Delivery system and method for interstitial radiation therapy

• US 7,060,020 B2
• Filed: 12/28/2001
• Issued: 06/13/2006
• Est. Priority Date: 11/02/2001
• Status: Expired due to Fees

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Ideamatrix Incorporated
• Inventors: Terwilliger, Richard A., Lamoureux, Gary A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/035,083
• Publication Number:
  US 20030088140A1
• Time in Patent Office: 1,628 Days
• Field of Search: 600 1- 8
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1024 Seeds
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy
• CPC Class Codes: B29C 48/03 characterised by the shape of the extruded material at extrusion
• CPC Class Codes: B29C 48/151 Coating hollow articles
• CPC Class Codes: B29C 48/157 Coating linked inserts, e.g. chains
• CPC Class Codes: G21G 4/08 specially adapted for medical application radiation therapy using radioactive sources A61N5/10

Abstract

A delivery system and method for interstitial radiation therapy comprising a substantially axially stiff and longitudinally flexible elongated member made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the member. The delivery system and method further customize the member based on a prescription.

Claims

1. A therapeutic element comprising:

a polymeric material;

a plurality of radioactive seed elements;

wherein

said polymeric material forms an elongated member by encapsulating and connecting adjacent radioactive seed elements end-to-end at desired intervals; and

said elongated member being axially rigid and radially flexible.

2. The therapeutic element of claim 1 wherein the polymeric material is a polymer.

3. The therapeutic element of claim 1 wherein the polymeric material is a co-polymer.

4. The therapeutic element of claim 1 wherein the polymeric material is a natural bio-compatible material.

5. The therapeutic element of claim 1 wherein the polymeric material is a synthetic bio-compatible material.

6. The therapeutic element of claim 1 wherein the polymeric material is a natural bio-absorbable material.

7. The therapeutic element of claim 1 wherein the polymeric material is a synthetic bio-absorbable material.

8. The therapeutic element of claim 1 wherein the elongated member has alternating segments of polymeric material and seed elements.

9. The therapeutic element of claim 1 wherein the elongated member has a substantially constant diameter.

10. The therapeutic element of claim 1 wherein the elongated member has a diameter substantially similar to the diameter of the radioactive seed elements.

11. The therapeutic element set forth in claim 1 wherein said elongate member is sufficiently rigid axially to prevent jamming or collapsing while being pushed out of a needle.

12. The therapeutic element set forth in claim 1 wherein said elongate solid member has sufficient radial flexibility to maintain locational accuracy relative to a tumor target as said tumor target shrinks in size.

13. The therapeutic element set forth in claim 1 wherein the thickness of said elongate solid member around said radioactive seeds is sufficient to decrease normal tissue necrosis from a high local dose of radiation.

14. The therapeutic element set forth in claim 1 wherein said elongate solid member is longitudinally flexible.

15. The therapeutic element set forth in claim 1 wherein said polymeric material is impregnated with a hormone.

16. The therapeutic element set forth in claim 1 wherein said polymeric material is impregnated with a drug.

17. The therapeutic element set forth in claim 1 wherein said radioactive seed elements are positioned at various intervals along the length of said elongate solid member.

18. The therapeutic element set forth in claim 1 wherein said radioactive seed elements are impregnated with a hormone.

19. The therapeutic element set forth in claim 1 wherein said radioactive seed elements are impregnated with a drug.

20. The therapeutic element set forth in claim 1 wherein said radioactive seeds contain a compound or element that emits photonic radiation having a low energy and a short half-life.

21. The therapeutic element set forth in claim 1 wherein said radioactive seeds contain an isotope consisting of the group iodine 125, palladium 103, iridium 192, cesium 131, gold 198 yttrium 90 and phosphorus 32.

22. The therapeutic element set forth in claim 1 wherein said polymeric material is absorbed by living tissue within about 70 to 120 days after implant.

23. The therapeutic element set forth in claim 1 wherein said polymeric material is absorbed by living tissue at substantially the same time as the half-life of the radioactive seed elements are reached.

24. The therapeutic element set forth in claim 1 wherein said polymeric material is selected from the group consisting of polymers and copolymers of glycolide, lactide and polydiaxanone.

25. The therapeutic element set forth in claim 1 wherein said elongate solid member is echogenic.

26. The therapeutic element set forth in claim 1 wherein said elongate solid member has air bubbles dispensed within.

27. The therapeutic element of claim 1 wherein said elongate member has a durometer in the range of about 20 to about 40.

