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CN114848247A - Bead string component, method for the production thereof and use thereof - Google Patents

Bead string component, method for the production thereof and use thereof Download PDF

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Publication number
CN114848247A
CN114848247A CN202011195618.XA CN202011195618A CN114848247A CN 114848247 A CN114848247 A CN 114848247A CN 202011195618 A CN202011195618 A CN 202011195618A CN 114848247 A CN114848247 A CN 114848247A
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CN
China
Prior art keywords
component
beaded
inflatable body
expandable body
cylindrical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202011195618.XA
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Chinese (zh)
Inventor
吕怡然
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aike Medical Devices Beijing Co ltd
Original Assignee
Aike Medical Devices Beijing Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aike Medical Devices Beijing Co ltd filed Critical Aike Medical Devices Beijing Co ltd
Priority to CN202011195618.XA priority Critical patent/CN114848247A/en
Priority to EP21885019.6A priority patent/EP4238540A4/en
Priority to US18/034,387 priority patent/US20230293324A1/en
Priority to PCT/CN2021/125205 priority patent/WO2022089292A1/en
Publication of CN114848247A publication Critical patent/CN114848247A/en
Pending legal-status Critical Current

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    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable

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  • 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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The present disclosure relates to bead string components and methods of making and using the same. The beaded component comprises an expandable body and at least two shaped assemblies, each shaped assembly comprising a first component and a second component; the first member having a cylindrical inner cavity in which a partial section of the expandable body is constricted to form a constricted section of the beaded member; or the first component has a cylindrical outer surface to which the inner surface of a partial section of the expandable body is fixedly connected to form a constricted section of the beaded component; the second part is a tubular part, and the contraction section is sleeved in the second part; an expansion section of the bead string-shaped component is formed between two adjacent contraction sections. The bead string-shaped component is beneficial to smooth release of the bracket and improvement of smoothness of bracket conveying, and has the advantages of simple structure, easiness in manufacturing and high reliability.

Description

Bead string component, method for the production thereof and use thereof
Technical Field
The present disclosure relates to the field of interventional therapeutics, and in particular, to bead string components and methods of making and using the same.
Background
Vascular stents (or simply "stents") may be implanted into blood vessels by vascular interventional procedures for the treatment of a variety of vascular conditions, such as blood flow-directing techniques for the treatment of hemangiomas, vascular reconstruction techniques for the treatment of stenosis or occlusion of the lumen of a blood vessel.
Problems are encountered when delivering vascular stents into blood vessels. For example, stents in a compressed state are subject to torsional stresses after reaching the treatment site, which restricts the stent from self-expanding. For another example, during stent delivery, the poor passability of the delivery system, poor vascular compliance, and poor rotational alignment make it difficult for the surgeon to precisely manipulate the shape and position of the stent implant within the vessel during the interventional procedure.
The conveying system has poor controllability on the stent implant, reduces the efficiency of conveying the stent, reduces the success rate of the stent reaching the lesion part, prolongs the operation time, and ensures that the risk of operation failure and postoperative complications is high.
Therefore, there is a need to provide a new technical solution for stent delivery.
Disclosure of Invention
The technical problem that this disclosure will solve is: on one hand, the bracket cannot be automatically released due to the influence of torsional stress; on the other hand, the operation in the process of conveying the stent is more laborious and difficult, and the efficiency of conveying the stent is reduced.
The present disclosure proposes the following technical solutions:
in a first aspect, there is provided a beaded component comprising an inflatable body and at least two shaped assemblies, each shaped assembly comprising a first component and a second component;
said first member having a cylindrical lumen in which a partial section of said expandable body is constricted to form a constricted section of said beaded member; or the first component has a cylindrical outer surface to which the inner surface of a partial section of the expandable body is fixedly connected to form a constricted section of the beaded component;
the second part is a tubular part, and the contraction section is sleeved in the second part;
and an expansion section of the bead string-shaped component is formed between two adjacent contraction sections.
