Embolic occlusion of uterine arteries

• US 20040202694A1
• Filed: 04/11/2003
• Published: 10/14/2004
• Est. Priority Date: 04/11/2003
• Status: Abandoned Application

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Altieri, Greig
• Application Number:
  US10/411,690
• Publication Number:
  US 20040202694A1
• Time in Patent Office: Days
• US Class Current: 424/430
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

A treatment procedure is disclosed which involves the short term, non-permanent occlusion of the patient'"'"'s blood vessels by depositing a bioabsorbable embolic mass within the patient'"'"'s blood vessel. The procedure is particularly suitable for treating uterine disorders by occluding a patient'"'"'s uterine arteries. A therapeutically effective time period for occlusion of a uterine artery is from about 0.5 to about 48 hours, preferably about 1 to about 24 hours, with occlusion times of about 1 to about 8 hours being suitable in many instances. The embolic mass may bioabsorbable particulate with minimum transverse dimensions of about 100 to about 2000 micrometers, preferably about 300 to about 1000 micrometers. The particulate may be a polymeric material formed of polylactic acid, polyglycolic acid or copolymers thereof, or a swellable copolymer of lactic acid and polyethylene glycol. The embolic material may be delivered to an intracorporeal site as a biocompatible solution containing a solute which is relatively insoluble in a water based fluid and a solvent which is relatively soluble in the water based fluid, where the solute forms the embolic mass which occludes or partially occludes a body lumen or fills or partially fills a body cavity.

Claims

18. A therapeutic procedure for treating a female patient'"'"'s uterine disorder, comprising:

a. advancing a delivery catheter through the patient'"'"'s vasculature until a distal portion of the catheter is disposed within a desired location of the patient'"'"'s first uterine artery; and

b. injecting a bioabsorbable, short lived embolic material through the delivery catheter into the desired location of the patient'"'"'s first uterine artery to temporarily occlude at least a portion of the patient'"'"'s first uterine artery for a therapeutically effective time period.

19. The procedure of claim 18 including withdrawing the catheter from the patient'"'"'s first uterine artery and monitoring blood flow through the first uterine artery to ensure reestablishing blood flow through the first uterine artery at the termination of the therapeutically effective time period.

20. The procedure of claim 18 including:

a. advancing a delivery catheter through the patient'"'"'s vasculature until a distal portion of the catheter is disposed within a desired location within the patient'"'"'s second uterine artery; and

b. injecting a bioabsorbable, short lived embolic mass through the delivery catheter into the desired location of the patient'"'"'s second uterine artery to temporarily occlude the patient'"'"'s second uterine artery for a therapeutically effective time period.

21. An embolic material for temporarily occluding a female patient'"'"'s uterine artery comprising a bolus formed at least in part of bioabsorbable particulate having a minimum transverse dimension of about 100 to about 2000 micrometer and a suitable carrier.

22. The embolic material of claim 21 wherein the bioabsorbable particulate has a minimum transverse dimension of about 300 to about 1000 micrometers.

23. The embolic material of claim 21 wherein the bioabsorbable particulate is formed at least in part of a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

24. The embolic material of claim 21, wherein the bioabsorbable embolic material is swellable particulate.

25. The embolic material of claim 24 wherein the swellable particulate is formed at least in part of a copolymer of polylactic acid and polyethylene glycol.

26. The embolic material of claim 25 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95:

5 to about 50;

50.

27. The embolic material of claim 25, wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

28. A therapeutic procedure for treating a female patient'"'"'s uterine disorder, comprising temporarily occluding one or more of the patient'"'"'s uterine arteries with a bolus of a bioabsorbable, short lived embolic material for a therapeutically effective time period.

29. The therapeutic procedure of claim 28 wherein the embolic material is a solution of a water soluble solvent and a water insoluble, bioabsorbable polymeric solute suitable for intracorporeal deployment.

30. The therapeutic procedure of claim 29 wherein the solvent contains dimethyl sulfoxide.

31. The therapeutic procedure of claim 29 wherein the water insoluble, bioabsorbable polymeric solute is a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

32. The therapeutic procedure of claim 28 wherein the embolic material is swellable particulate.

33. The therapeutic procedure of claim 32 wherein the swellable particulate is formed at least in part of a copolymer of polylactic acid and polyethylene glycol.

