WO2024046392A1 - 封堵装置 - Google Patents

封堵装置 Download PDF

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Publication number
WO2024046392A1
WO2024046392A1 PCT/CN2023/115922 CN2023115922W WO2024046392A1 WO 2024046392 A1 WO2024046392 A1 WO 2024046392A1 CN 2023115922 W CN2023115922 W CN 2023115922W WO 2024046392 A1 WO2024046392 A1 WO 2024046392A1
Authority
WO
WIPO (PCT)
Prior art keywords
film body
sealing
sealing frame
blocking device
points
Prior art date
Application number
PCT/CN2023/115922
Other languages
English (en)
French (fr)
Inventor
刘国良
李安宁
刘建勇
林志宏
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
Priority claimed from CN202222296405.7U external-priority patent/CN218075117U/zh
Priority claimed from CN202222638695.9U external-priority patent/CN219803754U/zh
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 WO2024046392A1 publication Critical patent/WO2024046392A1/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
    • 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, and in particular to a blocking device.
  • the left atrial appendage blocking device In order to effectively block the left atrial appendage, the left atrial appendage blocking device needs to be implanted in the left atrial appendage for a long time to achieve the blocking effect. Therefore, the left atrial appendage occluder needs to have a certain anchoring structure to enable it to seal the mouth of the left atrial appendage stably for a long time, while avoiding problems such as device embolization caused by its falling off.
  • a flow-blocking film is installed in the seal, and using the flow-blocking film for blocking is a common technology in the industry.
  • a single flow-blocking film cannot It has a good blocking effect.
  • a blocking device including a fixing part for fixing the blocking device at a predetermined position, and a sealing part that acts as a seal
  • the sealing part includes a sealing frame
  • the sealing part also includes A first film body, a second film body and a flexible member are provided inside the sealing frame, and the flexible member connects the first film body and the second film body.
  • the flexible member is in the shape of a ring, and the flexible member includes a first end, a second end opposite to the first end, and a second end connected between the first end and the second end.
  • the connecting section and the knotted shape formed by the first end and the second end A node is formed, and the node is located between the first film body and the second film body.
  • the connecting section of the flexible member passes through the middle region of the first film body and the middle region of the second film body.
  • the edge of the first film body is fixed at the intersection between two wires of the woven mesh of the sealing part, and/or the edge of the second film body is fixed at the sealing part. The intersection between the two wires of the braided mesh.
  • the first film body is located between the second film body and the fixing part.
  • the second membrane body is connected to the proximal end side of the sealing frame through the flexible member.
  • the sealing frame includes a plurality of braided wires, and the flexible member is connected to the braided wires on the proximal side of the sealing frame.
  • the flexible member includes a connecting section, which is wound around the braided wire on the proximal side of the sealing frame at least once and then connected to the first membrane body.
  • the distance between the position where the connecting section passes through the sealing frame and the axis of the sealing portion is between 0.25 and 0.5 times the radius of the sealing frame.
  • the proximal end of the sealing frame is provided with a gathering member that collects the braided wire, and the connection between the connecting section of the flexible member and the braided wire connected thereto is located outside the gathering member .
  • the proximal end of the braided wire on the proximal side of the sealing frame is converged on the gathering member through the proximal end of the gathering member, and the connecting section of the flexible member can be wound around it Slide on the braided wire, and the sliding distance is roughly equal to the axial length of the gathering member.
  • the cross-sectional area of the first film body is smaller than that of the second film body.
  • a blocking device including a fixing part for fixing the blocking device at a predetermined position and a sealing part for sealing.
  • the sealing part includes a sealing frame, and the sealing part further includes a sealing part provided on the The first film body and the second film body inside the sealing frame, the edge of the first film body is fixed to the sealing frame through a first connecting piece, and the edge of the second film body is fixed to the sealing frame through a second connecting piece.
  • the sealing frame includes a plurality of penetration points and winding points. The extension direction of the first connecting member located outside at least one penetration point is different from the extension direction of the first connecting member located outside at least one of the winding points. Some of the second connecting members extend in different directions.
  • the first connecting member is located in the extending direction of the portion outside the sealing frame at at least one of the passing point positions, and the second connecting member is located in at least one of the bypassing point positions.
  • the included angle between the extending directions of the outer portions of the sealing frame is between [30°, 90°].
  • the extending direction of the portion of the first connecting member located outside at least one penetration point extends along the circumferential direction of the sealing frame, and the portion of the second connecting member located outside at least one of the bypassing points
  • the connecting piece extends along the axial direction of the sealing frame.
  • the first connecting member circumferentially bypasses the filaments or inter-filament intersections of the first film body and the sealing frame, and at the wrapping point position, the second connecting member axially bypasses the wire or the intersection between the wires of the second membrane body and the sealing frame.
  • a plurality of said winding points are distributed between two adjacent said passing points.
  • the penetration points and the winding points are alternately distributed.
  • a plurality of exposed inter-wire intersections are spaced between two adjacent winding points, and the weaving points are evenly distributed in the same axis direction of the exposed inter-wire intersections.
  • an auxiliary film body is further included, the auxiliary film body is located between the first film body and the second film body, and the edge of the auxiliary film body is fixed to the auxiliary film body through a third connecting member.
  • the sealed frame is further included, the auxiliary film body is located between the first film body and the second film body, and the edge of the auxiliary film body is fixed to the auxiliary film body through a third connecting member.
  • the extending direction of the portion of the third connecting member located outside at least one interfilament intersection point is the same as the extending direction of the portion of the second connecting member located outside at least one of the winding points, or , the part of the third connecting member located outside at least one intersection point between wires, the part of the first connecting member located outside at least one of the threading points, and the part of the second connecting member located outside of at least one of the winding points.
  • the extension directions of the connectors are all different.
  • the sealing device provided by the utility model is provided with multiple film bodies. After the sealing device is implanted, the multiple film bodies can achieve multiple sealing, ensuring a good sealing effect, and the edges and seals of different film bodies are Different connection methods are used to connect the frames, so that at least part of the extension directions of different connectors located outside the sealing frame are different, so that the multiple films are complementary at the edges and greatly improve the sealing performance.
  • Figure 1 is a schematic structural diagram of the blocking device in Embodiment 1 of the present invention.
  • Figure 2 is a schematic structural diagram of the deformed sealing portion of the blocking device in Embodiment 1 of the present invention.
  • Figure 3 is a schematic structural view of the membrane body of the sealing part of the sealing device in the state of Figure 2;
  • Figure 4 shows the state of the blocking device without a flexible member between the first film body and the second film body in the delivery sheath.
  • Figure 5 is a schematic diagram of the membrane structure of the blocking device in Figure 4 after release;
  • Figure 6 is a schematic cross-sectional view of the edge position of the first membrane body of the blocking device in Embodiment 1 of the present invention.
  • Figure 7 is a schematic diagram of the connection method of the edge position of the second membrane body of the blocking device in Embodiment 1 of the present invention.
  • Figure 8 shows the way in which the braided wires at the proximal end of the sealing part of the occluding device are gathered in Embodiment 1 of the present invention.
  • 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
  • distal end the end that is farther from the operator
  • Figure 1 is a schematic structural diagram of the blocking device 100 in Embodiment 1 of the present invention.
  • the blocking device 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 is connected directly or through a connecting piece.
  • the sealing part 20 and the fixing part 10 are spaced apart along the axial direction of the blocking device 100 .
  • the sealing part 20 is located at the proximal end of the blocking device 100
  • the fixing part 10 is located at the distal end of the blocking device 100 .
  • the occlusion device 100 has a compressed state contained within the sheath to facilitate delivery, and a naturally deployed state as shown in Figure 1 after extending from the distal end of the sheath and self-expanding.
  • the shape of the occlusion device 100 after being released in the left atrial appendage cavity is completely or substantially consistent with that in Figure 1 .
