IP Library › Granted Patent US 12,708,370
Granted Patent B2
US 12,708,370 · App. 18/329,188 · Granted Aug 18, 2026

Systems and methods for selective occlusion of the peripheral venous vasculature to unload the heart

Inventor: Christopher Korkuch (Danvers, MA)
Assignee: ABIOMED, INC.
A61B17/12136A61M25/10A61M60/13A61M2025/1052A61M60/531
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Quick Facts
Patent No.
US 12,708,370
App. No.
18/329,188
Filed
Jun 5, 2023
Granted
Aug 18, 2026
Kind
B2
Art Unit
3799
USPC
600/16
Abstract

Systems and methods for intermittently occluding a patient's venous vasculature to unload the heart while increasing cardiac output and improving perfusion to the patient's heart is provided. The system may include first and second balloon catheters that may be selectively actuated to intermittently occlude first and second veins for increasing venous vascular resistance in the patient's lower and upper extremities, respectively, to thereby selectively reduce arterial blood flow to the lower and upper extremities, while maintaining arterial vascular resistance of the patient's heart and central organs and increasing perfusion to the patient's heart and central organs.

Claims (67)

1 . A system for unloading a heart of a patient to improve cardiac performance, the system comprising:

a first flow limiting element configured to be selectively actuated to occlude a superior vena cava (SVC) in fluid communication with a first extremity of the patient;

a second flow limiting element configured to be selectively actuated to occlude an inferior vena cava (IVC) in fluid communication with a second extremity of the patient;

a controller operatively coupled to the first and second flow limiting elements, the controller configured to cause the first and/or second flow limiting elements to expand according to a predetermined actuation regimen to selectively occlude the SVC and/or IVC to reduce cardiac preload and increase mean arterial pressure to thereby selectively increase arterial vascular resistance of the patient's extremities, while maintaining arterial vascular resistance of the patient's heart and end organs and increasing perfusion to the patient's heart and end organs.

2 . The system of claim 1 , further comprising:

a catheter operatively coupled to the controller,

wherein the first and second flow limiting elements are disposed on a distal region of the catheter.

3 . The system of claim 1 , wherein the predetermined actuation regimen is programmed to:

cause only the first flow limiting element to expand for a first time period;

cause the first and second flow limiting elements to expand for a second time period after the first time period;

cause only the second flow limiting element to expand for a third time period after the second time period; and

cause the first and second flow limiting elements to expand for a fourth time period after the third time period.

4 . The system of claim 1 , wherein the predetermined actuation regimen is programmed to cause at least 70% occlusion of the SVC and IVC during a treatment period.

5 . The system of claim 1 , wherein the predetermined actuation regimen is programmed in the controller such that the first flow limiting element or the second flow limiting element, or both, maintains occlusion throughout a treatment session.

6 . The system of claim 1 , further comprising one or more sensors configured to measure one or more parameters and to generate one or more signals indicative of the one or more measured parameters.

7 . The system of claim 6 , wherein a first sensor of the one or more sensors is disposed proximal to the first flow limiting element and a second sensor of the one or more sensors is disposed proximal to the second flow limiting element.

8 . The system of claim 6 , wherein the controller is configured to adjust the predetermined actuation regimen to selectively occlude the SVC and/or IVC responsive to the one or more signals indicative of the one or more measured parameters.

9 . A system for unloading a heart of a patient to improve cardiac performance, the system comprising:

a first flow limiting element configured to be selectively actuated to occlude a first vein in fluid communication with a first extremity of the patient;

a second flow limiting element configured to be selectively actuated to occlude a second vein in fluid communication with a second extremity of the patient;

a controller operatively coupled to the first and second flow limiting elements, the controller configured to cause the first and/or second flow limiting elements to expand according to a predetermined actuation regimen to selectively occlude the first and/or second veins to reduce cardiac preload and increase mean arterial pressure to thereby selectively increase arterial vascular resistance of the patient's extremities, while maintaining arterial vascular resistance of the patient's heart and end organs and increasing perfusion to the patient's heart and end organs,

wherein each occlusion period during a treatment session is at least one minute.

10 . The system of claim 9 , wherein the first vein is a contralateral iliac vein and the second vein is an ipsilateral iliac vein.

11 . The system of claim 10 , further comprising a mechanical circulatory support (MCS) device.

