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WO2022166063A1 - Dispositif d'ancrage et dispositif de valve cardiaque artificielle - Google Patents

Dispositif d'ancrage et dispositif de valve cardiaque artificielle Download PDF

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Publication number
WO2022166063A1
WO2022166063A1 PCT/CN2021/099452 CN2021099452W WO2022166063A1 WO 2022166063 A1 WO2022166063 A1 WO 2022166063A1 CN 2021099452 W CN2021099452 W CN 2021099452W WO 2022166063 A1 WO2022166063 A1 WO 2022166063A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
anchoring
connecting portion
telescopic
anchoring 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/CN2021/099452
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English (en)
Chinese (zh)
Inventor
赵婧
刘祥
闻靖
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.)
Shanghai Trulive Medtech Co Ltd
Original Assignee
Shanghai Trulive Medtech 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
Priority claimed from CN202120333382.5U external-priority patent/CN218832964U/zh
Application filed by Shanghai Trulive Medtech Co Ltd filed Critical Shanghai Trulive Medtech Co Ltd
Publication of WO2022166063A1 publication Critical patent/WO2022166063A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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

Definitions

  • the present invention relates to the technical field of medical devices, in particular to an anchoring device for anchoring a heart valve, and an artificial heart valve device.
  • the heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously.
  • the valve that separates the atrium from the ventricle is called the atrioventricular valve.
  • the atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the heart chambers.
  • the atrioventricular valve between the left atrium and the left ventricle is the mitral valve
  • the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve.
  • the pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium through the pulmonary veins.
  • the aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.
  • the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricle.
  • the atrioventricular valve opens to allow unobstructed flow from the atrium into the corresponding ventricle.
  • the tricuspid and mitral valves close normally, forming a seal that prevents backflow from the ventricle into the corresponding atrium.
  • valve anchoring Some of the existing mitral valve designs adopt the methods of clipping the valve leaflets and grasping the valve leaflets or tissue for anchoring. These anchoring methods will stretch the chordae tendineae and cause damage to the native valve leaflets. There is also anchoring through the Oversize design of the stent body. With this anchoring method, the stent compresses the tissue, which affects the contraction of the heart, and there is a risk of conduction block.
  • the present invention provides an anchoring device and an artificial heart valve device, which can solve the above-mentioned defects in the prior art.
  • An anchoring device for anchoring a heart valve at a native valve annulus, the heart valve is provided with a connecting piece extending in an axial direction
  • the anchoring device comprising: a first anchoring portion configured to have a plurality of telescopic units, In order to make the first anchoring part expand and contract during cardiac activity;
  • the second anchoring part includes a first anchoring part, a second anchoring part and a connecting part, the first anchoring part, the second anchoring part and the The connecting portion is coaxially arranged, wherein the first anchor and the second anchor are arranged oppositely, and one end of the connecting portion is fixed to the first anchor, and the other end is fixed to the second anchor;
  • One end of the first anchoring portion is fixed to the connecting piece, and the other end is fixed to the second anchoring portion
  • the connecting portion is configured with an accommodating space for a telescopic unit, and the first anchoring portion is configured to be at least partially accommodated in The telescopic unit is accommodated in the accommodating space.
  • first and second anchors can be fixed on both sides of the tissue, such as at the apex of the heart, or at the interventricular septum, such as the first anchor is attached to the apical epicardium, and the second The anchor is located on the inner wall of the heart apex, and has a large contact area with the tissue to provide axial retention force for the heart valve and prevent the heart valve from falling into the atrium; wherein, the first anchor part can be stretched during the heart activity, used to bear The force exerted on the valve prosthesis during the cardiac activity, so that the valve prosthesis can adapt to different tensile forces, and it is not easy to cause damage to the tissue due to stress concentration during the cardiac activity; the first anchoring part is at least partially accommodated in the connection The expansion and contraction unit in the inner part is contained in the accommodating space, so the first anchoring part is not easy to hook the tendon chord when it is expanded and contracted, so as to reduce the damage to the surrounding tissue.
  • a plurality of the telescopic units are coaxially arranged and connected in sequence.
  • the first anchoring part composed of a plurality of telescopic units has good axial extensibility and the ability to restore deformation, so that it can expand and contract during cardiac systole and diastole, and bear the force generated by cardiac activity.
  • the diameter of the telescopic unit increases in a direction away from the heart valve, so that the telescopic unit with the smallest diameter is deformed first, and the telescopic unit with the largest diameter is deformed during the stretching process of the first anchoring portion. Since it is far from the valve prosthesis, it is generally not deformed or the deformation amount is small, so that the first anchoring part can better share the force generated by the contraction of the heart.
  • the diameters of the telescopic units decrease in the direction away from the heart valve; or, in some embodiments, the diameters of a plurality of the telescopic units are the same, and the pulling force on the plurality of telescopic units is dispersed, Better anchorage.
  • the first anchor portion is configured to be received within the telescopic unit receiving space in an unextended state, and the first anchor portion is configured to be adjacent to at least a portion of the valve prosthesis
  • the telescopic unit can freely expand and contract in the accommodating space of the telescopic unit.
  • the first anchoring part completely accommodated in the accommodating space of the expansion and contraction unit is not easy to hook the tendon chords during expansion and contraction, does not interfere with external tissues and structures, and enables the first anchoring when the artificial heart valve device is delivered.
  • the first anchoring portion is accommodated in the accommodating space of the telescopic unit for delivery; and the first anchoring portion can freely expand and contract during the heart activity, so as to share the force on the artificial heart valve device when the heart contracts or relax, so that the valve prosthesis can be Adapt to different pulling forces.
