Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-06-15
2001-10-16
Bockelman, Mark (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C600S372000, C600S378000
Reexamination Certificate
active
06304784
ABSTRACT:
BACKGROUND OF INVENTION
FIELD OF THE INVENTION
The present invention relates in general to the field of signal monitoring and delivery. More particularly, the present invention relates to medical monitoring and treatment devices and their methods of manufacture.
BACKGROUND OF THE INVENTION
Presently known devices for monitoring conditions within a living body, such as neural probes and other catheter devices, are often limited by the number of available terminal or recording sites and are difficult to handle and insert into proper position within the body. For example, commercially available single-wire “hybrid” neural probes, such as the Activa® device available from Medtronic, Inc., are costly and limited to a relatively few number of recording sites. Such “hybrid” devices have separately manufactured circuit components, as opposed to integrated circuit components that are manufactured as a monolithic structure. It is well known in the art, however, that integrated circuits approach typically offer greater functionality, smaller size and lower cost. See W. Koller et al., “High-frequency Unilateral Thalamic Stimulation in the Treatment of Essential and Parkinsonian Tremor,” Annals of Neurology, vol. 42, no. 3, pp. 292-299 (September 1997).
Other known devices suitable for neural probes include multiple recording sites having planar integrated circuits formed by conventional planar silicon micro-fabrication techniques. See K. Najafi, K. D. Wise and T. Mochizuki, “A High Yield IC Compatible Multichannel Recording Array,” IEEE Transactions on Electron Devices, vol. ED-32, no. 7, pp. 1206-1211 (July 1985); K. Najafi and K. D. Wise, “An Multi-electrode Array with on Chip Signal Processing,” IEEE Journal of Solid State Circuits, vol. 21, no. 6, pp. 1035-1044 (December 1986); J. Ji, and K. D. Wise, “An Implantable CMOS Circuit Interface for Multiplexed Microelectrode Recording Arrays,” IEEE Journal of Solid State Circuits, vol. 27, no. 3, pp. 433-443 (March 1992); A. C. Hoogerwerf, and K. D. Wise, “A Three Dimensional Microelectrode Array For Chronic Neural Recording,” IEEE Transactions of Biomedical Engineering, vol. 41, no. 12, pp. 1136-1146 (December 1994); J. Chen, K. D. Wise, J. F. Hetke, and S. C. Bledsoe, Jr., “A Multichannel Neural Probe for Selective Chemical Delivery at the Cellular Level,” IEEE Transactions of Biomedical Engineering, vol. 44, no. 8, pp. 760-769 (August 1997); J. Chen and K. D. Wise, “A Silicon Probe with Integrated Microheaters for Thermal Marking and Monitoring of Neural Tissue,” IEEE Transactions of Biomedical Engineering, vol. 44, no. 8, pp. 770-774 (August 1997). Although such devices have been shown to be useful for cortical recording and stimulation, devices having planar circuits formed by conventional integrated circuit fabrication techniques are rigid and as such are difficult to handle during insertion. Conventional neural probes, for example, having rigid planar integrated circuits are therefore ill-suited for deep brain applications and other medical uses.
SUMMARY OF THE INVENTION
Therefore, a principal object of the present invention is to provide a flexible probing device having multiple terminal sites that is particularly useful for various medical applications including deep brain measurement and stimulation.
Another object of the present invention is to provide a method of manufacturing a flexible probing device having multiple terminal sites comprised of multiple non-planar integrated circuits.
Yet another object of the present invention is to provide a flexible probing device having a substantially increased number of terminal sites for performing localized and simultaneous monitoring and mapping of many electrical signals.
Yet another object of the present invention is to provide a flexible probing device that allows for the more effective monitoring and treatment of neurological and other medical disorders.
Still another object of the present invention is to provide a flexible probing device having multiple terminals wherein each terminal is used for both simultaneously monitoring and providing treatment functions.
Yet another object of the present invention is to provide a substantially cylindrical probing device wherein recording of neural or other biological signals is performed over a surface area extending over substantially 2&pgr; radians.
In accordance with the present invention, a probing device is provided having: an elongated, substantially cylindrical flexible fiber having a non-conducting outer surface; one or more electrical circuits disposed on the outer surface of the fiber each for simultaneously providing an electrical signal path to and from one or more corresponding locations, each of the electrical circuits comprising a non-planar integrated circuit extending lengthwise along the outer surface of the fiber; and an insulating layer substantially disposed over the electrical circuits and around the outer surface of the fiber, the insulating layer having one or more openings through which selected portions of the electrical circuits are exposed to the locations. The exposed electrical circuits on the outer surface of the fiber can be passive or active circuits for conveying electrical signals to and from the corresponding locations.
In another embodiment of the present invention, a medical probe includes: an elongated, substantially cylindrical flexible fiber having a non-conducting outer surface; a plurality of electrical circuits disposed on the outer surface of the fiber each for simultaneously providing an electrical signal path between a plurality of corporeal regions and one or more extracorporeal sites, each of the electrical circuits comprising a non-planar integrated circuit extending lengthwise along the outer surface of the fiber; and an insulating layer substantially disposed over the electrical circuits and around the outer surface of the fiber, the insulating layer having a plurality of openings through which selected portions of the electrical circuits are exposed to the corporeal regions.
In yet another preferred embodiment of the present invention, the medical probe of the present invention is adapted to function as a neural probe for monitoring neural activities and providing stimulation treatment. The neural probe, which is especially suited for deep brain measurement and stimulation, includes: an elongated, substantially cylindrical flexible fiber having a non-conducting outer surface; a plurality of electrical circuits disposed on the outer surface of the fiber each for simultaneously providing an electrical signal path between a plurality of neural regions and one or more extracorporeal sites, each of the electrical circuits comprising a non-planar integrated circuit formed on the outer surface of the fiber; and an insulating layer disposed over the electrical circuits and around the outer surface of the fiber, the insulating layer having a plurality of openings through which selected portions of the electrical circuits are exposed to the neural regions. Advantageously, the terminals of the neural probe can be used for recording neural activity and/or providing stimulation treatment to localized areas of the brain. Stimulation treatment may include, for example, thalamic stimulation for pain and tremor, sub-thalamic stimulation for hemiballismus and Parkinson's disease, pallidal stimulation for dysitonia, and other stimulation treatments for various phychiatric disorders.
In another aspect of the present invention, a method is provided for manufacturing a probing device having multiple non-planar integrated circuits disposed along the outer surface of an elongated, substantially cylindrical flexible fiber. The method includes the steps of: applying a first resist layer onto the outer surface of the fiber; patterning the first resist layer to form a pattern of multiple non-planar integrated circuits disposed along the outer surface of the fiber; depositing one or more material layers onto the patterned outer surface of the fiber to form the circuits; removing remaining portions of the first
Allee David R.
Jaw Link C.
Arizona Board of Regents, acting for and on behalf of Arizona St
Baker & Botts L.L.P.
Bockelman Mark
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