# Patent

## Title
Modular systems for monitoring the presence of a person using a variety of sensing devices

## Abstract

A capacitive sensor element for use with a patient monitoring system and a method for manufacturing and dispensing such sensor elements for use. The sensor elements include a flat, flexible, substrate layer that is manufactured into a roll that also includes at least two longitudinal conductive elements printed or layered onto one side of the substrate layer material. Individual capacitive sensor elements comprising a section of the substrate material with corresponding sections of the conductive elements may be separated from the manufactured roll by tearing along perforations across the width of the substrate layer material. Once an individual capacitive sensor element has been separated from the roll for use, one end of the element is folded over to align pairs of connector apertures positioned through the conductive elements and the associated substrate layer. Dual snap electrical connectors are positioned over and through the apertures to provide the necessary electrical connections between the capacitive sensor and the instrumentation of the patient monitoring system. The present invention further includes a method of manufacturing the roll of capacitive sensor elements according to the structures described above and providing such rolled elements in a dispenser configuration for use in facilities utilizing the patient monitoring systems.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
The Priority to U.S. Provisional Patent Application Ser. No. 61/088,672, filed Aug. 13, 2008, and U.S. provisional Patent Application Ser. No. 61/096,663, filed Sep. 12, 2008.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to devices for the detection of dielectric shift induced capacitive changes. The present invention relates more specifically to the use of such devices for the detection and monitoring of the presence or absence of a person from a medical bed, chair or other support structure so as to insure the safety of a patient occupying such a structure.
2. Description of the Related Art
A problem well known to medical service providers is that of making sure certain patients remain in their medical bed or chair. Reasons for this include the need to quickly locate the patient, administer medical treatment to the correct patient, and the prevention of patient injury. Such knowledge is particularly important when patients have become disoriented due to illness or medication.
Medical bed and chair occupancy monitoring systems have been devised to assist medical providers with monitoring the presence or absence of a person in their bed or chair. Such systems typically are equipped with an alarm or are electronically tied to a common monitoring location, such as a nurses station. Such systems principally use some form of pressure sensitive switch as their key sensing element. U.S. Pat. Nos. 4,484,043 and 4,565,910, both Musick et al, and other similar patents describe switch mechanisms which are used to open and close a circuit to indicate the evacuation of a bed or chair by a patient. In the above described patents, the switch apparatus is housed in a thin rectangular cover which may be placed between the patient and the mattress or between the patient and the seating surface. An alternative version of the above described switch mechanism is placed between the lower surface of the mattress and the upper surface of the bed frame. The switch devices in all of the above described mechanisms are each comprised of two rectangular conductors which run the length of the device, are parallel to each other and lie one on top of the other. The two conductors are separated at both ends by a pliable material such as foam and are held apart from each other through the rigidity of the switching apparatus itself. The switch is activated by the pressure of the patient's body weight on the device, either directly thereon or indirectly through the mattress. Once this weight is applied, the two conductive elements come into contact, the switch is closed, and the system indicates that the patient is in the bed or chair. When the switch is opened by the absence of the patient's weight in the bed or chair, the system then sounds an alarm or sends a signal to the medical facility call system through an appropriate interface.
Such pressure sensitive switching elements, as previously described, suffer from certain inherent problems. Switching elements which are placed under the mattress exhibit extremely limited sensitivity and selectivity in identifying the presence of a patient in the bed. This is due to the fact that the patient's weight in the bed is masked by the mattress itself. This masking effect tends to result in frequent false alarms due to the switch failing to close properly, as well as the failure to generate an alarm when the switch fails to open, even though the patient is no longer in the bed. As for pressure sensitive switches placed between the patient and the mattress or seating surface, they must be extremely thin to afford the patient a reasonable degree of comfort. Although such switches exhibit substantially improved sensitivity and selectivity, the required thinness of the movable switch elements, their supportive structure and the required dielectric space between them causes them to have a considerably limited life. Such switches are, therefore, manufactured as disposable devices whose costs prohibit their broad acceptance and use.
It is, therefore, an object of this invention to provide a proximity induced non-compressive dielectric shift sensing device, which replaces the existing pressure sensitive switches previously described for the monitoring of the presence of a patient in a medical environment. A further object of this invention is to provide such a device which either interfaces with occupancy monitoring control modules already in use or utilizes self-contained control module circuitry and controls.
It is another object of the present invention to provide a proximity induced non-compressive dielectric shift sensing device which may be used as a portable unit, or may be wholly or partly built into or mounted on a medical bed, chair, mattress, cushion or similar structure to sense the presence or absence of a person normally occupying the structure.
It is a further object of the present invention to provide a proximity monitoring device with a limited and controlled range that can reliably detect the presence or absence of a person, thereby decreasing the number of false and unreliable alarms.
It is another object of the present invention to provide a proximity monitoring device which will greatly decrease or eliminate patient discomfort by replacing mechanical pressure sensitive switches in the medical bed or chair with a considerably thinner and more flexible sensing element.
It is a further object of this invention to provide a proximity monitoring device, the sensing element of which will exhibit considerably lengthened service life through the elimination of all moving components within the sensing element.
It is a further object of this invention to provide a proximity monitoring device whose sensing element is inherently simpler in design and to manufacture, and utilizes less raw material, thereby resulting in a lower cost end user product.
Additional objects, advantages and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
SUMMARY OF THE INVENTION
According to the present invention, the foregoing and other objects and advantages are attained by an electronic device able to detect and monitor the presence or absence of a person within a pre-defined space. The device generally comprises a capacitive array housed within a polyester mat or other appropriate nonconductive substrate material which is interconnected with a control module. The control module supplies to the capacitive array a suitable oscillator derived driver current and concurrently senses capacitance value changes within the capacitive array induced through dielectric shifts within the array brought about by the proximity or absence thereof of the patient's body mass. The monitor/control module generally comprises a power supply, a driver/sensor circuit, a comparator/calibration logic circuit, a system interconnection integrity circuit and an alarm generation circuit. It may also optionally contain a nurse call relay circuit for interconnection to a facilities nurse call system.
The driver/sensor circuit provides and senses a suitable current to the capacitive array located in the patient's bed or chair. The driver/sensor circuit is connected to and controlled by a comparator/calibration logic circuit that is most preferably microprocessor based. This logic circuit continually analyzes and optimizes signals received from and generated by the driver/sensor circuit. In this way, the logic circuit defines capacitive value parameters which it interprets to indicate whether a patient is in close proximity to the capacitive array or absent from that array. In such manner, the logic circuit determines the presence or absence of a patient from his or her support structure. Should the capacitive value change and remain at a level indicative of a patient's absence from their support structure, the logic circuit would, after a suitable pre-programmed time delay, instruct an alarm circuit to activate. This alarm activation may consist solely of audible and/or visible alarms on or within the control module or may be directed to a medical facility's nurse call system through an appropriate interface relay circuit contained either within, or remote to, the control module.
In addition to the above described functions, the logic circuit receives continuous data from the control module system interconnection integrity circuit about the continuity of connection between the control module and the capacitive sensor array and, where appropriate, between the control module and the medical facility's nurse call system.
The logic circuit may also, if appropriate, continuously monitor the entire system during utilization for service faults and subsequently generate appropriate alarms.
The apparatus of the invention, uses a proximity induced non-compressive dielectric shift sensing mechanism, and thus reliably detects the presence or absence of a patient from a bed, chair or other support structure, with minimal discomfort to the patient and with a greatly extended sensor element service life.
Still other objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description, wherein multiple preferred embodiments of the invention are shown and described, simply by way of illustration of the best mode contemplated by the inventor for carrying out the invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic block diagram of a first preferred embodiment of the device's control/monitor module interconnected with a sensing element capacitive array.
FIG. 2 is a cross-section of the sensing element capacitive array as shown in FIG. 1.
FIG. 2a is a detailed cross-section of a first preferred embodiment of the snap-on connector of the present invention.
FIG. 2b is a plan view of an alternative sensing element capacitive array utilizing stacked conductive elements within the array.
FIG. 2c is a cross-section of the sensing element shown in FIG. 2b taken along line B.
FIG. 3 is a plan view of the structures of the various components of the present invention.
FIG. 3a is a plan view of an alternative strain-relief structure and function for the mat of the present invention.
FIG. 4 is a plan view of a preferred location for the sensing element capacitive array as shown in FIG. 1 in relation to a patient in a medical bed.
FIG. 5 is a perspective view of the wheelchair mounting clip of the present invention.
FIG. 6 is a perspective view of the wall mounting clip of the present invention.
FIG. 7 is an exploded perspective view of a locking embodiment of the wall mounting clip of the present invention.
FIG. 8 is a plan view of the in-line auxiliary alarm module of the present invention.
FIG. 9 is a schematic block diagram of the functional elements of the in-line auxiliary alarm module shown in FIG. 8.
FIG. 10 is a schematic block diagram of a second preferred embodiment of the system of the present invention.
FIG. 11a is a plan view of the active infra-red sensing module of the present invention.
FIG. 11b is a schematic block diagram of the functional elements of the active infra-red sensing module of the present invention.
FIG. 12 is a plan view of the in-line elapsed time module of the present invention.
FIG. 13 is a schematic block diagram of the functional elements of the in-line elapsed time module of the present invention.
FIG. 14 is a plan view of the wireless transmission modules of the system of the present invention.
FIG. 15 is a schematic block diagram of the system of the present invention incorporating the wireless transmission modules shown in FIG. 14.
FIG. 16 is an exploded perspective view of an alternative attachment mechanism for the snap-on electrical connectors of the system of the present invention.
FIG. 17a is a detailed exploded perspective view of the snap-on connectors shown in FIG. 16.
FIG. 17b is a detailed cross-sectional view of the snap-on connectors shown in FIG. 16.
FIG. 18 is a perspective view of an alternative mattress cover embodiment of the present invention.
FIG. 19 is a detailed plan view of the underside of the mattress cover embodiment shown in FIG. 18.
FIG. 20 is an exploded perspective view of an interconnect cord component associated with the system of the present invention.
