Devices, methods, and systems for treating chronic bronchitis

Abstract

To provide an improved tissue therapy device for treating the airway walls of a patient's lungs. [Solution] The tissue treatment device comprises a long-length member, an expandable grinding feature section disposed on the long-length member, a control mechanism that works in conjunction with the long-length member and is configured to expand the expandable grinding feature section until it contacts the airway wall of the lung, and a removal means. At least one strand of the expandable grinding feature section is configured to detach a plurality of mucus-secreting cells from the airway wall of the patient's lung without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall when the expandable grinding feature section is expanded by the control mechanism. The removal means is configured to remove the plurality of mucus-secreting cells detached from the patient's lung while maintaining the state in which the smooth muscle layer of the airway wall is supported by the cartilage layer of the airway wall.

Description

Technical Field

[0001] The present invention relates to an apparatus, method, and system for treating chronic bronchitis.

Background Art

[0002] The airway of the lung consists of various layers, each layer having one or more types of cells. The innermost cell layer of the airway wall is an epithelium or epithelial layer containing multi-columnar epithelial cells (PCEC), goblet cells, and basal cells. Goblet cells are involved in the secretion of mucus, and the inner wall of the airway is entirely covered with mucus. The multi-columnar epithelial cells have cilia that extend into this mucus covering. The cilia attached to the epithelium move towards the nose and mouth, pushing the mucus upwards in the airway to expel it.

[0003] Basal cells are attached to the basement membrane, and beneath the basement membrane is a submucosa or lamina propria. The lamina propria contains various types of cells and tissues such as smooth muscle. Smooth muscle is involved in the contraction and dilation of the bronchi. The lamina propria (LP) also contains submucosal glands. Submucosal glands are involved in many of the inflammatory responses to pathogens and foreign substances. Furthermore, nerves are also present. The nerve branches of the vagus nerve are located outside the airway wall or extend into the airway wall, distributing nerves to various types of cells such as mucus glands, airway smooth muscle, connective tissue, and fibroblasts, lymphocytes, and mast cells. Finally, beneath the lamina propria is a cartilage layer. The multi-columnar epithelial cells and goblet cells are joined to each other by tight junctions and adherens junctions. The multi-columnar epithelial cells and goblet cells are joined to the basal cells by desmosomes. The basal cells are joined to the basement membrane by hemidesmosomes.

[0004] Lung disorder Chronic bronchitis is characterized by persistent airflow obstruction, chronic cough, and sputum secretion occurring for 3 months or more per year for 2 consecutive years. Inflammation of the airway occurs in coincidence with hypertrophy of the epithelial layer.

[0005] Various lung disorders and diseases can cause pulmonary obstruction. Some of these disorders and diseases are briefly described below. Chronic obstructive pulmonary disease (COPD) Chronic obstructive pulmonary disease (COPD) is a common illness characterized by chronic and irreversible airflow obstruction and persistent inflammation, often resulting from harmful environmental stimuli such as cigarette smoke or other pollutants. COPD encompasses a range of conditions, primarily affecting the airways and involving chronic bronchitis. Emphysema, on the other hand, affects the alveoli, the air sacs that perform gas exchange. Some individuals may exhibit characteristics of both conditions.

[0006] In chronic bronchitis, the structure and function of the airways change. In chronic bronchitis, harmful irritants such as inhaled cigarette smoke and pollutants are recognized as foreign substances by the airways, triggering an inflammatory cascade. In individuals exposed to these irritants for extended periods, the airways show neutrophils, lymphocytes, macrophages, cytokines, and other inflammatory markers, indicating chronic inflammation and airway tissue repair. Goblet cells may develop hyperplasia (increased cell number) or hypertrophy (increased size). Generally, goblet cells secrete more mucus in response to inflammatory stimuli to remove inhaled toxins. Excessive mucus further narrows the airway lumen, making obstruction more likely. Harmful irritants damage the cilia, causing excess mucus to remain in the airway lumen, hindering airflow from proximal to distal during inspiration and from distal to proximal during expiration. Smooth muscle may hypertrophy and thicken, leading to bronchoconstriction. Hyperplasia and hypertrophy can also occur in the submucosal glands, increasing the overall thickness of the airway wall. In this case, the diameter of the lumen further constricts.

[0007] In addition to a decrease in the lumen diameter of the airways, excessive mucus secretion can lead to exacerbations and a deterioration of general health. As a result of excessive mucus and damage to the cilia, pathogens such as bacteria (e.g., Haemophilus influenzae, Streptococcus pneumoniae, Catararis bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, Sepacia bacteria, opportunistic Gram-negative bacteria, Mycoplasma pneumoniae, Chlamydia pneumoniae, etc.), viruses (rhinovirus, Influenza parainfluenza virus, Respiratory syncytial virus, Coronavirus, Herpes simplex virus, Adenovirus) and other microorganisms (fungi, etc.) may proliferate, causing exacerbations and a range of symptoms. These include worsening cough, congestion, increased sputum volume, changes in sputum quality, and / or shortness of breath. Treatment of acute exacerbations may require oral or intravenous steroids, antibiotics, oxygen, endotracheal intubation, and mechanical ventilation.

[0008] Chronic obstructive pulmonary disease (COPD) is a common, progressive, and debilitating lung disease that is often life-threatening. COPD patients are diagnosed with emphysema, chronic bronchitis, or more commonly, a combination of both. Symptoms of COPD include a persistent cough, especially a cough with a lot of mucus, shortness of breath (especially during exercise), wheezing during breathing, a barrel chest deformity, and chest muscle tension due to chest distension accompanied by a barrel chest deformity. In the later stages, the disease eventually obstructs gas flow from the lungs to almost completely, resulting in symptoms closer to slow and persistent asphyxiation. These symptoms initially only cause mild impairment of daily life, but later often make conversation and basic breathing difficult. COPD reduces the exchange of oxygen and carbon dioxide, resulting in circulatory problems such as decreased oxygen levels in the blood, brain, and heart muscle. This negatively impacts mental agility and increases the burden on the heart, causing a very rapid heart rate.

[0009] According to the National Institutes of Health, COPD is the third leading cause of death in the United States. The American Lung Association reports that more than 12 million people in the U.S. have been diagnosed with COPD. However, it is possible that another 24 million people are suffering from the disease without realizing it. Globally, there are approximately 65 million people with COPD.

[0010] COPD can develop in people with a genetic disorder called alpha-1 antitrypsin deficiency (A1AT deficiency), and can also be triggered by inhaling air under environmental conditions such as air pollution, contaminated air, and suboptimal working environments. However, COPD is most common in people over 40 with a history of smoking. Tobacco smoke is composed of more than 4,000 chemical substances, many of which are toxic. Both the smoke inhaled by the smoker (through the filter) and the smoke from the burning end are toxic. The three main components harmful to health are tar, nicotine, and carbon monoxide. Tar deposits in the lungs and promotes a series of changes that lead to obstructive pulmonary disease and lung cancer. Nicotine is an addictive component of tobacco that stimulates the nervous system, narrowing the diameter of arterioles and causing the secretion of adrenaline, which increases heart rate and blood pressure. In addition, nicotine increases platelet viscosity, increasing the risk of blood clotting. Carbon monoxide irreversibly binds to hemoglobin, preventing oxygen from binding effectively. As a result, greater pressure is required to supply the same amount of oxygen, putting a strain on the heart muscle.

[0011] Tobacco smoke and secondhand smoke enter the bronchi through the trachea. Next, this toxic smoke moves into the bronchioles, which contain tiny clusters of air sacs called alveoli. Capillaries are present within the alveoli. In healthy individuals, oxygen moves from the alveoli into the capillaries and bloodstream during inhalation, and oxygen-rich blood circulates throughout the body via the arterial system. Simultaneously, carbon dioxide is transported from the blood flowing through the capillaries via the venous pathways into the alveoli and expelled from the body with exhalation. This process is called gas exchange. Healthy air sacs are elastic, allowing this exchange to occur as lung volume changes with the respiratory cycle. However, inhaling smoke ultimately destroys this elasticity and the lung tissue itself.

[0012] Chronic obstructive pulmonary disease (hereinafter referred to as COPD) is a lung disease in which the airways narrow, restricting the flow of air into and out of the lungs, causing shortness of breath. COPD includes both chronic emphysema and chronic bronchitis, and is mainly caused by harmful particles or gases, most commonly smoking or polluted air, triggering an abnormal inflammatory response in the lungs. Other causes of COPD include intensive or long-term exposure to workplace dust in coal and gold mines, or in the cotton textile industry containing chemicals such as cadmium and isocyanates, as well as exposure of non-smokers to welding fumes and harmful particles and gases emitted by smokers. Symptoms of bronchitis and emphysema include lung damage, inflammation of the lung airways (alveoli), and blockage of the bronchial passages with mucus.

[0013] Generally, in lungs affected by COPD, enlargement of the bronchi and alveoli is observed. Alveoli are collections of tiny, grape-shaped air sacs located at the ends of the narrowest bronchi. They are where gas exchange takes place and are considered the main functional units of the lungs. Alveoli are densely covered by capillaries extending from the capillaries surrounding the bronchi, with blood being carried into the capillaries by the pulmonary arteries and expelled by the pulmonary veins. When the alveoli expand with inhaled air, oxygen diffuses into the blood within the capillaries and reaches the body's tissues. Carbon dioxide diffuses from the blood into the lungs and is exhaled.

[0014] asthma Asthma is a disease of the airways characterized by airway hyperresponsiveness. In asthma, thickening of the epithelium, excessive mucus secretion due to excessive secretion from goblet cells and submucosal glands, and thickening of smooth muscle may occur. As described herein, excessive mucus secretion or excess mucus can breed pathogens and lead to infection.

[0015] Interstitial pulmonary fibrosis Interstitial pulmonary fibrosis is thought to be caused by acute injury to lung tissue that induces chronic and abnormal inflammation. In response to inflammation, fibroblasts are activated, leading to pulmonary fibrosis, scarring, and deterioration of lung function. The survival rate for patients five years after diagnosis is only 20-30%.

[0016] Cystic fibrosis Cystic fibrosis is a systemic disease characterized by pulmonary symptoms, caused by a genetic abnormality. Mutations in the cystic fibrosis membrane conduction control (CFTR) gene lead to increased viscosity of secretions, making them difficult to drain. Chronic inflammation causes airway tissue repair and over-secretion by goblet cells and submucosal glands, leading to airway narrowing and infections that are difficult to completely resolve.

[0017] bronchiectasis Bronchiectasis is a condition in which the airways become dilated, thickened, and scarred. It is generally caused by infection, other conditions that damage the airway walls and impede mucus removal, or both. When this condition occurs, the airways lose their ability to remove mucus, which can lead to recurrent infections. Each infection causes further damage, eventually leading to moderate airflow obstruction. Bronchiectasis can be caused by genetic disorders such as primary ciliary dysplasia, but it can also be idiopathic.

[0018] lung treatment Depending on the case, the most effective treatment for lung damage is lifestyle changes, especially quitting smoking. This is particularly true for COPD. However, many patients are unable to quit smoking or do not want to. There are currently various treatments available to alleviate the symptoms of lung damage.

[0019] dosage COPD can be managed with one or more medications, including short-acting β-agonists (SABAs), long-acting β-agonists (LABAs), long-acting anticholinergics (LAMAs), steroids, chronic antibiotic therapy, and PDE4 inhibitors such as roflumilast. SABAs and LABAs act on β-receptors in airway smooth muscle to dilate the bronchi. LAMAs act via the anticholinergic pathway, inhibiting acetylcholine release and thus dilating the bronchi. LABAs and LAMAs have been shown to reduce the frequency of shortness of breath and exacerbations and improve quality of life, but their effect on reducing mortality has not been confirmed. Tiotropium, a LAMA, slows the rate of decline in lung function and prolongs the time to exacerbation. Inhaled corticosteroids directly target inflammation. Inhaled corticosteroids have been shown to reduce exacerbations, but have little effect on lung function or mortality. Combinations of LABAs, LAMAs, and inhaled corticosteroids have already been developed. Inhaled oxygen is known to reduce shortness of breath and improve mortality, but these results apply only to advanced disease demonstrated by strict criteria and require long-term administration via nasal cannula or alternative devices.

[0020] COPD can also be managed with one or more oral medications, such as PDE4 inhibitors, steroids, and antibiotics. Roflumilast is an oral medication and a selective long-acting inhibitor of the PDE4 enzyme. While its anti-inflammatory effect is very potent, it is poorly tolerated and associated with adverse effects such as diarrhea, weight loss, nausea, loss of appetite, and abdominal pain. For the treatment of acute inflammation during exacerbations, oral steroids such as prednisone can be prescribed to patients. If exacerbations recur after discontinuation, patients are known to continue oral steroids for extended periods. Oral steroids have various side effects, including weight gain, insomnia, thyroid dysfunction, and osteoporosis. Long-term administration of azithromycin or antibiotics has been shown to reduce the frequency of COPD exacerbations. This effect of antibiotics is due to antibacterial effects through other mechanisms, such as the killing of pathogens that cause exacerbations or, as seen with macrolide antibiotics, a reduction in mucus secretion. Side effects of long-term antibiotic administration include hearing loss and antibiotic resistance.

[0021] Many patients do not adhere to prescribed respiratory medications. Inhalation therapy requires deep inspiration in addition to synchronization with inhalation, which many patients, especially the elderly, cannot perform. Furthermore, some patients omit medication due to cost, past experiences with side effects, or both. Thus, all of the above factors can contribute to inappropriate and inconsistent medication.

