WO2022100398A1 - Implant de contraction annulaire et appareil de contraction annulaire - Google Patents

Implant de contraction annulaire et appareil de contraction annulaire Download PDF

Info

Publication number
WO2022100398A1
WO2022100398A1 PCT/CN2021/125370 CN2021125370W WO2022100398A1 WO 2022100398 A1 WO2022100398 A1 WO 2022100398A1 CN 2021125370 W CN2021125370 W CN 2021125370W WO 2022100398 A1 WO2022100398 A1 WO 2022100398A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
flexible
anchor
anchors
implant
Prior art date
Application number
PCT/CN2021/125370
Other languages
English (en)
Chinese (zh)
Inventor
郭荣辉
黄桥
张庭超
Original Assignee
杭州德晋医疗科技有限公司
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 CN202011245903.8A external-priority patent/CN114452036A/zh
Priority claimed from CN202022587690.9U external-priority patent/CN215080275U/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2022100398A1 publication Critical patent/WO2022100398A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the 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

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a ring-retracting implant and a ring-retracting device.
  • Heart valves are composed of valve annulus, valve leaflets, chordae tendineae and papillary muscles. To achieve the integrity of valve function, it is required that the size of the valve annulus is appropriate, the valve leaflet structure is complete, and the papillary muscles contract and stretch the chordae tendineae to make the valve leaflets close normally.
  • Annulus dilatation one of the most common causes of heart valve disease, can cause the valve leaflets to separate from each other during ventricular systole, creating gaps that can no longer close or coapt effectively, resulting in blood regurgitation and reduced blood output from the heart .
  • Annuloplasty for annular expansion is an important procedure for mitral or tricuspid valve repair.
  • the tricuspid valve orifice area is reduced to allow the leaflets to conform to each other, thereby reducing or eliminating regurgitation.
  • the technical problem to be solved by the present application is to provide a ring-retracting implant and a ring-retracting device, which can reduce the mutual interference between the anchors and the risk of the anchors causing damage to the tissue around the valve annulus.
  • the present application first provides a retractable ring implant, comprising M anchors, N first flexible sheaths, and at least one retraction control element, wherein M is a positive integer, and M ⁇ 3, N is a positive integer, and N ⁇ 2, at least some of the M anchors are in one-to-one correspondence with at least some of the N first flexible sheaths;
  • the anchors include an anchor seat and a The distal end of the anchor seat is fixedly connected to the nail body;
  • the anchor seat is located outside the corresponding proximal end of the first flexible sheath; in the non-implanted state, the first flexible sheath is movably sheathed Outside the nail body of the corresponding anchor, in the implanted state, the first flexible sheath is laminated and sandwiched between the corresponding anchor seat of the anchor and the valve annulus tissue; the shrinkage control member
  • the M anchors are connected in series for driving the M anchors relatively close to cause the annulus to contract.
  • a ring shrinking device comprising a support member and the above-mentioned ring shrinking implant;
  • the support member includes a stationary base, K pieces are arranged in a circumferential array around the stationary base and are Rigid support rods rotatably connected to the stationary base, K connecting rods rotatably connected to each support rod at one end, and adjustment rods rotatably connected to the other end of each of the connecting rods, where K is A positive integer, and K ⁇ M;
  • the adjusting rod is used to move in the axial direction to drive the K connecting rods to open the K supporting rods into an umbrella shape, wherein the M supporting rods and the The M anchors are in one-to-one correspondence; during the implantation process, the support rod provides support for the corresponding anchors.
  • the first flexible sheath is isolated from the first flexible sheath.
  • the adjacent anchors are placed, so that the risk of mutual interference between the anchors is reduced; in addition, during the delivery and implantation of the annulus, the part of the anchor body outside the annulus is always in the first position. In the wrapping of the flexible sheath, the risk of damage to the tissue surrounding the annulus by the anchor can be reduced.
  • FIG. 1 is a schematic diagram of a support member of the ring shrinking device provided in the first embodiment of the present application being accommodated at the distal end of an outer sheath;
  • FIG. 2 is a schematic view of the outer sheath tube exposed at the distal end of the support member and the delivery member of the ring shrinking device shown in FIG. 1;
  • FIG. 3 is a schematic view of the ring shrinking device shown in FIG. 1 with the first flexible sheath hidden;
  • FIG. 4 is a schematic perspective view of the support member in the ring shrinking device shown in FIG. 1 being stretched to form an umbrella;
  • Fig. 5 is the three-dimensional exploded structure schematic diagram of the support in the ring shrinking device
  • FIG. 6 is an enlarged schematic view of the proximal region of the support shown in FIG. 5;
  • FIG. 8 is an enlarged schematic view of the distal end region of the support shown in FIG. 5;
  • FIG. 9 is a schematic diagram of the assembly structure of the anchor and the anchor control rod in the ring-retracting implant
  • Figure 10 is a cross-sectional view of the anchor in the retractable ring implant and the anchor control rod being restrained by the support rod in the support in an assembled state;
  • FIG. 11 is a schematic view of the assembly structure of the ring shrink implant
  • FIG. 12 is a schematic view of the retractable ring implant when the flexible backing ring is in an open state
  • FIG. 13 is a schematic diagram of the retractable ring implant when the support is retracted so that the flexible backing ring is in a folded and retracted state;
  • Figure 14 is a schematic diagram of the ring retracting device reaching the left atrium through the outer sheath, wherein the support member is stretched to be umbrella-shaped;
  • Figure 15 is a schematic perspective view of the ring-retracting implant after implantation of the valve annulus
