Patents by Inventor Werner Hafelfinger
Werner Hafelfinger 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: 11865282Abstract: 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: GrantFiled: May 18, 2020Date of Patent: January 9, 2024Assignee: V-Wave Ltd.Inventors: Nir Nae, Tal Weisinger, Lior Rosen, James Whiting, Neal Eigler, Werner Hafelfinger, 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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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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Publication number: 20230277343Abstract: 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: ApplicationFiled: March 7, 2023Publication date: September 7, 2023Applicant: V-Wave Ltd.Inventors: Nir NAE, Lior ROSEN, Neal EIGLER, Erez ROZENFELD, Werner HAFELFINGER, Yeela SCOP
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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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Patent number: 11607327Abstract: 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: GrantFiled: April 14, 2022Date of Patent: March 21, 2023Assignee: V-Wave Ltd.Inventors: Nir Nae, Lior Rosen, Neal Eigler, Erez Rozenfeld, Werner Hafelfinger, Yeela Scop
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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: 11497631Abstract: 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: GrantFiled: September 2, 2021Date of Patent: November 15, 2022Assignee: V-Wave Ltd.Inventors: Lior Rosen, Neal Eigler, Erez Rozenfeld, Nir Nae, Yeela Scop, Werner Hafelfinger
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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: 20220241096Abstract: 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: ApplicationFiled: April 14, 2022Publication date: August 4, 2022Applicant: V-Wave Ltd.Inventors: Nir NAE, Lior ROSEN, Neal EIGLER, Erez ROZENFELD, Werner HAFELFINGER, Yeela SCOP
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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: 20220226113Abstract: A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.Type: ApplicationFiled: February 2, 2022Publication date: July 21, 2022Inventors: Robert James Siegel, Lawrence Eric Ong, Werner Hafelfinger, Niclas Henning Zieger
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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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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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Patent number: 11304831Abstract: 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: GrantFiled: November 11, 2020Date of Patent: April 19, 2022Assignee: V-Wave Ltd.Inventors: Nir Nae, Lior Rosen, Neal Eigler, Erez Rozenfeld, Werner Hafelfinger, Yeela Scop
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Patent number: 11241308Abstract: A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.Type: GrantFiled: July 22, 2016Date of Patent: February 8, 2022Assignee: Cedars-Sinai Medical CenterInventors: Robert James Siegel, Lawrence Eric Ong, Werner Hafelfinger, Niclas Henning Zieger