WO2024027761A1 - 左心耳封堵器 - Google Patents

左心耳封堵器 Download PDF

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Publication number
WO2024027761A1
WO2024027761A1 PCT/CN2023/110754 CN2023110754W WO2024027761A1 WO 2024027761 A1 WO2024027761 A1 WO 2024027761A1 CN 2023110754 W CN2023110754 W CN 2023110754W WO 2024027761 A1 WO2024027761 A1 WO 2024027761A1
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WO
WIPO (PCT)
Prior art keywords
section
support rods
left atrial
atrial appendage
adjacent support
Prior art date
Application number
PCT/CN2023/110754
Other languages
English (en)
French (fr)
Inventor
刘国良
阎晋
Original Assignee
先健科技(深圳)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
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2024027761A1 publication Critical patent/WO2024027761A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the utility model relates to the technical field of medical devices, in particular to a left atrial appendage occluder.
  • One of the split-type left atrial appendage occluders includes a fixing part for fixing the left atrial appendage occluder to the left atrial appendage, a sealing part for sealing, and a connector connecting the fixing part and the sealing part.
  • the fixed part includes a plurality of support rods, the roots of the plurality of support rods are fixedly connected to the connecting piece, and are arranged at intervals along the circumferential direction of the connecting piece.
  • the plurality of supporting rods extend from the connecting piece to the surroundings to form an elastic disk shape.
  • this elastic disc-shaped structure circumferentially adheres to the inner wall of the left atrial appendage and generates radial support force, thereby fixing the left atrial appendage occluder to the left atrial appendage.
  • the support rod of the fixed part is easily deformed under pressure, causing damage to the support rod.
  • the utility model provides a left atrial appendage occluder, which includes a fixing part for fixing the left atrial appendage occluder at a predetermined position, a sealing part for sealing, and a connecting part connecting the fixing part and the sealing part.
  • the fixed part includes a plurality of support rods. One end of the support rod is a fixed end connected to the connector, and the other end is a free end. A ball head is provided on the free end.
  • the gap width between the fixed ends of two adjacent support rods in any circumferential direction is smaller than the radial size of one of the ball heads on the two adjacent support rods; or, in any circumferential direction, The gap width between the fixed ends of two adjacent support rods is smaller than the radial size of any ball head on the two adjacent support rods; or, any two circumferentially adjacent support rods
  • the gap width of the fixed ends of the rods is smaller than the radial size of the ball head on any support rod in the fixed part; or, the gap width between the fixed ends of two adjacent support rods that are only partly circumferentially smaller than the adjacent one.
  • the radial size of one of the ball heads on the two adjacent support rods; or, only part of the gap width between the fixed ends of the two adjacent support rods is smaller than the diameter of any one of the ball heads on the two adjacent support rods. direction size.
  • the length direction of the support rod from the fixed end to the free end includes a connecting section and an expansion section in order, the proximal end of the connection section is connected to the connecting piece, and the distal end is connected to the expansion section;
  • the expansion section expands radially outward from the distal end of the connecting section and extends to the distal end.
  • the connecting section includes at least one vertical section, and the vertical section The segment extends generally in an axial direction parallel to the fixed portion, and the gap width between the vertical segments of at least two circumferentially adjacent support rods in the fixed portion is smaller than at least one of the two adjacent support rods. The radial size of the ball head.
  • the width of the gap between the vertical sections of at least two circumferentially adjacent support rods in the fixed portion is greater than or equal to the width of the fixed end of at least one of the two adjacent support rods. width.
  • each support rod there are at least two circumferentially adjacent support rods in the fixing part.
  • the connecting section of each support rod extends from the proximal end to the distal end.
  • the direction includes two vertical segments, which are the first vertical segment and the second vertical segment in sequence, and when the fixing part is in the unfolded state, the first vertical segment of the two adjacent support rods.
  • the gap width between the segments is less than or equal to the gap width between the second vertical segments of the two adjacent support rods, and the gap between the first vertical segments of the two adjacent support rods
  • the width is smaller than the radial size of at least one ball head on the two adjacent support rods.
  • the connecting section of at least one support rod in the fixed part includes a first vertical section, a second vertical section and the first and second vertical sections from the proximal end to the distal end. between vertical segments the inclined section, and the first vertical section and the second vertical section of the same support rod are located on the same side of the connecting piece in the radial direction, or the first vertical section and the second vertical section of the same support rod are The straight sections are arranged oppositely in the radial direction, respectively located on both sides of the connecting piece.
  • the radial distance from the distal end of the connecting section to the proximal end of the connecting section is greater than or equal to the radial size of the connecting piece.
  • the length direction of the support rod from the fixed end to the free end sequentially includes a connecting section, a deployment section, an anchoring section and a suspended section, and the anchoring section is connected to the distal end of the deployment section. After being bent, it extends toward the proximal end of the fixing part.
  • the suspended section is connected to the proximal end of the anchoring section and extends in a direction close to the central axis of the fixing part to form a free end.
  • the ball head Located on the free end of the suspended section; the radial distance from the ball head to the central axis of the fixed part is L1, the radial size of the fixed part is L2, and the percentage range of L1/L2 is 15% ⁇ 38%.
  • the percentage range of L1/L2 is one or more of 15% to 20%, 20% to 25%, 25% to 30%, and 30% to 38%.
  • the suspended section includes a first bending section and a second bending section along the length direction.
  • the first bending section is connected to the proximal end of the anchoring section and is bent.
  • the rear edge extends radially in a direction close to the central axis of the fixed part, and the second bending section is connected to the first bending section and extends after being bent in a direction close to the sealing part to form the free end, or the second bent section is bent and extended in a direction away from the sealing portion to form the free end.
  • the sealing part includes a mesh structure, the axial distance from the ball head to the mesh structure is L3, the radial size of the fixing part is L2, and the percentage range of L3/L2 It is 20% ⁇ 40%.
  • the percentage range of L3/L2 is one or more of 20% to 25%, 25% to 30%, 30% to 35%, and 35% to 40%.
  • At least two of the fixing parts when the fixing part is loaded into the delivery sheath, at least two of the fixing parts have different axial distances from the ball heads to the connecting piece.
  • multiple ball heads are located on the same cross-section of the fixing part, or at least two of the ball heads are not on the same cross-section of the fixing part. on the cross section.
  • the left atrial appendage occluder provided by the present invention, by making the gap width between the roots of at least two circumferentially adjacent support rods in the fixing part smaller than the radial size of one of the ball heads on the adjacent support rods, the left atrial appendage is blocked in the left atrial appendage.
  • the ball head on the free end of the support rod is easier to resist the root area of the support rod, thus Resist external forces to a certain extent, thereby reducing the risk of damage to the support rod.
  • Figure 1 is a schematic structural diagram of the left atrial appendage occluder in Embodiment 1 of the present invention
  • Figure 2 is a schematic structural diagram of the left atrial appendage occluder in Embodiment 1 of the present invention (part of the support rod is hidden);
  • FIG 3 is a schematic structural diagram of the fixing part and the connecting piece in Figure 2;
  • Figure 4 is a schematic structural diagram of the left atrial appendage occluder in another embodiment of the present invention.
  • Figure 5 is a schematic structural diagram of the left atrial appendage occluder in Embodiment 2 of the present invention.
  • Figure 6 is a schematic structural diagram of the fixing part and the connecting piece in Figure 5 (part of the support rod is hidden);
  • Figure 7 is a schematic structural diagram of the left atrial appendage occluder in Embodiment 3 of the present invention.
  • Figure 8 is a schematic structural diagram of the fixing part and the connecting piece in Figure 7 (part of the support rod is hidden);
  • Figure 9 is a partial enlarged schematic diagram of the connection section in Figure 8.
  • proximal end the end of a medical device implanted in the human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • proximal end the end of a medical device implanted in the human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • proximal end the end of a medical device implanted in the human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • Axial generally refers to the length direction of the medical device when it is transported
  • radial generally refers to the length of the medical device. The direction perpendicular to its “axial direction”, and based on this principle, the "axial direction” and “radial direction” of any component of the medical device are defined.
  • Figure 1 is a schematic structural diagram of the left atrial appendage occluder 100 in Embodiment 1 of the present invention.
  • the left atrial appendage occluder 100 includes a fixed part 10 and a sealing part 20 connected to the fixed part 10.
  • the fixed part 10 and the sealing part 20 are connected through a connector 30.
  • the central axis 01 of the connector 30 is used as the central axis 01 of the fixed part 10 and the sealing part 20 (the same below).
