Catheters including antimicrobial sleeve and methods of making catheters

• US 10,188,826 B2
• Filed: 09/29/2006
• Issued: 01/29/2019
• Est. Priority Date: 09/29/2006
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Heroux, Lise-Helene, Potter, Adin M., Frechette, Robert, Dadhania, Manisha M.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US11/529,672
• Publication Number:
  US 20080172011A1
• Time in Patent Office: 4,505 Days
• Field of Search: 604264-265, 604500, 604158, 424423
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• 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 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A catheter includes a tubular body having an outer surface, and a sleeve disposed on only a portion of the outer surface of the tubular body. The sleeve includes an outer layer overlying an inner layer. The catheter contains a water-soluble, anti-microbial agent in the outer layer of the sleeve. Methods of making the catheter are also disclosed.

Claims

1. A catheter, comprising:

a tubular body having an outer surface;

a hub disposed on the outer surface of the tubular body;

a tissue in-growth cuff disposed on the outer surface of the tubular body distal to the hub; and

a sleeve disposed on only a portion of the outer surface of the tubular body between the hub and the cuff, the sleeve comprising an outer layer co-extruded on an inner layer, the catheter comprising a water-soluble, anti-microbial agent contained only in the outer layer of the sleeve,

wherein the inner layer has a thickness at least about three times the thickness of the outer layer to reduce swelling of the sleeve and anchor the outer layer.

2. The catheter of claim 1, wherein the outer layer of the sleeve contains about 5 wt. % to about 20 wt. % of the water-soluble, anti-microbial agent.

3. The catheter of claim 2, wherein the outer layer of the sleeve contains about 15 wt. % to about 20 wt. % of the water-soluble, anti-microbial agent.

4. The catheter of claim 1, wherein the water-soluble, anti-microbial agent has a particle size of about 4 μ

m to about 30 μ

m.

5. The catheter of claim 4, wherein the water-soluble, anti-microbial agent has a particle size of about 10 μ

m to about 25 μ

m.

6. The catheter of claim 1, wherein the inner layer and the outer layer of the sleeve comprise the same hydrophilic polyurethane.

7. The catheter of claim 6, wherein the hydrophilic polyurethane is an aliphatic, polycarbonate-based thermoplastic polyurethane that can absorb a water content of about 0.3% to about 1% of the weight of dry resin.

8. The catheter of claim 1, wherein the inner layer and the outer layer of the sleeve comprise different hydrophilic polyurethanes.

9. The catheter of claim 8, wherein the outer layer of the sleeve comprises an aliphatic, polyether-based thermoplastic polyurethane that can absorb a water content of about 20% to about 100% of the weight of dry resin.

10. The catheter of claim 1, wherein the water-soluble, anti-microbial agent comprises an anti-microbial metal compound.

11. The catheter of claim 10, wherein the water-soluble, anti-microbial agent comprises a water-soluble glass which incorporates the anti-microbial metal compound.

12. The catheter of claim 1, wherein the water-soluble, anti-microbial agent comprises an anti-microbial silver compound in an amount of about 0.1 wt. % to about 90 wt. %, based on the total weight of the water-soluble, anti-microbial agent.

13. The catheter of claim 1, wherein the water-soluble, anti-microbial agent comprises phosphorus pentoxide and silver oxide.

14. The catheter of claim 1, further comprising a non-water-soluble, antimicrobial agent.

15. The catheter of claim 1, further comprising:

a coating containing an anti-thrombogenic agent disposed on the outer surface of the tubular body only between the cuff and a distal tip of the tubular body and disposed on substantially an entire inner surface of the tubular body.

16. The catheter of claim 1, further comprising a coating containing an anti-thrombogenic agent on substantially an entire outer surface and inner surface of the catheter.

17. The catheter of claim 16, wherein the anti-thrombogenic agent is an anti-thrombogenic/non-thrombogenic composition.

18. The catheter of claim 15, wherein the anti-thrombogenic agent is an anti-thrombogenic/non-thrombogenic composition.

19. The catheter of claim 1, wherein the tubular body comprises multiple lumens.

20. The catheter of claim 19, wherein the tubular body comprises two lumens and a distal tip including slots formed in opposite sides of the tubular body, each lumen communicates with a single slot.

21. The catheter of claim 1, which is a hemodialysis catheter.

22. The catheter of claim 1, wherein the sleeve is adhesively bonded to the outer surface of the tubular body.

23. The catheter of claim 22, wherein substantially an entire inner surface of the inner layer of the sleeve is bonded to the outer surface of the tubular body.

24. The catheter of claim 22, wherein the sleeve comprises a proximal end and a distal end, and the sleeve is adhesively bonded to the outer surface of the tubular body with a liquid-tight seal between at least the proximal end and the distal end of the sleeve and the outer surface.

