US20030114831A1 - Catheter having improved curve retention and method of manufacture - Google Patents

Catheter having improved curve retention and method of manufacture Download PDF

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Publication number
US20030114831A1
US20030114831A1 US10/020,521 US2052101A US2003114831A1 US 20030114831 A1 US20030114831 A1 US 20030114831A1 US 2052101 A US2052101 A US 2052101A US 2003114831 A1 US2003114831 A1 US 2003114831A1
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United States
Prior art keywords
catheter shaft
catheter
nucleating agent
tubular member
polymeric material
Prior art date
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Abandoned
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US10/020,521
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English (en)
Inventor
(Bruce) Yiqun Wang
John Chen
Lixiao Wang
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Boston Scientific Scimed Inc
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Scimed Life 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 Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Priority to US10/020,521 priority Critical patent/US20030114831A1/en
Assigned to SCIMED LIFE SYSTEM, INC. reassignment SCIMED LIFE SYSTEM, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CHEN, JOHN, WANG, (BRUCE) YIQUN, WANG, LIXIAO
Priority to JP2003552351A priority patent/JP2005537816A/ja
Priority to PCT/US2002/037818 priority patent/WO2003051421A1/fr
Priority to AU2002366338A priority patent/AU2002366338A1/en
Priority to CA2470468A priority patent/CA2470468C/fr
Priority to EP20020805076 priority patent/EP1453555A1/fr
Publication of US20030114831A1 publication Critical patent/US20030114831A1/en
Priority to US10/983,470 priority patent/US7128956B2/en
Abandoned legal-status Critical Current

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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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61L29/049—Mixtures of macromolecular compounds
    • 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
    • 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
    • Y10S138/00—Pipes and tubular conduits
    • Y10S138/08—Bent shaped retained
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393—Multilayer [continuous layer]