  • the connecting portion includes a first connecting portion and a second connecting portion, wherein the first connecting portion is fixed to the first anchor and the second connecting portion is fixed to the second connecting portion An anchor, wherein the first anchor and the second anchor are connected to the second connection through the first connection part.
  • the axial dimension of the connecting portion is smaller than the sum of the axial dimensions of the first anchor and the second anchor. Therefore, when the first anchor and the second anchor are used fixedly, the first anchor and the second anchor are subjected to mutual pressing force in the axial direction, so that a clamping force is generated between the first anchor and the second anchor. The holding force, which enables the second anchoring portion to be firmly attached to the tissue when in use, thereby enhancing the anchoring effect of the second anchoring portion.
  • the first anchor member and the second anchor member are respectively configured to have a plurality of circumferentially arranged bending units, one end of the plurality of the bending units is connected, and the other end is bent and extended outwards;
  • the bending unit of one anchor is bent toward the side of the second anchor, and the bending unit of the second anchor is bent toward the side of the first anchor.
  • the bending unit is a single rod-shaped or sheet-shaped structure, or the bending unit is a ring-shaped structure composed of a rod-shaped or sheet-shaped structure.
  • the first anchor and the second anchor can be pressed to the conveyor for delivery, and can be restored to the original state after being released; and, when several bending units are in contact with the tissue, there are more contact points to prevent stress concentration on the tissue. damage.
  • the second anchoring part is configured such that after the first anchoring part and the second anchoring part are connected by the connecting part, the bending unit of the first anchoring part and the second anchoring part The bending elements of the anchor are interspersed and distributed. This enables the first and second anchors to be squeezed and deformed in the axial direction when the first and second anchors are successively released on both sides of the tissue to form a clamping force, thereby forming a clamping force with the tissue. More secure anchoring.
  • the second anchor portion is configured such that the radial dimension of the first anchor is greater than the radial dimension of the second anchor, or the radial dimension of the second anchor is greater than all the radial dimension of the first anchor.
  • connection between the first connection part and the second connection part is at least one of a wire knot connection, a hook connection, a snap connection, a gapless connection or a screw connection.
  • a connection mode has the advantages of simple structure, and at the same time, a stable fixed connection can be formed between the first connection part and the second connection part.
  • the second anchor portion is integrally manufactured to improve the connection strength of the first anchor and the second anchor; or the first anchor and the second anchor are separately formed, and then The fixed connection reduces the difficulty of forming the first anchor and the second anchor.
  • the first anchor has a symmetrical structure with respect to the connecting portion
  • the second anchor has a symmetrical structure with respect to the connecting portion.
  • the symmetrical structure makes the forming of the first anchor and the forming of the second anchor easier, and when released to the tissue, the symmetrical structure makes the first anchor and the second anchor respectively contact with the tissue. will be more dispersed and thus more stable in anchoring to the tissue and will not move.
  • first anchoring portion and the second anchoring portion are respectively made of shape memory material.
  • the first anchoring part and the second anchoring part can be pressed into the catheter, and can be restored to a preset state after being released, so as to meet the needs of interventional operations.
  • the present invention also provides a prosthetic heart valve device comprising the anchoring device as described above.
  • the first anchor and the second anchor that are oppositely arranged can be fixed on both sides of the tissue, such as at the apex of the heart, or at the interventricular septum, It has a large contact area with the tissue to provide axial retention force for the heart valve to prevent the heart valve from falling into the atrium; and the first anchor and the second anchor can form a clamping effect from both sides of the tissue, so that the second anchor
  • the anchoring part provides stable anchoring force, and the anchoring is more reliable; when the axial dimension of the connecting part is smaller than the sum of the axial dimensions of the first anchor and the second anchor, or further the first anchor
  • the bending unit and the bending unit of the second anchor are interspersed and distributed, after the first anchor and the second anchor are placed at the target position, the two are pressed against each other, so that the first anchor and the second anchor are pressed against each other.
  • a greater clamping force is generated between the anchors, which can make the second anchoring portion more
  • the first anchoring part can expand and contract during the heart activity, and is used to bear part of the heart activity and exert the force on the valve prosthesis, so that the valve prosthesis can adapt to Different pulling forces are not easy to cause damage to the tissue due to stress concentration during the heart activity;
  • the first anchoring part is at least partially accommodated in the accommodating space of the telescopic unit in the connecting part, so the first anchoring part is not easily hooked during expansion and contraction chordae tendineae to reduce damage to surrounding tissues;
  • the first anchoring portion is configured to be accommodated in the accommodating space of the telescopic unit in an unextended state, so that the first anchoring portion is not easily hooked after release and during use The chordae tendineae are attached, which will not interfere with external tissues and structures; at least part of the telescopic units in the first anchoring part close to the valve prosthesis can freely expand and contract in the accommodating space of the telescopic unit, and you can worry about visceral contraction or The force on
  • the prosthetic heart valve device of the present invention can be crimped and loaded in the delivery device for delivery, such as delivery through the apical route and the atrial septal route.
  • the atrial septal route through the femoral vein is less invasive, and the audience Wider; under the transseptal approach, the anchoring portion can be anchored to the apex or to the ventricular wall.
  • FIG. 1 is a schematic structural diagram of an artificial heart valve device according to Embodiment 1 of the present invention.
  • Fig. 2 is the partial structure schematic diagram of the artificial heart valve device of the embodiment 1 of the present invention.
  • FIG. 3A is a schematic structural diagram of the first anchoring portion of Embodiment 1 of the present invention.
