CA2243951C - Improved ptfe vascular graft and method of manufacture - Google Patents
Improved ptfe vascular graft and method of manufacture Download PDFInfo
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- CA2243951C CA2243951C CA002243951A CA2243951A CA2243951C CA 2243951 C CA2243951 C CA 2243951C CA 002243951 A CA002243951 A CA 002243951A CA 2243951 A CA2243951 A CA 2243951A CA 2243951 C CA2243951 C CA 2243951C
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- ptfe
- tubular structure
- ptfe tubular
- porosity
- tube
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial 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
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
- A61F2002/0086—Special surfaces of prostheses, e.g. for improving ingrowth for preferentially controlling or promoting the growth of specific types of cells or tissues
-
- 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
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Abstract
An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube.
Description
CA 0224395l l998-07-20 W O 97/2S938 PCT~US97/01720 ~h/lPROVF.D PTFF VA~ R GRAl~ ANI) lVl~,T~OD OF M~NUFACTU~, FIF,T n OF ~VF,~TION:
The present i~v.,.llion relates generally to a tubu}ar imr~nt?~ble prosthesis such as vascular grafts and ~ndoprostheses formed of porous pol~lLt~nuorethy1ene~ More par~i.ul..,ly, the ~l~rCht i..~ ~..Dn relates to a multïl-l..y~ tubular vascular graft or endol,. uslh~ formed from e~pqr~-le.
pol,~ l~lrdfluorethylene.
BACKG~OUND OF T~ T~VFNTION:
It is well Icnown to use estruded tubes of po1,r~ an~ûr-ethylene (PTFE) as imph~n~ble intr~ min~l pr._" - s, particularly v;.scular grafts. PTFE is par~icuiarly suitable as an impl~r t~hle prosthesis as it t,~Lib:ls shl.e. ;or bioca~ tihility. PTF E tubes may be used as v,.;.. ~l,.r grafts in the replacement or repair of a blood vessel as PTFE e~hihit~low thrombogenicity. In vascular applications, the grafts are manufactured from e~r~nlle~l pol~ lr.~n~orethylene ~ePTFE) tubes. Thwe tubes have a microporous ~L~ uLh.r~: which allows natural tissue ingrowth and cell endolhcl~Lion once implanted in the vascular system.
1~ This contributes to long term healing and patency of the graft.
&rafts formed of ePTFE have a fibrous state which is defined by t~ c- ~ nodes iuL~--o ~n~rte~l by el~ kd fibrils. The spaces l,_-~ce.. the node surfaces that is sE~qnned by the fibrils is ~l~fin~l as the internodal distance ~IND). A graft having a large IND enhances tissue h~;ru~ and cell 2 o Pn-lo~h~ as the graft is inl.c.~.. ll~ more porous.
,. CA 022439~1 1 998 - 07 - 20 The art is replete with e~amples of microporous ePTFE tubes useful as vascular grafts. The porosity of an ePTFE vascular graft can be controlled by controlling the IND of the microporous structure of the tube. An increase in theIND within a given structure results in enhanced tissue growth as well as cell 5 endoth~lization along the inner surface thereof. However, such increase in theporosit~ of the tubular structure also results in reducing the overall radial tensile strengt}t of the tube as well as reducing the ability for the graft to retain a suture placed lherein during implantation. Also, such microporous tubular structures tend to exhibit low axial tear strength, so that a small tear or nick will tend to 10 propag;lte along the length of the tube.
The art has seen attempts to increase the radial tensile and axial tear strength of microporous ePTFE tubes. These attempts seek to modify the structure of the extruded PTFE tubing during formation so that the resulting 15 expanded tube has non-longitudinally aligned fibrils, thereby increasing bothradial tlensile strength as well as axial tear strength. U.S. Patent No. 4,743,480 shows one attempt to reorient the fibrils of a resultant PTFE tube by modifyin~
the extrusion process of the PTFE tube.
C)ther attempts to increase the radial tensile, as well as axial tear strength of a mic roporous ePTFE tube include forming the tubular graft of multiple layers placed ovcr one another. Examples of multi-layered ePTFE tubular structures useful as implantable prostheses are shown in U.S. Patent Nos. 4,816,339;
4,478,8'~8 and 5,061,276. Other examples of multi-layered structures are shown in Japanese Patent Publication nos. 6-343,688 and 0-022,792.
'While each of the above enumerated patents provides tubular graft structu] es exhibiting enhanced radial tensile strength, as well as enhanced axial tear strlength, these structures all result in tubes exhibiting lower porosity. More 30 specifically, the multi-layered ePTFE tubular structures of the prior art exhibit a smaller microporous structure overall, especially as the inner surface, and W O97~25g38 PC~rUS97/01720 .
aCCGI ~t~ y~ a reduction i~ the ability of the graft to promote endothP~ ;on along the inner ~.rr..ce.
It is therefore desirabie to provide a ePTFE ~ qr graft which çshihjt~
increased porosity especially at the inner surface thereof while ret~ining a high degree of radial ~ lL especially at the tAh.~ ~al surface théreof.
It is further desirable to produce an ePTFE vascular gra~t which ~
inc~ eas~d porosib at the outer surface thereof vhile re~ ing a high degree of radial tensile and suture ~ ~t~liol- ~Ir~ ;lhs.
SUMI~A~Y OF T~ INV~,NTION:
It is an obJect of the present i~,v~liOI. to ~l uvide an i~yru~,d ePTFE
Ya~cnlar graft.
It is a further object of the ~Jr~sL..t i~. ti~n to provide 5~ eP'l~ vascular graft ~yhihiting an enhanced l~lic-ulJorous slrucL--i G while ret~inin~ superior,LL.
It is a still r~l Ih~l object of the l~r~ t invention to provide an ePTFE
tubular slructure having an inner ~o. l;cn ~ ih~ ; enhanced porosity and an ouler ~ol lio~ e~chibiting enhanced radial tensile sl~ and suture elo- gilt;on chal ~cl~. ;..Lics.
It is yet another object of the present i~v~,LIio-l to provide a multi-layered 2 o ePTFE: tubular vascular graft having an inner layer which llas a porosity ~-~IT~ t to promote cell endûth~li7~tion and an outer layer having a high degreeof radial tensile ;~h .,~~;IL.
W 097125938 PCTrUS97/01720 It is an additional object of the present i-lv~nlio~ to provide a multi-layered ePTFE tubular vascular graft having an outer layer whose porosity is s~ffei~nt to promote enhanced cell growth and tissue incorporation, hence more rapid healing,and an inner layer having a high degree of ~Irc.~;lL.
