Cardiac electrode with drug delivery capabilities

• US 4,819,662 A
• Filed: 10/26/1987
• Issued: 04/11/1989
• Est. Priority Date: 10/26/1987
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Heil, Ronald W. Jr., Pederson, Brian D., Owens, Robert C.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/112,518
• Time in Patent Office: 533 Days
• Field of Search: 604/20, 604/891-892, 128/786, 128/784, 128/419 P
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

An implantable cardiac pacing lead includes a porous, platinum electrode, a flexible electrically conductive coil, and a crimp tube coupling the electrode to the distal end of the coil. A recess in the crimp tube, open to the electrode at the crimp tube distal end, houses a matrix impregnated with a therapeutic drug. The electrode is highly porous and loaded with a therapeutic drug in liquid or solid form. Immediately upon implant of the electrode at a selected myocardial location, the electrode begins dispensing the therapeutic drug. Meanwhile, the matrix begins to elute its drug at a rate more suited to chronic treatment. If desired, the recess can extend through the crimp tube to permit proximal end loading of the drug carrying matrix. A silicone plug, or an additional and proximal crimp tube section, is inserted into the recess after loading of the matrix to provide the required fluid seal. Finally, a variety of different matrices can be housed in the recess, to provide elution of different drugs and at differing rates.

Claims

1. An intravascular lead implantable inside a patient, including:

an electrically conductive electrode having a porosity of at least seventy-five percent;

a flexible electrical conductor;

a flexible, biocompatible and dielectric sheath surrounding said conductor along substantially the entire length thereof;

a coupling means for electrically and mechanically joining said electrode with respect to the distal end of said conductor, said electrode joined to and substantially covering the distal end of said coupling means;

means forming a recess in said coupling means and open to said electrode; and

a matrix containing a water soluble drug and retained in said recess; and

wherein said electrode is loaded with a therapeutic drug, and is positionable for fixation to body tissue at a selected location, said electrode being sufficiently porous to freely dispense said drug at said selected location upon contact with bodily fluid, and further sufficiently porous to facilitate dispensing of the drug from said matrix to said selected location.

2. The intravascular lead of claim 1 further including:

means forming a bore through said electrode from said recess to the exterior of said electrode to permit loading of said matrix into said recess through said bore.

3. The intravascular lead of claim 2 wherein:

said bore houses a portion of said matrix after said loading.

4. The intravascular lead of claim 1 including:

means forming a slot in said coupling means for the loading of said matrix into said recess.

5. The intravascular lead of claim 1 wherein:

said recess extends through said coupling means to the proximal end thereof, thereby to permit insertion of said matrix into said recess from the proximal end of said coupling means.

6. The intravascular lead of claim 5 further including:

a plug insertable into said coupling means at the proximal end thereof following insertion of said matrix, for forming a substantially fluid-tight seal between said matrix and said conductor.

7. The intravascular lead of claim 1 wherein:

said electrode is fastened to said coupling means at the periphery of the coupling means distal end, thereby to retain said matrix in said recess.

8. The intravascular lead of claim 1 wherein:

said recess is cylindrical, said matrix is cylindrical and has an outside diameter substantially equal to the inside diameter of said recess, and said coupling means includes an annular, radially inwardly directed flange at its distal end to retain said matrix in said recess.

9. An intravascular, implantable lead comprising:

an electrode positionable for fixation to bodily tissue at a selected location;

a flexible electrical conductor;

a flexible, biocompatible, dielectric sheath surrounding said conductor along substantially the entire length thereof;

a first coupling means for electrically and mechanically joining said electrode with respect to the distal end of said conductor; and

means forming a recess in said first coupling means and open to the proximal end of said first coupling means to permit proximal insertion of a drug carrying matrix into said coupling means; and

a sealing means for connection with said first coupling means following said proximal insertion of said matrix, for forming a substantially fluid-tight seal between said matrix and said conductor; and

means forming a fluid passageway for movement of bodily fluid into and out of said recess distally of said sealing means.

