WO2022148135A1 - Appareil d'occlusion - Google Patents

Appareil d'occlusion Download PDF

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Publication number
WO2022148135A1
WO2022148135A1 PCT/CN2021/130903 CN2021130903W WO2022148135A1 WO 2022148135 A1 WO2022148135 A1 WO 2022148135A1 CN 2021130903 W CN2021130903 W CN 2021130903W WO 2022148135 A1 WO2022148135 A1 WO 2022148135A1
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WO
WIPO (PCT)
Prior art keywords
inversion
rod
fixing portion
rods
turning
Prior art date
Application number
PCT/CN2021/130903
Other languages
English (en)
Chinese (zh)
Inventor
李安宁
刘建勇
贾佳
汤麟
Original Assignee
先健科技(深圳)有限公司
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Filing date
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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 WO2022148135A1 publication Critical patent/WO2022148135A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a blocking device.
  • the fixing plate used for implantation into the left atrial appendage to support and fix the function is currently made of a braided mesh by braiding a braided wire with a small diameter, or using a braided wire with a small diameter.
  • a skeleton structure including a plurality of support rods is made by cutting the tubular member by means of laser cutting or the like, that is, the fixed disc is made by pure weaving or pure cutting.
  • the support strength of the fixed disk made by cutting is higher than that of the woven mesh, but there is often a problem of stress concentration, or the support rod is easy to puncture the weak groove between the adjacent pectinate muscles in the left atrial appendage.
  • the braiding wire of such a fixed disc is often thinner, With good flexibility, the fixed plate can be turned over.
  • such a fixed disk tends to have a weak turning ability.
  • the resistance to the fixed disk is relatively large when the fixed disk is released, or because the deep position inside the left atrial appendage provides a slightly smaller space for the fixed disk to turn over, thus making the flipping
  • the fixed disk with weaker ability is blocked when it is turned over, and it is more difficult to fully unfold, which leads to weak fixation and even causes the occluder to fall off.
  • a blocking device comprises a sealing part and a fixing part connected with the sealing part
  • the fixing part comprises a support net and at least one inversion rod connected with the support net
  • the support net is passed through by a first braided wire Weaving into a mesh shape
  • the inversion rod is made into a rod shape by cutting a tubular member or a plurality of second braided wires are wound into a rod shape, and one end of the inversion rod is in the process of unfolding the fixing part, Extending toward the distal end and then turning outward toward the direction of the sealing portion, at least a part of the support net constitutes at least a part of the side wall of the fixing portion after the fixing portion is unfolded.
  • the fixing portion further includes a main end portion, one end of each of the plurality of turning rods is connected to the main end portion, and the other ends are connected from the main end portion.
  • the end portion is turned outwards in the direction of the sealing portion after being expanded radially outwards.
  • one end of the support net is connected to the other end of each of the plurality of turning rods at the distal end or side wall of the fixing portion, and the other end of the support net faces the seal extension in the direction of the section.
  • one end of the support mesh is expanded radially outward from the main end and turned outward toward the direction of the sealing portion, and then continues to extend toward the direction of the sealing portion.
  • the turning rods are respectively fixedly connected to the supporting nets.
  • the inversion strength of the whole formed by the plurality of inversion bars and the main end portion is greater than the inversion strength of the support net.
  • the one end of at least one of the inversion rods continues to extend toward the direction of the sealing portion after inversion.
  • the fixing part further includes a main end and a lead-out section, the lead-out section is made of a third braided wire to form a mesh tube, and one end of the lead-out section is carried out by the main end.
  • the closing mouth is fixed, and the other end is respectively connected with a plurality of the turning rods.
  • one end of the supporting net is respectively connected with the plurality of turning bars, and the other end extends toward the direction of the sealing part; or, the supporting net is multiple In each case, at least one of the turning rods is respectively connected with one end of at least one of the supporting nets.
  • the fixing portion is further provided with a spreading portion connected with the turning rod, and the spreading portion pushes the turning rod toward the seal during the unfolding process of the fixing portion.
  • the direction of the part is turned outward.
