Abstract:
Systems and methods are taught for non-invasively monitoring brainstem function and intra-cranial pressure in a patient. Repeated auditory stimulation is applied to the patient in at least one ear to generate an auditory brainstem response. The response waveform is detected with an electrode at a location on the patient&#39;s head. The detected waveform data is compared with known waveform data and an alarm is initiated when a change in the auditory brainstem response is detected based on the comparison that is indicative of a corresponding change in intra-cranial pressure in the patient.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 12/032,384, filed Feb. 15, 2008, which is a non-provisional filing of U.S. Provisional Application No. 60/890,116, filed Feb. 15, 2007. 
     
    
     BACKGROUND 
       [0002]    This invention relates to monitoring intracranial pressure, and in particular to non-invasive intracranial monitoring using waveforms evoked from a patient. 
         [0003]    The invention provides a system capable of monitoring intra-cranial pressure (ICP), using early onset auditory brainstem response (ABR), modified auditory brainstem response (MABR) and electrocochleography (ECochG) methods. The invention is used to estimate when ICP is increased, or has increased compared to the patient&#39;s earlier baseline value. This nurse-friendly, monitoring and warning system constitutes an important bedside surveillance system for a high risk patient group. It is fully automated in both the presentation of auditory stimuli and immediate analysis of the recorded potentials—not requiring that a neurologist, neurosurgeon or neurophysiologist be present for the test or its interpretation. 
         [0004]    Increased ICP is commonly seen in conditions such as brain tumors, head injury, stroke, or cerebral fluid (CSF) build up in hydrocephalus. The management of increased intra-cranial pressure remains a major obstacle to the successful treatment of many patients with life-threatening intra-cranial spacetaking lesions. At the present time, the measurement of ICP requires an invasive procedure—a hole must be drilled through the skull and often the cerebrum must be punctured. Various medical or surgical measures may be used to alleviate increased ICP if detected in a timely fashion. Patients with headaches or certain findings on clinical examination such as drowsiness or focal neurological signs or brain scans that suggest increased ICP, are usually seen in an emergency room and closely observed in the intensive care unit (ICU) Unfortunately, even today, patients with brain masses may rapidly deteriorate as lesions enlarge, and the urgency of surgical or medical measures to combat increased ICP can be misjudged. Nurses and physicians may be short staffed or busy with other patients, and neurological status may be clouded by sedative medications given for headache or restlessness. 
         [0005]    It has been known for many years that increased ICP is frequently associated with fullness in the ears, mild or moderate usually low tone hearing impairment, and dizziness or imbalance. The cause is likely related to the cochlear aqueduct, a distinct channel in the basal skull that interfaces CSF with perilymph destined for the cochlea. Animal studies bear out direct increased CSFIICP pressure transmission to the inner ear and associated damping of electrocochleography (EcochG) potentials. EcochG has not previously been used in patients with increased ICP. Some comparison has been made to Meniere&#39;s disease or ‘endolymphatic hydrops-typified by episodic symptoms of vertigo, progressive sensorineural hearing loss tinnitus, and fullness in the ear—with disturbed EcochG potentials recorded from symptomatic patients. 
         [0006]    Early-onset or short latency auditory evoked responses (ECochG, ABR, MABR) are robust, reliably recorded potentials largely refractory to the presence of depressant and anesthetic medications or the patient&#39;s level of consciousness—making these responses an ideal choice in the intensive care setting. Wave V—the most prominent waveform of the ABR and MABR, and the chosen target for automated analysis, is generated from the critical midbrain region of the brainstem. This same region is highly vulnerable to the effects of transtentorial brain herniation, the most common and fatal form of deterioration in patients with intracranial mass lesions and increased ICP. Thus the ABR and MABR Wave V can capture the early phases of this devastating deterioration associated with increasing ICP. 
