Patient screening tools for implantable cardiac stimulus systems

• US 9,380,955 B2
• Filed: 03/06/2015
• Issued: 07/05/2016
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Sanghera, Rick, Marcovecchio, Alan F., Keefe, James M.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/640,367
• Publication Number:
  US 20150196211A1
• Time in Patent Office: 487 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/322 Physical templates or devices for measuring ECG waveforms, e.g. electrocardiograph rulers or calipers by template matching A61B5/35
• CPC Class Codes: A61B 5/338 Recording by printing on paper
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Tools and devices are provided for determining whether a patient is well suited to receiving an implantable cardiac stimulation device by analyzing cardiac signals captured using external or cutaneous electrodes. Some of the illustrative tools include shapes for visual comparison to printed ECG strips. Kits for use of illustrative tools are also shown. Automatic devices are also disclosed which perform at least some analytical functions electronically for a user. In an example, a printed ECG strip is visually compared to a shape in order to ensure a patient is well suited to receiving a cardiac stimulation device having a particular implant location and/or cardiac signal analysis method implementation.

Claims

1. A patient screening device for use in determining whether a patient is well suited to receiving an implantable cardiac device (ICD) having a first configuration, the patient screening device comprising:

a user interface allowing for user input and display of information to a user;

inputs for coupling to a plurality of cutaneous electrodes; and

operational circuitry configured to emulate filtering and detection characteristics of the ICD of the first configuration;

wherein the operational circuitry is configured to perform a method comprising;

capturing data via the inputs from coupled cutaneous electrodes placed on a patient;

emulating the filtering and detection characteristics of the ICD of the first configuration, including applying a beat detection method that would be used by the ICD of the first configuration;

determining whether the ICD of the first configuration can accurately analyze cardiac data from the patient and;

if the ICD of the first configuration can accurately analyze cardiac data from the patient, determining that the patient is well suited to receiving the ICD of the first configuration;

or,

if the ICD of the first configuration is not likely to accurately analyze cardiac data from the patient, determining that the patient should not receive the ICD of the first configuration.

2. The patient screening device of claim 1, wherein, if it is determined that the patient should not receive the ICD of the first configuration, the patient screening device is configured to further analyze the data captured from the patient using emulation of the filtering and detection characteristics from an ICD of a second configuration to determine whether the patient is well suited to receive the ICD of the second configuration.

3. The patient screening device of claim 1, wherein the operational circuitry is configured to use the user interface to direct a user as to a correct location of cutaneous electrodes on the patient during testing for the ICD of the first configuration.

4. The patient screening device of claim 1, wherein the operational circuitry is configured to use the user interface to direct a user to instruct the patient to adopt at least a first posture and a second posture during the step of capturing data.

5. The patient screening device of claim 1, wherein the device is a programmer configured to perform follow-up evaluation of the ICD of the first configuration.

6. The patient screening device of claim 1, wherein the operational circuitry is configured to apply the beat detection method of the ICD of the first configuration and display detected beats via the user interface such that a user can indicate true and false detections in the detected beats.

7. The patient screening device of claim 1, wherein the inputs comprise wireless communication circuits for wirelessly coupling to wireless cutaneous electrodes.

8. The patient screening device of claim 1, wherein the inputs comprise wired connection jacks for coupling to cutaneous electrodes.

9. The patient screening device of claim 1 wherein:

the operational circuitry is configured to use the user interface to direct a user as to a correct location of cutaneous electrodes on the patient during testing for the ICD of the first configuration;

the operational circuitry is configured to use the user interface to direct a user to instruct the patient to adopt at least a first posture and a second posture during the step of capturing data; and

the operational circuitry is configured to apply the beat detection method of the ICD of the first configuration and display detected beats via the user interface such that a user can indicate true and false detections in the detected beats.

