Patents Assigned to Twelve, Inc.
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Publication number: 20250041056Abstract: Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system for delivering a prosthetic device into a heart of a patient includes an elongated catheter body and a delivery capsule. The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.Type: ApplicationFiled: October 25, 2024Publication date: February 6, 2025Applicant: Twelve, Inc.Inventors: Mark Deem, Hanson Gifford, III, John Morriss, Matt McLean, Michael Luna
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Patent number: 12201523Abstract: Systems for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, an elongated catheter body, a delivery capsule carried by the elongated catheter body, and two fluid chambers within the delivery capsule. The delivery capsule can be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for at least partially deploying the prosthetic heart valve device. For example, the delivery capsule can be urged towards the deployment configuration when fluid is removed from the first chamber and fluid is delivered into the second chamber, whereas the delivery capsule can be urged towards the containment configuration to resheathe the prosthetic heart valve device when fluid is removed from the second chamber and delivered into the first chamber.Type: GrantFiled: July 13, 2023Date of Patent: January 21, 2025Assignee: Twelve, Inc.Inventor: Matthew McLean
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Patent number: 12186188Abstract: Support devices and associated systems and methods for releasably retaining a delivery system handle while delivering a medical device to a target within a human are described herein. The support device is configured to engage the delivery system handle and enable a user to maneuver a distal end portion of the delivery system by manipulating features of the support device.Type: GrantFiled: April 29, 2020Date of Patent: January 7, 2025Assignee: Twelve, Inc.Inventors: Estella Wong, Joshua Dwork, Kevin Mauch, Christopher Switalski, David Grossman, Mike Simpson
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Patent number: 12178702Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.Type: GrantFiled: January 14, 2023Date of Patent: December 31, 2024Assignee: Twelve, Inc.Inventors: Hanson S. Gifford, III, James I Fann, John Morriss, Mark E. Deem, Jeffry J. Grainger
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Patent number: 12161552Abstract: Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system for delivering a prosthetic device into a heart of a patient includes an elongated catheter body and a delivery capsule. The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.Type: GrantFiled: September 27, 2021Date of Patent: December 10, 2024Assignee: Twelve, Inc.Inventors: Mark Deem, Hanson Gifford, III, John Morriss, Matt McLean, Michael Luna
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Patent number: 12016772Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member. The device further includes an extension member coupled to the anchoring member and having an annular first portion coupled to the anchoring member and a second portion coupled to the first portion. The extension member is folded in a delivery configuration such that the first portion overlaps the second portion. When released from the a delivery catheter, the extension member unfolds such that the first portion extends radially outwardly from the anchoring member and the second portion extends radially outwardly from the first portion.Type: GrantFiled: September 28, 2020Date of Patent: June 25, 2024Assignee: Twelve, Inc.Inventors: Richard Francis, Scott Robertson, Marian Lally, Katherine Miyashiro, Paraic Frisby
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Patent number: 11992404Abstract: A fluid diversion device configured in accordance with embodiments of the present technology can include, for example, a housing including channels configured to receive respective tubes, and a bore that extends laterally across the plurality of channels. The device can include an occlusion member disposed in the bore, where rotation of the occlusion member selectively occludes either a first subset of tubes or a second subset of tubes. The device can include an actuator that enables rotation of the occlusion member to a first position and a second position such that the first subset of tubes and the second subset of tubes are alternatively occluded in the first position or the second position for fluid communication in different directions relative to chambers of a delivery device operable to deploy and recapture the medical device.Type: GrantFiled: September 16, 2022Date of Patent: May 28, 2024Assignee: Twelve, Inc.Inventors: Niall F. Duffy, Gavin Kenny, Maurice Donoghue
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Patent number: 11877926Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.Type: GrantFiled: July 31, 2020Date of Patent: January 23, 2024Assignee: Twelve, Inc.Inventors: Richard Francis, Scott Robertson, Marian Lally, Alexander Hill, Katherine Miyashiro, Paraic Frisby, James R. Keogh
