Urinary catheter with one way check valve

• US 8,475,434 B2
• Filed: 08/28/2007
• Issued: 07/02/2013
• Est. Priority Date: 08/28/2006
• Status: Active Grant

• Current Assignee: Astra Tech AB
• Original Assignee: Astra Tech AB
• Inventors: Frjd, Gran
• Primary Examiner(s): SU, SUSAN SHAN
• Application Number:
  US11/892,900
• Publication Number:
  US 20080051763A1
• Time in Patent Office: 2,135 Days
• Field of Search: 604/540, 604/544, 604/328, 206/364
• US Class Current: 604/544
• 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: A61M 25/0111 Aseptic insertion devices

Abstract

A catheter and catheter assembly are disclosed comprising a urinary catheter comprising an insertion end, a rearward end, and a one way check valve arrangement. The check valve arrangement comprises a tubular part of a flexible material, connected to the rearward end of the catheter and extending past the rearward end in a direction opposite to the insertion end, thereby substantially limiting the flow through the catheter to a single direction from the insertion end to the rearward end. Hereby, a very effective anti-reflux function is achieved, and at the same time the construction is relatively simple and inexpensive, and does not require any essential modifications of the other parts of the urinary catheter.

Claims

1. A urinary catheter assembly for insertion into a body opening of a user, comprising:

a catheter having an insertion end and a rearward end;

a wetting fluid compartment adapted to release a wetting fluid to come in contact with and form a low friction surface of the catheter portion of the assembly prior to insertion of the catheter assembly into the body opening of the user;

the rearward end of the catheter forming a connector for the catheter, wherein the exterior of the rearward end has a frusto-conical shape, and the external diameter of said rearward end increases in a direction away from the catheter insertion end,

a one way check valve arrangement, wherein said check valve arrangement comprises a tubular part of a flexible material, said tubular part of a flexible material being connected to the frusto-conical rearward end of the catheter, so that an inner surface of the tubular part of a flexible material is adhered to an external surface of the frusto-conical rearward end of the catheter, and so that the tubular part of a flexible material extends past the rearward end in a direction opposite to the insertion end and is adapted to close when subjected to a fluid in a wetting receptacle that presses against the tubular part of flexible material to substantially limit the flow through the catheter to a single direction from the insertion end to the rearward end,

wherein the wetting receptacle encompasses the wetting fluid compartment, the catheter and the one way check valve, and which is adapted to be opened prior to insertion of the catheter into the body opening of the user, and

wherein the tubular part of the check valve arrangement has an inner diameter which is at least twice the inner diameter of a lumen of the catheter.

2. The urinary catheter according to claim 1, wherein the tubular part comprises two openings, one of which is sealingly connected to the rearward end of the catheter, and the other presenting an open end opposite to said sealingly connected end.

3. The urinary catheter according to claim 1, wherein the check valve arrangement has an inlet at its attachment to the rearward end, and an outlet at the opposite end of the tubular part, wherein said inlet remains substantially open for passage of fluids there through, and said outlet being biased to closure after discharge of fluids through said outlet, thereby substantially limiting the flow to a single direction from said inlet to said outlet.

4. The urinary catheter according to claim 1, wherein the tubular part has an elongated form, wherein the length of the tubular part is in a range from three times the diameter of the rearward end of the catheter to ten times said diameter.

5. The urinary catheter according to claim 1, wherein the tubular part has an elongated form, wherein the length of said tubular part is in a range from 30 mm to 80 mm.

6. The urinary catheter according to claim 1, wherein the check valve arrangement has a perimeter attached along an exterior periphery of the rearward end of the catheter.

7. The urinary catheter according to claim 1, wherein the tubular part is connected to said rearward end by means of at least one of the following methods:

shrinkage, force fitting, welding and adhesive bonding.

8. The urinary catheter according to claim 1, wherein the insertable length of the catheter is provided with a hydrophilic surface coating providing low-friction surface character of the catheter by treatment with a wetting fluid.