[0022] Asthma is a disease with a wide range of severity in adult patients, from mild to persistent. Mild asthma can be adequately managed by avoiding causative factors and taking short-acting beta-agonists (SABAs). On the other hand, the mainstream treatment for persistent asthma is inhaled glucocorticoids. Clinical trials have shown that regular use of inhaled glucocorticoids reduces the need for rescue inhalers, improves lung function, alleviates symptoms, and prevents exacerbations. Some patients benefit from the addition of leukotriene modifiers or LABAs. Tiotropium can be used as an alternative to inhaled glucocorticoids to improve lung function more effectively than inhaled glucocorticoids alone. In particularly severe cases, temporary or long-term treatment with oral corticosteroids may be necessary.

[0023] There is no known cure for interstitial pulmonary fibrosis (IPF). Mainstream management consists of oxygen supplementation as needed and preventative measures such as vaccination. Pirfenidone is an approved antifibrotic agent for IPF, aimed at slowing fibroblast formation, collagen deposition, and inflammatory cell infiltration in the disease. Clinical trials have shown that pirfenidone inhibits the decline in vital capacity (a criterion for assessing lung function) and demonstrates a reduction in all-cause mortality. Nintedanib is another approved drug for IPF, acting as a receptor blocker for multiple tyrosine kinases that mediate the synthesis of fibroblast growth factors (e.g., platelet-derived growth factor, vascular endothelial growth factor, fibroblast growth factor). Nintedanib is believed to slow the rate of disease progression in IPF. No device-based therapies for IPF have yet been approved.

[0024] The treatment of cystic fibrosis has rapidly evolved from chest physical therapy and oxygen supplementation therapy to therapies targeting the underlying defects in the CFTR gene. Ivacaftor is a CFTR potentiator that improves chloride transport through ion channels and has received FDA approval for some CFTR gene mutations. In clinical trials, it has been confirmed to improve FEV1 and reduce the frequency of exacerbations. Furthermore, mucociliary and cough clearance are improved. However, when used alone in patients with the most common delta F508 deletion, the results have not been improved. Other targeted therapies are in the clinical trial stage. Chronic antibiotics include azithromycin, which is said to have an anti-inflammatory effect, and inhaled tobramycin, which is used to treat Pseudomonas aeruginosa, and are commonly prescribed for CF. Similar to other obstructive diseases, bronchodilators, including FABA and FAMA, are effective in CF patients. Agents that promote airway secretion clearance include inhaled DNasc, which reduces the viscosity of mucus, inhaled hypertonic saline, which draws water from the airway into the mucus, and inhaled N-acetylcysteine, which cleaves disulfide bonds in mucin glycoproteins. Oral steroids are used in cases of exacerbation, but the long-term use of inhaled corticosteroids is not recommended in the guidelines.

[0025] Bronchiectasis is an anatomical sign of the host response to injury and results in the overexpansion of the airway lumen diameter. Therefore, treatment often targets the cause of the underlying disease. For example, non-tuberculous mycobacterial infections, primary immunodeficiency diseases, allergic bronchopulmonary aspergillosis, etc. The treatment of acute exacerbations focuses on treating harmful bacterial pathogens with antibiotics. Macrolide and non-macrolide antibiotics have been confirmed to reduce the frequency of exacerbations. The use of inhaled antibiotics in the absence of CF is as unclear as the use of mucolytics. Bronchodilators can also be administered to patients who show signs of airway obstruction on spirometry.

[0026] Treatment for primary ciliary dyskinesia (PCD) aims to improve secretion clearance and reduce respiratory infections through daily chest physical therapy and prompt treatment of respiratory infections. The role of nebulized DNase and other mucolytics is not clear.

[0027] Respiratory infections caused by pathogens in the airway can occur with the above diseases and are usually treatable with antibiotics. Unfortunately, drug development in this field has declined, and currently available treatments are very limited. One problem is that there may not be a single drug that can treat the diverse pathogens present in patients. Saliva tests can be used to determine the resident pathogens, but this may require obtaining samples by bronchoscopy using special techniques to avoid sample contamination, and often other collection methods and modalities are required. Another problem is that currently available drugs are not always effective because pathogens may develop resistance to these therapies.

[0028] Bronchitis is an inflammation of the bronchi that deliver air to the lungs. When the cells lining the bronchi are stimulated, the tiny hairs (cilia) that normally trap and eliminate particles in the air stop functioning. The formation of substances (mucus and sputum) related to the stimulation (inflammation) also increases, blocking the passage. The airway constricts due to the mucus / sputum and the inflammation of the bronchial inner wall, making the airway smaller and narrower, and making it difficult for air to enter and leave the lungs. As a body reaction to remove mucus / sputum from the narrowed airway, a persistent, severe cough occurs. Chronic bronchitis is often misdiagnosed or missed until it reaches an advanced state.

[0029] Compared to normal bronchi, the inner walls of bronchi affected by chronic bronchitis are thicker, resulting in a reduced airway lumen diameter. During inhalation, irritants in the air cause the bronchial walls to thicken or expand. When the bronchial walls become inflamed, the fine hairs (cilia) that normally protect the bronchi from foreign objects cease to function. As a result, mucus and sputum are formed in response to the irritation (inflammation), reducing the diameter of the airways and causing them to become blocked and narrowed. This reduction in the diameter of the airway lumen hinders the proper flow of air into and out of the lungs, impairing the natural function of the lungs.

[0030] When irritation is repeated, the lung epithelium produces more goblet cells, which increase the amount of mucus. The mucus is carried to the central airways by the cilia of the lungs, from where it is expelled by coughing. This is the lung's primary mechanism for removing harmful particles and pollutants. As inflammation occurs more frequently, the airway walls become damaged and the cilia become unable to regenerate, thus losing the primary means of transporting mucus from the lungs. Reduced mucus transport causes mucus to accumulate in the airways, where bacteria gather and remain, leading to repeated infections. Infection causes coughing, and coughing causes further inflammation in the airways. As this cycle continues, the body forms a large number of goblet cells and other cells in the airway walls to combat the invasion of foreign substances, inflammation, and infection. This cycle also leads to prolonged or, in some cases, continuous coughing in the patient. As a result of this cycle, standard tissue wound healing occurs in the airway walls, and tissue repair occurs continuously, producing more goblet cells and other mucus-secreting cells. Therefore, the airflow is restricted by the gradually thickening airway walls.

[0031] Emphysema refers to a condition in which the walls of the alveoli collapse or are destroyed, causing them to abnormally enlarge. In lungs affected by emphysema, the alveoli are enlarged and congested. When the alveoli collapse or are destroyed, the surface area available for oxygen-carbon dioxide exchange during respiration decreases, leading to poor oxygenation (a state of low oxygen concentration and high carbon dioxide concentration in the body). In addition, the reduced elasticity of the lungs themselves leads to the loss of the supporting structures within the lungs that maintain the airways, often causing the airways to collapse and further restricting airflow.

[0032] In emphysema, the alveoli deteriorate or are destroyed, causing the surrounding tissue to lose elasticity, resulting in the dilation and congestion of individual alveoli. Because the surrounding tissue loses elasticity, the abnormally enlarged alveoli are easily filled with air during inhalation, but they lose the ability to empty the lungs during exhalation.

[0033] In both chronic bronchitis and emphysema, COPD causes the airways to compress rather than expand due to lung pressure, resulting in the greatest reduction in airflow during exhalation. COPD patients may not be able to completely exhale before the next inhalation is needed. A small amount of air from the previous breath remains in the lungs at the start of the next breath. This condition, where the lungs are easily filled but not fully emptyed, leads to progressive hyperexpansion or dynamic hyperinflation of the lungs, reducing the efficiency of the respiratory mechanism. The combination of reduced oxygenation function and lung hyperexpansion / hyperinflation makes breathing gradually difficult.

[0034] To compensate for respiratory failure, patients with advanced COPD may breathe rapidly, but this often leads to dyspnea (chronic shortness of breath). Patients with less shortness of breath can tolerate low oxygen and high carbon dioxide concentrations in their bodies, but eventually develop headaches, drowsiness, high blood pressure, and even heart failure. Severe COPD can also cause complications outside the lungs, such as depression, muscle loss, weight loss, pulmonary hypertension, osteoporosis, and heart disease.

[0035] Currently, there is no cure for chronic bronchitis. Most treatments focus on reducing the severity of symptoms and preventing further damage. The most common types of treatment include lifestyle changes, medication, and oxygen therapy. Examples of medications include bronchodilators to widen the airways, corticosteroids to reduce inflammation, swelling, and phlegm secretion, and expectorants to stop the cough that is common in chronic bronchitis.

[0036] Lung volume reduction surgery (LVRS) is a treatment option for patients with severe emphysema. In LVRS, doctors remove approximately 20–35% of the damaged lung or the dysfunctional space that occupies the lung tissue from each lung. By making the lungs smaller, the remaining portion of the lung and the surrounding muscles can function more efficiently, making breathing easier.

[0037] Generally, LVRS is performed using techniques such as thoracoscopic surgery, sternotomy, and open thoracotomy. Thoracoscopic surgery is a minimally invasive technique in which three small incisions (approximately 2.54 cm (approximately 1 inch)) are made between the ribs on each side. A video-assisted thoracic surgery (VATS) instrument or video endoscope is placed through one of the incisions to allow the surgeon to visualize the lung. Special surgical staplers / graspers are inserted through the other incisions and used to cut off the damaged portion of the lung and then re-close the remaining portion of the lung to prevent leakage of blood or air. The incisions are closed with dissolvable sutures. Thoracoscopic surgery can be used to treat one or both lungs and allows for evaluation and resection of any portion of the lung. This technique also allows for thoracoscopic laser treatment of a portion of the lung. On the other hand, thoracoscopic laser treatment can remove emphysematous tissue only on the lung surface but cannot be applied to both lungs simultaneously.

[0038] In sternotomy or thoracotomy, an incision is made through the sternum, exposing both lungs. During this procedure, both lungs are sequentially reduced in size. The sternum is then wired together, and the skin is closed. This method is the most invasive and is used when thoracoscopic surgery is not appropriate. Generally, this technique is only applied to diseases of the upper lobes of the lung.

[0039] Thoracotomy is often performed when the surgeon cannot clearly visualize the lung with a thoracoscope or when dense adhesions (scar tissue) are present. An incision of 12.7 to 30.48 cm (5 to 12 inches) in length is made between the ribs. The ribs are separated without being destroyed in order to expose the lung. In this procedure, only one lung is reduced in size, and the muscles and skin are closed by suturing. [Overview of the Initiative] [Problems that the invention aims to solve]

[0040] The goal of surgical treatment for COPD is to extend life by alleviating shortness of breath, preventing secondary complications, and improving quality of life through improved functional status. However, LVRS (Lung Stroke Restoration System) for COPD is a more risky surgery than cardiac surgery. Other risks associated with LVRS include, but are not limited to, air leakage from lung tissue into the pleural cavity at the suture line, pneumonia, bleeding, stroke, heart attack, and death (due to the exacerbation of any of the aforementioned complications). Because LVRS is dangerous, despite advances in medical treatment, a great many patients with severe COPD face a poor quality of life and a significantly higher risk of death. Over the years, many minimally invasive methods have been developed as alternatives to LVRS, addressing the problems associated with LVRS and focusing on the selective destruction of specific areas of undesirable tissue. These methods include cryosurgery, non-selective chemical ablation, and ablation using radiofrequency (RF), ultrasound, microwave, laser, and thermoelectric methods. However, these developments have encountered many surgical-related obstacles, including problems such as large and difficult-to-maneuver mechanisms and uncontrolled treatment of the affected area. This is because traditional ablation techniques are non-selective methods that mediate cell death through methods such as those utilizing extremely high or low temperatures. Methods that locally destroy the affected area as described above have been shown to have non-selective adverse effects on blood vessels, nerves, and connective tissue adjacent to the ablation area. When nerves are destroyed, the body's natural ability to sense and regulate homeostasis and repair processes is locally impaired in and around the ablation area. When blood vessels are destroyed, the removal of fragments and debris is hindered. As a result, the repair system is stopped or limited, the return of immune system elements is hindered, and normal blood flow that delivers substances such as hormones to the target area is generally inhibited. If the steady introduction of new materials or natural substances into the damaged area is not achieved, the rearrangement of cellular material becomes inefficient or impossible, delaying the reconstruction of blood vessels and airway linings. Thus, the state of tissue after traditional ablation treatment is not optimal for self-repair that regenerates the target area.

[0041] Advances in medical devices and technology have led to renewed interest in surgical treatment of COPD. The effectiveness of surgical treatment for COPD is very similar to that of LVRS (Low-Level Respiratory Syndrome), but with fewer risks and complications associated with the conventional LVRS method. These recent developments have made it possible to improve the regenerative process after treatment. One such method is irreversible electroporation (IRE), a pioneering surgical technique that enables improved tissue ablation therapy. IRE has the significant advantage of inducing cell necrosis non-thermally without increasing or decreasing the temperature of the ablation area. Therefore, it can avoid some of the adverse effects of temperature changes in ablation methods such as radiofrequency (RF) ablation, microwave ablation, and cryoablation. IRE also allows for concentrated and localized treatment of the affected area. This concentrated and localized treatment makes it effective for treating delicate and complex organs such as the lungs. However, this method requires applying extremely high voltage to the lungs, which are close to the heart. Therefore, there is a risk of interference with signals that activate the myocardium, or interference with pacemakers or other sensitive electronic devices in the patient's body.

