Delivery system and method for interstitial radiation therapy using seed strands with custom end spacing

• US 6,997,862 B2
• Filed: 07/15/2003
• Issued: 02/14/2006
• Est. Priority Date: 05/13/2003
• 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): Gilbert, Samuel G.
• Application Number:
  US10/619,928
• Publication Number:
  US 20040230087A1
• Time in Patent Office: 945 Days
• Field of Search: 600 1- 8, 600/426, 600/427, 604/39, 604/19, 604/57, 604/65, 604/116, 250/507.1, 250/506.1, 424/1.13, 424/422, 424/426, 424/1.61, 424/4.25, 514/411, 128/898, 294/011
• US Class Current: 600/8
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• 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 2005/1012 Templates or grids for guiding the introduction of sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

A delivery system and method for interstitial radiation therapy comprising a substantially axially stiff and longitudinally flexible elongated strand made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the strand. The delivery system and method further customize the strand based on a prescription. The strands can have custom end spacings, which allow the optimal placing of seeds within the treatment tissue by implanting a plurality of strands to the same depth. A plurality of these strands can be implanted at the same time by the use of a guiding device.

Claims

1. A prescription method to create a plurality of treatment strands, comprising:

accepting a tissue treatment plan for the tissue to be treated, which treatment plan specifies a number and spacing of treatment seeds to be provided in each of a plurality of treatment strands that includes a distal end and a proximal end, where the distal end is intended to be implanted prior to the proximal end; and

creating the plurality of treatment strands so that the treatment strands satisfy the treatment plan when distal ends of the treatment strands are implanted into a patient to the same depth using needles that are inserted into the patient to the same depth;

wherein at least two of the plurality of treatment strands have a custom distal end spacing between the distal end of each treatment strand and the adjacent treatment seed to thereby enable the treatment plan to be satisfied when the distal ends of the plurality of the treatment strands are implanted to the same depth using needles that are inserted to the same depth; and

wherein the custom distal end spacings of at least two of the plurality of the treatment strands have different lengths.

2. The method of claim 1, wherein:

said step of creating the plurality of treatment strands includes positioning radioactive seeds in a mold and introducing into the mold a material to mold the radioactive seeds in place.

3. The method of claim 2, wherein the material introduced into the mold is bio-absorbable.

4. The method of claim 2, wherein the material introduced into the mold is a polymer.

5. The method of claim 1, further comprising:

aligning the created plurality of treatment strands in a template.

6. The method of claim 5, wherein all of the plurality of created treatment strands are the same length.

7. A prescription method to create a plurality of treatment seed strands for treating tissue, comprising:

accepting a tissue treatment plan for the tissue to be treated, said treatment plan specifying a number and spacing of a plurality of treatment seeds for each of a plurality of respective said treatment seed strands that includes a distal end and a proximal end, where the distal end is intended to be implanted prior to the proximal end; and

creating the plurality of treatment stranding, including providing a custom distal end spacing on each of the plurality of treatment seed stands to thereby enable the treatment seeds located adjacent to the distal ends of the treatment seed strands to be properly spaced relative to the distal ends of the treatment seed strands, in accordance with the treatment plan, when the distal ends of the plurality of the treatment seed strands are implanted to the same deoth using needles that are inserted to the same depth;

wherein the custom distal end spacings of the at least two of the plurality treatment seed strands have different lengths.

8. The method of claim 7, wherein:

said accepting step includes accepting said tissue treatment plan created with the use of a computer program.

9. The method of claim 7, wherein:

said accepting step includes accepting a treatment plan that specifies a number of radioactive seeds and a desired spacing between each pair of the radioactive seeds; and

wherein said creating step includes creating the plurality of treatment seed strands to the specified desired spacing.

10. The method of claim 7, wherein:

said creating step includes positioning radioactive seeds in a mold at desired spacings and introducing a material to mold with the plurality of radioactive seeds in place in the desired spacings.

11. The method of claim 10, wherein the material is bio-absorbable.

12. The method of claim 10, wherein the material is a polymer.

13. The method of claim 10, wherein:

said accepting step includes using the tissue treatment plan wherein the tissue treatment plan is created using an imaging device.

14. A therapeutic kit comprising:

a plurality of seed strands configured to be implanted into a patient to the same depth using needles that are inserted into the patient to the same depth, each having a length with a distal end;

a plurality of seeds provided along the length of each of the seed strands at spaced intervals without the use of pre-fabricated spacers; and

custom end spacings according to a treatment plan provided between the seed located adjacent to the distal end of each of said seed strands and the distal end of each said seed strand, said custom end spacings created without use of pre-fabricated spacers;

wherein the custom end spacings cause the seeds located adjacent to the distal ends of the seed strands to be properly spaced relative to the distal ends of the seed strands, according to the treatment plan, when the distal ends of the plurality of seed strands are implanted to the same depth using needles inserted to the same depth; and

wherein the custom end spacings of at least two of said plurality of seed strands have different lengths.