         [0007]    Many studies have demonstrated abnormalities in the conventional or standard click-evoked auditory brainstem response (ABR) in patients with increased ICP, and reversal of these abnormalities with normalization of ICP. The standard ABR is well known to be sensitive to brain stem lesions or compression, as found in later stages of increased ICP. However, the invention mirrors rises in ICP compared to a patient&#39;s earlier baseline, and captures mild or moderate increases in ICP, and also the late stages of actual brain stem shift. 
         [0008]    Published reviews in this field have yielded the knowledge that the conventional or routine-click evoked ABR, without actual midbrain shift, may reflect moderately increased ICP in less than one-half of patients, but often with only nonspecific abnormalities. This led the present inventor to develop the MABR to further challenge the cochlea yet keep the test practical and require minimal time. However, the results of these studies could not be accessed in a timely manner, as required to be useful to a critically ill patient under observation, and necessitated a neurologically trained physician or clinical neurophysiologist to interpret the results. Ordinarily, evoked potential studies require such a professional for interpretation. 
       SUMMARY 
       [0009]    The invention is a user-friendly automated system that samples and automatically analyzes early auditory responses, and produces a timely warning signal to alert nursing staff or others of changes reflecting increased ICP. In one form of the invention, it is directed to an intracranial pressure monitoring system, comprising an auditory stimulation and recording unit, which includes a stimulation controller, a memory for storing at least one of established patient baseline waveform data and normative range waveform data, a device for generating a comparison by comparing received waveform data with established patient baseline waveform data or normative range waveform data, and an alarm which is operable based upon that comparison. 
         [0010]    At least one cranial electrode is provided, which is attachable to a patient. An audible stimulation device is included, operable by the stimulation controls. 
         [0011]    In accordance with the preferred form of the invention, the auditory stimulation device includes at least one ear stimulation instrument and an auditory stimulator connected to the ear stimulation instrument. Preferably, there is a pair of ear stimulation instruments, and each ear stimulation instrument comprises an acoustic ear insert. 
         [0012]    Preferably there is a plurality of the cranial electrodes, for judicious placement cranially on a patient. Between three and five electrodes may be used. 
         [0013]    The alarm may be audible, visual or a combination of audible and visual. 
         [0014]    The method according to the invention comprises the steps of auditorially stimulating a patient to evoke a received waveform data indicative of intracranial pressure, then generating a comparison by comparing the received waveform data with one of established patient baseline waveform data and established normative waveform range data, and, finally, generating an alarm responsive to that comparison. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The invention is described in greater detail in the following description of examples embodying the best mode of the invention, taken in conjunction with the drawing figures, in which: 
           [0016]      FIG. 1  is a block diagram of a system according to the invention. 
           [0017]      FIG. 2  is an example of use of the invention with ABR click or pure tone, and 
           [0018]      FIG. 3  illustrates use of the invention with MABR. 
       
    
    
     DETAILED DESCRIPTION 
       [0019]    Patients would greatly benefit if a safe, non-invasive bedside method existed to automatically sample and interpret physiologic signals that reflect increasing ICP in a timely manner. The system of the invention is used to monitor ICP utilizes MABR or/and EcochG methodology, and is not significantly affected by patients taking depressant or paralytic medications, or under general anesthesia. The system should greatly impact patient care, save lives, and lead to fewer invasive ICP monitoring procedures. The system should be a valuable back-up safety measure to existing medical and surgical management, including invasive ICP monitors which can fail about 7% of the time. 
         [0020]    As explained in greater detail below, the invention may utilize conventional components, such as Bio-logic (Natus/Bio-logic, Mundelein, IL) instrumentation and accessories. A commercially available Navigator Pro laptop based unit can be used to perform stimulation, recording, amplification, averaging, and display of waveforms. A separate component stimulator and preamplifier is attached directly to the patient. Auditory stimulation is delivered by soft foam ER 3A insert headphones placed just within the external ear canal, and all recordings by noninvasive skin surface stick-on or gel electrodes. A Biologic TM (tympanic membrane) electrode is exclusively used for ECochG. Natus/Bio-logic is additionally a leader in the manufacture and distribution of automated, nurse friendly ABR devices used routinely world-wide as a hearing screen in neonates. 