FIG. 21 is a perspective view of an alternative mattress cover embodiment of the present invention.
FIGS. 22a and 22b are detailed cross sectional views of the alternative mattress cover embodiment shown in FIG. 21.
FIGS. 23A and 23B are detailed perspective views of a further alternative embodiment of the mattress cover configuration of the present invention showing the stretch fabric conductive thread structure.
FIG. 23C is a perspective view of the implementation of the thread structure disclosed in FIGS. 23A and 23B.
FIGS. 24A & 24B are perspective views of the wheelchair back sensor sleeve embodiment of the present invention.
FIG. 25 is a schematic block diagram of the interconnect component of a preferred embodiment of the present invention.
FIG. 26 is a perspective view of a roll of capacitive sensor elements of the present invention.
FIG. 27 is a perspective view of an individual capacitive sensor element of the present invention separated from the roll shown in FIG. 26.
FIG. 28 is a perspective view of an individual capacitive sensor element of the present invention shown in FIG. 27 as configured during its assembly with the electrical snap connector elements.



DESCRIPTION OF THE PREFERRED EMBODIMENT
As generally described above, the device of the present invention has practical application in a number of situations. The device may be used to monitor the presence of a person, or animal, within a pre-defined space. The invention described may be used in hospitals or other medical facilities to monitor the occupancy of medical beds, chairs or other supportive structures whenever it may be useful to determine the status of occupancy of such structures. In addition to its use as a stand alone system in combination with such structures, it is possible that the sensing element capacitive array, through its inherently long service life, could be embedded in or under the surface materials of bed mattress covers and seating surfaces. In such fashion a medical facility would then only have to supply and interconnect the control/monitor module component. Equivalently, if appropriate, the entire monitoring system could become an integral component of an appropriate medical bed or chair on a permanent basis either by original manufacture or by retrofit.
Outside the hospital area, the present device may be used in nursing homes, intermediate and long-term care facilities, mental hospitals, and other similar institutions needing to track the presence of individuals. The invention is not limited to institutional use, but also has practical application as a single, stand alone device in addition to its potential for becoming a built-in device. Such applications could include in-home health care and presence monitoring for the increasing number of patients who choose to have medical care provided in their own homes.
Reference is made, therefore, to FIG. 1 for a description of a first embodiment of the current invention. FIG. 1 shows a schematic block diagram showing control/monitor module (10) for the invention interconnected through connections (12) and (13) to one embodiment of sensing element (14). Control/monitor module (10) is made up of several circuit components, including power supply (16). Power supply (16) may consist of an internal power source such as a battery, an external source with an appropriate feed to control/monitor module (10) or any other appropriate source of power known in the art.
Additional circuit components disclosed in FIG. 1 include driver/sensor circuit (18) which provides an appropriate driver current to capacitive array (26) contained within sensing element (14) and concurrently senses capacitive value changes produced within capacitive array (26) through dielectric shifts caused by the proximity or absence of the patient's body mass. Also disclosed in FIG. 1 is comparator/calibration logic circuit (20) which is preferably a microprocessor circuit containing embedded programming suitable to the applications described herein. Comparator/calibration logic circuit (20) interfaces with driver/sensor circuit (18) and alarm generation circuit (22) also contained within control/monitor module (10). In addition, comparator/calibration logic circuit (20) receives input data from system interconnection integrity circuit (24). Comparator/calibration logic circuit (20) continuously monitors the functions of driver/sensor circuit (18) both optimizing the appropriate driver current to capacitive array (26) embedded within sensing element (14) and equivalently continuously monitors and analyzes signal data from the driver/sensor circuit (18).
When the overall system is first activated comparator/calibration logic circuit (20) will determine, through the capacitive value readings it initially obtains, whether the overall system is correctly connected (through data derived from system interconnection integrity circuit (24)) and, if such is the case, then whether a patient's body mass is already proximal to sensing element (14) or if the patient's body mass is absent. From the data derived from such capacitive value readings, comparator/calibration logic circuit (20) will set appropriate capacitive value calibration parameters which, when equaled or exceeded, would indicate the presence or absence of a patient's body mass from proximal contact with sensing element (14). Due to varying environmental conditions (humidity, the presence or absence of other grounded or non-grounded structures, body mass of the patient, etc.), that the capacitive elements (26) embedded within sensing element (14) may be subject to comparator/calibration logic circuit (20) may, as required, adjust the calibration of the capacitive value change parameters.
The principal signal characteristic utilized by comparator/calibration logic circuit (20) is not a direct analysis of capacitive change value derived from sensing element (14), but rather an analysis of the ratio comparing the inherent, resting “unoccupied” capacitance of sensing element (14) examined along side a capacitive value caused through a dielectric shift within sensing element (14) when a patient's body mass comes into contact with sensing element (14). It has been demonstrated through experimentation that a suitable ratio differential that provides accurate and reliable monitoring function by the invention, should be 3 to 1 or more.
The first embodiment of the invention utilizing sensing element (14), as shown in plan view in FIG. 1, has experimentally produced an inherent, resting capacitance value of approximately 15 to 20 picofarads when the capacitive array conductive elements are each 2 inches wide by 30 inches long, separated by a dielectric interspace (28) of 2 inches. This overall array is embedded in polyester substrate matrix (30) of sensing element (14) whose overall dimensions are approximately 6 inches wide by 30 inches long. The proximity application of an adult human body mass to sensing element (14) as shown in FIG. 4, has reliably produced capacitive value readings in excess of 250-300 picofarads or a ratio of 12 to 1 or more.
Existing materials utilized for capacitive array (26) manufacture may include copper film, aluminum film, silver/carbon conductive ink, etc. In a preferred embodiment sensing element (14) as shown in plan view in FIG. 1 and in cross-section in FIG. 2, consists of 1 mil copper conductive film hermetically sandwiched between two 2.5 mil layers of inert polyester substrate (30).
Referencing FIG. 2, the cross-sectional structure of sensing element (14) in general, and more specifically, the cross-section located at each connection point (13), is described in more detail. As indicated above, a metallic conductive film, 1 mil thick in the preferred embodiment, serves as capacitive array component (26). Capacitive array component (26) is hermetically sandwiched between two layers of inert polyester substrate (30). Connector (13) is a snap connection of the type that is typically used and referred to as an EKG connector. Attachment of snap connector (13) to conductive film (26) is made first by providing a circular window through polyester substrate (30) of a size sufficient to permit direct contact between the metallic components of snap connector (13) and the metallic conductive film, and then compressing the two-part components of snap connector (13) together so as to penetrate through conductive film (26) and compress a circular portion of conductive film (26) between the electrical contacting elements of snap connector (13). In order to provide further integrity to the connection, the electrical contacting elements of snap connector (13) may be soldered to the copper conductive film (26). Reinforcing layer (15b) is also configured with a window through which the electrically conductive components of snap connector (13) are allowed to protrude. The remaining portion of reinforcing layer (15b) adheres to the outer surfaces and edge of the sandwiched substrate/film/substrate layers as shown. This configuration provides not only an appropriate means for reinforcing the edge of sensing element (14) but also serves to seal the edge and the area around snap connection (13).
FIGS. 2b and 2c disclose yet another structural arrangement for sensing element (14) that under certain conditions would provide more optimal capacitive characteristics. In. FIG. 2b, capacitive array elements (26) are divided into three components (26a, 26b, and 26c). These components are laid one on top of another so that they are concentrically arranged operating a very long interface edge for a relatively small linear geometry. The actual construction of sensor element (14) as described in FIGS. 2b and 2c is best seen in cross-section in FIG. 2c taken along line B in FIG. 2b. While the various array elements (26a-26c) are in fact vertically stacked, the resultant structure is such as to create a sequence of concentric, coplanar elements that function much in the same way as the above-referenced two-dimensional configurations. Interspaces (28a and 28b) in this case would be layers of dielectric material such as, for example, the material utilized for polyester substrate (30). The primary requirement is that these layers be flexible and electrically insulative so as to create the electrical capacitive array described above.
Electrical connections for the embodiment shown in FIGS. 2b and 2c would be made as disclosed at connections (13a, 13b, and 13c). Capacitive elements (26a and 26c) would, in this embodiment, function as a single electrical element of the capacitive array with element (26b) functioning as the opposite element. Connections (13a) through (13c) are made according to this arrangement.
Reference is again made to FIG. 1 for further details on the operation of the electronics of the present invention. As previously stated, when comparator/calibration logic circuit (20) achieves or exceeds a pre-defined high or low ratio limit set by its calibration circuitry in an ongoing manner, its logic circuit will determine whether control monitor module (10) enters a “resting”, “monitor”, or “alarm” state. Appropriate “hold” and “monitor activate override” commands to the logic circuit may be given by an external operator, such as a patient care giver through appropriate switches integral to the circuitry. Under its own command, the logic circuit will analyze the initial absence of a patient's body mass from sensing element (14) when first activated and will enter a resting or “hold” status. On proximity application of a patient's body mass to sensing element (14) logic circuit (20) will sense the increased capacitance value generated by driver/sensor circuit (18) and enter a “monitor” status mode. On removal of the patient's body mass from sensing element (14) and an equivalent appropriate ratio capacitance value decrease derived from driver/sensor circuit (18), logic circuit (20) will enter an “alarm” status mode. Should this “alarm” status exist for longer than a predetermined, operator programmed time delay, logic circuit (20) will instruct alarm generation circuit (22) to enter an “alarm” mode. The purpose of the operator programmed time delay, if required, is to prevent improper or false alarms being generated by the described device through the transient shifting by the patient of his or her body mass adjacent to sensing element (14). An “alarm” mode activation by control module (10) will trigger activity of nurse call relay circuit (32), which will in turn activate a medical facility's nurse call system (34) if so interfaced.
Should comparator/calibration logic circuit (20) ultimately require alarm generation circuit (22) to enter an alarm generation state caused by the absence of the patient's body mass from the sensing element, the alarm status so generated will be maintained, under normal circumstances, even though the patient reapplies his/her body mass to the sensing element following the generation of such an alarm. Such programming (which may be overridden by the caregiving operator) will dissuade the patient from frequently moving off and on the sensing element. Comparator/calibration logic circuit (20) may also be programmed to perform other functions as required (for instance, automatically shifting to a “monitor” mode from a “resting” or “hold” mode when the patient's body mass has been proximal to sensing element (14) for a defined period of time).
