This disclosure relates generally to medical devices used to prevent aspiration and other complications in patients, and more specifically two-axis inclinometry devices used to warn caregivers about improper absolute angular orientation of a patient's upper body.
Hospitalized bedridden patients are at a high risk of aspirating and choking on secretions, food, medicines or gastric contents. These risks can be lowered by closely monitoring the absolute angular orientation of the patient's upper body. For example, patients on ventilators are especially vulnerable to developing severe pneumonia after aspirating gastric contents. Numerous studies have shown that such cases of pneumonia, known as ventilator-associated pneumonia, often can be prevented by elevating the plane of the upper body of the patient by approximately 30 degrees above the local horizontal plane. The plane of the upper body is defined as a plane that that passes through the line between the two shoulder joints and runs parallel with the spine. The local horizontal plane is defined as a plane normal to the local gravity vector. For the purposes of this disclosure it is assumed that the plane of the head of a hospital bed is parallel with the plane of the upper body and these terms may be used interchangeably.
While elevating the plane of the head of the bed is simple in principle, it is elusive in practice. This is because there are many reasons to lower the patient's upper body plane during the course of patient care. Some of these reasons include transport, bathing, or bedside medical procedures. Frequently, after the patient's upper body plane has been lowered for some reason and the caregiver forgets to elevate the head of the patient back in the elevated position. As a result, inadequate head elevation for at-risk patients is relatively common over the course of the treatment period. The disclosed subject matter helps to avoid this problem.
Known art, such as U.S. Pat. No. 7,117,607 by Horgan, discloses a device utilizing an “electronic inclinometer” to measure the head of bed angle to alert caregivers of dangerous head of bed angles for patients. However, known methods use a single axis inclinometer as the angle sensing device. These devices may suffer from the need for precise placement of the single sensing axis parallel with the head of bed axis of rotation.
Known art, such as U.S. Pat. No. 7,340,955 by Manninen, discloses a capacitive acceleration sensor arrangement that takes advantage of digital integration of the acceleration measurements. As quoted in Manninen:
The disclosure relates to an improved apparatus for notifying a caregiver of the absolute angular orientation of the patient's upper body utilizing two-axis inclinometry. One method of creating a two-axis inclinometer is to utilize a three-orthogonal-axis accelerometer set. An advantage may be gained by utilizing a digitally integrated three-axis accelerometer set that consumes extremely low amounts of power and enables a battery powered head of bed alarm with extremely long battery life or, in some cases, could be powered by a small light energy power system.
The advantage of using two-axis inclinometry for an aftermarket head of bed sensor (or a permanently attached unit) is significant. A two-axis inclinometer permits arbitrary rotation of the two-axis inclinometer on the axis normal to the plane of the head of the bed. This permits the placement of the head of bed sensing unit on the plane of the head of bed by relatively unskilled personnel. In other words, in the case of a magnetically attached sensing unit, (or for that matter any other attachment means such as Velcro, adhesive, mechanical attachment, etc.) if the magnet plane (i.e. the two-axis inclinometer plane of reference) is parallel to the plane of the head of the bed, the unit can be arbitrarily placed about the axis normal to the plane of the magnet (i.e. the plane of the head of the bed). Thus, the user simply applies the unit to the plane of the head of the bed and it will be able to sense the inclination angle of the head of the bed without precise alignment by the user.
Other advantages offered by the method of incorporation of digital integration accelerometers for two-axis inclination measurement are significant when the power consumption levels of traditional analog integrating accelerometers are compared with the digital technology known in the art, such as that outlined in U.S. Pat. No. 7,340,955. Traditional MEMS accelerometers utilizing an analog integration method typically draw on the order of 180 μA of current. The devices outlined in U.S. Pat. No. 7,340,955 draw from 70 to 7 μA of current and in some cases, using a special switching algorithm, can reduce power consumption into the 1 μA region. In particular, Horgan's patent contemplated the use of an accelerometer based electronic inclinometer consuming on the order of 5.2 mA which is 5200 times the power consumption of the Manninen device. Thus the improvement of utilizing a digital versus analog integrating accelerometer based inclinometer enables the device to be battery powered with a battery life on the order of six months to one year using an off the shelf 9 volt battery (e.g. Eveready Energizer Part number 522).
In one embodiment, the apparatus includes a three-orthogonal-axis digital integrating accelerometer set for use as a two-axis inclinometer for attachment in the region of a hospital bed near a patient's upper body to measure the patient's absolute upper body elevation angle. That measurement is then displayed on a display device to indicate the proper or improper orientation of the patient's upper body. In one embodiment the three-orthogonal-axis digital integrating accelerometer set is attached to the hospital bed frame parallel to the plane of the head of the bed that supports the patient's upper body. In another embodiment the three-orthogonal-axis digital integrating accelerometer set is attached to the patient such that the sensing plane of the two-axis inclinometer is parallel with the patient's upper body plane. In one embodiment, the display is green when the patient's upper body orientation is favorable and red when the orientation is unfavorable. In another embodiment, the device includes a processor that allows the caregiver to arbitrarily install the three-orthogonal-axis digital integrating accelerometer set on a bed at any angle, initialize the horizontal level setting and measure the absolute angular orientation of the patient's upper body. In one embodiment, the apparatus sends the patient's upper body orientation information to a nurse's station.
