Multi-dose duodenal ablation through an endoscope
Inventors
Sharma, Virender K. • Mencinger, Lloyd • McGill, Scott
Assignees
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Publication Number
US-12564435-B2
Publication Date
2026-03-03
Expiration Date
Abstract
Ablation catheters and systems include flexible catheter tips with at least one positioning element and ports for delivery of an ablative agent to a target tissue. The positioning element is used to define a treatment zone and position the catheter proximate the target tissue for ablation. Ablative fluid is delivered to the target tissue at subtherapeutic, therapeutic, or supratherapeutic doses over different time periods, with rest periods between each dose, to cause effective ablation of the target tissue.
Core Innovation
A method of ablating tissue includes inserting an endoscope into a gastrointestinal tract and passing a catheter through a channel of the endoscope so that a distal end of the catheter exits through the distal tip of the endoscope. A first amount of energy is directed to a first treatment zone through the distal end of the catheter over a first period of time, wherein the first treatment zone does not encompass the patient's ampulla of Vater, and a second amount of energy is then directed to the first treatment zone over a second period of time, wherein the first amount of energy and the second amount of energy are different.
After directing the second amount of energy, the catheter is moved to define a second treatment zone that does not encompass the ampulla of Vater, and a third amount of energy and a fourth amount of energy are directed to the second treatment zone, wherein the third amount of energy and the fourth amount of energy are different. In some embodiments, the energy delivery includes causing fluid to be delivered to the distal end, heated, and released as vapor toward the treatment zone.
The method is adapted to cause controlled tissue ablation extent, including contiguous circumferential ablation of a specified portion of mucosa, with selected limits on ablation in mucosa and submucosa, and additional constraints on ablation in muscularis propria. In some embodiments, the method includes an initial endoscope position such that a distal tip of the endoscope is positioned at least 15 cm distal to the patient's ampulla of Vater, and a first treatment zone volume in a range of 3 cubic centimeters to 450 cubic centimeters.
The catheter may comprise a sheath and a wire mesh structure positioned on the distal end, configured to transition from a compressed configuration when inside the sheath to an expanded configuration when outside the sheath, and the expanded wire mesh structure may define a treatment zone and include openings configured to allow portions of vapor to escape from the treatment zone.
Claims Coverage
Independent claims are present with a common framework of inserting an endoscope, passing a catheter, and directing different amounts of energy to first and second treatment zones that do not encompass the ampulla of Vater. The claims further include vapor delivery, sheath-compressed wire-mesh deployment, quantitative tissue-ablation constraints, treatment-zone volume, and initial endoscope positioning relative to the ampulla of Vater.
Staged endoscopic energy delivery to non-ampullary treatment zones
A method comprising inserting an endoscope into a gastrointestinal tract, passing a catheter through the endoscope channel such that the distal end exits the distal tip, directing a first amount of energy to a first treatment zone not encompassing the ampulla of Vater over a first period of time, directing a second amount of energy to the first treatment zone over a second period of time wherein the first and second amounts of energy are different, moving the catheter to define a second treatment zone not encompassing the ampulla of Vater, and directing a third amount of energy and a fourth amount of energy to the second treatment zone wherein the third and fourth amounts of energy are different.
Heated fluid released as vapor toward treatment zones
The energy delivery includes causing fluid to be delivered to the distal end, heated, and released as vapor toward the treatment zone over successive periods of time.
Expandable distal wire mesh structure in a sheath
The catheter includes a sheath and a wire mesh structure positioned on the distal end configured to transition from a compressed configuration when inside the sheath to an expanded configuration when outside the sheath, and the expanded wire mesh structure defines a treatment zone and includes openings configured to allow portions of vapor to escape.
Controlled ablation extent and treatment-zone constraints
The energy amounts are adapted to cause contiguous circumferential ablation of more than 50% of the patient's mucosa in a first treatment zone, or 25% to 90% of the patient's mucosa over a length of 2 cm to 25 cm, while also including limits such as less than 25% of mucosa in the first and second treatment zones and not more than 15% of the patient's submucosa in the first and second treatment zones.
Initial positioning and treatment-zone volume constraints
In some embodiments, an initial endoscope position places the distal tip at least 15 cm distal to the patient's ampulla of Vater, and the first treatment zone defines a volume in a range of 3 cubic centimeters to 450 cubic centimeters.
Across the independent claims, the core claim coverage centers on endoscope-guided catheter delivery of different energy amounts to sequential first and second treatment zones that exclude the ampulla of Vater. The claims further recite vapor delivery, an expandable compressed-to-expanded distal wire mesh catheter, spatial constraints, and quantitative limits on ablation extent and treatment-zone volume.
Stated Advantages
Allows contiguous circumferential ablation of more than 50% of the patient's mucosa in a first treatment zone.
Allows achievement of contiguous circumferential ablation of 25% to 90% of the patient's mucosa over a length of 2 cm to 25 cm.
Provides control of ablation extent by limiting ablation to less than 25% of mucosa in the first and second treatment zones.
Provides control of submucosal ablation by limiting ablation to not more than 15% of the patient's submucosa in the first and second treatment zones.
Documented Applications
GI tissue ablation with first and second treatment zones that do not encompass the ampulla of Vater, including embodiments where the first treatment zone is localized to the duodenum.
Colon.
Pancreatic tumor/cyst.
Bile duct tumor.
Bronchial thermoplasty.
Lung volume reduction.
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