Vapor-based ablation treatment methods with improved treatment volume vapor management
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Publication Number
US-12279803-B2
Publication Date
2025-04-22
Expiration Date
Abstract
Ablation catheters and systems include flexible catheter tips with a distal needle or ports for delivery of an ablative agent to a target tissue. Pressure monitoring during ablation ensure operation is performed within safe limits and with desired efficacy. Positioning elements help maintain the devices in the proper position with respect to the target tissue and also prevent the passage of ablative agent to normal tissues.
Core Innovation
The invention relates to an ablation system configured to treat a patient having at least one of excess weight, obesity, eating disorders, metabolic syndrome, dyslipidemia, diabetes, polycystic ovarian disease, fatty liver disease, non-alcoholic fatty liver disease, or non-alcoholic steatohepatitis disease by ablating duodenal tissue. The system includes a control unit comprising at least one processor, at least one pump in data communication with the at least one processor, and a catheter connection port in fluid communication with the at least one pump. A catheter is coupled to the catheter connection port and is adapted to be positioned within the patient's small intestine.
The catheter includes at least one lumen configured to receive a fluid and at least one electrode coupled to the at least one lumen and configured to receive an electrical current from the control unit. Upon the at least one electrode receiving the electrical current and the at least one lumen receiving the fluid, a vapor, having a first flow rate, is generated. A first positioning element and a second positioning element are coupled to a surface of the catheter and expand from compressed configurations to expanded configurations, forming a treatment volume when expanded in the patient's small intestine.
The treatment volume is bounded by a first surface of the expanded first positioning element and a second surface of the expanded second positioning element, and at least two ports are positioned between the first positioning element and the second positioning element and are adapted to release the vapor into the treatment volume. The first surface has a first plurality of spaces and the second surface has a second plurality of spaces, and the first plurality of spaces and the second plurality of spaces are adapted to permit respective portions of the vapor to be released outside the treatment volume.
Claims Coverage
The independent claim set consists of one independent claim. The coverage centers on a control unit, vapor generation at a catheter using electrical current and fluid, and expandable positioning elements that form a bounded treatment volume with at least two vapor-release ports and first and second pluralities of spaces for venting.
Control unit with pump and catheter connection port
A control unit comprising at least one processor, at least one pump in data communication with the at least one processor, and a catheter connection port in fluid communication with the at least one pump.
Vapor generation from electrode electrical current and lumen fluid
A catheter configured to couple to the catheter connection port and positioned within the patient's small intestine, wherein the catheter comprises at least one lumen configured to receive a fluid and at least one electrode coupled to the at least one lumen and configured to receive an electrical current from the control unit, such that vapor having a first flow rate is generated upon receiving the electrical current and the fluid.
Expandable first and second positioning elements forming a bounded treatment volume
A first positioning element and a second positioning element coupled to the catheter surface and adapted to expand from compressed to expanded configurations, wherein the expanded elements form a treatment volume bounded by the first surface and the second surface, with a first plurality of spaces on the first surface and a second plurality of spaces on the second surface.
At least two vapor release ports with vapor venting outside the treatment volume
At least two ports positioned between the first positioning element and the second positioning element, adapted to release vapor into the treatment volume, where the first plurality of spaces and the second plurality of spaces are adapted to permit portions of the vapor to be released outside the treatment volume.
The claim coverage combines duodenal tissue ablation with a small-intestine catheter that generates vapor from electrode-delivered electrical current and lumen-delivered fluid, plus expandable positioning elements that bound a treatment volume and vent vapor through ports and pluralities of spaces.
Stated Advantages
Improved vapor management by releasing portions of vapor outside the treatment volume via first and second pluralities of spaces.
Maintains a treatment-volume pressure level below 5 atm.
Documented Applications
Ablating duodenal tissue in patients having at least one of excess weight, obesity, eating disorders, metabolic syndrome, dyslipidemia, diabetes, polycystic ovarian disease, fatty liver disease, non-alcoholic fatty liver disease, or non-alcoholic steatohepatitis disease.
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