  • the sealing part 20 and the fixing part 10 are spaced apart along the axial direction of the left atrial appendage occluder 100 .
  • the sealing part 20 is located at the proximal end of the left atrial appendage occluder 100
  • the fixing part 10 is located at the distal end of the left atrial appendage occluder 100.
  • the left atrial appendage occluder 100 has a compressed state contained in the sheath to facilitate delivery, and an unfolded state as shown in Figure 1 after extending from the distal end of the sheath and self-expanding. Unless otherwise specified in the present invention, All describe the shape and structural features of the left atrial appendage occluder 100 in the deployed state.
  • the shape of the left atrial appendage occluder 100 after being released in the left atrial appendage cavity is completely or substantially consistent with that in Figure 1 .
  • the sealing part 20 includes a mesh structure 21, which is woven into a mesh tube by a plurality of braided wires, and the two ends of the mesh tube are closed and fixed respectively.
  • the mesh tube is then heat-set into a disk-like, columnar or plug-like shape, thereby obtaining the sealing portion 20 for blocking the left atrial appendage opening.
  • At least one layer of film body (not shown in the figure) is provided inside the mesh structure 21 of the sealing part 20 , and the edge of the film body is fixed on the braided wire at the edge of the sealing part 20 .
  • the membrane body is used to prevent blood flow from one side of the sealing portion 20 to the other side, so as to prevent blood flow from flowing between the left atrial appendage and the left atrium.
  • the fixed part 10 includes a plurality of support rods 12.
  • the plurality of support rods 12 may be rods obtained by cutting metal alloy tubes or polymer tubes, or may be rods made by braiding or winding braided wire.
  • the plurality of support rods 12 extend radially outward from the connecting member 30 and are turned toward the sealing portion 20 to form a supporting surface for contacting and supporting the left atrial appendage cavity wall.
  • the connecting piece 30 can also be made of the same material as the support rod 12, or can be made of different materials, and then be connected as a whole through welding, screwing, gluing, etc.
  • the connector 30 can also be a part of a metal alloy tube or a polymer tube. That is to say, the connector 30 can also be integrally formed with the plurality of support rods 12 .
  • each support rod 12 is a fixed end 121 connected to the connector 30 (it can also be called the root, that is, the end point where a support rod 12 intersects with the distal end of the connector 30), and the other end is a free end.
  • the free end 122 is provided with a ball head 14 . It should be noted that, in order to clearly show the structure of the support rods 12, some of the support rods 12 are hidden in FIG. 2. During the actual manufacturing process, the number of the support rods 12 can be set as needed.
  • the fixed end 121 of the support rod 12 can be directly connected to the connector 30 in a fixed or movable manner, or can be indirectly connected to the connector 30 in a fixed or movable manner through other components.
  • the support rod 12 also has An extension section (not shown) extending from the fixed end 121 to the proximal end is fixedly connected to the connector 30 through the extension section.
  • the length direction of the support rod 12 from the fixed end 121 to the free end 122 includes an expansion section 123 , an anchoring section 124 and a suspended section 125 .
  • the support rod 12 may be integrally formed, and the expansion section 123, the anchoring section 124 and the suspended section 125 are connected in sequence only for convenience of description and does not mean that the support rod 12 is a separate structure.
  • the proximal end of the deployed segment 123 is fixedly connected to the connecting member 30 , and expands radially outward from the connecting member 30 and extends distally to connect with the anchoring segment 124 .
  • 124 is connected to the distal end of the expansion section 123 and extends towards the proximal end of the fixed part 10 after being bent.
  • the suspended section 125 is connected to the proximal end of the anchoring section 124 and extends in a direction close to the central axis 01 of the fixed part 10 to form a free
  • the ball head 14 is disposed on the free end 122 .
  • the suspended section 125 sequentially includes a first bending section 1251 and a second bending section 1252 along the length direction.
  • the first bending section 1251 is connected to the proximal end of the anchoring section 124 and is bent along the diameter.
  • the second bending section 1252 is bent and extended in a direction away from the sealing part 20 (refer to FIG. 1 ) to form a free end. 122.
  • the second bending section 1252 is connected to the first bending section 1251 and is bent to extend in a direction close to the sealing portion 20 to form a free end 122 .
  • the above-mentioned second bending section 1252 may be omitted, and the ball head 14 may be provided at the free end of the first bending section 1251.
  • the suspended section 125 can be omitted, and the ball head 14 can be provided at the free end of the anchoring section 124 .
  • the anchoring segment 124 is in contact with the left atrial appendage.
  • the walls abut each other and form an anchor.
  • the suspended sections 125 of two or more support rods 12 can also abut each other, or the support rods The suspended section 125 of the support rod 12 can abut against the root of the support rod 12 to resist the external force to a certain extent and avoid excessive deformation of the fixed portion 10 .
  • the length of the above-mentioned suspended section 125 should be appropriate to avoid being too long and causing the ball head 14 to be too close to the root of the support rods 12, thereby increasing the risk of the ball head 14 getting stuck in the gap between the support rods 12. At the same time, it should also be Avoid being too short to make the curved shape of the suspended section 125 more difficult to deform, which not only increases the difficulty of loading into the sheath, but also makes the free end of the suspended section 125 continue to abut against the inner wall of the sheath, causing Sheath damage. Therefore, please refer to FIG. 2 again.
  • the radial distance from the ball head 14 to the central axis 01 of the fixing part 10 is L1
  • the radial size of the fixing part 10 is L2
  • L1/L2x100% 15% to 38%.
  • the value range of L1/L2x100% can also be 15% to 20%, 20% to 25%, 25% to 30%, 30% to 38%, for example, 18%, 22%, 25% %, 27%, 29%, 32%, 34%, 36%, etc.
  • two support rods 12 whose fixed ends 121 are adjacent in the circumferential direction are regarded as circumferentially adjacent support rods 12 .
  • the fixed ends 121 of the plurality of support rods 12 of the fixed part 10 are fixed to the distal end of the connecting member 30 at equidistant intervals, that is, the gap width between the fixed ends 121 of two adjacent support rods 12 in the circumferential direction (also known as The spacing distance (D1 shown in Figure 3) is substantially equal (that is, the error does not exceed ⁇ 25%), and the radial size of the ball head 14 on the free end 122 of each support rod 12 (D2 shown in Figure 3 ) are also basically equal (that is, the error does not exceed ⁇ 25%), and the gap width of the fixed ends 121 of any two circumferentially adjacent support rods 12 is smaller than the radial direction of the ball head 14 on the free end 122 of any support rod 12 size.
  • the ball head 14 may be one or more of a sphere, a hemisphere, a drop shape, a cylinder, a cone, and a polyhedron.
  • its radial dimension is the diameter of the spherical structure;
  • its radial dimension is the maximum radial dimension of the ball head 14, and the maximum radial dimension refers to the diameter of the ball head.
  • 14 is the maximum width perpendicular to the length direction of the support rod 12.
  • a vernier caliper is used to measure the width of multiple parts of the ball head 14 at different positions in the length direction of the support rod 12. The measured maximum width is the maximum diameter. direction size.
  • the fixed ends 121 of the multiple support rods 12 are arranged at non-equidistant intervals along the circumferential direction of the connector 30 , that is, the gap widths between the fixed ends 121 of two adjacent support rods 12 in the circumferential direction may be unequal. .
  • the radial dimensions of the ball heads 14 of the plurality of support rods 12 may also be unequal.
  • the gap width between the fixed ends 121 of any two circumferentially adjacent support rods 12 may be smaller than the radial size of one of the ball heads 14 on the two adjacent support rods 12; or, It may be that the gap width between the fixed ends 121 of any two circumferentially adjacent support rods 12 is smaller than the radial size of any ball head 14 on the two adjacent support rods 12 .
  • the gap width between the fixed ends 121 of two adjacent support rods 12 may be only partially circumferentially smaller than the radial size of one of the ball heads 14 on the two adjacent support rods 12; or, Only part of the gap width between the fixed ends 121 of two adjacent support rods 12 is smaller than the radial size of any ball head 14 on the two adjacent support rods 12 .
  • the ball head 14 on the free end 122 of the support rod 12 cannot easily pass through.
  • the gap between the roots of two adjacent support rods 12 makes it easier to contact the root area of the support rods 12, thereby resisting external forces to a certain extent, thereby reducing the risk of damage to the support rods 12.
  • the gap width between the fixed ends 121 of two circumferentially adjacent support rods 12 should not be too small.
