WO1999040875A1 - Prothese tubulaire conique et procede de fabrication - Google Patents

Prothese tubulaire conique et procede de fabrication Download PDF

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Publication number
WO1999040875A1
WO1999040875A1 PCT/US1999/001868 US9901868W WO9940875A1 WO 1999040875 A1 WO1999040875 A1 WO 1999040875A1 US 9901868 W US9901868 W US 9901868W WO 9940875 A1 WO9940875 A1 WO 9940875A1
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WIPO (PCT)
Prior art keywords
tubular
tubular prosthesis
prosthesis
warp threads
segment
Prior art date
Application number
PCT/US1999/001868
Other languages
English (en)
Inventor
Richard L. Koch
James P. Campbell
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 AU27593/99A priority Critical patent/AU2759399A/en
Publication of WO1999040875A1 publication Critical patent/WO1999040875A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/02—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
    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D3/00—Woven fabrics characterised by their shape
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • This invention is directed to a woven tapered tubular prosthesis and a method of making a tapered tubular prosthesis by weaving.
  • the tubular prosthesis may be implanted into a patient for various therapeutic purposes.
  • Tubular prostheses are used in a variety of surgical procedures.
  • One particular application for the tubular prosthesis of the present invention is as a vascular graft.
  • Vascular grafts have been used for a number of years in conventional surgical techniques to replace sections of natural blood vessels which have been damaged by trauma or disease, or which have been removed through surgery.
  • Vascular grafts also may be used as bypasses or shunts to bypass an occluded portion of a blood vessel, or to form a new blood passage during vascular reconstruction procedures.
  • a guiding catheter placed at the location of the aneurysm.
  • a graft is then passed through the guiding catheter and released at the site of the aneurysm.
  • the graft is attached to the walls of the blood vessel by expandable stents mounted on the graft, or by other means.
  • the stents may be of the self-expanding type, or may be expanded using a balloon catheter or similar devices.
  • the guiding catheter is then withdrawn, leaving the graft in place as a reinforcement to the damaged vessel. If the graft is porous, surrounding tissue may grow into the pores of the graft, thereby further strengthening the repair.
  • endovascular grafts Because endovascular grafts must pass through a catheter, it is important that endovascular grafts have as thin a wall as possible. Thus, the wall of an endovascular graft should be much thinner in comparison with conventional non- endovascular grafts.
  • the thin wall enables the graft to be compressed into a small size, thereby enabling the graft to be passed through a smaller diameter catheter.
  • the smaller the diameter of the catheter the greater the number of sites in the body which the catheter may access, and, accordingly, the greater the number of sites which are eligible for treatment with a graft.
  • the catheter diameter is sufficiently small, the catheter can be inserted percutaneously into an artery without cutting of the artery.
  • Fabric grafts may be woven, knitted, or braided, and may have smooth or velour surface textures.
  • knitted and braided grafts were widely accepted over woven grafts because of several perceived advantages.
  • the perceived advantages of knitted grafts included softness and flexibility.
  • the inherent high porosity and velour surfaces of the grafts were believed to promote healing by the ingrowth of tissue, while softness and flexibility help the graft conform more easily to particular vessel configurations.
  • Braided grafts generally have an even greater porosity than knitted grafts, and are generally substantially less flexible and not as soft as knitted or woven grafts.
  • Woven grafts have certain advantages over knitted and braided grafts.
  • woven grafts may be manufactured with thinner walls than knitted or braided grafts.
  • woven grafts are generally of higher strength, and can be manufactured with a porosity which is lower than that of knitted and braided grafts.
  • Woven grafts can also be constructed with greater fabric uniformity.
  • Woven grafts generally consist of warp threads (i.e., the threads running in the direction along the major axis of the graft) interwoven with weft threads (also known as pick or fill threads, which are the threads running transversely to the length of the graft).
  • a fabric graft When a fabric graft has pores of a size that would normally allow blood to soak through, the pores are often pre-clotted to prevent blood penetration.
  • pre- clotting the patient's blood is drawn, and the graft is immersed in the patient's blood for about fifteen minutes to uniformly soak the graft prior to implantation. The blood- drenched graft is then allowed to air dry for a short period of time sufficient for fibrin to build up within the pores of the graft, thereby closing the pores.
  • Pre-clotting can prevent hemorrhaging, while still allowing subsequent tissue ingrowth. However, sometimes pre-clotting is not permissible, as where the patient has been treated with anticoagulants or has bleeding diathesis.
