根据一实施例，所述抱箍件为闭环结构，所述抱箍件穿过所述夹瓣机构。
根据另一实施例，所述抱箍件连接所述夹瓣机构并形成闭环结构，所述抱箍件为2段线或丝，并且所述抱箍件的两端与所述夹瓣机构固定连接。
根据一实施例，所述抱箍件与所述夹瓣机构至少包括2个连接点，并且所述抱箍件与所述夹瓣机构的连接点的高度不同。
根据另一实施例，在所述人工瓣膜置换系统用于替换二尖瓣瓣膜时，所述抱箍件在所述夹瓣机构上的连接点的高度不同，具体的，所述抱箍件在前瓣叶区域的高度要大于所述抱箍件在后瓣叶区域的高度，这既能显著提拉前瓣叶，避免对左室的流出道产生阻挡，又能避免抱箍件对后瓣叶区域的腱索过渡牵拉，保护腱索组织。
根据另一实施例，所述夹瓣机构包括多个夹持构件，并且，所述抱箍件与各所述夹持构件的连接点的高度不同，使得在所述第二形态下，所述抱箍件呈波浪形的形态；或者，在所述第二形态下，所述抱箍件在前瓣叶区域的高度要高于抱箍件在后瓣叶区域的高度；这能将前瓣叶提拉到较高的位置，避免在置换后，前瓣叶对左室流出道产生阻挡。
根据一实施例，所述抱箍件与所述夹瓣机构连接点的位置不能太高，例如其连接点的位置在自体瓣叶近端三分之二的区域，可以有效避免抱箍件过度牵拉腱索组织。
根据一实施例，所述夹瓣固定装置处于第二形态时，所述抱箍件处于腱索与自体瓣叶之间，并且，所述瓣膜支架径向扩张使得所述抱箍件至少部分被向上移位并带动自体瓣叶和腱索向上提拉。
根据一实施例，所述夹瓣固定装置在第二形态下，所述抱箍件以张紧的状态系在所述夹瓣机构的外周，自体瓣叶被所述抱箍件向上提拉后，并且所述自体瓣叶被回折至自身至少部分地重叠。
根据一实施例，在所述第二形态下，所述抱箍件还将所述夹瓣机构和所述自体瓣叶沿环向地箍紧在所述瓣膜支架的外周。
根据一实施例，所述夹瓣固定装置在第一形态转换到第二形态的过程中，所述瓣膜支架从未径向扩张的状态逐步地径向扩张，并且逐步地撑开所述夹瓣固定装置，使得所述抱箍件从松弛状态逐渐地展开并被张紧，由此逐渐地提拉腱索和被夹持的自体瓣叶，并箍紧所述瓣膜支架和所述夹瓣机构。
根据一实施例，在所述夹瓣机构捕捉和夹持自体瓣叶的过程中，所述夹瓣机构向心房方向移动，使得部分自体瓣叶及腱索被回折在所述夹瓣机构形成的瓣叶容置腔内和/或自体瓣环的下方与所述抱箍件之间。
根据一实施例，在所述第一形态下，所述夹瓣机构的一端抵靠被夹持的自体瓣叶的根部。
根据一实施例，所述夹瓣固定装置包括单个夹瓣件、心房支撑段(在夹瓣固定装置安装就位后，心房支撑段位于心房内并提供支撑力)、心室段以及抱箍件，其中，所述抱箍件分别与所述夹瓣件和心室段连接，并且，在平行于所述夹瓣固定装置中心轴线的截面上，所述抱箍件呈倾斜形态；更具体的，所述抱箍件与所述夹瓣件连接处的高度要高于抱箍件区域部分的高度；而在用于二尖瓣治疗时，所述夹瓣件被用于夹持前瓣叶，并且，抱箍件能显著对前瓣叶及相关腱索组织进行牵拉。
根据一实施例，所述夹瓣机构包括第一夹持半体和第二夹持半体，所述第一夹持半体和第二夹持半体可拆卸地连接，或者所述第一夹持半体与第二夹持半体为两个彼此分离的独立构件；并且所述第一夹持半体和第二夹持半体构造成分别捕捉并夹持不同的自体瓣叶，并且所述抱箍件形成的闭环的周长略小于径向扩张到位的瓣膜支架的周长。
根据一实施例，所述第一夹持半体和第二夹持半体在所述夹瓣固定装置的约束状态下一起构成大体套筒状的构造，所述大体套筒状的构造套在所述内芯管上且被所述外鞘管套在外周。
根据一实施例，所述第一夹持半体和第二夹持半体具有互补的形状，并且在所述夹瓣固定装置的约束状态下可拆卸地卡扣连接。
根据一实施例，所述第一夹持半体具有第一支撑段，从所述第一支撑段延伸的第一可拆式配合段，和从所述第一可拆式配合段进一步延伸的第一夹持段，在所述第一支撑段设有第一夹爪；并且所述第二夹持半体具有第二支撑段，从所述第二支撑段延伸的第二可拆式配合段，和从所述第一可拆式配合段进一步向下延伸的第二夹持段，在所述第二支撑段设有第二夹爪。
根据一实施例，第一夹持半体和第二夹持半体分别包括瓣叶捕捉件和压瓣件，抱箍件与瓣叶捕捉件的一端连接。
根据一实施例，所述第一夹爪和第二夹爪均设有齿，其齿可限定第一夹持半体、第二夹持半体与自体瓣叶之间的相对位置，所述齿构造成用于咬住和固定被夹持的自体瓣叶。
根据一实施例，其齿可以是倒刺或其他可以与瓣叶锁定的结构，使其第一夹持半体和第二夹持半 体能牢牢咬住自体瓣叶。
根据另一实施例，其齿可以分别设置在第一夹持半体和第二夹持半体的一端，齿能“订住”自体瓣叶，以防止第一夹持半体和第二夹持半体夹持自体瓣叶之后出现滑脱的情况。
根据一实施例，所述第一夹持段通过弹片段与所述第一可拆式配合段相连，所述第一夹爪通过弹片段与所述第一支撑段相连；并且所述第二夹持段通过弹片段与所述第二可拆式配合段相连，所述第二夹爪通过弹片段与所述第二支撑段相连。
根据一实施例，所述第一夹持半体是一体成形的，并且所述第二夹持半体是一体成形的。
根据一实施例，所述第一夹持半体和所述第二夹持半体均由形状记忆合金构成。
根据一实施例，所述第一夹持半体的和第二夹持半体均构造成可各自形成瓣叶容置腔，当所述第一夹持半体和第二夹持半体捕捉并夹持自体瓣叶时，部分自体瓣叶被回折在所述瓣叶容置腔内。