  • a gap width that is too small will easily restrict the movement of the support rods 12, thereby limiting the elastic deformation of the fixed part 10. , which is not conducive to the radial compression or expansion of the fixing part 10, making it more difficult to release and recover the fixing part 10.
  • too small a gap width may cause the fixation part 10 to be unable to better adapt to the left atrial appendage's systolic and diastolic movements with the heart, causing the left atrial appendage occluder 100 to deform and move. Please refer to Figure 3 again.
  • the gap widths between the fixed ends 121 of two adjacent support rods 12 in the circumferential direction of the fixed part 10 are basically the same (that is, the error does not exceed ⁇ 25%), and each The widths of the fixed ends 121 of the support rods 12 (D3 shown in Figure 3) are all basically equal (that is, the error does not exceed ⁇ 25%), and the gap widths between the fixed ends 121 of two adjacent support rods 12 are greater than The width of the fixed end 121 of any support rod 12.
  • the gap widths between the fixed ends 121 of two adjacent support rods 12 in the circumferential direction may be unequal, and the widths of the fixed ends 121 of the support rods 12 may also be unequal.
  • width of the gap between the fixed ends 121 of two adjacent support rods 12 is equal or not, whether the width of the fixed ends 121 of the support rods 12 is equal or not, as long as there are at least two circumferentially adjacent support rods 12 fixed in the fixing part 10
  • the width of the gap between the ends 121 only needs to be greater than or equal to the width of at least one fixed end 121 of the adjacent support rods 12 .
  • the fixing part 10 and the sealing part 20 may not necessarily remain coaxial.
  • the fixing part 10 is in the left atrial appendage.
  • the interior of the atrial appendage may be tilted. As the interior of the left atrial appendage contracts and relaxes, it may cause the ball head 14 on the support rod 12 to get stuck in the mesh of the sealing part 20. Therefore, the ball head 14 on the support rod 12 and the sealing part 20 are separated. The distance should be appropriate.
  • the axial distance (ie, the distance parallel to the axial direction) from the ball head 14 to the mesh structure 21 of the sealing portion 20 is L3
  • the radial size of the fixed portion 10 is L2
  • the ratio of L3/L2 is 20% to 40%.
  • the percentage range of L3/L2 can also be 20% to 25%, 25% to 30%, 30% to 35%, 35% to 40%, for example, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, etc.
  • the support rod 12 can be provided with an anchor 13.
  • the anchor 13 is provided on the support rod 12 by welding, hot melting, entangling, bonding, etc., but it does not exclude the possibility of cutting to form a support.
  • the anchor 13 is directly cut and formed at the same time.
  • the anchor 13 adopts an anchor structure, and the tip of the anchor penetrates into the inner wall of the left atrial appendage, so that the fixing part 10 is stably anchored on the inner wall of the left atrial appendage, so that the left atrial appendage occluder 100 can achieve Blocking of the mouth of the left atrial appendage.
  • the outside of the fixing part 10 can be covered with a membrane (not shown) to further seal the left atrial appendage and avoid stress on the left atrial appendage while ensuring that the sealing part 20 can achieve sealing. Too much blood is concentrated on the surface of the fixed part.
  • the covering film can block the root of the anchor 13 to prevent the blood from flowing out from the micro-wound, accelerating the blood flow. Micro-wounds spread quickly.
  • the support rod 12 in Embodiment 2 also includes a connecting section 126.
  • the proximal end of the connecting section 126 ie, the fixed end 121 of the support rod 12
  • the distal end of the connecting section 126 extends toward the distal direction and is fixedly connected to the proximal end of the deployment section 123 .
  • the support rod 12 may be integrally formed, and the connecting section 126, the expansion section 123, the anchoring section 124 and the suspended section 125 are connected in sequence does not mean that the support rod 12 is a separate structure.
  • the support rods 12 of this embodiment all include connecting sections 126 . In other embodiments, only some of the support rods 12 include the connecting sections 126 . Another part of the supporting rods 12 may not include the connecting sections 126 , but can be directly connected to the connecting section 123 through the expansion section 123 . Connector 30 connects.
  • the connecting section 126 of each support rod 12 includes a vertical section 126 a , and the vertical section 126 a extends generally along the axial direction of the fixing part 10 .
  • the vertical segment 126a extends along the axial direction of the fixing part 10 and does not limit the vertical segment 126a to be parallel to the central axis 01 of the fixing part 10. It is allowed to exist between the vertical segment 126a and the central axis 01 of the fixing part 10. included angle, the angle range of the included angle is ⁇ 5°.
  • the connecting section 126 may include a plurality of vertical sections 126a, and the plurality of vertical sections 126a may be distributed in any axial area of the connecting section 126.
  • the stress component generated by the inner wall of the left atrial appendage on the support rod 12 can be divided into axial and radial directions.
  • the vertical direction in the connecting section 126 The segment 126a can elastically deform when subjected to radial force, thereby offsetting part of the radial force component, thereby reducing the torsion caused by the radial force transmitted to the root of the support rod 12, thereby reducing the risk of fatigue fracture of the root of the support rod 12.
  • the gap width (refer to D4 in FIG. 6 ) between the vertical segments 126a of two circumferentially adjacent support rods 12 can be the same as the gap width between the fixed ends 121 of the two adjacent support rods 12.
  • the gap width (refer to D1 in Figure 3) is approximately the same (i.e. the error does not exceed ⁇ 25%).
  • the gap width between the vertical segments 126a of circumferentially adjacent support rods 12 may also be the same as that of the adjacent support rods.
  • the gap width between the fixed ends 121 of 12 is different. It should be noted that the gap width between the vertical segments 126a of two circumferentially adjacent support rods 12 refers to the minimum gap width between the vertical segments 126a of the two circumferentially adjacent support rods 12.
  • the vertical segments 126a of more than two support rods 12 in the fixing part 10 may also be arranged at non-equidistant intervals, that is, there are gaps between two adjacent vertical segments 126a in the circumferential direction.
  • the widths may be different, and the radial dimensions of different ball heads 14 in the fixing part 10 may also be different. Regardless of whether the vertical segments 126a of the plurality of support rods 12 are arranged at equidistant intervals, and whether the radial dimensions of different ball heads 14 are equal, there is a gap between the vertical segments 126a of at least two circumferentially adjacent support rods 12.
  • the width is smaller than the radial size of at least one ball head 14 on the two adjacent support rods 12 .
  • the gap width between the vertical sections 126a of any two circumferentially adjacent support rods 12 may be smaller than the radial size of one of the ball heads 14 on the two adjacent support rods 12; or, it may be The width of the gap between the vertical sections 126a of any two circumferentially adjacent support rods 12 is smaller than the radial size of any ball head 14 on the two adjacent support rods 12.
  • the gap width between the vertical segments 126a of two adjacent support rods 12 may be only partially circumferentially smaller than the radial size of one of the ball heads 14 on the two adjacent support rods 12; Alternatively, only part of the gap width between the vertical sections 126a of two adjacent circumferential support rods 12 is smaller than the radial size of any ball head 14 on the two adjacent support rods 12 .
  • the probability of the ball head 14 being stuck in the gap between two adjacent support rods 12 can be further reduced, thereby improving the contact between the ball head 14 and the root of the support rod 12. area probability.
  • the width of the gap between the vertical segments 126a of two circumferentially adjacent support rods 12 should not be too small, so that there can be at least two circumferentially adjacent vertical segments of the support rods 12 in the fixed part 10
  • the width of the gap between 126a is greater than or equal to the width of at least one fixed end 121 of the two adjacent support rods 12 .
  • the width of the gap between the vertical sections 126a of at least two circumferentially adjacent support rods 12 is greater than or equal to the width of one of the fixed ends 121 of the two adjacent support rods 12; or, there are at least two circumferentially adjacent support rods 12.
  • the width of the gap between the vertical sections 126a of the support rods 12 is greater than or equal to the width of any fixed end 121 of the two adjacent support rods 12.
  • the gap widths are basically equal (that is, the error does not exceed ⁇ 25%), and the widths of the fixed ends 121 of each support rod 12 are basically equal (that is, the error does not exceed ⁇ 25%).
  • the vertical widths of two adjacent support rods 12 are The width of the gap between the segments 126 a is greater than the width of the fixed end 121 of any support rod 12 .
  • At least one area in the connecting section 126 can have a hardness that is smaller than the hardness of the deployed section 123.
