(19)
`
`(12)
`
`Europäisches Patentamt
`
`European Patent Office
`
`Office européen des brevets
`
`*EP000881921B1*
`EP 0 881 921 B1
`
`(11)
`
`EUROPEAN PATENT SPECIFICATION
`
`(45) Date of publication and mention
`of the grant of the patent:
`23.03.2005 Bulletin 2005/12
`
`(21) Application number: 97930246.0
`
`(22) Date of filing: 16.01.1997
`
`(51) Int Cl.7: A61L 29/00, A61M 25/00,
`A61M 25/10, A61M 29/02
`
`(86) International application number:
`PCT/US1997/000843
`
`(87) International publication number:
`WO 1997/026027 (24.07.1997 Gazette 1997/32)
`
`(54) LUBRICOUS AND READILY BONDABLE CATHETER SHAFT
`
`GLEITFÄHIGER LEICHT HAFTBARER KATHETERSCHAFT
`
`CORPS AXIAL DE CATHETER, GLISSANT ET A FIXATION FACILE
`
`(84) Designated Contracting States:
`BE CH DE FR GB IT LI NL
`
`(30) Priority: 16.01.1996 US 587330
`
`(43) Date of publication of application:
`09.12.1998 Bulletin 1998/50
`
`(73) Proprietor: ADVANCED CARDIOVASCULAR
`SYSTEMS, INC.
`Santa Clara, California 95052-8167 (US)
`
`(72) Inventor: LEE, Jeong, Soo
`Diamond Bar, CA 91765 (US)
`
`(74) Representative: Molnia, David
`Dörries Frank-Molnia Pohlman,
`Triftstrasse 13
`80538 München (DE)
`
`(56) References cited:
`EP-A- 0 124 955
`EP-A- 0 747 070
`WO-A-93/15781
`WO-A-95/09667
`US-A- 5 304 134
`
`EP-A- 0 697 219
`WO-A-92/08512
`WO-A-94/00176
`WO-A-96/03163
`
`Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give
`notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in
`a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art.
`99(1) European Patent Convention).
`
`Printed by Jouve, 75001 PARIS (FR)
`
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`place guidewire which is slidably received within an in-
`ner lumen within the catheter. As such, it is desirable to
`minimize the friction between the guidewire and the sur-
`face of the inner lumen of the catheter by constructing
`the catheter from a lubricous material such as a high
`density polyethylene. However, lubricous polymeric ma-
`terials frequently lack other desirable properties, includ-
`ing, for example, the ability to readily bond to incompat-
`ible polymeric materials such as polyethylene tereph-
`thalate and nylon. Due to the high inflation pressures
`(up to 300 psi or more) associated with coronary balloon
`angioplasty, it is imperative to provide a strong bond be-
`tween one or more ends of the dilatation balloon and the
`catheter shaft. Polyolefin balloons can be effectively fu-
`sion bonded to a polyethylene shaft but balloons made
`of nylon and other polyamide materials, and balloons
`made of polyesters such as polyethylene terephthalate
`do not easily bond to polyolefinic materials. Nylon and
`polyethylene terephthalate balloons usually require sur-
`face treatment and the use of a suitable adhesive to
`bond to polyolefin materials such as polyethylene. The
`additional manufacturing steps of surface treatments
`and incorporating and curing an adhesives, greatly com-
`plicate the manufacturing process and can introduce
`significant quality control problems. A catheter shaft
`should also have adequate strength for pushability and
`resistance to buckling or kinking. As another example,
`it may be desirable to provide a catheter shaft with elas-
`tomeric properties to improve flexibility. However, most
`lubricous materials are not elastomeric.
`[0005] United States Patent No. 5,304,134 to Kraus
`et al., which is hereby incorporated in its entirety by ref-
`erence, attempts to provide a solution to the poor bond-
`ing of lubricous by providing the catheter shaft with an
`inner tubular member having a lubricous proximal por-
`tion and a non-lubricous, bondable distal portion. How-
`ever, this approach does not represent a complete so-
`lution, because the lubricous proximal portion must still
`be bonded to the non-lubricous distal portion. The Kraus
`et al. system also requires that some portion of the
`guidewire lumen be formed from a non- lubricous mate-
`rial which restricts guidewire movement within the lu-
`men.
