Granted Patent B2

US 12,350,499 · App. 17/939,653 · Granted Jul 8, 2025

Inventors: Rick Sanghera (San Clemente, CA); Alan Marcovecchio (San Clemente, CA); Sean P. McGeehan (Rancho Santa Fe, CA)

Assignee: AtaCor Medical, Inc.

A61N1/36585A61N1/0504A61N1/0587A61N1/059A61N1/362A61N1/3752A61N1/36535

Abstract

Claims (116)

1. A system comprising:

a pulse generator including a housing, the pulse generator configured to generate therapeutic electrical pulses;

at least one lead configured to electrically couple with the pulse generator, the at least one lead including an electrode;

a first sensor configured to monitor a physiological characteristic of a patient; and

a controller configured to:

receive input signals from the first sensor;

apply one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals, the one or more filters includes a hardware filter that is a band-pass filter having a plurality of bands with a first band corresponding to a heart rate of the patient and a second band corresponding to a respiration rate of the patient; and

generate the therapeutic electrical pulses based at least partially on the filtered input signals.

2. The system of claim 1 , the controller further configured to adjust a bandpass setting, the adjusting comprising:

monitoring a second signal representing a second physiological characteristic of the patient;

detecting a change in the second physiological characteristic; and

adjusting the bandpass setting during a time of the change.

3. The system of claim 1 , the controller further configured to apply a secondary digital filter profile to the input signals based on a criteria.

4. The system of claim 3 , wherein the criteria includes one or more changes in morphology, which comprises one or more of monophasic or biphasic characteristics of a cardiac signal, patterns of peaks and nadirs, or timing between signal characteristics of the input signals.

5. The system of claim 3 , the controller further configured to apply the secondary digital filter profile to the input signals based on the criteria being states of the pulse generator that include one or more of a storage mode prior to implant, a set up mode at the time of implant, a follow-up mode while communicating with a programmer, an explant mode while surgically removing the system, or a protective state while in the presence of surgical procedures including electrocautery, ultrasound, or MRI.

6. The system of claim 3 , wherein the criteria includes a high degree of radio frequency noise in the environment of the system.

7. The system of claim 1 , wherein the one or more filters includes an active baseline algorithm configured to:

detect a baseline-shifting event that changes a sensing baseline of the input signals;

apply a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

remove the correction when the baseline-shifting event is no longer present.

8. The system of claim 7 , further comprising an implantable cardioverter defibrillator (ICD) that is in communication with the pulse generator, the ICD configured to notify the active baseline algorithm of a pending defibrillation shock, the active baseline algorithm further configured to condition the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

9. The system of claim 8 , wherein the active baseline algorithm further configured to:

determine whether the system is delivering the therapeutic electrical pulses to the patient; and

maintain the sensing baseline when the system is delivering the therapeutic electrical pulses.

10. A system comprising:

a pulse generator including a housing, the pulse generator configured to generate therapeutic electrical pulses;

at least one lead configured to electrically couple with the pulse generator, the at least one lead including an electrode;

a first sensor configured to monitor a physiological characteristic of a patient; and

a controller configured to:

receive input signals from the first sensor;

apply one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals; and

generate the therapeutic electrical pulses based at least partially on the filtered input signals; and

adjust a bandpass setting, the adjusting comprising:

monitoring a second signal representing a second physiological characteristic of the patient;

detecting a change in the second physiological characteristic; and

adjusting the bandpass setting during a time of the change.

11. The system of claim 10 , the controller further configured to apply a secondary digital filter profile to the input signals based on a criteria.

12. The system of claim 11 , wherein the criteria includes one or more changes in morphology, which comprises one or more of monophasic or biphasic characteristics of a cardiac signal, patterns of peaks and nadirs, or timing between signal characteristics of the input signals.

13. The system of claim 11 , the controller further configured to apply the secondary digital filter profile to the input signals based on the criteria being states of the pulse generator that include one or more of a storage mode prior to implant, a set up mode at the time of implant, a follow-up mode while communicating with a programmer, an explant mode while surgically removing the system, or a protective state while in the presence of surgical procedures including electrocautery, ultrasound, or MRI.

14. The system of claim 11 , wherein the criteria includes a high degree of radio frequency noise in the environment of the system.

15. The system of claim 10 , wherein the one or more filters includes an active baseline algorithm configured to:

detect a baseline-shifting event that changes a sensing baseline of the input signals;

apply a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

remove the correction when the baseline-shifting event is no longer present.

16. The system of claim 15 , further comprising an implantable cardioverter defibrillator (ICD) that is in communication with the pulse generator, the ICD configured to notify the active baseline algorithm of a pending defibrillation shock, the active baseline algorithm further configured to condition the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

17. The system of claim 16 , wherein the active baseline algorithm further configured to:

determine whether the system is delivering the therapeutic electrical pulses to the patient; and

maintain the sensing baseline when the system is delivering the therapeutic electrical pulses.

18. A system comprising:

a pulse generator including a housing, the pulse generator configured to generate therapeutic electrical pulses;

at least one lead configured to electrically couple with the pulse generator, the at least one lead including an electrode;

a first sensor configured to monitor a physiological characteristic of a patient; and

a controller configured to:

receive input signals from the first sensor;

apply one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals;

apply a secondary digital filter profile to the input signals based on a criteria; and

generate the therapeutic electrical pulses based at least partially on the filtered input signals.

19. The system of claim 18 , wherein the criteria includes one or more changes in morphology, which comprises one or more of monophasic or biphasic characteristics of a cardiac signal, patterns of peaks and nadirs, or timing between signal characteristics of the input signals.