根据一实施例，所述第一夹持半体的和第二夹持半体张开并捕捉自体瓣叶时，自体瓣叶位于第一夹持半体的张角和第二夹持半体张角之间，此时可操作输送系统使得整个夹瓣固定装置向心房方向上移，从而使得部分自体瓣叶被折叠在第一夹持半体和第二夹持半体之间，具体来说，自体瓣叶的尖端部分被折叠在所述瓣叶容置腔内，这样能有效缩短在自体瓣叶的长度，避免其阻挡左室流出道。
根据一实施例，所述瓣膜支架上还可设有将被定位于心房内的定位环，所述定位环被构造成适应自体瓣环的生理结构的形态，并且所述定位环设有辅助固定杆。
根据一实施例，所述辅助固定杆数量为三根或四根，既能起到有力的支撑作用，又能避免对原生瓣环造成过度的牵拉，减少植入物。
根据一实施例，所述定位环设有柔性的密封膜，并且在瓣膜支架安装就位后，所述密封膜贴合心房组织。
根据一实施例，所述瓣膜支架上设有用于辅助固定的倒刺，并且所述倒刺设置在所述定位环上。
根据一实施例，所述瓣膜支架上设有固定夹合件，并且，在所述第二形态下，所述固定夹合件夹合自体瓣叶并使得自体瓣叶被夹在所述瓣膜支架与固定夹合件之间。
根据一实施例，人工瓣膜置换系统还包括内芯管和外鞘管；所述夹瓣固定装置被构造为还能够呈现被约束在所述外鞘管内且处于所述内芯管与所述外鞘管之间的约束状态；并且在所述约束状态中，所述夹瓣固定装置不能夹持自体瓣叶。
根据一实施例，还包括内芯管；并且，瓣膜支架可沿着内芯管进入并抵达夹瓣机构的中间区域。
根据一实施例，第一夹持半体和第二夹持半体为可拆卸连接，内芯管设有扩大端，第一夹持半体设有第一可拆式配合段，第二夹持半体设有第二可拆式配合段；并且，第一可拆式配合段和第二可拆式配合段通过内芯管实现可拆卸连接；并且，扩大端大体上呈圆柱形构造，第一可拆式配合段和第二可拆式配合段可以相互嵌合，形成类似卡扣连接，然后扩大端插入到第一可拆式配合段和第二可拆式配合段中间，形成可拆卸连接；当扩大端从第一可拆式配合段和第二可拆式配合段中间撤离后，瓣膜支架为第一夹持半体和第二夹持半体提供径向扩张力，使其完成拆卸分离。
根据一实施例，当瓣膜支架处于夹瓣机构的中间区域时，扩大端相对夹瓣机构向近端撤离，从而实现与夹瓣机构拆卸分离。
根据一实施例，瓣膜支架可以是球扩支架或自膨支架。
根据一实施例，抱箍件大体呈条状、丝状或麻绳状。
根据一实施例，抱箍件的外周覆膜，其覆膜可增加与自体瓣叶之间的摩擦力。
根据本申请的另外一方面，还提供了一种人工瓣膜置换系统，包括：夹瓣固定装置，包括在约束状态下由第一夹持半体和第二夹持半体构成大体套筒状构造的夹瓣机构，和栓系在所述夹瓣机构的远端且构成环绕所述夹瓣机构的闭环的抱箍件；内芯管；外鞘管；和可径向扩张的管状瓣膜支架，其中，在所述夹瓣固定装置的约束状态下，所述夹瓣机构套在所述内芯管上且被约束在所述外鞘管中；其中，在所述夹瓣固定装置的第一形态下，所述第一夹持半体和第二夹持半体从所述外鞘管中露出并变形至各自能够夹持自体瓣叶的构造，所述抱箍件处于松弛的状态；其中，在所述夹瓣固定装置的第二形态下，所述瓣膜支架处于径向扩张的状态并定位于所述第一夹持半体和第二夹持半体之间，所述抱箍件 被径向扩张的所述瓣膜支架张紧并由此箍紧所述瓣膜支架和其上栓系的所述第一夹持半体和第二夹持半体。
根据一实施例，在所述第一形态下，自体瓣叶保持局部开合的功能；并且，在所述第二形态下，至少部分自体瓣叶被折叠。
根据一实施例，所述人工瓣膜置换系统还包括定位环，所述定位环被构造成具有适应自体瓣环生理结构的形态。
根据一实施例，所述定位环与所述夹瓣固定装置集成为一体。
根据本申请的另外一方面，还提供了一种操作人工瓣膜置换系统的方法，包括：操作所述人工瓣膜置换系统的外鞘管进入手术部位；使所述外鞘管相对于内芯管向近端逐渐回撤，逐步地露出所述外鞘管内的在约束状态下的夹瓣机构，并随着所述外鞘管的回撤逐步地释放所述夹瓣机构的由形状记忆合金构成的第一夹持半体和第二夹持半体，使之逐渐变形至各自捕捉并夹持相应的自体瓣叶；将所述外鞘管完全从手术部位撤出，并保留所述内芯管在原位；操作瓣膜支架输送装置将管状瓣膜支架沿所述内芯管进入并到达介于所述夹瓣机构的第一夹持半体和第二夹持半体之间，并撤出所述内芯管；径向扩张所述瓣膜支架，并由此径向地扩张所述夹瓣机构，由此展开和张紧栓系在所述夹瓣机构外周的抱箍件，其中，所述抱箍件的展开和张紧则沿着所述瓣膜支架的轴向方向逐步地提拉腱索以及自体瓣叶，直到所述抱箍件箍紧所述瓣膜支架和所述夹瓣机构，并最终实现自体瓣叶提拉以及回折；和撤出所述瓣膜支架输送装置。
根据本申请的一方面，提供了一种人工瓣膜置换系统，包括：瓣膜支架；和夹瓣固定装置，夹瓣固定装置包括夹瓣机构和抱箍件，并且抱箍件被配置在夹瓣机构上；其中，夹瓣固定装置具有第一形态和第二形态；当夹瓣固定装置处于第一形态时，夹瓣机构被构造成以夹持局部自体瓣叶的方式预先固定于自体瓣膜的中间区域，抱箍件处于松弛形态，自体瓣叶能保持局部开合的功能；当夹瓣固定装置处于第二形态时，瓣膜支架径向扩张并带动夹瓣机构和抱箍件同步展开，抱箍件逐步提拉腱索、自体瓣叶及毗邻组织，最终实现自体瓣叶的回折。
