Surgery – Diagnostic testing
Reexamination Certificate
2001-08-20
2003-10-21
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C128S903000, C128S904000
Reexamination Certificate
active
06635016
ABSTRACT:
FIELD OF THE INVENTION
This invention is directed towards electronic data collection, and more particularly towards a system and method for remote collection and processing of biomedical data.
BACKGROUND
As medical science advances, more and better sensors and equipment are available to help monitor and maintain patients. However, such equipment is often expensive and difficult to properly use. Therefore, many patients must visit medical facilities on a regular basis in order to have tests and measurements done. This is expensive and inconvenient for many patients on an out-patient basis. Providing biomedical sensors and equipment which can be used by patients and users in their homes is a reasonable and cost saving solution. But biomedical systems in medical offices and especially in patients homes may frequently be used by users with minimal technical skills and therefore the exploitation of such systems should be as simple as possible. To make such systems affordable for a widespread use at patient homes the system's cost should be minimized, including cost of hardware and software.
A real-time system for collection and processing of biomedical data using cards inserted in the slots of PC that supports the PCMCIA bus standard was previously described in U.S. Pat. No. 5,827,179 and issued to Lichter. The PCMCIA bus was designed for portable PC types such as “laptop” and “notebook.” In accordance with Lichter, each additional biomedical signal requires an additional PCMCIA card. Thus the number of cards needed is equal to the number of signals to be measured. This makes the system described in Lichter cumbersome and expensive. Additional disadvantage of such an approach is related to the fact that not all manufacturers produce PCMCIA-compatible PCs. To overcome the incompatibility problem four PCMCIA standards were designed—from PCMCIA type 1 to PCMCIA type 4.
The approach proposed in Lichter also requires that the software that controls the process of collecting and processing the incoming biomedical information from each PCMCIA card, be permanently installed in the user's PC. As a result the user have to purchase the specialized data acquisition software which increases the cost of the system. In addition, the user must possess sufficient technical skills to install the specialized software. This complicates the usage of the system not only at the stage of initial installation of the specialized software but also each time when software upgrade installation is required.
A remote pulmonary function tester to assess lung function at a patient's home and to transmit the collected information to a remote data center was previously described in U.S. Pat. No. 4,296,756 and issued to Dunning. According to Dunning, the information was sent via a telephone line to a central computer to assess patient functional status. The tester consisted from pressure transducer, Analog-to-Digital Converter (ADC), keyboard for alphanumeric data entry, microprocessor system for data storage and identification, modem interface to communicate with the central computer over telephone line and a microprocessor to control the tester. The functionality of the system is permanently limited by analysis of a predefined set of lung function parameters without a possibility of any modification. The signal acquisition and data analysis software must be permanently installed in the user's computer.
A system for monitoring and reporting medical measurements and transmission of the collected information to remote terminal for assessment by a clinician was described in such patents as U.S. Pat. Nos. 5,549,117; 5,626,144; 5,704,366; and 5,732,709, all to Tacklind et al. The system is similar to the one described in Lichter since software for data collections, analysis and transfer should reside permanently in the user's microprocessor unit. The system is for analysis of one signal exclusively.
A method and apparatus for automated spirometry data acquisition and processing was described in U.S. Pat. No. 5,241,469 and issued to Nelson. The apparatus includes a printed circuit board inserted in PC internal slot and connected with PC bus from one side and with a volumetric spirometer from another side. The printed circuit board includes hardware logic for analog signal pre-processing, ADC and interface for PC bus. The software to control the printed circuit board and to analyze the received data is permanently installed in the PC. The approach implemented in this apparatus has several limitations. Installation of the printed circuit board into internal PC slot requires opening the computer case and can be performed only by a person with sufficient technical skills. Part of signal processing is implemented in the printed circuit board hardware and therefore is impossible to change or upgrade without replacing the entire printed circuit board. The specialized data acquisition software which is supposed permanently reside on the computer hard drive consumes hard drive space. If the hard drive is damaged the entire apparatus becomes non-functional. In addition, the software can become non-functional if the entire software package or some of its components are accidentally erased by a person or damaged by a computer virus. These situations would have to be recognized by a professional and would require complete software re-installation. Each software installation or update requires certain percent of time effort of a skilled personnel.
A portable device to measure parameters of expiratory air flow is described in Vitalograph manual, published by Vitalograph Ltd., Maids Moreton House, Buckingham, MK18 1SW, England, Ref. No. 07038, Issue 1, 1998. The device's data processing logic is fully implemented in its hardware. The electronic circuit of this device is responsible for air flow signal registration, analysis and presentation of the measured parameters. The device also includes digital data interface to transfer analysis results to PC via a serial port. The device sends to PC the results of data processing for storage and further analysis. Specialized software should be permanently installed on PC hard drive to allow the data transmission feature. The specialized software allows data transmission from the portable device to PC but it does not allow to send data to a remote computer. To implement this feature for the described system it would be necessary to develop and install on the PC additional custom software.
In summary, based on the disclosed prior art, current systems for collecting and processing of biomedical information follow one of two conceptual models as illustrated in FIG.
1
A and FIG.
1
B. Each model includes both hardware and software. Hardware in the model
1
includes set of sensors Si (at least one sensor in some cases), printed circuit cards Ci (at least one card in some cases) to process and convert analog signals into a digital form, and digital data interface providing compliance with one of the standard computer data interfaces. The software is represented by an executable modules (at least one in some cases) which permanently reside in the computer and should be pre-installed before the hardware is being used.
According to the prior art
1
presented in
FIG. 1A
, the Hardware Unit (HU) is responsible for collecting, processing and conversion of biomedical information registered by the sensor/s. The HU transfers the obtained information to the computer for further analysis via one of pre-selected standardized data interfaces. Thus, the data processing is distributed between hardware and software and the task distribution depends on a particular implementation.
The prior art
2
presented in the
FIG. 1B
differs from the model
1
in that it allows transmit information from the computer to a remote data processing center via a modem. The information may then be stored in a remote computer and analyzed by a remote user.
There is a common feature in the both models which limits their functionality: the specialized software modules should be pre-installed before the h
Brown Rudnick Berlack & Israels LLP
Finkelstein Joseph
Lowry David D.
McCrosky David J.
Winakur Eric F.
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