Preferably, the end of the second part is provided with a chamfer structure;
preferably, the first part has a cylindrical inner cavity, and the shape of the first part is selected from a cylinder, a prism, a sphere or a round table;
preferably, the first component has a cylindrical outer surface;
preferably, the cylindrical inner cavity is cylindrical or the cylindrical outer surface is cylindrical.
Preferably, the connection mode of the partial section of the expandable body and the cylindrical inner cavity is selected from welding, bonding, hot melting connection or tight fit;
preferably, the connection between the inner surface of the partial section of the expandable body and the cylindrical outer surface is selected from welding, adhesive bonding or hot melt connection;
preferably, the second member is connected to the contraction section by welding, bonding, hot-melt bonding or interference fit.
Preferably, the inflatable body is a mesh tube, a solid-walled tube, or an inflatable balloon;
preferably, the second part is made of a metal material or a polymer material;
preferably, the second member is a heat shrink tube;
preferably, the material of the second part is selected from a polyolefin material, a fluorinated ethylene propylene copolymer, a neoprene or a fluoroelastomer.
Preferably, the distance L between two adjacent said shaping assemblies satisfies formula (1):
L>D (1)
wherein D is the outer diameter of the second component;
preferably, the expandable body comprises a first expandable body and a second expandable body, the first expandable body is sleeved in the second expandable body, and a part of the second expandable body is constricted in the cylindrical inner cavity.
In a second aspect, there is provided a method of manufacturing a beaded part as described in any of the embodiments of the first aspect of the present disclosure, comprising:
deflating the inflatable body;
sleeving at least two of said first members outside said inflatable body, or placing at least two of said first members inside said inflatable body;
fixedly connecting the cylindrical inner cavity or the cylindrical outer surface of the first member with the inflatable body;
sleeving at least two of said second members over the connection of said first member to said inflatable body;
and fixedly connecting the second component with the first component or the expandable body to obtain the bead string-shaped component.
Preferably, the second member is a heat shrink tube; said fixedly connecting said second component to said first component or said inflatable body, comprising:
heating the second component to thermally fuse the second component to the first component or the expandable body.
In a third aspect, there is provided a stent delivery system comprising a delivery catheter, a delivery guidewire, and a bead string component according to any embodiment of the first aspect of the disclosure;
the far end of the conveying guide wire is fixedly connected with the near end of the bead string-shaped component;
the bead string component is positioned within the delivery catheter and is in a compressed state.
Preferably, the stent delivery system further comprises a stent positioned between the delivery catheter and the beaded member and in a compressed state;
preferably, the stent delivery system further comprises a delivery clip;
the conveying clamp comprises a base and at least two clamping wings; the at least two clamping wings are respectively and rotatably connected with the base; when the at least two clamping wings are in the first position state, a furling part with a prism shape is formed together, and the furling part is provided with an inner space for furling at least part of the bracket; when the at least two clamping wings rotate from the first position state to the second position state, the clamping wings are separated from each other to enable the furling part to expand;
the base of the conveying clamp is fixedly sleeved outside the near end of the bead string-shaped component; the clamping wings of the conveying clamp are in a first position state and at least part of the bracket is folded in.
The beneficial effects of the invention include:
in the beaded part and the manufacturing method and application thereof provided by the present disclosure, a portion of the tube section of the expandable body is bunched in the cylindrical inner cavity or the inner surface of the portion of the tube section of the expandable body is fixedly connected with the cylindrical outer surface, so that the portion of the tube section of the expandable body is shrunk, thereby forming the beaded part. When the bead string-shaped component is used for conveying the stent (namely, the stent is sleeved outside the bead string-shaped component for conveying), on one hand, the expansion of the bead string-shaped component is beneficial to the smooth release of the stent, so that the stent is completely attached to a diseased blood vessel; on the other hand, because the shaping assembly enables part of the pipe section of the expandable body to contract, the contact area between the expandable body and the inner wall of other instruments or the inner wall of a blood vessel is reduced, further the accidental injury to the intima of the blood vessel is reduced, meanwhile, the expansion section of the expandable body can be correspondingly deformed according to the trend and the shape of the blood vessel, the resistance of stent delivery is favorably reduced, and the smoothness of stent delivery is improved.
