Non-invasive intracranial pressure system

Non-invasive intracranial pressure detection and/or monitoring and use of data with respect thereto. Illustratively, with respect to a method, there can be a method to digitally produce and communicate intracranial pressure data from skull deformation electric signals, the method including: receiving, from at least one sensor, detected skull deformation electric signals at electrical equipment configured to transform and process the skull deformation signals that are received; transforming and processing, by the electrical equipment, the received skull deformation electric signals to produce digital intracranial pressure data; and outputting, by the electrical equipment, the digital intracranial pressure data via an output device operably associated with the electrical equipment to render the digital intracranial pressure data.

I. TECHNICAL FIELD

The technical field includes machine, manufacture, article, process, and product produced thereby, as well as necessary intermediates, which in some cases, pertains to non-invasive intracranial pressure detection and/or monitoring and use of data with respect thereto.

Depending on the implementation, there is apparatus, a method for use and method for making, and corresponding products produced thereby, as well as data structures, articles, computer-readable media tangibly embodying program instructions, manufactures, and necessary intermediates of the foregoing, each pertaining to non-invasively detecting and/or monitoring intracranial pressure, e.g., in animals, humans, which may be in ex-vivo and/or in-vivo conditions.

Intracranial Pressure (ICP) is the relation between the volume of the intracranial space and its components: Cerebral spinal fluid (CSF), blood and brain parenchyma. ICP monitoring can be used in the diagnosis and prognostics of various disorders such as neurological disorders, e.g., stroke, hydrocephalus, tumors well as trauma. Rather than using an invasive technique, i.e., requiring shaving, incision in the patient's head, trepanation of the skull bone and sensor insertion in the brain tissue, embodiments herein involve noninvasive embodiments, e.g., for monitoring this medical parameter, through the cranial bone.

Generally, there can be at least one sensor located to detect intracranial pressure noninvasively, in contrast to being directed to a sensor located invasively, e.g., within a skull or under the skin or where the skin has been removed, e.g., by incision. (The following discussion refers to “sensor” in the singular, with the understanding that embodiments can be configured with one or more sensors.) The sensor can be located with a strap, as an example of a non-invasive manner of locating the sensor with respect to the subject's head. In some embodiments, the sensor can be detecting intracranial pressure by a spring located between the sensor and the patient's head. In any case, the sensor detects intracranial pressure with signals that can be communicated to equipment. Equipment processes the received signals as signal data. That is, if the signals are analog signals, they are converted to digital signal data. In any case, the signal data is saved to a memory configured to store the signal data. The signal data can be processed and also saved in memory configured to store the processed signal data, and can be rendered at a display.

The embodiments can be such as to non-invasively detect and/or monitor what is happening directly inside the central nervous system, e.g., in the patient's head, for such variables otherwise not known to be observable without invasive methods. The central nervous system observations are unique because of the many physiological barriers such as blood-brain-barriers of complex nature containing biochemical, electrophysiological and other components. Peripherical measurements of the arterial or venous pressure or haemodynamic variables normally used in present medical procedures do not necessarily correspond to the corresponding variables monitored by embodiments herein described.

The accompanying figures and discussion of embodiments are intended to illustrate and exemplify in a teaching manner, by way of the prophetic teachings. With this in mind, turn toFIG. 1and consider that equipment1can include sensor device2can non-invasively located adjacent and proximate to the head of a subject, such as a human “patient”. Sensor device2, can be located, for example, so as to allow movement by the patient, e.g., with a strap3. In another embodiment, sensor device2can be located, for example, so as to immobilize the patient or in a helmet.

In some embodiments, the sensor device2can detect skull deformation by such as by an electric strain gage, an optical sensor, an optical fiber, a magnetic sensor, an interferometric sensor, or any other device which detects and/or monitors the skull deformation without trichotomy or surgical incision. Sensor device2can, but need not, be configured to be disposable or reusable after use by the patient in a detecting session.

