Urinary catheter package and lubricator therefor with combined gripping and sealing means

• US 6,578,709 B1
• Filed: 07/19/2001
• Issued: 06/17/2003
• Est. Priority Date: 07/19/2001
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Rodtmann, Thorsten, Creaven, Martin P., Sweeney, Sean, Kavanagh, Seamus T.
• Primary Examiner(s): Ackun, Jacob K.
• Application Number:
  US09/910,500
• Time in Patent Office: 698 Days
• Field of Search: 206/571, 206/363, 206/364, 604/328, 604/327, 604/329, 604/330, 604/331, 604/346, 604/349, 604/265
• US Class Current: 206/364
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/1096 Male
• 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: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/013 One-way gripping collars

Abstract

A urinary catheter package takes the form of a pouch containing a catheter and a lubricating device. The lubricating device comprises a housing with distal and proximal end portions and a lubricant-containing chamber therebetween. A frusto-conical collar at the proximal end of the device performs dual functions of preventing lubricant leakage into the pouch and unintentional sliding movement of the catheter when the package is in use.

Claims

1. A lubricating device for a urinary catheter, comprising a guide housing having proximal and distal end portions defining a lubricant chamber therebetween;

a body of lubricant within said chamber;

said proximal end portion including a first end wall having an opening therethrough for receiving a catheter extending through said opening and into said body of lubricant;

said first end wall being deformable and shape-recoverable and having edges defining said opening for firmly and sealingly engaging unlubricated outer surface portions of a catheter for restraining longitudinal movement of such catheter until a threshold level of axial force is applied thereto.

2. The device of claim 1 in which a urinary catheter extends through said opening and into said lubricant chamber.

3. The device of claim 2 in which said opening, when said first end wall is undeformed, has a diameter smaller than the outside diameter of a catheter to be extended therethrough.

4. The device of claim 3 in which said first end wall is fruto-conical in shape with a taper extending in a distal direction.

5. The device of claim 1, 2, 3 or 4 in which said lubricant is a lubricant gel.

6. The device of claim 1 in which said distal end portion of said housing is generally cylindrical;

said housing having a bulbous body portion between said proximal and distal end portions.

7. The device of claim 6 in which said body portion is of oval cross section.

8. The device of claim 1 in which said distal end portion includes a second end wall having a opening for advancement of a catheter therethrough.

9. The device of claim 8 in which said housing includes a passage-defining introducer sleeve projecting distally from said second end wall and communicating directly with said opening thereof.

10. The device of claim 9 in which said passage of said introducer sleeve and said opening of said seconds end wall have diameters substantially larger than the outside diameter of a catheter extendable therethrough.

11. The device of claim 9 or 10 in which said introducer sleeve is formed of soft, deformable and shape-recoverable material and has a rounded distal end wall with a multiplicity of crossed diametrically-extending slits defining a series of at least six radially inwardly tapering flaps.

12. The device of claim 11 in which there are eight of said flaps.

13. The device of claim 8 in which said second end wall is formed of deformable and shape-recoverable material and has a multiplicity of crossed slits defining a circumferential series of inwardly-tapering flaps for closing said opening of said second end wall until a catheter is advanced therethrough.

14. The device of claim 13 in which there are-at least six of said flaps with each of said flaps being equal in size.

15. The device of claim 14 in which there are eight of said flaps.

16. The device of claim 8 in which said distal end portion has therein a plurality of circumferentially-spaced stiffening and guiding ribs extending towards said second wall.

17. The device of claim 16 in which said ribs are located along an inside surface of said cylindrical portion and taper in a proximal direction.

18. The device of claim 1 in which said guide housing is integrally and entirely formed of soft, deformable and shape-recoverable plastic material.

19. The device of claim 18 in which said plastic material is elastomeric.

20. A urinary catheter package comprising a pouch having side walls of flexible thermoplastic film and proximal and distal ends;

a urinary catheter within said pouch; and

a catheter lubricating device secured within said pouch at the distal end thereof;

said device comprising a guide housing having proximal and distal end portions defining a lubricant chamber therebetween;

a body of lubricant within said chamber;

said proximal end portion of said housing including a deformable and shape-recoverable proximal end wall having an opening therethrough with said catheter extending through said opening and into said body of lubricant;

said proximal end wall having edges defining said opening in sealing contact with surfaces of said catheter for retaining lubricant against proximal displacement from said chamber;

said distal end portion including a deformable and shape-recoverable distal end wall having an opening for advancement of said catheter therethrough;

said distal end wall having a multiplicity of crossed slits defining a circumferential series of at least six inwardly-tapering flaps for closing said opening until said catheter is advanced therethrough.

21. The package of claim 20 in which there are eight of said flaps.

22. The package of claim 20 in which said distal end portion has therein a plurality of circumferentially-spaced stiffening and guiding ribs extending towards said distal end wall;

said ribs defining a passageway substantially larger in diameter than the outside of said catheter.

23. The package of claim 21 in which said ribs taper in a proximal direction.

24. The package of claim 20 in which said side walls of said pouch are generally flat and coplanar when said pouch is empty.

25. The package of claim 24 in which said distal end portion of said housing is generally cylindrical;

said housing having a bulbous body portion extending between said proximal end and distal end portion.