Driver/sensor circuit (18) is positioned in close attachment to sensing element (14) in order to reduce any extraneous electromagnetic field effects. Driver/sensor circuit (18) comprises circuitry appropriate for measuring the capacitance in capacitive array (26) and generating a variable frequency signal relative to the capacitance value. The variable frequency output thus encodes the capacitance value in a signal that is less susceptible to interference from extraneous fields. The signal can be provided through ordinary wire connections (12) in FIG. 1 back to control/monitor module (10).
Reference is now made to FIG. 3 for a detailed description of the structural nature of the system described schematically in FIG. 1. Sensing element (14) is structurally much as described in FIG. 1, being made of a flexible substrate (30) with embedded flexible capacitive array elements (26). Capacitive array (26) is separated by interspace (28). Substrate (30) effectively surrounds and encases capacitive array (26).
At each end of sensing element (14), as shown in FIG. 3 are reinforcing layers (15a) and (15b). These layers, as described generally above with respect to FIG. 2, serve the dual purpose of reinforcing the attachment ends of sensing element (14) and sealing these ends at the same time. At a first end of sensing element (14), reinforcing layer (15a) covers the upper and lower surfaces of sensing element (14) and wraps around its edge much in the manner described in FIG. 2 with respect to reinforcing layer (15b). Hole or slot (11a) is punched through the entire structure (five layers) and is positioned to facilitate the attachment of a means for holding sensing element (14) to the patient's bed.
Likewise, reinforcing layer (15b) is positioned at an opposite end of sensing element (14) and wraps around the edge thereof in the manner described with regard to FIG. 2. Hole or slot (11b) is punched through the layers of sensing mat (14) and provides a means for attaching this end of sensing element (14) to the patient's bed. In addition, hole or slot (11b) provides a strain-relief mechanism as described in more detail below.
Conductors (17a) and (17b) connect the array elements (26) to the electronics of the present invention through connection points (13a) and (13b). As described above, in the preferred embodiment, these connection points (13a) and (13b) constitute EKG-type snap connectors. These types of connectors provide a sufficiently rigid, yet removable electrical attachment. FIG. 3a shows an alternative preferred embodiment and function of hole or slot (11b). To facilitate a strain-relief function on conductors (17a) and (17b), hole or slot (11b) is elongated and provides an aperture through which conductors (17a) and (17b) pass before connecting to connection points (13a) and (13b). In this manner, any strain on conductors (17a) and (17b) pulls at connection points (13a) and (13b) in a direction that is less likely to result in a disconnection.
In the preferred embodiment, driver/sensor circuit (18) is encased within a small enclosure immediately adjacent connection points (13a) and (13b). It is anticipated that in order to minimize external electromagnetic field influences, conductors (17a) and (17b), which are unshielded, would be relatively short. In the preferred embodiment, conductors (17a) and (17b) are approximately 3 inches in length. As indicated and described above, driver/sensor circuit (18) converts the capacitive values measured from sensing element (14) into a frequency output that is less susceptible to external electromagnetic field interference. This frequency signal is provided by way of connector (12) to control monitor module (10) as shown. In the preferred embodiment, connector (12) is a four-conductor telephone-type cable terminating in a removable plug insertable into an appropriate telephone-type jack in control monitor module (10).
In the preferred embodiment, control monitor module (10) comprises a box shell of dimensions approximately 4.50 inches high by 2.25 inches wide by 1.00 inches deep, surrounding the electronics described above. On the external surface of the module enclosure is provided guard (31) which serves the dual purpose of protecting and shielding control button (19) by way of cover panel (33) and acting as an attachment point for the module through strap slots (35). The attachment of monitor module (10) to the patient's bed is described in more detail below.
Control monitor module (10) includes, in the preferred embodiment, a piezoelectric acoustic sounder as is well known in the art for use with alarm systems and the like. Control monitor module (10) of the present invention, however, is structured so as to be capable of incorporating a piezoelectric device much larger than might normally be utilized in a modular enclosure of the size described above. This is possible because the resonance chamber for the piezoelectric sounder is incorporated into the wall structure of the control monitor module box. The cylindrical chamber normally associated with “off-the-shelf” sounders is eliminated and replaced with a chamber created by the front and back walls of the monitor module enclosure. This greatly reduces the amount of space required for a sounder with a high decibel output.
In addition, monitor module (10) retains a plurality of LED indicators as shown to provide the user (the care giver or nurse) with indications regarding the status of the system. According to the functions described above and below, monitor module (10) incorporates low battery indicator (21), check mat indicator (23), alarm indicator (25), monitor mode indicator (27) and hold mode indicator (29).
Monitor module (10) is connected by way of cable (37) to nurse call system connector (43). Connector (43) terminates in a standard phono jack (41) as is typically utilized in existing nurse call system connections. Connector (43) is intended to provide the electrical connection to nurse call system (34) shown above in FIG. 1.
Control monitor module (10) in the preferred embodiment is powered by a 3 VDC power supply typically provided by two AA type alkaline or lithium batteries. The present invention may also operate off of an AC power source with an appropriate AC adaptor circuit. When operable through an AC adaptor, control monitor module (10) incorporates an automatic battery backup switch-over circuit to maintain operation of the device in the event of AC power interruption or failure. Such battery backup systems are well known in the art.
The low battery indicator (21) shown in FIG. 3 is connected to the electronics of the present invention so as to provide two stage indications of the internal power supply. Low battery indicator (21) is configured to begin blinking when the voltage of the internal power supply falls below 2.6 VDC. This would be indicative of a non-urgent need to replace the battery within the unit. A second stage low battery indication provided at LED (21) would occur when the power supply voltage falls below 2.48 VDC, indicating a more urgent need to replace the battery. In conjunction with the blinking low battery LED, an audible signal, as well as a closing (or opening as the case may be) of the nurse call connection would occur.
It should be noted that driver/sensor circuit (18) does not require a separate power supply to convert the capacitance values measured in sensing element (14) to a frequency shift values utilized by control monitor module (10).
Control monitor module (10) is designed to operate through manipulation of a single button to control its mode and status. The LED indicators described above are intended to provide a full system visual status identification and indication means for the user. There are two separate system integrity alarms that are incorporated into the electronics described above. The first involves a disconnected mat state that causes the check mat LED, the alarm, and the nurse call system to activate when the mat is not connected to the system. A second integrity alarm occurs when an internal electronic function failure occurs. When such an internal function failure occurs, all LEDs on control monitor module (10) are illuminated. In addition, the electronics of control monitor module (10) are configured so as to provide a means for indicating the presence of a battery when no LEDs are illuminated. Pushing control button (19) one time will also provide a single, short audible tone to indicate the presence of a battery within the system.
In general, control monitor module (10) is electronically configured to provide multiple alarm tones selectable by the user or installer. Five settings that include a “no audible alarm” state can be controlled and set by a standard DIP switch positioned within the enclosure. These DIP switch settings provide the user with the ability to select the delay time (the time between the sensing of an off-the-mat condition and the initiation of the alarm) and the duration and character of the alarm once it is activated. The electronics are configured so as to permit the selection of instantaneous alarm activation once an off-the-mat condition is detected, in which case, if the patient returns to the mat, the alarm is immediately silenced. Alternatively four or eight second delays between an off-the-mat condition and the alarm can be programmed. When such delays are utilized, it is preferable for the alarm to remain on even after the patient has returned to the mat. Utilization of the externally accessible time delay dip switch settings, as identified above, permit control monitor module (10) to conveniently and concurrently perform the dual roles of bed monitor or chair monitor as required.
In addition, the dip switches available to the user permit modification of a number of additional settings associated with the alarm and the type of system control monitor module (10) is utilized in conjunction with. The dip switches permit the selection of four different alarm tones for a particular control monitor module (10) so as to permit a care giver to distinguish between various patients within a single room or otherwise identify a particular patient by a particular type of alarm tone.
The dip switch settings also permit the user to time out the alarm tones for either a 30 second or two minute period of time. The switches also permit the user to select a completely silent alarm at the control monitor module while still utilizing and activating the existing nurse call system. Finally, the dip switches permit the system of the present invention to adapt to a normally open or a normally closed nurse call system, both of which are known in the art. These user accessible dip switch settings permit the system of the present invention, and in particular the control monitor module (10) of the system to be readily adaptable to any of a number of existing systems and environments within which the patient monitor is utilized.
The process of installing and activating the system shown in FIG. 3 is simple and straightforward. With the appropriate batteries installed and the connections between control monitor module (10) and driver sensor circuitry (18) in place, connections are made at (13a) and (13b) to sensing element (14). Three audible pulses are heard to indicate that the system has been switched on when this mat connection is made. Likewise, when this mat connection is removed, a single audible pulse indicates the system is off. Should control monitor module (10) be connected in like manner to a pressure sensitive switch array mat, two audible pulses are triggered. Control monitor module (10) then automatically continues to function in conjunction with the pressure sensitive mat with no external adjustment to its circuitry, in a manner identical to its function with the dielectric shift sensing mat of the present invention.
In the activation process, LED indicators on the front panel flash once to indicate their function and then the single LED hold indicator (29) activates. Once a patient is placed on the mat, the system will automatically enter a monitor mode after 15 seconds. Monitor mode may alternatively be immediately activated by pushing control button (19). The system may be switched back and forth between the hold and monitor mode by repeatedly pushing control button (19). It should be noted that the automatic activation of a monitor mode after 15 seconds, once a patient's body mass has been applied proximal to the sensing mat is different from earlier described and utilized circuits. In the present invention, the patient's body mass does not have to be removed from the sensing mat and subsequently returned to the sensing mat to reactivate the automatic monitor mode from the hold mode, once the hold mode has been manually activated. As long as the patient's body mass is consistently in contact with the sensing mat, the system will automatically enter the monitoring mode after 15 seconds with no necessity to remove the patient's body mass from the sensing mat and then reapply it.
