Method for treatment of uterine fibroid tumors

• US 20060251581A1
• Filed: 05/09/2005
• Published: 11/09/2006
• Est. Priority Date: 05/09/2005
• Status: Abandoned Application

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Madenjian, Arthur, McIntyre, Jon T.
• Application Number:
  US11/124,828
• Publication Number:
  US 20060251581A1
• Time in Patent Office: Days
• US Class Current: 424/9.300
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/045 Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/734 Alginic acid
• CPC Class Codes: A61K 31/74 Synthetic polymeric materials
• CPC Class Codes: A61K 31/79 Polymers of vinyl pyrrolidone
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 49/0002 General or multifunctional contrast agents, e.g. chelated agents
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

Various injectable or insertable uterine fibroid treatment formulations are provided, which comprise a uterine fibroid treatment agent in an amount effective to cause shrinkage or elimination of uterine fibroids. The injectable or insertable formulations are typically solids, semi-solids or high-viscosity fluids. Other aspects of the invention are directed to systems and methods for treatment of uterine fibroids.

Claims

1. A method for the treatment of uterine fibroids, said method comprising:

providing an injectable or insertable formulation that comprises a uterine fibroid treatment agent in an amount effective to cause shrinkage of uterine fibroids; and

injecting or inserting said formulation into the uterine fibroid.

2. The method of claim 1, wherein said formulation is injected or inserted into said fibroid transabdominally.

3. The method of claim 1, wherein said formulation is injected or inserted into said fibroid transvaginally

4. The method of claim 1, wherein said formulation is injected or inserted into said fibroid under image guidance.

5. The method of claim 4, wherein said image is at least one of a direct visual image and a non-direct visual image.

6. The method of claim 5, wherein said direct image is scope image.

7. The method of claim 5, wherein said non-direct visual image is an MRI image.

8. The method of claim 7, wherein said formulation comprises an MRI contrast agent.

9. The method of claim 5, wherein said non-direct visual image is an ultrasound image.

10. The method of claim 9, wherein said formulation comprises an ultrasound contrast agent.

11. The method of claim 5, wherein said non-direct visual image is a fluoroscopic image.

12. The method of claim 11, wherein said formulation comprises an x-ray contrast agent.

13. The method of claim 1, wherein said uterine fibroid treatment agent is selected from a chemical ablation agent, a non-steroidal anti-inflammatory drug, an oral contraceptive, a GnRH agonist, an antiprogestogen, and a selective progesterone receptor modulator.

14. The method of claim 1, wherein said uterine fibroid treatment agent is a chemical ablation agent.

15. The method of claim 14, wherein said chemical ablation agent is a salt.

16. The method of claim 14, wherein said chemical ablation agent is selected from an enzyme, an acid, a base and an oxidizing agent.

17. The method of claim 1, wherein said formulation comprises a plurality of different uterine fibroid treatment agents.

18. The method of claim 1, wherein said formulation is a solid formulation.

19. The method of claim 18, wherein said formulation comprises a biodisintegrable binder.

20. The method of claim 19, wherein said biodisintegrable binder is selected from a glycolic acid polymer, a cellulose ether, and a crosslinked polymer.

21. The method of claim 18, wherein said formulation is a dosage form having a largest dimension between 1 mm and 20 mm.

22. The method of claim 18, wherein said formulation is delivered through a hollow channel into said fibroid.

23. The method of claim 18, wherein said formulation is encapsulated.

24. The method of claim 1, wherein said formulation is a powder.

25. The method of claim 24, wherein said powder is introduced into said fibroid by jet injection.

26. The method of claim 1, wherein said formulation is a high-viscosity formulation.

27. The method of claim 26, wherein said formulation comprises a viscosity adjusting agent.

28. The method of claim 27, wherein said viscosity adjusting agent is present in an amount effective to provide a viscosity ranging from 10,000 cps to 50,000 cps.

29. The method of claim 1, wherein said formulation is a gel.

30. The method of claim 1, wherein said formulation is a fluid formulation that is converted in vivo into a solid, a semi-solid or a high-viscosity liquid.

31. The method of claim 1, wherein said formulation is a fluid formulation that is crosslinked in vivo.

32. The method of claim 31, wherein a crosslinking agent is injected into said fibroid in a step separate from the injection of said fluid formulation.

33. The method of claim 31, wherein said formulation is ionically crosslinked in vivo.

34. The method of claim 33, wherein said formulation comprises an alginate polymer.

35. The method of claim 1, wherein said formulation has a lower critical solution temperature (LCST) that is less than or equal to the body temperature of said patient, and wherein said formulation is injected at a temperature that is less than said lower critical solution temperature (LCST).

36. The method of claim 35, wherein said formulation comprises a polyoxyethylene-polyoxypropylene block copolymer.

37. The method of claim 1, wherein said formulation has a melting point that is greater than the body temperature of said patient, and wherein said formulation is injected at a temperature that is greater than said melting point.

38. The method of claim 37, wherein said formulation comprises gelatin.

39. A system for the treatment of uterine fibroids, said system comprising:

(a) an injectable or insertable formulation that comprises a uterine fibroid treatment agent in an amount effective to cause shrinkage of uterine fibroids; and

(b) an apparatus for injecting or inserting said formulation into said fibroids.

40. A fibroid injectable or insertable formulation that comprises a uterine fibroid treatment agent, selected from a non-steroidal anti-inflammatory drug, an oral contraceptive, a GnRH agonist, an antiprogestogen, and a selective progesterone receptor modulator, in an amount effective to cause shrinkage of uterine fibroids.