Cervical drug delivery system

• US 6,526,980 B1
• Filed: 08/25/2000
• Issued: 03/04/2003
• Est. Priority Date: 08/26/1999
• Status: Expired due to Term

• Current Assignee: West Virginia University
• Original Assignee: West Virginia University
• Inventors: Glover, Douglas D., Soisson, Andrew P., Tracy, Timothy S., Callery, Patrick S., McFarlin, Barbara L., Brancazio, Leo R., Smith, James E.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/649,170
• Time in Patent Office: 921 Days
• Field of Search: 128/830-840, 604/55, 604/54, 604/275-279
• US Class Current: 128/830
• CPC Class Codes: A61F 13/26 Means for inserting tampons , i.e. applicators
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion
• CPC Class Codes: A61F 6/12 Inserters or removers

Abstract

An cervical drug delivery apparatus having an absorbent cylindrical structure with a cervical cap attached to one end. One or more therapeutic agents are applied to the internal surface of the cervical cap. The cervical drug delivery apparatus is housed within an applicator and inserted into a patient'"'"'s vagina. Upon deployment of the cervical drug delivery apparatus, the cervical cap is automatically positioned over the patient'"'"'s cervix providing for the direct application of the therapeutic agents on the patient'"'"'s cervix. Alternative features of the cervical drug delivery apparatus include, a break-away cylindrical structure, a collapsible support structure for the cervical cap, an inflatable means for supporting the cervical cap, and the ability of the cylindrical structure and/or the cervical cap to contain one or more therapeutic agents that can be delivered by outside means.

Claims

1. A cervical agent delivery apparatus, comprising:

a cylindrical structure of absorbent material having a front end and a back end; and

a means for dispensing one or more cervical agents to a cervix of a patient, said means for dispensing attached to the front end of said cylindrical structure.

2. The cervical agent delivery apparatus according to claim 1, wherein said means for dispensing the one or more cervical agents is a sponge adapted for receiving the cervical agent.

3. The cervical agent delivery apparatus according to claim 1, wherein said means for dispensing the one or more cervical agents is a cervical cap being generally concave in shape and adapted for receiving the one or more cervical agents on an internal surface.

4. The cervical agent delivery apparatus according to claim 3, wherein said cervical cap is within the range of 30-90 mm in diameter.

5. The cervical agent delivery apparatus according to claim 3, wherein said cervical cap is a flexible composite material.

6. The cervical agent delivery apparatus according to claim 3, wherein said means for dispensing one or more cervical agents further comprises:

an elongated tube passing through said cervical cap to said internal surface; and

a means for delivering the one or more cervical agents through said elongated tube to said cervical cap.

7. The cervical agent delivery apparatus according to claim 6, wherein said means for delivering is a syringe.

8. The cervical agent delivery apparatus according to claim 6, wherein said means for delivering is a bulb.

9. The cervical agent delivery apparatus according to claim 6, wherein said elongated tube passes through said cylindrical structure.

10. The cervical agent delivery apparatus according to claim 3, further comprising a medicated pad having an exterior surface adapted to attach to said internal surface of said cervical cap.

11. The cervical agent delivery apparatus according to claim 1, wherein at least one said cervical agent is selected from the group of misoprostol, lidocaine, aldara, anti-neoplastic, local anesthetic, anti-fungal, anti-infectives, estrogens, progestins, spermicides, and anti-emetics.

12. The cervical agent delivery apparatus according to claim 1, further comprising a means for removing the cervical agent delivery apparatus from a patient.

13. The cervical agent delivery apparatus according to claim 2, wherein said means for removing is a string attached to the back end of said cylindrical structure.

14. The cervical agent delivery apparatus according to claim 1, wherein said means for dispensing the one or more cervical agents to the cervix further comprises a collapsible support structure.

15. The cervical agent delivery apparatus according to claim 14, wherein said collapsible support structure is a plurality of flexible fingers attached to said front end of said cylindrical structure and in contact with means for dispensing such that said collapsible support structure supports said means for dispensing.

16. The cervical agent delivery apparatus according to claim 14, wherein said collapsible support structure is made of flexible, memory plastic.

17. The cervical agent delivery apparatus according to claim 14, wherein said collapsible support structure is embedded within said means for dispensing the one or more cervical agents.

18. The cervical agent delivery apparatus according to claim 14, wherein said collapsible support structure is a flexible rim on an outer edge of said means for dispensing the one or more cervical agents.

19. The cervical agent delivery apparatus according to claim 14, wherein said collapsible support structure is impregnated with one or more cervical agents.

20. The cervical agent delivery apparatus according to claim 1, wherein said cylindrical structure contains one or more cervical agents.

21. The cervical agent delivery apparatus according to claim 1, wherein said means for dispensing is removably detachable from said front end of said cylindrical structure.

22. The cervical agent delivery apparatus according to claim 21, wherein said means for dispensing comprises a means for removing said means for dispensing from the patient.

23. The cervical agent delivery apparatus according to claim 22, wherein said means for removing said means for dispensing is a string.

24. The cervical agent delivery apparatus according to claim 1, further comprising:

an applicator having an elongated rod and an elongated hollow tube with an internal chamber, an open end, and an application end, wherein said elongated rod fits within said elongated hollow tube and said cylindrical structure with said means for dispensing the one or more cervical agents is housed within said internal chamber of said elongated hollow tube such that said means for dispensing is aligned with the application end of said elongated hollow tube.