[0042] As is clear from the above, there is a need for non-thermal, non-cryoablation devices and methods that do not use electromagnetic excitation to induce cell necrosis in lung tissue and airway lumen. Furthermore, it is desirable that these devices and methods can be easily delivered to and positioned in the lung tissue. These devices and methods must efficiently kill mucus-secreting cells and promote wound healing of lung tissue by reducing the number of mucus-secreting cells compared to the tissue before replacement, thereby allowing tissue regeneration. [Means for solving the problem]

[0043] Embodiments of the present invention relate to apparatus and methods for performing ERS (Epithelial Replacement Surgery). In ERS, a minimally invasive technique, an apparatus having an abrasive surface or abrasive feature is pressed against target lung tissue or unwanted tissue, and force is applied to generate relative movement with respect to the tissue or contact points with the tissue, causing abrasive cell necrosis in the target tissue without destroying important structures of the target tissue such as complete airway walls, tubes, blood vessels, and nerves. More specifically, these apparatus and methods enable the en bloc removal of mucus- and sputum-secreting cells by ERS treatment, causing cell membrane defects and cell death, and in some cases leading to a breakdown of homeostasis and autoregulation of the lung epithelium, while preserving structures and tissues for connectivity and support. Thus, destruction of unwanted tissue is performed in a controlled local area, while surrounding healthy tissues and organs can be preserved. By damaging or removing epithelial cells using these apparatus and methods, the epithelium is replaced, healed, or regenerated by structures including normal and healthy replacement tissue or abnormal scar tissue. In any case, the new tissue has a reduced number of mucus-secreting cells. This differs from other devices and methods that use light, thermal ablation, cryoablation, or electromagnetic energy, which are known to completely destroy cells and other important surrounding organs and body structures.

[0044] The apparatus, systems, and methods described herein are used for the treatment or manipulation of lung tissue, or for the treatment of lung diseases or disorders of COPD or COPD-related conditions (e.g., chronic bronchitis, emphysema), asthma, interstitial pulmonary fibrosis, cystic fibrosis, bronchiectasis, primary ciliary dysfunction syndrome (PCD), acute bronchitis, and / or other lung diseases or disorders. One or more features of these embodiments can be combined with one or more features of one or more other embodiments to form new embodiments within the scope of this disclosure. Examples of lung tissue include, but are not limited to, epithelium (goblet cells, stratified ciliated columnar epithelial cells, and basal cells), lamina propria, submucosa, submucosal glands, basement membrane, smooth muscle, cartilage, nerves, pathogens present near or within the tissue, or combinations thereof.

[0045] The methods, apparatus, and systems disclosed herein treat lung tissue by energy delivery. This energy delivery is characterized by applying manual motion, linear or rotational pulses, or combinations thereof, to target tissue using a surface equipped with a grinding instrument or grinding medium, in order to remove the target tissue without causing a clinically significant inflammatory healing response. However, in other embodiments, some degree of inflammatory healing response is acceptable. Also, healthy new target tissue is regenerated within a few days of treatment. In other embodiments, due to the nature of energy delivery and grinding action, pathogens present in the airway are removed by destruction or other means without causing substantial impact or damage to other airway structures.

[0046] In some embodiments, selective treatment involves selectively removing specific cells from the airway wall. In some embodiments, removal involves cell exfoliation. For example, cell exfoliation is achieved by scraping away the lumen of the affected airway. In some embodiments, removal involves cell death. For example, cell death is achieved by destroying the cell walls of epithelial cells. Alternatively, cell death may be induced by other mechanisms. Similarly, removal may involve grinding, stripping, damaging, or a combination of other mechanisms.

[0047] In some embodiments, certain cells include epithelial cells but not basal cells. For example, the epithelial cells include abnormal or hyperplastic goblet cells. Alternatively, the epithelial cells include abnormal pluristratified ciliated columnar epithelial cells.

[0048] In some embodiments, specific cells include basement membrane cells, and selective treatment includes modifying basement membrane cells and altering basement membrane permeability. In some embodiments, specific cells include submucosal gland cells, and selective treatment includes inducing submucosal gland cell death. In some embodiments, specific cells include pathogens, and selective treatment includes inducing pathogen cell death. In some embodiments, selective treatment includes selectively modifying specific cells to alter mucus secretion.

[0049] In some embodiments, the cells include epithelial cells but not basal cells. For example, the epithelial cells include abnormal or hyperplastic goblet cells. Alternatively, the epithelial cells include abnormal pluristratified ciliated columnar epithelial cells.

[0050] In some embodiments, the cells include lymphocytes, macrophages, eosinophils, fibroblasts, plasma cells, mast cells, leukocytes, or a combination thereof. In some embodiments, the cells include submucosal gland cells, and removal includes causing cell death of the submucosal gland cells. In other embodiments, the cells include pathogens.

[0051] Embodiments of the present invention include novel medical devices, methods of use, systems, methods for selecting patients, methods for determining whether retreatment is recommended, and means for assessing patient health, for achieving improved quality of life and extended lifespan for persons with chronic obstructive pulmonary disease (COPD). More specifically, embodiments of the present invention relate to devices and methods for destroying, killing, and / or removing epithelial and mucosecrine cells by specific methods that can regenerate these tissues while suppressing the number of mucosecrine cells. These devices described herein may utilize blades, sharp corners, or edges to cut, scrape, shave, peel, slice, microtome, or grind in other ways, or may vibrate a rough surface against the tissue, or may use rough materials, bristles, needles, brush tips, or other shapes that cause grinding and destruction of living cells. These devices can promote tissue regeneration by aspirating tissue from the patient, improve lung function, and reduce complications associated with other procedures that deliver cryofluids or heat or electromagnetic energy.

[0052] In one aspect of the present invention, a therapeutic device is provided that grinds against the lung airway wall of an animal or human in order to suppress mucus secretion. In some aspects of the present invention, grinding contact is provided by a grinding medium, a grinding mesh and / or blade, an edge, a grinding shape feature such as a triangle, square or circle.

[0053] In another embodiment of the present invention, there is a device for cutting, scraping, cutting, peeling, slicing, microtoming or grinding by means of a blade, sharp corners, edges, rough materials, uneven materials, bristles, needles, brush tips or other shapes that cause grinding destruction of living cells.

[0054] In another aspect of the present invention, a therapeutic device is provided that grinds against the airway lumen wall of an animal or human lung to damage mucosecting tissue or connective tissue that forms attachment points for mucosecting tissue. In another aspect of the present invention, a therapeutic device is provided which damages mucus-secreting tissue by grinding into the airway wall of an animal or human lung, destroying a smaller area than the entire airway wall.

[0055] In another aspect of the present invention, a therapeutic device is provided that damages mucosecrous tissue by grinding against the luminal wall of an animal or human lung airway, destroying a smaller area than the entire airway wall. In another aspect of the present invention, a therapeutic device is provided that damages mucosecrous tissue by grinding against the inner wall of the lung airway lumen of an animal or human, destroying a smaller area than the entire airway wall.

[0056] In another aspect of the present invention, a therapeutic device is provided that grinds and contacts at least a portion of the luminal wall of an animal or human lung airway to cause one or more of the following changes in a treated patient.

[0057] 1. To alleviate the symptoms caused by bronchitis in patients. 2. Reduce the thickness of the airway wall in the treated tissue. 3. Reduce the level of inflammation in the patient's airway walls.

[0058] 4. Reduce the frequency of coughing in patients with bronchitis. 5. Reduce the frequency of coughing in patients with bronchitis. 6. Reduce the annual number of cough episodes in bronchitis patients.

[0059] 7. Reduce the amount of sputum secreted by patients with bronchitis. 8. Reduce the frequency of lung infections in patients with bronchitis. 9. Reduce the number of bacterial infection sites in the patient's airways or lungs.

[0060] 10. Reduce the amount of bacteria formed in the patient's saliva. 11. Alter the composition of the patient's mucus, sputum, or saliva. 12. Reduce the amount of mucus secreted in the treated lung.

[0061] 13. Reduce the flow, secretion rate, volume, time course, nature, and mass of mucus secreted in one or both treated lungs. 14. Reduce the hydration level of mucus secreted by the patient.

[0062] 15. Increase the hydration level of the mucus secreted by the patient. 16. Reduce the number of goblet cells remaining in the lungs. 17. Reduce the number of goblet cells that regenerate in the lungs.

[0063] 18. Reduce the number of goblet cells regenerated in the lungs during 30, 60, 180, 360, or 540 days after treatment. 19. Reduce the density of goblet cells remaining in the lungs.

[0064] 20. Reduce the thickness of the inner layer of the airway epithelium. 21. Reduce the volume of the inner layer of the airway epithelium. 22. Degrades or kills connective tissue that maintains epithelial and / or goblet cells in a healthy state.

[0065] 23. Degrades or kills the tissue that supplies nutrients to the airway epithelium and / or goblet cells. 24. Lift the diaphragm relative to the reference rib position. 25. As a result of treatment, measure the elevation of the diaphragm relative to the reference rib position while the patient maintains exhalation.

[0066] 26. Lift the base of at least one lung towards the upper part of the patient's chest. 27. Reduce coughing. 28. Reduce mucus secretion.

[0067] 29. Reduce coughing caused by trapped air or mucus. 30. Reduce the glottal closure reflex. 31. Improve the patient's ability to remove mucus from the lungs.

[0068] 32. Increase the arterial oxygen concentration in the bloodstream. 33. Increase the percentage of arterial oxygen in the bloodstream. 34. Lower the concentration of arterial CO2 in the bloodstream.

[0069] 35. Reduce the proportion of arterial CO2 in the bloodstream. 36. Improve mobility as measured by the current standard 6-minute walk test. 37. Increase the number of meters a patient can walk in 6 minutes.

[0070] 38. Increase the diameter of the lung airways as measured using high-resolution CT. 39. Enlarge the airway diameter. 40. Increase lung volume during exhalation.

[0071] 41. Increase the diameter of the airway lumen. 42. Provides radially outward support to the airway. 43. Helps reduce lung volume during exhalation.

[0072] 44. Reduce the volume of at least one lung. 45. Reduce the volume of the lung lobes. 46. ​​Reduce the volume of both lungs.

[0073] 47. Reduce the volume of each lung. 48. Reduce paired TLCs in the lungs. 49. Implement organizational downsizing.

[0074] 50. Compress the tissue of the lung lobes. 51. Remove sagging from lung tissue. 52. Restore the elastic contractile force of lung tissue to its physiological function where the lung expansion pressure is 2-200 cmH2O.

[0075] 53. Increase the elastic contraction force of the lungs. 54. Reduces lung compliance. 55. Modify the shape of the pressure-volume curve obtained by patient respiratory measurement.

[0076] 56. Enlarge the area within the pressure-volume curve representing the patient's respiration. 57. Post-processing CT images comparing inhalation and exhalation data to shift the location of cracks observed in the image.

[0077] 58. Delaying airway closure during exhalation. This is determined by comparing pre- and post-treatment airway volumes in similar regions of the lung using post-processed CT image data. 59. Reduce lung volume.

[0078] 60. Reduce airway resistance. 61. Reduce the volume of one or more of the patient's lungs. 62. Reduce inspiratory effort as measured by pulse transit time method or respiratory inductance plethysmography.

[0079] 63. Reduce dynamic hyperinflation as measured by CT, 6-minute walk test, or plethysmography. 64. Reduce end-tidal lung volume.

[0080] 65. Reduce functional residual capacity. 66. Reduce the incidence of respiratory failure. 67. Extend the interval between COPD exacerbations.

[0081] 68. Increase the time that the airway remains open during exhalation. 69. Increase forced expiratory volume in one second (FEV1). 70. Increase forced vital capacity (FVC).

[0082] 71. Increase the ratio of FEV1 / FVC. 72. Reduces mood swings. 73. Reduce pressure on the heart.

[0083] 74. Reduce pressure on the coronary arteries. 75. Reduces high blood pressure. 76. Reduces excessive tension in the lungs.

[0084] 77. Reduces high blood pressure in the blood vessels that supply blood to the heart muscle. 78. Lowers systolic and / or diastolic blood pressure. 79. Lower your heart rate.

[0085] 80. Lower systolic blood pressure. 81. Increase the cardiac ejection fraction. 82. Lower pulmonary artery pressure.

[0086] 83. Reduce lung tissue density (800 to 810-1000 HU (Hunsfield units)). 84. Make lung tissue density more uniform (adjust the difference in average lobe density between lung lobes to 1-200 Hunsfield units).

[0087] 85. Increase the forced exhalation volume during exhalation. 86. Reduce the amount of residual air (RV) remaining in the lungs during or after exhalation. 87. Reduce the amount of gas trapped in the lungs during or after exhalation.

[0088] 88. Reduce the amount of gas trapped in the lung lobes during or after exhalation. 89. Increase the change in resting expiratory volume during tidal breathing at rest.

[0089] 90. Increase the inspiratory reserve volume in tidal breathing at rest. 91. Lower the patient's respiratory rate. 92. Lower the patient's heart rate.

[0090] 93. Increase the patient's cardiac ejection fraction. 94. Reduce the patient's total lung capacity. 95. Reduces lung compliance.

[0091] 96. Reduces compliance in areas of lung lobes or lung tissue. 97. Improve the uniformity of lung tissue compliance between the upper and lower lobes. 98. Improve the uniformity of lung tissue compliance between lung lobes in patients.

[0092] 99. Improve the uniformity of lung tissue compliance between lung lobe segments. 100. Reduce intake effort. 101. Reduce total lung volume (TLC).

[0093] 102. Reduce the RV / TLC ratio. 103. Increase the volume of the airways in the lung lobes during inspiration. 104. Increase the volume of the airways in the lung lobes during exhalation.

