CN115429372B - Tumor intracavity sealing support - Google Patents

Tumor intracavity sealing support Download PDF

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Publication number
CN115429372B
CN115429372B CN202211322381.6A CN202211322381A CN115429372B CN 115429372 B CN115429372 B CN 115429372B CN 202211322381 A CN202211322381 A CN 202211322381A CN 115429372 B CN115429372 B CN 115429372B
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China
Prior art keywords
stent
sealing part
sealing
distal
axial elastic
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CN202211322381.6A
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Chinese (zh)
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CN115429372A (en
Inventor
刘颖
董永贺
申宝胜
朱明哲
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Beijing Huamai Taike Medical Instrument Co ltd
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Beijing Huamai Taike Medical Instrument Co ltd
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Publication of CN115429372A publication Critical patent/CN115429372A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823Stents, different from stent-grafts, adapted to cover an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices 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
    • A61F2002/8483Barbs

Abstract

The invention provides a tumor cavity internal sealing bracket, which relates to the field of medical instruments and comprises a near-end expanding sealing part, a middle axial elastic part and a far-end supporting sealing part which are sequentially connected from a near end to a far end; in a free state: the middle axial elastic portion is capable of being compressed in the axial direction to shorten in length; released in the tumor cavity: the film of the near-end expanding sealing part seals the gap between the outer peripheral surface of the stent and the near-end inner wall of the tumor cavity along the circumferential direction; the far-end supporting sealing part supports the middle axial elastic part and the near-end expanding sealing part; the middle axial elastic part is pressed and compressed by the proximal end expanding sealing part and the distal end supporting sealing part in the axial direction. The invention at least has the advantages of small compression volume of the whole single-layer structure, easy implantation, no need of reconstructing branch vessels during implantation, suitability for aneurysms without anchoring areas and even involving the branch vessels, stable shape after implantation, good sealing effect, difficult displacement, difficult internal leakage and no complications such as occlusion and the like.

Description

Tumor cavity inner sealing support
Technical Field
The invention relates to the technical field of medical instruments, in particular to a tumor cavity inner sealing support.
Background
The aortic dissection refers to the state that blood in an aortic cavity enters an aortic tunica media from the intimal tear part of the aorta, so that the media are separated and expanded along the major axis direction of the aorta to form true and false separation of two cavities of the aortic wall, aneurysm is the expression of limited or diffuse expansion or bulging of the arterial wall due to lesion or injury of the arterial wall, and takes an expansive and pulsated mass as a main expression, and can be generated at any part of the arterial system, but limb main arteries, the aorta and carotid arteries are common. In the existing treatment of aortic dissection or aneurysm, a tectorial stent is mostly used for interventional therapy.
When the aneurysm is treated by the interventional technique, a certain degree of healthy anchoring area is required to be arranged at the proximal end of the blood vessel, but for the interventional technique for treating the aneurysm without an anchoring area or with insufficient anchoring area at the proximal end, even the aneurysm with a branched blood vessel at the proximal end, such as infrarenal aneurysm without an anchoring area, or the aneurysm of a subclavian artery, blood supply of the branched blood vessel still needs to be considered at present, even if the branched blood vessel has no lesion, the branched stent is implanted into the branched blood vessel to reconstruct the anchoring area by adopting the techniques of windowing, chimney, branched stent and the like, and the technical problems of complex operation, easy displacement, internal leakage, easy blood supply insufficiency caused by the folding and/or the occlusion of the branched stent exist.
Disclosure of Invention
The invention aims to provide a tumor cavity internal sealing bracket to relieve the technical problems in the prior art.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
the embodiment of the invention provides a tumor cavity inner sealing support which comprises a near-end expanding sealing part, a middle axial elastic part and a far-end supporting sealing part, wherein the near-end expanding sealing part, the middle axial elastic part and the far-end supporting sealing part are sequentially connected from a near end to a far end;
the near-end expanding sealing part, the middle axial elastic part and the far-end supporting sealing part respectively comprise a stent and a covering film arranged on the peripheral surface of the stent; and in a free state: the middle axial elastic portion is capable of being compressed in an axial direction to shorten in length;
in a state where the intratumoral sealing stent is released in the tumor cavity: the film of the near-end expanding sealing part seals a gap between the outer peripheral surface of the stent of the near-end expanding sealing part and the near-end inner wall of the tumor cavity along the circumferential direction; the far-end supporting sealing part supports the middle axial elastic part and the near-end expanding sealing part; the middle axial elastic part is compressed by being pressed by the proximal expanding sealing part and the distal supporting sealing part in the axial direction.
