WO2010065678A1

WO2010065678A1 - Method and apparatus for configurable systems

Info

Publication number: WO2010065678A1
Application number: PCT/US2009/066463
Authority: WO
Inventors: Herbst Ewa
Original assignee: Innovations Holdings, L.L.C.
Priority date: 2008-12-02
Filing date: 2009-12-02
Publication date: 2010-06-10

Abstract

The invention relates to methods and devices to define and control the design of a configurable chip module, instrument or systems, for example, for measurement, control and communication systems (for example, for biomedical applications), or any part thereof. The module may include one or a plurality of chip elements. This can be achieved using, for example, a Graphical User Interface (GUI), by transforming selections made by the user to a hardware and/or software configuration for the system in a process transparent to the user. This enables implementation of a plurality of devices and larger subsystems, for example, measuring devices and subsystems, directly on a chip or a chip module without specific semiconductor design know-how from the user. This transformation process is thus accomplished transparent to the user, who operates the GUI only, and defines the measurement or action which needs to be performed (such as patient treatments); and which, in turn, results in an automatic combination of hardware and/or software elements available to create a specific configuration.

Description

METHOD AND APPARATUS FOR CONFIGURABLE SYSTEMS

GOVERNMENT RIGHTS

This invention was made with government support under grant R44 RR021814 awarded by the National Institutes of Health. The government may have certain rights in the invention.

Copyright Notice

A portion of the disclosure in this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

CROSS-REFERENCE TO RELATED APPLICATIONS

The invention relates to a flexible analog/digital configuration, preferably on a single silicon or other semi-conductor chip for use in receiving various inputs, processing them, and being able to provide in response an electrical stimuli or control signal which can be generated, for example, by a multi-functional electric stimulator output such as those described in United States Patents 6,029,090, 6,684,106, and United States Patent Application Serial No. 11/213,050, all identifying Ewa Herbst as the inventor, the patents and patent application being incorporated herein by reference, in their entirety. This application claims the benefit of and priority under 35 U. S. C. § 119(e) to U.S. Provisional Patent Application No. 61/119,244, filed December 2, 2008, which is hereby incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention The invention relates generally to a flexible analog/digital configuration, the system being preferably on a chip, and used for receiving various inputs, processing them, and being able to display/communicate the results and/or provide a response thereto. The invention also relates to a user-configurable instrument designed as a system on a chip (SoC) or as a stand-alone, handheld, user-wearable, or implantable device with functionality defined through a Graphical User Interface (GUI) or other methodology. The invention also relates to analysis methods and equipment, and in particular to measurement, diagnostic, and treatment equipment able to perform any or all of the functions substantially simultaneously or in a prescribed order. It allows not only for immediate testing but also for long term monitoring of a disease, and for treatment in response to such monitoring, as well as for monitoring of treatment efficacy, which can have importance both for personalized medicine and for drug discovery.

2. Status of Prior Art

The medical device field for measurement, analysis, and treatment of the human (and non-human) condition has grown substantially over the past years as the ability to build customized equipment, easily and quickly using specialized chips, has enabled both large and small companies to enter the field. Of particular interest has been the use of so-called "biomarkers", each of which can be defined to represent a specific measurement or series of measurements, representative of a specific condition or function of the biological system. Other measurements of parameters such as blood gases (e.g., pθ₂, pCO₂), pH, electrolytes, temperature, measured bodily electrical signals (e.g., EKG, EEG, EMG), etc are often made independently of biomarker measurements.

Biomarkers may be associated with a particular disease, or with a range of diseases, or alternatively with a series of predefined biomarkers as dictated by the user. Methods such as genomics, proteomics, and/or molecular imaging, among other methods, can be used in the generation of the biomarker information. Among specific methods used, a variety of spectroscopic methods can be applied, such as fluorescent spectroscopy and mass spectroscopy, which can be used, e.g., for gene expression profiling, Raman spectroscopy and lately Fourier transform infrared spectroscopy (FTIR). Substantial quantities of data relating to biomarkers and other parameters regarding the human condition such as blood gases, pH, electrolytes, temperature, electrical signals and the like, have been collected for many specific diseases of the body. Also automatic test equipment has been marketed and has been, typically, measurement driven. Equipment is available for measuring pH, oxygen, and temperature at various parts of the body, and various biological measurement schema which are intended to measure, for example, sugar levels, blood counts, the presence of various genes, proteins, acids, etc., and so on are also available. Such equipment is available from many different vendors and provides in many cases, excellent results for the measurement for which they were designed. It is then, typically, up to the doctor or an automated analysis device, which is used by the lab or the doctor and into which selected data is provided, as requested by the doctor, to provide a diagnosis of the patient. Similar advances are being made in connection with non-human measurement and analysis, as well as in the measurement and analysis of environmental "parameters" (for example, quality of water) in an effort to improve and automate the analysis and resulting diagnosis and conclusions relating to the input data.