[0094] 105. Reduce the volume difference of the lung lobes and airways during respiration. 106. Treatment increases the total blood volume in the patient's lungs or lung lobes. 107. In patients with emphysema, local blood volume in severely damaged lung tissue is reduced to decrease the amount of blood with low oxygen concentration mixed with normal blood.

[0095] 108. Increase the change in lung lobe volume between inspiration and expiration in the respiratory cycle. 109. Reduce the amount of air trapped in the lung lobes after exhalation. 110. Reduce the amount of air expiring from the lungs after treatment.

[0096] 111. Increase the volume of one or more lung lobes during exhalation. 112. Increase the volume within the apical airway of one or more lung lobes. 113. Increase the volume of the central airways in one or more lung lobes.

[0097] 114. Reduces impedance in the central airways of one or more lung lobes. 115. Reduce the impedance of one or both lungs. 116. Reduce resistance to airflow in one or more lung lobes.

[0098] 117. Reduce resistance to airflow in one or both lungs. 118. Increase the vascular density of one or more lung lobes. 119. Increase the number of blood vessels per liter of lung lobe volume.

[0099] 120. Increase the volume of the airway wall in one or more lung lobes. 121. Increase the volume of the airway wall in the central airway of one or more lung lobes. 122. Reduce the percentage of damaged tissue per liter of lung volume in one or more lung lobes.

[0100] 123. Increase the aerosol transport rate in one or more lung lobes by keeping the airway open for an extended period. 124. Prolong the airway opening to increase the local concentration of aerosol-delivered drugs in one or more lung lobes.

[0101] By measuring one or more fissures that moved beyond 125.2 mm, it can be shown that the volume of the lung lobe changed. 126. Changes in lung volume can be indicated by measuring one or more tears in the chest wall that have moved more than 2 mm relative to the ribs.

[0102] 127. Reduce the proportion of lung tissue with less attenuation in one or more lung lobes. 128. Reduce the volume of lung tissue with less attenuation in one or more lung lobes. 129. Reduce the proportion of low-density tissue (≥950 HU) in one or more lung lobes.

[0103] 130. Reduce the volume of low-density tissue of 950 HU or more in one or more lung lobes. In another aspect of the present invention, a therapeutic device is provided that is delivered directly to the treatment site without the assistance of a delivery system.

[0104] In another aspect of the present invention, a therapeutic device is provided which is guided by a guide wire and delivered to a treatment location. In another aspect of the present invention, a therapeutic device is provided that is delivered directly to the treatment site via the lumen of a catheter.

[0105] In another aspect of the present invention, a therapeutic device is provided that is delivered directly to the treatment site via the lumen of an endoscope. In another aspect of the present invention, a therapeutic device is provided that is delivered directly to the treatment site via the lumen of a bronchoscope.

[0106] In another aspect of the present invention, a therapeutic device is provided that is delivered directly to a therapeutic site using any combination of the components of the delivery system described herein. In another aspect of the present invention, a therapeutic device is provided that performs treatment while expanding the device at a fixed position relative to a point along the longitudinal axis of the airway.

[0107] In another aspect of the present invention, a therapeutic device is provided that performs treatment while advancing the therapeutic device toward a point along the longitudinal axis of the airway. In another aspect of the present invention, a therapeutic device is provided that performs treatment while moving the device from any position in the airway of the lung toward the trachea along the longitudinal axis of the airway.

[0108] In another aspect of the present invention, a therapeutic device is provided that performs treatment while rotating the therapeutic device within the lumen of the airway. In another aspect of the present invention, a therapeutic device is provided that performs treatment while rotating the therapeutic device within the lumen of the airway around the longitudinal axis of the airway.

[0109] In another aspect of the present invention, a therapeutic device is provided which is driven by a physician or by an electromagnetic motor or transducer within the lumen of the airway to perform treatment while moving a grinding surface linearly against the airway wall in a vibrating state.

[0110] In another aspect of the present invention, a therapeutic device is provided that performs treatment by rotating an abrasive surface against the airway wall in order to generate circumferential vibrational abrasion in the airway lumen. The vibration is driven by a physician or an electromagnetic motor or transducer to generate a stable, constant movement, and the position in the bronchial tree and the treatment area within the airway tissue can be controlled by a closed-loop system of a physician or robot.

[0111] In another aspect of the present invention, a device is provided for causing tissue contact, grinding, and cell death against the airway lumen wall at a controlled depth of 0.1 to 3 mm, more preferably 0.5 to 0.68 mm in some embodiments. In some examples, the controlled depth is about 0.02 mm, or about 20 microns. In some examples, the controlled depth is 1 to 500 microns. In some examples, the controlled depth is 10 to 100 microns. In some examples, the controlled depth is 10 to 50 microns.

[0112] In another aspect of the present invention, a device is provided for inducing tissue contact, grinding, and cell death at a controlled depth in a manner that does not allow for continuous movement resulting in continuous erosion of the airway lumen wall over time. An example of such a device is a large balloon fixed to the tip of a catheter. The balloon is expanded relative to the airway lumen and continuously contacts the entire inner circumference of the airway lumen. The balloon can be rotated, moved linearly along the axis of the airway, or both simultaneously. The movement may be essentially vibration, with a frequency between 1 and 500 million Hz, and more preferably between 40 and 300 cycles per second in some embodiments. In some examples, the operating frequency is selected to avoid or suppress the gripping of tissue by the grinding feature and to facilitate the sliding of the grinding feature along the tissue. The movement may be powered by an electromechanical drive mechanism such as a speaker motor or a rotary motor. The motor may be powered using a power source such as AC from a power plant, or by a rechargeable DC battery. The abrasive medium may be permanently attached to the outer surface of the balloon, protruding radially outward from the outer surface of the balloon and spaced apart from the outer surface, and having a specific rough surface. The protrusion may be 0.5 to 0.68 mm, or it may be made larger to abrade to a depth of 0.5 to 0.68 mm of the airway wall while removing accumulated biomaterial. When the balloon inflates and expands against the tissue, and movement occurs, the abrasive surface scrapes the surface of the tissue, causing cell death. Thus, an apparatus and means for inducing cell death are provided. Furthermore, the abrasive medium may be attached to the outer surface of the balloon in a predetermined pattern or area ratio such that only a portion of the outer surface of the balloon makes abrasive contact with the airway wall tissue. The area ratio is set so that 0.1 to 99 percent of the area of ​​the outer surface of the balloon is covered with the abrasive medium. More preferably, 2 to 50 percent of the outer surface of the balloon is covered with the abrasive medium. The remaining portion of the outer surface of the balloon may be smooth and lubricated. By providing a device with such a configuration, the smooth portion of the balloon can be positioned in the tissue as a support or depth-limiting element, and this portion of the balloon does not erode the lung tissue.The adjacent areas on the surface of the balloon fitted with the abrasive material erode the tissue to a limited depth only. This is an example of a device that can perform depth-controlled erosion on lung tissue. The abrasive material may be fitted to the balloon in a continuous stripe pattern in the circumferential direction, so that the entire circumference of the airway lumen or inner wall is subjected to abrasive action. As the device moves forward or backward along the axis of the airway, the entire circumference and length along the path of movement of the device are completely treated. It is important that it functions as described above, as the goal of this treatment is to completely kill the airway epithelium, eliminate mucus-secreting cells, and promote tissue repair. If locally untreated areas remain, the remaining mucus-secreting cells may regenerate and proliferate, which could worsen the original problem. In this example, a device is provided that induces complete cell death along the length of the epithelial surface of the lung airway without destroying the basal structure or membrane of the lung airway.

[0113] In another aspect of the present invention, a therapeutic device is provided that performs treatment while carrying out any combination of the exercises described herein. In another aspect of the present invention, a therapeutic device is provided in which the device moves by the method herein to expand, thereby contacting at least a portion of the inner circumference of the airway lumen wall and / or to induce grinding and cell death in order to reduce mucus secretion in the lung.

[0114] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or movement driven by pneumatic or hydrostatic pressure. In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or motion driven by elastic strain energy stored in a material, such as the material used to form a spring element. The material used to form the spring element includes, for example, one or more of the following: nitinol, steel, iron or non-ferrous metals, polymers, elastomers, carbon and carbon fibers, and ceramic or CMC materials (ceramic matrix composite materials).

[0115] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or motion driven by mechanical means using a link mechanism, a torque-driven cable or wire, a push rod, a pull rod or a tether.

[0116] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or motion driven by pneumatic, hydrostatic, accumulated strain energy, or mechanical means. The driving or control of the expansion or motion is performed by heat, pressure, force, light, voltage, current, accumulated strain energy, friction, a drive mechanism using components such as optically coupled sensors or actuators, electrically operated sensors, piezoelectric crystal drive mechanisms, linear or rotary magnetic actuators, linear or rotary motors, capacitors, inductors, crystals, fluids, elements, or combinations of elements. These elements or combinations of elements are elements or combinations of elements from the periodic table of chemical elements that change in response to voltage, current, magnetic field, light, pressure, sound, heat, or other stimuli, thereby operating the device to make contact with the lung airway wall or to move the device to grind and destroy cells.

[0117] In another aspect of the present invention, a therapeutic device is provided that makes abrasive contact with lung tissue by generating expansion and / or movement of a brush instrument. The brush instrument makes contact with the entire circumference of the airway wall, causing abrasion of surface cells, damage to goblet cells, intentional tissue repair of the pulmonary airway wall, and / or other destruction that reduces mucus secretion as a treatment for chronic bronchitis and COPD.

[0118] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating the expansion and / or movement of a brush. The brush is mechanically actuated and expanded to contact multiple locations on the inner circumference of the lung airway.

[0119] In another aspect of the present invention, a therapeutic device for abrasive contact with lung tissue is provided, comprising a brush that is mechanically operated to expand or move while maintaining a constant pressure against the lung tissue.

[0120] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue, comprising an inflatable structure that is operated by pneumatics to expand or move while maintaining a constant pressure against the lung tissue.

[0121] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue, comprising an expansion structure that is operated by pneumatics to expand or move while maintaining a constant pressure against the lung tissue even if the diameter of expansion changes during treatment.

[0122] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue, comprising an expansion structure operated by pneumatics to expand or move while maintaining a constant pressure against the lung tissue even if the diameter of expansion changes during treatment, wherein pneumatic or depressurized pressure is required to maintain a constant pressure against the lung tissue.

[0123] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or movement. The expansion and / or movement is driven by pneumatic or hydrostatic pressure, or by elastic strain energy using a material capable of accumulating elastic strain energy (nitinol, steel, metal, polymer, elastomer, ceramic such as carbon or carbon fiber, CMC material (ceramic matrix composite material)).

[0124] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or movement. The expansion and / or movement is mechanically driven by components such as linkage mechanisms, torque drive mechanisms, push tethers, pull tethers, optically coupled sensors and actuators, electrically operated sensors or drive mechanisms, piezoelectric, magnetic, motor, capacitor and inductor components, etc., which rotate or move the grinding element to expand in contact with at least a portion of the airway wall and induce cell death.

[0125] In another aspect of the present invention, a therapeutic device is provided which includes a brush system that grinds into lung tissue by generating expansion and / or movement. The brush system is configured such that the bristles are arranged spirally or in a staggered pattern, and the entire inner circumference of the airway is affected when the brush is pulled longitudinally along the airway axis.

[0126] In another aspect of the present invention, a therapeutic device is provided that makes abrasive contact with lung tissue by generating expansion and / or movement driven by a balloon. The balloon is inflatable to contact the airway wall and is pulled proximal to abrasive material mounted on the outside of the balloon surface to contact the airway wall and kill mucus-secreting cells. Abrasive materials include sandpaper and abrasive media used in industrial applications, such as alumina, carbide, sand, quartz, glass, metal, ceramic, plastic, forms of carbon such as diamond, oxides, silicon carbide particles, metal particles, polymer particles, particles with a diameter of 2-3000 μm, and biocompatible materials that generally result in abrasion. Abrasive grains and other abrasive materials usable in embodiments of the present invention are described in U.S. Patent Nos. 4,214,877, 4,828,582, 4,916,869, 5,066,335, 5,094,672, and 5,367,024. The contents of each of these patents are incorporated herein by reference. Exemplary abrasive grains or other abrasive materials include silicon carbide, aluminum oxide, co-fused alumina zirconia, garnet, flint, diamond, cubic boron nitride, glass, tungsten carbide, cobalt, alumina, glassy polysaccharides, sintered sol gel, styrene acrylonitrile copolymer, silicon carbide, alumina zirconia, garnet, emery, chromium(III) oxide, and the like. In some embodiments, the size of the abrasive grains is in the range of 5 microns to 2000 microns in average particle size.

[0127] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or motion driven by the release of accumulated strain energy. The therapeutic device makes contact with the airway wall such that an abrasive material attached to the tissue contact surface contacts the airway wall and kills mucus-secreting cells. The abrasive material includes sandpaper and grinding media used in industrial applications, such as alumina, carbide, sand, quartz, glass, metal, ceramic, plastic, forms of carbon such as diamond, oxides, silicon carbide particles, metal particles, polymer particles, particles with a diameter of 2-3000 μm, and biocompatible materials that generally result in grinding.

[0128] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue. This therapeutic device comprises a balloon that expands a blade element. The blade element is mounted on the outside of the balloon and functions as a grinding element when expanded or when the balloon is pulled along the longitudinal axis of the airway.

[0129] In another aspect of the present invention, a therapeutic device is provided that makes abrasive contact with lung tissue. This therapeutic device comprises a balloon which expands to press abrasive particles of a specific size against the lung tissue, causing them to penetrate the tissue only over a predetermined and controlled distance.

[0130] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue. This therapeutic device comprises a balloon which expands a grinding mesh material, such as a polymer material mixed with abrasive particles, a metal mesh material, or a composite mesh material, into the airway wall.

