US20120261857A1 - Catheter having a coextruded fluoropolymer layer - Google Patents
Catheter having a coextruded fluoropolymer layer Download PDFInfo
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- US20120261857A1 US20120261857A1 US13/537,631 US201213537631A US2012261857A1 US 20120261857 A1 US20120261857 A1 US 20120261857A1 US 201213537631 A US201213537631 A US 201213537631A US 2012261857 A1 US2012261857 A1 US 2012261857A1
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- polyvinylidene fluoride
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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
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/15—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
- B29C48/154—Coating solid articles, i.e. non-hollow articles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
- B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
- B29C48/21—Articles comprising two or more components, e.g. co-extruded layers the components being layers the layers being joined at their surfaces
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/30—Extrusion nozzles or dies
- B29C48/32—Extrusion nozzles or dies with annular openings, e.g. for forming tubular articles
- B29C48/335—Multiple annular extrusion nozzles in coaxial arrangement, e.g. for making multi-layered tubular articles
- B29C48/336—Multiple annular extrusion nozzles in coaxial arrangement, e.g. for making multi-layered tubular articles the components merging one by one down streams in the die
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/04—Polymers of ethylene
- B29K2023/06—PE, i.e. polyethylene
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
- B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
- B29K2027/16—PVDF, i.e. polyvinylidene fluoride
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2071/00—Use of polyethers, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2075/00—Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2077/00—Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2009/00—Layered products
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2022/00—Hollow articles
- B29L2022/02—Inflatable articles
- B29L2022/022—Balloons
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
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- 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]
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- 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]
- Y10T428/1355—Elemental metal containing [e.g., substrate, foil, film, coating, etc.]
- Y10T428/1359—Three or more layers [continuous layer]
-
- 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]
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Manufacturing & Machinery (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
A catheter shaft including an elongate tubular member including a first polymeric layer and a second polymeric layer bonded to the first polymeric layer. The first polymeric layer is formed of a polymer generally not bondable to fluoropolymers, and the second polymeric layer is formed of a fluoropolymer bonded to the polymer of the first polymeric layer. The fluoropolymer of the second polymeric layer is a functionalized polyvinylidene fluoride which has a bonding affinity to the polymer of the first polymeric layer. The functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride which readily bond to the polymer chain of the polymer of the first polymeric layer.
Description
- This application is a continuation of U.S. application Ser. No. 12/207,692, filed Sep. 10, 2008, the entire disclosure of which is incorporated herein by reference.
- The invention is directed to elongated medical devices. More particularly, the invention is directed to a catheter shaft having a coextruded fluoropolymer layer directly bonded to another polymer layer.
- Catheters, such as intravascular catheters, are commonly constructed of multi-layer tubular members including multiple layers of polymeric material. The polymeric material for one layer of the multi-layer tubular member may be chosen for certain desired characteristics, while the polymeric material for another layer of the multi-layer tubular member may be chosen for other certain desired characteristics. In some instances, the polymeric material of the first layer may be incompatible with the polymeric material of the second layer. For example, the polymeric material of the first layer may not be readily bonded or adhered to the polymeric material of the second layer. In such instances, an intermediate layer or tie layer may be placed between the first layer and the second layer. The intermediate or tie layer may readily bond or adhere to each of the first layer and the second layer, thus “tying” the first layer to the second layer.
- It is generally known that fluoropolymers, such as polyvinylidene fluoride (PVDF), are generally not bondable to other polymeric materials, such as polyamide, polyether block amide, polyurethane, polyethylene and polyester. Thus, if it is desired to use a fluoropolymer, such as polyvinylidene fluoride (PVDF) as one layer of a multi-layer catheter tubing, and a non-compatible polymer, such as polyamide, polyether block amid, polyurethane, or polyester, as another layer of the multi-layer catheter tubing, then a tie layer is necessary to prevent delamination of the fluoropolymer layer from the other polymer layer.
- The inclusion of the intermediate or tie layer in the catheter tubing adds thickness to the tubing, as well as adds additional cost to the manufacture of the catheter tubing. For instance, in addition to the additional cost of the tie layer material, an additional extruder would be necessary in order to co-extrude the tie layer with the inner and outer layers of the tubular member.