Definitions

  • the present invention relates generally to the field of catheter devices having a pre-formed flexible curve along the length of the catheter body. More specifically, the present invention relates to the use of certain polymeric materials, and the treatment of those polymeric materials, to manufacture pre-formed curves that are more flexible and have a greater curve retention.
  • This invention resides in the construction and use of catheters for interventional procedures in such fields as cardiology, neurology, urology and gastroenterology. Design features are incorporated in these catheters to facilitate their use in: (1) the advancement of the catheter through a patient's bodily passages to reach specific sites in vessels or chambers of interest; (2) correct placement of the catheter's distal tip at a targeted site within the patient, and finally (3) holding the catheter at a targeted site while procedures with other devices are completed including while the site moves in response to normal bodily functions such as breathing or a heart beat.
  • Guide catheters are one type of catheter utilized in these procedures.
  • Guide catheters are relatively large lumen catheters used to guide smaller diameter catheters such as therapeutic, diagnostic or imaging catheters into bodily passages that are curved or branched. More specifically, guide catheters provide a conduit for at least a portion of the path followed by these additional catheters to desired target sites within a patient's vasculature or other body lumen or organ. In order for the catheter to be effective, however, the catheter must be able to traverse the tortuous pathways of a patient's vasculature or other anatomy in a manner as atraumatic as possible.
  • guide catheters In order to function efficiently, guide catheters generally have a relatively stiff main body portion and a relatively soft distal portion.
  • the stiff main body portion gives the guide catheter sufficient pushability and torqueability to allow the guide catheter to be inserted percutaneously into an artery, moved and rotated in the vasculature to position the distal end of the catheter at the desired site.
  • the distal portion should have sufficient flexibility so that it can track over a guide wire and be maneuvered through a tortuous path to the treatment site.
  • a soft distal tip at the very end of the catheter should be used to minimize the risk of causing trauma to a blood vessel while the guide catheter is being moved through the vasculature to the proper position.
  • a catheter must be stiff enough to resist the formation of kinks, while at the same time, the catheter must possess flexibility to be responsive to maneuvering forces when guiding the catheter through the vascular system.
  • catheters must be designed to reach a targeted site and maintain the position at that site throughout the procedure.
  • Guide catheters typically have pre-formed bends formed along their distal portion to facilitate both the placement of the distal end of the guide catheter and to the ostium of a particular coronary artery of a patient and to remain stable once in position.
  • angiographic catheters which are used in evaluating the progress of coronary artery disease in patients, generally have a desired distal end curvature configuration to facilitate both the steering of the catheter to a particular artery to be examined and to provide a stable positioning of the catheter's distal portion.
  • a guide catheter especially designed for a procedure in a coronary artery is shaped such that when the guide catheter is inserted into the femoral artery and through the aorta of a patient, the curvature of the catheter will place its distal tip inside one of the coronary ostia.
  • a guide catheter for the right coronary artery is shaped differently than one for the left coronary artery.
  • a guide catheter designed to provide access to a carotid artery is again shaped differently.
  • guide catheters of still other shapes are designed for other bodily passages and regions of interest. Further, there are differences between patients' body structures which require varying sizes of each curve type.
  • the present invention provides a polymeric treatment for curved regions in shaft assemblies that increases curve retention without significantly affecting the flexibility within these regions. More specifically, the method of the present invention modifies the underlying crystalline morphology of a polymer in order to decrease crystal fracturing.
  • the present invention treats polymeric materials suitable for catheter construction with a nucleating agent.
  • a nucleating agent is a material that affects the number and size of crystals formed during the nucleation process. Nucleating agents introduce more nuclei into a polymer's nucleation process. Therefore, under similar cooling procedures, a polymer treated with a nucleating agent results in a rise in the number of crystals formed and a reduction in the overall size of each crystal when compared with an untreated polymer.
  • FIG. 1 is a partial plan view of a catheter assembly in accordance with the present invention
  • FIG. 2A is an illustration of the crystal morphology of a polymeric material lacking nucleating agent treatment
  • FIG. 2B is an illustration of the crystal morphology of the same polymeric material as shown in FIG. 2A, having been treated with a nucleating agent;
  • FIG. 3 is partial plan view of a diagnostic catheter assembly in accordance with the present invention.
  • FIG. 1 is a partial plan view of a catheter in accordance with the present invention.
