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WO2000012145A1 - Sonde a ballonnet contenant de la polycetone aliphatique - Google Patents

Sonde a ballonnet contenant de la polycetone aliphatique Download PDF

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Publication number
WO2000012145A1
WO2000012145A1 PCT/US1999/018925 US9918925W WO0012145A1 WO 2000012145 A1 WO2000012145 A1 WO 2000012145A1 US 9918925 W US9918925 W US 9918925W WO 0012145 A1 WO0012145 A1 WO 0012145A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
balloon
aliphatic polyketone
intraluminal catheter
intraluminal
Prior art date
Application number
PCT/US1999/018925
Other languages
English (en)
Inventor
Stephen Schaible
Original Assignee
Advanced Cardiovascular Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Cardiovascular Systems, Inc. filed Critical Advanced Cardiovascular Systems, Inc.
Priority to AU56804/99A priority Critical patent/AU5680499A/en
Publication of WO2000012145A1 publication Critical patent/WO2000012145A1/fr

Links

Classifications

    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • This invention generally relates to intraluminal catheters, such as balloon dilatation catheters used in percutaneous transluminal coronary angioplasty
  • PTCA is a widely used procedure for the treatment of coronary heart disease.
  • a balloon dilatation catheter is advanced into the patient's coronary artery and the balloon on the catheter is inflated within the stenotic region of the patient's artery to open up the arterial passageway and thereby increase the blood flow there through.
  • a guiding catheter having a preshaped distal tip is first percutaneously introduced into the cardiovascular system of a patient by the Seldinger technique through the brachial or femoral arteries.
  • the catheter is advanced until the preshaped distal tip of the guiding catheter is disposed within the aorta adjacent the ostium of the desired coronary artery, and the distal tip of the guiding catheter is then maneuvered into the ostium.
  • a balloon dilatation catheter may then be advanced through the guiding catheter into the patient's coronary artery until the balloon on the catheter is disposed within the stenotic region of the patient's artery.
  • the balloon is inflated to open up the arterial passageway and increase the blood flow through the artery.
  • the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilatation but not over expand the artery wall.
  • blood flow resumes through the dilated artery and the dilatation catheter can be removed therefrom.
  • Stents may also be used to repair vessels having an intimal flap or dissection or to generally strengthen a weakened section of a vessel.
  • Stents are usually delivered to a desired location within a coronary artery in a contracted condition on a balloon of a catheter which is similar in many respects to a balloon angioplasty catheter, and expanded to a larger diameter by expansion of the balloon. The balloon is deflated to remove the catheter and the stent left in place within the artery at the site of the dilated lesion. See for example, U.S. Pat. No.
  • the balloons for prior dilatation catheters utilized in angioplasty procedures generally have been formed of relatively inelastic polymeric materials such as polyvinyl chloride, polyethylene, polyethylene terephthalate (PET), polyolefinic ionomers, and nylon.
  • An advantage of such inelastic materials when used in catheter balloons is that the tensile strength, and therefore the mean rupture pressure, of the balloon is high.
  • Catheter balloons must have high tensile strength in order to exert sufficient pressure on the stenosed vessel and effectively open the patient's passageway. Consequently the high strength balloon can be inflated to high pressures without a risk that the balloon will burst during pressurization.
  • the wall thickness of high strength balloons can be made thin, in order to decrease the catheter profile, without a risk of bursting.
  • the inelastic material provides balloons having minimal and controlled expansion, which therefore avoids trauma to the patient's vessel caused by over expansion of the balloon.
  • a catheter balloon Many inelastic materials used to form a catheter balloon, including PET and nylon, are relatively hard. The hardness of these materials impairs the ability of the catheter to track the tortuous vasculature of the patient and cross the stenosis. Thus, a soft balloon is preferable, to improve the trackability of the catheter and the ability of the catheter to effectively position the balloon at the stenosis.