In the efficient ~ mf~nt of these and other ob~ects, the ~ t invention provides an i-np!~Tlt~hle polytetrafluorethylene (PTFE) vascular graft. The graft includes a first ePTFE tubular slr~ rc, and a second ePTFE tubu}ar structure circumf~. ~ ..hally di~l~csed exteriorly about the first tubular ~ . The porosity and physical ~ln,.~ characteristics of each of the aforem~ntioned tubular ~Irul lu~ ~.. can be varied independently of each other. This resulh in a structus e whose first ePTFE tubular structure exhibits a 1~~l o~ily s~ -t topromote cell endol}~e~ ;on there along, while the second sl, ucLul ~ exhibits ~L. ~.,glL in e~ccess of the slr~ lh of the first tubular :~lrucl~ . AlL . ~.,lively the first ePTFE tubular sl, ucl.~rc exhibits sl, ~lh in excess of the ~ .L IL of thesecond tubular structure, while the second tubular sll ... cl~re e~ hi~c a porosity s-~ffl- i~nt to promote more rapid tissue incorporation.
As more particularly des., ibcd by way of the EJrL.~ ~ ~,d embo~ t herein, the first and second PTFE tubular structures are formed of e~p~ de~l poiyt~lr~nuorethylene (ePTFE). Further, the second ePTFE tubular :~lruLlui l is 2 0 adl~e. ;.. ~l~ supported over the first ePTFE tubular structure to form a composite tubular graft. The sl~ IL of this adhesion can be varied as desired to control the characl~. ;,li~ e~hibited by the resultant co~ Gsile structure.
In its method aspect, the l)r~ ~nt h.v~nlion provides a method of forming a Yascular graft. The ~A~ the steps of E~ a first ePTFE tubular shuclul~ having a desired porosity and ~Ir.. ~ combination. A second ePTFE
r slr~ .re is provided, also having the desired ~o~ and slr.,..~
com~ination. ~he second ePTFE structure is disposed over the first ePTFE so as to ~efine a composite vascular graft.
W 09712593$ PCTrUS97/01720 The method of the present i--v- -,lion also provides for the pocit;~ ing of an intermediate structure l,~ n the first and second ePTFE; tubular structures.
l~r~ les of such sl~ u~Ll~ es include an ~rltlition~l ePTFE layer and fibers or thin f~:ms of PTFE or other suitable polymers. This intermediate structure also ca ntributes to the resultant porosity and strength of the vascular graft.
BlR~FF Dli .~C~lPTION OF T~F Dl~AWINGS:
Figure 1 is a schematic longitudinal cross-section of a multi-layer ePTFE
vascular graft of the present i~v~ u.
Figure 2 is a lon~h~Ain~l cross-section of an alternate emboAin~e~t of the IJr~s-~lt invention producing a multi-layer ePTFE vascular graft.
Figure 3 is a sC~nr~in~ elc.lru~ mic, u~ h(.~ g a cross s~ ~icnal view of a vascular graft produced using the present invention.
Figure 4 is a ~c. ;,~e.live showing of one of the tubular s~ r~s of the graft of Figure 1 over-wrapped with a layer of ePTFE tape.
lS Figure ~ is a cross-sectional showing of an alternate embo(li~L~t of the ePTFE vascular graft of the present invention. In this instance, the view is taken through the lines II-II of the view shown in Figure 2.
DhTA~T Fn DESCR~PTIO~ OF T~ p~FFRR~n F'l~IBOD~M~l~TS:
The ~. u~ f -i~ of the pr~f~. 1 ed emboAin~ntc of the present invention is a 2 0 mu;lti l.. y~l d tubular structure which is particularly suited for use as an encloE,~ v:,lhesis or vascular graft. The prosthesis is formed of e~ctruded polyl~:l.afluoret}~ylene (PTFE) as PTFE eshibits ~u~c,;or bioco~r~t~l~ility.
Fu~rther, PTE~: is particularly suita3~1e for vascular appli~ ~tion~ as it exhibits low W O 97J25~38 PCTrUS97/01720 .
tbrombogenicity. Tubes formed of extruded PTFE may be ~rq lerl to form ePTFE tubes where the ePTFE tubes have a fibrous state which is defined by elongated fibrils interco nectell by spaced apart nodes. Such tubes are said to have a microporous ~L~ ucl~, e, tbe porosity of which is deh . ,-lil,ed by the distance ~h. GCI~ the surfaces of the nodes, referred to as the internodal distance (IND).
Tubes having a large IND (greater than 40 microns) generally exhibit long term ~;,alc~-~ as the larger pores promote cell endothelization along the inner bloodcontacting surface. Tubes having lower IND (less than 40 microns) exhibit inferior he~ling chara~lt. ,~li.;" however they offer superior radial tensile and suture rete.,lion sl~ lLs desirable in a vascular graft. The pr.S~ l invention provides a composite tubular ~Iru-,lu~e which promotes long term patency of the graft hy providil~g for enhanced cell endofh~li7~tion along the inner surface while exhibiting enhanced ~lr~ lh due to the p~ esencc of the outer layer.
Referring to Figures 1 and 2 of the dr~ s~ composite graft 10 of the present h~v~l~lion is shown. Graft 10 is a elongate tubular structure formed of PT~E. Graft 10 includes a pair of coqYi~lly disposed ePTFI~ tubes 12 and 14, tube 12 heing the outer tube and tube 14 bcing the inner tube. A central lumen 15 extends through composite graft 10, defined further by the inner wall 14a of inner tnbe 14, which permits the ~as~ e of blood through graft 10 once the graft is 2 o pl o~,el ly implanted in the vascular system.
Each tube 12 and 14 may be formed in a separate e~ctrusion process. The 1" oc~s for the paste ~ ,r of PTFE tubes is well Icnown in the estrusion art.
Once e2ctruded, the tubes are e2~panded to form ePTFE ~ubes. As will be dcs_. ,I,ed hereinbelow, the tubes are ~p~n-lPA using dirr~ process parameters ~rates, 2 5 deformation levels, te.,.~c. ,.tures, etc) to develop the desired microporous structures. The spe~ ifi~lly designed structure of the ,~ composite tube has defined ~l op~. Lies of slr~,nglL and porosity which yield a graft 10 having long term patency and good healing char..cle. ;..lics as well as superior strength clharacteristics.