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Patent number: 11826249Abstract: A heart valve repair device may include a support configured to extend through a native annulus of a native heart valve, wherein the support comprises an upstream portion and a downstream portion; an annular expandable retainer extending from the upstream portion of the support, and an arm extending from the downstream portion of the support. The annular expandable retainer may include a C-shaped cross-section that is open inwardly. The arm may be configured to reach behind a leaflet of the native heart valve and sandwich the leaflet between the arm and the support.Type: GrantFiled: June 18, 2020Date of Patent: November 28, 2023Assignee: Twelve, Inc.Inventors: John Morriss, Hanson S. Gifford, III, James I. Fann, Jean-Pierre Dueri, Darin Gittings, Michael Luna, Mark E. Deem, Douglas S Sutton
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Patent number: 11786370Abstract: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.Type: GrantFiled: October 5, 2020Date of Patent: October 17, 2023Assignee: Twelve, Inc.Inventors: Kevin Mauch, Joshua Dwork, Finn Rinne, Siyan Som, Estella Wong
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Patent number: 11737873Abstract: Systems for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, an elongated catheter body, a delivery capsule carried by the elongated catheter body, and two fluid chambers within the delivery capsule. The delivery capsule can be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for at least partially deploying the prosthetic heart valve device. For example, the delivery capsule can be urged towards the deployment configuration when fluid is removed from the first chamber and fluid is delivered into the second chamber, whereas the delivery capsule can be urged towards the containment configuration to resheathe the prosthetic heart valve device when fluid is removed from the second chamber and delivered into the first chamber.Type: GrantFiled: January 24, 2020Date of Patent: August 29, 2023Assignee: Twelve, Inc.Inventor: Matthew McLean
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Patent number: 11712334Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.Type: GrantFiled: August 21, 2020Date of Patent: August 1, 2023Assignee: Twelve, Inc.Inventors: John Morriss, Hanson S. Gifford, III
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Patent number: 11654021Abstract: A method for treating a native valve of a human heart having a native annulus and native leaflets includes positioning a capsule of a delivery device proximate a native heart valve. The method further includes partially deploying a prosthetic heart valve device from the capsule such that an inflow region of a valve support and an inflow region of a fixation structure are radially expanded. A portion of the prosthetic heart valve device remains coupled to the delivery device while a gap exists between a downstream end of a prosthetic valve disposed within the valve support and a distal terminus of the capsule such that fluid can flow through the prosthetic valve with the prosthetic heart valve device partially deployed. The method may further include recapturing the prosthetic heart valve device within the capsule.Type: GrantFiled: June 17, 2020Date of Patent: May 23, 2023Assignee: Twelve, Inc.Inventor: Katherine Miyashiro
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Patent number: 11628063Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.Type: GrantFiled: March 29, 2022Date of Patent: April 18, 2023Assignee: Twelve, Inc.Inventors: John Morriss, Matt McLean, Maureen Bensing, Jean-Pierre Dueri, Hanson Gifford, III, Katie Miyashiro, David Jerry Scott, David Trask, Kirsten Valley
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Patent number: 11617648Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.Type: GrantFiled: March 29, 2022Date of Patent: April 4, 2023Assignee: Twelve, Inc.Inventors: John Morriss, Matt McLean, Maureen Bensing, Jean-Pierre Dueri, Hanson Gifford, III, Katie Miyashiro, David Jerry Scott, David Trask, Kirsten Valley
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Patent number: 11576782Abstract: Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration, and an appendage, such as a flap or apron extending from the support. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet, and the appendage is configured to extend beyond an edge of the posterior leaflet toward the anterior leaflet.Type: GrantFiled: November 2, 2020Date of Patent: February 14, 2023Assignee: TWELVE, INC.Inventor: Hanson Gifford, III
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Patent number: 11571303Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.Type: GrantFiled: November 15, 2019Date of Patent: February 7, 2023Assignee: TWELVE, INC.Inventors: Hanson S. Gifford, III, James I. Fann, John Morriss, Mark E. Deem, Jeffry J. Grainger
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Patent number: 11559398Abstract: Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.Type: GrantFiled: May 8, 2020Date of Patent: January 24, 2023Assignee: Twelve, Inc.Inventors: Kevin Mauch, Joshua Dwork
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Patent number: 11523900Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.Type: GrantFiled: March 29, 2022Date of Patent: December 13, 2022Assignee: Twelve, Inc.Inventors: John Morriss, Hanson S. Gifford, III
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Patent number: 11497603Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.Type: GrantFiled: March 29, 2022Date of Patent: November 15, 2022Assignee: Twelve, Inc.Inventors: John Morriss, Matt McLean, Maureen Bensing, Jean-Pierre Dueri, Hanson Gifford, III, Katie Miyashiro, David Jerry Scott, David Trask, Kirsten Valley