WO1994024960A1 - Prothese tubulaire tissee ferme - Google Patents

Prothese tubulaire tissee ferme Download PDF

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Publication number
WO1994024960A1
WO1994024960A1 PCT/US1994/004606 US9404606W WO9424960A1 WO 1994024960 A1 WO1994024960 A1 WO 1994024960A1 US 9404606 W US9404606 W US 9404606W WO 9424960 A1 WO9424960 A1 WO 9424960A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
ply
plies
yarns
woven fabric
Prior art date
Application number
PCT/US1994/004606
Other languages
English (en)
Inventor
Peter J. Schmitt
Original Assignee
Meadox Medicals, 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
Priority claimed from US08/052,657 external-priority patent/US5370682A/en
Application filed by Meadox Medicals, Inc. filed Critical Meadox Medicals, Inc.
Priority to CA002138640A priority Critical patent/CA2138640C/fr
Priority to JP6524499A priority patent/JP3017290B2/ja
Priority to EP94914921A priority patent/EP0651625B1/fr
Priority to AU67139/94A priority patent/AU670198B2/en
Priority to DE69415275T priority patent/DE69415275T2/de
Publication of WO1994024960A1 publication Critical patent/WO1994024960A1/fr
Priority to FI946033A priority patent/FI946033A/fi

Links

Classifications

    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D3/00—Woven fabrics characterised by their shape
    • D03D3/02—Tubular fabrics
    • 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
    • D03D11/00—Double or multi-ply fabrics not otherwise provided for
    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D15/00—Woven fabrics characterised by the material, structure or properties of the fibres, filaments, yarns, threads or other warp or weft elements used
    • D03D15/50—Woven fabrics characterised by the material, structure or properties of the fibres, filaments, yarns, threads or other warp or weft elements used characterised by the properties of the yarns or threads
    • D03D15/587—Woven fabrics characterised by the material, structure or properties of the fibres, filaments, yarns, threads or other warp or weft elements used characterised by the properties of the yarns or threads adhesive; fusible

