US-12622724-B2 - Devices, methods, and systems to treat chronic bronchitis

US12622724B2US 12622724 B2US12622724 B2US 12622724B2US-12622724-B2

Abstract

Systems and methods involve abrading a patient lung airway wall to reduce mucus production therein. Exemplary techniques include rotationally and/or linearly oscillating an abrasive material against the airway wall so as to damage mucus producing tissues, for example by removing goblet cells, while destroying less than the entire airway wall. The abrasive material may be present on the surface of an expandable balloon body or another expandable device, which can be delivered to the patient treatment site via a bronchoscope. In some cases, the abrasion techniques can cause cell damage or death at a controlled or predetermined tissue depth.

Inventors

Mark L. Mathis

Assignees

FREE FLOW MEDICAL, INC.

Dates

Publication Date: 20260512
Application Date: 20200914

Claims (20)

1 . A method for detaching and removing an amount of mucus from an airway wall of a lung of a patient, comprising: introducing an elongate member of a treatment device into the lung of the patient, the elongate member having an expandable abrasion feature comprising at least one strand or at least one spring element; expanding the expandable abrasion feature until it makes contact with the airway wall of the lung, the airway wall comprising a basement membrane, a smooth muscle layer, and a cartilage layer; detaching the amount of mucus from the airway wall of the lung of the patient with the at least one strand or the at least one spring element of the expandable abrasion feature, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall; and removing the amount of mucus from the airway wall of the lung of the patient while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall; wherein the at least one strand comprises a member selected from the group consisting of a metallic wire, a fiber, and a braid, or wherein the at least one spring element comprises a member selected from the group consisting of shape memory material, a ferrous metal, a non-ferrous metal, a polymer, an elastomer, and a ceramic.
2 . The method according to claim 1 , wherein the expandable abrasion feature comprises an abrasive mesh, an abrasive geometrical feature, or an abrasive media selected from the group consisting of as alumina, carbide, sand, quartz, glass, metal, ceramic, plastic, carbon, diamond, oxide, silicon carbide, polymer, aluminum oxide, co-fused alumina zirconia, garnet, flint, cubic boron nitride, tungsten carbide, cobalt, glass-like polysaccharide, sintered sol-gel, styrene acrylonitrile co-polymer, alumina-zirconia, emery, and chromium (III).
3 . The method according to claim 2 , wherein the abrasion feature comprises the abrasive media, and wherein the abrasive media has a grit size within a range from about 2 microns in average particle diameter to 3000 microns in average particle diameter.
4 . The method according to claim 1 , wherein the elongate member comprises an expandable mechanism, and the expandable abrasion feature is disposed on the expandable mechanism, the method further comprising expanding the expandable mechanism.
5 . The method according to claim 1 , further comprising drawing the amount of mucus into a filter trap using a vacuum source.
6 . The method according to claim 1 , wherein the expandable abrasion feature is mounted on a guidewire.
7 . The method according to claim 6 , wherein the guidewire comprises a blunt distal tip.
8 . The method according to claim 6 , wherein the guidewire is advanced within the patient's airway that is zero generation or higher.
9 . The method according to claim 6 , wherein the guidewire comprises a wire cable.
10 . The method according to claim 6 , wherein the guidewire has a diameter within a range of 0.005 inches to 0.100 inches.
11 . The method according to claim 1 , wherein the elongate member of the treatment device comprises a guidewire.
12 . The method according to claim 1 , wherein the expandable abrasion feature is delivered through a catheter.
13 . The method according to claim 1 , wherein the expandable abrasion feature comprises the at least one strand.
14 . The method according to claim 13 , wherein the at least one strand comprises the metallic wire.
15 . The method according to claim 13 , wherein the at least one strand comprises a cross-section selected from the group consisting of a round cross-section, a square cross-section, and a rectangular cross-section.
16 . The method according to claim 13 , wherein the at least one strand comprises a shape selected from the group consisting of a helical shape, a random shape, an egg-beater shape, a sinusoidal shape, and a troposkein shape.
17 . The method according to claim 13 , wherein the at least one strand comprises multiple strands.
18 . The method according to claim 13 , wherein the at least one strand comprises nitinol.
19 . The method according to claim 13 , wherein the at least one strand comprises a shape memory material.