28. The therapeutic element of claim 1 wherein said elongate member has a durometer in the range of about 20 to about 80.

29. A therapeutic element comprising:

an elongate member made of a bio-absorbable polymeric material;

radioactive seed elements;

wherein

said radioactive seed elements are secured along the elongate member by molding said seed elements directly into the bio-absorbable polymeric material; and

said elongate member is axially rigid and radially flexible.

30. The therapeutic element of claim 29, wherein

said radioactive seed elements are secured at desired intervals along the elongate member.

31. The therapeutic element of claim 29, wherein each of said desired intervals is independently set.

32. The therapeutic implant of claim 31, wherein said desired intervals are set by a pre-operative diagnosis plan of a patient.

33. The therapeutic implant of claim 29, wherein the radioactive seed elements are secured along the elongate member without the use of pre-fabricated spacers.

34. The therapeutic implant of claim 29, wherein said therapeutic implant is fashioned by compression molding techniques.

35. The therapeutic element of claim 29 wherein the polymeric material is a polymer.

36. The therapeutic element of claim 29 wherein the polymeric material is a co-polymer.

37. The therapeutic element of claim 29 wherein the polymeric material is a natural bio-compatible material.

38. The therapeutic element of claim 29 wherein the polymeric material is a synthetic bio-compatible material.

39. The therapeutic element of claim 29 wherein the polymeric material is a natural bio-absorbable material.

40. The therapeutic element of claim 29 wherein the polymeric material is a synthetic bio-absorbable material.

41. The therapeutic element of claim 29 wherein the elongated member has alternating segments of polymeric material and seed elements.

42. The therapeutic element of claim 29 wherein the elongated member has a substantially constant diameter.

43. The therapeutic element of claim 29 wherein the elongated member has a diameter substantially similar to the diameter of the radioactive seed elements.

44. The therapeutic element set forth in claim 29 wherein said elongate member is sufficiently rigid axially to prevent jamming or collapsing while being pushed out of a needle.

45. The therapeutic element set forth in claim 29 wherein said elongate member has sufficient radial flexibility to maintain locational accuracy relative to a tumor target as said tumor target shrinks in size.

46. The therapeutic element set forth in claim 29 wherein the thickness of said elongate member around said radioactive seeds is sufficient to decrease normal tissue necrosis from a high local dose of radiation.

47. The therapeutic element set forth in claim 29 wherein said polymeric material is impregnated with a hormone.

48. The therapeutic element set forth in claim 29 wherein said polymeric material is impregnated with a drug.

49. The therapeutic element set forth in claim 29 wherein said radioactive seed elements are positioned at various intervals along the length of said elongate member.

50. The therapeutic element set forth in claim 29 wherein said radioactive seed elements are impregnated with a hormone.

51. The therapeutic element set forth in claim 29 wherein said radioactive seed elements are impregnated with a drug.

52. The therapeutic element set forth in claim 29 wherein said radioactive seeds contain a compound or element that emits photonic radiation having a low energy and a short half-life.

53. The therapeutic element set forth in claim 29 wherein said radioactive seeds contain an isotope consisting of the group iodine 125, palladium 103, iridium 192, cesium 131, gold 198 yttrium 90 and phosphorus 32.

54. The therapeutic element set forth in claim 29 wherein said polymeric material is absorbed by living tissue within about 70 to 120 days after implant.

55. The therapeutic element set forth in claim 29 wherein said polymeric material is absorbed by living tissue at substantially the same time as the half-life of the radioactive seed elements are reached.

56. The therapeutic element set forth in claim 29 wherein said polymeric material is selected from the group consisting of polymers and copolymers of glycolide, lactide and polydiaxanone.

57. The therapeutic element set forth in claim 29 wherein said elongate member is echogenic.

58. The therapeutic element set forth in claim 29 wherein said elongate member has air bubbles dispensed within.

59. The therapeutic element of claim 29 wherein said elongate member has a durometer in the range of about 20 to about 40.

60. The therapeutic element of claim 29 wherein said elongate member has a durometer in the range of about 20 to about 80.

61. The therapeutic element of claim 29 wherein said polymeric material is moldable during manufacture of the therapeutic element.

62. The therapeutic element of claim 29 wherein the therapeutic element does not comprise spacers.

63. The therapeutic element of claim 29 wherein the radioactive seed elements are secured along the elongate member without spacers.