  • the fixing part further comprises a main end part, and one end of the supporting mesh is expanded radially outward from the main end part and turned outward toward the direction of the sealing part to form a concave area and the distal end face connected with the concave area, and then continue to extend towards the direction of the sealing part, the inversion rod is at least fixed on a part of the concave area of the support net and a part of the distal end face superior.
  • the end of the support mesh is open and bent toward the interior of the fixing portion
  • the sealing portion includes a distal disk surface at the distal end thereof, and at least a portion of the distal disk surface of the sealing portion is at least A part of the first film body is provided.
  • the turning rods there are a plurality of the turning rods, and a second film body is arranged on the fixing portion, and the second film body connects the plurality of turning rods in series along the circumferential direction of the fixing portion .
  • the supporting net and/or the inversion rod are provided with anchor thorns, and the ends of the anchor thorns face the sealing portion.
  • the length from the end of the inversion rod to the position between the vertex of the most distal end of the inversion rod ranges from 2 to 15 mm.
  • the inversion rod is made into a rod shape by cutting a tubular member or a plurality of second braided wires are wound into a rod shape, and its inversion strength is greater than that of the braided wires with the same axial length and predetermined bending shape. Inversion strength; and, compared with the sheet-like woven mesh structure with the same deployment diameter and inversion path, the inversion bar also has greater inversion strength, so it is easier to turn outwards during the unfolding process of the fixed portion, thereby ensuring the fixation The part can be fully deployed after release.
  • the side wall of the fixing part is composed of a mesh-like support mesh woven with the first woven wire, and when the fixing part is released and abuts against the cavity wall of the left atrial appendage, it can maintain a large contact area with the cavity wall , so that the extrusion force of the cavity wall by the fixed part is more uniform and dispersed, and the phenomenon of stress concentration is avoided.
  • the first braided filaments in the support mesh cross each other and the mesh holes are often small in practice, they can form surface contact with the cavity wall, and there is no chance that a certain part of the fixed part abuts between the adjacent comb muscles. The situation in the weak gullies between them avoids the adverse consequences caused by abrasion or puncturing of the cavity wall of the left atrial appendage.
  • the plugging device of the present application adopts a rod-shaped structure with high turnover strength combined with a soft woven mesh support structure to form a fixed part, which overcomes the existing problems of the fixed disk made by pure cutting or pure weaving in the prior art. For some problems, take the strengths of the two and make up for the weaknesses of the two, and at the same time overcome the technical prejudice that only the pure cutting method and the pure weaving method are used to make the fixed disk in the prior art. progress.
  • Example 1 is a schematic diagram of the overall structure of the plugging device of Example 1;
  • Fig. 2 is a schematic diagram of measuring the overturning strength of the overturning rod by means of a tensile machine
  • Figure 3 is a schematic diagram of measuring the inversion strength of a single first braided wire by means of a tensile machine
  • FIG. 4 is a schematic structural diagram of the fixing portion of the occluding device in FIG. 1 when viewed from the proximal end toward the distal end;
  • Example 5 is a schematic cross-sectional structure diagram of the plugging device of Example 2.
  • FIG. 6 is a schematic cross-sectional structure diagram of the plugging device of Example 3.
  • FIG. 7 is a schematic cross-sectional structural diagram of the plugging device of Example 4.
  • FIG. 7 is a schematic cross-sectional structural diagram of the plugging device of Example 4.
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end farther from the operator
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end farther from the operator
  • distal end the end farther from the operator
  • the occlusion device proposed in Example 1 can be used to occlude the left atrial appendage, and can also be used to occlude other in vivo tissues with openings, such as atrial septal defect.
  • the following will take the occlusion of the left atrial appendage as an example to introduce the occlusion device in detail.
  • the blocking device 100 includes a sealing portion 110 and a fixing portion 120 connected to the sealing portion 110 .
  • the sealing portion 110 and the fixing portion 120 are spaced apart along the axial direction of the plugging device 100 .
  • the sealing part 110 is located at the proximal end of the occlusion device 100
  • the fixing part 120 is located at the distal end of the occlusion device 100 .
  • the occlusion device 100 has a compressed state housed within a sheath to facilitate delivery within the body, and a deployed state (ie, a natural state) as shown in FIG. 1 after extending outward from the distal end of the sheath and self-expanding.