根据一实施例，当瓣膜支架径向扩张并带动夹瓣机构和抱箍件同步展开时，抱箍件牵引自体瓣叶及腱索向抱箍件与夹瓣机构连接点方向位移并带动部分自体瓣叶被回折；最终，抱箍件将部分自体瓣叶及腱索、夹瓣机构环固在瓣膜支架的外周上。
根据一实施例，在夹瓣机构捕捉并夹持自体瓣叶的过程中，夹瓣机构向心房方向移动使得部分自体瓣叶及腱索被回折在夹瓣机构内和/或自体瓣环的下方与抱箍件之间，如此可以提拉瓣叶的高度，避免对左室流出道有阻隔。
根据一实施例，第一夹持半体和第二夹持半体可拆卸连接；并且，第一夹持半体和第二夹持半体可分别捕捉并夹持不同的自体瓣叶。
根据另一实施例，第一夹持半体与第二夹持半体为两个独立构件，并且在外鞘管内轴向排布，第一夹持半体与第二夹持半体能彼此独立地捕捉并夹持不同的自体瓣叶。
与相关技术相比，本申请的优点和有益技术效果至少包含以下所列：
1.传统的瓣膜假体，在植入手术后大多依靠撑在自体瓣环上的径向支撑力来锚固瓣膜假体，这样会对原生瓣环产生压迫，长期使用明显不利，其锚固的缺陷显而易见；并且，现有的利用瓣叶锚固支架的方案，无法解决左室流出道受阻隔的影响；根据本申请的一实施例，利用夹瓣机构捕捉、夹持自体瓣叶实现类“缘对缘”修复，可以有效减少瓣膜的反流，同时置换的瓣膜支架未植入之前，自体瓣膜依旧能正常工作，为手术争取更多时间并有效降低了并发症；同时，瓣膜支架可沿内芯管顺利抵达夹瓣机构的中间区域，定位准确且操作更为便捷，当瓣膜支架径向扩张并带动夹瓣机构和抱箍件同步展开时，抱箍件牵引腱索及自体瓣叶向抱箍件与夹瓣机构连接点方向位移并带动自体瓣叶向上提拉，避免了在置换后自体瓣叶对左室流出道的阻挡；最终，抱箍件将部分自体瓣叶及腱索、夹瓣机构环固在瓣膜支架的外周上，其锚定方式能避免径向支撑自体瓣环，避免对原生瓣膜的形态造成不利影响，同时解决了相关技术中关于二尖瓣置换术治疗的两大技术痛点，具有很好的临床意义。
2.相关技术中，抱箍件只起到固定瓣膜支架的作用，而不能解决自体瓣叶对左室流出道的阻挡影 响，区别于相关技术，在本申请的一实施例中，夹瓣机构先锚定在自体瓣叶上，抱箍件与夹瓣机构的连接点要高于自体瓣叶尖端部分与腱索组织的连接处，并且，抱箍件的长度是固定的，当瓣膜支架径向扩张时，抱箍件向着与夹瓣机构的连接点位置上移，在此过程中，抱箍件以所述连接点为支点并牵拉腱索进一步带动自体瓣叶上提，最终使得抱箍件能箍紧瓣膜支架，避免其径向支撑自体瓣环，同时可以有效避免自体瓣叶对流出道的阻挡，具有很好的临床意义。
3.区别于相关技术，在本申请的一实施例中，第一夹持半体的一端和第二夹持半体的一端均设有瓣叶容置腔，使得夹瓣机构在捕捉、夹持瓣叶时可将部分自体瓣叶回折在瓣叶容置腔内，回折后瓣叶的长度缩短了，这样有效避免了对左室流出道的阻隔，减少原生瓣叶组织在置换后对血流的影响；尤其在用于二尖瓣置换时，针对二尖瓣前叶较长的生理特点，非常适用，具有很好的临床意义。
4.区别于相关技术，在本申请的一实施例中，定位环为夹瓣机构提供了在瓣环或心房处的锁定力，使得第一夹持半体和第二夹持半体在捕捉并夹持瓣叶后并且瓣膜支架还未进入释放位置时，夹瓣机构能很好的保持在心内的位置，避免夹瓣机构出现滑落。
5.区别于相关技术，本申请的一实施例中，内芯管既能控制夹瓣机构的拆卸连接，又能作为瓣膜支架进入夹瓣机构内的导引路线，使其能大幅缩短操作时间并且提高操作精度，扩大端只需从第一可拆式配合段和第二可拆式配合段中间撤离后，瓣膜支架在逐步径向扩张恢复功能形态的过程中为第一夹持半体和第二夹持半体提供径向扩张力，使其完成拆卸分离；结构装配简单、拆卸的操作也非常便捷，有利于临床手术的开展，具有很好的临床意义。
6.区别于相关技术，本申请的一实施例中，抱箍件在夹瓣机构上的连接点的高度不同，具体的，抱箍件在前瓣叶区域的高度要大于抱箍件在后瓣叶区域的高度，这既能显著提拉前瓣叶，避免对左室的流出道产生阻挡，又能避免抱箍件对后瓣叶区域的腱索过渡牵拉，保护腱索组织。
附图说明
图1a-1c为根据本申请一实施例的瓣膜支架、夹瓣固定装置和抱箍件的结构的示意图。
图2a-2j为根据本申请一实施例的夹瓣固定装置的细节和工作原理的示意图。
图3a-3d显示了根据本申请的另一实施例的抱箍件。
图4a-4d为根据本申请一实施例的外鞘管进入心脏的过程的示意图。
图5a-5k为根据本申请一实施例的夹瓣固定装置、抱箍件与瓣膜支架配合完成瓣膜置换的过程示意图。
图6a-6c显示了根据本申请一实施例的设置定位环的一种实施方式。
图7a-7h为根据本申请一实施例的定位环的工作原理的示意图。
图8a显示了根据本申请的另一实施例的定位环。
图9a-9d显示了根据本申请的另一实施例的球囊扩张支架示意图。
图10a和图10b显示了根据本申请的另一实施例的示意图。
图11a和图11b显示了根据本申请的另一实施例的示意图。
图12a-12c显示了根据本申请的另一实施例的示意图。
图13a和图13b显示了根据本申请的另一实施例的示意图。
附图中各数字所指代的特征名称如下：