  • the present invention satisfies these and other needs.
  • the invention is directed to an intraluminal catheter having a component formed at least in part of an aliphatic polyketone material.
  • the intraluminal catheter is a balloon catheter having a balloon formed of a polymeric material comprising the aliphatic polyketone material.
  • the balloon of the invention exhibits high rupture and tensile strength, high elongation, and low flexural modulus.
  • Aliphatic polyketones generally comprise polymers of carbon monoxide and olefins.
  • the aliphatic polyketone is a linear alternating polymer of carbon monoxide and at least one ethylenically unsaturated hydrocarbon, such as a semi-crystalline thermoplastic polymer sold under the trade name CARILON®, available from Shell Oil Company.
  • CARILON® is described in U.S. Patents 5,049,650 and 4,940,777, which are incorporated herein by reference.
  • Aliphatic polyketones provide high rupture and fatigue strength balloons which have improved trackability due to the softness of the material. The softness of a balloon is expressed in terms of the balloon modulus, where a relatively soft balloon has a relatively low flexural modulus.
  • the presently preferred balloon is formed from 100% aliphatic polyketone.
  • the balloon can be formed of a blend of aliphatic polyketone with one or more different polymeric materials. Suitable polymeric materials for blending with the aliphatic polyketone include those thermoplastic polymers listed above used to make balloons for prior dilatation catheters, such as olefinic polymers and polyamides, or aromatic polyketones such as polyetheretherketone.
  • the balloon is a single polymeric layer.
  • the balloon may also be multilayered, where the balloon is formed by coextruding two or more layers with one or more layers formed at least in part of aliphatic polyketone.
  • the balloon catheter of the invention generally comprises a catheter having an elongated shaft with an inflatable balloon.
  • Various designs for balloon catheters well known in the art may be used in the catheter of the invention having a balloon formed at least in part aliphatic polyketone.
  • the catheter may be a conventional over-the-wire dilatation catheter for angioplasty having a guidewire receiving lumen extending the length of the catheter shaft from a guidewire port in the proximal end of the shaft, or a rapid exchange dilatation catheter having a short guidewire lumen extending to the distal end of the shaft from a guidewire port located distal to the proximal end of the shaft.
  • the catheter may be used to deliver a stent mounted on the catheter balloon.
  • the aliphatic polyketone material will provide a balloon with thin walls having high rupture and tensile strength, and a relatively low flexural modulus.
  • the balloon of the invention formed at least in part of aliphatic polyketone material, combines improved softness and tensile strength, to provide low profile balloon catheters having excellent ability to tract the patient's vasculature, cross the stenosis, and compress the stenosis to open the patient's vessel.
  • Fig. 1 is an elevational view, partially in section, of the catheter of the invention showing the balloon in an unexpanded state within a patient's body lumen.
  • Fig. 2 is a transverse cross sectional view of the catheter of Fig. 1 taken along lines 2-2.
  • Fig. 3 is a transverse cross sectional view of the catheter of Fig. 1 taken along lines 3-3.
  • Fig. 4 is an elevational view, partially in section, of the catheter of Fig. 1 , showing the balloon in an expanded state within the body lumen.
  • Fig. 5 is a transverse cross sectional view of the catheter of Fig. 4 taken along lines 5-5.
  • Fig. 6 is an elevational view of the catheter of Fig. 4, showing the balloon deflated with the stent expanded within the body lumen.
  • the catheter 10 of the invention generally includes a an elongated catheter shaft 11 having a proximal section 12 and distal section 13, an inflatable balloon 14, formed at least in part of aliphatic polyketone, on the distal section 13 of the catheter shaft 11 , and an adapter 17 mounted on the proximal section 12 of shaft 11 to direct inflation fluid to the interior of the inflatable balloon.
  • Figs. 2 and 3 illustrate transverse cross sections of the catheter shown in Fig. 1 , taken along lines 2-2 and 3-3 respectively.
