Catheters with lubricious linings and methods for making and using them

• US 20070074805A1
• Filed: 01/26/2006
• Published: 04/05/2007
• Est. Priority Date: 10/04/2005
• Status: Active Grant

• Current Assignee: CLPH, LLC
• Original Assignee: Dae Shin Led Co., Ltd.
• Inventors: Leeflang, Stephen, Mourlas, Nicholas, Eversull, Christian
• Granted Patent: US 7,553,387 B2
• Time in Patent Office: Days
• US Class Current: 156/84
• 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: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0048 with an outer layer made from silicon
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• 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: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 48/001 Combinations of extrusion moulding with other shaping operations
• CPC Class Codes: B29C 48/0021 combined with joining, lining or laminating
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• CPC Class Codes: B29C 48/08 flexible, e.g. films
• 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 48/11 comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/13 Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes
• CPC Class Codes: B29C 48/151 Coating hollow articles
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 53/40 for articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 61/006 the force created by the liberation of the internal stresses being used for compression moulding or for pressing preformed material
• CPC Class Codes: B29C 66/1122 : Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/1142 : Single butt to butt joints
• CPC Class Codes: B29C 66/131 : Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/432 : for making tubular articles or closed loops, e.g. by joining several sheets B29C66/547 takes precedence; bending and joining sheets at right angles to the longitudinal axis of the article being formed and joining the edges B29C53/38; for making hollow articles or hollow preforms
• CPC Class Codes: B29C 66/4322 : by joining a single sheet to itself B29C66/4332 takes precedence
• CPC Class Codes: B29C 66/49 : Internally supporting the, e.g. tubular, article during joining B29C66/63 takes precedence
• CPC Class Codes: B29C 66/52272 : concentrically, e.g. for forming multilayer tubular articles
• CPC Class Codes: B29C 67/0018 : Turning tubes inside out for lining internal surfaces B29C63/36
• CPC Class Codes: B29C 69/001 : a shaping technique combined with cutting, e.g. in parts or slices combined with rearranging and joining the cut parts for reinforced material B29C70/545; B29C49/4278, B29C51/268 take precedence
• CPC Class Codes: B29D 23/001 : Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29L 2031/602 : composed of several elementary tubular elements
• 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: B32B 1/08 : Tubular products
• CPC Class Codes: B32B 2255/10 : on synthetic resin layer or on natural or synthetic rubber layer
• CPC Class Codes: B32B 2255/24 : Organic non-macromolecular coating
• CPC Class Codes: B32B 2255/26 : Polymeric coating
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/12 : next to a fibrous or filamentary layer
• CPC Class Codes: B32B 27/285 : comprising polyethers
• CPC Class Codes: B32B 27/40 : comprising polyurethanes
• CPC Class Codes: B32B 5/028 : Net structure, e.g. spaced apart filaments bonded at the crossing points
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: Y10T 156/1013 : and edge-joining of one piece blank to form tube
• CPC Class Codes: Y10T 156/1034 : Overedge bending of lamina about edges of sheetlike base
• CPC Class Codes: Y10T 156/1036 : Bending of one piece blank and joining edges to form article
• CPC Class Codes: Y10T 156/1038 : Hollow cylinder article
• CPC Class Codes: Y10T 156/1054 : and simultaneously bonding [e.g., cut-seaming]
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]

Abstract

A method for making a tubular device includes coating a first surface of a thin sheet, rolling the sheet such that side edges of the sheet are disposed adjacent one another with the coating disposed inwardly, creating a longitudinal seam along the side edges to create a sleeve, and attaching a tubular structure around the sleeve. In another embodiment, the method includes coating a first surface of a thin sheet, wrapping the sheet partially around a mandrel with the coating disposed inwardly, positioning a slotted tube around the sheet and mandrel, attaching the tube to the thin, and trimming any excess material of the sheet. In another embodiment, the method includes coating an outer surface of a thin sleeve, inverting the sleeve, and attaching a tubular structure around the inverted sleeve, thereby providing a tubular device including a lubricious, hydrophilic, and/or otherwise coated inner surface.

Claims

1. A method for making a tubular device sized for introduction into a body lumen, comprising:

providing a thin sheet comprising first and second side edges;

coating a first surface of the thin sheet with a coating having one or more desired properties;

rolling the thin sheet such that the first and second side edges are disposed adjacent one another and the coating is disposed inwardly;

creating a longitudinal seam along the first and second side edge to create a sleeve; and

attaching-a tubular structure around the sleeve.

