Method and device for treating dysfunctional cardiac tissue
Inventors
Chin, Sing-Fatt • Annest, Lon • O'Reilly, Robert
Assignees
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Publication Number
US-11259929-B2
Publication Date
2022-03-01
Expiration Date
Abstract
Various methods and devices are provided for reducing the volume of the ventricles of the heart. In one embodiment, a method for reducing the ventricular volume of a heart chamber is provided including the steps of inserting an anchoring mechanism onto dysfunctional cardiac tissue, deploying one or more anchors into the dysfunctional cardiac tissue, raising the dysfunctional cardiac tissue using the anchors, and securing the anchors to hold the dysfunctional cardiac tissue in place. Further, a device for reducing the volume of the ventricles of a heart chamber is provided where the device has one or more clips for placement on dysfunctional cardiac tissue of a heart, one or more anchors for deployment and securement into the dysfunctional cardiac tissue, and a lifting mechanism for raising the one or more anchors and the dysfunctional cardiac tissue.
Core Innovation
The invention relates to reducing a volume of a ventricle of a heart by excluding or folding dysfunctional or infarcted cardiac tissue using an off-pump, minimally invasive ventricular volume reduction system. A clip/clamp-and-anchor system is delivered via thoracoscopic or subxiphoid approaches to position a clamp defining an opening and a cap coupled with the clamp on cardiac tissue of a wall of the heart. The cap is positionable in a first state and reconfigurable to a second state to pull cardiac tissue through the opening and into a volume defined by the cap, thereby reducing the volume of the ventricle.
In the second state, the clamp is positioned on a periphery of the cap and the cap is configured to cover the cardiac tissue. An anchor is configured to pull the cardiac tissue towards the cap and into contact with the cap, and the system can bring opposing portions of the cardiac tissue towards and into contact with each other such that folded cardiac tissue remains inside the volume defined by the reconfigurable cap.
The disclosed embodiments include variations with cap and anchor configurations, including an anchor deployment and locking arrangement with reconfigurable cap concepts. The document further discloses device embodiments that integrate sensing for real-time cardiac function monitoring during therapy, including sonometricrometer piezoelectric crystals associated with clips/clamps and ultrasound transmitter/receiver crystal pairs that provide cardiac dimensions in real time.
Claims Coverage
The provided set includes one independent method claim and five independent apparatus claims. Across these independent claims, there are three recurring inventive feature themes: a reconfigurable cap with a first state and a second state, a clamp defining an opening positioned on a periphery of the cap in the second state, and cardiac tissue being pulled into a cap-defined volume with folded tissue and/or opposing portions clamped into contact.
Reconfigurable cap and clamp opening for ventricular volume reduction
A clamp defining an opening and a cap coupled with the clamp, where the cap is positionable on cardiac tissue of a wall of the heart in a first state and is reconfigurable to a second state to pull the cardiac tissue through the opening and into a volume defined by the cap to reduce the volume of the ventricle, with the clamp positioned on a periphery of the cap and the cap configured to cover the cardiac tissue in the second state.
Cap reconfiguring and folding with clamping opposing tissue portions
Placing a cap on cardiac tissue of the ventricle of the heart in a first state; reconfiguring the cap to a second state to bring the cardiac tissue into a volume defined by the cap, wherein the cardiac tissue is folded inside the volume to reduce the volume of the ventricle; and clamping opposing portions of the cardiac tissue with a clamp such that the opposing portions contact each other and the folded cardiac tissue remains inside the volume defined by reconfiguring the cap to the second state.
Removably received clamp in a reconfigurable cap
A clamp defining an opening and a cap coupled with the clamp, where the cap is positionable on cardiac tissue of a wall of the heart in a first state and reconfigurable to a second state to pull the cardiac tissue through the opening into a volume defined by the cap to reduce the volume of the ventricle, with the clamp removably received in a slot of the cap.
Integral cap/clamp that exerts forces to maintain a second state
A clamp defining an opening and a cap coupled with the clamp, where the clamp forms an integral part of the cap and is configured to exert forces to reconfigure the cap into the second state and maintain the cap in the second state.
Spring-operated clamp for reconfiguring and maintaining the cap second state
A clamp defining an opening and a cap coupled with the clamp, where the clamp comprises a spring configured to reconfigure the cap into the second state and to maintain the cap in the second state.
Across the independent claims provided, the claim coverage centers on apparatus and method structures for reducing ventricular volume by using a clamp defining an opening in combination with a reconfigurable cap that moves from a first state to a second state to pull and capture cardiac tissue within a cap-defined volume, with the clamp positioned on a periphery of the cap in the second state and arranged to bring tissue portions into contact. Additional independent claim-specific differentiators include an anchor configured to pull tissue toward the cap, a clamp removably received in a cap slot, an integral clamp forming part of the cap to exert forces and maintain the second state, and a spring in the clamp to reconfigure and maintain the second state.
Stated Advantages
Real-time cardiac function monitoring during therapy.
Feedback to modify electrical/pharmacological therapy.
Avoiding opening the left side of the heart while directly monitoring ventricular function.
Documented Applications
Thoracoscopic or subxiphoid approaches for ventricular volume reduction therapy.
Left and right ventricular monitoring.
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