W O 97t25938 PCTrUS97/01720 The present invention is designed to produce grafts with s~lbst~n~ ly . c..t node/fibril ~1- u-LI~r~5 with respect to the internal and external portions of the graft which are adjacent to the internal and external graft surfaces. ~s an r pl~ the inner tube 14 is designed to have rll..lively high INO while the outerS tube 12 is de~ .ed to have a lower IND. Further, a distinct porosity change is q clcarly defined at the interface 13 between tubes 12 and 14. The inner tube 14 h.lving a higher IND to allow enhanced ce11 endothelization, while the outer tube 12 having a lower IND provides superior strength to tbe overall composite.
An electron micrograph of such a structure produced according to the present invention is showm in Figure 3. The disparate IND's between the inner tube 14 a~d outer tube 12 are clearly evident, along with the step change in IND at the interface 13 between the inner tube 14 and outer tube 12. In this example, the of the interface 13 has been established by the pr C.,~ conditions described below to fully adhere the inner tube 14 and outer tube together, hencepr~eventing relative motion and providi,.g enhanced ~lr~n~
Graft I0 of the present inv~.~1iu may be formed by e~psr~lin~ a thin wall imler tube 14 at a r~,lali~ely high degree of elongation, on the order of ap~roxim~t~ly between 400 and 2000% elongation preferably from about between 700% and 900%. Tube 14 is expanded over a cylindrical man~rel (not shown), 2 o such as a stainless steel mandrel at a temperature of beh. ee.. room temperature and ~4~~F, I,rtrel ably about ~00~F. Tube 14 is preferably but not ~ecessarily fullly ~ te. ~d after eY~rciom Sintering is Iy~. - lly accomplished at a tem~c. ~lLre of between 64~~F and 800~F preferably at about 660~F and for a tim;e of l~e-lw~_., about 5 minutes to 30 ~ 1~s, preferably about IS mir~-tes. The co~nbination of the ePTFE tube 14 over the mandrel is then employed as a second mandrel, over which outer tube 12 is eSp~ e~l The ID of the oDter tube 12 is s~le~te~ so that it may be easily but tightly ~li..l.osed over the OD of inner tube 14.
The composite structure 10 is then sintered at ~Jr~ bly similar parameters. The level of elongation of outer tube 12 is lower than that of inner tu~e 14, CA 0224395l l998-07-20 w o 97!25938 PCT~US97/01720 appro~ teiy bet~. t_~. 200% and ~00% elo!lgP*nn preferably about 400%. The e~ -. and sintering of outer tube 12 over the inner tube 14 serves to adLc. ;-~ bond the interface 13 between the two tubes, rPs~ltin~ in a single composite ~ elul c 10.
As shol~vn in Figùre 3, the reS~ltin~ co~lJG3iL~: structure has an inner surface ~l~fine~l by inner tube 14 which e~hibits an IND of 1)el~ 40 and 100 microns, spanned by moderate number of fibrils. Such microporous structure is suf~ ntly large so as to promote ~nh~rce~ cell endothelization once blood flow is established through graft 10. Such cell endothelization enhances the long term patency of the graft.
The outer sl- ucl.., ~, defined by outer tube 12, has a smaller microporous structure, with IND of 15-35 microns and a substantial fibril density. Such outer structure results in an increase in the ~ lL of the outer tube, and hence of thecomposite structure. Importantly, the outer surface defined by the outer tube 12~hi~jtc eD,hanced suture retenffon due to the smaller IND.
Fl.~ lhe. ~ore, the res~lffng co...~.c;.ile ~L. u~lur~ a sharp porosity change between the outer t~be 12 and inner tube 14. This sharp porosit~
transition is achieved by providing an inner tube 14 having generally a given uniform porosity therealong and then providing a separate outer tube 14 having a2 0 r~_ It~nt different porosity uniformly therealong. Thus a ~lictinct porosity change is e~ ite~l on either side of the interface 13 ~lefine~ between inner tube 14 and outel tube 12.
In addition, the forming ~. uc~,.,a described above results in a bonded interface between inner tube 14 and outer tube 12. The interface e~hibits sufficient interfacial ~ ll. resulting from the direct i,".tc~ g of the outer tube I2 over the inner tube 14 so as to assure complete bonding of the two tubes. Thes~ lh of the interface b_h. .,eh the two tubes may be independently varied -CA 0224395l l998-07-20 W O 97~2~938 PCT~US97/01720 th!rough sPlr~ of~lo¢~ condition~and r~ e~ o ofprec~r~or es-truded tubes 1Z and 14 as desired to yield a range of performance.
The following e~amples serve to provide further a~l.rec;a~ion of the iu~ ntion but are not meant in any way to restrict the scope of ~he invention.
~XAMPI ~ I
A thin estruded tube having wall thickness of 0.41 mm and an inner diameter of 6.2 mm was expanded over a stainless steel mandrel at 500~F to 900%
elongation. The ePTFE tube was then sintered at 660~F for 14 minutes, cooled, anll removed from the oven. A second thin estruded tube having wall thickness of0 0.4~ mm and an inner diameter of 6.9 mm was e~cpanded over the first tube/mandrel combination at 500~F and 400% elongation. The composite was then ~il.le.~d at 660~F for il4 minutes, cooled and removed from the o~en. The resullant co...l,c,ile tube had a wall thi~knesc of 0.65 mm and ID of ~.8 mm.
F~A7UPI F II
A thin e~truded tube having wall thi-~kneC~ of 0.41 mm and an inner dia1~eter of 6.2 mm was expanded over a st~inl~cs steel mandrel at 500~F to 700%elon~ation. The ePTFE tube was then sintered at 660~F for 14 minutes, cooled, and removed from the oven. A second thin e~ctruded tube having wall thi.~rn~c.c of 0.4~i mm an~ an inner diameter of 6.9 mm was esr~ over the first tube at 2 0 SOO~F and 400% elongation. The composite was ~ . .d at 660~F for 14 minutes, cool~ed, and removed from the oven. The resultant co~l.u .ile tube had a wall thickness of 0.67 mm and an inner diameter of 5.8 mm.
Table I 1~- ~ s~-lls physical ~l b~e-Ly data for a vascular graft of the type deplcted in Example I dese. il,ed above. The composite graft was removed from the mandrei and subjected to standard testing of radial tensile strength and suture WO 97/25938 PCT~US97/01720 .
hole elongation. The radial strength of the 90û%/400% composite graft is e~uivalent to a single layer 400% elong~tion graft and substantially ~ll u~,e~ than a single layer 900% elong~tior graft, despite an overall thinner wall ~li~er~ion.
itir~r ~lly~ the superior strength of the composite graft is demo~ atc1 by the higher elongation capable of being borne by the graft prior to failure. The lower suturc hole elongation, indicative of a smaller tear being caused by s~lul iJlg and tensioning at a fi~ed value of 100 grams is clearly dc. c~strated for the graft prepared by the method of the current invention.
