IP Library Granted Patent US 12,357,833
Granted Patent B2
US 12,357,833 · App. 18/790,733 · Granted Jul 15, 2025

Systems, methods, and apparatus for ambulatory cardiac pacing

Inventors: David V. Daniels (Petaluma, CA); Christopher Eugene Woods (Redwood City, CA); Scott Mazar (Woodbury, MN)
Assignee: Merit Medical Systems, Inc.
A61N1/365A61N1/056A61N1/3625A61N1/3702A61N1/371
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Quick Facts
Patent No.
US 12,357,833
App. No.
18/790,733
Granted
Jul 15, 2025
Kind
B2
Abstract

Systems and method for ambulatory cardiac pacing are provided. A method may include providing an implantable medical device and a medical lead and inserting the medical lead into a vein of a patient and securing the holder adjacent to an insertion site of the medical lead. The method may include selecting a pacing algorithm from among a first pacing algorithm configured to provide intermittent pacing support and a second pacing algorithm configured to provide continuous pacing support, for execution by the implantable medical device.

Claims (54)

1. A method for operating an ambulatory pacing device, the method comprising:

receiving a patient physiologic condition indicator;

selecting a pacing algorithm from a first pacing algorithm or a second pacing algorithm based on the patient physiologic condition indicator, wherein the first pacing algorithm provides first pacing parameters based on the patient physiologic condition indicator and the second pacing algorithm provides second pacing parameters independent of the patient physiologic condition indicator;

operating the ambulatory pacing device based on the first pacing parameters or the second pacing parameters;

comparing a number of pace inhibitions per unit time to a predetermined threshold; and

adjusting one or more pacing parameters based on a result of the comparing the number of pace inhibitions per unit time to the predetermined threshold, to determine a measure of pacing dependence.

2. The method of claim 1 , wherein patient physiological condition indicator is based on measured electrocardiogram (ECG) data.

3. The method of claim 1 , wherein the second pacing parameters include reducing a paced pulse rate (PPR) over time.

4. The method of claim 1 , wherein the second pacing parameters include reducing a paced pulse rate (PPR) over time, and wherein the second pacing algorithm further comprises measuring a heart rate (HR) over time.

5. The method of claim 1 , wherein the second pacing algorithm comprises reducing a paced pulse rate (PPR) over time, and wherein the second pacing algorithm further comprises measuring a heart rate (HR) over time and further comprising:

increasing the PPR when the HR reaches a threshold indicative of pacing dependence.

6. The method of claim 1 , wherein the second pacing algorithm comprises reducing a paced pulse rate (PPR) over time, and wherein the second pacing algorithm further comprises measuring a heart rate (HR) over time and further comprising: decreasing the PPR when the HR reaches a threshold indicative of pacing independence.

7. The method of claim 1 , further comprising performing a periodic capture check to determine if one or more paced signals are effectively pacing a heart of the patient, wherein the periodic capture check comprises:

pacing the heart at an elevated rate for a predetermined number of beats;

skipping one pace signal; and

determining that the one or more paced signals are effectively pacing the heart of the patient by detecting an intrinsic heartbeat after skipping the one pace signal.

8. The method of claim 1 , wherein the ambulatory pacing device comprises a communications circuit for transmitting data to and receiving commands from a remote site.

9. The method of claim 1 , wherein the patient physiologic condition indicator is received from a medical lead positioned in a vein of a patient.

10. A method for operating an ambulatory pacing device, the method comprising:

receiving a patient physiologic condition indicator;

selecting a pacing algorithm from a first pacing algorithm or a second pacing algorithm based on the patient physiologic condition indicator,

wherein the first pacing algorithm provides first pacing parameters based on the patient physiologic condition indicator and the second pacing algorithm provides second pacing parameters independent of the patient physiologic condition indicator,

wherein the second pacing algorithm comprises:

reducing a paced pulse rate (PPR);

measuring a heart rate (HR) over time; and

increasing the PPR when the HR reaches a threshold indicative of pacing dependence; and

operating the ambulatory pacing device based on the first pacing parameters or the second pacing parameters.

11. The method of claim 10 , wherein patient physiological condition indicator is based on measured electrocardiogram (ECG) data.

12. The method of claim 10 , wherein the second pacing algorithm further comprises decreasing the PPR when the HR reaches a threshold indicative of pacing independence.

13. The method of claim 10 , further comprising performing a periodic capture check to determine if one or more paced signals are effectively pacing a heart of the patient, wherein the periodic capture check comprises:

pacing the heart at an elevated rate for a predetermined number of beats;

skipping one pace signal; and

determining that the one or more paced signals are effectively pacing the heart of the patient by detecting an intrinsic heartbeat after skipping the one pace signal.

14. The method of claim 10 , further comprising:

comparing a number of pace inhibitions per unit time to a predetermined threshold; and

adjusting one or more pacing parameters based on a result of the comparing the number of pace inhibitions per unit time to the predetermined threshold, to determine a measure of pacing dependence.

15. A method for operating an ambulatory pacing device, the method comprising:

receiving a patient physiologic condition indicator;

selecting a pacing algorithm from a first pacing algorithm or a second pacing algorithm based on the patient physiologic condition indicator,

wherein the first pacing algorithm provides first pacing parameters based on the patient physiologic condition indicator and the second pacing algorithm provides second pacing parameters independent of the patient physiologic condition indicator,

wherein the second pacing algorithm comprises:

reducing a paced pulse rate (PPR);

measuring a heart rate (HR) over time; and

decreasing the PPR when the HR reaches a threshold indicative of pacing independence; and

operating the ambulatory pacing device based on the first pacing parameters or the second pacing parameters.

16. The method of claim 15 , wherein patient physiological condition indicator is based on measured electrocardiogram (ECG) data.

17. The method of claim 15 , wherein the second pacing algorithm further comprises increasing the PPR when the HR reaches a threshold indicative of pacing dependence.

18. The method of claim 15 , further comprising performing a periodic capture check to determine if one or more paced signals are effectively pacing a heart of the patient, wherein the periodic capture check comprises:

pacing the heart at an elevated rate for a predetermined number of beats;

skipping one pace signal; and

determining that the one or more paced signals are effectively pacing the heart of the patient by detecting an intrinsic heartbeat after skipping the one pace signal.

19. The method of claim 15 , further comprising:

comparing a number of pace inhibitions per unit time to a predetermined threshold; and

adjusting one or more pacing parameters based on a result of the comparing the number of pace inhibitions per unit time to the predetermined threshold, to determine a measure of pacing dependence.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE ADDRESS OF THE CONVEYING PARTY PREVIOUSLY RECORDED ON REEL 71067 FRAME 696. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Sep 8, 2025
From: SOLO PACE, INC.
To: MERIT MEDICAL SYSTEMS, INC.
Reel/Frame 072852/0824 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 8, 2025
From: SOLO PACE INC.
To: MERIT MEDICAL SYSTEMS, INC.
Reel/Frame 071067/0696 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 29, 2024
From: DANIELS, DAVID V.; WOODS, CHRISTOPHER EUGENE; MAZAR, SCOTT
To: SOLO PACE INC.
Reel/Frame 068437/0308 →
Continuity (2)
Provisional Application 63516941 · Aug 1, 2023
Related Publication 20250041608A1 · Feb 6, 2025
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