CN116672137B - Skirt edge structure, branch bracket assembly and branch vascular medical equipment - Google Patents
Skirt edge structure, branch bracket assembly and branch vascular medical equipment Download PDFInfo
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- CN116672137B CN116672137B CN202310935344.0A CN202310935344A CN116672137B CN 116672137 B CN116672137 B CN 116672137B CN 202310935344 A CN202310935344 A CN 202310935344A CN 116672137 B CN116672137 B CN 116672137B
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- 230000002792 vascular Effects 0.000 title claims description 11
- 239000012528 membrane Substances 0.000 claims abstract description 59
- 238000005452 bending Methods 0.000 claims description 46
- 230000000452 restraining effect Effects 0.000 claims description 8
- 230000007423 decrease Effects 0.000 claims 1
- 230000017531 blood circulation Effects 0.000 abstract description 9
- 238000002513 implantation Methods 0.000 abstract description 7
- 208000002251 Dissecting Aneurysm Diseases 0.000 description 4
- 206010002895 aortic dissection Diseases 0.000 description 4
- 210000003128 head Anatomy 0.000 description 4
- 230000000903 blocking effect Effects 0.000 description 3
- 230000036770 blood supply Effects 0.000 description 3
- 239000010408 film Substances 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000013039 cover film Substances 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 210000002489 tectorial membrane Anatomy 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
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- 239000000463 material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/856—Single tubular stent with a side portal passage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E30/00—Energy generation of nuclear origin
- Y02E30/30—Nuclear fission reactors
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a skirt edge structure, a branch bracket component and branch vessel medical equipment, which relate to the technical field of medical equipment, wherein the skirt edge structure comprises: a skirt membrane and an elastic support; the elastic support comprises a plurality of first clamping arms and a plurality of second clamping arms, the first clamping arms and the second clamping arms are respectively arranged along the circumference of the outer sheath tube at intervals, any one of the first clamping arms is connected with at least one of the second clamping arms, each first clamping arm extends from one end connected with the second clamping arm to the far end in a compressed state, each second clamping arm extends from one end connected with the first clamping arm to the near end, the first clamping arms and the second clamping arms have a trend of expanding along the radial direction of the outer sheath tube, the skirt membrane piece is connected between the first clamping arms and/or the second clamping arms, the side wall of the covered membrane support on the periphery of the window opening window can be clamped between the first clamping arms and the second clamping arms, the implantation position of the skirt structure can be ensured to be stable, the occurrence of internal leakage can be avoided, and the blood flow inside the aortic support can be prevented from being blocked by the tilted skirt.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a skirt edge structure, a branch bracket assembly and branch vessel medical equipment.
Background
Aortic dissection refers to the state in which blood in the aortic lumen enters the aortic intima from the aortic intima tear, and the aortic intima is torn to a greater extent, so that the true and false two cavities of the aortic wall are separated, which is called aortic dissection. A covered stent is implanted in the interventional operation to reconstruct a blood flow channel, thereby achieving the aim of treating aortic dissection. Since aortic dissection may involve branch vessels on the arch, and a stent graft cannot provide three branch blood supply after implantation, it is necessary to window the main body stent and implant a branch stent at the fenestration position to maintain the branch blood supply. However, after the branch stent is implanted, since the branch stent is in line contact with the fenestration of the main stent, it is difficult to sufficiently seal the fenestration, and thus internal leakage is easily caused. The mode of adding the skirt edge on the branch bracket is adopted, so that the generation of internal leakage can be reduced theoretically, but the risk of inaccurate placement of the skirt edge bracket and blocking of the blood flow of the main body tectorial membrane bracket exists. In addition, because of physiological deflection of the branch blood vessel on the arch, the skirt is easy to generate a tilting edge on one side of the acute angle between the branch stent and the main stent after the skirt stent is implanted, so that the skirt of the branch stent is not adhered to the inner side of the main stent, thereby possibly causing internal leakage and blocking blood flow in the main stent.
Disclosure of Invention
The invention aims to provide a skirt edge structure, a branch bracket assembly and branch vessel medical equipment so as to relieve the technical problems that the implantation position of the skirt edge structure is difficult to stabilize and internal leakage and edge tilting are easy to occur.