  • FIG. 3B is a schematic structural diagram of another first anchoring portion according to Embodiment 1 of the present invention.
  • FIG. 3C is a schematic structural diagram of yet another first anchoring portion according to Embodiment 1 of the present invention.
  • Fig. 4 is the front view structure schematic diagram of the second anchoring part of the embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural diagram of the second anchoring portion in the prefabricated state of Embodiment 1 of the present invention.
  • FIG. 6A is a schematic diagram of the overall structure of the first anchor and the second anchor according to Embodiment 1 of the present invention.
  • 6B is another schematic structural diagram of the first anchor and the second anchor according to Embodiment 1 of the present invention.
  • 6C is another structural schematic diagram of the first anchor and the second anchor according to Embodiment 1 of the present invention.
  • 6D is a schematic diagram of the overall structure of another second anchoring portion according to Embodiment 1 of the present invention.
  • FIG. 6E is a schematic diagram of the overall structure of yet another second anchoring portion according to Embodiment 1 of the present invention.
  • FIG. 7A is a schematic diagram of the delivery structure of the artificial heart valve device according to Embodiment 1 of the present invention.
  • FIG. 7B is a schematic diagram of the release structure of the second anchoring portion according to Embodiment 1 of the present invention.
  • FIG. 7C is a schematic diagram of the delivery completion structure of the artificial heart valve device according to Embodiment 1 of the present invention.
  • valve prosthesis 100 first region 101; second region 102; third region 103; stent 110; anchoring device 200; 223; second anchor 222; bending unit 224; first bending unit 2241; second bending unit 2242; first anchoring part 230; telescopic unit 231; Section 2232.
  • valve prosthesis is also referred to as a heart valve, which is a prosthetic structure deployed at the native valve annulus to replace the native valve.
  • the artificial heart valve device of the present invention may be a mitral valve valve or a tricuspid valve valve.
  • the accommodating space for the telescopic unit in the connecting portion is a column-shaped space, or a substantially column-shaped space, so that the first anchoring portion can expand and contract therein, wherein the connecting portion can adopt It is integrally manufactured and formed, at this time, the connecting part is a hollow tubular structure with both ends open; or the connecting part is formed by connecting the first connecting part and the second connecting part.
  • the radial dimension of the accommodating space of the telescopic unit that is, the inner diameter of the connecting portion.
  • the axial dimension of the first anchor is the axial dimension of the first anchor in the prefabricated state
  • the axial dimension of the second anchor is the axial dimension of the second anchor in the prefabricated state
  • Interspersed distribution refers to interspersed along the axial direction of the heart valve.
  • the distal end refers to the side away from the operator, and the proximal end refers to the side closer to the operator.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • FIG. 1 to FIG. 7C are schematic structural diagrams of the artificial heart valve device in this embodiment, wherein the heart valve is composed of a valve prosthesis 100 , a connector 210 and an anchoring device 200, the valve prosthesis 100 includes a stent 110, a skirt and artificial valve leaflets.
  • the artificial heart valve device of this embodiment can be longitudinally divided into a first region 101 , a second region 102 and a third region 103 .
  • the first region 101 is attached to the native mitral valve.
  • the valve prosthesis 100 is prevented from falling from the left atrium to the left ventricle.
  • the second area 102 is used to carry the artificial valve leaflets, and at the same time, it is supported on the tissue to play a certain role of fixing and sealing;
  • the third area 103 is the The anchoring mechanism of the heart valve in the left ventricle prevents the prosthesis from being impacted by blood into the left atrium when the prosthesis is closed.
  • stent 110 can provide several functions for valve prosthesis 100, including serving as the main structure of the valve, carrying internal prosthetic leaflets, serving as a seal to inhibit paravalvular leakage between valve prosthesis 100 and the native valve, and delivering The connection structure of the system (hanging ears or fixed ears), etc.
  • the stent 110 is woven or cut.
  • the stent 110 is made of nickel-titanium alloy or other biocompatible materials with shape memory properties, and elastically or plastically deformable materials, such as balloons, can also be selected. Expandable material.
  • the bracket 110 is a columnar structure with open ends, such as a cylinder, an ellipse column, etc., and its cross-section is configured as a circle, an ellipse, a petal shape, a round shape, a D shape, and the like.
  • the stent 110 is constructed as a grid-like structure, which is composed of a number of closed geometric cells arranged, such as diamond, square, heart, teardrop, etc., so that the stent 110 can be compressed into the sheath when loaded, and can be recovered when released. undisturbed.
  • the prosthetic leaflets are dynamically switched between open and closed states, in which the prosthetic leaflets are closed or joined in sealing abutment.
  • the prosthetic valve leaflets can be formed from any suitable material or combination of materials, and in some embodiments, biological tissue such as chemically stable tissue from a heart valve from an animal such as a pig, or pericardial tissue from an animal such as bovine (bovine pericardium) or sheep (sheep pericardium) or pig (porcine pericardium) or equine (horse pericardium), preferably bovine pericardium tissue.
  • Prosthetic leaflets can also be made from small intestinal submucosal tissue, in addition, synthetic materials can also be used for the prosthetic leaflets, such as expanded polytetrafluoroethylene or polyester; Ether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylene.
  • synthetic materials such as expanded polytetrafluoroethylene or polyester; Ether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylene.
  • biocompatible polymers can be used for prosthetic valve leaflets, optionally including polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride , other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block copolymers using them.
  • the prosthetic leaflets have a surface that is treated (or reacted with) an anticoagulant, including but not limited to heparinized polymers.
