Brachytherapy seed deployment system

• US 20030109769A1
• Filed: 08/09/2002
• Published: 06/12/2003
• Est. Priority Date: 10/20/2000
• Status: Active Grant

• Current Assignee: Bard Brachytherapy, Inc. (Becton, Dickinson & Co)
• Original Assignee: Bard Brachytherapy, Inc. (Becton, Dickinson & Co)
• Inventors: Lowery, Guy Russell, Bowman, Eric E.
• Granted Patent: US 6,949,064 B2
• Time in Patent Office: Days
• 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. In one embodiment, the system includes a number of brachytherapy seed deployment needles, each preloaded with brachytherapy seeds in patterns and activities predetermined for a unique patient. The seeds are contained in transparent tubular sleeves, thereby allowing direct visualization of the brachytherapy seeds and spacers, so that the seed pattern may be inspected at the clinical site. A releasable retainer prevents accidental brachytherapy seed loss. The system additionally includes shipping containers, separately accessible calibration seeds and a display stand for use at the clinical site. Methods are also disclosed. In another embodiment, the system includes at least two seeds secured together by a filament. The filament may be rigid or flexible. The system also includes 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.

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, further comprising an anchor along the filament.

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

11. The brachytherapy seed deployment system of claim 9, wherein the anchor comprises a hook secured to the filament.

12. The brachytherapy seed deployment system of claim 9, wherein the anchor comprises a T bar secured to the filament.

13. The brachytherapy seed deployment system of claim 1, further comprising an anchor secured to a distal seed.

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

15. 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.

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

17. The brachytherapy seed deployment system of claim 15, wherein the filament comprises a material including a matrix that is rigid outside the body and flexible within the body.

18. A brachytherapy seed deployment system comprising:

at least two seeds;

a non-bioabsorbable filament 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.

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

20. The brachytherapy seed deployment system of claim 18, wherein the sleeve further comprises a hub.

21. The brachytherapy seed deployment system of claim 18, wherein the needle further comprises a hub.

22. 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.

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

24. The method of assembling a brachytherapy seed deployment system of claim 22, further comprising the step of providing a second filament.

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

26. The method of assembling a brachytherapy seed deployment system of claim 22, wherein the seed and collar are secured to the filament by heat shrinking.

27. The method of assembling a brachytherapy seed deployment system of claim 22, further comprising the step of inserting at least one spacer between adjacent seeds.

28. The method of assembling a brachytherapy seed deployment system of claim 22, further comprising the step of knotting and cutting an end of the filament.

29. The method of assembling a brachytherapy seed deployment system of claim 22, further comprising the step of inserting the seed, collar and filament into a sleeve.

30. 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.

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

32. The method of implanting brachytherapy seeds of claim 30, wherein the filament includes an anchor.

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

34. The method of implanting brachytherapy seeds of claim 33, 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.

35. The method of implanting brachytherapy seeds of claim 32, wherein the anchor comprises a knot in the filament.

36. The method of implanting brachytherapy seeds of claim 32, wherein the anchor comprises a hook.

37. The method of implanting brachytherapy seeds of claim 32, wherein the anchor comprises a T bar.

38. The method of implanting brachytherapy seeds of claim 32, 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.

39. A brachytherapy seed deployment system comprising:

at least two seeds; and

a laminate encapsulating the at least two seeds.

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

41. The brachytherapy seed deployment system of claim 39, further comprising at least one spacer between adjacent seeds.

42. The brachytherapy seed deployment system of claim 39, further comprising a filament secured to the at least two seeds.

43. The brachytherapy seed deployment system of claim 42, wherein the filament and seeds are located between two sheets of a biocompatible polymeric material.

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

providing a filament;

securing a first seed to the filament;

securing a second seed to the filament such that the two seeds are tethered to one another by the filament.

45. The method of securing at least two brachytherapy seeds to a filament of claim 44, wherein the seeds are secured to the filament via an adhesive.

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

47. The method of securing at least two brachytherapy seeds to a filament of claim 44, further comprising the step of placing a spacer between the seeds.

48. The method of securing at least two brachytherapy seeds to a filament of claim 47, wherein the spacer is secured to the filament.