  • woven grafts have an advantage over knitted and braided grafts, and, therefore, woven grafts are preferred over knitted and braided grafts.
  • An alternative to pre-clotting of fabric grafts is the coating of the grafts with a bio-compatible substance such as gelatin, collagen, albumin, or the like. These coatings initially make the graft impervious to blood, but gradually dissipate or otherwise allow tissue ingrowth into the graft material following implantation.
  • the coatings eliminate the need for pre-clotting of the grafts, but the coatings also tend to make the walls of the grafts thicker, stiffer, and more difficult to handle during implantation.
  • grafts be as thin-walled as possible for endovascular use.
  • coated grafts are generally more expensive and difficult to manufacture, and may require special packaging and storage. Accordingly, woven grafts having a low porosity which obviates additional surface treatments are preferred.
  • the woven grafts be soft and supple for easy handling during implantation.
  • Conventional woven grafts are formed in a tubular configuration in which the weft filling is a single long thread shuttled continuously through a two-layer array of warp threads, forming a flat tubular body, as described in U.S. Patent No. 3,316,557. The tubular body is then opened to a cylindrical configuration, set, and crimped.
  • the prior art woven grafts are formed with a constant lumen diameter throughout the length of the graft.
  • the prior art does not teach a woven graft having a tapered lumen.
  • the prior art teach a method for forming a woven graft having a tapered configuration.
  • a fabric graft in which one end of the graft has a lumen opening which is a different size than the lumen opening at the opposite end of the graft.
  • Such grafts are useful for implantation into vessels having tapered configurations, for connecting vessel openings of differing sizes, or for repairing and bridging an aneurysm in which the vessel lumen on one side of the aneurysm is larger than the vessel lumen at the other side of the aneurysm.
  • One common use for endovascular grafts is in repairing an aneurysm of the abdominal aorta. The abdominal aorta is prone to aneurysm between the renal and iliac arteries.
  • the catheter is passed percutaneously through an incision in the femoral artery.
  • the distal opening of the catheter is placed at the abdominal aorta, and the vascular graft is passed through the catheter and attached to the walls of the arteries.
  • a bifurcated graft is usually required, as the aneurysm usually occurs at the point where the abdominal aorta branches into the two iliac arteries.
  • Descriptions of typical endovascular abdominal aneurysm repair procedures are set forth in U.S. Patent No. 5,387,235 to Chuter and U.S. Patent No. 5,489,295 to Piplani et al.
  • the prior art does not address the problem of matching varying vessel lumen diameters to graft diameter.
  • the prior art does not teach the use of a woven graft having a tapered lumen.
  • Tapered grafts have been formed in the past by braiding, as shown in U.S. Patent No. 4,441 ,215 to Kaster.
  • Kaster shows a vascular graft which is braided using multiple filaments to form a tapered lumen.
  • Kaster does not teach or suggest a tapered vascular graft having a woven construction.
  • the graft of Kaster is not intended for endovascular use, and, because of its construction, wall thickness, stiffness, and the like, would not be practical for such an application.
  • the tubular prosthesis should be constructed with low porosity, when desired, so that pre- clotting is not required.
  • the tubular prosthesis should also be thin-walled so that it may be compacted for endovascular or other non-invasive delivery.
  • the tubular prosthesis and method of the present invention overcome the shortcomings associated with the prior art tubular prostheses, and provide a substantial advance in the art.
  • the present invention embodies a novel tubular prosthesis and method for manufacturing a tubular prosthesis.
  • the tubular prosthesis is of woven construction, and has a taper formed along at least a portion of its length.
  • the tubular prosthesis is of low porosity so that it will minimize hemorrhaging, and the tubular prosthesis is thin-walled so that it may be compacted into a small package diameter for use as an endovascular graft.
  • the tapered portion or portions of the tubular prosthesis may be of various lengths, and may be steep or slight.
  • the tapered segments may be incorporated in both single-lumen tubular prostheses, and also in tubular prostheses of the bifurcated type.
  • prostheses may be formed having multiple tapers along their lengths, and the tapered segments of the bifurcated prostheses may be non-uniform, if desired.
  • the tapered segments of the tubular prosthesis may be formed by controlling the spacing of the warp threads during weaving.
  • the weaving is begun by forming a first-diameter segment of the tubular prosthesis by weaving in a conventional manner.
  • the tapered portion of the tubular prosthesis is then woven by gradually moving the warp threads closer to each other or further apart. This may be accomplished by progressively moving a tapered reed in relation to the warp threads.
  • a predetermined number of weft thread picks are filled into the warp threads, and the warp threads are again moved closer together or further apart.
