WO2022042718A1 - Dispositif d'occlusion d'appendice auriculaire gauche - Google Patents

Dispositif d'occlusion d'appendice auriculaire gauche Download PDF

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Publication number
WO2022042718A1
WO2022042718A1 PCT/CN2021/115281 CN2021115281W WO2022042718A1 WO 2022042718 A1 WO2022042718 A1 WO 2022042718A1 CN 2021115281 W CN2021115281 W CN 2021115281W WO 2022042718 A1 WO2022042718 A1 WO 2022042718A1
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WO
WIPO (PCT)
Prior art keywords
anchoring
left atrial
atrial appendage
anchoring structure
film
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Application number
PCT/CN2021/115281
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English (en)
Chinese (zh)
Inventor
李建民
丘家明
王永胜
Original Assignee
杭州德诺电生理医疗科技有限公司
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Application filed by 杭州德诺电生理医疗科技有限公司 filed Critical 杭州德诺电生理医疗科技有限公司
Publication of WO2022042718A1 publication Critical patent/WO2022042718A1/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

Definitions

  • the present application relates to medical devices, in particular to a left atrial appendage occluder that can be delivered to a selected part of the human body by percutaneous puncture.
  • Percutaneous puncture technology has been used more and more in the treatment of diseases.
  • a variety of materials, devices and drugs can be placed into the heart and arteriovenous vessels of the human body.
  • a left atrial appendage occluder can be placed in the left atrial appendage to block the entrance of the left atrial appendage cavity and block all or most of the blood flow to the left atrial appendage cavity, thereby preventing the left atrial appendage cavity due to atrial fibrillation.
  • Form a thrombus to eliminate the stroke caused by the thrombus ascending to the brain; or prevent the thrombus from reaching other parts of the body through the human blood circulation system, causing systemic embolism.
  • the left atrial appendage occluder is divided into two types: one-piece and split-type.
  • the integrated type means that the left atrial appendage occluder needs to be fully inserted into the left atrial appendage cavity
  • the split type means that the left atrial appendage occluder includes a sealing disc and an anchoring disc connected to the sealing disc.
  • Transcatheter delivery to the entrance of the left atrial appendage cavity and re-deployment wherein the sealing disc is used to cover the entrance, blocking all or most of the blood flow to the left atrial appendage, and the anchoring disc is usually inserted into the inner wall of the left atrial appendage cavity Or in the tissue near the entrance, or fixed in the left atrial appendage cavity according to its own pressing force on the left atrial appendage cavity wall, so that the sealing disc is positioned at the aforementioned entrance to prevent the occluder from falling off and to avoid blocking leakage as much as possible, So as to play a good blocking effect.
  • the surface of the anchoring disc is covered with a blocking membrane.
  • the radial support force of the anchoring disc of such a left atrial appendage occluder is too large, so that the pressing force of the anchoring disc on the wall of the left atrial appendage cavity is too large, which is likely to cause complications.
  • the present application provides a left atrial appendage occluder capable of avoiding excessive radial support force of the anchoring disc.
  • the present application discloses a left atrial appendage occluder, which is characterized by comprising a membrane, an anchoring structure arranged at the distal end, and a sealing disc arranged at the proximal end, the sealing disc is fixedly connected to the anchoring structure, and the The covering film is covered on at least part of the anchoring structure, and in the first direction of the anchoring structure, the full length of the covering film is greater than the area of the anchoring structure covered by the covering film. Extended length.
  • the first direction is the circumferential direction and/or the axial direction of the anchoring structure.
  • the surface of the anchoring structure includes a first area and a second area located in different ranges in the first direction, the coating is provided with a raised area and other areas that are connected to each other, and the raised area is Correspondingly covering the first area, the other areas correspondingly covering the second area, the gap between the film in the raised area and the first area is larger than the film in the other areas and the gap between the film and the first area. gaps between the second regions.
  • the coating is provided with a plurality of the raised regions and a plurality of the other regions, the plurality of the raised regions are arranged along at least one of the first directions, and the other regions are connected. between two adjacent raised areas.