[0131] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by generating expansion and / or motion of a balloon that expands to drive a grinding brush fibrous material against the airway wall.

[0132] In another aspect of the present invention, a therapeutic device is provided that uses a balloon to generate expansion and / or movement, thereby making abrasive contact with lung tissue. The balloon is made of a highly elastic polymer that allows the balloon to conform to various diameters of the airway as it moves along the longitudinal axis of the airway.

[0133] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by generating the expansion and / or movement of a balloon. The balloon is expanded using a constant amount of fluid or gas. The expansion of the balloon is performed using either an open-loop system that maintains a constant pressure or a closed-loop system that maintains either volume or pressure by feeding back volume or pressure data while the device is treating the patient.

[0134] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by generating expansion and / or movement. The therapeutic device comprises a suction catheter having an open tip and a tip-protruding stylet fitted with an abrasive. The device is configured such that suction draws the airway toward the side of the tip-protruding stylet, and the device is pulled toward the proximal end to grind the epithelium and simultaneously aspirate material from the patient.

[0135] In another aspect of the present invention, a therapeutic device is provided that, during treatment, makes grinding contact with lung tissue by generating expansion and / or movement using a closed-loop or open-loop system used to control suction pressure, volume or both.

[0136] In another aspect of the present invention, a therapeutic device for grinding contact with lung tissue is provided. The therapeutic device comprises a catheter having a closed tip and at least one open side port. The side port transmits suction that pulls the airway so that the airway comes into contact with at least a portion of the side of the catheter and with an abrasive material or grinding edge that grinds away to induce cell death in order to reduce mucus secretion.

[0137] In another aspect of the present invention, a therapeutic device is provided that makes abrasive contact with lung tissue by providing a catheter with an outer surface mixed with or coated with an abrasive material. As the device is moved to another location in the lung while maintaining contact between the abrasive material and the airway wall, cell death is induced by the abrasive material coming into contact with a point on the wall of the airway lumen.

[0138] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by providing at least one grinding surface containing a mixture of abrasives. The abrasives are attached to a portion of the surface of the device that comes into contact with the lung tissue to enhance the grinding effect.

[0139] In another aspect of the present invention, a therapeutic device for abrasive contact with lung tissue is provided by providing catheters having various diameters so that tissue is aspirated to a preferred diameter and the penetration depth of the abrasive material in contact with the tissue can be controlled.

[0140] In another aspect of the present invention, a therapeutic device is provided that grinds against lung tissue by setting large differences in the gradual dimensional variations of the outer diameter of the catheter. The gradual diameter differences are, for example, 0.2 to 20 mm, and more preferably 0.5 to 3 mm.

[0141] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by providing a catheter, mechanical structure, or balloon equipped with a grinding surface. The grinding surface is located at the largest diameter portion of the device in order to increase the penetration pressure at which the grinding surface contacts the tissue and to increase the speed and efficiency of the treatment.

[0142] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by providing a catheter, mechanical structure, or balloon equipped with a grinding surface. In order to reduce the penetration pressure at which the grinding surface contacts the tissue, and to limit the speed and efficiency of the treatment, the grinding surface is not located in the largest diameter portion of the device.

[0143] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by providing a catheter, mechanical structure, or balloon equipped with a grinding surface. The grinding surface is not located in the largest diameter portion of the device in order to limit the depth of penetration into which the grinding surface contacts the tissue, and to limit the speed and efficiency of the treatment.

[0144] In another aspect of the present invention, a therapeutic device is provided that makes abrasive contact with lung tissue by providing a catheter, mechanical structure, or balloon equipped with an abrasive surface. Contact of the abrasive surface with the tissue is achieved using a low-pressure source such as air suction or vacuum.

[0145] In another aspect of the present invention, a therapeutic device is provided that makes grinding contact with lung tissue by providing a catheter, one or more balloons fixed to the catheter, and a grinding surface. Contact of the grinding surface with the lung tissue is achieved using a low-pressure source such as air suction or vacuum.

[0146] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by providing a catheter, a conduit and port for transmitting low-pressure gas or fluid, and a grinding surface positioned at a selected location on the catheter. A low-pressure source, such as air suction or vacuum, is transmitted through the conduit and port of the catheter, bringing the lung tissue into contact with the selected location, including the grinding surface, thereby inducing cell death in the lung tissue.

[0147] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by providing a catheter, mechanical structure, or balloon that is driven to vibrate or rotate using a brushless rotary motor or a linear motor drive mechanism.

[0148] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by providing a catheter, mechanical structure, or balloon that is driven to vibrate or rotate using electrical energy supplied by an electrical circuit. The electrical circuit includes a removable plug between the device and the electrical energy source that drives the device.

[0149] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by providing a catheter, mechanical structure, or balloon that is driven to vibrate or rotate using electrical energy supplied by an electrical circuit including a battery.

[0150] In another aspect of the present invention, a therapeutic device is provided that grinds into lung tissue by providing a catheter, mechanical structure, or balloon that is driven to vibrate or rotate using electrical energy supplied by an electrical circuit including a secondary battery.

[0151] In another aspect of the present invention, a therapeutic device system is provided that grinds and contacts lung tissue by providing a catheter, mechanical structure, or balloon comprising at least one grinding surface driven to rotate or vibrate within the lung airway, a rotation or vibration drive mechanism powered by electrical energy, and an electrical circuit having a battery and a charger.

[0152] In another aspect of the present invention, a therapeutic device system is provided that grinds into lung tissue by providing a catheter, mechanical structure, or balloon comprising at least one grinding surface driven to rotate or vibrate within the lung airway, a rotation or vibration drive mechanism powered by pneumatic or vacuum, and a pneumatic circuit having a pneumatic or vacuum source.

[0153] In another aspect of the present invention, a therapeutic device system is provided that grinds and contacts lung tissue by providing a catheter, mechanical structure, or balloon comprising at least one grinding surface driven to rotate or vibrate within the lung airway, and a rotation or vibration drive mechanism powered by a dimensional change of a crystal such as quartz or crystal.

[0154] In another aspect of the present invention, a therapeutic device system is provided that makes grinding contact with lung tissue by providing a grinding surface that exerts a grinding action on the lung tissue. In some examples, the grinding action is achieved by inflating and / or deflating a balloon on which the grinding feature is located, or by inflating and deflating a mechanism on which the grinding feature is located. The grinding action occurs as a result of the balloon or mechanism expanding and / or contracting when the diameter of the balloon or mechanism increases and / or decreases, and / or when the linear length of the balloon or mechanism increases and / or decreases. Such expansion and contraction contribute to the grinding action because it creates relative motion between the grinding surface and the tissue surface.

[0155] In another aspect of the present invention, a therapeutic device system is provided that makes grinding contact with lung tissue by providing a grinding surface that exerts a grinding action on the lung tissue. The device is capable of self-controlling the grinding depth.

[0156] In yet another embodiment, embodiments of the present invention include a tissue therapy device having an elongated member, a grinding feature portion disposed on or connected to the elongated member, and a control mechanism that operates in conjunction with the elongated member. In some examples, the control mechanism is configured to generate vibrational motion in the grinding feature portion. Such vibrational motion functions to grind tissue along the luminal wall of the patient. In some examples, the elongated element is provided as or comprises a balloon catheter shaft, balloon body, balloon, catheter shaft, catheter, tip-side grinding body, grinding element shaft, grinding brush, elongated element, etc. In some examples, the grinding feature portion is provided as or comprises abrasive grains, abrasive grain patterns, grinding mesh, raised edges, expanded grinding surfaces, bands with abrasive grains, abrasive material, one or more grinding edges, strands, grinding media, raised grinding edges, grinding bristles, expanded or expandable foam, sponge, ribbon structure or bundle, etc. In some examples, the control mechanism is provided as a motor assembly, motion-driven handpiece, handpiece, etc., or comprises these. In some examples, the vibration motion includes rotational vibration. In some examples, the vibration motion includes linear vibration. In some examples, the vibration motion includes both rotational and linear vibration. In some examples, the device is configured to grind tissue to a controlled depth. In some examples, the controlled depth is approximately 20 microns. In some examples, the device further comprises a vacuum mechanism that functions to pull the tissue toward the grinding feature. In some examples, the vacuum mechanism is provided as a vacuum source or comprises a vacuum source. In some examples, the vacuum mechanism functions to remove the ground tissue from the patient's lumen.In some examples, the grinding feature section comprises a grinding mesh, a grinding shape feature section, or a grinding medium, and the grinding medium is selected from the group consisting of alumina, carbide, sand, quartz, glass, metal, ceramic, plastic, carbon, diamond, oxide, silicon carbide, polymer, silicon carbide, aluminum oxide, co-fused alumina zirconia, garnet, flint, diamond, cubic boron nitride, tungsten carbide, cobalt, glassy polysaccharides, sintered sol gel, styrene acrylonitrile copolymer, alumina zirconia, garnet, emery, and chromium(III). In some examples, the particle size of the grinding medium is in the range of approximately 2 microns to 3000 microns in average particle size. In some examples, the elongated member has an expandable mechanism, and the grinding feature section is arranged on the expandable mechanism.

[0157] In yet another embodiment, embodiments of the present invention encompass a method for treating the walls of a patient's lumen. An exemplary method may include introducing an elongated member of a treatment device having a grinding feature into the patient's lumen, and generating vibrational motion in the grinding feature to grind tissue along the wall of the patient's lumen. In some examples, the vibrational motion includes rotational vibrational motion. In some examples, the vibrational motion includes linear vibrational motion. In some examples, the vibrational motion includes rotational and linear vibrational motion. In some examples, the grinding step includes grinding the tissue to a controlled depth. In some examples, the controlled depth is about 20 microns. In some examples, the method includes using a vacuum mechanism to pull the tissue toward the grinding feature. In some examples, the method includes using a vacuum mechanism to remove the ground tissue from the lumen. In some examples, the grinding feature portion has a grinding mesh, a grinding shape feature portion, or a grinding medium, and the grinding medium is selected from the group consisting of alumina, carbide, sand, quartz, glass, metal, ceramic, plastic, carbon, diamond, oxide, silicon carbide, polymer, silicon carbide, aluminum oxide, co-fused alumina zirconia, garnet, flint, diamond, cubic boron nitride, tungsten carbide, cobalt, glassy polysaccharides, sintered sol gel, styrene acrylonitrile copolymer, alumina zirconia, garnet, emery, and chromium(III). In some examples, the particle size of the grinding medium is in the range of about 2 microns to 3000 microns in average particle size. In some examples, the elongated member has an expandable mechanism, the grinding feature portion is arranged on the expandable mechanism, and the method includes expanding the expandable mechanism.

[0158] All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent as when each individual publication, patent, or patent application is specifically and individually indicated as being incorporated by reference.

[0159] Novel features of the present invention are specifically described in the appended claims. The features and effects of the present invention can be further understood by referring to the following detailed description and accompanying drawings illustrating exemplary embodiments in which the spirit of the present invention is used. [Brief explanation of the drawing]

[0160] [Figure 1] A diagram showing a typical bronchoscope. [Figure 2] A diagram showing the bronchial tree of the human lung. [Figure 3] A diagram showing a cross-section of the airway wall in a human lung. [Figure 4] A diagram showing a cross-section of healthy human epithelium. [Figure 5] A diagram showing a cross-section of human epithelium in a bronchitis patient. [Figure 6] A figure showing one embodiment of a lung treatment device equipped with a long balloon catheter having an abrasive surface that comes into contact with tissue. [Figure 7A] A diagram showing an embodiment of a lung treatment device, control method, and grinding surface extended to contact tissue. [Figure 7B] A diagram showing an embodiment of a lung treatment device, control method, and grinding surface extended to contact tissue. [Figure 7C] A diagram showing an embodiment of a lung treatment device, control method, and grinding surface extended to contact tissue. [Figure 7D] A diagram showing an embodiment of a lung treatment device, control method, and grinding surface extended to contact tissue. [Figure 8A] A diagram showing a lung therapy device in an undeployed configuration that can be easily delivered. [Figure 8B] A diagram showing the deployed configuration of a lung treatment device. [Figure 9] A diagram showing a lung treatment system delivered via a bronchoscope, along with its accessories. [Figure 10] A diagram showing a lung treatment system with an expandable grinding basket. [Figure 11] A diagram showing a lung treatment system with twisted elastic wires and expandable pull wires. [Figure 12] A side view showing a lung treatment device equipped with a grinding spring element. [Figure 13] A top view showing a lung treatment device equipped with a grinding spring element. [Figure 14] A diagram showing a lung treatment system equipped with a grinding guidewire and a suction catheter. [Figure 15] A diagram showing a lung treatment system equipped with a grinding catheter. [Figure 16] A diagram showing a lung treatment system equipped with a grinding brush and a suction catheter. [Figure 17] A diagram showing a lung treatment system equipped with a grinding brush and a brush guide catheter. [Figure 18] A diagram showing an embodiment of a motor drive assembly that generates vibration and rotation. [Figure 18A] A diagram showing an embodiment of a motor drive assembly that generates vibration and rotation. [Figure 19] A diagram showing a motor drive assembly that generates linear oscillation motion. [Figure 20] A diagram showing a bronchoscope and lung treatment equipment. [Figure 21] A diagram showing a treatment device that treats patients without using a bronchoscope. [Figure 22] A diagram showing a guide wire with multiple wire configurations. [Figure 23] A diagram showing an expansion device. [Figure 24] A diagram showing an expander with a curved tip. [Figure 25] A diagram showing an expander having a tip section that includes multiple curved sections. [Figure 26] A diagram illustrating a lung treatment system equipped with a multi-lumen catheter. [Figure 27] A diagram showing a treatment device equipped with an expandable foam scraping element. [Figure 28] A diagram showing a treatment device equipped with an expanded foam scraping element. [Modes for carrying out the invention]

[0161] Specific embodiments of the disclosed apparatus, delivery system, and method are described below with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or process is essential to the invention.