  • FIG. 1 is a perspective view of a single-lumen tubular prosthesis of the present invention.
  • FIG. 2 is a representative view showing how the warp threads of the tubular prosthesis of FIG. 1 are spaced more closely together in the reduced diameter portions.
  • FIG. 3 is a front elevation view of a loom apparatus for use with the method of the invention.
  • FIG. 4a is a side cross section view of the loom of FIG. 3, taken along line 4- 4, illustrating a process for weaving the tubular prosthesis of the invention.
  • FIG. 4b shows the loom of FIG. 4a following a pass of the flying shuttle.
  • FIG. 4c shows the loom of FIG. 4a illustrating the reed in a raised position.
  • FIG. 5 is a plan view of a first embodiment of a bifurcated tubular prosthesis formed in accordance with the present invention.
  • FIG. 6 is a plan view of a second embodiment of a bifurcated tubular prosthesis formed in accordance with the present invention.
  • DESCRIPTION OF THE PREFERRED EMBODIMENT The invention is directed to a woven tubular prosthesis formed of interwoven warp and weft threads.
  • the tubular prosthesis is formed having at least one tapered segment which transforms the tubular prosthesis lumen smoothly from a first lumen diameter to a second lumen diameter.
  • the taper is formed in the prosthesis by gradually moving the warp threads closer together or further apart during weaving of the tapered portion of the tubular prosthesis.
  • FIG. 1 shows a tubular prosthesis 10 of the present invention.
  • Tubular prosthesis 10 is a single-lumen tubular prosthesis in the form of an elongate tubular body 12.
  • Tubular prosthesis 10 preferably may be used as an endovascular graft, but also may be used for other suitable applications, such as a shunt, bypass, or the like.
  • tubular body 12 includes a plurality of warp threads 14 interwoven with a plurality of weft threads 16 woven together in a plain weave construction. Warp threads 14 run parallel to the major axis of tubular body 12, while weft thread picks 16 run perpendicularly to the major axis of tubular body 12.
  • weft thread picks 16 are comprised of a single thread which is continuously passed back and forth between plural runs of warp threads 14, as will be described in more detail below.
  • Tubular prosthesis 10 includes a first-diameter segment 18, a tapered segment 20, and a second-diameter segment 22.
  • the relative lengths of segments 18, 20, and 22 may be controlled for various different applications of tubular prosthesis 10.
  • the relative lumen diameters of segments 18, 20, and 22, and the degree of taper of segment 18 also may be controlled for various applications. For example, in FIG.
  • first-diameter segment 18 may be formed with a constant diameter D 1 of 30 mm and a length of 8 cm; second-diameter segment 22 may be formed with a constant diameter D 2 of 17 mm and a length of 17 cm; and tapered segment 20 may be 5 cm in length and taper from first diameter D 1 to second diameter D 2 .
  • these dimensions represent one example, and the relative lengths and diameters of segments 18, 20, and 22 will vary depending on the particular application for which tubular prosthesis 10 is to be used.
  • tubular prostheses 10 typically might be manufactured having a minimum diameter as small as 8 mm or a maximum diameter as large as 44 mm, although other tubular diameters outside of these ranges may be produced with properly sized equipment and thread.
  • warp threads 14 in segment 18 are initially spaced apart from each other a specified distance during the filling of weft thread picks 16.
  • FIG. 2 is only representative of a tubular prosthesis of the present invention, and that the number of warp threads 14 and weft thread picks 16 are actually much greater than what is depicted.
  • a typical tubular prosthesis of the present invention might have as many as 350 warp threads 14 per inch per face (i.e. in a tubular prosthesis 2 inches in circumference, there would be 8
  • weave density is a function of the number of weft picks 16 per inch multiplied by the number of warp threads (or ends) 14 per inch.
  • the number of weft picks 16 per inch may be varied along the length of the prosthesis. For example, if first diameter segment 18 is formed having 130 picks per inch, and second diameter segment 22 is formed having 100 picks per inch, with tapered segment 20 transitioning between these values, then a tubular prothesis may be formed in which there is little variation between the porosity of first-diameter segment 18, tapered segment 20 and second-diameter segment 22. This is because while warp threads 14 are spaced further apart in segment 18 than they are in segments 20 and 22, weft threads 16 are spaced closer together so that the actual area of the pores does not vary considerably. In addition, even if the number of picks per inch is constant over the length of the prosthesis, because of the tight packing of weft threads 16, the open area of pores 24 does not vary greatly from one end of tubular prosthesis 10 to the other.
  • tubular prosthesis 10 would usually be formed with a generally constant porosity along its length, although the porosity may be controlled in particular segments by adjusting the number of picks per inch.