In this embodiment, the beneficial effect that this tumour intracavity sealing support can reach includes:
first, the volume after radial compression is small, and the device can be easily loaded in the outer tube of the conveyer, and the operation is very convenient during implantation: specifically, in the prior art, if an ordinary single-layered stent graft is directly released into a tumor cavity, the single-layered stent graft cannot be adaptively filled in the whole tumor cavity space, but the single-layered stent graft needs to have a very high compression-elongation ratio if the single-layered stent graft is to be adaptively filled in the whole tumor cavity space, but if the single-layered stent graft meets such conditions, the stent graft on the surface of the stent graft can adapt to the high deformation of the stent, but actually, the tumor cavity generally has a large axial length, even if the stent graft is made of an elastic material, the high deformation of the stent graft cannot be adapted to the high deformation of the stent graft, the above-mentioned function of sealing the tumor cavity port cannot be achieved, if the sealing is required, an outer-layer stent graft is additionally arranged at the proximal end and the distal end outside the stent body, so that if the outer-layer stent graft is integrally made with the stent graft body, the volume is inevitably too large after radial compression, and the conveyor cannot be limited by the diameter of a human blood vessel, the outer-layer stent graft cannot be implanted into the outer-graft body, and the outer-stent graft is difficult to be operated in a split mode, if the outer-stent graft body is difficult to be operated in two times; in contrast, the sealed stent in the tumor cavity provided by the embodiment does not have the above problems at all, the sealed stent in the tumor cavity provided by the embodiment has a single-layer covered stent structure as a whole, the proximal expanding sealing part, the middle axial elastic part and the distal supporting sealing part are connected with each other in the axial direction, and after being released in the tumor body, only the middle axial elastic part needs to be self-adapted to the tumor cavity space, so that the proximal expanding sealing part and the distal supporting sealing part can be axially supported by resilience force, and further the function of sealing the two ends of the tumor cavity is achieved, each structure which does not need to be released in the tumor cavity meets a high compression-extension ratio, the elastic requirement on a covered membrane is low, the manufacture is easy, and when the structure is radially compressed, the volume is small, the structure can be easily loaded in the outer tube of a conveyor, and the operation is very convenient when the structure is implanted;
secondly, the branch vessel does not need to be rebuilt when the implant is implanted, and the implant is suitable for aneurysms without anchoring areas and even involving the branch vessel; after implantation, the shape is stable, the sealing effect is good, the displacement and the internal leakage are not easy to occur, and complications such as occlusion and the like can not be caused: under the state that the tumor cavity internal sealing stent is released in the tumor cavity, the middle axial elastic part is axially compressed by the near-end expanding sealing part and the far-end supporting sealing part, and the middle axial elastic part respectively forms axial supporting force on the near-end expanding sealing part and the far-end supporting sealing part, so that a film of the near-end expanding sealing part seals a gap between the stent peripheral surface of the near-end expanding sealing part and the tumor cavity near-end inner wall along the circumferential direction; the axial length of the middle axial elastic part can be self-adaptive to the shape of the tumor cavity; and under the action of the middle axial elastic part, the whole tumor cavity inner sealing stent forms a stable supporting structure in the tumor cavity, so that the stent is suitable for aneurysms without an anchoring area and even involving branch vessels, such as infrarenal aneurysms without an anchoring area or aneurysms of a nearly left subclavian artery, without reconstructing the branch vessels.
In an optional implementation manner of this embodiment, it is preferable that, in a state where the tumor cavity internal sealing stent is released in the tumor cavity, a portion of the distal end supporting sealing portion supported at the distal end outlet position of the tumor cavity is a distal end supporting position of the distal end supporting sealing portion, and a developing point is respectively provided at a distal end supporting position of the distal end supporting sealing portion and a proximal end position of the proximal end expanding sealing portion.