TABI.F, I
400% gO0%/400% 900%
10PhysicalProperty Elong~iûn Elongation Elo~lion Measurement Single Layer Cc~osile Single Layer Graft Graft Graft Radial Tensile Slr~ 0.48 0.48 0.2 (kglmm2) Radial Slrain at Break 550 690 ~31 15 (%) Suture Hole Elongation 87 81 158 (%) Wall Thickness 0.72 0.6~ 0.73 Ref~ now to Figures 4 snd 5, a further embodiment of the present 2 o invention is shown. Tubular graft 20is a co~ csil~ structure similsr to graft 10 described above. Graft 20 includes an outer tube 22 and an inner tube 24 formed generally in the m~nl~sr described above. In order to further control the porosity and strength of the graft 20~ especially at the interface beh. e.,.. outer tube 22 and inner tube 24, an additional layer may be employed in combination with outer 2 5 tube 22 and inner tube 24.
CA 0224395l l998-07-20 W ~ 97/2s938 PCTAUS97/01720 As speci4ir~11y shown in Figures 4 and ~, an àdditional layer 26 may be employed b- h. ~ ~ inner tube 24 and outer tube 22. Layer 26 may inrlu-le a helical wrap of ePTFE tape 27 placed over inner tube 24. The ad~i~n~l layer 26, hawever, may also exist as a sheet, film, yarn, monofilament or multi fil~m~r~t wrap, or ~d~ or~l tube. The additional 1aycr 26 may consist of PTFE, FEP, or other suitable polymer composition to obtain the desired performance chllracteristics. Layer 26 may be used to impart enhanced properties of porosityand/or strength to the co~osile gra* 2Q. For eY~mrlç, an additional layer 26 of ePTFE tape 27 having a low IND and wrapped orthogonally to the length 0 direction of graft 20 would increase the radial sl~ of the resultant composite graft. Simi}arly, a layer of ePTFE having a high IND would iue. . ase the porosity of the composite structure thereby further promoffllg celi endothelization and/or tissue iu~r~ ~ lh.
As shown in Figure 4, layer~6 is ~ osed between inner tube 24 and outer tube 22, and functions as an iute~ ,nediate ~ayer therein bet veen. It is further contempl~te~l that the additional layer may be employed over outer tube 22, or an additional layer may be used both over outer tube Z2 and over inner tube 24.
Various changes to the foregoing described and shown structures would no~v be evident to those skilled in the art. Accordingly, the particularly disclosed 2 o scolpe of the invention is set forth in the ~ollowing claims.
The present i~v.,.llion relates generally to a tubu}ar imr~nt?~ble prosthesis such as vascular grafts and ~ndoprostheses formed of porous pol~lLt~nuorethy1ene~ More par~i.ul..,ly, the ~l~rCht i..~ ~..Dn relates to a multïl-l..y~ tubular vascular graft or endol,. uslh~ formed from e~pqr~-le.
pol,~ l~lrdfluorethylene.
BACKG~OUND OF T~ T~VFNTION:
It is well Icnown to use estruded tubes of po1,r~ an~ûr-ethylene (PTFE) as imph~n~ble intr~ min~l pr._" - s, particularly v;.scular grafts. PTFE is par~icuiarly suitable as an impl~r t~hle prosthesis as it t,~Lib:ls shl.e. ;or bioca~ tihility. PTF E tubes may be used as v,.;.. ~l,.r grafts in the replacement or repair of a blood vessel as PTFE e~hihit~low thrombogenicity. In vascular applications, the grafts are manufactured from e~r~nlle~l pol~ lr.~n~orethylene ~ePTFE) tubes. Thwe tubes have a microporous ~L~ uLh.r~: which allows natural tissue ingrowth and cell endolhcl~Lion once implanted in the vascular system.
1~ This contributes to long term healing and patency of the graft.
&rafts formed of ePTFE have a fibrous state which is defined by t~ c- ~ nodes iuL~--o ~n~rte~l by el~ kd fibrils. The spaces l,_-~ce.. the node surfaces that is sE~qnned by the fibrils is ~l~fin~l as the internodal distance ~IND). A graft having a large IND enhances tissue h~;ru~ and cell 2 o Pn-lo~h~ as the graft is inl.c.~.. ll~ more porous.
,. CA 022439~1 1 998 - 07 - 20 The art is replete with e~amples of microporous ePTFE tubes useful as vascular grafts. The porosity of an ePTFE vascular graft can be controlled by controlling the IND of the microporous structure of the tube. An increase in theIND within a given structure results in enhanced tissue growth as well as cell 5 endoth~lization along the inner surface thereof. However, such increase in theporosit~ of the tubular structure also results in reducing the overall radial tensile strengt}t of the tube as well as reducing the ability for the graft to retain a suture placed lherein during implantation. Also, such microporous tubular structures tend to exhibit low axial tear strength, so that a small tear or nick will tend to 10 propag;lte along the length of the tube.
The art has seen attempts to increase the radial tensile and axial tear strength of microporous ePTFE tubes. These attempts seek to modify the structure of the extruded PTFE tubing during formation so that the resulting 15 expanded tube has non-longitudinally aligned fibrils, thereby increasing bothradial tlensile strength as well as axial tear strength. U.S. Patent No. 4,743,480 shows one attempt to reorient the fibrils of a resultant PTFE tube by modifyin~
the extrusion process of the PTFE tube.
C)ther attempts to increase the radial tensile, as well as axial tear strength of a mic roporous ePTFE tube include forming the tubular graft of multiple layers placed ovcr one another. Examples of multi-layered ePTFE tubular structures useful as implantable prostheses are shown in U.S. Patent Nos. 4,816,339;
4,478,8'~8 and 5,061,276. Other examples of multi-layered structures are shown in Japanese Patent Publication nos. 6-343,688 and 0-022,792.
'While each of the above enumerated patents provides tubular graft structu] es exhibiting enhanced radial tensile strength, as well as enhanced axial tear strlength, these structures all result in tubes exhibiting lower porosity. More 30 specifically, the multi-layered ePTFE tubular structures of the prior art exhibit a smaller microporous structure overall, especially as the inner surface, and W O97~25g38 PC~rUS97/01720 .
aCCGI ~t~ y~ a reduction i~ the ability of the graft to promote endothP~ ;on along the inner ~.rr..ce.