  • the water porosity of the prostheses of the present invention generally ranges between 100 and 1200 9 ml/min/cm 2 @ 120 mm Hg, and would normally not vary more than 25 percent along the length of the prosthesis.
  • the wall of the prosthesis is very thin. If a plain weave pattern is used in the construction of prosthesis 10, with a 40 denier thread size, the wall thickness for prosthesis 10 will be approximately 0.004 inch. This thin-walled design enables graft 10 to be compacted into a small diameter, ideal for endovascular applications.
  • FIGS. 3 and 4a-4c illustrate one form of an apparatus which may be used in the method of manufacturing the tubular prostheses of the present invention.
  • tubular prosthesis 10 may be manufactured using a loom 50 having a tapered reed 52.
  • Tapered reed 52 is a generally "V"-shaped arrangement of fine wires 56 (known as "dents") which separate warp threads 14 from other warp threads 14 in a manner that is known in the art of weaving.
  • FIG. 3 illustrates tapered reed 52 mounted within a loom frame 54. Tapered reed 52 may be moved up and down within loom frame 54 manually by turning knob 58.
  • knob 58 is mounted on a threaded rod 60 which is attached to tapered reed 52. As knob 58 is turned, tapered reed 52 is moved up or down within loom frame 54. Knob 58 may be turned manually by a worker, or may be controlled by a computer or other automatic control device (not shown). Additionally, other methods of moving tapered reed 52 and/or frame 54 include various electromechanical, pneumatic, or hydraulic systems (not shown).
  • FIGS. 4a and 4b illustrate the weaving process in which three runs of warp threads simultaneously pass through tapered reed 52.
  • a first run 62 is located over a second run 64 and a third run 66.
  • Each run 62, 64, 66 consists of a plurality of warp threads spaced apart from the other warp threads within their respective runs by dents 56.
  • first-diameter segment 18 of tubular body 12 is woven in the shape of a flattened tube, as in known in the art.
  • reed 52 is raised or lowered a prescribed distance.
  • tapered reed 52 is progressively raised to weave a tapered tubular prosthesis having a progressively smaller diameter.
  • additional weft layers may be packed into the warp runs 62, 64, 66, while leaving tapered reed 52 in a constant position.
  • the larger diameter segment may be woven first, followed by the tapered segment, and then the smaller diameter segment, or vice versa.
  • an alternative apparatus may be used to weave the tubular prostheses of the present invention. For example, any loom or reed design which enables adjustment of the spacing of the warp threads during the weaving process may be used.
  • the invention is not limited to weaving with a tapered reed.
  • FIG. 5 illustrates a bifurcated embodiment 110 of a tubular prosthesis of the present invention.
  • Tubular prosthesis 110 has a bifurcated tubular body 112 having a tubular trunk 130 and a pair of contiguous tubular legs 132.
  • a septum 134 is formed at the junction of legs 132 and trunk 130.
  • the lumen of trunk 130 splits at septum 134 into the lumens of legs 132.
  • Each leg 132 has an initial large-diameter segment 136.
  • Legs 132 then taper along tapered segments 138 to smaller-diameter segments 140.
  • Tubular prosthesis 110 is particularly useful for endovascular treatment of abdominal aortic aneurysms, as described above in the Background of the Invention.
  • Trunk 130 is placed in the abdominal aorta and legs 132 are placed in the iliac arteries so that prosthesis 110 bridges the aneurysm.
  • the taper of legs 132 enables smaller-diameter segment 140 to match the diameter of the iliac vessels when tubular prosthesis 110 is implanted, while trunk 130 is of a diameter which matches the diameter of the abdominal aorta.
  • legs 132 need not be uniform with each other.
  • a prosthesis may be formed to closely match a particular patient's anatomy.
  • a range of grafts would be provided having a variety of different lumen diameters for each of trunk 103 and legs 132.
  • Such variety is not available with the grafts of the prior art. It will be apparent that the present invention is a substantial advance over the one-size-fits-all approach of the prior art prostheses.
  • bifurcated woven grafts having a main trunk segment and constant-diameter leg segments is known in the art, and is described, for example, in U.S. Patent Nos. 2,924,250 and 4,816,028.
  • the trunk and the legs of the bifurcated portion are a constant diameter along their entire lengths.
  • Tapered segments 138 of legs 132 are formed in a manner similar to that described above with respect to tapered segment 20 of tubular prosthesis 10 of the first embodiment, although a loom having a pair of tapered reeds may be used in place of a single tapered reed.
  • large-diameter segments 136 of legs 132 are formed, also in a conventional manner.
  • tapered segments 138 are formed on legs 132 in the manner described above, by moving warp threads 14 progressively closer together and adjusting weft picks 16 to maintain desired weave density. This may be accomplished using one or more tapered reeds, as described above, or by other suitable means.
  • Septum 134 may be closed by interweaving excess warp threads, as described in the above-mentioned U.S. Patent No.
  • FIG. 6 shows an additional embodiment 210 of a bifurcated tubular prosthesis.