In addition, in some optional embodiments of this embodiment, it is preferable that the distal end support sealing portion includes a proximal end straight cylindrical section and a distal end bifurcated section, a proximal end of the proximal end straight cylindrical section is connected to a distal end of the middle axial elastic portion, a proximal end of the distal end bifurcated section is connected to a distal end of the proximal end straight cylindrical section, a distal end of the distal end bifurcated section is provided with two guide ports, and the two guide ports are spaced from each other and form a triangular support bifurcated angle with an opening facing the distal end at a position spaced from each other.
Further preferably, the distal support seal has: the distal end bifurcation section still includes a tube-shape tectorial membrane support landing leg, the near-end body coupling of tube-shape tectorial membrane support landing leg is in arbitrary the direction mouth, perhaps, the distal end bifurcation section still includes two tube-shape tectorial membrane support landing legs, two the near-end one-to-one of tube-shape tectorial membrane support landing leg is connected in two the direction mouth.
Further optionally, the covering membrane of the proximal straight cylindrical section is a cylindrical covering membrane, wherein: the bracket of the proximal straight cylinder section comprises a plurality of bracket rings which are arranged at intervals along the axial direction of the cylindrical coating; or the stent of the proximal straight cylinder section comprises a plurality of stent rings and at least one longitudinal metal wire, the stent rings are arranged at intervals along the axial direction of the cylindrical coating, and the longitudinal metal wire is connected to the cylindrical coating and/or any stent ring.
In some optional implementations of this embodiment, the membrane of the middle axial elastic portion is a cylindrical membrane, wherein: the bracket of the middle axial elastic part comprises at least one first metal wire which is wound spirally around the central axis of the cylindrical film; and/or the bracket of the middle axial elastic part comprises a plurality of second metal wires, one end of each second metal wire is connected to the near-end expanding sealing part, the other end of each second metal wire is connected to the near end of the far-end supporting sealing part, and the second metal wires are arranged in a pairwise interval manner along the circumferential direction of the cylindrical film.
Further, in the above optional implementation manner of this embodiment, it is preferable that the first wire is repeatedly bent in a wavy shape along the length direction, and/or the second wire is repeatedly bent in a wavy shape along the length direction.
In other alternate embodiments of this embodiment, the central axial spring portion is a covered mesh stent.
In some optional embodiments of this embodiment, preferably, the sealed stent in tumor cavity further comprises a proximal anchoring portion, and a distal end of the proximal anchoring portion is connected to a proximal end of the proximal expanded diameter sealing portion for anchoring on the vessel wall near the proximal end of tumor cavity.
Further preferably, it includes bare support and locates to be said near-end anchor portion barb on the bare support, just the barb includes forward barb and reverse barb, forward barb expands towards distal end direction, reverse barb expands towards proximal end direction.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a free state schematic view of an alternative configuration of a sealed stent within a tumor space provided by an embodiment of the present invention;
FIG. 2 is a schematic structural view of the intratumoral sealing stent shown in FIG. 1 released in the tumor cavity in an axially compressed state;
FIG. 3 is a free state schematic view of an alternative configuration of a sealed stent within a tumor cavity provided by an embodiment of the present invention;
FIG. 4 is a schematic view of the overall structure of the intratumoral sealing stent shown in FIG. 3 in an axially compressed state;
FIG. 5 is a free state diagram of yet another alternative configuration of a sealed stent within a tumor space provided by an embodiment of the present invention;
FIG. 6 is a schematic view of the overall structure of the intratumoral sealing stent shown in FIG. 5 in an axially compressed state;
FIG. 7 is a structural diagram of the sealed stent in the aneurysm cavity released inside the abdominal aortic aneurysm cavity when the mesh covered stent is used as the middle axial elastic part in the sealed stent in the aneurysm cavity according to the embodiment of the present invention;
FIG. 8 is a structural diagram of the sealed stent in the aneurysm cavity released inside the thoracic aortic aneurysm cavity when the mesh covered stent is used as the middle axial elastic part in the sealed stent in the aneurysm cavity according to the embodiment of the present invention;
FIG. 9 is a block diagram of the steps of an implantation method for implanting the sealed intratumoral stent provided by an embodiment of the invention into a human body for treatment;
FIG. 10 is a schematic view of a first step in the implantation method shown in FIG. 9;
FIG. 11 is a schematic view of a second step in the implantation method shown in FIG. 9;
fig. 12 is a schematic view of a third step in the implantation method shown in fig. 9;
FIG. 13 is a fourth step schematic illustration of the implantation method shown in FIG. 9;
fig. 14 is a schematic view of a fifth step in the implantation method shown in fig. 9.