- It would be advantageous to manufacture a catheter tube having a fluoropolymer layer, such as polyvinylidene fluoride (PVDF), directly bonded to another polymer layer without the need for an intervening tie layer disposed between the fluoropolymer layer and the other polymer layer. Thus, such catheter tubing may benefit from the inclusion of a fluoropolymer layer without the concern of the fluoropolymer layer delaminating from the other polymeric layer of the catheter tube.
- The disclosure is directed to several alternative designs, materials and methods of manufacturing medical device structures and assemblies.
- Accordingly, one illustrative embodiment is a catheter shaft including an elongate tubular member having a first end, a second end and a tubular wall extending between the first end and the second end. The elongate tubular member includes an outer polymeric layer formed of a polymer generally not bondable to fluoropolymers, and an inner fluoropolymer layer directly bonded to the outer polymeric layer. The inner fluoropolymer layer includes a functionalized polyvinylidene fluoride which has a bonding affinity to the outer polymeric layer, wherein the functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride.
- Another illustrative embodiment is a catheter shaft including an elongate tubular member having a first end, a second end and a tubular wall extending between the first end and the second end. The elongate tubular member includes an inner polymeric layer formed of a polymer generally not bondable to fluoropolymers, and an outer fluoropolymer layer directly bonded to the inner polymeric layer. The outer fluoropolymer layer includes a functionalized polyvinylidene fluoride which has a bonding affinity to the inner polymeric layer, wherein the functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride.
- Another illustrative embodiment is a method of forming a catheter shaft. The method includes extruding a first polymer in a molten state onto a mandrel, forming a first molten layer of the first polymer. A second polymer is extruded in a molten state over the first molten layer of the first polymer, forming a second molten layer of the second polymer over the first molten layer of the first polymer. The first molten layer of the first polymer and the second molten layer of the second polymer are then passed through an extrusion die while the first molten layer and the second molten layer remain in their molten state. Then the first molten layer of the first polymer and the second molten layer of the second polymer are allowed to cool, wherein a bilayer polymer tube is formed having an outer layer formed of the first polymer directly bonded to an inner layer formed of the second polymer without any intervening layer positioned between the inner layer and the outer layer of the bilayer polymeric tube. One of the first polymer and the second polymer is a functionalized polyvinylidene fluoride, while the other of the first polymer and the second polymer is a polymer generally not compatible with polyvinylidene fluoride.
- The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the invention.
- The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
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FIG. 1 is a plan view of an illustrative catheter; -
FIG. 2 is a longitudinal cross-sectional view of the catheter ofFIG. 1 ; -
FIG. 3 is a transverse cross-sectional view of the shaft of the catheter ofFIG. 1 taken along line 3-3; -
FIG. 4 is a cross-sectional view on a tubular member of another medical device; and -
FIG. 5 is a cross-sectional view of an extrusion system for co-extruding a multi-layer tubular member. - While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
- For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
- All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may be indicative as including numbers that are rounded to the nearest significant figure.
- The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.
- As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
- The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.
