Patents by Inventor James S. Whiting
James S. Whiting has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20240075260Abstract: Devices are provided with a bridge made of a biocompatible material that surrounds a neck region of an encapsulated shunt. In one embodiment, the bridge is configured to maintain an outer diameter while the diameter of the neck region is reduced or increased in vivo to adjust the fluid flow rate through the device. The bridge may have an outer diameter that is configured to be placed within an enlarged septal hole. Methods for adjusting the flow of fluid and methods for the manufacture of such devices are also provided.Type: ApplicationFiled: November 10, 2023Publication date: March 7, 2024Applicant: V-Wave Ltd.Inventors: Nir NAE, Neal EIGLER, James S. WHITING, Lior ROSEN, Werner HAFELFINGER, Or MAYO, Erez ROZENFELD
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Patent number: 11850138Abstract: Systems and methods for implanting a shunt for regulating blood pressure between a patient's left and right atria are provided. The shunt comprises an anchor having a neck region, first and second end regions, and a conduit affixed with the anchor formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism. The shunt may be advanced through the sheath until the first region protrudes from the sheath and self-expands within the left atrium. The shunt and the sheath may then be retracted until the first region contacts the left side of the atrial septum. The sheath may further be retracted until the counterforce exerted by shunt tension on the atrial septum overcomes the friction of the retained portions of the shunt such that the second region is exposed from the sheath and self-expands within the second atrium.Type: GrantFiled: August 29, 2022Date of Patent: December 26, 2023Assignee: V-Wave Ltd.Inventors: Neal Eigler, Nir Nae, Lior Rosen, Werner Hafelfinger, Erez Rozenfeld, James S. Whiting, Menashe Yacoby, Yaacov Nitzan
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Publication number: 20230404587Abstract: A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.Type: ApplicationFiled: August 30, 2023Publication date: December 21, 2023Applicant: V-Wave Ltd.Inventors: Tamir BEN-DAVID, Neal EIGLER, Nir NAE, Lior ROSEN, Erez ROZENFELD, James S. WHITING
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Patent number: 11813386Abstract: Devices are provided with a bridge made of a biocompatible material that surrounds a neck region of an encapsulated shunt. In one embodiment, the bridge is configured to maintain an outer diameter while the diameter of the neck region is reduced or increased in vivo to adjust the fluid flow rate through the device. The bridge may have an outer diameter that is configured to be placed within an enlarged septal hole. Methods for adjusting the flow of fluid and methods for the manufacture of such devices are also provided.Type: GrantFiled: April 13, 2023Date of Patent: November 14, 2023Assignee: V-Wave Ltd.Inventors: Nir Nae, Neal Eigler, James S. Whiting, Lior Rosen, Werner Hafelfinger, Or Mayo, Erez Rozenfeld
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Publication number: 20230330398Abstract: Devices are provided with a bridge made of a biocompatible material that surrounds a neck region of an encapsulated shunt. In one embodiment, the bridge is configured to maintain an outer diameter while the diameter of the neck region is reduced or increased in vivo to adjust the fluid flow rate through the device. The bridge may have an outer diameter that is configured to be placed within an enlarged septal hole. Methods for adjusting the flow of fluid and methods for the manufacture of such devices are also provided.Type: ApplicationFiled: April 13, 2023Publication date: October 19, 2023Applicant: V-Wave Ltd.Inventors: Nir NAE, Neal EIGLER, James S. WHITING, Lior ROSEN, Werner HAFELFINGER, Or MAYO, Erez ROZENFELD
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Publication number: 20230285133Abstract: Interatrial shunts are described herein that are designed to benefit both the left side of the heart and the right side of the heart. The interatrial shunt is anchored in the atrial septum to permit blood to flow between atrial heart chambers across the atrial septum. In accordance with some aspects, the lumen of the shunt has an effective office area selected to permit blood flow across the atrial septum to unload the patient's left ventricle with beneficial effects on the patient's right ventricle. The shunts are structured to be suitably anchored at the atrial septum for long-term implantation. Further, the shunts preferably have insignificant late lumen loss. The interatrial shunts are expected to treat pathologies such as heart failure and pulmonary hypertension.Type: ApplicationFiled: May 18, 2023Publication date: September 14, 2023Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Nir NAE, Lior ROSEN, Werner HAFELFINGER, Erez ROZENFELD, James S. WHITING, Menashe YACOBY, Yaacov NITZAN