Generally, equipment1associates the skull deformation with intracranial pressure detection and changes. Equipment1can, but need not, include a signal amplifier4to amplify signals received from sensor device2. Equipment1can, but need not, include an analog to digital converter6. That is, if an analog implementation is carried out, there can be a conversion of the analog signals into digital signals, e.g., signal data. Equipment1can be powered by regular utility electricity, e.g., an AC power source, or by battery power, e.g., to allow and/or protect monitoring during a power failure or to under conditions where regular electrical utilities are unavailable, e.g., in an ambulance. The equipment1has a capability of receiving signals from at least one, and in some embodiments, multiple sensors, and working with different acquisition frequencies.

Equipment1can include a processor8, e.g., in a multiparametric monitor, computer, etc, which processes the signal data to produce output data that is stored in memory operably associated with the processor8, e.g., a digital memory10. The digital memory (device)10can have a database configured to store the signal data and/or the output data. The signal data and/or the output data can be rendered on an internal display12and/or on an external display14.

The equipment1can be configured so that an intracranial pressure apparatus, whatever be the implementation desired, produces output which can include real-time curves of physiological parameters such as intracranial pressure, respiratory and cardiac cycles, and the like on an internal display12and/or an external display14. The equipment1can save the data the patient's time series, e.g., for subsequent review and/or processing, in memory10.

Consider now the embodiment illustrated inFIGS. 2 and 3, wherein a non-invasive sensor device2for detecting or monitoring ICP includes a sensor device2, which is configured to provide protection and location for at least one ICP monitoring sensor (not shown inFIG. 2). The sensor device2can be attached to the patient's head with a strap3which can be produced, for example, from an elastic or rigid material and configured to provide dimensional adjustment to the patient's head.

The strap3can be coupled to the sensor device2through fittings or other means, e.g., at both ends, such as direct affixing in an upper portion of the sensor housing (FIG. 3). The strap3can locate one or more of sensor device2. The strap3can, but need not, include an adjustment system5.

Helmets, hoods, or arcs may instead be used to affix a sensor device2with respect to the patient's head, or other means can be used to provide an equivalent function as the strap3.

In the illustration ofFIG. 4, there can be a sensor housing comprising a lid7and a sensor box base9. Attached to the base9, there can be a support11for a sensor bar13, adapted for stabilizing and affixing the strain sensor15with respect to the base9.

At an end of sensing bar13(opposite the support11) there can be a pin16configured for contacting the patient's head. This pin16can be fixed to bar13to communicate changes in skull volume to sensor15.

Components such as7,9,11,13, and16can be produced out of metal, polymer, carbon, glass fibers, and any combination thereof.

Alterations in ICP cause changes in cranial volume, detected by pin16. The pin16of the sensor15contacts the surface of the patient's head, to detect variations in the volume of the skull. Pin16causes a deformation in, or communicated by, bar13, and the deformation is captured by the sensor15adjacent to an opposite end of the bar13. Accordingly, the device2, and methods of its use, can be used to detect and/or monitor ICP in humans or animals, even in diverse situations, such as trauma, hydrocephalus, intracranial tumors, stroke, pharmacological studies, etc.

So in the illustrated embodiments illustrated inFIGS. 2-12, there can be one or more noninvasive sensor devices2, a strap3or the like, and equipment1, which can is communicatively arranged with the sensor15, e.g., via wires, wireless communication technologies, etc. The equipment1filters and amplifies signals from sensor15, may in some embodiments digitalize the signal from the sensor15, and can send the signal or other output to a printer, computer, tablet, mobile phone, medical monitor, its own display12, etc. There can be a digital memory10in equipment1, e.g., a memory card, to store the digital data, allowing for later analysis.

The noninvasive monitor can facilitate adjusting equipment1for sensitivity to acquire the characteristic morphology of intracranial pressure waves, with their peaks P1, P2, and P3(FIG. 28). The sensor15used may, for example, be a full-bridge, a quarter-bridge, or half-bridge sensor, presenting values of electrical resistance in a system detecting ICP.