  • the hardness measurement method can be to use an ultrasonic hardness tester to test the surface hardness of the connecting section 126 and the expanded section 123. As long as the surface hardness value of a certain area in the connecting section 126 is smaller than the surface hardness value of a certain area in the expanded section 123, it can be considered as The hardness of the connecting section 126 is smaller than the hardness of the unfolding section 123 . In other embodiments, the surface hardness value of any area in the connecting section 126 can be smaller than the surface hardness value of any area in the expansion section 123 .
  • the fixing part 10 when the fixing part 10 is loaded into the delivery sheath, at least two ball heads 14 in the fixing part 10 have different axial distances from the connecting member 30 .
  • the vertical distances of different lengths can be provided for the support rods 12 .
  • the segment 126a realizes that the axial distance from the ball heads 14 of different support rods 12 to the connecting member 30 is different, thereby preventing the ball heads 14 of multiple support rods 12 from gathering on the same cross section when the fixing part 10 is in a compressed state. , causing the compression size of the fixing part 10 to be too large and unable to be sheathed.
  • the fixing part 10 When the fixing part 10 is in the unfolded state, at least two ball heads 14 are not on the same cross-section of the fixing part 10 . In other embodiments, multiple ball heads 14 are located on the same cross-section of the fixing part 10 .
  • the connecting section 126 of the support rod 12 in Embodiment 3 is close to Both ends include two vertical sections in the distal direction, namely a first vertical section 1261 and a second vertical section 1262.
  • the first vertical section 1261 is fixedly connected to the connector 30, and the second vertical section 1261 is fixedly connected to the connector 30.
  • the segment 1262 is fixedly connected to the proximal end of the deployment segment 123.
  • only part of the connecting section 126 of the support rod 12 includes two vertical segments.
  • the gap width between the first vertical segments 1261 of two circumferentially adjacent support rods 12 may be the same as the gap width between the second vertical segments 1262 (D6 in FIG. 9 ) are the same or different.
  • the gap width between the first vertical sections 1261 of two circumferentially adjacent support rods 12 is less than or equal to the gap width between the second vertical sections 1262 .
  • only part of the gap width between the first vertical sections 1261 of two adjacent support rods 12 is less than or equal to the width of the second vertical section 1262 of the two adjacent support rods 12 .
  • the gap width between them, or the gap width between the first vertical sections 1261 of two circumferentially adjacent support rods 12 is greater than the gap width between the second vertical sections 1262 of the two adjacent support rods 12 Gap width.
  • the width of the gap between the first vertical sections 1261 of at least two circumferentially adjacent support rods 12 is smaller than the radial size of at least one ball head 14 of the two adjacent support rods 12 .
  • the width of the gap between the second vertical sections 1262 of at least two circumferentially adjacent support rods 12 is smaller than the radial dimension of at least one ball head 14 of the two adjacent support rods 12 .
  • the gap width between the first vertical sections 1261 of at least two circumferentially adjacent support rods 12 is smaller than the radial dimension of at least one ball head 14 of the two adjacent support rods 12
  • the width of the gap between the second vertical sections 1262 of the two adjacent support rods 12 is smaller than the radial size of at least one ball head 14 of the two adjacent support rods 12 .
  • the width of the gap between the first vertical sections 1261 is greater than or equal to the width of at least one fixed end 121 of the two adjacent support rods 12 .
  • the width of the gap between the first vertical sections 1261 of at least two circumferentially adjacent support rods 12 is greater than or equal to the width of one of the fixed ends 121 of the two adjacent support rods 12; or, there are at least two adjacent support rods 12.