  • the catheter of the present invention may be used in conjunction with most catheter devices suited for placement within the human anatomy.
  • the catheter assembly may be utilized in cardiology, neurology, urology and gastroenterology, among others.
  • gastroenterological devices the catheter of the present invention may be incorporated into the shaft design of an endoscope, or alternatively, into a biliary catheter.
  • the catheter assembly 10 of the present invention may be incorporated into the shaft design of a guide or diagnostic catheter, or in the alternative, into the vascular catheters used to ultimately treat the maladies requiring the medical procedure.
  • the catheter 10 is shown as a guide or diagnostic catheter, which is representative of a catheter that can incorporate the present invention.
  • Other intravascular catheter embodiments are additionally suitable without deviating from the spirit and scope of the present invention.
  • the guide catheter 10 includes a shaft assembly 12 .
  • a conventional manifold assembly 14 is connected to the proximal end of the shaft assembly 12 .
  • the proximal end of the shaft assembly 12 attaches to a strain relief 16 that further extends into the manifold assembly 14 .
  • the strain relief 16 is generally made of a polyurethane material that snap-fits into the manifold assembly 14 at one end.
  • the other end of the strain relief 16 is generally adhesively bonded to the shaft assembly 12 , forming a continuous and sealed fluid connection from the proximal end of the manifold assembly 14 to the distal end of the shaft assembly 12 .
  • a single manifold portion 18 or multiple manifold ports 18 as shown in FIG. 1 extend from the manifold assembly 14 for attaching and fluidly connecting ancillary apparatus to a lumen extending through the guide catheter.
  • Each manifold port 18 includes a lumen terminating into either a common lumen or a dedicated lumen extending within the shaft assembly 12 (e.g., a guidewire lumen).
  • the manifold assembly 14 additionally provides a convenient place for a physician to apply longitudinal or rotational forces in order to manipulate the guide catheter during a medical procedure.
  • a guide catheter 10 is generally characterized as having a multi-layer tubular member construction. This tubular member includes at least a single lumen extending the length of the shaft assembly 12 .
  • the lumen within the guide catheter 10 possesses an inner diameter capable of receiving another catheter, preferably a diagnostic catheter. Since many diagnostic catheters have outer diameters in the range of 5F-10F, a guide catheter must either accommodate the largest diagnostic catheter, or identify those catheter sizes the guide catheter 10 may receive.
  • the dimensions of guide catheters are well known in the art.
  • Nylon and similar polyamides such as DURETHAN® are particularly suitable for rigid tubular members.
  • Other suitable materials for a rigid tubular member include polyetheretherketone (PEEK), polyimide (PI), and polyetherimide (PEI). Rigidity may additionally be imparted to the tubular member by incorporating a braid on or within the tubular member.
  • Polyether block amide (PEBA) in contrast to the rigid polyamides, is a relatively flexible polymeric material having a durometer of approximately 70D.
  • CRISTAMID® available from Elf Atochem
  • the distal tip 20 generally comprises a soft polymeric material that allows the guide catheter 10 to navigate and traverse the tortuous pathways of a patient's vasculature in a manner as atraumatic as possible.
  • Materials suitable for the distal tip 20 include a polyethylene, polyamide, or block copolymer such as PEBAX® having a lower durometer than the proximal shaft materials.
  • a distal tip 20 comprising a polymeric material having a durometer of about 28D is heat welded or bonded to the distal end of the tubular member.
  • the last 1 ⁇ 2 to 1 mm of the tip at its distal end is made of a different material from the tip material to form a tip extension.
  • the last 1 ⁇ 2 to 1 mm is made from a material that is more durable relative to the softer tip material.
  • the more durable material will resist deforming or tearing when in use, such as in tracking the patient's tortuous anatomy.
  • this last 1 ⁇ 2 mm to 1 mm may be manufactured from Marlex high-density polyethylene having approximately a 63D durometer. This distal tip 20 material selection often improves the integrity of the tip region at its distal-most end.
  • the distal tip 20 is molded to aid in catheter navigation, or alternatively, in a manner that more securely engages the distal tip 20 with a targeted site within the patient's anatomy. Distally tapering a distal tip 20 from a larger outer diameter to a smaller outer diameter enhances navigation of guide catheter 10 . A smaller distal tip 20 allows the guide catheter 10 to more readily follow passages that are curved or branched.
  • the stabilization of a guide catheter's position within a patient's anatomy is often achieved through curves or bends 22 imparted into the shaft assembly by the manufacturer.
  • These pre-formed curves 22 act by anchoring a selected portion of the shaft assembly 12 against an opposing wall within a patient's vasculature or other body portion.
  • Proper anchoring is often achieved by matching the predisposed shape of the curved shaft assembly 12 with the general curved anatomical shape around a targeted site.
  • a curve 22 is imparted to the distal end of a shaft assembly 12 with the intention of placing the catheter's distal tip 20 at a desired angle.