  • Tubular prosthesis 210 includes a tubular body 212 constructed from longitudinal warp threads 14 having a plurality of weft thread picks 16 interwoven therein.
  • Tubular prosthesis 210 includes a tapered trunk 230 and a pair of 12 contiguous legs 232. It is not known in the prior art to have a woven bifurcated tubular prosthesis having a tapered trunk 230. Trunk 230 may taper inward toward legs 232, as shown in FIG. 6, or may taper outward (not shown), depending upon the anatomy of the patient that prosthesis 210 is intended to be used with.
  • tapered trunk 230 is useful for matching the diameters of the arteries, and for smoothing the transition from the larger diameter of the abdominal aorta to the smaller diameters of the iliac arteries when bifurcated tubular prosthesis 210 is implanted.
  • the taper of trunk 230 helps match the size of the tubular prosthesis to the size of the vessel into which the tubular prosthesis is implanted.
  • Legs 232 of prosthesis 210 are shown in FIG. 6 as having a constant diameter. However, one or both of legs 232 may also be tapered as discussed above with respect to legs 132 of tubular prosthesis 110. Accordingly, a graft may be formed having both a tapered trunk and/or tapered legs. Tapered trunk 230 is produced using the method described above, with warp threads 14 being moved gradually closer together during weaving of the tapered portion of tubular prosthesis 210. Legs 232 and septum 234 are formed using conventional methods, as referenced above, if legs 232 having a constant diameter are desired. If tapered legs are desired, then the legs would be formed as described above with reference to tubular prostheses 10 and 110.
  • the thread used in forming the tubular prostheses of the present invention is preferably a yarn approved for medical use by the U.S. Food and Drug Administration, such as polyester.
  • a typical size yarn used may be 40 denier/27, which represents 40 grams of yarn per 9000 meters of yarn, and comprises 27 filaments in a single strand of yarn, or 1.48 denier per filament.
  • the selection of 40 d/27 yarn as the standard for the industry is to a certain extent dictated by what is available on the market and approved for medical use.
  • other suitable yarns of different deniers and materials may be used to construct the tubular prosthesis of the present invention. Accordingly, the invention is not limited to a particular yarn type or denier.
  • the yarn used may be of the textured type or the flat type.
  • the use of textured yarn will allow the prosthesis to stretch in one or more directions, but also may give the prosthesis a greater wall thickness. As stated above, it is desirable to keep wall thickness at a minimum.
  • Typical wall thickness for the prostheses of the present invention range from 0.003 to 0.010 inch, dependent upon denier of thread and weave pattern.
  • the tubular prostheses are scoured to remove any oils or other impurities which may have adhered to the threads during the weaving process. This is done by placing the tubular prostheses in a solution of hot water (typically 120° F) and detergent. The prostheses are then rinsed with water to remove the detergent.
  • hot water typically 120° F
  • the weaving process produces a tubular prosthesis in the shape of a flat tube.
  • the tubular prostheses in an open tubular configuration (i.e. with a circular cross section).
  • the tubular prosthesis is placed on a cylindrical metal mandrel having a tapered shape which matches that of the tubular prosthesis lumen.
  • the tubular prosthesis is then heat-set on the mandrel to form the tubular prosthesis into an open tubular configuration.
  • the tubular prostheses of the present invention are preferably not kinked or corrugated, as is the case with some prior art tubular prostheses, but they could be subjected to such additional treatment if desired.
  • tubular prostheses of the present invention have their ends sealed or otherwise secured to prevent unraveling of the fabric.
  • the sealing may be accomplished by heating or other known means.
  • the tubular prostheses may then be fitted with stents or other devices to facilitate their implantation, and packaged for shipment.
  • tubular prostheses of the present invention may be incorporated into the tubular prostheses of the present invention.
  • one or more colored warp threads may be used when weaving the tubular prostheses.
  • the colored thread is used by surgeons to indicate kinking or twisting of the tubular prosthesis.
  • the tubular prosthesis outer surface may be veloured to further encourage ingrowth of tissue following implantation. The velouring process is performed by forming additional loops on the outer surface during filling of the weft threads, as is known in the art of weaving.
  • the present invention sets forth a tubular prosthesis having a woven construction with at least one tapered segment formed therein.
  • the ability to form tapered segments in the prostheses of the present invention enables the prostheses to more closely match the anatomy of a patient than was possible using the prostheses of the prior art.
  • the prostheses of the present invention are thin walled to facilitate endovascular implantation, and of low porosity.
  • the invention also sets forth a process for manufacturing the a tapered prosthesis of woven construction. Such a prosthesis and method of construction is not known or suggested in the prior art.