In a first aspect, the present invention provides a skirt structure, compressible and insertable into an outer sheath, the skirt structure comprising: a skirt membrane and an elastic support;
the elastic support includes: the device comprises a first arm support and a second arm support connected with the first arm support;
the skirt membrane is connected with the first arm support and/or the second arm support;
in a compressed state, the first arm support and the second arm support are compressed along the radial direction of the outer sheath tube, and the first arm support and the second arm support are sequentially arranged from the proximal end to the distal end along the axial direction of the outer sheath tube;
in the unfolding state, the first arm support and the second arm support are elastically unfolded along the radial direction of the outer sheath tube, and the clamping opening between the first arm support and the second arm support is tightened.
With reference to the first aspect, the present invention provides a first possible implementation manner of the first aspect, wherein the first arm support includes a plurality of first arm clamps, and the second arm support includes a plurality of second arm clamps; the first clamping arms and the second clamping arms are respectively arranged at intervals along the circumference of the outer sheath tube, and any one of the first clamping arms is connected with at least one of the second clamping arms;
in a compressed state, each first clamping arm extends proximally from an end connected with the second clamping arm, each second clamping arm extends distally from an end connected with the first clamping arm, and the first clamping arm and the second clamping arm have a radial expansion trend along the sheath tube;
the skirt membrane is connected to the first clamp arm and/or the second clamp arm.
With reference to the first possible implementation manner of the first aspect, the present invention provides a second possible implementation manner of the first aspect, wherein a plurality of the first clamping arms and a plurality of the second clamping arms are alternately distributed along a circumferential direction of the outer sheath.
With reference to the first possible implementation manner of the first aspect, the present invention provides a third possible implementation manner of the first aspect, wherein the elastic support includes an elastic rib, and the elastic rib is bent to form a plurality of the first clamping arms and a plurality of the second clamping arms.
With reference to the first aspect, the present invention provides a fourth possible implementation manner of the first aspect, wherein the first arm support is provided with a first bending portion, and the first bending portion is bent towards the distal end along a direction away from the axis of the outer sheath in the unfolded state;
the second arm support is provided with a second bending part, and the second bending part is bent towards the near end along the direction deviating from the axis of the outer sheath tube in the unfolded state.
With reference to the fourth possible implementation manner of the first aspect, the present invention provides a fifth possible implementation manner of the first aspect, wherein, in the deployed state, an end portion of the first bending portion facing away from the outer sheath axis is provided with a third bending portion, the third bending portion extending in a radial direction of the outer sheath, or the third bending portion bending proximally in a direction facing away from the outer sheath axis;
in the unfolded state, the end part of the second bending part, which is away from the axis of the outer sheath, is provided with a fourth bending part, and the fourth bending part extends along the radial direction of the outer sheath, or the fourth bending part bends towards the distal end along the direction away from the axis of the outer sheath.
With reference to the first aspect, the present invention provides a sixth possible implementation manner of the first aspect, where in a deployed state, the first arm and the second arm have projection overlapping portions on any tangential projection plane of the circumference of the outer sheath.
With reference to the first aspect, the present invention provides a seventh possible implementation manner of the first aspect, where in a deployed state, the first arm support and the second arm support are disposed at intervals along an axial direction of the outer sheath, and the nip is formed between the first arm support and the second arm support.
With reference to the first aspect, the present invention provides an eighth possible implementation manner of the first aspect, wherein, from a compressed state to an expanded state, the first arm and the second arm have an included angle on any tangential projection plane of the circumference of the outer sheath.
In a second aspect, the present invention provides a branch stent assembly comprising: the branch stent body and the skirt structure according to the first aspect, wherein the skirt membrane and/or the elastic stent are/is connected to the branch stent body.
With reference to the second aspect, the present invention provides a first possible implementation manner of the second aspect, wherein the elastic support is flexibly connected with the branch support body.
With reference to the second aspect, the present invention provides a second possible implementation manner of the second aspect, wherein the cover film on the branch stent body extends and is connected to the elastic stent to form the skirt membrane.
In a third aspect, the present invention provides a branched vascular medical device comprising: a conveyor and a branch stent assembly according to the second aspect;
the conveyor comprises an outer sheath tube which is used for sleeving the branch stent body and the skirt edge structure in a compressed state.
With reference to the third aspect, the present invention provides a first possible implementation manner of the third aspect, wherein the conveyor includes: the handle, the sliding driving piece, the restraining piece and the release pulling piece;
the sliding driving piece is arranged on the handle and is connected with the outer sheath tube;
the constraining member is for constraining the skirt structure in a compressed state;
the release pulling member is connected with the restraint member and extends out from the handle, and the release pulling member is used for driving the restraint member to release the restraint of the skirt structure.
