THERAPEUTIC MEMBER INCLUDING A RAIL TO RESIST MOVEMENT WITHIN A NEEDLE USED IN BRACHYTHERAPY AND OTHER RADIATION THERAPY

• US 20090203953A1
• Filed: 02/26/2009
• Published: 08/13/2009
• Est. Priority Date: 07/22/2005
• Status: Active Grant

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Biocompatibles Incorporated (Boston Scientific Corporation)
• Inventors: Matons, James, Lamoureux, Gary A., Rice, Warren, Johnston, Warren, Bouffard, Matthew
• Granted Patent: US 8,187,159 B2
• Time in Patent Office: Days
• US Class Current: 600/8
• 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 5/1027 Interstitial radiation therapy

Abstract

A therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle comprises a single radioactive source encapsulated by a bio-absorbable material having an outer surface including one or more ribs encircling the single radioactive source, a leading edge endcap rib and a trailing edge endcap rib. The one or more ribs reduces a tendency of the member to migrate and rotate within a patient'"'"'s body after implantation. The encapsulating material further includes a first rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, and a second rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, the second rail arranged in a plane substantially perpendicular to a plane in which the first rail is arranged.

Claims

1. A therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle, comprising:

a single radioactive source;

a bio-absorbable material that encapsulates the radioactive source, an outer surface of the encapsulating material including one or more ribs encircling the single radioactive source, a leading edge endcap rib and a trailing edge endcap rib;

wherein the one or more ribs reduces a tendency of the member to migrate and rotate within a patient'"'"'s body after implantation; and

a first rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member; and

a second rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, the second rail arranged in a plane substantially perpendicular to a plane in which the first rail is arranged.

2. The therapeutic member of claim 1, wherein the first rail and second rail are adapted to at least partially collapse when the therapeutic member is positioned within the needle.

3. The therapeutic member of claim 1, wherein elasticity of the first rail and second rail applies a force against an inner diameter of the needle to resist movement of the therapeutic member within the needle.

4. The therapeutic member of claim 1, wherein the first rail and second rail extend along a substantial portion of the outer surface in a longitudinal direction so that the one or more ribs, the leading edge endcap rib, and the trailing edge endcap rib are connected with the rail.

5. The therapeutic member of claim 1, wherein one or both of the first rail and the second rail includes an edge that is one of serrated and saw-toothed.

6. A therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle, comprising:

a radioactive source;

an outer structure encapsulating at least a portion of the radioactive source, the outer structure formed from a bio-absorbable material; and

a rail extending from the outer structure, the rail formed from the bio-absorbable material; and

wherein the rail is adapted to at least partially collapse when the therapeutic member is positioned within the needle.

7. The therapeutic member of claim 6, wherein elasticity of the rail applies a force against an inner diameter of the needle to resist movement of the therapeutic member within the needle.

8. The therapeutic member of claim 6, wherein the outer structure includes one or more protrusions to reduce a tendency of the member to migrate and rotate within a patient'"'"'s body after implantation.

9. The therapeutic member of claim 8, wherein the rail extends along a substantial portion of the outer structure in a longitudinal direction so that the one or more protrusions are connected with the rail.

10. The therapeutic member of claim 6, wherein the outer structure is a sleeve sized so that the radioactive source projects from the sleeve.

11. The therapeutic member of claim 6, further comprising a plurality of rails extending from the outer structure;

wherein the radioactive source is substantially centered within the outer structure; and

wherein the rails extends along at least a portion of the outer structure in a longitudinal direction and are approximately evenly spaced about a longitudinal axis of the therapeutic member so that the radioactive source is substantially centered when positioned in the needle.

12. The therapeutic member of claim 6, further comprising a plurality of rails extending from the outer structure;

wherein the rails are riblets that encircle the outer structure and are spaced along a longitudinal axis of the therapeutic member so that the radioactive source is substantially centered when positioned in the needle.

13. The therapeutic member of claim 6, wherein the rail includes a serrated outer edge.

14. The therapeutic member of claim 6, wherein the rail includes a saw-tooth outer edge.

15. A method of fabricating a therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle, comprising:

positioning a radioactive source within a mold including at least two portions mateable at a parting line;

providing a bio-absorbable polymeric material into the mold so that the bio-absorbable polymeric material at least partially surrounds the radioactive source;

allowing flash to form at the parting line;

cooling the bio-absorbable polymeric material to form an outer structure of the therapeutic member;

removing the therapeutic member from the mold; and

retaining at least a portion of the flash as a rail extending from the outer structure.

16. The method of claim 15, further comprising:

trimming the flash to form a rail having a desired length.

17. The method of claim 15, further comprising:

trimming the flash to form a rail having a desired shape.

18. A method for using a therapeutic member in brachytherapy and other radiation treatment, comprising:

accepting a therapeutic member with radioactive source, an outer structure at least partially encapsulating the radioactive source, and a rail extending from the outer structure;

loading the therapeutic member into a hollow needle so that the rail is at least partial collapse such that the rail exerts an elastic force against an inner diameter of the hollow needle; and

using the hollow needle to implant the therapeutic member, into patient tissue;

determining when the therapeutic member is delivered to an implantation site based on resistance to movement of the therapeutic member within the hollow needle caused by the elastic force of the rail.

19. A therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle, comprising:

a radioactive source;

a bio-absorbable material that encapsulates at least a portion of the radioactive source, an outer surface of the encapsulating material including one or more protrusions to reduce a tendency of the member to migrate and rotate within a patient'"'"'s body after implantation; and

a rail extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, the rail formed from the bio-absorbable material.

20. The therapeutic member of claim 19, wherein the rail is adapted to at least partially collapse when the therapeutic member is positioned within the needle.

21. The therapeutic member of claim 20, wherein elasticity of the rail applies a force against an inner diameter of the needle to resist movement of the therapeutic member within the needle.

22. The therapeutic member of claim 19, wherein the rail extends along a substantial portion of the outer surface in a longitudinal direction so that the one or more protrusions are connected with the rail.

23. The therapeutic member of claim 19, wherein the outer structure is a sleeve sized so that the radioactive source projects from the sleeve.

24. The therapeutic member of claim 19, further comprising a plurality of rails extending from the outer structure;

wherein the radioactive source is substantially centered within the outer structure; and

wherein the rails extends along at least a portion of the outer structure in a longitudinal direction and are approximately evenly spaced about a longitudinal axis of the therapeutic member so that the radioactive source is substantially centered when positioned in the needle.

25. The therapeutic member of claim 19, wherein the rail includes an edge that is one of serrated and saw-toothed.