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Publication numberUS3688317 A
Publication typeGrant
Publication dateSep 5, 1972
Filing dateAug 25, 1970
Priority dateAug 25, 1970
Also published asCA957802A1, DE2129004A1, DE2129004B2
Publication numberUS 3688317 A, US 3688317A, US-A-3688317, US3688317 A, US3688317A
InventorsLeonard D Kurtz
Original AssigneeSutures Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Vascular prosthetic
US 3688317 A
A vascular prosthetic comprising a multilayered tubular fabric contains an anticoagulant on an inner layer to reduce the likelihood of clot formation. An outer layer does not contain an anticoagulant and may contain an anticoagulant inhibitor or antagonist to permit clot formation adjacent the outer layer to thus prevent exsanguination.
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Description  (OCR text may contain errors)

United States Patent Kurtz Sept. 5, 1972 [54] VASCULAR PROSTHETIC 3,425,418 2/1969 Chvapil et al. ..128/334 R [72] Inventor: Leonard D. Kurtz, Woodmere, N.Y.

Primary ExammerR1chard A. Gaudet [73] Assigneez Sutures Inc., Coventry, Conn. Assistant Examine, Rona1d L Frinks [22] Filed: Aug 5 7 Att0rneyLarson, Taylor and Hinds [21] Appl. No.: 66,710 57 ABSTRACT A vascular prosthetic comprising a multilayered tubu- 3/DIG' lar fabric contains an anticoagulant on an inner layer I! to reduce the of clot formation- An outer [58] Field of Search ..3/l, DIG. 1; 128/334 R layer does not contain an anticoagulamand may Com tain an anticoagulant inhibitor or antagonist to permit [56] References cued clot formation adjacent the outer layer to thus prevent UNITED STATES PATENTS exsanguination- 3,105,492 10/1963 Jeckel ..128/334 R 6 Claims, 1 Drawing Figure mfiefiiasw 5 m2 INVENTOR LEONARD D. KURTZ ATTORNEYS BACKGROUND OF THE INVENTION The present invention relates to prosthetic devices, vascular implants and the like for surgical use in the repair and replacement of vessels and tracts in human and animal bodies.

In the practice of vascular surgery, such defects in he vascular system as aneurysms or occlusions are corrected by the technique of suture anastomosis, by which the area or segment of pathology is excised or resected, and replaced by a prosthetic device, or graft, which is implanted, or sutured in. The vascular prosthetic grafts are employed in various sizes and in all parts of the vascular system, and comprise straight or variously branched tubes of flexible, porous construction or fabrication from fibers or strands run together or interlaced in an interstitial or mesh structure.

The vascular prosthetic grafts here concerned desirably are non-toxic and non-allergenic; non-deteriorating upon implantation for prolonged periods; and capable of deforming without collapsing and twisting without kinking. Desirably also the porosity of the grafts on implantation is low enough to permit the implantation without pre-cloting.

The body heals by fibrosis; that is, the organisms reaction to the implantation of the foreign body is to attempt to completely encapsulate the graft with fibrous or scar tissue, forming both an outer layer or capsule of fibrous tissue and an inner capsule of fibrous tissue within the lumen of the graft. The healing process is initiated withing hours of implantation by the deposit of a thin fibrous layer or mat on the inside of the graft in contact with the blood stream. The fibrous mat then organized more slowly, within a period of days to weeks, into a layer of mature scar tissue. The origin of the fibroblasts forming the inner layer or capsule is considered to be migration or growth from the outer capsule through the mesh or interstices of the graft. The fibrous inner layer, then, is dependent for its blood supply and integrity on interstitial tissue ingrowth, and a principal factor limiting the biological fate of the graft is the case with which the fibrous tissue may grow through the implant wall.

It has been proposed to heparinize the prosthetic to reduce the likelihood of clot formation within the lumen of the graft. The use of an anticoagulant, however, inhibits the formation of clots not only in the graft lumen but throughout the implant itself as well which may result in exsanguination. This adverse result may be minimized by reducing porosity, but this has the adverse effect of interfering with the normal healing process as described above. Alternatively, a reduced amount of heparin may be utilized but this results in increased likelihood of clot formation in the graft lumen. Furthermore, in both of these cases, the anticoagulant affects clotting to substantially the same extend throughout the implant.

