Methods for making therapeutic elements for implantation into patient tissue

• US 7,244,226 B2
• Filed: 11/10/2003
• Issued: 07/17/2007
• 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): Gilbert; Samuel G.
• Application Number:
  US10/705,133
• Publication Number:
  US 20040102671A1
• Time in Patent Office: 1,345 Days
• Field of Search: 600 1- 8, 128/898, 295/92, 294/58, 295/722, 297/03
• US Class Current: 600/37
• 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
• 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 radially 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 is also provided. The delivery system and method further customize the member based on a prescription.

Claims

1. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements within a first elongate half-shell member having a diameter that is less than the inner diameter of the hollow needle;

mating an empty second elongate half-shell member also having a diameter that is less than the inner diameter of the hollow needle; and

heating the mated said first and second elongate half shell members to mold the half shell members tightly to said radioactive seeds to thereby form a therapeutic element configured to be implanted into patient tissue using a hollow needle.

2. The method for making a therapeutic element set forth in claim 1 wherein said dispersing step positions said radioactive seed elements at independent intervals that may vary the spacing between the seed elements.

3. The method for making a therapeutic element set forth in claim 1 wherein said first and second solid half-shell members are impregnated with a hormone.

4. The method for making a therapeutic element set forth in claim 1 wherein said first and second elongate half shell members are impregnated with a drug.

5. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements within a first elongate half-shell member having a diameter that is less than the inner diameter of the hollow needle;

flowing a polymer into at least one of said first half shell member and a second half-shell member also having a diameter that is less than the inner diameter of the hollow needle;

mating the second elongate half-shell member to the first half-shell member; and

heating the mated said first and second elongate half shell members to mold the half-shell members tightly to said radioactive seeds to thereby form a therapeutic element configured to be implanted into patient tissue using a hollow needle.

6. The method for making a therapeutic element set forth in claim 5 wherein said dispersing step positions said radioactive seed elements at independent intervals that may vary the spacing between the seed elements.

7. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

providing first and second elongate half-shell members, each of which has an outer surface that is generally half-cylindrical in shape, and each of which has a diameter that is less than the inner diameter of the hollow needle;

dispersing radioactive seed elements within the first elongate half-shell member;

mating the second elongate half-shell member to the first elongate half-shell member; and

fusing the first and second elongate half-shell members to thereby form a therapeutic element that has an outer surface that is generally cylindrical in shape and that is configured to be implanted into patient tissue using a hollow needle.

8. The method for making a therapeutic element set forth in claim 7 wherein said dispersing step positions said radioactive seed elements at independent intervals that may vary the spacing between the seed elements.

9. The method of claim 7, wherein the fusing step includes heating the mated said first and second elongate half-shell members to mold the half-shell members tightly to said radioactive seeds.

10. The method of claim 7, wherein the radioactive seed elements have a center bore.

11. The method of claim 7, wherein the fusing step includes flowing a polymer into at least one of the said first and second half-shell members, so that when the polymer solidifies, said first and second half-shell members are fused together.

12. The method of claim 11, wherein the flowing of the polymer is performed after the dispensing step but before the mating step.

13. A method of assembling a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

providing first and second elongate half-shell members, each of which has an outer surface that is generally half-cylindrical in shape, and each of which has a diameter that is less than the inner diameter of the hollow needle;

dispensing radioactive seed elements into the first elongate half shell member; and

attaching the first and second half-shell members to fully encapsulate each of the seed elements between longitudinal ends of the first and second halfshell members and thereby form a therapeutic element configured to be implanted into patient tissue using a hollow needle.

14. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements and spacers within a channel of a first elongate member that has an outer surface that is generally half-cylindrical in shape; and

attaching a second elongate member, that also has an outer surface that is generally half-cylindrical in shape, to the first elongate member to thereby encapsulate the seed elements and the spacers between the first and second elongate members;

wherein the therapeutic element, made by attaching the first and second elongate members together with the seed elements and the spacers therebetween, has an outer surface that is generally cylindrical in shape and has a diameter that is less than the inner diameter of the hollow needle.

15. The method of claim 14, wherein the second elongate member also includes a channel.

16. The method of claim 14, wherein the first and second elongate members each comprise a half shell member having a diameter that is less than the inner diameter of the hollow needle.

17. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements within a first elongate member; and

attaching a second elongate member to the first elongate member to thereby encapsulate the seed elements between the first and second elongate members;

wherein the therapeutic element, made by attaching the first and second elongate members together with the seed elements therebetween, has a diameter that is less than the inner diameter of the hollow needle; and

wherein the attaching step includes;

mating the first and second elongate members; and

heating the mated first and second elongate members to mold the members tightly to the seeds elements to thereby form the therapeutic element configured to be implanted into patient tissue using a hollow needle.

18. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements within a channel of a first elongate member that has an outer surface that is generally half cylindrical in shape; and

attaching a second elongate member, that also has an outer surface that is generally half-cylindrical in shape, to the first elongate member to thereby encapsulate the seed elements between the first and second elongate members;

wherein the therapeutic element, made by attaching the first and second elongate members together with the seed elements therebetween, has an outer surface that is generally cylindrical in shape and has a diameter that is less than the inner diameter of the hollow needle; and

wherein the attaching step includes;

mating the first and second elongate members; and

fusing the mated first and second elongate members together to thereby form the therapeutic element configured to be implanted into patient tissue using a hollow needle.

19. A method of assembling a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

providing first and second elongate half-shell members, each of which has an outer surface that is generally half-cylindrical in shape, and each of which has a diameter that is less than the inner diameter of the hollow needle;

dispensing radioactive seed elements into the first elongate half shell member; and

attaching the first and second half-shell members to encapsulate the seed elements between the first and second half-shell members and thereby form a therapeutic element configured to be implanted into patient tissue using a hollow needle;

wherein said dispensing step positions said radioactive seed elements at independent intervals that may vary the spacing between the seed elements.

20. The method of claim 19 wherein liquid polymer is dispensed into one half-shell member before mating the two half-shell members in order to fuse the half-shell members together.

21. The method of claim 19 wherein the mated half-shell members are heated to fuse the half-shell members together.

22. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements within indentations of a first elongate member; and

attaching a second elongate member to the first elongate member to thereby fully encapsulate each of the seed elements between longitudinal ends of the first and second elongate members;

wherein the therapeutic element, made by attaching the first and second elongate members together with the seed elements therebetween, has a diameter that is less than the inner diameter of the hollow needle.

23. A method for making a therapeutic element configured to be implanted into patient tissue using a hollow needle having an inner diameter, comprising:

dispersing radioactive seed elements and spacers within a first bio-absorbable elongate member; and

attaching a second bio-absorbable elongate member to the first elongate member to thereby encapsulate the seed elements and the spacers between the first and second elongate members;

wherein the therapeutic element, made by attaching the first and second bioabsorbable elongate members together with the seed elements and the spacers therebetween, has a diameter that is less than the inner diameter of the hollow needle.

24. The method of claim 23, wherein each of the first and second bio-absorbable elongate members has an outer surface that is generally half-cylindrical in shape.