  • the skirt can be a single-layer structure, or a double-layer structure inside and outside. Knitted, woven, woven polyester fabrics, PTFE, ePTFE and other materials can be selected, which mainly play the role of sealing and prevent backflow.
  • the end of the valve prosthesis 100 is provided with a connecting piece 210 , and the connecting piece 210 extends along the axial direction of the valve prosthesis 100 .
  • the ends are joined, such as by stitching.
  • the connector 210 provides traction for the stent 110 to prevent the stent 110 from being impacted by blood and displaced to the left ventricle when the heart contracts.
  • the valve prosthesis 100 can also be configured with other anchoring structures to prevent the valve prosthesis 100 from falling from the left atrium. into the left ventricle.
  • the connector 210 may be, for example, a pull cord, wire, or rod-like structure, etc., and may be made of, for example, a biocompatible polymeric material including, but not limited to, ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene, and the like.
  • UHMWPE ultra-high molecular weight polyethylene
  • the connector 210 may be inelastic to provide a more robust stent anchoring force, or elastic to provide a higher degree of stretch compliance during the cardiac cycle.
  • the connector 210 may be made of a bioabsorbable material and thereby provide temporary fixation until endothelialization between the prosthesis and assembly is sufficient to provide an anchoring force for the valve prosthesis.
  • the connecting member includes a pulling rope, a connecting wire or a connecting rod, and the like.
  • the anchoring device 200 includes a first anchoring part 230 and a second anchoring part 220, the first anchoring part 230 is configured to have a plurality of telescopic units 231, so that the first anchoring part 230 is in the Telescoping during cardiac activity;
  • the second anchoring part 220 includes a first anchoring part 221 , a second anchoring part 222 and a connecting part 223 , the first anchoring part 221 , the second anchoring part 222 , and the connecting part 223 Coaxial arrangement, wherein the second anchor 222 is arranged opposite to the first anchor 221, one end of the connecting portion 223 is fixed to the first anchor 221, and the other end is fixed to the second anchor 222; one end of the first anchoring portion 230 is fixed to the connecting member 210, and the other end is fixed to the second anchoring portion 220, the connecting portion 223 is configured with a telescopic unit accommodating space 2230, and the first anchoring portion 230 is configured to be at least partially accommodated within the telescopic
  • the oppositely arranged first anchor 221 and second anchor 222 can be respectively released on both sides of the tissue. Or attached at the interventricular septum, with a large contact area with the tissue, to provide axial retention for the heart valve and prevent the heart valve from falling into the atrium.
  • the first anchoring portion 230 can expand and contract during heart activity, and can be used to analyze the force applied to the valve prosthesis 100 during heart activity, so that the valve prosthesis can adapt to different pulling forces and is not affected during heart activity.
  • the first anchoring part 230 is at least partially accommodated in the telescopic unit accommodating space 2230 in the connecting part, so the first anchoring part 230 is not easy to hook the tendon chord when it expands and contracts, so as to reduce the impact on the surrounding area. tissue damage.
  • the telescopic unit 231 is configured as a helical coil.
  • a plurality of the telescopic units 231 are coaxially arranged and connected end to end in sequence, and the first anchoring portion 230 composed of the plurality of telescopic units 231 has good axial extensibility and the ability to restore deformation, thereby It can expand and contract during cardiac systole and diastole, and withstand the force generated by cardiac activity.
  • the diameters of the plurality of telescopic units 231 increase in the direction away from the valve prosthesis 100 , as shown in FIG. 3A , that is, the telescopic unit with the largest diameter among the plurality of telescopic units 231 is located away from the connector 210 , and the multi- Among the telescopic units 231 , the telescopic unit with the smallest diameter is located close to the connecting member 210 , and the telescopic unit with the smallest diameter is connected with the connecting member 210 .
  • the telescopic unit with the smallest diameter is deformed first (because the contraction force of the heart is first transmitted to the end of the connector 210 close to the valve prosthesis 100), and the diameter Since the largest telescopic unit is far away from the valve prosthesis 100 , it is generally not deformed or the deformation amount is small, so that the first anchoring portion 230 can better share the force generated by the heart contraction.
  • the diameter of the telescopic unit 231 decreases in a direction away from the valve prosthesis 100 .
  • the telescopic unit with the largest diameter is arranged close to the connecting piece 210
  • the telescopic unit with the smallest diameter is arranged at a position away from the connecting piece 210 , wherein the telescopic unit with the largest diameter is connected with the connecting piece 210 , and similarly
  • the purpose of making the first anchoring portion 230 cooperate with the connecting member 210 to adapt to the beating of the heart can be achieved.
  • the diameters of the plurality of telescopic units 231 are the same. As shown in FIG. 3C , a plurality of telescopic units 231 with the same diameter are connected in sequence in the axial direction, and the telescopic units 231 are preferably distributed at equal intervals. When the two ends of the connecting member 210 have tension, the telescopic unit 231 close to the connecting member 210 among the multiple telescopic units 231 with the same diameter is stretched first, and the remaining multiple telescopic units 231 are in order from near to far away from the connecting member 210 Stretch until the elastic force of the plurality of telescopic units 231 with the same diameter is balanced with the contraction force of the heart.
  • the telescopic units 231 of the plurality of telescopic units 231 with the same diameter that are far away from the connecting piece 210 first return to their original state, and the remaining multiple telescopic units 231 return to their original state in order from farthest to the closest to the connecting piece 210 .
  • the advantage of this embodiment is that the tensile force received by the plurality of telescopic units 231 is dispersed, and the anchorage is better.