It is therefore desirabie to provide a ePTFE ~ qr graft which çshihjt~
increased porosity especially at the inner surface thereof while ret~ining a high degree of radial ~ lL especially at the tAh.~ ~al surface théreof.
It is further desirable to produce an ePTFE vascular gra~t which ~
inc~ eas~d porosib at the outer surface thereof vhile re~ ing a high degree of radial tensile and suture ~ ~t~liol- ~Ir~ ;lhs.
SUMI~A~Y OF T~ INV~,NTION:
It is an obJect of the present i~,v~liOI. to ~l uvide an i~yru~,d ePTFE
Ya~cnlar graft.
It is a further object of the ~Jr~sL..t i~. ti~n to provide 5~ eP'l~ vascular graft ~yhihiting an enhanced l~lic-ulJorous slrucL--i G while ret~inin~ superior,LL.
It is a still r~l Ih~l object of the l~r~ t invention to provide an ePTFE
tubular slructure having an inner ~o. l;cn ~ ih~ ; enhanced porosity and an ouler ~ol lio~ e~chibiting enhanced radial tensile sl~ and suture elo- gilt;on chal ~cl~. ;..Lics.
It is yet another object of the present i~v~,LIio-l to provide a multi-layered 2 o ePTFE: tubular vascular graft having an inner layer which llas a porosity ~-~IT~ t to promote cell endûth~li7~tion and an outer layer having a high degreeof radial tensile ;~h .,~~;IL.
W 097125938 PCTrUS97/01720 It is an additional object of the present i-lv~nlio~ to provide a multi-layered ePTFE tubular vascular graft having an outer layer whose porosity is s~ffei~nt to promote enhanced cell growth and tissue incorporation, hence more rapid healing,and an inner layer having a high degree of ~Irc.~;lL.
In the efficient ~ mf~nt of these and other ob~ects, the ~ t invention provides an i-np!~Tlt~hle polytetrafluorethylene (PTFE) vascular graft. The graft includes a first ePTFE tubular slr~ rc, and a second ePTFE tubu}ar structure circumf~. ~ ..hally di~l~csed exteriorly about the first tubular ~ . The porosity and physical ~ln,.~ characteristics of each of the aforem~ntioned tubular ~Irul lu~ ~.. can be varied independently of each other. This resulh in a structus e whose first ePTFE tubular structure exhibits a 1~~l o~ily s~ -t topromote cell endol}~e~ ;on there along, while the second sl, ucLul ~ exhibits ~L. ~.,glL in e~ccess of the slr~ lh of the first tubular :~lrucl~ . AlL . ~.,lively the first ePTFE tubular sl, ucl.~rc exhibits sl, ~lh in excess of the ~ .L IL of thesecond tubular structure, while the second tubular sll ... cl~re e~ hi~c a porosity s-~ffl- i~nt to promote more rapid tissue incorporation.
As more particularly des., ibcd by way of the EJrL.~ ~ ~,d embo~ t herein, the first and second PTFE tubular structures are formed of e~p~ de~l poiyt~lr~nuorethylene (ePTFE). Further, the second ePTFE tubular :~lruLlui l is 2 0 adl~e. ;.. ~l~ supported over the first ePTFE tubular structure to form a composite tubular graft. The sl~ IL of this adhesion can be varied as desired to control the characl~. ;,li~ e~hibited by the resultant co~ Gsile structure.
In its method aspect, the l)r~ ~nt h.v~nlion provides a method of forming a Yascular graft. The ~A~ the steps of E~ a first ePTFE tubular shuclul~ having a desired porosity and ~Ir.. ~ combination. A second ePTFE
r slr~ .re is provided, also having the desired ~o~ and slr.,..~
com~ination. ~he second ePTFE structure is disposed over the first ePTFE so as to ~efine a composite vascular graft.
W 09712593$ PCTrUS97/01720 The method of the present i--v- -,lion also provides for the pocit;~ ing of an intermediate structure l,~ n the first and second ePTFE; tubular structures.
l~r~ les of such sl~ u~Ll~ es include an ~rltlition~l ePTFE layer and fibers or thin f~:ms of PTFE or other suitable polymers. This intermediate structure also ca ntributes to the resultant porosity and strength of the vascular graft.
BlR~FF Dli .~C~lPTION OF T~F Dl~AWINGS:
Figure 1 is a schematic longitudinal cross-section of a multi-layer ePTFE
vascular graft of the present i~v~ u.
Figure 2 is a lon~h~Ain~l cross-section of an alternate emboAin~e~t of the IJr~s-~lt invention producing a multi-layer ePTFE vascular graft.
Figure 3 is a sC~nr~in~ elc.lru~ mic, u~ h(.~ g a cross s~ ~icnal view of a vascular graft produced using the present invention.
Figure 4 is a ~c. ;,~e.live showing of one of the tubular s~ r~s of the graft of Figure 1 over-wrapped with a layer of ePTFE tape.
lS Figure ~ is a cross-sectional showing of an alternate embo(li~L~t of the ePTFE vascular graft of the present invention. In this instance, the view is taken through the lines II-II of the view shown in Figure 2.
DhTA~T Fn DESCR~PTIO~ OF T~ p~FFRR~n F'l~IBOD~M~l~TS:
The ~. u~ f -i~ of the pr~f~. 1 ed emboAin~ntc of the present invention is a 2 0 mu;lti l.. y~l d tubular structure which is particularly suited for use as an encloE,~ v:,lhesis or vascular graft. The prosthesis is formed of e~ctruded polyl~:l.afluoret}~ylene (PTFE) as PTFE eshibits ~u~c,;or bioco~r~t~l~ility.
Fu~rther, PTE~: is particularly suita3~1e for vascular appli~ ~tion~ as it exhibits low W O 97J25~38 PCTrUS97/01720 .
tbrombogenicity. Tubes formed of extruded PTFE may be ~rq lerl to form ePTFE tubes where the ePTFE tubes have a fibrous state which is defined by elongated fibrils interco nectell by spaced apart nodes. Such tubes are said to have a microporous ~L~ ucl~, e, tbe porosity of which is deh . ,-lil,ed by the distance ~h. GCI~ the surfaces of the nodes, referred to as the internodal distance (IND).