Semiconductor manufacturing technology has progressed substantially to allow more custom definitions of systems on a single chip. Nevertheless, researchers in many fields, including, without limitation, biological and medical sciences, and physiotherapy, and clinicians who make use of electrical stimulators and sensors for activities in which they engage, seek further instrumentation which enables them to treat patients with specialized and customizable equipment, but at a reasonable cost, in conformance, for example, with established industry guidelines. Such equipment, while often available at high price and for specialized purposes, often does not meet the needs of these workers. As a result, those working in these and other fields of endeavor are limited in their ability to quickly react to and provide for either patient use or experimental use systems meeting their needs. Further, by "patient", we mean, as used in its broadest sense, human and non-human mammals and other animals, as well as plants (i.e. multicellular organisms), tissues and cells (aggregate and single cells). Accordingly, it is desirable to find a method and apparatus to enable such workers to quickly generate and use systems meeting their electrical stimulation and input receiving needs without undue delay or cost. In addition, such systems need to be able to be produced as both one of a kind systems, as well as in production quantities in order to satisfy current needs.

SUMMARY OF INVENTION

In one aspect, the invention relates to a method and device to define and control the design of a configurable chip module, for example, for measurement, control and communication systems (for example, for biomedical applications), or any part thereof. The module may include one or a plurality of chip elements. This can be achieved using, for example, a Graphical User Interface (GUI), by transforming selections made by the user to a hardware and/or software configuration for the system. This enables implementation of a plurality of devices and larger subsystems, for example, measuring devices and subsystems, directly on a chip or a chip module without specific semiconductor design know-how from the user. This transformation process is accomplished transparent to the user, who operates the GUI only, and defines the measurement or action which needs to be performed (such as patient treatments); and which, in turn, results in an automatic combination of hardware and/or software elements available to create a specific configuration.

In another aspect, a configurable semiconductor chip module system has analog elements, digital elements, and connection elements between the analog and digital elements. Ones of the analog and digital elements receive inputs from respective sources, and ones of the analog and digital elements output signals for generating control signals having selected electrical and time spatial properties. The connection elements are configurable after creation of the analog elements, the digital elements, and the connection elements.

In another aspect, a configurable semiconductor single chip module for use in patient treatment has analog elements, digital elements, and connection elements between the analog and digital elements. Ones of the digital and analog elements receive analog inputs from respective sources, and ones of the digital and analog elements output signals for controlling control signals having selected electrical and time spatial properties useful in medical treatment. The connection elements are configurable after creation of the analog elements, the digital elements, and the connection elements.

In a further aspect, a passive (that is, without feedback) configurable semiconductor single chip module for use in making analytical measurements of parameters related to patients' status has analog elements, digital elements, and connection elements between the analog and digital elements. Ones of the analog and digital elements receive analog inputs from respective analog sensors, and ones of the analog and digital elements output signals relating to measurements from the sensors. The connection elements are configurable after creation of the analog elements, the digital elements, and the connection elements.

A method of the invention for manufacturing a flexibly configurable semiconductor single or multiple chip module for receiving and outputting various signals not specifically known at the time of manufacture; manufactures a plurality of analog elements, digital elements, and connection elements between said analog and digital elements; enables ones of the analog and digital elements for receiving inputs from respective sources, ones of the analog and digital elements for outputting signals for generating or controlling control signals having selected electrical and time spatial properties; and configures the connection elements after creation of the analog elements, the digital elements, and connection elements, to configure the module.

In yet another aspect, the invention relates to a method and device to define and control functionality of measurement, control and communication systems (for example, for biomedical applications), or any part thereof, using for example a Graphical User Interface (GUI), by transforming selections made by the user to a hardware and/or a software configuration for the system. This enables implementation of a plurality of devices and larger subsystems, for example, measuring devices and subsystems, without requiring an engineering expertise from the user. This transformation process is accomplished transparent to the user, who operates the GUI only, and defines the measurement or action which needs to be performed (such as patient treatments); and which, in turn, results in an automatic combination of hardware and/or software elements available to create a specific configuration. This therefore enables the user to perform without "technical know- how," a specific measurement, a series of measurements, a treatment or another operation.