  • At least a part of the raised area is arranged parallel or inclined with respect to the axial direction of the anchoring structure.
  • the anchoring structure has an anchoring portion, the anchoring portion is cylindrical and extends in the circumferential direction of the anchoring structure, the anchoring portion is spaced apart from the sealing disc, The proximal end of the anchor portion extends toward the side where the sealing disc is located.
  • the anchoring structure further includes a connecting portion accommodated in the anchoring portion, the connecting portion is formed by extending from the sealing disc, and is connected to the distal end of the sealing disc and the anchor. Between the distal ends of the anchoring parts, the anchoring part and the connecting part together form a cavity.
  • the coating covers at least part of the area of the anchor portion and/or the connection portion, and the side of the anchor portion and the connection portion away from the cavity is the outside, so the The side of the anchoring portion and the connecting portion facing the cavity is the inner side, and the covering film is located on the inner side and/or the outer side of the anchoring structure.
  • the distal end of the connecting portion is funnel-shaped and surrounds an opening, the connecting portion is located between the cavity and the opening, and at least part of the coating covers the opening.
  • the barb also includes a barb fixedly connected to the anchoring portion, the barb includes a barb connecting portion and a barb suspended portion, and the barb connecting portion is fixedly connected to the barb suspended portion Between the anchor portion and the anchor portion, the barb suspended portion extends toward the proximal end, and when the covering film covers the outside of the anchor portion, the barb connecting portion passes through the covering film, so The barb suspended portion and the anchor portion are respectively located on two sides of the covering film.
  • it also includes a sealing film covering the sealing disc.
  • the membrane has less restraint on the anchoring structure, so that the contribution of the membrane to the radial support force of the anchoring structure is small, and the amount of deformation of the membrane occurs. It is not easy to affect the deformation amount of the anchoring structure, that is, in the first direction, the membrane is not easy to pull or bind the anchoring structure due to the extrusion of the left atrial appendage cavity wall, so that the radial support force of the anchoring structure will not be too much. It is large and causes damage to the human body, which is beneficial for the anchoring structure to better fit the wall of the left atrial appendage cavity.
  • FIG. 1 is a schematic three-dimensional structural diagram of the left atrial appendage occluder provided by the first embodiment of the present application.
  • FIG. 2 is a schematic plan view of the left atrial appendage occluder shown in FIG. 1 .
  • FIG. 3 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 2 along F-F.
  • FIG. 4 is a schematic diagram of an application scenario of the left atrial appendage occluder shown in FIG. 1 .
  • FIG. 5 is a schematic plan view of the left atrial appendage occluder provided by the second embodiment of the present application.
  • FIG. 6 is a schematic cross-sectional view along A-A of the left atrial appendage occluder shown in FIG. 5 .
  • FIG. 7 is a schematic three-dimensional structural diagram of the left atrial appendage occluder shown in FIG. 5 .
  • FIG. 8 is a partial structural schematic diagram of the anchoring structure and the membrane of the left atrial appendage occluder shown in FIG. 5 .
  • the position close to the operator is generally defined as the proximal end, and the position away from the operator is defined as the distal end;
  • the circumferential direction of objects such as cylinders and tubes is defined as the circumferential direction.
  • the left atrial appendage occluder 100 for implanting into the left atrial appendage of the heart, blocking the entrance of the left atrial appendage cavity, and blocking the flow to the left atrial appendage All or most of the blood flow in the cavity and block the thrombus inside the left atrial appendage from entering the left atrium.
  • the left atrial appendage occluder 100 includes a membrane 10 , an anchoring structure 30 arranged at the distal end, and a sealing disc 50 arranged at the proximal end. The sealing disc 50 is fixedly connected to the anchoring structure 30 .
  • the anchoring structure 30 is used to abut against the inner wall of the left atrial appendage cavity to prevent the left atrial appendage occluder 100 from falling off from the left atrial appendage cavity.