Further, in the bead string-shaped member and the manufacturing method and application thereof provided by the present disclosure, the bead string-shaped member can be formed on the basis of the existing inflatable body (for example, a mesh tube, a solid-walled tube, and an inflatable balloon), without changing the existing manufacturing method of the inflatable body, and the bead string-shaped member is simple in structure, easy to manufacture, and high in reliability.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the description of the embodiments of the present disclosure will be briefly introduced below; the accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this disclosure, illustrate embodiments of the disclosure and together with the description serve to explain the disclosure and not to limit the disclosure.
FIG. 1 is a schematic structural view from one perspective of a beaded component according to a first embodiment of the present disclosure;
FIG. 2 is a schematic structural view from another perspective of a bead string component according to a first embodiment of the present disclosure;
FIG. 3 is a schematic structural view from one perspective of a beaded component according to a second embodiment of the present disclosure;
FIG. 4 is a schematic structural view from one perspective of a beaded component according to a third embodiment of the present disclosure;
FIG. 5 is a schematic structural view from one perspective of a beaded component according to a fourth embodiment of the present disclosure;
FIG. 6 is a schematic structural view from one perspective of a stent delivery system according to a sixth embodiment of the present disclosure;
fig. 7 is a structural schematic diagram of a perspective view of a transport clip according to a sixth embodiment of the present disclosure.
Description of reference numerals: 1-an expandable body; 1 a-a first expandable body; 1 b-a second expandable body; 2-shaping the component; 201-a first component; 202-a second component; 202 a-a chamfer configuration; 2 a-a first shaping component; 2 b-a second shaping component; 2 c-a third shaping component; 3-delivering guide wires; 4-a delivery catheter; 5-a bracket; 6-a bead string component; 8-conveying the clamp; 801-a base; 802-clip wing; 802 a-a first clip wing; 802 b-second clip wing.
Detailed Description
The present disclosure is described in further detail below with reference to the accompanying drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant invention and not restrictive of the invention. It should be noted that, for convenience of description, only the portions related to the related invention are shown in the drawings.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships only for the convenience of description and simplification of description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed in a specific orientation, and be operated, 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.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the description of the present invention, it is to be noted that the embodiments and features of the embodiments in the present disclosure may be combined with each other without conflict.
Fig. 1 is a schematic structural view from one perspective of a beaded component according to a first embodiment of the present disclosure. As shown in fig. 1, the bead string component is divided into a contraction section a and an expansion section B. The number of the contraction sections A and the expansion sections B is multiple and the contraction sections A and the expansion sections B are arranged in a staggered mode. Wherein, the expansion section B is in a spindle shape, namely, the middle is thicker and the two ends are thinner.
As shown in fig. 1, the beaded part comprises an expandable body 1 and a plurality of shaped components 2a, 2b and 2 c. Wherein a plurality of shaped elements 2a, 2B and 2c are used to form the contracted sections a, and between two adjacent contracted sections a, the expanded sections B are formed.
Fig. 2 is a schematic structural view from another perspective of a bead string component according to a first embodiment of the present disclosure. As shown in fig. 2, each shaping assembly comprises a first part 201. First member 201 has a cylindrical inner cavity in which a partial section of inflatable body 1 is constricted.
Since the first member 201 is cut away in fig. 2, the first member 201 is shown in fig. 2 as upper and lower halves. It will be readily appreciated that in actual construction, the upper and lower halves of the first member 201 are integral.
In this embodiment, the first member 201 has a cylindrical shape. In other embodiments, the first member 201 may also have a prism, a sphere, a truncated cone, or the like.
In this embodiment, the inner cavity of the first member 201 is cylindrical. That is, the first member 201 is a circular tubular member as a whole. In other embodiments, the internal cavity of the first component 201 may also be prismatic or other shapes.
In this embodiment, the material of the first member is a metal material or a polymer material.
In this embodiment, the shaping assembly 2 further comprises a second part 202. The second member 202 is a tubular member. The contracted section of the beaded part is sleeved inside the second part 202.
The second part 202 is shown in fig. 2 as being cut-away, and thus is shown in fig. 2 as upper and lower halves. It will be readily appreciated that in actual construction, the upper and lower halves of the second member 202 are integral.