It is an object of the present invention to provide a vascular prosthetic which includes an anticoagulant but which is free from the disadvantages mentioned above.

BRIEF SUMMARY OF THE PRESENT INVENTION of the Present Invention The foregoing and other objects are achieved according to the present invention by providing a vascular prosthetic comprising a porous, multilayered tubular fabric comprising a first tubular fabric layer containing an anticoagulant and a second tubular fabric layer surrounding said first fabric layer, said second layer being free of anticoagulant.

DESCRIPTION OF PREFERRED EMBODIMENTS There'follows a detailed description of a preferred embodiment of the invention, together with accompanying drawings. However, it is to be understood that the detailed description and accompanying drawings are provided solely for the purpose of illustrating a preferred embodiment and that the invention is capable of numerous modifications and variations apparent to those skilled in the art without departing from the spirit and scope of the invention.

The drawing is a perspective view, partially cut away, of a vascular prosthetic according to the present invention.

With reference to the drawings, a vascular prosthetic according to the present invention comprises a porous, multilayered tubular fabric 1 comprising a first tubular fabric layer 2 and a second tubular fabric layer surrounding the first tubular fabric layer. A portion of second layer 3 is cut away in the drawing to reveal first layer 2. The multilayered prosthetic is conveniently made by inserting one vascular prosthetic within another and stitching the two together. One or both of the prosthetics may be crimped and each is of conventional construction such as woven or knitted. The composite prosthetic may be in the form shown in US. Pat. No. 3,105,492, herein incorporated by reference. The graft may be fabricated from fibers of synthetic resins useful in prosthetics such as polyesters such as polyethylene terephthalate, polyamides such as nylon 66, acrylics and modacrylics such as Orlon, and polyhalogenated hydrocarbons such as Teflon, or from mixtures of these fibers with one another or with animal derivative fibers such as disclosed in US. Pat. No. 3,316,557, herein incorporated by reference. Thus, each layer of the prosthetic, as well as the composite prosthetic, is conventional in configuration, the porosity, size and other structural features being selected as desired for a given use according to known considerations.

In accordance with the present invention, a first fabric layer of the implant is provided with an anticoagulant and a second fabric layer of the implant surrounds the first. The anticoagulant is preferably heparin and is provided in the first layer by impregnation of the fibers making up the layer or by impregnation of the layer prior to assembling the composite prosthetic. In a preferred embodiment, a tubular fabric prosthetic of crimped woven Dacron is immersed into a 5 percent aqueous solution of sodium heparin for a few minutes and the thus-impregnated implant is dried providing about 0.5 percent by weight of heparin in the prosthetic.

The impregnated prosthetic is then inserted inside a second tubular prosthetic fabric having an inside diameter slightly larger than the outside diameter of the impregnated prosthetic. The second prosthetic is preferably woven more loosely than the first.

An implant constructed in the foregoing manner is utilized in surgery in the usual manner. The presence of heparin anticoagulant in the inner layer minimizes the risk of clotting within the implant. The outer layer, however, is free of anticoagulant and permits the formation of clots outside the inner layer thus minimizing the likelihood of exsanguination due to the presence of heparin in the prosthetic.

The inhibiting effect of the outer layer on the anticoagulant can be enhanced according to the invention in several ways. First, the second layer may be relatively large in thickness relative to the first layer thus providing greater capacity to absorb the anticoagulant. Alternatively, the second layer may comprise a material which inhibits the effect of the anticoagulant. The inhibitor may be the fabric material itself or a material added thereto such as an anticoagulant antagonist or inhibitor.

Heparin anticoagulant is an organic acid which will react with a base. The fabric may comprise a basic material, such as silk or other protenaceous fiber, which will chemically combine with heparin thus effectively inhibiting the effect of heparin on clotting in the second fabric layer.

