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WO2000078250A1 - Element de fixation pour prothese a extenseur - Google Patents

Element de fixation pour prothese a extenseur Download PDF

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Publication number
WO2000078250A1
WO2000078250A1 PCT/US2000/016490 US0016490W WO0078250A1 WO 2000078250 A1 WO2000078250 A1 WO 2000078250A1 US 0016490 W US0016490 W US 0016490W WO 0078250 A1 WO0078250 A1 WO 0078250A1
Authority
WO
WIPO (PCT)
Prior art keywords
graft
lengthwise
filaments
substrate
attachment
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.)
Ceased
Application number
PCT/US2000/016490
Other languages
English (en)
Inventor
E. Skott Greenhalgh
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.)
Secant Group LLC
Original Assignee
Prodesco Inc
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 Prodesco Inc filed Critical Prodesco Inc
Priority to AU56154/00A priority Critical patent/AU5615400A/en
Publication of WO2000078250A1 publication Critical patent/WO2000078250A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • This invention relates to woven, knitted and braided substrates having a plurality of attachment structures defining attachment points for attaching items or appliances thereto.
  • Such substrates when formed as a graft, are particularly suitable for use as a stent graft for the repair of arterial disorders, particularly aneurysms, the attachment structure being integrally woven, knitted or braided into the graft for attaching the stents and other components to the graft.
  • Occlusive diseases refer to the closing of vessels such as the iliac, carotid, biliary and coronary arteries for example.
  • Aneurysms are defined as a pathologic dilation of a vessel and can affect the aortic, thoracic, renal and iliac arteries among others.
  • the stent graft comprises a tubular structure
  • the graft which effects a connection between portions of a vascular vessel.
  • the graft is typically flexible and preferably formed of biocompatible filaments or yarns interlaced by weaving, knitting or braiding to form a tube or sleeve.
  • the stent is positioned circumferentially around and supports the graft and is preferably formed from elastic, resilient materials such as nitinol, titanium or stainless steel which have a high yield stress and are also compatible for implantation within the human body.
  • an endovascular stent graft to treat an aortic aneurysm is described below, it being understood that the example is for illustrative purposes only and in no way limits the invention disclosed herein to the treatment of any particular vascular disorder, as will be appreciated by those of ordinary skill in the art. It is further recognized that the invention is also applicable in the treatment of other occlusive diseases or aneurysms, such as neurological, esophageal and bronchial aneurysms .
  • An aneurysm is a pathologic dilation of a segment of a blood vessel which constitutes a weakened portion of the vessel.
  • a fusiform aneurysm 10 such as can occur in the abdominal aorta 12 as seen in Figure 1, the entire circumference of the vessel is dilated and weakened.
  • the majority of these aortic aneurysms are located in the distal abdominal aorta between the renal arteries 14 and the bifurcation point 16 where the abdominal aorta splits into the common iliac arteries 18.
  • Such aortic aneurysms constitute a serious condition, as an acute rupture of the aneurysm is fatal unless an emergency operation is performed. However, even when such operations are performed in time, the mortality rate is still greater than 50%.
  • stent graft 20 comprises a tubular graft 22, which could be woven, knitted or braided, graft 22 having one end 24 which is attached to the inner surface of the artery above the aneurysm 10.
  • the opposite end 26 of the stent graft is split into two tubular grafts 26a and 26b which branch into and are attached to the inside surfaces of the iliac arteries 18 below the aneurysm 10.
  • the stent graft replaces the abdominal aorta in the region of the aneurysm 10, relieving the pressure on the arterial wall and avoiding a potentially fatal rupture.
  • Stent graft 20 further comprises stents 28 and 30 in the form of continuous wire springs positioned in the ends 24 and 26a and 26b of the graft. Also positioned at the ends are hooks 32, arranged circumferentially around the graft with hook ends 34 facing outwardly.
  • the stents 28 and 30 are each formed into a plurality of crests and troughs circumferentially of the graft and normally bias the graft ends into a substantially circular, open configuration when the graft is positioned within the artery.
  • the stents are elastically collapsible to a small diameter, however, so as to enable the graft to be advanced through the bore of a catheter which fits within the artery.
  • the catheter is inserted into the aorta from one of the iliac arteries, the catheter tip being positioned within the artery above the aneurysm.
  • the stent graft is advanced through the catheter, and when the end 24 emerges from the catheter, stent 28 expands radially outwardly under the biasing spring forces of the stent, opening the graft and filling the artery diameter.