  • the sealing disc 50 is used to block the entrance of the left atrial appendage cavity
  • the membrane 10 is used to block all or most of the blood flow to the left atrial appendage cavity, and is sandwiched between the anchoring structure 30 and the left atrial appendage tissue, It is used to reduce the stimulating effect of the material used to make the anchoring structure 30 on the left atrial appendage tissue, and the membrane 10 increases the contact area between the left atrial appendage occluder 100 and the left atrial appendage tissue, and the left atrial appendage cavity wall is more uniformly stressed , the force per unit area is smaller, and the damage to the wall of the left atrial appendage caused by excessive local force is avoided.
  • the left atrial appendage occluder 100 may also include membranes arranged at other positions.
  • the covering film 10 covers at least part of the anchoring structure 30 .
  • the full length of the covering film 10 is greater than the area covered by the covering film 10 in the anchoring structure 30 . extension length.
  • the first direction is the circumferential direction and the axial direction of the anchoring structure 30 .
  • the complete length of the film 10 in a certain direction refers to the length of the film 10 in the direction when the film 10 is fully unfolded in the direction.
  • the full length of the film 10 refers to the length of the film 10 in the circumferential direction of the anchoring structure 30 when the film 10 is spread out along the outer peripheral surface of the anchoring structure 30 .
  • the full length of the film 10 refers to the length of the film 10 in the axial direction of the anchoring structure 30 when the film 10 is spread out along the outer peripheral surface of the anchoring structure 30. length.
  • the extension length of the anchoring structure 30 in a certain direction refers to the distance that the anchoring structure 30 extends along the surface of the anchoring structure 30 in the direction.
  • the extension length of the anchoring structure 30 in the circumferential direction refers to the distance extending along the surface of the anchoring structure 30 in the circumferential direction.
  • the extension length of the anchoring structure 30 in the axial direction refers to the distance extending along the surface of the anchoring structure 30 in the axial direction.
  • the full length of the covering film 10 is greater than the extended length of the area covered by the covering film 10 in the anchoring structure 30 .
  • the covering film 10 is provided with a certain redundancy in the circumferential direction of the surface of the anchoring structure 30, so that the covering film 10 loosely covers the anchoring structure 30 in the circumferential direction, and provides the deformation of the anchoring structure 30 in the circumferential direction.
  • the contribution of , that is, the amount of deformation of the membrane 10 is not easy to affect the amount of deformation of the anchoring structure 30, that is, the membrane 10 is not easily pulled or bound in the circumferential direction of the anchoring structure 30 due to being squeezed by the left atrial appendage cavity wall, So that the radial support force of the anchoring structure 30 will not be too large to cause damage to the human body, it is beneficial for the anchoring structure 30 to better fit on the wall of the left atrial appendage cavity.
  • the full length of the covering film 10 is greater than the extended length of the area covered by the covering film 10 in the anchoring structure 30 .
  • the film 10 is provided with a certain amount of redundancy in the axial direction of the surface of the anchoring structure 30, so that the film 10 can loosely cover the anchoring structure 30 in the axial direction, and the anchoring structure 30 is the anchoring structure 30 in the axial direction.
  • the certain space provided by the deformation of the anchoring structure 30 is beneficial to reduce the binding force of the covering film 10 to the anchoring structure 30 during the deformation process of the anchoring structure 30 in the axial direction, and further reduce the diameter of the covering film 10 to the anchoring structure 30 Contribution to the support force, that is, the deformation amount of the membrane 10 is not easy to affect the deformation amount of the anchoring structure 30, that is, the membrane 10 is not easily pulled or restrained in the axial direction due to being squeezed by the wall of the left atrial appendage cavity.
  • the anchoring structure 30 prevents the radial supporting force of the anchoring structure 30 from being too large to cause damage to the human body, which is beneficial for the anchoring structure 30 to better fit the wall of the left atrial appendage cavity.
  • the first direction refers to both the circumferential direction and the axial direction, that is, the film 10 is provided with redundant film amounts relative to the anchoring structure 30 in both the circumferential direction and the axial direction.
