Flexible and/or elastic brachytherapy seed or strand

• US 8,821,835 B2
• Filed: 06/13/2013
• Issued: 09/02/2014
• Est. Priority Date: 11/16/2000
• Status: Expired due to Fees

• Current Assignee: Microspherix LLC
• Original Assignee: Microspherix LLC
• Inventors: Kaplan, Edward J.
• Primary Examiner(s): Vu, Jake
• Assistant Examiner(s): SAMALA, JAGADISHWAR RAO
• Application Number:
  US13/916,916
• Publication Number:
  US 20130280168A1
• Time in Patent Office: 446 Days
• Field of Search: 424/1.11, 424/1.25, 424/1.29, 424/9.4, 600 1- 8, 623/1.1, 623/1.34, 623/1.38
• US Class Current: 424/1.25
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 41/0038 Radiosensitizing, i.e. administration of pharmaceutical agents that enhance the effect of radiotherapy radiotherapy per se A61N5/10
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61K 49/00 Preparations for testing in vivo
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 31/02 Inorganic materials
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• 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 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1027 : Interstitial radiation therapy

Abstract

A flexible or elastic brachytherapy strand that includes an imaging marker and/or a therapeutic, diagnostic or prophylactic agent such as a drug in a biocompatible carrier that can be delivered to a subject upon implantation into the subject through the bore of a brachytherapy implantation needle has been developed. Strands can be formed as chains or continuous arrays of seeds up to 50 centimeters or more, with or without spacer material, flaccid, rigid, or flexible.

Claims

1. A seed, for implantation into a subject, comprising:

a marker component configured to allow for the determination of the position of the seed within a target tissue, the marker component having a length extending along a centerline of the marker component between a first end and a second end and having a substantially continuous wall bounding a hollow interior; and

a therapeutic, prophylactic, and/or diagnostic agent, wherein the agent is disposed within the hollow interior;

wherein the length of the marker component is greater than the diameter of the hollow interior and wherein the substantially continuous wall includes at least one opening adapted to allow the agent to pass out of the hollow interior.

2. The seed according to claim 1 wherein the marker component has a maximum length of 10 mm.

3. The seed according to claim 1 wherein at least one of the marker component and the agent is imageable.

4. The seed according to claim 3 wherein the marker component is imageable.

5. The seed according to claim 1 wherein the marker component comprises one or more structures that resist migration of the seed from the site of implantation, one or more biodegradable structures effective to maintain orientation in tissue, one or more compliant setal or hair structures which impart adhesive properties upon implantation into a target tissue, or combinations thereof.

6. The seed according to claim 5 wherein the marker component comprises one or more structures that resist migration of the seed from the site of implantation, one or more biodegradable structures effective to maintain orientation in tissue or combinations thereof.

7. The seed of claim 6, wherein the structures to maintain location or orientation comprise a smart polymer, a shape memory polymer, or other substrate to achieve configuration modification.

8. The seed according to claim 6 wherein the structure includes an anchor.

9. The seed according to claim 1 wherein the marker component comprises a biocompatible component and the agent is dispersed in a coating on the biocompatible component.

10. The seed according to claim 1 wherein the agent is mixed together with the marker component.

11. The seed according to claim 10 wherein the marker component is biodegradable.

12. The seed according to claim 11 wherein the marker component is configured to degrade over time at the implantation site and release the agent by controlling the rate of degradation and/or release rate at the implantation site.

13. The seed according to claim 1 wherein the marker component comprises a coil.

14. The seed according to claim 1 wherein the at least one opening comprises a plurality of pores.

15. The seed according to claim 1 wherein the target tissue includes a cancer or a lumpectomy site.

16. The seed according to claim 1 wherein the agent is selected from the group consisting of an anti-inflammatory, anti-coagulant, cytostatic, antibiotic, anti-neoplastic, vasodilator, anti-viral, immunosuppressive, growth factor, pro-agent, hormone, radiotherapeutic, radiopaque, peptide, protein, enzyme, or combinations thereof.

17. A seed comprising a marker component and a therapeutic, prophylactic, and/or diagnostic agent, the agent, marker, or both, being imageable, the marker component having a length extending along a centerline of the marker component between a first end and a second end and having a substantially continuous wall along the length, the substantially continuous wall bounding a hollow interior and at least partially enveloping the agent within the hollow interior, and wherein the length of the marker component is greater than an average diameter of the hollow interior and the substantially continuous wall includes at least one opening adapted to allow the agent to pass out of the hollow interior.

18. The seed according to claim 17, wherein the marker component comprises an imageable substrate and the agent is dispersed in a coating on the substrate.

19. The seed according to claim 17, wherein the marker component comprises a substrate comprising a biodegradable material further comprising the agent.

20. A seed comprising:

a marker component configured to mark the position of the seed in a target tissue, the marker component comprising a tube having open ends, and having a substantially continuous wall bounding a hollow interior; and

a therapeutic, prophylactic, and/or diagnostic agent, wherein the agent is disposed within the hollow interior of the tube, and wherein the open ends facilitate passing of the agent out of the hollow interior of the tube to the environment surrounding the seed; and

wherein the seed further comprises a plurality of openings that extend through the wall, and wherein the plurality of openings facilitate the passing of the agent out of the hollow interior of the tube into the surrounding tissue.