10. The intravascular lead of claim 9 wherein:

said recess is cylindrical, and said sealing means comprises an elastically deformable cylindrical plug having an outside diameter slightly larger than the inside diameter of said recess.

11. The intravascular lead of claim 10 wherein:

said plug is constructed of silicone rubber and fastened to the interior of said recess with a biocompatible adhesive.

12. The intravascular lead of claim 9 wherein:

said sealing means comprises a second coupling means between said first coupling means and said conductor, the distal end of said second coupling means being configured for engagement with the proximal end of said first coupling means.

13. The intravascular lead of claim 12 wherein:

said second coupling means includes a reduced diameter portion at its distal end, of a size to enter said recess, and wherein said reduced diameter portion is externally threaded for a threaded engagement with an internally threaded proximal portion of the wall of said first coupling means defining said recess.

14. The intravascular lead of claim 9 wherein:

said electrode is porous and comprises said fluid passageway, and said recess is open to said electrode.

15. An intravascular, implantable lead including:

an electrode positionable for fixation to bodily tissue at a selected location;

a flexible electrical conductor;

a flexible, biocompatible, dielectric sheath surrounding said conductor substantially along the entire length thereof;

a coupling means for electrically and mechanically joining said electrode and the distal end of said conductor; and

means forming a recess in said coupling means, means forming a passageway for admitting bodily fluid into and out of said recess, and a plurality of matrices contained in said recess, each matrix loaded with a water soluble drug, said matrices differing from one another in at least one of the following characteristics;

(a) the drug contained in the matrix;

(b) the concentration of the drug contained in the matrix; and

(c) the constituent material forming the matrix.

16. The intravascular lead of claim 15 wherein:

said recess is cylindrical and open to the distal end of said coupling means; and

wherein said matrices are serially arranged and cylindrical, each matrix having an outside diameter substantially equal to the inside diameter of said recess.

17. The intravascular lead of claim 16 wherein:

said matrices contain the same drug, with the concentration of said drug in said matrices increasing sequentially from the most proximal to the most distal matrix.

18. The intravascular lead of claim 15 wherein:

said recess is cylindrical and open to the distal end of said coupling means, and wherein said matrices are serially arranged and toroidal, each matrix having an outside diameter substantially equal to the inside diameter of said recess.

19. The intravascular lead of claim 18 wherein:

the drug loaded into each of said matrices is uniformly distributed throughout its associated matrix.

20. The intravascular lead of claim 15 wherein:

said recess is cylindrical and open to the distal end of said coupling means, and wherein said matrices are toroidal, each matrix having an outside diameter less than the inside diameter of said recess.

21. The intravascular lead of claim 20 wherein:

first, second and third ones of said matrices contain an antibiotic, an anti-inflammation drug, and an anti-arrhythmic drug, respectively.

22. The intravascular lead of claim 15 wherein:

said recess is cylindrical and open to the distal end of said coupling means, and wherein said matrices are elongate and in side-by-side arrangement, with each matrix spanning substantially the length of said recess.

23. The intravascular lead of claim 15 wherein:

each of said matrices contains a different drug.

24. The intravascular lead of claim 15 wherein:

said recess is substantially cylindrical and open to the distal end of said coupling means, and wherein said matrices comprise elongate, concentric toroidal members spanning substantially the length of said recess.

25. An intravascular, implantable lead including:

an electrode positionable for fixation to bodily tissue at a selected location;

a flexible electrical conductor;

a flexible, biocompatible, dielectric sheath surrounding said conductor substantially along the entire length thereof;

a coupling means for electrically and mechanically joining said electrode and the distal end of said conductor; and

means forming a recess in said coupling means, means forming a passageway for admitting bodily fluid into and out of said recess, and a toroidal matrix loaded with a water soluble drug and contained in said recess.