UNIVERSAL BALLOON FOR BRACHYTHERAPY APPLICATOR

• US 20130085315A1
• Filed: 09/21/2012
• Published: 04/04/2013
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Radiadyne LLC (AngioDynamics, Inc.)
• Inventors: ISHAM, John, WIATER, Stephen J., EPSTEIN, Adam, SPRINGS, Christen
• Granted Patent: US 9,227,084 B2
• Time in Patent Office: Days
• US Class Current: 600/7
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1016 Gynaecological radiation therapy
• CPC Class Codes: A61N 5/1071 for verifying the dose delivered by the treatment plan
• CPC Class Codes: B23P 17/04 characterised by the nature of the material involved or the kind of product independently of its shape
• CPC Class Codes: Y10T 156/1002 with permanent bending or reshaping or surface deformation of self sustaining lamina
• CPC Class Codes: Y10T 29/4997 At least one part nonmetallic

Abstract

A toroidal brachytherapy balloon is provided that fits over any brachytherapy applicator and reproducibly positions the applicator on every use.

Claims

1. A universal brachytherapy balloon, said balloon having:

a) a cylindrical inner surface, said inner surface defining an interior hollow of diameter D with at least one open end into which a separate brachytherapy applicator of diameter x≦

D can fit,

b) an outer surface;

c) said inner and outer surface defining an inflatable elongated toroidal shape having a distal and a proximal end;

d) said distal end having a diameter less than x;

e) a closable means for introducing a fluid into said balloon to inflate said balloon.

2. The universal brachytherapy balloon of claim 1, further comprising a retention ring of at said distal end of said balloon that prevents said brachytherapy applicator from protruding beyond said retention ring.

3. The universal brachytherapy balloon of claim 1, wherein said interior hollow has two open ends.

4. The universal brachytherapy balloon of claim 1, further comprising a retention ring of at said distal end, wherein said retention ring is a weld between said inner surface and said outer surface, wherein said retention ring weld prevents said brachytherapy applicator from protruding beyond said retention ring.

5. The universal brachytherapy balloon of claim 1, comprising a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

6. The universal brachytherapy balloon of claim 1, further comprising a retention ring at said distal end of said balloon that prevents said brachytherapy applicator from protruding beyond said retention ring and a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

7. The universal brachytherapy balloon of claim 2, wherein said retention ring is an O-ring inside said balloon at said distal end of said balloon and further comprising a weld connecting said inner surface to said outer surface adjacent and proximal to said O ring, and a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

8. The universal brachytherapy balloon of claim 2, wherein said retention ring is retention ring weld between said inner surface and said outer surface at said distal end of said balloon, and further comprising a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

9. The universal brachytherapy balloon of claim 1, wherein said outer surface of said balloon is cylindrical.

10. The universal brachytherapy balloon of claim 1, further comprising a opaque marker that can be imaged.

11. The universal brachytherapy balloon of claim 1, further comprising a passive radiation sensor.

12. The universal brachytherapy balloon of claim 1, further comprising an active radiation sensor.

13. The universal brachytherapy balloon of claim 1, further comprising an electromagnetic motion sensor.

14. The universal brachytherapy balloon of claim 1, further comprising a gas lumen that allows the passage of external gas or fluid from the beyond distal end to beyond the proximal end.

15. The universal brachytherapy balloon of claim 1, wherein said closable means for introducing a fluid into said balloon is a lumen fitted with a valve means and a connector for an fluid supply.

16. The universal brachytherapy balloon of claim 1, wherein said closable means for introducing a fluid into said balloon is a lumen fitted with i) a stopcock and luer connector, or ii) a luer lock.

17. The universal brachytherapy balloon of claim 1, which is made of thermoplastic polyurethane.

18. The universal brachytherapy balloon of claim 1, which is made of thermoplastic polyurethane and is welded shut at said proximal end and has a secondary weld between said proximal and distal ends connecting said inner and outer surfaces.

19. The universal brachytherapy balloon of claim 1, which is translucent.

20. The universal brachytherapy balloon of claim 1, which is made of translucent thermoplastic polyurethane having a 80-100 Shore A durometer, a tensile strength of at least 3000 psi;

and 100% modulus of 500-1000 psi.

23. A method of brachytherapy treatment comprising inserting a separate brachytherapy applicator into the universal brachytherapy balloon of claim 1, inserting said balloon and applicator in a body cavity of a patient, inflating said balloon, and providing brachytherapy radiation to said patient via said applicator.

21. A universal brachytherapy balloon, said balloon comprising:

a) an inner surface and an outer surface;

b) said inner surface and said outer surface together defining an inflatable elongated toroidal shape having a distal and a proximal end;

c) said inner surface being cylindrical and defining an interior hollow space with two open ends into which a brachytherapy applicator can fit;

d) said outer surface being cylindrical;

e) a retention ring at said distal end to prevent said brachytherapy applicator from protruding beyond said distal end;

f) closable means for introducing a fluid into said balloon; and

g) a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

22. The universal brachytherapy balloon of claim 21, wherein said retention ring has diameter smaller than a diameter of said brachytherapy applicator, and is a circular weld between said inner surface and said outer surface or an O-ring.

24. A method of brachytherapy treatment comprising inserting a brachytherapy applicator into the universal brachytherapy balloon of claim 21, inserting the balloon and applicator into a body cavity of a patient, inflating said balloon, and providing radiation to said patient via said applicator.

25. A method of making a universal brachytherapy balloon, comprising:

a) making an elongated toroidal balloon having a distal end and a proximal end, said distal end having a constricted portion, and said elongated toroidal balloon having an interior hollow with two open ends shaped to receive a brachytherapy applicator;

b) adding a retention ring to said constricted portion;

c) adding fluid introducing means at or near said proximal end; and

d) adding an optional secondary weld between said proximal and distal ends.

26. A method of making a universal brachytherapy balloon, comprising:

a) cutting two pieces of flat polymeric film of generally rectangular shape and having a constricted portion of lesser width about midway, and wherein one half is as wide or slightly wider than another half;

b) welding said two pieces together along a two sides to make a tube;

c) folding one half of said tube down over said constricted portion;

d) adding a retention ring at said constricted portion;

e) welding the two open ends of said tube together to form an elongated toroidal balloon;

f) adding fluid introducing means to said film, tube or toroidal balloon; and

g) adding an optional secondary weld between a proximal and a distal ends of said toroidal balloon.