Definitions

  • the present invention relates to tubular prostheses, and, more particularly, to woven tubular prostheses having increased wall stiffness.
  • tubular prostheses have commonly been manufactured by, for example, weaving a plurality of warp yarns and a plurality of fill yarns into a tubular fabric.
  • Such products typically lack sufficient radial stiffness to maintain an open lumen, i.e., if unsupported, they will radially collapse.
  • the tendency to radially collapse or kink is particularly problematic to a surgeon during implantation of the prosthesis.
  • prior art prostheses are typically crimped at equidistant lengths along their longitudinal axis.
  • the crimping is believed to provide the prosthesis with sufficient radial stiffness to maintain an open lumen.
  • the crimping additionally provides a degree of longitudinal compliance to the prosthesis.
  • Crimping is not without its disadvantages. For example, the crimps create a plurality of irregularities along the inner wall of the prosthesis that may create blood flow disturbances. These blood flow disturbances become more pronounced and consequently less acceptable as the diameter of the prosthesis is reduced. In addition, thrombi can accumulate in the valleys of the crimps, tending to form hyperplastic pockets.
  • An alternative prior art technique for providing radial stiffness to a woven prosthesis involves the use of a stiffening component.
  • the fabric is woven around a suitable stiffener or, alternatively, such a stiffener is secured to either the interior or exterior of the prosthesis following weaving.
  • a stiffener creates its own drawbacks. For example, tissue ingrowth may be hindered by the stiffener, the porosity of the prosthesis may be affected by the stiffener and, finally, the ability to suture the prosthesis to the host vessel may be hindered by the stiffener.
  • a woven tubular prosthesis that contains sufficient inherent wall stiffness so as to be radially self-supporting.
  • Such a graft would not require crimping or the use of stiffening components, thereby providing a smooth, continuous inner wall that better simulates the natural hemodynamics of the connecting vessels, even with respect to those prostheses having a relatively small diameter, e.g., down to about 4 mm.
  • the same prosthesis would be less prone to pinching, kinking or other collapsing tendencies when subjected to bending forces, as well as being resistant to ravelling when cut to size during surgery.
  • the prosthesis would also have the ability to hold sutures well.
  • the pore structure would be more tortuous, thereby providing better hemostasis at the time of implantation and the ability to support long term healing and tissue incorporation.
  • the present invention relates to implantable multi-pl woven tubular prostheses, such as vascular grafts, intra- luminal devices, such as endoprostheses, and the like.
  • Th prosthetic devices of the present invention are fabricated from a multi-ply solid weave construction which inherently provides increased radial strength over traditional simple one-ply weave patterns.
  • the multi-ply solid weaves are characterized in that the woven fabric has a plurality of superposed plies including a plurality of circumferentiall extending fill yarns and a plurality of longitudinally extending warp yarns.
  • the warp or fill yarns must continuously pass through at least two adjacent plies. That is, at least two adjacent layers must have common yarns which serve to interlock and integrate the plies into a unitary structure.
  • a porosity gradient from the innermost to the outermost ply can be incorporated into the prosthesis, thereby reducing blood loss yet, at the same time, encouraging tissue ingrowth and assimilation of the prosthesis into the body.
  • different types of yarns may be used in the interlocking plies to achieve a gradient of properties such as stiffness, compliance, texture, ravel resistance and fray resistance. This can be achieved by using, for example, different yarns or by subjecting the same or different yarns to different treatments prior to incorporation into the fabric.
  • elastomeric yarns are incorporated, in an elongated state, into the prosthesis in the warp direction such that subsequent to the weaving process the fabric will retract longitudinally, thereby providing longitudinal compliance.
  • Other means of providing longitudinal compliance such as heat-setting techniques, are also contemplated.
  • the implantable prosthetic devices of the present invention may be used in a variety of locations in the body, such as intraluminal applications in the vascular system, pulmonary system or gastrointestinal track.
  • locations in the body such as intraluminal applications in the vascular system, pulmonary system or gastrointestinal track.
  • vascular grafts that are implanted surgically or by endoscopic means.
  • Fig. 1 is a perspective view of a solid woven tubular prosthesis
  • Fig. 2 is a cross-sectional view taken along lines 2-2 of Fig. 1;
  • Fig. 3 is a cross-sectional view similar to Fig. 2 wherein each of the outermost warp yarns float over three fill yarns;