1-瓣膜支架；11-定位环；2-夹瓣固定装置；21-夹瓣机构；211-第一夹持半体；2111-第一可拆式配合段；2112-第一支撑段；212-第二夹持半体；2121-第二可拆式配合段；2122-第二支撑段；213-齿；214-瓣叶容置腔；215-可扩张通道；22-捕捉控制件；23-拆卸控制件；24-定位环控制件；25-夹持构件，3-抱箍件；4-内芯管；41-扩大端；5-定位环；51-杆形支撑件；52裙边；53-自体瓣环适应段；54-心房组织适应段；55-骨架；56-膜；6-外鞘管；7-瓣膜支架输送装置，8-连接结构，9－固定夹合件，10-夹瓣件，101-心房支撑段，102-心室段。
具体实施方式
本申请中，“近端”是指接近手术操作者的一端，“远端”是指远离手术操作者的一端。
实施例一
如图1a-1c和图2a-2j示意性地所示，根据本申请的一实施例，提供了一种人工瓣膜置换系统，它可包括瓣膜支架1和与瓣膜支架1一起配置的夹瓣固定装置2。夹瓣固定装置2可包括夹瓣机构21和抱箍件3，抱箍件3被配置在夹瓣机构21上，如图1a-1b所示。
夹瓣机构21如图1a-1c和图2a-2j所示，夹瓣机构21可由形状记忆合金构成的两个半体，即，第一夹持半体211和第二夹持半体212构成。该第一夹持半体211和第二夹持半体212如图2e所示各自可一体成形，并且在手术之前二者可围绕内芯管4(下文详述)一起构成套在内芯管4上的整体上类似于套筒状的构造，并且被外鞘管6紧紧地从外套住且约束在管6内，如图2a-2b所示。
第一夹持半体211和第二夹持半体212可分别捕捉并夹持不同的自体瓣叶，如图1b和2c所示。
第一夹持半体211和第二夹持半体212均设有齿213，其齿213可咬住与自体瓣叶并固定第一夹持半体211、第二夹持半体212与自体瓣叶之间的相对位置，如图2e-2g所示。
齿213可以是尖齿、小柱、倒刺或其他可以固定瓣叶的结构，使其第一夹持半体211和第二夹持半体212能牢牢咬住自体瓣叶。
第一夹持半体211的一端和第二夹持半体212的一端均设有瓣叶容置腔214，当第一夹持半体211和第二夹持半体212捕捉并夹持自体瓣叶时，部分自体瓣叶被回折在瓣叶容置腔214内，如图1b和2g所示。
更具体而言，如图2e所示，第一夹持半体211和第二夹持半体212如图2e所示可具有互补的、彼此配合(例如嵌合)的形状，并且形成可拆卸的连接，例如可在受力时，例如被内芯管4的扩大端41从配合部位抽离时并且瓣膜支架1从配合(例如嵌合)部位撑开时，可彼此分离。
如图2e所示，第一夹持半体211可具有第一支撑段2112，从第一支撑段2112延伸且与之一体的第一可拆式配合段2111，和从第一可拆式配合段2111一体地进一步向下延伸的第一夹持段2113。在第一支撑段2112上可形成，例如在第一支撑段2112的主体中通过激光切割形成仍通过弹片段2131与之一体连接的例如其上可带齿213的第一夹爪2130。第一夹持段2113类似地通过弹片段2110与第一可拆式配合段2111一体连接。第一夹持半体211整体可由记忆合金构成，并且弹片段2131、弹片段2110如图所示具有菱形波、S杆或细直杆的构造，使得其易于弹性变形，例如易于挺直以在手术前装入外鞘管6内(例如，如图2b和图2e所示)，并且易于弯折以在手术时和术后回折瓣叶(如图2j-图3d所示，并且如下详述)。
类似地，如图2e所示，第二夹持半体212可具有第二支撑段2122，从第二支撑段2122延伸且与之一体的第二可拆式配合段2121，和从第二可拆式配合段2121一体地进一步向下延伸的第二夹持段2123。在第二支撑段2122上可形成，例如在第二支撑段2122的主体中通过激光切割形成仍通过弹片段2132与之一体连接的例如其上可带齿213的第二夹爪2133。第二夹持段2123类似地通过弹片段2120与第二可拆式配合段2121一体连接。第二夹持半体212整体可由形状记忆合金构成，并且弹片段2132、弹片段2120如图所示具有菱形波、S杆或细直杆的构造，使得其易于弹性变形，例如易于挺直以在手术前装入外鞘管6内(例如，如图2b和图2e所示)，并且易于弯折以在手术时和术后回折瓣叶(如图2j-图3d所示，并且如下详述)。
如图2b所示，由第一支撑段2112、第一可拆式配合段2111和第一夹持段2113一体构成的第一夹持半体211，与由第二支撑段2122、第二可拆式配合段2121和第二夹持段2123一体构成的第二夹持半体212，以套筒状的构造套在内芯管4上并被装入外鞘管6内，其中第一可拆式配合段2111的两个凸部2115与第二可拆式配合段2121的两个互补形状的凹部2125对应地彼此卡合(或称嵌合)在一起而固定并保持第一夹持半体211和第二夹持半体212构成套筒状的构造，此时内芯管4的扩大端41已深入该第一可拆式配合段2111与第二可拆式配合段2121形成的套筒内(如图2a-2b所示)。
在手术期间，当装在外鞘管6内的上述夹瓣机构21到达手术位置时，向近端(即，沿图2c所示直线箭头的方向)回撤外鞘管6而先露出(释放)第一夹持段2113和第二夹持段2123以及第一可拆式配合段2111以及第二可拆式配合段2121。此时，第一夹持段2113和第二夹持段2123露出并被释放，借助于其自身的形状记忆效应(弹片段)从之前挺直的、与第一和第二支撑段2112,2122大体上成一直线的状态而分别向上(图2c中的弯曲箭头所示)朝向第一和第二支撑段2112,2122弯折，如图2c-2d。 在手术期间，在此种状态下，自体瓣叶已经被兜住并贴在第一夹持段2113和第二夹持段2123上。
