Device for delivery of a foamable composition

• US 8,617,100 B2
• Filed: 09/04/2008
• Issued: 12/31/2013
• Est. Priority Date: 09/04/2007
• Status: Active Grant

• Current Assignee: VYNE Therapeutics, Inc.
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Eini, Meir, Schuz, David, Hazot, Yohan, Tamarkin, Dov, Shifrin, Helen
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/204,771
• Publication Number:
  US 20090068118A1
• Time in Patent Office: 1,944 Days
• Field of Search: 604/73, 604/275, 604/278, 604/279, 604/514, 604/515, 604/517
• US Class Current: 604/73
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A device for delivery of a foamable composition to a body cavity includes a pressurized composition reservoir; a hollow body having a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir; and an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body; wherein said body has a length less than about 125 mm and internal diameter in the range of about 1.5 mm to about 3.5 mm, wherein said length and internal diameter are selected to provide a delivery of at least about 70% of the foamable composition during operation. The foam delivery device can have multiple apertures.

Claims

1. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurizable composition reservoir capable of receiving a foamable composition;

a hollow body having distal and proximal ends and a plurality of apertures comprising at least first and second apertures provided through a side wall of said hollow body, the proximal end in fluid communication with the reservoir via an actuator, said hollow body being shaped and adapted for insertion within a body cavity; and

an actuator including a valve operatively connected to the composition reservoir for effecting release of the foamable composition from said composition reservoir into a body cavity through said actuator and hollow body,

wherein said hollow body has a length less than about 125 mm;

wherein the plurality of apertures of the hollow body are located at distances from said proximal end that are within the range from about 90% to about 25% of the length of said hollow body and said hollow body lacks an aperture at its distal end;

wherein said first aperture is located closer to the distal end, and said second aperture is located closer to the proximal end, and

wherein the aperture size of said first aperture is larger than the aperture size of said second aperture.

2. The device of claim 1, wherein the hollow body has a tip at the distal end having a shape selected from the group consisting of bulbous, rounded and triangular.

3. The device of claim 1, wherein the device further comprises a guard surrounding the hollow body at a location along its length.

4. The device of claim 3, wherein the guard is movable between stops located above and below the guard at locations along the length of said hollow body.

5. The device of claim 1, wherein the composition reservoir is pressurized with a low pressure propellant gas.

6. The device of claim 1, wherein the diameter of said second aperture is in the range of about 0.5 mm to about 6 mm.

7. The device of claim 1, wherein the diameter of said second aperture is in the range of about 0.9 mm to about 3.2 mm.

8. The device of claim 1, wherein said pressurized composition reservoir contains a propellant.

9. The device of claim 1, further comprising a metering chamber.

10. The device of claim 1,

wherein said hollow body has a length of about 55-65 mm.

11. The device of claim 10, wherein said hollow body has an internal diameter and the ratio of said internal diameter to the length of said hollow body is about 1:

40 to about 1;

16;

or wherein said ratio is about 2;

65-1;

21.

12. The device of claim 11, wherein said ratio is about 2:

65-2;

50.

13. The device of claim 1,

wherein said hollow body has a length of about 95-105 mm.

14. The device of claim 13, wherein said hollow body has an internal diameter and the ratio of said internal diameter to the length of said hollow body is about 1:

60 to about 1;

15;

or wherein said ratio is about 1;

50-1;

19.

15. The device of claim 14, wherein said ratio is about 1:

50-1;

32.

16. The device of claim 1,

wherein said hollow body has a length of about 120-125 mm.

17. The device of claim 16, wherein said hollow body has an internal diameter and the ratio of said internal diameter to the length of said hollow body is about 2:

150 to about 1;

19;

or wherein said ratio is about 2;

125-1;

24.

18. The device of claim 17, wherein said ratio is about 2:

125-1;

40.

19. The device of claim 1,

wherein the location and relative size of the apertures are selected to provide delivery of the foam in a preselected proportion from each aperture.

20. The device of claim 19, wherein said hollow tube has an internal diameter in the range of about 1.5 mm to about 3.5 mm and the diameter of said second aperture is in the range of about 0.9 mm to about 3.2 mm.

21. The device of claim 19, wherein said hollow tube has an internal diameter and the ratio of the internal diameter to the length of said hollow tube is about 2:

150 to about 1;

19.

