IP Library › Granted Patent US 12,614,623
Granted Patent B2
US 12,614,623 · App. 17/785,647 · Granted Apr 28, 2026

Planning and navigation in superselective drug delivery via the tracheobronchial airway

Inventor: Brian H. Craig (Minneapolis, MN)
Assignee: ISOLA THERAPEUTICS, INC.
G16H20/40G16H30/40
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Quick Facts
Patent No.
US 12,614,623
App. No.
17/785,647
Filed
Jun 15, 2022
Granted
Apr 28, 2026
Kind
B2
Art Unit
3681
USPC
705/2
Abstract

Devices, systems, and methods for localized delivery of a chemotherapy, hormonal therapy, or targeted drug/biologic therapy to a target tissue area of an internal body organ of a patient. Computer systems may be used for planning and navigation in super selective drug delivery via a tracheobronchial airway. A catheter may be used to form a sealed treatment chamber in a natural lumen extending through the target tissue area. Air is purged from the chamber, which is then filled with a liquid drug solution for an adequate treatment session time, solution volume and drug concentration to saturate the target tissue area, thereby providing the treatment. The liquid drug solution may be circulated or recirculated through the chamber or maintained stationary therewithin to saturate the target tissue area. The chamber is evacuated at the end of the treatment session.

Claims (54)

1 . A system for providing tumor treatment within a respiratory tract, the system comprising:

a drug-delivery catheter;

at least one memory unit;

at least one processing unit programmed according to instructions on the at least one memory unit to configure the at least one processing unit to:

access image data acquired by non-invasive imaging of a lower respiratory tract of a patient;

create, according to the image data, a digital map identifying one or more lung cancer tumors and one or more respiratory airways;

select one or more identified respiratory airways of the one or more respiratory airways that are proximate to or overlapping the one or more lung cancer tumors;

identify, according to an analysis of the digital map, defined treatment positions in the one or more respiratory airways for delivery of a chemotherapeutic drug solution to one or more treatment chambers defined by the drug-delivery catheter within the one or more respiratory airways,

determine one or more tumor treatment zones for permeation of the chemotherapeutic drug solution into lung tissue surrounding the treatment chamber when the chemotherapeutic drug solution is delivered to the one or more treatment zones, wherein the one or more tumor treatment zones are defined as the lung tissue surrounding the entire portion of the one or more distal respiratory airways distal of the defined treatment positions in the one or more respiratory airways;

compare the one or more tumor treatment zones to the one or more lung cancer tumors to determine whether the one or more treatment zones exceed the margins of the one or more lung cancer tumors;

backtrack the defined treatment positions to successively more proximal positions within the one or more respiratory airways to include additional airways and increase the size of the one or more treatment zones until the one or more treatment zones associated with the defined treatment positions exceed the margins the one or more lung cancer tumors; and

generate a treatment plan according to the defined treatment positions,

wherein the drug-delivery catheter is configured to:

be delivered to the defined treatment positions;

create the one or more treatment chambers including the entire portion of the one more distal respiratory airways distal of the defined treatment positions; and

circulate the chemotherapeutic drug solution within the one or more treatment chambers.

2 . The system of claim 1 , wherein the image data includes computerized tomography (CT) data, magnetic resonance (MR) data, or positron emission tomography (PET) data.

3 . The system of claim 1 , wherein the at least one processing unit is further configured to define the one or more tumor treatment zones by at least one of:

identifying direct overlap of one or more respiratory airways to a lung cancer tumor, and

assessing proximity of one or more respiratory airways to the lung cancer tumor.

4 . The system of claim 1 , wherein the analysis of the digital map includes at least one of a two-dimensional (2D) analysis and a three-dimensional (3D) analysis.

5 . The system of claim 1 , the at least one processing unit is further configured to define one or more proposed routes for navigation of the drug-delivery catheter through a respiratory airway system to the defined treatment position in each of the one or more respiratory airways; and

include the one or more proposed routes in the treatment plan.