It is anticipated that the system of the present invention can be installed with the elements shown in FIG. 3 or may be installed in conjunction with an existing nurse call activation system within the hospital. The switches within monitor control module (10) allow it to activate either a normally open or normally closed nurse call switch system.
Reference is now made to FIG. 4 for a detailed description of the placement of the apparatus of the present invention on the typical hospital bed. Bed (39) incorporates a plurality of side rails (38) that facilitate both the attachment and the use of the system of the present invention. Patient (40) is positioned on bed (39) as shown. As described above, the placement of sensing element (14) of the present invention is best made near the larger mass areas of patient (40). In FIG. 4, sensing element (14) is positioned beneath the upper torso portion of patient (40). Sensing element (14) is placed beneath a mattress sheet or mattress cover (not shown) in an area beneath the upper torso of patient (40). Sensing element (14) is positioned on and held to the mattress of bed (39) through the use of elastic straps (9a) and (9b) as shown. In an alternative embodiment, a reverse side of sensing element (14) may be provided with adhesive material that allows the removable positioning of sensing element (14) on mattress (39) without permanent attachment to its surface. Various adhesives are well known in the art to permit such removable attachment of a flexible surface.
Positioned immediately adjacent to sensing element (14) is driver/sensor circuit (18). In the preferred embodiment both the enclosure and the circuitry associated with driver/sensor circuit (18) are sufficiently lightweight and flexible as to easily be suspended by connectors (17a) and (17b) along the side of mattress (39). It is anticipated that the mattress cover or mattress sheets (not shown) would partially cover driver/sensor circuit enclosure (18). Conductor (12) connects driver/sensor circuit (18) to control monitor module (10) which is more rigidly mounted at a position near the patient on the structural components of bed (39) or on the wall adjacent to the head of the patient's bed. Attachment to the wall is effected through the use of a wall mounted bracket that appropriately engages and retains strap slots (35).
Various mechanisms for the positioning and placement of control monitor module (10) are disclosed in FIG. 5, FIG. 6, and FIG. 7. FIG. 5 discloses the manner in which control module (10) may be mounted on a patient's wheelchair through the use of mounting clip (70). The longer section (72) of wheelchair mounting clip (70) is slid over the flexible seat backing typically found on a patient's wheelchair, with the longer section (72) of wheelchair mounting clip (70) facing towards the front of the chair. Wheelchair mounting clip (70) is positioned in this manner close to one of the wheelchair handles. Control module (10) is then mounted on the shorter hook side (74) of wheelchair mounting clip (70) by inserting hook element (76) through lower strap slot (35) of control unit finger guard (31).
In the preferred embodiment, control monitor module (10) is attached to the wall adjacent to the patient's bed (39) by means of wall clip (80), shown in FIG. 6, which in turn has been attached to the wall structure through the use of either screws, positioned through holes (88) in back plate (82), or through the use of double sided adhesive tape placed on the back of back plate (82). Front lip (86) of hook structure (84) protruding from clip (80) engages through top strap slot (35) of finger guard (31) to secure control monitor module (10) to the wall.
Yet a further, more secure, means for attaching control monitor module (10) to a wall adjacent the patient's bed is disclosed in FIG. 7. Lockable wall clip (90) is attached to the wall surface in much the same manner as described above with respect to wall clip (80) shown in FIG. 6. Lockable wall clip (90) is attached to the wall structure through the use of either screws, positioned through holes (98) in back plate (92), or through the use of double sided adhesive tape placed on the back of back plate (92). Protruding from back plate (92) of clip (90) is support plate (94) with extended edge (96) through which is positioned hole (99). Extended edge (96) of support plate (94) engages through top strap slot (35) of finger guard (31) to secure control monitor module (10). In this manner, hole (99) aligns with hole (97) positioned in cover panel (33) and permits the insertion of locking device (95) there through. Locking device (95) may be any of a number of well known devices designed to secure two objects through aligned holes. Small pad locks and plastic cable ties are typical examples.
An alternative method of positioning control monitor (10) adjacent to a patient's bed (39) is by attaching it to bed railing (38) by means of flexible attachment strap (7). Attachment strap (7) slips through strap slots (35) (shown in FIG. 3) and attaches control monitor module (10) to the bed in a position serviceable by care giver personnel. It is anticipated that the care giver would be the individual responsible for activating and monitoring the function of the system of the present invention so control monitor module (10) is positioned on the outside of bed rail (38). Finally, as described above, connector (37), which may be an electrical cord of any reasonable length, connects the system of the present invention to existing nurse call system connections. In the preferred embodiment, connecting cord (37) is completely detachable from control monitor module (10) through the use of any suitable, easy to use electrical connector (such as a modular U.S. style telephone connector) this enables connecting cord (37) to be completely removed from control monitor module (10) when such monitor module may be utilized as a mobile monitor—for instance on a patient's wheelchair—and where no connection is required between control monitor module (10) and a nurse call system connection.
It is anticipated that the flexible structure of the sensing element of the present invention permits large variations in the placement for association with a particular patient. The adaptability of the electronics of the system further permits use of a single sensing element structure in a number of applications with variations in the patient body mass that is brought in proximity to the sensing element.
In addition to being installed in environments where patient monitoring systems have not been in use, the structures of the present invention lend themselves to be retrofit into existing patient monitor systems previously based upon alternate sensing mechanisms. In many cases, existing electronics are already in place that provide the link between the patient monitor and the nurse's call system.
Optional System Components
One objective of the present invention is versatility of use in conjunction with a number of different nurse call systems installed within a number of different health care environments. FIGS. 8 through 15 provide various additional optional elements to the patient monitoring system that have specific advantages under certain conditions and patient environments. The objective of versatility is achieved through the consistent use of 4 and 6 wire modular phone jack connectors and the use of “pass-through” electronics that permit the devices to be “daisy chained” together into the system.
FIG. 8 is a plan view of an auxiliary alarm module (100) of the present patient monitoring system. Alarm module (100) incorporates means for providing specialized alarms in the vicinity of the patient as conditions might require. Module (100) provides (in addition to the alarm in the control monitor module (10) and the standard nurse call system alarm) a selectable extra loud tone or a voice announcement alarm. Module (100) is connected to the nurse call system output of control monitor module (10) of the present invention by way of 6 wire modular cord (102) and modular phone jack (104). Connection to the existing nurse call system is maintained through 6 pin modular output connector (106) in a manner described in more detail below.
Utilizing well known electronic circuits, module (100) provides the ability to switch between an extra loud tone and a voice announcement by way of switch (110). Both audible alarms are produced through speaker (108) positioned centrally in module (100). In either case the volume of the audible alarm selected may be incrementally varied between high and low levels through the use of volume switch (112). The extra loud tone generated as an alarm in module (100) is electronically established through well known tone generating circuits triggered by an alarm state as described in more detail below. The voice announcement alarm is likewise triggered by an alarm state as relayed by control monitor module (10) and provides a digitally recorded voice message appropriate for the particular patient's situation. Commands such as “please return to bed” may be digitally recorded to be played back upon the occurrence of an alarm event. To facilitate the recording of such customized commands, module (100) provides a play button switch (114), a record button switch (116), and a microphone (118). The electronic circuits for providing these functions are well known in the art and may typically be found in hand held digital voice memo recorders and telephone answering machines and the like.
Reference is now made to FIG. 9 for a general description of the various electronic circuit components that are incorporated into auxiliary alarm module (100). As indicated above, control monitor module (10) provides, by way of its output to the nurse call system, a switched indication of an alarm state. This is received into module (100) through 6 pin input connector (104). Depending on the position of mode select switch (110), the alarm condition trigger is provided either to loud tone circuit (120) or voice announce circuit (122). Whichever circuit is activated, the audible alarm is generated through the speaker (108) of module (100). In conjunction with generating the audible alarm, both loud tone circuit (120) and voice announce circuit (122) activate output relay (124) which duplicates the on-off state of the alarm condition provided by control monitor module (10). This on-off alarm condition state is output from module (100) through 6 pin output connector (106) where the system is again connected to the existing nurse call system as described above with the primary embodiment.
In addition to being installed in environments where patient monitoring systems have not been in use, the structures of the present invention lend themselves to be retrofit into existing patient monitor systems previously based upon alternate sensing mechanisms. In many cases, existing electronics are already in place that provide the link between the patient monitor and the nurse's call system. FIG. 10 describes just such a situation and indicates how the structures of the present invention can be retrofit to take advantage of the existing electronics in place and still provide the benefits of the improvements found in the present invention.
In place of control module (10) in the above described embodiment of the invention, interconnect adaptor module (50) connects with driver/sensor circuit (18). The structures of sensing element (14) and its capacitive array (26) with interspace (28) positioned within substrate (30) are basically as described above. Within interconnect adaptor module (50) is input data logic circuit (52) which in turn is connected with relay circuit (54). Both are provided with power from power supply circuit (16). Power supply circuit (16) also supplies power through interconnection (12) to driver sensor circuit (18).
Interconnect adaptor module (50) is connected to an existing switch-based monitor/control unit (60) through logic circuit (62) contained therein. Connection (64) therefore typically carries an on/off condition between interconnect adaptor module (50) and existing switch based monitor/control unit (60). Logic circuit (62) of switch based monitor/control unit (60) typically generates an electrical signal into connections (64) which, if the system were using a mechanical switch sensor would determine the opening or closing of contacts within that sensor. The driver current produced by logic circuit (62) might typically be 6-10 volts at 2-3 microamps. Should the contacts of a mechanical switch sensor be closed, thereby completing the driver circuit, logic circuit (62) of the switch based monitor/control unit (60) would signal and indicate a monitoring status mode within monitor/control unit (60). Should the switch sensor contacts open in such an arrangement, then by sensing an open circuit status, logic circuit (62) would in turn generate an appropriate status signal which would activate alarm circuit (66) and relay circuit (68) to effectively generate an alarm condition from monitor/control unit (60). This alarm status condition may or may not be interconnected with the medical facility's nearest call system as desired.
