Implantable devices for the controlled release of cytotoxic agents

• US 20040013702A1
• Filed: 07/16/2002
• Published: 01/22/2004
• Est. Priority Date: 07/16/2002
• Status: Abandoned Application

• Current Assignee: Mentor Corporation (Johnson & Johnson)
• Original Assignee: Mentor Corporation (Johnson & Johnson)
• Inventors: Glover, Eugene G.
• Application Number:
  US10/196,463
• Publication Number:
  US 20040013702A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Abstract

An implantable device that includes at least one sealed chamber containing any of a variety of therapeutic or cytotoxic agents is described. The device is implanted into the patient at one or more sited requiring treatment, e.g., at several sites within a tumor. Once the device is implanted in the patient, the chamber retains its contents until a bioresorbable element of the chamber (e.g., a seal) dissolves, creating an opening through which the agent migrates out of the chamber and enters the body. The bioresorbable element can be simply a plug seal in a plastic or metal chamber. Alternatively, all or part of the chamber itself can be formed of a bioresorbable material. The agent can be chemical or biological.

Claims

1. An implantable device for localized delivery of an agent to a region of the body of a patient, the device comprising:

(a) at least one chamber having one or more sealable openings; and

(b) a therapeutic or a cytotoxic agent contained within the at least one chamber,

wherein the one or more sealable openings are releasably sealed with a biodegradable polymer that retains the therapeutic or cytotoxic agent within the chamber for at least a first predetermined time period after implantation of the device in a patient.

2. The implantable device of claim 1 wherein the chamber is formed of a biodegradable material that does not substantially degrade within the first predetermined time period after implantation.

3. The implantable device of claim 1 wherein the chamber is formed of a non-biodegradable material.

5. The implantable device of claim 3 wherein the chamber is formed of silicone rubber.

6. The implantable device of claim 1 further comprising biocompatible coating on the outer surface of the device.

7. The implantable device of claim 1 further comprising a lubricious coating on the outside of the device.

8. The implantable device of claim 1 further comprising an antibiotic coating on the outside of the device.

9. The implantable device of claim 1 wherein the device is cylindrical.

10. The implantable device of claim 1 wherein the device is ovoid.

11. The implantable device of claim 1 comprising a plurality of chambers.

12. The implantable device of claim 1 comprising at least two chambers.

13. The implantable device of claim 12 comprising at least a first chamber having at least one opening releasably sealed with a biodegradable polymer that retains the therapeutic or cytotoxic agent within the first chamber for at least a first predetermined time period after implantation and at least a second chamber having at least one opening releasably sealed with a biodegradable polymer that retains the therapeutic or cytotoxic agent within the second chamber for a time after implantation that is greater than the first predetermined time period after implantation.

14. The implantable device of claim 1 wherein the therapeutic or cytotoxic agent is admixed with a biodegradable polymer.

15. The implantable device of claim 1 wherein the biodegradable polymer degrades by bulk erosion.

16. The implantable device of claim 1 wherein the biodegradable polymer degrades by surface erosion.

17. The implantable device of claim 1 having a first chamber filled with a first therapeutic or cytotoxic agent and a second chamber filled with a second, different therapeutic or cytotoxic agent.

18. The implantable device of claim 1 wherein the chamber is filled with a cytotoxic agent selected from the group consisting of:

an acid, a base, and salt.

19. The implantable device of claim 1 wherein the therapeutic or cytotoxic agent is encapsulated.

20. The implantable device of claim 1 comprising a plurality of chambers, each chamber connected to at least one other chamber by a flexible linkage.

22. The device of claim 1 wherein the predetermined period of time is more than one day, but less than 100 days.

23. The device of claim 1 wherein the predetermined period of time is more than one day, but less than 50 days.

24. The device of claim 1 wherein the predetermined period of time is more than one day, but less than 10 days.

25. A kit comprising two or more of the devices of claim 1 or claim 21 and instructions for use contained in packaging.

26. The kit of claim 25 wherein the two or more devices retain their therapeutic or cytotoxic agents for different predetermined periods of time.

4. The implantable device of claim wherein the chamber is formed of a metal selected from the group consisting of a stainless steel alloy, a copper alloy, aluminum, tantalum, titanium alloy, and a nickel alloy.

21. An implantable device for localized delivery of an agent to a region of the body, the device comprising:

(a) at least one chamber formed of a biodegradable material and having one or more sealable openings; and

(b) a therapeutic or a cytotoxic agent contained within the chamber,

wherein the sealable openings are releasably sealed with a biodegradable polymer and wherein the biodegradable polymer retains the therapeutic or cytotoxic agent within the chamber for at least a first predetermined time period after implantation.