With reference to the first possible implementation manner of the third aspect, the present invention provides a second possible implementation manner of the third aspect, wherein the handle is connected with a middle tube, and the outer sheath tube is sleeved outside the middle tube;
the intermediate tube is provided with a pull wire channel through which the restraining member or the release pulling member passes.
With reference to the first possible implementation manner of the third aspect, the present invention provides a third possible implementation manner of the third aspect, wherein the conveyor includes: a guidewire tube, a guide head and a luer fitting;
the guide wire tube passes through the handle, the guide head is connected to the distal end of the guide wire tube, and the luer connector is connected to the proximal end of the guide wire tube.
The embodiment of the invention has the following beneficial effects: the elastic support comprises a plurality of first clamping arms and a plurality of second clamping arms, the first clamping arms and the second clamping arms are respectively arranged along the circumference of the outer sheath tube at intervals, any one of the first clamping arms is connected with at least one of the second clamping arms, each first clamping arm extends from one end connected with the second clamping arm to the far end in a compressed state, each second clamping arm extends from one end connected with the first clamping arm to the near end, the first clamping arms and the second clamping arms have a trend of expanding along the radial direction of the outer sheath tube, the skirt membrane piece is connected between the first clamping arms and/or the second clamping arms, the side wall of the membrane support on the periphery of the window opening can be clamped between the first clamping arms and the second clamping arms, the skirt structure is contacted with the surface of the membrane support on the periphery of the window opening, the implantation position of the skirt structure can be ensured to be stable, the edge tilting phenomenon of the skirt membrane piece can be avoided, the inner side of the skirt membrane piece can be avoided, and the inner side of the skirt support can be prevented from being blocked by the tilted skirt.
In order to make the above objects, features and advantages of the present invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the related art, the drawings that are required to be used in the description of the embodiments or the related art will be briefly described, and it is apparent that the drawings in the description below are some embodiments of the present invention, and other drawings may be obtained according to the drawings without inventive effort for those skilled in the art.
FIG. 1 is a schematic view of a skirt structure in an unfolded state according to an embodiment of the present invention;
FIG. 2 is a schematic view of a skirt structure in a compressed state according to an embodiment of the present invention;
FIG. 3 is a schematic view of a branch stent assembly according to an embodiment of the present invention in a compressed state;
FIG. 4 is a schematic view of an elastic support of a skirt structure according to an embodiment of the present invention;
FIG. 5 is a front view of a first elastic leg arrangement of a skirt configuration according to an embodiment of the present invention;
FIG. 6 is a front view of a second elastic leg arrangement of a skirt configuration according to an embodiment of the present invention;
FIG. 7 is a front view of a third elastic leg arrangement of a skirt configuration according to an embodiment of the present invention;
FIG. 8 is a schematic view of a skirt structure according to an embodiment of the present invention in a state in which a branch stent body is inclined with respect to a main stent;
FIG. 9 is a cross-sectional view of a delivery device for a branched vascular medical device provided by an embodiment of the present invention;
FIG. 10 is an enlarged partial schematic view of a delivery device for a branched vascular medical device 0 according to an embodiment of the present invention;
fig. 11 is an enlarged partial schematic view of another conveyor of a branched vascular medical device according to an embodiment of the present invention.
Icon: 100-skirt membrane; 200-elastic support; 021-first arm support; 022-a second boom; 201-clamping ports; 202-projection overlap; 210-a first clamping arm; 211-a first bend; 212-a third bend; 220-a second clamp arm; 221-a second bend; 222-fourth bends; 300-branch stent body; 400-conveyor; 401-lumen; 402-a pull wire channel; 410-an outer sheath; 420-handle; 430-a slip drive; 440-constraint; 450-release pull; 460-an intermediate tube; 470-guidewire; 480-guide heads; 490-luer fitting.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Physical quantities in the formulas, unless otherwise noted, are understood to be basic quantities of basic units of the international system of units, or derived quantities derived from the basic quantities by mathematical operations such as multiplication, division, differentiation, or integration.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
As shown in fig. 1, 2 and 9, the skirt structure provided in the embodiment of the present invention is compressible and inserted into the outer sheath 410, and the skirt structure includes: a skirt membrane 100 and a resilient bracket 200; the elastic support 200 includes: a first boom 021 and a second boom 022 connected to the first boom 021; the skirt membrane 100 is connected to the first arm 021 or the second arm 022, or the first arm 021 and the second arm 022 are respectively connected to the skirt membrane 100.
