Systems, apparatuses, and methods for treating tissue and controlling stenosis
Inventors
Dimmer, Steven C. • Mayse, Martin L. • Deem, Mark E. • Gifford, Hanson S.
Assignees
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Publication Number
US-11389233-B2
Publication Date
2022-07-19
Expiration Date
Abstract
Systems, delivery devices, and methods to treat to ablate, damage, or otherwise affect tissue. The treatment systems are capable of delivering a coolable ablation assembly that ablates targeted tissue without damaging non-targeted tissue. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input. The system, delivery devices, and methods can damage tissue and manage scarring and stenosis.
Core Innovation
The invention relates to an intraluminal energy delivery device for treating tissue within a lumen to reduce or prevent stenosis. The device includes a catheter shaft and an energy delivery assembly with a cooling element that is movable between a collapsed state and an expanded state. An energy emitter assembly is provided with a conduit for flowing fluid between the shaft and the cooling element, with the conduit extending about an external surface of the cooling element and carrying a plurality of energy emitters positioned along the conduit.
The energy emitters are configured to deliver energy to a plurality of target regions of a lumen that are spaced apart with respect to a longitudinal axis of the energy delivery assembly. With the cooling element in the expanded state, the energy emitters are circumferentially offset from one another about a longitudinal axis. Fluid is flowed through the conduit to form lesions that are spaced apart from surface tissue of the lumen, thereby targeting nerve tissue for denervation while limiting injury to epithelial and other non-target tissue.
The disclosed targeting approach coordinates lesion patterns to attenuate vagal signaling while avoiding a continuous 360° scar ring. Lesions are described as arc-limited and circumferentially distributed with axially spaced placement, including intercartilaginous lesions between cartilage rings and staggered or discontinuous lesion arrangements. The device architectures further include configurations using balloon expanders and electrode or cooling assemblies arranged in helical, corkscrew, or serpentine patterns, together with internal coolant conduits, coolant jets, or vents, and thermodynamic performance that supports cooled energy delivery for deeper cell death while keeping surface temperature below damaging thresholds.
Claims Coverage
The independent claim covers an energy delivery device having an expandable cooling element and a fluid-flow conduit supporting circumferentially offset energy emitters that form multiple longitudinally spaced, surface-spaced lesions while fluid is flowed through the conduit. Dependent claims add additional lesion-pattern geometry and cooling and emitter configuration refinements.
Expandable cooling element with fluid-flow conduit and distributed energy emitters
A catheter shaft and an energy delivery assembly including a cooling element movable from a collapsed state to an expanded state; an energy emitter assembly with a conduit for flowing fluid between the shaft and the cooling element, the conduit extending about an external surface of the cooling element; and a plurality of energy emitters coupled to and positioned along the conduit.
Circumferentially offset energy emitters delivering to longitudinally spaced target regions
With the cooling element in the expanded state, the energy emitters are circumferentially offset from one another about a longitudinal axis of the energy delivery assembly and configured to deliver energy to a plurality of target regions of a lumen that are spaced apart with respect to the longitudinal axis while fluid is flowed through the conduit to form lesions spaced apart from surface tissue.
Lesions spaced from one another with respect to the lumen long axis
The energy delivery device is configured to produce lesions spaced from one another along the long axis of the lumen.
Arcuate treatment region defined by projection onto a plane orthogonal to the assembly axis
The energy delivery elements are positionable so that projecting the target regions onto a plane orthogonal to the assembly longitudinal axis defines an arcuate treatment region.
Heat exchanger elements or electrodes as energy emitters
The energy delivery elements comprise heat exchanger elements or electrodes.
Axially separated sets of lesions along the longitudinal axis
The energy delivery elements form a first axially separated set of lesions and a second set of lesions along the longitudinal axis of the energy delivery assembly.
Distinct coolant introduction conditions into the cooling element and the conduit
Coolant is introduced into the cooling element at a first temperature and first flow velocity, and a second coolant is independently introduced into the conduit at a second temperature and second flow velocity, with at least one of these values different.
Overall, the claim set centers on a catheter-based, expandable cooling arrangement with a fluid-flow conduit carrying circumferentially offset energy emitters that create multiple lesions spaced apart from surface tissue, with dependent claims further specifying longitudinal and axial lesion spacing, arcuate treatment region geometry, emitter type, and distinct coolant conditions between the cooling element and the conduit.
Stated Advantages
The device targets nerve tissue for denervation while limiting injury to epithelial and other non-target tissue.
The disclosed targeting approach attenuates vagal signaling while avoiding a continuous 360° scar ring.
The thermodynamic performance supports cooled energy delivery for deeper cell death while keeping surface temperature below damaging thresholds.
Documented Applications
Treating tissue within a lumen to reduce or prevent stenosis.
Targeting nerve tissue for denervation.
Attenuating vagal signaling.
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