  • the sealing part 20 is woven into a mesh tube by a plurality of braided wires, and the ends of the braided wires are closed and fixed by a plug at both ends of the network tube.
  • the network tube is then heat-set into disk-like, columnar or plug-like shapes, thereby obtaining a method for sealing the left atrial appendage.
  • Open sealing portion 20 Open sealing portion 20 .
  • the sealing part 20 includes a sealing frame 25 on the outside and at least one layer of film body located inside the sealing frame.
  • the material of the film body can be polyester, EPTFE, PET, PTFE, etc., and the edge of the film body is fixed on the sealing frame of the sealing part 20 On the braided wire at the edge.
  • 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 fixing part 10 includes a plurality of support rods 12, and the fixing part 10 and the sealing part 20 are directly connected or indirectly connected through a connecting part.
  • the support rod 12 on the fixed part 10 can be a rod obtained by cutting a metal alloy tube or a polymer tube.
  • the fixed part 10 can also include a mesh structure made of braided wires that are braided or wound.
  • this embodiment does not place any restrictions on the structure and shape of the fixing part 10 , as long as it can play a fixing role.
  • the proximal ends of the plurality of support rods 12 are connected to the connecting portion 30, and the distal ends extend radially outward from the central end and turn toward the sealing portion, thereby forming a structure for contacting the wall of the left atrial appendage. And it serves as a supporting surface.
  • 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, weaving, etc., but it is not excluded that the support rod can be formed by cutting.
  • the anchor 13 is formed by cutting directly 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 blocking device 100 can realize the left atrial appendage. Blockage of the mouth of the atrial appendage.
  • the outside of the fixation part 10 is covered with a coating to further seal the left atrial appendage while ensuring that the sealing part 20 can achieve sealing, and to avoid excessive concentration of stress on the left atrial appendage on the fixation part.
  • the covering film can block the root of the anchor 13 to prevent blood flow from flowing out of the micro-wound and accelerate the rapid spread of the micro-wound.
  • the sealing part 20 is disk-shaped in the natural state.
  • the sealing part 20 is cylindrical in the natural state, or has various structures such as cylindrical frustum, inverted cone, step shape, etc. That is, the shape of the sealing portion 20 is not limited.
  • Figure 2 is a schematic structural diagram of the sealing portion 20 of the blocking device 100 in this embodiment after deformation. This figure is to further show the specific distribution of the film body in the sealing portion 20.
  • Figure 3 This is a schematic structural diagram of the membrane body of the sealing portion 20 of the sealing device 100 in the state of Figure 2 in this embodiment. It should be noted that Figure 3 is to further illustrate the sealing portion of the sealing device in this embodiment and is explained in conjunction with Figure 2 A schematic diagram is used, that is to say, in the deformed state of FIG. 2 , the film body inside the sealing part 20 in this embodiment appears in the state of FIG. 3 .
  • the sealing part 20 includes at least two layers of film.
  • the membrane body 212 is located at the distal end of the first membrane body 211. Specifically, the edge of the first membrane body 211 is fixed at the first position 201 of the sealing part 20, and the edge of the second membrane body 212 is fixed at the second position of the sealing part 20.
  • the fixing method is not limited to suture stitching, bonding, etc.
  • the sealing part 20 is pressed against the inner wall of the atrial appendage, thereby driving the edge of the first film body 211 and/or the second film body 212 to be close to the inner wall of the atrial appendage, thereby causing the first film body 211 and/or the second film body 212 to expand.
  • the opening is close to the inner wall of the atrial appendage, thereby ensuring a good blocking effect.
  • first position 201 and the second position 202 are to show the relative relationship between the positions, that is, the first position 201 is located at the proximal end of the second position 202, but it does not mean that the first position 201 and the second position 202 must be set.
  • the exact position of the sealing portion 20 does not mean that the distance between the first position 201 and the second position 202 needs to correspond to the scale of the drawings of this embodiment.
  • the edge of the first film body 211 and the edge of the second film body 212 are sewn at multiple intersections between the two wires of the woven mesh of the sealing portion 20 through multiple stitching points to avoid excessive slippage of the edges. .
  • the first film body 211 is connected to the second film body 212 through the flexible member 213, so that the cavity volume between the first film body 211 and the second film body 212 is not too large, and the first film body 211 and the second film body 212 are not too large.
  • the second film body 212 can deform as a whole or in conjunction with the deformation of the sealing part 20, thereby avoiding undue external force and concentration of external force on a certain point due to random deformation of the first film body 211 and the second film body 212.
  • Figures 4-5 Figure 4 is a schematic diagram of the membrane body structure of the blocking device in the delivery sheath when no flexible parts are provided.
  • Figure 5 is a schematic diagram of the membrane body structure of the blocking device in the delivery sheath when no flexible parts are provided. From the schematic diagram of the state after release, it can be seen that the first film body 211 and the second film body 212 are independent of each other. When there is no flexible member 213 to connect, the arrangement in Figure 4 is likely to occur in the sheath, that is, the first film body 211 and the middle part of the second membrane body 212 are far away from each other. If it is released in this state, when the sealing part of the occlusion device is released and just comes against the inner wall of the left atrial appendage, due to the extrusion of the inner wall of the left atrial appendage, the membrane structure will follow the sealing frame.
  • a cavity is formed between the first thin film body 211 and the second thin film body 212, and the middle parts of the first thin film body 211 and the second thin film body 212 are far away from each other.
  • Room 212 has the largest cavity volume.
  • the position to be blocked by the blocking device as a whole is on the distal side of the first membrane body 211 (i.e., the upper side as shown in the figure). When the sealing frame moves with the beating of the heart, the distal side of the first membrane body 211 is blocked.
  • the blocked fluid (blood, air flow, thrombus, etc.) will squeeze the first membrane body 211, causing the first membrane body 211 to deform toward the proximal side, thereby squeezing the gap between the first membrane body 211 and the second membrane body 212.
  • the cavity volume is in the maximum state, and the first membrane body is pressed towards During the proximal deformation process and before the middle part of the first film body 201 passes over 201, the middle part of the first film body 211 is hardly pulled by the edge connection position, and the middle part of the first film body 211 has almost no resistance to the fluid impact from the distal side. function, the stress is substantially all transferred to the second membrane body 212; in this case, on the one hand, the fluid in the cavity may follow the gap between the membrane body and the sealing frame (especially the gap between the second membrane body 212 and the sealing frame). The gap between the frames) flows out.
  • the deformation space left is small, and the fluid pressure in the cavity easily expands the first film.
  • the gap between the body 211 and/or the second film body 212 and the external frame will lead to a decrease in the sealing effect.
  • Figure 6 is a cross-sectional schematic diagram of the edge position of the first membrane body of the blocking device in Embodiment 1 of the present utility model.
  • Figure 7 is a schematic diagram of the edge of the first membrane body of the blocking device in Embodiment 1 of the present utility model.
  • the first film body 211 and the second film body 212 are fixed to the sealing frame 21 in different ways.
  • the sealing frame 21 is located outside the first film body 211 and the second film body 212, specifically as follows:
  • the first film body 211 is fixed to the sealing frame 21 through the first connecting member 231.
  • the first connecting member 231 is inserted around the horizontal direction (that is, the circumferential direction). rows, passing through the wires of the first film body 211 and the sealing frame 21 or the intersection points of the wires in the frame in sequence, thereby fixing the edge of the first film body 211 to the sealing frame 21.
  • the first connecting member 231 is a flexible member, preferably a seam. Thread, you can choose multiple sutures or one continuous thread.
  • the position where the first connector 231 passes through the sealing frame 21 (that is, the position on the sealing frame 21 where the first connector 231 is wound around the outside of the sealing frame 21) is recorded as the penetration point of the sealing frame 21.