12 . The system of claim 10 , further comprising:

a third flow limiting element operatively coupled to the controller, and configured to be selectively actuated to occlude a superior vena cava (SVC) of the patient,

wherein the controller is configured to cause the third flow limiting element to expand according to a second predetermined actuation regimen to occlude the SVC and reduce cardiac preload.

13 . The system of claim 12 , further comprising a mechanical circulatory support (MCS) device.

14 . The system of claim 10 , further comprising:

a third flow limiting element operatively coupled to the controller, and configured to be selectively actuated to occlude a contralateral subclavian vein of the patient; and

a fourth flow limiting element operatively coupled to the controller, and configured to be selectively actuated to occlude an ipsilateral subclavian vein of the patient,

wherein the controller is configured to cause the third and/or fourth flow limiting elements to expand according to a second predetermined actuation regimen to selectively occlude the contralateral and/or ipsilateral subclavian veins to reduce cardiac preload and increase mean arterial pressure to thereby selectively increase arterial vascular resistance of the patient's extremities, while maintaining arterial vascular resistance of the patient's heart and end organs and increasing perfusion to the patient's heart and end organs.

15 . The system of claim 14 , further comprising a mechanical circulatory support (MCS) device.

16 . The system of claim 14 , further comprising:

a fifth flow limiting element operatively coupled to the controller, and configured to be selectively actuated to occlude a superior vena cava (SVC) of the patient,

wherein the controller is configured to cause the fifth flow limiting element to expand according to a third predetermined actuation regimen to occlude the SVC and reduce cardiac preload.

17 . The system of claim 16 , further comprising a mechanical circulatory support (MCS) device.

18 . The system of claim 9 , wherein the first vein is a superior vena cava (SVC) and the second vein is an inferior vena cava (IVC).

19 . The system of claim 18 , further comprising a mechanical circulatory support (MCS) device.

20 . The system of claim 18 , further comprising:

a first catheter operatively coupled to the controller; and

a second catheter operatively coupled to the controller,

wherein the first flow limiting element is disposed on a distal region of the first catheter, and the second flow limiting element is disposed on a distal region of the second catheter.

21 . A method for unloading a heart of a patient to improve cardiac performance, the method comprising:

positioning a first flow limiting element within a superior vena cava (SVC) in fluid communication with a first extremity of the patient;

positioning a second flow limiting element within an inferior vena cava (IVC) in fluid communication with a second extremity of the patient; and

causing the first and/or second flow limiting elements to expand according to a predetermined actuation regimen to selectively occlude the SVC and/or IVC to reduce cardiac preload and increase mean arterial pressure to thereby selectively increase arterial vascular resistance of the patient's extremities, while maintaining arterial vascular resistance of the patient's heart and end organs and increasing perfusion to the patient's heart and end organs.

22 . The method of claim 21 , further comprising:

positioning a third flow limiting element within a contralateral iliac vein of the patient, and

positioning a fourth flow limiting element within an ipsilateral iliac vein of the patient.

23 . The method of claim 21 , further comprising:

positioning a third flow limiting element within a contralateral subclavian vein of the patient;

positioning a fourth flow limiting element within an ipsilateral subclavian vein of the patient; and

causing the third and/or fourth flow limiting elements to expand according to a second predetermined actuation regimen to selectively occlude the contralateral and/or ipsilateral subclavian veins to reduce cardiac preload and increase mean arterial pressure to thereby selectively increase arterial vascular resistance of the patient's extremities, while maintaining arterial vascular resistance of the patient's heart and end organs and increasing perfusion to the patient's heart and end organs.

24 . The method of claim 21 , further comprising:

positioning a third flow limiting element within a third vein of the patient; and

intermittently actuating the third flow limiting element according to a second predetermined actuation regimen to occlude the third vein.

25 . The method of claim 21 , further comprising:

positioning a mechanical circulatory support (MCS) device within the patient's heart; and

actuating the MCS device.

26 . The method of claim 21 , wherein causing the first and/or second flow limiting elements to expand according to the predetermined actuation regimen comprises causing the first flow limiting element or the second flow limiting element, or both, to maintain occlusion throughout a treatment session.

27 . The method of claim 21 , where causing the first and/or second flow limiting elements to expand according to the predetermined actuation regimen comprises:

causing only the first flow limiting element to expand for a first time period;

causing the first and second flow limiting elements to expand for a second time period after the first time period;

causing only the second flow limiting element to expand for a third time period after the second time period; and

causing the first and second flow limiting elements to expand for a fourth time period after the third time period.