FIG. 2illustrates a brain strap embodiment in which the sensor device2is non-invasively contacting a surface of a patient's head, proximate to the skull bone, with a band3. The strap and/or band can, but need not, be configured to be disposable than be reused after use by the patient in a detecting session. In such an embodiment, the band3can be of a material that is non-rigid, such as a polymer or metallic, for example, foil, strip, tape, or the like. Sensor device2can be attached to, or positioned with respect to, the material and the patient's head so as to allow for detection of ICP.

In such embodiments, there can be a connector, such as a wire or other means (not shown in the Figures), communicating the signals from the sensor device to the equipment1. (In other embodiments, the sensor device(s) can be communicatively associated with the equipment1by Bluetooth, ZigBee, or any other remote communication systems.)

Note that a configuration fixes the sensor15and sensor device2on the patient's head, without trichotomy or surgical incision, allowing his or her (or its) movement during the intracranial pressure detecting and monitoring.

FIG. 11andFIG. 12illustrate more of a helmet-type embodiment in which the sensor15is non-invasively contacting a surface of a patient's head, proximate to the skull bone, with a helmet device17. Device17, e.g., with a stereotaxic apparatus, can be such as to immobilize the head of the patient with respect to the sensor device2in a fixed position contacting with the surface of the patient's head. One may, but need not, use such a configuration where certain patient movement is not of particular interest, or for reproducibility of detecting and/or monitoring a condition where position is held constant. In such an embodiment, there can also be a portion of a strap3, with the sensor device2, that can, but need not, be configured to be disposable rather than be reused after use by the patient in a detecting session.

As illustrated more particularly inFIG. 12, device17can be a stereotaxic apparatus to fix the patient's position geometrically in the system (17a—support for temporal regions,17b—support for forehead, and17c—support for the chin). In some such embodiments, there can be quantitative numerical marks on the bars that regulate the supports (17a,17b,and17c) for reference. As illustrated by comparison ofFIGS. 11 and 12, the device17can comprise movable arms18that locate the patient, or in another way of thinking the sensor15, with respect to each other.

The strap embodiments, or the more helmet-type embodiments, can use the flexible material approach discussed above, e.g., such as foil, with a (e.g., strain gage) sensor15, e.g., configured in connection with device17. Another approach is to use a sensor15with a spring (seeFIGS. 13 and 14), e.g., in a housing20.

Turning toFIGS. 13 and 14, the noninvasive sensor can use one or more springs19in detecting the intracranial pressure. One end of the spring19can be adjacent to an upper end of housing20. A pin16is urged by the spring19into contact with the head of the patient.FIGS. 13 and 14show various configurations of the noninvasive sensor15in communication via the spring19with a pin16locatable into contact with the patient's head.

There can be various embodiments hereinafter. In one embodiment, the output or raw data can also be stored and rendered via polygraph system.

Illustratively, embodiments can be carried out by such as the following.

In one embodiment, the equipment1can be used, for example, with the brain strap sensor approach, by:1—Placing the sensor15tip16over the adequate region of the skull bone, for instance the parietal bone region;2—Using an elastic strap3to fix the sensor device2on the head of the patient, e.g., as shown inFIG. 2;3—Connecting the sensor device2to the equipment1using wires (or connecting by wireless protocols);4—Commencing detection and/or monitoring procedure to obtain intracranial pressure signals;5—Processing, including by a processor8, the intracranial pressure signals to produce intracranial pressure data;6—Storing the intracranial pressure data in a database configured to store the intracranial pressure data, the database in a memory10operably associated with the processor8; and7—Displaying12/14the intracranial pressure data.

In some embodiments, there can be such as:1—Communicating signals from the sensor15, i.e., a full detected signal, to the equipment1, the full signal can be a sum of cardiologic, respiratory, ICP signals—and others, if so desired;2—Receiving, the full signal (e.g., in microvolts) at an amplifier4and amplifying the microvolts to volts (1000×);3—Converting, by an analog-to-digital converter6, the analog signal into a digital data;4—Processing the digital data with such as mathematical analyses to produce output;5—Storing the digital data and at least some of the output in the database;6—Rendering the output or communicating it to be output, to a display12/14.