  • the sealing frame 21 includes a plurality of penetration points, and a part of the first connecting member 231 is located outside the penetration points. It can also be understood that in the circumferential direction of the same cross-section, there is a gap between two adjacent penetration points. There are several exposed wires (or intersection points between multiple wires). In this embodiment, it is preferable that there is one exposed wire (or intersection point between wires) between two adjacent insertion points, so that the first The film body 211 is fixed uniformly and densely.
  • the first connecting member 231 adopts a circumferential winding method at the penetration point position, that is, at a single penetration point position, the portion of the first connecting member 231 located outside the sealing frame 21 extends along the circumferential direction. (the extension direction of the part of the first connecting member 231 located outside the penetration point is along the circumferential direction). In this case, when the sealing frame 21 is deformed, the first connecting member 231 will not form additional Tensile force, and when the sealing frame 21 is compressed, the penetration point position of the first connecting member 231 will shrink synchronously with the sealing frame 21, except for the sealing frame.
  • the design of the first connector 231 will not cause the sealing frame to drive the first film body 211 at the penetration point to deform synchronously, thereby causing the edge of the first film body 211 to Excessive wrinkles or gaps occur, so that the first film body 211 is maintained in an open shape as much as possible.
  • the connection between the edge of the first film body 211 and the sealing frame 21 is buffered, so that the first film body 211 is less affected by the stress at the connection location. Small.
  • the penetration section 2311 refers to the sealing frame 21 as the interface, located at A part of the first connecting member 231 outside the sealing frame 21 at a penetration point.
  • the extension direction of the penetration section 2311 is distributed along the circumferential direction, which is the part located outside the penetration point in this embodiment.
  • the extension direction of a connecting member 231 is along the circumferential direction. It should be noted that the first connecting member 231 can go around the penetration point multiple times, but the penetration section 2311 only refers to the section where the sealing frame 21 is used as the interface and is located A part of the first connecting piece 231 on the outside of the sealing frame 21 .
  • sealing frame 21 since the sealing frame 21 is in a compressed state after implantation, there will be no large gap between the first membrane body 211 and the sealing frame 21 designed in this way after implantation.
  • the location of the penetration point of the sealing frame 21 is at the intersection point between the wires of the sealing frame 21, and there are two exposed intersection points between the wires between two adjacent penetration points.
  • the position of the penetration point of the sealing frame 21 is at the intersection point between the wires of the sealing frame 21, and the number of intersection points between the wires spaced between each group of two adjacent penetration points is not completely equal.
  • the second film body 212 is fixed to the sealing frame 21 through a second connecting piece 232.
  • the second connecting piece 232 is a flexible piece, preferably a suture.
  • the second connecting piece 232 can be It can be multiple sutures or one continuous thread.
  • the edge of the second film body 212 is fixed to the intersection point between the wires of the sealing frame 21. It should be noted that the second connecting member 232 passes through the second film body 212 and the longitudinal direction (that is, along the axis direction).
  • the second connector 232 on the sealing frame 21 around the sealing frame 21 passes the second connector 232 on the sealing frame 21 around the sealing frame 21 (that is, the second connector 232 is wound around the sealing frame 21).
  • the outer position is recorded as the winding point. It should be noted that at a single winding point position, since the second connecting member 232 extends in the axial direction (that is, longitudinally) and is wound from top to bottom on the intersection point between the wires, That is to say, the extension direction of the part of the second connecting member 232 located outside the winding point extends in the axial direction, while the edge of the second film body 212 extends in the circumferential direction (that is, transversely).
  • the second connecting member 232 Multiple shorter sutures can be used to connect each intersection of threads separately. This In addition, since the second membrane body 212 is stressed along the axial direction when carrying blood, the axial connection of the second connecting member 232 will make the second membrane body 212 have a stronger bearing capacity, which is why the second membrane body 212 One of the reasons is that it is located at the proximal end of the first membrane body 211 .
  • the part of the second connecting member 232 located outside the bypass point here is the same as the part of the first connecting member 231 located outside the bypass point.
  • the part of the second connecting member 232 located outside the bypass point refers to the sealing frame. 21 serves as the interface, a part of the second connecting member 232 located outside the sealing frame 21 at a winding point position.
  • a plurality of winding points are distributed between two adjacent penetrating points in the overall circumferential direction.
  • the penetration points and the wrapping points are alternately distributed at intervals.
  • a plurality of exposed inter-wire intersections are spaced between two adjacent winding points, and the exposed inter-wire intersections are evenly distributed with threading points in the same axis direction.
  • the edge of the second film body 212 is fixed at each intersection point of a certain cross-section of the sealing frame 21, so as to obtain a good sealing effect.
  • the main difference between the first connecting member 231 and the second connecting member 232 is that at a single penetration point, the portion of the first connecting member 231 located outside the sealing frame 21 extends circumferentially (located at The extension direction of the first connecting member 231 outside the penetration point is along the circumferential direction), and at the position of a single winding point, the portion of the second connecting member 232 located outside the sealing frame 21 extends along the axial direction (the portion outside the winding point is The extension direction of part of the second connecting member 232 is along the axial direction).
  • the edges of the first film body 211 and the edges of the second film body 212 are fixed in different ways, if a gap occurs in the first film body 211 due to lateral connection, the gap will also be caused by the second film body 212 At the same time, the gap that may occur due to the fixation of the second film body 212 in the axial direction will also be reinforced by the lateral connection of the first film body 211, so that the first film body 211 and the second film body The body 212 is complementary, further improving the blocking effect.
  • the extension direction of the first connecting member 231 located outside at least one penetration point is along the circumferential direction, and the portion located outside at least one bypass point
  • the effect of complementary gap filling can also be achieved, that is, the sealing effect can still be improved.
  • the portion of the first connecting member 231 located outside the sealing frame 21 extends in the axial direction, and the second connecting member 231 extends along the axial direction.
  • the portion of the connector 232 located outside the sealing frame 21 extends in the circumferential direction.
  • the extending direction of the parts of the first connecting member 231 and the second connecting member 232 located outside the sealing frame 21 does not necessarily need to be limited to the direction specified in this embodiment.
  • the portion of 231 located outside the sealing frame 21 extends along the circumferential direction, and the portion of the second connecting member 232 located outside the sealing frame 21 extends along the axial direction, which is the optimal choice to achieve the best sealing effect.
  • the extension direction of the portion of the first connecting member 231 located outside the sealing frame 21 and the portion of the second connecting member 232 located outside the sealing frame 21 is between 30°. to 90°, including 30° and 90°.
  • an auxiliary film body is provided at the proximal end of the first film body 211 , and the edges of the auxiliary film body and the second film body 212 are fixed to the sealing frame 21 in the same way, so that the film in the entire sealing part 20
  • the body is fixed in a longitudinal-transverse-longitudinal alternating manner, so that the edges of the film body are connected to the sealing frame 21 in different connection ways, thereby obtaining the best sealing effect.
  • the auxiliary film body is connected to the sealing frame through a third connecting member, and the extension direction of the portion of the third connecting member of the auxiliary film body located outside the sealing frame is consistent with the first connecting member and the third connecting member.
  • the two connectors are different.
  • the sealing part 20 may be in a compact disc shape in its natural state, or may be in the form of a cylinder, a truncated cone, etc. in other shapes, in order to make the first film body 211, the second film body 212 and possible existing
  • the connection relationship between the auxiliary film body and the sealing frame 21 is clear.
  • the sealing part 20 should be oriented toward The proximal and distal sides are elongated at the same time, and the shape is judged after the state shown in Figure 2.
  • the first film body 211 and the second film body 212 are connected through the flexible member 213.
  • the first film body 211 and the second film body 212 can be used as the sealing part 20 when deforming. Deform as a whole or in conjunction, that is, the first film body 211 and the second film body 212 share the stress with each other through the flexible member 213, thereby improving the service life and sealing effect of the film body, and at the same time, avoiding the first film body 211 and the second film body
  • the cavity volume between the bodies 212 is too large, that is, the amount of deformation reserved for the two thin film bodies is too small.