In the compressed state, the first boom 021 and the second boom 022 are compressed along the radial direction of the outer sheath 410, and the first boom 021 and the second boom 022 are sequentially arranged from the proximal end to the distal end along the axial direction of the outer sheath 410;
in the unfolded state, the first and second arms 021 and 022 are elastically unfolded along the radial direction of the outer sheath 410, and the clamping opening 201 between the first and second arms 021 and 022 is tightened.
It should be noted that, the middle part of the skirt membrane 100 forms a through hole, and the elastic support 200 may be provided with an opening opposite to the through hole, so that the elastic support 200 may be free of openings, or the opening diameter of the elastic support 200 may be smaller than the diameter of the through hole in the middle part of the skirt membrane 100, and the elastic support 200 is made of a wire material in a net shape, so that the blood supply of the branch vessel may be maintained, and a certain filtering function may be provided, which is helpful for reducing the embolism probability of the distal vessel. The central through hole radial support force of the skirt membrane 100 is provided by the elastic support 200, and the skirt membrane 100 is in flexible contact with and tightly engaged with the body support fenestration.
In one embodiment, the skirt membrane 100 may be an integral annular membrane, with a central portion of the skirt membrane 100 defining a through-hole for blood flow. In a state that the elastic support 200 is compressed, the annular membrane can be folded or elastically contracted so as to adapt to the shape change of the elastic support 200; when the elastic support 200 is unfolded, the annular membrane is unfolded along with the elastic support 200 and is flexibly contacted with the windowing of the main support.
In another embodiment, the skirt membrane 100 may also employ multiple valves that overlap in sequence and collectively enclose a through-hole for blood flow. When the fenestration is smaller, the overlapping area of adjacent valves is larger, so that the different fenestration sizes can be adapted, the skirt membrane 100 is prevented from generating folds, and the folds of the skirt membrane 100 are prevented from obstructing blood flow or inducing internal leakage.
In an alternative embodiment, both the first boom 021 and the second boom 022 may be configured as disk-like structures, and may be compressed in the radial direction, and may also rebound in the radial direction.
In this embodiment, the first arm rack 021 includes a plurality of first arm clamps 210, and the second arm rack 022 includes a plurality of second arm clamps 220; the elastic support 200 includes: a plurality of first clip arms 210 and a plurality of second clip arms 220, the plurality of first clip arms 210 and the plurality of second clip arms 220 being respectively disposed at intervals along the circumference of the outer sheath 410, any one of the first clip arms 210 being connected to at least one of the second clip arms 220; in the compressed state, each first clip arm 210 extends proximally from an end connected to the second clip arm 220, each second clip arm 220 extends distally from an end connected to the first clip arm 210, and both the first clip arm 210 and the second clip arm 220 have a tendency to radially expand along the outer sheath 410; the skirt membrane 100 is connected to the first clamp arm 210 and/or the second clamp arm 220.
Specifically, the skirt membrane 100 may be connected to one of the first and second clamp arms 210 and 220, or both the first and second clamp arms 210 and 220 may be connected to the skirt membrane 100. After release of the implant, the skirt structure springs back to the deployed state. In the unfolded state, the plurality of parts of the covered stent along the periphery of the peripheral window of the fenestration are clamped between the adjacent first clamping arm 210 and the second clamping arm 220, so that the implantation position of the skirt structure can be ensured to be stable, the edge tilting phenomenon of the skirt membrane 100 is avoided, the internal leakage is avoided, and the blocking of the blood flow at the inner side of the aortic stent by the tilted skirt can be avoided.
It should be noted that the context refers to the handheld operation position, and the handheld end is in principle a distal end, and the handheld end is in proximity to the proximal end, so as to facilitate the structural description and understanding.
As shown in fig. 1, 2, 3, 4, 5 and 9, in the embodiment of the present invention, the plurality of first clamping arms 210 and the plurality of second clamping arms 220 are alternately distributed along the circumferential direction of the outer sheath 410, and in the post-implantation deployment state, the aortic stent graft is clamped between any adjacent first clamping arm 210 and second clamping arm 220, so that the skirt structure is kept stable along the circumferential direction of the fenestration position, and the skirt structure is prevented from deflecting relative to the fenestration window.