Tubes having a large IND (greater than 40 microns) generally exhibit long term ~;,alc~-~ as the larger pores promote cell endothelization along the inner bloodcontacting surface. Tubes having lower IND (less than 40 microns) exhibit inferior he~ling chara~lt. ,~li.;" however they offer superior radial tensile and suture rete.,lion sl~ lLs desirable in a vascular graft. The pr.S~ l invention provides a composite tubular ~Iru-,lu~e which promotes long term patency of the graft hy providil~g for enhanced cell endofh~li7~tion along the inner surface while exhibiting enhanced ~lr~ lh due to the p~ esencc of the outer layer.
Referring to Figures 1 and 2 of the dr~ s~ composite graft 10 of the present h~v~l~lion is shown. Graft 10 is a elongate tubular structure formed of PT~E. Graft 10 includes a pair of coqYi~lly disposed ePTFI~ tubes 12 and 14, tube 12 heing the outer tube and tube 14 bcing the inner tube. A central lumen 15 extends through composite graft 10, defined further by the inner wall 14a of inner tnbe 14, which permits the ~as~ e of blood through graft 10 once the graft is 2 o pl o~,el ly implanted in the vascular system.
Each tube 12 and 14 may be formed in a separate e~ctrusion process. The 1" oc~s for the paste ~ ,r of PTFE tubes is well Icnown in the estrusion art.
Once e2ctruded, the tubes are e2~panded to form ePTFE ~ubes. As will be dcs_. ,I,ed hereinbelow, the tubes are ~p~n-lPA using dirr~ process parameters ~rates, 2 5 deformation levels, te.,.~c. ,.tures, etc) to develop the desired microporous structures. The spe~ ifi~lly designed structure of the ,~ composite tube has defined ~l op~. Lies of slr~,nglL and porosity which yield a graft 10 having long term patency and good healing char..cle. ;..lics as well as superior strength clharacteristics.
W O 97t25938 PCTrUS97/01720 The present invention is designed to produce grafts with s~lbst~n~ ly . c..t node/fibril ~1- u-LI~r~5 with respect to the internal and external portions of the graft which are adjacent to the internal and external graft surfaces. ~s an r pl~ the inner tube 14 is designed to have rll..lively high INO while the outerS tube 12 is de~ .ed to have a lower IND. Further, a distinct porosity change is q clcarly defined at the interface 13 between tubes 12 and 14. The inner tube 14 h.lving a higher IND to allow enhanced ce11 endothelization, while the outer tube 12 having a lower IND provides superior strength to tbe overall composite.
An electron micrograph of such a structure produced according to the present invention is showm in Figure 3. The disparate IND's between the inner tube 14 a~d outer tube 12 are clearly evident, along with the step change in IND at the interface 13 between the inner tube 14 and outer tube 12. In this example, the of the interface 13 has been established by the pr C.,~ conditions described below to fully adhere the inner tube 14 and outer tube together, hencepr~eventing relative motion and providi,.g enhanced ~lr~n~
Graft I0 of the present inv~.~1iu may be formed by e~psr~lin~ a thin wall imler tube 14 at a r~,lali~ely high degree of elongation, on the order of ap~roxim~t~ly between 400 and 2000% elongation preferably from about between 700% and 900%. Tube 14 is expanded over a cylindrical man~rel (not shown), 2 o such as a stainless steel mandrel at a temperature of beh. ee.. room temperature and ~4~~F, I,rtrel ably about ~00~F. Tube 14 is preferably but not ~ecessarily fullly ~ te. ~d after eY~rciom Sintering is Iy~. - lly accomplished at a tem~c. ~lLre of between 64~~F and 800~F preferably at about 660~F and for a tim;e of l~e-lw~_., about 5 minutes to 30 ~ 1~s, preferably about IS mir~-tes. The co~nbination of the ePTFE tube 14 over the mandrel is then employed as a second mandrel, over which outer tube 12 is eSp~ e~l The ID of the oDter tube 12 is s~le~te~ so that it may be easily but tightly ~li..l.osed over the OD of inner tube 14.
The composite structure 10 is then sintered at ~Jr~ bly similar parameters. The level of elongation of outer tube 12 is lower than that of inner tu~e 14, CA 0224395l l998-07-20 w o 97!25938 PCT~US97/01720 appro~ teiy bet~. t_~. 200% and ~00% elo!lgP*nn preferably about 400%. The e~ -. and sintering of outer tube 12 over the inner tube 14 serves to adLc. ;-~ bond the interface 13 between the two tubes, rPs~ltin~ in a single composite ~ elul c 10.
As shol~vn in Figùre 3, the reS~ltin~ co~lJG3iL~: structure has an inner surface ~l~fine~l by inner tube 14 which e~hibits an IND of 1)el~ 40 and 100 microns, spanned by moderate number of fibrils. Such microporous structure is suf~ ntly large so as to promote ~nh~rce~ cell endothelization once blood flow is established through graft 10. Such cell endothelization enhances the long term patency of the graft.
The outer sl- ucl.., ~, defined by outer tube 12, has a smaller microporous structure, with IND of 15-35 microns and a substantial fibril density. Such outer structure results in an increase in the ~ lL of the outer tube, and hence of thecomposite structure. Importantly, the outer surface defined by the outer tube 12~hi~jtc eD,hanced suture retenffon due to the smaller IND.
Fl.~ lhe. ~ore, the res~lffng co...~.c;.ile ~L. u~lur~ a sharp porosity change between the outer t~be 12 and inner tube 14. This sharp porosit~
transition is achieved by providing an inner tube 14 having generally a given uniform porosity therealong and then providing a separate outer tube 14 having a2 0 r~_ It~nt different porosity uniformly therealong. Thus a ~lictinct porosity change is e~ ite~l on either side of the interface 13 ~lefine~ between inner tube 14 and outel tube 12.
In addition, the forming ~. uc~,.,a described above results in a bonded interface between inner tube 14 and outer tube 12. The interface e~hibits sufficient interfacial ~ ll. resulting from the direct i,".tc~ g of the outer tube I2 over the inner tube 14 so as to assure complete bonding of the two tubes. Thes~ lh of the interface b_h. .,eh the two tubes may be independently varied -CA 0224395l l998-07-20 W O 97~2~938 PCT~US97/01720 th!rough sPlr~ of~lo¢~ condition~and r~ e~ o ofprec~r~or es-truded tubes 1Z and 14 as desired to yield a range of performance.
The following e~amples serve to provide further a~l.rec;a~ion of the iu~ ntion but are not meant in any way to restrict the scope of ~he invention.