  • Figure 16 is a schematic partial cross-sectional view of the ring-retracting implant after implantation of the valve annulus
  • Fig. 17 is the schematic diagram of Fig. 15 concealing valve annulus tissue
  • FIG. 18 is a schematic structural diagram of a flexible backing ring and a shrinking control member of a shrinking ring implant provided by the second embodiment of the present application;
  • FIG. 19 is a schematic diagram of the state of the ring-retracting implant provided by the third embodiment of the application after the implantation is completed;
  • 20 is a schematic structural diagram of a flexible backing ring and a shrinking control member of a ring shrinking implant provided by the fourth embodiment of the present application.
  • the expression “and/or” includes any and all combinations of the associated listed words.
  • the expression “including A and/or B” may include A, may include B, or may include both A and B.
  • the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end.
  • the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction.
  • the circumferential direction is the direction around the axis of a cylinder, a pipe, and other objects.
  • a first embodiment of the present application provides a ring shrinking device 1 , which includes a support member 11 , a conveying member 12 and a ring shrinking implant 13 .
  • the delivery member 12 is movably passed through the outer sheath tube 10 serving as a delivery channel, and is used for delivering the support member 11 and the shrink-ring implant 13 .
  • the support member 11 is connected to the distal end of the delivery member 12 for loading the retractable ring implant 13 and providing support for anchoring the anchor 14 in the retractable ring implant 13 into the valve annulus tissue.
  • the ring-retracting implant 13 is used to implant the valve annulus tissue and perform retraction of the valve annulus.
  • the support member 11 includes a stationary base 111 , a plurality of rigid support rods 112 , an adjustment rod 114 , a movable base 115 and a plurality of connecting rods 117 .
  • the stationary base 111 is fixedly connected to the distal end of the delivery member 12 .
  • the proximal end of each support rod 112 is rotatably connected to the stationary base 111 , and a plurality of support rods 112 are arranged in a circumferential array around the stationary base 111 .
  • the adjusting rod 114 moves axially through the center of the stationary base 111 , and the movable base 115 is fixedly connected with the distal end of the adjusting rod 114 .
  • the distal end of each connecting rod 117 is rotatably connected to the movable base 115 .
  • a plurality of connecting rods 117 are provided around the distal end of the adjusting rod 114 .
  • the plurality of support rods 112 are relatively gathered at the stationary base 111 .
  • the adjusting rod 114 is used to move in the axial direction to drive the plurality of connecting rods 117 to spread the plurality of supporting rods 112 into an umbrella shape.
  • the movable base 115 moves along the axial direction with the adjusting rod 114 to move away from or approach the stationary base 111 , and the movable base 115 drives each connecting rod 117 to push or pull the corresponding support
  • the rod 112 moves, and the support rod 112 opens or closes with respect to the adjustment rod 114 with the end of the support rod 112 that converges relative to the stationary base 111 as the base point of rotation.
  • the overall structure of the support member 11 is configured as: when the support rod 112 is retracted relative to the adjusting rod 114 , that is, when the support member 11 is in the retracted state, the axial distance between the movable base 115 and the stationary base 111 It is greater than the axial distance between one end of the connecting rod 117 connected to the corresponding support rod 112 and the stationary base 111 .
  • the adjusting rod 114 moves proximally in the axial direction
  • the movable base 115 approaches the stationary base 111
  • the movable base 115 drives each connecting rod 117 to spread the corresponding supporting rod 112 , and each supporting rod 112 is opposite to the corresponding supporting rod 112 .
  • the adjustment lever 114 is opened.
  • the movable base 115 and the adjustment rod 114 may be of an integral structure or a non-integrated structure.
  • the movable base 115 and the adjustment rod 114 are of a non-integrated structure but are fixedly connected to each other.
  • the stationary base 111 has a plurality of first U-shaped grooves 1111 penetrating the distal and proximal end surfaces of the stationary base 111 distributed along the circumferential direction for accommodating the proximal end of the support rod 112 .
  • a first annular groove 1112 communicated with all the first U-shaped grooves 1111 is defined in the middle of the stationary base 1111 in the circumferential direction.
  • the support rod 112 includes a first connection buckle 1121 , a second connection buckle 1122 and a support rod body 1123 .
  • the first connection buckle 1121 is fixedly sleeved on the proximal end of the support rod body 1123
  • the second connection buckle 1122 is fixedly sleeved on the substantially middle part of the support rod body 1123 .
  • the first connection buckle 1121 , the second connection buckle 1122 and the support rod body 1123 can be fixed by laser welding; in other embodiments, the first connection buckle 1121 is connected with the second connection buckle 1121
  • the buckle 1122 and the support rod body 1123 can be processed into one body, and each component is preferably a polymer material, such as poly-ether-ether-ketone (PEEK for short), High Density Polyethylene (HDPE for short), etc.
  • the support rod body 1123 may be hollow, and its cross-sectional shape is not limited, and may be circular, oblate, oval, rectangular, polygonal, or the like.
  • the support member 11 further includes a first annular hoop 113 , the first annular hoop 113 is sleeved in the first annular groove 1112 and passes through the preset openings on the first connecting buckle 1121 , thereby connecting a plurality of The first connection buckles 1121 on the support rod body 1123 are connected in series, the two sides of the first connection buckle 1121 are clamped by the first U-shaped grooves 1111 on the stationary base 111 , and the first connection buckle 1121 and the first ring hoop 113 are locked.
  • a rotating pair is formed, so the first connecting buckle 1121 can only swing relative to the axial direction of the stationary base 111 , that is, the plurality of support rods 112 can rotate relative to the stationary base 111 to converge or diverge.
