Multilayer extrusion of angioplasty balloons

• US 5,270,086 A
• Filed: 07/09/1991
• Issued: 12/14/1993
• Est. Priority Date: 09/25/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Hamlin, Robert N.
• Primary Examiner(s): Robinson, Ellis P.
• Assistant Examiner(s): DYE, RENA
• Application Number:
  US07/727,664
• Time in Patent Office: 889 Days
• Field of Search: 606/192, 606/194, 604/96, 428/34.9, 428/35.2, 428/36.9, 428/36.92, 428/35.7
• US Class Current: 428/35.2
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/1029 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
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: B29C 49/04 Extrusion blow-moulding
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/083 EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C08L 23/00 Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 : Single layer [continuous layer]

Abstract

A method of producing laminated inflatable, substantially inextensible expander members having composite properties enhancing their use on intravascular catheters, such as angioplasty catheters is described. Diverse polymeric compounds of differing properties are coextruded to create a multilayer parison. The parison is subsequently drawn and expanded in a blow molding operation to yield an expander member exhibiting enhanced properties including lubricity, burst-strength, limited radial expansion, bondability, and rupture characteristics.

Claims

1. A coaxially-layered, multilayer expander member for attachment to a medical catheter body member comprising:

an outer extruded tensile layer consisting essentially of a biaxially-oriented tubular polymeric film exhibiting high tensile strength and low distensibility;

an inner bonding layer consisting essentially of a polymeric plastic film co-extruded with the outer tensile layer and adhered to the outer tensile layer, forming therewith a layer combination, the inner bonding layer further being one which adheres readily to a catheter body using a process selected from the group consisting of melt bonding and adhesive bonding; and

wherein the mode of high pressure failure of the layer combination is for the expander member to rupture rather than develop leaks.

2. A coaxially-layered, multilayer expander member for attachment to a medical catheter body member comprising in combination:

an outer extruded biaxially-oriented tubular polymeric film tensile layer exhibiting high tensile strength and low distensibility selected from materials of the group consisting of high and medium melt temperature copolymers, high melt temperature polyesters, high melt temperature polyethers, medium melt temperature polyethers, and medium melt temperature polyamides; and

an inner easily expanded polymeric plastic film bonding layer co-extruded with the outer layer and adhered to the outer tensile layer forming therewith a layer combination the inner bonding layer being one which readily adheres to a catheter body using a process selected from the group consisting of melt bonding and adhesive bonding; and

wherein the mode of high pressure failure of the layer combination is for the expander member to rupture rather than develop leaks.

3. The multilayer expander member of claim 2 wherein the inner layer is not coextensive with the inner surface of the outer layer.

4. The multilayer expander member of claim 2 wherein:

the outer tensile layer further consists essentially of a material selected from the group consisting of ABS (acrylonitrile-butadiene-styrene), ABS/nylon, ABS/polyvinyl chloride (PVC), ABS/polycarbonate and combinations thereof, acrylonitrile copolymer, polyacrylamide, polyacrylate, polyacrylsulfone, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), liquid crystal polymer (LCP), polyester/polycaprolactone polyester/polyadipate, polyetheretherketone (PEEK), polyethersulfone (PES), polyetherimide (PEI), polyetherketone (PEK), polymenthylpentene, polyphenylene ether, polyphenylene sulfide, styrene acrylonitrile (SAN), nylon 6, nylon 6/6, nylon 6/66, nylon 6/9, nylon 6/10, nylon 6/12, nylon 11 and nylon 12; and

wherein the inner bonding layer consists of a material selected from the group consisting of ethylene propylene, ethylene vinylacetate and ethylene vinyl alcohol (EVA), various ionomers, polyethylene type I-IV, polyolefins, polyurethane, polyvinyl chloride, and polysiloxanes (silicones).

5. The multilayer expander member of claim 4 wherein the material of the inner layer adheres to surfaces readily by melt bonding and has a melting point below that of the outer layer.

6. The multilayer expander member of claim 5 wherein the inner layer is not coextensive with the inner surface of the outer layer.

7. The multilayer expander member of claim 2 wherein the material of the inner layer adheres to surfaces readily by melt bonding and has a melting point below that of the outer layer.