9. The urinary catheter according to claim 1, wherein the tubular part of the check valve arrangement is formed from a plastic material.

10. The urinary catheter according to claim 1, wherein the tubular part of the check valve arrangement has a wall thickness less than 0.5 mm.

11. The urinary catheter according to claim 1, wherein the inner diameter of the tubular part of the check valve arrangement is wider at the outlet than at the inlet, wherein the outlet inner diameter is at least twice the inlet inner diameter.

12. The urinary catheter of claim 1, wherein the wetting receptacle forms a urine collection bag;

and

wherein the catheter has a storage position in which the catheter is fully contained within the wetting receptacle, and an operative position in which the catheter is located outside of the wetting receptacle, and is adapted to move between the storage position and the operative position via an opening in the wetting receptacle; and

wherein the flared rearward end is adapted to engage with the wetting receptacle to form a sealed connection therebetween; and

wherein the one-way check valve is connected to the catheter for concurrent movement with the catheter.

13. A urinary catheter assembly for insertion into a body opening of a user, comprising

a urinary catheter having an insertion end and a rearward end, and a wetting receptacle, arranged to accommodate said catheter;

a wetting fluid compartment adapted to release a wetting fluid to come in contact with and form a low friction surface of the catheter portion of the assembly prior to insertion of the catheter assembly into the body opening of the user;

wherein the rearward end forms a connector for the catheter, the exterior of the rearward end of the catheter has a frusto-conical shape, and the external diameter of which increases in a direction away from the catheter insertion end;

a one way check valve arrangement, wherein said check valve arrangement comprises a tubular part of a flexible material, said tubular part of flexible material being connected to the frusto-conical exterior of the rearward end of the catheter, so that an inner surface of the tubular part of flexible material is directly connected to an exterior surface of said frusto-conical rearward end, the tubular part of flexible material extending past the rearward end in a direction opposite to the insertion end and is adapted to close when subjected to a fluid in the wetting receptacle that presses against the tubular part of flexible material to substantially limit the flow to a single direction from the insertion end to the rearward end,

wherein the wetting receptacle encompasses the wetting fluid compartment, the catheter and the one way check valve, and which is adapted to be opened prior to insertion of the catheter into the body opening of the user, and

wherein an inner diameter of the tubular part of the check valve arrangement is wider at the outlet than at the inlet, wherein the outlet inner diameter is at least twice the inlet inner diameter.

14. The urinary catheter assembly according to claim 13, wherein the tubular part comprises two openings, one of which is sealingly connected to the rearward end of the catheter, and the other presenting an open end opposite to said sealingly connected end.

15. The urinary catheter assembly according to claim 13, wherein the tubular part has an inlet at its attachment to the rearward end, and an outlet at the opposite end of the tubular part, wherein said inlet remains substantially open for passage of fluids there through, and said outlet being biased to closure after discharge of fluids through said outlet, thereby substantially limiting the flow to a single direction from said inlet to said outlet.

16. The urinary catheter assembly according to claim 13, wherein the wetting receptacle is also a urine collection bag.

17. The urinary catheter assembly according to claim 13, wherein at least a part of the catheter is provided with a hydrophilic surface coating.

18. The urinary catheter assembly according to claim 17, wherein the wetting receptacle has an elongate pocket, defining a wetting fluid receiving area, which accommodates the insertable length of said urinary catheter.

19. The urinary catheter assembly according to claim 17, wherein the wetting fluid compartment comprises a wetting fluid container, the wetting fluid container containing a wetting fluid and being openable to enable the wetting fluid to be discharged for wetting of the urinary catheter.

20. The urinary catheter assembly according to claim 18, wherein the elongate pocket of the wetting presents an openable forward end, thereby enabling at least the insertable length of the urinary catheter to be projected through an opening, wherein said opening being arranged to engage with the rearward end of the catheter upon projection, thereby substantially sealing the connection.

21. The urinary catheter assembly according to claim 13, wherein the tubular part has an elongated form, wherein the length of said tubular part is in a range from three times the diameter of the rearward end of the catheter to ten times said diameter.