  • the movable base 115 is circumferentially distributed with a plurality of second U-shaped grooves 1151 penetrating the distal and proximal end surfaces of the movable base 115 , and one and all second U-shaped grooves 1151 are arranged in the middle of the movable base 115 in the circumferential direction.
  • the U-shaped groove 1151 communicates with the second annular groove 1152 .
  • the support 11 further includes a second annular hoop 116, and the distal end of the connecting rod 117 is provided with a connecting hole 1171.
  • the second annular hoop 116 is sleeved in the second annular groove 1152 and passes through the connecting hole 1171 on the distal end of the connecting rod 117 , so as to connect a plurality of connecting rods 117 in series, and the distal end of the connecting rod 117 is in turn supported by the movable base 115
  • the second U-shaped groove 1151 on the upper part is stuck, and the connecting rod 117 and the second annular hoop 116 form a rotating pair.
  • the center of the movable base 115 is provided with an opening 1153 , and the distal end of the adjusting rod 114 is fixedly connected to the opening 1153 . It can be understood that the fixed connection manner of the adjusting rod 114 and the movable base 117 is not limited, such as screw connection or laser welding.
  • the proximal end of the connecting rod 117 is rotatably connected with the second connecting buckle 1122 of the supporting rod 112 through the pin 118 . It can be understood that the connection manner between the connecting rod 117 and the supporting rod 112 is not limited.
  • each support rod 112 When the adjusting rod 114 moves in the proximal direction, each support rod 112 is stretched by the corresponding connecting rod 117 to form an umbrella shape.
  • the movable base 115 can also be arranged on the proximal side of the first connection buckle 1121, and when the adjusting rod 114 moves to the distal direction, each support rod 112 is connected correspondingly The rod 117 is stretched and is in the shape of an umbrella, and the greater the distance that the adjusting rod 114 moves to the distal direction, the greater the extent that the supporting rod 112 is stretched, and the larger the opening of the umbrella;
  • each support rod 112 is retracted by the corresponding connecting rod 117, and the greater the distance that the adjustment rod 114 moves toward the proximal direction, the greater the degree of retraction of the support rod 112, and the smaller the umbrella-shaped opening until each support The rod 112 is generally vertical.
  • the static base 111 , the plurality of rigid support rods 112 , the plurality of connecting rods 117 and the adjusting rods 114 form a link structure, so that the axial movement of the adjusting rods 114 can drive each connecting rod 117 to support the corresponding support rod 112 open, so that the plurality of support rods 112 are opened in an umbrella shape relative to the adjustment rod 114 . It can be understood that when the position of the adjusting rod 114 is relatively fixed, the link structure is fixed, and the positions of the plurality of support rods 13 are fixed.
  • the ring shrinking implant 13 includes a plurality of anchors 14 , a plurality of first flexible sheaths 132 corresponding to the anchors 14 one-to-one, and a shrinkage control member 133.
  • the plurality of support rods 112 are in one-to-one correspondence with the plurality of anchors 14 .
  • the anchor 14 includes a nail body 141 and an anchor seat 142 , and the nail body 141 is fixedly connected with the distal end of the anchor seat 142 .
  • the anchor seat 142 of each anchor 14 is located beyond the proximal end of the corresponding first flexible sheath 132 . As shown in FIGS.
  • each first flexible sheath 132 in the non-implanted state, is movably sheathed outside the nail body 141 of the corresponding anchor 14 .
  • each first flexible sheath 132 in the implanted state, is laminated and sandwiched between the anchor seat 142 of the corresponding anchor 14 and the annulus tissue.
  • the constriction control member 133 can directly or indirectly connect a plurality of anchors 14 in series, so as to drive the plurality of anchors 14 to be relatively close, thereby reducing the area of the valve orifice and implementing the shrinking ring.
  • the non-implanted state means that the nail body 141 of the anchor 14 is not anchored into the valve annulus, that is, the anchor 14 is not in contact with the valve annulus; the implanted state means that the nail body 141 of the anchor 14 is anchored into the valve annulus.
  • the first flexible sheath 132 isolates the adjacent anchors nails 14 so that all anchors 14 do not interfere with each other.
  • the parts of the nails 141 outside the annulus are always wrapped by the first flexible sheath 132, and will not cause any damage to the tissue around the annulus. accidental damage.
  • the anchor 14 is usually made of a metal material with good biocompatibility and a certain rigidity, such as stainless steel, titanium, nickel-titanium, etc.
  • the first flexible sheath 132 is preferably made of a biocompatible polymer polyester It is made of cloth, such as polyethylene terephthalate (PET for short, commonly known as polyester) cloth. After the implantation is completed, the first flexible sheath 132 is laminated between the anchor seat 142 and the valve annulus.
  • PET polyethylene terephthalate
  • the cloth is rougher, has pores and better biocompatibility, and the cells of the valve annulus tissue are easy to crawl on the first flexible sheath 132, so it is more conducive to the endothelium of the implant Therefore, the risk of the anchor 14 falling off after implantation can be significantly reduced.
  • the axial length of the first flexible sheath 132 is greater than or equal to the axial length of the nail body 141 of the anchor 14 .
  • the axial length of the nail body 141 can be selected from [1.0, 10.0] mm.
  • the axial length of the nail body 141 is [5.0, 8.5 mm]. ]mm.
  • the axial length range of the first flexible sheath 132 can be selected to be [1.0, 11.0] mm, and preferably, the axial length range of the first flexible sheath 132 is [5.0, 9.5] mm.
  • the distal end of the first flexible sheath 132 may be open, that is, the distal end of the first flexible sheath 132 has an opening (not shown).
  • the distal end of the staple body 141 can directly protrude from the opening of the distal end of the first flexible sheath 132 .