In this embodiment, the material of the second member 202 is a polymer material. More specifically, the second member 202 is a heat shrinkable tube having a property of shrinking by heat. In other embodiments, the material of the second member 202 may also be a metallic material.
In one example, the material of the second component is selected from a polyolefin material, a fluorinated ethylene propylene copolymer, a neoprene rubber, or a fluoroelastomer.
In the present embodiment, the connection manner between the second member 202 and the first member 201 or the expandable body 1 is a thermal fusion connection. That is, the second member 202 is a heat shrinkable tube, and is connected to the first member 201 and the expandable body 1 by heating after being fitted over the shrunk section. In other embodiments, the connection between the second member and the first member or inflatable body may be by welding, adhesive bonding, interference fit, or the like.
In this embodiment, the diameter of the cylindrical inner cavity of the first part 201 is smaller than the outer diameter of the expandable body 1 in the expanded state. Thus, a partial section of the expandable body 1 is constricted in the compressed state in the cylindrical inner cavity of the first member 201.
In this embodiment, a partial section of the expandable body is constricted in the cylindrical lumen, so that the partial section of the expandable body contracts, thereby forming a beaded component. When the bead string-shaped component is used for conveying the stent, on one hand, the expansion of the bead string-shaped component is beneficial to smooth release of the stent, so that the stent is completely attached to a diseased blood vessel; on the other hand, as the shaping assembly enables partial sections of the expandable body to contract, the contact area between the expandable body and the inner wall of other instruments or the inner wall of a blood vessel is reduced, further the accidental injury to the intima of the blood vessel is reduced, and meanwhile, the expansion section of the expandable body can be correspondingly deformed according to the trend and the shape of the blood vessel, so that the resistance of stent delivery is favorably reduced, and the smoothness of stent delivery is improved. By providing the second part 202, i.e. a shaped assembly with a double structure, the stability and reliability of the beaded part is further facilitated.
In addition, the shaping assembly can form the bead string-shaped component on the basis of the existing expandable body, does not need to change the manufacturing method of the existing expandable body, and enables the bead string-shaped component to have simple structure, easy manufacture and high reliability.
In the embodiment that the second part adopts the heat shrinkable tube, the hot melting connection mode does not involve production particles in the welding or bonding mode, so that the production particles are prevented from falling into blood vessels to bring danger to human health. Furthermore, the risk of the component material entering the blood vessel can be further reduced due to the wrapping of the second component on the outermost layer.
In the present embodiment, both ends of the second member 202 have chamfered structures 202 a. Chamfer structure 202a may provide a smooth transition in the form of a chamfer between the outer surface of second member 202 and the outer surface of inflatable body 1. It should be noted that the chamfer structure in the present disclosure may be any bevel structure capable of achieving smooth transition, and the chamfer structure may be formed in other manners besides cutting. For example, the chamfered structure may be formed by injection molding. Also for example, the chamfered structure, such as chamfered structure 202a,.
The end part of the second component is provided with the chamfer structure, so that the resistance in the process of conveying the bracket can be further reduced.
In this embodiment, three partial sections of inflatable body 1 are successively constricted in the cylindrical lumens of first, second and third shaping assemblies 2a, 2b, 2 c. In other embodiments, the inner surfaces of multiple segments of the inflatable body may be fixedly connected to the cylindrical outer surfaces of multiple shaping assemblies.
In this embodiment, inflatable body 1 is a mesh tube. In other embodiments, inflatable body 1 may also be a solid-walled tube or an inflatable balloon. Under the condition that the inflatable body is the inflatable balloon, the expansion size of each section of the bead string balloon can be limited by controlling the distance between the shaping components, and the conveying capacity of the conveying system in the axial direction can be improved by controlling the pressure value of the inflatable balloon and combining the bead string structure.
In the present embodiment, the distance L between two adjacent shaping members satisfies the formula (1):
L>D(1)
wherein D is the outer diameter of the second member. Wherein the distance L between the two shaping members is the distance between the opposing end faces of the two shaping members, as shown in figure 1. By designing the distance L between two adjacent shaping assemblies to satisfy equation (1), it can be ensured that the diameter of the expansion section is greater than that of the contraction section, thereby forming a bead string-like structure.