  • a guide catheter 10 especially designed for a procedure in a coronary artery has a shaft assembly 12 shaped so that when the guide catheter 10 is inserted through the aorta of the patient, the curvature of the catheter's shaft assembly 12 will place its distal tip 20 at an angle that engages one of the coronary ostia.
  • Guide catheters currently include a variety of shapes specific for different bodily passages and procedures. Those of skill in the art recognize these different shapes by names such as Judkins Right, Judkins Left, Amplatz Right, Amplatz Left, Bentson, Shepherd Hook, Cobra, Headhunter, Sidewinder, Newton, Sones and others, each formed in a different shape.
  • the guide catheter 10 of FIG. 1 generally depicts a curve. Although one selected curve is shown in detail, additional pre-formed curves and bends, being known in the art, and including those listed above, are also incorporated as within the scope of the present invention. In order to understand how pre-formed curves and bends 22 are imparted to a guide catheter 10 , and more specifically, how those bends 22 retain their shape, it is important to understand the physical characteristics of the polymers forming the curves 22 .
  • FIG. 2A illustrates the crystal 28 morphology of a typical polymeric material suitable for the present invention.
  • the Figure depicts numerous individual crystals 28 each having a nucleus 30 , and an array of fine grain structures 32 radiating from the nucleus 30 .
  • the crystalline morphology of a polymeric catheter tubular member is developed after the tubular member is extruded.
  • the molten polymeric material is shaped into a desired form and then cooled to retain that desired shape.
  • the crystals 28 propagate to support the desired shapen framework.
  • the completion of the nucleation and cooling process results in a crystalline microstructure not unlike that depicted in FIG. 2A.
  • the nucleation process is very fast, and for other polymers, the process is so slow that the polymer generally retains an amorphous morphology.
  • a key to understanding a polymer's crystalline microstructure, and later in manipulating that microstructure is through quantifying the polymer's crystal growth rate.
  • the crystal growth rate for any particular polymer is influenced by the polymer's nucleus density, the growth rate of crystals 28 in the polymer and the degree of cooling of the polymer melt.
  • Materials suitable for forming the shaft assembly 12 of the present invention PEEK, PI, PEI, PEBA and certain polyamides
  • these materials are quantified as having crystal growth rates that permit their crystalline microstructure to be modified during the nucleation process.
  • Modification of the crystalline microstructure is desirable in order to overcome some shortcomings in traditional manufacturing processes. Specifically, it is desirable to modify the crystalline microstructure in guide catheters 10 having pre-formed bends and curves 22 .
  • crystals 28 develop large elongated fine grain structures 32 that radiate from the crystal's nucleus 30 .
  • the relative size of crystals 28 makes them prone to fracturing along their elongated fine grain structures 32 . Consequently, fracturing of the elongated fine grain structures 32 cause the polymeric material, as a whole, to lose retention in its imparted shape. Crystal fracturing is a particular problem in curved areas 22 of a guide catheter 10 where curve retention is paramount to stabilizing the guide catheter's position within a patient's anatomy.
  • the present invention modifies the underlying crystalline morphology of a polymer in order to decrease crystal fracturing.
  • the present invention treats polymeric materials suitable for guide catheter 10 construction with a nucleating agent.
  • a nucleating agent is a material that affects the number and size of crystals formed during the nucleation process.
  • FIG. 2B depicts the same polymeric material shown in FIG. 2A.
  • the material in FIG. 2B has been treated with a nucleating agent.
  • Nucleating agents introduce more nuclei into a polymer's nucleation process. Therefore, under similar cooling procedures, a polymer treated with a nucleating agent results in an increase in the number of crystals 28 formed and a reduction in the overall size of each crystal 28 , when compared with an untreated polymer under the same conditions.
  • the discrepancy in crystal 28 number and size is best illustrated by comparing FIG. 2A (untreated) with FIG. 2B (treated with nucleating agents).
  • crystal fracturing occurs along the elongated fine grain structures 32 of the crystal 28 .
  • the fine grain structures 32 are not highly elongated. Individual crystals 28 are highly crowded in nucleating agent treated polymers. As a result, crystal growth accretion is extremely short before a crystal 28 abuts a neighboring crystal 28 . Thus, the elongated fine grain structures 32 are also very short. It is these shorter fine grain structures 32 that resist fracturing as a result of stresses applied to the crystalline framework.
  • nucleating agents suitable for shaft assembly 12 construction are commercially available.
  • inorganic additives, organic additives and polymers are preferred nucleating agents.
  • inorganic additives include, but are not limited to, talc, silica, kaolin, molybdenum disulfide, iron sulfide, titanium dioxide and sodium phenylphosphonate.
  • organic additives include, but are not limited, to sodium p-tert-butylbenzoate, monton wax, montanic ester salts, salts of monocarboxylic acids and polycarboxylic acids.