  • the intravascular catheter 10 of the invention is an over-the-wire catheter, and is illustrated within a patient's body lumen 18 with the balloon 14 in an unexpanded state.
  • the catheter shaft 11 has an outer tubular member 19 and an inner tubular member 20 disposed within the outer tubular member and defining, with the outer tubular member, inflation lumen 21.
  • Inflation lumen 21 is in fluid communication with the interior chamber 15 of the inflatable balloon 14.
  • the inner tubular member 20 has an inner lumen 22 extending therein, which is configured to slidably receive a guidewire 23 suitable for advancement through a patient's coronary arteries.
  • the distal extremity of the inflatable balloon 14 is sealingly secured to the distal extremity of the inner tubular member 20 and the proximal extremity of the balloon is sealingly secured to the distal extremity of the outer tubular member 19.
  • the aliphatic polyketone material is a linear alternating polymer have a repeating unit of the general formula -CO- (A)-, wherein A is a moiety of ethylenically unsaturated hydrocarbon which may be polymerized through the ethylenic linkage.
  • a variety of ethylenically unsaturated hydrocarbons preferably of up to 20 carbon atoms inclusive, and most preferably up to 10 carbon atoms inclusive, may be used. Illustrative of such hydrocarbons are ethylene, propylene, 1-butene, isobutylene, hexene, styrene, 1-octene and 1-dodecene.
  • the preferred linear alternating polymers are copolymers of carbon monoxide and ethylene, or terpolymers of carbon monoxide, ethylene and a second ethylenically unsaturated hydrocarbon of at least 3 carbon atoms, particularly an -olefin such as propylene.
  • the preferred linear alternating polymer material is represented by the repeating formula
  • G is a moiety of the second ethylenically unsaturated hydrocarbon of at least 3 carbon atoms, particularly propylene, polymerized through the ethylenic unsaturation thereof.
  • G has up to 20 carbon atoms inclusive, and is most preferably selected from the group consisting of propylene, 1-butene, isobutylene, hexene, styrene, 1-octene and 1-dodecene.
  • the -CO(-CH 2 CH 2 )- units and -CO(-G)- units when present are generally found randomly throughout the polymer chain.
  • Copolymers are represented by the above formula I wherein y is zero, and terpolymers are represented by the above formula I wherein y is greater than zero.
  • Suitable linear alternating aliphatic polyketones include CARILON®, and preferably CARILON® grades D26FX100, D26CX100, and D26HM100.
  • the preferred aliphatic polyketone polymers have a melting point from about 175°C. to about 300°C, and typically about 220°C.
  • the aliphatic polyketone polymers have a hardness of about 60 to about 150 hardness Rockwell, and preferably about 40 to about 60 hardness Rockwell (D785 test method), and a flexural modulus of about 150 kpsi (1 GPa) to about 300 kpsi (2 GPa), and typically about 230 kpsi (1.6 GPa).
  • the general processes for polyketone production are illustrated by a number of published European patent applications, including Nos. 121 ,965, 181 ,014, 213,671 and 257,663, incorporated herein by reference.
  • the presently preferred aliphatic polyketone material has an elongation at break at about room temperature of at least about 150%, preferably about 300% or higher and up to a maximum of about 400%, and a tensile strength at break of at least about 6,000 psi (42 MPa), and preferably about 8,000 psi (55 Mpa) to about 9,200 psi (63 MPa) or higher and up to a maximum of about 10,000 psi.
  • the flexural modulus of the material is about 180,000 psi (1240 Mpa) to about 300,000 psi (2070 Mpa), and preferably about 230,000 psi (1585 MPa).
  • the balloon formed from the aliphatic polyketone material has sufficient strength to withstand the inflation pressures needed to inflate the balloon and compress a stenosis in a patient's vessel.
  • the rupture pressure of the balloon is at least about 10 ATM, and is typically about 16-23 ATM.
  • the flexural strength of the balloon is at least about 10,000 psi (69 MPa), and typically from about 15,000 psi (10 MPa) to about 25,000 psi (170 MPa).
  • the inflatable balloon 14 shown in Fig. 1 is formed of a single layer of polymeric material.
  • the balloon may be 100% aliphatic polyketone or a aliphatic polyketone/polymer blend.
  • the presently preferred weight percent of CARILON® is from about 50% to about 95%, and most preferably about 70% to about 90%, of the total weight of the blend.