  • the deformation space is provided for the anchoring structure 30 in the axial direction, the restraint on the anchoring structure 30 is reduced, the contribution to the radial support force of the anchoring structure 30 is reduced, and the radial support force of the anchoring structure 30 is reduced. It will not be too large to cause damage to the human body.
  • the first direction refers to at least one of the circumferential direction, the axial direction or other directions.
  • the anchoring structure 30 has a connecting portion 31 and an anchoring portion 33 .
  • the connecting portion 31 is formed by extending from the sealing disc 50 to the distal end.
  • the connecting portion 31 is accommodated in the anchoring portion 33 and connected to the sealing disc 50 . between the distal end of the anchor portion 33 and the distal end of the anchor portion 33 .
  • the anchoring portion 33 is cylindrical and extends in the circumferential direction of the anchoring structure 30.
  • the anchoring portion 33 is spaced apart from the sealing disc 50, and the proximal end of the anchoring portion 33 extends toward the side where the sealing disc 50 is located.
  • the distal end of 33 extends away from the side where sealing disc 50 is located.
  • the anchoring portion 33 and the connecting portion 31 together form a cavity 32 .
  • the distal end of the connecting portion 31 is funnel-shaped and surrounds an opening 312.
  • the direction of the opening 312 faces the distal end.
  • the connecting portion 31 is located between the cavity 32 and the opening 312.
  • the film 10 covers the opening 312.
  • the region of the membrane 10 near the central axis of the opening 312 is concave proximally.
  • the covering film 10 is flat at the opening 312 or protrudes distally; in the modified embodiment, the distal end of the connecting portion 31 is flat, that is, the opening is omitted.
  • the anchoring structure 30 further includes a constriction portion 35 formed by the proximal end of the anchoring portion 33 being bent and extending toward the direction of the connecting portion 31 .
  • the anchoring structure 30 omits the provision of the constricted portion 35 .
  • the extension length of the region covered by the coating film 10 in the connecting portion 31 and the anchor portion 33 is smaller than that of the coating film 10 covering the region.
  • the full length, in the axial direction of the anchoring portion 33 , the extension length of the region covered by the coating film 10 in the connecting portion 31 and the anchoring portion 33 is less than the full length of the coating film 10 covering this region, that is, the coating film 10 It loosely covers the connecting portion 31 and the anchoring portion 33 . In this way, the restraint of the film 10 on the anchor portion 33 and the connection portion 31 is reduced, thereby reducing the contribution of the film 10 to the supporting force of the anchor portion 33 and the connection portion 31 in all directions.
  • the region of the membrane 10 near the central axis of the opening 312 is not limited to be recessed toward the proximal end.
  • the area of the film 10 close to the central axis of the opening 312 can also be flatly covered at the opening 312 .
  • the coating film 10 covers the anchor portion 33 and the partial regions of the connection portion 31 .
  • the side of the anchoring portion 33 and the connecting portion 31 away from the cavity 32 is the outside, and the side of the anchoring portion 33 and the connecting portion 31 facing the cavity 32 is the inside.
  • the membrane 10 is located at the anchoring part 33 and the outside of the connecting part 31 .
  • the membrane 10 is located between the anchoring portion 33 and the left atrial appendage cavity wall, which greatly increases the contact area between the anchoring portion 33 and the left atrial appendage cavity wall , the force on the wall of the left atrial appendage is more uniform, and the force on the wall of the left atrial appendage per unit area is smaller, so as to avoid the damage to the human body caused by excessive local force on the wall of the left atrial appendage.
  • the anchoring portion 33 and the connecting portion 31 are covered by the film 10, and it is within the protection scope of the present application that the film 10 covers at least part of the anchoring portion 33 and/or the connecting portion 31 .
  • the film 10 covers at least part of the anchoring portion 33 and/or the connecting portion 31 .
  • one of the anchor portion 33 and the connection portion 31 may be covered with the coating film 10 , but not limited to.