20. The system of claim 18 , the controller further configured to apply the secondary digital filter profile to the input signals based on the criteria being states of the pulse generator that include one or more of a storage mode prior to implant, a set up mode at the time of implant, a follow-up mode while communicating with a programmer, an explant mode while surgically removing the system, or a protective state while in the presence of surgical procedures including electrocautery, ultrasound, or MRI.

21. The system of claim 18 , wherein the criteria includes a high degree of radio frequency noise in the environment of the system.

22. The system of claim 18 , wherein the one or more filters includes an active baseline algorithm configured to:

detect a baseline-shifting event that changes a sensing baseline of the input signals;

apply a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

remove the correction when the baseline-shifting event is no longer present.

23. The system of claim 22 , further comprising an implantable cardioverter defibrillator (ICD) that is in communication with the pulse generator, the ICD configured to notify the active baseline algorithm of a pending defibrillation shock, the active baseline algorithm further configured to condition the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

24. The system of claim 23 , wherein the active baseline algorithm further configured to:

determine whether the system is delivering the therapeutic electrical pulses to the patient; and

maintain the sensing baseline when the system is delivering the therapeutic electrical pulses.

25. A system comprising:

a pulse generator including a housing, the pulse generator configured to generate therapeutic electrical pulses;

at least one lead configured to electrically couple with the pulse generator, the at least one lead including an electrode;

a first sensor configured to monitor a physiological characteristic of a patient; and

a controller configured to:

receive input signals from the first sensor;

apply one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals, the one or more filters including an active baseline algorithm configured to:

detect a baseline-shifting event that changes a sensing baseline of the input signals;

apply a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

remove the correction when the baseline-shifting event is no longer present; and

generate the therapeutic electrical pulses based at least partially on the filtered input signals.

26. The system of claim 25 , the controller further configured to apply a secondary digital filter profile to the input signals based on a criteria that includes one or more changes in morphology, which comprises one or more of monophasic or biphasic characteristics of a cardiac signal, patterns of peaks and nadirs, or timing between signal characteristics of the input signals.

27. The system of claim 25 , the controller further configured to apply a secondary digital filter profile to the input signals based on a criteria being states of the pulse generator that include one or more of a storage mode prior to implant, a set up mode at the time of implant, a follow-up mode while communicating with a programmer, an explant mode while surgically removing the system, or a protective state while in the presence of surgical procedures including electrocautery, ultrasound, or MRI.

28. The system of claim 25 , further comprising an implantable cardioverter defibrillator (ICD) that is in communication with the pulse generator, the ICD configured to notify the active baseline algorithm of a pending defibrillation shock, the active baseline algorithm further configured to condition the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

29. The system of claim 28 , wherein the active baseline algorithm further configured to:

determine whether the system is delivering the therapeutic electrical pulses to the patient; and

maintain the sensing baseline when the system is delivering the therapeutic electrical pulses.

30. A non-transitory, machine-readable medium storing instructions which, when executed by at least one programmable processor, cause the at least one programmable processor to perform operations comprising:

receiving input signals from a first sensor configured to monitor a physiological characteristic of a patient;

applying one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals;

generating therapeutic electrical pulses with a pulse generator, the therapeutic electrical pulses generated based at least partially on the filtered input signals; and

adjusting a bandpass setting, the adjusting comprising:

monitoring a second signal representing a second physiological characteristic of the patient;

detecting a change in the second physiological characteristic; and

adjusting the bandpass setting during a time of the change.

31. The machine-readable medium of claim 30 , wherein the one or more filters includes an active baseline algorithm configured to perform operations comprising:

detecting a baseline-shifting event that changes a sensing baseline of the input signals;

applying a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

removing the correction when the baseline-shifting event is no longer present.

32. The machine-readable medium of claim 31 , the operations further comprising:

receiving, from an implantable cardioverter defibrillator (ICD) in communication with the pulse generator, a notification of a pending defibrillation shock; and

conditioning, by the active baseline algorithm, the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

33. The machine-readable medium of claim 32 , the operations further comprising:

determining, by the active baseline algorithm, whether the pulse generator is delivering the therapeutic electrical pulses to the patient; and

maintaining, by the active baseline algorithm, the sensing baseline when the pulse generator is delivering the therapeutic electrical pulses.

34. A non-transitory, machine-readable medium storing instructions which, when executed by at least one programmable processor, cause the at least one programmable processor to perform operations comprising:

receiving input signals from a first sensor configured to monitor a physiological characteristic of a patient;

applying one or more filters to the input signals to identify and/or reduce noise and/or interference in the input signals, the applying generating filtered input signals, the one or more filters includes an active baseline algorithm configured to perform operations comprising:

detecting a baseline-shifting event that changes a sensing baseline of the input signals;

applying a correction to the sensing baseline to maintain or reestablish the sensing baseline in response to the baseline-shifting event; and

removing the correction when the baseline-shifting event is no longer present; and

generating therapeutic electrical pulses with a pulse generator, the therapeutic electrical pulses generated based at least partially on the filtered input signals.

35. The machine-readable medium of claim 34 , the operations further comprising:

receiving, from an implantable cardioverter defibrillator (ICD) in communication with the pulse generator, a notification of a pending defibrillation shock; and

conditioning, by the active baseline algorithm, the one or more filters prior to the defibrillation shock to maintain the sensing baseline following the defibrillation shock.

36. The machine-readable medium of claim 35 , the operations further comprising:

determining, by the active baseline algorithm, whether the pulse generator is delivering the therapeutic electrical pulses to the patient; and

maintaining, by the active baseline algorithm, the sensing baseline when the pulse generator is delivering the therapeutic electrical pulses.

Assignments (1)

Continuity (10)

References Cited (400)