  • the inflatable balloon 14 may also comprise multiple layers formed from coextruded tubing, in which one or more layers is at least in part formed from aliphatic polyketone.
  • the balloon of the invention can be produced by conventional techniques for producing catheter inflatable members, such as blow molding, and may be preformed by stretching a straight tube, at elevated temperatures, before the balloon is blown.
  • the balloons may be formed by expansion of tubing, as for example at a hoop ratio of between about 3 and about 8.
  • the presently preferred aliphatic polyketone balloon material is not crosslinked, although the balloon material may be crosslinked.
  • the bonding of the balloon to the catheter may be by conventional techniques, such as adhesives and fusion with compatibilizers, as for example are described in U.S. Pat. No. 5,074,845 (Miraki et al.), incorporated by reference.
  • Fig. 2 showing a transverse cross section of the catheter shaft 11 , illustrates the guidewire receiving lumen 22 and inflation lumen 21.
  • the balloon 14 can be inflated by radiopaque fluid from an inflation port 24 through inflation lumen 21 contained in the catheter shaft 11.
  • the details and mechanics of balloon inflation vary according to the specific design of the catheter, and are well known in the art.
  • the length of the balloon 14 may be about 0.5 cm to about 6 cm, preferably about 1.0 cm to about 4.0 cm.
  • the outer diameter of the balloon at nominal pressure e.g. 6-8 ATM
  • the single wall thickness is about 0.0004 in (0.0102 mm) to about 0.01 in (0.25 mm), and typically about 0.0015 in (0.0381 mm) to about 0.005 inches (0.13 mm), and more specifically about 0.0006 in (0.0152 mm).
  • the inner layer single wall thickness is about .0003 in (0.0076 mm) to about .0006 in (0.0152 mm)
  • the outer layer is about .0002 in (0.0051 mm) to about .0005 in (0.0127 mm).
  • a stent 16 is disposed about the balloon 14 for delivery within patient's vessel.
  • the stent 16 may be any of a variety of stent materials and forms designed to be implanted by an expanding member, see for example U.S. Patent 5,514,154 (Lau et al.) and 5,443,500 (Sigwart), incorporated by reference.
  • the stent material may be stainless steel, a NiTi alloy or various other materials.
  • the stent is shown in an unexpanded state in Fig. 1. The stent has a smaller diameter for insertion and advancement into the patient's lumen, and is expandable to a larger diameter for implanting in the patient's lumen.
  • Fig. 4 illustrates the balloon 14 and stent 16 thereon expanded within the body lumen 18.
  • Fig. 5 illustrates a transverse cross section of the catheter shown in Fig. 4, taken along lines 5-5.
  • the balloon is deflated and withdrawn from the body lumen, leaving the expanded stent implanted therein.
  • a glass mold at a temperature inside the mold of about 200°F-300°F (90°C-150°C ), preferably about 250°F (120°C), and a blow pressure of 325 psi (2240 kPa), form a balloon from the tubing having an OD of 3 mm, a length of 20 mm, and a working length wall thickness of 0.0006 in (0.0152 mm) to 0.0007 in (0.0178 mm).
  • the mean rupture pressure of the balloons is expected to be about 300 psi (2070 kPa), and the tensile strength is expected to be about 15,000 psi (102 MPa).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un cathéter intraluminal dont un élément est formé, du moins en partie, d'un matériau en polycétone aliphatique. Actuellement, selon un mode de réalisation préféré, le cathéter intraluminal est une sonde à ballonnet, lequel ballonnet est formé d'un matériau polymérique comportant de la polycétone aliphatique. Selon l'invention, le ballonnet présente des propriétés élevées de résistance à la traction et d'allongement et un faible module d'élasticité en flexion. Actuellement, selon un mode de réalisation préféré, le polycétone aliphatique est un polymère alterné linéaire de monoxyde de carbone et au moins un hydrocarbure éthyléniquement insaturé, par exemple un polymère thermoplastique commercialisé sous la marque de fabrique CARILON®. Le ballonnet peut être à 100 % en polycétone aliphatique ou mélangé à un autre polymère.
PCT/US1999/018925 1998-08-27 1999-08-17 Sonde a ballonnet contenant de la polycetone aliphatique WO2000012145A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU56804/99A AU5680499A (en) 1998-08-27 1999-08-17 Aliphatic polyketone containing balloon catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14187698A 1998-08-27 1998-08-27
US09/141,876 1998-08-27