- A
catheter 10, generally disclosed as an angioplasty catheter, is illustrated inFIG. 1 . Although thecatheter 10 is described as an angioplasty catheter, one of skill in the art would understand that the present discussion may apply equally to other types of catheters, such as guide catheters, stent delivery catheters, biliary catheters, urethra catheters, atherectomy catheters, and other medical catheters, as well as guidewires, and the like. - The
catheter 10 may include anelongate shaft 12 extending from aproximal end 14 to adistal end 16. Ahub assembly 18 may be attached to theproximal end 14 of theelongate shaft 12. Additionally, thecatheter 10 may include aninflatable balloon 20 disposed on a distal region of theelongate shaft 12. Adistal tip 22, such as an atraumatic tip, may extend distal of theballoon 20 at thedistal end 16 of theelongate shaft 12. -
FIG. 2 is a cross-sectional view of thecatheter 10 ofFIG. 1 . As shown inFIG. 2 , theshaft 12 may include an innertubular member 24 and an outertubular member 26. Theinner tubular member 24 may include aguidewire lumen 28 extending therethrough for receiving a guidewire. The proximal end of the outertubular member 26 may be disposed in thehub assembly 18 and secured thereto. - The
inner tubular member 24 may be disposed within the outertubular member 26 such that theouter surface 30 of theinner tubular member 24 is spaced away from theinner surface 32 of the outer tubular member, defining aninflation lumen 34 between theinner tubular member 24 and the outertubular member 26. Theinflation lumen 34 may be in fluid communication with the interior of theballoon 20, such that an inflation fluid may be directed through theinflation lumen 34 to the interior of theballoon 20 in order to inflate theballoon 20 during a medical procedure. - As shown in
FIG. 2 , theballoon 20 may have aproximal waist 36 and adistal waist 38. Thedistal waist 38 of theballoon 20 may be secured to the distal end of theinner tubular member 24, and theproximal waist 36 of theballoon 20 may be secured to the distal end of the outertubular member 26. Theballoon 20 may be secured to theinner tubular member 24 and the outertubular member 26 by adhesive bonding, laser welding, or the like. -
FIG. 3 is a cross-section of thecatheter shaft 12 transverse to the longitudinal axis of thecatheter shaft 12. As shown inFIG. 3 , theinner tubular member 24 may be a multi-layer tubular member, such as a bilayer tubular member having anouter layer 42 and aninner layer 44. Theinner layer 44 may be directly bonded to theouter layer 42 of theinner tubular member 24, with no intervening layer between theinner layer 44 and theouter layer 42. - The
outer layer 42 may be formed of a polymeric material, such as polyamide, polyether block amide, polyurethane, polyethylene or polyether. Theinner layer 44 of theinner tubular member 24 may be a fluoropolymer, such as polyvinylidene fluoride (PVDF), giving theinner layer 44 lubricious properties. Namely, theinner layer 44 may be formed of a functionalized polyvinylidene fluoride which is directly bonded to theouter layer 42. Directly bonded or adhered is meant that there is no intervening tie layer present. It is the affinity of the functionalized polyvinylidene fluorideinner layer 44 that causes the bonding or adhesion of thelayers 42/44 without the use of a tie layer between the inner andouter layers 44/42. Thus, unlike other polyvinylidene fluoride polymers which are not readily bonded to other polymeric materials, the functionalized polyvinylidene fluorideinner layer 44 may be directly bonded, such as covalently bonded, to the polymerouter layer 42. - The functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of polyvinylidene fluoride. For example, the functionalized polyvinylidene fluoride may be KYNAR® ADX, sold by Arkema, Inc. of Philadelphia, Pennsylvania. The reactive functional groups of the functionalized polyvinylidene fluoride layer may form covalent bonds with the polymer chain of the
outer layer 42. - In some embodiments, the reactive functional groups include an unsaturated carboxylic acid, such as maleic acid, fumaric acid, cinnamic acid, crotonic acid, or linoleic acid. In some embodiments, the reactive functional groups may include maleic anhydride.
- In some embodiments, the functionalized polyvinylidene fluoride may include radiation-grafted reactive functional groups. The radiation-grafted functional groups may include a compound including a carboxylic acid, or a derivative of a carboxylic acid.
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FIG. 4 is a cross-section of anothertubular member 60 which may be used in a medical device, such as a catheter. Thetubular member 60 may be a bilayer tubular member having anouter layer 62 and aninner layer 64. Theinner layer 64 may be directly bonded to theouter layer 62 of thetubular member 60, with no intervening layer between theinner layer 64 and theouter layer 62. - The
inner layer 64 may be formed of a polymeric material, such as polyamide, polyether block amide, polyurethane, polyethylene or polyether. Theouter layer 62 of thetubular member 60 may be a fluoropolymer, such as polyvinylidene fluoride (PVDF), giving theouter layer 62 lubricious properties. Namely, theouter layer 62 may be formed of a functionalized polyvinylidene fluoride which is directly bonded to theinner layer 64. Directly bonded or adhered is meant that there is no intervening tie layer present. It is the affinity of the functionalized polyvinylidene fluorideouter layer 62 that causes the bonding or adhesion of thelayers 62/64 without the use of a tie layer between the inner andouter layers 64/62. Thus, unlike other polyvinylidene fluoride polymers which are not readily bonded to other polymeric materials, the functionalized polyvinylidene fluorideouter layer 62 may be directly bonded, such as covalently bonded, to the polymerinner layer 64. - The functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of polyvinylidene fluoride. For example, the functionalized polyvinylidene fluoride may be KYNAR® ADX, sold by Arkema, Inc. of Philadelphia, Pa. The reactive functional groups of the functionalized polyvinylidene fluoride layer may form covalent bonds with the polymer chain of the
inner layer 64. - In some embodiments, the reactive functional groups include an unsaturated carboxylic acid, such as maleic acid, fumaric acid, cinnamic acid, crotonic acid, or linoleic acid. In some embodiments, the reactive functional groups may include maleic anhydride.
