Universal balloon for brachytherapy applicator

• US 9,227,084 B2
• Filed: 09/21/2012
• Issued: 01/05/2016
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Radiadyne LLC (AngioDynamics, Inc.)
• Inventors: Isham, John, Springs, Christen, Wiater, Stephen J., Epstein, Adam
• Primary Examiner(s): Kuhlman, Catherine B
• Assistant Examiner(s): McBride, Shannon
• Application Number:
  US13/624,342
• Publication Number:
  US 20130085315A1
• Time in Patent Office: 1,201 Days
• US Class Current: 1/1
• 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 brachytherapy balloon system, including a brachytherapy applicator and a brachytherapy balloon, is described. The brachytherapy balloon is shaped and sized to fit a vagina, a rectum or an esophagus and is made of elastomeric polymer and has a cylindrical inner surface defining an interior hollow of diameter D with at least one open end into which a brachytherapy applicator of diameter x<D can fit, and an outer surface. The inner and outer surfaces of the brachytherapy balloon together define an inflatable elongated toroidal shape having a distal and a proximal end. The distal end has a diameter less than x, a valve for inflating the balloon, and a retention ring that prevents the brachytherapy applicator from protruding beyond the retention ring and reproducibly positioning the applicator on every use.

Claims

1. A brachytherapy balloon system, comprising a brachytherapy applicator and a brachytherapy balloon, said brachytherapy balloon adapted to fit a vagina, a rectum or an oesophagus and being made of elastomeric polymer and having:

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

D can fit, b) an outer surface;

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

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

e) a closable means for introducing a fluid into said brachytherapy balloon to inflate said brachytherapy balloon; and

f) a retention ring at said distal end of said brachytherapy balloon that prevents said brachytherapy applicator from protruding beyond said retention ring.

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

3. The brachytherapy balloon system of claim 1, wherein said retention ring is a weld between said inner surface and said outer surface.

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

5. The brachytherapy balloon system of claim 1, wherein said retention ring is an O-ring inside said brachytherapy balloon at said distal end of said brachytherapy 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.

6. The brachytherapy balloon system of claim 1, wherein said retention ring is a retention ring weld between said inner surface and said outer surface at said distal end of said brachytherapy balloon, and further comprising a secondary weld connecting said inner surface to said outer surface between said proximal and said distal ends.

7. The brachytherapy balloon system of claim 1, wherein said outer surface of said brachytherapy balloon is cylindrical.

8. The brachytherapy balloon system of claim 1, further comprising an opaque marker that can be imaged.

9. The brachytherapy balloon system of claim 1, further comprising a passive radiation sensor.

10. The brachytherapy balloon system of claim 1, further comprising an active radiation sensor.

11. The brachytherapy balloon system of claim 1, further comprising an electromagnetic motion sensor.

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

13. The brachytherapy balloon system 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 a fluid supply.

14. The brachytherapy balloon system 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.

15. The brachytherapy balloon system of claim 1, wherein the brachytherapy balloon is made of thermoplastic polyurethane.

16. The brachytherapy balloon system of claim 1, wherein the brachytherapy balloon is made of thermoplastic polyurethane and is welded shut at said proximal end and has a weld between said proximal and distal ends connecting said inner and outer surfaces.

17. The brachytherapy balloon system of claim 1, wherein the brachytherapy balloon is translucent.

18. The brachytherapy balloon system of claim 1, wherein the brachytherapy balloon 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.

19. A method of contact brachytherapy treatment comprising inserting said brachytherapy applicator of claim 1 into said brachytherapy balloon of claim 1, inserting said brachytherapy balloon and brachytherapy applicator into a vagina, a rectum or an oesophagus of a patient, inflating said brachytherapy balloon, and providing brachytherapy radiation to said patient via said brachytherapy applicator.