An icon: 1-proximal end expanding sealing part; 2-a middle axial elastic portion; 3-a distal support seal; 301-a first wire; 302-a second wire; 31-a guide port; 32-cylindrical tectorial membrane stent supporting legs; 4-a proximal anchor portion; 41-bare stent; 42-barbs.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined or explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "proximal", "distal", "front", "rear", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention conventionally place when in use, and are used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.
As used herein, the term "proximal" refers to the end of the patient's heart that is closer to the heart during surgery, and "distal" refers to the end opposite the "proximal".
Furthermore, the terms "horizontal", "vertical" and the like do not imply that the components are absolutely horizontal or hanging, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present invention, it should also be noted that, unless otherwise explicitly stated or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.
The embodiment provides a tumor cavity internal sealing stent, and referring to fig. 1 to 6, the tumor cavity internal sealing stent comprises a proximal end expanding sealing part 1, a middle axial elastic part 2 and a distal end supporting sealing part 3 which are sequentially connected from a proximal end to a distal end, wherein the specific connection mode includes, but is not limited to, two-by-two sewing connection of covering films of two adjacent parts or integral connection of covering films of two adjacent parts, and the stents of two adjacent parts can be connected or separated from each other; the proximal end expanding sealing part 1, the middle axial elastic part 2 and the distal end supporting sealing part 3 respectively comprise respective stents and covering films arranged on the peripheral surfaces of the stents, wherein the covering films of the proximal end expanding sealing part 1 are partially or completely connected with the stents of the proximal end expanding sealing part 1, the covering films of the distal end supporting sealing part 3 are partially or completely connected with the stents of the distal end supporting sealing part 3, and the covering films of the middle axial elastic part 2 can be connected or not connected with the stents of the middle axial elastic part 2; when the membrane of the middle axial elastic part 2 is not connected with the stent of the middle axial elastic part 2, the membranes of the proximal end expanding sealing part 1, the middle axial elastic part 2 and the distal end supporting sealing part 3 are sequentially connected, and the stents of the proximal end expanding sealing part 1, the middle axial elastic part 2 and the distal end supporting sealing part 3 are sequentially connected. In a free state: the middle axial elastic portion 2 can be compressed in the axial direction to shorten the length.
In a state where the sealed stent within the tumor cavity is released within the tumor cavity: the film of the near-end expanding sealing part 1 seals a gap between the outer peripheral surface of the bracket of the near-end expanding sealing part 1 and the inner wall of the near end of the tumor cavity along the circumferential direction; the distal end support sealing part 3 supports the middle axial elastic part 2 and the proximal end expanding sealing part 1; the middle axial elastic part 2 is compressed by being pressed in the axial direction by the proximal end expanding seal part 1 and the distal end supporting seal part 3.