34. The therapeutic procedure of claim 33 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95:

5 to about 50;

50.

35. The therapeutic procedure of claim 33 wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

36. The therapeutic procedure of claim 28 wherein the embolic material is a viscous fluid.

37. A therapeutic procedure for treating a female patient'"'"'s uterine disorder, comprising the steps of:

a. advancing a delivery catheter through the patient'"'"'s vasculature until a distal portion of the catheter is disposed within a desired location of the patient'"'"'s first uterine artery; and

b. injecting a first bioabsorbable, short lived embolic material through the delivery catheter into the desired location of the patient'"'"'s first uterine artery to temporarily occlude at least a portion of the patient'"'"'s first uterine artery for a therapeutically effective time period.

38. The method of claim 37 including withdrawing the catheter from the patient'"'"'s first uterine artery and monitoring blood flow through the first uterine artery.

39. The method of claim 37 including the steps of

a. advancing a delivery catheter through the patient'"'"'s vasculature until a distal portion of the catheter is disposed within a desired location within the patient'"'"'s second uterine artery;

and

c. injecting a second bioabsorbable, short lived embolic mass through the delivery catheter into the desired location of the patient'"'"'s second uterine artery to temporarily occlude the patient'"'"'s second uterine artery for a therapeutically effective time period.

40. The method of claim 39 including withdrawing the catheter from the patient'"'"'s second uterine artery and monitoring blood flow through the second uterine artery.

41. An embolic material for temporarily occluding a female patient'"'"'s uterine artery comprising a solute of bioabsorbable polymeric material which forms an occluding mass within the patient'"'"'s artery in a suitable water soluble biocompatible solvent.

42. The embolic material of claim 41 wherein the solvent is dimethyl sulfoxide.

43. The embolic material of claim 41 wherein the bioabsorbable solute is at least in part a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers thereof.

44. A therapeutic or diagnostic procedure comprising temporarily occluding one or more of a patient'"'"'s blood vessels with a bioabsorbable, short lived embolic material for a therapeutically effective time period.

45. An embolic material for temporarily occluding a patient'"'"'s artery comprising a bolus formed at least in part of bioabsorbable polymeric material and a suitable carrier.

1. A therapeutic procedure for treating a female patient'"'"'s uterine disorder, comprising non-permanently occluding at least one of the patient'"'"'s uterine arteries with a bioabsorbable, short lived embolic mass for a therapeutically effective time period.

2. The therapeutic procedure of claim 1 wherein blood flow through the uterine artery system is monitored to ensure re-establishing blood flow through the uterine artery system at the termination of said therapeutically effective time period.

3. The therapeutic procedure of claim 2 wherein the blood flow is monitored by ultrasound.

4. The therapeutic procedure of claim 2 wherein the pH of the uterine wall is monitored during the treatment period.

5. The therapeutic procedure of claim 1 wherein the embolic mass is formed of particulate having a minimum transverse cross section of about 100 to about 2000 micrometers.

6. The therapeutic procedure of claim 5, wherein the particulate has a particle size of about 300 to about 1000 micrometers.

7. The therapeutic procedure of claim 1, wherein the bioabsorbable embolic mass is formed of particulate of a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid or copolymers thereof.

8. The therapeutic procedure of claim 1, wherein the bioabsorbable embolic mass is a swellable particulate material formed of a copolymer of polylactic acid and polyethylene glycol.

9. The therapeutic procedure of claim 8 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95/5 to about 50/50.

10. The therapeutic procedure of claim 8, wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

11. The therapeutic procedure of claim 1 wherein the bioabsorbable embolic mass is a viscous fluid.

12. The therapeutic procedure of claim 1, wherein the occlusion of the uterine artery system includes bilateral occlusion of the uterine artery system.

13. The therapeutic procedure of claim 1, wherein the therapeutically effective time period is about 0.5 to about 48 hours.

14. The therapeutic procedure of claim 1, wherein the therapeutically effective time period is about 1 to about 24 hours.