~XAMPI ~ I
A thin estruded tube having wall thickness of 0.41 mm and an inner diameter of 6.2 mm was expanded over a stainless steel mandrel at 500~F to 900%
elongation. The ePTFE tube was then sintered at 660~F for 14 minutes, cooled, anll removed from the oven. A second thin estruded tube having wall thickness of0 0.4~ mm and an inner diameter of 6.9 mm was e~cpanded over the first tube/mandrel combination at 500~F and 400% elongation. The composite was then ~il.le.~d at 660~F for il4 minutes, cooled and removed from the o~en. The resullant co...l,c,ile tube had a wall thi~knesc of 0.65 mm and ID of ~.8 mm.
F~A7UPI F II
A thin e~truded tube having wall thi-~kneC~ of 0.41 mm and an inner dia1~eter of 6.2 mm was expanded over a st~inl~cs steel mandrel at 500~F to 700%elon~ation. The ePTFE tube was then sintered at 660~F for 14 minutes, cooled, and removed from the oven. A second thin e~ctruded tube having wall thi.~rn~c.c of 0.4~i mm an~ an inner diameter of 6.9 mm was esr~ over the first tube at 2 0 SOO~F and 400% elongation. The composite was ~ . .d at 660~F for 14 minutes, cool~ed, and removed from the oven. The resultant co~l.u .ile tube had a wall thickness of 0.67 mm and an inner diameter of 5.8 mm.
Table I 1~- ~ s~-lls physical ~l b~e-Ly data for a vascular graft of the type deplcted in Example I dese. il,ed above. The composite graft was removed from the mandrei and subjected to standard testing of radial tensile strength and suture WO 97/25938 PCT~US97/01720 .
hole elongation. The radial strength of the 90û%/400% composite graft is e~uivalent to a single layer 400% elong~tion graft and substantially ~ll u~,e~ than a single layer 900% elong~tior graft, despite an overall thinner wall ~li~er~ion.
itir~r ~lly~ the superior strength of the composite graft is demo~ atc1 by the higher elongation capable of being borne by the graft prior to failure. The lower suturc hole elongation, indicative of a smaller tear being caused by s~lul iJlg and tensioning at a fi~ed value of 100 grams is clearly dc. c~strated for the graft prepared by the method of the current invention.
TABI.F, I
400% gO0%/400% 900%
10PhysicalProperty Elong~iûn Elongation Elo~lion Measurement Single Layer Cc~osile Single Layer Graft Graft Graft Radial Tensile Slr~ 0.48 0.48 0.2 (kglmm2) Radial Slrain at Break 550 690 ~31 15 (%) Suture Hole Elongation 87 81 158 (%) Wall Thickness 0.72 0.6~ 0.73 Ref~ now to Figures 4 snd 5, a further embodiment of the present 2 o invention is shown. Tubular graft 20is a co~ csil~ structure similsr to graft 10 described above. Graft 20 includes an outer tube 22 and an inner tube 24 formed generally in the m~nl~sr described above. In order to further control the porosity and strength of the graft 20~ especially at the interface beh. e.,.. outer tube 22 and inner tube 24, an additional layer may be employed in combination with outer 2 5 tube 22 and inner tube 24.
CA 0224395l l998-07-20 W ~ 97/2s938 PCTAUS97/01720 As speci4ir~11y shown in Figures 4 and ~, an àdditional layer 26 may be employed b- h. ~ ~ inner tube 24 and outer tube 22. Layer 26 may inrlu-le a helical wrap of ePTFE tape 27 placed over inner tube 24. The ad~i~n~l layer 26, hawever, may also exist as a sheet, film, yarn, monofilament or multi fil~m~r~t wrap, or ~d~ or~l tube. The additional 1aycr 26 may consist of PTFE, FEP, or other suitable polymer composition to obtain the desired performance chllracteristics. Layer 26 may be used to impart enhanced properties of porosityand/or strength to the co~osile gra* 2Q. For eY~mrlç, an additional layer 26 of ePTFE tape 27 having a low IND and wrapped orthogonally to the length 0 direction of graft 20 would increase the radial sl~ of the resultant composite graft. Simi}arly, a layer of ePTFE having a high IND would iue. . ase the porosity of the composite structure thereby further promoffllg celi endothelization and/or tissue iu~r~ ~ lh.
As shown in Figure 4, layer~6 is ~ osed between inner tube 24 and outer tube 22, and functions as an iute~ ,nediate ~ayer therein bet veen. It is further contempl~te~l that the additional layer may be employed over outer tube 22, or an additional layer may be used both over outer tube Z2 and over inner tube 24.
Various changes to the foregoing described and shown structures would no~v be evident to those skilled in the art. Accordingly, the particularly disclosed 2 o scolpe of the invention is set forth in the ~ollowing claims.
Claims (24)
1. An implantable tubular prosthesis comprising:
an expanded polytetrafluoroethylene (ePTFE) composite tubular structure including a clearly defined tissue contacting expanded outer tube and concentrically adjacent separately expanded inner tube, an inner surface of which is a blood contacting surface;
said outer and inner tubes each having a given porosity defined by node and fibril spacing of said expanded structure, said given porosity of said innertube being different from said given porosity of said outer tube and wherein a distinct difference in porosity between said inner tube and said outer tube is defined on either side of an interface therebetween.
an expanded polytetrafluoroethylene (ePTFE) composite tubular structure including a clearly defined tissue contacting expanded outer tube and concentrically adjacent separately expanded inner tube, an inner surface of which is a blood contacting surface;
said outer and inner tubes each having a given porosity defined by node and fibril spacing of said expanded structure, said given porosity of said innertube being different from said given porosity of said outer tube and wherein a distinct difference in porosity between said inner tube and said outer tube is defined on either side of an interface therebetween.
2. An implantable tubular prosthesis of claim 1 wherein said outer tube exhibits a radial strength in excess of the radial strength of said inner portion.
3. An implantable tubular prosthesis of claim 1 wherein said given porosity of said inner tube is greater than said given porosity of said outer tube.
4. An implantable polytetrafluoroethylene (PTFE) tubular vascular prosthesis comprising:
a first PTFE tubular structure having been expanded to provide a given radial strength; and a second PTFE tubular structure circumferentially disposed externally about said first expanded PTFE tubular structure;
said first expanded PTFE tubular structure exhibiting a porosity sufficient to promote cell endothelization therealong and said second PTFE tubular structure exhibiting radial strength in excess of the radial strength of said first expanded PTFE tubular structure.
a first PTFE tubular structure having been expanded to provide a given radial strength; and a second PTFE tubular structure circumferentially disposed externally about said first expanded PTFE tubular structure;
said first expanded PTFE tubular structure exhibiting a porosity sufficient to promote cell endothelization therealong and said second PTFE tubular structure exhibiting radial strength in excess of the radial strength of said first expanded PTFE tubular structure.
