Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-11-01
2001-09-11
Schaetzle, Kennedy (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C607S116000, C600S374000, C600S377000
Reexamination Certificate
active
06289251
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to implantable medical leads generally and more particularly to multi-conductor implantable leads employing coiled conductors that extend to a distal portion of the lead.
In the context of implantable pacing and cardioversion leaves, it is desirable that the lead be provided with a tensile member that extends along the entire length of the lead. Such a tensile member is desirable in that it prevents disassembly of the lead in response to traction forces applied to the proximal end of the lead, in conjunction with removal of the lead after implant. One approach to providing such a longitudinal reinforcement is set forth in U.S. Pat. No. 5,231,996 issued to Bardy et al, which suggests adding a nonconductive tensile reinforcing member from the connector assembly at the proximal end of the lead to an electrode located at the distal end of the lead. An alternative approach to providing a tensile member extending the length of the lead is set forth in U.S. patent application Ser. No. 08/938,269 by Bischoff et al., filed on Sep. 27, 1997, which discloses a structure in which the tip and ring electrode are mounted to a rigid plastic head and the conductor extending from the proximal end of the lead to the ring electrode is mechanically interconnected with the rigid plastic head. The disadvantage with the approach set forth in the Bardy et al patent is that it requires an additional tensile member extending the entire length of the lead, which in turn generally increases in the required diameter of the lead body over the majority of its length. Although the approach set forth in the above-cited Bischoff et al. application avoids the problem of an increased lead diameter, it requires a rigid member interconnecting the ring electrode and the tip electrode in order to provide tensile reinforcement all the way to the distal electrode. In the context of tined leads or other leads in which a coiled conductor is used to connect to the tip electrode and in which the portion of the lead body intermediate the tip electrode and electrodes located proximal thereto is typically fabricated out of a flexible elastomer, the approach of the Bischoff et al. application is not readily applicable.
SUMMARY OF THE INVENTION
The present invention is directed toward a provision of a pacing or cardioversion lead of the type having a distal or tip electrode and one or more electrodes located proximal to the tip electrode, separated therefrom by a flexible lead body segment, and having a coiled conductor extending from the proximal end of the lead to the tip electrode, permitting passage of a stylet. In such leads, the coiled conductor does not prevent stretching and breaking of the flexible lead body segment between the tip electrode and the electrode located most closely proximal thereto and has the potential for causing serious problems during attempted extractions of the lead, in that the coiled conductor is capable of significant longitudinal extension. The present invention provides a mechanism for providing a reinforcement extending the entire length of the lead body, in such a lead, without the disadvantage of an over-all increase in lead body diameter.
The present invention accomplishes the objects discussed above by means of a reinforcement member which is mechanically coupled to and extends distally from an inextensible conductor coupled to an electrode or sensor located proximal to the tip electrode, and which in turn is mechanically coupled to the tip electrode located at the distal end of the lead. The reinforcement member mechanically couples but does not electrically couple the inextensible conductor and the tip electrode. Because the reinforcement extends from the distal termination of a lead conductor, it can occupy the portion of the lead body that the lead conductor occupies in portions of the lead body proximal thereto, avoiding the necessity for an increased lead body diameter along the entire length of the lead. The reinforcement member is preferably non-conductive but may be conductive if insulated from the inextensible conductor to which it is coupled and/or from the distal or tip electrode. Limiting the reinforcement member to a distal portion of the lead also simplifies construction of the lead, in that it requires no additional interconnections to be made between the reinforcement member and the connector assembly at the proximal end of the lead. The reinforcement member is preferably coupled to the largest and/or strongest of the inextensible conductors within the lead body.
REFERENCES:
patent: 5231996 (1993-08-01), Bardy et al.
patent: 5246014 (1993-09-01), Williams et al.
patent: 5584873 (1996-12-01), Shoberg et al.
patent: 5676694 (1997-10-01), Boser et al.
patent: 5935159 (1999-08-01), Cross, Jr. et al.
patent: 6016436 (2000-01-01), Bischoff et al.
patent: 6119042 (2000-10-01), Verness et al.
U.S. Patent Application, SN 08/938,269 filed Sep. 26, 1997, Bischoff et al, entitled Medical Electrical Lead.
Huepenbecker George M.
Laske Timothy G.
McMahon Beth L.
Medtronic Inc.
Schaetzle Kennedy
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