Systems, apparatuses, and methods for treating tissue and controlling stenosis

Inventors

Dimmer, Steven C. • Mayse, Martin L. • Deem, Mark E. • Gifford, Hanson S.

Assignees

Nuvaira Inc

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Publication Number

US-12290309-B2

Patent

Publication Date

2025-05-06

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 document describes an intraluminal airway treatment system that positions an ablation assembly with respect to an airway and outputs energy to target regions of the airway. The treatment forms lesions in airway tissue that are spaced apart from surface tissue and are positioned between cartilaginous rings of the airway, including target regions that are axially spaced apart with respect to a longitudinal axis.

The disclosed ablation assemblies include a cooling element that is movable from a collapsed state to an expanded state, such that the energy emitter and the cooling element cooperate during lesion formation. The energy emitter includes an intercartilaginous energy emitter with a plurality of electrodes circumferentially offset from one another about a longitudinal axis, enabling delivery to a plurality of target regions spaced apart along the longitudinal axis.

A central refinement is separate cooling delivery, in which a cooling channel of the energy emitter is separate from a chamber of the cooling element. This arrangement enables independent delivery of a first coolant from the catheter shaft to the channel of the energy emitter and independent delivery of a second coolant to the chamber of the cooling element.

In addition, the document describes intraluminal delivery with an expandable device and electrodes spaced about a circumference of the expandable member to output energy to discrete target regions and form lesions. Lesions can be configured so that at least a portion of a first lesion is axially spaced apart from and circumferentially adjacent to or overlapping a second lesion.

Claims Coverage

The document includes three independent claims. The claims center on intraluminal ablation/electrode arrangements for axially spaced target regions and lesion formation, together with separate, independently delivered cooling between an electrode cooling channel and a cooling chamber.

Intercartilaginous electrode arrangement with expanded cooling element

A catheter shaft with an ablation assembly including a cooling element movable from a collapsed state to an expanded state, and an intercartilaginous energy emitter with a plurality of electrodes circumferentially offset about a longitudinal axis that deliver energy to a plurality of target regions spaced apart along the longitudinal axis, forming intercartilaginous lesions spaced apart from surface tissue and positioned between cartilaginous rings.

Independent coolant delivery to electrode cooling channel and cooling element chamber

A cooling channel of the energy emitter is separate from a chamber of the cooling element to enable independent delivery of a first coolant from the catheter shaft to the channel of the energy emitter and a second coolant to the chamber of the cooling element.

Expandable intraluminal ablation with axially spaced and circumferentially adjacent or overlapping lesions

An intraluminal delivery device with an ablation assembly including an expandable device and a plurality of electrodes spaced apart about a circumference of the expandable member to output energy to discrete target regions to form lesions, wherein at least a portion of a first lesion is axially spaced apart from and circumferentially adjacent to or overlapping a second lesion.

Independent coolant delivery to electrode channels and expandable-member chamber

A cooling channel of the plurality of electrodes is separate from a chamber of the expandable member to enable independent delivery of a first coolant to the channel of the plurality of electrodes and a second coolant to the chamber of the expandable member.

Treating by energy delivery to overlapping profiles of axially spaced target regions along the airway long axis

A method of treating a subject comprising positioning an ablation assembly with respect to an airway and outputting energy from the ablation assembly to axially spaced apart target regions of the airway, wherein profiles of the target regions overlap when viewed in a direction along a long axis of the airway.

Separately controlling cooling by independently delivering two coolants to electrode cooling channel and cooling chamber

Independently delivering a first coolant to an electrode cooling channel of the ablation assembly and independently delivering a second coolant to a cooling chamber of the ablation assembly.

Across the independent claims, the inventive coverage is directed to intraluminal energy delivery using electrodes configured for axially spaced target regions that form intercartilaginous lesions, including overlapping profiles along the airway long axis, and to a cooling architecture in which electrode cooling channels and the cooling element chamber receive independently delivered coolants.

Stated Advantages

Reduces airway smooth muscle contraction, mucus production, inflammation, and edema.

Minimizes stenosis.

Allows temperature control to protect surface tissue while achieving deeper nerve tissue destruction.

Documented Applications

Intraluminal airway treatment for denervating nerve trunks to reduce airway smooth muscle contraction, mucus production, inflammation, and edema while minimizing stenosis.

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