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

Abstract

La présente invention concerne une nouvelle prothèse (10) tubulaire et son procédé de fabrication. Cette prothèse (10) tubulaire a une structure tissée sans couture et est partiellement conique (20). La partie conique (20) est tissée par le rapprochement progressif ou l'écartement des fils de chaîne (14). C'est un peigne conique (56) qui effectue le tissage en se déplacement progressivement par rapport aux fils de chaîne (14). Chaque fois que les fils de chaîne (14) se rapprochent ou s'écartent les uns des autres, un nombre prédéterminé de groupes (16) de fil de trame remplit les fils de chaîne (14), ces derniers se rapprochant ou s'écartant à nouveau les uns des autres. Le processus de formation du cône peut être appliqué à la fois à des prothèses tubulaires à lumen unique et à des prothèses tubulaires en forme de fourche.
PCT/US1999/001868 1998-02-12 1999-02-10 Prothese tubulaire conique et procede de fabrication WO1999040875A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU27593/99A AU2759399A (en) 1998-02-12 1999-02-10 Tapered tubular prosthesis and method of making

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US2288298A 1998-02-12 1998-02-12
US09/022,882 1998-02-12

Publications (1)

Publication Number Publication Date
WO1999040875A1 true WO1999040875A1 (fr) 1999-08-19

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WO (1) WO1999040875A1 (fr)

Cited By (17)

