Abstract:
The present invention is a method of producing an electrode probe assembly, comprising, providing a flexible polymer substrate bearing a coating of conductive material and using photolithography and electroplating to form a set of contacts and conductors on the flexible polymer substrate. A resilient material substrate is provided and laminated to the flexible polymer substrate. The assembly may be sized and shaped so that it may be driven through brain tissue.

Description:
RELATED APPLICATIONS 
     This application is a division of application Ser. No. 09/518,006, which was filed Mar. 2, 2000, now U.S. Pat. No. 6,368,147. 
    
    
     STATEMENT OF GOVERNMENTAL SUPPORT 
     This invention which is the subject of this application was funded in part by SBIR grant No. 2R44NS 33427. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention is a zero insertion force percutaneous connector and a flexible brain probe assembly. 
     Fitting a probe assembly for measuring electrical activity of a mammalian test subject or patient&#39;s brain is a challenging operation. A problem is encountered in fitting the subject with a percutaneous connector assembly (a connector assembly having an in vivo connector half that extends through the skin) that does not unduly cause pain or creates a risk of infection. Complicating this task is the necessity of passing many different signal conductors through the percutaneous connector, a requirement that has significantly increased the size of the typical percutaneous connector. 
     Also, the in vivo connector half generally mates with an ex vivo connector half that routs the signals created by the connector to a destination, such as a piece of test equipment. Each time this cable is connected, some force must typically be applied to create the connection. As the site of the percutaneous connector may be quite tender, this generally causes pain or pressure to the subject. In a separate consideration, it is highly desirable to amplify the signals produced by the brain as closely as possible to the signal origin. 
     Creating the probe that contacts the brain tissue also represents a challenge to researchers. Researchers typically wish to measure electrical activity at specific sites within the brain that share a well-defined physical relationship to one another. Probes produced by photolithographic techniques, such as the probe designed by personnel at the University of Michigan that is known in the industry and research community as the “University of Michigan Probe,” permit the accurate placement of electrode sites that are sufficiently small to permit the measurement of electrical activity at a specific set of predefined sites within the brain. Unfortunately, the desire to use photolithography has prompted the use of silicon as a substrate. Because this material is quite brittle, the use of it creates a risk of breakage inside the brain, endangering the subject or patient and limiting the insertion strategies available to researchers. Moreover, the use of silicon prevents the University of Michigan probe from moving with the brain, which does move about slightly within the skull. In addition, silicon is subject to some restoring force, which tends to cause a silicon probe to migrate over time. Both of these drawbacks have the potential result of causing trauma to the brain tissue. 
     Another type of probe that is currently available includes a set of insulated wires having laser created apertures exposing electrode sites. Although this type of probe is useful for many applications, it does not yield the precision or the freedom of electrode placement that the University of Michigan probe permits. 
     What is needed but not yet available is an electrode probe and method of making the same that affords unconstrained and accurate placement of the electrodes, but offers flexibility and robustness and is thereby less susceptible to breakage than currently available probes. 
     Also needed but not yet available is a percutaneous connector wherein the male-half can be inserted into the female-half without exerting pressure against the female-half, thereby avoiding the pain and/or tissue trauma that the insertion operation currently causes to patients and test subjects. In addition, a percutaneous connector is needed that brings a set of op-amps closer to the site where the signals exit the body than has heretofore been possible. 
     SUMMARY 
     In a first separate aspect, the present invention is a percutaneous connector. It comprises a female-half including a housing having a pair of side walls, each having an interior surface. An electrical contact assembly is arranged along the interior surface of at least one of the side walls and has a set of first electrical contacts. Insulating material electrically isolates the electrical contacts from one another. In addition, an electrical conductor attached to each electrical contact extends outside of the housing. A male-half includes a sheet of resilient material, bent into a U-shape and having two opposed outer surfaces. A handle assembly is adapted to permit a user to squeeze the two opposed outer surfaces closer to each other. In addition a set of second contacts is attached to at least one of the outer surfaces and is arranged in matching configuration to the first set of contacts. Insulating material electrically isolates the contacts from one another. With this design, a user can grasp the male-half by the handle assembly, squeeze together the two outer surfaces, place the male-half in the female-half and release the handle assembly so that the male set of contacts touches the female set of contacts. 