In this embodiment, in the implantation method of the tumor cavity internal sealing stent, the implantation step at least includes 5 steps as shown in fig. 9, and more specifically, the following steps are included:
with a conventional conveyor comprising a guide head, an outer tube and an intermediate tube:
a first step S1, which is a pushing step of pushing the transporter equipped with the tumor cavity internal sealing stent to a lesion site so that the proximal end of the proximal end diameter-expanding sealing part 1 is positioned at the distal end of the renal branch vessel, as shown in fig. 10;
a second step S2, releasing the near-end expanded diameter sealing part 1 and the middle axial elastic part 2, fixing a guide head and a middle tube of the conveyor, withdrawing an outer tube of the conveyor, pulling the outer tube to the position of the far end of the middle axial elastic part 2, and releasing the near-end expanded diameter sealing part 1 and the middle axial elastic part 2 in the tumor cavity;
a third step S3 of releasing the distal support sealing part 3 at the first stage, as shown in fig. 12, fixing the guide head of the transporter, and advancing the outer tube and the intermediate tube of the transporter forward so that the distal support point of the distal support sealing part 3 is flush with the iliac branch;
the fourth step S4 is to release the distal end support sealing portion 3 at the second stage, as shown in fig. 13, fix the middle tube and the guide head of the transporter, pull the outer tube backward, release the distal end support sealing portion 3 inside the aneurysm cavity, and support the distal end support position of the distal end support sealing portion 3 at the iliac branch position at the distal end of the aneurysm, at this time, the middle axial elastic portion 2 is compressed by the proximal end expanded diameter sealing portion 1 and the distal end support sealing portion 3 in the axial direction, and the sealing stent inside the aneurysm cavity is: the near-end expanding sealing part 1 is attached to the near end of the tumor body, the far-end supporting sealing part 3 is supported on the far end of the tumor body, and the middle axial elastic part 2 is axially shortened, so that in the form, the middle axial elastic part 2 is axially shortened and has resilience force stretching in the axial direction, and the middle axial elastic part 2 respectively forms axial supporting force on the near-end expanding sealing part 1 and the far-end supporting sealing part 3, so that a film of the near-end expanding sealing part 1 seals a gap between the outer peripheral surface of a bracket of the near-end expanding sealing part 1 and the near-end inner wall of the tumor cavity along the circumferential direction;
in a fifth step S5, a complete release step, as shown in FIG. 14, the transporter is withdrawn, and the sealed stent in the tumor cavity is completely released.
In this embodiment, the beneficial effect that this sealed support in tumor chamber can reach includes:
first, the volume after radial compression is small, and the device can be easily loaded in the outer tube of the delivery device, and the operation is very convenient during implantation: specifically, in the prior art, if an ordinary single-layered stent graft is directly released into a tumor cavity, the single-layered stent graft cannot be adaptively filled in the whole tumor cavity space, but the single-layered stent graft needs to have a very high compression-elongation ratio if the single-layered stent graft is to be adaptively filled in the whole tumor cavity space, but if the single-layered stent graft meets such conditions, the stent graft on the surface of the stent graft can adapt to the high deformation of the stent, but actually, the tumor cavity generally has a large axial length, even if the stent graft is made of an elastic material, the stent graft cannot adapt to the high deformation of the stent, the above-mentioned function of sealing the tumor cavity port cannot be achieved, if the stent graft is to be sealed, an outer-layer stent graft is additionally arranged at the near end and the far end outside the stent body, so that if the outer-layer stent graft is integrally made with the stent graft body, the volume is inevitably too large after radial compression, and the conveyor cannot be limited by the diameter of a human blood vessel, the outer-layer stent graft cannot be implanted into the stent graft body, or the outer-graft stent graft body cannot be operated in a split manner, and the outer-graft body is difficult to be operated in a split type; in contrast, the intratumoral sealing stent provided by the embodiment does not have the above problems at all, the whole intratumoral sealing stent provided by the embodiment is of a single-layer covered stent structure, the proximal expanded diameter sealing part 1, the middle axial elastic part 2 and the distal supporting sealing part 3 are connected with each other in the axial direction, and after being released in a tumor body, only the middle axial elastic part 2 is required to be self-adapted to the space of the tumor cavity, so that the proximal expanded diameter sealing part 1 and the distal supporting sealing part 3 can be axially supported through resilience force, and further the functions of sealing two ends of the tumor cavity are achieved, each structure which is not required to be released in the tumor cavity meets a high compression-extension ratio, the elastic requirement on a covered membrane is low, the stent is easy to manufacture, and when the stent is radially compressed, the stent has a small volume, can be easily loaded in an outer tube of a conveyor, and is very convenient to operate during implantation;
secondly, the branch vessel does not need to be reconstructed when the implant is implanted, and the implant is suitable for aneurysms without anchoring areas and even involving the branch vessel; after implantation, the shape is stable, the sealing effect is good, the displacement and the internal leakage are not easy to occur, and complications such as occlusion and the like can not be caused: under the state that the tumor cavity internal sealing support is released in the tumor cavity, the middle axial elastic part 2 is axially extruded and compressed by the near-end expanding sealing part 1 and the far-end supporting sealing part 3, and the middle axial elastic part 2 respectively forms axial supporting force on the near-end expanding sealing part 1 and the far-end supporting sealing part 3, so that the coating of the near-end expanding sealing part 1 seals a gap between the support outer peripheral surface of the near-end expanding sealing part 1 and the tumor cavity near-end inner wall along the circumferential direction; the axial length of the middle axial elastic part 2 can be self-adapted to the shape of the tumor cavity; moreover, under the action of the middle axial elastic part 2, the whole tumor cavity inner sealing stent forms a stable supporting structure in the tumor cavity, and is suitable for aneurysms without an anchoring area and even involving branch vessels, such as infrarenal aneurysms without an anchoring area or aneurysms of a near-left subclavian artery, without reconstructing the branch vessels.
