Abstract:
An implantable, integrated apparatus that contacts the brain with a plurality of metal needles to detect electrical signals or to transmit signals to the brain. The needles are connected by wires that pass along a flex connector to a ceramic case that contains electrodes to carry the signals to the electrical processing components that are hermetically contained in the ceramic case. The processed signals are received by or are transmitted by an antenna to a remote central processor.

Description:
RELATED APPLICATION(S)  
       [0001]     The present application claims the benefit under 35 USC 119(e) to Provisional Patent Application U.S. Ser. No. 60/586,368, filed Jul. 7, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to an integrated, implantable apparatus for brain sensing and stimulation that wirelessly controls body functions.  
       BACKGROUND OF THE INVENTION  
       [0003]     Information is transmitted in the human body by the nervous system, which correlates and integrates various bodily processes, reactions and adjustments. Electrical pulses travel along the extension (axon) of a nerve cell, from one nerve cell to another, establishing functional pathways to make up the nervous system of the body. Thus, a function of a nerve is to take electric signals from various sources to the receiving locations within the body.  
         [0004]     An electrode array may be used anywhere in a nervous system, at the end organs, (for example, without limitation, brain, kidney, liver, stomach, muscle or other tissue) or along the nerve (afferent or efferent) pathways in between. Sensory nerves in the body provide information as to the various bodily conditions, processes, reactions and adjustments. Such information is in the form of electrical signals and may be monitored by neurosensing using appropriate electrical or electronic equipment.  
         [0005]     Certain nerves in the body direct muscular action and by electrically stimulating an appropriate nerve (neurostimulation), muscular action can be effected. In some cases, the muscle as well as other organs or excitable tissue may be directly or indirectly stimulated, in order to treat a disorder. Such treatment may include providing a number of coordinated, stimulation signals to various parts of the muscle or the body. “Stimulation” may mean providing signals which cause motion or movement of the muscles. “Stimulation” in connection with the brain may result in a physical response or it may result in a sensory response (such as vision, feeling, smell, etc.) which involves the senses rather than a physical motion. “Tissue” means any body tissue, nerve, muscle, organ, including the brain and the spinal cord, or other body part. “Excitable tissue” means tissue to which may be sent electrical signals in order to evoke a response, including a resulting beneficial effect on or treatment of the patient.  
         [0006]     Both sensing and stimulating require a connection to transfer the electrical signal, whether it be nerve, muscle, organ, or otherwise. For example, there are usually thousands of fibers in a nerve, and each fiber may be carrying a unique signal. Consequently, problems arise as to how to connect to the desired location on, or within, the selected nerve, in order to sense signals from, or provide signals to, individual fibers.  
         [0007]     Current techniques for connecting to nerves also involve nerve cuffs, which are placed around the nerve, and which can only stimulate large numbers of fibers within the nerve. It is known that multiple needle-electrodes may be individually inserted into the brain to make contact in a localized area.  
         [0008]     In 1989, Byers, et al. (U.S. Pat. No. 4,837,049) disclosed a very small implantable, biocompatible electrode array “bed of nails” having numerous small, sharp, conductive protuberances (needles) which penetrate brain, nerves, organs, muscle, or other body parts for electrical signal sensing or simulation. It is disclosed that the protuberances are carried on a rigid or flexible base and include electrical conductors connecting the protuberances to terminals for other electrical connections. An array placed on the brain can communicate wirelessly to control a muscle, nerve, or other body part. One or more arrays attached to the motor cortex of the brain, can transmit, in tetherless fashion, many channels of information to receiving body parts, such as muscles. This patent is incorporated herein by reference in its entirety.  
         [0009]     In 1990, Byers, et al. (U.S. Pat. No. 4,969,468) disclosed an implantable, biocompatible “bed of nails” electrode array for making multiple electrical contacts to electrically sense or stimulate biological tissues. The arrays may be used singly or in combination with a second array and may involve transmission, multiplexing, filtering, data processing or other electronic techniques. One or more electrode array attached to the motor cortex of the brain, in tetherless fashion, can transmit many channels of information to receiving body parts, such as muscles, to which electrode arrays are attached.  