`[0006] A different approach involves forming the dila-
`tation balloon as an integral portion of the catheter shaft
`itself, but this requires the balloon and the shaft to be
`formed from the same material, which is not always de-
`sirable because the property requirements for the bal-
`loon and the shaft can be quite different, particularly for
`dilatation catheters for PTCA .
`[0007] Accordingly, there remains a need to provide
`a catheter shaft having a lubricous inner surface defin-
`ing a guidewire lumen while allowing an easy, secure
`bond with a dilatation balloon or other catheter compo-
`nents formed of non-lubricous polymeric materials. The
`present invention satisfies these and other needs.
`
`Description
`
`BACKGROUND OF THE INVENTION
`
`[0001] This invention relates to catheters for perform-
`ing intravascular procedures such as percutaneous
`transluminal coronary angioplasty (PTCA) and more
`specifically to elongated shafts for such catheters.
`[0002] PTCA is now one of the most widely used treat-
`ment modalities for heart disease. The procedure basi-
`cally comprises advancing a dilatation catheter, having
`an inflatable balloon on its distal extremity, into the pa-
`tient's coronary anatomy over a guidewire until the bal-
`loon of the dilatation catheter is properly positioned
`across the lesion to be dilated. Once properly posi-
`tioned, the dilatation balloon is inflated with liquid to a
`predetermined size at relatively high pressures, e.g. up
`to 20 atmospheres or more, to expand the arterial pas-
`sageway. Generally, the inflated diameter of the balloon
`is approximately the same diameter as the native diam-
`eter of the body lumen being dilated so as to complete
`the dilatation but not overexpand the artery wall. After
`the balloon is finally deflated, blood flow resumes
`through the dilated artery and the dilatation catheter can
`be removed therefrom.
`[0003]
`In most PTCA procedures, a guiding catheter
`having a preshaped distal tip is first percutaneously in-
`troduced into the cardiovascular system of a patient by
`means of a conventional Seldinger technique and ad-
`vanced therein until the preshaped distal tip of the guid-
`ing catheter is disposed within the aorta adjacent to the
`ostium of the desired coronary artery. The guiding cath-
`eter is twisted or torqued from its proximal end, which
`extends out of the patient, to guide the distal tip of the
`guiding catheter into the desired coronary ostium. Once
`the guiding catheter is in proper position within the pa-
`tient's vasculature,
`the dilatation catheter with a
`guidewire slidably disposed within an inner lumen of the
`dilatation catheter is positioned within the inner lumen
`of the guiding catheter. The guidewire is first advanced
`out the distal tip of the guiding catheter seated in the
`coronary ostium into the patient's coronary artery and
`directed to the region of the patient's coronary anatomy
`where the procedure is to occur. A torque may be ap-
`plied to the proximal end of the guidewire, which extends
`out of the proximal end of the guiding catheter, to guide
`the curved or otherwise shaped distal end of
`the
`guidewire into a desired branch of the coronary artery.
`The advancement of the guidewire within the selected
`artery continues until it crosses the lesion to be dilated.
`The dilatation catheter is then advanced over the previ-
`ously advanced guidewire, until the balloon on the distal
`extremity of the dilatation catheter is properly positioned
`across the lesion which is to be dilated.
`[0004] Current intravascular catheter designs are lim-
`ited by the need to incorporate conflicting characteris-
`tics. For example, most dilatation catheters are de-
`signed to be introduced into a body lumen over an in-
`
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`SUMMARY OF THE INVENTION
`
`[0008] The present invention is directed to an intralu-
`minal catheter as claimed in Claim 1 and to a balloon
`dilatation catheter as claimed in Claim 15 which are suit-
`able for performing angioplasty procedures.
`[0009] Preferred embodiments of these catheters are
`subject of the dependent claims.
`[0010]
`In accordance with the present invention, the
`catheter shaft or catheter shaft segment is formed of a
`polymeric blend comprising at least 30% by weight, pref-
`erably at least 50% by weight of a lubricous polymeric
`component, not more than 60%, preferably not more
`than 40% of a bonding polymeric component and up to
`30%, preferably not more than 10% of a polymeric com-
`ponent for compatiblizing the lubricous and bonding
`components. Optionally, up to 25% by weight, usually
`not more than 10% by weight of the blend should be a
`catalytic material to facilitate cross linking the shaft ma-
`terial after forming the product. The lubricous compo-
`nent and the bonding component must be compatible or
`capable of being made compatible. As used herein the
`term "compatible" and words of similar import mean that
`two polymer materials readily form an intimate mixture
`when they are melt processed together. Usually, they
`are miscible when both are in a molten condition.
