Inner curvature charge concentration device for tissue laceration
Inventors
Lederman, Robert J. • Khan, Jaffar M. • Rogers, Toby
Assignees
US Department of Health and Human Services
Publication Number
US-12349957-B2
Publication Date
2025-07-08
Expiration Date
2039-02-19
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Abstract
Disclosed monopolar and bipolar tissue lacerators can comprise a wire partially covered by electrical insulation, wherein the wire has a kink defining an inner curvature, wherein the wire is exposed through the insulation at one or two exposed regions along or near the inner curvature of the kink, wherein the wire is configured to conduct electrical energy through the one or two exposed regions and through a tissue target positioned adjacent the inner curvature to lacerate the tissue target via the electrical energy. The tissue target can be a native or prosthetic heart valve leaflet in a patient's heart.
Core Innovation
The invention disclosed relates to electrosurgical tissue lacerators configured as monopolar or bipolar devices that comprise a wire partially insulated electrically, with a kink forming an inner curvature. The wire is exposed through the insulation at one or two focal regions near the inner curvature, enabling the conduction of electrical energy through these exposed regions into a tissue target positioned adjacent to the inner curvature to achieve tissue laceration by electrical energy. This configuration concentrates electrical energy precisely at the intended tissue site for efficient laceration.
The problem being solved addresses the difficulty of safely and effectively cutting cardiac tissues such as native or prosthetic heart valve leaflets, which can obstruct blood flow, especially in procedures involving transcatheter heart valve replacement. Conventional methods risk unintentional damage due to charge dispersion and poor alignment of the cutting element with the tissue. The disclosed technology overcomes these issues by insulating most of the wire except for localized exposed areas on the inner curvature of a kinked wire, focusing the electrical energy on the tissue to be lacerated while minimizing remote current and heat dispersion.
The invention further discloses methods of using these electrically energized kinked wires, combined with irrigation catheters to introduce non-ionic liquids around the exposed portions to displace blood and reduce electrical dissipation and thermal damage. This technology supports percutaneous or transvascular delivery to cardiac structures, enabling intentional laceration of valve leaflets such as the anterior mitral leaflet or aortic valve leaflets to prevent obstruction complications during transcatheter mitral or aortic valve replacement procedures.
Claims Coverage
The patent contains two independent claims that focus on the structure and functionality of an electrosurgical lacerator wire with specific insulating and exposed regions for focused tissue laceration.
Focused electrically exposed wire regions on an inner curvature kink
The wire is V-shaped kinked with an acute angle, having two continuous, non-circumferentially focally denuded and exposed regions on the inner curvature forming a cutting edge arranged proximally on opposing sides of the kink, with the rest of the wire insulated including the entire outer circumference to limit remote current and heat dispersion.
Electrical configuration and conductance for tissue laceration
The wire is configured to conduct electrical energy through the two exposed regions and through the tissue target positioned between them to achieve electrosurgical laceration, with at least one wire end connected to an electrosurgical generator.
Bipolar wire lacerator configuration
The lacerator has two exposed regions with opposite polarity on the inner curvature of the V-shaped kink creating a bipolar configuration, whereby the electrical current flows between these exposed regions through the tissue to be lacerated.
Irrigation catheter integration
The lacerator can be combined with an irrigation catheter that introduces a non-ionic liquid adjacent to the exposed wire regions, displacing blood to reduce electrical dissipation, carbonization, thrombus formation, and tissue escharification during electrosurgical laceration.
Percutaneous or transvascular delivery
The lacerator is adapted for percutaneous or transvascular delivery into a patient's heart to perform tissue laceration within a fluid-filled space.
The independent claims disclose a kinked, insulated wire with continuous, localized exposed inner curvature regions forming a focused electrosurgical cutting edge for tissue laceration, including monopolar and bipolar configurations, and optionally combined with irrigation for improved safety and efficacy during percutaneous cardiac procedures.
Stated Advantages
Concentrates electrical energy and heat at narrowly exposed regions on the inner curvature of the wire to focus laceration precisely on the target tissue while minimizing remote current and heat dispersion to avoid unintentional tissue damage.
Aligns the lacerator with tissue targets effectively through the kinked wire design, enabling improved interaction with tissue such as heart valve leaflets.
Combining the lacerator with irrigation using non-ionic biocompatible liquids displaces blood to prevent electrode carbonization, thrombus formation, and tissue escharification during electrosurgical laceration.
Allows percutaneous or transvascular use in fluid-filled cardiac spaces, enabling minimally invasive laceration of native or prosthetic heart valve leaflets to prevent flow obstruction during transcatheter valve replacement procedures.
Documented Applications
Electrosurgical laceration of native or prosthetic heart valve leaflets within a patient's heart to prevent obstruction in transcatheter mitral valve replacement (LAMPOON procedure).
Electrosurgical laceration of aortic valve leaflets, native or bioprosthetic, to prevent coronary artery obstruction after transcatheter aortic valve replacement (BASILICA procedure).
Electrosurgical laceration of Mitra-Clip Alfieri stitch failures (ELASTIC procedure).
Use of kinked, localized exposed wire lacerators in percutaneous cardiac interventions for tissue laceration to avoid obstructions of blood flow through valve leaflets or prevent complications during transcatheter valve implantations.
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