Method and apparatus for closing off a portion of a heart ventricle
Inventors
Chin, Sing-Fatt • Annest, Lon S.
Assignees
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Publication Number
US-11793643-B2
Publication Date
2023-10-24
Expiration Date
Abstract
Apparatus and methods to reduce ventricular volume are disclosed. The device takes the form of a transventricular anchor assembly, which presses a portion of the ventricular wall inward, thereby reducing the available volume of the ventricle. The anchor assembly is deployed using a curved introducer that may be inserted into one ventricle, through the septum and into the opposite ventricle. Barbs or protrusions along a tension member of the anchor assembly combined with a mechanical stop and a sealing member hold the device in place once deployed.
Core Innovation
The disclosed transventricular anchor assembly is configured to temporarily or permanently close or reduce ventricular volume by pressing a ventricular wall inward and holding the ventricular wall in a modified configuration. The deployment includes a curved introducer/needle inserted into one ventricle, moved through the septum, and positioned into the opposite ventricle.
After deployment, the system is arranged to prevent backpassage using a distal mechanical stop with pivoting arms. The assembly further includes an anchor system in which, after a needle is removed, a proximal resilient sealing lock is slid onto a tension member that carries protrusions or barbs.
The resilient sealing lock folds the ventricular wall inward and holds the folded wall in apposition. The disclosure also describes left-ventricle reconstruction approaches using left or right ventricular access, including treatment of left ventricular hypertrophy.
Needle guidance is optionally equipped with sensors, including a pressure sensor at the needle tip and an electrical sensor for guidance, such as EKG or monophasic action potential. The described anatomy includes access through a ventricular anterior wall and use of the septum to reach the opposite ventricle.
Claims Coverage
The provided independent claims cover 3 device-level feature sets and 1 method feature set. The claims define a tension-member-based anchoring system in which a tissue-penetrating needle is used to penetrate external walls and is then moved out, after which tensioning advances an anchor, including a second or additional anchor, along the tension member into engagement with external wall(s).
Tension member with proximal anchor and slidably advanced second anchor
A tension member with a proximal anchor attached to a proximal end and a second anchor slidably attached to the tension member, where the tension member is configured to be tensioned after the needle penetrates the external walls of the heart to advance the second anchor along at least a portion of the length of the tension member into engagement with one of the external walls of the heart.
Needle with tissue penetrating tip configured for penetrating external walls and advancing anchoring
A needle attached to a distal end of the tension member, the needle including a tissue penetrating tip configured to penetrate through external walls of the heart and be moved out of the heart, such that pulling and subsequent tensioning advances an anchor into engagement with an external wall.
Additional removably coupleable anchor to engage an opposing external wall for closing a lower portion
An additional anchor removably coupleable with the distal end of the tension member and slidable proximally along the tension member to engage an opposing external wall of the external walls of the heart to close a lower portion of the heart, with the tension member configured to be tensioned after the needle penetrates to advance the anchor into engagement with one external wall.
Method of applying anchor by penetrating external walls, pulling to advance, and engaging an external wall
Penetrating external walls of the heart via a needle of an anchor device with a tension member and an anchor attached to a proximal end of the tension member; pulling the needle through the external walls of the heart to advance the anchor, via the tension member, toward the heart; and engaging a first external wall of the external walls of the heart with the anchor.
The independent claims collectively define a tension-member-based anchoring system in which a tissue-penetrating needle is used to penetrate external walls and is then moved out, after which tensioning advances an anchor into engagement with external wall(s) to close or reduce ventricular volume or close a lower portion, together with a method for applying such an anchor by penetration, pulling, and engagement.
Stated Advantages
Temporarily or permanently close or reduce ventricular volume by pressing a ventricular wall inward and holding the ventricular wall in a modified configuration.
Prevent backpassage after deployment using a distal mechanical stop with pivoting arms.
Close a lower portion of the heart by engaging an opposing external wall with an additional anchor.
Fold the ventricular wall inward and hold the folded wall in apposition.
Support left-ventricle reconstruction approaches, including treatment of left ventricular hypertrophy.
Documented Applications
Left-ventricle reconstruction approaches using left or right ventricular access.
Treatment of left ventricular hypertrophy.
Temporarily or permanently closing/reducing ventricular volume by transventricular anchoring and folding the ventricular wall inward.
Closing a lower portion of the heart by engaging an opposing external wall with a removably coupleable, slidably advanced anchor.
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