* Cited by examiner, † Cited by third party
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WO2002094135A1 (fr) * 2001-05-21 2002-11-28 Aesculap Ag & Co. Kg Implant chirurgical, procede de production et utilisation
WO2002039928A3 (fr) * 2000-11-15 2003-03-13 Mcmurray Fabrics Inc Protheses tubulaires en tissu souple avec transitions a jonction
WO2003011190A3 (fr) * 2001-07-31 2003-05-30 Aesculap Ag & Co Kg Gaine pour veines, procede permettant de la produire et son utilisation en chirurgie
US6814754B2 (en) * 2000-10-30 2004-11-09 Secant Medical, Llc Woven tubular graft with regions of varying flexibility
NL1023389C2 (nl) * 2003-05-12 2004-11-15 Hendrik Glastra Werkwijze voor het vormen van een uit een weefsel van elkaar kruisende draden opgebouwd driedimensioneel, hol product, product verkregen onder toepassing van deze werkwijze en uitgaande daarvan verkregen lichaamsvatprothese.
EP1935375A1 (fr) * 2006-12-22 2008-06-25 Aesculap AG & Co. KG Prothèse tissulaire de sinus aortique avec bulbe
DE102007063267A1 (de) * 2007-12-17 2009-06-18 Aesculap Ag Gewebte textile Gefäßprothese
EP2074960A1 (fr) * 2007-12-17 2009-07-01 Aesculap AG Prothèse vasculaire textile tissulaire
WO2009149645A1 (fr) * 2008-06-10 2009-12-17 微创医疗器械(上海)有限公司 Tube revêtu pour stent à deux branches et procédé de découpe de sa membrane
CN102212931A (zh) * 2011-06-01 2011-10-12 东华大学 一种织制变直径管状织物的设备及方法
US8388679B2 (en) 2007-01-19 2013-03-05 Maquet Cardiovascular Llc Single continuous piece prosthetic tubular aortic conduit and method for manufacturing the same
WO2014011380A1 (fr) * 2012-07-12 2014-01-16 United Technologies Corporation Structure tissée et procédé de tissage de celle-ci
US8696741B2 (en) 2010-12-23 2014-04-15 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
US9833597B2 (en) 2014-05-12 2017-12-05 Cook Medical Technologies Llc Textile balloon catheters
US20190231511A1 (en) * 2018-01-31 2019-08-01 The Secant Group, Llc Woven graft composite with varied density
CN110251285A (zh) * 2019-05-21 2019-09-20 泰升医疗有限公司 扩张支架
CN115369543A (zh) * 2022-09-08 2022-11-22 东华大学 一种三维球囊型管状机织物及其制备方法

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US4340091A (en) * 1975-05-07 1982-07-20 Albany International Corp. Elastomeric sheet materials for heart valve and other prosthetic implants
US5653746A (en) * 1994-03-08 1997-08-05 Meadox Medicals, Inc. Radially expandable tubular prosthesis
US5653747A (en) * 1992-12-21 1997-08-05 Corvita Corporation Luminal graft endoprostheses and manufacture thereof
US5800514A (en) * 1996-05-24 1998-09-01 Meadox Medicals, Inc. Shaped woven tubular soft-tissue prostheses and methods of manufacturing

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Publication number Priority date Publication date Assignee Title
US3108357A (en) * 1962-06-20 1963-10-29 William J Liebig Compound absorbable prosthetic implants, fabrics and yarns therefor
US4340091A (en) * 1975-05-07 1982-07-20 Albany International Corp. Elastomeric sheet materials for heart valve and other prosthetic implants
US5653747A (en) * 1992-12-21 1997-08-05 Corvita Corporation Luminal graft endoprostheses and manufacture thereof
US5653746A (en) * 1994-03-08 1997-08-05 Meadox Medicals, Inc. Radially expandable tubular prosthesis
US5800514A (en) * 1996-05-24 1998-09-01 Meadox Medicals, Inc. Shaped woven tubular soft-tissue prostheses and methods of manufacturing

