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1. WO2020110049 - ENDOPROTHÈSE OU CATHÉTER URÉTÉRAL REVÊTU ET/OU IMPRÉGNÉ ET PROCÉDÉ

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

WHAT IS CLAIMED IS:

1. A coated and/or impregnated urinary catheter or urinary stent device, comprising:

(a) a proximal portion; and (b) a distal portion, the distal portion comprising a retention portion that comprises at least one protected drainage hole(s), port(s) or perforation(s) and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the at least one protected drainage hole(s), port(s) or perforation(s) upon application of negative pressure through the catheter; and

at least one coating(s) upon and/or at least one impregnation(s) within at least a portion of the protective surface area, the at least one coating(s) and/or at least one impregnation(s) comprising at least one of lubricant(s), antimicrobial material(s), pH buffer(s) or anti-inflammatory material(s).

2. The device of claim 1, wherein the at least one lubricant is configured to become lubricious in a presence of fluid.

3. The device of claim 1, wherein the at least one lubricant comprises a hydrophilic material.

4. The device of claim 3, wherein the hydrophilic material comprises a gel.

5. The device of claim 1, wherein the at least one lubricant comprises at least one of polyethylene glycol, polyvinylpyrrolidone, polytetrafluoroethylene, polyvinyl alcohol, polyacrylamide, polymethacrylate, acrylic polymers or copolymers thereof, poly electrolytes, hydrogels comprising polyacrylic acid and/or disulphide-crosslinked (poly(oligo(ethyleneoxide) monomethyl ether methacrylate).

6. The device of claim 1, wherein the at least one lubricant comprises at least one of polytetrafluoroethylene, siloxane(s), silicone(s) or polysiloxane(s).

7. The device of claim 1, wherein the at least one coating(s) and/or impregnation(s) comprises at least one outermost layer comprising at least one lubricant.

8. The device of claim 7, wherein the at least one coating(s) and/or impregnation(s) further comprises at least one sublayer positioned between the protective surface area of the device and the at least one outermost layer, wherein the at least one sublayer comprises at least one antimicrobial material.

9. The device of claim 8, wherein the at least one lubricant dissipates into surrounding fluid or tissue over time, thereby exposing the at least one sublayer to fluid and/or to the tissue surrounding the deployed device.

10. The device of claim 9, wherein the at least one lubricant dissipates over a period of from 1 day to 10 days, following insertion of the device into the urinary tract of the patient.

11. The device of claim 9, wherein, upon dissipation of the at least one lubricant of the outermost layer, the at least one antimicrobial material of the at least one sublayer is configured to release into surrounding fluid or tissue.

12. The device of claim 8, wherein the at least one antimicrobial material of the at least one sublayer is configured for slow release into surrounding fluid or tissue over a period of from about 1 day to about one year.

13. The device of claim 8, wherein the at least one sublayer comprises a first sublayer applied to the protective surface area of the device, the first sublayer comprising a pH buffering material, and a second sublayer covering at least a portion of the first sublayer, the second sublayer comprising the at least one antimicrobial material.

14. The device of claim 1, wherein the at least one antimicrobial material(s) comprises at least one of antiseptic material(s), antiviral material(s), antibacterial material(s), antifungal material(s), or an antibiotic material(s).

15. The device of claim 1, wherein the at least one antimicrobial material comprises at least one of chlorhexidine, silver ions, nitric oxide, bacteriophage(s), sirolimus, heparin, phosphorylcholine, silicone dioxide, diamond-like carbon, caspofungin, chitosan,

organosilane(s), sulfonamide(s) or antimicrobial peptide(s).

16. The device of claim 14, wherein the at least one antibiotic material comprises at least one of amdinocillin, levofloxacin, penicillin, tetracyclines, sparfloxacin, or vancomycin.

17. The device of claim 1, wherein the at least one antimicrobial material comprises at least one antibacterial material and at least one antibiotic material.

18. The device of claim 1, wherein the at least one coating(s) and/or impregnation(s) comprises at least one lubricant and at least one antimicrobial material.

19. The device of claim 18, wherein the at least one lubricant is present in an outermost layer of the coating.

20. The device of claim 1, wherein the at least one antimicrobial material is present in a sublayer of the coating positioned between the protective surface area of the device and an outermost layer of the coating.

21. The device of claim 1, wherein the at least one coating comprises: an innermost layer positioned on a portion of the protective surface area of the device , the innermost layer comprising at least one hydrophilic material,

a first sublayer comprising the at least one antibacterial material positioned on at least a portion of the innermost layer,

at least one second sublayer comprising the at least one antibiotic material positioned on the at least one first sublayer,

a third sublayer positioned on the second sublayer, the third sublayer comprising the at least one antibacterial material, and

an outermost layer positioned on the third sublayer, the outermost layer comprising the at least one hydrophilic material.

22. The device of claim 21, wherein the sublayer(s) comprising the antibacterial material is configured for slow release of the at least one antibacterial material into bodily fluid or tissue surrounding the device over a period of at least 24 hours, and

wherein the at least one second sublayer comprising the at least one antibiotic material is configured to release the at least one antibiotic material into the fluid or tissue surrounding the device over a period of less than 24 hours.

