Ablation system with automated ablation energy element
Inventors
Melsky, Gerald • Estabrook, Brian • Baxter, Lincoln • Babko-Malyi, Sergei • Green, Ronald • DiCesare, Paul
Assignees
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Publication Number
US-11883094-B2
Publication Date
2024-01-30
Expiration Date
Abstract
An ablation instrument (e.g., an ablation balloon catheter system) includes an elongate catheter having a housing with a window formed therein. An energy emitter is coupled to the elongate catheter and is configured to deliver ablative energy. A controller is received within the window and is coupled to the energy emitter such that axial movement of the controller within the window is translated to axial movement of the energy emitter and rotation of the controller within the window is translated into rotation of the energy emitter. The instrument includes a motor that is at least partially disposed within the housing of the catheter; a first gear that is operatively connected to and driven by the motor; and a second gear that is coupled to the energy emitter and is driven by the first gear to cause rotation of the energy emitter, while allowing the energy emitter to move axially.
Core Innovation
The invention relates to an ablation instrument that includes an elongate catheter having a housing with a window formed therein, and an energy emitter coupled to the elongate catheter to deliver ablative energy. A controller is received within the window and is coupled to the energy emitter so that axial movement of the controller within the window is translated to axial movement of the energy emitter and rotation of the controller within the window is translated into rotation of the energy emitter.
The ablation instrument further includes a motor at least partially disposed within the housing of the catheter, a first gear operatively connected to and driven by the motor, and a second gear coupled to the energy emitter and driven by the first gear to cause rotation of the energy emitter. The second gear drives rotation of the energy emitter while allowing the energy emitter to move axially, providing automated sweeping of an arc-shaped ablation segment with overlapping increments.
The system also incorporates real-time visualization and assessment of lesion sufficiency using endoscopic imaging of distal blood-pool perturbation, with baseline image and real-time image comparison and user feedback or warnings. Additional described components include aiming light, lesion quality determination flow, and software modules that support visualization of gap detection and lesion sufficiency during automated sweeping.
Claims Coverage
The independent claim identified is clm-00001, covering a core mechanism with axial-and-rotational translation of a catheter-mounted energy emitter using a motor-driven first and second gear arrangement that permits axial movement while the energy emitter rotates. Dependent claim refinements add specific coupling structures, motion-preserving controller geometry, modular motor/disposable removal features, and an optional expandable substantially transparent member delivering an arc-shaped radiant ablative energy segment.
Axial-to-axial and rotational-to-rotational controller translation
A controller received within the window and coupled to the energy emitter such that axial movement of the controller within the window is translated to axial movement of the energy emitter and rotation of the controller within the window is translated into rotation of the energy emitter.
Gear-driven energy emitter rotation while allowing axial movement
A first gear operatively connected to and driven by the motor and a second gear coupled to the energy emitter and driven by the first gear to cause rotation of the energy emitter, while allowing the energy emitter to move axially.
Knob and slider controller geometry preserving rotation during axial movement
A fixedly coupled knob and a slider with an opening that captures the knob to allow free knob rotation while axially moving the energy emitter via sliding coupling to the catheter housing, without interfering with simultaneous rotation.
Splined-shaft and keyed-through-hole engagement for axial relative motion
The energy emitter includes a splined shaft fixedly attached to the controller and the second gear has a keyed through hole that receives splines of the splined shaft, allowing axial movement of the splined shaft relative to the second gear while remaining engaged to transmit drive-shaft rotation into rotation of the outer jacket and energy emitter.
Recessed channel and protrusion coupling to permit axial slide with axial-stationary second gear
Where the outer jacket includes at least one recessed channel and the second gear includes a through hole with a protrusion disposed in the channel, second gear rotation rotates the outer jacket while the outer jacket can move axially within the through hole, and the second gear is at least substantially stationary in the axial direction while engaging the first gear.
Disposable modular motor unit with disengagement and removal via adapter/socket mating
The motor has a main drive shaft that mates with an adapter whose distal tip is received within a socket at the proximal end of a secondary drive shaft to permit free disengagement of the motor from the secondary drive shaft and removal of the disposable modular unit from the tubular extension.
Expandable substantially transparent member delivering arc-shaped radiant ablative energy segment
Adds an expandable member attached to the catheter that is substantially transparent to radiant ablative energy and includes an elastic portion that conforms to a target tissue region upon expansion, with the energy emitter movably disposed in a catheter lumen to deliver an arc-shaped segment of radiant ablative energy through the expandable member to the target tissue region.
Overall claim coverage centers on translating a controller’s axial movement and rotation to corresponding axial movement and rotation of an energy emitter using a motor with first and second gears where rotation of the emitter is maintained while axial emitter motion is permitted. Dependent features narrow or add specific mechanisms for maintaining rotation during axial sliding, provide particular axial-coupling geometries, include modular/disposable motor disengagement and removal, and optionally add an expandable substantially transparent member to constrain delivery to an arc-shaped radiant ablative energy segment to a target tissue region.
Stated Advantages
Automated sweeping to form larger arc-shaped lesion segments with reduced manual step count.
Real-time visualization and assessment of lesion sufficiency using endoscopic imaging of distal blood-pool perturbation with baseline versus real-time comparison and user feedback or warnings.
Support for overlapping increments lesion formation during automated sweeping.
Allows axial movement of the energy emitter while maintaining rotation driven by gear transmission.
Documented Applications
Automated cardiac ablation using an ablation balloon catheter system to form arc-shaped lesion segments with overlapping increments.
In-procedure endoscopic visualization and assessment of lesion sufficiency based on distal blood-pool perturbation, including baseline versus real-time image comparison and gap detection for lesion adequacy feedback and warnings.
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