之后，进一步回撤外鞘管6，露出第一支撑段2112及其上的第一夹爪2130以及第二支撑段2122及其上的第二夹爪2133(图2f)。第一夹爪2130和第二夹爪2133各自借助于其自身的形状记忆效应(弹片段)从之前分别嵌在第一和第二支撑段2112,2122内且顺应其整体形状的状态而经由其弹片段变形向下(如图2f中的弯曲箭头所示)弯折，压靠在对应的第一夹持段2113和第二夹持段2123上，如图2h-2i所示。在手术期间，在此种状态下，之前被兜住并贴在第一夹持段2113上的自体瓣叶就被夹在第一夹爪2130与第一夹持段2113之间并被第一夹爪2130上的齿213咬住并固定；之前被兜住并贴在第二夹持段2123上的自体瓣叶就被夹在第二夹爪2133与第二夹持段2123之间并被第二夹爪2133上的齿213咬住并固定，如图2j所示。
此时，夹瓣机构21处于捕捉状态，第一支撑段2112与第二支撑段2122之间形成可扩张通道215，如图2j所示，以供后续进入的瓣膜支架1进入并留出其扩张的空间。
在瓣膜支架1被瓣膜支架输送装置7载带(例如图5c)沿着内芯管4的路径进入，套在第一和第二支撑段2112,2122上并进入可扩张通道215后(图5e)，内芯管4的扩大端41回撤而从夹瓣机构21上分离(图5f)，并且瓣膜支架1可被释放而径向地扩张(膨胀)至功能形态并促使第一夹持半体211与第二夹持半体212进一步分离(图5g-5h)。
抱箍件3一般为线状或条带状的柔性件构成，例如穿过第一夹持段2113和第二夹持段2123末端上的穿孔(图2c-2d)，而在释放后形成一个可约束第一夹持段2113和第二夹持段2123位置(即，径向扩张)的封闭的环或圈。
抱箍件3的充分展开状态下的周长一般设置成小于充分扩张(膨胀)后的瓣膜支架1的横截面圆形的圆周。这样，可确保瓣膜支架1径向扩张(膨胀)后被抱箍件3以一定的预应力紧紧箍住(此时抱箍件3还将自体瓣环夹在中间紧紧箍住，如图2j和图5i-5j所示)，并且约束瓣膜支架1以避免其过度扩张至大于自体瓣环尺寸而造成损伤。另一方面，在瓣膜支架1径向扩张就位并恢复为功能形态的过程中，由于瓣膜支架1被夹住自体瓣叶的夹瓣机构21上所栓系的抱箍件3紧紧箍住而受到其径向支撑，因此瓣膜支架1通过抱箍件3而间接固定在自体瓣叶组织上。
抱箍件3整体可以是柔性的环或圈，例如可由大体上呈柔性的条状、丝状、线状、绞线或绳状件构成的环或圈。抱箍件3的外周例如还可被覆膜，覆膜可增加与自体瓣叶之间的摩擦力。
抱箍件3可为闭环结构，或者抱箍件3与夹瓣机构21配合形成闭环结构。当夹瓣机构21捕捉自体瓣叶后，抱箍件3处于自体瓣叶的外周并环抱自体瓣叶(如图2j和图5i-5j)。
瓣膜支架1例如也可以为自膨式的网状支架，其形状例如为可在到达手术部位扩张并固定就位的筒状构造。
瓣膜支架1上还可设有将在手术时定位于心房内的定位环11，定位环11被构造成可适应自体瓣环生理结构的形态。定位环11上可被覆膜，以避免出现瓣周漏。
综上所述，夹瓣固定装置2可呈现第一形态和第二形态。
当夹瓣固定装置2处于第一形态时，夹瓣机构21被构造成以夹持自体瓣叶局部的方式而预先固定于自体瓣膜的例如中间区域，此时抱箍件3处于未箍住瓣膜支架1的松弛形态。此时自体瓣叶可保持局部开合的功能。
当夹瓣固定装置2处于第二形态时，瓣膜支架1径向地扩张并带动夹瓣机构21和抱箍件3同步地扩展并最终被抱箍件3紧紧箍住，此过程中抱箍件3位于自体瓣叶和腱索组织之间并逐步向上提拉(例如图5h的向上箭头所示)并箍住自体瓣叶及毗邻组织，带动被夹住的自体瓣叶向上提拉和逐步地回折。
根据一示例，当瓣膜支架1径向扩张并带动夹瓣机构21和抱箍件3同步展开时，抱箍件3向上牵引箍住的自体瓣叶及腱索向抱箍件3与夹瓣机构21连接点方向位移并带动自体瓣叶回折；最终，抱箍件3将部分自体瓣叶及腱索、夹瓣机构21环向固定在瓣膜支架1的外周上，例如如图1c所示。
根据一示例，当夹瓣机构21捕捉并夹持自体瓣叶时，夹瓣机构21向心房方向移动；并且，当瓣膜支架1径向扩张恢复预设形态时，瓣膜支架1与抱箍件3协作并将部分自体瓣叶回折的同时向上提拉，使瓣叶位置升高，避免对左室流出道有阻隔。相比之下，由于二尖瓣的前自体瓣叶长度较长，传 统的置换术会使得前自体瓣叶对左室流出道的阻挡非常明显。使用本方案可以有效减少原生的自体瓣叶组织在置换后对血流的影响，因为自体瓣叶组织不仅被部分回折而减轻了阻流的风险，而且还借助于瓣膜支架1的径向扩张而被向上提拉而减少了其阻碍左室流出道血流的可能性。
人工瓣膜置换系统的操作
本实施例一用于修复二尖瓣瓣膜的一示范性操作过程如下。
1.操作外鞘管6从下腔静脉进入心脏，随后操作外鞘管6使得夹瓣机构21穿过房间隔，如图4a-4d所示；继续操作外鞘管6弯曲使得夹瓣机构21正对二尖瓣的瓣口；
