Surgery – Diagnostic testing
Reexamination Certificate
1998-12-23
2002-06-04
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
C128S904000
Reexamination Certificate
active
06398727
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to a management system and a method of providing patient care in the home or alternate care setting, i.e., to a system which functions as a virtual hospital room.
A hospital room is a place where a patient can receive medical treatment and have his physiological condition monitored under the supervision of a healthcare professional both continuously and at prescribed times. As the cost of health care increases, the trend is to discharge the patient from the hospital earlier, but to continue the therapy at the patient's home or at an alternative care facility. Various medical devices, such as infusion pumps and respirators, allow the patient to receive therapy outside the hospital environment. In many instances the caregiver must visit the patient's home to monitor and control the medical device. Some medical devices, however, include means for enabling the caregiver (or healthcare professional) to monitor and control the medical device's functions from a remote location.
Co-pending U.S. patent application Ser. No. 08/951,976, filed Oct. 16, 1997, titled “Medical Apparatus With Remote Virtual Input Device”, which is assigned to the assignee of this application, describes a medical apparatus for remote monitoring and controlling of a medical treatment device, such as an infusion pump. The medical apparatus described therein includes a medical device for administering a medical treatment and a remote controller. The caregiver can control operation of the medical device either at the patient's location using the device's input device or from the remote location by activating a virtual input device.
U.S. Pat. No. 5,807,336 for “Apparatus for Monitoring and/or Controlling a Medical Device”, which is assigned to the assignee of this application, describes an apparatus for remotely monitoring and controlling a medical device in which stored data can be transferred from the medical device on a real-time basis to the remote controller while the medical device is administering medical treatment.
Co-pending U.S. patent application Ser. No. 08/703,543, filed Aug. 27, 1996, titled “Medical Treatment Apparatus and Method”, which is assigned to the assignee of this application, describes a combination of a medical treatment device, such as an infusion pump, and one or more sensors, which detect the medical condition of the patient. The sensors are connected to the medical treatment device, so that signals generated by the sensors, which indicate the patient's medical condition, can be stored as data in a memory contained within the medical treatment device. By connecting the sensors directly to the medical treatment device, such data can be safely stored within the device for later downloading by a remote monitor/controller. The use of such sensors during the administration of a treatment, however, may limit the patient's mobility.
U.S. Pat. No. 5,522,396 to Langer et al. discloses a remote system for monitoring a patient's heart. A patient station, which is intended to be worn by the patient, includes a monitor for monitoring a patient's heart or other physiological function and a transmitter for transmitting data. The patient station, however, does not provide for alarms should the patient's condition require contacting the caregiver.
U.S. Pat. No. 5,590,648 to Mitchell et al. discloses a unitary command center (generally resembling a cart) having a computer for receiving, storing, processing and transmitting information, and a plurality of interfacing ports. Various patient monitoring sensors modules and therapy modules are intended to be connected to the ports. However, the command center is suitable for an ambulatory patient.
U.S. Pat. No. 5,678,562 to Sellers discloses an ambulatory physiological monitor intended for Holter monitoring with a removable disk cartridge and a wireless modem. Transmitting data over a cell phone system is costly and not all patients may be capable of using the removable disk cartridges.
U.S. Pat. No. 5,568,814 to Gallant et al. discloses an ambulatory patient monitoring system for measuring and storing predetermined diagnostic parameters of a patient. One or more plug-in sensor units is coupled to a portable portion of the system, which is worn by the patient. The portable portion is designed to be coupled to a personal computer for programming, downloading and monitoring of the data, but does not provide for alarms should the patient's condition be outside prescribed values.
In addition to providing therapy at home or in the alternative care facility, many patients may still need monitoring of their physiological conditions. Some patients may require continuous monitoring of respiration and heart rate, for example. Other patients may only need their vital signs, such as temperature, blood pressure, heart rate, taken at scheduled times or when a caregiver requests the measurements, such as for diagnosis.
There is a need for a patient home management system which provides for continuous monitoring of physiological conditions of an ambulatory patient. There is a need for a lightweight, easy to wear patient monitor for an ambulatory patient, which can be configured to accept a wide variety of diagnostic and monitoring sensors. There is a need for an ambulatory patient monitor which is versatile, but not unnecessarily complex. There is a need for a patient home management system which provides for measurement of a patient's vital signs on a regular schedule or at the direction of a caregiver at a remote location. There is a need for a patient home management system which provides for ease of communication with the caregiver. There is a need for a patient home management system which provides for the storage and transmission of patient physiological condition data. There is also a need for a patient home management system which monitors the patient's condition and when the patient's physiological condition falls outside prescribed limits, provides a means of notifying the patient to contact the caregiver or automatically contacts the caregiver. There is a further need for a patient home management system which provides for the monitoring of the various sensors used to detect the patient's physiological condition.
SUMMARY OF THE INVENTION
A patient home management system embodying the invention provides a comprehensive system for monitoring ambulatory or homebound patients in the home or alternative care environment. The patient management system includes a programmable, ambulatory patient monitor for monitoring and recording a plurality of physiological conditions of a patient. A plurality of patient monitoring sensors are electrically coupled to the programmable, ambulatory patient monitor. Each sensor detects a particular physiological condition of the patient, such as core temperature, respiration characteristics including respiration rate, electrocardiographic electrodes for providing signals to produce an electrocardiogram and blood oximetry sensors. The ambulatory patient monitor is small and compact and easily worn by the patient during his normal at-home activities.
To provide communication with the caregiver, a communications unit is disposed in the patient's home or the alternate care facility. The communications unit includes a modem or other telecommunications device which can communicate with a remote controller at the caregiver's office. The communications unit is generally larger than the ambulatory patient monitor and is situated at a convenient location where the patient can hear or see messages from it. The communications unit may be selectively coupled to the programmable, ambulatory patient monitor for receiving, storing and transmitting to the remote controller patient physiological condition data and for transmitting instructions from the remote controller to the programmable, ambulatory patient monitor. The patient can communicate with the caregiver using the communications unit. When the patient
Bui Tuan
Cooper Thomas
Deckert Clint
Levitas Doron
Macha Emil S.
Baxter International Inc.
Nasser Robert L.
Wallenstein & Wagner LTD
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