The principle effect of the described interconnect adaptor module (50) is to replace, in an electrically transparent manner, the contact points of a mechanical switch sensor with those of an appropriate relay circuit (most preferably of a solid state design) which will effectively imitate the mechanical switch sensor from the viewpoint of monitor/control unit (60). A capacitance shift value produced by sensing element (14), which might typically be 20 picofarads in a resting, unoccupied state, to 200 picofarads or more in an active occupied state is converted by driver/sensor circuit (18) to an equivalent frequency drop generated by an appropriate oscillator circuit imbedded in driver/sensor circuit (18). This oscillator driven frequency drop may typically be 100 kilocycles in a resting unoccupied state to 20 kilocycles in an active occupied state. This frequency shift signal is carried through conductive elements (12) from driver/sensor circuit (18) to input data logic circuit (52) within interconnect adaptor module (50). By analyzing this input frequency shift, the input data logic circuit (52) may determine the active/occupied status or equivalent inactive/unoccupied status of capacitive sensing element (14). This data is fed into relay circuit (54), also contained within interconnect adaptor module (50, which will open or close its secondary conducting elements interfacing directly to logic circuit (62) of monitor control unit (60). In this manner, the alternative manufacturer's monitor control unit (60) may, through interconnect adaptor module (50) and driver/sensor circuit (18) directly interface, and equivalently and appropriately respond to status signals generated by the capacitive sensing elements of the present invention.
Those skilled in the art will also recognize that appropriate adaptor circuit modules could be incorporated in line with the patient monitoring system of the present invention in order to allow the use of switch based sensor mats in conjunction with the control monitor module (10) based system of the first preferred embodiment. Such a switch to capacitance adaptor circuit would receive the on/off input from a pressure sensing mat (for example) by sampling the open or closed status of the switching circuit at a preset sampling weight (for example, four samples per second). Appropriate, well known, circuit elements would respond to the on/off condition of the pressure sensing mat by generating a capacitance value at an output connection in one of two capacitance ranges. In the preferred embodiment, for example, a switch off condition in the pressure sensing mat could originate a 10 to 20 picofarad capacitance value at the connector output. Likewise, a switch on condition in the pressure sensing mat would generate a 750 to 1000 picofarad capacitance value. These capacitance values would be seen by the driver/sensor circuit of the present system and would be appropriately interpreted into a frequency signal for the control monitor module.
In similar fashion, appropriate circuits, well known in the art, could be inserted between other manufacturer's capacitance based sensing mats in order to bring the capacitance ranges for alarm conditions into line with the system of the present invention. As an example, an input capacitance value of 10 to 20 picofarads could translate directly to the same output capacitance range while an input capacitance range of 200 to 400 picofarads (would be translated to an output capacitance range of 750 to 1000 picofarads in order to match with the parameters of the system of the present invention).
FIG. 11a and FIG. 11b provide an optional mechanism for sensing the presence or absence of a patient within a predefined space such as a hospital bed, a wheel chair, or a hospital room toilet facility. The device disclosed comprises the use of a reflective energy beam such as is described in U.S. Pat. No. 5,471,198 entitled Device for Monitoring the Presence of a Person Using a Reflective Energy Beam, the disclosure of which is incorporated herein by reference. In the preferred embodiment an infrared (IR) sensor system is employed. Active IR sensing module (130) is designed to replace the capacitive sensor mat (14) described above. Otherwise the system components required for patient monitoring are the same as described above. Module (130) is connected to control monitor module (10) sensor input by way of modular cord (135) with terminal modular connectors (136) and (134). Modular connector (134) is plugged into modular jack (133) positioned on sensor module (130).
IR sensor module (130) incorporates bidirectional IR transmitters (132a)/(132b) and sensors (134a)/(134b) switchable by means of directional slide switch (136). In this manner the most appropriate orientation and attachment of module (130) can be achieved. In either case, electromagnetic waves are generated by IR transmitters (132a)/(132b), reflect off of objects (the patient) within the field of view, and are detected by IR sensors (134a)/(134b). In the preferred embodiment a selectable alarm delay time is provided to avoid false alarms for ordinary patient movement. This alarm delay selectability is provided by way of three position slide switch (138). Module (130) additionally provides an on indicator (140) and a low battery indicator (142). A sense indicator (144) is illuminated when an occupant is detected within the field of view.
FIG. 11b describes the basic functional circuit elements provided in sensor module (130) to achieve the operation as discussed above. Control logic circuit (150), which in the preferred embodiment is a digital processor controls pulsed waveform generator (146) which in turn controls IR source (132) which generates the interrogating energy beam. The reflected beam is received back at IR sensor (134) whose output passes through a window comparator circuit (148) tuned to identify appropriate variations in the reflected signal indicative of an alarm or a no-alarm condition. When an alarm condition is detected due to the movement of a patient from the field of view for a selectable period of time (0 seconds, 4 seconds, or 8 seconds) control logic circuit (150) activates output relay (152) which provides the preferred on-off alarm condition described above in conjunction with the first preferred embodiments of the present invention. The sensor module (130) retains its own internal power source (154) as indicated and is powered on when this power source (battery) is installed. The sensor module (130) described is operable in three modes once powered. A first, passive, “hold” mode represents a standby condition prior to the sensing of an occupant in the field of view for the sensor. A second, “sense” mode represents the condition where an occupant has been sensed within the field of view and the sense indicator (144) is illuminated. The third, “alarm” mode occurs when the occupant leaves the field of view for at least a selectable period of time (the alarm delay). Under “alarm” conditions, an internal relay (152) is closed for ten seconds (an alarm condition that is output to the control monitor module) before returning to the “hold” mode.
FIGS. 12 and 13 disclose a further optional, in-line component of the patient monitoring system of the present invention designed to provide a record of alarm events and care giver response times. Elapsed time module (160), like auxiliary alarm module (100) described above, may be inserted into the system in-line between the control monitor module and the existing nurse call system. Elapsed time module (160) comprises modular cord (162) terminating in modular phone jack (164) for connection to control monitor module (10), or to a device such as auxiliary alarm module (100) which is connected to control monitor module (10).
Externally, module (160) is a simple device that is positioned in-line in the system, having output modular connector (166) for further connection of the existing nurse call system. On front panel (168) of module (160) is positioned IR window (170) which is transparent to IR transmitter (172) and IR sensor (174). This transmitter/sensor pair carries out data communication between module (160) and an external, IR communication capable, programmable processor. The function of elapsed time module (160) is understood from the schematic block diagram shown in FIG. 13. Module (160) includes control logic circuit (175), which in the preferred embodiment is a digital microprocessor. Control logic circuit (175) receives the on-off alarm status of the overall system as communicated by control monitor module (10) through 6 pin input connector (164). Control logic circuit (175) functions in association with clock (176) as an event recorder by storing in memory (178) an array of event data comprising alarm state and time every time the alarm condition switches state. Thus, when an alarm condition is triggered control logic circuit (175) stores the date/time of the event and waits for the next change in alarm status, which will most likely be the deactivation of the alarm by the responding care giver. In this manner a record of patient movement and care giver response is maintained.
In the preferred embodiment, module (160) is provided with memory sufficient to maintain a record of 100 events. IR input/output (180) is provided to communicate or download this data from module (160) to a data processing device for reporting and analysis. In addition, the clock parameters may be set and reset through this same IR communication link. The circuitry and protocols by which this communication may be carried out are well known in the art and are now commonly used in conjunction with various data processing and data storage devices. As indicated above, elapsed time module (160) is an in-line device that duplicates the input alarm on-off state at an output relay (182) that provides this alarm state through 6 pin output connector (166) to the existing nurse call system (34).
FIGS. 14 and 15 describe yet another optional component operable in conjunction with the system of the present invention. Wireless remote alarm module (190) comprises two primary elements; wireless transmitter (192) and wireless receiver (194). Wireless module (190) is designed to function in the absence of an existing nurse call system, a condition that might be found for example within a residential home environment. In addition (or in place of) the alarm provided by the control monitor module (10) or the auxiliary alarm module (100), wireless module (190) provides a remote alarm activated by the sensor systems described above. The combination of wireless transmitter (192) and wireless receiver (194) is frequently utilized in the art as a wireless doorbell system or the like. Such radio frequency transmitters and receivers are capable of operating over short distances and provide a convenient means for signaling events within a residential dwelling. Transmitter (192) is connected to the system of the present invention in place of the existing nurse call system through modular cord (198) terminating in modular phone jack (202). One manner of operating transmitter (192) is by pushing button switch (196) in the manner typical for such signaling systems. A second manner of activating transmitter (192) is by using the on-off alarm state provided by the control monitor module (10) which is connected in parallel with switch (196) within transmitter (192). In either case, transmitter (192) generates a radio frequency signal that is readily detectable by wireless receiver (194). Receiver (194) is a self-powered RF tuned receiver that incorporates an alarm (or signal) relay which generates an alarm tone though speaker (200). System on and low battery indicators (204) and (206) are provided. In this manner, the remote alarm will be activated if either the patient signals the care giver by pressing button switch (196) on transmitter (192) or the control monitor module (10), in response to a condition from a sensor device, indicates an alarm on state in the system. A typical arrangement according to this function is shown in FIG. 15 wherein sensor mat (14), connected through driver sensor circuit (18) provides the patient occupancy state to control monitor module (10), which in turn relays this state to RF transmitter (192). Transmitter (192) operates as described above to send a signal to receiver (194) to alert the remote care giver of the alarm condition.
Reference is now made to FIG. 16, FIG. 17a, and FIG. 17b for a description of an alternative mechanism for attaching conductors to the capacitance sensing mat of the present invention. FIG. 16 shows one end of sensing element (14) with connection points (212) and (214) appropriately positioned on capacitive array components (26). In the alternative embodiment described herein, connection points (212) and (214) are apertures cut into sensing element (14) for attachment of snap-on connector (210). Conductor (216) provides the electrical connection from snap-on connector (210) to the balance of the electronics of the system of the present invention. Connection points (212) and (214) each comprise holes or apertures through the layers of sensing element (14) as well as a concentric window through the upper layer of insulation on sensing element (14) through to the conductive components (26).