8. The multilayer expander as in claim 2 wherein the inner film layer comprises an amorphous polyester.

9. A coaxially-layered, multilayer expander member for attachment to a medical catheter body member comprising:

an outer extruded tensile layer consisting essentially of a biaxially-oriented tubular polymer film exhibiting high tensile strength and low distensibility;

an inner bonding layer consisting essentially of a polymeric plastic film co-extruded with the outer tensile layer and adhered to the outer tensile layer, forming a layer combination, the inner bonding layer further being one which adheres readily to a catheter body using a process selected from the group consisting of melt bonding and adhesive bonding;

wherein the mode of high pressure failure of the layer combination is for the expander member to rupture rather than develop leaks; and

a coating of an hydrophilic, lubricous polymer material on the outer surface of the tensile layer.

10. A coaxially-layered, multilayer expander member for attachment to a medical catheter body member comprising in combination:

an outer extruded biaxially-oriented tubular polymeric film tensile layer exhibiting high tensile strength and low distensibility selected from materials of the group consisting of high and medium melt temperature copolymers, high melt temperature polyesters, high melt temperature polyethers, medium melt temperature polyethers, and medium melt temperature polyamides; and

an inner easily expanded polymeric plastic film bonding layer co-extruded with the outer layer and adhered to the outer layer the bonding layer being one which readily adheres to a catheter body using a process selected from the group consisting of melt bonding and adhesive bonding;

wherein the mode of high pressure failure of the layer combination is for the expander member to rupture rather than develop leaks; and

a coating of an hydrophilic, lubricous polymer material on the outer surface of the tensile layer.

11. The expander as in claim 10 wherein the inner layer comprises a polyolefin.

12. The expander as in claim 10 wherein the hydrophilic polymer is polycaprolactam.

13. A coaxially-layered, multilayer expander member for attachment to a medical catheter body member comprising in combination:

an outer extruded biaxially-oriented tubular polymeric film tensile layer exhibiting high tensile strength and low distensibility selected from materials of the group consisting of ABS (acrylonitrile-butadiene-styrene), ABS/nylon, ABS/polyvinyl chloride (PVC), ABS/polycarbonate and combinations thereof, acrylonitrile copolymer, polyacrylamide, polyacrylate, polyacrylsulfone, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), liquid crystal polymer (LCP), polyester/polycaprolactone polyester/polyadipate, polyetheretherketone (PEEK), polyethersulfone (PES), polyetherimide (PEI), polyetherketone (PEK), polymenthylpentene, polyphenylene ether, polyphenylene sulfide, styrene acrylonitrile (SAN), nylon 6, nylon 6/6, nylon 6/66, nylon 6/9, nylon 6/10, nylon 6/12, nylon 11 and nylon 12;

an inner easily expanded polymeric plastic film bonding layer co-extruded with the outer layer and adhered to the outer tensile layer forming therewith a layer combination the inner bonding layer being one which readily adheres to a catheter body using a process selected from the group consisting of melt bonding and adhesive bonding, wherein the inner bonding layer consists of a material selected from the group consisting of ethylene propylene, ethylene vinylacetate and ethylene vinyl alcohol (EVA), various ionomers, polyethylene type I-IV, polyolefins, polyurethane, polyvinyl chloride, and polysiloxanes (silicones);

a coating of an hydrophilic, lubricous polymer material on the outer surface of the tensile layer; and

wherein the mode of high pressure failure of the layer combination is for the expander member to rupture rather than develop leaks.

14. The multilayer expander member of claim 13 wherein the coating of hydrophilic, lubricous polymer material on the outer surface of the tensile layer is selected from the group consisting of polycaprolactam, polyvinylindol and vinyl pyrrolidone and hydrogels.

15. The multilayer expander member of claim 13 wherein the material of the inner layer adheres to surfaces readily by melt bonding and has a melting point below that of the outer layer.

16. The multilayer expander member of claim 14 wherein the material of the inner layer adheres to surfaces readily by melt bonding and has a melting point below that of the outer layer.

17. An expander member for attachment to an intravascular catheter body member comprising:

an outer coating layer of an hydrophilic, lubricous polymer;

an extruded tubular tensile layer of biaxially oriented polyethylene terephthalate carrying the outer coating layer and exhibiting a radial expansion not exceeding 3-10 percent;

an inner tubular layer of an amorphous polyester plastic material co-extruded with the tensile layer coaxially adhered to the tensile layer;

wherein the predetermined burst pressure is in excess of 7 atmospheres pressure; and

wherein the expander member has failure characteristics in which the expander will burst rather than develop small leaks.

18. The expander as in claim 17 and further including hot-melt adhesive layers disposed between the tensile and inner layers.