25. The cervical agent delivery apparatus according to claim 24, wherein said application end is a perforated opening.

26. The cervical agent delivery apparatus according to claim 24, wherein said applicator is clear plastic.

27. The cervical agent delivery apparatus according to claim 24, further comprising:

a reservoir chamber adapted for holding one or more therapeutic agents;

an elongated tube having a front end and a back end, wherein said front end is connected to said means for dispensing and said back end is connected to said reservoir chamber,

wherein upon application of pressure to said elongated rod, the one or more therapeutic agents are delivered from said reservoir chamber though said elongated tube to said means for dispensing.

28. A cervical agent delivery apparatus, comprising:

a cylindrical structure having a front end and a back end, wherein said cylindrical structure contains at least one neutralizing agent; and

a means for dispensing one or more cervical agents to a cervix of a patient, said means for dispensing attached to the front end of said cylindrical structure.

29. A cervical agent delivery apparatus, comprising:

a cylindrical structure having a front end and a back end;

a means for dispensing one or more cervical agents to a cervix of a patient, said means for dispensing attached to the front end of said cylindrical structure; and

an inflatable means for supporting said means for dispensing the one or more cervical agents.

30. The cervical agent delivery apparatus according to claim 29, wherein said inflatable means for supporting is an inflatable ring attached to said front end of said cylindrical structure, an elongated tube having a first end connected to a bulb and a second end connected to said inflatable ring.

31. A cervical ripening compound for use with a pregnant woman to induce labor, comprising:

about 25 to 100 micrograms of Misoprostol; and

a topical application vehicle.

32. The cervical ripening compound according to claim 31, wherein said topical application vehicle is selected from the group of gel, cream, foam, or suspension medium.

33. The cervical ripening compound according to claim 31, wherein the cervical ripening compound is applied to an internal surface of a cervical cap, said cervical cap attached to a front end of a cylindrical structure.

34. A method for dispensing one or more cervical agents to a patient'"'"'s cervix, comprising the steps of:

a. inserting an applicator having an elongated rod and an elongated hollow tube with an internal chamber housing a cervical agent delivery apparatus into a patient'"'"'s vaginal canal, said cervical agent delivery apparatus having a cylindrical structure with a front end and a back end, and a cervical cap having an internal surface and being generally concave in shape, wherein said cervical cap is attached to said front end of said cylindrical structure and is adapted for having one or more cervical agents on said internal surface;

b. pushing said elongated rod of said applicator until said cervical agent delivery apparatus is deployed such that said cervical cap covers the patient'"'"'s cervix; and

c. removing said applicator from the patient.

35. The method according to claim 34, further comprising the step of:

d. removing said cervical agent delivery apparatus from the patient.

36. The method according to claim 34, further comprising the step of:

d. attaching a medicated pad to said internal surface of said cervical cap prior to said step (a), wherein said medicated pad contains one or more therapeutic agents.

37. The method according to claim 34, wherein said cervical cap is detachable from said cylindrical structure, the method further comprising the steps of:

d. detaching said cylindrical structure from said cervical cap; and

e. removing said cylindrical structure from the patient.

38. The method according to claim 37, further comprising the step of:

f. removing said cervical cap from the patient.

39. The method according to claim 34, wherein said cervical agent delivery apparatus has an elongated tube passing through said cervical cap to said internal surface and a means for delivering the one or more cervical agents through said elongated tube, and zero or more therapeutic agents are contained on said internal surface of said cervical cap, the method further comprising the step of:

d. delivering one or more therapeutic agents with said means for delivering through said elongated tube onto said internal surface of said cervical cap.

40. The method according to claim 39, wherein said means for delivering is a syringe connected to said elongated tube, the method further comprising the step of:

e. filling said syringe with one or more therapeutic agents.

41. The method according to claim 39, wherein said means for delivering is a reservoir chamber adapted for containing the one or more therapeutic agents within said applicator and positioned between said elongated rod and said cylindrical device, said elongated tube connecting said reservoir chamber with said internal surface of said cervical cap.

42. The method according to claim 34, wherein one therapeutic agent is a cervical ripening compound, the method further comprising the step of:

d. leaving the cervical agent delivery apparatus in place within the patient with said cervical cap in contact with the patient'"'"'s cervix for a desired amount of time.

43. The method according to claim 42, wherein the cervical ripening compound is about 25-100 micrograms of Misoprostol.

44. A method for dispensing one or more cervical agents to a patient'"'"'s cervix, comprising the steps of:

a. inserting an applicator having an elongated rod and an elongated hollow tube with an internal chamber housing a cervical agent delivery apparatus into a patient'"'"'s vaginal canal, said cervical agent delivery apparatus having a cylindrical structure with a front end and a back end, a cervical cap having an internal surface and being generally concave in shape, and an inflatable means for supporting said cervical cap, wherein said cervical cap is attached to said front end of said cylindrical structure and is adapted for having one or more cervical agents on said internal surface;

b. pushing said elongated rod of said applicator until said cervical agent delivery apparatus is deployed such that said cervical cap covers the patient'"'"'s cervix;

c. removing said applicator from the patient; and

d. inflating said inflatable means after said step (b).

45. The method according to claim 44, wherein said inflatable means is an inflatable ring attached to said front end of said cylindrical structure, an elongated tube having a first end connected to a bulb and a second end connected to said inflatable ring.