  • the first film body 211 and the second film body 212 are simultaneously connected to the proximal side of the sealing frame of the sealing part 20 through the flexible member 213, so that during the transportation process, the first film body 211 and second The middle part of the film body 212 always faces the proximal side, thereby defining or partially defining the initial release state of the first film body 211 and the second film body 212, so that the cavity volume between the first film body 211 and the second film body 212 is is smaller, so that the stress is more evenly distributed to the two membrane bodies; at the same time, the first membrane body 211 and the second membrane body 212 are in a pre-stressed or pressure-bearing state after release, preventing the fluid from driving the first membrane body 211 And the middle part of the second membrane body 212 moves from the distal end to the proximal end, bringing excessive impulse to the position where the first membrane body 211 is connected to the sealing frame and/or the position where the second membrane body 212 is connected to the sealing frame
  • the flexible member 213 can be made of polymer materials, such as PET polyester thread, PP suture thread, PA suture thread, etc., or can also be made of other materials such as rubber.
  • the flexible member 213 passes through the middle area of the first film body 211 and the middle area of the second film body 212, and in this embodiment, the flexible member 213 includes a first end, a second end opposite to the first end, and a second end connected to the first end.
  • the connecting section between the first end and the second end, the first end and the second end are knotted to form a flexible ring, the node 2131 of the flexible member 213 is located between the first film body 211 and the second film body 212, To prevent node 2131 from contacting the blood to form a relatively large thrombus.
  • the distal end of the flexible member 213 passes through the proximal side of the sealing frame of the sealing part 20. Since the middle of the proximal side of the sealing part 20 leaves a matching structure with the steel cable, the distal end of the flexible member 213
  • the distance between the proximal side of the sealing frame of the sealing part 20 and the axis of the sealing part 20 is the radius R of the sealing frame of the sealing part 20 (the radius of the sealing frame refers to the maximum vertical direction of the sealing frame in the naturally unfolded state).
  • the radius of the section of the longitudinal central axis of the plugging device is between 0.25 and 0.5 times, that is, 0.25R to 0.5R.
  • the first membrane body 211 when the sealing part 20 is deformed, the first membrane body 211 always faces the proximal end of the sealing part 20, so that the first membrane body 211 can withstand and block more blood flow or thrombus. It should be noted that there may be two positions where the flexible member 213 passes through the sealing portion 20 to seal the proximal side of the frame. In order to obtain the best effect, both positions are limited to meet the above definition.
  • first connecting member 231 is also used in conjunction with the flexible member 213.
  • the first connecting member 231 is connected horizontally, and there is a gap between two adjacent penetration points, so that the first film body 211 There is sufficient margin to accommodate the pulling of the flexible member 213.
  • the middle part of the second film body 212 is fixed or bound to the middle part of the bottom of the sealing frame of the sealing part 20 by sutures or adhesives, that is, the middle part of the second film body 212 always faces toward the proximal surface. end side, thereby defining or partially defining the initial release position of the middle part of the second membrane body 212, so that the second membrane body 212 is in a pre-pressure or pressure-bearing state after release, to prevent the fluid from driving the middle part of the second membrane body 212 from The distal end begins to move to the proximal end, bringing excessive impulse to the location where the second membrane body 212 is connected to the sealing frame.
  • the flexible member 213 is wrapped at least once around the braided wire on the proximal side of the sealing frame to prevent a portion of the flexible member from swinging at will and entering the blood.
  • FIG. 8 illustrates how the proximal end of the sealing frame of the sealing portion 20 is gathered.
  • the braided wire 22 at the proximal end of the sealing frame of the sealing portion 20 is gathered to a gathering member. 23.
  • the gathering member 23 can be a hollow bolt head. It should be noted that Figure 8 is only to show the way in which the braided wires of the sealing frame are gathered, and it does not mean that the cross-sectional shape of the gathering member 23 is completely consistent with that shown in Figure 8 .
  • the position where the connecting section of the flexible member 213 connects to the sealing frame is located outside the gathering member 23.
  • the proximal end of the braided wire 22 passes through the distal end of the gathering member 23, the outside of the gathering member 23, and the proximal side of the gathering member 23.
  • the end 23 is bundled by the binding member 23, so that the binding member 23 bundles the outer braided wire 22.
  • the position between the components 23 has the following effects: on the one hand, the flexible component 213 avoids the position of the binding component 23, which improves the fatigue resistance of the flexible component 213; on the other hand, the binding component 23 and the braided wire 22 simultaneously The flexible part 213 realizes partial restriction and prevents the flexible part 213 from falling off.
  • the flexible member 213 can slide on the braided wire 22 relative to the braided wire 22, and the sliding distance is approximately equal to the axial length L of the gathering member to further reserve the deformation amount of the film body. , the ability to buffer external impact.
  • the sliding distance is approximately equal to the axial length L of the gathering member means that the sliding distance is between 120% L and 80% L, which can be understood as approximately equal.
  • the cross-sectional area of the first film body 211 is larger than that of the second film body 212 .
  • the cross-sectional area in this application refers to the area of the film body after it is removed from the sealing frame and spread out flatly, or the area of the film body after it is spread out flatly within the sealing frame.
  • the cross-sectional area of the second film body 212 is larger than that of the first film body 211, so that the second film body 212 can serve as the final sealing position to achieve a complete sealing effect and avoid the first film body 211 due to the area.
  • a good blocking effect cannot be obtained because the area of the second membrane body 212 is insufficient.
  • the sealing part of the present invention is preferably made of braiding. However, this does not mean that the sealing part of the present invention can only use a braided structure of at least one wire. It can also be made of a mesh-shaped structure cut from the whole. structure, or a mesh structure formed by welding multiple wires.
  • the wire referred to in the present utility model refers to the braided wire
  • the intersection point between the wires refers to the overlapping point formed by the two wires being superimposed on each other;
  • the wires here refer to the ribs of the mesh structure, and the intersection points between the wires refer to the intersection points between multiple ribs.

