Devices for delivering agents to a vaginal tract
The present invention is directed to devices for delivering agents to a vaginal tract, a device of the invention comprises a non-porous polymeric material substantially impermeable to an environment of the vaginal tract, the non-porous polymeric material forming a closed envelope which forms an internal space, wherein the closed envelope contains two or more distinct apertures.
1 . A vaginal device comprising a non-porous polymeric material substantially impermeable to an environment of the vaginal tract, the non-porous polymeric material forming a closed envelope which forms an internal space, wherein the closed envelope contains two or more distinct apertures.
2 . The device of claim 1 , wherein the closed envelope forms greater than one internal space.
3 . The device of claim 1 , wherein the closed envelope forms from one to six internal spaces.
4 . (canceled)
5 . The device of claim 1 , further comprising a matrix contained within the internal space.
6 . (canceled)
7 . The device of claim 5 , wherein the matrix further comprises an agent capable of diffusing from the matrix into the vaginal tract.
8 . (canceled)
9 . (canceled)
10 . (canceled)
11 . The device of claim 7 , wherein the agent is released from the device to the environment of the vaginal tract at a rate of about 0.001 mg/day to about 100 mg/day.
12 . (canceled)
13 . (canceled)
14 . The device of claim 7 , wherein the distinct apertures contain a second agent different from the agent in the matrix.
15 . The device of claim 14 , wherein the second agent prevents clogging of the distinct apertures.
16 . (canceled)
17 . (canceled)
18 . (canceled)
19 . The device of claim 7 , wherein the non-porous polymeric material comprises a second agent different from the agent in the matrix.
20 . The device of claim 19 , wherein the second agent is an agent that prevents clogging of the distinct apertures.
21 . (canceled)
22 . (canceled)
23 . (canceled)
24 . A method of administering an agent to a subject in need of the agent, the method comprising administering the device of claim 7 to the subject.
25 . The method of claim 24 , wherein the administering of an agent occurs continuously for about one hour to about one year.
26 . (canceled)
27 . (canceled)
28 . The device of claim 1 , wherein at least one of the distinct apertures has a length and a width having a ratio of less than 20:1.
29 . The device of claim 1 , wherein the closed envelope has a thickness of between about 5 μm to about 1 cm.
30 . (canceled)
31 . (canceled)
32 . The device of claim 1 , wherein the non-porous polymeric material is a thermoplastic material, thermoplastic elastomeric material, thermosetting material or combinations thereof.
33 . (canceled)
34 . The device of claim 32 , wherein the thermoplastic material is a thermoplastic olefin blend, a crosslinked polymer, a copolymer, a block copolymer, or combinations thereof.
35 . (canceled)
36 . (canceled)
37 . (canceled)
38 . (canceled)
39 . (canceled)
40 . (canceled)
41 . (canceled)
42 . (canceled)
43 . The device of claim 1 , wherein the closed envelope is annular in shape.
44 . The device of claim 43 , wherein the closed envelope is an intravaginal ring.
45 . The device of claim 1 , wherein the distinct apertures are formed by laser drilling.
46 . (canceled)
47 . (canceled)
48 . (canceled)
49 . (canceled)
50 . (canceled)
51 . (canceled)
52 . (canceled)
53 . (canceled)
54 . A method of making a device for delivering an agent to a vaginal tract, the method comprising:
(a) forming a closed envelope comprising a non-porous polymeric material substantially impermeable to an environment of the vaginal tract, wherein the closed envelope forms an internal space; and
(b) forming two or more distinct apertures in the closed envelope of (a).
55 . The method of claim 54 further comprising:
(c) placing a matrix containing an agent into the internal space of (a), thus forming a matrix encased by the closed envelope.
56 . The method of claim 55 wherein the distinct apertures are formed by laser drilling.
57 . A method of making a device for delivering an agent to a vaginal tract, the method comprising:
(a) forming a closed envelope comprising a non-porous polymeric material substantially impermeable to an environment of the vaginal tract, wherein the closed envelope forms an internal space;
(b) forming two or more distinct apertures in the closed envelope of (a); and
(c) placing a matrix containing an agent into the internal space of (a), thus forming a matrix encased by the closed envelope.