Reference is now made to FIG. 17a for a detailed description of the structure of snap-on connector (210) as used in FIG. 16 above. Snap-on connector (210) is comprised of female snap component (222) and male snap component (220). Each of these snap components are positioned on flexible support structure (218). Support structure (218) is folded as indicated to permit female snap component (222) to mate with male snap component (220). The detailed structures of the snap components and their assembly is also disclosed in FIG. 17a as is well known in the art.
FIG. 17b shows in cross-sectional view the attachment of snap component (210) to sensing element (14) to provide electrical connection thereto. Sensing element (14) is shown in its multi-layer configuration comprising substrate layers (28) and conductive layer (26). Flexible support structure (218) retains and appropriately positions male snap component (220) below sensing element (14) and female snap component (222) coaxially above sensing element (14). In this manner snapping the components together creates pressure against conductive layer (26) through the window aperture described above in the upper substrate layer (28). Electrical connections provided by way of wire conductor (216) as described above.
Reference is now made to FIGS. 18 and 19 for a further alternative embodiment of the sensor structure of the present invention. FIG. 18 discloses in perspective view the implementation of the capacitive sensing elements of the present invention on the underside of a typical bed mattress cover. In this manner the sensing element component of the present invention is semi-permanently established on the patient's bed in a manner that eliminates the need to replace sensing elements after use. In the embodiment described herein, bed (39) is covered with mattress cover (240) having a generally planar top surface (242) surrounded by orthogonal wall components (244). As is typical in the art, an elastic band (246) is placed on the periphery of wall components (244) in order to secure the mattress cover to the surface of bed (39).
The capacitive sensing array in this embodiment comprises a pair of bands (248a) and (248b) made up of principal conductive ink deposited on an underside of mattress cover (240) as shown. Various durable conductive materials may be utilized for the deposited capacitive sensing array elements. Appropriate snap connectors (250) are positioned at terminal ends of each conductive band (248a) and (248b) as in a manner similar to that described above in conjunction with the disposable sensing element. In this manner electrical connections can be made to the under mattress cover sensing element at the side of the bed where wall panels (244) of mattress cover (240) extend down.
In FIG. 19 a more complete view of the printed conductive ink sensing elements (248a) and (248b) are shown. In this view the underside of top panel (242) of mattress cover (240) is shown flattened out. Side wall panels (244) are shown on either side bearing the terminal ends of conductive bands (248a) and (248b). Positioned at these terminal ends just inside of elastic band (246) are connectors (250) positioned as described above. The balance of the components of the present invention may be utilized in conjunction with the under mattress cover sensing element of this alternative embodiment.
Reference is now made to FIG. 21 for a brief description of an alternative embodiment of the mattress cover construction of the present invention. FIG. 21 shows a typical mattress cover for a hospital bed or the like in an inverted view showing the underside of the mattress cover that would normally be in contact with the mattress. In this view, mattress cover (300) comprises top panel (302) surrounded by side walls (304) shown in a construction well known in the art. Perimeter edge (306) may comprise an attachment or closure means such as a zipper or elastic band intended to secure the mattress cover either to a matching panel positioned below the mattress on the bed or simply to surround the mattress in a manner well known in the art.
In this embodiment the conductive sensor elements (308) each comprise a layer of silver oxide conductive ink (310a) and (310b) which adhere to the underside of top panel (302) of the mattress cover. Covering each of the layers of silver oxide ink (310a) and (310b) are carbon graphite impregnated rubber protective elements (312a) and (312b). These rubber protective elements (312a) and (312b) extend beyond the layers of conductive ink (310a) and (310b) and effectively seal a major portion of the conductive elements to the mattress cover.
Exposed on each end of each conductive element is an amount of silver oxide ink conductive material wherein snap connectors (314) are placed through the mattress cover as described in more detail below. Four of these snap connectors (314) are positioned as indicated in FIG. 21.
FIG. 22a discloses in cross sectional detail the layering of the sensor elements described above. Specifically, the top panel (302) of the mattress cover (300) is layered first with two silver oxide ink conductive elements (310a) and (310b) and then secondly is layered with carbon graphite impregnated rubber protective elements (312a) and (312b). In this manner the conductive sensor elements necessary for operation of the present invention are appropriately positioned and retained on the bed beneath the patient. The appropriate distance between the sensor elements is therefore maintained regardless of any movement of the patient on the mattress.
FIG. 22b shows in cross sectional detail the structure of the end connector for each of the sensor elements. In this view mattress cover (300) is shown to comprise top panel(302) and side wall (304). Side wall (304) retains the attachment mechanism (306) which in the preferred embodiment is an attachment zipper or elastic material. Silver oxide ink conductive element (310a) is shown adhered to the underside of top panel (302) and carbon graphite impregnated rubber protecting element (312a) is shown over conductive element (310a). A portion of conductive element (310a) is left exposed so that snap connector (314) may be attached there through to be exposed on the upper surface of top panel (302). This provides ready access for the caregiver to attach the remaining components of the present invention to the sensor element shown and described herein.
The fabric of the mattress cover described above may be any of a variety of different mattress cover materials already used in the industry. Typically, these mattress covers for hospital applications and the like consist of low friction nylon woven material as an outside surface bounded to a butyl rubber layer or urethane layer backing providing an inside surface. Adherence of the conductive materials described above to any of these standard mattress cover fabrics can be achieved by methods well known in the art.
The primary conductive elements of the present invention shown in this embodiment of the mattress cover comprise high density silver oxide ink of high electrical conductivity. This silver oxide ink is bonded to the backing of the mattress cover, typically in four inch wide bands separated by one-half inch. The protective rubber secondary element comprises a graphite impregnated rubber material that serves to provide abrasion protection to the primary conductive element. Foam core mattresses, for example, can have a significantly abrasive upper surface that might otherwise degrade or destroy the conductive sensor element. In addition, the protective rubber secondary element provides a stabilizing and supporting surface for the primary conductive element. Further, the graphite impregnated rubber provides a back-up secondary electrical conductivity material should any part of the primary conductive element fracture through use. It is therefore the combination of the two layers that serve as the complete electrical sensor element of the present invention.
The snap connectors shown in this alternative embodiment of the mattress cover structure are as described above with the previous embodiments. The snap connectors herein pass through the primary conductive element and the mattress cover to an access point on the outside surface of the mattress cover.
To permit the interconnection of capacitive sensing elements (such as those described above) with patient occupancy monitoring electronic controls that may already be present on a medical bed (such as those manufactured by Hill-Rom and others), an interface connector is needed and is described in FIG. 20. Interface connector (260) consists of an appropriate female electronic connector (262), namely a Molex Part #03-06-2043, connected to an appropriate length of four conductor modular telephone cord (264). The four conductors of the modular telephone cord (264) are paired and connected red to black and green to yellow and attached to two pins of the female Molex connector (262) in a diagonal manner relative to the locator key (266) of the Molex connector (262). In this manner, the two connecting pins of the Molex connector (262) simulate the standard connection to the medical bed patient occupancy monitoring controls, such as those on a Hill-Rom medical bed, for a single under mattress pressure sensing element.
The distal end of the four conductor modular telephone cord (264) terminates in a four conductor modular telephone plug (268), or alternatively in a four conductor female telephone socket (not shown). Modular telephone plug (268) may be adapted to a four conductor socket through the attachment of a modular telephone cord in-line connector (270).
Through the above described medical bed interface connecting cord, connection between a capacitive based sensing element as described above, or any other “switch” function based pressure sensing element, and medical bed patient occupancy monitoring system, such as those found on Hill-Rom medical beds, may be effected.
The basic patient monitoring system described herein includes a sensor/driver module that generates a frequency shift output as an indication of a capacitance shift in the sensing element. The capacitance shift indicates a change in the presence of the patient adjacent the sensor. To utilize a capacitive sensing element, as described above, a self powered interconnect adapter (272) is located between the frequency shift output of the sensor/driver module as described above, and the input to the “switch” sensing existing medical bed patient occupancy monitor controls. This interconnect adapter (272) employs the same functional electronics described in the control/monitor module of the above referenced embodiment, but excludes the incorporation of system controls, function indicator lights or audible alarms. Its function is to convert the variable frequency output from sensor/driver module associated with the capacitance based sensor to a “switch” function through an electronic relay activation.
The circuitry of interconnect adapter (272) is straightforward and well known in the art. The circuitry detects and measures the frequency shift associated with the capacitance change measured in the capacitive sensing element and activates or deactivates a relay connection accordingly. The state of this relay connection provides an open circuit or a closed circuit condition in the cabling and connectors to the existing patient occupancy monitor circuitry. In this manner the “switch” function based patient occupancy monitor control electronics embedded in existing medical bed systems such as those manufactured by Hill-Rom are able to perceive and interpret the variable frequency output of the sensor/driver module associated with a capacitance based sensor, as a “switch” function, and to respond accordingly.
FIGS. 23A and 23B are detailed perspective views of a further alternative embodiment of the mattress cover configuration of the present invention showing the stretch fabric conductive thread structure. FIG. 23C is a perspective view of the implementation of the thread structure disclosed in FIGS. 23A and 23B.
FIG. 24 is a perspective view of an alternative embodiment of the present invention as implemented on a wheelchair back. FIGS. 23A-23C show a further alternative preferred embodiment of the present invention wherein the mattress cover comprises a stretch fabric. To accommodate the stretch fabric (either by way of the material or the weave) the electrically conductive fibers (silver, steel, carbon impregnated, or some other metal based fibers) are loosely wound about a monofilament nylon (or other synthetic material known in the art) support thread as shown. This composite fiber construction is shown in FIG. 23A. This composite fiber may then be knitted in a manner that allows it to form a stretch fabric, the knitting method being the same as what might be carried out with the monofilament thread alone and being any of a number of different weaving methods well known in the art. The knitted composite as woven into a stretch fabric configuration is shown in FIG. 23B. FIG. 23C shows the manner in which these composite fibers may be incorporated into a stretch fabric mattress cover to form the conductive panels utilized in the present invention as the sensor panels for the occupancy monitor. The placement and electrical connection to these panels would be the same as that disclosed and described in conjunction with FIGS. 18 and 19 above.