`[0011]
`In one presently preferred embodiment, the
`catheter or catheter segment is formed of a blend of 50%
`to 80% polyethylene (a lubricous component), up to
`50% of a copolyester such as Hytrel® (the bonding com-
`ponent) and up to 30% of a compatiblizing agent such
`as an acrylate. The polymer components are intimately
`mixed and extruded into a tubular product which is uti-
`lized as the inner tubular member of an intravascular
`catheter. The surface defining an inner lumen of the tu-
`bular member has a kinematic frictional coefficient of
`0.08 to 0.3 on a smooth glass. A balloon formed of PET
`readily fusion bonds to the outer surface of the tubular
`member.
`[0012] These and other advantages of the invention
`will become more apparent from the following detailed
`description of the invention when taken in conjunction
`with the accompanying exemplary drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0013]
`
`Fig. 1 is an elevational view, partially in section, of
`an over-the-wire dilatation catheter having an inner
`tubular member embodying features of the inven-
`tion.
`Fig. 2 is a transverse cross section of the embodi-
`ment shown in Fig. 1 taken along the lines 2-2.
`Fig. 3 is an elevational view, partially in section, of
`the distal section of a rapid exchange type dilatation
`catheter having an inner tubular member embody-
`ing features of the invention.
`
`5
`
`Fig. 4 is a transverse cross section of the embodi-
`ment shown in Fig. 4 taken along the lines 4-4.
`Fig. 5 is an elevational view, partially in section, of
`an alternative embodiment wherein the distal sec-
`tion of the catheter shaft is formed of an extrusion
`of a polymer blend.
`Fig. 6 is a transverse cross section of the embodi-
`ment shown in Fig. 6 taken along the lines 6-6.
`
`10
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0014] Reference is made to Figs. 1 and 2 which illus-
`trate a balloon dilatation catheter 10 embodying fea-
`tures of the invention. Generally, the catheter 10 com-
`prises an outer tubular member 11, an inner tubular
`member 12, a dilatation balloon 13 on a distal portion of
`the catheter and an adapter 14 on the proximal end of
`the catheter. The inner tubular member 12 has a
`guidewire receiving inner lumen 15 which slidably re-
`ceives guidewire 16. The outer surface of the inner tu-
`bular member 12 and the inner surface of the outer tu-
`bular member 11 define an annular inflation lumen 17
`which is in fluid communication with the interior of bal-
`loon 13 and side arm 18 of adapter 14.
`[0015] The distal skirt 20 of balloon 13 is bonded, pref-
`erably fusion bonded, to the exterior of the inner tubular
`member 12 and the proximal skirt 21 is fusion bonded
`to the exterior of the outer tubular member 11. The fu-
`sion bonds are preferably formed by applying laser en-
`ergy to the exterior of the skirts 20 and 21 which causes
`the interface between the skirts and the exterior of the
`outer and inner tubular members 11 and 12. In one pres-
`ently preferred embodiment, both the outer and inner
`tubular members 11 and 12 are formed of a polymer
`blend in accordance with the invention.
`[0016] Figs. 3-4 depict another embodiment of the in-
`vention directed to a rapid exchange type dilatation
`catheter 30. The catheter 30 includes a relatively stiff
`proximal shaft 31 formed of hypotubing and a relatively
`flexible distal shaft section 32. The distal shaft section
`32 includes an inner tubular member 33, an outer tubu-
`lar member 34 and a dilation balloon 35. The inner tu-
`bular member 33 has a guidewire receiving inner lumen
`36 which is in fluid communication with a distal
`guidewire port 37 in the distal end of the catheter 30 and
`a proximal guidewire port 38 disposed a short distance,
`e.g. 10 to 45 cm from the proximal end of the balloon
`35. The proximal shaft 31 comprises a metallic hypotube
`40 (e.g. stainless steel or NiTi alloys) and an outer pol-
`ymer jacket 41 formed of suitable polymer material such
`as high density polyethylene. The distal end 32 of the
`hypotube 40 is truncated and fits into the interior of the
`outer tubular member 34 and bonded thereto by suitable
`adhesive 42. Support tube 43, preferably formed of poly-
`imide, is disposed between the inner and outer tubular
`members 33 and 34 and defines inflation lumen.44. As
`shown in more detail in Fig. 4, the outer tubular member
`is partially bonded to the inner tubular member 33 and
`
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`partially to the support tube 43. A filler material 46, such
`as 75/25 high density/low density polyethylene, is dis-
`posed between the outer tubular member 34 and the
`support tube 43.
