WO2004037309A1 - Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers - Google Patents

Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers Download PDF

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Publication number
WO2004037309A1
WO2004037309A1 PCT/US2003/020861 US0320861W WO2004037309A1 WO 2004037309 A1 WO2004037309 A1 WO 2004037309A1 US 0320861 W US0320861 W US 0320861W WO 2004037309 A1 WO2004037309 A1 WO 2004037309A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
medical device
balloon
wall
layers
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2003/020861
Other languages
English (en)
French (fr)
Inventor
Ernest J. St. Pierre
Ronald A. Sahatjian
Peter L. Dayton
David Vafiades
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Corp
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Corp
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 Boston Scientific Corp, Scimed Life Systems Inc filed Critical Boston Scientific Corp
Priority to EP03742399A priority Critical patent/EP1556096B1/en
Priority to JP2004546685A priority patent/JP2006503642A/ja
Priority to CA002502778A priority patent/CA2502778A1/en
Priority to AU2003301657A priority patent/AU2003301657A1/en
Priority to AT03742399T priority patent/ATE512678T1/de
Publication of WO2004037309A1 publication Critical patent/WO2004037309A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • 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
    • 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
    • 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
    • B29C48/03—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
    • B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • 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
    • 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
    • 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
    • B29C48/3363—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 using a layered die, e.g. stacked discs
    • 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
    • B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
    • B29C48/49—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using two or more extruders to feed one die or nozzle
    • 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
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/919—Thermal treatment of the stream of extruded material, e.g. cooling using a bath, e.g. extruding into an open bath to coagulate or cool the material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/10—Interconnection of layers at least one layer having inter-reactive properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • 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
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/16—Cooling
    • B29C2035/1616—Cooling using liquids
    • 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
    • B29C2793/00—Shaping techniques involving a cutting or machining operation
    • B29C2793/009—Shaping techniques involving a cutting or machining operation after shaping
    • 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
    • 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
    • B29C48/34—Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
    • 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
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/885—External treatment, e.g. by using air rings for cooling tubular films
    • 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
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • 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
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • B29C48/9115—Cooling of hollow articles
    • B29C48/912—Cooling of hollow articles of tubular films
    • 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
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • 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
    • 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
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0085—Copolymers
    • 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

Definitions

  • Medical procedures can utilize a balloon in different ways.
  • a balloon is used to open an occluded lumen, as in angioplasty.
  • a balloon is used to position another medical implement, such as a stent or graft, within a lumen.
  • a balloon is used to selectively block a passageway.
  • a balloon is used in various combinations of these procedures.
  • the balloon is positioned on the end of a catheter shaft.
  • the balloon is typically wrapped around the catheter shaft to reduce the radial profile for easier insertion.
  • the catheter is then threaded through the body to position the balloon at a location of treatment and the balloon is inflated. Finally, the balloon is deflated and the catheter is withdrawn from the body.
  • the invention features a medical device having a wall.
  • the wall includes a first layer including a polyester or a polyester copolymer, a second layer including a polyamide or a polyamide copolymer, and a third layer including an adhesive material.
  • the thickness of the third layer is less than about 20 percent of a total thickness of the wall.
  • the invention features a medical device having a wall.
  • the wall includes a first layer including a polyester or a polyester copolymer, a second layer including a polyamide or a polyamide copolymer, and a third layer including an adhesive material.
  • the third layer is less than about 0.005 inch thick.
  • the invention features a method of forming a tube.
  • the method includes coextruding first second and third materials to form a wall of the tube with first, second and third layers.
  • the first layer includes a polyester or a polyester copolymer.
  • the second layer includes a polyamide or a polyamide copolymer, and the third layer includes an adhesive material.
  • the invention features a method of forming a tube.
  • the method includes coextruding multiple polymer layers to form a wall of the tube, and forming the tube into a balloon.
  • the method also includes heating the balloon to a temperature of at least about 50°C at a pressure of at least about 50 pounds per square inch.
  • the invention features an extrusion apparatus.
  • the apparatus includes at least three extruders, and a cross-head in fluid communication with the extruders.