  • the shape of the occlusion device 100 after being released in the cavity of the left atrial appendage is exactly the same as or substantially the same as that shown in FIG. 1 .
  • the distal end of the sealing portion 110 abuts the proximal end of the fixing portion 120 .
  • the sealing portion 110 and the fixation portion 120 can approach or abut each other after release to fix the occlusion device 100 in the space between the left atrium and the right atrium to achieve blocking.
  • the fixing portion 120 includes a main end portion 121 at its proximal end, a plurality of inversion rods 122 connected with the main end portion 121 , and a support net 123 connected with each inversion rod 122 .
  • the main end portion 121 may be a hollow tubular shape, the distal end of which is connected with the proximal end of each inversion rod 122 , and the proximal end is directly or indirectly connected with the distal end of the sealing portion 110 .
  • the support mesh 123 is made of one or more first braided wires 1231 to be woven into a mesh shape, and the inversion rod 122 is cut into a rod shape using a tubular member.
  • the cut inversion rod 122 is generally stiffer than the braided wire used in the occlusion device 100 and has a larger cross section than the braided wire.
  • the inversion rod 122 is stiffer and has a larger cross section than the first braided wire 1231 hardness and large cross section.
  • the inversion rod 122 can be formed into a rod shape by superimposing and winding one or more second braided wires, so that the hardness of the inversion rod 122 is greater than that of a single second braided wire, and the cross section It is larger than the cross section of a single second braided wire.
  • the first braided wire 1231 can be a braided wire made of nickel-titanium alloy, other alloys, or polymers
  • the second braided wire can be a braided wire made of nickel-titanium alloy, other alloys, or polymers.
  • the wire diameter of the wire may be thicker or the same as the wire diameter of the first braided wire 1231 .
  • the tubular parts used for cutting can be nickel-titanium alloy tubes, other alloy tubes or polymer tubes, etc. All of these materials have superelasticity and good shape memory properties.
  • the cross section or outer diameter of the inversion rod 122 is much larger than the cross section or outer diameter of a single first braided wire 1231 , specifically, the cross section or outer diameter of the inversion rod 122
  • the cross section is 1.5 to 5 times the cross section of the single first braided wire 1231
  • the outer diameter of the turning rod 122 is 1.5 to 5 times the outer diameter of the single first braided wire 1231 .
  • the elasticity of the material used for the inversion rod 122 is greater than that of the material used for the first braided wire 1231 , or the elasticity of the material used for the inversion rod 122 is greater than the elasticity of the material used for the first braided wire 1231 , and the transverse direction of the inversion rod 122
  • the cross section or outer diameter is much larger than that of a single first braided wire 1231 or the like.
  • the inversion strength can be measured with the aid of an existing tensile machine.
  • an inversion rod 122 and a first braided wire 1231 as an example, and the axial length of the inversion rod 122 is the same as the axial length of the first braided wire 1231 , both of them have the same curved shape through heat setting, that is, the flipping trajectory is the same.
  • the flipping rod 122 When the flipping rod 122 is in a natural state, it is naturally bent into a predetermined shape as shown in (a) in FIG. 2 . At this time, the proximal end of the flipping rod 122 is first fixed on the immovable fixing device, and then the flipping rod is fixed. The distal end of 122 is connected to a tensile machine (not shown).
  • the turning rod 122 is straightened under the driving of the pulling machine, and the measured value F1 on the pulling machine at this time is recorded. According to the basic knowledge of mechanics, the measured value F1 is related to the turning rod 122 The inversion strength is equal. As shown in FIG. 3 , using the same method as the inversion rod 122 to measure, it can be obtained that the inversion strength of the single first braided wire 1231 is equal to the measured value F2 on the tension machine. After a lot of experimental measurements and comparing the values of F1 and F2, it can be concluded that the inversion strength of the inversion rod 122 is greater than the inversion strength of the single first braided wire 1231 .
  • the portion located at the proximal end is described as the proximal end of each component in the fixing portion 120
  • the portion located at the distal end is described as the distal end of each component in the fixing portion 120 .