Further, the elastic support 200 includes an elastic rib, and the elastic rib is bent to form a plurality of first clamping arms 210 and a plurality of second clamping arms 220, so that the plurality of first clamping arms 210 and the plurality of second clamping arms 220 are in an integrated structure, and can be processed by adopting a hot press forming process, preferably a nickel-titanium alloy wire weaving or laser cutting forming mode, and the elastic support is easy to form and stable in structure.
As shown in fig. 3, 4, 5, 6, 8 and 9, the first arm 021 is provided with a first bending portion 211, and in the unfolded state the first bending portion 211 is bent distally in a direction away from the axis of the outer sheath 410; the second boom 022 is provided with a second bending portion 221, and the second bending portion 221 is bent proximally in a direction away from the axis of the outer sheath 410 in the deployed state.
The first and second arms 021 and 022 are radially compressed and inserted into the outer sheath 410 in a compressed state, and the first bending portion 211 is bent distally and the second bending portion 221 is bent proximally in an expanded state. From the compressed state to the expanded state, the first boom 021 swings distally and the second boom 022 swings proximally, thereby clamping the side wall of the main bracket between the first boom 021 and the second boom 022. The first curved portion 211 and the second curved portion 221 clamp the edge of the skirt film 100 together, so that edge warpage of the skirt film 100 can be prevented. Even when the branch stent body 300 is deflected in the radial direction with respect to the main stent, the skirt membrane 100 can be closely fitted to the side wall of the main stent, and the skirt membrane 100 is in contact with the side wall surface of the main stent and closely fitted, thereby avoiding the occurrence of inner leakage.
As shown in fig. 3, 7, 8 and 9, in the deployed state, the end of the first bending portion 211 facing away from the axis of the outer sheath 410 is provided with a third bending portion 212, the third bending portion 212 extending in the radial direction of the outer sheath 410, or the third bending portion 212 bending proximally in the direction facing away from the axis of the outer sheath 410; in the unfolded state, the end of the second bending part 221 facing away from the axis of the outer sheath 410 is provided with a fourth bending part 222, and the fourth bending part 222 extends in the radial direction of the outer sheath 410, or the fourth bending part 222 is bent distally in a direction facing away from the axis of the outer sheath 410.
Wherein, the third bending portion 212 is reversely bent with respect to the first bending portion 211, a first protruding portion protruding distally is formed between the third bending portion 212 and the first bending portion 211, the fourth bending portion 222 is reversely bent with respect to the second bending portion 221, and a second protruding portion protruding proximally is formed between the fourth bending portion 222 and the second bending portion 221. The side wall of the main support and the skirt membrane 100 are pressed between the first protruding portion and the second protruding portion, the contact area between the elastic support 200 and the skirt membrane 100 is increased, the contact area between the skirt membrane 100 and the side wall of the main support is increased, the side wall of the main support and the skirt membrane 100 can be tightly attached, and inner leakage is further avoided. At the same time, the skirt membrane 100 and the main support sidewall are prevented from being pressed or worn out.
As shown in fig. 6, 7, 8 and 9, in the unfolded state, the first arm 021 and the second arm 022 are arranged at intervals along the axial direction of the outer sheath 410, and a clamping opening 201 is formed between the first arm 021 and the second arm 022. Wherein, the lateral wall of the main support and the skirt membrane 100 are pressed in the clamping opening 201, enough space is reserved through the clamping opening 201, so that the lateral wall of the main support and the skirt membrane 100 are clamped, the skirt membrane 100 is attached to the lateral wall of the main support, the skirt membrane 100 is kept flat relative to the lateral wall of the main support, and the skirt membrane 100 is prevented from being excessively pressed to generate wrinkles.
Referring to fig. 4, 5 and 9, in an alternative embodiment, the first and second arms 021, 022 gradually tend to overlap from the compressed state to the expanded state, thereby clamping the side wall of the main bracket and the skirt membrane 100 between the first and second arms 021, 022.
If the included angle between the first arm 021 and the second arm 022 is positive, the side wall of the main bracket and the skirt membrane 100 are clamped between the first arm 021 and the second arm 022.
If the included angle between the first arm 021 and the second arm 022 approaches to 0 degree, the side wall of the main bracket and the skirt membrane 100 are clamped between the first arm 021 and the second arm 022, and the skirt structure tends to be flat.