  • the cross-head is capable of holding from about 3.2 cubic centimeters to about five cubic centimeters of a fluid from one of the first extruders.
  • the invention features an extrusion apparatus that includes at least three extruders, and a cross-head in fluid communication with the first, second and third extruders.
  • the cross-head is capable of holding from about three cubic centimeters to about 4.5 cubic centimeters of a fluid from one of the extruders.
  • FIG. 1 is a side view of an embodiment of a balloon catheter system
  • polyesters include the polyethylene terephthalate (PET) polymers, polybutylene terephthalate (PBT) polymers and blends and combinations thereof.
  • PET polyethylene terephthalate
  • PBT polybutylene terephthalate
  • polyesters include the Selar PT family of polymers (e.g., Selar PT 8307, Selar PT4274, Selar PTX280), which are commercially available from E. I.
  • the adhesive is a polymer (e.g., a substantially pure polymer, or a blend of polymers), h general, an adhesive refers to a material that is capable of forming a bond with its adjacent layers of materials so that the resulting multilayer device (e.g., a medical device, such as a tube or balloon catheter) can be used for its intended purpose.
  • Preferred adhesive materials maintain their desired adhesive properties (e.g., undergo substantially no chemical degradation) when exposed to process conditions described herein.
  • An adhesive can be selected, for example, from the Bynel family of polymers (e.g., Bynel CXA Series, Bynel 1000 Series, Bynel 1123, Bynel 1124, Bynel 11E554, Bynel 11E573, Bynel CXA E-418), commercially available from E. I.
  • Bynel family of polymers e.g., Bynel CXA Series, Bynel 1000 Series, Bynel 1123, Bynel 1124, Bynel 11E554, Bynel 11E573, Bynel CXA E-418
  • DuPont de Nemours Wilmington, DE
  • the Plexar family of polymers e.g., PX360, PX360E, PX380, PX3227, PX3236, PX3277, PX5125, PX5327, PX206, PX209, PX2049, PX165, PX175, PX180, PX909, PX101, PX107A, PX108, PX114, PX1164), commercially available from Equistar Chemicals (Newark, NJ), and/or the BLOX family of polymers (e.g., BLOX 200 Series), commercially available from the Dow Chemical Company (Midland, MI).
  • a nonlimiting list of exemplary nylons includes Nylon 12, commercially available from Atofina (Philadelphia, PA), Nylon 6, commercially available from Honeywell (Morristown, NJ), Nylon 6/10, coimnercially available from BASF (Mount Olive, NJ), Nylon 6/12, commercially available from Ashley Polymers (Cranford, NJ), Nylon 11, Nylon MXD-6, the Grivory family of polymers, commercially available from EMS (Sumter, SC), the Grilamid family of polymers, commercially available from EMS (Sumter, SC), and the Nestamid family of polymers, commercially available from Daicel-Degussa Ltd.
  • one or more of the layers of wall 18 can contain additional material(s).
  • one or more layers of wall 18 can contain one or more additional polymers (e.g., blended therewith), such as liquid crystal polymer(s) (LCPs), polyester(s), polyamide(s), and/or their copolymers.
  • additional polymers e.g., blended therewith
  • LCPs liquid crystal polymer(s)
  • polyester(s) polyester(s)
  • polyamide(s) polyamide
  • examples of such materials include the Nectra family of polymers (e.g., Nectra A, Nectra B, Nectra LKX, Nectra LKX 1111) and the Nectran family of polymers (e.g.
  • the thicl ⁇ iess of layers 20, 22 and 24 can be varied as desired. h certain embodiments, the thickness of layer 20 is at least about 50 percent
  • the thickness of layer 24 is less than about 50 percent (e.g., less than about 40 percent, less than about 30 percent, less than about 20 percent, less than about 10 percent, less than about five percent, less than about two percent) of the total thickness of wall 18.
  • the balloon can have a diameter of, for example, at least about one millimeters (e.g., at least about two millimeters, at least about tliree millimeters).
  • the balloons have a relatively large diameter (e.g., at least about four millimeters, at least about five millimeters, at least about six millimeters, at least about seven millimeters, at least about eight millimeters, at least about nine millimeters, at least about 10 millimeters, at least about 11 millimeters, at least about 12 millimeters, at least about 20 millimeters, at least about 30 millimeters, at least about 40 millimeters).