Publications (1)

Publication Number Publication Date
WO2000012145A1 true WO2000012145A1 (fr) 2000-03-09

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PCT/US1999/018925 WO2000012145A1 (fr) 1998-08-27 1999-08-17 Sonde a ballonnet contenant de la polycetone aliphatique

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WO (1) WO2000012145A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1115018A1 (fr) * 2000-01-04 2001-07-11 Lucent Technologies Inc. Tube d' amortissement pour fibres optiques en aliphatique polykétones
CN111629835A (zh) * 2018-01-24 2020-09-04 阿普塔尔法国简易股份公司 流体产品分配装置

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4495312A (en) * 1982-03-16 1985-01-22 Sekisui Kagaku Kogyo Kabushiki Kaisha Resin composition suitable for use in medical devices
US4940777A (en) 1988-05-04 1990-07-10 Shell Oil Company Carbon monoxide/1,2-alkadiene copolymer
US5049650A (en) 1988-12-29 1991-09-17 Shell Oil Company Polymerization of CO/non-conjugated diene/diol
US5458615A (en) 1993-07-06 1995-10-17 Advanced Cardiovascular Systems, Inc. Stent delivery system
WO1996003162A1 (fr) * 1994-07-25 1996-02-08 Advanced Cardiovascular Systems, Inc. Sonde intraluminale dotee d'un axe proximal a haute resistance
EP0697219A2 (fr) * 1994-07-25 1996-02-21 Advanced Cardiovascular Systems, Inc. Mélange de polymères pour utilisation dans la fabrication d'articles médicaux y compris de cathéthers et de ballons pour cathéters de dilatation
US5507768A (en) 1991-01-28 1996-04-16 Advanced Cardiovascular Systems, Inc. Stent delivery system
EP0747070A2 (fr) * 1995-06-06 1996-12-11 Advanced Cardiovascular Systems, Inc. Ballonnet pour cathéter à usage médical
WO1999029353A2 (fr) * 1997-12-12 1999-06-17 Intella Interventional Systems, Inc. Instruments medicaux a proprietes ameliorees

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4495312A (en) * 1982-03-16 1985-01-22 Sekisui Kagaku Kogyo Kabushiki Kaisha Resin composition suitable for use in medical devices
US4940777A (en) 1988-05-04 1990-07-10 Shell Oil Company Carbon monoxide/1,2-alkadiene copolymer
US5049650A (en) 1988-12-29 1991-09-17 Shell Oil Company Polymerization of CO/non-conjugated diene/diol
US5507768A (en) 1991-01-28 1996-04-16 Advanced Cardiovascular Systems, Inc. Stent delivery system
US5458615A (en) 1993-07-06 1995-10-17 Advanced Cardiovascular Systems, Inc. Stent delivery system
WO1996003162A1 (fr) * 1994-07-25 1996-02-08 Advanced Cardiovascular Systems, Inc. Sonde intraluminale dotee d'un axe proximal a haute resistance
EP0697219A2 (fr) * 1994-07-25 1996-02-21 Advanced Cardiovascular Systems, Inc. Mélange de polymères pour utilisation dans la fabrication d'articles médicaux y compris de cathéthers et de ballons pour cathéters de dilatation
EP0747070A2 (fr) * 1995-06-06 1996-12-11 Advanced Cardiovascular Systems, Inc. Ballonnet pour cathéter à usage médical
WO1999029353A2 (fr) * 1997-12-12 1999-06-17 Intella Interventional Systems, Inc. Instruments medicaux a proprietes ameliorees

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1115018A1 (fr) * 2000-01-04 2001-07-11 Lucent Technologies Inc. Tube d' amortissement pour fibres optiques en aliphatique polykétones
CN111629835A (zh) * 2018-01-24 2020-09-04 阿普塔尔法国简易股份公司 流体产品分配装置

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