         [0021]    Electrocochleography (ECochG)—Analysis of electrical signals generated by the cochlea which—require proximity to the inner car to be reliably recorded following moderately loud (100-105 dBpeSPL) auditory click stimulation delivered by insert headphones. An adequate eighth nerve action potential (AP) voltage of about 1 microvolt (uV) is recorded from the tympanic membrane (TM) electrode referred to the contralateral mastoid skin surface (nasion ground) with a latency of about 1.5 millisecond after the auditory stimulation. In addition to the AP, are two earlier cochlear hair-cell receptor potentials whose onset begins with the auditory stimulation—the cochlear microphonic (CM), and summating potential (SP). 
         [0022]    Auditory Brainstem Response (ABR)—consists of five positive vertex scalp recorded waves generated by the auditory nerve and 4 auditory brainstem nucleii or tracts, recorded within 6 to 7 milliseconds. Foam insert headphones deliver a moderately loud (100-105 dBpeSPL) auditory click stimulus at approximate rates between 11-22 per second. Wave V (and following Vn) are usually most prominent with a voltage (amplitude) approaching ½ microvolt (uV). For ABR the active skin surface electrode is placed at the frontal vertex (Fz) and referenced at the ipsilateral mastoid skin surface. A surface ground electrode is placed at the nasion. The ABR, most notably Wave V, can also be generated by an insert headphone that delivers a pure tone burst stimulus, and is recorded with identically placed recording electrodes. In some instances, this tonal ABR may have more promise than the conventional click ABR in capturing ICP. 
         [0023]    Modified Auditory Brainstem Response (MABR) - is elicited by a rapid click stimulation rate of about 40-70 per second and binaural (bilateral simultaneous) presentation to both ears, both modifications augment the amplitude of the prominent Wave V (and Vn) which are the major waveforms of interest The frontal vertex (Fz) referred to C2 neck linkage also augments Wave V amplitude. A ground is placed at the nasion. This augmentation is necessary since the MABR is performed at 4 moderate loudness intensities (i.e. 85,75,72,65 dBpeSPL), all well below that of the standard ABR (100-105 dBpeSPL). These maneuvers stress the cochlea, yet yield a robust Wave V (approximately 1 uV) for automated Wave V recognition, Wave V latency/intensity and Wave V amplitude/intensity curves for analysis, display if desired, and warning. An MABR wave V (and Vn) can also be generated by a pure tone. 
         [0024]    This invention is for a bed-side auditory stimulation and surface scalp recording device that can use tympanic membrane recorded electrocochleography (ECochG), the conventional click-evoked, or pure tone burst auditory brainstem response (ABR), and modified click or tone burst evoked ABR (MABR) tests involving bilateral (binaural) or unilateral- rapid stimulation rates of diminishing stimulation intensities to create Wave V latency/intensity and Wave V amplitude/intensity decay curves. Easily tolerated soft foam insert headphones deliver the stimuli and simple skin surface electrodes are used for recording the potentials. Wave V, the most prominent ABR waveform, can be windowed and captured (peak picking) with software facilitating automated wave form recognition and analysis. Software can also handle waveforms derived at diminishing intensities and create the above mentioned latency/intensity and amplitude/intensity curves. When these curves reach critical values compared to an earlier baseline in the same patient or curves derived from normals, a warning tone and light alerts hospital staff of the concern for increasing ICP in the patient. The early-onset evoked response battery can be automatically set to be administered every 10 or 20 minutes (etc), as determined by the nursing staff or physicians. 
         [0025]    A non-invasive, bedside intra-cranial pressure monitoring system  10  according to the invention is generally illustrated in block form in  FIG. 1 . The system  10  includes an auditory stimulation and recording unit  12  which may, as explained below, be a single unit or a series of individual elements joined as a unit. The auditory stimulation and recording unit  12  is used for monitoring the ICP of a patient  14 , as also explained further below. 