Fig. 3 is a schematic structural view from one perspective of a bead string component according to a second embodiment of the present disclosure. This embodiment differs from the first embodiment in that the first part 201 has a cylindrical outer surface and in that a partial section of the expandable body 1 is fixedly connected to this cylindrical outer surface. That is, the first member in the first embodiment is disposed outside the inflatable body, whereas the first member in this embodiment is disposed inside the inflatable body. Further, in the present embodiment, the second member 202 is provided on the outer surface of the inflatable body 1.
In this embodiment, the first member 201 has a cylindrical outer surface. Furthermore, similar to the first embodiment, the first member 201 also has a cylindrical through lumen, i.e., the first member 201 is a circular tubular member as a whole.
In this embodiment, the inner surface of a partial section of inflatable body 1 is fixedly attached to the cylindrical outer surface of first member 201 by adhesive bonding. For example, the inner surface of a partial section of inflatable body 1 is coated with an adhesive and pressed onto the cylindrical outer surface of first member 201, thereby fixedly attaching the two. Alternatively, an adhesive is applied to the cylindrical outer surface of the first member 201, and the inner surface of a partial section of the expandable body 1 is press-fitted to the cylindrical outer surface of the first member 201, thereby fixedly connecting the two. In other embodiments, the inner surface of a partial section of inflatable body 1 and the cylindrical outer surface of first member 201 may be fixedly connected by welding, heat fusion, or the like.
In the present embodiment, both ends of the second member 202 are also provided with chamfered structures 202 a.
In this embodiment, the inner surface of the partial section of the expandable body is fixedly connected with the cylindrical outer surface of the first component, so that the partial section of the expandable body contracts, thereby forming a beaded component, and the second component wraps the connection region of the first component and the expandable body at the outermost layer. Therefore, the bead string component in this embodiment can achieve the similar technical effects as the first embodiment, and is not described here again.
In addition, because the first component in the embodiment is arranged in the expandable body, the first component in the embodiment can prevent the expandable body from further contracting at the joint position of the expandable body and the first component, so that the expandable body is prevented from being separated from the shaping assembly due to the contraction of the expandable body when the tight fit connection is adopted, and the structural stability is improved.
Fig. 4 is a schematic structural view from one perspective of a beaded component according to a third embodiment of the present disclosure. The present embodiment differs from the second embodiment in that the first member 201 in the second embodiment has a through cavity, whereas the first member 201 in the present embodiment is of a solid structure.
The first component in the embodiment adopts a solid structure, so that the manufacturing difficulty of the first component is reduced, and the structural strength of the bead string-shaped component is improved.
Fig. 5 is a schematic view of a bead string component according to a fourth embodiment of the present disclosure from one perspective. The bead string-like member in the present embodiment is different from that in the first embodiment in that the bead string-like member in the present embodiment includes two expandable bodies, i.e., a first expandable body 1a and a second expandable body 1 b.
In this embodiment, the first expandable body 1a is sleeved outside the second expandable body 1b, and a partial section of the second expandable body 1b is constrained in the cylindrical inner cavity of the first member 201. Therefore, the bending resistance and the kinking resistance of the bead string-shaped component are improved.
A fifth embodiment of the present disclosure provides a method of manufacturing a beaded part, including the steps of:
first, the inflatable body is tightened. For example, the expandable body is stretched to tighten it.
Next, the at least two first members are placed outside the inflatable body, or the at least two first members are placed inside the inflatable body.
Again, the cylindrical inner lumen or cylindrical outer surface of the first member is fixedly attached to the inflatable body. For example, the two are fixedly connected by welding, bonding, hot-melt bonding or tight fitting.
Thereafter, at least two second components are placed over the first component and the inflatable body at their connection.
And finally, fixedly connecting the second component with the first component or the expandable body to obtain the bead string-shaped component. The first member and the inflatable body are each fixedly attached to the second member, for example, by a heat-fused attachment.