  • the distal end of the first flexible sheath 132 can also be a closed end, so that the distal end of the nail body 141 can be completely wrapped by the first flexible sheath 132.
  • the distal end (usually the tip) of the nail body 141 can penetrate the closed end of the first flexible sheath 132 and enter the annulus tissue, further reducing the distance between the distal end of the nail body 141 and the valve annulus. Risk of accidental injury to surrounding tissue.
  • the nail body 141 includes a helical segment, and the first flexible sheath 132 is sleeved outside the helical segment.
  • the inner diameter of the first flexible sheath 132 is slightly larger than the diameter of the helical segment of the nail body 141, so that the The flexible sheath 132 is a clearance fit with the nail body 141 .
  • the range of the gap between the inner wall of the first flexible sheath 132 and the helical segment of the nail body 141 may be [0.1, 0.2] mm, so as to facilitate the anchoring of the nail body 141 into the annulus tissue and save the space occupied by the first flexible sheath 132 space.
  • the wall thickness of the first flexible sheath 132 is too thin, the protection and isolation of the nail body 141 will be limited; if the wall thickness of the first flexible sheath 132 is too thick, after the valve annulus tissue is implanted, the first flexible sheath
  • the thickness of the sleeve 132 stacked between the nail base 511 and the annulus tissue will be relatively large, which affects the depth of the effective implantation of the anchor 14 into the annulus tissue and the reliability of the connection between the anchor 14 and the annulus tissue.
  • the wall thickness range of the first flexible sheath 513 is preferably [0.1, 1.0] mm, and particularly preferably, the wall thickness range of the first flexible sheath 513 is [0.3-0.5] mm, so as to effectively isolate and protect the nails
  • the anchor 14 can be effectively implanted into the valve annulus tissue to a sufficient depth, and the reliability of the connection between the anchor 14 and the valve annulus tissue is improved.
  • the anchor seat 142 includes a seat body 1420 and a boss 1421 protruding from the proximal end of the seat body 1420 in the circumferential direction.
  • the boss 1421 is used to abut against the support rod body 1123 to facilitate the anchor seat 142 and the assembly of the support rod body 1123.
  • the ring shrinking device 1 further includes an anchor joint 143 and an anchor control rod 144 , the distal end of the anchor joint 143 is detachably connected with the proximal end of the anchor seat 142 , and the proximal end of the anchor joint 143 is connected with the anchor control rod 144 remote fixed connection.
  • the anchor control rod 144 is movably passed through the strut body 1123 for driving the anchor joint 143 , the anchor seat 142 and the nail body 141 to move.
  • the support rod body 1123 is sleeved on the anchor joint 143, the base body 1420 of the anchor seat 142 and the distal end of the anchor control rod 144, and the boss 1421 is located outside the support rod body 1123 and is connected to the support rod.
  • the distal end surface of the rod body 1123 abuts against.
  • the proximal end of the base body 1420 is provided with a first buckling portion 1425
  • the distal end of the anchor joint 143 is provided with a second buckling portion 1431
  • the second buckling portion 1431 is connected with the first buckling portion 1425 .
  • the first buckling portion 1425 is substantially an S-shaped structure
  • the second buckling portion 1431 is an S-shaped structure complementary to the first buckling portion 1425 .
  • the second snap portion 1431 is snap-connected to the first snap portion 1425 and bound by the inner cavity of the support rod 1123 , and the anchor seat 142 cannot be separated from the anchor joint 143 .
  • the anchor 14 can be driven to rotate, so that the nail body 141 of the anchor 14 is implanted into the annulus tissue.
  • the driving support 11 is retracted from the distal end to the proximal end relative to the anchor control rod 144, so that the second engaging portion 1431 and the first engaging portion 1425 are completely removed from the support rod body.
  • the inside of 1123 is exposed, and the second buckling portion 1431 and the first buckling portion 1425 are released from the restraint of the inner cavity of the support rod body 1123 , and the anchor control rod 144 can be withdrawn proximally to make the anchor seat 142 detach from the anchor joint 143 .
  • the nail body 141 can be made of wire, the wire diameter of the nail body 141 is smaller than the diameter of the base body 1420, the nail body 141 and the anchor base 142 are preferably made of stainless steel material with good biocompatibility, such as stainless steel 316L, the nail body 141 and the anchor
  • the fixing method between the nail bases 142 may be, but not limited to, laser welding.
  • the delivery member 12 is a multi-lumen catheter, including a first sub-lumen (not shown) and a plurality of second sub-lumens (not shown).
  • a plurality of second sub-chambers are arranged around the first sub-chamber, the first sub-chamber is used for inserting the adjusting rod 114 in the support 11, the second sub-chamber is used for inserting the anchor control rod 144, the adjusting rod 114 and the
  • the anchor control rods 144 respectively pass through the first sub-chamber and the second sub-chamber in the conveying member 12 to the corresponding driving member on the connecting handle (not shown).
  • the stationary base 111 , the plurality of rigid support rods 112 , the plurality of connecting rods 117 and the adjusting rods 114 constitute a link structure, and driving the adjusting rods 114 to move in the axial direction can drive each connecting rod 117 to move the corresponding
  • the support rods 112 are stretched, so that the plurality of support rods 112 are opened into an umbrella shape relative to the adjustment rods 114, and at the same time, the ring-retracting implant 3 is also transformed from the state of being gathered by the support members 11 (as shown in FIG. 13 ) to the scattered state. open state (as shown in FIG.
  • each support rod 112 corresponds to The anchor 14 provides support to ensure that the anchor 14 can be accurately and securely anchored into the corresponding position of the annulus tissue.
  • the number of the anchors 14 , the number of the first flexible sheaths 132 , and the number of the support rods 112 are all equal, such as 8, so that An anchor 14 corresponds to a support rod 112 , and an anchor 14 corresponds to a first flexible sheath 132 .
