Medical diagnostic ultrasound instrument with ECG module, authorization mechanism and methods of use

• US 6,962,566 B2
• Filed: 02/01/2002
• Issued: 11/08/2005
• Est. Priority Date: 04/19/2001
• Status: Expired due to Term

• Current Assignee: FUJIFILM SonoSite, Inc. (Fujifilm Holdings Corporation)
• Original Assignee: Sonosite Incorporated (Fujifilm Holdings Corporation)
• Inventors: Pailoor, Ramchandra, Little, Blake W., Nguyen, Hung, Quistgaard, Jens U., Siedenburg, Clinton T., Catallo, Leo R., Hirschi, D. Scott, Vannelli, Anthony R., Holmberg, Randy T., Hwang, Juin Jet
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US10/062,179
• Publication Number:
  US 20030009102A1
• Time in Patent Office: 1,376 Days
• Field of Search: 600/437, 600/439, 600/443, 600453-456, 600509-513
• US Class Current: 600/437
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61B 8/14 Echo-tomography
• CPC Class Codes: A61B 8/4427 Device being portable or laptop-like
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61B 8/462 characterised by constructional features of the display
• CPC Class Codes: A61B 8/467 characterised by special input means
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: G01S 15/899 Combination of imaging systems with ancillary equipment
• CPC Class Codes: G01S 7/003 Transmission of data between radar, sonar or lidar systems and remote stations
• CPC Class Codes: G01S 7/52017 particularly adapted to short-range imaging G01S7/53 takes precedence
• CPC Class Codes: G01S 7/52084 related to particular user interfaces special user input means for ultrasonic medical diagnostic devices A61B8/467

Abstract

A handheld ultrasound instrument is disclosed having enhanced diagnostic modes including pulse/continuous wave Doppler, time-motion analysis, spectral 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 CW/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.

Claims

1. 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;

wherein said handheld module further comprises circuitry for performing spectral Doppler analysis and allowing for simultaneous ECG readings to be overlaid on a spectral Doppler display;

wherein the signal processing circuitry of the ECG module includes first amplification and filtering circuitry for signals from the leads and second amplification and filtering circuitry for processing signals from the first amplification and filtering circuitry for application to the handheld module, the first and second amplification and filtering circuitry being electrically isolated whereby a patient is electrically isolated from the handheld unit.

2. The ultrasound diagnostic instrument as defined by claim 1, wherein the ECG module receives control and power signals from the handheld module.

3. The ultrasound diagnostic instrument as defined by claim 1, wherein the first amplification and filtering circuit receives electrical power from the handheld module, the electrical power being capacitively coupled to the first amplification and filtering circuitry.

4. The ultrasound diagnostic instrument of claim 3, wherein the transducer assembly is coupled to the system circuitry through a cable.

5. The ultrasound diagnostic instrument as defined by claim 3, wherein the transducer assembly is integral with the handheld module.

6. The ultrasound diagnostic instrument as defined by claim 1, wherein, the first and second amplification and filtering circuitry are optically coupled.

7. The ultrasound instrument as defined by claim 1, wherein the first and second amplification and filtering circuitry are magnetically coupled.

8. The ultrasound instrument as defined by claim 1, wherein the first and second amplification and filtering circuitry are capacitively coupled.

9. The ultrasound diagnostic instrument as defined by claim 1, wherein the transducer assembly is coupled to the system circuitry through a cable.

10. The ultrasound diagnostic instrument as defined by claim 1, wherein the transducer assembly is integral with the handheld module.

11. A system for performing electrocardiography comprising:

a portable ultrasound device having a transducer, a beamformer, an image processor and one or more digital signal processors for signal filtering, detection and mapping;

a portable electrocardiogram monitor 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; and

a portable display module for simultaneously displaying an image from said ultrasound device and signals from said electrocardiogram monitor;

wherein signal processing circuitry of the electrocardiogram monitor includes first amplification and filtering circuitry for signals from the leads and second amplification and filtering circuitry for processing signals from the first amplification and filtering circuitry for application to the ultrasound device, the first and second amplification and filtering circuitry being electrically isolated whereby a patient is electrically isolated from the ultrasound device.

12. The system of claim 11, wherein the electrocardiogram monitor receives control and power signals from the ultrasound device.

13. The system of claim 11, wherein the first and second amplification and filtering circuitry are optically coupled.

14. The system of claim 11, wherein the first and second amplification and filtering circuitry are magnetically coupled.

15. The ultrasound instrument as defined by claim 11, wherein the first and second amplification and filtering circuitry are capacitively coupled.