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Abstract

一种封堵装置（100），包括用于将封堵装置（100）固定在预定位置的固定部（10）和起密封作用的密封部（20），密封部（20）包括密封框架（21），密封部（20）还包括设于密封框架（21）内部的第一薄膜体（211）和第二薄膜体（212），第一薄膜体（211）的边缘通过第一连接件（231）固定至密封框架（21），第二薄膜体（212）的边缘通过第二连接件（232）固定至密封框架（21），密封框架（21）包括多个穿设点和绕设点，位于至少一个穿设点外侧的部分第一连接件（231）的延伸方向，与位于至少一个绕设点外侧的部分第二连接件（232）的延伸方向不同。通过设置多个薄膜体（211、212），在封堵装置（100）植入后，多个薄膜体（211、212）可以实现多重封堵，保证良好的封堵效果，且不同薄膜体（211、212）的边缘与密封框架（21）选用不同的连接方式，使得不同连接件（231、232）位于密封框架（21）外侧的至少部分的延伸方向不同，从而使得多张薄膜在边缘部分互补，大幅提高密封性能。

Description

封堵装置 技术领域
本实用新型涉及医疗器械技术领域，尤其涉及一种封堵装置。
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。因此，左心耳封堵器需具备一定的锚定结构，使其长期稳定的封堵于左心耳口部，同时避免其脱落导致器械栓塞等问题。
为实现左心耳封堵器在左心耳口部封堵，一般而言，在密封件中设置阻流膜，利用阻流膜进行封堵是业内常用的技术，但是，单张阻流膜并不能起到良好的封堵效果。
发明内容
基于此，有必要针对现有技术中封堵装置的密封效果不足的问题提供一种新的封堵装置。
一种封堵装置，一种封堵装置，包括用于将所述封堵装置固定在预定位置的固定部，起密封作用的密封部，所述密封部包括密封框架，所述密封部还包括设于所述密封框架内部的第一薄膜体、第二薄膜体和柔性件，所述柔性件连接所述第一薄膜体和所述第二薄膜体。
在其中一个实施例中，所述柔性件呈环状，所述柔性件包括第一端、与所述第一端相对的第二端、连接于所述第一端及第二端之间的连接段、及由所述第一端和第二端打结形 成的结点，所述结点位于所述第一薄膜体和所述第二薄膜体之间。
在其中一个实施例中，所述柔性件的连接段穿过所述第一薄膜体的中部区域和所述第二薄膜体的中部区域。
在其中一个实施例中，所述第一薄膜体的边缘固定在所述密封部的编织网的两丝之间的交叉处，和/或所述第二薄膜体的边缘固定在所述密封部的编织网的两丝之间的交叉处。
在其中一个实施例中，所述第一薄膜体位于所述第二薄膜体和所述固定部之间。
在其中一个实施例中，所述第二薄膜体通过所述柔性件连接于所述密封框架的近端侧。
在其中一个实施例中，所述密封框架包括多根编织丝，所述柔性件与所述密封框架的近端侧的编织丝连接。
在其中一个实施例中，所述柔性件包括连接段，所述连接段至少缠绕所述密封框架的近端侧的编织丝一圈后再与第一薄膜体相连。
在其中一个实施例中，所述连接段穿过所述密封框架的位置距离所述密封部的轴线的距离为所述密封框架的半径的0.25倍～0.5倍之间。
在其中一个实施例中，所述密封框架近端设有收束所述编织丝的收束件，所述柔性件的连接段与与其相连的编织丝的连接处位于所述收束件的外侧。
在其中一个实施例中，所述密封框架的近端侧的编织丝的近端经所述收束件的近端收束于所述收束件，所述柔性件的连接段可在其缠绕的编织丝上滑动，滑动距离大致等于所述收束件的轴向长度。
在其中一个实施例中，所述第一薄膜体的横截面面积小于所述第二薄膜体。
还提供了一种封堵装置，包括用于将所述封堵装置固定在预定位置的固定部和起密封作用的密封部，所述密封部包括密封框架，所述密封部还包括设于所述密封框架内部的第一薄膜体和第二薄膜体，所述第一薄膜体的边缘通过第一连接件固定至所述密封框架，所述第二薄膜体的边缘通过第二连接件固定至所述密封框架，所述密封框架包括多个穿设点和绕设点，位于至少一个穿设点外侧的部分所述第一连接件的延伸方向，与位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向不同。
在其中一个实施例中，所述第一连接件在至少一个所述穿设点位置位于所述密封框架外侧的部分的延伸方向和所述第二连接件在至少一个所述绕设点位置位于所述密封框架外侧的部分的延伸方向间的夹角介于[30°，90°]。
在其中一个实施例中，位于至少一个穿设点外侧的部分所述第一连接件的延伸方向沿所述密封框架的周向延伸，位于至少一个所述绕设点外侧的部分所述第二连接件沿所述密封框架的轴向延伸。
在其中一个实施例中，在所述穿设点位置，所述第一连接件沿周向绕过所述第一薄膜体和所述密封框架的丝或丝间交点，在所述绕设点位置，所述第二连接件沿轴向绕过过所述第二薄膜体和所述密封框架的丝或丝间交点。
在其中一个实施例中，在同一横截面内，相邻所述穿设点间隔有若干裸露的丝和/或丝间交点。
在其中一个实施例中，相邻的两所述穿设点间分布有若干所述绕设点。
在其中一个实施例中，所述穿设点和所述绕设点交替分布。
在其中一个实施例中，相邻的两所述绕设点之间均隔有多个裸露的丝间交点，且裸露的丝间交点的同一轴线方向上均分布有所述穿设点。
在其中一个实施例中，还包括辅助薄膜体，所述辅助薄膜体位于所述第一薄膜体和所述第二薄膜体之间，所述辅助薄膜体的边缘通过第三连接件固定至所述密封框架。
在其中一个实施例中，位于至少一个丝间交点外侧的部分所述第三连接件的延伸方向，与位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向相同，或，位于至少一个丝间交点外侧的部分所述第三连接件、位于至少一个所述穿设点外侧的部分所述第一连接件、位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向均不同。
本实用新型提供的封堵装置，通过设置多个薄膜体，在封堵装置植入后，多个薄膜体可以实现多重封堵，保证的良好的封堵效果，且不同薄膜体的边缘与密封框架的连接选用不同的连接方式，使得不同连接件位于所述密封框架外侧的至少部分延伸方向不同，从而使得多张薄膜在边缘部分互补，大幅提高密封性能。
附图说明
图1为本实用新型的实施例1中封堵装置的结构示意图；
图2是本实用新型的实施例1中封堵装置的密封部变形后的结构示意图；
图3是图2状态下封堵装置的密封部的薄膜体的结构示意图；
图4为第一薄膜体和第二薄膜体之间不设置柔性件的封堵装置的在输送鞘管中的状态 示意图；
图5为图4中封堵装置的薄膜体结构在释放后的状态示意图；
图6为本实用新型的实施例1中封堵装置的第一薄膜体的边缘位置的横截面示意图；
图7为本实用新型的实施例1中封堵装置的第二薄膜体的边缘位置的连接方式示意图；
图8为本实用新型的实施例1中封堵装置的密封部的近端的编织丝的收束方式。
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1-2所示，图1为本实用新型的实施例1中封堵装置100的结构示意图，封堵装置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直接连接或通过连接件连接。
本实施例中，密封部20和固定部10沿封堵装置100的轴向方向间隔设置。密封部20位于封堵装置100的近端，固定部10位于封堵装置100的远端。封堵装置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所示的自然展开状态。封堵装置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由多根编织丝编织成网管，网管的两端分别通过一个栓头将编织丝的端部收口并固定。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包括居于外侧的密封框架25以及位于密封框架内部的至少一层薄膜体，薄膜体的材料可以采用聚酯、EPTFE、PET、PTFE等，薄膜体的边缘固定在密封部20的密封框架边缘处的编织丝上。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包括多个支撑杆12，固定部10和密封部20直接连接或通过连接部间接连接。固定部10上的支撑杆12可以为通过切割金属合金管或高分子管后得到的杆，此外，固定部10也可以包括由编织丝经过编织或缠绕等方式制成的网状结构，用以替代杆的设计，本实施例对固定部10的结构和形状不做限制，只要能起到固定作用即可。