BRIEF DESCRIPTION OF DRAWINGS

Various objects, features and advantages of the present invention can be more fully appreciated with reference to the following detailed description of the invention when considered in connection with the following drawings, in which like reference numbers identify like elements:

FIG. 1 describes a general block functionality in accordance with embodiments of the present invention.

FIG. 2 illustrates a more detailed view of the general block functionality in accordance with one embodiment of the invention.

FIG. 3 illustrates in more block level detail, an embodiment of elements of the system on a chip and details as to the acronyms relating to various of the elements.

FIG. 4 illustrates a multifunctional stimulator in greater detail.

FIG. 5 illustrates a particular implementation of the system on the chip in accordance with an embodiment of the invention.

FIG. 6 illustrates details regarding an exemplary sensor interface and conditioning module.

FIGS. 7 and 8 are charts illustrating various flexibilities available in constructing elements described herein in accordance with an embodiment of the invention. FIG. 9 illustrates various sensor-interface modules in accordance with embodiments of the invention.

FIGS. 1OA and 1OB illustrate a typical system specification for various elements of a system for enabling operation of a module and its manufacturing construction, in accordance with the embodiments of the invention.

FIGS. 11-34 illustrate screen shots of operation of a graphical user interface in accordance with embodiments of the invention.

DETAILED DESCRIPTION

The general block functionality of an embodiment of the invention is illustrated in Figure 1. Referring to Figure 1, the system includes a sensor interface and conditioning module 100, a multi-functional electrical simulator and output module 102, a sensor and chip identification module 104, a phase-lock loop clocking module 106, a JTAG module 108, a processor and controller module 110, a memory module 114, a communications interface module 116, a power and thermal management module 118, and a user-programmable module 120, which can be implemented as CPLD/FPGA. These elements are designed in particular to be incorporated on a single chip such as a configurable application specific standard product (ASSP) which has for example a plurality of fixed layers, on top of which several layers can be placed to customize the chip and to allow interconnections as desired between elements or modules in the fixed layers. Thus, for example, elements 100-118 might be the fixed elements on the chip and the user space would be several layers on top of the fixed layers to effect connections, additional elements needed for the chip, etc. Other chip or multichip configurations could be used as semiconductor manufacturing methods are developed or to minimize the manufacturing cost, for example, separating analog and digital functions between two chips. Further, the layers can be fixed with programmability features as known in the field.

A "system on a chip" (SoC) advantageously can measure multiple parameters; and when properly programmed, can easily organize the data from multiple sensors or other analog or digital sources. It can present or display different, or similar, pages for setting up each measurement (or each measured parameter), for example by sensor, class of sensors, etc., to enable an easy to use approach for non-technical individuals without needing to know the specifics as to many parameters. This user- friendly, and lower-cost approach further enables the measurement and interconnection to be performed using a configurable standard basic chip according to the invention. Figures 11-34 and the related description describe one illustrative approach, using an easy to use GUI for configuring the system for desired measurements and analyses.

Considering the modules of Figure 1 in more detail, and referring now to Figure 2, the sensor interface and conditioning module 100 can include sensor-specific preamplifiers, precision analog-to-digital conversion circuitry, filters for filtering the signal inputs, and other special features depending upon the particular application to which the circuit is put. And, as described in more detail below, various components can be connected to be grouped as a family, for example by sensor functionality or characteristic, such as impedance, signal levels, etc., to more efficiently connect the analog and digital elements of the modules, in a chip layer, or between chip layers. This can also result in a smaller chip/module footprint.

The processor and controller module 110 is thus programmable by the user and/or configurable in hardware, using, for example, the GUI of Figures 11-34, to perform the functions of measurement, analysis, diagnostics, operations, and system management, and to enable feedback control algorithms as required. Each of these functions can be the subject of software applications which are stored in memory 114 (Fig. 1). Memory 114, in some embodiments, includes a DRAM and/or SRAM module 130, a flash or EE PROM memory 132 and can have available space for memory expansion 134 (Fig. 2). The multi-functional electrical stimulator and output module 102, in addition to providing a multi-functional electrical stimulation unit, such as that described in the Herbst patents and patent application identified above, can also provide a power stage for controlling current and voltage as well as a pulse width modulator stage (PWM) for effecting the outputs of the module 102. Furthermore, the communications interface 116 can communicate to various peripherals using video, audio, or any of a number of protocols, all of which can be supported by a suitable design on the chip. Those protocols can include, for example, USB, Ethernet, I2C, SPI, GPIO, user communications protocols, SERDES protocols. Other protocols, as they are developed or as they are required by the user, could also be either preprogrammed into the hardware or programmed into the software depending upon the particular design of the chip or chip set. Further the "peripherals" can include servers and server interfaces, and functions of the electrostimulator module, for example, power, sensing/sensors, feedback controls, and protocol conversions.

