Tube-in-tube balloon

• US 8,168,275 B2
• Filed: 10/24/2011
• Issued: 05/01/2012
• Est. Priority Date: 03/02/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Lee, Nao, Xiong, Ying, Khammoungkhoune, Joe, Chen, John J.
• Primary Examiner(s): Dye, Rena
• Assistant Examiner(s): Kashnikow, Erik
• Application Number:
  US13/279,913
• Publication Number:
  US 20120041467A1
• Time in Patent Office: 190 Days
• Field of Search: 428/35.7, 428/35.2, 428/36.9, 428/36.91, 604/96.01, 604/103.11, 604/192, 606/192
• US Class Current: 428/35.7
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• 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: B29C 2035/0827 using UV radiation
• CPC Class Codes: B29C 2035/0872 using ion-radiation, e.g. alpha-rays
• CPC Class Codes: B29C 2049/7862 characterised by temperature values or ranges
• CPC Class Codes: B29C 2949/3094 preform having at least partially loose components, e.g. at least partially loose layers
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 49/04 Extrusion blow-moulding
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29C 55/26 biaxial
• CPC Class Codes: B29C 65/1403 characterised by the type of electromagnetic or particle radiation B29C65/1603 takes precedence
• CPC Class Codes: B29C 65/1406 Ultraviolet [UV] radiation
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4815 Hot melt adhesives, e.g. thermoplastic adhesives
• CPC Class Codes: B29C 65/482 Drying adhesives, e.g. solvent based adhesives
• CPC Class Codes: B29C 65/4825 Pressure sensitive adhesives
• CPC Class Codes: B29C 65/4835 Heat curing adhesives
• CPC Class Codes: B29C 65/484 Moisture curing adhesives
• CPC Class Codes: B29C 65/4845 : Radiation curing adhesives, e.g. UV light curing adhesives
• CPC Class Codes: B29C 66/52271 : one tubular article being placed inside the other
• CPC Class Codes: B29C 66/63 : Internally supporting the article during joining B29C66/49 takes precedence
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/712 : the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B29K 2021/003 : Thermoplastic elastomers
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2023/083 : EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2023/086 : EVOH, i.e. ethylene vinyl alcohol copolymer
• CPC Class Codes: B29K 2023/16 : EPM, i.e. ethylene-propylene copolymers; EPDM, i.e. ethylene-propylene-diene copolymers; EPT, i.e. ethylene-propylene terpolymers
• CPC Class Codes: B29K 2023/18 : Polymers of hydrocarbons having four or more carbon atoms, e.g. polymers of butylene, e.g. PB, i.e. polybutylene
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2033/18 : Polymers of nitriles
• CPC Class Codes: B29K 2033/20 : PAN, i.e. polyacrylonitrile
• CPC Class Codes: B29K 2039/06 : Polymers of N-vinyl-pyrrolidones
• CPC Class Codes: B29K 2055/02 : ABS polymers, i.e. acrylonitrile-butadiene-styrene polymers
• CPC Class Codes: B29K 2065/00 : Use of polyphenylenes or polyxylylenes as moulding material
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2067/006 : PBT, i.e. polybutylene terephthalate
• CPC Class Codes: B29K 2067/04 : Polyesters derived from hydroxycarboxylic acids
• CPC Class Codes: B29K 2071/00 : Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/10 : Aromatic polyamides [polyaramides] or derivatives thereof
• CPC Class Codes: B29K 2079/085 : Thermoplastic polyimides, e.g. polyesterimides, PEI, i.e. polyetherimides, or polyamideimides; Derivatives thereof
• CPC Class Codes: B29K 2081/06 : PSU, i.e. polysulfones; PES, i.e. polyethersulfones or derivatives thereof
• CPC Class Codes: B29K 2096/005 : Ionomers
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2105/0079 : Liquid crystals
• CPC Class Codes: B29K 2105/0085 : Copolymers
• CPC Class Codes: B29K 2677/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, for preformed parts, e.g. for inserts
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2009/001 : the layers being loose
• CPC Class Codes: B29L 2022/022 : Balloons
• CPC Class Codes: B29L 2031/605 : concentrically
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: B29L 2031/7543 : Balloon catheters
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]