In another embodiment a tilt switch with a ball housed in a cone shaped cup is used as a two-axis inclinometer for attachment in the region of a hospital bed near a patient's upper body to sense if the patient's absolute upper body elevation angle is above or below a predetermined angle, that angle being determined by the angle of the cone shaped cup in the tilt switch. That state is then displayed on a display device to indicate the proper or improper orientation of the patient's upper body. In one embodiment the tilt switch is attached to the hospital bed frame parallel to the plane of the head of the bed that supports the patient's upper body. In another embodiment the tilt switch is attached to the patient such that the sensing plane of the two-axis inclinometer tilt switch is parallel with the patient's upper body plane. In one embodiment, the display is green when the patient's upper body orientation is favorable and red when the orientation is unfavorable. In another embodiment, the device includes a processor that allows the caregiver to arbitrarily install the two-axis inclinometer tilt switch on a bed at any rotation angle, and measure the absolute angular orientation of the patient's upper body. In one embodiment, the apparatus sends the patient's upper body orientation information to a nurse's station.
This disclosure also relates to a method for measuring the absolute angular orientation of a patient's upper body plane. In one embodiment, the absolute angular orientation of a patient's upper body plane is measured using a two-axis inclinometer comprising a three-orthogonal-axis digital integrating accelerometer set and then displayed on a display unit. In another embodiment the display unit presents a single color to indicate the correct absolute angular orientation of a patient's upper body. In another embodiment the display unit presents a single color to indicate the incorrect absolute angular orientation of a patient's upper body. In another embodiment the absolute angular orientation of a patient's upper body information is transmitted to a processor. In still another embodiment, the apparatus transmits the absolute angular orientation of a patient's upper body information to a nurses' station. In another embodiment the processor is programmed to alert the caregiver of a plurality of alarm conditions.
Additional advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the aspects of the disclosure as described herein. The advantages can be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the aspects of the disclosure, as claimed.
The features, nature, and advantages of the disclosed subject matter will become more apparent from the detailed description set forth below when taken in conjunction with the accompanying drawings, wherein:
The present disclosure may be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this disclosure is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.
As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to an “analyzer” can include two or more such analyzers unless the context indicates otherwise.
Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
Reference will now be made in detail to certain embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.
The utilization of a two-axis inclinometer enables the disclosed device to be placed in any arbitrary rotational orientation on the plane of the head of a hospital bed such that the unit will accurately measure the head of the bed in relation to the local horizontal plane (i.e. the plane normal to the local gravity vector). For example, the device could be affixed to the metal underside of a hospital bed by a magnet where the magnet is parallel to the plane of the head of the hospital bed but the unit is not constrained to any particular rotation around an axis normal to the head of the bed plane. The same unit could be placed on the top side of the head of bed by simply modifying the software to accommodate an angular range of interest opposite of that on the underside of the head of bed plane. The unit will perform the same function even though the orientation of the unit with respect to the bed is 180 degrees opposite that from the underside of bed use. As such, the device could be placed on either side of the bed, on top, bottom in any orientation so long as the two-axis inclinometer is parallel with respect to the head of bed plane.
Head of bed angle α is especially important for bedridden patients for a variety of reasons. For example, for a patient connected to a ventilator, ventilator-associated pneumonia can be reduced by maintaining the upper body of the ventilated patient at an angle of thirty degrees or greater. In one embodiment, the apparatus is programmed to alert the hospital staff when the upper body of a patient on the ventilator is below 30 degrees. In one embodiment, the display color is solid green when the patient's upper body is 30 degrees or greater. When the upper body is under 30 degrees, the display is colored blinking red. An additional embodiment uses sound as the alarm mechanism, such as a bell, horn or tone. In another embodiment, the words “Ventilated Patients Beds Must be Elevated to at Least 30 Degrees” are printed by the display.
The disclosed subject matter is also useful for patients who have recently had strokes, are weak, or have a high risk of inhaling their food and drink. Any of these situations can lead to a possibly fatal event of the patient choking on food, saliva, or other bodily fluids or substances. The apparatus can be set to aspiration precautions, which instructs the caregiver to elevate the head of the bed to 45 or 60 degrees when the patient is eating or drinking or to any arbitrary angle setting.
Additionally, the patient can develop pressure sores on the buttocks and lower back when the angle is much higher than 30 to 35 degrees. Therefore, in another embodiment, the apparatus can be programmed to display an alarm when the patient's upper body has been above 35 degrees in excess of the pre-programmed time. In another embodiment, the display contains selection buttons: one for a mobile patient which has no limit for time above 35 degrees, and another for an immobilized patient which is set to a maximum time (e.g. 15 minutes) above 35 degrees or other predetermined angle.
Remote computer 503 can also be an interconnected device such as a tube feeding pump or ventilator. In the example of the tube feeding pump, the tube feeding pump would sound an alarm and cease to operate if the head of bed were below say, 30 degrees.