  • Ends 34 of hooks 32 positioned at end 24 engage and grip the inner surface of the artery, fixing the stent graft into position.
  • the catheter is then withdrawn as the stent graft is further advanced and released from the catheter.
  • the respective stents 30 expand radially within the artery, opening the stent graft 20 at ends 26a and 26b.
  • the ends are positioned into a respective iliac artery where hooks 32 engage and grip the interior surface of the iliac arteries, thereby fixing the stent graft 20 into position within the aneurysm 10.
  • the stents 28, as well as the hooks are sutured to the graft 22 by means of a thread 36.
  • Suturing is also used to attach other items, such as radio opaque markers and knapped yarns to the graft.
  • Suturing is necessarily a hand operation given the small size, delicacy of the components and the precision required to produce a usable stent graft. Hand suturing is done by skilled workers, and each piece takes a relatively long time to complete, resulting in low production rates and high production costs.
  • sutures can become untied during the operation or after the stent graft is implanted. If the sutures fail during the operation and the stent or hooks separate from the graft (even partially) , then all of the pieces have to be retrieved and removed from the artery before another attempt to implant a stent graft can be made.
  • sutures also adds bulk to the stent graft.
  • the stent graft must fit within and advance along the bore of the catheter during the operation, and the bulkier the stent graft the larger a catheter is required, thereby limiting the size of artery which can be treated by the implantation of a stent graft.
  • Sutures also tend to snag on the walls or tip of the catheter, thus, making it difficult to smoothly advance the stent graft along the bore or readily release it from the catheter, potentially complicating the operation.
  • sutures are expensive and time consuming to use, tend to increase the bulk of the stent graft and tend to snag the walls of the catheter, they are used sparingly to attach the stent and hooks to the graft. Fewer attachment points means greater potential for failure at some point during or after the operation.
  • stents and hooks are attached to the graft in a way which avoids the disadvantages of sutures.
  • the invention concerns an attachment tether fixed to a substrate formed of interlaced filaments.
  • the attachment tether comprises an elongated filamentary member having a first lengthwise portion interlaced with the filaments to anchor the filamentary member to the substrate and at least a second lengthwise portion being free of the substrate.
  • the first lengthwise portion is positioned between two ends of the filamentary member, the attachment tether having two of the second lengthwise portions extending from the first lengthwise portion free of the substrate.
  • the attachment tether comprises a plurality of the first lengthwise portions, each being interlaced with the filaments at a plurality of locations on the substrate to anchor the filamentary member to the substrate.
  • a plurality of the second lengthwise portions, each being free of the substrate, are each positioned between two of the first lengthwise portions in alternating fashion.
  • the invention contemplates an endovascular stent graft comprising a tubular graft formed of interlaced filaments, a stent positioned circumferentially around and supporting the graft and attachment tether means interlaced with the filaments for attaching the stent to the graft.
  • the attachment tether means comprises first and second elongated filamentary members arranged circumferentially around the graft in spaced relation to one another.
  • Each of the filamentary members has a plurality of first lengthwise portions which are interlaced with the graft filaments and thereby anchored at a plurality of circumferentially spaced locations.
  • a plurality of second lengthwise portions, which are free of the graft, are each positioned between two respective first lengthwise portions. The stent is captured between the second lengthwise portions and the graft and affixed thereto.
  • the stent comprises a flexible, resilient wire formed into a plurality of alternating crests and troughs.
  • the second lengthwise portions of the first filamentary member are in overlying relation with the crests and the second lengthwise portions of said second filamentary member are in overlying relation with the troughs, each second lengthwise portion capturing the crest or trough which it overlies.
  • the stent graft also has a plurality of attachment hooks positioned at the ends of the graft to anchor it to a vascular vessel . Second attachment tether means are interlaced with the interlaced filaments for attaching the attachment hooks to the graft.
  • the attachment hooks are formed of an elongated wire having a first reverse bend approximately mid way between its ends and a second reverse bend at each end interengagable with the vessel.
  • the second attachment tether means comprises a plurality of elongated filamentary members each having two first lengthwise portions interlaced with the filaments and a second lengthwise portion positioned between the two first lengthwise portions. The second lengthwise portion is free of the filaments and is positioned in overlying relation with the elongated wire to capture it.
  • the invention also includes a method of attaching an item to a substrate formed of interlaced filaments.
  • the method comprises the steps of interlacing a first lengthwise portion of an elongated filamentary member with the filaments to anchor it to said substrate, the filamentary member having a second lengthwise portion being free of said substrate and securing the second lengthwise portion to the item.