在本实施例中，多个支撑杆12的近端均与连接部30连接，远端均从中心端部径向向外延伸并朝向密封部翻转，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。
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、编织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，使得封堵装置100实现对左心耳口部的封堵。
在另一实施例中，固定部10的外部覆盖有覆膜，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。
在本实施例中，密封部20在自然状态下为盘状，在另一实施例中，密封部20在自然状态下为圆柱，或者是柱状的圆台、倒锥、阶梯状等多种结构，也即密封部20的形状不做限制。
参照图2，图2是本实施例中封堵装置100的密封部20变形后的结构示意图，本图是为了进一步表现密封部20中的薄膜体的具体分布，同时，结合图3，图3是本实施例中图2状态下封堵装置100的密封部20的薄膜体的结构示意图，应当说明，图3是为了进一步说明本实施例的封堵装置的密封部，而配合图2进行说明用的示意图，也就是说，在图2的变形状态下，本实施例中密封部20内部的薄膜体表现为图3中的状态。
为了使密封部20能实现良好的密封效果，密封部20至少包括2层薄膜体，第二薄 膜体212位于第一薄膜体211的远端，具体地，第一薄膜体211的边缘固定在密封部20的第一位置201处，第二薄膜体212的边缘固定在密封部20的第二位置202处，固定方式不限于缝线缝合、粘结等。密封部20在植入后贴紧心耳内壁，从而带动第一薄膜体211和/或第二薄膜体212的边缘贴紧心耳内壁，从而使得第一薄膜体211和/或第二薄膜体212张开贴近心耳内壁，继而保证良好的封堵效果。
应当说明的是，第一位置201和第二位置202是为了展示位置的相对关系，即第一位置201位于第二位置202的近端，而并非表示第一位置201和第二位置202必须设置在密封部20的准确位置，也并非表示第一位置201和第二位置202的间隔需对应本实施例附图的比例尺。
作为优选，第一薄膜体211的边缘和第二薄膜体212的边缘通过多个缝合点缝合在密封部20的编织网的两丝之间的多个交叉处，以避免边缘出现过多滑移。
作为优选，第一薄膜体211通过柔性件213连接第二薄膜体212，从而使得第一薄膜体211和第二薄膜体212之间的腔体体积不至于过大，且第一薄膜体211和第二薄膜体212随着密封部20形变时可以作为一个整体或者联动地变形，从而避免第一薄膜体211和第二薄膜体212随机形变出现不应有的外力受力和外力集中在某个薄膜体上，参照图4-5，图4是未设置柔性件时封堵装置的薄膜体结构在输送鞘管中的状态示意图，图5是未设置柔性件时封堵装置的薄膜体结构在释放后的状态示意图，可以看出，第一薄膜体211和第二薄膜体212相互独立，没有柔性件213连接时，在鞘管中容易出现图4中的排布，即第一薄膜体211和第二薄膜体212的中部相互远离，如果依照此状态释放，在封堵装置的密封部释放后刚刚抵持左心耳内壁时，因左心耳内壁的挤压，薄膜体结构会跟随密封框架呈现图5的状态，此时，第一薄膜体211和第二薄膜体212间形成腔体，第一薄膜体211和第二薄膜体212的中部相互远离，第一薄膜体211和第二薄膜体212间的腔体体积最大。同时，封堵装置整体上要封堵的位置在于第一薄膜体211的远端侧(即图示的上方)，当密封框架随着心脏跳动运动时，第一薄膜体211远端侧的被阻挡的流体(血液、气流、血栓等)会挤压第一薄膜体211，使得第一薄膜体211朝向近端侧变形，也就挤压了第一薄膜体211和第二薄膜体212间的腔体；被挤压的腔体变形后朝向第二薄膜体212传递应力，由于第一薄膜体的边缘固定于密封框架，刚释放时第一薄膜体的中部朝向远端，也即初始状态下，腔体体积处于最大状态，在第一薄膜体受压朝向 近端变形过程中且第一薄膜体的中部越过201之前，第一薄膜体211的中部几乎不受边缘连接位置的牵拉，第一薄膜体211中部对于来自远端侧的流体冲击几乎没有抵抗作用，其应力大体上全部传递给第二薄膜体212；在这种情况下，一方面，腔体内的流体可能沿着薄膜体与密封框架之间的缝隙(尤其是第二薄膜体212与密封框架之间的缝隙)流出，另一方面，第一薄膜体211和第二薄膜体212间的腔体受挤压时，留出的形变空间较小，腔体内的流体压力容易扩大第一薄膜体211和/或第二薄膜体212与外部框架连接的缝隙，进而导致密封效果下降。
在本实施例中，进一步参照图6-7，图6为本实用新型的实施例1中封堵装置的第一薄膜体的边缘位置的横截面示意图，图7为本实用新型的实施例1中封堵装置的第二薄膜体的边缘位置的连接方式示意图，也就是说，图6是垂直于轴线的截面视角，而图7则是与其余附图相同的主视图视角。
第一薄膜体211和第二薄膜体212的与密封框架21的固定方式不同，密封框架21位于第一薄膜体211和第二薄膜体212的外侧，具体如下：
对于第一薄膜体211而言，参见图6，第一薄膜体211通过第一连接件231固定至密封框架21，具体地，第一连接件231沿着水平方向(也就是周向)穿插绕行，依次穿过第一薄膜体211和密封框架21的丝或框架中丝的交点，从而将第一薄膜体211的边缘固定至密封框架21，第一连接件231为柔性件，优选为缝线，既可以选用多根缝线，也可以选择一根连续的线。本实施例中，将第一连接件231穿绕过密封框架21的位置(即密封框架21上第一连接件231绕设到密封框架21外侧的位置)记为密封框架21的穿设点，则密封框架21上包括多个穿设点，第一连接件231的一部分位于穿设点的外侧，也可以理解为，在同一横截面的周向上，相邻的两穿设点之间，隔有若干裸露的丝(或多根丝的丝间交点)，本实施例优选为，相邻的两穿设点之间隔有1根裸露的丝(或一个丝的丝间交点)，从而使得第一薄膜体211的固定均匀而致密。还应当说明的是，由于第一连接件231在穿设点位置采用周向的穿绕方式，也即，在单个穿设点位置，第一连接件231位于密封框架21外侧的部分沿着周向延伸(位于穿设点外侧的部分第一连接件231的延伸方向沿周向)，在这样的情况下，出现密封框架21变形时，第一连接件231不会对密封框架21形成额外的拉力，且当密封框架21受压时，密封框架21的不会导致第一连接件231的穿设点位置跟随密封框架21同步缩小，从而除开由于密封框架 21本身变形影响的第一薄膜体211的形变外，不会由于第一连接件231的设计导致密封框架带动穿设点位置的第一薄膜体211同步变形，从而导致第一薄膜体211的边缘出现过多的褶皱或空隙，从而使得第一薄膜体211尽可能地处于维持张开的形状。此外，由于相邻的两穿设点之间留有间隔，使得第一薄膜体211的边缘与密封框架21的连接留有缓冲量，从而使得第一薄膜体211受到连接位置的应力的影响较小。
为了表示位于穿设点外侧的部分第一连接件231的具体位置，可以参见图6中第一连接件231的穿设段2311，穿设段2311指的是以密封框架21作为分界面，位于密封框架21外侧的、在一个穿设点位置的第一连接件231的一部分，该穿设段2311的延伸方向沿周向分布，也就是本实施例中指代的位于穿设点外侧的部分第一连接件231的延伸方向沿周向，应当注意的是，第一连接件231可以多次绕过该穿设点，但是穿设段2311只指代这其中以密封框架21作为分界面且位于密封框架21外侧的第一连接件231的一部分。