22. The device of claim 1, wherein the ratio of the diameter of said first aperture to the diameter of said second aperture is in the range of from about 1:

1 to about 4;

1.

23. The device of claim 22, wherein said ratio is about 2:

1.

24. The device of claim 22, wherein said ratio is selected to provide uniform delivery from said first aperture and said second aperture.

25. The device of claim 22, wherein said ratio is selected to provide uniform pressure at said first aperture and said second aperture.

26. The device of claim 1, wherein the device has a distance ratio (DR) in the range of from about 1:

2 to about 1;

10, wherein DR is defined as the ratio of the distance between said first aperture to said distal end (D1) to the distance between said first aperture and said second aperture (D2).

27. The device of claim 26, wherein said DR is in the range of about 1:

3 to about 1;

7.

28. The device of claim 1, wherein the diameter of said first aperture is in the range of about 0.5 mm to about 10 mm.

29. The device of claim 1, wherein the diameter of said first aperture is in the range of about 0.9 mm to about 3.2 mm.

30. The device of claim 19, wherein the ratio of the diameter of said first aperture to the diameter of said second aperture is in the range of about 1:

1 to about 4;

1.

31. The device of claim 30, wherein said ratio is in the range of about 2:

1 to about 4;

1.

32. The device of claim 1, wherein the device comprises an aperture ratio (AR) ranging from 1 to 5, where AR is defined as the ratio of the diameter of said first aperture to the diameter of said second aperture.

33. The device of claim 19, wherein said hollow tube has an internal diameter in the range of about 1.5 mm to about 3.5 mm, wherein said length and internal diameter are selected to provide a delivery of at least about 70% of the foamable composition during operation.

34. The device of claim 1, further provided with a flexible insertion tube.

35. The device of claim 1,

wherein said hollow body has a length of about 55-125 mm;

and

wherein the diameter of said second aperture is in the range of about 0.9 mm to about 3.2 mm.

36. The device of claim 1, wherein said hollow body has an internal diameter in the range of about 1.5 mm to about 3.5 mm and wherein said length and internal diameter are selected to provide a delivery to the body cavity of at least about 70% of the foamable composition which is released into the hollow body from the reservoir.

37. The device of claim 1, further comprising a volume for receiving the foamable composition after passing through the actuator valve.

38. The device of claim 1 further comprising a reservoir in the actuator.

39. The device of claim 38, wherein the foamable composition after entering the reservoir in the actuator is discharged thereby effecting release of the foamable composition into a body cavity through said actuator and hollow body.

40. The device of claim 36, wherein said length and said internal diameter are selected to provide a delivery to the body cavity of at least about 90% of the foamable composition which is released into the hollow body from the reservoir.

41. The device of claim 36, wherein said internal diameter of said hollow body is in the range of from about 2.0 mm to about 3.1 mm.

42. The device of claim 36, wherein the ratio of the internal diameter of said proximal end to the internal diameter of said distal end is in the range of from about 1:

1 to about 1;

4.

43. The device of claim 42, wherein said ratio is about 1:

2.

44. The device of claim 42, wherein said internal diameter increases gradually along the length of said hollow body.

45. The device of claim 42, wherein said internal diameter increases stepwise along the length of said hollow body.

46. A kit for delivery of a foamable composition comprising:

a pressurized canister comprising a foamable composition comprising an active ingredient;

a hollow body having distal and proximal ends and a plurality of apertures comprising at least first and second apertures provided through a side wall of said hollow body, the proximal end in fluid communication with the reservoir via an actuator, said hollow body being shaped and adapted for insertion within a body cavity;

an actuator operatively connected to the composition reservoir for effecting release of the foamable composition from said composition reservoir into a body cavity through said hollow body; and

a port for providing fluid communication between said hollow body and said actuator;

wherein the plurality of apertures of the hollow body are located at distances from said proximal end that are within the range from about 90% to about 25% of the length of said hollow body and said hollow body lacks an aperture at its distal end;

wherein said first aperture is located closer to the distal end, and said second aperture is located closer to the proximal end;

wherein the aperture size of said first aperture is larger than the aperture size of said second aperture; and

wherein said hollow body has a length and internal diameter selected for optimal delivery of the foamable composition to the body cavity.

47. The kit of claim 46, wherein said body cavity is selected from the group consisting of the vagina, the rectum, the colon and the small intestine.