Further, in order to facilitate implantation, in this embodiment, it is preferable that, in a state where the tumor cavity inner sealing stent is released in the tumor cavity, a portion of the distal end supporting sealing portion 3 supported at the distal end outlet position of the tumor cavity is a distal end supporting position of the distal end supporting sealing portion 3, and developing points are respectively provided at the distal end supporting position of the distal end supporting sealing portion 3 and the proximal end position of the proximal end expanding sealing portion 1.
Further, in the sealed stent inside the tumor cavity provided in this embodiment, there are various specific structural forms of the distal supporting and sealing portion 3, for example, but not limited to, as shown in fig. 1 to 6, such that the distal supporting and sealing portion 3 includes a proximal straight section and a distal bifurcation section, the proximal end of the proximal straight section is connected to the distal end of the middle axial elastic portion 2, the proximal end of the distal bifurcation section is connected to the distal end of the proximal straight section, two guiding ports 31 are provided at the distal end of the distal bifurcation section, and the two guiding ports 31 are spaced from each other and form a triangular supporting bifurcation angle with an opening facing the distal end at a position spaced from each other, and after being implanted inside the tumor cavity, the triangular supporting bifurcation angle supports the distal supporting position as the distal supporting and sealing portion 3 at the iliac branch position at the distal end of the tumor body, so as to further ensure the stability of the sealed stent inside the tumor cavity, and by implanting the branch covered stent as a leg, further avoid blood leakage and displacement. Wherein, further preferably, in the distal support seal 3: the distal bifurcation section further comprises a cylindrical stent graft leg 32, the proximal end of the cylindrical stent graft leg 32 is integrally connected to any one of the guide ports 31, or the distal bifurcation section further comprises two cylindrical stent graft legs 32, the proximal ends of the two cylindrical stent graft legs 32 are connected to the two guide ports 31 in a one-to-one correspondence manner, wherein the proximal ends of the cylindrical stent graft legs 32 are connected to the corresponding guide ports 31 in a manner including, but not limited to, sewing or integral connection.
In addition, in the present embodiment, the stent of the proximal expanded diameter sealing portion 1 and the stent of the distal supporting sealing portion 3 may have various optional structures, for example, further, in the distal supporting sealing portion 3, the stent of the proximal straight-cylindrical section includes a plurality of stent rings arranged at intervals along the axial direction of the cylindrical stent thereof; alternatively, it is also preferable for increasing the supporting force in the axial direction of the distal end support seal portion 3 that the covering film of the proximal end straight-tube section is a cylindrical covering film, and the stent of the proximal end straight-tube section includes a plurality of stent rings arranged at intervals in the axial direction of the cylindrical covering film thereof and at least one longitudinal wire connected to the cylindrical covering film and/or any stent ring thereof; the stent ring is preferably an undulating stent ring.