  • the first lengthwise portion is positioned between the ends of the filamentary member.
  • the filamentary member will have two second lengthwise portions extending from the first lengthwise portion free of the substrate.
  • the securing step for this embodiment comprises tying the two second lengthwise portions together around the item.
  • the elongated filamentary member comprises a plurality of the first and second lengthwise portions arranged alternatingly with one another
  • the interlacing step comprises interlacing the plurality of first lengthwise portions with the filaments to anchor the filamentary member to the substrate, thus, leaving the plurality of second lengthwise portions free of the substrate so that the securing step comprises inserting the item between the second lengthwise portions and the substrate.
  • Figure 1 is an elevational cross-sectional view of an aneurysm in the abdominal aorta repaired by a stent graft;
  • Figure 2 is a partial view of the stent graft of Figure 1 on an enlarged scale showing a detail of the attachment of the stent to the graft according to the prior art;
  • Figure 3 shows a perspective view of an attachment tether according to the invention
  • Figure 4 shows a perspective view of another embodiment of an attachment tether according to the invention.
  • Figure 5 shows a perspective view of yet another embodiment of an attachment tether according to the invention.
  • Figure 6 shows a perspective view of a simple float according to the invention
  • Figure 7 shows a cross-sectional end view of the simple float shown in Figure 6;
  • Figure 8 shows a cross-sectional end view of a surface float according to the invention
  • Figure 9 shows a perspective view of a simple loop according to the invention.
  • Figure 10 shows a cross-sectional end view of the simple loop shown in Figure 9;
  • Figure 11 shows a cross-sectional end view of a surface loop according to the invention
  • Figure 12 shows a partial perspective view of the stent graft of Figure 1 on an enlarged scale
  • Figure 13 shows a partial perspective view of a graft according to the invention
  • Figure 14 shows a partial perspective view of a graft according to the invention
  • Figure 15 shows a partial perspective view of the graft seen in Figure 14;
  • Figure 16 is a perspective view of a graft according to the invention.
  • Figure 17 is a perspective view of a stent graft according to the invention having a simple tubular shape
  • Figure 18 is a perspective view of a stent graft according to the invention having a conical shape
  • Figure 19 is a perspective view of a stent graft according to the invention wherein the graft comprises a sack;
  • Figure 20 is a perspective view of a graft according to the invention formed from a flat sheet
  • Figure 21 shows a perspective view of a weft knit fabric with a loop according to the invention
  • Figure 22 shows a plan view of a weft knit fabric with a float according to the invention
  • Figure 23 shows a plan view of a weft knit fabric with a float according to the invention.
  • Figure 24 shows a perspective view of a warp knit fabric with a loop according to the invention
  • Figure 25 shows a plan view of a warp knit fabric with a float according to the invention
  • Figure 26 shows a braided graft having loops formed by a carrier fed yarn according to the invention
  • Figure 27 shows a braided graft having loops formed by axial yarns according to the invention.
  • Figure 28 shows an extended float formed in a knitted fabric.
  • the attachment tether 11 preferably comprises an elongated filamentary member 13 fixed to a substrate 15 formed of interlaced filaments 17.
  • Filamentary member 13 has a irst lengthwise portion 19 interlaced with the filaments 17 to anchor the filamentary member to the substrate 15 and at least a second lengthwise portion 21 being free of the substrate.
  • first lengthwise portion 19 may be positioned between two ends of the filamentary member 13, resulting in the attachment tether 11 having two second lengthwise portions 21 free of the substrate.
  • attachment tether 11 may have a plurality of first lengthwise portions 19, each being interlaced with the filaments 17 at a plurality of locations 23 on the substrate 15.
  • This embodiment also has a plurality of second lengthwise portions 21, each being free of the substrate and each positioned in alternating fashion between two of the first lengthwise portions 19.
  • attachment tether is readily adaptable for use with any manner of filament interlacing, for example, weaving, knitting and braiding, to easily and reliably secure items to the substrate on which the attachment tethers are anchored.
  • filament interlacing for example, weaving, knitting and braiding
  • the embodiments and their variations are described below by way of example in the context of flat, tubular and conical substrates, the tubular substrate being particularly useful for the manufacture of endovascular stent grafts.
  • the endovascular stent graft 20 preferably comprises a tubular graft 22 formed of interlaced filaments 17.