还值得说明的是，由于密封框架21在植入后是受压压缩状态，这样设计的第一薄膜体211和密封框架21之间在植入后也不会留有较大空隙。
在另一实施例中，密封框架21的穿设点的位置在于密封框架21的丝间交点处，相邻的两穿设点之间均隔有2个裸露的丝间交点。
在另一实施例中，密封框架21的穿设点的位置在密封框架21的丝间交点处，每组相邻的两穿设点之间间隔的丝间交点的数量不完全相等。
对于第二薄膜体212而言，参见图7，第二薄膜体212通过第二连接件232固定至密封框架21，第二连接件232为柔性件，优选为缝线，第二连接件232可以是多个缝线，也可以是一根连续的线。本实施例中，第二薄膜体212的边缘被固定至密封框架21的丝间交点，应当注意的是，第二连接件232沿纵向(也即沿轴线方向)穿过第二薄膜体212和密封框架21的丝或丝间交点之间，优选为丝间交点，将密封框架21上第二连接件232穿绕过密封框架21的位置(即第二连接件232绕设到位于密封框架21外侧的位置)记为绕设点，应当说明的是，在单个绕设点位置，由于第二连接件232是沿轴向(也即纵向)延伸自上而下绕设在丝间交点上，也就是说，位于绕设点外侧的部分第二连接件232的延伸方向沿轴向延伸，而第二薄膜体212的边缘是沿周向(也即横向)延伸，因此，第二连接件232可以选用多根较短的缝线，对于每个丝间交点分别进行连接。此 外，由于第二薄膜体212薄膜体在承载血液时是沿轴线方向受力，第二连接件232的轴向连接会使得第二薄膜体212的承载力更强，这也是第二薄膜体212位于第一薄膜体211的近端的原因之一。
此处位于绕设点外侧的部分第二连接件232与前面位于穿设点外侧的部分第一连接件231同理，位于绕设点外侧的部分第二连接件232指代的是以密封框架21作为分界面，位于密封框架21外侧的、在一个绕设点位置的第二连接件232的一部分。
在本实施例中，在整体的周向上，相邻的两穿设点间分布有绕设点(从几何定义的角度而言，这里指的是，相邻的两穿设点分别与轴线形成的平面围成的扇形区域内，分布有绕设点，下同)。
在另一实施例中，在整体的周向上，相邻的两穿设点间分布有多个绕设点。
在另一实施例中，在整体的周向上，穿设点、绕设点间隔交替分布。
在另一实施例中，在整体的周向上，相邻的两绕设点之间隔有多个裸露的丝间交点，且裸露的丝间交点的同一轴线方向上均分布有穿设点。
在另一实施例中，第二薄膜体212的边缘与密封框架21的某个横截面的每个丝间交点都固定，从而获得良好的密封效果。
本实施例中，综合来看，第一连接件231和第二连接件232的主要区别在于，在单个穿设点位置，第一连接件231位于密封框架21外侧的部分沿周向延伸(位于穿设点外侧的部分第一连接件231的延伸方向沿周向)，在单个绕设点的位置，第二连接件232位于密封框架21外侧的部分沿轴向延伸(位于绕设点外侧的部分第二连接件232的延伸方向沿轴向)。
应当注意的是，由于第一薄膜体211的边缘和第二薄膜体212的边缘的固定方式不同，假使第一薄膜体211由于横向连接导致出现间隙，该间隙也会由于第二薄膜体212的存在而被阻挡，而同时，第二薄膜体212由于沿轴向方向固定可能产生的间隙，也会被第一薄膜体211的横向连接进行补强，从而使得第一薄膜体211和第二薄膜体212互补，进一步提升了封堵效果，因此，在另一实施例中，位于至少一个穿设点外侧的部分第一连接件231的延伸方向沿周向，位于至少一个绕设点外侧的部分第二连接件232的延伸方向沿轴向延伸时，也可以实现互补填充间隙的效果，即仍能提高密封效果。
在另一实施例中，第一连接件231位于密封框架21外侧的部分沿轴向延伸，第二连 接件232位于密封框架21外侧的部分沿周向延伸。
也就是说，第一连接件231和第二连接件232位于密封框架21外侧的部分的延伸方向并不一定需要限制为本实施例中规定的方向，只是本实施例中规定的第一连接件231位于密封框架21外侧的部分沿周向延伸，第二连接件232位于密封框架21外侧的部分沿轴向延伸是能起到最好密封效果的最优选择。
因此，进一步地，为了获得良好的、互补的密封效果，第一连接件231位于密封框架21外侧的部分和第二连接件232位于密封框架21外侧的部分的延伸方向，夹角介于30°到90°之间，包括30°和90°。
在另一实施例中，第一薄膜体211的近端设有辅助薄膜体，该辅助薄膜体与第二薄膜体212的边缘与密封框架21的固定方式相同，从而使得整个密封部20中薄膜体的固定方式呈现纵向——横向——纵向交替连接，从而使得薄膜体的边缘按照不同的连接方式连接至密封框架21，从而获得最好的封堵效果。
进一步地，在另一实施例中，辅助薄膜体通过第三连接件连接至密封框架，辅助薄膜体的第三连接件的位于所述密封框架外侧的部分的延伸方向与第一连接件、第二连接件均不同。
还应注意的是，由于密封部20在自然状态下可能是紧密的盘状，或者是有其余形状的圆柱、圆台等形态，为了使第一薄膜体211、第二薄膜体212以及可能存在的辅助薄膜体与密封框架21的连接关系清楚，涉及第一连接件231、第二连接件232和第三连接件的位于所述密封框架外侧的部分的延伸方向时，均应将密封部20朝向近端、远端两侧同时拉长，形如图2中的状态后进行判断。
本实施例中，第一薄膜体211和第二薄膜体212通过柔性件213连接，通过柔性件213的设计，使得第一薄膜体211和第二薄膜体212随着密封部20形变时可以作为一个整体或者联动地变形，也即第一薄膜体211和第二薄膜体212通过柔性件213相互分摊应力，提高薄膜体的使用寿命和密封效果，同时，避免第一薄膜体211和第二薄膜体212之间的腔体体积过大，也就是说，避免两薄膜体预留的形变量太少。
在另一实施例中，作为优选，第一薄膜体211和第二薄膜体212同时通过柔性件213连接至密封部20的密封框架的近端侧，使得在输送过程中，第一薄膜体211和第二 薄膜体212的中部始终朝向近端一侧，从而限定或部分限定第一薄膜体211和第二薄膜体212的初始释放状态，使得第一薄膜体211和第二薄膜体212间的腔体体积较小，从而使得所受应力更均匀地分摊至两个薄膜体；同时第一薄膜体211和第二薄膜体212在释放后处于预承受压力或者承压状态，避免流体带动第一薄膜体211和第二薄膜体212的中部从远端开始运动到近端，给第一薄膜体211与密封框架连接的位置和/或第二薄膜体212与密封框架连接的位置带来过多的冲量。
本实施例中，柔性件213可由高分子材料制成，如PET聚酯线，PP缝合线，PA缝合线等，也可以由其它材料如橡胶等制成。柔性件213穿过第一薄膜体211的中部区域和第二薄膜体212的中部区域，且在本实施例中，柔性件213包括第一端、与第一端相对的第二端以及连接于第一端及第二端之间的连接段，第一端和第二端打结从而形成一个柔性环，柔性件213的结点2131位于第一薄膜体211和第二薄膜体212之间，以防止结点2131接触血液形成比较大的血栓。
更进一步地，柔性件213的远端穿过密封部20的密封框架的近端一侧，由于密封部20的近端一侧的中部中央留出与钢缆的配合结构，柔性件213的远端穿过密封部20密封框架的近端一侧的位置距离密封部20的轴线的距离为密封部20密封框架的半径R(密封框架的半径指，在自然展开状态下，密封框架最大的垂直于封堵装置纵向中心轴的截面的半径)的0.25倍～0.5倍之间，即0.25R～0.5R。这样可以使得在密封部20变形时，第一薄膜体211始终朝向密封部20的近端，从而使得第一薄膜体211能承担和阻挡更多的血流或血栓。应当注意的是，柔性件213穿过密封部20密封框架的近端一侧的位置可能有两处，为了获得最好的效果，限定两处位置均满足上面的限定。
还应注意的是，第一连接件231的也配合了柔性件213的使用，第一连接件231采用横向连接，且相邻的两穿设点之间留有间隔，使得第一薄膜体211具有充足的余量，以适应柔性件213的拉扯。