10. A method of determining whether a patient is well suited to receiving an implantable cardiac device (ICD) having a first configuration, using an electronic screening device having control circuitry, input circuitry and a user interface, the method comprising:

an electronic screening device capturing data from cutaneous electrodes which have been placed on a patient;

the electronic screening device emulating one or more filtering and detection characteristics of the ICD of the first configuration, including applying a beat detection method that would be used by the ICD of the first configuration, to the captured data;

the electronic screening device determining whether the ICD of the first configuration can accurately analyze cardiac data from the patient and;

if the ICD of the first configuration can accurately analyze cardiac data from the patient, the electronic screening device indicating that the patient is well suited to receiving the ICD of the first configuration;

or,

if the ICD of the first configuration is not likely to accurately analyze cardiac data from the patient, the electronic screening device determining that the patient should not receive the ICD of the first configuration.

11. The method of claim 10 wherein, if the electronic screening device determines that the patient should not receive the ICD of the first configuration, the method further comprises the patient screening device analyzing signals captured from the patient using emulation of filtering and detection characteristics from an ICD of a second configuration to determine whether the patient is well suited to receive the ICD of the second configuration.

12. The method of claim 10 further comprising the electronic screening device providing, via the user interface, instructions for a user as to a correct location of cutaneous electrodes on the patient during testing for the ICD of the first configuration.

13. The method of claim 10 further comprising the electronic screening device providing, via the user interface, instructions for a user to instruct the patient to adopt at least a first posture and a second posture during the step of capturing data.

14. The method of claim 10 wherein the emulating step includes the electronic screening device applying the beat detection method and generating one or more detected beats, wherein the method further comprises the electronic screening device displaying, via the user interface, detected beats via the user interface such that a user can indicate true and false detections in the detected beats.

15. The method of claim 10 wherein the input circuitry of the electronic screening device comprises a wireless communication circuit for wirelessly coupling to one or more wireless cutaneous electrodes, and the step of the electronic screening device capturing data includes the electronic screening device receiving information from one or more wireless cutaneous electrodes.

16. The method of claim 10, further comprising:

the electronic screening device providing, via the user interface, instructions for a user as to a correct location of cutaneous electrodes on the patient during testing for the ICD of the first configuration; and

further comprising the electronic screening device providing, via the user interface, instructions for a user to instruct the patient to adopt at least a first posture and a second posture during the step of capturing data; and

wherein the emulating step includes the electronic screening device applying the beat detection method and generating one or more detected beats, wherein the method further comprises the electronic screening device displaying, via the user interface, detected beats via the user interface such that a user can indicate true and false detections in the detected beats.

17. A patient screening device for use in determining whether a patient is well suited to receiving an implantable cardiac device (ICD) having a first configuration, the patient screening device comprising:

interface means for obtaining inputs from and providing information to a user;

input means for receiving data from a plurality of cutaneous electrodes; and

processing means for using the interface means and the input means and including emulation means for emulating filtering and detection characteristics of the ICD of the first configuration;

wherein the processing means is configured to;

capture data via the input means from coupled cutaneous electrodes placed on a patient;

filter and perform beat detection on the captured data, including applying a beat detection method that would be used by the ICD of the first configuration;

determine whether the ICD of the first configuration can accurately analyze cardiac data from the patient and;

if the ICD of the first configuration can accurately analyze cardiac data from the patient, determine that the patient is well suited to receiving the ICD of the first configuration;

or,

if the ICD of the first configuration is not likely to accurately analyze cardiac data from the patient, determine that the patient should not receive the ICD of the first configuration.

18. The patient screening device of claim 17, wherein the processing means is configured to use the interface means to instruct a user as to a correct location of cutaneous electrodes on the patient during testing for the ICD of the first configuration.

19. The patient screening device of claim 17, wherein the processing means is configured to use the interface means to direct a user to instruct the patient to adopt at least a first posture and a second posture during the step of capturing data.

20. The patient screening device of claim 17, wherein the processing means is configured to apply the beat detection method of the ICD of the first configuration to obtain detected beats and use the interface means to display detected beats via the user interface such that a user can indicate true and false detections in the detected beats.