  • One or more stents, for example, 28 and 30, are positioned circumferentially around and support the graft.
  • the graft is attached to vessel 12 by means of hooks 32.
  • the stent graft has attachment tether means, described below, interlaced with the filaments 17 for attaching the stents and the hooks to the graft.
  • the attachment tether means comprise the attachment tethers 11 described above and take the form of floats and/or loops to attach stents, hooks or other components to the graft.
  • the floats and loops are formed by arranging the attachment tethers in either or both the weft and warp directions of the graft.
  • a float 38 in a woven fabric is formed by a second lengthwise portion 21 of filamentary member 13 that extends over two or more adjacent filaments 40 oriented perpendicularly to the float.
  • a loop 42 is a second lengthwise portion 21 of filamentary member 13 which extends outwardly from between two adjacent yarns 44 oriented perpendicularly to the loop.
  • Figure 21 illustrates an example of a loop 96 in weft knit substrate which is formed by an extra length of yarn 98 extending from a particular wale 100.
  • Figures 22 and 23 depict floats 104 and 110 respectively, formed in a weft knitted substrate by allowing a second lengthwise portion 21 of yarn to lie against the surface of the substrate over one or more wales of the knit.
  • Figure 24 shows a loop 114 formed in a warp knit substrate
  • Figure 25 shows a float 138 also formed in a warp knit substrate.
  • Figures 26 and 27 depict two examples of floats or loops formed in a braided graft. Each of these embodiments is described in detail below.
  • the floats and loops forming the attachment tethers are integrally formed in the graft (or other substrate) and extend free of the surface of the substrate to allow a component to be inserted between the attachment tether and the substrate. If necessary, the attachment tether may then be drawn or slipped tight to cinch the component against the substrate, thereby forming an attachment means integral to the substrate.
  • warp and weft floats and loops to attach components such as hooks or stents to woven, knitted or braided substrates to form a stent graft, for example, provides tremendous manufacturing advantage because the floats and loops are integrally incorporated into the substrate by machine during the weaving, knitting or braiding process.
  • the floats and loops can be readily positioned on either surface of the substrate and their length, relative spacing and position on the graft can be easily varied automatically as desired, for example, by the use of a programmable Jacquard loom, as is well known in the art.
  • Weft Floats and Loops in Woven Fabric Figure 6 can be used to illustrate a weft float if filamentary member 13 is a weft yarn and filaments 40 are warp yarns in a woven fabric.
  • Weft floats can be simple floats with the weft yarn 13 positioned on both sides of the fabric, as seen in Figure 7, or surface floats formed from yarns positioned on only one side of the fabric, as seen at 39 in Figure 8.
  • Figure 12 shows the upper end 24 of the stent graft 20 according to the invention which uses weft floats 46 extending from the outer surface of graft 22 to attach stent 28.
  • weft floats 48 are used to attach hooks 32 to the inside surface of the graft.
  • the weft floats act like straps which extend along the weft of the fabric, passing over and binding the stent or hook between the float and the graft surface.
  • weft floats 46 are arranged in four spaced apart levels labeled 46a-46d.
  • the floats are spaced circumferentially around graft 22, as well, and vary in length at each level to accommodate the crests and troughs of the stent to position it securely at the end 24 of the stent graft 20. Because the floats extend outwardly from the graft surface, it is a relatively easy matter to insert the apexes 27 of the crests and troughs between the floats and the graft surface to attach the stent to the graft. This is a far less time consuming procedure than suturing the stent to the graft and can be performed by less skilled workers, thus, resulting in higher production rates and less expensive production costs.
  • weft floats 46 and 48 are also used to attach the stent 28 and hooks 32 (respectively) to a straight woven tube 88 ( Figure 17) ; to a woven conical tube 90 ( Figure 18) ; to a sack 92 ( Figure 19) ; and to a flat fabric 94 ( Figure 20) .
  • the weft float yarns 13 are interlaced among the warp yarns 40 as a series of continuous loops 50 helically encircling the graft 22 around its circumference. If each loop is severed outside of the graft, separate weft loops 52 having loose ends 54 are formed. Each separate weft loop can be slipped or drawn within the weave, allowing the weft floats 38 to be enlarged to permit easy passage of a stent (for example) between the float and the fabric.
  • a stent for example
  • weft floats 38 formed by using a separate weft float shuttle can also be incorporated into any shape graft or other woven structures, examples of which are illustrated in Figures 17-20.
  • Figure 18 shows a conical tube having a weft float 38 formed from a loop 52 having severed ends 54 as described in detail above.
