Title:  Temporary medical electrical lead having biodegradable electrode mounting pad loaded with therapeutic drug

United States Patent:  6,385,491

Assignee:  Medtronic, Inc. (Minneapolis, MN)

Filed:  October 4, 1999

A temporary cardiac electrical stimulating lead comprises a stimulating electrode mounted in or on a biodegradable electrode mounting pad disposed at a distal end of the lead. The electrode mounting pad is capable of biodegradably dissolving over time in human body fluids and is loaded with a drug for therapeutically treating a medical condition of a patient's heart. The electrode mounting pad may be loaded with any of a variety of different drugs, such anti-arrhythmia or anti-inflammatory drugs. When the lead body is pulled away from the electrode mounting pad and removed from the patient, any portion of the electrode mounting pad remaining within the patient dissolves over time and disappears.

SUMMARY OF THE INVENTION

The present invention has certain objects. That is, various embodiments of the present invention provide solutions to one or more problems existing in the prior art respecting implantable pacing and/or defibrillation leads and conventional antiarrhythmic, pain-relieving or infection-inhibiting drugs, including one or more of: (a) patients experiencing post-operative arrhythmias and/or pain which may not be adequately treated through the use of temporary medical leads and defibrillatory electrical pulses only; (b) patients experiencing post-operative arrhythmias and/or pain which may not be adequately treated through the use of transvenously or orally delivered anti-arrhythmic or pain relieving drugs, and (c) patients developing post-operative implant-associated bacterial, viral or other infections of the heart.

Various embodiments of the present invention have certain advantages, including one or more of: (a) permitting lower defibrillation energy levels to be employed; (b) permitting fewer defibrillation pulses to be employed; (c) providing more efficient localized delivery of therapeutic or pain-relieving drugs to a patient's heart, and (d) providing quicker localized delivery of therapeutic or pain-relieving drugs to a patient's heart.

Various embodiments of the present invention have certain features, including one or more of: (a) a collagen or biodegradable electrode mounting pad loaded with one or more anti-arrhythmic drugs; (b) a collagen or biodegradable electrode mounting pad loaded with one or more pain-relieving drugs; (c) a collagen or biodegradable electrode mounting pad loaded with one or more antibiotic or antiviral drugs; (e) a method of making a drug-loaded collagen or biodegradable electrode mounting pad and associated electrode, and (f) a drug-loaded collagen or biodegradable electrode mounting pad which dissolves and disappears within a patient's body after a pre-determined post-operative period of time has elapsed which permits the electrical stimulating and drug delivery functions of the pad to have been performed.

Claim 1 of 57 Claims

We claim:

1. A temporary medical electrical lead for pacing or defibrillating a heart of a patient, the lead having distal and proximal ends, comprising:

(a) a lead body having proximal and distal ends, comprising:

(i) at least one electrical conductor having proximal and distal ends;

(ii) an insulative sheath formed of biocompatible and electrically insulative material, the sheath extending over and covering at least portions of the at least one electrical conductor;

(b) an electrical connector assembly attached to the proximal end of the at least one electrical conductor for attachment to a device capable of providing pacing or defibrillation pulses therethrough;

(c) an electrode mounting pad comprising lower and upper surfaces separated by a pad thickness, the pad having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the electrode mounting pad being disposed near the distal end of the lead body, at least one of the distal end of the at least one electrical conductor and an electrode member secured to the distal end of the at least one electrical conductor being attached to or integrated into the electrode mounting pad such that all portions of the distal end of the conductor are disposed at locations disposed upwardly from the lower surface such that no such portions of the conductor distal end penetrate the lower surface of the electrode mounting pad, the distal end of the single electrical conductor forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the electrode mounting pad such that at least portions of the sinusoldally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the electrode mounting pad and such that the electrode may be removed from a patient's body after implantation therein through the application of a pulling force exerted by a physician the electrode mounting pad comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and

(d) a drug for treating a medical condition of the patient's heart, the drug being incorporated in, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient's body adjacent the heart.

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