Medical diagnostic ultrasound instrument with ECG module, authorization mechanism and methods of use
First Claim
1. A handheld ultrasound device weighing less than fifteen pounds, including a transducer, beamformer and image processor and a first digital signal processor capable of processing B mode and flow (2D Doppler) scans, having an second digital processor block comprised of a FPGA circuit and a second digital signal processor core comprising:
- a digital Doppler QBP filter for filtering PW Doppler signals; and
a PW Doppler signal processing circuit.
2 Assignments
0 Petitions
Accused Products
Abstract
A handheld ultrasound instrument is disclosed having enhanced diagnostic modes including pulse wave Doppler, time-motion analysis, and tissue harmonic imaging. An external electrocardiograph (ECG) recording unit is also disclosed. The ECG unit is adaptable to be used with the handheld ultrasound instrument to provide for ECG monitoring while performing an ultrasound scan in B-mode, Doppler, color Doppler, M-mode, and PW mode. The enhanced handheld ultrasound instrument further includes a security mechanism allowing any combination of the diagnostic modes to be enabled by the manufacturer, and later to enable or disable any one or group of the diagnostic modes. The invention also discloses a method for a manufacturer to maintain a database of handheld ultrasound instrument capabilities after the instruments enter the stream of commerce.
205 Citations
66 Claims
-
1. A handheld ultrasound device weighing less than fifteen pounds, including a transducer, beamformer and image processor and a first digital signal processor capable of processing B mode and flow (2D Doppler) scans, having an second digital processor block comprised of a FPGA circuit and a second digital signal processor core comprising:
-
a digital Doppler QBP filter for filtering PW Doppler signals; and
a PW Doppler signal processing circuit. - View Dependent Claims (2, 3, 4, 5, 6, 7)
-
-
8. An ultrasound diagnostic instrument comprising:
-
a) a handheld module including a display, manual controls, and system circuitry for processing signals for display;
b) a transducer assembly coupled to the system circuitry for providing electrical signals from ultrasound waves for processing; and
c) an electrocardiograph (ECG) module coupled to the handheld module by a cable and including leads for receiving ECG signals from a patient and ECG signal processing circuitry for applying ECG signals to the handheld module through the cable. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
-
-
19. For use with a handheld ultrasound diagnostic instrument, an electrocardiograph (ECG) module comprising:
-
leads for receiving ECG signals from a patient;
ECG signal processing circuitry; and
A cable for applying ECG signals from the ECG signal processing circuitry to the handheld module. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27)
-
-
28. In an electrocardiograph (ECG) module having first signal processing circuitry for processing ECG signals from a patient and second signal processing circuitry for further processing of the ECG signals for diagnostic use, a power supply circuit for providing electrical power from the system to the first signal processing circuitry comprising:
-
a) a serial inductive path for receiving a DC voltage and a shunt capacitive path and a shunt switch connecting the serial inductive path to a power ground;
b) a first coupling capacitor for coupling the serial inductive path to the first signal processing circuitry and a second coupling capacitor for coupling the power ground to the first signal processing circuitry; and
c) a rectifying circuit in the first signal processing circuitry including a forward polarity diode connecting the first coupling capacitor to a first terminal of a positive charge capacitor and a reverse polarity diode coupling the first coupling capacitor to a first terminal of a negative charge capacitor, and an isolated reference terminal connected to the second coupling capacitor and to a second terminal of the positive charge capacitor and to a second terminal of the negative charge capacitor whereby electrical power is coupled through the coupling capacitors to the charge capacitors at the frequency of the shunt switch. - View Dependent Claims (29)
-
-
30. A light weight, handheld system for performing electrocardiography comprising:
-
a handheld ultrasound device weighing less than seven pounds having a transducer, a beamformer, an image processor and one or more digital signal processors for signal filtering, detection and mapping; and
a portable electrocardiogram monitor weighing less than three pounds and having at least three electrical leads for measuring electrical potential across a person'"'"'s chest, a differential amplifier for amplifying the measured electrical potential, a plurality of signal filters and gain amplifiers, and a means for electronically isolating the measured signal from other electrical inputs and interferences. - View Dependent Claims (31)
-
- 32. In a programmable diagnostic ultrasound instrument having stored software and data for operation control, a software security mechanism which restricts modification of software or data including an algorithm which generates a keycode based on a unique system identifier which allows a person or agency to perform a system or data update.