[0162] The exemplary systems, apparatus, and methods disclosed herein are very suitable for use in the treatment of a patient's pulmonary airway. In some examples, the grinding techniques and systems disclosed herein can be used to treat undesirable lesions, surfaces, or growths occurring in a patient's peripheral vascular system (e.g., arteries or veins), a patient's coronary vascular system (e.g., arteries or veins), a patient's organ or lumen wall, and a patient's tissue surface.

[0163] Overview of delivery in bronchitis treatment The lung therapy devices described herein are sized and configured to be delivered by a delivery device configured to be inserted into the lung, such as a maneuverable bronchoscope (e.g., bronchoscope 1) as shown in Figure 1. In some embodiments, the lung therapy device 13 is configured to be delivered through the lumen of the delivery device by pushing the therapy device through the lumen of the bronchoscope, catheter, introducer, sheath, sleeve, or similar device. In other embodiments, the lung therapy device 13 is configured to be delivered by being mounted on the outside of a delivery device such as a bronchoscope, catheter (e.g., balloon catheter), introducer, sheath, sleeve, guidewire, or similar device. In some embodiments, when mounted on the outside of a delivery device, the therapy device 13 can slide freely along the length of the delivery device. The lung therapy device 13 may also be configured to be delivered using a combination of the above-described components of the delivery device, for example, the therapy device 13 may be attached to a guidewire or balloon catheter shaft and the assembly delivered through the lumen of the bronchoscope. When a guidewire is used, the delivery system may be configured as over-the-wire (OTW) or rapid exchange (RX), and the guidewire may exit the delivery system at a specific position for configuration. For example, in an OTW design, the guidewire exits the delivery system at its proximal end and extends along the entire length of the delivery device. In an RX design, on the other hand, the guidewire extends only along a short section (approximately 25 cm) of the delivery device and exits through a side port. This design saves time compared to a configuration in which the guidewire is advanced along the entire length of the delivery device. In some embodiments, the delivery system or device 16 for delivering the therapeutic device 13 includes a bronchoscope 1, a guidewire, a guide catheter, a handpiece and / or additional elements described herein.Exemplary over-the-wire (OTW) features usable with embodiments of the system and method of the present invention are described in U.S. Patent Nos. 4,540,404, 5,163,911, 5,382,234, 5,470,315, 5,891,110, 5,951,568, 6,171,279, 6,610,068 and 8,372,054. Furthermore, exemplary Rapid Exchange (RX) features usable in conjunction with embodiments of the system and method of the present invention are described in U.S. Patent Nos. 5,334,147, 5,336,184, 5,383,853, 5,413,560, 5,458,613, 5620,417, 5690,642, 5738,667, 5814,061, 6371,961, 6371,940, 7815,600, 8043,256, 8758,325 and 10245,410. The contents of each of these patents are incorporated herein by reference.

[0164] In some embodiments, the treatment device 13 is inserted into the bronchoscopy port 7, and the bronchoscope 1 is advanced through the bronchial tree to a target location in the lung. In patients with advanced COPD, the lung tissue and airways are inflamed, prone to bleeding, and react to even minor trauma such as the advancement of a guidewire or catheter. Therefore, in this embodiment, unlike conventional intrabronchial valves and coils, the device 13 can be delivered without using a guidewire and / or catheter. In this embodiment, the device 13 enters the bronchoscopy port 7, with the distal end 14 of the device 13 pointed distally from the channel exit port 11, and the proximal end 15 of the device 13 extending proximally from the bronchoscopy port 7. The bronchoscope 1 is maneuvered non-traumatically within the airway so that the tip does not pierce the airway wall. The tip 14 can have various shapes, such as a looped, coiled, ball-shaped, bullet-shaped, teardrop-shaped, conical, or tapered shape, to minimize tissue trauma. Generally, the tip of the bronchoscope 1 often advances into the fourth generation of airways or far beyond, into areas of the lung containing severely damaged tissue. This can be easily achieved if the outer diameter of the bronchoscope is less than 4.5 mm. Typically, bronchoscopes with channels and ports of 2.0 mm in diameter are often used. However, the therapeutic devices described herein may also be advanced through narrower bronchoscopes with an outer diameter of less than 3.0 mm and a channel lumen of less than 1.5 mm. Treatment of larger airways located centrally can be performed using wider bronchoscopes with a working channel of 2.5 mm or more. However, generally, bronchoscopes with a working channel in the range of 1.8 to 3.2 mm are most preferred.

[0165] The bronchoscope shown in Figure 1 is typically used to deliver therapeutic elements to the lungs. The bronchoscope tip 9 bends up and down when the physician operates the control handle 4 up and down. When the bronchoscope is rotated 90 degrees by grasping and rotating the bronchoscope body 6, the bronchoscope can be moved left and right by operating the handle. The user can advance the flexible body 8 through the patient's mouth, trachea, and lungs while manipulating the bronchoscope. Electronic image data files are acquired by the camera 10, processed by the camera head 3, and sent to the monitor 138 via the data cable 2, as shown in Figure 9. As shown in Figure 14, a hose for suction from the hospital's vacuum system may be attached to the suction port 5, configured to suction mucus, bacteria, and other foreign matter from the pulmonary airways into the channel exit port 11 and into the filter trap 231 from the suction port 5. At the tip of the bronchoscope, the bronchoscope tip 9 is provided with a working channel exit port 11 and a light source 12. The light source 12 is typically a polished end of a light-transmitting fiber bundle capable of transmitting light energy. The camera 10 is positioned at the bronchoscope tip 9 so that the field of view of the bronchoscope's path is not obstructed. As the physician advances the flexible body 8 into the patient's body and the bronchoscope tip 9 is positioned near or adjacent to the treatment site, the tip 14 of the lung treatment device 13 is inserted into the bronchoscope channel insertion port 7. The device 13 is advanced until it exits the channel exit port 11. After treatment, the device is removed from the bronchoscope channel, and the bronchoscope 1 is removed from the patient. Terms such as "therapy device," "treatment device," "lung treatment device," and "tissue treatment device" are used interchangeably throughout this specification.

[0166] Figure 2 shows a typical human lung bronchial tree. The trachea 20 is the main airway leading to the lungs. The trachea 20 is also called the zero-generation airway. Generally, the trachea has a diameter of approximately 18-25 mm and a length of approximately 120 mm. At the tracheal bifurcation 21, the trachea branches into the left main bronchus 22 and the right main bronchus 23, which are called the first-generation airways. The main bronchi 22 and 23 are usually 12-15 mm in diameter and approximately 50 mm in length. The main bronchi 22 and 23 branch into lobar bronchi 24, which are also called the second-generation airways. The lobar bronchi 24 are usually 8-12 mm in diameter and approximately 20 mm in length. The lobar bronchi branch into segmental bronchi 25, which are also called the third-generation airways. These airways are usually 5-8 mm in diameter and approximately 8 mm in length. The segmental bronchi 25 branch into subsegmental bronchi 26, also called fourth-generation airways, with a diameter of 4-5 mm, and finally, subsubsegmental bronchi, also called fifth-generation airways, branch off from the subsegmental bronchi. These may be as narrow as 2 mm in diameter. The treatments described herein are intended to treat all of the above airways, including the sixth, seventh, and eighth generations of the bronchial tree (these may also be referred to as part of the terminal bronchioles, including airways from the fifth to the sixteenth generation). In some examples, it is also possible to treat the airway tissue up to the thirtieth generation. In exemplary embodiments, treatment is performed in the third, fourth, fifth, and / or sixth-generation airways. In some embodiments, treatment is performed in the airways where goblet cells are located.

[0167] The bronchial tree is the anatomical and functional part of the respiratory system that guides air from the larger upper airways into the lung parenchyma. It is composed of various tracheae and intrapulmonary airways, including bronchi, bronchioles, and terminal bronchioles. The trachea and bronchi are thick and fibrous due to the presence of cartilage walls, which maintains patency during respiration. The bronchi branch into multiple points, eventually becoming terminal bronchioles, which naturally lack cartilage. Gas enters and leaves the bloodstream in the respiratory bronchioles and alveoli at the very front of the tree.

[0168] As the bronchi branch into smaller airways, the airway epithelium undergoes histological changes, forming terminal bronchioles. The 17th to 19th generations of bronchioles form a transitional zone. These bronchioles enter pyramidal lobules, separated from each other by thin septa. The apex of each lobule faces the hilum and contains 5 to 7 terminal bronchioles. The last two or three generations of bronchioles have alveoli in their walls and constitute the respiratory region. The region of the lung at the apex of the terminal bronchioles is called the acinus. The final branch is called the respiratory bronchiole, which further branches into multiple alveolar ducts. Alveoli, the functional units of the respiratory system, appear from the respiratory bronchiole stage, and the majority of gas exchange takes place in this region. Importantly, the majority of healthy lung volume is composed of alveolar tissue. The airway network branches from the trachea through various parts of the lungs, supplying large amounts of oxygen and expelling carbon dioxide from the alveoli, which are present throughout almost the entire lung. The bronchial tree and the arterial network that carries blood from the right side of the heart through the lungs to the left side of the heart occupy a small volume in the lungs.

[0169] Figure 3 shows a cross-section of a typical airway wall 34. The main structure of the airway is supported by cartilage 42 located on the side away from the center of the airway wall, along with layers of glands 41 and smooth muscle 40. The lamina propria 39 separates the smooth muscle 40 from the basement membrane 38. Mucus 35 and epithelium 36 form the outline of the lumen of the lung airway. The epithelium contains goblet cells 37 that secrete mucus 35.

[0170] Figure 4 shows a cross-section of typical healthy epithelium 50. In a healthy human body, the basement membrane 38, basal cells 57, and ciliated cells 52 form the airway basal layer. Cilia 55 grow on the surface of the epithelium 50, except where goblet cells 37 are exposed to the airway lumen 51. Goblet cells 37 have MCVs 54 that produce and secrete a mucus layer 56 on the surface of the airway lumen 51.

[0171] Figure 5 shows a cross-section of epithelium 65 where bronchitis has occurred. Long-term smoking chronically irritates the airways. Repeated irritation leads to goblet cell hyperplasia 67, where the number of goblet cells in the lung epithelium 65 increases, and the amount of mucus secreted increases (e.g., mucus 56 shown in Figure 4). In Figure 5, the increased mucus secretion is shown as a hypersecretory mucus layer 66. Normally, cilia 55 function to transport mucus (e.g., mucus 56 in Figure 4) toward the trachea (e.g., trachea 20 in Figure 2), and the mucus is expelled from the trachea with coughing. This is the main mechanism of the lungs for clearing harmful particles and pollutants. With frequent inflammation, the airway walls are damaged and the cilia 55 become irreparable, so the main means of transporting mucus (e.g., mucus 56 in Figure 4) from the lungs is lost. The reduced mucus transport leads to the accumulation of mucus (e.g., mucus 56 in Figure 4), where bacteria gather and remain, resulting in repeated infections. Infection causes coughing, and coughing further inflames the airways. As this cycle continues, the body forms goblet cell hyperplasia 67 and other cells in the airway walls to combat the invasion of foreign substances, inflammation, and infection. This cycle also leads to prolonged or, in some cases, continuous coughing in the patient. As a result of this cycle, standard tissue wound healing occurs in the airway walls, and tissue repair continuously occurs, generating more goblet cell hyperplasia 67 and other cells that secrete mucus (mucus 56 in Figure 4, etc.). This gradually thickens the airway walls, restricting airflow. Goblet cell hyperplasia 67 impairs the cilia 55 covering of the airway lumen 51, further worsening the symptoms of bronchitis. Such patients remain chronically infected with little means of expelling the secreted mucus (mucus 56 in Figure 4, etc.). As a result of the continued inflammation in the patient's lungs, respiratory capacity decreases, the possibility of normal healing is almost lost, and a hypersecretory mucus layer 66 is formed due to increased mucus secretion. As can be seen in Figures 4 and 5, the epithelium 65 in Figure 5, where bronchitis has occurred, has significantly fewer cilia 55 compared to the healthy, normal epithelium 50 in Figure 4.

[0172] Figure 6 shows a cross-section of an airway 75 in which bronchitis has occurred, with the lung treatment device 13 positioned in the airway 75. The epithelial layer 83 adhering to the basal airway lumen wall 76 requires treatment because goblet cell hyperplasia (hyperplasia 67 in Figure 5, etc.) has occurred due to bronchitis. The lung treatment device 13 is equipped with a balloon body 80, and abrasive grains 82 are attached to the balloon surface 81 of the balloon body 80. The balloon body 80 is connected to a balloon catheter shaft 79 that has advanced along a guidewire 78. When the lung treatment device 13 moves forward or backward, it can rotate, move toward the apical or basal end along the longitudinal axis of the airway, and / or perform rotational vibration or linear vibration within the airway 75. For example, the lung treatment device 13 shown in Figure 6 is pulled backward toward the basal end (indicated by arrow A) while performing rotational vibration (indicated by arrow B). In some cases, the treatment involves pushing the device 13 toward the tip in the direction opposite to arrow A to create a grinding action between the abrasive grains 82 and the airway tissue. As shown in Figure 6, the abrasive grains 82 scrape off the epithelial layer 83. From the wall of the airway lumen 77 toward the tip, the epithelial layer 83 is peeled away. This is shown as the airway wall 84 being ground away, exposing the basement membrane 85. The lung treatment device 13 scrapes off the epithelial layer 83 and induces tissue repair of the epithelial layer 83 so that the number of goblet cells (e.g., goblet cells 37 in Figure 4) is reduced (e.g., to a normal and healthy number). By eliminating goblet cells and goblet cell hyperplasia (e.g., goblet cell hyperplasia 67 in Figure 5), the treatment reduces mucus (e.g., mucus 35 in Figure 4) and / or hypersecretory mucus layer (e.g., hypersecretory mucus layer 66 in Figure 5) and associated bacteria, promoting drying of the patient's bronchial tree and accelerating wound healing. These measures suppress inflammation in the patient, resulting in the post-treatment changes in the patient described in the abstract of the invention herein. In some examples, the balloon catheter shaft 79 and / or balloon body 80 (e.g., Figures 6 and 7A-7D) may also be referred to as the elongated member. In some examples, the abrasive grains 82 may also be referred to as the grinding feature.

