Cardiac tissue anchoring devices, methods, and systems for treatment of congestive heart failure and other conditions
Inventors
Moshe, Meir • Annest, Lon • Van Bladel, Kevin
Assignees
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Publication Number
US-10588613-B2
Publication Date
2020-03-17
Expiration Date
Abstract
A heart tissue gripping device may include a body portion, an elongate shaft, and a tissue gripping member that is attached to the distal end of the elongate shaft. The tissue gripping member being may be positioned adjacent a heart surface by insertion through an incision in the body. The tissue gripping member may releasably attach to tissue of the heart surface to facilitate a surgical instrument in performing one or more procedures. A coupling of the tissue gripping member may releasably attach the surgical device to the tissue gripping member to allow the device to access the tissue of the heart surface.
Core Innovation
The invention relates to cardiac tissue anchoring systems, including a heart tissue gripping device for congestive heart failure (CHF). The device includes a grippable body portion that allows a user to control the device so that one or more components are insertable through an incision in a body to position the one or more components adjacent a surface of the heart. An elongate shaft is coupled to the body portion and has a distal end, and a tissue gripping member is fixedly coupled to the distal end of the elongate shaft.
The tissue gripping member includes a main body and a lumen extending coaxially through the main body from a proximal most end to a distal most end. The tissue gripping member is insertable through the incision so that the entire tissue gripping member is positionable within the body and against the heart surface when inserted, and the tissue gripping member is configured to releasably attach to tissue of the heart surface. The elongate shaft extends laterally from a sidewall of the main body such that the elongate shaft extends off-axis from the lumen, and when inserted, at least a portion of the elongate shaft is configured to remain outside the incision.
The device further provides a coupling feature for releasably attaching a catheter device and/or tissue penetrating device to the tissue gripping member to allow access to tissue of the heart surface. In some implementations, the device includes a fastening component and a tension member to enable removal of the tissue gripping member after tissue penetration, and the fastening component is described as a wire noose in an annular groove/channel with cinching and a lock mechanism to grip the tension member and provide hemostasis.
Claims Coverage
The partial content provides one independent claim (clm-00001) and dependent refinements. The claim coverage centers on a heart tissue gripping device with an off-axis elongate shaft, a coaxial-lumen tissue gripping member, a coupling feature, and fastening/tension-member refinements.
Grippable control with incision positioning of tissue gripping member
A body portion that is grippable by a user to allow the user to control the device such that one or more components are insertable through an incision in a body to position the one or more components adjacent a surface of the heart.
Off-axis elongate shaft extending laterally from tissue gripping member lumen
An elongate shaft coupled with a tissue gripping member such that the distal end of the elongate shaft is attached to and extends laterally from a sidewall of the main body between the distal most end and the proximal most end, such that the elongate shaft extends off-axis from the lumen of the tissue gripping member and such that when the tissue gripping member is inserted, at least a portion of the elongate shaft remains outside the incision.
Coaxial lumen tissue gripping member for releasable attachment to heart surface
A tissue gripping member fixedly coupled to the distal end of the elongate shaft, having a main body and a lumen extending coaxially through the main body from a proximal most end to a distal most end, the tissue gripping member being insertable through the incision so the entire tissue gripping member is positionable against the heart surface and configured to releasably attach to tissue of the heart surface.
Coupling feature for catheter device and/or tissue penetrating device access
A coupling feature for releasably attaching a catheter device and/or tissue penetrating device to the tissue gripping member to allow said device to access the tissue of the heart surface.
Malleable yet sufficiently rigid off-axis insertion and maneuvering
The elongate shaft is malleable for positioning while being sufficiently rigid to resist bending during insertion and maneuvering.
Fastening component using a tension member for removal with hemostasis
A fastening component that releasably fastens to a tension member inserted through a wall of the heart so the tissue gripping member can be removed while providing hemostasis to the heart wall.
Cinchable wire noose fastening component
A cinchable wire noose is used as the fastening component tightened around the tension member by tensioning the wire noose.
Annular channel configured to receive and releasably couple wire noose
The tissue gripping member includes an annular channel on an exterior surface configured to receive and releasably couple a wire noose.
Threaded central lumen coupling feature
The coupling feature includes a threaded central lumen in the tissue gripping member.
Across the independent claim and dependent refinements, the inventive features include a grippable body portion controlling an off-axis elongate shaft, a coaxial-lumen tissue gripping member configured to releasably attach to the heart surface, a coupling feature enabling catheter or tissue-penetrating device access, and refinements for insertion behavior and removal with hemostasis using a wire-noose fastening and tension member system.
Stated Advantages
Provides hemostasis to the heart wall during removal of the tissue gripping member.
Enables catheter device and/or tissue penetrating device access to tissue of the heart surface via the coupling feature.
Allows the elongate shaft to remain outside the incision while the tissue gripping member is positioned against the heart surface.
Allows releasable attachment of the tissue gripping member to tissue of the heart surface.
In catheter-based systems, draws walls together, excludes scar tissue, and reduces left-ventricle volume.
Documented Applications
Cardiac tissue anchoring systems for congestive heart failure (CHF).
Catheter-based procedures using external-wall and septal anchors connected by a tension member to draw walls together, exclude scar tissue, and reduce left-ventricle volume.
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