Abstract

A tube-in-tube assembled parison for preparation of an elongated medical device. The parison if formed by assembling in tube-in-tube fashion a first tube of orientable polymer material and a second tube formed of orientable polymer material disposed around the first tube, with an adhesive tie layer disposed between the first and second tubes. The tubes are brought into contact to form a unitary parison. The adhesive may allow movement between the polymer layers during balloon blowing. The first tube, or the second tube, or both, may have been longitudinally pre-stretched after formation thereof but before assembly of the parison.

Claims

1. A medical balloon formed by a process comprising, obtaining an assembled tubular parison comprising:

a first tube of orientable polymer material,

a second tube formed of orientable polymer material disposed around the first tube,

the first tube, or the second tube, or both, having been longitudinally pre-stretched after formation thereof but before assembly of the parison, and

an adhesive layer disposed between the first and second tubes and contacting the first and second tubes, the adhesive is selected to allow relative movement of the materials of the first and second tubes during heated radial expansion of the parison to form a balloon but which subsequent to balloon formation is effective to adhere the materials of the two layers together at human body temperature, and subjecting the assembled tubular parison to radial expansion.

2. The medical balloon of claim 1, the adhesive layer comprising a heat activatable aqueous dispersion adhesive, a heat activatable solvent based adhesive, a moisture curable adhesive, or a radiation curable adhesive the adhesive is unactivated or uncured during radial expansion of the parison.

3. The medical balloon of claim 1 wherein the adhesive is a pressure sensitive adhesive.

4. The medical balloon of claim 3 wherein the adhesive is a heat activatable adhesive.

5. The medical balloon of claim 3 wherein the adhesive is a moisture curable adhesive.

6. The medical balloon of claim 3 wherein the adhesive is a UV or ionizing radiation curing adhesive.

7. The medical balloon of claim 1 wherein the adhesive is an emulsion adhesive.

8. The medical balloon of claim 1 wherein the first and second tubes, independently, are formed of a material selected from the group consisting of polyamide block copolymers, polyester block copolymers, polyesters, polyamides, polyurethanes, polyurethane block copolymers, polyetheretherketones, polyolefins, polyolefin ionomers, liquid crystal polymers, acrylonitrile polymers and copolymers, or a mixture or two or more thereof.

9. The medical balloon of claim 1 wherein the first and second tubes are formed of the same material.

10. The medical balloon of claim 1 wherein the first and second tubes are formed of different polymer materials.

11. The medical balloon of claim 1 wherein the first tube comprises a low compliant, high strength polymer and the second tube comprises a softer and more flexible polymer material relative to the first polymer material.

12. The medical balloon of claim 1 wherein, after formation of the assembly, the assembly has been longitudinally post-stretched.

13. The medical balloon of claim 1 wherein the adhesive layer should provides 20% or less of the balloon wall thickness.

14. The medical balloon of claim 1 wherein the adhesive layer provides 10% or less of the balloon wall thickness.

15. The medical balloon of claim 1 wherein after formation of the medical balloon the medical balloon has a diameter of about 1-10 mm and the unimolecular thickness of the adhesive layer is about 0.05 μ

m to about 2 μ

m.

16. The medical balloon of claim 1 wherein the adhesive layer after the balloon has been formed has a unimolecular thickness to about 2 μ

m.

17. The medical balloon of claim 1 wherein the first tube comprises a low compliant, high strength polymer.

18. The medical balloon of claim 17 having an additive burst strength of greater by at least 50% than a medical balloon formed from the first polymer tube alone.

19. The medical balloon of claim 1 wherein the second tube comprises a softer and more flexible polymer material relative to the first polymer material.

20. The medical balloon of claim 19 having an additive burst strength of great by at least 75% of a medical balloon formed from the second polymer tube alone.