In the present embodiment, the coating of the middle axial elastic portion 2 is a cylindrical coating, and the specific structure of the stent constituting the middle axial elastic portion 2 is various, for example, but not limited to:
as shown in fig. 1 to 4, the stent of the middle axial elastic part 2 comprises at least one first wire 301, and the first wire 301 is wound in a spiral shape around the central axis of the cylindrical coating, wherein the first wire 301 may be linear in the length direction as shown in fig. 1 and 2, or, preferably, the first wire 301 is repeatedly bent in a wave shape in the length direction as shown in fig. 3 and 4;
alternatively, as shown in fig. 5 and 6, the specific structure of the stent constituting the middle axial elastic part 2 may further include a plurality of second wires 302, one end of each of the second wires 302 is connected to the proximal expanded diameter sealing part 1, the other end is connected to the proximal end of the distal support sealing part 3, and the plurality of second wires 302 are arranged at intervals in pairs along the circumferential direction of the cylindrical coating thereof, and similarly, the second wires 302 may be linear along the length direction, or, preferably, as shown in fig. 5 and 6, the second wires 302 are repeatedly bent in a wavy shape along the length direction;
alternatively (not shown), the specific structure of the stent constituting the middle axial elastic portion 2 may further include at least one first wire 301 and a plurality of second wires 302; the first wire 301 is wound spirally around the central axis of its cylindrical coating as shown in fig. 1 to 4; as shown in fig. 5 and 6, one end of each of the second wires 302 is connected to the proximal end expanding sealing part 1, and the other end is connected to the proximal end of the distal end supporting sealing part 3, and the plurality of second wires 302 are arranged at intervals in the circumferential direction of the cylindrical film; wherein the first wire 301 and the second wire 302 may or may not be connected to each other, the support of the middle axial elastic portion 2 under this structure is stable, and in this structure, too, similarly, wherein the first wire 301 and the second wire 302 may be linear along the length direction, or, preferably, the first wire 301 and the second wire 302 are repeatedly bent into a wave shape along the length direction.
Alternatively, as shown in fig. 7 and 8, the middle axial elastic part 2 may be made of a covered mesh stent to ensure the supporting force of the middle axial elastic part.
In each optional embodiment of this embodiment, the above-mentioned cylindrical film of the middle axial elastic part 2 may have the same diameter at each position along the axial direction, the outer contour is straight cylindrical, or may change regularly or irregularly along the axial diameter, the outer contour is drum-shaped, shuttle-shaped or conical, preferably drum-shaped, shuttle-shaped or conical, so as to reduce the surface area and wrinkles after the film is stacked, and meanwhile, the diameters of the proximal end and the distal end are closer to the proximal expanded diameter sealing part 1 and the distal end supporting sealing part 3, respectively, so as to facilitate the film butt joint with the proximal expanded diameter sealing part 1 and the distal end supporting sealing part 3; after being axially compressed, the cylindrical coating may be straight cylindrical or have an outer profile as shown in fig. 1-8 in a fusiform shape with a proximal diameter and a distal diameter both axially smaller than the diameter of the middle portion.
With continued reference to fig. 1-6, in some preferred embodiments of this embodiment, the sealed stent further comprises a proximal anchoring portion 4, wherein the distal end of the proximal anchoring portion 4 is connected to the proximal end of the proximal expanded diameter sealing portion 1 for anchoring to the vessel wall near the proximal end of the tumor cavity, and the proximal anchoring portion 4 can be released after the fifth complete release step shown in fig. 14, and is fixed to the front end of the delivery device in other steps.
Wherein, the actual optional structure of near-end anchor portion 4 also has the multiple, for example but not limited to adopt the tubular tectorial membrane support, cooperate the anchor nail to carry out anchor fixing position etc. in addition, for the convenience of operation, it is further preferred that this near-end anchor portion 4 includes bare support 41 and locates barb 42 on bare support 41, and this barb 42 is preferred including forward barb and reverse barb, this forward barb expands towards distal direction, in order to prevent this sealed support in the tumor chamber because blood flow strikes and takes place the aversion, this reverse barb expands towards proximal direction, in order to prevent that this sealed support is whole to be shifted to the near-end under the effect of middle part axial elasticity portion 2 in this tumor chamber, shutoff renal artery branch blood vessel.
Finally, it should be noted that: the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and these modifications or substitutions do not depart from the spirit of the corresponding technical solutions of the embodiments of the present invention.

