Implant and biodegradable tissue marker compositions and methods

Patent metadata

Field	Value
Publication number	US-11786612-B2
Application number	US-202016999703-A
Country	US
Kind code	B2
Filing date	Aug 21, 2020
Priority date	Dec 15, 2009
Publication date	Oct 17, 2023
Grant date	Oct 17, 2023

Abstract

Implantable materials may be used as spacers for separating tissues to reduce a dose of radioactivity received by one of the tissues. Applications include introducing a hydrogel spacer to a position between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, Further, there may be a step of administering a dose of radioactivity to at least the first tissue location or the second tissue location and/or a step of visualizing margins of the hydrogel spacer. A hydrogel spacer may comprise a polysaccharide and a radioopaque agent and may be used for fiducial marking.

First claim

The invention claimed is:

1. A method for radiation therapy comprising introducing a hydrogel spacer at a site between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, the site being chosen to decrease radiation at the first tissue when the second tissue receives a dose of therapeutic radiation, wherein the hydrogel spacer comprises a polysaccharide and a radioopaque agent, wherein the hydrogel spacer has a Hounsfield number of at least about 90.

2. The method of claim 1 , wherein the polysaccharide is hyaluronic acid.

3. The method of claim 1 , wherein the radioopaque agent is a covalently attached radioopaque iodine agent.

4. The method of claim 1 , wherein the first tissue location is associated with the rectum and the second tissue location is associated with the prostate gland.

5. The method of claim 1 , wherein the spacer provides a fiducial marker for administration of the therapeutic radiation.

6. The method of claim 5 , further comprising visualizing the interface of the fiducial marker and the second tissue.

7. The method of claim 6 , wherein the visualizing comprises computerized tomography or X-ray.

8. The method of claim 1 , further comprising making a radiation plan based on a visualization of the hydrogel spacer, with the hydrogel spacer being in contact with the second tissue.

9. The method of claim 8 , with the plan having a reduced uncertainty in target definition relative to a radiation plan made without the hydrogel spacer.

10. The method of claim 1 , wherein the hydrogel spacer has a Hounsfield number from about 100 to about 2000.

11. The method of claim 1 , wherein the hydrogel spacer, as placed in the tissue, has a volume between 1 and 40 ml.

12. The method of claim 1 , further comprising visualizing margins of the hydrogel spacer with a machine selected from computerized tomography or X-ray.

13. The method of claim 1 , further comprising a therapeutic agent in the hydrogel spacer.

14. The method of claim 1 , with the radioopaque agent being present in the hydrogel spacer at a concentration of at least about 0.1% w/w.

15. A method for radiation therapy comprising introducing a hydrogel spacer at a site between a first tissue location and a second tissue location, the site being chosen to decrease radiation at the first tissue when the second tissue receives a dose of therapeutic radiation, wherein the hydrogel spacer comprises hyaluronic acid and a covalently attached radioopaque agent, wherein the hydrogel spacer has a Hounsfield number of at least about 90.

16. The method of claim 15 , herein the first tissue location is associated with the rectum and the second tissue location is associated with the prostate gland.

17. The method of claim 15 , wherein the hydrogel spacer, as placed in the tissue, has a volume between 1 and 40 ml.

18. The method of claim 15 , wherein the spacer provides a fiducial marker for administration of the therapeutic radiation.

19. A method for radiation therapy comprising (a) introducing a hydrogel spacer at a site between a first tissue location and a second tissue location, the site being chosen to decrease radiation at the first tissue when the second tissue receives a dose of therapeutic radiation, wherein the hydrogel spacer comprises hyaluronic acid and a radioopaque agent and (b) visualizing margins of the hydrogel spacer with external imaging, wherein the hydrogel spacer has a Hounsfield number of at least about 90.

20. A method for radiation therapy comprising introducing a hydrogel spacer at a site between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, the site being chosen to decrease radiation at the first tissue when the second tissue receives a dose of therapeutic radiation, wherein the hydrogel spacer comprises a polysaccharide and a covalently attached radioopaque agent, wherein the hydrogel spacer has a Hounsfield number of at least about 90.

Assignees

• Incept Llc

Inventors

• Campbell Patrick
• Sawhney Amarpreet S

Classifications

• A61K49/0442 Primary

  Polymeric X-ray contrast-enhancing agent comprising a halogenated group · CPC title

• A61K49/0419

  Microparticles, microbeads, microcapsules, microspheres, i.e. having a size or diameter higher or equal to 1 micrometer · CPC title

• A61K51/1244

  microparticles or nanoparticles, e.g. polymeric nanoparticles · CPC title

• A61L27/50 Primary

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• A61L27/52

  Hydrogels or hydrocolloids · CPC title