  • the covering film 10 is not limited to be positioned outside the anchoring portion 33 and the connecting portion 31 , and that the covering film 10 is positioned inside and/or outside the anchoring portion 33 and the connecting portion 31 is within the protection scope of the present application.
  • the coating 10 is located inside the anchoring portion 33 and the connecting portion 31 .
  • both the inner side and the outer side of the anchor portion 33 and the connecting portion 31 are covered with the coating film 10 .
  • the covering film 10 can be sewed on the anchoring part 33 and/or the connecting part 31 by using but not limited to using sutures, and the covering film 10 can also be adhered to the anchoring part 33 and/or the connecting part 31 by using, but not limited to, medical glue. /or on the connecting portion 31 .
  • the coating 10 has at least one opening (not shown).
  • the ratio of the sum of the area of the openings to the area of the covering film 10 is the porosity of the covering film 10.
  • the membrane 10 is not limited to have at least one opening.
  • the membrane 10 may not include an opening, that is, the membrane 10 can also, but is not limited to, neither allow thrombus to pass through nor A blocking membrane that allows blood flow to pass through.
  • an anticoagulant eg, heparin
  • heparin is attached to the surface of the film 10 so that the film 10 has antithrombin properties.
  • the surface of the coating film 10 may also, but not be limited to, adhere to compounds with other properties, or the surface of the coating film 10 may also be, but not limited to, not coated with compounds, which is not limited in this application.
  • the shape of the coating 10 is not limited, and the coating 10 may be a two-dimensional sieve, a porous membrane, a woven or non-woven mesh, or a similar structure.
  • the material for making the film 10 is not limited, and the film 10 can be made of metal or metal mesh with fine fibers, or can be made of biocompatible materials, such as expanded polytetrafluoroethylene (expanded polytetrafluoroethylene) , ePFTE), polyester, polytetrafluoroethylene (PTFE), silicone, urethane, metal fiber, medical silicone, polyester, or other biocompatible polymers.
  • the cover film 10 may be one layer or multiple layers, wherein, when the cover film 10 is made of multiple layers, the flow blocking effect of the cover film 10 can be significantly improved.
  • the left atrial appendage occluder 100 further includes a barb 70 that is fixedly connected to the anchoring portion 33.
  • the barb 70 includes a barb connecting portion 71 and a barb suspension portion 73.
  • the barb connection portion 71 is fixedly connected to the barb suspension portion 73 and the barb suspension portion 73.
  • the barb overhangs 73 extend toward the proximal end.
  • the barb suspended portion 73 is used to penetrate the wall of the left atrial appendage to prevent the left atrial appendage occluder 100 from falling off from the left atrial appendage.
  • the barb connecting portion 71 passes through the covering film 10 , and the barb suspended portion 73 and the anchoring portion 33 are respectively located on both sides of the covering film 10 . Because the barb connecting portion 71 passes through the membrane 10, on the one hand, it is beneficial to fix the membrane 10 and prevent the membrane 10 from falling off the anchoring portion 33; After the cavity wall, the membrane 10 can be located between the anchoring portion 33 and the left atrial appendage cavity wall, so as to increase the contact area between the anchoring portion 33 and the left atrial appendage cavity wall, so as to avoid the penetration depth of the barb suspended portion 73 being too large. damage to the human body.
  • the sealing disc 50 includes a disc surface 51 , a waist portion 53 and a sealing film 55 , and the waist portion 53 is fixedly connected to the distal end of the disc surface 51 .
  • the disk surface 51 and the waist 53 are formed together to form a cavity, the side close to the cavity is defined as the inner side, and the side away from the cavity is defined as the outer side.
  • the sealing disc 50 is provided with two sealing films 55 , wherein one sealing film 55 is fixedly connected to the inner side of the disk surface 51 , and the other sealing film 55 is also fixedly connected to the waist 53 inside. Because the sealing membrane 55 is provided, the sealing performance of the sealing disc 50 is enhanced, the formation of blood flow at the left atrial appendage is avoided, and the thrombus is prevented from entering the left atrium.