2.操作外鞘管6，使夹瓣机构21的第一夹持半体211和第二夹持半体212分别捕捉二尖瓣的前小叶和后小叶，并分别与第一夹爪2130和第二夹爪2133一起夹持对应的前小叶和后小叶，如图5a-5b所示，具体步骤例如可参考和结合图2a-2g所示和所述；在夹瓣机构21夹持好瓣叶后，外鞘管6从体内撤出，并保留内芯管4在原位；
3.之后，操作瓣膜支架输送装置7进入，使其沿着内芯管4的路径进入心内，如图5c-5e所示；当瓣膜支架1进入到夹瓣机构21的中间区域时，操作内芯管4(例如后撤)使其与夹瓣机构21拆卸分离，如图5f和5g所示；之后，进一步操作瓣膜支架输送装置7逐步释放瓣膜支架1，瓣膜支架1径向扩张并恢复功能形态；
4.瓣膜支架1的径向扩张使夹瓣机构21的第一夹持半体211和第二夹持半体212在例如如图3a的弯曲箭头所示方向上进一步移动至靠近或者甚至贴靠在瓣膜支架1的外周，被夹持的瓣叶由此被部分回折；瓣膜支架1的进一步径向扩张使其外扩并被支撑在瓣膜支架1外周所箍紧的抱箍件3上，并恢复为功能形态而锚固在心内，此时自体瓣叶被夹在抱箍件3与瓣膜支架1之间，之后可将瓣膜支架输送装置7从体内撤出，如图5h-5k所示。
实施例二
实施例二与实施例一大体上相同，不同之处在于该实施例中夹瓣机构21还包括有定位环5，定位环5可为夹瓣机构21提供了在瓣环或心房处的锚定力，使得第一夹持半体211和第二夹持半体212在捕捉并夹持瓣叶后、并且瓣膜支架1还未进入释放位置时，夹瓣机构21能很好地保持在心内的位置，避免夹瓣机构21出现脱落，如图6a-6c所示。
在本实施例中，夹瓣固定装置2可包括夹瓣机构21和抱箍件3，并且抱箍件3可被配置在夹瓣机构21上。本实施例中还设有定位环5，定位环5可被构造成适应瓣环生理结构的形态；其中，夹瓣固定装置2可具有第一形态和第二形态；当夹瓣固定装置2处于第一形态时，夹瓣机构21可被构造成以夹持局部自体瓣叶的方式预先固定于自体瓣膜的例如中间区域，抱箍件3可处于松弛形态，自体瓣叶能保持局部开合的功能，定位环5位于心房内；当夹瓣固定装置2处于第二形态时，瓣膜支架1可径向扩张并带动夹瓣机构21和抱箍件3同步展开，抱箍件3可逐步提拉自体瓣叶及毗邻组织，最终实现自体瓣叶的回折。
更具体而言，在本实施例中，定位环5可由放射状的杆形支撑件51组成，该杆形支撑件51可有效防止瓣膜支架左右晃动，有助于减少或避免瓣周漏的发生，如图6a-6c所示。杆形支撑件51可包括两个主支撑件511和至少一个辅助支撑件512，杆形支撑件51的一端可与定位环的本体固定连接为固定端，杆形支撑件51的另一端游离为游离端，相邻的杆形支撑件51之间可设置有例如柔性的裙边52，定位环5完全释放时能够自适应为闭环结构如D形结构，主支撑件511游离端的连线可构成提供D形结构的直线段，辅助支撑件512的游离端可位于D形结构的弧线段上，例如如图6c所示。
在本实施例中，人工瓣膜置换系统还可包括捕捉控制件22、拆卸控制件23以及定位环控制件24；其中，拆卸控制件23可控制第一夹持半体211和第二夹持半体212的拆卸分离。
在本实施例中，在预装时，第一夹持半体211和第二夹持半体212以彼此接合的、拉直的形态装入外鞘管6内，当夹瓣固定装置2处于自体瓣膜的例如中间区域并需要捕捉自体瓣叶时，外鞘管6的外鞘向近端撤离，进一步操纵捕捉控制件2可使得第一夹持半体211的远端和第二夹持半体212的远端被释放而恢复为预设形态，并使其夹瓣固定装置2处于第一形态。
在本实施例中，当第一夹持半体211和第二夹持半体212捕捉并夹持自体瓣叶后，外鞘管6的外 鞘继续向近端撤离使得夹瓣固定装置2全部裸露出来，操纵定位环控制件24使其定位环5释放而恢复为预设的形态，定位环5可顺应患者自身瓣膜瓣环的不均匀轮廓且不限制心房的收缩功能。
在本实施例中，第一夹持半体211和第二夹持半体212可为独立的两个构件，并且分别与定位环5固定连接，如图7e所示，第一夹持半体211和第二夹持半体212例如均可采用金属记忆合金材料制成，例如镍钛合金。
在本实施例中，定位环5具有预设的形态，定位环5可呈网格状或“Z”字型构造或波浪状构造，如图6b所示，这样的构造使得定位环5可进行较大尺度的尺寸调整而仍然处于弹性变形的范围内。
在本实施例中，定位环5与夹瓣机构21可以是一体式结构，如图8a所示，也可以是分体式结构。
在本实施例中，定位环5可采用金属记忆合金材料制成，例如镍钛合金；并且定位环5可被覆膜。
本实施例二修复二尖瓣瓣膜的一个示范性的操作过程如下：
1.操作外鞘管6从下腔静脉进入心脏，随后操作外鞘管6使得夹瓣机构21穿过房间隔，如图4a-4d所示；继续操作外鞘管6弯曲使得夹瓣机构21正对二尖瓣的瓣口。
2.操作外鞘管6的外鞘向近端撤离，进一步操纵捕捉控制件2可使得第一夹持半体211的远端和第二夹持半体212的远端被释放恢复为预设形态并分别捕捉并夹持二尖瓣的前小叶和后小叶，当夹瓣机构21夹持瓣叶后，外鞘管6的外鞘继续向近端撤离使得夹瓣固定装置2全部裸露出来，操纵定位环控制件24使其定位环5释放恢复为预设的形态，将外鞘管6从体内撤出，并保留内芯管4在原位，如图7c-7g所示。