Referring now to Figure 3, which illustrates in more block level detail one embodiment of the elements of a system on a chip and which provides detail as to the acronyms related to various of the elements, the sensor interface and conditioning module preamplifier section 140 can include any (or all) of a number of amplifier types such as a high impedance amplifier, a differential amplifier with or without excitation, a temperature amplifier, a bioamplifϊer, an ultrasound amplifier, a transimpedance amplifier, and generally a general purpose analog amplifier with or without isolation.

The multi-functional electrical stimulation and output module 102 can have in particular an output section which enables the multi-functional electrical stimulator 142 in a manner comparable to that described in the patents identified above to generate output signals in response to instructions or control signals from the processor and/or controller, the signal conditioning and data acquisition module, or the user-programmable module. The output of the multi-functional electrical stimulator can be provided directly to output receiving elements (not shown) or through an amplifier or power drive 144 to such receiving elements. In a particular embodiment, outputs from the output module can be fed back (146) as an input to the sensor interface and conditioning module 100 through a separate process to help provide closed-loop control of the output stimulation signals. The output module 102 can also be used to generate desired output signals in response to, for example, user programming.

In a specific example, a system can be created as a general voltage/current measurement system, a biosensor based system, an environmental measurement system, or a gas measurement system; and any of the above systems with a feedback control mechanism, to influence an outcome such as a specific treatment scheme or regiment, for example electrical stimulation or drug delivery, and where as any of the above have communications elements and especially wireless communication elements.

The signal conditioning in data acquisition portions 150 of the sensor interface and conditioning module 100 connect to a first bus 152 which in some embodiments connects also to a peripheral bus 154.

The processor and controller module 110, referring to Figure 3, is further broken down to show various elements of the module 110. The module may include many of the "standard" elements of a standard processor including the CPU or digital signal processing element or multiple processing unit, cache, a user interface module, a direct memory access (DMA) channel or channels, a memory management unit (MMU), an interrupt controller, and an external memory interface. These can be connected through a processor bus 156 to various portions of the memory, such as SRAM, DRAM or the non volatile (NV) storage flash memory. In the illustrated embodiment, the processor and controller module 110 has two processor bus elements 156 and 158 which connect to bus 154. The communications interface module 116 connects to bus 154. As illustrated, the communications module can have, in addition to the elements identified in connection with Figure 2, a UART, an interrupt/GPIO, an RTC/Watchdog timer, an Ethernet MAC, an optical peripheral device, and the USB protocol identified in Figure 3 as USB 2.0. Figure 3 also sets forth many of the acronyms used in the figure for convenience.

Referring now to Figure 4, the multi-functional stimulator is shown in greater detail with reference to the multi-functional stimulator described in the above-identified patents. The reader is referred to, for example, U.S. Patent 6,029,090 for a more complete and detailed description and understanding of the various elements described in Figure 4 and which would correspond substantially to portions of module 102, referring to Figure 1.

Referring now to Figure 5, there is illustrated a particular embodiment of the system showing the general interconnection and operation of the various components, and including some specificity with regard to the sensors which might be connected to the interface and signal conditioning, the ability to provide two analog outputs and eight digital outputs, as an example, the use of a sensor RFID module 510, and using the power and temperature management module 104 across the chip. On the other side of the chip or module, the ability to wirelessly connect to the module through antenna 518 and remote sending and receiving module 520 is illustrated. Alternatively, a computer can be connected to the module through USB IF (USB interface) element 522. Other interface connecting signals in this illustrated embodiment are provided through the serial deserializer 524. The multi-functional electrical stimulator is illustrated as being controlled by the microcontroller or DSP 528 and provides outputs as illustrated. The JTAG module 530 for example, connects also to the microcontroller as well as to an external computer.

Referring now to Figure 6, further detail is provided with regard to an exemplary sensor interface and conditioning module 100. As illustrated, different sensors can be provided and treated differently by the high impedance, differential, and transimpedance amplifiers provided in the pre-amplifier module 610. The output of the pre-amplification is sent in some embodiments to the signal conditioning and data acquisition module where it can be multiplexed, sampled, filtered, and converted to a digital value as illustrated, typically, in that module. Various calibration controls are available as illustrated.