  • the number of anchors 14 may be M
  • the number of first flexible sheaths 132 may be N
  • the number of support rods 112 may be K, wherein M, N, and K are all positive integers.
  • the value of M should be at least 3, M and N may be equal or not, but the value of N should be at least 2, so that the first flexible sheath 132 can isolate Adjacent anchors 14 reduce the risk of adjacent anchors 14 interfering with each other.
  • the anchor 14 can correspond to the first flexible sheath 132 one-to-one, that is, in the non-implanted state, a first flexible sheath 132 is movably sheathed outside the nail body 141 of an anchor 14; when M>N, the nail body 141 of at least one anchor 14 is exposed, but as long as the first flexible sheath 132 is provided on the nail body 141 adjacent to the exposed nail body 141, the mutual distance between adjacent anchors 14 can be reduced. Risk of interference; when M ⁇ N, at least one of the first flexible sheaths 132 can be left empty, and the other first flexible sheaths can be in one-to-one correspondence with all the anchors 14 .
  • the number of anchors 14 when the number of anchors 14 is 3, the number of the first flexible sheaths 132 may be 2, 3, 4, etc.; when the number of anchors is 5, the number of the first flexible sheaths 132 may be 3, 4, 5, 6, 7, etc.
  • the ring shrinking implant 13 may further include a flexible backing ring 131 .
  • the flexible backing ring 131 is provided with at least the same number of connecting holes 1311 as the first flexible sheath 132 .
  • the connecting holes 1311 are arranged in the circumferential direction of the flexible backing ring 131 and pass through the distal and near side end surfaces of the flexible backing ring 131 .
  • the proximal end of each first flexible sheath 132 is fixedly connected to the flexible backing ring 131 and communicated with the corresponding connecting hole 1311 .
  • the flexible backing ring 131 is located between the anchor seat 142 and the first flexible sheath 132 .
  • the nail body 141 of the anchor 14 passes through the connecting hole 1311 .
  • the flexible backing ring 131 is further provided with at least two connecting portions 1315 , and the at least two connecting portions 1315 are arranged in the circumferential direction of the flexible backing ring 131 .
  • the number of the shrinking control members 133 is at least one, and the shrinking control member is movably connected with the at least two connecting portions 1315 to indirectly connect the anchors 14 in series for shrinking the flexible backing ring 131 to make at least the anchors 14 approach each other.
  • the connecting portion 1315 is an opening penetrating through the flexible backing ring 131 in the axial direction.
  • the shrinking control member 133 is movably penetrated through the opening, and the two free ends of the shrinking control member 133 are located outside the flexible gasket 131 and extend to the outside of the body through the conveying member 12 to facilitate the operation of the shrinking control member 133 .
  • the shrinkage control member 133 is movably connected to the flexible backing ring 131 in an up-and-down manner, so as to be connected in series with each anchor 14 in an indirect manner.
  • the connecting portion 1315 may also be an opening in other forms, as long as the opening penetrates the distal and proximal end surfaces of the flexible backing ring 131 .
  • the flexible backing ring 131 When the support member 11 is stretched and the two free ends of the control and retraction member 133 are not pulled, the flexible backing ring 131 can be in the open state shown in FIGS. 11 and 12 . After that, the anchor 14 is anchored into the valve annulus tissue, and when the two free ends of the shrinking control member 133 are tightened, the flexible backing ring 131 is pulled by the shrinking control member 133 to be able to shrink and reduce the radial size, This causes the valve annulus to contract.
  • the flexible backing ring 131 is closed in the circumferential direction, that is, the flexible backing ring 131 is a closed-loop structure, so that the entire valve annulus is uniformly stressed.
  • the shape enclosed by the flexible backing ring 131 may be a circle or a "D" shape that is closer to the shape of the valve annulus. It can be understood that the flexible backing ring 131 may also be open in the circumferential direction, that is, the flexible backing ring 131 has an open-loop structure.
  • the thickness of the flexible backing ring 131 is in the range of [0.5, 1.5] mm, so as not to affect the effective implantation depth of the anchor 14 in the valve annulus, and to ensure that the flexible backing ring 31 is sufficient to withstand the tightening of the control member 133 to make it flexible
  • the backing ring 3 drives each anchor 14 to be relatively close to implement the force generated when the ring is retracted.
  • the flexible backing ring 131 can include a variety of sizes to select for different patient annulus sizes.
  • the proximal end of the first flexible sheath 132 is connected to the flexible backing ring 131 and communicated with the corresponding connecting hole 1311 .
  • the first flexible sheath 132 and the flexible backing ring 131 can be sewn together with sutures.
  • the material of the flexible backing ring 131 is preferably the same polymer material with good biocompatibility as the first flexible sheath 132 , preferably a polyester material such as polyethylene terephthalate and the like.
  • the shrinking control member 133 includes, but is not limited to, a flexible wire, a flexible strip, or a flexible tape, and the cross-sectional shape of the flexible strip or the flexible tape includes, but is not limited to, an oblate circle, a rectangle, and the like.
  • the number of the control shrinking element 133 is at least one. It can be understood that one of the two ends of the shrinking control member 133 can be fixed on the flexible backing ring 131, and the other can be used as a free end to pass through the flexible backing ring 131 from the connecting portion 1315.
  • the connecting portion 1315 can be protruded on the outer surface of the flexible gasket 131, the connecting portion 1315 is provided with an installation hole (not shown), and the control member 133 can move through all the connecting portions.
  • the installation hole of 1315 for example, the connecting portion 1315 can be a ring-shaped retaining ring structure, and the axial direction of the installation hole of the connecting portion 1315 is perpendicular to the axial direction of the flexible backing ring 131 .