  • polymers include, but are not limited to, ethylene and acrylic ester copolymers, fumeric acid polymers, ethylene, propylene 1,4-hexadiene and norbornadiene.
  • These nucleating agents possess superior nucleation rates for materials suitable for forming the guide catheter 10 . More specifically, these nucleating agents are particularly suitable for polymeric materials used to form the pre-formed bends and curves 22 of particular catheter assembly embodiments. Utilization of additional nucleating agents suitable for the preferred polymeric materials listed above, being known in the art, is also incorporated as within the scope of the present invention.
  • Nucleating agents are commercially available in a variety of differing material states. For example, specific nucleating agents are commercially available as powders, pastes and liquids. The use of one material state may be more appropriate than another depending upon the manner of manufacturing of the resulting catheter device. Nucleating agents in powder form are particularly suited for incorporation within a polymeric material. The powdered nucleating agent is measured, added and dispersed within the polymeric material to maintain a specified concentration throughout the mixture. The required ratio of nucleating agent to polymer that initiates the desired change in crystalline morphology may vary depending upon the specific polymeric material used. In certain polymeric materials, any further increases in the required concentration ratio fail to further improve the crystalline microstructure of the polymer. In some embodiments, the ratio of nucleating agent to polymer is about 0.5% to about 99.5% by weight. In preferred embodiments, the nucleating agent is present in a concentration of about 0.01% to about 1.0% by weight.
  • the polymeric mixture is then fed into an extruder.
  • the extruder then dispenses the admixed polymeric material to form a tubular member, and this member is configured to a desired shape.
  • Nucleating agents in paste and liquid form are additionally suitable for this manufacturing method.
  • the desired shape can be formed in a subsequent heat treatment process wherein a select portion including a curve is melted and recrystallized in a desired configuration.
  • the catheter assembly of the present invention may also be incorporated into other catheters.
  • the multi-lumen shaft assemblies of balloon dilatation catheters 40 are suited for the catheter assembly improvement of the present invention.
  • the basic construction and use of multi-lumen balloon dilatation catheters 40 are all well known in the art.
  • An example of an OTW catheter may be found in commonly assigned U.S. Pat. No. 5,047,045 to Arney et al.
  • An example of an SOE catheter is disclosed in commonly assigned U.S. Pat. No. 5,156,594 to Keith.
  • Multi-lumen catheter 40 construction generally includes the use of an inner tubular member 42 and an outer tubular member 44 .
  • the spatial orientation of the two tubular members is such that the outer tubular member 44 is coaxially displaced over the inner tubular member 42 defining an annular inflation lumen therebetween. This spatial relationship is best illustrated with reference to FIG. 3.
  • Materials used to form the outer tubular member may vary upon the stiffness desired for the shaft assembly 12 .
  • Nylon and similar polyamides such as DURETHAN® (available from Bayer) are particularly suitable for rigid outer tubular member 44 .
  • Other suitable materials for a rigid outer tubular member 44 include polyetheretherketone (PEEK), polyimide (PI), and polyetherimide (PEI).
  • Polyether block amide (PEBA) in contrast to the rigid polyamides, is a relatively flexible polymeric material having a durometer of approximately 70D.
  • a polyamide such as CRISTAMID® (available from Elf Atochem) imparts a slightly less rigid durometer than the rigid polyamides and slightly greater than the flexible PEBA material. All of these materials possess crystal growth rates that support a crystalline morphology. Moreover, these materials are quantified as having crystal growth rates that permit their crystalline microstructure to be modified during the nucleation process.
  • the inner tubular member 42 defines a guidewire lumen, which provides a passage for a guidewire 46 .
  • the inner tubular member 42 is generally made of polyethylene such as Marlex HDPE.
  • the inner tubular member is made of, or lined with, a lubricious material such as polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • Materials suitable for forming the inner tubular member 42 are generally classified as having a rapid crystallization growth rate.
  • materials forming the outer tubular member 44 materials forming the inner tubular member 42 generally possess such rapid crystal growth rates that they fail to support a crystalline morphology that may be modified using nucleating agents.
  • the benefits of modifying the outer tubular member 44 may be transferred to the inner tubular member 42 , and thereby, to the balloon dilatation catheter 40 as a whole. Because of the spatial relationship within the multi-lumen catheter assembly, the outer tubular member 44 restrains the inner tubular member 42 . Therefore, modifying the outer polymeric structure of tubular member 44 , in effect, also modifies the performance characteristics experienced by the inner tubular member 42 . Nucleating agent modifications to the outer tubular member 42 are similar to those with reference to the guide catheter assembly 16 of FIG. 1.

