Catheter assembly

• US 20050043715A1
• Filed: 04/29/2003
• Published: 02/24/2005
• Est. Priority Date: 04/30/2002
• Status: Active Grant

• Current Assignee: Astra Tech AB
• Original Assignee: Astra Tech AB
• Inventors: Nestenborg, Daniel, Schmid, Andrea
• Granted Patent: US 8,740,863 B2
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2210/1085 Bladder
• 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 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

A catheter assembly is provided comprising a catheter (3;530;630;730) including a catheter tube (32) and a connector (31;531) arranged in one end of the catheter tube. The catheter is preferably a urinary, hydrophilic catheter. Further, the assembly comprises a catheter receptacle (2;520;620;720) for accommodation of at least the catheter tube, wherein the receptacle is provided with an opening (22;622;722), said opening being connected to and closed by the connector (31;531) of the catheter. A method for producing such a catheter assembly is also provided.

Claims

1. A catheter assembly comprising:

a catheter (3;

530;

630;

730) having on at least part of its surface a hydrophilic surface layer intended to produce a low-friction surface character of the catheter by treatment with a wetting fluid prior to use of the catheter;

a catheter receptacle (2;

520;

620;

720) forming a cavity for accommodation of at least part of the catheter; and

a compartment accommodating said wetting fluid, wherein said compartment forms an integrated part of the receptacle, but being separated from said cavity,

characterised by an additional outer layer attached to the receptacle, said layer being arranged to at least partly cover the part of the receptacle forming said wetting fluid compartment.

2. The catheter assembly of claim 1, wherein the receptacle is formed of a flexible plastics material.

3. The catheter assembly of claim 1 or 2, wherein the receptacle is formed of a transparent material.

4. The catheter assembly of any one of claim 1, wherein the catheter is a hydrophilic urinary catheter.

5. The catheter assembly of claim 1, wherein the wetting fluid compartment is arranged in a part of the receptacle extending rearwardly from the catheter.

6. The catheter assembly of claim 5, wherein the rearward part of the receptacle accommodating the wetting fluid compartment is in fluid communication with the forward part housing the catheter.

7. The catheter assembly of claim 1, wherein the separation between the wetting fluid compartment and the cavity accommodating the catheter provides a sealed closure, said closure being openable for enabling of a fluid communication between the compartment and the cavity and thereby an activation of the catheter.

8. The catheter assembly of claim 7, wherein the openable closure is formed by a separable joint between the compartments.

9. The catheter assembly of claim 1, wherein the additional cover material is gas-impermeable.

10. The catheter assembly of claim 1, wherein the additional cover material provides a protection for the wetting fluid against a sterilizing agent used on the assembly.

11. The catheter assembly of claim 10, wherein the cover material provides protection against ethylene oxide.

12. The catheter assembly of claim 1, wherein the additional outer layer is arranged to cover essentially the whole part of the receptacle forming said wetting fluid compartment.

13. The catheter assembly of claim 1, wherein the additional outer layer comprises at least one of aluminium foil laminate, poly(vinylidene chloride) or a laminate comprising metallised film such as metallised poly(ethylene terepthalate), or a silicon oxide coated film, or a laminate comprising aluminum oxide.

14. The catheter assembly of claim 1, wherein the additional outer layer is attached to the receptacle by means of an adhesive.

15. The catheter assembly of claim 1, wherein the additional outer layer is attached to the receptacle by means of welding.

16. The catheter assembly according to claim 1, wherein the receptacle comprises opening means for opening of the receptacle, said opening means preferably being arranged in an end of the receptacle being opposite to the connection between the receptacle and the catheter.

17. The catheter assembly according to claim 16, wherein the opening means comprises a peel-off joint.

18. The catheter assembly according to claim 16, wherein the opening means comprises a tear line.

19. The catheter assembly of claim 1, wherein the whole catheter is arranged within the bounds of the receptacle.

20. The catheter assembly of claim 1, wherein the catheter has a part of which forms an insertable length to be inserted through a body opening, and wherein the receptacle is connected to the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the catheter outside the receptacle.

51. The catheter assembly of claim 23, additionally comprising the features claim 1.

21. A method for producing a catheter assembly, comprising:

providing a receptacle;

providing a hydrophilic catheter;

arranging at least part of the catheter tube in a cavity of the receptacle;

arranging a wetting fluid in a compartment forming an integrated part of the receptacle, but being separated from said cavity; and

attaching an additional outer layer to the receptacle to at least partly cover the part of the receptacle forming said wetting fluid compartment.

22. The method of claim 21, comprising the subsequent step of sterilizing the assembly, whereby the additional cover serves as a protection for the wetting fluid against the sterilizing agent.

53. The method of claim 52, additionally comprising the features of claim 21.

23. A catheter assembly comprising:

a catheter (3;

530;

630;

730) having on at least part of its surface a hydrophilic surface layer intended to produce a low-friction surface character of the catheter by treatment with a wetting fluid prior to use of the catheter;

a catheter receptacle (2;

520;

620;

720) forming a cavity for accommodation of at least part of the catheter; and

a compartment accommodating said wetting fluid, wherein said compartment forms an integrated part of the receptacle, but being separated from said cavity,

wherein the separation between the wetting fluid compartment and the cavity accommodating the catheter provides a rupturable sealed closure,

characterised in that said closure is provided with at least one point of weakness, in order for an induced rupture to occur in a predetermined position, thereby enabling fluid communication between the compartment and the cavity housing the catheter.