  • the connecting portion 1315 can also be a sheet structure with holes.
  • the conveying member 12 drives the supporting member 11 to establish a channel in the outer sheath 10 ( 14 , the outer sheath 10 passes through the femoral vein, inferior vena cava, right atrium A, atrial septum, and left atrium B as an example) until the ring-retracting implant 13 approaches the mitral valve annulus.
  • each support rod 112 is driven to spread out into an umbrella shape, the flexible backing ring 131 is unfolded, and then each anchor 14 is driven to rotate one by one or at the same time, so that the nail body 141 of each anchor 14 is rotated.
  • Anchored into the annular tissue Anchored into the annular tissue.
  • the anchor seat 142 will push the flexible backing ring 131 to move toward the valve ring, and the flexible backing ring 131 can be well Fitted to the surface of the valve annulus, showing a shape that fits the valve annulus.
  • the flexible backing ring 131 is contracted by tightening the shrinkage control member 133 , which drives the anchors 14 to approach each other.
  • the first flexible sheath 132 is laminated and squeezed between the anchor seat 142 and the valve annulus tissue, which can not only disperse the pressing force of the anchor seat 142 on the valve annulus 300, but also facilitate tissue cells to climb over.
  • the ring shrinking device 1 provided in the first embodiment of the present application has at least the following advantages: First, when the supporting rods 112 are relatively gathered together, the first flexible sheath 132 wraps the nail body 141 of the anchor 14, and subsequent Whether the support rods 112 are gathered or stretched, the nail bodies 141 of the anchors 14 are isolated from each other by the first flexible sheath 132, which reduces the risk of mutual interference between the nail bodies 141 of the anchors 14; The flexible sheath 132 wraps the distal end of the nail body 141, which can reduce the risk of accidental damage to the surrounding tissue during the delivery or anchoring process; thirdly, when the nail body 141 of the anchor 14 is implanted , the first flexible sheath 132 is extruded to form multiple layers and sandwiched between the anchor seat 142 and the valve annulus tissue to form a protective pad, reducing the risk of scratching and crushing the annulus caused by the anchor seat 142; Fourth, since the first flexible sheath 132 is made of a flexible
  • the flexible backing ring 131 may also be omitted from the ring-retracting implant 13, and a spacer is provided between the boss 1421 of each anchor seat 142 and the corresponding first flexible sheath 132 (not shown in the figure), the gaskets can be circular, oval or other shapes, and the gaskets are connected in series by the shrinking control member 133 to realize the indirect series connection of the anchors 14 .
  • the flexible backing ring 131 and the gasket can be omitted, only the first flexible sheath 132 sleeved outside the nail body 141 of the anchor nail 14 is retained, and the shrinkage control member 133 is directly connected to each anchor in series On the nail seat 142, during the anchoring process, the first flexible sheath 132 prevents the mutual interference between the anchors 14 and protects the valve annulus; A flexible sheath 132 can also serve as a protective pad and help cells to crawl.
  • the structure of the ring-retracting implant provided by the second embodiment of the present application is substantially the same as that of the ring-retracting implant provided by the first embodiment.
  • the shrinking member 133 is made of shape memory material (eg, nickel titanium wire).
  • the shrink-ring implant 13 further includes a limiting block 134 , and the limiting block 134 is fixed to the free end of each shrinking control element 133 .
  • the limiting block 134 is located outside the flexible backing ring 131 and is used to prevent the shrinking control member 133 from being separated from the flexible backing ring 131 .
  • the shape of the compression control member 133 is similar to the shape of the valve annulus, but the circumferential size is smaller than the actual size of the valve annulus.
  • the free ends are respectively connected with a limit block 134 to prevent the retraction control member 133 from being separated from the flexible backing ring 131 .
  • the shrinkage control member 133 can drive the flexible backing ring 131 to shrink by its own shrinkage, so as to realize the shrinkage of the ring.
  • the operations of tightening the constriction control member 133, locking the knot and cutting off the redundant control constriction member 133 are omitted, which helps to simplify the operation steps and reduce the operation time.
  • control and contraction member 133 can also be an elastic ring closed in the circumferential direction, and the limiting block 134 can be omitted.
  • the structure of the ring-retracting implant provided by the third embodiment of the present application is substantially the same as the structure of the ring-retracting implant provided by the first embodiment, except that the ring-retracting implant further includes a plurality of first Two flexible sheaths 135, a plurality of second flexible sheaths 135 are in one-to-one correspondence with a plurality of anchors 14, each second flexible sheath 135 is sleeved outside the anchor seat 142 of the corresponding anchor 14, and the anchor is lifted Cell crawling speed and endothelialization speed on seat 142.
  • the material of the second flexible sheath 135 is preferably a polymer material with good biocompatibility, preferably a polyester material, such as polyethylene terephthalate and the like.
  • the structure of the ring-retracting implant provided by the fourth embodiment of the present application is substantially the same as that of the ring-retracting implant provided by the first embodiment.
  • the difference is that the flexible backing ring 131 is provided with a surrounding flexible backing ring.
  • the shrinking control member 133 is partially movably passed through the threading cavity 137 , and the free end of the shrinking control member 133 passes through the threading cavity 137 to the outside of the flexible gasket 131 .
  • the shrinking control member 133 is pre-embedded in the threading cavity 137 in the flexible gasket 131, and at least one free end of the shrinking control member 133 is located outside the flexible gasket 131. Compared with the first embodiment, when the shrinking control member 133 is tightened, the For convenience and effort.