- In some embodiments, the functionalized polyvinylidene fluoride may include radiation-grafted reactive functional groups. The radiation-grafted functional groups may include a compound including a carboxylic acid, or a derivative of a carboxylic acid.
- Either the
tubular member 24 shown inFIG. 3 or thetubular member 60 shown inFIG. 4 may be formed in a coextrusion process where theouter layer 42/62 is coextruded simultaneously with theinner layer 44/64. In describing theouter layer 42/62 as being coextruded simultaneously with theinner layer 44/64, what is meant is that theouter layer 42/62 is coextruded with theinner layer 44/64 during the same extrusion process where both theinner layer 44/64 and theouter layer 42/62 are concurrently in the molten state of the polymer during the extrusion process. By coextruding theouter layer 42/62 over theinner layer 44/64, thelayers 44/64 may be directly bonded to one another. For instance, the inclusion of the reactive functional groups chemically bonded to a polymer chain of polyvinylidene fluoride of the functionalized polyvinylidene fluoride may form a chemical bond, such as a covalent bond, between theouter layer 42/62 and theinner layer 44/64 of thetubular member 24/60. - As shown in
FIG. 5 , an illustrative extrusion system which may be used during the coextrusion process may include afirst extruder 110, asecond extruder 120, amandrel 130, and anextrusion die 140. - A first
molten polymer 112 may be extruded onto themandrel 130 by thefirst extruder 110. For instance, thescrew 114 of thefirst extruder 110 may feed the firstmolten polymer 112 out the head of theextruder 110 over themandrel 130. Themandrel 130, coated with the firstmolten polymer 112 may then enter thesecond extruder 120. A secondmolten polymer 122 may be extruded over the firstmolten polymer 112 by thesecond extruder 120. For instance, thescrew 124 of thesecond extruder 120 may feed the secondmolten polymer 122 out the head of theextruder 120 over the firstmolten polymer 112. Thus, a layer of the firstmolten polymer 112 and a layer of the secondmolten polymer 122 may be coaxially disposed over themandrel 130. - The layer of the first
molten polymer 112, the layer of the secondmolten polymer 122, and themandrel 130 may then be passed through the extrusion die 140 while the first layer ofmolten polymer 112 and the second layer ofmolten polymer 122 remain in their molten state. As the layers of molten polymer are passed through the extrusion die 140, abilayer polymer tube 150 is formed having anouter layer 142 directly bonded to aninner layer 144, without any intervening layer positioned between theinner layer 144 and theouter layer 142. - One of the
inner layer 144 and theouter layer 142 may be a functionalized polyvinylidene fluoropolymer, while the other of theinner layer 144 and theouter layer 142 may be a polymer generally not compatible with fluoropolymers, such as polyvinylidene fluoropolymer. For example, the other of theinner layer 144 and theouter layer 142 may be polyamide, polyether block amide, polyurethane, polyethylene or polyether. - When a functionalized polyvinylidene fluoropolymer as described herein is used as one of the
inner layer 144 or theouter layer 142, theinner layer 144 may be chemically bonded to theouter layer 142 due to the inclusion of the reactive functional groups chemically bonded to a polymer chain of polyvinylidene fluoride of the functionalized polyvinylidene fluoride. - The
bilayer polymer tube 150 may be used as a tubular member of a medical device, for example an inner tubular member or outer tubular member of a catheter shaft. The chemical bonds formed between theinner layer 144 and theouter layer 142 may prevent delamination of thepolymer tube 150 during use. Thus, it can be seen that a tubular member of a catheter including a fluoropolymer layer giving the tubular member lubricious properties may be manufactured in which the lubricious fluoropolymer layer is directly bonded to another polymeric layer generally not bondable to a fluoropolymer. - Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.