With respect to the processing, the equipment1can carry out mathematical processing, such as Fourier Transform, to separate the signals, which can then be stored and rendered, e.g., via an output device such as a printer and/or display12/14. In some embodiments, the equipment1renders signals such as the filtered signal via an output device, such as a multiparametric monitor, printer, computer or monitor, computer-to-computer communication device, such as a router or gateway.

As mentioned above, in other embodiments, equipment1has a processor8, and in some but not all embodiments, the processor8can be a processor (a processor can be multiple processors working in cooperation) of a computer system as is illustratively represented inFIG. 15. In another configuration, a computer system can be operably associated or in communication with a processor8of a multiparametric monitor, and either or both can be in communication with another computer system.

More particularly, by way of example, there can be a computer system21, which in some embodiments can include processor8and in other embodiments can receive data from equipment1. In either case, computer system21can interact with another computer system22, via a network23. As used herein, the term “computer” generally refers to hardware or hardware in combination with one or more program(s), such as can be implemented in software. Computers can be implemented as general-purpose computers, specialized devices, or a combination of general-purpose and specialized computing devices. Computing devices can be implemented electrically, optically, quantumly, biologically, and/or mechanically or in any combination of these technologies. A computer as used herein can be viewed as at least one computer having all functionality or as multiple computers with functionality separated to collectively cooperate to bring about the functionality, e.g., the functions shown as being carried out by a single computer can be carried out by more than one computer, and the functions shown as being carried out by more than one computer can be carried out by a single computer, without departing from the present intent. In some, but not all embodiments, the computer24can include a single processor, such as processor8and/or multi-processor8implementations of a computer. A processor8can include any device that processes information or executes instructions. Computer logic flow and operations can be used in processing devices, including but not limited to: signal processors, data processors, microprocessors, and communication processors. Logic flow can be implemented in discrete circuits, combinational logic, ASICs, FPGAs, reconfigurable logic, programmed computers, or an equivalent.

Computer-readable media or medium, as used herein, includes any technology that includes a characteristic of memory, e.g., tangibly embodying a program of instructions executable by a computer to perform operations according to an embodiment herein. Memory technologies can be implemented using magnetic, optical, mechanical, or biological characteristics of materials. Common examples of memory are RAM, ROM, PROM, EPROM, FPGA, and floppy or hard disks. Communications medium or connection, as used herein, is any pathway or conduit in which information can be communicated or exchanged. The pathway or conduit can be wired, optical, fluidic, acoustic, wireless, or any combination of the foregoing.

A “computer” or “computer system(s)” as used herein can include one or more computers, which illustratively can be PC systems, server systems, mobile devices, and any combination of the foregoing. Depending on the implementation, a computer can be adapted to communicate among themselves, or over a network such as the Internet. Programs, as used herein, are instructions that when executed by a processing device causes the processor to perform specified operations. Programs can be written in various languages, including but not limited to assembly, COBOL, FORTRAN, BASIC, C, C++, Java, or JavaScript. Languages can be object-oriented like C++ and Java, for example. The programming language can be interpreted or compiled, or a combination of both. The programs are usually processed by a computing system having an operating system. An operating system can be processor-specific, like an RTOS (real time operating system) used in cell phones, or commercial like Mac OS X, UNIX, Windows, or Linux. An operating system or program can be hardwired, firmware, reside in memory, or implemented in an FPGA or reconfigurable logic.

A “network” as described here can be a preconfigured network, like a local area network (“LAN”) of computers, servers, and peripheral devices in a single office, or an ad hoc network caused by the temporary interconnection of computers over the Internet, by modem, via telephone, cable television, radio communication, combinations of these (like a telephone call made in response to a television solicitation), or otherwise to conduct a particular transaction. In the latter sense, the computers in the network do not need to all be linked up at once; as few as two of them can be linked at a time. The link can be a formal link or a casual link, as by sending e-mails or other communications from one computer to the other, or logging one computer into a website maintained on another via the Internet.

The network or Internet-type network connections or communication paths described above can be made in various ways. In one embodiment, the Internet connection can be enabled by a series of devices and transmission lines or paths including: a first computer; a modem connected to the first computer; a telephone (regular or DSL) or cable television transmission line or radio communication channel connected with or generated by a transmitter associated with the modem; a first Internet Service Provider (ISP) receiving the communication; the Internet, to which the first ISP is connected; a second ISP connected to the Internet, receiving the communication; a telephone or cable television transmission line or radio communication channel connected with or generated by the ISP; a modem connected to the second computer; and the second computer.