         [0026]    The auditory stimulation and recording unit  12  includes a CPU  16 , which may be a general purpose computer, as identified above, and which includes all software and memory needed in order to perform not only storage of waveform data, but also analysis required by the invention. The CPU  16  thus includes, as indicated on the CPU  16 , memory, the master program necessary for operation, automated peak recognition for analyzing waveform data received from the patient  14 , latency/intensity curves which provide normative range waveform data, and baseline and population comparisons. The baseline can include patient baseline waveform data collected from the patient  14 , and the population comparisons can include waveform data gathered from patients with known levels of increased ICP. A user input  18 , which may be as simple as a keyboard, is used to import data into the CPU  16 . 
         [0027]    The unit  12  also includes alarm and parameters display  20 . The display  20  can be as simple as an audible alarm, or a visual display, or a combination of both audible and visual displays to provide an indication relative to comparison of waveform data received from the patient  14  with data stored in the CPU  16 . 
         [0028]    The unit  12  also includes a stimulator control  22 . The stimulator control  22  is used to send stimulating signals to the patient  14  via a cable  24 , or wirelessly if wireless connections are used. 
         [0029]    For appropriate connection to electrodes placed on the patient  14 , the auditory stimulation and recording unit  12  is connected through a typical preamplifier  26 . Depending on the system being used to obtain waveform data from the patient  14 , electrodes  28  through  36 , which may be non-invasive skin surface stick on or gel electrodes, are employed. The electrodes  28  through  36  are connected via cables  38  to the preamplifier  26  and then to the auditory stimulation and recording unit  12 . 
         [0030]    For auditory stimulation, ear inserts  40  and  42  are used. The inserts  40  and  42  may be standard soft foam insert headphones which are placed just within the external ear canal of the patient  14 . Each of the ear inserts  40  and  42  is activated by a respective conventional auditory stimulator  44  and  46  through a respective acoustic tube  48  and  50 . 
         [0031]      FIG. 2  illustrates the invention, using auditory brainstem response (ABR). For this purpose, the electrode  30  is placed at the frontal vertex and the electrode  32  is placed at the nasion as a surface ground electrode. The electrodes  34  and  36  are mastoid electrodes from which waveform data may also be obtained. 
         [0032]      FIG. 3  illustrates the use of the invention with MABR. The electrode  30  is connected to the frontal vertex and the electrode  32  is connected at the nasion as a ground. The electrode  28  is connected at the neck to augment the wave V amplitude. 
         [0033]    Initiation of an alarm at the display  20  depends on set limits that are set in the unit  12 . Intensive care unit monitoring of early-onset (short latency) auditory evoked responses is similar to intra-operative monitoring, and if there is a fifty percent drop in the wave V amplitude, or ten percent increase in wave V latency, compared to the patient&#39;s baseline waveform data, the CPU  16  can be set to issue a warning via the display  20 . Other limits can also be set, such as a wave V latency shift or wave V amplitude drop beyond  2 . 5  standard deviations can trigger a warning by the display  20 . 
         [0034]    While the invention has been described with respect to comparison of patient waveform data with either the patient&#39;s baseline waveform data or normative range waveform data, it can also be compared with other waveform data, such as waveform data from a group of patients with known levels of increased ICP. 
         [0035]    Even more rapid rates of auditory stimulation (100 or more clicks or tone bursts per second—requiring maximum-length sequence techniques) may bring out first and higher order nonlinear responses, which may prove more sensitive to changes in ICP. A stimulator and preamplifier component may be attached directly to the patient, held by a neck band or pocket, and this portable component (the size of a deck of cards) communicating wirelessly with the near-by bedside unit  12 . The patient could return from tests without a need to remove the electrodes or ear inserts, and once again be within range of the base unit for monitoring. 
         [0036]    Various changes can be made to the invention without departing from the spirit thereof or scope of the following claims.