Patents Assigned to V-Wave Ltd.
  • Patent number: 12005214
    Abstract: A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a loft heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.
    Type: Grant
    Filed: May 4, 2020
    Date of Patent: June 11, 2024
    Assignee: V-Wave Ltd.
    Inventors: Yaacov Nitzan, Boaz Harari, Ascher Shmulewitz, Tovy Sivan
  • Publication number: 20240075260
    Abstract: 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: Application
    Filed: November 10, 2023
    Publication date: March 7, 2024
    Applicant: V-Wave Ltd.
    Inventors: Nir NAE, Neal EIGLER, James S. WHITING, Lior ROSEN, Werner HAFELFINGER, Or MAYO, Erez ROZENFELD
  • Patent number: 11865282
    Abstract: A device for precise control of blood flow across an interatrial septum is provided. The device includes a sheath having a first set of openings disposed within a first atrium while a second set of openings is disposed within a second atrium. An actuator may be actuated to move an inner sleeve within the sheath to modify the area of second set of openings to permit blood to flow between the first and second atria responsive to a pressure gradient across the interatrial septum via the first and second openings at a blood flow rate corresponding with the area of the second set of openings of the sheath. In addition, the patient's hemodynamics responsive to the shunting of blood across the interatrial septum at each incremental area of the opening may be monitored for selecting a specific sized implantable interatrial shunt for the patient.
    Type: Grant
    Filed: May 18, 2020
    Date of Patent: January 9, 2024
    Assignee: V-Wave Ltd.
    Inventors: Nir Nae, Tal Weisinger, Lior Rosen, James Whiting, Neal Eigler, Werner Hafelfinger, Erez Rozenfeld
  • Patent number: 11850138
    Abstract: 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: Grant
    Filed: August 29, 2022
    Date of Patent: December 26, 2023
    Assignee: V-Wave Ltd.
    Inventors: Neal Eigler, Nir Nae, Lior Rosen, Werner Hafelfinger, Erez Rozenfeld, James S. Whiting, Menashe Yacoby, Yaacov Nitzan
  • Publication number: 20230404587
    Abstract: 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: Application
    Filed: August 30, 2023
    Publication date: December 21, 2023
    Applicant: V-Wave Ltd.
    Inventors: Tamir BEN-DAVID, Neal EIGLER, Nir NAE, Lior ROSEN, Erez ROZENFELD, James S. WHITING
  • Patent number: 11813386
    Abstract: 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: Grant
    Filed: April 13, 2023
    Date of Patent: November 14, 2023
    Assignee: V-Wave Ltd.
    Inventors: Nir Nae, Neal Eigler, James S. Whiting, Lior Rosen, Werner Hafelfinger, Or Mayo, Erez Rozenfeld
  • Publication number: 20230330398
    Abstract: 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: Application
    Filed: April 13, 2023
    Publication date: October 19, 2023
    Applicant: V-Wave Ltd.
    Inventors: Nir NAE, Neal EIGLER, James S. WHITING, Lior ROSEN, Werner HAFELFINGER, Or MAYO, Erez ROZENFELD
  • Publication number: 20230285133
    Abstract: 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: Application
    Filed: May 18, 2023
    Publication date: September 14, 2023
    Applicant: V-Wave Ltd.
    Inventors: Neal EIGLER, Nir NAE, Lior ROSEN, Werner HAFELFINGER, Erez ROZENFELD, James S. WHITING, Menashe YACOBY, Yaacov NITZAN
  • Publication number: 20230277343
    Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.
    Type: Application
    Filed: March 7, 2023
    Publication date: September 7, 2023
    Applicant: V-Wave Ltd.
    Inventors: Nir NAE, Lior ROSEN, Neal EIGLER, Erez ROZENFELD, Werner HAFELFINGER, Yeela SCOP
  • Patent number: 11744589
    Abstract: 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: Grant
    Filed: January 19, 2019
    Date of Patent: September 5, 2023
    Assignee: V-Wave Ltd.
    Inventors: Tamir Ben-David, Neal Eigler, Nir Nae, Lior Rosen, Erez Rozenfeld, James S. Whiting
  • Patent number: 11690976
    Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium, and apparatus for delivery the device, are provided. The delivery apparatus may include one or more latching legs, a release ring, a pull chord, and a catheter wherein the latching legs are configured to engage the device for delivery. The inventive devices 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. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.
