IP Library › Granted Patent US 10,502,747
Granted Patent B2
US 10,502,747 · App. 13/756,129 · Granted Dec 10, 2019

Systems and methods using biomarker panel data

Inventors: Craig M. Stolen (New Brighton, MN); Timothy E. Meyer (North Oaks, MN); Milan Seth (Minneapolis, MN); Francis G. Spinale (Blythewood, SC); Nicholas David Wold (Arden Hills, MN)
Assignees: Cardiac Pacemakers, Inc.; MUSC Foundation for Research Development
G01N33/6893A61B5/0031A61B5/076A61B5/14503A61B5/14546A61B5/686A61N1/3627A61N1/36557A61N1/3956G01N2800/52
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Quick Facts
Patent No.
US 10,502,747
App. No.
13/756,129
Granted
Dec 10, 2019
Kind
B2
Abstract

Embodiments of the disclosure are related to systems and methods for utilizing biomarker panel data with respect to medical devices and methods, amongst other things. In an embodiment, the disclosure can include a method of predicting the likelihood of response to CRT therapy. The method can include quantifying levels of one or more biomarkers in a biological sample of a patient, analyzing the quantified levels to determine response to CRT therapy, wherein a panel of biomarkers includes at least two selected from the group consisting of CRP, SGP-130, sIL-2R, sTNFR-II, IFNg, BNP, sST2, MMP-2, MMP-9, TIMP-1, TIMP-2, TIMP-4. Other embodiments are also included herein.

Claims (31)

1. A method of treating a patient with CRT therapy comprising:

selecting a patient exhibiting heart failure symptoms and lacking a CRT device;

quantifying levels of a panel of biomarkers in a biological sample of the patient;

analyzing the quantified levels to determine response to CRT therapy with an external medical device comprising a microprocessor, wherein the microprocessor

analyzes the quantified levels comprising comparing quantified levels to threshold levels to determine likelihood of response to CRT therapy; and

places the patient into one of a set of categories using the quantified levels, the set of categories including at least one of CRT therapy responders, CRT therapy non-responders, and indeterminate response;

referring the patient for CRT device implant if the patient is in the CRT therapy responders category;

the panel of biomarkers comprising at least CRP, sST2, TIMP-1, and TIMP-2.

2. The method of claim 1 , further comprising implanting a CRT device if the patient is in the CRT therapy responders category.

3. The method of claim 1 , the panel of biomarkers further including at least one additional biomarker selected from the group consisting of SGP-130, sIL-2R, sTNFR-II, IFNg, BNP, MMP-2, MMP-9, and TIMP-4.

4. The method of claim 1 , further comprising selecting a patient that is not indicated for CRT therapy.

5. The method of claim 1 , the heart failure symptoms comprising one or more of cardiac pump function, fluid accumulation, activity/exercise tolerance, kidney and cerebral/cognitive function.

6. A method of treating a patient that is receiving CRT therapy:

selecting a patient that is receiving CRT therapy;

quantifying levels of a panel of biomarkers in a biological sample of the patient;

analyzing the quantified levels to determine an expected response to CRT therapy with an external medical device comprising a microprocessor, wherein the microprocessor

compares the expected response to CRT therapy to the patient's actual response to CRT therapy; and

adjusts parameters of the CRT therapy if the patient's actual response to CRT therapy is worse than the expected response to CRT therapy;

the panel of biomarkers comprising at least CRP, sST2, TIMP-1, and TIMP-2.

7. The method of claim 6 , further comprising analyzing the change in quantified levels over time to perform one or more selected from the group consisting of analyzing response to therapy changes and monitoring disease progression.

8. The method of claim 6 , the parameters of the CRT therapy comprising at least one of A-V delay, V-V delay, and stimulation vector.

9. The method of claim 6 , the panel of biomarkers further including at least one additional biomarker selected from the group consisting of SGP-130, sIL-2R, sTNFR-II, IFNg, BNP, MMP-2, MMP-9, and TIMP-4.

10. The method of claim 6 , further comprising providing an alert notice to a clinician regarding changes in parameters of CRT therapy.

11. A method of treating a patient with CRT therapy comprising:

selecting a patient exhibiting heart failure symptoms and lacking a CRT device;

quantifying levels of a panel of biomarkers in a biological sample of the patient;

analyzing the quantified levels to determine response to CRT therapy with an external medical device comprising a microprocessor, wherein the microprocessor

analyzes the quantified levels comprising comparing quantified levels to threshold levels to determine likelihood of response to CRT therapy; and

places the patient into one of a set of categories using the quantified levels, the set of categories including at least one of CRT therapy responders, CRT therapy non-responders, and indeterminate response;

treating the patient with a CRT device if the patient is in the CRT therapy responders category;

the panel of biomarkers comprising at least CRP, sST2, TIMP-1, and TIMP-2.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 27, 2014
From: MEDICAL UNIVERSITY OF SOUTH CAROLINA
To: MUSC FOUNDATION FOR RESEARCH DEVELOPMENT
Reel/Frame 032541/0654 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2014
From: STOLEN, CRAIG M; MEYER, TIMOTHY E.; SETH, MILAN; WOLD, NICHOLAS DAVID
To: CARDIAC PACEMAKERS, INC.
Reel/Frame 031961/0876 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 19, 2013
From: STOLEN, CRAIG M.; MEYER, TIMOTHY E.; SETH, MILAN; WOLD, NICHOLAS DAVID
To: CARDIAC PACEMAKERS, INC,
Reel/Frame 031821/0343 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 19, 2013
From: SPINALE, FRANCIS G.
To: MEDICAL UNIVERSITY OF SOUTH CAROLINA
Reel/Frame 031821/0422 →
Continuity (2)
Provisional Application 61593037 · Jan 31, 2012
Related Publication 20130237439A1 · Sep 12, 2013
Cited By (1)
US 12,611,115