Cited By (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6814754B2 (en) * 2000-10-30 2004-11-09 Secant Medical, Llc Woven tubular graft with regions of varying flexibility
WO2002039928A3 (fr) * 2000-11-15 2003-03-13 Mcmurray Fabrics Inc Protheses tubulaires en tissu souple avec transitions a jonction
US6994724B2 (en) 2000-11-15 2006-02-07 Mcmurray Fabrics, Inc. Soft-tissue tubular prostheses with seamed transitions
AU2002230522B2 (en) * 2000-11-15 2004-06-03 Atex Technologies , Inc. Soft-tissue tubular prostheses with seamed transitions
US8591572B2 (en) 2001-05-21 2013-11-26 Aesculap Ag Surgical implant, method for the production and use thereof
EP2095792A1 (fr) * 2001-05-21 2009-09-02 Aesculap AG Implant chirugical, procédé de fabrication et utilisation
WO2002094135A1 (fr) * 2001-05-21 2002-11-28 Aesculap Ag & Co. Kg Implant chirurgical, procede de production et utilisation
DE10125712B4 (de) * 2001-05-21 2012-06-06 Aesculap Ag Implantat für die Chirurgie
US7530996B2 (en) 2001-05-21 2009-05-12 Aesculap Ag & Co. Kg Surgical implant, method for the production and use thereof
WO2003011190A3 (fr) * 2001-07-31 2003-05-30 Aesculap Ag & Co Kg Gaine pour veines, procede permettant de la produire et son utilisation en chirurgie
US7691460B2 (en) 2001-07-31 2010-04-06 Aesculap Ag & Co. Kg Covering element for veins, method for the production and use thereof in surgery
NL1023389C2 (nl) * 2003-05-12 2004-11-15 Hendrik Glastra Werkwijze voor het vormen van een uit een weefsel van elkaar kruisende draden opgebouwd driedimensioneel, hol product, product verkregen onder toepassing van deze werkwijze en uitgaande daarvan verkregen lichaamsvatprothese.
WO2008083767A1 (fr) * 2006-12-22 2008-07-17 Aesculap Ag Prothèse tissée de cuspide aortique avec bulbe
US8728152B2 (en) 2006-12-22 2014-05-20 Aesculap Ag Woven aortic sinus prosthesis having a bulb
EP1935375A1 (fr) * 2006-12-22 2008-06-25 Aesculap AG & Co. KG Prothèse tissulaire de sinus aortique avec bulbe
US8388679B2 (en) 2007-01-19 2013-03-05 Maquet Cardiovascular Llc Single continuous piece prosthetic tubular aortic conduit and method for manufacturing the same
EP2074960A1 (fr) * 2007-12-17 2009-07-01 Aesculap AG Prothèse vasculaire textile tissulaire
DE102007063267A1 (de) * 2007-12-17 2009-06-18 Aesculap Ag Gewebte textile Gefäßprothese
US8728151B2 (en) 2007-12-17 2014-05-20 Aesculap Ag Woven textile vascular prosthesis
WO2009149645A1 (fr) * 2008-06-10 2009-12-17 微创医疗器械(上海)有限公司 Tube revêtu pour stent à deux branches et procédé de découpe de sa membrane
US10010401B2 (en) 2010-12-23 2018-07-03 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
US10682221B2 (en) 2010-12-23 2020-06-16 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
US8696741B2 (en) 2010-12-23 2014-04-15 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
JP2019150586A (ja) * 2010-12-23 2019-09-12 マッケ カーディオバスキュラー エルエルシー 織られたプロテーゼ及びその製造方法
US9402753B2 (en) 2010-12-23 2016-08-02 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
JP2017080509A (ja) * 2010-12-23 2017-05-18 マッケ カーディオバスキュラー エルエルシー 織られたプロテーゼ及びその製造方法
US11517417B2 (en) 2010-12-23 2022-12-06 Maquet Cardiovascular Llc Woven prosthesis and method for manufacturing the same
CN102212931A (zh) * 2011-06-01 2011-10-12 东华大学 一种织制变直径管状织物的设备及方法
CN102212931B (zh) * 2011-06-01 2014-05-28 东华大学 一种织制变直径管状织物的设备及方法
WO2014011380A1 (fr) * 2012-07-12 2014-01-16 United Technologies Corporation Structure tissée et procédé de tissage de celle-ci
US9725833B2 (en) 2012-07-12 2017-08-08 United Technologies Corporation Woven structure and method for weaving same
US9833597B2 (en) 2014-05-12 2017-12-05 Cook Medical Technologies Llc Textile balloon catheters
US10434290B2 (en) 2014-05-12 2019-10-08 Cook Medical Technologies Llc Textile balloon catheters
US20190231511A1 (en) * 2018-01-31 2019-08-01 The Secant Group, Llc Woven graft composite with varied density
CN110251285A (zh) * 2019-05-21 2019-09-20 泰升医疗有限公司 扩张支架
CN110251285B (zh) * 2019-05-21 2021-06-18 泰升医疗有限公司 渐缩型血管支架
CN115369543B (zh) * 2022-09-08 2024-04-12 东华大学 一种三维球囊型管状机织物及其制备方法
CN115369543A (zh) * 2022-09-08 2022-11-22 东华大学 一种三维球囊型管状机织物及其制备方法

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