If the included angle between the first arm frame 021 and the second arm frame 022 is negative, the side wall of the main bracket and the skirt membrane 100 can be tightly clamped, and the clamping sealing performance is better.
From the compressed state to the expanded state, the included angle between the first arm 021 and the second arm 022 on any tangential projection surface of the circumference of the outer sheath 410 is reduced, in other words, the included angle between the adjacent first arm 210 and second arm 220 is reduced, even the first arm 210 and second arm 220 are dislocated, and the angle is reduced from a positive angle and forms a negative angle. During implantation, the plurality of first clamp arms 210 in a compressed state are passed through the fenestration, and then the skirt structure is released, which springs back to an expanded state, thereby clamping the stent graft sidewalls around the fenestration between the adjacent first and second clamp arms 210, 220.
In the deployed state, the end of each first clip arm 210 remote from the axis of the outer sheath 410 has a first curved portion 211 that curves distally, and the end of each second clip arm 220 remote from the axis of the outer sheath 410 has a second curved portion 221 that curves proximally. The first curved portion 211 and the second curved portion 221 can reduce the diameter of the two axial ends of the skirt structure in the compressed state; in the unfolded state, the first bending part 211 can avoid the outer wall of the aortic stent graft, and the second bending part 221 can be matched with the radian of the inner wall of the aortic stent graft, so that the skirt structure is tightly attached to the aortic stent graft, and the occurrence of internal leakage is avoided.
As shown in fig. 5, in the unfolded state, the first arm rest 021 and the second arm rest 022 have projection overlapping portions 202 on any tangential projection surface of the circumference of the outer sheath 410, in other words, the first arm rest 210 and the second arm rest 220 have projection overlapping portions 202 on any tangential projection surface of the circumference of the outer sheath 410. Along the circumference of the fenestration window, the side wall of the aortic tectorial membrane stent is clamped between the first clamping arm 210 and the second clamping arm 220, the peripheral part of the window tends to be flat relative to the projection overlapping part 202, the edge tilting can be avoided, the thickness of the whole skirt structure after being unfolded can be reduced, the crushing of the main body stent is reduced, the influence on blood flow is reduced, the window and the skirt structure can be tightly combined, and the internal leakage is avoided.
As shown in fig. 3, a branch bracket assembly provided in an embodiment of the present invention includes: the branch stent body 300 and the skirt structure described in any of the above embodiments, the skirt membrane 100 and/or the elastic stent 200 are connected to the branch stent body 300.
Specifically, one of the skirt membrane 100 and the elastic support 200 is connected to the branch support body 300, or both the skirt membrane 100 and the elastic support 200 are connected to the branch support body 300, and the branch support assembly has the beneficial effects of the above-mentioned skirt structure, which is not described herein.
Further, the elastic stent 200 is flexibly connected with the branch stent body 300, and the elastic stent 200 and the branch stent body 300 can be flexibly connected through a coating film or a silk thread, so that different branch vessel directions can be adapted, and the skirt membrane 100 is prevented from generating edge tilting and internal leakage after the branch stent assembly is implanted.
Further, the cover film on the branch stent body 300 is extended and connected to the elastic stent 200 to form the skirt membrane 100, thereby making the branch stent assembly easy to process, more compact in structure and lower in manufacturing cost.
As shown in fig. 3 and 9, a branched vascular medical device provided by an embodiment of the present invention includes: a conveyor 400 and a branch stent assembly according to any of the above embodiments; the delivery device 400 includes an outer sheath 410, the outer sheath 410 being configured to encase the branch stent body 300 and skirt structure in a compressed state.
In an alternative embodiment, when releasing the branch stent assembly, the intermediate tube 460 or other support member is used to maintain the position of the branch stent assembly stable, and the plurality of first clamping arms 210 and the plurality of second clamping arms 220 can be released by retracting the outer sheath tube 410, so that the aortic stent at the fenestration is clamped between the adjacent first clamping arms 210 and the second clamping arms 220.
In the present embodiment, the conveyor 400 includes: a handle 420, a slip drive 430, a constraint 440, and a release pull 450; the sliding driving member 430 is mounted to the handle 420, and the sliding driving member 430 is connected to the outer sheath 410; the constraining member 440 is used to constrain the skirt structure in a compressed state; the release pull 450 is connected to the restraint 440, and the release pull 450 extends from the handle 420, the release pull 450 being used to actuate the restraint 440 to release the restraint from the skirt structure.
