Data logger for transportable life support system

Surgery – Miscellaneous

Reexamination Certificate

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Details

C128S845000

Reexamination Certificate

active

06234176

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to medical devices utilized to treat intensive care patients and more particularly to a data logger for a self-contained transportable life support system such as those which are utilized in the resuscitation, stabilization, and transport of medical patients. The data logger of the present invention interfaces to the medical devices of the transportable life support system in a manner which does not substantially interfere with the operation thereof, thereby attempting to maintain prior governmental clearance, such as Food and Drug Administration (FDA) clearance of medical devices in the United States.
BACKGROUND OF THE INVENTION
The need to transport medical patients and persons suffering from various medical emergency conditions such as heart attacks, strokes, etc. is well-known. Medical personnel speak of a “golden hour” within which such a medical patient must be transported to a medical facility so that proper medical care can be provided therefor. The survival rate for such medical patients is greatly enhanced if they are transported to the medical facility within the golden hour.
However, as those skilled in the art will appreciate, it is often difficult to transport a patient to a remotely located medical facility in a timely manner, particularly within the golden hour. Frequently accidents occur at remote locations and thus a substantial amount of time is required to transport the medical patient to a distant hospital. Also, in battlefield situations it is frequently impossible to transport a casualty immediately. In either instance, the patient may be located hundreds, if not thousands, of miles from a hospital, thus necessitating several hours of transport time. As such, it is frequently beneficial to perform various emergency medical procedures at the site of the medical problem, and then to attempt to provide ongoing medical care during transport to a remote hospital. The mortality rate of such transported medical patients is substantially reduced.
It is well-known to use various different medical devices in the field, i.e., at locations remote from a medical facility, so as to enhance a medical patient's chance of survival. For example, it is well-known to use an ECG and a defibrillator upon heart attack victims so as to monitor the condition thereof and so as to provide medical treatment therefor in field.
Typically, the medical patient is placed upon a stretcher and then various different medical devices are used upon the patient, as necessary. During transport the medical devices may either be temporarily disconnected from the patient, or alternatively may be hand carried along therewith by additional personnel. However, disconnection of the medical devices from the patient results in the undesirable disruption of medical monitoring and/or treatment therefor. Hand carrying the medical devices along with the patient requires extra personnel, which may not be available, or for which there may not be adequate room within the transport vehicle.
As such, it is desirable to provide a system for transporting a medical patient wherein the medical devices are carried along with the stretcher. In an attempt to provide such a system for transporting a medical patient while facilitating the continuous use of medical devices thereupon, the Mobile Intensive Care Rescue Facility (MIRF) was developed by the Royal Australian Army Medical Corp. The MIRF is intended to provide sufficient medical equipment to have the capabilities of an intensive care hospital ward. The MIRF is designated so as to facilitate the removal and replacement of the various pieces of medical equipment therefrom for maintenance. The MIRF is specifically designed to accommodate two major roles: the transfer of critically ill people from one point to another, such as from a ward to an x-ray room or from one hospital to another; and the bringing of life support systems quickly to the scene of an accident or other medical emergency.
The MIRF can be configured to include a blood pressure cuff, an invasive blood pressure monitor, a body temperature sensor, a heart rate sensor (finger clip sensor), an oxygen saturation sensor, an exhaled air carbon dioxide sensor, and an electrocardiograph, so as to facilitate medical monitoring of a patient. Further, the MIRF can include a ventilation system, a volumetric infusion pump, a syringe pump, a suction unit, and a defibrillator so as to facilitate medical treatment.
Another contemporary system is the MOBI described in U.S. Pat. No. 4,957,121, issued to Icenogle et al. on Sep. 18, 1990. The MOBI is similar to the MIRF in concept. That is, like the MIRF, the MOBI utilizes off-the-shelf medical devices which are attached to the housing thereof so as to be transportable therewith, thus eliminating disruptions in the medical care provided thereby during transport.
Further examples of such contemporary life support systems include those disclosed in U.S. Pat. Nos. 4,584,989; 4,352,991; 4,691,397; 3,304,116; and 3,341,246.
U.S. Pat. No. 4,584,989 discloses a life support stretcher bed adapted to accommodate patients in intensive or cardiac care units in hospitals. The life support stretcher bed is broadly adapted for electrical medical devices, medical supplies and features an under carriage including a support structural, wheels, a patient housing with a mattress, an electrical power source and supports for mounting the medical equipment.
U.S. Pat. No. 4,352,991 teaches a life support system adapted for field use in a vehicle with available power and includes electrically operable life support units, means for supporting the life support units, a patient stretcher, and a DC power source adapted for battery or remote power source.
U.S. Pat. No. 4,691,397 teaches a device for carrying the life supporting devices of a bedridden patient including a table like means for supporting the devices, an IV holder, wheeled transport means and a hospital bed footboard securing means.
U.S. Pat. No. 3,341,246 teaches a hospital stretcher adapted broadly with a litter structure having telescopic post elements and other means for manipulating the patient to various positions.
As those skilled in the art will appreciate, it would further be desirable to monitor the operation of each of the medical devices and to store or log the results of such monitoring so as to provide both medical and maintenance personnel with useful information. Medical personnel could use the results of such data logging for determining the condition of the patient as well as the treatment which has already been provided to the patient. Maintenance personnel could use such data logging to determine if the medical devices have been operating properly.
Thus, when the transportable life system arrives at a medical facility, medical personnel could immediately access the data logger to determine the status of the patient. Rapid access to such information would greatly aid in the diagnosis and treatment of the patient. For example, if the patient had an irregular heart beat during transport, then medical personnel would immediately be alerted as to the need to continue with monitoring of the heart beat, as well as to the possible need to treat the irregularity.
Maintenance personnel could review the data log so as to determine if the medical monitoring devices were monitoring the patient properly and if the medical treatment devices were applying treatment to the patient in the desired manner. Further, logged parameters such as the time and service for each medical device would provide maintenance personnel with an easy means for determining when routine maintenance should be performed upon each medical device.
However, when the medical devices have previously been approved by a governmental agency, then it is necessary that such data logging be accomplished without interfering with the operation of the medical devices, so as to attempt to maintain the validity of such prior approval. Thus, any signals associated with the medical devices must be taken in

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