The output section contains the electrical controller mentioned above. Various digital to analog converters, here 16 bit DACs, are provided, the output of which is presented to an output stage capable of driving one or more electrical stimulation outputs. Other components illustrated in Figure 6 are noted and are similar to, if not identical to, the related elements in Figure 5. The charts in Figures 7 and 8, illustrate various flexibilities available in constructing any of the elements hereinbefore. This flexibility provides not only for a very useful and "burnable" circuitry over time, but in addition enables the user to substantially design how the system will work. In that respect, therefore, the elements of Figure 6, representing the chip-level layer, provide, for these embodiments of the invention, a particularly advantageous methodology for building the chip containing the elements and modules described herein. Thus the modules/functions can be configured by the user (for example who may not need to be technically trained) in response to needed application parameters or as a result of available classes or types of sensors/inputs to create a customized chip; that is, a chip having user-selected chip functions and modules/building blocks. In fact, if this occurs early enough in the manufacturing cycle, a smaller footprint, and perhaps fewer "user" layers may be achieved. This interactive process results in a faster and simpler time to use of the system on a chip (SoC).

In particular embodiments of a typical controller interface, a method for the design of configurable electronic systems, for example, the system on a chip (SoC), for measurement, control and communications (specifically for biomedical applications), or any part thereof, uses a Graphical User Interface (GUI) for transforming input selections made by the user to a hardware and/or software system. These systems include mask-based systems, such as ASSP, as well as one time programmable (OTP), or re-programmable, systems. This allows for implementation of a multitude of devices and larger systems for example measuring systems, directly on a chip, without a requirement for engineering expertise by the user. This is accomplished transparent to the user, who operates the user friendly GUI to define the measurement or action that needs to be performed (such as a patient treatment), which, in turn, results in an automatic combination of hardware and/or software elements available, for example, to create a specific configuration, thereby enabling the user to perform specific measurements, a series of measurements, a treatment or other operation. The hardware elements are chosen automatically in response to the GUI based inputs, from a library of hardware elements, based on required functionality defined by the user. For example, if a user wants to design an instrument which performs pH measurement or measure a specific ion using an ion selective electrode (ISE), and defines the electrode as a glass electrode, the system will automatically choose an impedance buffer on the input to a measurement system due to high output impedance of the glass electrode. This is described in more detail in the GUI description of Figs. 11 to 34. To reduce power requirements, especially for handheld or implantable devices, only the chosen hardware elements will be connected to a power supply during the configuration process. The hardware elements, for the most part, are functional hardware elements, such as defined in the patent application Serial No. 12/113,200. Referring now to Figure 9, there are illustrated various sensor pre-amplifier interface modules.

Thus, the various sensors and sensor pre-amplifier interface modules are illustrated for various embodiments of the invention. As will be clear to one practiced in this field, various of these modules can be made "standard" for a chip, while others, can be added by the user, depending upon the needs of the user.

Referring now to Figures 1OA and 1OB, there is provided a high level typical system specification for the various elements of the system on a chip and for enabling operation of this flexible module and its manufacturing construction based upon the needs described herein.

Referring to Figures 11 to 34, the GUI can be created in any way appropriate to a specific application and implemented on a PC, PDA, embedded web server, or in any other way convenient for the user. An example of such a GUI for a biomedical system technology platform is illustrated in the screen shots of Fig. 11 through Fig. 34. Those figures show screen shots for definition of a measurement and control system for biomedical instrumentation, analytical instrumentation, or biomedical devices or sub-systems based on a user-specific sensor input and desired measuring methodology.

The same, or similar GUI can be used to define hardware (from the library of functional hardware elements) required to perform a desired measurement, or other operation, and to connect the hardware elements using connecting devices described above, to create configurable systems, including an SoC.

In both applications, a user can utilize the GUI to configure number of inputs, outputs, and feedback elements (see Fig. 12), define type and other specifics of inputs (see Figs. 14-19 and 31-34) and outputs (see Figs. 20-23), define various settings for feedback (see Figs 24-26), etc. Each screen has several drop down menus or sub- screens creating a tree structure, which functions to both define a useful functional methodology for the user (user tree), as well as a hidden operational structure for the instrument, a hardware and/or software configuration for the system, or an automatic SoC design (hidden tree). The hidden tree is not visible to the user and can employ various methods to choose appropriate hardware, software, and connecting elements as described above, to arrive at a user-defined functional solution. For example, for a user-picked voltage level of ± 10V. in Fig. 16, the machine generated tree will implement the user selection by choosing an appropriate amplifier to generate an output of ±IOV. from a set of available voltage amplifiers. Based on the user choices, there may arise conflicts, such as between amplitude and bandwidth, which in such situations need to be communicated to the user.

