Coating gradient for lubricious coatings on balloon catheters

• US 6,261,630 B1
• Filed: 01/17/2001
• Issued: 07/17/2001
• Est. Priority Date: 06/03/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Wang, Lixiao, Nazarova, Irina
• Primary Examiner(s): Wu, David W.
• Assistant Examiner(s): LU, C CAIXIA
• Application Number:
  US09/764,180
• Publication Number:
  US 20010006700A1
• Time in Patent Office: 181 Days
• Field of Search: 427/2.12, 604/265, 428/213, 428/212
• US Class Current: 427/2.12
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
• 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 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 49/10 using mechanical means for prestretching
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C08L 35/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a carboxyl radical, and containing at least one other carboxyl radical in the molecule, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: Y10T 428/24942 : including components having same physical characteristic in differing degree
• CPC Class Codes: Y10T 428/2495 : Thickness [relative or absolute]
• CPC Class Codes: Y10T 428/31511 : Of epoxy ether
• CPC Class Codes: Y10T 428/31725 : Of polyamide
• CPC Class Codes: Y10T 428/31935 : Ester, halide or nitrile of addition polymer

Abstract

This invention relates to a dilatation balloon formed from an extruded tubular preform by blowing, said balloon having a body, at least one cone and at least one waist portion wherein said balloon has a lubricity coating gradient from the body portion which has the lowest coat thickness to the waist portion which has the highest coat thickness said coating applied to said extruded tubular preform prior to forming said balloon by blowing.

Claims

1. A method of forming a lubriciously coated dilatation balloon, comprising the steps of:

a) extruding balloon material into a tubular preform;

b) coating said tubular preform with a lubricious coating material; and

c) blowing said coated tubular preform into a balloon, said balloon having a body, at least one cone portion and at least one waist portion,

wherein the balloon surface has a gradient of lubricity.

2. The method of claim 1 wherein said tubular preform is stretched prior to blowing the balloon.

3. The method of claim 2 wherein said lubricity coating is applied to said balloon material before said tubular form is stretched.

4. The method of claim 1 wherein said lubricious coating is dissolved in a solvent or cosolvent mixture.

5. The method of claim 2 wherein said lubricity coating is applied to said balloon material after said tubular form is stretched.

6. The method of claim 1 wherein said lubricious coating is selected from the group consisting of hydrophobic polymers and hydrophilic polymers.

7. The method of claim 1 wherein said lubricious coating comprises at least one copolymer of maleic acid.

8. The method of claim 1 wherein said copolymer of maleic acid is obtained from maleic anhydride copolymer modified by reaction of some of the anhydride groups thereof with a member selected from the group consisting of monofunctional amines, alcohols, epoxies, imines and mixtures thereof.

9. The method of claim 8 wherein said copolymer of maleic anhydride is selected from the group consisting of poly(ethylene-maleic anhydride) copolymer and maleic anhydride-methyl vinyl ether copolymer.

10. The method of claim 1 wherein said lubricity coating comprises a hydrogel polymer.

11. The method of claim 10 wherein said hydrogel polymer comprises polyethylene oxide captured in an interpenetrating crosslinked acrylic polymer network.

12. The method of claim 1 wherein said lubricity coating comprises at least one polycarboxylic acid.

13. The method of claim 1 wherein said lubricity coating comprises a (meth)acrylic acid homopolymer or copolymer.

14. The method of claim 1 wherein said lubricity coating comprises a vinyl pyrrolidone homopolymer or copolymer.

15. The method of claim 1 wherein said lubricious coating on said tubular preform before blowing is at a coating thickness of about 1 μ

m to about 10 μ

m.

16. The method of claim 1 wherein said lubricious coating on said balloon body after blowing is at a coating thickness of about 0.1 μ

m to about 1.0 μ

m and on said waist portion and said cone portion is from about 1 m to about 10 μ

m.

17. A method of forming a lubriciously coated medical device balloon, comprising the steps of:

a) coating said tubular preform with a lubricious coating material; and

b) blowing said coated tubular preform into a balloon, said balloon having a body, at least one cone portion and at least one waist portion,

wherein the balloon surface has a gradient of lubricity.