Tissue cutting systems and methods
Inventors
Rafiee, Nasser • Lederman, Robert J • Busold, Rany • House, Morgan • Khan, Jaffar • Rogers, Toby • Bruce, Christopher G
Assignees
Telltale LLC • National Institutes of Health NIH • US Department of Health and Human Services
Publication Number
US-11337753-B2
Publication Date
2022-05-24
Expiration Date
2040-10-09
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Abstract
The disclosure provides various embodiments of systems to facilitate the cutting of luminal tissue structures percutaneously.
Core Innovation
The invention provides guidance and means for cutting luminal tissue structures percutaneously, particularly focusing on heart valve leaflets that can obstruct blood flow when displaced, such as in the implantation of prosthetic valves. The system introduces tissue cutters, including wires with partially exposed conductive regions on kinked sections that enable electrosurgical cutting of target tissue like native or prosthetic heart valve leaflets.
The disclosed guidewires feature a core wire insulated with a dielectric coating except at selected exposed inner curvature regions defined by a kink, where electrical energy can be applied via an electrosurgical generator to lacerate tissue. Radiopaque marker patterns on the guidewire aid in positioning and visualization, with a central region designed for crimping and stripping of insulation to form the cutting surface.
Supporting devices including guiding catheters and grippers facilitate controlled placement and stabilization of the guidewire during cutting procedures. An irrigation catheter can deliver nonionic liquid to the area to displace blood and reduce electrical dissipation. The system also includes a specialized kinker and denuder device to precisely strip insulation and form the kinked cutting configuration.
The problem solved relates to obstructions caused by heart valve leaflets during procedures such as transcatheter valve implantation. Existing systems are less safe, slower, and less consistent. The disclosed system improves safety, predictability, and efficacy in leaflet cutting to prevent obstruction, especially in interventions like the BASILICA procedure for aortic valve leaflet laceration and other cardiac valve treatments.
Claims Coverage
The patent includes three independent claims covering the electrosurgical guidewire, an electrosurgical system employing the guidewire with guiding catheters and grippers, and a kit comprising the guidewire and associated devices. These claims highlight features central to the electrosurgical cutting functionality, guidewire construction, and system assembly.
Electrosurgical guidewire with V-shaped kink and exposed cutting region
A core wire with a dielectric coating and a radiopaque marker pattern, wherein a central section is kinked into a 'V' shape with the inner curvature stripped of dielectric coating and marker pattern to expose the core wire electrically. The proximal and distal ends are exposed for electrosurgical generator connection, and the outer surface retains insulation.
Electrosurgical system with guiding catheters spaced from exposed kinked region
A system comprising an electrosurgical generator, a pair of guiding catheters disposed over the guidewire on either side of the V-shaped kink, with catheter distal ends aligned with radiopaque measurement indicia to maintain spacing from the exposed cutting region, thus preventing catheter damage. The proximal and distal ends of the guidewire are connected to the generator.
Kit including guidewire, guiding catheters, grippers, and a kinker-denuder device
A kit containing the electrosurgical guidewire as claimed, a pair of guiding catheters to position on either side of the kinked region, grippers to clamp and fix the position of the guidewire relative to the catheters, and a kinker and denuder device configured to hold the guidewire and permit controlled kinking and removal of coating in the central region.
The independent claims collectively define a system centered on a specially constructed electrosurgical guidewire with a kinked, electrically exposed cutting region, integrated with guiding catheters, grippers, and a kinker-denuder device, enabling precise and safe cutting of tissue such as heart valve leaflets.
Stated Advantages
Enables safer, faster, more consistent, and predictable cutting procedures compared to previous equipment.
Facilitates cutting of heart valve leaflets to prevent obstruction of blood flow, especially during prosthetic valve implantation.
Allows precise positioning and supports visualization using radiopaque markers.
Reduces risk of catheter damage during cutting by maintaining spacing using measurement indicia.
Utilizes irrigation with nonionic liquid to reduce electrical dissipation and prevent charring or thromboembolism during electrosurgery.
Documented Applications
Cutting of heart valve leaflets including aortic, mitral, tricuspid, and pulmonary valves to prevent obstruction during prosthetic valve implantation.
Support of the BASILICA procedure (Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during transcatheter aortic valve replacement).
Clearing space for replacement valves by cutting native or prosthetic valve leaflets.
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