  • the width of the gap between the first vertical sections 1261 of circumferentially adjacent support rods 12 is greater than or equal to the width of any fixed end 121 of the two adjacent support rods 12 .
  • first vertical segments 1261 of the support rods 12 arranged in the fixed part 10 at equal intervals, that is, two adjacent first vertical segments in the circumferential direction.
  • the widths of the gaps between 1261 are basically equal (that is, the error does not exceed ⁇ 25%), and the widths of the fixed ends 121 of each support rod 12 are basically equal (that is, the error does not exceed ⁇ 25%).
  • Two adjacent support rods The width of the gap between the first vertical sections 1261 of the support rods 12 is greater than the width of the fixed end 121 of any support rod 12 .
  • An inclined section 1263 can be provided between the first vertical section 1261 and the second vertical section 1262.
  • the proximal end of the inclined section 1263 is connected to the distal end of the first vertical section 1261.
  • the distal end of the inclined section 1263 is connected to the proximal end of the second vertical section 1262.
  • the first vertical section 1261 , the inclined section 1263 and the second vertical section 1262 are located on the same side in the radial direction (that is, on the same side of the connecting member 30 ).
  • the first vertical segment 1261 and the second vertical segment 1262 may be disposed radially opposite each other.
  • the inclined section 1263 of a certain support rod 12 spans the central axis of the fixed part 10 from one side of the connecting member 30 to the opposite side of the connecting member 30, and the inclined section 1263 of another adjacent supporting rod 12 is also self-connected.
  • One side of the member 30 spans to the opposite side, so that the orthographic projections of the two inclined sections 1263 on the cross section of the fixing part 10 have an intersection point.
  • the advantage of this arrangement is that a fulcrum can be formed between the inclined sections 1263 that span each other, which can provide support for the support rod 12 .
  • the radial distance ie, the distance perpendicular to the axial direction
  • the radial distance from the distal end of the connecting section 126 to the proximal end of the connecting section 126 can be set to be greater than or equal to the radial size of the connecting piece 30 , such a setting is beneficial to the connecting section 126
  • the distal region obtains a larger deformation space, thereby generating elastic deformation to offset the radial component force experienced by the support rod 12 .

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Abstract

本实用新型涉及一种左心耳封堵器，包括用于将左心耳封堵器固定在预定位置的固定部，起密封作用的密封部，以及连接固定部和密封部的连接件，固定部包括多根支撑杆，支撑杆的一端为与连接件连接的固定端，另一端为自由端，自由端上设置有球头，当固定部处于展开状态时，固定部中至少存在两根周向相邻的支撑杆的固定端之间的间隙宽度小于该相邻支撑杆上至少一个球头的径向尺寸。本实用新型的左心耳封堵器可降低在左心耳封堵器生产、测试、装载等多个环节中，支撑杆损伤的风险。

Description

左心耳封堵器 技术领域
本实用新型涉及医疗器械技术领域，尤其涉及一种左心耳封堵器。
背景技术
近年来，非瓣膜病房颤患者中，因房颤导致的脑卒中，其中90％源自左心耳。有临床资料显示房颤时，心脏外科手术中切除左心耳可降低脑卒中的发生率，这提示左心耳在血栓栓塞中的危害。既然左心耳是血栓的窝点，那么封堵左心耳的开口就可以消除左心耳内血栓形成的基础。通常，通过左心耳封堵器对左心耳封堵是一种有效的预防房颤导致的脑卒中方式。
为将左心耳进行有效封堵，需长期将左心耳封堵器植入于左心耳内，以实现封堵效果。其中一种分体式左心耳封堵器包括用于将左心耳封堵器固定于左心耳的固定部、起密封作用的密封部，以及连接固定部和密封部的连接件。其中，固定部包括多根支撑杆，该多根支撑杆的根部固定连接在连接件上，且沿连接件的周向间隔排列，多根支撑杆自连接件发出后向四周延伸形成弹性盘状结构，该弹性盘状结构周向紧贴左心耳内壁，并产生径向支撑力，从而使左心耳封堵器固定于左心耳，但在左心耳封堵器生产、测试、装载等多个环节中，固定部的支撑杆较易受压变形从而造成支撑杆损伤。
发明内容
基于此，有必要针对现有技术中左心耳封堵器的支撑杆因发生过大形变而造成支撑杆损伤的问题提供一种新的左心耳封堵器。
本实用新型提供一种左心耳封堵器，包括用于将所述左心耳封堵器固定在预定位置的固定部，起密封作用的密封部，以及连接所述固定部和所述密封部的连接件，所述固定部包括多根支撑杆，所述支撑杆的一端为与所述连接件连接的固定端，另一端为自由端，所述自由端上设置有球头，当所述固定部处于展开状态时，所述固定部中至少存在两根周向相邻的支撑杆的固定端之间的间隙宽度小于该相邻支撑杆上至少一个球头的径向尺寸。
在其中一个实施例中，任一周向相邻的两根所述支撑杆的固定端之间的间隙宽度小于该相邻两根支撑杆上其中一个球头的径向尺寸；或者，任一周向相邻的两根所述支撑杆的固定端之间的间隙宽度均小于该相邻的两根支撑杆上任意一个球头的径向尺寸；或者，任一周向相邻的两根所述支撑杆的固定端的间隙宽度均小于所述固定部中任一支撑杆上所述球头的径向尺寸；或者，仅部分周向相邻的两根支撑杆的固定端之间的间隙宽度小于该相邻的两根支撑杆上其中一个球头的径向尺寸；或者，仅部分周向相邻的两根支撑杆的固定端之间的间隙宽度小于该相邻的两根支撑杆上任意一个球头的径向尺寸。
在其中一个实施例中，所述支撑杆自所述固定端至自由端的长度方向依次包括连接段、展开段，所述连接段的近端连接所述连接件，远端连接所述展开段；当所述固定部处于展开状态时，所述展开段自所述连接段的远端径向向外展开并向远端延伸，所述连接段包括至少一个竖直分段，所述竖直分段大致沿平行于所述固定部的轴向延伸，所述固定部中至少存在两根周向相邻的支撑杆的竖直分段之间的间隙宽度小于该相邻的两根支撑杆上至少一个球头的径向尺寸。
在其中一个实施例中，所述固定部中至少存在两根周向相邻的支撑杆的竖直分段之间的间隙宽度大于或等于该相邻两根支撑杆中至少一根支撑杆的固定端的宽度。
在其中一个实施例中，所述固定部中至少存在两根周向相邻的支撑杆，在所述相邻的两根支撑杆中，每一根所述支撑杆的连接段自近端向远端方向包括两个竖直分段，依次为第一竖直分段和第二竖直分段，且当所述固定部处于展开状态时，该相邻的两根支撑杆的第一竖直分段之间的间隙宽度小于或等于该相邻的两根支撑杆的第二竖直分段之间的间隙宽度，且该相邻的两根支撑杆的第一竖直分段之间的间隙宽度小于该相邻的两根支撑杆上至少一个球头的径向尺寸。