  • Fig. 3a depicts the prostheses of Fig. 3 after a heat-setting process in which the outermost warp yarns form a raised filamentous velour surface;
  • Fig. 4 is a cross-sectional view similar to Fig. 2 wherein a pair of elastomeric warp yarns have been incorporated into the prostheses; and Fig. 4a depicts the prostheses of Fig. 4 after a heat-setting process wherein the outermost warp yarns form a raised filamentous velour surface.
  • Woven prostheses are ideal in that they provide strong, pressure-resistant vessels. These same grafts, however, typically require radial support through mechanical treatment, such as crimping, or through the incorporation of radial stiffening yarns.
  • a woven tubular prosthesis 10 fabricated in accordance with the present invention is shown.
  • the prosthesis may include longitudinally-extending warp yarns 12 and circumfer- entially-extending fill yarns 14.
  • the prosthesis of the present invention differs from prior art woven prostheses (which typically were formed with simple, one ply weaves) in that the present prosthesis includes a plurality of solid woven plies (i.e., the plies are not separable into discrete layers) .
  • the use of several plies allows certain ideal characteristics to be designed into the prosthesis.
  • different yarns can be used in the different plies.
  • a porosity gradient can be created in the wall of the prosthesis.
  • Such a gradient resists leaking of fluid from the inner wall, yet still allows ingrowth of natural tissue into the outer wall.
  • the discretely-designed plies are interconnected in such a fashion that the plies become inseparable and also, at the same time, provide sufficient inherent wall stiffness to the prostheses to allow it to be radially self-supporting.
  • the solid woven prosthesis of the present invention can best be understood by reference to Figs.
  • fill yarn 14a is located in the outermost ply
  • fill yarn 14b is located in the intermediate ply
  • fill yarn 14c is located in the innermost ply.
  • a plurality of warp yarns 12 are solidly woven throughout these fill yarns.
  • each warp yarn (or fill yarn) in a solid woven prosthesis must pass continuously through, and therefore be part of, at least two adjacent plies.
  • the design of the prosthesis may require that each warp yarn pass continuously through each and every ply. In such a case, all of the plies will have warp yarns in common to form a unitary solid structure.
  • the prosthesis is fabricated with three plies.
  • the outermost ply preferably contains textured or filamentous materials for enhanced tissue attachment.
  • the intermediate ply preferably contains a fusible material to aid in ravel resistance.
  • the innermost ply preferably contains a bioresorbable material to aid in healing, long term patency and zero preclotting.
  • the solid woven prosthesis of the present invention has a wall thickness greater than that of the typical prior art device, thereby providing a degree of radial support.
  • wall thicknesses may range from 0.50 mm to
  • the solid woven design provides greater wall stiffness and resistance to kinking or pinching, as compared to single-ply grafts due to the increased wall thickness. Notwithstanding the increased wall thickness of the multi-ply unitary construction, excellent longitudinal or axial flexibility for handling is retained. Specifically, tubular products made from this weave structure are sufficiently flexible and compliant to meet the requirements of a prosthetic implant or graft.
  • the inner wall of the prosthesis can be fabricated as a smooth, continuous surface.
  • the inner wall of a conventional crimped one-ply prosthesis includes a plurality of irregularities or corrugations that disturb the flow of fluid therethrough, e.g., the flow of blood through an artery. This is additionally problematic because debris may collect in these irregularities causing further complications in patients with arterial disease. In larger-sized prostheses, these disturbances have little effect on the flow of fluid. However, as the diameter of the prostheses decreases, the acceptability of the disturbances decreases.
  • the present invention by providing a prostheses having a smooth, continuous inner wall, overcomes this disadvantage associated with the prior art and, as a result, is capable of being employed to fabricate relatively small-sized prostheses.
  • a solid woven texturized graft having raised velour loops can be fabricated in accordance with the present invention.
  • prosthesis 10' is woven such that the warp yarns located at the outer ⁇ most surface pass externally over at least two fill yarns.
  • warp yarn 12' passes over fill yarns 14a v 14a 2 and 14a 3 .
  • the "loose" surface weave allows these warp yarns to rise from the surface following heat-setting, thereby forming a filamentous velour surface as shown in Fig. 3a.
  • At least one elastomeric warp yarn 16 is incorporated into the fabric.
  • Prosthesis 10" is woven with the elastomeric warp yarns in a stretched state such that subsequent to weaving the fabric will longitudinally retract, thereby providing a degree of longitudinal compliance. Longitudinal compliance assists the surgeon in sizing the length of the prosthesis for implantation and also provides a degree of flexibility to the prosthesis following implantation.