The release pull 450 may employ a snap ring with a pull ring attached to the constraint 440 by a pull wire. The outer sheath 410 is driven to move in the axial direction with respect to the handle 420 by the slip driving member 430, thereby accomplishing the retracting operation of the outer sheath 410.
As shown in fig. 3, 9 and 10, the handle 420 is connected with an intermediate tube 460, and the outer sheath tube 410 is sleeved outside the intermediate tube 460; the intermediate tube 460 is provided with a pull wire channel 402 through which the constraint 440 or release pull 450 passes.
Upon release of the branch stent assembly, the distal end of the intermediate tube 460 abuts the proximal end of the branch stent body 300, thereby preventing the branch stent assembly from retracting with the outer sheath tube 410. Upon withdrawal of the outer sheath 410 off of the first clip arms 210, the plurality of first clip arms 210 are deployed; subsequently, the restraint 440 is pulled by releasing the pulling member 450, whereby the restraint 440 can be disengaged from the second clamp arms 220, and the plurality of second clamp arms 220 can be deployed, whereby the aortic stent at the window is clamped between the adjacent first and second clamp arms 210, 220.
Referring to fig. 10, in an alternative embodiment, the restraining member 440 employs a plurality of connecting wires that connect the proximal ends of the plurality of second clamp arms 220 in a one-to-one correspondence, and in a state of being pulled proximally, the plurality of second clamp arms 220 may be maintained in a compressed state. In the case where the release pulling member 450 pulls the plurality of connection lines through the pull wire, the plurality of connection lines are released with respect to the second clip arms 220, thereby achieving release of the plurality of second clip arms 220.
Referring to fig. 11, in another alternative embodiment, the restraint 440 employs a coil or collar that is sleeved over the plurality of second clamp arms 220 in a compressed state. When the release pulling member 450 pulls the restraining member 440 through the pull wire, the restraining member 440 slides off the plurality of second clamp arms 220, thereby releasing the plurality of second clamp arms 220.
As shown in fig. 9, 10, and 11, the conveyor 400 includes: a guidewire tube 470, a guide tip 480, and a luer fitting 490; the guidewire tube 470 is threaded through the handle 420, a guide tip 480 is attached to the distal end of the guidewire tube 470, and a luer fitting 490 is attached to the proximal end of the guidewire tube 470. The guide wire tube 470 passes through the lumen 401 of the intermediate tube 460, and the guide wire can pass through the luer connector 490, the guide wire tube 470 and the guide head 480, and can also be subjected to operations such as liquid injection, air exhaust and the like through the luer connector 490.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (14)
1. A skirt structure compressible and insertable into an outer sheath (410), the skirt structure comprising: a skirt membrane (100) and an elastic support (200);
the elastic support (200) comprises: a first arm support (021) and a second arm support (022) connected with the first arm support (021);
the skirt membrane (100) is connected with the first arm support (021) and/or the second arm support (022);
in a compressed state, the first arm support (021) and the second arm support (022) are compressed along the radial direction of the outer sheath tube (410), and the first arm support (021) and the second arm support (022) are sequentially arranged from the proximal end to the distal end along the axial direction of the outer sheath tube (410);
in the unfolded state, the first arm support (021) and the second arm support (022) are elastically unfolded along the radial direction of the outer sheath tube (410), and the clamping opening (201) between the first arm support (021) and the second arm support (022) is tightened;
the first arm support (021) comprises a plurality of first clamping arms (210), and the second arm support (022) comprises a plurality of second clamping arms (220);
a plurality of first clamping arms (210) and a plurality of second clamping arms (220) are respectively arranged at intervals along the circumference of the outer sheath tube (410), and any one of the first clamping arms (210) is connected with at least one second clamping arm (220);
in a compressed state, each of the first clip arms (210) extends proximally from an end connected to the second clip arm (220), each of the second clip arms (220) extends distally from an end connected to the first clip arm (210), and the first clip arms (210) and the second clip arms (220) each have a tendency to radially expand along the outer sheath (410);
-said skirt membrane (100) is connected to said first clamp arm (210) and/or said second clamp arm (220);
the plurality of first clip arms (210) and the plurality of second clip arms (220) are alternately distributed along the circumferential direction of the outer sheath tube (410).
