Multilumen Catheters and Method of Manufacturing

• US 20100191165A1
• Filed: 12/28/2009
• Published: 07/29/2010
• Est. Priority Date: 01/29/2009
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Lancette, Carol L., Beyer, Theodore J., Appling, William M.
• Granted Patent: US 8,585,950 B2
• Time in Patent Office: Days
• US Class Current: 604/6.16
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: B29C 53/14 Twisting for textile fibres D01H
• CPC Class Codes: B29C 65/20 with direct contact, e.g. using "mirror"
• CPC Class Codes: B29C 65/305 involving the use of cartridge heaters
• CPC Class Codes: B29C 65/76 Making non-permanent or releasable joints
• CPC Class Codes: B29C 66/0044 : using a separating sheet, e.g. fixed on the joining tool
• 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 66/5227 : for forming multi-tubular articles by longitudinally joining elementary tubular articles wall-to-wall (e.g. joining the wall of a first tubular article to the wall of a second tubular article) or for forming multilayer tubular articles
• 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 66/72523 : multi-channelled or multi-tubular B29C66/438, B29C66/5227 take precedence
• CPC Class Codes: B29C 66/8122 : characterised by the composition of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
• CPC Class Codes: B29C 66/836 : Moving relative to and tangentially to the parts to be joined, e.g. transversely to the displacement of the parts to be joined, e.g. using a X-Y table B29C66/65 takes precedence
• CPC Class Codes: B29C 66/91231 : of the joining tool
• CPC Class Codes: B29C 66/91421 : of the joining tools
• CPC Class Codes: B29C 66/91431 : the temperature being kept constant over time
• CPC Class Codes: B29C 66/934 : by controlling or regulating the speed
• CPC Class Codes: B29C 66/939 : characterised by specific speed values or ranges
• CPC Class Codes: B29K 2019/00 : Use of rubber not provided for in a single one of main groups B29K2007/00 - B29K2011/00, as moulding material
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2083/00 : Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2827/18 : PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2031/602 : composed of several elementary tubular elements
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A multilumen catheter assembly and method of making the catheter assembly is provided that involves providing a plurality of tubes, each tube having a first end, a second end, at least one lumen, and at least one surface, selectively heating at least a portion of the surface of at least a first tube of the plurality of tubes, and contacting the selectively heated portion of the tube with a portion of the surface of a second tube to form a multilumen catheter shaft that is joined together along at least a portion of the length of the catheter shaft.

Claims

1. A method of making a multilumen catheter assembly, comprising:

providing a plurality of tubes, each tube having a first end, a second end, at least one lumen extending longitudinally through at least a portion of each tube, and at least one surface;

selectively heating at least a portion of the at least one surface of at least a first tube of the plurality of tubes; and

contacting the selectively heated portion of the first tube with at least a portion of a second tube to form a multilumen catheter shaft that is joined together along at least a portion of the length of the catheter shaft.

2. The method of claim 1, wherein the method further comprises:

simultaneously selectively heating at least a portion of a surface of the second tube; and

contacting the selectively heated portion of the first tube and the selectively heated portion of the second tube.

3. The method of claim 1, wherein the method further comprises providing at least one tube having a substantially D-shaped cross-sectional lumen profile.

4. The method of claim 1, wherein the method further comprises providing at least one sealing means and sealing at least a portion of the first end of the first catheter tube and the first end of the second catheter tube.

5. The method of claim 4, wherein the method further comprises sealing at least a portion of the second end of the first tube and the second end of the second tube.

6. The method of claim 1, wherein the method further comprises providing a tube holding means.

7. The method of claim 6, wherein the method further comprises placing at least a portion of the first tube and a portion of the second tube within a portion of the tube holding means.

8. The method of claim 7, wherein the method further comprises juxtaposing a portion of the first tube with a portion of the second tube to establish contact between a portion of the surface of the first tube and a portion of the surface of the second tube.

9. The method of claim 1, wherein the method further comprises connecting at least a portion of the first tube and at least a portion of the second tube to at least one pressure source.

10. The method of claim 9, wherein the method further comprises pressurizing at least one lumen of the plurality of tubes.

11. The method of claim 8, wherein the method further comprises providing a tube joining assembly and placing at least a portion of the tube holding means within at least a portion of the tube joining assembly.

12. The method of claim 1, wherein the method further comprises providing at least one heating means, wherein the heating means comprises an outer surface and at least one receiving means.

13. The method of claim 12, wherein the method further comprises contacting at least a portion of the first catheter tube surface and a portion of the second catheter tube surface with a portion of the outer surface of the heating means.