2. The method of claim 1, wherein providing the thin sheet comprises attaching first and second layers of material together.

3. The method of claim 1, wherein the tubular structure comprises a thickness that is substantially greater than a thickness of the sleeve.

4. The method of claim 1, wherein the tubular structure comprises a reinforcement layer and an outer continuous layer.

5. The method of claim 1, wherein the sleeve and tubular structure are attached together by at least one of laminating, bonding, and heat sealing.

6. The method of claim 1, wherein the thin sheet comprises polyurethane and the tubular structure comprises at least one of PEBAX and Urethane.

7. The method of claim 6, wherein the sheet comprises Ester-based polyurethane.

8. The method of claim 1, wherein the coating comprises a hydrophilic material.

9. The method of claim 1, further comprises removing excess material along the longitudinal seam, thereby removing a portion of the first and second side edges.

10. The method of claim 1, wherein the step of attaching the tubular structure around the sleeve comprises:

positioning the sleeve around a mandrel to create a first assembly; and

positioning the tubular structure over the first assembly to create a second assembly.

11. The method of claim 10, wherein the step of attaching the tubular structure around the sleeve further comprises:

positioning heat shrink tubing over the second assembly;

heating the heat shrink tubing; and

removing the shrink tubing from around the second assembly.

12. The method of claim 10, further comprising removing the mandrel after attaching the tubular structure to the sleeve.

13. A method for making a tubular device sized for introduction into a body lumen, comprising:

coating a first surface of a thin sheet with a coating imparting one or more desired properties to the first surface;

wrapping the thin sheet at least partially around a mandrel with the first surface disposed inwardly;

positioning a slotted tube around the thin sheet and mandrel;

attaching the slotted tube to the thin sheet to form a tubular structure; and

removing the tubular structure from the mandrel.

14. The method of claim 13, further comprising trimming excess edges of the thin sheet from the tubular structure.

15. The method of claim 13, wherein the slotted tube is attached to the thin sheet by at least one of lamination, bonding, and heat-sealing.

16. The method of claim 13, wherein the slotted tube comprises longitudinal edges defining a slot, and wherein the slotted tube is positioned around the thin sheet and mandrel by separating the longitudinal edges.

17. The method of claim 16, wherein the longitudinal edges are bonded together when the slotted tube is attached to the thin sheet.

18. The method of claim 13, wherein the slotted tube comprises a thickness that is substantially greater than a thickness of the thin sheet.

19. The method of claim 13, wherein the slotted tube comprises a reinforcement layer and an outer layer.

20. The method of claim 13, wherein the thin sheet comprises polyurethane and the slotted tube comprises at least one of PEBAX and Urethane.

21. The method of claim 13, wherein the coating comprises a hydrophilic material.

22. The method of claim 13, wherein the one or more desired properties comprise a predetermined lubricity.

23. The method of claim 13, wherein the slotted tube is attached to the thin sheet by directing the slotted tube, thin sheet, and mandrel through a heated die.

24. The method of claim 13, wherein the tubular structure is formed by a continuous process.

25. A method for making a tubular device sized for introduction into a body lumen, comprising:

providing a sheet of material comprising a first surface and a second surface;

coating the first surface of the sheet with a coating to impart the first surface with one or more desired properties; and

rolling the sheet until longitudinal edges of the sheet are disposed adjacent one another; and

attaching the longitudinal edges to one another to form a continuous wall defining a lumen.

26. The method of claim 25, wherein the coating comprises a hydrophilic material.

27. The method of claim 25, wherein the one or more desired properties comprise a predetermined lubricity.

28. The method of claim 25, wherein the longitudinal edges are attached to one another by using at least one of heat bonding, an adhesive, and lamination.

29. A method for making a tubular device sized for introduction into a body lumen, comprising:

providing a thin sheet comprising a first surface and a second surface;

coating the first surface with a coating to impart the first surface with one or more desired properties;

forming the thin sheet into a thin sleeve such that the first surface defines an inner surface; and

attaching a tubular structure around the thin sleeve, thereby providing a tubular device comprising an inner surface with the one or more desired properties.