     In a second separate aspect, the present invention is a connector assembly for connecting a set of first conductors to a set of second conductors that includes a first half and a second half that mates to the first half. The first half includes a substrate of resiliently compressible, insulating material, which supports a set of first contacts, each connected to a the first conductor. In addition, the substrate of resiliently compressible, insulating material defines a set of isolation cuts, each disposed about one of the first contacts and detaching the substrate of resiliently compressible, insulating material inside of the isolation cut from the substrate of material outside of the isolation cut. The second half of the connector assembly comprises an insulating substrate and a set of second contacts, each connected to the second conductor and supported by the insulating substrate, and positioned in matching arrangement to the set of first contacts. A connective bracket assembly is adapted to hold the first set of contacts in contact to the second set of contacts. 
     In a third additional separate aspect, the present invention is a method of producing an electrode probe assembly, comprising, providing a flexible polymer substrate bearing a coating of conductive material and using photolithography and electroplating to form a set of contacts and conductors on the flexible polymer substrate. 
     In a fourth additional separate aspect, the present invention is a percutaneous connector comprising a first half and a mating second half. The first half is adapted to be set into the body of a patient and includes an array of first contacts having a density of greater than 25 contacts per cm 2 . The second half is adapted to mate with the first half and includes an array of second contacts positioned in mating conformity with the set of first contacts and further including a set of op-amps, each connected to one of the second contacts and positioned within 2 cm that second contact. 
     The foregoing and other objectives, features and advantages of the invention will be more readily understood upon consideration of the following detailed description of the preferred embodiment(s), taken in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side view of the connector of FIG. 1, shown attached to a skull and connected to a brain probe that is embedded in brain tissue. 
     FIG. 2 is an exploded perspective view of a connector according to the present invention. 
     FIG. 3 is a perspective view of the connector of FIG. 1, with the two connector halves mated. 
     FIG. 3A is a perspective of a portion of an alternative embodiment to FIG. 1, showing the differing structure of the alternative embodiment. 
     FIG. 4 is a greatly expanded plan view of a connective surface of the connector of FIG.  1 . 
     FIGS. 5 a - 5   g  is a series of greatly enlarged side cross-sectional views showing the construction of the connector flex circuit, or thin film, which may include the brain probe flex circuit of FIG. 1 in a single unit. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIG. 1, a percutaneous connector  10  is screwed into the skull  1  and is connected, by way of a multi-conductor microcable  20 , to a brain probe  24  that passes through an aperture  2  in the skull, through the dura  4  (and into the brain  6 ), for measuring brain activity at a specific set of points. 
     Referring to FIGS. 2,  3  and  3 A a percutaneous connector  10  according to the present invention includes a male-half  12 , a female-half bracket  14  and a female-half flex circuit (or flexible polymer) connective assembly  16  bearing a set of contacts  17  and conductive traces  19 . A multi-conductor microcable  20  forms a portion of assembly  16  and is threaded through an aperture  22  in bracket  14 . The microcable  20  attaches to and extends traces  19  to brain probe  24 . As shown in FIG. 3 a  in an alternative embodiment, a connective assembly  16 ′ includes a microcable  20 ′ that includes a brain probe  24 ′ as a unitary part of its construction. The male-half includes a resilient clip portion  28 , the exterior of which is covered with a flex-circuit  34  bearing a set of contacts  36  (matching the arrangement of contacts  19 ) and conductive traces  38 . 
     A first prong  40  and a second prong  42 , which is physically coincident with an op-amp housing, partially defines clip portion  28 . A user can grasp male-half  12  by the first and second prongs  40  and  42  to squeeze these prongs  40  and  42  together. The male-half  12  can then be inserted into the female-half  14 , without exerting pressure against female-half  14 , which could cause pain or tissue trauma to the patient or test subject. Finally, the user releases prongs  40  and  42  so that the resiliency of clip  28  will force each exterior side of clip  28 , and therefore contacts  36 , to touch the contacts  17  in female-half  14 . 
