Simultaneous cardiac pacing and local drug delivery

• US 5,865,787 A
• Filed: 09/13/1996
• Issued: 02/02/1999
• Est. Priority Date: 10/06/1992
• Status: Expired due to Term

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Cortrak Medical Incorporated
• Inventors: Shapland, James E., Hildebrand, Keith R.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/710,146
• Time in Patent Office: 872 Days
• Field of Search: 604/20-21, 604/96, 607/120
• US Class Current: 604/21
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

An apparatus and method for delivering a drug selectively and locally to internal body tissue with a catheter using electric current/voltage controlled in conjunction with active pacing of cardiac activity.

Claims

1. An apparatus for local delivery of a drug to internal body tissue of a patient comprising:

(a) a catheter having drug delivery means;

(b) a plurality of electrodes, at least one of said electrodes being operably connected to the catheter;

(c) drug delivery current/voltage means electrically connected to at least two of said electrodes for transport of said drug from said drug delivery means to said internal body tissue; and

(d) pacing means electrically connected to at least two of said electrodes, the pacing means being configured to generate a pulse for stimulating the patient'"'"'s heart to begin the refactory period of the heart beat, the drug-delivery current/voltage means being synchronized with the pacing means to transport at least a portion of said drug after generation of said pulse.

2. The apparatus of claim 1, wherein said at least two electrodes electrically connected to said drug delivery current/voltage means are also said at least two electrodes electrically connected to said pacing means.

3. The apparatus of claim 1, wherein said drug delivery current/voltage means and said pacing means are provided as a single apparatus for both iontophoretic transport and controlling cardiac activity.

4. The apparatus of claim 1, wherein said drug delivery means comprises:

(1) a drug delivery chamber proximate said distal end of said catheter;

(2) a permeable membrane defining at least a portion of said drug delivery chamber; and

(3) a fluid delivery lumen extending between said proximal end of said catheter and said drug delivery chamber.

5. The apparatus of claim 4, wherein said at least one of said electrodes located proximate said distal end of said catheter is located within said drug delivery chamber.

6. The apparatus of claim 4, wherein said drug delivery chamber is expandable in a direction radial from a longitudinal axis of said catheter.

7. The apparatus of claim 6, wherein said drug delivery chamber is inflatable.

8. The apparatus of claim 4, wherein said permeable membrane further comprises a microporous membrane with pore sizes of less than 3 microns.

9. The apparatus of claim 4, wherein said permeable membrane further comprises a microporous membrane with pore sizes of less than 0.5 microns.

10. The apparatus of claim 4, wherein said drug delivery chamber further comprises at least one impermeable end section.

11. The apparatus of claim 4, wherein said permeable membrane is located around only a portion of a circumference of said catheter, wherein said drug delivery is substantially restricted to a portion of said circumference.

12. The apparatus of claim 1, wherein said drug delivery means comprises a polymer matrix material containing said drug for delivery to said internal body tissue.

13. The apparatus of claim 12, wherein said at least one of said electrodes located proximate said distal end of said catheter is located within said polymer matrix material.

14. The apparatus of claim 12, wherein said polymer matrix material is coaxially aligned about at least a longitudinal axis of said catheter.

15. The apparatus of claim 12, further comprising expansion means for expanding said polymer matrix material in a direction substantially radial to a longitudinal axis of said catheter.

16. The apparatus of claim 15, wherein said expansion means comprises a wire basket.

17. The apparatus of claim 15, wherein said expansion means comprises a balloon.

18. The apparatus of claim 1, further comprising means for sensing intrinsic cardiac activity.

19. The apparatus of claim 1, wherein said drug delivery current/voltage means supplies a pulsed waveform to said electrodes with a frequency of at least about 200 Hz.

20. The apparatus of claim 1, wherein said waveform has a frequency of at least about 2 kHz.

21. The apparatus of claim 1, wherein all of the electrodes connected to the catheter are configured to have the same polarity.

22. The apparatus of claim 1, wherein at least two of the electrodes connected to the catheter are configured to have an opposite polarity.