  • Figure 20 shows flat fabric 94 with weft floats 38 formed by a separate weft float shuttle. It should be understood that the weft floats 38 are not limited in their application to any particular woven structure.
  • Using a separate float shuttle also allows yarns which are different from the regular weft yarns to be used for the float yarns.
  • float yarn having a contrasting color from the other weft yarns can be used to readily identify floats against the graft surface. This will speed the production process, as it will be easy for a worker to pick out the floats and insert the components, such as hooks or stent to be attached to the graft.
  • yarns of several different colors, each on its own shuttle can be used to identify floats specific to a certain component. For example, red yarns could be used to form floats to attach a stent to the graft, while blue yarns could be used to attach the hooks.
  • float yarns of a larger denier or with a higher tensile strength can be used exactly where required to provide greater strength to the graft, such as at the attachment points of the stent and hooks.
  • Such a design is very economical since the more expensive high strength yarns are used only where needed, thus, reducing the material costs of production.
  • the overall bulk of the stent graft is kept small. Reducing the bulk of the stent graft is important to enable it to fit into the bore of a catheter.
  • the floats are formed from any biologically compatible material such as PTFE and PET, but it may be useful in some circumstances to form the float yarns from wire, such as gold, platinum, stainless steel or other biologically compatible metal. Use of suitably dense material will render the stent graft visible under X-rays.
  • biodegradable materials such as polyglycolic acid (PGA) , polylactic acid (PLA) and mixtures of the two can be used to form the filaments comprising the loops or floats.
  • PGA and PLA dissolve in the body at different rates, and the two materials can be mixed to tailor the rate of dissolution of the filament.
  • Biodegradable filaments are useful for forming stent grafts or other structures which will allow the separation of the stent from the graft after the attachment tethers (loops or floats) dissolve.
  • Figures 6-8 can also be used to illustrate a warp float if filamentary member 13 is a warp yarn and filaments 40 are weft yarns.
  • Warp floats can be simple floats 38, as seen in Figures 6 and 7, or surface floats 39 formed from yarns positioned on only one side of the fabric, as seen in Figure 8.
  • Warp floats are formed from overfed warp yarns on the creel of the loom and provide the same advantages as the weft floats but are oriented in the warp direction. Warp floats can be formed in any desired position and length along the stent graft according to the loom program. Different warp float yarns having different properties such as color, denier, tensile strength and density, can be employed as well.
  • the warp float can be formed into a relatively long float, which allows easy insertion of a component, such as a hook or stent, or the warp float can be formed into a relatively short float, both types of which may be drawn or slipped to cinch a component to the graft.
  • FIGs 9-11 illustrate a warp loop 42 where filamentary member 13 is a warp yarn and filaments 44 are weft yarns.
  • Warp loop 42 behaves in a similar manner to the warp float and provides loops in the warp direction through which components such as hooks 32 (see Figure 12) can be inserted before the first lengthwise portions 19 are drawn to cinch the component.
  • the simple warp loop seen in Figures 9 and 10 is formed by a yarn 13 positioned on both sides of the fabric, while the surface warp loop 43, seen in Figure 11 is positioned only on one side of the fabric.
  • Figure 12 illustrates hooks 32 attached to the inside surface of graft 22 using warp floats 56 and warp loops 58. Similarly,
  • FIGS 17-20 show hooks 32 attached to various other woven structures by means of warp floats 56 and warp loops 58, it being understood that warp floats and loops are in no way limited in their use to any particular application.
  • the second lengthwise portions 21 of filamentary members 13 which float free above the fabric surface to accept and secure the desired item to the woven graft are relatively short.
  • most of the length of filamentary members 13 comprise the first lengthwise portions 19 which are interwoven within the graft.
  • the second lengthwise portions 21 comprise most of the length of the filamentary member 13, thereby forming an extended float 60.
  • the first lengthwise portions 19 which are interwoven with the filaments 17 forming the substrate are relatively short.
  • the value of the extended float is manifest when the yarn is cut, for example, at points 64 and 66, thus, forming an elongated severed yarn segment 60a (seen in Figure 15) having two second lengthwise portions 21 on either side from the first lengthwise portion 19.
  • Yarn segment 60a can be used to attach a stent, hook or other item onto the graft 22 simply by placing the item in overlying relation with the first lengthwise portion 19 and tying the second lengthwise portions 21 over the item.
  • the extended float 60 can be readily positioned at any desired point in the graft 22 by controlling the weave program.