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Patent number: 11744589Abstract: A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.Type: GrantFiled: January 19, 2019Date of Patent: September 5, 2023Assignee: V-Wave Ltd.Inventors: Tamir Ben-David, Neal Eigler, Nir Nae, Lior Rosen, Erez Rozenfeld, James S. Whiting
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Publication number: 20230191093Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient’s heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.Type: ApplicationFiled: April 29, 2021Publication date: June 22, 2023Applicant: V-Wave LtdInventors: Nir NAE, Nathan BUKHDRUKER, John WARDLE, James S. WHITING, Lior ROSEN, Erez ROZENFELD, Werner HAFELFINGER, Neal EIGLER
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Publication number: 20220409357Abstract: Systems and methods for implanting a shunt for regulating blood pressure between a patient's left and right atria are provided. The shunt comprises an anchor having a neck region, first and second end regions, and a conduit affixed with the anchor formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism. The shunt may be advanced through the sheath until the first region protrudes from the sheath and self-expands within the left atrium. The shunt and the sheath may then be retracted until the first region contacts the left side of the atrial septum. The sheath may further be retracted until the counterforce exerted by shunt tension on the atrial septum overcomes the friction of the retained portions of the shunt such that the second region is exposed from the sheath and self-expands within the second atrium.Type: ApplicationFiled: August 29, 2022Publication date: December 29, 2022Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Nir NAE, Lior ROSEN, Werner HAFELFINGER, Erez ROZENFELD, James S. WHITING, Menashe YACOBY, Yaacov NITZAN
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Publication number: 20220387009Abstract: The inventive device may include a delivery catheter that remains coupled to an expandable stent portion having an hourglass or “diabolo” shape. The temporary stent device is configured to lodge the shunt portion securely in the atrial septum, preferably the fossa ovalis, to function as an interatrial shunt, allowing blood flow between the left atrium to the right atrium responsive to a pressure differential across the atrial septum. Upon completion of the treatment, a delivery sheath may be used in conjunction with cinching cord coupled to the stent portion to retrieve and remove the temporary shunt device from the patient.Type: ApplicationFiled: June 1, 2022Publication date: December 8, 2022Applicant: V-Wave Ltd.Inventors: Nathan BUKHDRUKER, Nir NAE, Lior ROSEN, Erez ROZENFELD, James S. WHITING, Werner HAFELFINGER, Neal EIGLER, Gad KEREN
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Patent number: 11458287Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.Type: GrantFiled: April 22, 2022Date of Patent: October 4, 2022Assignee: V-Wave Ltd.Inventors: Neal Eigler, Nir Nae, Nathan Bukhdruker, James S. Whiting, Lior Rosen, Erez Rozenfeld, Werner Hafelfinger, Tamir Ben-David
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Publication number: 20220241565Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.Type: ApplicationFiled: April 22, 2022Publication date: August 4, 2022Applicant: V-Wave LtdInventors: Nir NAE, Neal EIGLER, Nathan BUKHDRUKER, James S. WHITING, Lior ROSEN, Erez ROZENFELD, Werner HAFELFINGER, Tamir BEN-DAVID
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Publication number: 20220151784Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The shunt may include an anchor having a first flared region, a second flared region, and a neck region disposed between the first flared region and the second flared region, and a biocompatible covering disposed on the anchor to form a lumen. The one or more sensors may be pivotally coupled to the first flared region such that the one or more sensors may transition between a delivery configuration and a deployed configuration where the sensing surface of the one or more sensors is in fluid communication with the lumen.Type: ApplicationFiled: January 28, 2022Publication date: May 19, 2022Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Erez ROZENFELD, Nir NAE, Lior ROSEN, James S. WHITING, John WARDLE, Werner HAFELFINGER, James D. LOUDIN, Brian M. MANN