Claims (8)

1. A tumor intracavity sealing support is characterized in that: comprises a near-end expanding sealing part (1), a middle axial elastic part (2) and a far-end supporting sealing part (3) which are sequentially connected from the near end to the far end;
the near-end expanding sealing part (1), the middle axial elastic part (2) and the far-end supporting sealing part (3) respectively comprise respective stents and covering films arranged on the peripheral surfaces of the stents; and in a free state: the central axial elastic portion (2) being capable of being compressed in the axial direction to shorten in length;
in a state where the intratumoral sealing stent is released in the tumor cavity: the film of the near-end expanding sealing part (1) seals a gap between the outer peripheral surface of the bracket of the near-end expanding sealing part (1) and the near-end inner wall of the tumor cavity along the circumferential direction; the far-end supporting sealing part (3) supports the middle axial elastic part (2) and the near-end expanding sealing part (1); the middle axial elastic part (2) is pressed and compressed by the near end expanding sealing part (1) and the far end supporting sealing part (3) in the axial direction;
wherein:
the middle axial elastic part (2) adopts a film-covered grid support;
alternatively, the first and second electrodes may be,
the film of the middle axial elastic part (2) is a cylindrical film; the bracket of the middle axial elastic part (2) comprises at least one first metal wire (301), and the first metal wire (301) is wound into a spiral shape around the central axis of the cylindrical film; and/or the stent of the middle axial elastic part (2) comprises a plurality of second metal wires (302), one end of each second metal wire (302) is connected to the near-end expanding sealing part (1), the other end of each second metal wire is connected to the near end of the far-end supporting sealing part (3), and the second metal wires (302) are arranged at intervals in pairs along the circumferential direction of the cylindrical film.
2. The intratumoral sealing stent according to claim 1, characterized in that in the state of being released in the tumor cavity, the part of the distal end support sealing part (3) supported at the distal end exit position of the tumor cavity is the distal end support position of the distal end support sealing part (3), and the distal end support position of the distal end support sealing part (3) and the proximal end position of the proximal end expanding sealing part (1) are respectively provided with a developing point.
3. The intratumoral sealing stent according to claim 1, characterized in that said distal supporting and sealing portion (3) comprises a proximal straight cylindrical section and a distal bifurcated section, the proximal end of said proximal straight cylindrical section is connected to the distal end of said middle axial elastic portion (2), the proximal end of said distal bifurcated section is connected to the distal end of said proximal straight cylindrical section, the distal end of said distal bifurcated section is provided with two guiding ports (31), and said two guiding ports (31) are spaced from each other and form a triangular supporting bifurcated angle with the opening facing the distal end at the spaced position.
4. The intratumoral sealing stent of claim 3, characterized in that: in the distal support seal (3): the distal end bifurcation section still includes a tube-shape covered stent landing leg (32), the near-end body coupling of tube-shape covered stent landing leg (32) is in arbitrary guide port (31), perhaps, the distal end bifurcation section still includes two tube-shape covered stent landing legs (32), two the near-end one-to-one of tube-shape covered stent landing leg (32) is connected in two guide port (31).
5. The intratumoral sealing stent of claim 3, characterized in that: the tectorial membrane of near-end straight section of thick bamboo section is the tube-shape tectorial membrane, wherein:
the bracket of the proximal straight cylinder section comprises a plurality of bracket rings which are arranged at intervals along the axial direction of the cylindrical coating;
alternatively, the first and second electrodes may be,
the stent of the proximal straight cylindrical section comprises a plurality of stent rings and at least one longitudinal wire, the stent rings are arranged at intervals along the axial direction of the cylindrical coating, and the longitudinal wire is connected to the cylindrical coating and/or any stent ring.
6. The intratumoral sealing stent of claim 1, wherein: the first wire (301) and/or the second wire (302) are repeatedly bent in a wave shape in a longitudinal direction.
7. The intratumoral sealing stent of claim 1, wherein: the tumor cavity inner sealing stent further comprises a near-end anchoring part (4), wherein the far end of the near-end anchoring part (4) is connected to the near end of the near-end expanding sealing part (1) and is used for anchoring on a blood vessel wall close to the near end of the tumor cavity.
8. The intratumoral sealing stent of claim 7, wherein: near-end anchor portion (4) include naked support (41) and locate barb (42) on naked support (41), just barb (42) are including forward barb and reverse barb, forward barb expands towards distal end direction, reverse barb expands towards proximal end direction.
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CN116747060B (en) * 2023-08-16 2023-11-17 北京华脉泰科医疗器械股份有限公司 Endovascular prosthesis for hemangioma

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