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WO2025046612A1 - Dispositif médical intraluminal à résistance à la fatigue élevée - Google Patents

Dispositif médical intraluminal à résistance à la fatigue élevée Download PDF

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Publication number
WO2025046612A1
WO2025046612A1 PCT/IN2024/051551 IN2024051551W WO2025046612A1 WO 2025046612 A1 WO2025046612 A1 WO 2025046612A1 IN 2024051551 W IN2024051551 W IN 2024051551W WO 2025046612 A1 WO2025046612 A1 WO 2025046612A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
peaks
undulating pattern
circular
peak
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
PCT/IN2024/051551
Other languages
English (en)
Inventor
Debasish Pradhan
Sandeep Jagannath Walde
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.)
Biorad Medisys Private Ltd
Original Assignee
Biorad Medisys Private 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 Biorad Medisys Private Ltd filed Critical Biorad Medisys Private Ltd
Publication of WO2025046612A1 publication Critical patent/WO2025046612A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents 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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91566—Adjacent bands being connected to each other connected trough to trough

Definitions

  • the present invention generally relates to medical devices for supporting, maintaining, or repairing a lumen, passageway or opening in a living body.
  • the invention relates to particular intravascular stents, which are adapted to be implanted into a patient's body lumen, such as a blood vessel or coronary artery, to maintain the patency thereof.
  • Carotid artery stenosis is a condition where the carotid arteries, which supply blood to the brain, become narrowed or blocked due to plaque buildup. This can reduce blood flow to the brain and increase the risk of stroke.
  • One of the treatments for carotid artery stenosis is carotid stenting which involves inserting a mesh tube (stent) into the vessel to serve as a scaffold that helps prevent the artery from narrowing again.
  • a stent is a well-known medical scaffolding device that is often tubular that is used for maintaining the patency of a large variety of lumens of the human body. Modern intravascular stents are available in balloonexpandable and self-expanding varieties.
  • stents have been made by different techniques, including forming from wire and machining from a hollow tube. Such machining can be done by photo-chemical etching, laser-cutting, stamping, piercing, or other material-removal processes. Other manufacturing techniques have been proposed, such as vacuum or chemical deposition of material or forming a tube of machined flat material, but those “exotic” methods have not been widely commercialized.
  • an implantable prosthesis device that maintains the patency of a vessel with the ability to adapt to the tortuous anatomy of the host by being highly flexible and highly durable w'hile being loadable into a delivery catheter of sufficiently small profile and easily deliverable to a target site in the vessel or duct by having the ability to navigate tortuous ducts or vessels.
  • This invention is therefore directed towards providing an effective vascular implant, which is relatively simple in design and structure, and is highly effective for its intended purpose.
  • Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.
  • the present invention discloses a intravascular stent.
  • the stent comprising a plurality of circular structure.
  • the plurality of circular structure comprises a first structure and a second structure.
  • the first structure and the second structure is made up of plurality of peaks and valleys to form an undulating pattern.
  • the undulating pattern of the first structure and the second structure is mirror to each other.
  • the undulating pattern comprises a plurality of first peaks and a plurality of second peaks.
  • a height of the plurality of second peaks is less than the plurality of first peak.
  • the plurality of second peaks and the plurality of first peaks are alternate.
  • the plurality of circular structure further comprises a plurality of links.
  • the plurality of links are coupled in between the plurality of second peaks of the first structure and second structure.
  • the plurality of circular structures are connected at the plurality of first peak to form a radially expandable stent.
  • Fig 1 illustrates a illustrates a flat layout view of stent in accordance with an exemplary embodiment of the present disclosure
  • FIG. 2 illustrates a perspective view of a stent in accordance with an exemplary embodiment of the present disclosure
  • the great majority of stents delivered trans luminally and percutaneously to a stenting site in a human body are made of a biologically compatible material which is a metal.
  • Many stents are made of stainless steel, and many others are made of nickel titanium shape memory alloy.
  • the nickel titanium stents are invariably self-expanding stents that utilise a shape memory effect for moving between a radially compact transluminal delivery disposition and a radially larger stenting disposition after placement in the body.