In some alternative embodiments, the second member is a heat shrink tube. The step of fixedly attaching the second component to the first component or the inflatable body comprises: the second component is heated to thermally fuse the second component to the first component or the expandable body.
Fig. 6 is a schematic structural view from one perspective of a stent delivery system according to a sixth embodiment of the present disclosure. As shown in FIG. 6, the stent delivery system includes a delivery catheter 4, a delivery guidewire 3, and a beaded member 6. Wherein the beaded part 6 comprises an expandable body 1 and a plurality of shaped components 2.
In this embodiment, the distal end of the delivery guidewire 3 (i.e., the left end in FIG. 6) is fixedly attached to the proximal end of the beaded component 6 (i.e., the right end in FIG. 6). The bead-string like member 6 is located within the delivery conduit 4 and is in a compressed state.
In some alternative embodiments, the stent delivery system further comprises a stent 5. The stent 5 is positioned between the delivery catheter 4 and the beaded part 6 and is in compression.
In the process of stent delivery, the delivery catheter 4 can be firstly sent into a human body, the distal opening of the delivery catheter is positioned near the target position, then the delivery guide wire 3 is pushed to deliver the bead string-shaped component 6 connected with the delivery guide wire to the distal end, and the bead string-shaped component 6 drives the stent 5 to move together.
After the stent 5 reaches the distal opening of the delivery catheter 4, the beaded part 6 and the stent 2 can be gradually removed from the delivery catheter 4 by pushing on the delivery guidewire 3. Because the expandable body 1 has the self-expansion characteristic, the expansion section of the bead string-shaped part 6, which is moved out of the catheter, can expand and expand along the radial direction and drive the stent 5 sleeved outside the expansion section to expand, so that the stent 5 is released smoothly.
In some alternative embodiments, the stent delivery system further comprises a delivery clip 8.
FIG. 7 is a schematic diagram of a perspective view of a transport clip according to a sixth embodiment of the present disclosure. As shown in fig. 7, the transport clip 8 includes a base 801 and at least two clip wings 802; at least two clamping wings 802 are respectively connected with the base 801 in a rotating way; when the at least two clamping wings 802 are in the first position state, a furling part with a prism shape is formed together, and the furling part is provided with an inner space for furling at least part of the bracket; when the at least two wings 802 are rotated from the first position to the second position, they are separated from each other so that the folded portion is expanded.
As shown in FIG. 6, the base 801 of the delivery clip 8 fits snugly over the proximal end of the beaded component 6. The first clip wing 802a and the second clip wing 802b of the transport clip 8 are in the first position state and gather the partial sections of the support 5 inside.
In the present embodiment, the transport clip 8 in fig. 6 is in the first position state, and the transport clip 8 in fig. 7 is in the second position state.
In this embodiment, the at least two clip wings form a furling part with a prism shape together when in the first position state, the furling part has an inner space for furling at least part of the stent, and the furling parts are separated from each other to expand when in the second position state. On the one hand, the stent can be recovered under the conditions that the release position of the stent is wrong or needs to be adjusted, on the other hand, the stent conveying component keeps line contact with the inner wall of the conveying conduit, so that the contact area is reduced, the friction resistance is reduced, the operation difficulty is reduced, and the conveying efficiency is improved.
The foregoing description is only exemplary of the preferred embodiments of the disclosure and is illustrative of the principles of the technology employed. It will be appreciated by those skilled in the art that the scope of the invention in the present disclosure is not limited to the specific combination of the above-mentioned features, but also encompasses other embodiments in which any combination of the above-mentioned features or their equivalents is possible without departing from the inventive concept as defined above. For example, the above features and (but not limited to) the features disclosed in this disclosure having similar functions are replaced with each other to form the technical solution.

Claims (10)

1. A beaded component comprising an expandable body and at least two shaped assemblies, each of said shaped assemblies comprising a first component and a second component;
said first member having a cylindrical lumen in which a partial section of said expandable body is constricted to form a constricted section of said beaded member; or the first component has a cylindrical outer surface to which the inner surface of a partial section of the expandable body is fixedly connected to form a constricted section of the beaded component;
the second component is a tubular component, and the contraction section is sleeved in the second component;
and an expansion section of the bead string-shaped component is formed between two adjacent contraction sections.