3.操作瓣膜支架输送装置7使其沿着内芯管4的路径进入心内，当瓣膜支架1进入到夹瓣机构21的中间区域时，操纵拆卸控制件23使其第一夹持半体211和第二夹持半体212彼此分离，如图7h所示；进一步操作瓣膜支架输送装置7逐步释放瓣膜支架1，瓣膜支架1径向扩张并恢复预设形态。
4.瓣膜支架1的径向扩张使夹瓣机构21的第一夹持半体211和第二夹持半体212贴靠瓣膜支架1的外周，进一步径向扩张使其支撑抱箍件3并恢复为预设形态锚固在心内，自体瓣叶被夹在抱箍件3与瓣膜支架1之间，随后，将瓣膜支架输送装置7从体内撤出。
就此而言，实施例二的相关构造和构思类似于实施例一，因此在这里不再重复描述。
实施例三
实施例三与实施例一大体上相同，不同之处在于，该实施例中的瓣膜支架1为球囊扩张支架。
在本实施例中，瓣膜支架1可为球扩瓣膜,如图9a～9d所示。当夹瓣机构21捕捉并夹持自体瓣叶时，夹瓣机构21向心房方向移动。当瓣膜支架1处于夹瓣机构21的例如中间区域时，可释放瓣膜支架1而径向扩张恢复至功能形态，瓣膜支架1与抱箍件3可协作并将部分自体瓣叶逐步地、程度增加地回折(如图3d和图5b-5j)，同时可以在向上提拉(例如图5h的向上箭头所示)的同时带动自体瓣叶向上提拉和回折，从而进一步扩宽了左室流出道并减小自体瓣叶对左室流出道形成阻隔的风险。相比之下，由于二尖瓣的前自体瓣叶长度较长，传统的置换术会使得前自体瓣叶对左室流出道的阻挡非常明显，而球囊扩张支架的轴向高度更短，在支架被植入后，可进一步减小对左室流出道的血流影响。本申请的这一发明构思和技术效果显然解决了这一业内久而未决的技术问题。
就此而言，实施例三的相关构造和构思类似于实施例一，因此在这里不再重复描述。
实施例四
实施例四与实施例三大体上相同，不同之处在于，该实施例中中抱箍件3与夹瓣机构21的连接点的高度不同，使得抱箍件3有针对性的对自体瓣叶提拉，如图10a和10b所示。
在本实施例中，该置换系统用于替换二尖瓣瓣膜时，抱箍件3与夹瓣机构21的连接点位置的高度不同，具体的，在前瓣叶区域，抱箍件3与夹瓣机构21的连接点要高于在后瓣叶区域的连接点。这样设计的好处在于：根据生理解剖结构可知，前瓣叶的长度较长，并且，在置换后，前瓣叶容易对左室流出道产生遮挡，因此，抱箍件3在前瓣叶区域与夹瓣机构21的连接位置较高，在第二形态时，抱箍件3对前瓣叶的提拉幅度更大，确保前瓣叶不会影响左室流出道，而后瓣叶区域，抱箍件3的牵拉幅度较小，这能避免抱箍件3对腱索组织的过度牵拉，有利于保护组织。
就此而言，实施例四的相关构造和构思类似于实施例一，因此在这里不再重复描述。
实施例五
实施例五与实施例一大体上相同，不同之处在于，该实施例中夹瓣机构21包括多个夹持构件25，并且，所述抱箍件3与各所述夹持构件25的连接点的高度不同，如图11a和图11b所示，使得在所述第二形态下，所述抱箍件3呈波浪形的形态。
在本实施例中，所述夹瓣机构21包括多个夹持构件25，并且，所述抱箍件3与各所述夹持构件25的连接点的高度不同，使得在所述第二形态下，所述抱箍件3呈波浪形的形态。
在本实施例中，在前瓣叶区域，夹持构件25与抱箍件3的连接位置要高于后瓣叶区域夹持构件25与抱箍件3的连接位置，这样设计的目的在于：根据生理解剖结构可知，前瓣叶的长度较长，并且，在置换后，前瓣叶容易对左室流出道产生遮挡，因此，抱箍件3在前瓣叶区域与夹瓣机构21的连接位置较高，在第二形态时，抱箍件3对前瓣叶的提拉幅度更大，确保前瓣叶不会影响左室流出道，而后瓣叶区域，抱箍件3的牵拉幅度较小，这能避免抱箍件3对腱索组织的过度牵拉，有利于保护组织。
就此而言，实施例五的相关构造和构思类似于实施例一，因此在这里不再重复描述。
实施例六
实施例六与实施例一大体上相同，不同之处在于，该实施例中瓣膜支架1上设有固定夹合件9，该固定夹合件9用于夹持自体瓣叶，在起到一定锚定作用的同时也能增加瓣叶与瓣膜支架1的贴合度，起到良好的防漏作用。
在本实施例中，所述瓣膜支架1上设有固定夹合件9，并且，在所述第二形态下，所述固定夹合件9夹合自体瓣叶并使得自体瓣叶被夹在所述瓣膜支架1与固定夹合件9之间，如图12a-12c所示。
在本实施例中，所述固定夹合件9的位置与夹瓣机构21不重叠。
就此而言，实施例六的相关构造和构思类似于实施例一，因此在这里不再重复描述。
实施例七
实施例七与实施例一大体上相同，不同之处在于该实施例中夹瓣固定装置2只有单个夹瓣件10，抱箍件3的一侧与夹瓣件10连接，抱箍件3的另一侧与心室段102连接。
在本实施例中，所述夹瓣固定装置2包括单个夹瓣件10、心房支撑段101、心室段102以及抱箍件3，其中，所述抱箍件3分别与所述夹瓣件10和心室段102连接，并且，在平行于所述夹瓣固定装置2中心轴线的截面上，所述抱箍件3呈倾斜形态；所述心房支撑段101位于心房内并为夹瓣固定装置2提供了支撑力，所述夹瓣件10与心室段102连接并位于前瓣叶的一侧，所述抱箍件3与夹瓣件10连接，并且所述抱箍件3与位于后瓣叶区域的心室段102固定连接，使得在平行于所述夹瓣固定装置2中心轴线的截面上，所述抱箍件3呈倾斜形态，如图13a和13b所示。