2. The skirt structure of claim 1, wherein the resilient support (200) comprises a resilient rib that is bent to form a plurality of the first clamp arms (210) and a plurality of the second clamp arms (220).
3. The skirt structure according to claim 1, wherein the first arm support (021) is provided with a first bending portion (211), the first bending portion (211) being bent distally in a direction away from the axis of the outer sheath (410) in the deployed state;
the second boom (022) is provided with a second bending portion (221), and the second bending portion (221) is bent proximally in a direction away from the axis of the outer sheath tube (410) in the unfolded state.
4. A skirt structure according to claim 3, wherein in the deployed state, the end of the first bend (211) facing away from the axis of the outer sheath (410) is provided with a third bend (212), the third bend (212) extending radially of the outer sheath (410) or the third bend (212) being bent proximally in a direction facing away from the axis of the outer sheath (410);
in the unfolded state, the end part of the second bending part (221) facing away from the axis of the outer sheath tube (410) is provided with a fourth bending part (222), and the fourth bending part (222) extends along the radial direction of the outer sheath tube (410) or the fourth bending part (222) bends towards the distal end along the direction facing away from the axis of the outer sheath tube (410).
5. The skirt structure according to claim 1, wherein in the deployed state, the first arm (021) and the second arm (022) have projection overlapping portions (202) on any tangential projection plane of the circumference of the outer sheath (410).
6. The skirt structure according to any one of claims 1-5, wherein in the deployed state, the first arm (021) and the second arm (022) are arranged at intervals along the axial direction of the outer sheath tube (410), and the nip (201) is formed between the first arm (021) and the second arm (022).
7. The skirt structure according to any one of claims 1-5, wherein the angle between the first arm (021) and the second arm (022) on any tangential projection plane of the circumference of the sheath tube (410) decreases from a compressed state to an expanded state.
8. A branch stent assembly, comprising: a branch stent body (300) and a skirt structure according to any of claims 1-7, said skirt membrane (100) and/or said elastic stent (200) being connected to said branch stent body (300).
9. The branch stent assembly according to claim 8, wherein the elastic stent (200) is flexibly connected with the branch stent body (300).
10. The branch stent assembly according to claim 8, wherein the cover on the branch stent body (300) extends and is connected to the elastic stent (200) to form the skirt membrane (100).
11. A branched vascular medical device, comprising: a conveyor (400) and a branched stent assembly as claimed in any of claims 8-10;
the transporter (400) comprises an outer sheath (410), the outer sheath (410) being adapted to encase the branch stent body (300) and the skirt structure in a compressed state.
12. The branched vascular medical device according to claim 11, wherein the conveyor (400) comprises: a handle (420), a slip drive (430), a restraint (440), and a release pull (450);
the sliding driving piece (430) is installed on the handle (420), and the sliding driving piece (430) is connected with the outer sheath tube (410);
-said restraining means (440) for restraining said skirt structure in a compressed state;
the release pull (450) is connected to the restraint (440), and the release pull (450) extends from the handle (420), the release pull (450) being configured to actuate the restraint (440) to release the restraint from the skirt structure.
13. The branched vascular medical device according to claim 12, wherein the handle (420) is connected with an intermediate tube (460), the outer sheath tube (410) being sleeved outside the intermediate tube (460);
the intermediate tube (460) is provided with a pull wire channel (402) through which the restraining member (440) or the release pulling member (450) passes.
14. The branched vascular medical device according to claim 12, wherein the conveyor (400) comprises: a guidewire tube (470), a guide head (480), and a luer fitting (490);
the guide wire tube (470) passes through the handle (420), the guide head (480) is connected to the distal end of the guide wire tube (470), and the luer connector (490) is connected to the proximal end of the guide wire tube (470).
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| CN202310935344.0A CN116672137B (en) | 2023-07-28 | 2023-07-28 | Skirt edge structure, branch bracket assembly and branch vascular medical equipment |
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| CN202310935344.0A CN116672137B (en) | 2023-07-28 | 2023-07-28 | Skirt edge structure, branch bracket assembly and branch vascular medical equipment |
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| CN116672137B true CN116672137B (en) | 2023-11-07 |
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| CN117442405B (en) * | 2023-12-25 | 2024-03-22 | 北京华脉泰科医疗器械股份有限公司 | Integrated aortic multi-branch stent and aortic vascular repair assembly |
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