15. The therapeutic procedure of claim 1, wherein the therapeutically effective time period is about 1 to about 8 hours.

16. The therapeutic procedure of claim 1, wherein the uterine disorder is the presence of uterine fibroids.

17. The therapeutic procedure of claim 1, wherein the uterine disorder is selected from the group consisting of DUB, PPH and bleeding from caesarian section surgery.

46. The embolic material of claim 45 wherein the bioabsorbable polymeric material is in the form of particulate having a minimum transverse dimension of about 100 to about 2000 micrometer.

47. The embolic material of claim 45 wherein the bioabsorbable polymeric material is in the form of particulate having a minimum transverse dimension of about 400 to about 1000 micrometers.

48. The embolic material of claim 45 wherein the bioabsorbable polymeric material is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

49. The embolic material of claim 45 wherein the carrier is a solvent for the polymeric material.

50. The embolic material of claim 49 wherein the solvent contains dimethyl sulfoxide.

51. The embolic material of claim 49 wherein the solute is essentially water insoluble.

52. The embolic material of claim 49 wherein the polymeric material is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers thereof

53. The embolic material of claim 45, wherein the bioabsorbable polymeric material is a swellable polymer.

54. The embolic material of claim 52 wherein the swellable polymer is at least in part a copolymer of polylactic acid and polyethylene glycol.

55. The embolic material of claim 53 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95:

5 to about 50;

50.

56. The embolic material of claim 53, wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

56-1. The embolic material of claim 45 wherein the bioabsorbable polymeric material is a viscous fluid.

57. A biocompatible solution suitable for intracorporeal deployment comprising a solvent which is relatively soluble in a water based fluid and a bioabsorbable polymeric solute which is relatively insoluble in the water based fluid.

58. The biocompatible solution of claim 57 wherein the solvent is dimethyl sulfoxide.

59. The biocompatible solution of claim 57 wherein the water insoluble, bioabsorbable polymeric solute is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

60. The biocompatible solution of claim 57 containing about 1 to about 35% by weight water insoluble, bioabsorbable polymeric solute.

61. The biocompatible solution of claim 57 containing about 2 to about 20% by weight water insoluble, bioabsorbable polymeric solute.

62. A therapeutic or diagnostic intracorporeal procedure comprising temporarily occluding one or more of a patient'"'"'s blood vessels with a bolus of a bioabsorbable, short lived embolic material which is a solution of a water soluble solvent and a water insoluble, bioabsorbable polymeric solute.

63. The procedure of claim 62 wherein the solvent contains dimethyl sulfoxide.

64. The procedure of claim 62 wherein the water insoluble, bioabsorbable polymeric solute is a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

65. The procedure of claim 62 wherein the embolic material is swellable particulate.

66. The procedure of claim 65 wherein the swellable particulate is formed at least in part of a copolymer of polylactic acid and polyethylene glycol.

67. The procedure of claim 65 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95:

5 to about 50;

50.

68. The procedure of claim 65 wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

69. The procedure of claim 62 wherein the embolic material is a viscous fluid.

70. An intracorporeal procedure comprising at least partially filling a body cavity or at least partially occluding a body lumen with a bolus of a bioabsorbable, short lived embolic material which is a solution of a solvent which is relatively soluble in a water based fluid and a bioabsorbable polymeric solute which is relatively insoluble in the water based fluid.

71. The procedure of claim 70 wherein the solvent contains dimethyl sulfoxide.

72. The procedure of claim 70 wherein the water insoluble, bioabsorbable polymeric solute is a polymeric material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone and copolymers, blends and mixtures thereof.

73. The procedure of claim 70 wherein the embolic material is swellable particulate.

74. The procedure of claim 73 wherein the swellable particulate is formed at least in part of a copolymer of polylactic acid and polyethylene glycol.

75. The procedure of claim 73 wherein the weight ratio of polylactic acid to polyethylene glycol is about 95:

5 to about 50;

50.

76. The procedure of claim 73 wherein the copolymer comprises 70% (by wt) polylactic acid and 30% (by wt.) polyethylene glycol.

77. The procedure of claim 73 wherein the embolic material is a viscous fluid.