  • all the flipping rods 122 are spaced apart around the main end 121 , and there is no intersection between any flipping rod 122 and other flipping rods 122 .
  • each inversion rod 122 is welded on the main end portion 121, or all inversion rods 122 and the main end portion 121 are an integral structure formed by cutting the same tubular piece, so that all inversion rods 122 can be It is fixedly connected to the main end 121 .
  • Each inverting rod 122 expands radially outward from the main end portion 121 while extending a distance toward the distal end, and then inverts outward in the direction of the sealing portion 110 .
  • the distal end of the inversion rod 122 is disposed on the distal end face 126 of the fixing portion 120.
  • the support mesh 123 is disposed at the distal end of the fixing portion 120 , and includes a plurality of closed ends 1232 that close the first braided wires 1231 . All the closed ends 1232 are connected with all the inversion rods 122 in a one-to-one correspondence, specifically, one closed end 1232 is fixedly connected with the distal end of one inversion rod 122, such as welding, socketing, bonding, etc.
  • the support nets 123 extend a certain distance from each of the closed ends 1232 toward the sealing portion 110 , so as to constitute the side walls 124 of the fixing portion 120 . After that, as shown in FIG. 4 , the distal end of the support mesh 123 is bent toward the inside of the fixing portion 120 , and the distal end of the support mesh 123 is opened.
  • the whole formed by each inversion rod 122 and the main end 121 has a larger inversion strength (the two can be used by a tensile machine to adopt the above-mentioned inversion strength.
  • the fixing portion 120 has sufficient turning ability during the unfolding process, and it is easier to turn outwards, so as to ensure that the fixing portion 120 can be fully unfolded after release.
  • the side wall 124 of the fixing portion 120 is composed of a hollow mesh tube woven with the first braided wire 1231.
  • first braided wires 1231 in the hollow mesh tube cross each other and the meshes are often small, they can form surface contact with the cavity wall, and there is no chance that a certain part of the fixing portion 120 abuts between adjacent pectinate muscles The situation in the weak gully avoids the adverse consequences of grinding or puncturing the cavity wall of the left atrial appendage.
  • the end of the support net 123 is open, but not bent toward the interior of the fixing portion 120 , that is, the end of the support net 123 maintains the original direction toward the sealing portion 110 .
  • two adjacent flipping rods 122 may be connected by one or more struts, so as to keep the adjacent flipping rods 122 from crossing or shifting, and can strengthen the flipping rods 122 rollover strength.
  • the sealing portion 110 is braided into a mesh tube by a plurality of third braided wires 111 , and both ends of the mesh tube are closed and fixed by a sleeve 112 respectively at the ends of the third braided wires 111 . Then, the mesh tube is heat-set into a plug shape as shown by the sealing part 110 in FIG. 1 , so as to obtain the sealing part 110 for sealing the opening of the left atrial appendage. In other implementations, the sealing portion 110 can also be heat-set into a shape such as a disk shape or a column shape.
  • the sealing portion 110 includes a distal disk surface 113 located at its distal end and facing the fixing portion 120 , and a proximal disk surface 114 opposite to the distal disk surface 113 .
  • the interior of the sealing portion 110 may be provided with at least one layer of a third film body (not shown), wherein the edge of one third film body is fixed on the braided wire at the edge of the sealing portion 110, and the other third film bodies may be fixed on the sealing portion 110.
  • the other positions in the portion 110 may be as long as the passage of blood flow can be blocked.
  • the third membrane body is used to prevent blood flow from one side of the sealing portion 110 to the other side, so as to prevent blood flow from circulating between the left atrial appendage and the left atrium.
  • At least a part of the distal disk surface 113 of the sealing portion 110 is provided with a first film body (not shown), and the first film body is preferably disposed at a position opposite to the end opening of the support net 123 to prevent When the end of the support mesh 123 is bent toward the interior of the fixing part 120 , it is hooked to the third braided wire 111 on the distal disk surface 113 of the sealing part 110 and cannot be unfolded, thereby causing the occlusion device 100 to be unstablely fixed.
  • the first thin film body may further have a flow blocking effect.