Referring now to Figures 11-34, there is illustrated a series of screen shots illustrating the process by which a user is enabled to configure the system using the user programmable module through the graphical user interface even though the user may lack the technical know-how not only to understand what is happening within the system, but the details thereof. This particular embodiment shows the graphical user interface for a biosensor measurement system, however the concept of the interface and its actions should not be limited solely to the biosensor measurement environment.

Turning to Figure 11 , there is illustrated a typical sign-on/welcome screen. Once the user signs on, he can load a new program at 200, an existing program at 202, or can use the factory provided defaults at 204. Referring to Figure 12, if a new program is opened, the user is shown a screen having choices on the number of inputs, outputs, and controllers. The user can save his choices remotely or locally. Referring now to Figure 13, the user names the program, and in Figure 14, the user can configure each selected channel as desired. In Figure 14, the user can configure the channel as single or differential, and in Figure 15, the user can select the sensor class for each channel. In Figure 16, the user can select the type of sensor to be used for the channel, and in particular as illustrated, where the sensor class was voltage, the sensor type includes a selectable voltage range. Note that the sensor type is changeable depending upon the sensor class, and whether the channel is single ended or differential. Next, referring to Figure 17, the trigger option menu is provided for the channel. As illustrated in Figure 17, the trigger option has been set to "auto". Referring to Figures 31-34, if the sensor class selected had been "Electrochemical" rather than "Voltage", then the sensor type drop-down menu, as shown in Figures 31 and 33 would no longer have voltage ranges, but instead would list various types of electrochemical sensors such as galvanometric, glucose, salinity, etc. Upon selection of one of those sensor types, for example pH or galvanometric, the units, illustrated in Figures 32 and 34 will correspondingly change in their respective drop-down menus, enabling the user to simply select the appropriate and preferred units for this input channel selection. Other selections result in different menus creating in effect a tree structure to be navigated, with a mouse for example, through the matrix of drop-down menus available in the input channel setup.

Referring to Figure 18, in an advanced input mode, each channel can be used to enable data logging, to set up filtering, or to calibrate a particular input channel. This advanced setup option also allows a self test of that particular channel. The appropriate software "buttons" are illustrated in the figure. In Figure 19, a calibration window becomes available with one point calibration being illustrated. The user can choose other calibration modes and can feed all buffer values to calibrate the channel. For example, in a 2-point Dissolved Oxygen calibration the user will fill in the numbers for 0% solution and 100% solution in buffer 1 and buffer 2 and hit Accept Value. The Calibration Constants will then be calculated and the calibration process is complete when the Apply tab is hit.

Referring to Figure 20, the options available to set up each output channel are shown. This screen is reached by pressing the output button highlighted in Figure 20. As with the input channels, each channel can have either a differential output or a single ended output. This choice is shown in Figure 20. Once that choice is made, and referring to Figure 21, the other parameters are set. In Figure 21, for each channel, under the heading "waveform", a drop down window provides various options for the output signal waveform. Similarly, referring to Figure 22, an advanced output drop down menu is provided for identifying, in more detail, the various waveform parameters including, for example, waveform period, delay time, minimum and maximum voltages, voltage offset, the number of cycles in the burst mode and the cycle period, and the various trigger options as illustrated in Figure 23. Referring now to Figure 24, all of the controller parameters are set using the control buttons available as illustrated in Figure 24. Multiple controllers can be added or deleted using the "add controller" and "delete controller" tabs (at the bottom of Figure 24). The "start" tab and "stop program" tabs are used to run the programmed controller. Referring to Figure 25, there is illustrated the capability of providing as a controller input any of the channels available to be set up. These are denominated in the controller input drop down menu.

Referring to Figure 26, the advanced controller parameter menu allows a user to set up advanced features such as controller gain, titrate details, and further allows the user to set an alarm indicator for the selected controller. Other parameters are also illustrated and able to be set as shown in the screen chart of Figure 26.

Figure 27 allows a user to set up data logging intervals and durations. The log file can also be selected here, for example in accordance with established industry guidelines and standards and there is an option to save raw data.

The system further, referring to Figure 28, allows a user to view graphically as well as numerically, the data. The channels which are currently displayed graphically and/or numerically are selected using the input channel setup page, and can be displayed as illustrated in Figure 28. The display has various desirable features such as zoom, reset, play and pause, and the display can be expanded to a full page display.