Claims (20)
1. A method of forming a catheter shaft, the method comprising:
disposing a first polymer in a molten state onto a mandrel, forming a first molten layer of the first polymer;
disposing a second polymer in a molten state over the first molten layer of the first polymer, forming a second molten layer of the second polymer over the first molten layer of the first polymer; and
allowing the first molten layer of the first polymer and the second molten layer of the second polymer to cool;
wherein one of the first polymer and the second polymer is a functionalized polyvinylidene fluoride, while the other of the first polymer and the second polymer is a polymer generally not compatible with polyvinylidene fluoride.
2. The method of claim 1 , further comprising passing the first molten layer of the first polymer and the second molten layer of the second polymer through an extrusion die while the first molten layer and the second molten layer remain in their molten state.
3. The method of claim 1 , wherein a bilayer polymer tube is formed having an inner layer formed of the first polymer bonded to an outer layer formed of the second polymer without any intervening layer positioned between the inner layer and the outer layer of the bilayer polymeric tube.
4. The method of claim 1 , wherein the functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride.
5. The method of claim 4 , wherein the first polymer is a functionalized polyvinylidene fluoride, and wherein the functionalized polyvinylidene fluoride is covalently bonded to the second polymer.
6. The method of claim 5 , wherein the second polymer is one of the group of polyamide, polyether block amide, polyurethane, polyethylene and polyether.
7. The method of claim 4 , wherein the second polymer is a functionalized polyvinylidene fluoride, and wherein the functionalized polyvinylidene fluoride is covalently bonded to the first polymer.
8. The method of claim 7 , wherein the first polymer is one of the group of polyamide, polyether block amide, polyurethane, polyethylene and polyether.
9. A method of forming a catheter shaft, the method comprising:
extruding a first polymer in a molten state onto a mandrel, forming a first molten layer of the first polymer;
extruding a second polymer in a molten state over the first molten layer of the first polymer, forming a second molten layer of the second polymer over the first molten layer of the first polymer;
passing the first molten layer of the first polymer and the second molten layer of the second polymer through an extrusion die while the first molten layer and the second molten layer remain in their molten state; and
allowing the first molten layer of the first polymer and the second molten layer of the second polymer to cool;
wherein one of the first polymer and the second polymer is a functionalized polyvinylidene fluoride.
10. The method of claim 9 , wherein a bilayer polymer tube is formed having an inner layer formed of the first polymer bonded to an outer layer formed of the second polymer without any intervening layer positioned between the inner layer and the outer layer of the bilayer polymeric tube.
11. The method of claim 9 , wherein one of the first polymer and the second polymer is a polymer generally not compatible with polyvinylidene fluoride.
12. The method of claim 9 , wherein the functionalized polyvinylidene fluoride includes reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride.
13. The method of claim 12 , wherein the first polymer is a functionalized polyvinylidene fluoride, and wherein the functionalized polyvinylidene fluoride is covalently bonded to the second polymer.
14. The method of claim 10 , wherein the second polymer is one of the group of polyamide, polyether block amide, polyurethane, polyethylene and polyether.
15. The method of claim 12 , wherein the reactive functional groups include maleic anhydride.
16. The catheter shaft of claim 9 , wherein the functionalized polyvinylidene fluoride includes radiation-grafted reactive functional groups.
17. The catheter shaft of claim 16 , wherein the radiation-grafted reactive functional groups include a compound including a carboxylic acid or a derivative of a carboxylic acid.
18. The method of claim 12 , wherein the second polymer is a functionalized polyvinylidene fluoride, and wherein the functionalized polyvinylidene fluoride is covalently bonded to the first polymer.
19. The method of claim 18 , wherein the first polymer is one of the group of polyamide, polyether block amide, polyurethane, polyethylene and polyether.