  • the first anchoring portion 230 is configured to be accommodated in the telescopic unit accommodating space 2230 in an unextended state, and the first anchoring portion 230 is configured to be close to the valve prosthesis. At least part of the telescopic units 231 can be freely expanded and contracted in the telescopic unit accommodating space 2230 .
  • the first anchoring portion 230 in a natural state, is completely accommodated in the connecting portion, so that the first anchoring portion 230 is not easily hooked to the tendon chord after release and during use, and the external The tissue and structure will not interfere; and, when the prosthetic heart valve device of this embodiment is delivered, the first anchoring portion 230 is accommodated in the accommodating space of the telescopic unit for delivery.
  • the first anchoring portion 230 in the stretched state, may be completely accommodated in the telescopic unit accommodating space 2230; or, the first anchoring portion 230 may also be configured such that the stretched portion is accommodated in the telescopic unit Outside the space 2230, for example, the stretched and elongated portion extends to a position close to the valve prosthesis 100, which will not be repeated here.
  • the first anchoring portion 230 is configured such that in an unextended state, the telescopic unit 231 close to the valve prosthesis 100 is accommodated in the telescopic unit accommodating space 2230 and away from the valve
  • the telescopic unit 231 of the prosthesis 100 is disposed outside the telescopic unit accommodating space 2230 , that is, away from the telescopic unit 231 of the valve prosthesis 100 and extends beyond the first anchor 221 , so that the end of the first anchor portion 230 is It can be fixed on the outer side of the first anchor 221 to facilitate the fixing between the first anchor part 230 and the second anchor part 220 .
  • the connecting portion 223 has a uniform inner diameter along the axial direction.
  • the telescopic unit 231 of the first anchoring portion 230 has an inner diameter.
  • the radial dimension should be smaller than the radial dimension of the telescopic unit accommodating space 2230 .
  • the radial dimension of at least part of the telescopic unit 231 should be smaller than the radial dimension of the telescopic unit accommodating space 2230 , and further, at least part of the telescopic unit 231 close to the valve prosthesis 100 has a diameter
  • the radial dimension should be smaller than the radial dimension of the telescopic unit accommodating space 2230 . Therefore, during the cardiac activity of the first anchoring portion 230, at least part of the telescopic unit 231 can be freely expanded and contracted in the connecting portion 223 to withstand the force generated during the cardiac activity.
  • the telescopic unit 231 away from the valve prosthesis 100 may be configured to have the same radial dimension as the telescopic unit accommodating space 2230 or a size larger than that of the telescopic unit accommodating space 2230 .
  • the radial dimension is larger, while the radial dimension of the telescopic unit 231 close to the valve prosthesis 100 should be smaller than the radial dimension of the telescopic unit accommodating space 2230, so that the telescopic unit 231 close to the valve prosthesis 100 can freely expand and contract .
  • the radial dimension of the telescopic unit 231 close to the valve prosthesis 100 should be smaller than the radial dimension of the telescopic unit accommodating space 2230 .
  • the radial dimensions of the plurality of telescopic units 231 are smaller than the radial dimensions of the telescopic unit accommodating space 2230 , so that the entire first anchoring portion 230 can freely expand and contract in the connecting portion.
  • the radial dimension of the telescopic unit 231 should be slightly smaller than the radial dimension of the telescopic unit accommodating space 2230 , so that the first anchoring portion 230 can freely expand and contract in the axial direction.
  • the first anchoring portion 230 is configured to be at least partially close to the telescopic unit 231 of the valve prosthesis and can be connected to the telescopic unit Free expansion and contraction in the accommodating space 2230, that is, the radial dimension of the telescopic unit 231 close to the valve prosthesis should be smaller than the radial dimension of the telescopic unit accommodating space 2230 on the side close to the valve prosthesis, so that during the heart activity process , the telescopic unit 231 close to the valve prosthesis can be stretched and contracted to bear the force generated during the heart activity.
  • the end of the first anchoring portion 230 is fixed to the second anchoring portion 220, and the fixing method can be wire knot or welding; the end of the first anchoring portion 230 can be fixed in the telescopic unit accommodating space 2230, Or fixed to the outer side of the first anchor 221 , and the fixing method can be selected according to actual needs, which will not be repeated here.
  • the second anchoring portion 220 may be integrally manufactured. That is, the first anchor 221 , the second anchor 222 , and the connecting portion 223 are integrally manufactured. For example, a tubular structure is cut by a cutting process. The integral manufacturing process makes the first anchor 221 , the second anchor The connection strength of the anchor 222 is higher, and the overall structure of the second anchor portion 220 is more stable.
  • connection part includes a first connection part 2231 and a second connection part 2232, see FIG. 4-FIG. 6C, the first connection part 2231 is fixed to the first anchor 221, the first connection part 2231 Two connecting parts 2232 are fixed to the second anchor 222 , and the first anchor 221 and the second anchor 222 are connected to the second connecting part 2232 through the first connecting part 2231 .
  • the first connecting portion 2231 and the first anchor member 221 can be manufactured integrally
  • the second connecting portion 2232 and the second anchor member 222 can be manufactured integrally
  • the first connecting portion 2231 and the second connecting portion 2232 can be fixedly connected .
  • the first anchor 221 , the second anchor 222 , and the connecting portion 223 are formed separately, and two ends of the connecting portion 223 are respectively fixed to the first anchor 221 and the second anchor 222 .
  • the first anchor 221, the second anchor 222, the first connecting part 2231 and the second connecting part 2232 can also be manufactured separately, and then the first connecting part 2231 and the first anchor 221 are fixed, and the first connecting part 2231 and the first anchor 221 are fixed.