  • the fixing portion 120 is provided with a second film body, and the second film body connects each of the turning rods 122 in series along the circumferential direction of the fixing portion 120 .
  • the second film body can be in a shape similar to a hemisphere, and is attached to the outer surface or inner surface of the fixing portion 120, and is fixedly connected with each inversion rod 122 by sutures or adhesives, etc., so that the multiple The plurality of turning rods 122 are connected in series along the circumferential direction of the fixing portion 120 to prevent the problem of hinge between the turning rods 122 during the unfolding process of the fixing portion 120 .
  • the second thin film body may further have a flow blocking effect.
  • a plurality of anchor barbs 125 are arranged on the support mesh 123 at intervals along the circumferential direction of the fixing portion 120 , and one end of the anchor barbs 125 is fixed on one of the first braided wires 1231 or wound around one or more first braided wires On the wire 1231, the end of the anchor barb 125 faces the sealing part 110, so that after the fixing part 120 is deployed, the anchor barb 125 penetrates into the body tissue, thereby assisting in fixing the occlusion device 100 and making it more stable.
  • the anchor barbs 125 are only provided on the inversion rod 122 , for example, at least one inversion bar 122 is provided with the anchor barbs 125 , and one end of the anchor barbs 125 is fixed on the inversion rod 122 or integrally formed with the inversion rod 122 , the end of the anchor barb 125 faces the sealing part 110 .
  • not only a plurality of anchor barbs 125 are provided on the support net 123, but also a plurality of anchor barbs 125 are respectively provided on the plurality of turning rods 122, and the ends of the anchor barbs 125 are all facing the sealing portion 110.
  • the anchor barbs 125 on the support net 123 and the anchor barbs 125 arranged on the overturning rod 122 form a staggered distribution along the axial direction of the fixing part 120 , which can fix the blocking device 100 in multiple directions and lift the fixed position of the blocking device 100 . stability. In other implementations, the anchor barb 125 may not be provided on the fixing portion 120 .
  • the value range of the length between the end of the flipping rod 122 and the vertex P of the most distal end of the flipping rod 122 is 2 to 15 mm, so that the entire fixing portion 120 is relatively smooth during the flipping process and can ensure sufficient flipping strength.
  • the vertex P at the farthest end of the turning rod 122 is often the point where the bending degree of the turning rod 122 is the greatest.
  • the occlusion device 100 can be delivered and controlled release in vivo with existing sheaths and delivery rods.
  • the proximal sleeve 112 of the sealing portion 110 is detachably connected to the distal end of the delivery rod.
  • the sealing part 110 is connected with the delivery rod and both are accommodated in the sheath, and are transported to the target position in the body along with the sheath.
  • the delivery rod is then pushed distally to release and deploy the fixation portion 120 from the distal end of the sheath.
  • the delivery rod is further pushed distally, so that the sealing portion 110 protrudes from the distal end of the sheath for release and deployment, so as to close the opening of the tissue in the body.
  • the connection between the delivery rod and the sealing part 110 is released, and the delivery rod and the sheath are recovered to the outside of the body, thereby completing the occlusion operation.
  • the occlusion device 200 of Embodiment 2 is substantially similar to the occlusion device 100 of Embodiment 1, and the same features will not be repeated here.
  • the main difference between the second embodiment and the first embodiment is that, as shown in FIG. Spread out and stretch for a distance toward the distal end, then turn outward toward the direction of the sealing portion 110, and then continue to extend for a distance toward the direction of the sealing portion 110, and finally, the distal end of the supporting mesh 223 is bent toward the interior of the fixing portion 120 to To prevent the end of the support mesh 223 from abutting on the cavity wall of the left atrial appendage after the fixing part 220 is deployed, causing abrasion.
  • the proximal end of the support mesh 223 can be crimped through the main end 121, or can be crimped through a sleeve.
  • the sleeve can be further accommodated in the cavity of the main end 121 , or sleeved outside the main end 121 to accommodate the proximal end of the first braided wire 1231 between the sleeve and the main end 121 . within the gap.
