1. A method for occluding two fallopian tubes in a human or animal body, comprising,
a) providing a delivery system that delivers an effective amount of an occlusive material composition, wherein the delivery system comprises a delivery device comprising an introducer shaft comprising an atraumatic tip and defining two openings spaced from the atraumatic tip for providing two catheters; two catheters, wherein each catheter comprises an end structure on a delivery end; and means for providing an occlusive material composition into and through the two catheters;
b) positioning the atraumatic tip of the introducer shaft at or near the fundus of a uterus;
c) positioning the delivery end of each of the catheters at or near a uterine cornua such that each of the end structures is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition;
d) delivering from each cathether an effective amount of an occlusive material composition at or near the ostia of the fallopian tubes; and
e) occluding the fallopian tubes by forming an occlusion with the occlusive material composition within the lumen of each fallopian tube.
2. The method of claim 1, wherein the two fallopian tubes are occluded without removal and re-introduction, or substantial repositioning, of the introducer shaft.
3. The method of claim 2, wherein the two fallopian tubes are fallopian tubes of a human.
4. The method of claim 1, wherein the occlusive material composition comprises a tissue adhesive.
5. The method of claim 1, wherein the occlusive material composition is ultrasound visible.
6. The method of claim 5, wherein the ultrasound visible material comprises microbubbles of air or gas or microparticles of a material that entrap air or gas.
7. The method of claim 4, wherein the tissue adhesive is cyanoacrylate, polyacrylic acids, polyethylene glycols, modified polyethylene glycols, thrombin, collagen, collagen-based adhesives, fibrin, fibrin glue compositions, gelatin-resorcinol-formaldehyde-glutaraldehye (GRFG) glue, autologous blood in combination with collagen or thrombin, crosslinked albumin adhesives, modified glycosaminoglycans, poly(N-isopropylacrylamide)-based adhesives, alginates, or chitosan or gelatin, crosslinked with carbodiimide or genepin or combinations thereof.
8. The method of claim 4, wherein the cured composition swells less than 20%.
9. The method of claim 4, wherein the composition is about 20% to about 100% substantially resorbed or degraded in a range of about 30 to about 90 days.
10. The method of claim 9, wherein the occlusion is maintained by tissue ingrowth or wound healing or similar type response.
11. The method of claim 6, wherein the occlusive material composition further comprises polymers or particles.
12. The method of claim 11, wherein the particles are nano- or micro-particles.
13. The method of claim 11, wherein the composition comprises polymers.
14. The method of claim 11, wherein the composition is viewable by ultrasound.
15. The method of claim 4, wherein the composition further comprises tissue scarring agents, fibrosis agents, wound healing promoting agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof.
16. The method of claim 11, wherein the composition further comprises a curable carrier for the occlusive materials, a control release agent, tissue scarring agents, wound healing promoting agents, fibrosis agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof.
17. A method for contraception, comprising,
a) providing a delivery system that delivers an effective amount of an occlusive material composition, wherein the delivery system comprises a delivery device comprising an introducer shaft comprising an atraumatic tip and defining two openings spaced from the atraumatic tip for providing two catheters; two catheters, wherein each catheter comprises an end structure on a delivery end; and means for providing an occlusive material composition into and through the two catheters;
b) positioning the atraumatic tip of the introducer shaft at or near the fundus of a uterus;
c) positioning the delivery end of each catheter at or near a uterine cornua such that the end structure is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition;
d) delivering an effective amount of an occlusive material composition at or near the tubal ostium such that the occlusive material material is provided to a portion of a lumen of each fallopian tube; and
e) occluding the two fallopian tubes by forming an occlusion with the occlusive material composition within the lumen of each fallopian tube.
18. A transcervical device, comprising, an introducer shaft comprising an atraumatic tip and defining at least one opening spaced from the atraumatic tip for providing at least one catheter; at least one catheter comprising an end structure on a delivery end for maintaining the delivery end in the uterine cornua and aiding in localized delivery of a composition; attachment elements on a proximal end, and elements for providing the composition into and through the at least one catheter.
19. The device of claim 18, wherein the end structure is a cup, nozzle, or a balloon.
20. The device of claim 18, further comprising a delivery device stabilizer for holding the transcervical device in place once positioned.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A pharmaceutical combination useful for the treatment of viral infections comprising at least one of ()–D-2,6-diaminopurine-1,3- dioxolane(-D-DAPD) and ()–D-1,3-dioxolane guanine(-D-DXG) and at least one further therapeutic agent chosen from zidovudine, didanosine, zalcitabine, stavudine, lamivudine, nevirapine, delavirdine, efavirenz, indinavir, nelfinavir, saquinavir or ritonavir.
2. A pharmaceutical combination according to claim 1 wherein the -D-dioxolane is at least 97% free of the corresponding () enantiomer.
3. A pharmaceutical combination according to claim 1 wherein at least one further therapeutic agent is chosen from zidovudine, lamivudine, nevirapine and combinations thereof.
4. A pharmaceutical combination according to claim 2 wherein at least one further therapeutic agent is chosen from. zidovudine, lamivudine, nevirapine and combinations thereof.
