Implantable cardiac electrode with rate controlled drug delivery

• US 5,496,360 A
• Filed: 04/12/1994
• Issued: 03/05/1996
• Est. Priority Date: 04/12/1994
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Ventritex Incorporated (Abbott Laboratories)
• Inventors: Bush, M. Elizabeth, Hoffmann, Drew A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Parker, Marianne
• Application Number:
  US08/226,594
• Time in Patent Office: 693 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 607/120
• US Class Current: 607/120
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

A body implantable electrode with rate controlled drug delivery is disclosed. A body implantable lead is provided for the delivery of stimulation energy to a desired body site includes a drug dispenser carried by the lead which retains a drug to be dispensed at least adjacent the desired body stimulation site. The drug may be one which is intended to counter thrombus formation, fibrosis, inflammation or arrhythmias, for example. The drug may be in liquid or powder form retained in a reservoir carried by the lead. The reservoir is formed as a pump which controls dispensing of the drug using a fluid drawing agent such as a salt.

Claims

1. An implantable device, comprising:

an electrode for implantation in a patient, said electrode having a reservoir located within said electrode;

an insulated conductor having a distal end and a proximal end and coupled to said electrode at said distal end of said conductor and having a connector at said proximal end of said conductor;

at least one therapeutic drug carried in said reservoir; and

at least one drawing agent contained in said reservoir, having an ability to draw body fluid into said reservoir for modulating drug delivery rate of said at least one therapeutic drug to body tissue.

2. The implantable device of claim 1, wherein said agent is hydrophilic.

3. The implantable device of claim 1, wherein said agent is lipophilic.

4. The implantable device of claim 1, wherein more than one said agent is contained in said reservoir to provide different pumping effects.

5. The implantable device of claim 2 wherein said hydrophilic agent is a salt.

6. The implantable device of claim 2 wherein said hydrophilic agent is a protein.

7. The implantable device of claim 1 and further including a polymeric matrix within said reservoir, wherein said drawing agent is impregnated in said polymeric matrix.

8. The implantable device of claim 7 wherein said polymeric matrix is biodegradable.

9. The implantable device of claim 2 and further including a polymeric matrix within said reservoir, wherein said hydrophilic agent comprises a hydrophilic species chemically attached to said polymeric matrix.

10. The implantable device of claim 1 and further including a polymeric matrix within said reservoir, wherein said therapeutic drug is impregnated in said polymeric matrix.

11. The implantable device of claim 9 wherein said polymeric matrix is biodegradable.

12. The implantable device of claim 1 wherein said therapeutic drug is in liquid form.

13. The implantable device of claim 1, wherein said drawing agent is impregnated in a first polymeric matrix, and said therapeutic drug is impregnated in a second polymeric matrix, and said drug and said drawing agent are separated by an impermeable membrane, said first polymeric matrix expanding upon solvation of said drawing agent to press on said drug and said second polymeric matrix with said impermeable membrane, causing said drug to be dispensed.

14. The implantable device of claim 1 wherein said drug and said drawing agent are mixed together into a polymeric matrix.

15. The implantable device of claim 1, and further comprising a barrier layer containing a drawing agent which must be dissolved before said drug can be dissolved to begin elution.

16. A pump for dispensing a therapeutic drug to a patient'"'"'s body, comprising:

a chamber containing a polymeric matrix, a therapeutic drug, and a hydrophilic agent, wherein said hydrophilic agent is embedded in said polymeric matrix;

an electrically insulating material forming an outer wall of said chamber; and

an electrode forming an inner wall of said chamber.

17. The pump of claim 16 wherein said electrode has a channel from said chamber to said patient'"'"'s body.

18. A body implantable lead comprising:

an electrode for sensing or stimulation for implantation in a patient'"'"'s body;

an insulated conductor having a distal end and a proximal end and coupled to said electrode at said distal end of said conductor and having a connector at said proximal end of said conductor; and

a drug eluting system located within said electrode having at least one therapeutic drug and at least one fluid drawing agent for use as a pump for delivering said at least one therapeutic drug to tissue.

19. The lead of claim 18, wherein said drug eluting system has a plurality of fluid drawing agents to provide different pumping effects.

20. The lead of claim 18 wherein said fluid drawing agent is lipophilic.

21. The body implantable lead of claim 18 and further comprising a polymeric matrix within said electrode, wherein said fluid drawing agent is impregnated in said polymeric matrix.

22. The lead of claim 18 and further comprising a polymeric matrix within said electrode, wherein said therapeutic drug is impregnated in said polymeric matrix.

23. The lead of claim 22 wherein said polymeric matrix is biodegradable.

24. The lead of claim 18 wherein said therapeutic drug and said fluid drawing agent are separated by an impermeable membrane, said fluid drawing agent expanding upon drawing of fluid to press on said drug with said impermeable membrane, causing said drug to be dispensed.

25. The lead of claim 18, and further comprising a chamber containing said drug and a fluid drawing agent which is embedded in a polymeric matrix, said chamber having an electrically insulating material forming an outer wall and said electrode forming an inner wall.

26. The lead of claim 25 wherein said electrode has a channel from said chamber to the patient'"'"'s body,.

27. The lead of claim 25 wherein said electrically insulating material is semipermeable.

28. A drug eluting system for use in an implantable electrode comprising:

a porous electrode;

an outer chamber formed by a semipermeable electrically insulating material and containing at least one therapeutic drug;

an inner chamber formed by a semipermeable membrane and containing a hydrophilic agent for use as an osmotic pump for delivering said at least one therapeutic drug to tissue;

an impermeable membrane separating said outer chamber from said inner chamber, said semipermeable membrane allowing body fluid to pass through to said inner chamber, said hydrophilic agent expanding upon hydration to press on said drug with said impermeable membrane, causing said drug to be dispensed through said semipermeable electrically insulating material and through said porous electrode.