Where a material is added to the second fabric layer as an inhibiting agent, that material may simply react chemically with the anticoagulant to form a reaction product having no effect on clotting. For example, the second fabric may be coated or impregnated with a basic salt, such as a quaternary ammonium germicide, for example benzethonium chloride, which will react chemically with heparin to form a highly insoluble material having very little anticoagulating effect. Alternatively, the second fabric may be coated or impregnated with a heparin antagonist such as a protamine or protamine zinc or with an antifibrinolytic agent such as epsilon amino caproic acid. Other heparin inhibitors which may be provided in the second fabric include Acridine Blue, Polybrene, and Toluidine Blue.

The amount of anticoagulant is, in general, less than that which would give the normal dosage of anticoagulant if released. Preferably, the amount of anticoagulant is not more than one-tenth that amount. Thus, the conventional dosage of heparin anticoagulant is about 50 mg i.v. Therefore, the maximum amount of heparin anticoagulant in a prosthetic would generally be about 50 mgm., preferably about 5 mgm. Where a heparin antagonist or inhibitor is utilized in the second fabric layer, the amount thereof will, in general, be at least an amount sufficient to inhibit a substantial amount of the anticoagulant in the first layer. For example, where anticoagulant inhibition is achieved by chemical reaction, the amount of inhibitor is at least sufficient to react with a substantial amount, preferably a major proportion of the anticoagulant present in the prosthetic. The maximum amount of the inhibitor is preferably about five times the amount theoretically needed to inhibit all of the anticoagulant, and more preferably, about twice that amount.

While the preferred prosthetic has two layers as shown, additional fabric layers may be added. However, at least the inner layer will be heparinized in accordance with the invention and at least one outer layer, preferably the outermost layer, will be free of heparin according to the present invention.

What is claimed is: 1. A vascular prosthetic comprising a porous, multilayered tubular fabric comprising a first tubular fabric layer containing an anticoagulant and a second tubular fabric layer surrounding said first fabric layer, said second layer being free of anticoagulant and containing an inhibitor for said anticoagulant.

2. A vascular prosthetic according to claim 1 wherein said anticoagulant comprises heparin.

3. A vascular prosthetic according to claim 2 wherein said inhibitor comprises a heparin inhibitor.

4. A vascular prosthetic according to claim 3 wherein said heparin inhibitor is selected from the group consisting of epsilon amino caprioc acid, protamine, protamine zinc, acridine blue, polybrene and toludine blue.

5. A vascular prosthetic according to claim 3 wherein said heparin inhibitor comprises a basic salt capable of reacting with heparin to form an insoluble salt with heparin.