For example, a computer system21and/or22can each comprise a computer24(e.g., a Lenovo, HP, Apple, or other personal computer; an enterprise server computer; distributed computing; etc.) with one or more processors8(e.g., an Intel or AMD processor or the like), memory10(e.g., RAM, a hard drive, disk drive, etc.) not shown inFIG. 15, one or more input devices25(e.g., keyboard, mouse, modem, sensor15, e.g., via amplifier4and analog to digital converter6or the like (seeFIG. 1)), and one or more output devices26(e.g., a modem, a printer, a display12monitor, external display14, and/or other such output devices). Note that a gateway27or modem28or router29are each illustrative of a computer-to-computer communication device that can operate as an input/output device. To provide other illustrative embodiments, the computer system(s)21/22can comprise at least one of a desktop computer, a telephonic device, a console, a laptop computer, a tablet, and a mobile communication device. The mobile communication device can comprise at least one of a cellular telephone, laptop, a PDA, and a smartphone-type device such as an iPhone. Communications between devices may be wired (e.g., cabled Ethernet home or office network), wireless (e.g., IEEE 802.11 A/B/G/N network transceivers), or near-field radio-frequency communications (e.g., Bluetooth), or optical (e.g., infrared). Networking between devices may be through WANs, LANs, Intranets, Internet or peer-to-peer arrangements, or in a combination of them. The network23may include, for example, gateways, routers, bridges, switches, front-end and back-end servers, ISPs (Internet Service Providers), which may interact with content provider servers, scanners, copiers, printers, and user computing devices. Devices on the network may include interfaces that can be simple, such as a keyboard with an LCD screen, or can be complex, such as a web interface. Web interfaces are presented in a web browser environment. Web browsers render XML or HTML containing pictures, video, audio, interactive media, and links in the display of a computer. Firefox, Internet Explorer, Safari, Chrome, and Opera are examples of well-known web browsers that are available for PCs and mobile devices. Network23can be the Internet.

FIG. 16illustrates, again in a teaching rather than in a limiting manner, logic flow of at least one computer system configured to carry out an embodiment. In the embodiment illustrated, not in a limiting manner, sensor15provides a full signal to amplifier4which amplifies the full signal to produce an amplified full signal. The amplified full signal is communicated to analog-to-digital converter6, which converts the amplified full signal to produce signal data. The signal data is communicated to processor8, which can process and transform the signal data, e.g., by applying a Fourier Transform30and/or Fast Fourier Transform filters31, wavelets32and/or statistical tolls33. Fourier filters decompose a sequence of values into components of different frequencies, for example, most people present a heart rate between 50 and 120 bpm, and these filters can detect the signals in this frequency range and exhibit such as heartbeat signals. The filters can, but need not, be such as origin, matlab, qtiplot, or other signal analysis filter, some of which may use methods such as fast fourier transforms, wavelet processing, and statistical methods for signal analysis and interpretation. The filtering can be carried out to display, or to isolate, physiological components such as cardiologic, respiratory and intracranial pressure data.

The signal data is processed or transformed by the Fourier Transform30to produce a frequency spectrum data34. The signal data is processed or transformed by the

Fast Fourier Transform filters31, wavelets32and/or statistical tolls33to separate out and produce intracranial pressure signal data35, cardiac signal data36, and respiratory signal data37.

The frequency spectrum data34, intracranial pressure data35, cardiac data36, and respiratory data37are communicated to memory10and display12and/or14and/or other output device. Memory10includes a database configured to store the frequency spectrum data34, intracranial pressure data35, cardiac data36, and respiratory data37. In some, but not all, embodiments, computer system21associates or further processes some or all of data34,35,36, and37, into further output, e.g., which can in some embodiments be communicated as illustrated inFIG. 15from computer system21to computer system22, either of which can further process or transform some or all of the output received so as to produce yet further output.

