Surgery – Diagnostic testing
Reexamination Certificate
1999-04-15
2002-07-09
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C600S301000, C128S903000, C128S904000
Reexamination Certificate
active
06416471
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a system and method for monitoring vital signs and capturing data from a patient remotely using radiotelemetry techniques. In particular, the present invention is a low cost, patient-friendly, ambulatory monitoring system for remote electronic capture of nonincasive vital signs data including, e.g., full waveform ECG, repiration rate, skin temperature, and blood pressure. The present invention also has the capability for real-time monitoring or recording of continuous or point-in-time information with the data presented to the user in a tailored form. Monitoring software included in the system of the invention may also incorporate full ECG analysis as well as alarms for arrhythmias and other abnormalities determined from the measured vital signs.
2. Description of the Prior Art
Before drugs and related therapies are approved for widespread use by physicians, such drugs and therapies typically undergo numerous trials for efficacy and safety. Successful human trials are critical to regulatory approval of a new drug or therapy, and accordingly, much money an effort goes into the human trials. At present, patients are selected for the trial and placed on the regimen under test. The efficacy and safety of the drug and/or therapy is tested by having the patient make numerous visits to his or her physician for testing during the trial period. While a great deal of information can be gathered at such tests, generally there is no method for collecting the data between physician visits, thereby causing decisions regarding efficacy and safety to be made based on a small sampling of the patients' experiences with the drug and/or therapy. More frequent visits to the physician would improve the data pool; unfortunately, such visits are expensive, add to the overall cost of the trial, and, because a limited data set is available, the trial duration is lengthened, thereby delaying the drug's market introduction.
An improved technique for testing the efficacy and safety of a drug and/or therapy is desired which does not require additional visits to the physician. It is desired to develop a technique for collecting data from a human subject at all times during a trial without requiring any visits to the physician's office, thereby eliminating the cost and inconvenience of visiting the physician's office for routine monitoring.
Also, an improved remote patient monitoring/management system is generally desired whereby useful vital signs data may be obtained from a patient without requiring frequent visits to the physician's office. Such remote monitoring/management is particularly desirable for home patient monitoring of patients with chronic illnesses such as congestive heart failure of for post-operative or out-patient monitoring. Prior art patient telemetry systems have had limited commercial success for a variety of reasons such as difficult of use and cost.
Remote patient monitoring techniques are generally known in which electrodes are placed on the patient to monitor the patient's vital signs and the captured data is transmitted to a remote display for monitoring the patient's condition. Remote monitoring systems are known which permit a doctor or nurse to monitor the conditions of several hospitalized patients from a central monitoring site in the hospital. Typically, sophisticated patient monitoring equipment is used to collect data from the patient, and the collected data is transmitted via wire to the central monitoring site in the hospital. Generally, wireless systems are problematic in the hospital setting because of the proximity of the respective patients and the amount of interference found in such a setting.
Typically, most of the patients receiving a particular drug regimen or therapy being tested are ambulatory and, in many cases, participating in the study from home. Remote monitoring of patients from their homes introduces an entirely new set of challenges for transmitting the gathered data to a central location for evaluation. Numerous attempts have been made to facilitate such data collection and trasmission; however, in each case, cumbersome and uncomfortable monitoring equipment is placed on the patient and the patient is tethered to the monitoring equipment by electrical cords, thereby limiting the patient's movement. In some prior art systems, the electrical cords have been removed and the transmissions to the monitoring equipment made using telemetry techniques; however, such systems have been used primarily for real-time vital signs monitoring and not for data collection of the type needed for diagnosis and efficacy and safety testing. Moreover, such systems also limited the movement of the patient to a limited area near the vital signs monitor.
For example, an early telemetry system is described is U.S. Pat. No. 3,603,881 in which short transmission distances to a building's wiring system are covered using VHF transmission. Physiologic data such as electrocardiographic (ECG) data is collected by a sensor and transmitted by a VHF transmitter to a fixed VHF receiver RF transmitter coupled to the wiring system in the building. An RF receiver demodulator monitor is coupled to the building's wiring system at the nurse's station for receiving the physiologic data for patient monitoring and/or data recording.
A similar telemetry system for monitoring ECTG signals is described in U.K. Patent Application No. 2 003 276 except that telephone connections are used in place of the building wiring and the system is also designed to collect blood pressure, pulse rate, respiratory rate and the like and to relate that information to the physician via the telephone connections.
Other early telemetry systems of the type described by Lewis in U.S. Pat. No. 3,943,918 and by Crovella et al. in U.S. Pat. No. 4,121,573 use telemetric techniques to transmit data from a sensor device attached to the patient's chest via RF to a radio telemetry receiver for display and/or recording as desired. S.S. Ng described yet another telemetry system for ECG monitoring in an article entitled “Microprocesor-based Telemetry System for ECG Monitoring,” IEEE/Ninth Annual Conference of the Engineering in Medicine and Biology Society, CH2513-0, pages 1492-93 (1987). Ng therein describes a system for providing continuous ECG monitoring and analysis by means of a PC AT via wireless link. In the Ng system, the patient requires a transmitter which is carried by the patient for sensing and transmitting the patient's ECG signal to a central base station via wireless link. At the base station, a receiver recovers the original ECG signal from a few patients simultaneously for display.
Each of the above-described telemetry systems is designed primarily for hospital use and include relatively expensive sensor arrays and processing devices for real-time patient monitoring and diagnosis. The real-time monitoring is generally used in an “alarm” mode to capture events, rather than to collect data over a period of time to determine trends which might indicate a more gradual deterioration or improvement in the patient's condition or to predict a forthcoming event. Also, these systems require the patient to remain in close proximity to the base stations including the receivers.
Bornn et al. describe a portable physiological data monitoring/alert system in U.S. Pat. Nos. 4,784,162; 4,827,943; 5,214,939; 5,348,008; 5,353,793; and 5,564,429 in which one or more patients wear sensor harnesses including a microprocessor which detects potentially life-threatening events and automatically calls a central base station via radiotelemetry using a radio modem link. In a home or alternate site configuration, communications between the base station and remote unit is by way of commercial telephone lines. Generally, the system automatically calls “911” or a similar emergency response service when an abnormality is detected by the ECG monitor.
Unfortunately, the sensor harness is quite cu
Johnson Paul
Kumar Harpal S.
Llewellyn Michael D.
Mullarkey William J.
New, Jr. William
Astorino Michael
Nexan Limited
Winakur Eric F.
Woodcock Washburn Kurtz Mackiewicz & Norris LLP
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