FIG. 24 shows the implementation of the sensor system of the present invention on the back of a wheelchair. The wheelchair frame receives the wheelchair back sensor sleeve over the handles and side supports. Handle holes are provided in the fabric sleeve to allow the sleeve to be slipped on and off of the wheelchair frame. The sensor panels are shown incorporated into the fabric of the sleeve as shown. The sleeve fabric may be constructed in the same way as the mattress cover construction described in detail above with respect to FIGS. 18 & 19 and FIGS. 2 1,22a & 22b. The sensor fabric is positioned on the “front side” or occupant side of the fabric sleeve as shown by the dotted line representation. Contacts for the sensor panels are placed on extensions of the panels that extend over the top of the sleeve to the “back side” of the sleeve as shown. An optional monitor pocket may be sewn or otherwise integrated into the sleeve in a position apart from the sensor panels. Cord access holes are positioned in the base of the pocket.
It is anticipated that further embodiments and alternative applications of the present invention may be envisioned from the above description and the attached drawings. Since any number of potential applications for identifying the presence or absence of a person or other animate or inanimate object within a particular defined space may be desirable, various modifications of the sensing element and the electronics associated with its use are contemplated. Specific modifications of the geometry of the sensing element shown in the preferred embodiment are immediately discernable from the structures and geometries of the devices and environment within which the sensing element is to be placed. The particular geometries described above are appropriate primarily for patient bed configurations and could easily be adapted to be appropriate to, for example, wheelchair environments or other sitting structures. Likewise, placement of the sensing elements described, with appropriate geometry modifications, could be made in enclosures suitable for retaining animals in veterinary hospital environments. The ability of the system to constantly optimize the capacitance measurement ratio in a manner that distinguishes between occupied and unoccupied states permits significant variations in the placement of the sensing element. Such variations are anticipated and included within the scope of the description of the present invention occupancy alarm systems (“bed/chair alarms”) typically utilize a pressure sensing sensor element (a “switch-mat”) placed between the patient's body mass and the supporting bed or chair surface. Compression of the sensing element closes two conductive elements (“the switch”) allowing a driver current from the alarm control unit module to activate a monitor condition. Release of compression deactivates the switch causing an alarm mode to activate.
Alternate Interconnect Cable Embodiment
It is not uncommon for a healthcare facility to initially utilize a patient occupancy alarm system that includes a pressure switch sensor in conjunction with a matched pressure switch monitor (driver control module). It is also not uncommon for such healthcare facilities to subsequently purchase replacement sensor arrays and to utilize such replacement sensors with their existing control unit modules. Most often these sensor arrays and control unit modules are each directed to pressure switch based systems, and most commonly the specific pressure switch sensors are matched to specific pressure switch control unit modules such that the “signal” (open/closed condition) output by the sensor can be appropriately read and interpreted by the control unit.
More recently, the use of dielectric shift sensing elements in patient monitoring systems has increased. A dielectric shift sensing patient occupancy monitoring system is described in detail in U.S. Pat. No. 6,025,782 issued to Newham on Feb. 15, 2000, entitled Device for Monitoring the Presence of a Person using Proximity Induced Dielectric Shift Sensing (the '782 Patent), the full disclosure of which is incorporated herein by reference. Further features of such a system are described in detail in U.S. Pat. No. 6,297,738 issued to Newham on Oct. 2, 2001, entitled Modular System for Monitoring the Presence of a Person using a Variety of Sensing Devices (the '738 Patent), the full disclosure of which is incorporated herein by reference. Further features and accessory components for such a system are also described in detail in U.S. Pat. No. 6,778,090 issued to Newham on Aug. 17, 2004, entitled Modular System for Monitoring the Presence of a Person using a Variety of Sensing Devices (the '090 Patent), the full disclosure of which is incorporated herein by reference.
An example of an effort to make dielectric shift sensing elements compatible with systems designed to use pressure switch type sensing mats is briefly described in FIG. 10 for reference. A brief description of this approach to creating an interconnection between a dielectric shift sensing mat and a pressure switch control system is provided below. This effort, however, relies on the use of the existing driver sensor circuit module associated with the dielectric shift sensing mat in conjunction with a separate interconnect module.
It would be desirable to have an interconnect cable component that did not require the use of the separate driver sensor circuit module in order to permit the use of dielectric shift sensing mats with existing pressure sensing mat control systems. It would be preferable if the dielectric shift sensors and pressure switch control modules could be connected together, even if manufactured by different companies. It would further be desirable if the interconnect cable component incorporated a self-referencing function that allowed it to automatically detect and configure for the type of pressure switch control system being used.
FIG. 10 is schematic block diagram showing a previous effort to provide compatibility between a dielectric shift sensing mat and a pressure switch based control system.
FIG. 25 is a schematic block diagram of the system of the present invention that integrates the necessary circuitry into a single interconnect component.
As indicated above, the structures of the present invention lend themselves particularly to be retrofit into existing patient monitor systems previously based upon alternate sensing mechanisms, including pressure switch sensing systems. In many cases, existing electronics are already in place that provides the link between the patient monitor and the nurse's call system. FIG. 10 describes just such a situation and indicates a previous approach to creating an interconnection between a dielectric shift sensing mat and a pressure switch control system that utilizes multiple circuit modules. The manner in which this previous system interconnects two disparate systems is, however, instructive as to the goals and objectives of the present invention.
In FIG. 10 interconnect adaptor module 50 connects with driver/sensor circuit 18. The structures of sensing element 14 and its capacitive array 26 with inter-space 28 positioned within substrate 30 are basically as described in the above referenced Newham Patents. Within interconnect adaptor module 50 is input data logic circuit 52 which in turn is connected with relay circuit 54. Both are provided with power from power supply circuit 16. Power supply circuit 16 also supplies power through interconnection 12 to driver sensor circuit 18.
Interconnect adaptor module 50 is connected to an existing switch-based monitor/control unit 60 through logic circuit 62 contained therein. Connection 64 therefore typically carries an on/off condition between interconnect adaptor module 50 and existing switch based monitor/control unit 60. Logic circuit 62 of switch based monitor/control unit 60 typically generates an electrical signal into connections 64 which, if the system were using a mechanical switch sensor would determine the opening or closing of contacts within that sensor. The driver current produced by logic circuit 62 might typically be 6-10 volts at 2-3 microamps. Should the contacts of a mechanical switch sensor be closed, thereby completing the driver circuit, logic circuit 62 of the switch based monitor/control unit 60 would signal and indicate a monitoring status mode within monitor/control unit 60. Should the switch sensor contacts open in such an arrangement, then by sensing an open circuit status, logic circuit 62 would in turn generate an appropriate status signal which would activate alarm circuit 66 and relay circuit 68 to effectively generate an alarm condition from monitor/control unit 60.
The principle effect of the previously described interconnect adaptor module 50 is to replace, in an electrically transparent manner, the contact points of a mechanical switch sensor with those of an appropriate relay circuit (most preferably of a solid state design) which will effectively imitate the mechanical switch sensor from the viewpoint of monitor/control unit 60. A capacitance shift value produced by sensing element 14, which might typically be 20 picofarads in a resting, unoccupied state, to 200 picofarads or more in an active occupied state is converted by driver/sensor circuit 18 to an equivalent frequency drop generated by an appropriate oscillator circuit imbedded in driver/sensor circuit 18. This oscillator driven frequency drop may typically be 100 kilocycles in a resting unoccupied state to 20 kilocycles in an active occupied state. This frequency shift signal is carried through conductive elements 12 from driver/sensor circuit 18 to input data logic circuit 52 within interconnect adaptor module 50. By analyzing this input frequency shift, the input data logic circuit 52 may determine the active/occupied status or equivalent inactive/unoccupied status of capacitive sensing element 14. This data is fed into relay circuit 54, also contained within interconnect adaptor module 50, which will open or close its secondary conducting elements interfacing directly to logic circuit 62 of monitor control unit 60. In this manner, an alternative manufacturer's monitor control unit 60 may, through interconnect adaptor module 50 and driver/sensor circuit 18 directly interface, and equivalently and appropriately respond to status signals generated by the capacitive sensing elements of the present invention.
It is the objective of the alternative embodiment of the present invention to simplify the approach of the previously described effort by eliminating the need for the separate driver/sensor circuit module. FIG. 25 shows the basic structure of the system of the present invention. In this view, a flexible capacitance sensor 110 (a dielectric shift sensor) is shown connected to the integrated interconnect cable component 100 of the present invention. Interconnect component 100 includes three basic elements incorporated into a single module. These include integrated driver, sensor, comparator, calibration, logic circuit 112; relay activation circuit 114; and power supply (battery) 116. Circuit 112 takes the dielectric shift measured across the contacts for sensor mat 110 and drives relay activation circuit according to the condition of the mat (patient on or patient off). Relay activation circuit in turn provides the on/off switch condition that the existing pressure switch monitor circuit 120 expects to see at the connection cable 118.
Connection cable 118 would in the preferred embodiment be a section of typical “phone wire” comprising an insulated sheath enclosing four conductive wires, conventionally provided in color-coded insulation as red (R), black (B), yellow (Y), and green (G) conductors. In many applications these conductive wires are paired, R and B (for example), Y and G (for example), and the paired wires then jointly connected to the various circuit components. However, in an attempt to defeat connection of one manufacturer's switch-mat to another manufacturer's control-unit module, multiple combinations and configurations of the basic four wire (R, B, Y, G) cable have been devised (for example, R and B/Y; Y and G/B; etc.). By allowing any combination/configuration of the basic four-wire R, B, Y, G connectors within cable to be reconfigured, any control unit module can be connected. This configuration may be hardwired into the interconnect device of the present invention and may provide for a variety of different functioning pressure switch based control systems. A plurality of different hard wired adaptor cables might be provided, each specifically designed for use in connecting to a specific brand of control unit.