22. The urinary catheter according to claim 13, wherein the tubular part is connected to the rearward part by means of at least one of the following methods:

shrinkage, force fitting, welding and adhesive bonding.

23. The urinary catheter according to claim 13, wherein the tubular part of the check valve arrangement has a wall thickness less than 0.5 mm.

24. The urinary catheter assembly of claim 13, wherein the wetting receptacle forms a urine collection bag;

and

wherein the catheter has a storage position in which the catheter is fully contained within the wetting receptacle, and an operative position in which the catheter is located outside of the wetting receptacle, and is adapted to move between the storage position and the operative position via an opening in the wetting receptacle; and

wherein the flared rearward end is adapted to engage with the wetting receptacle to form a sealed connection therebetween; and

wherein the one-way check valve is connected to the catheter for concurrent movement with the catheter.

25. A method for manufacturing a urinary catheter assembly for insertion into a body opening of a user with a one way check valve arrangement, comprising the steps:

providing a urinary catheter having an insertion end and a rearward connector end and a wetting fluid compartment adapted to release a wetting fluid to come in contact with and form a low friction surface of the catheter portion of the assembly prior to insertion of the catheter assembly into the body opening of the user, wherein the exterior of the rearward connector end has a frusto-conical shape, and the external diameter of said rearward connector end increases in a direction away from the catheter insertion end;

providing a tubular part of a flexible material;

connecting an inner surface of said tubular part of a flexible material to an external surface of said frusto-conical rearward connector end of the urinary catheter in such a way that the tubular part extends past the rearward connector end in a direction opposite to the insertion end of the catheter, and is adapted to close when subjected to a fluid in a wetting receptacle that presses against the tubular part of a flexible material for provision of said check valve arrangement;

wherein the wetting receptacle encompasses the wetting fluid compartment, the catheter and the one way check valve, and is adapted to be opened prior to insertion of the catheter into the body opening of the user, and

wherein the inner diameter of the tubular part is wider at the outlet than at the inlet, wherein the inner outlet diameter is at least twice the inner inlet diameter.

26. The method according to claim 25, wherein the tubular part comprises two openings, one of which is sealingly connected to the rearward end of the catheter, and the other presents an open end opposite to said sealingly connected end.

27. The method according to claim 25, wherein the check valve arrangement has an inlet at its attachment to the rearward end, and an outlet at the opposite end of the tubular part, wherein said inlet remains substantially open for passage of fluids there through, and said outlet being biased to closure after discharge of fluids through said outlet, thereby substantially limiting the flow to a single direction from said inlet to said outlet.

28. The method according to claim 25, wherein the tubular part has an elongated form, wherein the length of the tubular part is in a range from three times the diameter of the rearward end of the catheter to ten times said diameter.

29. The method according to claim 25, wherein the tubular part is connected to said rearward end by means of at least one of the following methods:

shrinkage, force fitting, welding and adhesive bonding.

30. The method according to claim 25, comprising the further step of placing the urinary catheter in the wetting receptacle, arranged to accommodate said urinary catheter.

31. The method according to claim 25, wherein a perimeter of the tubular part is attached along an exterior periphery of the rearward end of the urinary catheter.

32. The method according to claim 25, wherein the tubular part is formed from an elastomeric/plastic material.

33. The method according to claim 25, wherein the tubular part has a wall thickness less than 0.5 mm.

34. The method of manufacturing a urinary catheter assembly of claim 25, wherein the wetting receptacle forms a urine collection bag;

and

wherein the catheter has a storage position in which the catheter is fully contained within the wetting receptacle, and an operative position in which the catheter is located outside of the wetting receptacle, and is adapted to move between the storage position and the operative position via an opening in the wetting receptacle; and

wherein the flared rearward end is adapted to engage with the wetting receptacle to form a sealed connection therebetween; and

wherein the one-way check valve is connected to the catheter for concurrent movement with the catheter.