在其中一个实施例中，所述固定部中至少存在一根支撑杆的连接段自近端向远端方向包括第一竖直分段、第二竖直分段和所述第一及第二竖直分段之间 的倾斜段，且同一支撑杆的第一竖直分段和第二竖直分段在径向上位于所述连接件的同侧，或者，同一支撑杆的第一竖直分段和第二竖直分段在径向上相对设置，分别位于所述连接件的两侧。
在其中一个实施例中，所述连接段的远端到所述连接段的近端的径向距离大于或等于所述连接件的径向尺寸。
在其中一个实施例中，所述支撑杆自所述固定端至自由端的长度方向依次包括连接段、展开段、锚定段和悬空段，所述锚定段与所述展开段的远端连接并经弯折后朝向所述固定部的近端延伸，所述悬空段与所述锚定段的近端连接并向靠近所述固定部的中轴线的方向延伸形成自由端，所述球头设于所述悬空段的自由端上；所述球头到所述固定部中轴线的径向距离为L1，所述固定部的径向尺寸为L2，L1/L2的百分比范围为15％～38％。
在其中一个实施例中，L1/L2的百分比范围为15％～20％、20％～25％、25％～30％、30％～38％中的一个或多个。
在其中一个实施例中，所述悬空段沿长度方向依次包括第一弯折段及第二弯折段，所述第一弯折段与所述锚定段的近端连接，并经弯折后沿径向朝靠近所述固定部中轴线的方向延伸，所述第二弯折段与所述第一弯折段连接并经弯折后朝向靠近所述密封部的方向延伸形成所述自由端，或者，所述第二弯折段弯折后朝向远离所述密封部的方向弯折延伸形成所述自由端。
在其中一个实施例中，所述密封部包括网状结构，所述球头到所述网状结构的轴向距离为L3，所述固定部的径向尺寸为L2，L3/L2的百分比范围为20％～40％。
在其中一个实施例中，L3/L2的百分比范围为20％～25％、25％～30％、30％～35％、35％～40％中的一个或多个。
在其中一个实施例中，所述连接段中至少存在一个区域的硬度小于所述展开段的硬度。
在其中一个实施例中，当所述固定部被装载至输送鞘管内时，所述固定部中至少存在两个所述球头到所述连接件的轴向距离不同。
在其中一个实施例中，当所述固定部处于展开状态时，多个所述球头位于所述固定部的同一横截面上，或者，至少两个所述球头不在所述固定部的同一横截面上。
本实用新型提供的左心耳封堵器，通过使固定部中至少存在两根周向相邻的支撑杆根部之间的间隙宽度小于该相邻支撑杆上其中一个球头的径向尺寸，在左心耳封堵器生产、测试、装载等多个环节中，支撑杆在受到较大径向向内的挤压力时，支撑杆自由端上的球头较易抵靠在支撑杆的根部区域，从而一定程度抵抗所受外力，进而降低支撑杆损伤的风险。
附图说明
图1为本实用新型的实施例1中左心耳封堵器的结构示意图；
图2为本实用新型的实施例1中左心耳封堵器的结构示意图(隐藏部分支撑杆)；
图3为图2中固定部及连接件的结构示意图；
图4为本实用新型另一实施例中左心耳封堵器的结构示意图；
图5为本实用新型的实施例2中左心耳封堵器的结构示意图；
图6为图5中固定部及连接件的结构示意图(隐藏部分支撑杆)；
图7为本实用新型的实施例3中左心耳封堵器的结构示意图；
图8为图7中固定部及连接件的结构示意图(隐藏部分支撑杆)；
图9为图8中连接段的局部放大示意图。
具体实施方式
为了使本实用新型的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本实用新型进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本实用新型，并不用于限定本实用新型。
需要说明的是，在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，并依据此原理定义医疗器械的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的 与其“轴向”垂直的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
以下将结合具体实施例进一步详细说明本实用新型的技术方案。
实施例1
如图1所示，图1为本实用新型的实施例1中左心耳封堵器100的结构示意图，左心耳封堵器100包括固定部10和与固定部10连接的密封部20，固定部10和密封部20通过连接件30连接，本实施例将连接件30的中轴线01作为固定部10及密封部20的中轴线01(下同)。
本实施例中，密封部20和固定部10沿左心耳封堵器100的轴向方向间隔设置。密封部20位于左心耳封堵器100的近端，固定部10位于左心耳封堵器100的远端。左心耳封堵器100具有收容在鞘管内的压缩状态，以便于输送，以及从鞘管的远端伸出并自膨胀展开后如图1所示的展开状态，本实用新型若未特别说明，均描述的是左心耳封堵器100处于展开状态的形状和结构特征。左心耳封堵器100在左心耳腔内释放后的形态与图1完全相同或大体一致。
密封部20包括网状结构21，该网状结构21由多根编织丝编织成网管，网管的两端分别收口并固定。之后将网管热定型为盘状、柱状或塞子状等形状，从而得到用于封堵左心耳开口的密封部20。密封部20的网状结构21内部设有至少一层薄膜体(图中未示出)，薄膜体的边缘固定在密封部20边缘处的编织丝上。薄膜体用于阻止血流从密封部20的一侧流向另一侧，以阻止血流在左心耳和左心房之间流通。
固定部10包括多根支撑杆12，该多根支撑杆12可以为通过切割金属合金管或高分子管后得到的杆，也可以为采用编织丝经过编织或缠绕等方式制成的杆。多根支撑杆12从连接件30径向向外延伸并朝向密封部20翻转，从而形成用于与左心耳腔壁相接触且起支撑作用的支撑面。连接件30同样可采用与支撑杆12相同的材料制成，也可以采用不同材料制成，再通过焊接、螺接、胶合粘结等方式连为一体。连接件30也可以为金属合金管或者高分子管的一部分，也就是说，连接件30也可以与多根支撑杆12一体成型。
请参照图2，每根支撑杆12的一端为与连接件30连接的固定端121(亦可称根部，即一根支撑杆12与连接件30远端端面相交的端点)，另一端为自由端122，该自由端122上设置有球头14。需要说明的是，为清楚的展示支撑杆12的结构，图2中隐藏了部分支撑杆12，在实际制作过程中，支撑杆12的数量可根据需要设置。此外，还需说明的是，支撑杆12的固定端121可以直接与连接件30固定连接或活动连接，也可通过其他部件间接与连接件30固定连接或活动连接，例如，支撑杆12还具有自固定端121向近端延伸的延伸段(图未示)，通过延伸段与连接件30固定连接。
请同时参照图3，在本实施例中，支撑杆12自固定端121至自由端122的长度方向依次包括展开段123、锚定段124和悬空段125。应当说明的是，支撑杆12可以是一体成型，展开段123、锚定段124和悬空段125依次相连只是便于描述说明，并不意味着支撑杆12是分体结构。
当所述固定部10处于展开状态时，展开段123的近端与连接件30固定连接，且自连接件30径向向外展开并向远端延伸以与锚定段124连接，锚定段124与展开段123的远端连接并经弯折后朝向固定部10的近端延伸，悬空段125与锚定段124的近端连接并向靠近固定部10的中轴线01的方向延伸形成自由端122，球头14设于该自由端122上。
本实施例中，悬空段125沿长度方向依次包括第一弯折段1251及第二弯折段1252，第一弯折段1251与锚定段124的近端连接，并经弯折后沿径向朝固定部10的内侧方向延伸(即靠近固定部10的中轴线01的方向)，第二弯折段1252弯折后朝向远离密封部20(参照图1)的方向弯折延伸形成自由端122。参照图4，在其他实施例中，第二弯折段1252与第一弯折段1251连接并经弯折后朝向靠近密封部20的方向延伸形成自由端122。
在其他实施例中，上述第二弯折段1252可省略，球头14可设置在第一弯折段1251的自由端。或者，悬空段125均可省略，球头14可设置在锚定段124的自由端。
本实施例的左心耳封堵器100在植入至左心耳后，锚定段124与左心耳内 壁相互抵靠且形成锚定，当左心耳封堵器100受到较大径向挤压力时，两根或两根以上的支撑杆12的悬空段125还可相互抵靠，或者，支撑杆12的悬空段125可抵靠至支撑杆12的根部，从而一定程度抵抗所受外力，避免固定部10过度变形。
需要注意的是，上述悬空段125的长度应当适宜，避免因过长而使球头14过于靠近支撑杆12的根部，进而提高球头14卡入支撑杆12之间间隙的风险，同时也应避免过短而使悬空段125的弯曲形态较难发生形变，不仅提高装载至鞘管中的难度，且在装载至鞘管内后，悬空段125的自由端还可能持续抵靠鞘管内壁，造成鞘管损伤。因此，请再次参照图2，在本实施例中，球头14到固定部10中轴线01的径向距离(即垂直于轴向方向的距离)为L1，固定部10的径向尺寸(例如，固定部10多根支撑杆12周向外缘形成的最大圆周的直径)为L2，L1/L2ⅹ100％＝15％～38％。在其他实施例中，L1/L2ⅹ100％的取值范围还可以是15％～20％、20％～25％、25％～30％、30％～38％，例如，18％、22％、25％、27％、29％、32％、34％、36％等。
请参照图2、图3，本实施例中，将固定端121在周向上相邻的两根支撑杆12作为周向相邻的支撑杆12。固定部10的多根支撑杆12的固定端121等距的间隔固定在连接件30的远端，即周向上两两相邻的支撑杆12的固定端121之间的间隙宽度(亦可称间隔距离，如图3中所示的D1)基本相等(即误差不超过±25％)，每根支撑杆12自由端122上的球头14的径向尺寸(如图3中所示的D2)也基本相等(即误差不超过±25％)，且任一周向相邻的两根支撑杆12的固定端121的间隙宽度均小于任一支撑杆12自由端122上球头14的径向尺寸。需要说明的是，本实施例并不限定球头14的形状，例如，球头14可以是球形、半球形、水滴形、柱形、锥形、多面体中的一种或多种。对于球形的球头14，其径向尺寸即为球形结构的直径；对于非球形的球头14，其径向尺寸即为球头14的最大径向尺寸，该最大径向尺寸是指球头14在垂直于支撑杆12长度方向的最大宽度，比如采用游标卡尺测量球头14在支撑杆12长度方向上不同位置的多个部位的宽度，测量出的最大宽度即为该最大径 向尺寸。
在其他实施例中，多根支撑杆12的固定端121沿连接件30的周向非等距的间隔排列，即周向上两两相邻的支撑杆12的固定端121之间的间隙宽度可以不相等。此外，多根支撑杆12的球头14的径向尺寸也可以不相等。