  • the sealing film 55 can also be fixedly connected to the outer side of the disk surface 51 , but is not limited to, or, in a modified embodiment, both the outer side and the inner side of the disk surface 51 are covered by the sealing film 55 .
  • the sealing film 55 may also, but is not limited to, be fixedly connected to the outer side of the waist portion 53 , or, in a modified embodiment, both the outer side and the inner side of the waist portion 53 are covered by the sealing film 55 .
  • the left atrial appendage occluder 100 may only include the sealing membrane 55 provided on the disk surface 51, or the left atrial appendage occluder 100 may only include the sealing membrane 55 provided on the disk surface 51.
  • the left atrial appendage occluder 100 can be delivered to a selected part of the human body through a percutaneous puncture technique.
  • the left atrial appendage occluder 100 includes a contracted state and a released state.
  • the left atrial appendage occluder 100 can be loaded into a delivery device with a smaller diameter, and then enter the upper cavity through, for example, femoral vein puncture. The vein then enters the right atrium a, and then punctures through the atrial septum b into the left atrium c, thereby reaching the left atrial appendage d.
  • the anchoring structure 30 is released inside the left atrial appendage, and the barbed suspended portion on the anchoring portion 33 pierces the wall of the left atrial appendage cavity;
  • the disk surface 51 of the sealing disk 50 is released at the position of the opening 312 of the left atrium, and the opening position of the left atrial appendage is closed.
  • the left atrial appendage occluder 100 is disengaged from the connection of the delivery device. At this time, the left atrial appendage occluder 100 is in a released state, and the released state is as shown in the figure.
  • left atrial appendage occluder 100 enters the left atrial appendage is not limited.
  • the membrane 210 in the left atrial appendage occluder 200 is in a pleated shape.
  • the first direction is the axial direction and the circumferential direction of the anchoring structure 230 .
  • a plurality of first regions 236 and a plurality of second regions 237 in different ranges upward, the plurality of first regions 236 are arranged along the circumferential direction of the anchoring structure 230 , and each second region 237 is located between two adjacent first regions 236 .
  • the film 210 is provided with several raised areas 216 and several other areas 217 , and the raised areas 216 and the other areas 217 are connected to each other.
  • the raised areas 216 correspond to cover the first area 236, and the other areas 217 correspond to cover the second area 237.
  • Several raised areas 216 are arranged along the circumferential direction in the first direction of the anchoring structure 230, and the other areas 217 are connected to two adjacent ones. between the raised regions 216 .
  • each raised area 216 extends from the proximal end to the distal end along the surface of the anchoring structure 230 .
  • the portion of the raised area 216 covering the anchoring portion 233 is along the axial direction of the anchoring portion 233 .
  • the portion of the raised area 216 covering the connecting portion 231 extends along the radial direction of the anchoring portion 233 .
  • the gap d1 between the film 210 in the raised region 216 and the first region 236 is larger than the gap between the film 210 and the second region 237 in the other regions 217 d2. It should be noted that, in this way, since the cover film 210 includes several convex regions 216 and several other regions 217 , the deformable space of the cover film 210 can be increased in the circumferential direction, and the stretchable range of the cover film 210 can be increased.
  • the membrane 210 is not easy to involve the anchoring structure 230, so as to avoid excessive radial support force of the anchoring structure 230. Large damage to the left atrial appendage cavity wall to avoid damage to the human body.
  • the number of raised areas 216 and other areas 217 is not limited, and the number of raised areas 216 and other areas 217 may be, but not limited to, one or more. It can be understood that the extension direction of the raised area 216 and the other areas 217 is not limited. In a modified embodiment, the raised area 216 and/or the other areas 217 may also be inclined relative to the axial direction of the anchor portion 233, or the raised area Regions 216 and/or other regions 217 may also extend along a spiral or other curve.
  • a mold is used to heat and shape the coating film 210 to generate multiple wrinkles, so that the coating film 210 forms protrusions in the convex area 216 , and the coating film 210 forms grooves in other areas 217 .
  • the shaped film 210 is fixed to the surface of the anchoring structure 230 .