2. The beaded component of claim 1, wherein the end of the second component is provided with a chamfered configuration;
preferably, the first part has a cylindrical inner cavity, and the shape of the first part is selected from a cylinder, a prism, a sphere or a round table;
preferably, the first component has a cylindrical outer surface;
preferably, the cylindrical inner cavity is cylindrical or the cylindrical outer surface is cylindrical.
3. The beaded component of claim 1 or 2, wherein the connection of the segments of the expandable body to the cylindrical inner cavity is selected from welding, adhesive bonding, heat staking or a tight fit;
preferably, the connection between the inner surface of the partial section of the expandable body and the cylindrical outer surface is selected from welding, adhesive bonding or hot melt connection;
preferably, the second member is connected to the contraction section by welding, bonding, hot-melt bonding or interference fit.
4. The beaded component of any of claims 1-3, wherein the inflatable body is a mesh tube, a solid-walled tube, or an inflatable balloon;
preferably, the second part is made of a metal material or a polymer material;
preferably, the second member is a heat shrink tube;
preferably, the material of the second part is selected from a polyolefin material, a fluorinated ethylene propylene copolymer, a neoprene or a fluoroelastomer.
5. The beaded component of any one of claims 1-4, wherein the distance L between two adjacent shaping assemblies satisfies the formula (1):
L>D (1)
wherein D is the outer diameter of the second member.
6. The beaded component of any of claims 1-5, wherein the inflatable body comprises a first inflatable body and a second inflatable body, the first inflatable body nested within the second inflatable body, a partial section of the second inflatable body being constricted within the cylindrical lumen.
7. A method of manufacturing the beaded component of any of claims 1-6, comprising:
deflating the inflatable body;
sleeving at least two of said first members outside said inflatable body, or placing at least two of said first members inside said inflatable body;
fixedly attaching the cylindrical inner lumen or the cylindrical outer surface of the first member to the inflatable body;
sleeving at least two of said second members over the connection of said first member to said inflatable body;
and fixedly connecting the second component with the first component or the expandable body to obtain the bead string-shaped component.
8. The method of claim 7, wherein the second component is a heat shrink tube; said fixedly connecting said second component to said first component or said inflatable body, comprising:
heating the second component to thermally fuse the second component to the first component or the expandable body.
9. A stent delivery system comprising a delivery catheter, a delivery guidewire, and the beaded component of any of claims 1-6;
the far end of the conveying guide wire is fixedly connected with the near end of the bead string-shaped component;
the bead string component is positioned within the delivery catheter and is in a compressed state.
10. The stent delivery system of claim 9, wherein the stent delivery system further comprises a stent positioned between the delivery catheter and the beaded member in a compressed state;
preferably, the stent delivery system further comprises a delivery clip;
the conveying clamp comprises a base and at least two clamping wings; the at least two clamping wings are respectively and rotatably connected with the base; when the at least two clamping wings are in the first position state, a furling part with a prism shape is formed together, and the furling part is provided with an inner space for furling at least part of the bracket; when the at least two clamping wings rotate from the first position state to the second position state, the clamping wings are separated from each other to enable the furling part to expand;
the base of the conveying clamp is fixedly sleeved outside the near end of the bead string-shaped component; the clamping wings of the conveying clamp are in a first position state and at least part of the bracket is folded in.
CN202011195618.XA 2020-10-30 2020-10-30 Bead string component, method for the production thereof and use thereof Pending CN114848247A (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202011195618.XA CN114848247A (en) 2020-10-30 2020-10-30 Bead string component, method for the production thereof and use thereof
EP21885019.6A EP4238540A4 (en) 2020-10-30 2021-10-21 Bead-string-shaped component, manufacturing method therefor and use thereof
US18/034,387 US20230293324A1 (en) 2020-10-30 2021-10-21 Beaded component, manufacturing method and application thereof
PCT/CN2021/125205 WO2022089292A1 (en) 2020-10-30 2021-10-21 Bead-string-shaped component, manufacturing method therefor and use thereof

Applications Claiming Priority (1)

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