    Type: Grant
    Filed: November 15, 2019
    Date of Patent: July 4, 2023
    Assignee: V-Wave Ltd.
    Inventors: Menashe Yacoby, Boaz Harari, Yaacov Nitzan
  • Publication number: 20230191093
    Abstract: 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: Application
    Filed: April 29, 2021
    Publication date: June 22, 2023
    Applicant: V-Wave Ltd
    Inventors: Nir NAE, Nathan BUKHDRUKER, John WARDLE, James S. WHITING, Lior ROSEN, Erez ROZENFELD, Werner HAFELFINGER, Neal EIGLER
  • Patent number: 11612385
    Abstract: Systems and methods for delivering a device for regulating blood pressure between a patient's left atrium and right atrium are provided. The delivery apparatus may include a first catheter, a hub having one or more engagers disposed thereon configured to releasably engage with a first expandable end of the shunt in a contracted delivery state within a lumen of a sheath, and a second catheter extending through a center lumen of the first catheter and the hub, wherein the first catheter, the hub, and the second catheter are independently moveable relative to the sheath. The inventive devices 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. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.
    Type: Grant
    Filed: April 3, 2019
    Date of Patent: March 28, 2023
    Assignee: V-Wave Ltd.
    Inventors: Nir Nae, Lior Rosen, Ye'ela Scop, Neal Eigler, Erez Rozenfeld
  • Patent number: 11607327
    Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.
    Type: Grant
    Filed: April 14, 2022
    Date of Patent: March 21, 2023
    Assignee: V-Wave Ltd.
    Inventors: Nir Nae, Lior Rosen, Neal Eigler, Erez Rozenfeld, Werner Hafelfinger, Yeela Scop
  • Publication number: 20220409357
    Abstract: 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: Application
    Filed: August 29, 2022
    Publication date: December 29, 2022
    Applicant: V-Wave Ltd.
    Inventors: Neal EIGLER, Nir NAE, Lior ROSEN, Werner HAFELFINGER, Erez ROZENFELD, James S. WHITING, Menashe YACOBY, Yaacov NITZAN
  • Publication number: 20220387009
    Abstract: 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: Application
    Filed: June 1, 2022
    Publication date: December 8, 2022
    Applicant: V-Wave Ltd.
    Inventors: Nathan BUKHDRUKER, Nir NAE, Lior ROSEN, Erez ROZENFELD, James S. WHITING, Werner HAFELFINGER, Neal EIGLER, Gad KEREN
  • Patent number: 11497631
    Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium.
    Type: Grant
    Filed: September 2, 2021
    Date of Patent: November 15, 2022
    Assignee: V-Wave Ltd.
    Inventors: Lior Rosen, Neal Eigler, Erez Rozenfeld, Nir Nae, Yeela Scop, Werner Hafelfinger
  • Publication number: 20220338989
    Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments, a control mechanism coupled to the adjustable flow regulation mechanism may be provided to remotely activate the adjustable flow regulation mechanism.
    Type: Application
    Filed: July 8, 2022
    Publication date: October 27, 2022
    Applicant: V-Wave Ltd.
    Inventors: Dan ROTTENBERG, Ori J. BRAUN, Avraham ABA ZAKAY, Ascher SHMULEWITZ, Yoram ROZY, Gad KEREN
  • Patent number: 11458287
    Abstract: 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: Grant
    Filed: April 22, 2022
    Date of Patent: October 4, 2022
    Assignee: V-Wave Ltd.
    Inventors: Neal Eigler, Nir Nae, Nathan Bukhdruker, James S. Whiting, Lior Rosen, Erez Rozenfeld, Werner Hafelfinger, Tamir Ben-David
  • Publication number: 20220241565
    Abstract: 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: Application
    Filed: April 22, 2022
    Publication date: August 4, 2022
    Applicant: V-Wave Ltd
    Inventors: Nir NAE, Neal EIGLER, Nathan BUKHDRUKER, James S. WHITING, Lior ROSEN, Erez ROZENFELD, Werner HAFELFINGER, Tamir BEN-DAVID