Brachytherapy seed deployment system

• US 6,949,064 B2
• Filed: 08/09/2002
• Issued: 09/27/2005
• Est. Priority Date: 10/20/2000
• Status: Expired due to Term

• Current Assignee: Bard Brachytherapy, Inc. (Becton, Dickinson & Co)
• Original Assignee: Bard Brachytherapy, Inc. (Becton, Dickinson & Co)
• Inventors: Bowman, Eric E., Lowery, Guy Russell
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/217,339
• Publication Number:
  US 20030109769A1
• Time in Patent Office: 1,145 Days
• Field of Search: 600 1- 8, 724/1.11, 606/130, 606/194, 606/198, 606/1, 604/19, 604/53, 604/103, 604/104, 604/106, 604/107, 604/202, 604/93, 604/96, 623/1.42, 623/1.21, 426/6, 376/158, 376/195, 376/201
• US Class Current: 600/7
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 2005/101 Magazines or cartridges for seeds
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• 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

Abstract

Disclosed is a brachytherapy seed deployment system for use in any of a variety of medical procedures such as radiation treatment of the prostate gland. The system includes at least two seeds secured together by a filament, which may be rigid or flexible. Also provided are methods of assembling the seeds and filaments, and methods of treating cancerous tissue using the seeds and filaments.

Claims

1. A brachytherapy seed deployment system comprising:

at least two seeds and

a filament secured to the at least two seeds in a manner such that the exterior of the filament is secured to the exterior of the seeds and at least one anchor is located along the filament.

2. The brachytherapy seed deployment system of claim 1, wherein the filament is not bioabsorbable.

3. The brachytherapy seed deployment system of claim 1, wherein the filament is bioabsorbable and a useful life of the seeds is shorter than an amount of time required for the filament to be absorbed.

4. The brachytherapy seed deployment system of claim 1, wherein each seed is independently secured to the filament with an adhesive.

5. The brachytherapy seed deployment system of claim 1, wherein each seed is independently secured to the filament with a cylindrical collar.

6. The brachytherapy seed deployment system of claim 5, wherein the collar comprises a polymeric material that shrinks upon application of heat.

7. The brachytherapy seed deployment system of claim 1, further comprising a second filament.

8. The brachytherapy seed deployment system of claim 1, further comprising at least one spacer located between adjacent seeds.

9. The brachytherapy seed deployment system of claim 1, wherein the anchor comprises a knot in the filament.

10. The brachytherapy seed deployment system of claim 1, wherein the anchor comprises a hook secured to the filament.

11. The brachytherapy seed deployment system of claim 1, wherein the anchor comprises a T bar secured to the filament.

12. The brachytherapy seed deployment system of claim 1, wherein an anchor is secured to a distal seed.

13. The brachytherapy seed deployment system of claim 12, wherein the anchor comprises at least one barb.

14. The brachytherapy seed deployment system of claim 1, wherein the filament comprises a material that is rigid outside the human body and flexible inside the human body.

15. The brachytherapy seed deployment system of claim 14, wherein the filament comprises a material that is rigid at temperatures below normal human body temperature and flexible at normal human body temperature.

16. The brachytherapy seed deployment system of claim 14, wherein the filament comprises a material including a matrix that is rigid outside the body and flexible within the body.

17. A brachytherapy seed deployment system comprising:

at least two seeds;

a filament; and

at least one anchor located along the filament, wherein the filament is secured to the at least two seeds;

a sleeve including a central lumen for containing the seeds and filament; and

a needle including a central lumen for containing the sleeve.

18. The brachytherapy seed deployment system of claim 17, further comprising an obturator insertable through a proximal end of the sleeve for ejecting the seeds and filament from the sleeve.

19. The brachytherapy seed deployment system of claim 17, wherein the filament comprises non-bioabsorbable materials.

20. The brachytherapy seed deployment system of claim 17, wherein the needle and/or the sleeve further comprises a hub.

21. A method of assembling a brachytherapy seed deployment system, the method comprising the steps of:

providing a fixture including a longitudinal slot;

placing a filament within the slot;

pulling the filament taut;

sliding at least one cylindrical collar onto the filament;

inserting a seed into the at least one collar;

locating the seed and collar at a desired point along a length of the filament; and

securing the seed and collar to the filament.

22. The method of assembling a brachytherapy seed deployment system of claim 21, further comprising the step of locating an anchor along the filament.