24. The catheter assembly of claim 23, wherein the closure is formed by a rupturable joint between the compartments.

25. The catheter assembly of claim 24, wherein the joint is a welded joint with a welding width variation, thus providing the at least one point of weakness.

26. The catheter assembly of claim 24, wherein the joint is a welded joint with a welding strength variation, thus providing the at least one point of weakness.

27. The catheter assembly of claim 24, wherein the joint is arranged in a non-linear arrangement, thus providing the at least one point of weakness.

28. The catheter assembly of claim 27, wherein the joint is arranged with at least one knee directed towards the wetting fluid compartment, thus providing the at least one point of weakness.

29. The catheter assembly of claim 28, wherein the knee is provided has an angled peak portion directed towards the wetting fluid compartment.

30. The catheter assembly of claim 29, wherein the angled peak portion forms an obtuse angle.

31. The catheter assembly of claim 29, wherein the angled peak portion forms an acute angle.

32. The catheter assembly of claim 28, wherein the knee is has an curved peak portion directed towards the wetting fluid compartment.

33. The catheter assembly of claim 23, wherein the receptacle is formed of a flexible plastics material.

34. The catheter assembly of claim 23, wherein the receptacle is formed of a transparent material.

35. The catheter assembly of claim 23, wherein the catheter is a hydrophilic urinary catheter.

36. The catheter assembly of claim 23, wherein the wetting fluid compartment is arranged in a part of the receptacle extending rearwardly from the catheter.

37. The catheter assembly of claim 36, wherein the rearward part of the receptacle accommodating the wetting fluid compartment is in fluid communication with the forward part housing the catheter.

38. The catheter assembly of claim 23, wherein an additional outer layer is attached to the receptacle, said layer being arranged to at least partly cover the part of the receptacle forming said wetting fluid compartment.

39. The catheter assembly of claim 38, wherein the additional cover material is gas-impermeable.

40. The catheter assembly of claim 38, wherein the additional cover material provides a protection for the wetting fluid against a sterilizing agent used on the assembly.

41. The catheter assembly of claim 40, wherein the cover material provides protection against ethylene oxide.

42. The catheter assembly of claim 38, wherein the additional outer layer is arranged to cover essentially the whole part of the receptacle forming said wetting fluid compartment.

43. The catheter assembly of claim 38, wherein the additional outer layer comprises at least one of aluminium foil laminate, poly(vinylidene chloride) or a laminate comprising metallised film such as metallised poly(ethylene terepthalate), or a silicon oxide coated film, or a laminate comprising aluminum oxide.

44. The catheter assembly of claim 38, wherein the additional outer layer is attached to the receptacle by means of an adhesive.

45. The catheter assembly of claim 38, wherein the additional outer layer is attached to the receptacle by means of welding.

46. The catheter assembly according to claim 23, wherein the receptacle comprises opening means for opening of the receptacle, said opening means preferably being arranged in an end of the receptacle being opposite to the connection between the receptacle and the catheter.

47. The catheter assembly according to claim 46, wherein the opening means comprises a peel-off joint.

48. The catheter assembly according to claim 46, wherein the opening means comprises a tear line.

49. The catheter assembly of claim 23, wherein the whole catheter is arranged within the bounds of the receptacle.

50. The catheter assembly of claim 23, wherein the catheter has a part of which forms an insertable length to be inserted through a body opening, and wherein the receptacle is connected to the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the catheter outside the receptacle.

52. A method for producing a catheter assembly, comprising:

providing a receptacle;

providing a hydrophilic catheter;

arranging at least part of the catheter tube in a cavity of the receptacle;

arranging a wetting fluid in a compartment forming an integrated part of the receptacle, but being separated from said cavity; and

wherein the separation between the wetting fluid compartment and the cavity accommodating the catheter is formed as a rupturable sealed closure, wherein said closure is provided with at least one point of weakness, in order for an induced rupture to occur in a predetermined position, thereby enabling fluid communication between the compartment and the cavity housing the catheter.

54. A catheter assembly comprising:

a catheter (3;

530;

630;

730), part of which forms an insertable length to be inserted through a body opening; and

a catheter receptacle (2;

520;

620;

720) for accommodation of at least part of the catheter,

characterised in that the receptacle is connected to the catheter, thereby enclosing the insertable length of the catheter, but leaving at least part of the catheter outside the receptacle.

55. The catheter assembly of claim 54, wherein the compartment formed by the receptacle and the catheter forms a microbial barrier towards the environment.

56. The catheter assembly of claim 54 or 55, wherein the catheter is a hydrophilic urinary catheter, and wherein the assembly further comprises a wetting fluid.

57. The catheter assembly of claim 56, wherein the wetting fluid is arranged in a compartment of the receptacle.

58. The catheter assembly of claim 57, wherein the wetting fluid compartment is formed by a compartment of the receptacle housing the catheter, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly.

59. The catheter assembly of claim 56, wherein the wetting fluid compartment is arranged to keep the wetting fluid separated from at least an insertable part of the catheter during storage, the compartment container being openable for activation of the catheter.

60. The catheter assembly of claim 56, wherein the receptacle is gas impermeable.

61. The catheter assembly of claim 56, wherein the wetting fluid container forms a compartment being separated from the receptacle.

62. A method for producing a catheter assembly, comprising:

providing a receptacle (2;

520;

620;

720) having an opening;

providing a catheter (3;

530;

630;

730) including a catheter tube and a connector arranged on one end thereof;

arranging the catheter tube in the receptacle; and

connecting the receptacle to the connector, thereby closing said opening.

63. The method of claim 62, wherein the receptacle is connected to the connector thereby sealingly closing the receptacle.