So for example, though not illustrated inFIG. 15, in some but not all embodiments, the equipment1is used to produce output which is then inserted by at least one of computer systems21and22into a report (or other document), such as a medical record. The report or medical record can be generated and configured so that some or all of data34,35,36, and37is located contextually into the report or medical record, which can then be stored e.g., in computer-readable memory, displayed electronically, communicated over a network, or output in hard copy at an output device, e.g., printer. The report or medical record can be generated so that some or all of data34,35,36, and37is located in a preconfigured location in the report or medical record and associated, by at least one of computer systems21and22with other data. So for example, the report can be generated and configured such that some of data34,35,36, and37is electronically located in the report or medical record in association with data one or more of neurological, physiological, pharmacological, endocrinological data, obtained from a memory, such as memory operably associated with at least one of computer systems21and22, e.g., having been previously input. In some embodiments, computer system21or22is programmed to request and capture patient data (e.g., name, age, identification of the patient, hospital registration number, pathology(ies), and other such data in forming, or combining the data34,35,36, and37into the report or medical record.

FIG. 17illustrates the output at, e.g., display12and/or14. The illustrated output is the signal data, e.g., prior to the Fourier Transform30or the Fast Fourier Transform Filters31. The signal data shows raw digital signal data of intracranial pressure. The display shows the full signal from the sensor15, i.e., the ICP signal, the respiratory signal and frequency, and the cardiac signal and frequency.

FIG. 18illustrates a display12/14of raw data includes34,35,36, and37, during a real-time monitoring, in connection with other data output. This display also shows the heart and respiratory rate. (Display12/14can also be adapted to display the real-time curves, e.g., on the computer21display or, through an adapter, to a multiparametric monitor.)

FIG. 19illustrates the results of Fast Fourier filters31applied to the raw signal data, after the use of mathematical tools which divide the signal data into the ICP35, cardiac data36, and respiratory37data.

Embodiments herein can, therefore, include the non-invasive equipment, or parts thereof or operably associated therewith, and methods to detect intracranial pressure (ICP) and use the detected ICP and related data. Any of this data can be processed and analyzed, for medical, pathological, and/or physiological situations, for diagnosis and treatment responsive to the detecting and output from the detecting, especially to identify an initial condition, identify how a patient is responding to a treatment and/or how to adjust a subsequent treatment based on the patient's detected reaction to the treatment, and when to cease the treatment because a target condition has been detected. This has application in the diagnoses of one or more pathologies, e.g., in the vascular, cardiac, respiratory, and central nervous system disorders, and responses to administrations of treatment.

To exemplify the foregoing, a display, e.g., display14, is presented inFIG. 20to illustrate the variation of physiologic parameters during a jugular compression.FIG. 20illustrates a baseline to the left of the peaks on the lower curves, a peak that illustrates an abnormality associated with jugular blood flow, and after administration of a treatment, a return to normal ranges, suggesting that further or alternative treatment is not needed or that the treatment has been sufficient. This is an example of the behavior of intracranial pressure in situations such as hemorrhagic stroke (increase of pressure—jugular compression) and the return (after jugular release) to baseline after treatment (e.g., decompressive craniotomy). The ICP value returns below the baseline, due to the body's defense mechanisms, which tries to maintain body's homeostasis by activating defense mechanisms.

In another teaching embodiment, detection of epilepsy seizures in Wistar rats is illustrated inFIG. 21.FIG. 21illustrates detecting and diagnostics for the seizures (above reference squares added to the bottom axis of the display) and the detected the physiological parameters. The output signals illustrate an epileptic's aura, the sign before the external symptoms. These results show variations in cardiologic, respiratory and ICP signals, monitored inside the skull. Variations in these signals may collaborate diagnosis and treatment monitoring of epileptic patients.

In another teaching embodiment, the equipment1can be used in the diagnostics of hydrocephaly, and to check for proper operation of the shunts.FIG. 22shows the results of the equipment1monitoring illustrative of hydrocephaly patients.

