IP Library Granted Patent US 11,389,658
Granted Patent B2
US 11,389,658 · App. 16/431,776 · Granted Jul 19, 2022

Methods and systems for treating cardiac malfunction

Inventors: Yuval Mika (Closter, NJ); Darren Sherman (Fort Lauderdale, FL); Daniel Burkhoff (Manhattan, NY)
Assignee: BackBeat Medical, LLC
A61N1/36564A61N1/3627A61N1/368A61N1/36571A61N1/36585
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,389,658
App. No.
16/431,776
Granted
Jul 19, 2022
Kind
B2
Abstract

Methods and systems for treating cardiac malfunction are disclosed, which according to an embodiment, may involve delivering a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart, with at least one of the stimulation pulses having a first stimulation setting configured to reduce at least one of end systolic volume (ESV) and end diastolic volume (EDV) in the heart and at least one of the stimulation pulses having a second stimulation setting different from the first stimulation setting, and with the stimulation pattern being configured to reduce the at least one of end systolic volume (ESV) and end diastolic volume (EDV) by at least 5% and maintain the at least one of end systolic volume (ESV) and end diastolic volume (EDV) on average at such reduced volume for a time period of at least one hour.

Claims (69)

1. A system for treating cardiac malfunction, comprising:

a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of a patient; and

at least one controller configured to execute delivery of a stimulation pattern of stimulation pulses to the at least one cardiac chamber over a time period of at least two months,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end systolic volume (ESV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting, and

wherein the stimulation pattern is configured to:

reduce, during the time period of at least two months, the end systolic volume (ESV) by at least 5%,

maintain, during the time period of at least two months, the end systolic volume (ESV) in the heart of the patient on average at such reduced volume,

maintain, during the time period of at least two months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value, and

limit, during the time period of at least two months, reduction in ejection fraction of the heart to a maximum of 6% reduction and a time average of 2% reduction.

2. The system of claim 1 , wherein the at least one controller is configured to receive input data relating to at least one sensed parameter indicative of cardiac strain for the time period of at least two months and to adjust the stimulation pattern according to the at least one sensed parameter.

3. The system of claim 2 , further comprising at least one sensor configured to sense the at least one sensed parameter and to communicate the input data to the at least one controller.

4. The system of claim 3 , wherein the at least one controller, the stimulation circuit, and the at least one sensor are combined in a single device.

5. The system of claim 1 , the at least one controller is configured to receive input data from an artery pressure sensor and to adjust the stimulation pattern according to the input data.

6. A system for treating cardiac malfunction, comprising:

a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of a patient; and

at least one controller configured to execute delivery of a stimulation pattern of stimulation pulses to the at least one cardiac chamber over a time period of at least two months,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end systolic volume (ESV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting, and

wherein the stimulation pattern is configured to:

reduce, during the time period of at least two months, the end systolic volume (ESV) by at least 5%,

maintain, during the time period of at least two months, the end systolic volume (ESV) in the heart of the patient on average at such reduced volume,

maintain, during the time period of at least two months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value, and

reduce cardiac strain, as measured by wall tension, by at least 2% and maintain the cardiac strain on average at such reduced strain for the time period of at least two months.

7. A method for treating cardiac malfunction, comprising:

delivering over a time period of at least two months a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart of a patient,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end systolic volume (ESV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting;

reducing, by delivery of the stimulation pattern over the time period of at least two months, the end systolic volume (ESV) by at least 5%;

maintaining, by delivery of the stimulation pattern over the time period of at least two months, the end systolic volume (ESV) in the heart of the patient on average at such reduced volume for the time period of at least two months; and

maintaining, by delivery of the stimulation pattern over the time period of at least two months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value for the time period of at least two months,

wherein the stimulation pattern is configured to limit, during the time period of at least two months, reduction in ejection fraction of the heart to a maximum of 6% reduction and a time average of 2% reduction.

8. The method of claim 7 , further comprising:

receiving input data from an artery pressure sensor; and

adjusting the stimulation pattern according to the input data.

9. The method of claim 7 , wherein the stimulation pattern is configured to prevent cardiac remodeling in the patient.

10. The method of claim 7 , further comprising:

applying the stimulation pattern at a stimulation pattern configuration for a first period;

sensing cardiac strain for the first period; and

adjusting the stimulation pattern configuration according to the sensing.

11. The method of claim 7 , wherein the first stimulation setting is configured to reduce the end systolic volume (ESV) by at least 5% and the second stimulation setting is configured to reduce a baroreflex response or adaptation to the reduction in the end systolic volume (ESV).

12. The method of claim 7 , wherein the stimulation pattern is configured to reduce a baroreflex response or adaptation to the reduction in the end systolic volume (ESV).

13. The method of claim 7 , wherein the stimulation pattern is configured to reduce a neuronal response or adaptation to the reduction in the end systolic volume (ESV).

14. The method of claim 7 , wherein the stimulation pattern is configured to increase hormonal secretion.

15. The method of claim 7 , wherein the stimulation pattern comprises at least one stimulation pulse having a third stimulation setting different from the first and second stimulation settings.