`[0017]
`In the embodiment of Figs. 3-4 the inner tubu-
`lar member 33 is formed of a polymer blend in accord-
`ance with the present invention. The distal skirt 47 of
`balloon 35 is fusion bonded to the exterior of the inner
`tubular member 33 as in the previously discussed em-
`bodiment shown in Figs. 1 and 2. The proximal skirt 48
`of the balloon 35 forms the outer tubular member 34 and
`is formed of essentially the same material as the bal-
`loon. In an alternative embodiment not shown the outer
`tubular member 34 may be a member separate and dis-
`tinct from the balloon and formed of a polymer blend in
`accordance with the present invention. In this latter case
`the proximal skirt of the balloon 35 is fusion bonded to
`the exterior of the outer tubular member.
`[0018] Figs. 5 and 6 illustrate yet another embodiment
`of the invention wherein the catheter 50 has a distal
`shaft 51 which is of a dual lumen construction and is
`formed by extruding a polymer blend in accordance with
`the present invention. A tubular extension 52 extends
`through the interior of the dilatation balloon 53 and has
`a distal guidewire port 54 in its distal end. The balloon
`53 has a distal skirt 55 fusion bonded to the distal end
`of the tubular extension 52 and a proximal skirt 56 fusion
`bonded to the distal shaft 51 as shown in the drawings.
`[0019] A presently preferred polymer blend includes
`about 65% high density polyethylene, about 30%
`Hytrel® (available from Dupont) and about 5% ethylene
`methyl acrylate such as Lotryl 24MA005 (available from
`Elf ATOCHEM). This blend readily fusion bonds to pol-
`yethylene terephthalate and has a coefficient of friction
`of about 0.1-0.2.
`[0020] Although individual features of embodiments
`of the invention may be shown in some of the drawings
`and not in others, those skilled in the art will recognize
`that individual features of one embodiment of the inven-
`tion can be combined with any or all the features of an-
`other embodiment.
`
`Claims
`
`1. An intraluminal catheter having an elongated shaft
`which has proximal and distal portions and which
`has at
`least a catheter shaft segment
`thereof
`formed of a polymeric blend comprising at least
`30% by weight of a lubricous polymeric component
`and not more than 60% by weight of a bonding pol-
`ymeric component, said polymeric blend being ca-
`pable of bonding to another catheter component.
`
`2. The intraluminal catheter of claim 1 wherein said
`another catheter component is formed of a non-lu-
`bricous polymeric material.
`
`3. The intraluminal catheter of Claim 2 wherein said
`another catheter component is a balloon.
`
`5
`
`4. The intraluminal catheter of Claim 1 wherein said
`bonding polymeric component is compatiblized with
`the lubricous polymeric component by means of a
`compatiblizing agent.
`
`5. The intraluminal catheter of Claim 4 wherein said
`compatiblizing agent is an acrylate.
`
`10
`
`6. The intraluminal catheter of Claim 5 wherein said
`compatiblizing agent is an alkyl acrylate having
`from 2 to 5 carbon atoms.
`
`7. The intraluminal catheter of Claim 1 wherein said
`lubricous polymeric component is polyethylene.
`
`15
`
`8. The intraluminal catheter of claim 1 wherein said
`polymeric bonding component is a copolyester.
`
`20
`
`9. The intraluminal catheter of Claim 4 wherein said
`polymeric blend comprises up to 30% by weight of
`said compatiblizing agent.
`
`10. The intraluminal catheter of claim 4 wherein said
`polymeric blend comprises not more than 10% by
`weight of said compatiblizing agent.
`
`11. The intraluminal catheter of Claim 1 wherein said
`polymeric blend comprises at least 50% by weight
`of said lubricous polymeric component.
`
`12. The intraluminal catheter of Claim 1 wherein said
`polymeric blend comprises not more than 40% by
`weight of said polymeric bonding component.
`
`13. The intraluminal catheter of Claim 4 wherein said
`polymeric blend comprises 65% by weight of high
`density polyethylene as said lubricous polymeric
`component, 30% by weight of Hytrel® copolyester
`as said polymeric bonding component, and 5% by
`weight of ethylene methyl acrylate as said compat-
`iblizing agent.