  • conventional stents may have drawbacks such as low flexibility, high radial force, poor wall apposition, and susceptibility to fatigue fracture.
  • Fatigue fracture is a failure mode of stents that occurs when they are subjected to repeated mechanical stress cycles at the deployment site in the body lumen. Fatigue fracture can compromise the structural integrity and functionality of the stent and lead to adverse outcomes such as restenosis, thrombosis, or embolization.
  • Self-expanding stents are usually manufactured in a ready-to-use compressed form within a catheter-based sheath that functions as a delivery system.
  • stents are implanted within a passageway by positioning the stent within the area to be treated and then expanding the stent from a compressed diameter to an expanded diameter.
  • the ability of the stent to expand from a compressed diameter makes it possible to thread the stent to the area to be treated through various narrow body passageways while the stent is in the compressed diameter.
  • the tubular support structure of the stent contacts and radially supports the inner wall of the passageway.
  • the implanted stent mechanically prevents the passageway from closing and keeps the passageway open to facilitate fluid flow through the passageway.
  • the present invention is related to a stent.
  • the stent comprising a plurality of circular structure.
  • the plurality of circular structure comprises a first structure and a second structure.
  • the first structure and the second structure is made up of plurality of peaks and valleys to form an undulating pattern.
  • the undulating pattern comprises a thickness range between 0.8 mm to 2 mm.
  • the undulating pattern of the first structure and the second structure is mirror to each other.
  • the undulating pattern comprises a plurality of first peaks and a plurality of second peaks.
  • a height of the plurality of second peaks is less than the plurality of first peak.
  • the plurality of second peaks and the plurality of first peaks are alternate.
  • the plurality of circular structure further comprises a plurality of links.
  • the plurality of links are coupled in between the plurality of second peaks of the first structure and second structure.
  • the length of the link varies between 40 mm to 80 mm.
  • the plurality of circular structures are connected at the plurality of first peak to form a radially expandable stent.
  • a high visibility radiopaque tantalum markers are provided at a proximal and a distal end of the stent.
  • the stent comprises a first dimeter in contracted condition.
  • the first diameter of the stent in contracted condition is varies from 3 mm to 5 mm.
  • the stent comprises a second dimeter in expanded condition, wherein the second diameter of the stent in expanded condition is varies from 10 mm to 14 mm.
  • the present invention provides a vascular implant that has high resistance to fracture when mechanically cycled at a site in a body lumen.
  • the present invention provides a stent having a high degree of flexibility so that it can be advanced through tortuous passageways and can be readily expanded.
  • the invention provides a stent that exhibits good strength while having the ability to follow the contour of the vessel within which it is implanted.
  • the present invention proposes a fatigue fracture resistant vascular implant, such as a self-expanding stent designed to address the limitations of existing stent designs.
  • the stent is constructed with a unique spiral cell connection pattern, enhancing its flexibility and allowing for controlled expansion and contraction. This innovative design reduces stress concentrations and minimizes the risk of fatigue-induced fractures.
  • the stent design is optimized to resist compression forces while maintaining excellent apposition against the luminal wall. This ensures stable deployment at the site of obstruction, preventing vessel collapse and maintaining an open lumen.
  • the stent incorporates a peak-to-peak nodes connection mechanism, which efficiently disperses mechanical forces across the entire stent structure. This feature contributes to the implant's overall mechanical integrity and fracture resistance.
  • Figures. 1-2 illustrates Intraluminal Medical Device having High Fatigue Resistance. It should be noted that Figure 1-2 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure.
  • a stent 100 comprising a plurality of circular structure 102.
  • the plurality of circular structure 102 comprises a first structure 103 and a second structure 105.
  • the first structure 103 and the second structure 105 is made up of plurality of peaks and valleys to form an undulating pattern 106.
  • the undulating pattern 106 comprises a thickness range between 0.8 mm to 2 mm.
  • the undulating pattern 106 of the first structure 103 and the second structure 105 is mirror to each other.
  • the undulating pattern 106 comprises a plurality of first peaks 108 and a plurality of second peaks 110.
  • a height of the plurality of second peaks 110 is less than the plurality of first peak 108.
  • the plurality of second peaks 110 and the plurality of first peaks 108 are alternate.
  • the plurality of circular structure 102 further comprises a plurality of links 104.