         [0010]     If the electrode array is to be used for sensing low voltage body signals, it is disclosed that an amplifier would be the first electrical circuit connected to the device. The signals may then be handled by analog or digital electronic methods. If the electrode array is to be used for electrically stimulating tissue, the terminals would be connected to circuits that provide to provide stimulation signals output to conductors which carry these stimulation signals from the terminals to the tissue-contacting needles. This patent is incorporated herein by reference in its entirety.  
         [0011]     In 1993, Norman, et al. (U.S. Pat. No. 5,215,088) disclosed an electrode array device for use as a neuron interface or as a cortical implant. A plurality of spire-shaped electrodes on a rigid base is disclosed. The electrodes are electrically isolated from each other at the base and may be multiplexed such that only a small number of lead wires need to be attached. The disclosed device may be used for a neuron interface and for a cortical implant for a vision prosthesis. This patent is incorporated herein by reference in its entirety.  
         [0012]     The complete package that is implantable in the skull to stimulate and or sense signals from the brain has not previously been disclosed. A need exists for an integrated, biocompatible, implantable brain implant device to effect body function. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  illustrates a cross-sectional view of the stimulator.  
         [0014]      FIG. 2  depicts a bottom view of the stimulator.  
         [0015]      FIG. 3  is a perspective view of the stimulator and attached electrode assembly.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0016]      FIG. 1  presents a cross-sectional view of the implantable sensor  2  comprising a ceramic case  4  that is comprised of a biocompatible material that is selected from the group of ceramic materials, such as alumina, titania, zirconia, stabilized-zirconia, partially-stabilized zirconia, tetragonal zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, yttria-stabilized zirconia, and calcia-stabilized zirconia, sapphire, and in a preferred embodiment ceramic case  4  is yttria-stabilized zirconia. In an alternative embodiment the ceramic case  4  is comprised of tetragonal zirconia. The case  4  is preferably a round circular cylinder with an integral enclosure on one end and an opening on the other having dimensions of about 0.20 to 0.24 inches high and about 0.8 inches in outer diameter with a wall thickness of about 0.010 inches.  
         [0017]     The ceramic case  4  forms a part of a hermetic enclosure for various processing electronic components  14  including, but not limited to, capacitors and oscillator crystal  16 , chip stack  18 , and battery  20 . These components process the electrical signals that are generated by the brain and are wirelessly transmitted via antenna  24  to remote location or locations in the body to effect function in the targeted living tissue.  
         [0018]     The battery charging system comprises the battery  20  that is charged by a remotely transmitted charging signal that is in turn detected by a coil  38  and that is processed in part by a ferrite  30 .  
         [0019]     The case  4  contains a plurality of feedthroughs  12 , numbering as many as about  128 , or  64  in a preferred embodiment, plus at least about two indifferent electrodes (not illustrated), where each feedthrough  12  is associated with an electrode  28  which conducts the electrical signals that are generated by the brain through the wall of the case  4  and to the processing electronics  14 . In a preferred embodiment, the diameter of each feedthrough  12  is about 0.010 to 0.020 inches. Each electrode  28  is hermetically sealed by known techniques to the case  4  at the interface formed by the electrode  28  and the feedthrough  12 . The electrodes  28  each have a rivet-like appearance with an outer diameter of the external button portion of about 0.030 inches.  
         [0020]     An important aspect of the invention is that the case  4  is closed by hermetically attaching a biocompatible interface ring  34  by brazing and then a diaphragm  32  by biocompatible means, preferably laser welding, to assure a hermetic seal. An interface ring  34  is placed between the preferably round case  4  and the diaphragm  32  to enable the joint to be formed. A braze ring  10  is located between the case  4  and the interface ring  34  to effect a braze joint between the diaphragm  32 , interface ring  34 , and the case  4  upon thermal processing. The braze ring  10  is comprised of a material that is selected from the class of known braze alloys for bonding case  4 , which is preferably comprised of ceramic, to interface ring  34 . The braze ring  10  is preferably selected from the group of biocompatible braze materials, such as 50% Ti-50% Ni, substantially pure nickel, or 33% Ti-67% Ni, percentages expressed in weight percent.  
