CATHETERS WITH LUBRICIOUS LININGS AND METHODS FOR MAKING AND USING THEM

• US 20090259202A1
• Filed: 06/22/2009
• Published: 10/15/2009
• Est. Priority Date: 01/26/2006
• Status: Active Grant

• Current Assignee: CLPH, LLC
• Original Assignee: Dae Shin Led Co., Ltd.
• Inventors: Mourlas, Nicholas J., Leeflang, Stephen A., Eversull, Christian S.
• Granted Patent: US 7,785,434 B2
• Time in Patent Office: Days
• US Class Current: 604/265
• 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 2025/0046 Coatings for improving slidability
• 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: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• 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 53/40 for articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 53/46 using external forming surfaces, e.g. sleeves
• 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 66/112 Single lapped joints
• 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 66/133 : Fin-type joints, the parts to be joined being flexible the parts to be joined being rigid B29C66/1312
• CPC Class Codes: B29C 66/135 : Single hemmed joints, i.e. one of the parts to be joined being hemmed 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 66/438 : Joining sheets for making hollow-walled, channelled structures or multi-tubular articles
• 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 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 66/723 : being multi-layered B29C66/7292, B29C66/72941 take precedence
• 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: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• 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 2250/24 : All layers being polymeric
• CPC Class Codes: B32B 2255/10 : on synthetic resin layer or on natural or synthetic rubber layer
• CPC Class Codes: B32B 2255/26 : Polymeric coating
• CPC Class Codes: B32B 2262/0269 : Aromatic polyamide fibres
• CPC Class Codes: B32B 2262/101 : Glass fibres
• CPC Class Codes: B32B 2262/103 : Metal fibres
• CPC Class Codes: B32B 2307/728 : Hydrophilic
• CPC Class Codes: B32B 2307/736 : Shrinkable
• CPC Class Codes: B32B 2307/746 : Slipping, anti-blocking, low friction
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• 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 27/34 : comprising polyamides
• 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 156/1008 : Longitudinal bending
• CPC Class Codes: Y10T 156/101 : Prior to or during assembly with additional lamina
• 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 156/1062 : Prior to assembly
• CPC Class Codes: Y10T 156/1066 : Cutting to shape joining edge surfaces only
• CPC Class Codes: Y10T 156/1313 : Cutting element simultaneously bonds [e.g., cut seaming]
• CPC Class Codes: Y10T 156/1322 : Severing before bonding or assembling of parts

Abstract

Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

Claims

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

providing first and second sheets adjacent one another such that first surfaces of the sheets are oriented towards one another and second surfaces of the sheets are oriented away from one another;

directing the first and second sheets through a cutting apparatus such that the first and second sheets are cut into multiple pairs of strips; and

bonding the pairs of strips together to create a plurality of thin-walled sleeves having inner lumens defined by the first surfaces.

2. The method of claim 1, wherein the pairs of strips are bonded together when the first and second sheets are directed through the cutting element.

3. The method of claim 1, wherein the first surfaces of the first and second sheets comprise a coating having one or more desired properties.

4. The method of claim 3, wherein the coating comprises a hydrophilic material.

5. The method of claim 1, wherein providing the first and second sheets comprises providing rolls including the first and second sheets wound around the rolls such that the sheets may be fed substantially continuously through the cutting element.

6. The method of claim 1, further comprising cutting the thin-walled sleeves into individual lengths.

7. The method of claim 6, further comprising attaching a tubular structure around each of the individual lengths of the thin-walled sleeves.

8. The method of claim 7, wherein the tubular structure comprises a reinforcement layer and an outer continuous layer.

9. The method of claim 1, wherein the first and second sheets comprise polyurethane.

10. The method of claim 1, further comprising winding the thin-walled sleeves around one or more collecting rollers.

11. The method of claim 1, wherein the cutting element maintains sufficient tension on the first and second sheets to maintain the first and second sheets in contact with one another when the first and second sheets are cut and bonded.

12. The method of claim 1, wherein the cutting element comprises a heated element that bonds longitudinal edges of the pairs of strips substantially simultaneously with cutting the first and second sheets.

13. The method of claim 1, wherein the pairs of strips are bonded together by directing the pairs of strips between respective mandrels and pairs of rollers.

14. The method of claim 13, wherein the pairs of rollers create longitudinal seams substantially continuously as the pairs of strips are directed through the respective mandrels and pairs of rollers.

15. A method for making a plurality of tubular devices sized for introduction into a body lumen, comprising:

providing first and second sheets adjacent one another such that first surfaces of the sheets are oriented towards one another and second surfaces of the sheets are oriented away from one another, the first surfaces comprising a coating having one or more desired properties;

directing the first and second sheets through a cutting apparatus to cut the first and second sheets into multiple pairs of strips defining longitudinal edges and bonding the longitudinal edges of adjacent first and second strips to create a plurality of thin-walled sleeves having inner lumens defined by the first surfaces; and

cutting each of the thin-walled sleeves into a plurality tubular devices.

16. A method for making a plurality of tubular devices sized for introduction into a body lumen, comprising:

providing a first sheet having first and second surfaces, the first surface comprise a coating having one or more desired properties;

feeding the first sheet through a cutting tool to separate the first sheet into a plurality of elongate strips;

forming the strips into elongate sleeves such that the first surface defines a lumen within the sleeves; and

cutting each of the sleeves into individual tubular devices.

17. The method of claim 16, further comprising attaching a tubular structure around each of the individual tubular devices to create a catheter.

18. The method of claim 16, wherein the strips are formed into elongate sleeves by feeding the strips through respective forming dies.

19. A method for making a plurality of catheters sized for introduction into a body lumen of a patient, comprising:

providing a first sheet having first and second surfaces, the first surface comprise a coating having one or more desired properties;

feeding the first sheet through a cutting tool to separate the first sheet into a plurality of elongate strips, each strip having first and second side edges;

thereafter, rolling each of the strips such that the first and second side edges are disposed adjacent one another and the coated first surface is disposed inwardly and the second surface of the strip is disposed outwardly; and

attaching a tubular structure around the rolled strip to create a catheter sized for introduction into a body lumen of a patient.

20. A tubular device, comprising a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends, the tubular device comprising:

an inner liner comprising one or more thin membrane sheets, each sheet comprising a coating on an inner surface thereof, the coating imparting one or more predetermined properties to a wall of the lumen; and

an outer layer surrounding the inner liner and comprising a tubular member formed or split into two portions and attached around the inner liner such that excess material from the one or more thin membrane sheets extends between the two portions, thereby creating a bonded seam extending along the tubular device.