Abstract

La présente invention concerne un implant de contraction annulaire et un appareil de contraction annulaire. L'implant de contraction annulaire comprend M éléments d'ancrage, N premières gaines souples et au moins un élément de commande de contraction, M étant un nombre entier positif, M étant égal ou supérieur à 3, N étant un nombre entier positif, et N étant égal ou supérieur à 2. Au moins certains des M éléments d'ancrage présentent une correspondance biunivoque avec au moins certaines des N premières gaines souples. Chaque élément d'ancrage comprend un siège d'ancrage et un corps d'ancrage relié de manière fixe à l'extrémité distale du siège d'ancrage. Le siège d'ancrage est situé à l'extérieur de l'extrémité proximale d'une première gaine souple correspondante. Dans un état non implanté, les premières gaines flexibles sont manchonnées de façon mobile sur les corps d'ancrage des éléments d'ancrage correspondants. Dans un état implanté, les premières gaines souples sont empilées et agencées entre les sièges d'ancrage des éléments d'ancrage correspondants et un tissu annulaire de valve ; et l'élément de commande de contraction relie les M éléments d'ancrage en série. L'implant de contraction annulaire et l'appareil de contraction annulaire selon la présente invention peuvent réduire les risques que les éléments d'ancrage interfèrent l'un avec l'autre, et que les éléments d'ancrage endommagent le tissu environnant d'un anneau de valve.
PCT/CN2021/125370 2020-11-10 2021-10-21 Implant de contraction annulaire et appareil de contraction annulaire WO2022100398A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202022587690.9 2020-11-10
CN202011245903.8A CN114452036A (zh) 2020-11-10 2020-11-10 缩环植入件及缩环装置
CN202011245903.8 2020-11-10
CN202022587690.9U CN215080275U (zh) 2020-11-10 2020-11-10 缩环植入件及缩环装置