         [0021]     The interface ring  34  is comprised of Ti-6AI-4V or Ti-8Al-1Mo-1V. The Ti-8Al-1Mo-1V has a relatively high electrical resistance of about 120 times that of copper, while the electrical resistance of Ti-6Al-4V is about 100 times that of copper. In a preferred embodiment, the interface ring  34  is comprised of Ti-8Al-1Mo-1V to minimize antenna  24  loses of efficiency. In a preferred embodiment, the ring has a cross sectional thickness of about 0.002 inches and is about 0.100 inches high, spanning the space between the case  4  and the diaphragm weldment  8 .  
         [0022]     Preferably, the diaphragm  32  is comprised of a biocompatible weldable material, preferably Ti-6Al-4V. In a preferred embodiment, the diaphragm  32  is welded, preferably by laser welding, although electron beam or other welding process are applicable, to interface ring  34 , thereby creating weldment  8 . It is important that the braze joint to case  4 , that is created before welding of the diaphragm  32 , not be adversely affected by the later applied welding process, hence the thin cross-section of interface ring  34  which limits heat transfer to the braze joint during the welding process. In addition, in a preferred embodiment, the distance between the braze ring  10  and the weldment is about 0.1 inches, which helps avoid braze joint thermal effects from the welding operation.  
         [0023]      FIG. 2  presents a bottom view of the sensor  2 , showing the antenna  24  and diaphragm  32 . Antenna  24  is located on the outer surface of case  4  and is connected to the electronics  14 , that are located inside case  4 , by a passage through the wall of case  4 . A biocompatible, electrically insulating coating  26  is placed over the antenna by known ceramic deposition processes. The coating  26  is preferably comprised of alumina, although it may also be a non-ceramic, such as an epoxy.  
         [0024]     Antenna  24  is preferably a painted or silk screen applied conductor that is formed by applying an electrically conductive metal in powder from paste suspension. The metal is preferably silver. Once applied, the dried antenna  24  is heated under controlled conditions to remove the organic binders and result in an electrically conductive antenna  24 . One known silver paste is silver epoxy 6144S, supplied by Lord Corporation, North Carolina, United States of America.  
         [0025]     The sensor  2  and integrally attached flex connector  22  that connects to neuro-needle array  42  are illustrated in  FIG. 3 . The neuro-needle array  42  preferably has an approximately square matrix of 8 by 8 neuro-needles  36  totaling 64 in number, although the array  42  may contain as many as about 128 needles. The array  24  is preferably described by the 1990, Byers, et al. U.S. Pat. No. 4,969,468 to a biocompatible “bed of nails” electrode array for making multiple electrical contacts to electrically sense or stimulate biological tissues, which is incorporated by reference herein in its entirety. In a preferred embodiment the needles are comprised of a biocompatible electrically conductive metal, such as platinum.  
         [0026]     The flex connector  22  is comprised of an electrically insulating and biocompatible material that contains a plurality of electrical conductors  44 . Each electrical conductor  44  is attached to a neuro-needle  36  and to an electrode  28  to conduct electrical signals therebetween. The electrical conductor  44  is bonded by known methods, such as gold bump bonding, to electrode  28  ( FIG. 1 ). A preferred form of conductor  44  is a biocompatible wire, such as gold wire. The matrix of the flex connector  22  is preferably comprised of polyimide, such as Kapton®, or amorphous fluoropolymers, such as Teflon®, or silicone are also candidates. A bonding layer  21 , preferably of epoxy, is formed to attach the flex connector  22  to ceramic case  4  and to electrodes  28 .  
         [0027]     Thus, in accordance with this invention, by utilizing a completely implantable sensor  2 , it is now possible to control the movement of a muscle by normal brain function when the normal nerve path is severed or otherwise not functioning. This is a surprising result since implantable self-contained brain generated signal receiver/processors have not been previously disclosed.  
         [0028]     Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.