The display on computer 503 alerts the user to the orientation of the patient's upper body and warns if the orientation is incorrect. In one embodiment, the electronics module 403 may be a solid state device that produces digital signals, which drive the display. The display on computer 503 is in one embodiment an LCD screen, a set of lights, an on or off display, or any number of forms that may be used to alert the user. In another embodiment, the user can continuously view the display screen to offer the user a constant reminder regarding the patient's upper body orientation. In another embodiment, the display can be all analog to show patient upper body orientation or minimum upper body orientation and can trigger the appropriate light when the upper body orientation meets any one of the other preset alarm conditions.
In one embodiment, the output of electronics module 403 or computer 503 is sent to an input channel of a ventilator. In another embodiment, the processor in electronics module 403 transmits the patient upper body orientation information to a network adapter and then to a Wi-Fi transceiver or to an Ethernet connection, which then relays the orientation information to various other devices and locations. In one such embodiment, the information is relayed to the nurses' station. In another embodiment, the patient orientation information is relayed to a personal digital assistant. In still another embodiment, the patient orientation information is relayed to a cell phone. In yet another embodiment, the patient orientation information can be relayed to the nurse call system, enabling the processor to call the nurse to the patient's room. In another embodiment, the processor can be programmed to alert the user at different settings or alarm conditions.
In another embodiment, the two-axis inclinometer is attached to the patient's body directly instead of to the head of bed plane 100. In the home care setting, the caregiver may use pillows rather than a mechanical bed to elevate the patient's upper body. Having the inclinometer attached to the patient's body, the caregiver can maintain correct head elevation without the use of a mechanical bed.
In one embodiment, the electronics module 403 processor calculates the patient upper body orientation value from the three-axis accelerometer (two-axis inclinometer) in electronics module 403. The processor then checks to see if the patient upper body orientation value is above or below the set value for the alarm condition. If the alarm condition is met, the processor sends a signal to an alarm mechanism (e.g. remote computer 503). If the alarm condition is not met, the electronics module 403 continues to monitor the angle of the head of bed plane 100 using two-axis inclinometry. In various embodiments, the alarm can be verbal, audio, visual, a display change, a light, or a warning to another set of devices.
In another embodiment the caregiver can input into the two-axis inclinometer apparatus an angle of inclination of the patient's upper body and the amount of time the patient may be non-detrimentally in that orientation or the amount of time the patient may rest outside of the allowed orientation on, for example, remote computer 503. When the patient's upper body is at the set orientation or outside the required orientation, a timer starts to run. When the patient is in the set orientation or outside the preferred orientation longer than the amount of time set by the caregiver, the apparatus sends an alarm. Thus, when the angle is changed for a medical reason, the apparatus can record when the patient's orientation is not in the desired orientation range and alert the caregiver when the patient is at that orientation for a detrimental amount of time.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.
This application claims priority to U.S. Provisional Application Ser. No. 61/318,707, which is hereby incorporated by reference for all purposes.
Number | Name | Date | Kind |
---|---|---|---|
2845762 | Wright | Oct 1958 | A |
3111036 | Kistler | Nov 1963 | A |
3806109 | Weber | Apr 1974 | A |
3962693 | Schamblin | Jun 1976 | A |
4102055 | Volk | Jul 1978 | A |
4306456 | Maerfeld | Dec 1981 | A |
4769584 | Irigoyen | Sep 1988 | A |
5006487 | Stokes | Apr 1991 | A |
5058283 | Wise | Oct 1991 | A |
5205004 | Hayes | Apr 1993 | A |
5611096 | Bartlett | Mar 1997 | A |
5715548 | Weismiller | Feb 1998 | A |
5923263 | Rodriguez | Jul 1999 | A |
5956855 | Foss | Sep 1999 | A |
6182509 | Leung | Feb 2001 | B1 |
6279183 | Kummer | Aug 2001 | B1 |
6353949 | Falbo | Mar 2002 | B1 |
6353950 | Bartlett | Mar 2002 | B1 |
6356203 | Halleck | Mar 2002 | B1 |
6505365 | Hanson | Jan 2003 | B1 |
6706978 | Wagatsuma | Mar 2004 | B2 |
6849814 | Ogden | Feb 2005 | B2 |
7117607 | Horgan | Oct 2006 | B2 |
7319386 | Collins | Jan 2008 | B2 |
7346944 | Shaw | Mar 2008 | B2 |
7487562 | Frondorf | Feb 2009 | B2 |
7500280 | Dixon et al. | Mar 2009 | B2 |
7562458 | Clark | Jul 2009 | B1 |
7594286 | Williams | Sep 2009 | B2 |
7934321 | Johnson | May 2011 | B2 |
20060021240 | Horgan | Feb 2006 | A1 |
20070044237 | Williams | Mar 2007 | A1 |
20070143920 | Frondorf et al. | Jun 2007 | A1 |
20070268480 | Kaye | Nov 2007 | A1 |
20090299229 | Johnson et al. | Dec 2009 | A1 |
Number | Date | Country | |
---|---|---|---|
20110234395 A1 | Sep 2011 | US |
Number | Date | Country | |
---|---|---|---|
61318707 | Mar 2010 | US |