14. The method of claim 1, wherein the method further comprises compressing at least a portion of the surface of the first catheter tube with at least a portion of the surface of the second catheter tube.

15. The method of claim 1, wherein the method further comprises bonding at least a portion of the surface of the first catheter tube to at least a portion of the surface of the second catheter tube.

16. The method of claim 1, wherein the method further comprises selectively altering at least one parameter.

17. The method of claim 16, wherein the parameter is selected from the group comprising:

temperature, draw speed, air pressure, die pressure, heating means shape, tube holding means shape, tube color, and tube material.

18. The method of claim 1, wherein the method further comprises cooling the plurality of catheter tubes.

19. The method of claim 1, wherein the method further comprises forming a multilumen catheter shaft, wherein the multilumen shaft is a unitary shaft along at least a portion of the length of the catheter shaft.

20. The method of claim 1, wherein the method further comprises forming a multilumen catheter shaft having a proximal end and a distal end, wherein a portion of the plurality of tubes at the distal end are capable of independent movement relative to each other.

21. The method of claim 1, wherein the method further comprises forming a multilumen catheter shaft that is joined together along substantially the entire length of the catheter shaft.

22. The method of claim 12, wherein the method further comprises providing at least one additive and feeding the at least one additive through at least a portion of the receiving means, such that the at least one additive becomes embedded within a portion of at least one of the plurality of tubes.

23. The method of claim 22, wherein the additive is selected from the group comprising:

at least one wire, at least one electrode, and radiopaque material.

24. The method of claim 1, wherein the method further comprises rotating the plurality of catheter tubes together to form a spiral shaped catheter shaft.

25. The method of claim 1, wherein the method further comprises providing at least one mandrel, positioning the mandrel between the first catheter tube and the second catheter tube, and forming a catheter shaft comprising a first lumen, a second lumen, and a third lumen, wherein the third lumen is defined between the first lumen and the second lumen.

26. The method of claim 1, wherein the method further comprises forming a catheter shaft that comprises at least a first lumen, a second lumen, and a third lumen, wherein the third lumen is defined between the first lumen and the second lumen.

27. A multilumen catheter assembly, comprising:

a catheter shaft having a plurality of tubes, wherein each tube of the plurality of tubes has a proximal end, a distal end, at least one lumen extending longitudinally along a longitudinal axis between the proximal end and the distal end through at least a portion of each tube, and at least an inner surface and an outer surface, wherein at least a portion of the inner surface of the first tube is selectively fused with at least a portion of the inner surface of the second tube along at least a portion of the longitudinal length of the catheter shaft.

28. The catheter assembly of claim 27, wherein at least a portion of the surface of the first tube that is selectively fused with at least a portion of the surface of the second tube comprises a heat-fusion bond.

29. The catheter assembly of claim 27, wherein each lumen comprises a substantially D-shaped cross-section.

30. The catheter assembly of claim 27, wherein the first tube has at least a first characteristic and the second tube has at least a second characteristic, and wherein the first characteristic and the second characteristic are different.

31. The catheter assembly of claim 29, wherein the characteristic is selected from the group comprising:

tube color, tube shape, lumen configuration, tube material, and tube length.

32. The catheter assembly of claim 27, wherein the at least a portion of the tubes are capable of independent movement relative to each other.

33. The catheter assembly of claim 27 wherein the catheter shaft is a unitary catheter shaft.

34. The catheter assembly of claim 27, wherein the tubes are joined together along substantially the entire length of the catheter shaft.

35. The catheter assembly of claim 27, wherein at least one surface of the tubes of the catheter shaft further comprises at least one additive, and wherein the additive is embedded onto at least a portion of the surface of the at least one tube.

36. The catheter assembly of claim 35, wherein the additive is selected from the group comprising:

at least one wire, at least one electrode, and radiopaque material.

37. The catheter assembly of claim 27, wherein at least a portion of the first tube forms a first substantially spiral shape, and at least a portion of the second tube forms a substantially spiral shape, wherein the first tube and the second tube extend along the longitudinal axis, said tubes being axially overlapped in nested relation to each other.

38. The catheter assembly of claim 27, wherein the catheter shaft comprises at least a first lumen, a second lumen, and a third lumen, wherein the third lumen is positioned between the first lumen and the second lumen.

39. The catheter assembly of claim 27, wherein the catheter is a catheter selected from group comprising:

a dialysis catheter, peripherally inserted central catheter (PICC), an angiographic catheter, and an angioplasty catheter.