Referring now to Figure 29, a custom view allows the user to pick and choose what is to be seen on screen. An example screen display is illustrated in the figure. In the custom view, all of the available channels are listed and the user can "add graphs/readout" and "delete graph/readout" to build the various custom views. In this way, channels which are unnecessary or which hide or mask other channels can be deleted or added and the resulting display effectively allows a better understanding of the signals input and output to and from the devices.

Referring to Figure 30, the custom views of channels 8, 6, and 7 are illustrated as custom view 1. While some of the features of the graphical user interface have been described, clearly the illustrated screenshots provide for many other features not specifically discussed. The graphical user interface provides, therefore, substantial flexibility in creating the environment needed by the system and to flexibly change the system in various connective and analytical/diagnostic ways. The graphical user interface can thus be used to either permanently configure, for example, a system on a chip or an analytical instrument, a research instrument or other device by using simple, non-technical approaches without having to understand the underlying intricacies of how one actually makes the connection, or implements in software the necessary processing required to read signals on input channels and provide output channels as described hereinabove. Further, this system, which transforms the user's simple commands into a complex arrangement of control signals, is neither specifically limited to the biosensor environment in which it is described, nor is it limited to the specific parameters which are illustrated and/or discussed herein.

As a result, the structure and system described hereinabove enables a flexible system on a chip to be produced using both analog and digital elements in a side-by-side relationship on a single chip (or if required two or more chips, for example an analog chip and a connected digital chip) to allow both hard- wired burning of connections as well as programmed connections to be made, and thus enable a single multi-layer chip structure or a multi-chip module to be easily modified for many purposes. Those purposes include various purposes described in U.S. Patents 6,029,090 and 6,684,106, as well as all the other Herbst issued U.S. Patents 6,021,347, 6,708,066, 7,526,334, 7,517,311, and 7,160,241, and U.S. pending patent application Nos. 11/063,195, 11/151,967, 11/213,050, 12/098,257, 12/113,200, 12/431,730 and 12/485,855. While these relate substantially to the medical application field, that is not the only use of such a system on a chip which can be adapted for uses beyond medical applications, including, for example, a wide-range of measurement and control systems.

Other features and advantages of the invention will be apparent to those practiced within the field, and are within the scope of the following claims.

Claims

What is claimed is:

1. A user configurable instrument comprising

(a) a configurable semiconductor chip module system comprising analog elements; digital elements; connection elements between said analog and digital elements; ones of analog and digital elements for receiving inputs from respective sources; ones of said analog and digital elements for outputting signals for generating control signals having selected electrical and time spatial properties; and said connection elements being configurable after creation of said analog elements, said digital elements, and said connection elements; and

(b) a user configurable graphical user interface for effecting said configuration in a process transparent to the user.

2. The instrument of claim 1 wherein said chip module system comprises a single chip module.

3. The user configurable instrument chip module of claim 2 wherein said chip comprises a plurality of predetermined mask layers and a plurality of custom configurable mask layers, wherein a user can custom design desirable functions in the custom mask layers.

4. The user configurable instrument chip module of claim 3 wherein said custom configurable mask layers are laid on top of a flexible, predefined, functional structure.

5. The user configurable instrument chip module of claim 2 wherein said analog and digital elements comprise: a sensor interface and conditioning module; a multi-functional electrical pulse generator output module; a processor and control module; and a memory module.

6. The user configurable instrument chip module of claim 5 wherein said analog and digital elements further comprise a communications interface module for receiving and sending wireless communications.

7. The user configurable instrument chip module of claim 2 further comprising a programmable, graphical user interface for enabling a non-technical user to input commands to the single chip module and/or functionally control operation of said single chip module.

8. The user configurable instrument chip module of claim 2 further wherein the digital elements for outputting signals comprise: elements responsive to input sensor signals; elements responsive to user control signals from a graphical user interface and from processing elements; wherein the output signal generated for application to a stimulation receptor, is created based upon said sensor inputs, said user control signals, and a configuration of said processing elements.

9. A user configurable instrument comprising

(a) a configurable semiconductor single chip module for use in patient treatment comprising analog elements; digital elements; connection elements between said analog and digital elements; ones of said digital and analog elements for receiving analog inputs from respective sources; ones of said digital and analog elements for outputting signals for controlling control signals having selected electrical and time spatial properties useful in medical said connections elements being configurable after creation of said analog elements, said digital elements, and said connection elements; and

(b) a-user configurable graphical user interface for effecting said configuration in a process transparent to the user.

