Granted Patent
B2
US 12,268,882 · App. 18/377,857 · Granted Apr 8, 2025
Beta blocker therapy with electrical administration
Inventors:
Benny Rousso (Rishon-LeZion, IL); Yuval Mika (Closter, NJ); Shlomo Ben-Haim (Geneva, CH); Hani N. Sabbah (Waterford, MI)
Assignee:
Impulse Dynamics NV
A61N1/3627A61N1/32A61N1/3628A61N2/004C12N13/00A61N1/205A61N1/3629C12Q1/6883C12Q2600/112C12Q2600/158G01N33/6893G01N2800/325
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Abstract
A method of modifying tissue behavior, comprising: determining a desired modification of tissue behavior for at least one of treatment of a disease, short or long term modification of tissue behavior, assessing tissue state and assessing tissue response to stimulation; selecting an electric field having an expected effect of modifying protein activity of at least one protein as an immediate response of a tissue to the field, said expected effect correlated with said desired modification; and applying said field to said tissue.
Claims (30)
1. A method of enhancing an effect on LVEF (left ventricle ejection fraction) increase of beta blocker therapy, comprising:
(a) selecting a patient with heart failure where an increase in LVEF beyond that expected for a beta blocker, is desired;
(b) electrically administering a non-excitatory electrical field to the heart with parameters suitable to provide one or more of (i) an acute increase in contractility; (ii) phosphorylation of phospholamban; and (iii) reversing a fetal gene program; and
(c) continuing said electrically administering while pharmaceutically administering beta blockers for a period of at least 3 months to increase the beta blocker therapy effect on LVEF.
2. The method of claim 1 , wherein said desired and enhanced increase comprises an increase of 6% in LVEF compared to expected effect of beta blockers alone.
3. The method of claim 1 , wherein said desired and enhanced increase comprises a doubling of LVEF improvement expected by beta blockers alone.
4. The method of claim 1 , wherein said selecting comprises selecting a patient with a LVEF of between 30% and 40%.
5. The method of claim 1 , wherein said continuing comprises continuing until an end systolic volume is improved by at least 50% more than expected by said beta blockers alone.
6. The method of claim 5 , wherein said improvement is in the absence of an increase in end diastolic volume.
7. The method of claim 1 , wherein said beta blocker is a sustained release beta blocker.
8. The method of claim 1 , wherein said beta blocker comprises metoprolol succinate.
9. The method of claim 1 , wherein said electrically administering in (c) comprises administering only during a cardiac refractory period of tissue to which the electrical field is administered.
10. The method of claim 1 , comprising compensating for pausing of beta blocker administration by said electrically administering.
11. The method of claim 1 , wherein at least one parameter of said electrically administering is selected to compensate for a side effect of said beta blocker.
12. The method of claim 1 , wherein at least one parameter of said electrically administering is selected to compensate for a reduced dose of said beta blocker.
13. The method of claim 1 , wherein at least one parameter of said electrically administering is selected to compensate for a reduced contractility caused by initial treatment with said beta blocker.
14. The method of claim 1 , comprising modifying at least one parameter of said electrically administering in response to a change in patient response to said beta blocker.
15. The method of claim 14 , wherein said response is a positive response.
16. The method of claim 1 , wherein at least one parameter of said electrically administering in (c) is selected to increase a sensitivity of said patient to said beta blocker.
17. The method of claim 1 , wherein at least one parameter of said pharmaceutically administering is selected to minimize a systemic effect of said beta blocker.
18. The method of claim 1 , wherein:
said electrically administering is commenced prior to starting said pharmaceutically administering of a beta blocker therapy, in an amount sufficient to cause changes in cardiac behavior; and
after such changes in cardiac behavior start, performing said pharmaceutically administering.
19. The method of claim 1 , wherein at least one parameter of said pharmaceutically administering is selected to reduced power needs of said electrically administering.
20. The method of claim 1 , wherein at least one parameter of said pharmaceutically administering is selected to reduce side effects of said beta blocker and/or said electrically administering.
21. The method of claim 1 , comprising evaluating a biochemical effect of non-excitatory electrical fields applied to the heart, comprising:
measuring a response of the patient to the pharmaceutically administering; and
determining a change in reactivity to beta blockers from what is expected without an effect of non-excitatory electrification of the heart.
22. The method of claim 1 , wherein said selecting comprises selecting a heart failure patient that receives non optimal drug therapy due to a drug side effect.
23. The method of claim 1 , wherein said selecting comprises selecting a heart failure patient that suffers from a drug side effect due to pharmaceutical therapy thereof.
Assignments (2)
SECURITY INTEREST
Recorded May 23, 2024
From: IMPULSE DYNAMICS, N.V.
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 067526/0072 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 19, 2024
From: ROUSSO, BENNY; MIKA, YUVAL; BEN-HAIM, SHLOMO; SABBAH, HANI N.
To: IMPULSE DYNAMICS NV
Reel/Frame 066176/0231 →
Continuity (12)
Continuation
11919491
Continuation
PCTUS2005044557
· Dec 9, 2005
Continuation
PCTIL2006000204
· Feb 16, 2006
Provisional Application
60634625
· Dec 9, 2004
Provisional Application
60677761
· May 4, 2005
Provisional Application
60719517
· Sep 22, 2005
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