Physiological sensor device

• US 8,620,402 B2
• Filed: 06/06/2011
• Issued: 12/31/2013
• Est. Priority Date: 10/30/2003
• Status: Expired due to Fees

• Current Assignee: Halthion Medical Technologies, Inc.
• Original Assignee: Halthion Medical Technologies, Inc.
• Inventors: Parker, John W. III, McGusty, Edwin A., Vosch, Michael J.
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US13/153,787
• Publication Number:
  US 20110237922A1
• Time in Patent Office: 939 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 sensor device is attachable to the skin of a person for collecting physiological signals generated by the person'"'"'s body. The device includes a flexible front layer made of a material that does not conduct electricity and a flexible back layer made of a material that does not conduct electricity. A flexible intermediate layer made of a material that does not conduct electricity is sandwiched between and fixed to the front layer and the back layer. 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. A conductive gel pad is adhered to and aligned with each of the electrodes and protrudes through a portals in the back layer to contact the skin of a person when the physiological sensor device is attached to the skin of a person. Each layer of the physiological sensor device has, 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 to give the physiological sensor device a shape like an inverted T. The vertically extending portion is intended to overly a person'"'"'s sternum and is sized to comfortably fit either a male or female patient.

Claims

1. A physiological sensor device attachable to the skin of a person for collecting physiological signals generated by the person'"'"'s body comprising:

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 back side of the back layer is provided with an adhesive for adhering the physiological sensor device to a patient;

a releasable liner layer that is fixed to the back side of the back layer and is removable from the physiological sensor device before the physiological sensor device is attached to a patient;

a flexible intermediate circuit 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 the single common connector is disposed in the horizontally extending portion of the physiological sensor device and is aligned with the vertically extending portion of the physiological sensor device, the single common connector being a means for fixing a data collection device to a front surface of the front layer of the physiological sensor device.

2. The physiological sensor device of claim 1 wherein the vertically extending portions of the front and back layers have substantially the same width, and the vertically extending portion of the intermediate layer has a width that is less than the widths of the front and back layers.

3. The physiological sensor device of claim 2 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 sensor device of claim 3 wherein the front surface of the front layer is provided with markings to aid in applying the physiological sensor device to a person as to the correct alignment of at least a vertically extending portion of the physiological sensor device to anatomical landmarks on a patient'"'"'s body.

5. 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.

6. The physiological sensor device of claim 1 wherein one of the electrodes is disposed to facilitate the collection of physiological data relating to at least one of body temperature and respiration.

7. The physiological sensor device 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.

8. The physiological sensor device of claim 7 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.

9. The physiological sensor device of claim 1 wherein the front surface of the front layer is provided with markings to aid in applying the physiological sensor device to a person as to the correct alignment of at least a vertically extending portion of the physiological sensor device to anatomical landmarks on a patient'"'"'s body.

10. A physiological sensor device attachable to the chest of either a male or female person for collecting physiological signals generated by the person'"'"'s body comprising:

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 back side of the back layer is provided with an adhesive for adhering the physiological sensor device to a patient;

a releasable liner layer that is fixed to the back side of the back layer and is removable from the physiological sensor device before the physiological sensor device is attached to 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, wherein the vertically extending portion has a width of no more than forty mm and a length of no more than one hundred and seventy mm to allow the physiological sensor device to be applied to either a male or a female person, and the single common connector is disposed in the horizontally extending portion of the physiological sensor device and is aligned with the vertically extending portion of the physiological sensor device, the single common connector being a means for fixing a data collection device to the front surface of a front layer of the physiological sensor device.

11. The physiological sensor device of claim 10 wherein comfort of the physiological sensor device 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.

12. A physiological sensor device attachable to the chest of either a male or female person for collecting physiological signals generated by the person'"'"'s body comprising:

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 back side of the back layer is provided with an adhesive for adhering the physiological sensor device to a patient;

a releasable liner layer that is fixed to the back side of the back layer and is removable from the physiological sensor device before the physiological sensor device is attached to 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 first horizontally extending portion located at a lower end of the vertically extending portion and extending to both sides of the vertically extending portion, a second horizontally extending portion located at an upper end of the vertically extending portion and extending to both sides of the vertically extending portion, wherein the vertically extending portion has a width of no more than forty mm and a length of no more than one hundred and seventy mm to allow the physiological sensor device to be applied to either a male or a female person, and the single common connector is disposed in the first horizontally extending portion of the physiological sensor device and is aligned with the vertically extending portion of the physiological sensor device, the single common connector being a means for fixing a data collection device to a front surface of the front layer of the physiological sensor device.

13. The physiological sensor device of claim 12 wherein comfort of the physiological sensor device 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.

14. The physiological sensor device of claim 12 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.