26. The package of claim 25 in which said bulbous body portion is of oval cross section.

27. The package of claim 26 in which said oval cross section has major and minor axes and said housing is oriented with said major axis extending parallel-with said coplanar side walls of said pouch.

28. The package of claim 20 in which said guide housing is entirely formed of soft, deformable and shape-recoverable plastic material.

29. The package of claim 28 in which said plastic material is elastomeric.

30. A urinary catheter package comprising a pouch having side walls of flexible thermoplastic film and proximal and distal ends;

a urinary catheter within said pouch; and

a catheter gripping and lubricating device secured within said pouch at the distal end thereof;

said device comprising a deformable, and shaped-recoverable guide housing having proximal and distal end portions defining a lubricant chamber therebetween;

a body of lubricant within said chamber;

said proximal end portion of said housing including a first end wall having an opening therethrough with said catheter extending through said opening and into said body of lubricant;

said end wall having edges defining said opening in firm sealing contact with unlubricated surfaces of said catheter for restraining longitudinal movement of said catheter until a threshold level of axial force is applied thereto.

32. The package of claim 30 in which said opening of said end wall, when said housing is unstretched, has a diameter smaller than the outside diameter of said catheter.

33. The package of claim 32 in which said end wall is frusto-conical in shape with a taper thereof extending in a distal direction.

34. The package of claim 32 or 33 in which said lubricant is a lubricant gel.

35. The package of claim 32 in which said side walls of said pouch are generally flat and coplanar when said pouch is empty.

36. The package of claim 35 in which said distal end portion of said housing is generally cylindrical;

said housing having a bulbous body portion of oval cross section extending between said proximal and distal end portions.

37. The package of claim 36 in which said oval cross section has major and minor axes and said housing is oriented with said major axis extending parallel with said coplanar side walls of said pouch.

38. The package of claim 36 in which said distal end portion includes a second end wall having an opening for advancement of said catheter therethrough.

39. The package of claim 38 in which said housing includes a passage-defining introducer sleeve projecting distally from said second end wall and communicating directly with said opening thereof.

40. The package of claim 39 in which said passage of said introducer sleeve and said opening of second end wall have diameters substantially larger than the outside of said catheter.

41. The package of claim 40 in which said introducer sleeve has a rounded distal end wall with a multiplicity of crossed diametrically-extending slits defining a series of at least six radially inwardly tapering flaps.

42. The package of claim 41 in which there are eight said flaps.

43. The package of claim 38 in which said second end wall has a multiplicity of crossed slits defining a circumferential series of equal-size inwardly-tapering flaps for closing said opening until said catheter is advanced therethrough.

44. The package of claim 43 in which there are at least six of said flaps.

45. The package of claim 44 in which there are eight of said flaps.

46. The package of claim 38 in which said distal end portion has therein a plurality of circumferentially-spaced stiffening and guiding ribs extending towards said second end wall;

said ribs defining a passageway substantially larger in diameter than the outside of said catheter.

47. The package of claim 46 in which said ribs are located along an inside surface of said cylindrical portion and taper in a proximal direction.

48. The package of claim 30 in which said guide housing is formed integrally and entirely of elastomeric material.

31. The package 30 of claim in which said thermoplastic film of said pouch is transparent.

49. A urinary catheter package comprising a pouch having side walls of flexible thermoplastic film and proximal and distal ends;

a urinary catheter within said pouch; and

a catheter lubricating device secured within said pouch at the distal end thereof;

said device comprising a deformable, and shape-recoverable guide housing having proximal and distal end portions defining a lubricant chamber therebetween;

a body of lubricant within said chamber;

said proximal end portion of said housing including a proximal end wall having an opening therethrough with said catheter extending through said opening and into said body of lubricant;

said proximal end wall having edges defining said opening in sealing contact with surfaces of said catheter for retaining lubricant in said chamber;

said distal end portion of said housing including a distal end wall having an opening for advancement of said catheter therethrough;

said housing including a passage-defining introducer sleeve projecting distally from said distal end wall and communicating directly with said opening thereof;

said passage of said introducer sleeve and said opening of said distal end wall having diameters substantially larger than the outside of said catheter; and

said introducer sleeve having a rounded distal end wall with a multiplicity of crossed diametrically-extending slits defining a series of at least six radially inwardly tapering flaps.

50. The package of claim 49 in which there are eight said flaps.

51. The package of claim 49 in which said distal end portion of said housing has a plurality of circumferentially-spaced stiffening guiding ribs disposed therein and extending towards said distal end wall;

said ribs defining a passageway substantially larger in diameter than the outside of said catheter.

52. The package of claim 51 in which said ribs are located along an inside surface of said cylindrical portion and taper in a proximal direction.

53. The package of claim 49 in which said side walls of said pouch are generally flat and coplanar when said pouch is empty.

54. The package of claim 53 in which said distal end portion of said housing is generally cylindrical;

said housing having a bulbous body portion extending between said proximal and distal end portions.

55. The package of claim 54 in which said bulbous body portion is of oval cross section.

56. The package of claim 54 in which said oval cross section has major and minor axes and said housing is oriented with said major axis extending parallel with said coplanar side walls of said pouch.

57. The package of claim 49 in which said guide housing is formed integrally and entirely of elastomeric material.