  • the balloon can have a relatively high burst pressure.
  • the balloon can have a burst pressure of at least about 200 psi (e.g., at least about 225 psi, at least about 250 psi, at least about 275 psi, at least about 300 psi, at least about 325 psi, at least about 350 psi, at least about 375 psi, at least about 400 psi, at least about 425 psi, at least about 450 psi).
  • the burst pressure of a balloon is determined as follows. The balloon is deflated and submerged in a water bath at 37°C. The balloon is then inflated with water at a rate of about 20 psi per second until the balloon bursts.
  • the balloon can have a relatively high degree of compliance.
  • the balloon can have a compliance of at least about two percent (e.g., at least about 2.25%, at least about 2.5%, at least about 2.75%, at least about tliree percent, at least about 3.25%, at least about 3.5%).
  • the degree of compliance of a balloon is determined as follows. The balloon is held at 37°C and inflated first to one atmosphere pressure, and then in increments of one atmosphere pressure while measuring the diameter of the balloon. This is done until the balloon reaches the rated burst pressure or until the balloon bursts.
  • FIG. 3 is a schematic diagram showing steps in a process 300 for making balloon 14.
  • layers 20, 22 and 24 are coextensively coextruded to form a tube.
  • a preform is fonned from the tube.
  • Layers 20, 22 and 24 in the preform are crystallized (e.g., biaxially oriented) during a step 330.
  • a free form balloon is prepared, and the balloon is optionally subjected to a mold heat set in step 350.
  • making the coextruded balloons with appropriate physical properties can involve using an extrusion apparatus and/or extrusion conditions that provide a residence time and adequate pressure for the polymers that is sufficient for appropriate adhesion to occur between the polymer layers but not so severe so that the polymers undergo undesirable degradation, particularly the adhesive layer material(s).
  • Fig. 5 is a schematic representation of an embodiment of extrusion apparatus 410 having extruders 412, 414 and 416, and a cross-head 418. Extruders 412, 414 and 416 have hoppers 413, 415 and 417, respectively.
  • FIG. 6 is a cross-sectional view of an embodiment of a cross-head 418.
  • Cross- head 418 has a body 600, a die retainer 610, an inner layer flow divider 620, a middle layer flow divider 630, an outer layer flow divider 640, bolts 650 and 660, divider alignment pins 670, 680 and 690, a tip 700, a die 710, a tip retainer 720, a body heater 730 and a die retainer heater 740.
  • the of cross-head 418 that contains the material(s) from layer 22 is formed is at least about two cubic centimeters (e.g., at least about 2.2 cubic centimeters, at least about 2.4 cubic centimeters) and/or less than about four cubic centimeters (e.g., less than about 3.5 cubic centimeters, less than about three cubic centimeters).
  • the volume of cross-head 418 that contains the material(s) from layer 24 is formed is at least about three cubic centimeters (e.g., at least about 3.3 cubic centimeters, at least about 3.6 cubic centimeters) and/or less than about 4.5 cubic centimeters (e.g., less than about 4.4 cubic centimeters, less than about 4.3 cubic centimeters).
  • Steps 320, 330 and 340 can be performed using standard processes, such as disclosed, for example, in U.S. Patent Nos. 5,195,969; 5,270,086 and 5,769,817, which are hereby incorporated by reference.
  • a temperature of at least about 120°C and/or less than about 125°C e.g., about 123.5°C
  • a temperature of at least about three minutes and/or less than about five minutes e.g., about four minutes.
  • optional mold heat set step 350 can assist in reducing (e.g., substantially eliminating) the presence of delamination in balloon 14.
  • the pressure used in step 350 is typically at least about 50 psi (e.g., at least about 100 psi, at least about 200 psi, at least about 225 psi) and/or less than about 400 psi (e.g., less than about 300 psi, less than about 275 psi), such as about 250 psi.
  • the temperature of the balloon in step 350 is usually at least about 50°C (e.g., at least about 150°C, at least about 125°C, at least about 140°C) and/or less than about 250°C (e.g., less than about 225°C, less than about 200 °C, less than about 175°C, less.than about 160°C), such as from about 145°C to about 150°C.
