Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-04-19
2003-05-27
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S437000, C600S375000, C600S523000
Reexamination Certificate
active
06569101
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates primarily to a handheld ultrasound instrument having various diagnostic modes and detachable modules. Also included is a means for manufacturer to strictly control the operational capabilities of the handheld ultrasound instrument after the instrument has entered the stream of commerce.
2. Description of the Prior Art
As is well known, modem ultrasound diagnostic systems are complex systems, many of which employ computer control circuits. The computer circuits, in turn are controlled by software and data, which is typically stored in some form of addressable memory associated with the instrument. This memory may be, for example, semiconductor memory or a rotating magnetic disk. As ultrasound systems have become more sophisticated, they have employed a greater quantity of software and data in the control of the instrument.
An advantage of extensive use of software programmable instruments that may rely on other stored data for operation is that new capabilities can be added or enabled by modifying this software or data. Also, design or implementation defects in software or data can be corrected by modifying the software or data. Modification of the software or data may be accomplished by introducing new software or data via a portable representation, such as a removable magnetic disk, optical memory, or semiconductor memory, or via an electronic communications network. The same mechanisms may be applied to alter existing software or data as opposed to introducing new software or data.
A significant limitation of current mechanisms for update or modification of data or software associated with diagnostic ultrasound systems is that of control of the update or modification process. Regulatory requirements typically stipulate that manufacturers must keep accurate records of any modification to diagnostic systems, including software or data updates. Thus the modification process must be restricted in some way so that appropriate data can be maintained. In addition it is desirable to limit access to certain functions of an instrument in order to provide lower cost, limited functionality systems that may later be upgraded with more extensive functionality. Typical mechanisms employed currently to implement such control over the modification process are either cumbersome or ineffective. Service personnel may be sent to a customer site to perform the process, or instruments may be returned to a central facility for update. Either mechanism incurs significant expense in both money and time. Other mechanisms may be employed to allow users of the instrument to perform the update process, but this limits the control that the manufacturer has over the process.
SUMMARY OF THE INVENTION
In accordance with the present invention, a handheld ultrasound instrument is provided having a group of diagnostic modes not previously available in portable devices due to restrictions on both weight, and signal processing capabilities in small circuit devices. ECG capacity is also described using a separate module to preserve weight in the handheld instrument, as well as a secure control means for the upgrade and control of the diagnostic capabilities of ultrasound instruments while providing a means to maintain a detailed user database are disclosed.
The first embodiment of the present invention is a handheld ultrasound device weighing less than fifteen pounds including a transducer, beamformer and image processor, a first digital signal processor (DSP), a second digital signal processor (DSP) block comprised of a DSP core and an external field programmable gate array (FPGA). The first DSP is capable of processing B mode and flow (2D Doppler) scans. The second DSP comprises a digital Doppler QBP filter for filtering PW Doppler signals and a PW Doppler signal processing circuit.
The ultrasound instrument may also have the capacity for time-motion display, frequently referred to as M mode. M mode signal processing occurs on the first digital signal processor using a micro-code block, and the interpolation of M-mode signal for video display is done on the second digital signal processor.
In an embodiment of an ECG module, ECG functionality is added to a handheld diagnostic ultrasound instrument without significantly increasing the weight or cost of the instrument. More particularly, an ECG module is provided with a cable system connector for connecting the module to the handheld ultrasound instrument. The module includes leads for interfacing with a patient and the basic electronics for ECG signal processing including amplification and filtering of signals for use by the handheld unit. In a first embodiment the module includes electrical ground isolation for isolating the patient leads from the system signals and ground. The module houses the ECG electronics with a first stage amplifier and filter provided in the isolated portion of the module and all other ECG electronics provided in the handheld ultrasound instrument of the module.
Alternatively the first and second stage amplifiers and filters are in the ECG module, as well as a display signal processor, for formatting the signal into a displayable format. The display signal is then exported to the display of the handheld ultrasound instrument. The display export may be in analog format, or through a analog to digital converter, and exported as a digital signal. Amplified and filtered signals from the patient leads are optically coupled from the lead portion to the system portion of the ECG module. Necessary power for the lead portion is generated using either capacitive or inductive type power converters from the system power supply to the isolated portion of the ECG module. Thus the patient is not ground connected directly to the system ground reference.
More particularly, the power supply circuit includes a serial inductor for receiving a DC voltage and a shunt capacitor and a shunt switch connecting the serial inductor to a power ground. A first coupling capacitor capacitively couples the serial inductor to an isolated first power processing circuit, and a second coupling capacitor couples the power ground to the first power processing circuit. A rectifying circuit in the first power processing circuit includes a forward polarity diode connecting the first coupling capacitor to a first terminal of a positive voltage capacitor, and a reverse polarity diode connecting the first coupling capacitor to the first terminal of a negative voltage capacitor. An isolated reference terminal is connected to the second coupling capacitor and to a second set of terminals of the positive voltage capacitor and the negative capacitor whereby electric power is coupled through the coupling capacitors at the frequency of the shunt switch to the isolated signal processing circuitry.
In accordance with the principles yet another embodiment of the present invention, a diagnostic ultrasound instrument is provided with a software security mechanism that effectively restricts modification or replacement of software or data associated with the instrument. Updates to software or data for a particular type of instrument can be developed and easily distributed, but control over the actual update or modification of any specific instrument is retained.
In one embodiment, a “keycode” is generated via an algorithm that takes a unique system identifier and information regarding the modification or update to be performed as inputs. Software in the instrument to be updated prevents any update or modification of the instrument's software or data unless the correct keycode is provided by the person or agency performing the upgrade process. Requiring the person or agency performing the update to obtain the keycode from one or more authorized agencies allows the manufacturer to control such upgrade process to satisfy both regulatory and feature-control requirements. This mechanism does not require service personnel to perform the update process, nor is any movement of the instrument to an update facility required
Catallo Leo R.
Hirschi D. Scott
Holmberg Randy T.
Hwang Juin Jet
Little Blake W.
Jaworski Francis J.
Patel Maulin M
Sonosite, Inc.
Townsend and Townsend / and Crew LLP
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