25. The catheter of claim 1, wherein the water-soluble, anti-microbial agent comprises first particles having a first particle size range and second particles having a second particle size range which is larger than the first particle size range, the first particles having a first release rate and the second particles having a second release rate which is less than the first release rate.

35. The method of claim 21, wherein the water-soluble, anti-microbial agent comprises an anti-microbial metal compound.

36. The method of claim 35, wherein the water-soluble, anti-microbial agent comprises a water-soluble glass which incorporates the anti-microbial metal compound.

37. The method of claim 21, wherein the water-soluble, anti-microbial agent comprises an anti-microbial silver compound in an amount of about 0.1 wt. % to about 90 wt. %, based on the total weight of the water-soluble, anti-microbial agent.

38. The method of claim 21, wherein the water-soluble, anti-microbial agent comprises phosphorus pentoxide and silver oxide.

39. The method of claim 21, wherein the catheter further comprises a non-water-soluble, anti-microbial agent.

40. The method of claim 21, wherein the water-soluble, anti-microbial agent comprises first particles having a first particle size range and second particles having a second particle size range which is larger than the first particle size range, the first particles having a first release rate and the second particles having a second release rate which is less than the first release rate.

41. The method of claim 21, wherein the tubular body comprises multiple lumens.

42. The catheter of claim 1, wherein the tubular body comprises a distal tip and the cuff comprises a second end, the catheter further comprising a coating on the outer surface of the tubular body between the second end of the cuff and the distal tip.

43. The catheter of claim 1, wherein the catheter is constructed such that when the catheter is implanted in a patient'"'"'s body, a portion of the length of the sleeve is implanted in the patient'"'"'s body and the remainder of the length of the sleeve remains outside of the patient'"'"'s body.

46. The catheter of claim 1, wherein the outer layer constitutes the outermost layer of the sleeve.

26. A method of making a catheter, comprising:

forming a hub on an outer surface of a tubular body;

applying a tissue in-growth cuff on the outer surface of the tubular body distal to the hub; and

applying a sleeve over only a portion of the outer surface of the tubular body between the hub and the tissue in-growth cuff, the sleeve comprising an outer layer co-extruded on an inner layer, the catheter comprising a water-soluble, anti-microbial agent contained only in the outer layer of the sleeve, wherein the inner layer has a thickness at least about three times the thickness of the outer layer to reduce swelling of the sleeve and anchor the outer layer.

27. The method of claim 26, wherein:

the inner layer and the outer layer of the sleeve comprise the same hydrophilic polyurethane; and

the outer layer of the sleeve contains about 5 wt. % to about 20 wt. % of the antimicrobial agent.

28. The method of claim 27, wherein the hydrophilic polyurethane is an aliphatic, polycarbonate-based thermoplastic polyurethane that can absorb a water content of about 0.3% to about 1% of the weight of dry resin.

29. The method of claim 26, wherein:

the inner layer and the outer layer of the sleeve comprise different hydrophilic polyurethanes; and

the outer layer of the sleeve contains about 5 wt. % to about 20 wt. % of the antimicrobial agent.

30. The method of claim 29, wherein the outer layer of the sleeve comprises an aliphatic, polyether-based thermoplastic polyurethane that can absorb a water content of about 20% to about 100% of the weight of dry resin.

31. The method of claim 26, further comprising applying a coating containing an anti-thrombogenic agent on the outer surface of the tubular body only between the cuff and a distal tip and on substantially an entire inner surface of the tubular body.

32. The method of claim 26, further comprising a coating containing an anti-thrombogenic agent, the coating being on substantially an entire outer surface and inner surface of the catheter.

33. The method of claim 32, wherein the anti-thrombogenic agent is an anti-thrombogenic/non-thrombogenic composition.

34. The method of claim 31, wherein the anti-thrombogenic agent is an anti-thrombogenic/non-thrombogenic composition.

44. A catheter comprising:

a tubular body having an outer surface;

a hub disposed on the outer surface of the tubular body;

a tissue in-growth cuff disposed on the outer surface of the tubular body distal to the hub; and

a sleeve disposed on only a portion of the outer surface of the tubular body between the hub and the cuff, the sleeve comprising an outer layer co-extruded on an inner layer, the sleeve comprising a water soluble, anti-microbial agent contained only in the outer layer of the sleeve, thereby reducing swelling of the sleeve.

45. The catheter of claim 44, wherein dissolution of the antimicrobial agent in the outer layer substantially limits voids formed in the sleeve by dissolution of the anti-microbial agent to the outer layer, thereby minimizing swelling of the sleeve.

47. The catheter of claim 44, wherein the outer layer constitutes the outermost layer of the sleeve.

48. The catheter of claim 44, wherein the inner layer has a sufficient thickness and strength relative to the thickness of the outer layer to reduce swelling of and anchor the outer layer.