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US10/020,521 2001-12-14 2001-12-14 Catheter having improved curve retention and method of manufacture Abandoned US20030114831A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
US10/020,521 US20030114831A1 (en) 2001-12-14 2001-12-14 Catheter having improved curve retention and method of manufacture
JP2003552351A JP2005537816A (ja) 2001-12-14 2002-11-25 湾曲保持性が向上されたカテーテル及びその製造方法
PCT/US2002/037818 WO2003051421A1 (fr) 2001-12-14 2002-11-25 Catheter a retention des courbes amelioree et procede de fabrication
AU2002366338A AU2002366338A1 (en) 2001-12-14 2002-11-25 Catheter having improved curve retention and method of manufacture
CA2470468A CA2470468C (fr) 2001-12-14 2002-11-25 Catheter a retention des courbes amelioree et procede de fabrication
EP20020805076 EP1453555A1 (fr) 2001-12-14 2002-11-25 Catheter a retention des courbes amelioree et procede de fabrication
US10/983,470 US7128956B2 (en) 2001-12-14 2004-11-08 Catheter having improved curve retention

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US10/020,521 US20030114831A1 (en) 2001-12-14 2001-12-14 Catheter having improved curve retention and method of manufacture

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US10/983,470 Continuation US7128956B2 (en) 2001-12-14 2004-11-08 Catheter having improved curve retention

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US10/983,470 Expired - Fee Related US7128956B2 (en) 2001-12-14 2004-11-08 Catheter having improved curve retention

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EP (1) EP1453555A1 (fr)
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CA (1) CA2470468C (fr)
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Cited By (8)

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US20080243222A1 (en) * 2007-04-02 2008-10-02 Cook Incorporated High flex introducer assembly
WO2014143762A2 (fr) 2013-03-15 2014-09-18 Armour Technologies, Inc. Appareil, système et procédé de courbure de dispositif médical
EP2727622A4 (fr) * 2011-06-29 2015-08-12 Terumo Corp Gaine pour dispositif d'introduction
US20160346508A1 (en) * 2015-05-29 2016-12-01 Covidien Lp Catheter distal tip configuration
US10357631B2 (en) 2015-05-29 2019-07-23 Covidien Lp Catheter with tapering outer diameter
AU2019202569B2 (en) * 2015-05-29 2020-08-13 Covidien Lp Catheter with tapering outer diameter
US11160952B2 (en) 2017-08-25 2021-11-02 Teleflex Life Sciences Limited Catheter
US11219740B2 (en) 2015-05-29 2022-01-11 Covidien Lp Catheter including tapering coil member

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WO2003051421A1 (fr) 2003-06-26
US7128956B2 (en) 2006-10-31
AU2002366338A1 (en) 2003-06-30
JP2005537816A (ja) 2005-12-15
EP1453555A1 (fr) 2004-09-08
US20050064124A1 (en) 2005-03-24
CA2470468A1 (fr) 2003-06-26

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