  • the prosthesis is sealed in a package.
  • the package, along with the prosthesis contained therein, is then subjected to a sterilization procedure, e.g., a radiation procedure, a heat procedure, etc.
  • a sterilization procedure e.g., a radiation procedure, a heat procedure, etc.
  • the prosthesis may be sterilized prior to being sealed in its packaging or may be sterilized by the physician performing the implant operation at the time of such surgery.
  • polymeric materials useful in the present invention include, without limitation, yarns made from polyester, polypropylene, polytetrafluoroethylene, polyethylene, polyurethane and resorbable polymers.
  • the material is scoured in a basic solution of warm water (e.g., 150°F) and cleaning detergent. It is then rinsed to remove the cleaning agents.
  • the prosthesis is heat-set on mandrels of the final desired inside diameter. Typically, the outside diameter of the mandrel is approximately equal to the diameter of the final prosthesis.
  • the woven tubing is woven to be 5-15% oversize so that it can be mounted onto a mandrel and shrink fitted to an exact diameter. Heat-setting can take place in a steam heated autoclave at about 250°F for about 5-10 minutes or in a convection oven at 250-400°F for about 10-30 minutes.
  • the material is scoured in a basic solution of warm water (e.g., 150°F) and cleaning detergent. It is then rinsed to remove the cleaning agents.
  • the prosthesis is heat-set on mandrels of the final desired inside diameter. Typically, the outside diameter of the mandrel is equal to the diameter of the final prosthesis.
  • the woven tubing is woven to be 5-15% oversize so that it can be mounted onto a mandrel and shrink fitted to an exact diameter.
  • Heat-setting can take place in a steam heated auto ⁇ clave at about 250°F for about 5-10 minutes or in a convection oven at 250-400°F for about 10-30 minutes.
  • the heat-setting can be done in a two-step process.
  • the first step involves heat-setting the prosthesis in its fully extended state to shrink fit the prosthesis snugly to the mandrel.
  • the second heat-setting step entails compressing the prosthesis longitudinally. The compression is on the order of 25-50%.
  • the prosthesis is then heat-set a second time using at least the same conditions as in the first heat-setting cycle.
  • the warp yarns buckl and crimp.
  • the heat locks the yarns in this geometry to build in "spring like” or elastomeric properties.
  • the material is scoured in a basic solution of warm water (e.g., 150°F) and cleaning detergent. It is then rinsed to remove the cleaning agents.
  • the prosthesis is heat-set on mandrels of the final desired inside diameter. Typically, the outside diameter of the mandrel is equal to the diameter of the final prosthesis.
  • the woven tubing is woven to be 5-15% oversize so that it can be mounted onto a mandrel and shrink fitted to an exact diameter.
  • Heat-setting can take place in a steam heated autoclave at about 250°F for about 5-10 minutes or in a convection oven at 250-400° for about 10-30 minutes.
  • the heat-setting can be done in a two-step process.
  • the first step involves heat-setting the prosthesis in its fully extended state to shrink fit the prosthesis snugly to the mandrel.
  • the second heat-setting step entails compressing the prosthesis longitudinally. The compression is on the order of 25-50%.
  • the prosthesis is then heat-set a second time using at least the same conditions as in the first heat-setting cycle.
  • the warp yarns buckle and crimp.
  • the heat locks the yarns in this geometry to build in "spring like” properties.
  • the warp yarns in the outer ply which are floating over 3 picks, would raise from the fabric, forming a filamentous velour surface.
  • the tubing is woven to include an elastomeric yarn in the warp direction, such as Lycra Spandex from DuPont.
  • the elastomeric yarn is woven into the fabric by inserting it between the first and second plies.
  • the elastomeric yarn is woven in a stretched state, so that after weaving the fabric will retract longitudinally.
  • the elastomeric yarn provides the longitudinal compliance to the graft.
  • the material is scoured in a basic solution of warm water (e.g., 150°F) and cleaning detergent. It is then rinsed to remove the cleaning agents.
  • warm water e.g. 150°F
  • the scouring process allows the woven tubing to fully retract by relieving the stress induced by weaving the elastomeric warp yarns in a stressed state.
  • the prosthesis is heat-set on mandrels of the final desired inside diameter.
  • the outside diameter of the mandrel is equal to the diameter of the final prostheses.
  • the tubing is woven to be 5-15% over-size so that it can be mounted onto a mandrel and shrink fitted to an exact diameter.
  • Heat-setting can take place in a steam heated autoclave at about 250°F for about 5-10 minutes or in a convection oven at 250-400°F for about 10-30 minutes.
  • the warp yarns in the outer ply which are floating over 3 picks, are raised from the fabric, forming a filamentous velour surface. Longitudinal compliance on the order of 25-50% can be achieved by this method.