48. The kit of claim 46, wherein the body cavity is the vagina.

49. The kit of claim 46, wherein said active ingredient is selected from the group consisting of an estradiol, pregn-4-ene-3,20-dione, also known as progesterone;

19-nor-pregn-4-en-3,20-dione;

17-hydroxy-19-nor-17α

-pregn-5(10)-3-en-20-yn-3-one;

di-β

-ethyl-17α

-ethynyl-17-β

hydroxypregn-4-en-3-one;

17α

-ethynyl-17-hydroxy-5(10)-estren-3-one;

17-α

-ethynyl-19-norestosterone;

6-chloro-17-hydroxypregn-4,6-diene-3,20-dione;

17-α

-hydroxy-6-α

-methyl-17-(1-propynyl)androst-4-en-3-one;

9-β

-10-α

-pregna-4,6-diene-3,20-dione;

17-hydroxy-17-α

-pregn-4-en-20-yn-3-one;

19-nor-17-α

-regn-4-en-20yne-3-β

-17-diol;

17-hydroxypregn-4-en-3,20-dione;

17-α

-hydroxy-progesterone;

17-hydroxy-6-α

-methylpregn-4-ene-3,10-dione;

an oxytocic agent, an ergot alkaloid, quinine, quinidine, histamine;

sparteine;

a prostaglandin;

an antimicrobial agent;

tetracycline, chlortetracycline, oxytetracycline, democlocycline, doxycycline, lymecycline, mecolcycline, rolitetracycline and minocycline.

50. A method for treatment of a subject in need thereof, the method comprising placing in a body cavity of the subject the kit of claim 46, and wherein the device when positioned in the body cavity releases the agent in the body cavity.

51. The method of claim 50, wherein the body cavity is the vagina.

52. The method of claim 50, wherein said treatment is selected from the group consisting of controlling fertility and treating a microbial infection of the vagina.

53. A method for treatment of a subject in need thereof, the method comprising placing in a deep body cavity of the subject the device of claim 46, and wherein the device when positioned in the deep body cavity releases the agent in the deep body cavity.

54. The method of claim 53, wherein said deep body cavity is selected from the group consisting of the stomach, the bladder, the uterus, and the intestine.

55. A device comprising:

a pressurized canister containing a foamable composition;

a catheter having a first and second catheter end;

wherein the catheter is sufficiently flexible to conform to the contours of a body cavity into which it is inserted and is suitable for delivering the foamable composition into a deep body cavity and deliver the foam to a target area within the deep body cavity;

a connector that connects the canister to the catheter at the first catheter end which, when connected, provides a first pressure sensitive seal so that foam released from the canister passes into and through the catheter without escaping through the first pressure-sensitive seal;

the second catheter end suitable for discharging foam or for receiving a foam applicator;

wherein the foam applicator is adapted to discharge foam into a body cavity and when connected to the second catheter end provides a second pressure sensitive seal so that foam does not escape from the second pressure-sensitive seal; and

wherein the pressurized canister comprises an actuator including a valve and port and the connector connects with the canister at the port to provide the first pressure sensitive seal.

56. A device according to claim 55, wherein the catheter is suitable for delivering the foamable composition into a deep body cavity selected from the group consisting of the stomach, the bladder, the uterus, and the intestine.

57. A device for delivery of a foamable composition to a body cavity, the device comprising:

a hollow body having distal and proximal ends, an inner diameter, and a plurality of apertures comprising at least first and second apertures provided through a side wall of said hollow body, the proximal end adapted to be in fluid communication with a reservoir via an actuator for receiving a foamable composition, said hollow body being shaped and adapted for insertion within a body cavity; and

an actuator including a valve and port operatively connected to the hollow body for effecting release of a foamable composition from said hollow body;

wherein the plurality of apertures of the hollow body are located at distances from said proximal end that are within the range from about 90% to about 25% of the length of said hollow body and said hollow body lacks an aperture at its distal end;

wherein said first aperture is located closer to the distal, and said second aperture is located closer to the proximal end;

wherein the aperture size of said first aperture is larger than the aperture size of said second aperture; and

wherein the location and relative size of said first and second apertures are selected to provide delivery of the foam in a preselected proportion from each aperture so as to provide the maximal coverage of a body coverage with the minimal amount of foamable composition.