Physiological data collection system

• US 8,626,262 B2
• Filed: 06/06/2011
• Issued: 01/07/2014
• Est. Priority Date: 10/30/2003
• Status: Expired due to Fees

• Current Assignee: Halthion Medical Technologies, Inc.
• Original Assignee: Halthion Medical Technologies, Inc.
• Inventors: McGusty, Edwin A., Parker, John W. III, Vosch, Michael J.
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US13/153,825
• Publication Number:
  US 20110237924A1
• Time in Patent Office: 946 Days
• Field of Search: 600391-393, 600/509
• US Class Current: 600/391
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

A physiological data collection system facilitates acquiring, recording, transferring and analyzing physiological signals generated from the skin of a human subject that may be used in generating an electrocardiogram for a patient in a continuous manner over an extended period of time of twenty four to forty eight hours. The physiological data collection system is an assembly of a disposable physiological sensor device and a reusable data collection module. Collected physiological data may be transmitted for analysis via either a cable or a wireless communication system.

Claims

1. A physiological data collection system comprising in combination a disposable physiological sensor device and a reusable data collection module wherein:

(a) the disposable physiological sensor device is attachable to the skin of a person for collecting physiological signals generated by the person'"'"'s body and comprises a flexible front layer comprising a material that does not conduct electricity;

a flexible back layer comprising a material that does not conduct electricity, the back layer including a plurality of portals and being provided with an adhesive for adhering the physiological sensor device to the chest of a patient;

a flexible intermediate layer comprising a material that does not conduct electricity sandwiched between and fixed to the front layer and the back layer, a plurality of electrodes and electrical conductors are fixed to a back side of the intermediate layer, each of the electrodes is attached to one of the electrical conductors and all of the electrical conductors are attached to a single common connector that protrudes through a portal in the front layer; and

a plurality of conductive gel pads, each gel pad adhered to and aligned with and in conductive communication with one of the electrodes and protruding through one of the portals in the back layer;

each layer of the physiological sensor device having, when attached to a standing person'"'"'s chest, a vertically extending portion with a horizontally extending portion located at a lower end of the vertically extending portion and extending to both sides of the vertically extending portion, at least one electrode located in the horizontally extending portion and at least one electrode located higher than the horizontally extending portion when the physiological sensor device is attached to a patient in its'"'"' operative location with the patient standing or sitting upright; and

(b) the reusable data collection module comprises a reusable device having a data collection port for connection to a source of physiological data that is in an analog format, the data collection port being in circuit communication with a plurality of bipolar amplifiers, the bipolar amplifiers being in circuit communication with a central processing unit provided with analog to digital converters, memory for signal processing and internal USB circuitry, the central processing unit being in circuit communication with a means for storing data and with a means for conveying the data in digital form via at least one of a USB port and a wireless communication system;

the data collection port of the data collection module being coupled to the single common connector, the single common connector being located in the horizontally extending portion of the disposable physiological sensor device and is aligned with the vertically extending portion of the disposable physiological sensor device, the single common connector of the physiological sensor device for transmission of physiological data collected in an analog format by the electrodes of physiological sensor device to the data collection module, and the data collection module being mounted to a front surface of the front layer of the physiological sensor device by a means for fixing the data collection module to the front surface of the front layer of the physiological sensor device.

2. The physiological sensor device of claim 1 wherein the electrodes are disposed to provide placement of the electrodes for acquiring physiological data for analysis and interpretation using an EASI electrocardiogram methodology.

3. The physiological data collection system of claim 1 wherein each layer of the physiological sensor device further comprises a horizontally extending portion located at an upper end of the vertically extending portion and extending to both sides of the vertically extending portion.

4. The physiological data collection system of claim 3 wherein the electrodes are disposed to provide placement of the electrodes for acquiring physiological data for analysis and interpretation using both a MEANS electrocardiogram methodology and an EASI electrocardiogram methodology.

5. The physiological data collection system of claim 3 wherein the central processing unit of the data collection module processes the physiological data received in an analog format to be in a format that can be processed and analyzed by using at least one algorithm that is accepted by the medical community for electrocardiograms.

6. The physiological data collection system of claim 3 wherein the data collection module is provided with a wireless communication system and the transmission of stored processed data takes place via the wireless transmission to a remote monitoring and analysis center at predefined intervals of time.

7. The physiological data collection system of claim 6 wherein the data collection module has a unique serial number that the remote monitoring and analysis center matches to a patient in a secure database and an encrypted report is then sent to a practitioner that ordered the use of the physiological data collection system.