  • the pressure and temperature are used for at least about five seconds (e.g., at least about 10 seconds, at least about 20 seconds) and/or at most about 50 seconds (e.g., at most about 40 seconds), such as about 30 seconds.
  • the burst pressure of a balloon was determined as follows. The balloon was deflated and submerged in a water bath at 37°C. The balloon was then inflated with water at a rate of about 20 psi per second until the balloon burst. The rated burst pressure corresponds to the average pressure at which a balloon burst based on a given population of balloons (e.g., a population of about 30 balloons).
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 550°F, 390°F, and 350°F, respectively.
  • the pressures of the extruders were 2180-2240 psi, 1545-1550 psi, and 890-940 psi, respectively.
  • the cooling bath temperature was 45°F, and the line speed was 90 feet per minute.
  • the tube had an inner diameter of 0.0146 inch and an outer diameter of 0.0377 inch.
  • the tube was formed into a balloon using a balloon formation temperature of 95°C and a balloon pressure of 140 psi. No heat set was used.
  • the balloon had a diameter of 3.0 millimeters, and a length of 20 millimeters.
  • the overall single wall thickness of the balloon was 0.0007 inch.
  • the balloon had a burst pressure of 374 psi (no observed delamination), and a compliance of 3.4%. Compliance was measured as follows. The balloon was held at 37°C and inflated first to one atmosphere pressure, and then in increments of one atmosphere pressure while measuring the diameter of the balloon. This was done until the balloon reaches the rated burst pressure or until the balloon bursted. A plot of the results was generated, and the slope from four atmospheres pressure to the rated burst pressure was calculated, and was the compliance value (diameter versus pressure).
  • Example 2 A three-layer balloon was prepared as follows.
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 610°F, 350°F, and 495°F, respectively.
  • the pressures of the extruders were 4610-4800 psi, 1052-1187 psi, and 2850-2980 psi, respectively.
  • the cooling bath temperature was 45 °F, and the line speed was 60 feet per minute.
  • the tube had an inner diameter of 0.027 inch and an outer diameter of 0.063 inch.
  • the tube was formed into a balloon using a balloon formation temperature of 93°C and a balloon pressure of 340 psi.
  • the heat set temperature was 170°C.
  • the heat set pressure was 200 psi, and the heat set duration was 30 seconds.
  • the balloon had a diameter of 5.0 millimeters, and a length of 40 millimeters.
  • the overall single wall thickness of the balloon was 0.0011 inch.
  • the balloon had a burst pressure of 377 psi (no observed delamination), a compliance of 3.2% (measured as described in Example 1), and a maximum puncture force of 4.2 pounds.
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 550°F, 390°F, and 400°F, respectively.
  • the pressures of the extraders were 3020-3090 psi, 1110-1115 psi, and 970-1010 psi, respectively.
  • the cooling bath temperature was 45°F, and the line speed was 30 feet per minute.
  • the tube had an inner diameter of 0.039 inch and an outer diameter of 0.075 inch.
  • the tube was fonned into a balloon using a balloon formation temperature of 95°C and a balloon pressure of 255 psi.
  • the heat set temperature was 170°C.
  • the heat set pressure was 250 psi, and the heat set duration was 30 seconds.
  • the balloon had a diameter of 7.0 millimeters, and a length of 40 millimeters.
  • the overall single wall thickness of the balloon was 0.0012 inch.
  • the balloon had a burst pressure of 311 psi (no observed delamination), and a compliance of 3.5% (measured as described in Example 1).
  • Example 4
  • a three-layer balloon was prepared as follows.
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 550°F, 390°F, and 400°F, respectively.
  • the pressures of the extraders were 2970-3080 psi, 1330-1350 psi, and 790-840 psi, respectively.
  • the cooling bath temperature was 45°F, and the line speed was 30 feet per minute.
  • the tube was fo ⁇ ned into a balloon using a balloon formation temperature of
  • the heat set temperature was 170°C.
  • the heat set pressure was 200 psi, and the heat set duration was 30 seconds.