  • the number of filaments 17 which are interwoven with the first lengthwise portion 19 can also be easily controlled, six filaments being shown for illustration only.
  • the float 60 can be made almost any length by forming multiple loops as desired before and after the first lengthwise portion 19 is interwoven into the graft 22.
  • the extended float is not limited in any way to the woven structures illustrated in Figures 14 and 15. Any shape graft or woven element can employ the extended float. Two examples of other woven structures are provided in
  • Figures 19 and 20 which show an extended float 60 employed with a sack structure 92 and a flat fabric 94 respectively.
  • the extended float 60 can be formed from yarns having different properties from the yarns comprising graft 22. Color, denier, strength, elastic modulus, material, as well as other characteristics, all can be varied to suit a particular need.
  • an extended float 72 can also be incorporated in the warp direction of graft 27.
  • the position and number of such extended warp floats are again readily and precisely controlled by means of the weave program. It is found particularly advantageous to interweave the extended warp floats at each end of the graft, as indicated at 74a and 74b, in addition to whatever points 76 along the graft the extended floats are interwoven to provide attachment points for stents or hooks and the like.
  • Attaching the extended floats at or near the ends keeps the extended float yarns organized, thus, preventing tangling of the floats at points along the graft away from the intended attachment points 76 and allowing the floats to be readily identified and cut as needed during assembly of the stent graft.
  • the extra attachment points 74a and 74b are easily incorporated into the weaving program and provide a significant time savings in that a particular float yarn, for example, 78, can be quickly identified from among many others without confusion.
  • This yarn can be severed at points 80 and 82 flanking the interweaving point 84 intended to form the attachment point to the graft.
  • FIG. 21 illustrates the formation of a loop 96 during weft knitting, wherein an extra length of yarn 98 is formed into one of the wales 100 of the knit fabric by controlling the motion of needle "A" typically by a cam (not shown) and forcing the needle through a greater range of motion to draw the extra length of yarn forming the loop during knitting.
  • the yarn 98 forms an extended loop projecting from the fabric surface and can be used to cinch a component to the fabric at the location defined by course 102 and wale 100, thus, allowing for precise placement of the attachment anywhere along the graft.
  • Figures 22 and 23 illustrate examples of floats formed by weft knitting.
  • Float 104 in Figure 22 is formed along a particular course 106 by not raising the knitting needles associated with one or more wales (in this case 4 wales) 108.
  • the loops from the adjacent previously knitted course 106a are retained and knit on the next course 106b, but the yarn for course 106 falls behind the needles and floats on the surface of the fabric, forming float 104.
  • Figure 23 shows a similarly formed float 110 extending over one wale 112.
  • the size of the weft knit float can be controlled, depending upon the number of wales over which it extends.
  • the floats 104 and 110 form straps which can be used to hold components against the fabric surface at precise locations on the graft.
  • Warp knit fabrics are generally preferred for grafts and other surgical implants because they do not unravel when cut.
  • Figure 24 illustrates a loop 114 in a warp knit fabric 116, the loop being formed by introducing an extra length of yarn 118 by controlling the motion of guide bar "F" which moves left and right to feed the yarn to various of the needles A- D.
  • warp knit loop 114 can be positioned at any course and wale and can span one or more courses and/or wales, thereby controlling the size of the loop.
  • loop 114 can be cut to form an attachment tether which can be tied to capture and retain a component to the fabric 116 without the fear that the fabric will unravel.
  • a float 138 is formed in a warp knit fabric by missing one or more stitches.
  • the knitting needle producing the stitch on the left will not catch the yarn at the point in the knitting process designated by the line A'-A 1 , thus, allowing the yarn to float on the surface of the warp knitted fabric.
  • This is contrasted with the stitches 140 on the right of Figure 25, where the needle has caught the yarn at point A-A and formed continuous stitches of the warp knit fabric.
  • the relatively simple example is shown here for illustrative purposes only, it being understood that the same principle can be applied to form a float in more complicated warp knit fabrics.
  • Figure 26 shows floats or loops 122 of various sizes formed at various locations in a braided graft 124.
  • Loops 122 are formed by extending yarns on the braider carriers outwardly from the graft surface.
  • the carrier yarns are extended by mechanically grasping the yarns and drawing them outwardly of the graft 130 during the braiding process, thus, forming the loop away from the graft surface.
  • the loops can be formed on either the inside or outside of the graft.