[0173] Figure 7A shows a lung therapy device 13 having a balloon body 80 joined to a balloon catheter shaft 79. The lung therapy device 13 is deliverable via a guidewire or guidewire shaft 78 equipped with a guidewire hub 90. The balloon body 80 is inflated by a gas or fluid transported via a balloon inflation hose 91, such as water, saline, silicone, other biocompatible fluids, air, nitrogen, oxygen, or other biocompatible gases. In this way, the hose 91 supplies pressurized gas to the balloon. The gas or fluid can be maintained at a constant pressure by adjusting a pressure regulator 92 equipped with a pressure gauge. The pressure may be pulsed and periodically varied to cause the balloon to oscillate, moving between two or more diameters. This allows grinding to be performed while minimizing large movements and tissue damage. The change in diameter within each pressure pulse cycle is, for example, in the range of a minimum of 0.01 mm to a maximum of 28 mm, and in exemplary embodiments, between 0.1 and 15 mm. The pulse frequency is, for example, 0.25 to 5000 cycles per second, and in exemplary embodiments, between 1 and 50 Hz. The pressure is controlled and varied within a range of approximately 6.894 pascals to 4136.854 kilopascals (0.001 to 600 pounds / square inch). The pressure is kept low for compliant balloons and high for non-compliant balloons. The pressure is supplied using a pump 93. In some examples, the pump 93 is an electric pump. The pump is powered using DC energy, and the power source may be a battery 94. In some examples, the pump 93 operates in a pulsating manner, so that the pressure inside the balloon body 80 increases and decreases periodically, oscillating, or sinusoidally. In some examples, the pump 93 operates in such a way that oscillating motion occurs on the surface of the balloon body 80. The bonded abrasive pattern 95 is an intersecting linear abrasive pattern 95 configured to enhance the grinding effect against the pulmonary airway lumen (e.g., airway lumen 51 in Figure 5) when the balloon body 80 is inflated and expanded. The abrasive grain pattern 95 grinds the airway wall by contacting the airway wall epithelial layer (airway wall epithelial layer 83 in Figure 6) so that only the exposed basement membrane (exposed basement membrane 85 in Figure 6, etc.) remains.In some embodiments, the grinding effect can be generated or increased by moving the balloon body 80 linearly as indicated by arrow A and / or by moving it rotationally and oscillating as indicated by arrow B. Embodiments of the present invention have any of the joined abrasive grain patterns 95 of various shapes, such as rings, stripes, curves, straight lines, mountain shapes, sinusoidal lines, circular spots, non-circular spots, etc. In some embodiments, the pattern 95 moves, shifts or otherwise changes as the balloon body 80 expands and / or contracts, and the grinding action of the abrasive grain pattern 95 is improved by the change in the pattern. For example, the angle and / or alignment of intersecting linear abrasive grain patterns 95 changes. In some embodiments, sufficient grinding action for treatment is provided simply by expanding and / or contracting the balloon body 80, so it is not necessary to move the balloon body 80 linearly and / or rotationally to scrape off tissue. In some embodiments, the abrasive grain pattern 95 may also be referred to as a grinding feature.

[0174] Figure 7B shows a lung therapy device 13 having a balloon body 80 joined to a balloon catheter shaft 79. The lung therapy device 13 is deliverable via a guidewire 78. The balloon body 80 is inflated by a gas or fluid transported via a balloon inflation hose 91, such as water, saline solution, silicone, other biocompatible fluids, air, nitrogen, oxygen, or other biocompatible gases. The gas or fluid can be maintained at a constant pressure by adjusting a pressure regulator 92. The pressure is supplied using a pump 93. The pump is powered using alternating current energy, and the power source may be electricity supplied from a power system network via a common wall outlet, etc. As shown in Figure 7B, the energy is supplied via an electrical cable 135 and a wall electrical plug 100. The abrasive medium joined to the balloon body 80 is a band having an abrasive mesh 101 made from any expandable polymer or film. The abrasive mesh 101 contains a material having the properties of abrasive grains 82. In some examples, the grinding mesh 101 is a flexible, thin steel or metal filament with sharp ends. The raised edges of the grinding medium 125 contact the airway wall epithelium (e.g., airway wall epithelium 83 in Figure 6) to grind the wall, leaving only the exposed basement membrane (e.g., basement membrane 85 in Figure 6). In some examples, the grinding effect can be generated or increased by moving the balloon body 80 linearly as indicated by arrow A and / or rotationally and oscillating as indicated by arrow B.

[0175] As shown in Figure 7B, the grinding mesh 101 occupies a relatively small proportion (e.g., less than 30%) of the surface area of ​​the balloon 80. In some examples, the proportion of the surface area of ​​the balloon body 80 occupied by the grinding mesh 101 affects the grinding depth of the device 13. For example, when an uncovered portion of the balloon body 80 comes into contact with and / or presses against the airway wall, the mesh 101 expands or contracts as the balloon body 80 expands / contracts. In some examples, the uncovered proximal surface 86 and / or distal surface 87 of the balloon body 80 act as support surfaces against the airway wall. In some examples, the uncovered proximal surface 86 and / or distal surface 87 of the balloon body 80 act to limit the depth to which the mesh 101 penetrates the airway wall. In some examples, the grinding mesh 101 may also be referred to as the grinding feature.

[0176] Figure 7C shows a lung therapy device 13 having a balloon body 80 joined to a balloon catheter shaft 79. The lung therapy device 13 is deliverable via a guidewire 78. The balloon body 80 is inflated by a gas or fluid transported via a balloon inflation hose 91, such as water, saline solution, silicone, other biocompatible fluids, air, nitrogen, oxygen, or other biocompatible gases. The gas or fluid can be maintained at a constant pressure by adjusting a pressure regulator 92. The pressure is supplied using a pump 93. The pump is powered using alternating current energy, and the power source may be electricity supplied from a power grid via a common wall outlet, etc. As shown in Figure 7C, the energy is supplied via an electrical cable 135 and a wall electrical plug 100. The abrasive medium joined to the balloon body 80 is a band having abrasive grains 103 of mixed size. The mixed-size abrasive grains 103 are bonded to the balloon body 80 as a band 104 of irregularly sized abrasive grains, so that as the expanded balloon body 80 rotates, the contact point with the airway epithelial layer (e.g., epithelial layer 83 in Figure 6) changes. The mixed-size abrasive grains 103 contact the airway wall epithelial layer (e.g., airway wall epithelial layer 83 in Figure 6) and grind the wall so that only the exposed basement membrane (e.g., basement membrane 85 in Figure 6) remains. In some examples, the grinding effect can be generated or increased by moving the balloon body 80 linearly as indicated by arrow A and / or rotationally and oscillating as indicated by arrow B. In some examples, the abrasive grains 104 may also be referred to as the grinding feature portion.

[0177] In some examples, the size, distribution, and / or composition of the mixed-size abrasive grains 103 can be selected to constitute a depth-control feature. For example, the composition of the abrasive grains 103 can be configured to perform deep grinding, or to perform shallow grinding. If the abrasive grains 103 are too small, little to no grinding may occur. If the abrasive grains 103 are too large, the grains may penetrate excessively into the surface of the airway wall and cause damage.

[0178] As shown in Figure 7C, the abrasive band 104 occupies a relatively small proportion (e.g., less than 30%) of the surface area of ​​the balloon 80. In some examples, the proportion of the surface area of ​​the balloon body 80 occupied by the abrasive band 104 affects the grinding depth of the device 13. For example, when an uncovered portion of the balloon body 80 contacts and / or presses against the airway wall, the abrasive band 104 expands or contracts as the balloon body 80 expands / contracts. In some examples, the uncovered proximal surface 86 and / or distal surface 87 of the balloon body 80 act as support surfaces against the airway wall. In some examples, the uncovered proximal surface 86 and / or distal surface 87 of the balloon body 80 function to limit the depth to which the abrasive band 104 penetrates the airway wall. The embodiment shown in Figure 7C has a single abrasive band 104. In some embodiments, the treatment device has multiple abrasive bands.

[0179] Figure 7D shows a lung therapy device 13 having a balloon body 80 joined to a balloon catheter shaft 79. The lung therapy device 13 is deliverable via a guidewire 78. The balloon body 80 is inflated by a gas or fluid transported via a balloon inflation hose 91, such as water, saline, silicone, other biocompatible fluids, air, nitrogen, oxygen, or other biocompatible gases. The pressure of the gas or fluid is supplied using a syringe pressure source 105. In some examples, the syringe pressure source 105 is a manual device. When in use, the syringe 105 is pumped or operated one or more times to inflate the balloon body 80, and the pressure source 105 is locked to maintain a constant pressure within the balloon body 80. The balloon body 80 is pulled in the airway (e.g., via a motor-driven mechanism operably connected to the balloon catheter shaft 79) and / or vibrated rotationally and / or linearly. The abrasive material bonded to the balloon body 80 is a series of metals, plastics, ceramics, hard rubber, ropes, glass, or other biocompatible materials that form raised edges 106. The raised edges 106 scrape off the epithelial layer (e.g., epithelial layer 83 in Figure 6) when the balloon body 80 expands, rotates, or moves linearly. The raised edges 106 contact and grind the airway wall epithelial layer (e.g., airway wall epithelial layer 83 in Figure 6) so that only the exposed basement membrane (e.g., exposed basement membrane 85 in Figure 6) remains. In some examples, the abrasive effect can be generated or increased by moving the balloon body 80 linearly as indicated by arrow A and / or rotationally and oscillating as indicated by arrow B. In some examples, the raised edges 106 are feature parts of a blade element. The blade element is attached to the outside of the balloon and functions as a scraping element when the balloon expands or when the balloon is pulled along the longitudinal axis of the airway. In some cases, the raised edge portion 106 may be referred to as the grinding feature portion.

[0180] In some embodiments, the balloon body (e.g., balloon body 80) is compliant, non-compliant (i.e., rigid), or semi-compliant (i.e., semi-rigid). When exposed to a certain amount of atmospheric pressure, the diameter of a compliant balloon body increases compared to a non-compliant balloon, which has a smaller diameter. Therefore, in devices with relatively high compliance of the balloon body, the bonded abrasive grains 82, abrasive pattern 95, grinding mesh 101, abrasive bands 104, raised edge portions 106, or other grinding features or elements disclosed herein are pressed deeper into the airway wall or with greater force compared to devices with relatively low compliance of the balloon body.

[0181] In some cases, as the balloon body 80 inflates, only the grinding element or grinding feature contacts and penetrates the airway wall. That is, the proximal surface 86 and the tip surface 87 of the balloon body 80 do not contact the airway wall until a desired grinding depth corresponding to the depth of the grinding element or grinding feature is achieved.

[0182] Figure 8A shows an embodiment of a lung treatment device 13 according to an embodiment of the present invention. As shown, the treatment device 13 is inserted into the flexible body portion 8 of a bronchoscope 1 and advanced until it exits through the channel exit port 11 at the bronchoscope tip 9 of the bronchoscope 1. As shown, the bronchoscope 1 has a camera 10 and a light source 12. The treatment device 13 has a guide catheter 120, or can be positioned within the guide catheter 120, and has a balloon catheter shaft 79, an uninflated balloon 121, and a folded grinding mesh 122 connected to the balloon 121. Furthermore, the treatment device 13 has a guide wire 78, or is positioned along the guide wire 78. In some examples, the guide wire 78 is positioned optionally. The guide catheter 120 functions to guide the delivery of the balloon 121. In some examples, the bronchoscope 1 is used as a catheter that crosses the vocal cords when the treatment device 13 is delivered to the treatment site in the patient's lung airway. In some cases, the bronchoscope 1 can be left in place during the treatment procedure, and the bronchoscopy physician, doctor, surgeon, or other operator can replace the treatment device 13 with another device during the procedure. In some cases, the radiologist performs the treatment procedure without using the bronchoscope 1.

[0183] As shown in Figure 8A, the guidewire 78 is positioned via the guide catheter 120. In this way, the surgeon or operator advances the catheter 120 deep into the bronchial tree, positions the balloon catheter shaft 79 on the guidewire 78, and advances the balloon catheter shaft 79 via the guide catheter 120. This technique helps to minimize damage to the airway wall.

