Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-08-09
2002-05-21
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06393327
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention deals generally with neural prosthesis, specifically the concept of achieving a retinal prosthesis for blind patients through the creation of an electrical interface between a high-density electrode array and the curved surface of the retina.
2. Description of the Related Prior Art
There is a great deal of recent interest in the area of neural prosthesis, specifically the concept of achieving a retinal prosthesis for blind patients has been hypothesized by a number of researchers and is an active area of medical research. In a normal eye, in a basic concept
10
,
FIGS. 1
a
and
1
b
shows a ray trace of two photons
12
focused on a retina
21
. Note that the incoming photons
12
pass through several layers of transparent retinal cells
16
and
18
before being absorbed by the photoreceptors
22
. In a damaged eye, a retinal prosthesis device
24
, as shown in
FIGS. 1
c
and
1
d
, is positioned against the retina
21
. In this case, the photons
12
are absorbed by a microelectronic stimulating array or device
26
that is hybridized to a glass piece
28
containing an embedded array of microwires. The glass has a curved surface that conforms to the inner radius of the retina
21
. The microelectronic imaging device
26
is made of thin silicon containing very large scale integrated (VSLI) circuitry and photon detectors that convert the incident photons
12
to an electronic charge. The charge is then converted to a proportional amount of electronic current which is input to the nearby retinal cell layer
18
. The cells fire and a signal is sent to the optic nerve
28
.
A typical retinal prosthesis device combines two technologies: first, nanochannel glass (NGC) electrode arrays and secondly a two-dimensional (2-D) multiplexer array. NGC technology employs fiber optic fabrication techniques to produce thin wafers of glass with very small channels perpendicular to the plane of the wafer. Typical NGC wafers that will be required for retinal prosthesis devices are several millimeters in diameter and can contain millions of channels with channel diameters on the order of one micron. The channels are filled with a good electrical conductor and one surface of the glass is ground to a spherical shape consistent with the radius of curvature of the inside of the retina. The electrical conductors on the curved surface should protrude slightly to form efficient electrodes.
The 2-D multiplexer array is similar to infrared focal plane array (IRFPA) multiplexers that are microelectronic devices fabricated at silicon foundries. An IRFPA multiplexer is a 2-D array that reads out the infrared (IR) image captured by a complimentary detector array that converts photons into electrical charge. The charge is integrated and stored in each unit cell for a few milliseconds. The full image is then multiplexed off the array at frame rates compatible with commercial video. For a retinal prosthesis test device that obtains its input image from an external camera, the process is essentially reversed and the device acts as a de-multiplexer. That is, the prosthesis devices will perform de-multiplexing operations, but will be referred to here simply as a multiplexer.
The basic concept is straightforward: visual images can be produced in the brain by electrical stimulation of retinal cells. Two-dimensional arrays of retinal cells, such as ganglion or bipolar cells, can be stimulated using two-dimensional arrays of electrical impulses with the spatial form of an image. The axons of the ganglion cells then transmit the image through the optic nerve and on to the visual cortex. This is in lieu of the normal photo-transduction process that occurs in a healthy retina. In approximately 90 percent of blind patients, the photoreceptors are diseased, but the other retinal layers are still responsive to electrical stimulation.
Experimental test procedures, such as shown in
FIG. 2
, use standard retinal surgical techniques performed in an operating room environment by an ophtalmologist. It is necessary that the patient be administered local anesthesia rather than general anesthesia so that visual perceptions can be orally recorded during the procedure.
There are a number of technical issues to be addressed in designing and fabricating a retinal prosthesis device, particularly if the device is to generate a high resolution image. First, there is the issue of creating an electrical interface between the high-density electrode array and the curved surface of the retina. The electrode array must have a spherical, convexed shape in order to conform to the spherical concaved surface of the retina. The electrode array must be bio-compatible and safe for permanent implantation. Second, the electrical stimulation pulse shapes and repetition rates, while generally well known, may need to be optimized for each individual recipient of a prosthesis device. The pulse amplitude is of course modulated within the retina to be proportional to the pixel value. Third, direct electrical stimulation of the ganglion cells precludes certain image processing functions that normally would have occurred in earlier layers of the retina. Therefore, computationally based image preprocessing operations may need to be performed on the image before stimulation of the retina. Fourth, supplying power to a permanent implant will need to be engineered in a manner such that there are no wires or cables through the eye wall. Fifth, because a normal retina processes image information created by the photoreceptors in a simultaneous manner, it is assumed that a prosthesis device should similarly excite retinal cells in a simultaneous manner, as opposed to sequential raster scan that might cause synchronicity problems downstream in the lateral geniculate nucleus (LGN) or visual cortex.
SUMMARY OF THE INVENTION
An object of this invention is to provide a device for achieving a retinal prosthesis for blind patients.
Another object of this invention is to provide a retinal prosthesis test device for providing visual images to the brain during acute human experiments to achieve electrical stimulation of the retina tissue.
Another object of this invention is to provide a device for implant into the human eye that will allow electrical stimulation of the retinal or any neural tissue so as to provide visual images to the brain.
These and other objects are accomplished by the retinal prosthesis test device and retinal implant device comprising two basic technologies—nanochannel glass (NGC) electrode arrays and infrared focal plane array (IRFPA) multiplexers. In the retinal prosthesis test device, the device is positioned against the retina using standard retinal surgical techniques in an operating room environment. The device is comprised of a thin wafer of glass (NGC) with very small channels perpendicular to the plane of the wafer. The channels are filled with a good electrical conductor forming microwires with one surface of the glass being ground to a spherical shape consistent with the radius of curvature of the inside of the retina. Electrical conductors protrude slightly from the NGC on the curved surface to form electrodes. The NGC is hybridized to a silicon IRFPA multiplexer using indium bump bonds. An image is serially input into the multiplexer via a very narrow, flexible micro-cable. The multiplexer is mounted on a ceramic carrier such that interconnecting bond pads on each are in close proximity to one another. A video image is read into each of the unit cells on the multiplexer in pixel-by-pixel manner. Discrete samples of the analog video are input and stored as electrical charge on a MOS capacitor. After all unit cells have been loaded with the pixel values for the current frame, a biphasic pulse is sent through each unit cell and into the corresponding area of the retina. The biphase pulse is modulated in proportion to the pixel value stored therein. Because the biphasic pulse flows in parallel from a global external connection, the adjacent retinal neurons are all stimulated s
Getzow Scott M.
Karasek John J.
Mills III John Gladstone
The United States of America as represented by the Secretary of
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