Flexible and/or elastic brachytherapy seed or strand

• US 8,470,294 B2
• Filed: 06/25/2010
• Issued: 06/25/2013
• Est. Priority Date: 11/16/2000
• Status: Expired due to Term

• Current Assignee: Microspherix LLC
• Original Assignee: Microspherix LLC
• Inventors: Kaplan, Edward J.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): SAMALA, JAGADISHWAR RAO
• Application Number:
  US12/823,700
• Publication Number:
  US 20100261946A1
• Time in Patent Office: 1,096 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, wherein the seed is a combination product comprising

a) a biocompatible carrier,

b) one or more therapeutic components,

e) an imaging, radiopaque, or other diagnostic marker, and

d) one or more structures to maintain location or orientation of the seed selected from the group consisting of one or more biodegradable structures effective to prevent migration upon implantation of the seed in tissue, one or more biodegradable structures effective to maintain orientation in tissue, and one or more compliant setal or hair structures which impart adhesive properties upon implantation into a target tissue,

wherein the seed has a size and shape suitable for passing through the bore of a needle or catheter having an interior diameter of less than about 2.7 mm (10 gauge).

2. The seed of claim 1 wherein the seed is shaped into a cylinder or rod having a diameter of between about 0.8 to 3 mm and a length of up to 40 mm.

3. The seed of claim 2 wherein the biodegradable structures are comprised of polymeric substances, non-polymeric substances, inorganic substances, and combinations thereof.

4. The seed of claim 1 wherein a plurality of the seeds are formed as a continuous chain or array of seeds, optionally containing spacers.

5. The seed of claim 4 wherein the seeds and spacers in the chain or continuous array are indistinguishably linked.

6. The seed of claim 4 wherein the color, texture, diameter, hardness, or shape of the spacers is used for identification and demarcation.

7. The seed of claim 4 wherein the chain or continuous array comprises indiscrete seeds and is flaccid, rigid, flexible, spring-shaped, coiled, spiral-shaped, springy, bent, latticed, knotted, interconnected, linked, or fused.

8. The seed of claim 4 wherein spacers are located at varying distances from one another, separated by one, two, three, four, five or more seeds or wherein the seeds are located at varying distances from one another, separated by one, two, three, four, five, or more spacers.

9. The seed of claim 4, wherein the chain of seeds is configured into a knot, twist, coil, or combinations thereof.

10. The seed of claim 1 wherein one or more seeds are elongated into strands to form a continuous chain or array of seeds.

11. The seed of claim 5, wherein two or more strands are combined to form a knot, twist, coil, or combinations thereof.

12. The seed of claim 1 wherein the structures to maintain location or orientation comprise a smart polymer, a shape memory polymer, or other substrate to achieve configuration modification.

13. The seed of claim 1 wherein one or more of the therapeutic components is radioactive, non-radioactive, or combinations thereof.

14. The seed of claim 1 wherein the imaging, radiopaque, or diagnostic marker is the biocompatible carrier.

15. The seed of claim 13 further comprising a means of tracing the radioactive contents comprising the radioactive component.

16. The seed of claim 14 wherein the tracer is fluorescent, luminescent, colored, pigmented, dyed, tagged, or quantum dots.

17. The seed of claim 1, wherein the one or more structures that maintain location or orientation of the seed or impart adhesive properties to the seed, cover at least a portion of the seed.

18. The seed of claim 1, wherein the biocompatible carrier is metallic.

19. The seed of claim 1, wherein the one or more structures prevents migration or maintains orientation of the seed for a period of time of at least about one hour, preferably about three weeks, more preferably about three months, most preferably about six months.

20. The seed of claim 1, wherein the one or more therapeutic components;

imaging, radiopaque, or other diagnostic marker;

or combinations thereof are within the one or more biodegradable structures.

21. The seed of claim 1, wherein the one or more biodegradable structures comprise one or more ribs or wings.

22. The seed of claim 21, wherein the one or more biodegradable structures comprise one or more ribs or wings.

23. The seed of claim 1, wherein the seed provides substantially uniform dosimetry.