Publications (1)

Publication Number Publication Date
WO2022100398A1 true WO2022100398A1 (fr) 2022-05-19

Family

ID=81602126

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/125370 WO2022100398A1 (fr) 2020-11-10 2021-10-21 Implant de contraction annulaire et appareil de contraction annulaire

Country Status (1)

Country Link
WO (1) WO2022100398A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116327445A (zh) * 2023-03-28 2023-06-27 晨兴(南通)医疗器械有限公司 瓣环修复器械及修复方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201219005A (en) * 2010-11-05 2012-05-16 Topasia Internat Technology Inc with a hollow passage to work with a guide needle anchored on a bone to increase the accuracy of micro surgery
CN104203157A (zh) * 2011-12-12 2014-12-10 戴维·阿隆 心脏瓣膜修补器械
CN204600650U (zh) * 2015-04-27 2015-09-02 常州市电力开关厂有限公司 易取式骨钉
US20160074163A1 (en) * 2001-09-13 2016-03-17 Edwards Lifesciences Corporation Methods and apparatuses for deploying minimally-invasive heart valves
CN110381887A (zh) * 2017-02-10 2019-10-25 魅尔皮德股份有限公司 用于重塑心脏瓣膜环的可植入装置和输送系统
CN210124835U (zh) * 2019-05-06 2020-03-06 常州市第二人民医院 一种新型软组织保护螺钉套

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160074163A1 (en) * 2001-09-13 2016-03-17 Edwards Lifesciences Corporation Methods and apparatuses for deploying minimally-invasive heart valves
TW201219005A (en) * 2010-11-05 2012-05-16 Topasia Internat Technology Inc with a hollow passage to work with a guide needle anchored on a bone to increase the accuracy of micro surgery
CN104203157A (zh) * 2011-12-12 2014-12-10 戴维·阿隆 心脏瓣膜修补器械
CN204600650U (zh) * 2015-04-27 2015-09-02 常州市电力开关厂有限公司 易取式骨钉
CN110381887A (zh) * 2017-02-10 2019-10-25 魅尔皮德股份有限公司 用于重塑心脏瓣膜环的可植入装置和输送系统
CN210124835U (zh) * 2019-05-06 2020-03-06 常州市第二人民医院 一种新型软组织保护螺钉套

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116327445A (zh) * 2023-03-28 2023-06-27 晨兴(南通)医疗器械有限公司 瓣环修复器械及修复方法

Similar Documents

Publication Publication Date Title
US11730592B2 (en) Pre-constricted prosthetic heart valves
US11864995B2 (en) Implant for heart valve
US20210338427A1 (en) Axisymmetric adjustable device for treating mitral regurgitation
JP6576944B2 (ja) 僧帽弁置換におけるトグルセル固定
US20220133327A1 (en) Valve clip with coatings and valve clamping system
US20190175339A1 (en) Septomarginal trabecula attachment for heart valve repair
JP6526000B2 (ja) 封止デバイス、関係する送達装置、およびそれらの使用
US20230363911A1 (en) Heart valve sealing devices and delivery devices therefor
US20190183644A1 (en) Implant for heart valve
JP2022520377A (ja) 心臓弁封止デバイスおよびその送達デバイス
JP2022551365A (ja) 心臓弁封止デバイスおよびその送達デバイス
JP2022549981A (ja) 心臓弁封止デバイスおよびその送達デバイス
JP2016506794A (ja) 僧帽弁置換のための人工弁
EP2814427A1 (fr) Rapprochement des papilles ventriculaires droites
WO2022100398A1 (fr) Implant de contraction annulaire et appareil de contraction annulaire
US20230025890A1 (en) Transcatheter Valve To Treat Small Native Mitral Anatomy
CN215080275U (zh) 缩环植入件及缩环装置
US11951002B2 (en) Apparatus and methods for valve and tether fixation
CN114452036A (zh) 缩环植入件及缩环装置
TWI840422B (zh) 用於修復病患之自體瓣膜的瓣膜修復裝置
WO2022057799A1 (fr) Stent de valve cardiaque artificielle, valve cardiaque artificielle et système de remplacement de valve cardiaque artificielle
CN114903651A (zh) 按需型瓣膜夹合装置及瓣膜夹合系统
WO2023158594A1 (fr) Mécanisme de verrouillage pour une valvule prothétique mécaniquement extensible

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21890925

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21890925

Country of ref document: EP

Kind code of ref document: A1