Abstract

Prothèse (10) tubulaire tissée ferme, ayant une rigidité de paroi inhérente suffisante pour que ladite prothèse soit radialement autoporteuse. La prothèse (10) tissée ferme peut être constituée d'une paroi intérieure continue lisse qui améliore le flux hémodynamique, si l'on compare avec une prothèse tissée classique, ce qui facilite l'écoulement fluidique dans ladite prothèse.
PCT/US1994/004606 1993-04-26 1994-04-25 Prothese tubulaire tissee ferme WO1994024960A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA002138640A CA2138640C (fr) 1993-04-26 1994-04-25 Prothese tubulaire solidement tissee
JP6524499A JP3017290B2 (ja) 1993-04-26 1994-04-25 ソリッド織り管状補てつ物
EP94914921A EP0651625B1 (fr) 1993-04-26 1994-04-25 Prothese tubulaire tissee ferme
AU67139/94A AU670198B2 (en) 1993-04-26 1994-04-25 Solid woven tubular prosthesis
DE69415275T DE69415275T2 (de) 1993-04-26 1994-04-25 Gewobene, rohrförmige prothese mit hoher festigkeit
FI946033A FI946033A (fi) 1993-04-26 1994-12-22 Kiinteä kudottu putkimainen proteesi

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/052,657 1993-04-26
US08/052,657 US5370682A (en) 1993-04-26 1993-04-26 Solid woven tubular prosthesis

Publications (1)

Publication Number Publication Date
WO1994024960A1 true WO1994024960A1 (fr) 1994-11-10

Family

ID=21979047

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/004606 WO1994024960A1 (fr) 1993-04-26 1994-04-25 Prothese tubulaire tissee ferme

Country Status (2)

Country Link
CA (1) CA2138640C (fr)
WO (1) WO1994024960A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998016173A1 (fr) * 1996-10-11 1998-04-23 C.R. Bard, Inc. Tissu non tisse de greffe vasculaire
EP3305336A4 (fr) * 2015-05-27 2019-01-09 Toray Industries, Inc. Structure de tissé tubulaire
EP3533914A4 (fr) * 2016-10-07 2020-09-16 Toray Industries, Inc. Tissu tubulaire

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4923470A (en) * 1985-04-25 1990-05-08 American Cyanamid Company Prosthetic tubular article made with four chemically distinct fibers
WO1991010766A1 (fr) * 1990-01-15 1991-07-25 Albany International Corp. Structure tressee
WO1992016166A1 (fr) * 1991-03-25 1992-10-01 Meadox Medical Inc. Prothese vasculaire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4923470A (en) * 1985-04-25 1990-05-08 American Cyanamid Company Prosthetic tubular article made with four chemically distinct fibers
WO1991010766A1 (fr) * 1990-01-15 1991-07-25 Albany International Corp. Structure tressee
WO1992016166A1 (fr) * 1991-03-25 1992-10-01 Meadox Medical Inc. Prothese vasculaire

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998016173A1 (fr) * 1996-10-11 1998-04-23 C.R. Bard, Inc. Tissu non tisse de greffe vasculaire
US5824047A (en) * 1996-10-11 1998-10-20 C. R. Bard, Inc. Vascular graft fabric
EP3305336A4 (fr) * 2015-05-27 2019-01-09 Toray Industries, Inc. Structure de tissé tubulaire
EP3533914A4 (fr) * 2016-10-07 2020-09-16 Toray Industries, Inc. Tissu tubulaire
US11371172B2 (en) 2016-10-07 2022-06-28 Toray Industries, Inc. Tubular woven fabric

Also Published As

Publication number Publication date
CA2138640A1 (fr) 1994-11-10
CA2138640C (fr) 1998-07-28

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