Urinary catheter device with a pharmaceutically active composition

• US 20060058777A1
• Filed: 12/11/2003
• Published: 03/16/2006
• Est. Priority Date: 12/11/2002
• Status: Abandoned Application

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Nielsen, Pia Norup
• Application Number:
  US10/538,832
• Publication Number:
  US 20060058777A1
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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 25/0111 Aseptic insertion devices

Abstract

The invention relates to a device for urinary catheterisation comprising a catheter element and a pharmaceutically active composition containing a hormone, an efferent blocking agent, an afferent blocking agent and/or a sympathomimetic agent, the catheter element being adapted to deliver the pharmaceutically active composition in the lower urinary tract system during catheterisation. The invention also relates to the use of said pharmaceutically active composition for the manufacture of a device for the treatment, alleviation or prophylaxis of incontinence in a human and to a method of treating a human suffering from or being susceptible to incontinence. The invention further relates to a device for urinary catheterisation comprising a discrete unit dose comprising a pharmaceutically active composition and a catheter element adapted to shed said pharmaceutically active composition in the lower urinary tract system during catheterisation.

Claims

1. A device for urinary catheterisation comprising a catheter element adapted to be inserted in the urethra of a human, said catheter element comprising on the outer surface, before insertion of the catheter element, a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, such that the pharmaceutically active composition is delivered to the lower urinary tract system during catheterisation.

2. A device according to claim 1, wherein said pharmaceutically active composition comprises a hormone.

3. A device according to claim 1, said device being provided in a sealed package, wherein a major part of said pharmaceutically active composition is present on an outer surface of the catheter element.

4. A device according to claim 1, wherein the pharmaceutically active composition is distributed over a section of the catheter element having a length of at least 50% of the total length of the catheter element.

5. A device according to claim 1, wherein the catheter element is adapted for intermittent catheterisation.

6. A device according to claim 1, wherein said catheter element is comprised in a female catheter.

7. A device according to claim 1, wherein said catheter element has a coating covering at least a portion of the outer surface of the catheter element and said coating contains at least a part of said pharmaceutically active composition and is adapted to release said pharmaceutically active composition within the lower urinary tract system.

8. A device according to claim 1, wherein at least a part of said catheter element has a polymer coating, and at least a portion of said polymer coating is impregnated with at least a part of said pharmaceutically active composition.

9. A device according to claim 1, wherein at least a portion of said catheter element has a hydrophilic coating.

10. A device according to claim 9, wherein said hydrophilic coating is impregnated with at least a part of said pharmaceutically active composition.

11. A device according to claim 1, wherein said catheter element has depressions on the outer surface, which are adapted to hold at least a part of said pharmaceutically active composition.

12. A device according to claim 1, wherein at least a part of said pharmaceutically active composition is provided in a gel or creme.

13. A device according to claim 1, wherein said device is comprising a lubricating gel adapted to reduce friction between the catheter element and urethra, and said gel is containing at least a part of said pharmaceutically active composition.

14. A device according to claim 1, wherein said device is comprising a discrete unit dose containing said pharmaceutically active composition said device is adapted to shed said discrete unit dose in the lower urinary tract system.

15. A device according to claim 1, wherein said hormone is a female sex hormone or a derivative thereof.

16. A device according to claim 15, wherein said hormone is selected from oestrogen or an oestrogen derivative.

17. A device according to claim 15, wherein said hormone is oestriol or oestradiol.

18. A device according to claim 1, wherein said pharmaceutically active composition comprises an efferent blocking agent selected from the group consisting of anti-cholinergical agents, sympathomimetics agents, alfa-adrenergic agonists and nicotinic cholinergic agonists.

20. A device according to claim 1, wherein said pharmaceutically active composition comprises an afferent blocking agent.

19. A device according to claim 19, wherein said efferent agent is oxybutynin or trospiumchlorid.

21. Use of a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, for the manufacture of a device for the treatment, alleviation or prophylaxis of incontinence in a human, said device comprising a catheter element adapted to be inserted in the urethra of said human, said catheter element comprising the pharmaceutically active composition, and said catheter element being adapted to deliver said agent in the lower urinary tract system during catheterisation.

22. The use according to claim 21, wherein the human is a female.

23. The use according to claim 21, wherein the device is as defined in a device for urinary catheterisation comprising a catheter element adapted to be inserted in the urethra of a human, said catheter element comprising on the outer surface, before insertion of the catheter element, a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, such that the pharmaceutically active composition is delivered to the lower urinary tract system during catheterisation.

26. The method according to claim 23, wherein the device is as defined in a device for urinary catheterisation comprising a catheter element adapted to be inserted in the urethra of a human, said catheter element comprising on the outer surface, before insertion of the catheter element, a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, such that the pharmaceutically active composition is delivered to the lower urinary tract system during catheterisation.

24. A method of treating a human suffering from or being susceptible to incontinence, the method comprising the steps of catheterisation of said human by arranging a proximal end of a catheter element of a device for urinary catheterisation in the urethra of said human, said catheter element comprising a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, and said catheter element being adapted to deliver said composition in the lower urinary tract system during catheterisation.

25. The method according to claim 24, wherein the human is a female.

27. A kit comprising a device for urinary catheterisation and a pharmaceutically active composition comprising at least one agent selected from the group consisting of hormones, efferent blocking agents, afferent blocking agents and sympathomimetic agents, said device comprising a catheter element adapted to be inserted in the urethra of a human.

28. A device for urinary catheterisation, said device comprising a catheter element with a proximal end adapted to be inserted in a urinary canal, characterised in that said device is comprising a discrete unit dose, said discrete unit dose comprising a pharmaceutically active composition and said catheter element being adapted to shed said pharmaceutically active composition in the lower urinary tract system during catheterisation.

29. A device according to claim 28, wherein said discrete unit dose is placed at the tip of the catheter.