  • Figure 27 shows loops 126 formed using axial yarns 128 on a braided graft 130.
  • interbraided axially oriented yarns 128, which are not fed from a braider carrier are extended outwardly from the surface of the graft to produce the loop 126.
  • the loops in the braided graft can be of any size, positioned anywhere along the graft, and on the inside and/or outside as well.
  • Figure 12 can be used to illustrate the attachment of stent 28 and hooks 32 to a knitted or braided graft 22. If graft 22 is knitted, floats 46 take the form of knitted weft floats 104 or 110 seen in Figures 22 and 23. Similarly, warp floats 56 in Figure 12 take the form of warp loop 114 or warp float 138, seen in Figures 24 and 25.
  • the loops and floats used to attach the stents and hooks are similar to the carrier loops 122, seen in Figure 26, or the axial yarn loops 126 of Figure 27.
  • Analogous to the woven structures, knitted or braided warps and loops can be applied to virtually any interlaced structure including the bifurcated graft of Figure 1, the straight tube 88 of Figure 17, the conical tube 90 of Figure 18, the sack 92 of Figure 19, and the flat fabric 94 seen in Figure 20.
  • the extended float 60 shown in Figure 15 can be implemented for both a braided or knitted substrate.
  • Figure 28 shows a detailed view of the extended float 60 in a knitted substrate 31.
  • the yarn 132 forming the extended loop is laid into the substrate at region 62. (This is accomplished, as seen in Figure 24, by placing the yarn 132 between one or more of the loops 134 on needles A-D, and the diagonal yarn segments 136 on the carrier bars E-H.)
  • Ends 64a and 66a form extensions which can be tied together to secure a component, such as a stent, to the substrate 31 at the laid-in point 62.
  • One or more extended floats can be arranged along courses or wales of the knitted fabric and laid-in at several locations to yield the construction seen in Figure 16.
  • Figure 26 shows an extended float 60 used on a braided graft 124, the float having a laid-in point 62 which corresponds to the point of attachment of a component secured to the graft by means of the extended float.
  • Extended float 60 can be laid-in under one or more of the braided yarns comprising the graft.
  • the floats and loops of the knitted and braided structures can be formed from yarns having different properties, such as strength, denier, color, elastic modulus, as well as other characteristics.
  • a graft according to the invention having attachment tethers comprising floats and loops precisely sized and positioned on the graft automatically by the weaving, knitting or braiding program for the attachment of stents, hooks and other items to the graft provides a graft which can be assembled in less time by less skilled workers more precisely with fewer mistakes and rejected items than is currently possible using the prior art techniques of stent graft production.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un élément de fixation pour fixer des crochets et des extenseurs à des prothèses endovasculaires formées de filaments entrelacés. L'élément de fixation présente au moins une ou plusieurs premières parties longitudinales entrelacées avec les filaments, de sorte qu'il puisse être ancré à la prothèse, et au moins une ou plusieurs deuxièmes parties longitudinales, s'étendant librement par rapport au greffon, de sorte qu'elles capturent l'extenseur ou le crochet et qu'elles le fixent à la prothèse. Les deuxièmes parties longitudinales peuvent former des flotteurs ou des boucles qui font office de sangles pour maintenir l'extenseur ou le crochet contre la prothèse. Les deuxièmes parties peuvent également présenter des extrémités non fixées, liées ensembles, de sorte que l'extenseur ou le crochet soit fixé à la prothèse. L'entrelacement des première parties peut s'effectuer par tissage, tricotage ou tressage.