6. A vascular prosthetic according to claim 5 wherein said basic salt comprises a quaternary ammonium salt germicide.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3105492 *Oct 1, 1958Oct 1, 1963Us Catheter & Instr CorpSynthetic blood vessel grafts
US3425418 *Apr 15, 1964Feb 4, 1969Spofa Vereinigte Pharma WerkeArtificial blood vessels and method of preparing the same
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3908201 *Jun 8, 1973Sep 30, 1975Ici LtdProsthetics
US3908657 *Jan 15, 1973Sep 30, 1975Univ Johns HopkinsSystem for continuous withdrawal of blood
US3976081 *Apr 10, 1974Aug 24, 1976Abraham LapidotLaminar middle ear vent tube assembly
US4008717 *Mar 5, 1976Feb 22, 1977The Johns Hopkins UniversitySystem for continuous withdrawal and analysis of blood
US4042978 *Jun 11, 1975Aug 23, 1977Imperial Chemical Industries LimitedProsthetics
US4061134 *Oct 28, 1975Dec 6, 1977Samuels Peter BArterial graft device
US4086665 *Dec 16, 1976May 2, 1978Thermo Electron CorporationArtificial blood conduit
US4130904 *Jun 6, 1977Dec 26, 1978Thermo Electron CorporationProsthetic blood conduit
US4186448 *Nov 21, 1977Feb 5, 1980Brekke John HDevice and method for treating and healing a newly created bone void
US4321711 *Oct 12, 1979Mar 30, 1982Sumitomo Electric Industries, Ltd.Polytetrafluroethylene containing an anticoagulatn conded to an elastomer cointaining an coagulant
US4361552 *Sep 26, 1980Nov 30, 1982Board Of Regents, The University Of Texas SystemWound dressing
US4652263 *Jun 20, 1985Mar 24, 1987Atrium Medical CorporationElasticization of microporous woven tubes
US4814120 *Apr 21, 1987Mar 21, 1989Bioetica S.A.Extrusion, coagulation, aziding, drying vein prosthesis or nerve sutures
US4870966 *Feb 1, 1988Oct 3, 1989American Cyanamid CompanyBioabsorbable surgical device for treating nerve defects
US4871365 *Dec 24, 1986Oct 3, 1989American Cyanamid CompanyPolyglycolic acid, trimethylene carbonate linkager
US4986831 *Apr 25, 1988Jan 22, 1991Angeion CorporationMedical implant
US4990158 *May 10, 1989Feb 5, 1991United States Surgical CorporationElastic core and inelastic sheath yarn
US4997440 *Aug 10, 1990Mar 5, 1991American Cyanamid CompanyVascular graft with absorbable and nonabsorbable components
US5084065 *Jul 10, 1989Jan 28, 1992Corvita CorporationReinforced graft assembly
US5147400 *Sep 12, 1990Sep 15, 1992United States Surgical CorporationConnective tissue prosthesis
US5217494 *Apr 5, 1991Jun 8, 1993Coggins Peter RTissue supporting prosthesis
US5217495 *Nov 13, 1990Jun 8, 1993United States Surgical CorporationSynthetic semiabsorbable composite yarn
US5376118 *Mar 26, 1993Dec 27, 1994United States Surgical CorporationSupport material for cell impregnation
US5476506 *Feb 8, 1994Dec 19, 1995Ethicon, Inc.Bi-directional crimped graft
US5527353 *Dec 2, 1993Jun 18, 1996Meadox Medicals, Inc.Implantable tubular prosthesis
US5542594 *Oct 6, 1993Aug 6, 1996United States Surgical CorporationFor driving surgical fasteners into body tissue
US5584877 *Jun 23, 1994Dec 17, 1996Sumitomo Electric Industries, Ltd.Antibacterial vascular prosthesis and surgical suture
US5716660 *May 31, 1995Feb 10, 1998Meadox Medicals, Inc.Impregnating microvoids in prosthesis with solution of soluble, biocompatible, biodegradable material comprising extracellular matrix proteins, raising ph to precipitate in situ
US5800510 *Jun 6, 1995Sep 1, 1998Meadox Medicals, Inc.Implantable tubular prosthesis
US5851230 *Oct 18, 1996Dec 22, 1998Meadox Medicals, Inc.Vascular graft with a heparin-containing collagen sealant
US5904717 *Jan 9, 1995May 18, 1999Thm Biomedical, Inc.Method and device for reconstruction of articular cartilage
US5908427 *May 30, 1997Jun 1, 1999United States Surgical CorporationSurgical stapling apparatus and method
US5911753 *Nov 24, 1997Jun 15, 1999Meadox Medicals, Inc.The present invention relates to an implantable tubular prosthesis having a textile substrate with a fluid-tight microporous lining.