10. The user configurable instrument single chip module of claim 9 wherein said chip comprises a plurality of predetermined mask layers and plurality of custom configurable mask layers, wherein a user can custom design desirable functions in the custom mask layers.

11. The user configurable instrument single chip module of claim 10 wherein said custom configurable mask layers are laid on top of a flexible, predefined, functional structure.

12. The user configurable instrument single chip module of claim 9 wherein said analog and digital elements further comprise a communications interface module for receiving and sending wireless communications from and to sensors monitoring bodily parameters.

13. The user configurable instrument single chip module of claim 9 further comprising a programmable, graphical user interface for enabling a non-technical user to input commands to the single chip module and/or functionally control operation of said single chip module.

14. The user configurable instrument single chip module of claim 9 further wherein the digital elements for outputting signals comprise: elements responsible to input sensor signals; elements responsive to user control signals from the graphical user interface and processing elements; wherein the output signal generated for application to a stimulation receptor, is created based upon said sensor inputs, said user control signals and a configuration of said processing elements.

15. A user configurable instrument comprising

(a) a configurable semiconductor single chip module for use in making analytical measurements of parameters relating to the condition of patients comprising analog elements; digital elements; connection elements between said analog and digital elements; ones of said analog and digital elements for receiving analog inputs from respective analog sensors; ones of said analog and digital elements for outputting signals relating to measurements from said sensors; and said connections elements being configurable after creation of said analog elements, said digital elements, and said connection elements; and

16. The user configurable instrument single chip module of claim 15 wherein said chip module comprises a plurality of predetermined layers and plurality of custom configurable layers, wherein a user can custom design desirable functions in the custom layers.

17. The user configurable instrument single chip module of claim 16 wherein said custom configurable layers are laid on top of a flexible, predefined, functional structure.

18. A method of manufacturing a flexible and configurable semiconductor single chip module for receiving and outputting various signals not specifically known at the time of manufacture in a user configurable instrument, comprising making a plurality of analog elements, digital elements, and connection elements between said analog and digital elements; enabling ones of said analog and digital elements for receiving inputs from respective sources, ones of said analog and digital elements for outputting signals for controlling control signals having selected electrical and time spatial properties; and configuring said connections elements after creation of said analog elements, said digital elements, and connection elements, to configure the module; and effecting said configuration using a process transparent to the user with a graphical user-interface.

19. The method of claim 18 comprising laying a plurality of predetermined layers and plurality of custom configurable layers on a substrate, and enabling a user to custom design desirable functions in the custom layers.

20. The method of claim 19 comprising laying said custom configurable layers on top of a flexible, predefined, functional multi-layer structure.

21. A method of manufacturing a flexible and configurable semiconductor single chip module for receiving and outputting various signals not specifically known at the time of manufacture in a user configurable instrument, comprising making a plurality of analog elements, digital elements, and connection elements between said analog and digital elements; enabling ones of said analog and digital elements for receiving inputs from respective sources, ones of said analog and digital elements for outputting signals for controlling control signals having selected electrical and time spatial properties; and configuring said connections elements after creation of said analog elements, said digital elements, and connection elements, to configure the module; and

(b) effecting said configuration using a configurable graphical user interface for transforming selections made by the user to a hardware and/or software configuration in a process transparent to the user.

22. The method of claim 21 further comprising operating the graphical user interface by a user for defining a measurement or an action which needs to be performed, and which results in an automatic combination of hardware and/or software elements which are available to create a specific configuration.

23. A user configurable instrument comprising

(b) a user-configurable graphical user interface for effecting said configuration in a process transparent to the user, said graphical user interface having an input from a user who operates the graphical user interface only, and defines a measurement or action which needs to be performed.

24. The instrument of claim 23, further comprising components resulting in an automatic combination of hardware and/or software elements to create a specific configuration in response to the user inputs to the graphical user interface.

25. The instrument of claim 23, further comprising a graphic user interface for use as an input mechanism for at least one of a medical diagnostic and treatment system.

26. The instrument of claim 23 further comprising the graphical user interface defining measurements for at least one of pθ₂, pH, various ions, temperature, blood gases, and biomarkers.

27. A user configurable instrument comprising (a) a configurable system comprising analog, digital and connection elements for receiving inputs from respective sources and for outputting signals for generating control signals having selected electrical and time spatial properties; and said connection elements being configurable after creation of said analog elements, said digital elements, and said connection elements; and