Selectively loadable/sealable bioresorbable carrier assembly for radioisotope seeds

• US 20070135673A1
• Filed: 05/25/2004
• Published: 06/14/2007
• Est. Priority Date: 05/25/2004
• Status: Active Grant

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Mills Biopharmaceuticals, LLC
• Inventors: Hoedeman, George, Berkey, John, Elliott, Daniel
• Granted Patent: US 7,351,192 B2
• Time in Patent Office: Days
• US Class Current: 600/7
• CPC Class Codes: A61N 2005/1009 Apparatus for loading seeds into magazines or needles
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

A selectively loadable/sealable bioresorbable carrier assembly for retaining and positioning elements used in brachytherapy procedures comprises a bioresorbable tube having a closed distal end and a proximal open end. The bioresorbable tube is loaded with a selectable arrangement of elements, including at least one radioactive seed, through the proximal open end. After the bioresorbable tube is selectably loaded, the bioresorbable tube is heat sealed at a sealing position adjacent a proximalmost element. Once sealed, the bioresorbable tube maintains the arrangement of elements throughout the treatment duration.

Claims

1. A system for selectively loading and sealing a plurality of bioresorbable carriers for low dose radioisotope seeds comprising:

a plurality of bioresorbable tubes each having a distal closed end and a proximal open end and a lumen therebetween;

a loading station that permits a user to load a selectable arrangement of elements including at least one radioisotope seed into the lumen through the proximal open end of each bioresorbable tube; and

a finishing station including an automated heat source that selectively seals the proximal open end of each bioresorbable tube at a sealing position along the bioresorbable tube that is generally adjacent to a proximal end of the selectable arrangement of elements such that the selectable arrangement of elements is retained within the bioresorbable tube;

such that the sealing position for different ones of the plurality of bioresorbable tubes is located at different distances from the distal closed end dependent upon the selectable arrangement of elements advanced into that bioresorbable tube.

2. The system of claim 1, wherein the loading station is an automated loading station.

3. The system of claim 2, further comprising a loading tube external and coaxial to each bioresorbable tube and having two open ends with a loading adapter at one end that interfaces with an aperture on the automated loading station.

4. The system of claim 3, wherein the loading adapter comprises a flared portion of the loading tube with locking structure thereon that mates with corresponding structure proximate the aperture on the automated loading station.

5. The system of claim 3, wherein at least a portion of the loading tube is transparent to permit visual inspection of the selectable arrangement of elements.

6. The system of claim 3, further comprising a packaging tube external and coaxial to at least a portion of each loading tube and a removable stylet disposed between the packaging tube and the loading tube at the end opposite to the loading adapter.

7. The system of claim 3, wherein at least a portion of the loading tube and a corresponding portion of the packaging tube are transparent to permit visual inspection of the selectable arrangement of elements.

8. The system of claim 2, wherein the plurality of bioresorbable tubes are selectively loaded in accordance with a desired treatment plan.

9. The system of claim 1, further comprising:

a loading tube external and coaxial to each bioresorbable tube and having an open end corresponding to the proximal end of the bioresorbable tube and an open distal end corresponding to the distal closed end of the bioresorbable tube; and

means for releasably retaining the bioresorbable tube within the loading tube.

10. The system of claim 9, wherein the means for releasably retaining the bioresorbable tube comprises a friction fit created by a material surrounding at least a portion of the bioresorbable tube proximate the proximal end of the bioresorbable tube that interfaces with a portion of an interior surface of the proximal end of the loading tube.

11. The system of claim 9, wherein the finishing station comprises:

a positioning channel having a first end and a second end, the first end adapted to receive the bioresorbable tube from the distal end of the loading tube when a stylet is advanced into the proximal open end of the bioresorbable tube;

a resilient member at the second end of the positioning channel that compresses when the stylet advances the bioresorbable tube into the resilient member and recoils to position the bioresorbable tube at a sealing position; and

a heating element positioned along the positioning channel proximate the sealing position that is selectively activated to heat seal the bioresorbable tube;

such that each bioresorbable tube is positioned at the sealing position in response to a combined length of the selectable arrangement of elements loaded into that bioresorbable tube.

12. A method for retaining a selectable arrangement of elements within a brachytherapy carrier comprising:

loading a bioresorbable tube with the selectable arrangement of elements wherein the selectable arrangement of elements include at least one low dose radioisotope seed, the selectable arrangement of elements being directed into the bioresorbable tube at a proximal open end and retained by a distal closed end;

defining a sealing position along the length of the bioresorbable tube, the sealing position being determined by the selectable arrangement of elements within the bioresorbable tube, the sealing position being generally adjacent a proximalmost element and wherein the sealing position is in proximity to an automated heat source;

sealing the bioresorbable tube with the automated heat source, the automated heat source melting the bioresorbable tube at the sealing position such that the selectable arrangement of elements are encased within a sealed bioresorbable tube.

13. The method of claim 12, wherein the selectable arrangement of elements includes at least one spacer.

14. The method of claim 12, wherein the selectable arrangement of elements defines an arrangement length within a range of 4.5 mm-70 mm.

15. The method of claim 12, wherein an automated loader loads the selectable arrangement of elements into the bioresorbable tube.

16. The method of claim 12, further comprising inserting the sealed bioresorbable tube into a seeding needle such that the sealed bioresorbable tube is deliverable into a cancerous tissue.

17. The method of claim 12, wherein defining the sealing position includes placing the bioresorbable tube within a channel on a finishing station such that a stylet pushes against the proximalmost element and positions the proximalmost element adjacent the automated heat source irrespective of the selectable arrangement of elements.

18. The method of claim 12, wherein the automated heat source includes a control circuit that initiates a temperature cycle during which the bioresorbable tube is first melted followed by a cooling cycle during which the sealed bioresorbable tube is allowed to cool.

19. The method of claim 18, wherein the control circuit includes a visual indicator wherein completion of the temperature cycle is displayed.

20. The method of claim 12, wherein at least a portion of the bioresorbable tube is transparent to permit visual confirmation of the selectable arrangement of elements.

21. The method of claim 12, further comprising repeating the aforementioned steps for a plurality of bioresorbable tubes such that a plurality of sealed bioresorbable tubes are prepared as defined by a treatment plan.

22. The method of claim 21, wherein the plurality of sealed bioresorbable tubes are prepared at a treatment site.

23-29. -29. (canceled)