  • the protrusions of the cover film 210 in the convex area 216 and the grooves of the cover film 210 in other areas 217 may also be, but are not limited to, produced during the process of the cover film 210 being fixed to the anchoring structure 230 .
  • the cover film 210 includes a concave connection point (not shown) disposed in the other area 217, and the cover film 210 is fixedly connected with the anchoring structure 230 at the concave connection point.
  • the covering film 210 is flat and wrinkle-free before being fixed to the anchoring structure 230.
  • the length of the covering film 210 between adjacent concave connection points is greater than that of the adjacent concave concave connection points.
  • the gap between them is larger than the gap between the film 210 in the other regions 217 and the second region 237 .
  • the above-mentioned raised areas 216 and other areas 217 are alternately distributed in the axial direction in the first direction, that is, the raised areas 216 and other areas 217 extend along the circumferential direction of the anchoring structure 230 and form protrusions of annular and recessed belts.
  • the above-mentioned raised areas 216 and other areas 217 are alternately distributed in the circumferential direction and the axial direction in the first direction, that is, a plurality of raised areas 216 are arranged in an array along the surface of the anchoring structure 230, it can be understood that , the form of the array arrangement is not limited, and the form of the array may be, but not limited to, a rectangular array, a circular array, a triangular array, and the like.
  • the raised areas 216 are ordered in two mutually perpendicular directions, and other areas 217 is arranged around the first area 236 .
  • the two mutually perpendicular directions may be the circumferential direction and the axial direction of the anchoring structure 230 , respectively.
  • the membrane 210 is not easily pulled or bound by the left atrial appendage cavity wall, so that the radial supporting force of the anchoring structure 230 will not be too strong.
  • the above-mentioned raised regions 216 and other regions 217 are alternately distributed in other directions in the first direction.

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Abstract

L'invention concerne un dispositif d'occlusion d'appendice auriculaire gauche (100), comprenant un film de recouvrement (10), une structure d'ancrage (30) disposée à l'extrémité distale, et un disque d'étanchéité (50) disposé à l'extrémité proximale. Le disque d'étanchéité (50) est relié de manière fixe à la structure d'ancrage (30). Le film de recouvrement (10) recouvre au moins une partie de la structure d'ancrage (30). Dans une première direction de la structure d'ancrage (30), la longueur totale du film de recouvrement (10) est supérieure à la longueur d'extension de la zone de la structure d'ancrage (30) recouverte par le film de recouvrement (10). Le film de recouvrement (10) recouvre de manière lâche la structure d'ancrage (30), de sorte que le film de recouvrement (10) améliore l'effet d'occlusion du dispositif d'occlusion de l'appendice auriculaire gauche (100) au niveau de la structure d'ancrage (30). De plus, lorsque le dispositif d'occlusion de l'appendice auriculaire gauche (100) est pressé dans la cavité de l'appendice auriculaire gauche, le film de recouvrement (10) contribue à une faible force de support radiale à la structure d'ancrage (30) et ensuite l'amplitude de déformation du film de recouvrement (10) n'est pas susceptible d'affecter l'amplitude de déformation de la structure d'ancrage (30), ce qui veut dire que le film de recouvrement (10) n'est pas susceptible de tirer ou de retenir la structure d'ancrage (30) sous la pression de la paroi de cavité de l'appendice auriculaire gauche, de sorte que la force de support radiale de la structure d'ancrage (30) n'est pas suffisamment grande pour endommager le corps humain, et la structure d'ancrage (30) peut être mieux fixée à la paroi de la cavité de l'appendice auriculaire gauche.
PCT/CN2021/115281 2020-08-31 2021-08-30 Dispositif d'occlusion d'appendice auriculaire gauche WO2022042718A1 (fr)

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Application Number Priority Date Filing Date Title
CN202021867671.5U CN214387541U (zh) 2020-08-31 2020-08-31 左心耳封堵器
CN202021867671.5 2020-08-31

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WO2022042718A1 true WO2022042718A1 (fr) 2022-03-03

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