5. A pharmaceutical combination according to claim 3 for use in medical therapy.
6. A pharmaceutical combination according to claim 4 for use in medical therapy
7. The pharmaceutical combination according to claim 3 for use in the treatment of HIV infection.
8. The pharmaceutical combination according to claim 4 for use in the treatment of HIV infection.
9. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 1 with at least one pharmaceutically acceptable carrier or excipient.
10. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 2 with at least one pharmaceutically acceptable carrier or excipient.
11. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 3 with at least one pharmaceutically acceptable carrier or excipient.
12. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 4 with at least one pharmaceutically acceptable carrier or excipient.
13. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 7 with at least one pharmaceutically acceptable carrier or excipient.
14. A pharmaceutical formulation comprising a pharmaceutical combination according to claim 8 with at least one pharmaceutically acceptable carrier or excipient.
15. A pharmaceutical combination according to claim 1 wherein the anti-viral active compounds and the therapeutic agents are present in a synergistic ratio.
16. A pharmaceutical combination according to claim 2 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
17. A pharmaceutical combination according to claim 3 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
18. A pharmaceutical combination according to claim 4 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
19. A pharmaceutical combination according to claim 7 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
20. A pharmaceutical combination according to claim 8 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
21. A pharmaceutical combination according to claim 1 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
22. A pharmaceutical combination according to claim 1 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
23. A pharmaceutical combination according to claim 1 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
24. A pharmaceutical combination according to claim 2 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
25. A pharmaceutical combination according to claim 2 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
26. A pharmaceutical combination according to claim 2 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
27. A pharmaceutical combination according to claim 3 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
28. A pharmaceutical combination according to claim 3 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
29. A pharmaceutical combination according to claim 3 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
30. A pharmaceutical combination according to claim 4 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
31. A pharmaceutical combination according to claim 4 wherein the antiviral active compounds and the therapeutic. agents are present in a ratio between about 1:50 to about 50:1.
32. A pharmaceutical combination according to claim 4 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
33. A pharmaceutical combination according to claim 7 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
34. A pharmaceutical combination according to claim 7 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
35. A pharmaceutical combination according to claim 7 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
36. A pharmaceutical combination according to claim 8 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
37. A pharmaceutical combination according to claim 8 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
38. A pharmaceutical combination according to claim 8 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
39. A method for the treatment of viral infections comprising administering a therapeutically effective amount of at least. one of ()–D-2,6-diaminopurine-1,3- dioxolane(-D-DAPD) and ()–D -1,3-dioxolane guanine(-D-DXG) and at least one further therapeutic agent chosen from zidovudine, didanosine, zalcitabine, stavudine, lamivudine, nevirapine, delavirdine, efavirenz, indinavir, nelfinavir, saquinavir or ritonavir to a subject in need of such treatment.
40. The method of claim 39 wherein the -D-dioxclane is at least 97% free of the corresponding () enantiomer.
41. The method of claim 39 wherein at least one further therapeutic agent is chosen from zidovudine, lamivudine, nevirapine and combinations thereof.
42. The method of claim 40 wherein at least one further therapeutic agent is chosen from zidovudine, lamivudine, nevirapine and combinations thereof.
43. The method according to claim 41 wherein the viral infection is an HIV infection.
44. The method according to claim 42 wherein the viral infection is an HIV infection.
45. The method according to claim 39 wherein the compounds and the other therapeutic agents are administered sequentially.
46. The method according to claim 40 wherein the compounds and the other therapeutic agents are administered sequentially.
47. The method according to claim 43 wherein the compounds and the other therapeutic agents are administered sequentially.
48. The method, according to claim 44 wherein the compounds and the other therapeutic agents are administered sequentially.
49. The method according to claim 39 wherein the compounds and the other therapeutic agents are administered simultaneously.
50. The method according to claim 40 wherein the compounds and the other therapeutic agents are administered simultaneously.
51. The method according to claim 43 wherein the compounds and the other therapeutic agents are administered simultaneously.
52. The method according to claim 44 wherein the compounds and the other therapeutic agents are administered simultaneously.
53. The method of claim 39 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
54. The method of claim 40 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
55. The method of claim 43 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
56. The method of claim 44 wherein the antiviral active compounds and the therapeutic agents are present in a synergistic ratio.
57. The method of claim 39 wherein antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
58. The method of claim 39 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
59. The method of claim 39 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
60. The method of claim 40 wherein antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
61. The method of claim 40 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
62. The method of claim 40 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
63. The method of claim 43 wherein antiviral active compounds and the therapeutic agents are present in a ratio between about 1.250 to about 250:1.
64. The method of claim 43 wherein the antiviral active compounds and the therapeutic agents ate present in a ratio between about 1:50 to about 50:1.
65. The method of claim 43 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.
66. The method of claim 44 wherein antiviral active compounds and the therapeutic agents are present in a ratio between about 1:250 to about 250:1.
67. The method of claim 44 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:50 to about 50:1.
68. The method of claim 44 wherein the antiviral active compounds and the therapeutic agents are present in a ratio between about 1:20 to about 20:1.