  • Example 5 Nine balloons were prepared according to the same method. Each balloon was exposed to the multiple inflation test and showed no signs of delamination (10X magnification) after bursting. Example 5
  • a three-layer balloon was prepared as- follows.
  • the tube was formed into a balloon using a balloon formation temperature of 93°C and a balloon pressure of 370 psi.
  • the heat set temperature was 170°C.
  • the heat set pressure was 270 psi, and the heat set duration was 30 seconds.
  • the balloon had a diameter of 5.0 millimeters, and a length of 40 millimeters.
  • the overall single wall thickness of the balloon was 0.0013 inch.
  • the balloon had a burst pressure of 406 psi.
  • the balloon was exposed to the multiple inflation test and showed no signs of delamination (10X magnification) after bursting.
  • Example 6 A three-layer balloon was prepared as follows.
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 540°F, 350°F, and 350°F, respectively.
  • the pressures of the extraders were 6020-6210 psi, 3860-3870 psi, and 4070-5220 psi, respectively.
  • the cooling bath temperature was 45°F, and the line speed was 70 feet per minute.
  • the tube was fonned into a balloon using a balloon fonnation temperature of 93°C and a balloon pressure of 360 psi.
  • the heat set temperature was 170°C.
  • the heat set pressure was 200 psi, and the heat set duration was 60 seconds.
  • the balloon had a diameter of 5.0 millimeters, and a length of 40 millimeters.
  • Example 7 A three-layer balloon was prepared as follows.
  • Example 8 A three-layer balloon was prepared as follows.
  • a tube having layers fo ⁇ ned of Melinar 5922C (E. I. DuPont de Nemours), Bynel CXA E-418 (E. I. DuPont de Nemours), and Vestamid L2101F (Atofina), respectively, was formed using an extrusion apparatus.
  • the volumes of the portion of the cross-head containing the material was 3.7 cubic centimeters, 2.7 cubic centimeters, and 3.9 cubic centimeters, respectively.
  • the temperatures of the extruders were 565°F, 250°F, and 520°F, respectively.
  • the pressures of the extraders were 4220-4240 psi, 2000-2020 psi, and 2200-2280 psi, respectively.
  • the cooling bath temperature was 45°F, and the line speed was 45 feet per minute.
  • the balloon had a diameter of 8.0 millimeters, and a length of 40 millimeters.
  • the overall single wall thickness of the balloon was 0.0013 inch.
  • the balloon had a burst pressure of 316 psi. The balloon was exposed to the multiple inflation test and showed no signs of delamination (10X magnification) after bursting.
  • the balloons can be used in various medical procedures.
  • the balloons can be used to open an occluded lumen, as in angioplasty.
  • the balloons can be used to position another medical implement, such as a stent or graft, within a lumen.
  • the balloons can be used to selectively block a passageway.
  • the balloons can be used in various combinations of these procedures.
  • the methods can be used to fonn medical devices other than a balloon, such as a catheter shaft.
  • Other embodiments are in the claims.

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PCT/US2003/020861 2002-10-21 2003-07-01 Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers Ceased WO2004037309A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP03742399A EP1556096B1 (en) 2002-10-21 2003-07-01 Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers
JP2004546685A JP2006503642A (ja) 2002-10-21 2003-07-01 ポリエステル層、ポリアミド層、接着材料層を備え、共押出成形された多層医療用具
CA002502778A CA2502778A1 (en) 2002-10-21 2003-07-01 Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers
AU2003301657A AU2003301657A1 (en) 2002-10-21 2003-07-01 Coextruded multilayer medical device comprising polyester, polyamide and adhesive material layers
AT03742399T ATE512678T1 (de) 2002-10-21 2003-07-01 Coextrudierte mehrschichtige medizinische vorrichtung enthaltend polyester-, polyamid- und klebstoffschichten

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US10/274,633 2002-10-21
US10/274,633 US7488339B2 (en) 2002-10-21 2002-10-21 Multilayer medical device

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US7488339B2 (en) 2009-02-10
EP1556096A1 (en) 2005-07-27
ATE512678T1 (de) 2011-07-15
CA2502778A1 (en) 2004-05-06
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