在其他实施例中，可以是任一周向相邻的两根支撑杆12的固定端121之间的间隙宽度小于该相邻两根支撑杆12上其中一个球头14的径向尺寸；或者，可以是任一周向相邻的两根支撑杆12的固定端121之间的间隙宽度均小于该相邻两根支撑杆12上任意一个球头14的径向尺寸。
在其他实施例中，还可以是仅部分周向相邻的两根支撑杆12的固定端121之间的间隙宽度小于该相邻两根支撑杆12上其中一个球头14的径向尺寸；或者，仅部分周向相邻的两根支撑杆12的固定端121之间的间隙宽度小于该相邻两根支撑杆12上任意一个球头14的径向尺寸。
在左心耳封堵器100生产、测试、装载等多个环节中，支撑杆12在受到较大径向向内的挤压力时，支撑杆12的自由端122上的球头14不易穿过相邻两根支撑杆12根部之间的间隙，而较易抵靠在支撑杆12的根部区域，从而一定程度抵抗所受外力，进而降低支撑杆12损伤的风险。
本实施例中，周向相邻的两根支撑杆12的固定端121之间的间隙宽度不宜过小，过小的间隙宽度易使得支撑杆12运动受限，从而造成固定部10的弹性形变受限，不利于固定部10径向压缩或展开，造成固定部10释放和回收难度增大。此外，过小的间隙宽度还可能造成固定部10不能较好的适应左心耳随心脏收缩和舒张运动，造成左心耳封堵器100发生变形和运动。请再次参照图3，本实施例中，固定部10中周向上两两相邻的支撑杆12的固定端121之间的间隙宽度均基本相等(即误差不超过±25％)，且每根支撑杆12的固定端121的宽度(如图3所示的D3)均基本相等(即误差不超过±25％)，两两相邻的支撑杆12的固定端121之间的间隙宽度均大于任一支撑杆12的固定端121的宽度。在其他实施例中，周向上两两相邻的支撑杆12的固定端121之间的间隙宽度可以不相等，支撑杆12的固定端121的宽度也可不相等。
不论两两相邻的支撑杆12的固定端121之间的间隙宽度是否相等，支撑杆12的固定端121的宽度是否相等，只要固定部10中至少存在两根周向相邻的支撑杆12的固定端121之间的间隙宽度大于或等于该相邻支撑杆12中至少一个固定端121的宽度即可。例如，至少存在两根周向相邻的支撑杆12的固定端121之间的间隙宽度大于或等于该相邻两根支撑杆12中其中一根支撑杆12的固定端121的宽度；或者，至少存在两根周向相邻的支撑杆12的固定端121之间的间隙宽度大于或等于该相邻两根支撑杆12中任意一根支撑杆12的固定端121的宽度。
进一步地，由于人体左心耳的形态各异，且内部结构复杂，左心耳封堵器100在植入左心耳后，固定部10和密封部20并不一定能保持同轴，固定部10在左心耳内部可能倾斜设置，随着左心耳内部收缩和舒张运动，亦可能导致支撑杆12上的球头14卡入密封部20的网孔中，因此，支撑杆12上球头14与密封部20的距离应当适宜。参照图2，本实施例中，球头14到密封部20网状结构21的轴向距离(即平行于轴向的距离)为L3，固定部10的径向尺寸为L2，L3/L2的百分比范围为20％～40％。在其他实施例中，L3/L2的百分比范围还可以是20％～25％、25％～30％、30％～35％、35％～40％，例如，22％、24％、26％、28％、30％、32％、34％、36％、38％等。
进一步地，支撑杆12上可设有锚定件13，一般而言，锚定件13通过焊接、热熔、缠结、粘结等方式设置在支撑杆12上，但是不排除在切割形成支撑杆12时，直接同时切割形成锚定件13。在本实施例中，锚定件13选用锚刺结构，锚刺的尖端刺入左心耳的内壁中，从而使得固定部10稳定地锚定在左心耳的内壁，使得左心耳封堵器100实现对左心耳口部的封堵。
在另一实施例中，固定部10的外部可覆盖覆膜(图未示)，以在保证密封部20能够实现密封的情况下，对左心耳进行进一步的封堵，以及避免左心耳的应力过多集中在固定部表面，同时，当固定部10的锚定件13刺入左心耳内壁造成微型伤口时，覆膜可以堵住锚定件13的根部，避免血流从微型伤口流出，加速微型伤口快速爬覆。
实施例2
参照图5、图6，实施例2的左心耳封堵器100与实施例1的区别在于，实施例2的支撑杆12还包括连接段126。连接段126的近端(即支撑杆12的固定端121)与连接件30固定连接，连接段126的远端朝向远端方向延伸并与展开段123的近端固定连接。应当说明的是，支撑杆12可以是一体成型的，连接段126、展开段123、锚定段124和悬空段125依次相连并不意味着支撑杆12是分体结构。此外，本实施例的支撑杆12均包括连接段126，在其他实施例中，仅部分支撑杆12包括连接段126，另一部分支撑杆12可不包括连接段126，而是通过展开段123直接与连接件30连接。
本实施例中，每个支撑杆12的连接段126均包括一个竖直分段126a，该竖直分段126a大致沿固定部10的轴向延伸。此处竖直分段126a沿固定部10的轴向延伸并不限定竖直分段126a与固定部10的中轴线01平行，允许竖直分段126a与固定部10的中轴线01之间存在夹角，该夹角的角度范围为±5°。在其他实施例中，还可设置仅部分支撑杆12的连接段126包括竖直分段126a，其他支撑杆12的连接段126不包括竖直分段126a。
在其他实施例中，连接段126可包括多个竖直分段126a，多个竖直分段126a可分布于连接段126的任意轴向区域。
当左心耳封堵器100植入后，左心耳随着心脏运动收缩和舒张时，左心耳的内壁对支撑杆12产生的应力分力可以分为轴向和径向，连接段126中竖直分段126a能在受到径向力时产生弹性变形，从而抵消部分径向分力，从而降低传导至支撑杆12根部的径向力所造成的扭转，进而降低支撑杆12根部疲劳断裂的风险。
本实施例中，周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度(参照图6中的D4)可与该相邻的两根支撑杆12的固定端121之间的间隙宽度(参照图3中的D1)大致相同(即误差不超过±25％)。在其他实施例中，周向相邻的支撑杆12的竖直分段126a之间的间隙宽度也可与该相邻的支撑杆 12的固定端121之间的间隙宽度不同。需要说明的是，两根周向相邻的支撑杆12的竖直分段126a之间的间隙宽度是指两根周向相邻的支撑杆12的竖直分段126a之间的最小间隙宽度。
本实施例中，参照图6(为清楚的展示支撑杆12的结构，图6中隐藏了部分支撑杆12，在实际制作过程中，支撑杆12的数量可根据需要设置)，固定部10中存在多根支撑杆12的竖直分段126a等距的间隔排列，即周向上两两相邻的竖直分段126a之间的间隙宽度基本相等(即误差不超过±25％)，每根支撑杆12自由端122上的球头14的径向尺寸也基本相等(即误差不超过±25％)，且任一周向相邻的两根竖直分段126a之间的间隙宽度均小于任一支撑杆12自由端122上球头14的径向尺寸。
在其他实施例中，固定部10中存在两根以上的支撑杆12的竖直分段126a也可非等距的间隔排列，即周向上两两相邻的竖直分段126a之间的间隙宽度可不等，固定部10中不同球头14的径向尺寸也可不等。不论多根支撑杆12的竖直分段126a是否等距的间隔排列，不同球头14的径向尺寸是否相等，至少存在两根周向相邻的支撑杆12的竖直分段126a之间的间隙宽度小于该相邻两根支撑杆12上至少一个球头14的径向尺寸。
例如，可以是任一周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度小于该相邻两根支撑杆12上其中一个球头14的径向尺寸；或者，可以是任一周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度均小于该相邻两根支撑杆12上任意一个球头14的径向尺寸。
在其他实施例中，还可以是仅部分周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度小于该相邻两根支撑杆12上其中一个球头14的径向尺寸；或者，仅部分周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度小于该相邻两根支撑杆12上任意一个球头14的径向尺寸。
本实施例通过设置相邻竖直分段126a之间的间隙宽度，可进一步降低球头14卡入相邻两根支撑杆12间隙之间的概率，以提高球头14抵靠支撑杆12根部区域的概率。
本实施例中，周向相邻的两根支撑杆12的竖直分段126a之间的间隙宽度不宜过小，故可使固定部10中至少存在两根周向相邻的支撑杆12的竖直分段126a之间的间隙宽度大于或等于该相邻两根支撑杆12中至少一个固定端121的宽度。例如，至少存在两根周向相邻的支撑杆12的竖直分段126a之间的间隙宽度大于或等于该相邻两根支撑杆12其中一个固定端121的宽度；或者，至少存在两根周向相邻的支撑杆12的竖直分段126a之间的间隙宽度大于或等于该相邻两根支撑杆12中任意一个固定端121的宽度。
示例性的，请再次参照图6，固定部10中存在两根以上的支撑杆12的竖直分段126a等距的间隔排列，即周向上两两相邻的竖直分段126a之间的间隙宽度基本相等(即误差不超过±25％)，且每根支撑杆12的固定端121的宽度均基本相等(即误差不超过±25％)，两两相邻的支撑杆12的竖直分段126a之间的间隙宽度均大于任一支撑杆12的固定端121的宽度。
进一步地，为提高连接段126的弹性变形能力，可使连接段126中至少存在一个区域的硬度小于展开段123的硬度。硬度的测量方式可选用超声波硬度检测仪测试连接段126和展开段123的表面硬度，只要连接段126中存在某一区域的表面硬度值小于展开段123中某一区域的表面硬度值即可认为连接段126的硬度小于展开段123的硬度。在其他实施例中，还可以使连接段126中任一区域的表面硬度值均小于展开段123中任一区域的表面硬度值。
进一步地，当固定部10被装载至输送鞘管内时，固定部10中至少存在两个球头14到连接件30的轴向距离不同，例如，可通过为支撑杆12设置不同长度的竖直分段126a实现，不同支撑杆12的球头14到连接件30的轴向距离不同，从而可防止固定部10处于压缩状态时，多根支撑杆12的球头14均聚集在同一横截面上，造成固定部10的压缩尺寸过大而无法进鞘。当固定部10处于展开状态时，至少两个球头14不在固定部10的同一横截面上。在其他实施例中，多个球头14位于固定部10的同一横截面上。
实施例3