16. The method of claim 7 , wherein the cardiac malfunction is congestive heart failure.

17. The method of claim 7 , further comprising:

applying the stimulation pattern at a stimulation pattern configuration for a first period;

sensing at least one parameter indicative of at least one of end systolic volume (ESV), end diastolic volume (EDV), cardiac strain, or blood pressure for the first period; and

adjusting the stimulation pattern configuration according to the sensing.

18. The method of claim 17 , wherein the adjusting the stimulation pattern configuration includes adjusting at least one of the first stimulation setting or the second stimulation setting.

19. The method of claim 17 , wherein the adjusting the stimulation pattern configuration includes adjusting at least one of a number or proportion of at least one of stimulation pulses having the first stimulation setting or stimulation pulses having the second stimulation setting within the stimulation pattern.

20. The method of claim 7 , further comprising:

delivering the stimulation pattern for twenty-four months;

reducing, by delivery of the stimulation pattern from twelve months to twenty-four months, the end systolic volume (ESV) on average by at least 5% from twelve months to twenty-four months; and

maintaining, by delivery of the stimulation pattern from twelve months to twenty-four months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value from twelve months to twenty-four months.

21. A method for treating cardiac malfunction, comprising:

delivering over a time period of at least two months a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart of a patient,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end systolic volume (ESV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting;

reducing, by delivery of the stimulation pattern over the time period of at least two months, the end systolic volume (ESV) by at least 5%;

maintaining, by delivery of the stimulation pattern over the time period of at least two months, the end systolic volume (ESV) in the heart of the patient on average at such reduced volume for the time period of at least two months; and

maintaining, by delivery of the stimulation pattern over the time period of at least two months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value for the time period of at least two months,

wherein the stimulation pattern is configured to reduce cardiac strain, as measured by wall tension, by at least 2% and maintain the cardiac strain on average at such reduced strain for the time period of at least two months.

22. A method for treating cardiac malfunction, comprising:

delivering over a time period of at least three months a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart of a patient,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end systolic volume (ESV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting;

reducing, by delivery of the stimulation pattern over the time period of at least three months, the end systolic volume (ESV) by at least 5%;

maintaining, by delivery of the stimulation pattern over the time period of at least three months, the end systolic volume (ESV) in the heart of the patient on average at such reduced volume for the time period of at least three months; and

maintaining, by delivery of the stimulation pattern over the time period of at least three months, blood pressure of the patient within an average pressure of ±10% as compared to a pretreatment blood pressure value for the time period of at least three months,

wherein the first stimulation setting comprises stimulating a ventricle of the heart 40-90 milliseconds after atrial activation,

wherein the second stimulation setting comprises stimulating the ventricle of the heart 100-180 milliseconds after atrial activation, and

wherein the stimulation pattern includes at least 4 consecutive heartbeats having the first stimulation setting for every 1 consecutive heartbeat having the second stimulation setting.

Assignments (7)
SECURITY INTEREST Recorded Aug 7, 2025
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; BACKBEAT MEDICAL, LLC; CALIBER THERAPEUTICS, LLC
To: MEDTRONIC, INC.
Reel/Frame 072341/0075 →
SECURITY INTEREST Recorded Aug 4, 2025
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; BACKBEAT MEDICAL, LLC; CALIBER THERAPEUTICS, LLC
To: LIGAND PHARMACEUTICALS, INC.
Reel/Frame 072359/0219 →
SECURITY INTEREST Recorded Nov 6, 2024
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; CALIBER THERAPEUTICS, LLC; BACKBEAT MEDICAL, LLC; FREEHOLD SURGICAL, LLC
To: HERCULES CAPITAL, INC.
Reel/Frame 069312/0758 →
RELEASE OF IP SECURITY INTEREST Recorded Oct 9, 2023
From: AVENUE VENTURE OPPORTUNITIES FUND, L.P.
To: ORCHESTRA BIOMED, INC.; CALIBER THERAPEUTICS, LLC; BACKBEAT MEDICAL, LLC; FREEHOLD SURGICAL, LLC; ACCELERATED TECHNOLOGIES, INC.
Reel/Frame 065192/0001 →
SECURITY AGREEMENT Recorded Jun 6, 2022
From: ORCHESTRA BIOMED, INC.; CALIBER THERAPEUTICS, LLC; BACKBEAT MEDICAL, LLC; FREEHOLD SURGICAL, LLC; ACCELERATED TECHNOLOGIES, INC.
To: AVENUE VENTURE OPPORTUNITIES FUND, L.P., AS AGENT
Reel/Frame 060286/0021 →
ENTITY CONVERSION Recorded Feb 13, 2020
From: BACKBEAT MEDICAL, INC.
To: BACKBEAT MEDICAL, LLC
Reel/Frame 051930/0075 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 12, 2019
From: MIKA, YUVAL; SHERMAN, DARREN; BURKHOFF, DANIEL
To: BACKBEAT MEDICAL, INC.
Reel/Frame 050024/0652 →
Cited By (3)
US 12,440,653 US 12,458,805 US 12,605,554