8. The physiological data collection system of claim 1 wherein comfort of the physiological data collection system is enhanced for a female person by the vertically extending portions of the front and back layers having substantially the same width, and the vertically extending portion of the intermediate layer having a width that is less than the widths of the front and back layers to enhance the horizontal flexibility of a vertically extending portion of the physiological sensor device.

9. The physiological data collection system of claim 1 wherein the central processing unit of the data collection module processes the physiological data received in an analog format to be in a format that can be processed and analyzed by using at least one algorithm that is accepted by the medical community for electrocardiograms.

10. The physiological data collection system of claim 1 wherein the data collection module is provided with a wireless communication system and the transmission of stored processed data takes place via the wireless transmission to a remote monitoring and analysis center at predefined intervals of time.

11. The physiological data collection system of claim 10 wherein the data collection module has a unique serial number that the remote monitoring and analysis center matches to a patient in a secure database and an encrypted report is then sent to a practitioner that ordered the use of the physiological data collection system.

12. The physiological data collection system of claim 1 wherein the data collection module has a housing with opposed long sides and opposed short sides and the data collection module is provided with two data collection ports, one located on a long side of the data collection module and the other located on a short side of the data collection module such that the data collection module can be fixed to the physiological sensor device with the long sides oriented either vertically or horizontally.

13. The physiological data collection system of claim 1 wherein the data collection module has a housing with opposed long sides and opposed short sides and the data collection port is located on a short side of the data collection module such that the data collection module can be fixed to the physiological sensor device with the long sides oriented vertically.

14. The physiological data collection system of claim 1 wherein the data collection module may be fixed to the physiological sensor device and the resulting physiological data collection system can be attached to a person'"'"'s chest by a person who is not skilled or trained by the medical community.

15. A physiological data collection system comprising in combination a disposable physiological sensor device and a reusable data collection module wherein:

(a) the disposable physiological sensor device is attachable to the skin of a person for collecting physiological signals generated by the person'"'"'s body and comprises a flexible front layer comprising a material that does not conduct electricity;

a flexible back layer comprising a material that does not conduct electricity, the back layer including a plurality of portals;

a flexible intermediate layer comprising a material that does not conduct electricity sandwiched between and fixed to the front layer and the back layer, a plurality of electrodes and electrical conductors are fixed to a back side of the intermediate layer, each of the electrodes is attached to one of the electrical conductors and all of the electrical conductors are attached to a single common connector that protrudes through a portal in the front layer; and

a plurality of conductive gel pads, each gel pad adhered to and aligned with and in conductive communication with one of the electrodes and protruding through one of the portals in the back layer;

each layer of the physiological sensor device having, when attached to a standing person'"'"'s chest, a vertically extending portion with a horizontally extending portion located at a lower end of the vertically extending portion and extending to both sides of the vertically extending portion; and

(b) the reusable data collection module comprises a reusable device having a data collection port for connection to a source of physiological data that is in an analog format, the data collection port being in circuit communication with a plurality of bipolar amplifiers, the bipolar amplifiers being in circuit communication with a central processing unit provided with analog to digital converters, memory for signal processing and internal USB circuitry, the central processing unit being in circuit communication with a means for storing data and with a means for conveying the data in digital form via at least one of a USB port and a wireless communication system;

the data collection port of the data collection module being coupled to the single common connector that protrudes through the front layer of the physiological sensor device for transmission of physiological data collected in an analog format by the electrodes of physiological sensor device to the data collection module, and the data collection module being mounted to a front surface of the front layer of the physiological sensor device by a means for fixing the data collection module to the front surface of the front layer of the physiological sensor device, the data collection module having a housing with opposed long sides and opposed short sides and the data collection module is provided with two data collection ports, one located on a long side of the data collection module and the other located on a short side of the data collection module such that the data collection module can be fixed to the physiological sensor device with the long sides oriented either vertically or horizontally.

16. The physiological data collection system of claim 15 wherein the data collection module may be fixed to the physiological sensor device and the resulting physiological data collection system can be attached to a person'"'"'s chest by a person who is not skilled or trained by the medical community.

17. The physiological data collection system of claim 15 wherein the data collection module is provided with a wireless communication system and the transmission of stored processed data takes place via the wireless transmission to a remote monitoring and analysis center at predefined intervals of time.

18. The physiological data collection system of claim 17 wherein the data collection module has a unique serial number that the remote monitoring and analysis center matches to a patient in a secure database and an encrypted report is then sent to a practitioner that ordered the use of the physiological data collection system.

19. The physiological data collection system of claim 15 wherein comfort of the physiological data collection system is enhanced for a female person by the vertically extending portions of the front and back layers having substantially the same width, and the vertically extending portion of the intermediate layer having a width that is less than the widths of the front and back layers to enhance the horizontal flexibility of a vertically extending portion of the physiological sensor device.