In the preferred embodiment, however, the circuitry associated with relay activation circuit 114 could incorporate calibration circuitry that would initially “interrogate” the existing pressure switch monitor circuit to detect and determine the specific “signal” the system is setup to look for. The relay activation circuit may then configure itself to appropriately activate or deactivate the four wires within the cable 118 to match the circuitry of the existing control system.
Although the present invention has been described in terms of the foregoing preferred embodiment, this description has been provided by way of explanation only, and is not intended to be construed as a limitation of the invention. Those skilled in the art will recognize modifications of the present invention that might accommodate specific pressure switch sensor control unit modules. Such modifications, as to cable length, connector structure, individual wire numbers and arrangements, and even sensor configurations, where such modifications are coincidental to the type of sensors and control units being utilized, do not necessarily depart from the spirit and scope of the invention.
Alternative Embodiment Sensor Substrate
An improved manufacturing design for the structure of a capacitive sensor array for use in conjunction with patient monitoring systems and a method for manufacturing a number of individual sensor elements into a roll suitable for dispensing the sensor elements one at a time.
In a dielectric shift based patient monitoring system, such as described in U.S. Pat. No. 6,025,282; U.S. Pat. No. 6,297,783 B1; U.S. Pat. No. 6,778,090 B2 and others, where a capacitance or dielectric shift is measured as a means for detecting the presence or absence of a patient within a bed, chair, or other environment, an important but frequently replaced component is the capacitive sensor element or pad. Efforts have been made to make the capacitive sensor element component of a patient monitoring system, a disposable element and therefore a low cost, but robust element that still operates effectively (accurately) within the patient monitoring system. In the past, such capacitive sensor elements have been constructed of layers of polymer film or sheet materials with spaced layers of conductive elements to provide a capacitive surface area. The manufacture of these layered capacitive sensors has typically required specialized equipment and has generally been accomplished on an individual sensor basis. It would be desirable if a sensor structure, and a method for manufacturing the sensor, could be developed that allowed for the efficient manufacturing of multiple sensors at one time and the provision of a large number of such sensors in a dispensing configuration such as a roll.
The disclosures of U.S. Pat. No. 6,025,282; U.S. Pat. No. 6,297,783 B1; and U.S. Pat. No. 6,778,090 B2 are each incorporated herein in their entirety by reference. The present invention provides an improvement on the structure and the method of manufacturing the capacitive sensor elements utilized in the described in the above U.S. Patents. The present invention provides a flat, flexible, substrate layer that is manufactured into a roll that also includes at least two longitudinal conductive elements printed or layered onto one side of the substrate layer material. Individual capacitive sensor elements comprising a section of the substrate material with corresponding sections of the conductive elements may be separated from the manufactured roll by tearing along perforations across the width of the substrate layer material. Once an individual capacitive sensor element has been separated from the roll for use, one end of the element is folded over to align pairs of connector apertures positioned through the conductive elements and the associated substrate layer. Dual snap electrical connectors are positioned over and through the apertures to provide the necessary electrical connections between the capacitive sensor and the instrumentation of the patient monitoring system. The present invention further includes a method of manufacturing the roll of capacitive sensor elements according to the structures described above and providing such rolled elements in a dispenser configuration for use in facilities utilizing the patient monitoring systems.
These and other objectives and features of the present invention will be apparent to those skilled in the art upon review of the attached drawing figures and an understanding of the detailed description of the preferred embodiments.
FIG. 26 is a perspective view of a roll of capacitive sensor elements of the present invention.
FIG. 27 is a perspective view of an individual capacitive sensor element of the present invention separated from the roll shown in FIG. 26.
FIG. 28 is a perspective view of an individual capacitive sensor element of the present invention shown as configured during its assembly with the electrical snap connector elements.
Reference is made first to FIG. 26 for a detailed description of a manufactured roll of individual capacitive sensor elements of the present invention and the manner of manufacturing the sensor elements into the roll. In FIG. 26, capacitive sensor element roll 10 is primarily comprised of a roll of sheet-like substrate material 12 that is configured in a long strip having a width that is small in comparison to the length. This substrate layer 12 is manufactured and packaged in a roll configuration for easy dispensing of individual capacitive sensor elements as described in more detail below.
On one face of substrate layer 12 are positioned two (in the preferred embodiment) longitudinal conductive element strips 18. These conductive elements 18 are shown exposed on the outside surface portion of the conductive element roll shown in FIG. 26 and are elsewhere indicated with dashed lines as being positioned on the underside of the unrolled section of substrate layer 12 shown in FIG. 26. An individual capacitive sensor element may be separated from the roll 10 at perforation line 16 in a manner described in detail below. Positioned in appropriate spaced arrangement across the width of substrate 12 are adhesive strips 14, which are utilized to position and retain the individual capacitive sensor element on the bed, chair, or other patient support surface on which the element is placed and used in conjunction with the patient monitoring system.
Additionally shown in FIG. 26 is an array of paired connector apertures 20 positioned on either side of a fold line 22 that are utilized in the assembly of an individual capacitive sensor element for use. Dual snap connector apertures 20 are positioned in pairs and arranged such that two apertures can be matched for each of two snap connector components, one pair of apertures on each of the two conductive element strips 18. The manner of assembling the sensor element once an individual element has been removed from the roll 10 is described in detail below.
Reference is now made to FIG. 27 for a detailed description of an individual capacitive sensor element as separated from roll 10 shown in FIG. 26. In this view, a single section of substrate layer 12 is shown with conductive elements 18 hidden from view on the underside of the substrate layer. Adhesive strips 14 are again shown as they are positioned for maintaining the capacitive sensor element in place for use. Once again, pairs of dual snap connector apertures 20 are shown positioned on either side of fold line 22. The manner in which the edge of substrate layer 12 is folded over on fold line 22 to align the connector apertures 20 is shown.
FIG. 28 shows the manner in which the full assembly of the capacitive sensor element of the present invention is carried out. The individual capacitive sensor element shown in FIG. 27 is associated with a pair of dual snap connector conductor elements 24 which are attached to one end of the capacitive sensor element. As described above with regard to FIG. 27 one edge of substrate layer 12 is folded along fold line 22 so as to align the paired snap connector apertures 20 with each other in such a way as to provide a connection point for each of the dual snap connector conductor elements 24. As shown in FIG. 28, folding the edge of substrate 12 over exposes the conductive elements 18 on both sides of the capacitive sensor element in a manner that allows the conductive metal snap connectors 24 to be positioned on both conductive surfaces 18 above and below the capacitive sensor element. In this manner the snap connectors 24 are passed through the aligned apertures 20 and are connected together with electrical contact being made between the metallic components of the connectors 24 and the conductor elements 18 printed or layered onto the substrate 12. After assembly of the sensor element as shown in FIG. 3, the capacitive sensor may be used in conjunction with the patient monitoring system as described above. The electrical conductors (wires) extending from connectors 24 are typically a single pair of conductors that provide the necessary electrical response to the instrumentation of the system to detect the appropriate capacitance shift.
The substrate layer of the present invention may be constructed of a flexible layer of any of a number of different non-conductive materials that can serve as a robust foundation for the placement and positioning of the conductive elements. In the preferred embodiment, this layer of sheet-like material may comprise a layer of Tyvek® material or another form of woven paper varying in content from 100% cotton to a variety of different cotton/polyester woven blends. Various disposable, yet sufficiently stable, woven materials are available in the industry for use with the present invention. The primary requirement is that the material be suitable for the reception and retention of the layering of the conductive elements, either in the form of printed ink layers or other adhered layers, and that the material be sufficiently flexible. The material may preferably be such as to pass water vapor but not liquid water through the layer.
The conductive elements may comprise any of a number of different conductive ink layers that are printed onto one surface of the substrate layer or may comprise separate metallic or conductive material layers otherwise adhered to or bonded to one side of the substrate layer. The preferred embodiment includes a printed layer of metalicized ink or the like that is positioned on one surface of a woven paper type material manufactured in the form of the roll shown and described above.
As indicated in the above, the present invention includes an improved method for manufacturing the roll of material suitable for separation into individual capacitive sensor elements. Various existing manufacturing processes are known to be useful in the manufacture of rolls of paper or paper-like material, many of which include printed elements along the wound roll of material. The manufacture processes of the present invention would include slight modifications to existing paper roll manufacturing equipment in a manner that would make them suitable for the manufacture of a wound roll of material having perforations, printed conductive elements, and even laterally crossed with adhesive strips. Much along the lines of the manufacture of a roll of paper towels, the structure of the capacitive sensor element of the present invention could be manufactured into a roll that not only makes the manufacturing process more efficient, but provides for an efficient means of dispensing individual sensor elements one at a time for use by the facilities implementing the patient monitoring system.
Although the present invention has been described in terms of the foregoing preferred embodiments, these descriptions have been provided by way of explanation only and are not intended to be construed as limitations on the invention. Those skilled in the art will recognize modifications of the present invention that might accommodate specific capacitive sensor arrays and applications. Such modifications, as to sensor array element structure, electrical and electronic configurations, and the geometry and number of the conductive elements and perforations, where such modifications are coincidental to the type of sensor array being utilized, do not necessarily depart from the spirit and scope of the invention.

## Claims

1. A sensor for determining the presence of a person within the confines of a wheelchair, the sensor comprising:
a fabric shell configured to be slipped over the back support of the wheel chair, the fabric shell comprising:
a front panel positioned to be adjacent the back of the person when the person is positioned within the wheelchair, the front panel comprising a pair of electrically conductive bands woven into the fabric of the panel, the bands spaced in a generally parallel vertical arrangement about the midsection of the back support of the wheelchair;
a back panel positioned opposite the front panel and apart from the back of the person positioned in the wheelchair, the back panel comprising a holder for retaining sensor instrumentation, the back panel further comprising extensions of the bands on the front panel and including an electrical snap connector positioned through the back panel within the extensions of the bands,

wherein the bands serve to provide a capacitance sensor that changes capacitance with and without the presence of the person in the wheelchair adjacent the front panel.