23. The device of claim 1, wherein the at least one pH buffer(s) comprises at least one of sodium citrate, sodium acetate, or sodium bicarbonate.

24. The device of claim 1, wherein the at least one anti-inflammatory material comprises at least one of dexamethasone, heparin or alpha-melanocyte-stimulating hormone a-MSH).

25. The device of claim 1, wherein the at least one anti-inflammatory material comprises at least one of polyethylene glycol-containing polymers, poly(2-hydroxyethyl methacrylate), poly(N-isopropyl acrylamide), poly(acrylamide), phosphoryl choline-based polymers, mannitol, oligomaltose, or taurine groups.

26. The device of claim 1, wherein the device comprises at least one coating(s) upon at least a portion of the protective surface area.

27. The device of claim 1, wherein the device comprises at least one impregnation(s) within at least a portion of the protective surface area.

28. The device of claim 1, wherein the device is a ureteral catheter.

29. The device of claim 1, wherein the device is a bladder catheter.

30. The device of claim 1, wherein a proximal end of the proximal portion of the device is configured to be directly or indirectly connected to a pump for applying negative pressure to the device.

31. The device of claim 1, wherein the device comprises at least one of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone coated latex, silicone, polyglycolide or poly(glycolic acid) (PGA), Polylactide (PLA), Poly(lactide-co-glycolide), Polyhydroxyalkanoates, Polycaprolactone and/or Poly(propylene fumarate).

32. The device of claim 1, wherein the at least one protected drainage hole(s), port(s) or perforation(s) are disposed on a protected surface area or inner surface area of the retention portion, and wherein the outer periphery or protective surface area of the retention portion of the catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the ureteral catheter.

33. The device of claim 1, wherein the retention portion comprises one or more helical coils, each coil having an outwardly facing side and an inwardly facing side, and wherein the outer periphery or protective surface area comprises the outwardly facing side(s) of the one or more helical coil(s), and the at least one protected drainage hole(s), port(s) or perforation(s) are disposed on the inwardly facing side(s) of the one or more helical coil(s).

34. The device of claim 1, wherein the retention portion is configured to be extended into a deployed position in which a diameter of the retention portion is greater than a diameter of the drainage lumen portion.

35. The device of claim 1, wherein the number of the drainage holes, ports or perforations towards the distal end of the retention portion is greater that the number of the drainage holes, ports or perforations towards the proximal end of the retention portion.

36. The device of claim 1, wherein the size of one or more of the drainage holes, ports or perforations towards the distal end of the retention portion is greater that the size of one or more of the drainage holes, ports or perforations towards the proximal end of the retention portion.

37. The device of claim 1, wherein the total area of the drainage holes, ports or perforations towards the distal end of the retention portion is greater than the total area of the drainage holes, ports or perforations towards the proximal end of the retention portion.

38. The device of claim 1, wherein a sidewall of the proximal portion of the device is essentially free or free of drainage openings.

39. A coated urinary catheter or urinary stent device, comprising:

(a) a proximal portion; and (b) a distal portion, the distal portion comprising a retention portion that comprises at least one protected drainage hole(s), port(s) or perforation(s) and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the at least one protected drainage hole(s), port(s) or perforation(s) upon application of negative pressure through the catheter; and

at least one coating(s) upon at least a portion of the protective surface area, the coating comprising a lubricant and a pH buffering material.

40. The device of claim 39, wherein the coating comprises at least one outermost layer comprising the lubricant.

41. The device of claim 39, wherein the coating further comprises at least one sublayer positioned between the catheter or stent and the outermost layer, wherein the at least one sublayer comprises the pH buffering material.

42. A method of manufacture of a coated and/or impregnated catheter or stent device, the method comprising:

applying at least one sublayer of a coating to at least a portion of a catheter or stent, the at least one sublayer comprising at least one of an antimicrobial material and a pH buffering material; and

applying at least one outermost layer of the coating upon at least a portion of the at least one sublayer, the at least one outermost layer comprising a lubricant.

43. The method of claim 42, wherein the catheter or stent is configured to be deployed within a urinary tract of a patient, wherein, in a deployed position, the catheter or stent comprises a protective surface area and a protected surface area, and wherein the coating is applied to at least the protective surface area of the catheter or stent.

44. The method of claim 42, wherein the antimicrobial material comprises at least one of an antibacterial material and an antibiotic material.

45. The method of claim 42, further comprising:

forming at least one opening(s), hole(s), space(s), and/or micro-channel(s) on a distal portion of the catheter or stent; and

forming a deployable retention portion on the distal portion of the catheter or stent.

46. The method of claim 42, wherein applying the at least one sublayer comprises applying a first sublayer comprising the pH buffering material for reducing encrustation of urine crystals on the catheter or stent, and applying a second sublayer comprising the antimicrobial material covering at least a portion of the first sublayer.