  • the two connecting parts 2232 are fixed to the second anchor 222 , and then the first connecting part 2231 and the second connecting part 2232 are fixedly connected.
  • This configuration reduces the difficulty of manufacturing the second anchor portion 220 as a whole, and makes the manufacturing and molding of the first anchor 221 and the second anchor 222 easier.
  • the telescopic unit accommodating space 2230 is formed between the first connecting portion 2231 and the second connecting portion 2232 to accommodate the above-mentioned first anchoring portion 230 .
  • the axial dimension of the connecting portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 .
  • the first anchor 221 and the second anchor 222 are in a prefabricated state
  • the axial dimension of the first connecting portion 2231 is h1
  • the axial dimension of the first anchor 221 is H1
  • the second connecting portion 2232 The axial dimension is h2
  • the axial dimension of the second anchor 222 is H2 wherein, the axial dimension of the connecting portion 223 is h1+h2, and h1+h2 should be smaller than H1+H2. Therefore, after the first anchor 221 and the second anchor 222 are fixedly connected, as shown in FIG.
  • the first anchor 221 and the second anchor 222 are subjected to mutual pressing force in the axial direction, so that the first anchor A clamping force F is generated between the member 221 and the second anchor member 222 , and the clamping force F can make the second anchor portion 220 more firmly attached to the tissue, thereby enhancing the anchoring effect of the second anchor portion 220 .
  • the first anchor 221 and the second anchor 222 can be made of shape memory materials, preferably shape memory materials with better biocompatibility, such as shape memory metal materials such as nickel-titanium alloy or Shape memory polymer materials.
  • the first anchor 221 and the second anchor 222 are respectively configured to have several bending units 224, wherein the bending units 224 are configured to be formed by rod-like or sheet-like structures.
  • the bending units 224 are evenly distributed along the circumferential direction, so that the first anchor 221 and the second anchor 222 can be crimped to the conveyor for delivery, and can return to their original shape after being released.
  • the first anchor 221 and the second anchor 222 can also provide a certain blocking effect.
  • FIG. 6A-FIG. 6C they are schematic structural diagrams of the first anchor 221 and the second anchor 222 in a prefabricated state, wherein the first anchor 221 and the second anchor 222 are respectively configured as umbrellas
  • the bending unit 224 is an annular shape formed by a rod-shaped structure, a plurality of bending units 224 are evenly distributed along the circumferential direction, and adjacent bending units 224 are stacked.
  • the size of the first anchor 221 and the second anchor 222 may be the same or different, and the shapes of the first anchor 221 and the second anchor 222 may be the same or different.
  • the first anchor 221 and the second anchor 222 are respectively configured as umbrella-shaped structures of the same size, and the axial dimension of the first connecting portion 2231 is smaller than that of the first anchor 221 .
  • the axial dimension of the second connecting portion 2232 is smaller than the axial dimension of the second anchor 222 .
  • the first anchor 221 and the second anchor 222 have the same shape, and the size of the first anchor 221 is smaller than that of the second anchor 222 ; in the embodiment shown in FIG. 6C , the first anchor 221 is smaller in size than the second anchor 222 .
  • the anchor 221 and the second anchor 222 are different in size and shape.
  • the first anchor 221 is in the shape of a flat umbrella
  • the second anchor 222 is in the shape of a concave umbrella
  • the size of the first anchor 221 is larger than that of the second anchor 222 ;
  • the axial dimension of the first connecting part 2231 is larger than the axial dimension of the first anchor 221
  • the axial dimension of the second connecting part 2232 is smaller than the axial dimension of the second anchor 222
  • the first connecting part 2231 the first The sum of the axial dimensions of the two connecting portions 2232 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 .
  • the preferred size of the first anchor 221 can be larger than that of the second anchor 222, and has a relatively larger surface area, so that it can interact with the second anchor 222.
  • the tissue is in multi-point contact, so that the force is more dispersed, and the stress concentration is prevented from causing damage to the tissue.
  • the first anchor 221 and the second anchor 222 are respectively configured to have a plurality of bending units 224, wherein the second anchor portion 220 is configured to be used when the first anchor 221, After the second anchors 222 are fixedly connected, the bending units 224 of the first anchors 221 and the bending units 224 of the second anchors 222 are interspersed and distributed.
  • the first anchor 221 and the second anchor 222 are successively released on both sides of the tissue, the first anchor 221 and the second anchor 222 can be squeezed and deformed in the axial direction to form a clamping force, so as to form a more reliable anchoring effect with the tissue.
  • the first anchor 221 and the second anchor 222 are respectively configured as umbrella structures
  • the second anchor 222 has a second bending unit 2242
  • the first anchor 221 has a first bending unit 2241
  • the first bending unit 2241 and the second bending unit 2242 are respectively annular shapes constructed from rod-shaped structures, wherein the size of the second bending unit 2242 is larger than that of the first bending unit 2241, and is connected to
  • the axial dimension of the portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 .
  • the first bending unit 2241 is inserted into the second bending unit 2242, thereby forming an inserted structure, so that the first anchor 221 and the second anchor 222 are released. Then a clamping force is formed between the two.
  • the first anchor 221 and the second anchor 222 are respectively configured as radial structures
  • the second anchor 222 has a second bending unit 2242
  • the first anchor 221 has a first bending unit 2241
  • the first bending unit 2241 and the second bending unit 2242 are arc structures formed by sheet materials, respectively
  • the bending units of the first anchor 221 and the second anchor 222 are radially distributed in the same way
  • the axial dimension of the connecting portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 .
