Tunneling lead terminal having a disposal sheath

Details Tunneling lead terminal having a disposal sheath Tunneling lead terminal having a disposal sheath

1999-05-18

2001-11-27

Dvorak, Linda C. M. (Department: 3739)

Surgery

Diagnostic testing

Structure of body-contacting electrode or electrode inserted...

C600S378000, C606S129000

Reexamination Certificate

active

06324414

ABSTRACT:

CROSS REFERENCE TO RELATED APPLICATION
Not Applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable.
FIELD OF THE INVENTION
The invention relates generally to implantable medical devices, and more particularly, to systems having an implantable device coupled to an electrical lead for being tunneled through tissue to allow a connection to a mating terminal.
BACKGROUND OF THE INVENTION
Implantable medical devices are used in a variety of applications. One such medical application includes the monitoring of electrical impulses on the surface of a patient's brain. Tracking electrical activity of the brain is useful in conjunction with the treatment and/or diagnosis of certain medical conditions, such as epilepsy. Exemplary electrodes for contacting the brain are disclosed in U.S. Pat. Nos. 4,903,702 and 5,044,368, which are incorporated herein by reference.
In one technique, electrodes are implanted within the cranium in contact with the patient's brain. To position the electrodes, the surgeon typically forms a hole in the patient's skull for accessing selected tissue. One or more electrodes are positioned on the patient's brain for monitoring its electrical activity. After the electrodes are placed at the desired location, they must be coupled to a remote monitoring device which analyzes the data from the probes. A lead extends from the electrode to provide a signal pathway to the remote monitoring device.
In some procedures used to connect a terminal end of the probe lead to an external mating terminal, a trocar is tunneled under the patient's scalp for a predetermined distance after which it exits the scalp. The terminal end of the electrode lead is then threaded through a passageway in the trocar so that the terminal can be connected to a corresponding mating terminal of a lead coupled to the remote monitoring device.
During this procedure, the exposed terminal of the electrode lead becomes covered with bodily tissue and fluid as it passes through the trocar. Exposure to bodily substances can impair the integrity of an electrical connection between the terminal end of the eleectrode lead and the mating terminal of the remote device lead, which provides a signal path to the remote monitoring device. Due to the relatively high level of sensitivity that is required for accurate detection of signals generated by the brain, any attenuation or interference with the signals from the electrode can render the resulting data useless and/or misleading.
It would, therefore, be desirable to provide a system that is able to preserve the sensitivity of the electrode contacts during implantation within the body.
SUMMARY OF THE INVENTION
The present invention provides a system including a fluid impermeable sheath disposed on a lead terminal for preventing bodily fluids from contacting the terminal. Although the system is primarily shown and described in conjunction with a lead extending from an electrode for intracranial implantation, it is understood that the invention has other applications as well. For example, the electrode can be implanted at other locations in the body, such as in or near, the heart, the intestines and the extremities.
In one embodiment, the system includes an electrode adapted for implantation in the patient's body, such as on the surface of a patient's brain. A lead has a first end coupled to the electrode and a second end that provides an electrical terminal. A fluid impermeable sheath is disposed on the terminal for preventing bodily fluids and tissues from contacting the terminal. The sheath forms a barrier for maintaining the terminal in pristine condition while the lead terminal is tunneled under the patient's scalp and until it ultimately exits the scalp when it can be electrically connected with a mating terminal. The mating terminal can provide a signal path to a remote device for monitoring signals from the electrode and/or electrical stimulation of tissue.
In an exemplary embodiment, the sheath is removably engaged with the lead so as to cover the terminal. The sheath is at least semi-rigid with a distal end having an edge to facilitate tunneling of the lead under the scalp.
In another embodiment, the sheath is a flexible and can be torn away from the terminal after the lead has been tunneled through tissue. In one embodiment, the sheath is formed from a polymeric material which can be shrink-fitted onto the terminal.


REFERENCES:
patent: 5542173 (1996-08-01), Mar et al.
patent: 5782841 (1998-07-01), Ritz et al.
patent: 5871528 (1999-02-01), Camps et al.

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