28 . The method of claim 21 , wherein each occlusion period during a treatment session is at least one minute.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2023
From: KORKUCH, CHRISTOPHER
To: ABIOMED, INC.
Reel/Frame 063857/0883 →
Continuity (2)
Provisional Application 63365941 · Jun 6, 2022
Related Publication 20230389935A1 · Dec 7, 2023
References Cited (122)
US 4546759A · Solar · 1985 [cited by applicant]
US 4576181A · Wallace et al. · 1986 [cited by applicant]
US 4610256A · Wallace · 1986 [cited by applicant]
US 4846787A · Aall-Flood et al. · 1989 [cited by applicant]
US 4949723A · Wallace et al. · 1990 [cited by applicant]
US 5021046A · Wallace · 1991 [cited by applicant]
US 5097840A · Wallace et al. · 1992 [cited by applicant]
US 5330451A · Gabbay · 1994 [cited by applicant]
US 5458574A · Machold et al. · 1995 [cited by applicant]
US 6146354A · Beil · 2000 [cited by applicant]
US 6485500B1 · Kokish et al. · 2002 [cited by applicant]
US 6726651B1 · Robinson et al. · 2004 [cited by applicant]
US 6790043B2 · Aboud · 2004 [cited by applicant]
US 6843779B1 · Andrysiak et al. · 2005 [cited by applicant]
US 7476200B2 · Tal · 2009 [cited by applicant]
US 7896840B2 · Spencer et al. · 2011 [cited by applicant]
US 7909794B2 · Briscoe et al. · 2011 [cited by applicant]
US 7909844B2 · Alkhatib et al. · 2011 [cited by applicant]
US 7914643B2 · Simpson · 2011 [cited by applicant]
US 7951259B2 · Duchamp et al. · 2011 [cited by applicant]
US 7959667B2 · Ta et al. · 2011 [cited by applicant]
US 7967781B2 · Simpson et al. · 2011 [cited by applicant]
US 7972299B2 · Carter et al. · 2011 [cited by applicant]
US 8449565B2 · Duhay · 2013 [cited by applicant]
US 8646325B2 · Hoem et al. · 2014 [cited by applicant]
US 8679052B2 · Bellantone · 2014 [cited by applicant]
US 8876850B1 · Vollmers et al. · 2014 [cited by applicant]
US 8968239B2 · Herrera · 2015 [cited by applicant]
US 9393384B1 · Kapur et al. · 2016 [cited by applicant]
US 9878080B2 · Kaiser et al. · 2018 [cited by applicant]
US 9901722B2 · Nitzan et al. · 2018 [cited by applicant]
US 10279152B2 · Kapur et al. · 2019 [cited by applicant]
US 10639460B2 · Nitzan et al. · 2020 [cited by applicant]
US 10653871B2 · Nitzan et al. · 2020 [cited by applicant]
US 10758715B2 · Kapur et al. · 2020 [cited by applicant]
US 10842974B2 · Kapur et al. · 2020 [cited by applicant]
US 10842975B2 · Kapur et al. · 2020 [cited by applicant]
US 10926069B2 · Nitzan et al. · 2021 [cited by applicant]
US 11612725B2 · Kapur et al. · 2023 [cited by applicant]
US 11872361B2 · Kapur et al. · 2024 [cited by applicant]
US 12357799B2 · Kapur et al. · 2025 [cited by applicant]
US 12402884B2 · Kapur et al. · 2025 [cited by applicant]
US 20030186203A1 · Aboud · 2003 [cited by applicant]
US 20040022640A1 · Siess et al. · 2004 [cited by applicant]
US 20040064090A1 · Keren et al. · 2004 [cited by applicant]
US 20040167376A1 · Peters et al. · 2004 [cited by applicant]
US 20050015048A1 · Chiu et al. · 2005 [cited by applicant]
US 20060064059A1 · Gelfand et al. · 2006 [cited by applicant]
US 20060206029A1 · Yair · 2006 [cited by applicant]
US 20080294070A1 · Kinori · 2008 [cited by applicant]
US 20090131785A1 · Lee et al. · 2009 [cited by applicant]
US 20100318114A1 · Pranevicius et al. · 2010 [cited by applicant]
US 20100331876A1 · Cedeno · 2010 [cited by applicant]
US 20110202084A1 · Hoem et al. · 2011 [cited by applicant]
US 20110282274A1 · Fulton, III · 2011 [cited by applicant]
US 20110295177A1 · Mohl · 2011 [cited by applicant]
US 20110295302A1 · Mohl · 2011 [cited by applicant]
US 20120029466A1 · Callaghan et al. · 2012 [cited by applicant]