15. A prescription method to create a treatment strand, the method comprising:

accepting a tissue treatment plan forte tissue to be treated, which treatment plan specifies a number and spacing of treatment seeds to be provided in the treatment plan; and

creating a treatment strand that includes a custom distal end spacing that causes the treatment seed located adjacent to a distal end of the treatment strand to be properly spaced relative to the distal end of the treatment strand, according to the plan when the distal end of the treatment strand is implanted into a patient to a predefined depth using a needle that is inserted into the patient to the predefined depth.

16. A method of treating a patient with a plurality of treatment strands wherein each of said plurality of treatment stands has a plurality of spaced seeds and custom end spacings between a distal end seed in the strand and a distal end of the seed strand, the method comprising the steps of:

implanting a first strand at a desired location at a depth;

implanting the remainder of the plurality of seed strands at a plurality of respective desired locations to the depth of the first strand and wherein the custom end spacings of at least two of said plurality of seed strands have different lengths.

17. The method of claim 16 further comprising selecting at least two treatment seed strands that have custom end spacings of different lengths.

18. A prescription method to create a treatment seed strand, the method comprising:

accepting a tissue treatment plan for the tissue to be treated, said treatment plan specifying a number and spacing of a plurality of treatment seeds for each of a plurality of respective treatment seed strands;

creating the plurality of treatment seed strands from a material without using pre-fabricated spacers; and

providing a custom distal end spacing on each of the plurality of treatment seed strands without using pre-fabricated spacers;

wherein the custom distal end spacings cause the treatment seeds located adjacent to distal ends of the treatment seed strands to be properly spaced relative to the distal ends of the treatment seed strands, according to the treatment plan, when the distal ends of the plurality of treatment seed strands are implanted to the same depth using needles inserted to the same depth; and

wherein the custom distal end spacings of at least two of said plurality of seed strands have different lengths.

19. A prescription method to create a treatment seed strand, the method comprising the steps of:

accepting a tissue treatment plan for the tissue to be treated, said treatment plan specifying a number and spacing of a plurality of treatment seeds for each of a plurality of respective treatment seed strands; and

creating the plurality of treatment seed strands from a material without using pre-fabricated spacers, such that each of the plurality of treatment seed strands includes a custom distal and spacing determined by the treatment plan;

wherein the custom distal end spacings cause the treatment seeds located adjacent to distal ends of the treatment strands to be properly spaced relative to the distal end of the treatment strand;

wherein the custom distal end spacing on each of the plurality of treatment seed strands allows a health care professional to implant each of the plurality of treatment seed strands to a uniform depth in the tissue to be treated; and

wherein the custom distal end spacing on at least two of said plurality of treatment seed strands have different lengths.

22. The method of claim 19, wherein the material introduced into the mold is bio-absorbable.

20. A method of treating a patient with a plurality of treatment strands wherein each of said plurality of treatment strands has a plurality of seeds and a custom end spacing between a distal end seed of the treatment strand and a distal end of the treatment strand, said custom end spacing set without using pre-fabricated spacers, the method comprising the steps of:

implanting a first treatment strand at a desired location such that the distal end of the first treatment strand is implanted at a depth; and

implanting the remainder of the plurality of treatment strands at a plurality of respective desired locations with the distal ends of the plurality of the treatment strands implanted to the same depth of the first strand, wherein the distal end seed of at least two of said plurality of treatment strands are implanted to different depths due to the respective custom end spacing of the at least two treatment strands having different lengths.

21. A prescription method to create a treatment strand, the method comprising the steps of:

accepting a tissue treatment plan for the tissue to be treated, which treatment plan specifies a number and spacing of treatment seeds to be provided in each of a plurality of treatment strands;

creating the plurality of treatment strands according to said tissue treatment plan by positioning treatment seeds in a mold and introducing into the mold a material to mold the treatment seeds in place; and

wherein at least two of the plurality of treatment seeds have a custom distal end spacing between the end of each treatment strand and the adjacent treatment seed;

wherein the custom distal end spacings cause the treatment seeds located adjacent to distal ends of the at least two of the treatment strands to be properly spaced relative to the distal ends of the treatment strands, according to the treatment plan, when the distal ends of the at least two of the treatment strands are implanted to the same depth using needles inserted to the same depth; and

wherein the custom distal end spacings of the at least two of the treatment strands have different lengths.

23. The method of claim 21 wherein the material introduced into the mold is a polymer.

24. A therapeutic kit comprising:

a plurality of seed strands configured to be implanted into a patient to the same depth using needles that are inserted into the patient to the same depth, each having a length with a distal end;

a plurality of seeds provided along the length of each of the seeds strands; and

custom end spacings according to a treatment plan provided between the seed located adjacent to the distal end of each of said seed strands and the distal end of each said seed strand,

wherein the custom end spacings cause the seeds located adjacent to the distal ends of the seed strands to be properly spaced relative to the distal ends of the seed strands, according to the treatment plan, when the distal ends of the plurality of seed strands are implanted to the same depth using needles inserted to the same depth; and

wherein the custom end spacings of at least two of said plurality of seed strands have different lengths.