Splitable tip catheter with bioresorbable adhesive

• US 20050277862A1
• Filed: 06/09/2004
• Published: 12/15/2005
• Est. Priority Date: 06/09/2004
• Status: Active Grant

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Anand, PJ
• Granted Patent: US 8,992,454 B2
• Time in Patent Office: Days
• US Class Current: 604/4.10
• CPC Class Codes: A61M 1/285 Catheters therefor
• 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
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip

Abstract

Splitable-tip catheters are disclosed with bioresorbable adhesive to provide spatial separation of distal tip elements during use. The invention can be particularly useful in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, e.g., into a blood vessel using a single guidewire, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.

Claims

1. A multi-lumen catheter device for hemodialysis, comprising:

an elongate catheter body with at least a blood extraction lumen and a blood return lumen extending longitudinally therethrough, having a proximal end adapted for coupling to a hemodialysis apparatus, and having a distal end terminating in separable distal tip portions adapted for insertion in a blood vessel, the distal end further comprising;

a distal extraction tip portion for fluidic coupling of the extraction lumen with the blood vessel,

a distal return tip portion for fluidic coupling of the return lumen with the blood vessel, and

a bioresorbable adhesive joining the distal tip portions together for insertion into the blood vessel and facilitating separation of the distal tip portions from each other following insertion.

2. The device of claim 1, wherein the extraction and return lumens are independent of each other to provide simultaneous flow of blood in opposite directions during hemodialysis.

3. The device of claim 1, wherein the adhesive comprises a hydrophilic polymer.

4. The device of claim 1, wherein the adhesive comprises a water-soluble composition.

5. The device of claim 1, wherein the adhesive degrades in blood to provide separation of the distal tip portions from each other in less than a hour.

6. The device of claim 1, wherein the adhesive degrades in blood in a time period ranging from about 1 second to about 7 days.

7. The device of claim 1, wherein the adhesive degrades in blood in a time period ranging from about 1 second to about 1 day.

8. The device of claim 1, wherein the adhesive degrades in blood in time period ranging from about 1 second to about 1 hour.

9. The device of claim 1, wherein the adhesive comprises a composition selected from the group consisting of polylactides, polyglycolides, polylactones, polyorthoesters, polyanhydrides, and copolymers thereof.

10. The device of claim 1, wherein the adhesive comprises a protein, a sugar, and a starch.

11. The device of claim 1, wherein the adhesive comprises an antithrombotic, anti-septic, or anti-stenotic agent.

12. The device of claim 1, wherein the distal tip portions are flexible.

13. The device of claim 1, wherein the distal tip portions are formed from a polymer material.

14. The device of claim 1, wherein the distal tip portions are of different lengths.

15. The device of claim 1, wherein the extraction and return lumens have different cross-sectional areas.

16. The device of claim 1, wherein the distal tip portions each have at least one opening for fluid flow.

17. The device of claim 1, wherein at least one of the distal tip portions has a plurality of openings for fluid flow.

18. The device of claim 1, wherein the elongate catheter body has unibody construction with the extraction lumen and the return lumen incorporated therein.

19. The device of claim 1, wherein extraction and return lumens are separate tubular elements and partially joined by an outer sheath.

20. The device of claim 1, wherein the adhesive covers at least a portion of the outer surface of each distal tip portion

21. The device of claim 1, wherein the adhesive applied to the surface of each distal tip portion forms a continuous linear bond.

22. The device of claim 1, wherein the adhesive applied to the surface of each distal tip portion forms discrete spots.

23. The device of claim 1, wherein at least one distal tip portion comprises a shape memory material.

24. The device of claim 1, wherein at least one distal tip portion is coiled about another tip portion.

25. The device of claim 1, wherein the catheter contains an additional lumen for fluid administration or sampling.

26. A method for hemodialysis, comprising:

providing a multi-lumen catheter assembly with at least a blood extraction lumen and a blood return lumen extending longitudinally therethrough, having a proximal end adapted for coupling to a hemodialysis apparatus, and having a distal end terminating in separable distal tip portions for blood extraction and return, the tip portions joined together by a bioresorbable adhesive;

inserting the distal end of the catheter assembly into a blood vessel; and

allowing the adhesive to degrade such that the distal tip portions separate from each other within the blood vessel.

27. The method of claim 26, wherein the extraction and return lumens are independent of each other to provide simultaneous flow of blood in opposite directions during hemodialysis.

28. The method of claim 26, wherein the adhesive comprises a hydrophilic polymer.

29. The method of claim 26, wherein the adhesive comprises a water-soluble composition.

30. The method of claim 26, wherein the adhesive degrades in blood to provide separation of the distal tip portions from each other in less than a hour.

31. The method of claim 26, wherein the adhesive degrades in blood in a time period ranging from about 1 second to about 7 days.

32. The method of claim 26, wherein the adhesive degrades in blood in a time period ranging from about 1 second to about 1 day.

33. The method of claim 26, wherein the adhesive degrades in blood in time period ranging from about 1 second to 1 hour.

34. The method of claim 26, wherein the adhesive comprises a composition selected from the group consisting of polylactides, polyglycolides, polylactones, polyorthoesters, polyanhydrides, and copolymers thereof.

35. The device of claim 26, wherein the adhesive comprises a protein, a sugar, and a starch.

36. The device of claim 26, wherein the adhesive comprises an antithrombotic, anti-septic, or anti-stenotic agent.

37. The method of claim 26, wherein the distal tip portions are flexible.

38. The method of claim 26, wherein the distal tip portions are formed from a polymer material.

39. The method of claim 26, wherein the distal tip portions are of different lengths.

40. The method of claim 26, wherein the extraction and return lumens have different cross-sectional areas.

41. The method of claim 26, wherein the distal tip portions each have at least one opening for fluid flow.

42. The method of claim 26, wherein at least one of the distal tip portions has a plurality of openings for fluid flow.

43. The method of claim 26, wherein the elongate catheter body has unibody construction with the extraction lumen and the return lumen incorporated therein.

44. The method of claim 26, wherein extraction and return lumens are separate tubular elements and partially joined by an outer sheath.

45. The method of claim 26, wherein the adhesive covers at least a portion of the outer surface of each distal tip portion

46. The method of claim 26, wherein the adhesive applied to the surface of each distal tip portion forms a continuous linear bond.

47. The method of claim 26, wherein the adhesive applied to the surface of each distal tip portion forms discrete spots.

48. The method of claim 26, wherein at least one distal tip portion comprises a shape memory material.

49. The method of claim 26, wherein at least one distal tip portion is coiled about another tip portion.

50. The method of claim 26, wherein the catheter contains an additional lumen for fluid administration or sampling.