US 20130023909A1 · Duhay · 2013 [cited by applicant]
US 20150201944A1 · Starnes · 2015 [cited by applicant]
US 20150223707A1 · Ludoph · 2015 [cited by applicant]
US 20170049946A1 · Kapur et al. · 2017 [cited by applicant]
US 20180000488A1 · Hu et al. · 2018 [cited by applicant]
US 20180243541A1 · Kapur et al. · 2018 [cited by applicant]
US 20190070348A1 · Frost · 2019 [cited by applicant]
US 20190126014A1 · Kapur et al. · 2019 [cited by applicant]
US 20190255302A1 · Kapur et al. · 2019 [cited by applicant]
US 20200038566A1 · Johnson et al. · 2020 [cited by applicant]
US 20210077792A1 · Kapur et al. · 2021 [cited by applicant]
US 20210085525A1 · Palushi et al. · 2021 [cited by applicant]
US 20210177425A1 · Kapur et al. · 2021 [cited by applicant]
US 20220104828A1 · Keating et al. · 2022 [cited by applicant]
US 20220401718A1 · Kapur et al. · 2022 [cited by applicant]
CN 1819855A · 2006 [cited by applicant]
EP 2353501A1 · 2011 [cited by applicant]
EP 2353503A1 · 2011 [cited by applicant]
WO WO9300037A1 · 1993 [cited by applicant]
WO WO9841167A1 · 1998 [cited by examiner]
WO WO2004073796A2 · 2004 [cited by applicant]
WO WO2013061281A1 · 2013 [cited by applicant]
WO WO2015009028A1 · 2015 [cited by applicant]
WO WO2015109028A1 · 2015 [cited by applicant]
WO WO2017031068A1 · 2017 [cited by applicant]
WO WO2017081561A1 · 2017 [cited by applicant]
WO WO2019083989A1 · 2019 [cited by applicant]
WO WO2019140073A1 · 2019 [cited by applicant]
WO WO2020061143A1 · 2020 [cited by applicant]
WO WO2020097428A1 · 2020 [cited by applicant]
WO WO2021117021A1 · 2021 [cited by examiner]
International Search Report & Written Opinion dated Aug. 23, 2023 in Int'l PCT Patent Appl. Serial No. PCT/US2023/024440 (0510). [cited by applicant]
Atherton, et al., Diastolic Ventricular Interaction In Chronic Heart Failure, Lancet, 349(9067):1720-1724 (1997). [cited by applicant]
Bannon, et al., Anatomic Considerations for Central Venous Cannulation, 4 Risk Management and Healthcare Policy, 4:27-39 (2011). [cited by applicant]
Bilecen, et al., MR Angiography With Venous Compression, Radiology, 233(2):617-619 (Nov. 2004). [cited by applicant]
Delis, et al., Effect of Posture on Popliteal Artery Hemodynamics, 135(3):265-269 (Mar. 2000). [cited by applicant]
Difference Between Superior and Inferior Vena Cava, Pediaa (Aug. 28, 2018), https://pediaa.com/difference-between-superior-and-inferior-vena-cava/. [cited by applicant]
Extended EP Search Report dated Oct. 20, 2021 in EP Patent Application Serial No. 21177661.2 (0331). [cited by applicant]
Hansen, et al., Veno-occlusive unloading of the heart reduces infarct size in experimental ischemia-reperfusion, [cited by applicant]
Herrera, et al., First Percutaneous Transluminal Caval Flow Restriction in a Patient With Congestive Heart Failure, Abstract No. TCT-428, New Devices and Innovation, www.jacctctabstracts 2014.com, vol. 64/11/Suppl B, Se… [cited by applicant]
International Search Report & Written Opinion dated Jan. 28, 2019 in Int'l PCT Patent Appl. Serial No. PCT/US2018/057085 (0310). [cited by applicant]
International Search Report & Written Opinion dated Feb. 18, 2021 in Int'l PCT Patent Appl. Serial No. PCT/US2020/061386 (0410). [cited by applicant]
International Search Report & Written Opinion dated Oct. 18, 2016 in Int'l PCT Patent Application Serial No. PCT/US2016/047055 (0210). [cited by applicant]
Ishiguchi, et al., Endovascular Stent-Graft Deployment: Temporary Vena Caval Occlusion with Balloons to Control Aortic Blood Flow-Experimental Canine Study and Initial Clinical Experience, Radiology, 215:(2):594-599 (20… [cited by applicant]