  • the first bending unit 2241 is inserted into the gap formed by the adjacent two second bending units 2242 of the second anchor 222, thereby forming an alternately inserted
  • the structure enables the first anchor 221 and the second anchor 222 to form a clamping force between them after they are released.
  • first connection part 2231 and the second connection part 2232 can be connected by one of: wire knot connection, hook connection, snap connection, gapless connection, and screw connection, or two or more of them can be used. a combination of connections.
  • first connecting portion 2231 can be configured with a male structure
  • the second connecting portion 2232 can be configured with a female structure matching the male structure, so that the first connecting portion 2231 and the second connecting portion 2232 can form a stable connection, such as the first connection
  • the first connecting portion 2231 and the second connecting portion 2232 are configured with a male thread
  • the second connecting portion 2232 is configured with a female thread
  • the first connecting portion 2231 and the second connecting portion 2232 are connected by a thread
  • female buckle, the first connecting part 2231 and the second connecting part 2232 are connected by snaps; or, the first connecting part 2231 is configured with a hook
  • the second connecting part 2232 is configured with a concave part matched with the hook
  • the first anchor 221 has a symmetrical structure with respect to the connecting portion 223
  • the second anchor 222 has a symmetrical structure with respect to the connecting portion 223 .
  • the forming of the second anchor 222 will be easier, and when it is released to the tissue, the symmetrical structure makes the forces generated when the first anchor 221 and the second anchor 222 contact the tissue are more dispersed, so that the contact force with the tissue will be more dispersed.
  • the anchorage is also more stable and does not move.
  • the first anchor 221 and the second anchor 222 in this embodiment may be manufactured by a braiding process, or may be cut.
  • the first anchor 221 and the second anchor 222 may be manufactured by a cutting process.
  • the first anchor 221, The second anchor 222 can be manufactured by weaving or cutting. Specifically, it can be cut from a pipe, or woven from a metal wire.
  • the curved unit of the first anchor 221 can be extended toward the distal end, the curved unit of the second anchor 222 can be extended toward the proximal end, and the first anchor portion 230 is located in the telescopic unit accommodating space 2230 , thereby crimp loading the anchoring device 220 into the conveyor for delivery.
  • the artificial heart valve device of this embodiment is released on both sides of the tissue through the first anchor 221 and the second anchor 222, and a clamping force is generated between the first anchor 221 and the second anchor 222, so that the second anchor portion Compared with the existing anchoring methods for grasping tissue, the 220 can provide better anchoring effect and cause less damage to the tissue.
  • the first anchoring part 230 is configured to have axial extensibility, so during the systole and diastole of the heart, the first anchoring part 230 can expand and contract in the axial direction, so as to bear the force generated by the heart activity, and make the valve prosthesis 100 can better adapt to different pulling forces.
  • first anchoring portion 210 is at least partially accommodated in the telescopic unit accommodating space 2230 of the second anchoring portion 220 , so the first anchoring portion 210 will not interfere with the outside during expansion and contraction, and will not pull the tendon.
  • the cooperation of the first anchoring portion 230 and the second anchoring portion 220 provides stable, effective and reliable anchoring for the valve prosthesis 100 of this embodiment.
  • the anchoring device 200 includes a first anchoring portion 230, and the first anchoring portion 230 provides axial extensibility to withstand the force generated during the heart activity.
  • the anchoring device 200 only includes the second anchoring part 220 but not the first anchoring part 230 .
  • the end of the connecting piece 210 is directly connected with the second anchoring part 220 , and the anchoring effect is provided by the second anchoring part 220 .
  • the anchoring device 200 includes a first anchoring part 230 and a second anchoring part 220, wherein the second anchoring part 220 only includes the first anchoring part 221 and the connecting part 223, but does not include the second anchoring part 220 Anchor 222, attached to one side of the tissue through the first anchor 221 serves as an anchor.
  • the prosthetic heart valve device of this embodiment can be crimped and loaded into the delivery device for delivery, such as delivery via the apical route and the atrial septal route.
  • the transfemoral atrial septal route is less traumatic and has a wider audience.
  • the anchoring part can be anchored to the apex or to the ventricular wall.
  • the delivery process of the artificial heart valve device of the present embodiment is as follows:
  • FIG. 7A-7D embodiments of transseptal delivery of a prosthetic heart valve device are illustrated.
  • this example only describes the method in relation to the native mitral valve, it can similarly be used for other native heart valves (eg, the tricuspid valve).
  • Step 1 As shown in Figure 7A, the delivery 201 enters the right atrium via the inferior vena cava, and then traverses the atrial septum and mitral valve to the vicinity of the apex, where the distal end of the delivery 201 can pass through the apex of the heart as shown opening.
  • Step 2 As shown in Figure 7B, the anchoring device 200 is released by relative movement between it and a portion of the delivery 201 (eg, catheter or sheath).
  • a portion of the delivery 201 eg, catheter or sheath.
  • relative movement is meant that the anchoring device 200 can be advanced through the catheter or sheath and out of the distal end of the delivery device 201 .
  • the first anchor 221 is released first, and the second anchor 222 is released later. Further movement between the anchoring device 200 and the catheter or sheath can effectively deploy the location of the anchoring device 200, eg, pulling the anchoring device 200 proximally against the tip of the heart, which can be done by pulling on the suture or connector 210 to execute.
  • Step 3 As shown in Figure 7C, the catheter or sheath can be moved relative to the stent 110, releasing the stent portion of the valve prosthesis, allowing the valve prosthesis to be fully released at the target location.
  • the catheter or sheath can be withdrawn proximally relative to the stent 110 .
