Devices and methods for self-administered ECG examinations
First Claim
1. A device for recording an electrocardiogram (“
- ECG”
) said device comprising;
a base comprising a sheet of a flexible material with leads formed therein, the sheet having a first side and a second side, which are configured to conform to an abdomen of a subject, and a central portion formed between and integrally connected with the first side and the second side, the central portion having an area that is less than the area of either the first side or the second side;
a first sensor pad and a second sensor pad formed on a bottom surface of respectively, the first side and the second side of the sheet, wherein the first sensor pad and second sensor pad are configured to receive an ECG signal from the abdomen of the subject;
a control circuit disposed on a top surface of the sheet and centrally-located in the central portion between the first side and the second side, the control circuit coupled to the leads;
an outer housing surrounding the control circuit, the outer housing comprising a top section that resides on the top surface of the sheet and a bottom section that resides on the bottom surface of the sheet, wherein both the top section and the bottom section comprise interlocks that penetrate through openings in the sheet proximate the central portion to secure the top section and the bottom section together to enclose the control circuit therein;
an overlay engageable with the over the leads and forming a contact area that is sized and configured to receive a hand of a patient disposed flatly thereon; and
a finger cuff disposed on the overlay, the finger cuff forming a loop configured to engage only one finger,wherein the control circuit is configured to receive via the leads at least one or more ECG signals from the finger cuff, the first sensor pad, and the second sensor pad during at least one or more self-administered ECG examinations.
2 Assignments
0 Petitions
Accused Products
Abstract
Devices and methods comprise or provide an ECG recording device containing a mailable base and electrode assembly and/or other means engageable with the base to receive ECG signals from a subject during a self-administered ECG examination. The devices and methods may also include a single-use or limited-use ECG recording device, in which the base is disposable or reusable or recyclable. In addition, the device may be self-contained, battery-operated, portable, disposable, mailable to a location remote from an ECG examination, provide feedback, indicate its method of use, including graphically depicting same, contain a finger cuff and/or sensor pad for receiving ECG signals, and/or contain a memory. Preferably, the base conforms to various body shapes and/or sizes, is made of flexible and/or semi-flexible material, and/or contains a receptor, such as sealable blood well. The device can also communicate the ECG signals to an ECG processing system, which can be remote from the ECG examinations and comprise wireless communications.
22 Citations
33 Claims
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1. A device for recording an electrocardiogram (“
- ECG”
) said device comprising;a base comprising a sheet of a flexible material with leads formed therein, the sheet having a first side and a second side, which are configured to conform to an abdomen of a subject, and a central portion formed between and integrally connected with the first side and the second side, the central portion having an area that is less than the area of either the first side or the second side; a first sensor pad and a second sensor pad formed on a bottom surface of respectively, the first side and the second side of the sheet, wherein the first sensor pad and second sensor pad are configured to receive an ECG signal from the abdomen of the subject; a control circuit disposed on a top surface of the sheet and centrally-located in the central portion between the first side and the second side, the control circuit coupled to the leads; an outer housing surrounding the control circuit, the outer housing comprising a top section that resides on the top surface of the sheet and a bottom section that resides on the bottom surface of the sheet, wherein both the top section and the bottom section comprise interlocks that penetrate through openings in the sheet proximate the central portion to secure the top section and the bottom section together to enclose the control circuit therein; an overlay engageable with the over the leads and forming a contact area that is sized and configured to receive a hand of a patient disposed flatly thereon; and a finger cuff disposed on the overlay, the finger cuff forming a loop configured to engage only one finger, wherein the control circuit is configured to receive via the leads at least one or more ECG signals from the finger cuff, the first sensor pad, and the second sensor pad during at least one or more self-administered ECG examinations. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
- ECG”
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33. A device for recording an electrocardiogram (“
- ECG”
), said device comprising;a base comprising a sheet of a flexible material with leads formed therein, the sheet having a first side and a second side which are confined to conform to an abdomen of a subject and form a contact area that is sized and configured to receive a hand of a patient disposed flatly thereon, and a central portion formed between and integrally connected with the first side and the second side, the central portion having an area that is less than the contact area of either the first side or the second side; a control circuit disposed on the sheet coupled to the leads; an outer housing, surrounding the control circuit, the outer housing comprising a top section that resides on the top surface of the sheet and a bottom section that resides on the bottom surface of the sheet, wherein both the top section and the bottom section comprise interlocks that penetrate through openings in the sheet to secure the top section and the bottom section together; an overlay engageable with the sheet over the leads, the overlay comprising a graphic depiction of the hand of the subject to serve as a positioning guide, the overlay further comprising at least one finger cuff forming a loop coupled to the leads for engaging only one finger of at least one hand of the subject; and an electrode assembly coupled to the leads, wherein the electrode assembly is configured to receive at least one or more ECG signals from the finger and the abdomen of the subject, wherein the control circuit is configured to receive via the leads the ECG signals from the subject during at least one or more self-administered ECG examinations.
- ECG”
Specification