Drug eluting brachytherapy methods and apparatus

• US 7,524,275 B2
• Filed: 11/14/2003
• Issued: 04/28/2009
• Est. Priority Date: 11/14/2003
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Patrick, Timothy J., Stubbs, James B.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US10/714,586
• Publication Number:
  US 20050107653A1
• Time in Patent Office: 1,992 Days
• Field of Search: 600 1- 7, 604/19, 604/48, 604/57, 604/93.01, 604/96.01, 604/103.02, 604264-266, 604/272, 604/290, 604/500, 604506-511, 604/522, 606191-200, 128897-899
• US Class Current: 600/2
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

An interstitial brachytherapy apparatus and methods for treating proliferative tissue disorders with radiation and a surface delivered treatment agent. The brachytherapy device includes an insertion member having proximal and distal portions and at least one lumen extending therethrough. An expandable surface member is mated to the distal portion of the insertion member and includes a treatment agent releasably mated thereon. When the brachytherapy device is positioned within a tissue cavity and the expandable surface member is expanded, at least a portion of the treatment agent is delivered to tissue surrounding the tissue cavity.

Claims

1. A drug eluting brachytherapy device, comprising:

(a) an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough;

(b) an expandable surface member mated to the distal portion of the insertion member and defining a spatial volume therein, wherein said spatial volume is configured to receive a radiation source therein to enable a three-dimensional isodose profile that is substantially similar in shape to said expandable surface member; and

(c) a plurality of treatment releasably mated with an outer surface of the expandable surface member;

wherein at least a portion of each of the treatment agents is delivered to adjacent tissue when the brachytherapy device is positioned within a tissue cavity, and wherein a first treatment agent begins delivery before a second treatment agent.

2. The device of claim 1, wherein the expandable surface member is a fluid retaining expandable surface member.

3. The device of claim 1, wherein at least one treatment agent is nonradioactive.

4. The device of claim 1, wherein the treatment agents are coated on the outer surface of the expandable surface member.

5. The device of claim 4, wherein different treatment agents are disposed in different layers.

6. The device of claim 1, wherein at least one treatment agent is dispersed within a sidewall of the expandable surface member.

7. The device of claim 1, wherein at least one treatment agent is disposed on only a portion of the surface of the expandable surface member.

8. The device of claim 7, wherein the at least one treatment agent is disposed on less then about half the surface of the expandable surface member.

9. The device of claim 1, wherein the expandable surface member includes a first surface adapted for positioning against a tissue surface.

10. The device of claim 9, wherein at least one treatment agent is disposed only on the first surface.

11. The device of claim 1, wherein each treatment agent is selected from the group consisting of, a chemotherapy drug, an anti-neoplastic agent, an anti-angiogenesis agent, an immunomodulator, a hormonal agent, an immunotherapeutic agent, a pain reliever, an antibiotic or combinations thereof.

12. The device of claim 1, wherein at least one of the treatment agents is mixed with a binding agent.

13. The device of claim 12, wherein the binding agent is a bioresorbable polymeric binding agent.

14. A drug eluting tissue positioning device for positioning target tissue surrounding a resected tissue cavity so that the target tissue can receive a measured radiation dose, comprising:

a catheter body member having a proximal portion and a distal portion;

an expandable surface member, the expandable surface member defining a spatial volume therein, wherein said spatial volume is configured to receive a radiation source therein; and

a plurality of treatment releasably mated with an outer surface of the expandable surface member;

wherein at least a portion of each treatment agent is delivered to tissue surrounding the resected tissue cavity when the device is positioned within the resected tissue cavity, and wherein a first treatment agent begins deliver to the tissue before a second treatment agent begins delivery.

15. The device of claim 14, wherein the expandable surface member is constructed of a material permeable to a treatment agent.

16. The device of claim 15, wherein a third treatment agent capable of permeating through the walls of the expandable surface member is disposed within the expandable surface member.

17. The device of claim 16, wherein a fluid delivery path for the delivery of the third treatment agent extends through the catheter body member into the spatial volume within the expandable surface member, and out through the permeable expandable surface member.

18. The device of claim 14, wherein the expandable surface member includes permeable and nonpermeable portions, and the treatment agents are mated with only the nonpermeable portions.

19. The device of claim 14, wherein each treatment agent is selected from the group consisting of, a chemotherapy drug, an anti-neoplastic agent, an anti-angiogenesis agent, an immunomodulator, a hormonal agent, an immunotherapeutic agent, an antibiotic or combinations thereof.

20. The device of claim 14, wherein a radiation source is disposed within the expandable surface member.

21. The device of claim 14, wherein an external radiation source is disposed outside of the expandable surface member.

22. A method of delivering a treatment material, comprising:

providing a drug eluting brachytherapy device having a catheter body member with a proximal portion and a distal portion, an expandable surface member defining a spatial volume, and a plurality treatment agents releasably mated with an outer surface of the expandable surface member;

positioning the brachytherapy device within a tissue cavity; and

delivering the treatment agents to tissue surrounding the tissue cavity, wherein a first treatment agent begins releasing before a second treatment agent begins releasing.

23. The method of claim 22, wherein the tissue cavity is a resected tissue cavity created during a lumpectomy procedure.

24. The method of claim 22, wherein at least one treatment agent is a chemotherapy drug.

25. The method of claim 22, wherein the plurality of treatment agents are layered on the outer surface of the expandable surface member and the first treatment agent is disposed in an outer layer and the second treatment agent is disposed in an inner layer.

26. The method of claim 22, wherein the tissue cavity is a naturally occurring cavity.

27. The method of claim 26, wherein the cavity is selected from the group consisting of the bladder, the esophagus, the gut, the urethra, and the ureters.

28. The method of claim 22, wherein the tissue cavity is mechanically formed.