  • the plurality of links 104 are coupled in between the plurality of second peaks 110 of the first structure 103 and second structure 105.
  • the length of the link 104 varies between 40 mm to 80 mm.
  • the plurality of circular structures 102 are connected at the plurality of first peak 108 to form a radially expandable stent 100.
  • Each circular structure 102 includes undulating pattern 106 that are advantageously designed that may provide characteristics that can be expanded/bent without causing substantial damage to the stent and is joined to an adjacent circular structure by a connecting first peak 108.
  • a high visibility radiopaque tantalum markers 202 are provided at a proximal and a distal end of the stent 100.
  • the stent 100 comprises a first dimeter in contracted condition.
  • the first diameter of the stent in contracted condition is varies from 3 mm to 5 mm.
  • the stent 100 comprises a second dimeter in expanded condition, wherein the second diameter of the stent in expanded condition is varies from 10 mm to 14 mm.
  • the first peaks 108 can be configured to allow the undulating pattern 106 to circumferentially expand and contract to produce radial expansion/contraction of the stent 100 and can contribute to the radial outward force produced by the stent 100.
  • a high visibility radiopaque tantalum marker 202 are provided at the proximal and distal end of the stent 100.
  • the height value H may be between about 40-80 mm.
  • the stent 100 has undulating pattern 106 having a thickness of about 0.8 - 2 mm that provides outward radial force.
  • the stent 100 has a full diameter of about 12 mm and can crimp down to about 5 mm or less (not shown).
  • the present invention provides a vascular implant that has high resistance to fracture when mechanically cycled at a site in a body lumen.
  • the present invention provides a stent 100 having a high degree of flexibility so, that it can be advanced through tortuous passageways and can be readily expanded.
  • the invention provides a stent 100 that exhibits good strength while having the ability to follow the contour of the vessel within which it is implanted.
  • the present invention proposes a fatigue fracture resistant vascular implant, such as a self-expanding stent designed to address the limitations of existing stent 100 designs.
  • the stent 100 is constructed with a unique spiral cell connection pattern, enhancing its flexibility and allowing for controlled expansion and contraction. This innovative design reduces stress concentrations and minimizes the risk of fatigue-induced fractures.
  • the stent 100 design is optimized to resist compression forces while maintaining excellent apposition against the luminal wall. This ensures stable deployment at the site of obstruction, preventing vessel collapse and maintaining an open lumen.
  • the stent 100 incorporates a peak-to-peak nodes connection mechanism, which efficiently disperses mechanical forces across the entire stent 100 structure. This feature contributes to the implant's overall mechanical integrity and fracture resistance.
  • Figure 2 illustrates a perspective view of a stent 100 in accordance with an exemplary embodiment of the present disclosure
  • the undulations are shaped into a plurality of full-circle sections.
  • the plurality of the circular structures 102 are connected at the plurality of first peak 108 to form a radially expandable stent 100.
  • Fig. 1-2 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un stent (100). Le stent (100) comprend une pluralité de structures circulaires (102). La pluralité de structures circulaires (102) comprend une première structure (103) et une seconde structure (105). La première structure (103) et la seconde structure (105) sont constituées d'une pluralité de pics et de vallées pour former un motif ondulé (106). Le motif ondulé (106) comprend une pluralité de premiers pics (108) et une pluralité de seconds pics (110). La pluralité de seconds pics (110) alternent avec la pluralité de premiers pics (108). La pluralité de structures circulaires (102) comprend en outre une pluralité de liaisons (104). La pluralité de liaisons (104) sont accouplées entre la pluralité de seconds pics (110) de la première structure (103) et de la seconde structure (105).
PCT/IN2024/051551 2023-08-25 2024-08-25 Dispositif médical intraluminal à résistance à la fatigue élevée Pending WO2025046612A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202321057221 2023-08-25
IN202321057221 2023-08-25

Publications (1)

Publication Number Publication Date
WO2025046612A1 true WO2025046612A1 (fr) 2025-03-06

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Family Applications (1)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2198813A2 (fr) * 1998-03-05 2010-06-23 Boston Scientific Limited Endoprothèse intraluminale
US20100324657A1 (en) * 2007-06-22 2010-12-23 C. R. Bard, Inc. Locked segments pushable stent-graft

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2198813A2 (fr) * 1998-03-05 2010-06-23 Boston Scientific Limited Endoprothèse intraluminale
US20100324657A1 (en) * 2007-06-22 2010-12-23 C. R. Bard, Inc. Locked segments pushable stent-graft

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