5. A vascular prosthesis of claim 4 wherein said second PTFE tubular structure is adheringly supported over said first PTFE tubular structure.
6. A vascular prosthesis of claim 4 further including an additional structure formed over one of said first PTFE tubular structure and said second PTFE
tubular structure.
tubular structure.
7. A vascular prosthesis of claim 6 wherein said additional structure is interposed between said first PTFE tubular structure and said second PTFE
tubular structure.
tubular structure.
8. A vascular prosthesis of claim 7 wherein said additional structure exhibits a porosity which is less than said porosity of said first PTFE tubular structure.
9. A vascular prosthesis of claim 4 wherein said second PTFE structure is formed of expanded PTFE.
10. A vascular prosthesis of claim 4 wherein said first PTFE structure has a porosity greater than that of said second PTFE structure.
11. A vascular prosthesis of claim 10 wherein said additional structure exhibitsa strength which is greater than the radial strength of said first PTFE structure.
12. A vascular prosthesis of claim 11 wherein said additional structure exhibitsstrength less than said strength of said second PTFE structure.
13. A vascular prosthesis of claim 7 wherein said additional structure is formed of a polymer composition.
14. A vascular prosthesis of claim 13 wherein said polymer composition is PTFE.
15. A method of forming a tubular vascular prosthesis comprising the steps of:
(a) providing a first PTFE tubular structure having a given porosity sufficient to promote cell endothelization and a given strength;
(b) providing a second PTFE tubular structure having a radial strength greater than the radial strength of said first PTFE tubular structure; and (c) disposing said second PTFE tubular structure over said first PTFE
tubular structure to define a composite structure.
(a) providing a first PTFE tubular structure having a given porosity sufficient to promote cell endothelization and a given strength;
(b) providing a second PTFE tubular structure having a radial strength greater than the radial strength of said first PTFE tubular structure; and (c) disposing said second PTFE tubular structure over said first PTFE
tubular structure to define a composite structure.
16. A method of claim 15 further including the step of:
expanding said first PTFE tubular structure to form a first ePTFE
structure.
expanding said first PTFE tubular structure to form a first ePTFE
structure.
17. A method of claim 16 further including the step of:
expanding said second PTFE tubular structure to form a second ePTFE
structure.
expanding said second PTFE tubular structure to form a second ePTFE
structure.
18. A method of claim 17 wherein steps of expanding said first PTFE tubular structure includes:
expanding said first PTFE tubular structure at an elongation of between about 400% and 2000%.
expanding said first PTFE tubular structure at an elongation of between about 400% and 2000%.
19. A method of claim 15 wherein said step of expanding said second PTFE
tubular structure includes:
expanding said second PTFE tubular structure at an elongation of between 200% and 500%.
tubular structure includes:
expanding said second PTFE tubular structure at an elongation of between 200% and 500%.
20. A method of claim 19 further including the steps of:
providing an additional structure; and positioning said additional structure over either said first PTFE tubular structure or said second PTFE tubular structure, or both said first and second tubular structures.
providing an additional structure; and positioning said additional structure over either said first PTFE tubular structure or said second PTFE tubular structure, or both said first and second tubular structures.
21. A method of claim 20 wherein said positioning step includes:
disposing said additional PTFE tubular structure over said first PTFE
tubular structure.
disposing said additional PTFE tubular structure over said first PTFE
tubular structure.
22. A method of claim 21 wherein said additional structure is formed of PTFE.
23. A method of claim 15 wherein said providing step (a) further includes:
forming said first PTFE tubular structure over a mandrel.
forming said first PTFE tubular structure over a mandrel.
24. A method of claim 23 wherein said disposing step (c) includes:
forming said second PTFE tubular structure over said first PTFE structure and said mandrel.
forming said second PTFE tubular structure over said first PTFE structure and said mandrel.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/588,052 | 1996-01-22 | ||
US08/588,052 US5800512A (en) | 1996-01-22 | 1996-01-22 | PTFE vascular graft |
PCT/US1997/001720 WO1997025938A1 (en) | 1996-01-22 | 1997-01-22 | Improved ptfe vascular graft and method of manufacture |
Publications (2)
Publication Number | Publication Date |
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CA2243951A1 CA2243951A1 (en) | 1997-07-24 |
CA2243951C true CA2243951C (en) | 2002-09-10 |
Family
ID=24352275
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Application Number | Title | Priority Date | Filing Date |
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CA002243951A Expired - Fee Related CA2243951C (en) | 1996-01-22 | 1997-01-22 | Improved ptfe vascular graft and method of manufacture |
Country Status (8)
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US (4) | US5800512A (en) |
EP (1) | EP0879029B1 (en) |
JP (1) | JPH11504548A (en) |
AT (1) | ATE293935T1 (en) |
AU (1) | AU711304B2 (en) |
CA (1) | CA2243951C (en) |
DE (1) | DE69733122T2 (en) |
WO (1) | WO1997025938A1 (en) |
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US6579314B1 (en) * | 1995-03-10 | 2003-06-17 | C.R. Bard, Inc. | Covered stent with encapsulated ends |
US6264684B1 (en) | 1995-03-10 | 2001-07-24 | Impra, Inc., A Subsidiary Of C.R. Bard, Inc. | Helically supported graft |
US6451047B2 (en) * | 1995-03-10 | 2002-09-17 | Impra, Inc. | Encapsulated intraluminal stent-graft and methods of making same |
US6863686B2 (en) * | 1995-04-17 | 2005-03-08 | Donald Shannon | Radially expandable tape-reinforced vascular grafts |
AU707727B2 (en) * | 1995-08-24 | 1999-07-15 | Impra, Inc. | Covered endoluminal stent and method of assembly |
US6428571B1 (en) * | 1996-01-22 | 2002-08-06 | Scimed Life Systems, Inc. | Self-sealing PTFE vascular graft and manufacturing methods |
US5800512A (en) * | 1996-01-22 | 1998-09-01 | Meadox Medicals, Inc. | PTFE vascular graft |
US6416537B1 (en) | 1996-12-03 | 2002-07-09 | Atrium Medical Corporation | Multi-stage prosthesis |
US5824050A (en) * | 1996-12-03 | 1998-10-20 | Atrium Medical Corporation | Prosthesis with in-wall modulation |
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2007
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US5800512A (en) | 1998-09-01 |
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