Catheters including antimicrobial sleeve and methods of making catheters
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61M-025/00
A61L-029/06
A61L-029/16
A61M-039/02
A61M-025/06
출원번호
US-0529672
(2006-09-29)
등록번호
US-10188826
(2019-01-29)
발명자
/ 주소
Heroux, Lise-Helene
Potter, Adin M.
Frechette, Robert
Dadhania, Manisha M.
출원인 / 주소
Covidien LP
대리인 / 주소
Collier, Kenneth
인용정보
피인용 횟수 :
0인용 특허 :
55
초록▼
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. Met
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.
대표청구항▼
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; anda sleeve disposed on only a portion of the outer surface of the tubular body betwe
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; anda 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 μm to about 30 μm. 5. The catheter of claim 4, wherein the water-soluble, anti-microbial agent has a particle size of about 10 μm to about 25 μm. 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. 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; andapplying 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; andthe 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; andthe 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. 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. 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; anda 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. 46. The catheter of claim 1, wherein the outer layer constitutes the outermost layer 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.
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