20 . The method according to claim 13 , wherein the at least one strand has at least one etched surface.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a 35 U.S.C. § 371 U.S. National Stage of International Patent Application No. PCT/US2020/050660 filed Sep. 14, 2020, which claims the benefit of U.S. Provisional Patent Application No. 62/899,200 filed Sep. 12, 2019, the disclosures of which are incorporated herein by reference. BACKGROUND OF THE INVENTION The airways of the lung are comprised of various layers, each with one or several types of cells. The inner-most cellular layer of the airway wall is the epithelium or epithelial layer which includes pseudostratified columnar epithelial cells PCEC, goblets cells and basal cells. Goblet cells are responsible for the secretion of mucus, which lines the inner wall of the airways forming a mucus blanket. The pseudostratified columnar epithelial cells include cilia which extend into the mucus blanket. Cilia that are attached to the epithelium migrate towards the nose and mouth, propelling mucus up the airway in order for it to be expelled. The basal cells attach to the basement membrane, and beneath the basement membrane resides the submucosal layer or lamina propria. The lamina propria includes a variety of different types of cells and tissue, such as smooth muscle. Smooth muscle is responsible for bronchoconstriction and bronchodilation. The lamina propria LP also include submucosal glands. Submucosal glands are responsible for much of the inflammatory response to pathogens and foreign material. Likewise, nerves are present. Nerve branches of the vagus nerve are found on the outside of the airway walls or travel within the airway walls and innervate the mucus glands and airway smooth muscle, connective tissue, and various cell types including fibroblasts, lymphocytes, mast cells, in addition to many others. And finally, beneath the lamina propria resides the cartilaginous layer. Pseudostratified columnar epithelial cells and goblet cells are connected to each other by tight junctions and adherens junctions. The pseudostratified columnar epithelial cells and goblet cells are connected to the basal cells by desmosomes. The basal cells are connected to the basement membrane by hemidesmosomes. Pulmonary Disorders Chronic bronchitis is characterized by a persistent airflow obstruction, chronic cough, and sputum production for at least three months per year for two consecutive years. The airway inflammation is consistent with a thickened epithelial layer. A variety of pulmonary disorders and diseases lead to airway obstruction. A few of these disorders and diseases will be described briefly herein. Chronic Obstructive Pulmonary Disease (COPD) Chronic obstructive Pulmonary Disease (COPD) is a common disease characterized by chronic irreversible airflow obstruction and persistent inflammation as a result of noxious environmental stimuli, such a cigarette smoke or other pollutants. COPD includes a range of diseases with chronic bronchitis primarily affecting the airways; whereas, emphysema affects the alveoli, the air sacs responsible for gas exchange. Some individuals have characteristics of both. In chronic bronchitis, the airway structure and function is altered. In chronic bronchitis, noxious stimuli such as cigarette smoke or pollutants are inhaled and recognized as foreign by the airways, initiating an inflammatory cascade. Neutrophils, lymphocytes, macrophages, cytokines and other markers of inflammation are found in the airways of people with prolonged exposure, causing chronic inflammation and airway remodeling. Goblet cells can undergo hyperplasia, in which the cells increase in number, or hypertrophy, in which the goblet cells increase in size. Overall, the goblet cells produce more mucus as a response to the inflammatory stimulus and to remove the inhaled toxins. The excess mucus causes further airway luminal narrowing, leading to more obstruction. Cilia are damaged by the noxious stimuli, and therefore the excess mucus remains in the airway lumen, obstructing airflow from proximal to distal during inspiration, and from distal to proximal during the expiratory phase. Smooth muscle can become hypertrophic and thicker, causing bronchoconstriction. Submucosal glands can also become hyperplastic and hypertrophic, increasing the overall thickness of the airway wall and, which further constricting the diameter of the lumen. In addition to a reduction in the luminal diameter of the airway, mucus hypersecretion can also lead to an exacerbation, or general worsening of health. As a consequence of the excess mucus and damaged cilia, pathogens such as bacteria (e.g., Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia, opportunistic gram-negatives, Mycoplasma pneumoniae, and Chlamydia pneumoniae), viruses (rhinoviruses, influenze parainfluenza viruses, respiratory syncytial virus, coronaviruses, herpes simplex virus, adenoviruses), and other organisms (e.g., fungi) can