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Publication number: 20220151618Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The one or more sensors may be directly affixed to or within a lumenal surface of the shunt or may be disposed on a support structure in a spaced relation to the shunt lumen, the one or more sensors disposed at locations subject to little or no pannus formation or cardiac wall motion artifact.Type: ApplicationFiled: January 27, 2022Publication date: May 19, 2022Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Erez ROZENFELD, Nir NAE, Nathan BUKHDRUKER, Lior ROSEN, James S. WHITING, John WARDLE, Werner HAFELFINGER
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Patent number: 11234702Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The one or more sensors may be directly affixed to or within a lumenal surface of the shunt or may be disposed on a support structure in a spaced relation to the shunt lumen, the one or more sensors disposed at locations subject to little or no pannus formation or cardiac wall motion artifact.Type: GrantFiled: November 13, 2020Date of Patent: February 1, 2022Assignee: V-Wave Ltd.Inventors: Neal Eigler, Erez Rozenfeld, Nir Nae, Nathan Bukhdruker, Lior Rosen, James S. Whiting, John Wardle, Werner Hafelfinger
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Publication number: 20220015897Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum, and a drug-eluting biodegradable material that biodegrades over time to release a drug that limits tissue overgrowth. The inventive device also may include a biodegradable material that biodegrades to offset flow changes caused by tissue overgrowth. The inventive device may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.Type: ApplicationFiled: September 30, 2021Publication date: January 20, 2022Applicant: V-Wave Ltd.Inventors: Yaacov NITZAN, Menashe YACOBY, Neal EIGLER, James S. WHITING, Erez ROZENFELD
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Publication number: 20210338990Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.Type: ApplicationFiled: November 6, 2020Publication date: November 4, 2021Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Nir NAE, Nathan BUKHDRUKER, James S. WHITING, Lior ROSEN, Erez ROZENFELD, Werner HAFELFINGER
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Publication number: 20210161637Abstract: Systems and methods for implanting a shunt for regulating blood pressure between a patient's left and right atria are provided. The shunt comprises an anchor having a neck region, first and second end regions, and a conduit affixed with the anchor formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism. The shunt may be advanced through the sheath until the first region protrudes from the sheath and self-expands within the left atrium. The shunt and the sheath may then be retracted until the first region contacts the left side of the atrial septum. The sheath may further be retracted until the counterforce exerted by shunt tension on the atrial septum overcomes the friction of the retained portions of the shunt such that the second region is exposed from the sheath and self-expands within the second atrium.Type: ApplicationFiled: February 12, 2021Publication date: June 3, 2021Applicant: V-Wave Ltd.Inventors: Neal EIGLER, Nir NAE, Lior ROSEN, Werner HAFELFINGER, Erez ROZENFELD, James S. WHITING, Menashe YACOBY, Yaacov NITZAN
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Publication number: 20210121179Abstract: A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.Type: ApplicationFiled: January 19, 2019Publication date: April 29, 2021Applicant: V-Wave Ltd.Inventors: Tamir BEN-DAVID, Neal EIGLER, Nir NAE, Lior ROSEN, Erez ROZENFELD, James S. WHITING
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Patent number: 10945614Abstract: Systems, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.Type: GrantFiled: April 16, 2019Date of Patent: March 16, 2021Assignee: Pacesetter, Inc.Inventors: Yelena Nabutovsky, Neal L. Eigler, Lok Man Chu, James S. Whiting, Jenner Joseph