-
38. An ultrasound instrument having a software library and data for operational control stored on a persistent memory device, and having a means for securely enabling and disabling applications within the software library.
- 39. A programmable diagnostic ultrasound instrument having a plurality of diagnostic modes, wherein access to the diagnostic modes is controlled through a gate flag registry, the gate flag registry capable of modification through a verification procedure utilizing a secure means for extracting hidden bits from a keycode based on one or more unique system identifiers.
- 51. In a programmable diagnostic ultrasound instrument having stored software and data for operation control, a software security mechanism which restricts modification of software or data utilizing a 64-bit mixing algorithm and a bit-wise signature generator within an architecture using a X-OR logic to perform reversible encryption and decryption operations, thereby allowing a user to change software or data using a short sequence of numbers while providing the security of a large bit string verification scheme enabling signature verification, error correction and licensing verification.
-
54. A system for the tracking diagnostic modes in one or more programmable diagnostic ultrasound instrument(s) comprising:
-
a) a general purpose computer having a means for generating a unique keycode for each programmable diagnostic ultrasound instrument, the keycode having encrypted error detection bits, signature bits and options bits for enabling diagnostic modes in a particular instrument;
b) at least one programmable diagnostic ultrasound instrument having a plurality of diagnostic modes that can be enabled or disabled upon successful verification of the keycode, the verification procedure utilizing a secure means for extracting hidden bits used to modify a gate flag registry from the keycode; and
c) a data structure for centrally recording and tracking diagnostic modes of each diagnostic ultrasound instrument. - View Dependent Claims (55, 56, 57)
-
-
58. A method of upgrading the functional software of a programmable diagnostic ultrasound instrument comprising the steps of:
-
(a) generating a keycode generation algorithm comprising at least one encryption algorithm, at least one signature generator, and a reversible logic operation for mixing a bit string produced by said encryption algorithm and a bit string produce by said signature generator;
(b) generating a keycode using the keycode generation algorithm, said keycode utilizing data specific to a programmable diagnostic ultrasound instrument and data relating to a desired software upgrade;
(c) inputting the keycode obtained from the step (b) into the programmable diagnostic ultrasound instrument; and
(d) verifying the keycode generated by step (b) in the programmable diagnostic ultrasound instrument, using a reversing algorithm of step (a) to compare and verify the signature bits, error detection bits and option bits. - View Dependent Claims (59, 60, 61, 62, 63, 64, 65, 66)
(b1) inputting instrument specific information into a keycode encryption algorithm;
(b2) providing one or more secret constants to the keycode encryption algorithm;
(b3) executing the operation of the encryption algorithm;
(b4) choosing a series of options to enable, each option coding for a desired software upgrade, in the programmable diagnostic ultrasound instrument and entering the series of options into a signature generator algorithm;
(b5) generating a first bit string in the signature generator having an equal length to a second bit string produced by the encryption algorithm;
(b6) executing a X-OR function on the first and second bit strings to produce a third bit string;
(b7) converting the third bit string to a decimal string; and
(b8) producing a keycode.
-
-
60. The method of claim 58, wherein step (c) further comprises the step of:
-
(c1) loading a new software application into the programmable diagnostic ultrasound instrument; and
(c2) enabling the new software application by inputting the keycode obtained from the vendor, into the programmable diagnostic ultrasound instrument.
-
-
61. The method of claim 58, wherein step (d) further comprises the steps of;
-
(d1) converting the license string into the X-or bit string;
(d2) generating a second bit string by running the encryption algorithm internally within the programmable diagnostic ultrasound instrument;
(d3) reversing the X-or logic on the X-or bit string and the second bit string to produce a first bit string;
(d4) isolating the signature bits, option bits and error detection bits of the first bit string;
(d5) comparing the signature bits, the option bits and the error detection bits generated by the reverse X-or first bit string to the internally generated first bit string; and
(d6) enabling the necessary options programmed through the option bits.
-
-
62. The method of claim 58, further comprising the step of recording in a database the particular options that are enabled on a particular programmable diagnostic ultrasound instrument.
-
63. The method of claim 58, wherein the programmable diagnostic ultrasound device is portable.
-
64. The method of claim 58, wherein the programmable diagnostic ultrasound device is hand held.
-
65. The method of claim 58, wherein the programmable diagnostic ultrasound device is less than fifteen pounds (6.8 kg).
-
66. The method of claim 58, wherein the logic is executed within an application specific integrated circuit (ASIC) using one or more fixed registries for input values.
Specification