Catheters and manipulators with articulable ends
Inventors
Rafiee, Nasser • Lederman, Robert J. • Rogers, Toby • Yildirim, Dursun Korel • Diep, Mai Le • Rafiee, Koosha
Assignees
Transmural Systems LLC • US Department of Health and Human Services
Publication Number
US-12133962-B2
Publication Date
2024-11-05
Expiration Date
2038-08-27
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
The disclosure provides various embodiments of catheters having articulable ends that can be used for various procedures. Embodiments of methods are also provided that can be performed with catheters in accordance with the present disclosure.
Core Innovation
The invention provides various embodiments of catheters having articulable ends for use in multiple procedures, with corresponding methods to be performed using such catheters. These catheters include an outer tubular member housing a subassembly featuring first and second deployable stabilizers. Each stabilizer is configured to expand laterally and has a curved free distal end designed to be received within a cusp of a respective cardiac valve leaflet, which facilitates stabilization without directly grasping cardiac tissue. The subassembly and catheters allow for precise positioning and manipulation around cardiac valves.
The problem addressed relates to medical devices and techniques for diagnosis and treatment of cardiac valves, particularly improving handling of valve leaflets. Existing methods for removing clips, cysts, or modifying valve leaflets are limited in flexibility and precision. The disclosed system aims to provide improved capabilities for tissue removal, leaflet separation, and preparing valve sites for replacement or repair through innovative catheter design and articulation.
The disclosure further provides robotic manipulators with controllable elongate bodies and actuators that enable distal ends to articulate away from the longitudinal axis and toward each other. These manipulators can have end effectors configured to perform cutting, grasping, irrigating, evacuating, viewing, or suctioning functions. Various catheter embodiments incorporate pre-formed bends, steering wires, braided layers, and shape memory materials to achieve controllable articulation and tissue manipulation, enhancing minimally invasive procedures such as cardiac valve repair, removal, or replacement.
Claims Coverage
The patent includes one independent method claim focusing on a tissue dissection and removal catheter with articulated deployable stabilizers, and several dependent claims detailing specific features and uses of the catheter.
Method of removing cardiac valve tissue with a catheter having articulable stabilizers
A catheter with an outer tubular member and a slidable subassembly including first and second deployable stabilizers that expand laterally and have curved distal ends designed to be received within cardiac valve leaflet cusps. The catheter is introduced into vasculature, navigated to a cardiac valve, and the stabilizers are deployed without grasping tissue to stabilize the device. A further tool is deployed for tissue removal at the valve.
Stabilization without directly grasping cardiac tissue
The stabilizers stabilize the catheter position through engagement of curved ends within valve cusps rather than grasping, and are configured to be slidably and rotatably articulable relative to each other.
Deployable stabilizers comprising self-expanding loops of shape memory material
At least one stabilizer includes a self-expanding loop of material, such as a nickel titanium alloy, with a 360 degree loop that facilitates lateral collapsing and deployment, enhancing deployment control and adaptability at valve cusps.
Manipulation of catheter assembly for anatomical alignment
The subassembly and outer tubular member can be moved both slidably and rotatably relative to each other to align the stabilizers precisely with surrounding anatomy.
Removal of cardiac valve tissue connected to stitches or clips joining native leaflets
The tissue removal method is capable of separating native valve leaflets by removing tissue attached to stitches or clips such as MitralClips, including removal of tissue coupled with the clip itself.
Removal of valve leaflets and associated structures
The method encompasses removing at least a portion, substantially all, or entirety of one or more valve leaflets, and also cutting or removing structures coupled to the valve such as chordae.
The claims collectively describe a catheter system with articulable, deployable stabilizers that engage valve leaflets non-graspingly to stabilize position, enabling precise tissue removal including separated valve leaflets and associated structures, with features including self-expanding shape memory loops and manipulable articulatable components for alignment within cardiac anatomy.
Stated Advantages
Improved capability to remove clips, cysts, and other structures from valve leaflets.
Enhanced methods for modifying or removing luminal valve leaflets, including preparation for replacement valves.
Ability to stabilize catheter position within cardiac valve anatomy without directly grasping tissue.
Support for minimally invasive or percutaneous procedures with precise articulation and alignment features.
Documented Applications
Diagnosis and treatment of cardiac valves including removal of Alfieri stitches, clips such as MitralClips, and resection or cutting of valve leaflets.
Percutaneous procedures accessing patient's sinus passages, including polyp removal and breaching bone layers to access cranial cavity.
Ablation procedures including cardiac ablation and cryoablation.
Use in laparoscopic, urinary, gynecological, neurological, or orthopedic surgical procedures with minimally invasive approach.
Mitral cerclage procedures involving capturing guidewires and deployment of articulating catheters for leaflet grasping and valve manipulation.
Interested in licensing this patent?