Kaiser, et al., First-in-Human Experience of Mechanical Preload Control in Patients With HFpEF During Exercise, [cited by applicant]
Kappagoda, et al., Effect of Stimulating Right Atrial Receptors On Urine Floe In The Dog, J. Physiol, 235:493-502 (1973). [cited by applicant]
Kapur, et al., First-in-human experience with occlusion of the superior vena cava to reduce cardiac filling pressures in congestive heart failure, Catheter Cardiovasc. Interv., 93:1205-1210 (2019). [cited by applicant]
Kapur, et al., Intermittent Occlusion of the Superior Vena Cava Reduces Cardiac Filling Pressures in Preclinical Models of Heart Failure, Journal of Cardiovascular Translational Research, published on: Nov. 26, 2019, ht… [cited by applicant]
Kass, et al., Use of a conductance (volume) catheter and transient inferior vena caval occlusion for rapid determination of pressure-vol. relationships in man, Cathet. Cardiovasc. Diagn., 15(3):192-202 (1988). [cited by applicant]
Lee et al., Partial right atrial inflow occlusion for controlled systemic hypotension during thoracic endovascular aortic repair, [cited by applicant]
Low, Phillip A., “Venoarteriolar Reflex,” Primer On The Autonomic Nervous System, Second Edition, Chapter 38, pp. 152-153 (2004). [cited by applicant]
Mehta, M.D., Manish, Compliant Occlusion Balloons—Use of complaint occlusion balloons during EVAR for AAA rupture, insert to [cited by applicant]
Mork, et al., Impaired Neurogenic Control of Skin Perfusion In Erythromelalgia, Journal of Investigative Dermatology, 118(4):699-703 (Apr. 2002). [cited by applicant]
Moscucci, M., Grossman & Baim's Cardiac Catheterization, Angiography, and Intervention, 8th Edition, 2014. [cited by applicant]
Rachapalli, et al., Superior Vena Cava Syndrome: Role of the Interventionalist, Canadian Association of Radiologists Journal, 65:168-176 (2014). [cited by applicant]
Rodrigues, et al., Effect of baroreceptor denervation on the autonomic control of arterial pressure in conscious mice, Exp. Physiol., 96(9):853-862 (2011). [cited by applicant]
Rosenblum, et al., Conceptual Considerations For Device-Based Therapy in Acute Decompensated Heart Failure, Circulation: Heart Failure, 13(4):e006731 (Apr. 2020). [cited by applicant]
Ross, et al., Studies on Starling's Law of the Heart, IX. The Effects of Impeding Venous Return on Performance of the Normal and Failing Human Left Ventricle, Circulation, 30:719-727 (1964). [cited by applicant]
Shimizu, et al., Embolization of a Fractured Central Venous Catheter Placed Using The Internal Jugular Approach, International Journal of Surgery Case Reports, 5(5):219-221 (Jan. 2014). [cited by applicant]
Swan, et al., Catheterization Of The Heart In Man With Use Of A Flow-Directed Balloon-Tipped Catheter, New England Journal of Medicine, 283(9):447-451 (Aug. 1970). [cited by applicant]
Tucker, et al., Anatomy, Abdomen and Pelvis, Inferior Vena Cava, Jul. 27, 2021, available at https://www.ncbi.nlm.nih.gov/books/NBK482353/. [cited by applicant]
Tzifa, et al., Endovascular Treatment for Superior Vena Cava Occlusion or Obstruction in a Pediatric and Young Adult Population, A 22-Year Experience, Journal of the American College of Cardiology, 49(9):1003-1009 (2007… [cited by applicant]
Van Fossen, et al., Safety and efficacy of inferior vena caval occlusion to rapidly alter ventricular loading conditions in idiopathic dilated cardiomyopathy, The American Journal of Cardiology, 59(9):937-942 (1987). [cited by applicant]
Yancy, et al., 2013 ACCF/AHA Guideline for the Management of Heart Failure—A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, Circulation, 128:e240-e3… [cited by applicant]