在本实施例中，所述夹瓣件10用于夹持前瓣叶，并且，所述抱箍件3在夹瓣件10区域处的高度要高于所述抱箍件3在后瓣叶区域处的高度；这样设计的目的在于：夹瓣固定装置2在安装就位后，针对性对前瓣叶及相关腱索组织向上提拉，避免对左室流出道产生影响，而在后瓣叶区域，所述抱箍件3不会明显牵拉腱索及后瓣叶，减少对原生组织的影响。
就此而言，实施例七的相关构造和构思类似于实施例一，因此在这里不再重复描述。
出于说明的目的而提出了对本申请的示例实施例的前文描述。前文描述并非意图是穷举的，也并非将本申请限于所公开的精确配置和/或构造，显然，根据上文的教导，本领域的技术人员可作出许多修改和变型而不偏离本申请。本申请的范围和等同物旨在由所附权利要求限定。

Claims (12)

  1. 一种人工瓣膜置换系统，包括：瓣膜支架、与所述瓣膜支架协同操作的夹瓣固定装置，其特征在于：所述夹瓣固定装置被构造成用来夹持自体瓣叶的夹瓣机构和抱箍件，所述抱箍件至少部分被配置在所述夹瓣机构上；
    其中，所述夹瓣固定装置被构造为能够呈现第一形态和第二形态，且第二形态出现在第一形态后；
    其中，当所述夹瓣固定装置处于第一形态时，所述夹瓣机构被构造成可捕捉和夹持所述自体瓣叶；以及，
    其中，所述瓣膜支架径向扩张后，所述夹瓣固定装置处于第二形态，所述瓣膜支架的径向扩张导致所述抱箍件带动自体瓣叶向上移位并箍紧所述瓣膜支架。
  2. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述夹瓣机构的远端可拆卸连接，并且，所述夹瓣固定装置在第一形态下，所述夹瓣机构周边的瓣叶可实现自主开闭，当所述瓣膜支架进入所述夹瓣机构内，所述夹瓣机构远端被拆卸，所述瓣膜支架处于径向扩张的状态，所述瓣膜支架的径向扩张导致所述抱箍件带动自体瓣叶向上移位并箍紧所述瓣膜支架。
  3. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述瓣膜支架的径向扩张带动所述夹瓣机构、所述抱箍件、自体瓣叶和腱索联动，所述抱箍件至少部分被向上移位并带动自体瓣叶和腱索向上提拉，并且自体瓣叶和腱索组织中的至少一者被箍在所述抱箍件与所述瓣膜支架之间。
  4. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：在所述第一形态下，所述夹瓣机构夹持部分自体瓣叶，在所述第二形态下，所述夹瓣机构周边的自体瓣叶被所述抱箍件带动并向上移位。
  5. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述的人工瓣膜置换系统还包括内芯管，所述内芯管的远端与所述夹瓣机构的远端配合可拆卸连接，并且，所述瓣膜支架沿着所述内芯管进入所述夹瓣机构内。
  6. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述抱箍件与所述夹瓣机构至少包括2个连接点，并且所述抱箍件与所述夹瓣机构的连接点的高度不同。
  7. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述夹瓣固定装置包括单个夹瓣件、心房支撑段、心室段以及抱箍件，其中，所述抱箍件分别与所述夹瓣件和心室段连接，并且，在平行于所述夹瓣固定装置中心轴线的截面上，所述抱箍件呈倾斜形态。
  8. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述夹瓣机构包括多个夹持构件，并且，所述抱箍件与各所述夹持构件的连接点的高度不同，使得在所述第二形态下，所述抱箍件呈波浪形的形态。
  9. 根据权利要求5所述的人工瓣膜置换系统，其特征在于：所述夹瓣机构包括第一夹持半体和第二夹持半体，所述第一夹持半体和第二夹持半体可拆卸地连接，或者所述第一夹持半体与第二夹持半体为两个彼此分离的独立构件；并且所述第一夹持半体和第二夹持半体构造成分别捕捉并夹持不同的自体瓣叶。
  10. 根据权利要求9所述的人工瓣膜置换系统，其特征在于：所述第一夹持半体和第二夹持半体具有互补的形状，并且在所述夹瓣固定装置的约束状态下通过所述内芯管可拆卸地卡扣连接。
  11. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述瓣膜支架上还可设有将被定位于心房内的定位环，所述定位环被构造成适应自体瓣环的生理结构的形态，并且所述定位环设有辅助固定杆。
  12. 根据权利要求1所述的人工瓣膜置换系统，其特征在于：所述瓣膜支架上设有固定夹合件，并且，在所述第二形态下，所述固定夹合件夹合自体瓣叶并使得自体瓣叶被夹在所述瓣膜支架与固定夹合件之间。
PCT/CN2022/121698 2021-09-30 2022-09-27 人工瓣膜置换系统 Ceased WO2023051521A1 (zh)

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US20260041549A1 (en) 2026-02-12
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