Radiation delivery devices and methods for their manufacture

• US 6,749,553 B2
• Filed: 05/16/2001
• Issued: 06/15/2004
• Est. Priority Date: 05/18/2000
• Status: Expired due to Term

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Inventors: Moody, Michael R., White, Jack C., Dill, Glenn A., Brauckman, Richard A.
• Primary Examiner(s): Jues, Mary Beth
• Assistant Examiner(s): Veniaminov, Nikita R
• Application Number:
  US09/858,816
• Publication Number:
  US 20030204125A1
• Time in Patent Office: 1,126 Days
• Field of Search: 600/1-8, 604/19, 604/53, 604/103, 604/104, 604/106, 604/107, 604/202, 604/93, 604/96, 606/194, 606/198, 606/1, 623/1.42, 623/1.21, 427/5, 376/158, 376/195, 376/201
• 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 2005/1025 Wires
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

Radiation delivery devices useful in brachytherapy which employ radioactive palladium-103 as the radiation source material are disclosed. Certain embodiments of the disclosed radiation delivery devices have the advantages that they can be fabricated with the desired specific activity, that the self-shielding effects of the devices are minimized, that the radioactive source material is bonded to a substrate in a manner which substantially prevents it from becoming detached, and that a variety of customizable radiation delivery devices can be made using the concepts of the invention. Also disclosed are processes for bonding radiation source material to various substrates using electroless plating, chemical vapor deposition and polymer matrices. These processes have the advantage that they can be applied to bond the radiation source material to a wide variety of substrates including different substrate materials and differently shaped substrates, thereby providing the ability to tailor the radiation delivery devices to the specific requirements of a particular brachytherapy treatment.

Claims

1. A radiation delivery device, which comprises:

a substantially non-conductive, flexible substrate selected from the group consisting of flexible fiber and flexible film formed from a radiation compatible material and which is sufficiently flexible to deform under its own weight, and

a sufficient amount of radioactive palladium-103 bonded to the outer surface of the substrate to provide an apparent activity of the radiation delivery device, as measured adjacent to the surface of the substrate, of from about 0.5 μ

Ci to about 300 Ci/device, and wherein the radioactive palladium-103 comprises palladium-103 fabricated in a particle accelerator and said palladium-103 forms at least a substantial portion of the outer surface of the radiation delivery device such that the radioactive palladium-103 can be positioned closely adjacent to, or in direct contact with, a location to be treated with radiation.

2. A radiation delivery device as claimed in claim 1, wherein the radioactive palladium-103 is substantially homogeneously dispersed over the entire outer surface of the substrate to thereby provide a substantially uniform distribution of radiation from the radiation delivery device.

3. A radiation delivery device as claimed in claim 1, wherein the radioactive palladium-103 is non-uniformly dispersed over the outer surface or within the outer surface of the substrate to thereby provide a directional distribution of radiation from the radiation delivery device.

4. A radiation delivery device as claimed in claim 1, wherein the substrate comprises at least one material selected from the group consisting of:

polymeric materials, ceramic materials, hydrogels, metals, graphite and ion exchange resins.

5. A radiation delivery device as claimed in claim 1, wherein the substrate comprises a flexible material selected from the group consisting of elastomers, gels and foams.

6. A radiation delivery device as claimed in claim 1, further comprising a protective coating layer located on the outside of the radioactive layer.

7. A radiation delivery device as claimed in claim 1, having an apparent activity of from about 0.5 mCi to about 30 Ci per device.

8. A radiation delivery device as claimed in claim 1, wherein the substrate comprises at least one polymeric material selected from the group consisting of polyethylene glycol and polyethylene glycol-polyethylene oxide copolymers, polyurethanes and silicones.

9. A radiation delivery device as claimed in claim 1, further comprising a radiation shielding layer located on a side of the substrate opposite a side of the substrate on which the carrier-free palladium-103 is bonded.

10. A radiation delivery device as claimed in claim 1, wherein the palladium-103 is bonded to the substrate by electroless plating.

11. A deformable radiation delivery device which comprises:

a deformable substrate, and

a sufficient amount of radioactive palladium-103 bonded to the substrate to provide an apparent activity of the radiation delivery device, as measured adjacent to the surface of the substrate, of from about 0.5 μ

Ci to about 300 Ci/device, and wherein the radioactive palladium-103 comprises palladium-103 fabricated in a particle accelerator and said palladium-103 is bonded to the deformable substrate in a manner whereby substantially no radioactive palladium-103 detaches from the deformable substrate under normal use conditions, wherein the radioactive palladium-103 is bonded directly to the outer surface of the substrate by electroless plating.

12. A deformable radiation delivery device as claimed in claim 11, wherein the deformable substrate comprises an elastomer, gel or foam.

13. A deformable radiation delivery device as claimed in claim 11, further comprising a deformable coating of a biocompatible material on the outer surface of the radiation delivery device.

14. A radiation delivery device claimed in claim 11, wherein the substrate comprises at least one polymeric material selected from the group consisting of polyethylene glycol and polyethylene glycol-polyethylene oxide copolymers, polyurethanes and silicones.

15. A radiation delivery device as claimed in claim 11, further comprising a radiation shielding layer located on a side of the substrate opposite a side of the substrate on which the carrier-free palladium-103 is bonded.

16. A radiation delivery device as claimed in claim 11, wherein the substrate comprises at least one flexible polymeric material.

17. A radiation delivery device as claimed in claim 11, wherein the radioactive palladium-103 is substantially homogeneously dispersed over the entire outer surface of the substrate to thereby provide a substantially uniform distribution of radiation from the radiation delivery device.

18. A radiation delivery device as claimed in claim 11, wherein the radioactive palladium-103 is non-uniformly dispersed over the outer surface or within the outer surface of the substrate to thereby provide a directional distribution of radiation from the radiation delivery device.

19. A radiation delivery device as claimed in claim 11, wherein the substrate is substantially non-conductive.