# US 7,744,913 B2 · Fillers and methods for displacing tissues to improve radiological outcomes

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- Number: US 7,744,913 B2
- Document ID: US7744913B2
- Status: Granted
- Kind: B2
- Application number: 10/602,526
- Filed: 2003-06-24
- Published: 2004-05-20
- Granted: 2010-06-29
- Earliest claimed: 2002-06-24
- Assignees: Incept, LLC
- Inventors: William R. Noyes
- Web page: https://patentgrep.com/patent/US7744913B2

## CPC

- A61K 51/12: characterised by a special physical form, e.g. emulsion, microcapsules, liposomes {, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules (liposomes A61K51/1234)}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/042: {Polysaccharides}
- A61L 31/044: {Collagen}
- A61L 31/18: Materials at least partially X-ray or laser opaque
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Certain embodiments include a method of improvising radiological outcomes by introducing a filler to between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, and administering a dose of radioactivity to at least the first tissue location or the second tissue location. Collagen and hyaluronic acid are examples of fillers. Certain embodiments include a medical device having a biocompatible, biodegradable filler material, wherein the device comprises at least a portion that has a shape that substantially conforms to Denovillier's space between the rectum and prostate. Certain embodiments include a kit, the kit comprising a filler and instructions for placing the filler between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location.

## Claims

### Claim 1

A method of delivering a therapeutic dose of radiation to a patient comprising introducing a biocompatible, biodegradable filler device between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, and treating the second tissue location with the therapeutic dose of radiation so that the presence of the filler device causes the first tissue location to receive less of the dose of radioactivity compared to the amount of the dose of radioactivity the first tissue location would receive in the absence of the filler device, wherein the filler device is introduced an injectable material and is a gel in the patient that is removed by biodegradation of the filler device in the patient wherein the first tissue location is associated with the rectum and the second tissue location is associated with the prostate gland.

### Claim 2 (depends on 1)

The method of claim 1 wherein the filler is introduced into Denovillier's space.

### Claim 3 (depends on 1)

The method of claim 1 wherein the filler comprises a member of the group consisting of alginate, gelatin, fibrin, fibrinogen, albumin, polyethylene glycol, thixotropic polymers, thermoreversible polymers, and mixtures thereof.

### Claim 4 (depends on 1)

The method of claim 1 wherein the filler comprises at least one therapeutic agent.

### Claim 5 (depends on 4)

The method of claim 4 wherein the at least one therapeutic agent is a member of the group consisting of an anti-inflammatory drug, an antibiotic, an antimycotics, a hemostat, a steroid, and an analgesic.

### Claim 6 (depends on 1)

The method of claim 1 wherein the filler is biodegradable in vivo in less than approximately 90 days.

### Claim 7 (depends on 1)

The method of claim 1 wherein the filler comprises an extracellular matrix molecule.

### Claim 8 (depends on 1)

The method of claim 1 wherein the filler consists essentially of collagen.

### Claim 9 (depends on 1)

The method of claim 1 wherein the filler comprises at least one polysaccharide.

### Claim 10 (depends on 9)

The method of claim 9 wherein the at least one polysaccharide is hyaluronic acid.

### Claim 11 (depends on 1)

The method of claim 1 wherein the filler further comprises a member of the group consisting of a degradation inhibitor, a radio opaque marker, and an osmotic agent that causes water to become associated with the filler material by osmosis.

### Claim 12 (depends on 1)

The method of claim 1 wherein the filler further comprises a buffering agent.

### Claim 13 (depends on 1)

The method of claim 1 wherein the filler comprises a member of the group consisting of a degradation inhibitor, a radio opaque marker, and an osmotic agent that causes water to become associated with the filler material by osmosis.

### Claim 14 (depends on 1)

The method of claim 1 wherein the filler comprises a buffering agent.

### Claim 15 (depends on 1)

The method of claim 1 wherein the filler material comprises a synthetic polymer.

### Claim 16 (depends on 1)

The method of claim 1 wherein the filler occupies a volume in the range of about 10 to about 200 cubic centimeters in a patient.

### Claim 17

A method of delivering a therapeutic dose of radiation to a patient comprising: (i) injecting anesthesia and (ii) injecting saline to expand the space between the first and second tissue location, wherein the first tissue location is associated with the rectum and the second tissue location is associated with the prostate gland and introducing a biocompatible, biodegradable filler device between the first tissue location and the second tissue location to increase a distance between the first tissue location and the second tissue location, said biocompatible, biodegradable filler being collagen and introducing collagen into Denovillier's space and treating the second tissue location with a therapeutic dose of radiation, said therapeutic dose of radiation being 70 to 100 Gy, so that the presence of the filler device causes the first tissue location to receive less than 50% of the dose of radioactivity compared to the amount of the dose of radioactivity the first tissue location would have received in the absence of the filler device, wherein the filler device is removed by biodegradation of the filler device in the patient.

### Claim 18 (depends on 1)

The method of claim 1 wherein the filler comprises a member of the group consisting of polylactide, polyglycolide, polycaprolactone, poly(alpha-hydroxy acid).

### Claim 19 (depends on 1)

The method of claim 1 wherein the filler comprises alginate.

### Claim 20 (depends on 1)

The method of claim 1 wherein the filler comprises gelatin.

### Claim 21 (depends on 1)

The method of claim 1 wherein the filler comprises fibrin or fibrinogen.

### Claim 22 (depends on 1)

The method of claim 1 wherein the filler comprises albumin.

### Claim 23 (depends on 1)

The method of claim 1 wherein the filler comprises polyethylene glycol.

### Claim 24 (depends on 1)

The method of claim 1 wherein the filler comprises a thixotropic polymer.

### Claim 25 (depends on 1)

The method of claim 1 wherein the filler comprises a thermoreversible polymer.