参照图7-9(为清楚的展示支撑杆12的结构，图8中隐藏了部分支撑杆 12，在实际制作过程中，支撑杆12的数量可根据需要设置)，实施例3的左心耳封堵器100与实施例2的区别在于，实施例3的支撑杆12的连接段126自近端向远端方向均包括两段竖直分段，依次为第一竖直分段1261和第二竖直分段1262，第一竖直分段1261与连接件30固定连接，第二竖直分段1262则与展开段123的近端固定连接。在其他实施例中，仅部分支撑杆12的连接段126包括两段竖直分段。
通过在支撑杆12的连接段126中设置多段竖直分段，可分段抵消支撑杆12所受的部分径向分力，从而进一步降低传导至支撑杆12根部的径向力。周向相邻的两根支撑杆12的第一竖直分段1261之间的间隙宽度(如图9中的D5)可与第二竖直分段1262之间的间隙宽度(如图9中的D6)相同或不同。例如，本实施例中，周向相邻的两根支撑杆12的第一竖直分段1261之间的间隙宽度小于或等于第二竖直分段1262之间的间隙宽度。位于远端的第二竖直分段1262之间的间隙宽度较大时，可获得更大的形变空间，使得第二竖直分段1262能更好的产生弹性形变以抵消支撑杆12所受到的径向分力。
在其他实施例中，仅部分周向相邻的两根支撑杆12的第一竖直分段1261之间的间隙宽度小于或等于该相邻的两根支撑杆12的第二竖直分段1262之间的间隙宽度，或者，周向相邻的两根支撑杆12的第一竖直分段1261之间的间隙宽度均大于该相邻的两根支撑杆12的第二竖直分段1262之间的间隙宽度。
本实施例中，至少存在两根周向相邻的支撑杆12的第一竖直分段1261之间的间隙宽度小于该相邻两根支撑杆12中至少一个球头14的径向尺寸。在其他实施例中，至少存在两根周向相邻的支撑杆12的第二竖直分段1262之间的间隙宽度小于该相邻两根支撑杆12中至少一个球头14的径向尺寸。在其他实施例中，至少存在两根周向相邻的支撑杆12的第一竖直分段1261之间的间隙宽度小于该相邻两根支撑杆12中至少一个球头14的径向尺寸，且该相邻的两根支撑杆12的第二竖直分段1262之间的间隙宽度小于该相邻两根支撑杆12中至少一个球头14的径向尺寸。
进一步地，本实施例中，固定部10中至少存在两根周向相邻的支撑杆12 的第一竖直分段1261之间的间隙宽度大于或等于该相邻两根支撑杆12中至少一个固定端121的宽度。例如，至少存在两根周向相邻的支撑杆12的第一竖直分段1261之间的间隙宽度大于或等于该相邻两根支撑杆12其中一个固定端121的宽度；或者，至少存在两根周向相邻的支撑杆12的第一竖直分段1261之间的间隙宽度大于或等于该相邻两根支撑杆12中任意一个固定端121的宽度。
示例性的，请再次参照图8，固定部10中存在两根以上的支撑杆12的第一竖直分段1261等距的间隔排列，即周向上两两相邻的第一竖直分段1261之间的间隙宽度基本相等(即误差不超过±25％)，且每根支撑杆12的固定端121的宽度均基本相等(即误差不超过±25％)，两两相邻的支撑杆12的第一竖直分段1261之间的间隙宽度均大于任一支撑杆12的固定端121的宽度。
进一步地，请同时参照图9，第一竖直分段1261和第二竖直分段1262之间可设置倾斜段1263，该倾斜段1263的近端连接第一竖直分段1261的远端，倾斜段1263的远端则连接第二竖直分段1262的近端。本实施例中，第一竖直分段1261、倾斜段1263及第二竖直分段1262在径向上位于同侧(即位于连接件30的同侧)。在其他实施例中，第一竖直分段1261和第二竖直分段1262可在径向上相对设置。例如，某一支撑杆12的倾斜段1263自连接件30的一侧跨越固定部10的中轴线至连接件30的对侧，与之相邻的另一支撑杆12的倾斜段1263同样自连接件30的一侧向对侧跨越，使得两倾斜段1263在固定部10的横截面上的正投影存在交点。这样设置的优点在于，相互跨越的倾斜段1263之间可形成支点，能为支撑杆12提供支撑。此外，可设置连接段126的远端到连接段126的近端的径向距离(即垂直于轴向方向的距离)大于或等于连接件30的径向尺寸，这样设置有利于连接段126的远端区域获得更大的形变空间，从而产生弹性形变以抵消支撑杆12所受到的径向分力。
应当说明，以上所述实施例的各技术特征可以进行任意的组合，且也能同时应用于上面所述的各类左心耳封堵器以及结构存在类似的左心耳封堵器中。为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述， 然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本实用新型的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对实用新型专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本实用新型构思的前提下，还可以做出若干变形和改进，这些都属于本实用新型的保护范围。因此，本实用新型专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种左心耳封堵器，包括用于将所述左心耳封堵器固定在预定位置的固定部，起密封作用的密封部，以及连接所述固定部和所述密封部的连接件，其特征在于，所述固定部包括多根支撑杆，所述支撑杆的一端为与所述连接件连接的固定端，另一端为自由端，所述自由端上设置有球头，当所述固定部处于展开状态时，所述固定部中至少存在两根周向相邻的支撑杆的固定端之间的间隙宽度小于该相邻支撑杆上至少一个球头的径向尺寸。
  2. 根据权利要求1所述的左心耳封堵器，其特征在于，任一周向相邻的两根所述支撑杆的固定端之间的间隙宽度小于该相邻两根支撑杆上其中一个球头的径向尺寸；或者，任一周向相邻的两根所述支撑杆的固定端之间的间隙宽度均小于该相邻的两根支撑杆上任意一个球头的径向尺寸；或者，任一周向相邻的两根所述支撑杆的固定端的间隙宽度均小于所述固定部中任一支撑杆上所述球头的径向尺寸；或者，仅部分周向相邻的两根支撑杆的固定端之间的间隙宽度小于该相邻的两根支撑杆上其中一个球头的径向尺寸；或者，仅部分周向相邻的两根支撑杆的固定端之间的间隙宽度小于该相邻的两根支撑杆上任意一个球头的径向尺寸。
  3. 根据权利要求1所述的左心耳封堵器，其特征在于，所述支撑杆自所述固定端至自由端的长度方向依次包括连接段、展开段，所述连接段的近端连接所述连接件，远端连接所述展开段；当所述固定部处于展开状态时，所述展开段自所述连接段的远端径向向外展开并向远端延伸，所述连接段包括至少一个竖直分段，所述竖直分段大致沿平行于所述固定部的轴向延伸，所述固定部中至少存在两根周向相邻的支撑杆的竖直分段之间的间隙宽度小于该相邻的两根支撑杆上至少一个球头的径向尺寸。
  4. 根据权利要求3所述的左心耳封堵器，其特征在于，所述固定部中至少存在两根周向相邻的支撑杆的竖直分段之间的间隙宽度大于或等于该相邻两根支撑杆中至少一根支撑杆的固定端的宽度。
  5. 根据权利要求3所述的左心耳封堵器，其特征在于，所述固定部中至少存在两根周向相邻的支撑杆，在所述相邻的两根支撑杆中，每一根所述支撑杆的连接段自近端向远端方向包括两个竖直分段，依次为第一竖直分段和第二竖直分段，且当所述固定部处于展开状态时，该相邻的两根支撑杆的第一竖直分段之间的间隙宽度小于或等于 该相邻的两根支撑杆的第二竖直分段之间的间隙宽度，且该相邻的两根支撑杆的第一竖直分段之间的间隙宽度小于该相邻的两根支撑杆上至少一个球头的径向尺寸。
  6. 根据权利要求3所述的左心耳封堵器，其特征在于，所述固定部中至少存在一根支撑杆的连接段自近端向远端方向包括第一竖直分段、第二竖直分段和所述第一及第二竖直分段之间的倾斜段，且同一支撑杆的第一竖直分段和第二竖直分段在径向上位于所述连接件的同侧，或者，同一支撑杆的第一竖直分段和第二竖直分段在径向上相对设置，分别位于所述连接件的两侧。
  7. 根据权利要求6所述的左心耳封堵器，其特征在于，所述连接段的远端到所述连接段的近端的径向距离大于或等于所述连接件的径向尺寸。
  8. 根据权利要求1所述的左心耳封堵器，其特征在于，所述支撑杆自所述固定端至自由端的长度方向依次包括连接段、展开段、锚定段和悬空段，所述锚定段与所述展开段的远端连接并经弯折后朝向所述固定部的近端延伸，所述悬空段与所述锚定段的近端连接并向靠近所述固定部的中轴线的方向延伸形成自由端，所述球头设于所述悬空段的自由端上；所述球头到所述固定部中轴线的径向距离为L1，所述固定部的径向尺寸为L2，L1/L2的百分比范围为15％～38％。
  9. 根据权利要求8所述的左心耳封堵器，其特征在于，L1/L2的百分比范围为15％～20％、20％～25％、25％～30％、30％～38％中的一个或多个。
  10. 根据权利要求8所述的左心耳封堵器，其特征在于，所述悬空段沿长度方向依次包括第一弯折段及第二弯折段，所述第一弯折段与所述锚定段的近端连接，并经弯折后沿径向朝靠近所述固定部中轴线的方向延伸，所述第二弯折段与所述第一弯折段连接并经弯折后朝向靠近所述密封部的方向延伸形成所述自由端，或者，所述第二弯折段弯折后朝向远离所述密封部的方向弯折延伸形成所述自由端。
  11. 根据权利要求1所述的左心耳封堵器，其特征在于，所述密封部包括网状结构，所述球头到所述网状结构的轴向距离为L3，所述固定部的径向尺寸为L2，L3/L2的百分比范围为20％～40％。
  12. 根据权利要求11所述的左心耳封堵器，其特征在于，L3/L2的百分比范围为20％～25％、25％～30％、30％～35％、35％～40％中的一个或多个。
  13. 根据权利要求3所述的左心耳封堵器，其特征在于，所述连接段中至少存在一个区域的硬度小于所述展开段的硬度。
  14. 根据权利要求1所述的左心耳封堵器，其特征在于，当所述固定部被装载至输送鞘管内时，所述固定部中至少存在两个所述球头到所述连接件的轴向距离不同。
  15. 根据权利要求14所述的左心耳封堵器，其特征在于，当所述固定部处于展开状态时，多个所述球头位于所述固定部的同一横截面上，或者，至少两个所述球头不在所述固定部的同一横截面上。
PCT/CN2023/110754 2022-08-02 2023-08-02 左心耳封堵器 WO2024027761A1 (zh)

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