20. A method of forming a catheter shaft, the method comprising:
extruding a first polymer in a molten state onto a mandrel, forming a first molten layer of the first polymer;
extruding a second polymer in a molten state over the first molten layer of the first polymer, forming a second molten layer of the second polymer over the first molten layer of the first polymer;
passing the first molten layer of the first polymer and the second molten layer of the second polymer through an extrusion die while the first molten layer and the second molten layer remain in their molten state; and
allowing the first molten layer of the first polymer and the second molten layer of the second polymer to cool, wherein one of the first polymer and the second polymer is a functionalized polyvinylidene fluoride, wherein a bilayer polymer tube is formed having an inner layer formed of the first polymer bonded to an outer layer formed of the second polymer without any intervening layer positioned between the inner layer and the outer layer of the bilayer polymeric tube;
wherein one of the first polymer and the second polymer is a functionalized polyvinylidene fluoride including reactive functional groups chemically bonded to a polymer chain of a polyvinylidene fluoride, while the other of the first polymer and the second polymer is a polymer generally not compatible with polyvinylidene fluoride.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/537,631 US20120261857A1 (en) | 2008-09-10 | 2012-06-29 | Catheter having a coextruded fluoropolymer layer |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/207,692 US8216498B2 (en) | 2008-09-10 | 2008-09-10 | Catheter having a coextruded fluoropolymer layer |
US13/537,631 US20120261857A1 (en) | 2008-09-10 | 2012-06-29 | Catheter having a coextruded fluoropolymer layer |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/207,692 Continuation US8216498B2 (en) | 2008-09-10 | 2008-09-10 | Catheter having a coextruded fluoropolymer layer |
Publications (1)
Publication Number | Publication Date |
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US20120261857A1 true US20120261857A1 (en) | 2012-10-18 |
Family
ID=41343209
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US12/207,692 Expired - Fee Related US8216498B2 (en) | 2008-09-10 | 2008-09-10 | Catheter having a coextruded fluoropolymer layer |
US13/537,631 Abandoned US20120261857A1 (en) | 2008-09-10 | 2012-06-29 | Catheter having a coextruded fluoropolymer layer |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US12/207,692 Expired - Fee Related US8216498B2 (en) | 2008-09-10 | 2008-09-10 | Catheter having a coextruded fluoropolymer layer |
Country Status (4)
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US (2) | US8216498B2 (en) |
EP (1) | EP2344213B1 (en) |
JP (1) | JP5603867B2 (en) |
WO (1) | WO2010030525A2 (en) |
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US10589060B2 (en) | 2016-12-21 | 2020-03-17 | Biosense Webster (Israel) Ltd. | Extrusion with preferential bend axis |
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US20030165647A1 (en) * | 2002-03-04 | 2003-09-04 | Terumo Kabushiki Kaisha | Medical tubing and extrusion die for producing the same |
US20050170121A1 (en) * | 2003-12-01 | 2005-08-04 | Anthony Bonnet | Use of a hose based on an irradiation-grafted fluoropolymer for transporting petrol in a service station |
US20070078439A1 (en) * | 2004-05-27 | 2007-04-05 | Axel Grandt | Multiple lumen catheter and method of making same |
US20070282367A1 (en) * | 2005-01-21 | 2007-12-06 | Andrew Jeffrey | Catheter having a soft distal tip |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10589060B2 (en) | 2016-12-21 | 2020-03-17 | Biosense Webster (Israel) Ltd. | Extrusion with preferential bend axis |
US11491304B2 (en) | 2016-12-21 | 2022-11-08 | Biosense Webster (Israel) Ltd. | Extrusion with preferential bend axis |
Also Published As
Publication number | Publication date |
---|---|
US8216498B2 (en) | 2012-07-10 |
WO2010030525A2 (en) | 2010-03-18 |
JP5603867B2 (en) | 2014-10-08 |
EP2344213A2 (en) | 2011-07-20 |
WO2010030525A3 (en) | 2010-11-18 |
EP2344213B1 (en) | 2014-05-21 |
US20100063476A1 (en) | 2010-03-11 |
JP2012501794A (en) | 2012-01-26 |
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