Adjustable self-locking papillary muscle band

Inventors

Neustadter, David

Assignees

Cardiac Success Ltd

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Publication Number

US-12220316-B2

Patent

Publication Date

2025-02-11

Expiration Date


Abstract

Embodiments of the present disclosure include a cardiac device comprising a band configured to form a loop within a heart. The band may include a first end and a second end. The cardiac device may include an actuatable clasp associated with the first end of the band and configured to transition upon actuation from an open configuration to a closed configuration for forming the band into a fixed length loop when the second end passes through or past the clasp. The cardiac device may include a catheter configured to activate the actuatable clasp from the open configuration to the closed configuration. The cardiac device may include an insertion cable adapter, associated with the second end of the band, configured to be removably connected to a flexible insertion cable.

Core Innovation

The invention relates to a transcatheter cardiac device that includes a band configured to form a loop within a heart, with the band having a first end and a second end. An actuatable clasp is associated with the first end of the band and transitions upon actuation from an open configuration to a closed configuration to form the band into a fixed length loop when the second end passes through or past the clasp. A catheter is configured to activate the actuatable clasp from the open configuration to the closed configuration.

An insertion cable adapter is associated with the second end of the band and is configured to be removably connected to a flexible insertion cable. The flexible insertion cable pulls the second end of the band through or past the clasp and is disconnected from the insertion cable adapter after the clasp has been actuated to fix the band into a loop. The flexible insertion cable may include a screw at its distal end configured to be screwed into the insertion cable adapter, with disconnection occurring by unscrewing after clasp actuation.

The actuatable clasp includes a cylinder with a plurality of flaps protruding from one end of the cylinder, where in the closed configuration the flaps are bent inward toward a center of the cylinder to grasp a portion of the band that passes through the actuatable clasp. The flaps may include pointed tips configured to engage the band, may be biased towards the closed configuration and elastically bent into the open configuration to adjust the band, and may close between adjacent ones of protrusions on the band. The clasp may include at least one cut in a wall of the cylinder, with a ring disposed around the first end of the band over the at least one cut configured to push a material of the band into the at least one cut.

Claims Coverage

The independent claims describe a cardiac device with a loop-forming band secured by an actuatable clasp activated by a catheter, together with an insertion cable adapter and a flexible insertion cable for pulling and then disconnecting the band end after clasp actuation. The inventive feature set spans five main areas: loop formation with open-to-closed clasp actuation, removable insertion cable coupling/disconnection, clasp structural configuration using a cylinder with flaps, specific flap/protrusion engagement behaviors, and delivery-device compatibility via diameter relationships and complementary cut/pattern locking/disconnecting.

Loop-forming band secured by catheter-actuated actuatable clasp

A cardiac device includes a band configured to form a loop within a heart, with a first end and a second end, and an actuatable clasp associated with the first end configured to transition upon actuation from an open configuration to a closed configuration for forming the band into a fixed length loop when the second end passes through or past the clasp; a catheter activates the clasp from open to closed.

Removably connected insertion cable adapter and flexible insertion cable for pulling and disconnecting

An insertion cable adapter associated with the second end is configured to be removably connected to a flexible insertion cable, where the flexible insertion cable is configured to pull the second end of the band through or past the clasp and to be disconnected from the insertion cable adapter after the clasp has been actuated to fix the band into a loop.

Screw-based coupling and unscrewing disconnection between flexible insertion cable and adapter

The flexible insertion cable includes a screw at its distal end configured to be screwed into the insertion cable adapter, with the cable connected by screwing into the insertion cable adapter and disconnected by unscrewing from the insertion cable adapter after the clasp is actuated to fix the band into a loop.

Cylinder-with-flaps actuatable clasp that grasps the band in closed configuration

The actuatable clasp includes a cylinder with a plurality of flaps protruding from one end of the cylinder, wherein in the closed configuration the plurality of flaps is bent inward toward a center of the cylinder to form the actuatable clasp, the actuatable clasp being configured to grasp a portion of the band that passes through the actuatable clasp.

Closing between adjacent band protrusions; bead protrusions of plastic or metal

The second end of the band includes a plurality of protrusions, and the actuatable clasp is configured to close between adjacent ones of the plurality of protrusions, wherein the plurality of protrusions includes beads made of at least one of plastic or metal.

Directional passage: pass in first direction and prevent passage in opposite second direction

The second end of the band includes a plurality of protrusions, the plurality of protrusions is configured to pass in a first direction through the actuatable clasp, and the actuatable clasp is configured to prevent the plurality of protrusions from passing through the actuatable clasp in a second direction opposite the first direction when the actuatable clasp is in the closed configuration.

Cut-and-ring retention: clasp cylinder wall cut with a ring pushing band material into the cut

The actuatable clasp includes a cylinder with at least one cut in a wall of the cylinder, and a ring disposed around the first end of the band over the at least one cut, the ring configured to push a material of the band into the at least one cut.

Diameter relationships between actuatable clasp and distal end of delivery catheter

An inner diameter of the actuatable clasp is smaller than an outer diameter of a distal end of a delivery catheter, and an outer diameter of the actuatable clasp is larger than an inner diameter of the distal end of the delivery catheter.

Complementary cut pattern locking of flaps in open configuration and disconnecting in closed configuration

The distal end of the delivery catheter is cut with a pattern complementary to a shape of the plurality of flaps such that when the actuatable clasp is in the open configuration, the plurality of flaps are configured to lock into the pattern at the distal end of the delivery catheter, and when the actuatable clasp is in the closed configuration, the plurality of flaps is configured to disconnect from the pattern at the distal end of the delivery catheter.

Across the independent claims, the core inventive concept is a cardiac device that forms a fixed length loop using a band secured by a catheter-actuated actuatable clasp. The claims further emphasize a removably connected flexible insertion cable and adapter used to pull the band end through or past the clasp and then disconnect, and they define the actuatable clasp as a cylinder with flaps that grasp and engage band features, including directional and structural retention behaviors. Additional independent claim coverage includes clasp/delivery-catheter dimensional relationships and complementary cut-pattern locking and disconnecting.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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