`
`14. The intraluminal catheter of Claim 1 wherein said
`polymeric blend further comprising a catalytic ma-
`terial to facilitate cross linking in the catheter shaft
`segment.
`
`15. A balloon dilatation catheter comprising:
`
`a) an elongated shaft which has proximal and
`distal portions and which has at least a catheter
`shaft segment thereof formed of a polymeric
`blend comprising at least 30% by weight of a
`lubricous polymeric component and not more
`than 60% by weight of a bonding polymeric
`
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`component; and
`
`(b) a dilatation balloon formed of a non-lubri-
`cous material having at least a distal skirt bond-
`ed to said catheter shaft segment.
`
`16. The catheter of Claim 15 wherein the distal skirt is
`fusion bonded to the catheter shaft segment.
`
`Patentansprüche
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Intraluminaler Katheter mit einem gestreckten
`Schaft, welcher nahe und entfernte Bereiche auf-
`weist und bei welchem wenigstens ein Katheter-
`schaftsegment desselben aus einer polymerischen
`Mischung gebildet ist, welche wenigstens 30 Gew.-
`% einer gleitfähigen polymerischen Komponente
`und nicht mehr als 60 Gew.-% einer bindenden po-
`lymerischen Komponente aufweist, wobei die Poly-
`mermischung in der Lage ist, an einem anderen Ka-
`theterbestandteil zu haften.
`
`Intraluminaler Katheter gemäß Anspruch 1, wobei
`das andere Katheterbestandteil aus einem nicht-
`gleitfähigen polymerischen Material gebildet ist.
`
`Intraluminaler Katheter gemäß Anspruch 2, wobei
`die andere Katheterkomponente ein Ballon ist.
`
`Intraluminaler Katheter gemäß Anspruch 1, wobei
`die bindende polymerische Komponente mittels ei-
`nem Kompatibilisierungsmittel mit der gleitfähigen
`polymerischen Komponente kompatibel gemacht
`ist.
`
`Intraluminaler Katheter gemäß Anspruch 4, wobei
`das Kompatibilisierungsmittel ein Acrylat ist.
`
`Intraluminaler Katheter gemäß Anspruch 5, wobei
`das Kompatibilisierungsmittel ein Alkylacrylat mit 2
`bis 5 Kohlenstoffatomen ist.
`
`Intraluminaler Katheter gemäß Anspruch 1, wobei
`die gleitfähige polymerische Komponente Polye-
`thylen ist.
`
`Intraluminaler Katheter gemäß Anspruch 1, wobei
`die polymerische Bindekomponente ein Copoly-
`ester ist.
`
`Intraluminaler Katheter gemäß Anspruch 4, wobei
`die Polymermischung bis zu 30 Gew.-% des Kom-
`patibilisierungsmittels aufweist.
`
`10. Intraluminaler Katheter gemäß Anspruch 4, wobei
`die Polymermischung nicht mehr als 10 Gew.-%
`des Kompatibilisierungsmittels aufweist.
`
`5
`
`10
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`25
`
`30
`
`35
`
`40
`
`45
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`50
`
`55
`
`5
`
`11. Intraluminaler Katheter gemäß Anspruch 1, wobei
`die Polymermischung wenigstens 50 Gew.-% der
`gleitfähigen Polymerkomponente aufweist.
`
`12. Intraluminaler Katheter gemäß Anspruch 1, wobei
`die Polymermischung nicht mehr als 40 Gew.-% der
`polymerischen Bindekomponente aufweist.
`
`13. Intraluminaler Katheter gemäß Anspruch 4, wobei
`die Polymermischung 65 Gew.-% Polyethylen mit
`hoher Dichte als gleitfähige Polymerkomponente,
`30 Gew.-% Hytrel® Copolyester als polymerische
`Bindekomponente und 5 Gew.-% Ethylenme-
`thylacrylat als Kompatibilisierungsmittel aufweist.
`
`14. Intraluminaler Katheter gemäß Anspruch 1, wobei
`die Polymermischung weiter ein kathalytisches Ma-
`terial aufweist, um das Vernetzen in dem Katheter-
`schaftsegment zu erleichtern.
