Delivery system and method for interstitial radiation therapy using strands constructed with extruded strand housings

• US 7,074,291 B2
• Filed: 06/04/2002
• Issued: 07/11/2006
• Est. Priority Date: 11/02/2001
• Status: Expired due to Fees

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Ideamatrix Incorporated, Worldwide Medical Technologies, LLC
• Inventors: Terwilliger, Richard A., Lamoureux, Gary A.
• Primary Examiner(s): Maki, Steven D.
• Application Number:
  US10/162,006
• Publication Number:
  US 20030084988A1
• Time in Patent Office: 1,498 Days
• Field of Search: 156/244.12, 156/244.13, 156/294, 264/171.11, 600/7, 600/8
• US Class Current: 156/244.12
• 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
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/151 Coating hollow articles
• CPC Class Codes: B29C 48/157 Coating linked inserts, e.g. chains
• CPC Class Codes: G21G 4/08 specially adapted for medical application radiation therapy using radioactive sources A61N5/10

Abstract

A delivery system and method for interstitial radiation therapy comprising substantially axially stiff and longitudinally flexible elongated members made of material which is bioabsorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the elongate member. The radioactive seeds can be dispersed within assembled half-shells made of the same material. The housing for the radiation seeds can also be manufactured from extruded material. A system for manufacturing the interstitial radiation therapy seed strands that automatically makes the seed strands at the patient'"'"'s bedside. The delivery system and method further customize the member based on a prescription.

Claims

1. A method for embedding radioactive seed elements in a material comprising:

extruding a member with a bore from the material; and

loading said bore of said member with the radioactive seed elements to space the radioactive seed elements at variable positions;

wherein the loading step occurs simultaneously with the extruding step.

2. The method of claim 1 wherein said loading step includes introducing variable spacing between each of the radioactive seed elements.

3. The method of claim 1 wherein said material is biocompatible and bioabsorbable.

4. The method of claim 1 wherein said material contains one of a drug and a hormone.

5. The method of claim 1 wherein said material is made to be echogenic.

6. The method as in claim 1 wherein the loading step is carried out according to a pre-operative therapeutic plan of a patient.

7. The method as in claim 1 further comprising using the material in the extruding step wherein the material is selected from the group consisting of PGA, LPLA, DLPLA, PCL, PDO, PGA-TMC, 85/15 DLPLG, 75/25 DLPLG, 65/35 DLPLG, and 50/50 DLPLG.

8. The method as in claim 1 further comprising using the material in the extruding step wherein the material is selected from the group consisting of polymers of glycolide, polymers of polydioxanone, copolymers of glycolide, and copolymers of polydioxanone.

9. The method as in claim 1 further comprising using the material in the extruding step wherein the material is selected from the group consisting of natural biocompatible/bioabsorbable polymers and synthetic biocompatible/bioabsorbable polymers.

10. The method as in claim 1 further comprising the step of incorporating therapeutic agents into the material.

11. The method as in claim 1 further comprising the step of incorporating therapeutic agents into the radioactive seed elements.

12. The method as in claim 1 further comprising:

providing a system comprising;

a mandrel;

a piston; and

a die;

wherein the extruding step further comprises applying pressure to the material with the piston to extrude the material over the mandrel and through the die, forming the member with a bore therethrough.

13. The method as in claim 1 further comprising using the seed pusher in the loading step to load the radioactive seed elements according to a pre-operative plan of a patient.

14. A method for making an interstitial radiation therapy seed strand comprising:

extruding an elongate member with a bore from a material that is axially rigid and radially flexible when loaded with radioactive seed elements; and

inserting said radioactive seed elements into said bore at variable positions using a seed pusher;

wherein the inserting step occurs simultaneously with the extruding step.

15. The method of claim 14 wherein said inserting step includes placing the radioactive seeds at varying intervals within the bore.

16. The method of claim 14 wherein said elongate member with a bore is heated to fix said radioactive seed elements within the bore.

17. The method of claim 14 wherein said material is biocompatible and bioabsorbable.

18. The method of claim 14 wherein said material contains one of a drug and a hormone.

19. The method of claim 14 wherein said material is made to be echogenic.

20. A method for embedding radioactive seed elements in a material comprising:

extruding a member with a bore from the material; and

loading said bore of said member with the radioactive seed elements using a seed pusher to space the radioactive seed elements at variable positions;

wherein the loading step occurs simultaneously with the extruding step.

21. A method for embedding radioactive seed elements in a material comprising:

providing a system comprising;

a mandrel;

a piston; and

a die;

extruding a member with a bore from the material; and

loading the bore of the member with the radioactive seed elements using a seed pusher to space the radioactive seed elements at variable positions;

wherein the extruding step further comprises applying pressure to the material with the piston to extrude the material over the mandrel and through the die, forming the member with a bore therethrough; and

wherein the extruding and loading steps are performed simultaneously.

22. An extrusion method for embedding radioactive seed elements in a material comprising:

providing a system comprising;

a seed pusher;

a mandrel;

a piston; and

a die;

extruding the material over the mandrel and through the die with the piston,

wherein the piston is used to apply pressure to the material, to create an elongate axially stiff and radially flexible hollow member comprising a bore; and

loading the radioactive seed elements into the bore according to a pre-operative plan customized to a patient, the loading step including use of the seed pusher;

wherein the extruding step and the loading step are simultaneously performed using the system provided in the providing step.

23. The method as in claim 22 further comprising providing the radioactive seed elements wherein said radioactive seed elements further comprise a radio-opaque metal.

24. The method as in claim 22 further comprising providing the radioactive seed elements wherein said radioactive seed elements further comprise a bioabsorbable polymer.

25. An extrusion method for embedding radioactive seed elements in a material comprising:

providing a system comprising;

a mandrel;

a piston; and

a die;

extruding the material over the mandrel and through the die with the piston, wherein the piston is used to apply pressure to the material, to create an elongate hollow member comprising a bore; and

loading the radioactive seed elements into the bore according to a pre-operative plan customized to a patient;

wherein the loading step occurs simultaneously with the extruding step.

26. The method as in claim 25 wherein the loading step further comprises inserting the radioactive seed elements with a seed pusher.

27. The method as in claim 25 further comprising providing the radioactive seed elements wherein said radioactive seed elements further comprise a radio-opaque metal.

28. The method as in claim 25 further comprising providing the radioactive seed elements wherein said radioactive seed elements further comprise a bioabsorbable polymer.