Hydrocephalus is a disease diagnosed using imaging techniques; these devices are expensive and not available for the entire population. The equipment presented here is able to indicate a diagnosis of hydrocephalus through the analysis of low frequency waves on ICP (0 to 0.2 Hz), which vary greatly in amplitude in patients with hydrocephalus, as shown in FIG.22. It's possible see in this graph that patients after insertion of shunts show a decrease in the amplitude of these oscillations. An appropriate periodic monitoring routine now is possible with the equipment described herein.

In still another teaching embodiment, the sensor15and processing related thereto can detect and/or monitor the real-time drug effects, e.g., to determine the dosage and effect, the drug absorption, etc. In some embodiments, especially in children, in old age and patients require drug multi-therapy, and the detecting can be used to determine treatment, e.g., administer more of one or another medication, and determine, from the detected response of the patient, whether to adjust or cease the treatment, etc. For example, drugs can decrease the metabolism, or physiological parameters such as blood pressure, resulting in an intracranial pressure decrease that is detectable according to embodiments herein. Similarly, the reverse effect can be observed in drugs that raise blood pressure or body metabolism.

Monitoring of drugs can be exemplified in the three cases described below.

TheFIG. 23illustrates a display, e.g., display12and/or display14, with respect to an intravenous use of Sodium Thiopental in pigs with 4 Kg (dosage=7 mg/kg body weight), a barbiturate general anesthetic. TheFIG. 23illustrates a decrease in intracranial pressure after the use of this anesthetic (black arrow), thereby illustrating how the sensor15and processing related thereto can detect and/or monitor in connection with anesthesia, important information during surgical procedures.

FIG. 23is illustrative of detecting and/or monitoring of the depth of anesthesia, e.g., on a patient. A black arrow inserted intoFIG. 23shows the use of Sodium Thiopental.

Dipyrone is an analgesic. The decrease in blood pressure caused by this drug can be the subject of the sensor15and processing related thereto, e.g., with respect to ICP. InFIG. 24a display, e.g., display12and/or display14, with respect to rats with approximately 300 g, are illustrated as having received dipyrone by gavage (5 mg/kg body weight). The detecting and/or monitoring, in real time, of the action of the drugs is illustrative of maintenance of patients in intensive care units. Accordingly, embodiments herein can be configured and used to increasing, decrease, supplement, or cease administration of one or more pharmaceuticals or other treatments.

FIG. 24is illustrative of detecting and/or monitoring the effect of dipyrone, e.g., on a patient. Decreased intracranial pressure detected or monitored after the injection of analgesic.

There are substances that can increase the metabolism and the patient's blood pressure, such as adrenaline. The detecting and/or monitoring the effect of such drugs on a patient can be implemented with respect to maintaining of patient's homeostasis, and embodiments herein, are accordingly illustrated inFIG. 25(rats with 300 g, adrenaline dosage of 0.01 mg/Kg body weight). Accordingly, this effect can be detected or monitored via the sensor15and processing related thereto, e.g., with respect to ICPICP, as illustrated in theFIG. 25display, e.g., display12and/or display14.

FIG. 25is illustrative of detecting and/or monitoring a response to adrenaline, e.g., in a patient. The black arrow indicates the injection of the drug.

The sensor15and processing related thereto, e.g., with respect to ICP. InFIGS. 26 and 27, each show a display, e.g., display12and/or display14, with respect to diagnosing and monitoring diseases such as intracranial tumors, hydrocephalus, and others previously discussed herein, as well as in processes in which detections of a patient are used to determine treatment of the patient, e.g., by detected patient response to the treatment.FIGS. 26 and 27illustrate a diagnosis simulated with respect to animal experimentation.

FIG. 26is illustrative of (via a simulation) of intracranial tumor in rabbits (1.5 kg). For example, a rubber balloon can be inserted into the subdural space, the balloon connected to a cannula, so as to be able to inflate the balloon, e.g., with water. TheFIG. 26display, e.g., display12and/or display14, is illustrated as monitoring or detecting changes due to the increase in the balloon, which represents a tumor growth. This teaching illustration is provided to indicate the ability to diagnose and monitor disease progression, as well as the efficacy of treatments such as chemotherapy and radiotherapy.