6 . The system of claim 1 , wherein the at least one processing unit is further configured to:

access clinician-selectable features as inputs for defining the one or more tumor treatment zones, the inputs including at least one of:

a) drug delivery distance from tumor edge,

b) maximum number of defined treatment position in a single treatment plan, and

c) minimum diameter of airway for placement of a drug delivery catheter, and

use the inputs to define the one or more tumor treatment zones.

7 . The system of claim 1 , wherein the at least one processing unit is further configured to define the one or more tumor treatment zones by defining two tumor treatment zones surrounding portions of two different respiratory airways, the two tumor treatment zones abutting each other to provide drug treatment of at least one tumor.

8 . A method for providing tumor treatment plan within a respiratory tract using a drug-delivery catheter configured to create a treatment chamber distal to a treatment position in a respiratory airway and circulate chemotherapeutic drug solution within the treatment chamber, the method comprising:

accessing, by at least one processing unit programmed with computer program instructions, image data acquired by non-invasive imaging of a lower respiratory tract of a patient;

creating, by the at least one processing unit according to the image data, a digital map identifying one or more lung cancer tumors and one or more respiratory airways;

selecting, by the at least one processing unit, one or more identified respiratory airways of the one or more respiratory airways that are proximate to or overlapping the one or more lung cancer tumors;

identifying, by the at least one processing unit, according to an analysis of the digital map, defined treatment positions in the one or more respiratory airways for delivery of the chemotherapeutic drug solution to one or more treatment chambers defined by the drug-delivery catheter within the one or more respiratory airways, wherein the one or more treatment chambers are defined as the respective respiratory tracts distal of the defined treatment positions,

determining, by the at least one processing unit, one or more tumor treatment zones for permeation of the chemotherapeutic drug solution into lung tissue surrounding the treatment chamber when the chemotherapeutic drug solution is delivered to the one or more treatment zones, wherein the one or more tumor treatment zones are defined as the lung tissue surrounding the entire portion of the one or more distal respiratory airways distal of the defined treatment positions in the one or more respiratory airways;

comparing, by the at least one processing unit the one or more tumor treatment zones to the one or more lung cancer tumors to determine whether the one or more treatment zones exceed the margins of the one or more lung cancer tumors;

backtracking, by the at least one processing unit, the defined treatment positions to successively more proximal positions within the one or more respiratory airways to include additional airways and increase the size of the one or more treatment zones until the one or more treatment zones associated with the defined treatment positions exceed the margins the one or more lung cancer tumors;

generating, by the at least one processing unit, a treatment plan according to the defined treatment positions, and

carrying out the treatment plan via the drug-delivery catheter by delivering the chemotherapeutic drug solution at the defined treatment positions.

9 . The method of claim 8 , wherein the image data includes computerized tomography (CT) data, magnetic resonance (MR) data, or positron emission tomography (PET) data.

10 . The method of claim 8 , wherein defining the one or more tumor treatment zones further includes at least one of:

identifying direct overlap of the one or more respiratory airways to a lung cancer tumor, and

assessing proximity of the one or more respiratory airways to the lung cancer tumor.

11 . The method of claim 8 , wherein the analysis of the digital map includes at least one of a two-dimensional (2D) analysis and a three-dimensional (3D) analysis.

12 . The method of claim 8 , further comprising:

defining one or more proposed routes for navigation of the drug-delivery catheter through a respiratory airway system to the defined treatment position in each of the one or more respiratory airways; and

including the one or more proposed routes in the treatment plan.

13 . The method of claim 8 , wherein defining the one or more tumor treatment zones further includes:

accessing clinician-selectable features as inputs for defining the one or more tumor treatment zones, the inputs including at least one of:

a) a drug delivery distance from a tumor edge,

b) a maximum number of defined treatment position in a single treatment plan, and

c) a minimum diameter of a respiratory airway for placement of a drug delivery catheter, and

using the inputs to define the one or more tumor treatment zones.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2022
From: CONVERGASCENT LLC
To: ISOLA THERAPEUTICS, INC.
Reel/Frame 060488/0344 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 15, 2022
From: CRAIG, BRIAN H.
To: CONVERGASCENT LLC
Reel/Frame 060213/0602 →
Continuity (2)
Provisional Application 62951463 · Dec 20, 2019
Related Publication 20230049856A1 · Feb 16, 2023
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