PCT/US2000/016490 1999-06-18 2000-06-15 Element de fixation pour prothese a extenseur Ceased WO2000078250A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU56154/00A AU5615400A (en) 1999-06-18 2000-06-15 Attachment tether for stent grafts

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13983599P 1999-06-18 1999-06-18
US960/139,835 1999-06-18

Publications (1)

Publication Number Publication Date
WO2000078250A1 true WO2000078250A1 (fr) 2000-12-28

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WO (1) WO2000078250A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003007848A3 (fr) * 2001-07-14 2003-04-17 Ellis Dev Ltd Structure tubulaire
FR2833153A1 (fr) * 2001-12-11 2003-06-13 Perouse Lab Endoprothese tubulaire a manche tissee et armature de support
WO2004060211A3 (fr) * 2002-12-19 2004-12-02 Scimed Life Systems Inc Prothese tricotee compacte a etirage eleve et faible dilatation
WO2010024880A1 (fr) * 2008-08-29 2010-03-04 Cook Incorporated Prothèse implantable avec régions de densité réduite
EP2769699A1 (fr) * 2013-02-20 2014-08-27 Cook Medical Technologies LLC Fixation d'un stent à une greffe de tissu avec piquage d'ancrage de machine
US9198787B2 (en) 2010-12-31 2015-12-01 Cook Medical Technologies Llc Conformable prosthesis delivery system and method for deployment thereof
CN105559952A (zh) * 2014-10-21 2016-05-11 太雄医疗器株式会社 制造抗偏移支架的方法及通过该方法制成的支架
JP2021079270A (ja) * 2015-05-27 2021-05-27 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティドＷ．Ｌ． Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅｓ， Ｉｎｃｏｒｐｏｒａｔｅｄ 調節可能な幾何構造を有するアンカー部材を有するステントグラフト装置

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0621016A1 (fr) * 1993-04-22 1994-10-26 C.R. Bard, Inc. Prothèse vasculaire non migrante et son système d'implantation peu agressif
EP0818184A1 (fr) * 1996-07-10 1998-01-14 B. Braun Celsa Prothèse médicale en particulier pour anévrismes à liaison entre sa gaine et sa structure

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0621016A1 (fr) * 1993-04-22 1994-10-26 C.R. Bard, Inc. Prothèse vasculaire non migrante et son système d'implantation peu agressif
EP0818184A1 (fr) * 1996-07-10 1998-01-14 B. Braun Celsa Prothèse médicale en particulier pour anévrismes à liaison entre sa gaine et sa structure

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6939372B2 (en) 2001-07-03 2005-09-06 Scimed Life Systems, Inc. Low profile, high stretch, low dilation knit prosthetic device
WO2003007848A3 (fr) * 2001-07-14 2003-04-17 Ellis Dev Ltd Structure tubulaire
FR2833153A1 (fr) * 2001-12-11 2003-06-13 Perouse Lab Endoprothese tubulaire a manche tissee et armature de support
WO2004060211A3 (fr) * 2002-12-19 2004-12-02 Scimed Life Systems Inc Prothese tricotee compacte a etirage eleve et faible dilatation
WO2010024880A1 (fr) * 2008-08-29 2010-03-04 Cook Incorporated Prothèse implantable avec régions de densité réduite
US8353943B2 (en) 2008-08-29 2013-01-15 Cook Medical Technologies Llc Variable weave graft with metal strand reinforcement for in situ fenestration
US9198787B2 (en) 2010-12-31 2015-12-01 Cook Medical Technologies Llc Conformable prosthesis delivery system and method for deployment thereof
US9700400B2 (en) 2013-02-20 2017-07-11 Cook Medical Technology LLC Attachment of stent to graft fabric with an anchoring machine stitching
EP2769699A1 (fr) * 2013-02-20 2014-08-27 Cook Medical Technologies LLC Fixation d'un stent à une greffe de tissu avec piquage d'ancrage de machine
CN105559952A (zh) * 2014-10-21 2016-05-11 太雄医疗器株式会社 制造抗偏移支架的方法及通过该方法制成的支架
EP3042638A1 (fr) * 2014-10-21 2016-07-13 Taewoong Medical Co., Ltd. Procédé de fabrication d'un extenseur anti-migration et extenseur ainsi fabriqué
CN105559952B (zh) * 2014-10-21 2017-11-21 太雄医疗器株式会社 抗偏移支架
JP2021079270A (ja) * 2015-05-27 2021-05-27 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティドＷ．Ｌ． Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅｓ， Ｉｎｃｏｒｐｏｒａｔｅｄ 調節可能な幾何構造を有するアンカー部材を有するステントグラフト装置
JP7150920B2 (ja) 2015-05-27 2022-10-11 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティド 調節可能な幾何構造を有するアンカー部材を有するステントグラフト装置
JP2022173387A (ja) * 2015-05-27 2022-11-18 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティド 調節可能な幾何構造を有するアンカー部材を有するステントグラフト装置
JP7451641B2 (ja) 2015-05-27 2024-03-18 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティド 調節可能な幾何構造を有するアンカー部材を有するステントグラフト装置
US11944556B2 (en) 2015-05-27 2024-04-02 W. L. Gore & Associates, Inc. Stent graft device with anchoring members having adjustable geometries
US12376977B2 (en) 2015-05-27 2025-08-05 W. L. Gore & Associates, Inc. Stent graft device with anchoring members having adjustable geometries

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