  • the proximal ends of the plurality of inversion rods 122 are respectively connected to the main end portion 121 , and the inversion rods 122 are respectively attached to and fixedly connected to the support mesh 223 at intervals along the circumferential direction of the fixing portion 220 .
  • the overall inversion strength formed by all the inversion rods 122 and the main end portion 121 is greater than the inversion strength of the support net 223 . Therefore, when the fixing portion 220 protrudes from the distal end of the sheath tube, each inversion rod 122 and the supporting mesh 223 are unfolded and flipped together, and because the inversion strength of the inversion rod 122 is relatively large, the flip rod 122 can be driven to fit and fix it together.
  • the corresponding part of the support net 223 is turned over, so that the support net 223 can still be fully expanded under the obstruction of the pectus muscle inside the left atrial appendage or when the release space in the cavity is small, which improves the overall stability of the fixing part 220.
  • the turning strength ensures that the blocking device 100 can be normally fixed in the cavity.
  • the turning rod 122 can be wound and fixed on the first braided wire 1231 of the support net 223 by sutures, or openings can be provided at one or more places on the turning rod 122, and then the sutures can be passed through the openings and the openings.
  • the corresponding portion of the support mesh 223 is fixed.
  • the turning rod 122 can also be fixed at a suitable position of the supporting net 223 by means of adhesive or sleeve.
  • the turning rod 122 can be fitted and fixed on the inner surface or the outer surface of the support net 223 , and can also be fixedly connected with the first braided wire 1231 of the support net 223 in an interpenetrating manner.
  • the distal end of the supporting mesh 223 may not be bent toward the inside of the fixing part 220 , but along the direction toward the sealing part 110 , and the end of the supporting mesh 223 is woven along the fixing part 220 by the first woven wire 1231 .
  • the circumferential direction is closed without several separate ends.
  • a plurality of flexible ends may be provided at the end of the support mesh 223 along the circumferential direction of the fixing portion 220 .
  • both ends of the inversion rod 122 are free ends, which can also enhance the overall inversion strength of the fixed part 220, so that the fixed part 220 can be more easily flipped and fully unfolded when limited.
  • the plugging device 300 of Embodiment 3 is generally similar to the plugging device 100 of Embodiment 1 and the plugging device 200 of Embodiment 2, and the same features are not repeated here.
  • the main difference between Embodiment 3 and Embodiment 1 and Embodiment 2 is that, as shown in FIG. Section 326 leads out.
  • the lead-out section 326 is made of a third braided wire 3261 to be woven into a net tube shape with a hollow interior and open ends at both ends. Welding, bonding, splicing through sleeves, etc.
  • the distal end of the lead-out section 326 is in the shape of an opening, and the edge of the distal end is fixedly connected with the supporting mesh 323 .
  • the support net 323 is woven into an inner hollow net tube through one or more first braided wires 1231, and has only one opening, and the opening can be closed and fixed by a sleeve 3231, and the sleeve 3231 is then fixed on the overturning rod 122. end.
  • connection method of the above-mentioned fixed connection may be welding, bonding, and socket connection through a sleeve.
  • a support net 323 may be respectively connected to the ends of several inversion bars 122 .
  • the distal end of the support mesh 323 can also be set to be open, or can be further closed and fixed through another sleeve.
  • the plurality of support nets 323 in FIG. 6 can be replaced by one support net 123 as shown in Embodiment 1, the proximal end of the support net 123 is the same as the distal end of the plurality of inversion rods 122 in FIG. 6 .
  • the distal ends are respectively connected, and the distal ends extend toward the direction of the sealing portion 110 ; alternatively, the distal ends of the supporting meshes 123 may be further bent toward the inside of the fixing portion 320 .
  • the occlusion device 400 of Embodiment 4 is substantially similar to the occlusion device 200 of Embodiment 2, and the same features are not repeated here.
  • the main difference is that, as shown in FIG. 7 , the fixing portion 420 is further provided with a spreading portion 427 connected with the turning rod 122 , and the spreading portion 427 pushes the turning rod 122 toward the seal during the unfolding of the fixing portion 420 .
  • the orientation of the portion 110 is flipped outward.