Another teaching embodiment is directed to diagnosing hydrocephaly and evaluating the performance of shunts. TheFIG. 27display, e.g., display12and/or display14, is illustrated as detecting and/or monitoring of the disease by an experimental animal model (rats with 300 g) in which rats received saline injection into the spinal canal, thus simulating the accumulation of cerebrospinal fluid, characteristic of this disease. The display inFIG. 27is illustrated as showing in real time the increase in intracranial pressure resulting from this volume variation, e.g., in a patient.

FIG. 27provides a hydrocephaly simulation. Depending on the embodiment for the desired application, the sensor15and processing related thereto, can be configured and used to detect and/or monitor the intracranial pressure in patients with trauma, hydrocephaly, tumors, epilepsy, stroke, etc. so as to produce diagnostic data related to the corresponding medical condition and/or to produce data corresponding to a patient's reaction to treatment of that condition, e.g., so as to adjust the treatment responsive to what is detected. (Note that embodiments are not limited to human patient embodiments, and thus can include embodiments configured for animals, especially in connection with veterinary medicine and surgery.) Other examples include hydrocephaly diagnoses, and evaluating the functioning of hydrocephaly shunts, edemas, chronic pain, migraine, etc. (e.g., to evaluate the action of drugs and their half-life in the patient's brain). Still further examples include diagnostics and treatment of brain symptoms related to cerebral fluid flow, labyrinthits, nausea, secondary injury, and treatment thereof. And treatment can, for example, include administering medication, surgery, etc., in connection with the data or display or other output indicating a patient condition and response to the treatment.

FIG. 28is an illustrative embodiment of a display with respect to ICPNI

Monitoring. The ICP wave has typical morphological characteristics, this wave is composed by P1that is the result of the systolic wave of arterial blood pressure, P2that is consequence of the cardiac valve closure and P3that show the accommodation of blood pressure wave in the central nervous system.

Additional examples include diagnosing proper operation of a stent, analyzing cardiac and respiratory parameters with respect to the central nervous system, analyzing cardiologic, respiratory, cardiac and vascular parameters using maneuvers (postural changes, jugular compress, valsava maneuver and physical activity), etc.

Yet further examples include diagnostics and analyses of time series of the intracranial pressure, e.g., to determine the drug dosage required for the adequate homeostasis of the brain pressure. Additional examples include pharmaceutical clinical trials, detecting/monitoring/evaluating the depth of anesthesia procedures in general surgery and making adjustments thereto in response to the data. Yet still further examples include detecting or monitoring the efficiency of chemotherapy and radiotherapy in intracranial and/or skull tumors, cardiologic, and respiratory analyses related to the intracranial pressure signal, etc. and treatment adjustments in response to what is detected.

Other embodiments can similarly be configured for producing the data in connection with exercise physiology, gymnastics, etc. to monitor the effect of physical activity in the brain.

Due to the non-invasive aspects of embodiments herein, the detecting or monitoring can be carried out with respect to cases of loss consciousness (syncope) during space and flight situations, or in cases of pressure changes, such as divers, climbers or other activities with pressure changes.

In sum, appreciation is requested for the robust range of possibilities flowing from the core teaching herein. More broadly, however, the terms and expressions which have been employed herein are used as terms of teaching 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 various modifications are possible within the scope of the embodiments contemplated and suggested herein. Further, various embodiments are as described and suggested herein. Although the disclosure herein has been described with reference to specific embodiments, the disclosures are intended to be illustrative and are not intended to be limiting. Various modifications and applications may occur to those skilled in the art without departing from the true spirit and scope defined herein.

Thus, although illustrative embodiments have been described in detail above, it is respectfully requested that appreciation be given for the modifications that can be made based on the exemplary embodiments, implementations, and variations, without materially departing from the novel teachings and advantages herein. Accordingly, such modifications are intended to be included within the scope defined by claims. In the claims, and otherwise herein, means-plus-function language is intended to cover the structures described herein as performing the recited function and not only structural equivalents, but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment fastening wooden parts, a nail and a screw may be equivalent structures.