US5935594 *Apr 6, 1998Aug 10, 1999Thm Biomedical, Inc.Employing a surfactant for efficiently incorporating a bioactive agent into the interstices of a porous and biodegradable polylactic acid body, wherein the bioactive agent is deposited on the internal surface
US5964774 *Sep 12, 1997Oct 12, 1999United States Surgical CorporationSurgical stapling apparatus and method with surgical fabric
US5981825 *May 13, 1994Nov 9, 1999Thm Biomedical, Inc.Device and methods for in vivo culturing of diverse tissue cells
US6013099 *Apr 29, 1998Jan 11, 2000Medtronic, Inc.Medical device for delivering a water-insoluble therapeutic salt or substance
US6045560 *Jun 17, 1996Apr 4, 2000United States Surgical CorporationSurgical stapling apparatus with biocompatible surgical fabric
US6099557 *Feb 5, 1999Aug 8, 2000Meadox Medicals, Inc.Implantable tubular prosthesis
US6106454 *Jun 17, 1997Aug 22, 2000Medtronic, Inc.Medical device for delivering localized radiation
US6162247 *Dec 21, 1998Dec 19, 2000Meadox Medicals, Inc.Providing a stable collagen-heparin dispersion and applying the same to the synthetic vascular prosthesis to effectuate sealing and impart anti-thrombogenic properties thereto
US6203536Jun 17, 1997Mar 20, 2001Medtronic, Inc.Medical device for delivering a therapeutic substance and method therefor
US6264701Dec 7, 1998Jul 24, 2001Kensey Nash CorporationDevice and methods for in vivo culturing of diverse tissue cells
US6273897Feb 29, 2000Aug 14, 2001Ethicon, Inc.Surgical bettress and surgical stapling apparatus
US6325810Jun 30, 1999Dec 4, 2001Ethicon, Inc.Foam buttress for stapling apparatus
US6391052Oct 29, 1997May 21, 2002Scimed Life Systems, Inc.Immersion in aqueous electrolytes; electrodeposition of coating on metal surface
US6399144Feb 12, 2001Jun 4, 2002Medtronic Inc.Medical device for delivering a therapeutic substance and method therefor
US6436135Oct 24, 1974Aug 20, 2002David GoldfarbProsthetic vascular graft
US6589468May 12, 2000Jul 8, 2003Meadox Medical, Inc.Method of forming an implantable tubular prosthesis
US6730120Jan 26, 2001May 4, 2004Medtronic, Inc.Medical device for delivering a therapeutic substance and method therefor
US6814753May 7, 2003Nov 9, 2004Scimed Life Systems, Inc.Implantable tubular prosthesis
US6997949May 20, 2002Feb 14, 2006Medtronic, Inc.Medical device for delivering a therapeutic agent and method of preparation
US7112293Dec 17, 2001Sep 26, 2006Nicast Ltd.Method and apparatus for manufacturing polymer fiber shells via electrospinning
US7115220Dec 17, 2001Oct 3, 2006Nicast Ltd.Multilayer; variations in porosity; drug delivery
US7244116Mar 19, 2002Jul 17, 2007Nicast Ltd.Apparatus for improving mechanical characteristics of nonwoven materials
US7244272Feb 14, 2005Jul 17, 2007Nicast Ltd.Vascular prosthesis and method for production thereof
US7276271Mar 19, 2002Oct 2, 2007Nicast Ltd.Polymer fiber tubular structure having kinking resistance
US7419696Nov 30, 2005Sep 2, 2008Medtronic, Inc.Medical devices for delivering a therapeutic agent and method of preparation
US7794219Mar 19, 2002Sep 14, 2010Nicast Ltd.Portable electrospinning device
US7811317Oct 30, 2007Oct 12, 2010Medtronic, Inc.Medical devices for delivering a therapeutic agent and method of preparation
US8263170Jan 6, 2010Sep 11, 2012Advanced Cardiovascular Systems, Inc.Methods for immobilizing anti-thrombogenic material onto a medical device or into a coating thereon
US8491649Dec 10, 2012Jul 23, 2013Aga Medical CorporationMedical device including corrugated braid and associated method
US20120295871 *May 21, 2012Nov 22, 2012Oliva Eugene JHeparin-based compositions and methods for the inhibition of metastasis
USRE40404Dec 15, 1999Jun 24, 2008Maquet Cardiovascular, LlpThinly woven flexible graft
U.S. Classification623/1.43
International ClassificationA61F2/06, A61L27/54, A61L27/14, A61L33/00
Cooperative ClassificationA61F2/06, A61L2300/432, A61L2300/208, A61L27/14, A61L2300/42, A61L27/54, A61L2300/404, A61L2300/236, A61L33/0011, A61L2300/61
European ClassificationA61L27/14, A61F2/06, A61L27/54, A61L33/00H2
Legal Events
Oct 17, 1985AS01Change of name
Owner name: HOWMEDICA, INC.
Effective date: 19840624
Oct 17, 1985ASAssignment
Effective date: 19840624