  • the spreading portion 427 includes at least a first strut 4271 and a second strut 4272 , the proximal end of the first strut 4271 is fixedly connected to one of the flipping rods 122 , and the proximal end of the second strut 4272 is fixedly connected to the On the other flipping rod 122, the two flipping rods 122 may be arranged symmetrically or not.
  • the distal end of the first strut 4271 and the distal end of the second strut 4272 are fixedly connected together. In other implementations, the distal end of the first strut 4271 and the distal end of the second strut 4272 may be spaced apart from each other or abut each other.
  • the first strut 4271 extends from its proximal end toward the distal end and toward the direction close to the central axis of the fixing portion 420
  • the second strut 4272 also extends from its proximal end toward the distal end and toward the center of the fixing portion 420 .
  • the direction of the axis extends.
  • the first strut 4271 and the second strut 4272 are symmetrically arranged.
  • the number of struts in the spreading portion 427 may be multiple, for example, three or more. In other implementations, one end of the first strut 4271 and the second strut 4272 close to the central axis of the fixing portion 420 may extend toward the proximal end.
  • the first strut 4271 and the second strut 4272 are constrained in a linear shape, and are surrounded by each of the turning rods 122 .
  • the first strut 4271 and the second strut 4272 return to a predetermined shape due to their own elasticity, so that the first strut 4271 and the second strut 4272 are mutually Under the push of the opposing force, or under the push of the force exerted by the first strut 4271 and the second strut 4272 to the support net 223 during the unfolding process, the turning rod 122 is pushed toward the direction of the sealing part 110 It is turned outward, thereby enhancing the turning strength of the turning rod 122 , thereby improving the overall turning strength of the fixing portion 420 .
  • At least one distal end of the inversion rod 122 continues to extend toward the direction of the sealing portion 110 after inversion. That is, the end of the inversion rod 122 continues to extend toward the proximal end at the position shown in FIG. 5 , for example, the support mesh 223 extends for a distance toward the proximal end, or further extends to a position close to the end of the support mesh 223 , At this time, the distal end of the turning rod 122 is also bent toward the inside of the fixing portion 420 , so that the turning of the entire supporting net 223 is easier under the driving of the turning rod 122 .
  • the plugging device 100 of Embodiment 1 the plugging device 200 of Embodiment 2, and the plugging device 300 of Embodiment 3, respectively, on the at least two inversion rods 122 of the fixing portion thereof, respectively.
  • the opening portion 427 as in the fourth embodiment is provided to enhance the overturning strength of the overturning rod 122 , which will not be repeated here.

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  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

Un appareil d'occlusion (100) comprend une partie d'étanchéité (110) et une partie de fixation (120) reliée à la partie d'étanchéité (110) ; la partie de fixation (120) comprend une maille de support (123) et au moins une tige tournante (122) reliée à la maille de support (123) ; la maille de support (123) présente une forme de maille obtenue en tissant des premiers fils de tissage (1231), la tige tournante (122) présente une forme de tige obtenue par coupe d'un élément tubulaire ou par enroulement d'une pluralité de seconds fils de tissage ; une extrémité de la tige tournante (122) s'étend vers l'extrémité distale, puis est tournée vers l'extérieur dans la direction de la partie d'étanchéité (110) pendant le processus d'étalement de la partie de fixation (120) ; au moins une partie de la maille de support (123) forme au moins une partie de la paroi latérale de la partie de fixation (120) après que la partie de fixation (120) a été étalée. Dans l'appareil d'occlusion (100), la tige tournante (122) permet à la partie de fixation (120) d'offrir une plus grande résistance à la rotation et donc d'être plus facile à tourner complètement, ce qui permet d'éviter l'abrasion ou la perforation de l'oreillette gauche causées par la butée d'une certaine partie de la partie de fixation (120) contre l'intérieur d'une rainure entre les muscles pectinés.
PCT/CN2021/130903 2021-01-05 2021-11-16 Appareil d'occlusion WO2022148135A1 (fr)

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CN112315523B (zh) * 2021-01-05 2021-06-04 先健科技(深圳)有限公司 封堵装置

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CN112315523A (zh) * 2021-01-05 2021-02-05 先健科技(深圳)有限公司 封堵装置

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