     Referring to FIGS. 4 and 5 a - 5   g,  contacts  17  and traces  19  are made of conductive material, such as a metal (copper, gold or sliver) or a conductive polymer that has been deposited and etched on top of a laminate having a layer of dielectric substrate  50  and a base layer silicone  70  or some other biocompatible, compliant material. Semicircular isolation cuts  48  through the layers  50  and  70  (in an alternative preferred embodiment only layer  50  is cut through by the laser) positionally decouple a first contact  17   a  from neighboring contacts  17   b,    17   c  and  17   d,  permitting contact  17   a  to be depressed into the spongy layer of silicone  70  without pulling down the neighboring contacts  17   b,    17   c  and  17   d.  This independent depressability causes the protrusional misalignment of contacts  17  and  36  to be forgiven. 
     The miniature scale that is made possible by the use of photolithography and flex circuit technology, as described above, facilitates a further advantage that may be realized as part of the present invention. This is the placement of op amps in extremely close proximity to contacts  36 . For connectors in which the contacts are spread apart from each other, it is necessary to gather together conductive paths from all the different contacts prior to sending them all to a set of op amps. Because contacts  36  are all so close together, traces  38  are routed to a set of op amps  44 , that are about 0.5 cm away and are housed in the second prong  42 , which doubles as an op amp housing. As a result, signal line noise and cross talk are minimized. 
     Referring to FIGS. 5 a - 5   g,  the photolithography process for making the brain probe  24  and the contacts of the percutaneous probe contact structure  30  are quite similar, except that different materials may be used and the percutaneous probe contact structure  30  includes a base layer of silicone  70 , that is only shown in FIG. 5 g , for the sake of simplicity. Referring specifically to FIG. 5 a , the photolithography process begins with a layer of dielectric substrate  50 , the composition of which is discussed below, that is coated with a base layer of conductive material  52 , such as a titanium-gold-titanium sandwich. FIG. 5 b  shows the structure of FIG. 5 a , which at this point has been covered with a layer of photo resist material  54 , typically applied by spin-coating. FIG. 5 c  shows the effect of exposing the photo resist material to a pattern of light and washing off the exposed (or not exposed if a negative process is used) material with a developing agent. Next, as shown in FIG.  5   d,  additional conductive material (typically copper) is built up on the exposed base layer  52 , typically through electrolysis. As shown in FIG. 5 e,  the remaining photo resist material  54  is washed off with a solvent and a layer of dielectric (and permanent) photo resist  58  is applied and patterned, via exposure to a pattern of light and subsequent washing with a developing agent or solvent. Then, additional electrolytic plating is performed (FIG. 5 f ) to create a contact  60  and the substrate is cut with an nd:YAG laser to form a kerf or cut  62 . When the process shown in FIGS. 5 a - 5   g  is for producing connector  10 , cut  62  is the same as isolation cut  48 . When the process shown in FIGS. 5 a - 5   g  is for producing a brain probe  24 , cut  62  separates a first brain probe  24  from a wafer or thin plastic film upon which several brain probes have been etched. In contrast to the situation with respect to silicon, which may be separated by etching, it appears that no etching process has been developed for cutting the materials used for substrate  50 , which are discussed below. 
     The dielectric substrate  50  that is used for the brain probe  24  is preferably a polymer material having a high glass transition temperature, high tensile strength and low elasticity. More specifically, substrate  50  may be made of polyether sulfone, polyimide or other material having the desired characteristics. If polyimide is used, it should be coated or treated so that it does not dissolve in the body&#39;s interstitial fluid, or used for a probe that is not to be implanted for long enough for the polyimide to dissolve. Photo resist material  54  may be a photosensitive acrylate, polyether or polyurethane, preferably having a high molecular weight. Permanent photo resist  58  may be a permanent polyimide, a type of material that is widely available from well-known photo resist companies. These companies typically sell a wet etch agent specifically designed to etch each permanent polyimide photo resist that they sell. 
     The terms and expressions which have been employed in the foregoing specification are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.