23. The method of assembling a brachytherapy seed deployment system of claim 21, further comprising the step of providing a second filament.

24. The method of assembling a brachytherapy seed deployment system of claim 23, wherein the first and second filaments are located on opposite sides of the seed.

25. The method of assembling a brachytherapy seed deployment system of claim 21, wherein the seed and collar are secured to the filament by heat shrinking.

26. The method of assembling a brachytherapy seed deployment system of claim 21, further comprising the step of inserting at least one spacer between adjacent seeds.

27. The method of assembling a brachytherapy seed deployment system of claim 21, further comprising the step of knotting and cutting an end of the filament.

28. The method of assembling a brachytherapy seed deployment system of claim 21, further comprising the step of inserting the seed, collar and filament into a sleeve.

29. A method of implanting brachytherapy seeds, the method comprising the steps of:

providing a needle, the needle containing a sleeve, the sleeve containing at least two seeds tethered to one another by a filament;

penetrating a cancerous region with the needle; and

ejecting the seeds from the sleeve and implanting the seeds in the cancerous region.

30. The method of implanting brachytherapy seeds of claim 29, wherein the seeds are ejected from the sleeve by an obturator inserted through a proximal end of the sleeve.

31. The method of implanting brachytherapy seeds of claim 29, wherein the filament includes an anchor.

32. The method of implanting brachytherapy seeds of claim 31, wherein the anchor engages body tissue.

33. The method of implanting brachytherapy seeds of claim 32, wherein as the needle and sleeve are withdrawn from the cancerous region, the anchored filament creates tension in the filament, maintaining a desired spacing of the seeds.

34. The method of implanting brachytherapy seeds of claim 31, wherein the anchor comprises a knot in the filament.

35. The method of implanting brachytherapy seeds of claim 31, wherein the anchor comprises a hook.

36. The method of implanting brachytherapy seeds of claim 31, wherein the anchor comprises a T bar.

37. The method of implanting brachytherapy seeds of claim 31, wherein a distal seed includes a notch, and a rigid wire engages the notch to hold the distal seed in place in the cancerous region as the sleeve and needle are withdrawn.

38. A brachytherapy seed deployment system comprising:

at least two seeds;

a laminate encapsulating the at least two seeds; and

a filament having at least one anchor located thereon, wherein the filament is secured to the at least two seeds.

39. The brachytherapy seed deployment system of claim 38, wherein the laminate comprises at least two sheets of a biocompatible polymeric material.

40. The brachytherapy seed deployment system of claim 38, further comprising at least one spacer between adjacent seeds.

41. The brachytherapy seed deployment system of claim 38, wherein the filament and seeds are located between two sheets of a biocompatible polymeric material.

42. A method of securing at least two brachytherapy seeds to a filament, the method comprising the steps of:

providing a filament having one or more collars located thereon; and

securing a first seed and a second seed to the filament with the collars in a manner such that the exterior of the filament is secured to the collars such that the two seeds are tethered to one another by the filament.

43. The method of securing at least two brachytherapy seeds to a filament of claim 42, wherein the seeds are secured via an adhesive.

44. The method of securing at least two brachytherapy seeds to a filament of claim 42, wherein the seeds are secured to the filament via a heat-shrunk collar.

45. The method of securing at least two brachytherapy seeds to a filament of claim 42, further comprising the step of placing a spacer between the seeds.

46. The method of securing at least two brachytherapy seeds to a filament of claim 45, wherein the spacer is secured to the filament.

47. A brachytherapy seed deployment system comprising:

at least two collars, a filament and at least two seeds;

wherein the at least two seeds are retained in the collars, and the collars are secured to the filament.

48. The brachytherapy seed deployment system of claim 47, wherein the filament is not bioabsorbable.

49. The brachytherapy seed deployment system of claim 47, wherein the collar comprises a polymeric material that shrinks upon application of heat.

50. The brachytherapy seed deployment system of claim 47, further comprising at least one spacer located between adjacent seeds.

51. A brachytherapy seed deployment system comprising:

at least two seeds;

at least one spacer; and

a filament secured to the at least two seeds in a manner such that the exterior of the filament is secured to the seeds, and the spacer is located between adjacent seeds.

52. The brachytherapy seed deployment system of claim 51, wherein the filament is not bioabsorbable.

53. The brachytherapy seed deployment system of claim 51, wherein each seed is independently secured to the filament with at least one adhesive.

54. The brachytherapy seed deployment system of claim 53, wherein at least one anchor is located along the filament.