  • the length of the connector 210 can be modified at this stage or at any previous stage to adjust the tension of the connector 210 for optimal clamping force for the first anchor 221 and the second anchor 222; Finally, the connector 210 is fixed and cut, and then the delivery system is withdrawn to complete the release.
  • This embodiment also provides another delivery process of the artificial heart valve device, as follows:
  • the present invention may also be used to deliver a prosthetic heart valve device via a transapical approach, although this example only describes the method in relation to the native mitral valve, but is similarly applicable to other native heart valves (eg, the tricuspid valve).
  • Step 1 The delivery device 201 can be advanced through the tip of the heart to the vicinity of the native mitral valve.
  • the catheter or sheath is moved relative to the stent 110, gradually releasing the stent 110, skirt, and prosthetic valve leaflets, allowing the valve prosthesis to be deployed at the target location.
  • the position of the valve portion can be adjusted by the connector 210 .
  • Step 2 The sheath can be moved proximally relative to the stent 110 such that the distal end of the catheter or sheath is positioned outside the heart.
  • the connector 210 is released and the anchoring device 200 is released by relative movement between it and the catheter or sheath of the delivery 201 .
  • relative movement is meant that the anchoring device 200 can be advanced in a direction towards the heart (distal end) through the catheter or sheath. When the anchoring device 200 extends beyond the sheath or catheter, the anchoring device 200 is slowly released.
  • the second anchor 222 is released first, and the first anchor 221 is released later. Further movement between the anchoring device 200 and the catheter or sheath can effectively deploy the anchoring device 200 in position, fully releasing the anchoring device 200 at or near the apex of the heart.
  • the length of the connector 210 can be modified at this stage or any previous stage to adjust the tension of the connector 210 for optimal clamping force for the first anchor 221 and the second anchor 222.
  • Step 3 Finally, fix and cut the connector 210, and then withdraw from the conveying system to complete the release.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif d'ancrage (200), comprenant une première partie d'ancrage (230), qui est construite pour avoir une pluralité d'unités télescopiques (231) ; et une seconde partie d'ancrage (220), qui comprend un premier élément d'ancrage (221), un second élément d'ancrage (222) et une partie de connexion (223). La première partie d'ancrage (230) est conçue pour être au moins partiellement reçue dans un espace de réception d'unité télescopique (2230) de la partie de connexion (223). Par des moyens permettant de loger au moins partiellement la pluralité d'unités télescopiques de la première partie d'ancrage dans l'espace de réception d'unité télescopique, l'accrochage de cordages tendineux lorsque la première partie d'ancrage s'étend et se rétracte peut être réduit, ce qui permet de réduire les dommages aux tissus environnants. L'invention concerne en outre un dispositif de valve cardiaque artificielle comprenant le dispositif d'ancrage.
PCT/CN2021/099452 2021-02-05 2021-06-10 Dispositif d'ancrage et dispositif de valve cardiaque artificielle Ceased WO2022166063A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202110161983.7 2021-02-05
CN202120333382.5U CN218832964U (zh) 2021-02-05 2021-02-05 一种锚固装置及人工心脏瓣膜装置
CN202110161983 2021-02-05
CN202120333382.5 2021-02-05

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WO2022166063A1 true WO2022166063A1 (fr) 2022-08-11

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130110228A1 (en) * 2007-06-08 2013-05-02 St. Jude Medical, Inc Devices for transcatheter prosthetic heart valve implantation and access closure
US20140031926A1 (en) * 2011-04-04 2014-01-30 The Medical Research, Infrastructure, And Health Services Fund Of The Tel Aviv Medical Center Device and Method for Heart Valve Repair
WO2015017689A1 (fr) * 2013-08-01 2015-02-05 Robert Vidlund Dispositifs et procédés d'ancrage épicardique
WO2016126942A2 (fr) * 2015-02-05 2016-08-11 Vidlund Robert M Tampons épicardiques expansibles et dispositifs et procédés d'administration de ceux-ci
WO2017100785A1 (fr) * 2015-12-10 2017-06-15 Mvrx, Inc. Dispositifs, systèmes et procédés de remodelage d'anneau de valvule cardiaque
CN111012550A (zh) * 2019-12-31 2020-04-17 先健科技(深圳)有限公司 心脏瓣膜系绳及具有其的心脏瓣膜组件
CN111110400A (zh) * 2019-12-09 2020-05-08 先健科技(深圳)有限公司 心脏瓣膜系绳及具有其的心脏瓣膜组件

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130110228A1 (en) * 2007-06-08 2013-05-02 St. Jude Medical, Inc Devices for transcatheter prosthetic heart valve implantation and access closure
US20140031926A1 (en) * 2011-04-04 2014-01-30 The Medical Research, Infrastructure, And Health Services Fund Of The Tel Aviv Medical Center Device and Method for Heart Valve Repair
WO2015017689A1 (fr) * 2013-08-01 2015-02-05 Robert Vidlund Dispositifs et procédés d'ancrage épicardique
WO2016126942A2 (fr) * 2015-02-05 2016-08-11 Vidlund Robert M Tampons épicardiques expansibles et dispositifs et procédés d'administration de ceux-ci
WO2017100785A1 (fr) * 2015-12-10 2017-06-15 Mvrx, Inc. Dispositifs, systèmes et procédés de remodelage d'anneau de valvule cardiaque
CN111110400A (zh) * 2019-12-09 2020-05-08 先健科技(深圳)有限公司 心脏瓣膜系绳及具有其的心脏瓣膜组件
CN111012550A (zh) * 2019-12-31 2020-04-17 先健科技(深圳)有限公司 心脏瓣膜系绳及具有其的心脏瓣膜组件

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