在另一实施例中，第二薄膜体212的中部通过缝线、粘结的方式固定或被束缚在密封部20的密封框架的底部的中部，也即第二薄膜体212的中部始终朝向近端一侧，从而限定或部分限定第二薄膜体212的中部的初始释放位置，使得第二薄膜体212在释放后处于预承受压力或者承压状态，避免流体带动第二薄膜体212的中部从远端开始运动到近端，给第二薄膜体212与密封框架连接的位置带来过多的冲量。
在另一实施例中，柔性件213至少缠绕密封框架的近端侧的编织丝一圈，以避免柔性件的一部分随意摆动和进入血液。
在另一实施例中，参照图8，图8展示了密封部20的密封框架的近端的收束方式，密封部20的密封框架的近端的编织丝22被收束至一收束件23，收束件23可以为中空的栓头，应当说明，图8只为了展示密封框架的编织丝被收束的方式，并不意味着收束件23的截面形状与图8所示完全一致。柔性件213的连接段连接密封框架的位置位于收束件23的外侧，这是由于编织丝22的近端依次经收束件23的远端、收束件23的外侧、收束件的近端23被收束件23收束，从而使得收束件23是将外侧的编织丝22进行收束，柔性件213与密封框架的编织丝22连接时相当于穿过了编织丝22与收束件23间的位置，如此具有如下效果：一方面，柔性件213避让开了收束件23位置，提高了柔性件213的抗疲劳性能；另一方面，收束件23和编织丝22同时对柔性件213实现了部分限制，避免柔性件213脱落。同时，在收束件23外侧，柔性件213能够在编织丝22上相对编织丝22滑动，滑动距离大致等于所述收束件的轴向长度L，以进一步预留出薄膜体的可形变量，缓冲外力冲击的能力。滑动距离大致等于所述收束件的轴向长度L是指，滑动距离在120％L和80％L之间，均可以理解为大致等于。在另一实施例中，第一薄膜体211的横截面面积大于第二薄膜体212。
本申请中的横截面面积指的是，将薄膜体从密封框架上拆除后平铺展开的面积，或者是薄膜体在密封框架内平整展开后的面积。
在另一实施例中，第二薄膜体212的横截面面积大于第一薄膜体211，使得第二薄膜体212能作为最终的密封位置起到完整的密封效果，避免第一薄膜体211因为面积不够或者破损导致泄漏时，由于第二薄膜体212的面积不够从而不能获得良好的封堵效果。
应当说明的是，本实用新型的密封部优选为编织方式制成，但是并不代表本实用新型的密封部只能选用至少一根丝的编织结构，也可以选用从整体上切割形成的网状结构，或是多个丝焊接形成的网状结构。对应地，当本实用新型的密封部选用至少一根丝的编织结构，本实用新型所指的丝指的是编织丝，丝间交点指的是两丝相互叠压形成的交叠点；当本实用新型的密封部选用切割或焊接形成的结构时，这里的丝指的是网状结构的棱，其丝间交点指的是多个棱之间的交点。
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 (22)

  1. 一种封堵装置，包括用于将所述封堵装置固定在预定位置的固定部，起密封作用的密封部，所述密封部包括密封框架，其特征在于，所述密封部还包括设于所述密封框架内部的第一薄膜体、第二薄膜体和柔性件，所述柔性件连接所述第一薄膜体和所述第二薄膜体。
  2. 根据权利要求1所述的封堵装置，其特征在于，所述柔性件呈环状，所述柔性件包括第一端、与所述第一端相对的第二端、连接于所述第一端及第二端之间的连接段、及由所述第一端和第二端打结形成的结点，所述结点位于所述第一薄膜体和所述第二薄膜体之间。
  3. 根据权利要求2所述的封堵装置，其特征在于，所述柔性件的连接段穿过所述第一薄膜体的中部区域和所述第二薄膜体的中部区域。
  4. 根据权利要求1所述的封堵装置，其特征在于，所述第一薄膜体的边缘固定在所述密封部的编织网的两丝之间的交叉处，和/或所述第二薄膜体的边缘固定在所述密封部的编织网的两丝之间的交叉处。
  5. 根据权利要求1所述的封堵装置，其特征在于，所述第一薄膜体位于所述第二薄膜体和所述固定部之间。
  6. 根据权利要求5所述的封堵装置，其特征在于，所述第二薄膜体通过所述柔性件连接于所述密封框架的近端侧。
  7. 根据权利要求1所述的封堵装置，其特征在于，所述密封框架包括多根编织丝，所述柔性件与所述密封框架的近端侧的编织丝连接。
  8. 根据权利要求7所述的封堵装置，其特征在于，所述柔性件包括连接段，所述连接段至少缠绕所述密封框架的近端侧的编织丝一圈后再与第一薄膜体相连。
  9. 根据权利要求7所述的封堵装置，其特征在于，所述连接段穿过所述密封框架的位置距离所述密封部的轴线的距离为所述密封框架的半径的0.25倍～0.5倍之间。
  10. 根据权利要求7所述的封堵装置，其特征在于，所述密封框架近端设有收束所述编织丝的收束件，所述柔性件的连接段与与其相连的编织丝的连接处位于所述收束件的外侧。
  11. 根据权利要求10所述的封堵装置，其特征在于，所述密封框架的近端侧的编织丝的近端经所述收束件的近端收束于所述收束件，所述柔性件的连接段可在其缠绕的编织丝 上滑动，滑动距离大致等于所述收束件的轴向长度。
  12. 根据权利要求1所述的封堵装置，其特征在于，所述第一薄膜体的横截面面积小于所述第二薄膜体。
  13. 一种封堵装置，包括用于将所述封堵装置固定在预定位置的固定部和起密封作用的密封部，所述密封部包括密封框架，其特征在于，所述密封部还包括设于所述密封框架内部的第一薄膜体和第二薄膜体，所述第一薄膜体的边缘通过第一连接件固定至所述密封框架，所述第二薄膜体的边缘通过第二连接件固定至所述密封框架，所述密封框架包括多个穿设点和绕设点，位于至少一个穿设点外侧的部分所述第一连接件的延伸方向，与位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向不同。
  14. 根据权利要求13所述的封堵装置，其特征在于，所述第一连接件在至少一个所述穿设点位置位于所述密封框架外侧的部分的延伸方向和所述第二连接件在至少一个所述绕设点位置位于所述密封框架外侧的部分的延伸方向间的夹角介于[30°，90°]。
  15. 根据权利要求13所述的封堵装置，其特征在于，位于至少一个穿设点外侧的部分所述第一连接件的延伸方向沿所述密封框架的周向延伸，位于至少一个所述绕设点外侧的部分所述第二连接件沿所述密封框架的轴向延伸。
  16. 根据权利要求13所述的封堵装置，其特征在于，在所述穿设点位置，所述第一连接件沿周向绕过所述第一薄膜体和所述密封框架的丝或丝间交点，在所述绕设点位置，所述第二连接件沿轴向绕过过所述第二薄膜体和所述密封框架的丝或丝间交点。
  17. 根据权利要求13所述的封堵装置，其特征在于，在同一横截面内，相邻所述穿设点间隔有若干裸露的丝和/或丝间交点。
  18. 根据权利要求17所述的封堵装置，其特征在于，在整体的周向上，相邻的两所述穿设点间分布有若干所述绕设点。
  19. 根据权利要求17所述的封堵装置，其特征在于，在整体的周向上，所述穿设点和所述绕设点交替分布。
  20. 根据权利要求17所述的封堵装置，其特征在于，在整体的周向上，相邻的两所述绕设点之间均隔有多个裸露的丝间交点，且裸露的丝间交点的同一轴线方向上均分布有所述穿设点。
  21. 根据权利要求13-20中任一项所述的封堵装置，其特征在于，还包括辅助薄膜体，所 述辅助薄膜体位于所述第一薄膜体和所述第二薄膜体之间，所述辅助薄膜体的边缘通过第三连接件固定至所述密封框架。
  22. 根据权利要求21所述的封堵装置，其特征在于，位于至少一个丝间交点外侧的部分所述第三连接件的延伸方向，与位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向相同，或，位于至少一个丝间交点外侧的部分所述第三连接件、位于至少一个所述穿设点外侧的部分所述第一连接件、位于至少一个所述绕设点外侧的部分所述第二连接件的延伸方向均不同。
PCT/CN2023/115922 2022-08-30 2023-08-30 封堵装置 WO2024046392A1 (zh)

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