`
`15. Ballon-Dehnkatheter, welcher aufweist:
`
`a) einen gestreckten Schaft, welcher nahe und
`entfernte Bereiche aufweist, und bei welchem
`wenigstens ein Katheterschaftsegment dessel-
`ben aus einer Polymermischung gebildet ist,
`welche wenigstens 30 Gew.-% einer gleitfähi-
`gen polymerischen Komponente und nicht
`mehr als 60 Gew.-% einer bindenden polyme-
`rischen Komponente aufweist; und
`b) einen Ausdehnungsballon gebildet aus ei-
`nem nicht-gleitfähigen Material, welcher wenig-
`stens einen entfernten Rand aufweist, der mit
`dem Katheterschaftsegment verbunden ist.
`
`16. Katheter gemäß Anspruch 15, wobei der entfernte
`Rand mit dem Katherterschaftsegment schmelz-
`verbunden ist.
`
`Revendications
`
`1. Cathéter intravasculaire comprenant un corps al-
`longé qui présente des portions proximale et distale
`et qui porte au moins un segment de tige de cathé-
`ter sur lui réalisé dans un mélange polymère com-
`prenant au moins 30 % en poids d'un composant
`polymère lubrifiant et de pas plus de 60 % en poids
`d'un composant polymère de liaison, ledit mélange
`polymère étant apte à se lier sur un autre compo-
`sant de cathéter.
`
`2. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit un autre composant de cathéter
`est réalisé dans un matériau polymère non lubri-
`fiant.
`
`3. Cathéter intravasculaire selon la revendication 2
`
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`dans lequel ledit un autre composant de cathéter
`est un ballonnet.
`
`15. Cathéter de dilatation à ballonnet comprenant :
`
`a) un corps allongé qui présente des portions
`proximale et distale et qui porte au moins un
`segment de tige de cathéter sur lui réalisé dans
`un mélange polymère comprenant au moins 30
`% en poids d'un composant polymère lubrifiant
`et pas plus de 60 % en poids d'un composant
`polymère de liaison ; et
`(b) un ballonnet de dilatation réalisé dans un
`matériau non lubrifiant ayant au moins une jupe
`distale collée sur ledit segment de tige de ca-
`théter.
`
`16. Cathéter selon la revendication 15 dans lequel la
`jupe distale est collée par fusion sur le segment de
`tige de cathéter.
`
`4. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit composant polymère de liaison est
`rendu compatible avec le composant polymère lu-
`brifiant à l'aide d'un agent de compatibilité.
`
`5. Cathéter intravasculaire selon la revendication 4
`dans lequel
`ledit agent de compatibilité est un
`acrylate.
`
`6. Cathéter intravasculaire selon la revendication 5
`dans lequel
`ledit agent de compatibilité est un
`acrylate d'alkyle comprenant de 2 à 5 atomes de
`carbone.
`
`7. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit composant polymère lubrifiant est
`du polyéthylène.
`
`8. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit composant polymère de liaison est
`un copolyester.
`
`9. Cathéter intravasculaire selon la revendication 4
`dans lequel ledit mélange polymère comprend jus-
`qu'à 30 % en poids dudit agent de compatibilité
`
`10. Cathéter intravasculaire selon la revendication 4
`dans lequel ledit mélange polymère ne comprend
`pas plus de 10 % en poids dudit agent de compati-
`bilité.
`
`11. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit mélange polymère comprend au
`moins 50 % en poids dudit composant polymère lu-
`brifiant.
`
`12. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit mélange polymère ne comprend
`pas plus de 40 % en poids dudit composant poly-
`mère de liaison.
`
`13. Cathéter intravasculaire selon la revendication 4
`dans lequel ledit mélange polymère comprend 65
`% en poids d'un polyéthylène de haute densité en
`tant que ledit composant polymère lubrifiant, 30 %
`en poids de copolyester Hytrel® en tant que ledit
`composant polymère de liaison, et 5 % en poids de
`méthyl acrylate d'éthylène en tant que ledit agent
`de compatibilité.
`
`14. Cathéter intravasculaire selon la revendication 1
`dans lequel ledit mélange polymère comprend en
`outre une matière catalytique pour faciliter la réticu-
`lation dans le segment de tige de cathéter.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`6
`
`Page 6
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`Medtronic Exhibit 1066
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`

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`
`Page 7
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`Medtronic Exhibit 1066
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`7
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`Page 7
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`Medtronic Exhibit 1066
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`

`

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`Page 8
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`Medtronic Exhibit 1066
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`Page 8
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`Medtronic Exhibit 1066
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`Page 9
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`Medtronic Exhibit 1066
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