Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-05-26
2001-03-06
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
Reexamination Certificate
active
06198973
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to body implantable leads, and more particularly, to simplified construction of steroid eluting stimulation tip electrodes.
BACKGROUND OF THE INVENTION
Typical of known passive pacing tip electrodes currently in use is a design which comprises four separate components, namely, an electrode, a weld electrode, a steroid plug, and a tine. The assembly of these components has always been a challenging one because of their very small size. First, the steroid plug is inserted into the back end of the tip electrode. Next, the weld electrode is laser welded to the back end of the tip electrode containing the steroid plug. Finally, the tine is installed onto the welded tip subassembly.
The prior art contains numerous examples of tip electrode constructions which are intended to be simplified by the present invention. In this regard, FIGS. 4 and 5 of U.S. Pat. No. 4,711,251, to Stokes, discloses an implantable lead having tines and a plug-like structure to mount a drug to be dispensed. The use of plugs, apertures, and the like within a tined lead are also typically found in U.S. Pat. Nos. 5,496,360, to Hoffmann et al.; 4,819,662, to Heil, Jr. et al.; 4,606,118, to Cannon et al.; and 4,577,642 and 4,506,680, to Stokes. Also of interest are positive fixation designs with drug elution capabilities which are disclosed in U.S. Pat. Nos. 5,003,992, to Holleman et al.; 5,002,067 and 4,953,564, to Berthelsen et al.; and 4,819,661, to Heil, Jr. et al.
It was with knowledge of the foregoing state of the technology that the present invention has been conceived and is now reduced to practice.
SUMMARY OF THE INVENTION
The present invention relates to an electrode assembly for a body implantable lead for the delivery of stimulation energy to a desired body site which comprises a longitudinally extending dispenser housing having an internal cavity with opposed longitudinally extending openings for storing a drug to be dispensed. A tip electrode integral and axially aligned with the dispenser housing has a face adapted for positioning adjacent the desired body site, a transverse channel formed into and transversely across its face, and an orifice extending between the channel and the internal cavity for elution of the drug to the desired body site. A weld sleeve integral and axially aligned with the dispenser housing distant from the tip electrode has an outer peripheral surface for engageably receiving one end of an elongated electrical conductor, and a collar spaced from the dispenser housing. The electrical conductor is welded to the collar to obtain a welded connection for electrical continuity between the tip electrode and the electrical conductor. An insulative sheath of resilient material is fittingly received on the outer peripheral surface of the dispenser housing overlying the longitudinally extending openings and the welded connection between the electrical conductor and the weld sleeve. Insulative tubing is received on the coiled conductor and includes a skirt member distant from the tip electrode and coaxial with the insulative tubing and biased radially into engagement with the outer peripheral surface of the insulative tubing. A plurality of fixation tines are integral with, and extend radially outwardly from, the insulative sheath at a plurality of circumferentially spaced locations.
A primary feature, then, of the present invention is the provision of a simplified construction for steroid eluting pacing tip electrodes.
Another feature of the present invention is the provision of such a steroid eluting pacing tip electrode comprising a longitudinally extending dispenser housing having an outer peripheral surface and an internal cavity for storing a drug to be dispensed, the internal cavity having opposed longitudinally extending openings through the peripheral surface, a tip electrode integral and axially aligned with the dispenser housing and having a face adapted for positioning at least adjacent the desired body site, and a weld sleeve integral and axially aligned with the dispenser housing distant from the tip electrode and having an outer peripheral surface for engageably receiving one end of an elongated electrical conductor.
Still another feature of the present invention is the provision of such a steroid eluting pacing tip electrode wherein the tip electrode has an orifice extending between the face thereof and the internal cavity of the longitudinally extending dispenser housing for elution of the drug to the desired body site.
Still another feature of the present invention is the provision of such a steroid eluting pacing tip electrode wherein the tip electrode has a transverse channel formed into, and extending transversely across the face of the tip electrode, the orifice enabling communication between the internal cavity and the transverse channel for elution of the drug to the desired body site.
Yet another feature of the present invention is the provision of such a steroid eluting pacing tip electrode wherein the weld sleeve includes a collar spaced from the dispenser housing; and including an elongated coiled electrical conductor coaxially received on the weld sleeve and welded to the sleeve to obtain a welded connection for electrical continuity between the tip electrode and the electrical conductor and an insulative sheath fittingly received on the outer peripheral surface of the dispenser housing overlying the longitudinally extending openings and the welded connection between the electrical conductor and the weld sleeve.
Yet a further feature of the present invention is the provision of such a steroid eluting pacing tip electrode including a plurality of tines integral with the insulative sheath, respectively, and projecting radially outwardly at a plurality of circumferentially spaced locations.
Still a further feature of the present invention is the provision of such a steroid eluting pacing tip electrode including insulative tubing received on the coiled conductor extending from a first end adjacent the dispenser housing to a second end distant therefrom and having an outer peripheral surface and wherein the insulative sheath is of resilient material and includes a skirt member distant from the tip electrode and coaxial with the insulative tubing and biased radially into engagement with the outer peripheral surface of the insulative tubing.
Still another feature of the present invention is the provision of such a steroid eluting pacing tip electrode assembly of simplified design with fewer parts resulting in lower cost and a simplified assembly process.
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Caffee Lisa
Chitre Yougandh
Doan Phong
Getzow Scott M.
Pacesetter Inc.
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