[0184] Figure 8B shows an embodiment of a lung treatment device 13 according to an embodiment of the present invention. As shown, the treatment device 13 is inserted through the flexible body portion 8 of a bronchoscope 1 and advanced until it exits through the channel exit port 11 of the bronchoscope tip 9 of the bronchoscope 1. As shown, the bronchoscope 1 has a camera 10 and a light source 12. The treatment device 13 has a guide catheter 120, or can be positioned within the guide catheter 120, and has a balloon catheter shaft 79, an inflated balloon 123, and an expanded grinding mesh 124 connected to the balloon 123. The expanded grinding mesh 124 has raised edges 125 of grinding medium. Furthermore, the treatment device 13 has a guide wire 78, or is positioned along the guide wire 78. In some examples, the guide wire 78 is positioned optionally. As can be seen from Figures 8A and 8B, the uninflated balloon 121 in Figure 8A can be inflated to the inflated balloon 123 in Figure 8B, and as a result, the folded grinding mesh 122 in Figure 8A is unfolded and expanded to become the expanded grinding surface 124 in Figure 8B. The expansion of the mesh enables grinding of the airway wall epithelial layer. As shown in Figure 8B, the grinding effect can be generated or increased by moving the inflated balloon 123 linearly as indicated by arrow A and / or by moving it rotationally and oscillating as indicated by arrow B. In some examples, the balloon catheter shaft 79 and / or balloon 123 (Figures 8A and 8B, etc.) may also be referred to as the elongated member. In some examples, the expanded grinding surface 124 may also be referred to as the grinding feature.

[0185] Figure 9 shows an embodiment of a system 200 for treating a patient. The system 200 comprises a bronchoscope 1 having a flexible body 8 with a working channel exit port 11. As shown, a treatment device 13 (or other intrabronchial instrument) is inserted into the channel insertion port 7 of the bronchoscope 1 and advanced through the flexible body 8 of the bronchoscope 1 until it exits through the channel exit port 11 at the tip of the bronchoscope 1. The bronchoscope 1 has a control handle 4 and is connected to a video monitor 138 via a data cable 2. As shown, the monitor 138 can display a bronchoscopic image 137, which allows the operator to see what is happening inside the patient (e.g., inside the pulmonary airway). The treatment device 13 has a balloon 80 with mixed-size abrasive grains 103 attached, positioned along a guidewire 78. The system 200 also has a syringe pressure source 105 for the balloon 80, connected to a balloon inflation hose 91. In some examples, the balloon catheter shaft 79 has a separate lumen for inflating and / or deflating the balloon 80. As illustrated, the system 200 includes a balloon catheter hub 130 and a motor assembly 131 having a trigger switch 132. When in use, the operator operates the switch 132 to control the motor assembly 131. This operation allows the balloon 80 to rotate, translate, and / or inflate / deflate in an oscillating or oscillating manner, as described herein. A guidewire 78 extends proximal to the balloon catheter hub 130 and distal to the balloon 80. As illustrated, the balloon catheter hub 130 is connected to the balloon catheter shaft 78 inserted into the channel insertion port 7 of the bronchoscope 1. The motor assembly 131 is connected to a battery 134 via a power cable 133. The battery 134 functions to supply power to the motor assembly 131. A wall outlet plug 136 is connected to the battery 134 via an electrical cable 135. In some examples, battery 134 is a rechargeable battery. In some examples, system 200 has an AC / DC converter instead of battery 134.When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges the battery 134 or directly operates the motor assembly 131. In the embodiment shown in Figure 9, the system 200 does not have a guide catheter (e.g., the guide catheter 120 in Figures 8A and 8B). In some examples, the balloon catheter shaft 79 and / or balloon 80 (e.g., Figure 9) may also be referred to as the elongated member. In some examples, the band having mixed-size abrasive grains 103 may also be referred to as the grinding feature.

[0186] Figure 10 shows an embodiment of a system 200 for treating a patient. The system 200 comprises a bronchoscope 1 having a flexible body 8 with a working channel exit port 11. As shown, a treatment device 13 is inserted through the flexible body 8 of the bronchoscope 1 and advanced until it exits the channel exit port 11 at the tip of the bronchoscope 1. The treatment device 13 has an expandable grinding instrument 167. The grinding instrument 167 has a tip 151, a proximal end 152, and a plurality of elastic spring elements 153 positioned between the tip 151 and the proximal end 152. Furthermore, the expandable grinding instrument 167 has gaps 154 between adjacent elastic spring elements 153 and abrasive material 155 positioned on the elastic spring elements 153. In some examples, the abrasive material 155 is bonded or attached to the elastic spring elements 153. The abrasive material 155 constitutes a raised grinding edge 156. In some examples, the grinding edge 156 is formed by a cut or etched shape or pattern of the spring element 153 (e.g., without requiring another abrasive material 155). For example, the grinding shape or pattern of the grinding edge 156 is formed by cutting or arc welding the spring element 153. In some examples, a sharp indentation is formed on the spring element 153 by patterning or etching. The expandable grinding instrument 167 is positioned within the airway lumen 162 located on the proximal end side of the airway branch 163 and the next generation airway 164. The proximal end 152 of the expandable grinding instrument 167 is connected to the grinding catheter shaft 158 ​​via a connector hub 157. The grinding catheter shaft 158 ​​is connected to a motion-driven handpiece 159. In some embodiments, the grinding catheter shaft 158 ​​is made of metal or polymer material. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces.

[0187] As illustrated, the motion-driven handpiece 159 includes a slider switch 160, a guidewire exit port 161, and a pull-wire operating switch 165 having an operating switch button or slider 166. During use, the operator controls the motion-driven handpiece 159 by operating the switch 165. This operation allows the expandable grinding instrument 167 to rotate, translate, and / or expand / contract oscillating or oscillating, as described herein. In some examples, the operation of the button or slider 166 adjusts the frequency, amplitude, and / or direction in which the expandable grinding instrument 167 vibrates, oscillates, or moves.

[0188] The guidewire 78 extends from the guidewire exit port 161 of the motion-driven handpiece 159 toward the proximal end, and from the tip 151 of the extendable grinding tool 167 toward the proximal end. The motion-driven handpiece 159 is connected to a battery 134 via a power cable 133. The battery 134 functions to power the motion-driven handpiece 159. The wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cables 135 have or are connected by a connector 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 200 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges the battery 134 or directly powers the motion-driven handpiece 159.

[0189] In some examples, the spring element 153 is formed from a round wire, and in some embodiments, one or more portions of the round wire are flattened. Similarly, in other embodiments, the spring element is formed from a ribbon that already has a flattened shape. In this case, the ribbon may be twisted. In some examples, the spring element 153 is made of a laser-cut tube (e.g., a slit tube), a nitinol material, a spring steel material, or any shape memory material. As illustrated, when the expandable grinding instrument 167 is expanded, the shape of the instrument 167 becomes similar to the shape of the expanded or inflated balloon described herein. In some examples, the balloon catheter shaft 79 and / or balloon body 123 (e.g., Figures 8A and 8B) may also be referred to as the elongated member. In some examples, the abrasive material 155 or grinding edge portion 156 may also be referred to as the grinding feature portion.

[0190] Figure 11 shows an embodiment of a system 200 for treating a patient. The system 200 comprises a bronchoscope 1 having a flexible body 8 with a working channel exit port 11. As shown, the treatment device 13 is inserted through the flexible body 8 of the bronchoscope 1 and advanced until it exits through the channel exit port 11 at the tip of the bronchoscope 1. The treatment device 13 comprises a connector hub 157, an expandable grinding instrument 167, and a pull wire 175. The expandable grinding instrument 167 has a tip 151, a plurality of grinding wires 176 positioned between the tip 151 and the connector hub 157, and raised edges of grinding medium 125 positioned along the grinding wires 176. The grinding wires 176 are connected to a grinding catheter shaft 158 ​​via the connector hub 157. The grinding catheter shaft 158 ​​is connected to a motion-driven handpiece 159. As illustrated, the motion-driven handpiece 159 includes a slider switch 160, a guidewire exit port 161, and a pull-wire operating switch 165 having an operating switch button 166 for controlling the operation of the pull wire 175. The guidewire 78 extends from the guidewire exit port 161 of the motion-driven handpiece 159 toward the proximal end and from the tip 151 of the extendable grinding tool 167 toward the tip end. The motion-driven handpiece 159 is connected to a battery (such as a rechargeable battery) or an AC / DC converter as described herein. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces.

[0191] In some embodiments, the grinding device 167 is configured as a wire basket made of nitinol. In some examples, the grinding wire 176 has a grinding edge portion formed by a cut or etched shape or pattern of the wire 176 (e.g., without requiring another grinding medium 125). For example, the grinding shape or pattern of the grinding edge portion is formed by cutting or arc welding the wire 176. In some examples, sharp indentations are formed on the wire 176 by patterning or etching. In some examples, the wire 176 is formed from a round wire, and in some embodiments, one or more portions of the round wire are flattened. Similarly, in other embodiments, the wire 176 is formed from a ribbon that already has a flattened shape. In this case, the ribbon may be twisted. The wire 176 may be formed from a wire such as a wire having a circular cross-section, or from a ribbon having a square or rectangular cross-section. In some embodiments, the wire 176 is configured in various shapes such as a helical shape, a random shape, a whisker shape, a sinusoidal shape, or a troposkeleton shape. The overall shape and / or diameter of the grinding instrument 167 can be changed by manipulating the pull wire 175. In some embodiments, the pull wire 175 is operated to enlarge the diameter of the grinding instrument 167, for example by pulling the tip 151 toward the connector hub 157, and then the grinding instrument 167 is vibrated and / or pulled toward the proximal end along the airway, as described herein.

[0192] As illustrated, the motion-driven handpiece 159 includes a slider switch 160, a guidewire exit port 161, and a pull-wire operating switch 165 having an operating switch button or slider 166. During use, the operator controls the motion-driven handpiece 159 by operating the switch 165. This operation allows the expandable grinding instrument 167 to rotate, translate, and / or expand / contract oscillating or oscillating, as described herein. In some examples, the operation of the button or slider 166 adjusts the frequency, amplitude, and / or direction in which the expandable grinding instrument 167 vibrates, oscillates, or moves.

[0193] The strands 176 of the grinding device 167 may be composed of, or include, any of the following materials, but are not limited to, metal wires (such as stainless steel, titanium, nitinol, or other nickel-based alloys), monofilament or multifilament fibers, braids, polymers, or fibers made of ceramic or glass (such as Kevlar®, carbon fiber, nylon, polyurethane, polypropylene, or other durable materials), or organic materials such as carbon fiber, ceramic, plastic, glass, or combinations thereof. In some examples, the catheter shaft 158 ​​(Figures 10 and 11, etc.) may be referred to as the elongated member. In some examples, the strands 176 and / or the grinding medium 125 may be referred to as the grinding feature.

[0194] Figure 12 shows an embodiment of a system 200 for treating a patient. The system 200 comprises a bronchoscope 1 having a flexible body 8 with a working channel exit port 11. As shown, the treatment device 13 is inserted through the flexible body 8 of the bronchoscope 1 and advanced until it exits through the channel exit port 11 at the tip of the bronchoscope 1. The treatment device 13 has, along the direction from proximal to distal, a motion drive hub 187, a proximal grinding body 186, a distal grinding body 185, a crimping hub 188, a ribbon 189, a flat support surface 191, a raised grinding edge 190 (grinding medium 194 in Figure 13), a transition section 193, a flat support surface 191, a raised grinding edge 190, and a distal support section 192. When in use, the raised grinding edge 190 functions to contact and grind the airway wall epithelium 83. In this way, the epithelial layer 83 can be peeled from the airway lumen wall (shown here as the airway wall cross section 34). The tip support portion 192 can be formed into various shapes such as coiled, ball-shaped, tip-loop-shaped, conical, cylindrical, or other blunt or non-traumatic tip shapes that minimize irritation to the tissue during the treatment procedure. In some embodiments, the treatment device 13 is configured to expand within the patient's airway. For example, the treatment device 13 has a pull wire connected to the tip support portion 192. In another example, the treatment device 13 is spring-likely biased and expands radially outward to press against the airway wall. The motion drive hub 187 may be connected to a motor coupler as described herein. In some examples, the treatment device 13 is configured as a disposable device. In some examples, the tip grinding body 185 may also be referred to as an elongated member. In some examples, the raised edge portion 190 may also be referred to as a grinding feature portion.

[0195] Figure 13 is a plan view (e.g., top or bottom) corresponding to the elevation view (e.g., right or left) of Figure 12. As shown in Figure 13, the system 200 comprises a bronchoscope 1 having a flexible body 8 with a working channel exit port 11. As illustrated, the treatment device 13 is inserted through the flexible body 8 of the bronchoscope 1 and advanced until it exits through the channel exit port 11 at the bronchoscope tip of the bronchoscope 1. The treatment device 13 has, along the direction from the proximal end to the distal end, a motion drive hub 187, a proximal end grinding body 186, a distal end grinding body 185, a crimping hub 188, a ribbon 189, a flat support surface 191, a grinding medium 194 (forming the raised grinding edge portion 190 in Figure 12), a transition portion 193, and a distal end support portion 192. During use, the treatment device 13 is advanced into the airway lumen 162, and the abrasive medium 194 functions to contact and abrade the airway wall epithelial layer 83. In this way, the epithelial layer 83 can be peeled off from the airway lumen wall (shown here as the airway wall cross section 34). In some examples, the tip abrasive body 185 may be referred to as the elongated member. In some examples, the abrasive medium 194 may be referred to as the abrasive feature.

[0196] Figure 14 shows an embodiment of a patient treatment system 300. The system 300 includes a treatment device 13 having a grinding element shaft 225 and a vacuum hub 226 connected to a hollow catheter 238. The tip 239 of the catheter 238 is inserted into the proximal airway lumen 76, and the grinding element shaft 225 extends through the catheter 238 into the proximal airway lumen 76. The proximal end 240 of the catheter 238 is connected to the vacuum hub 226 via a coupling 237. The proximal end 235 of the grinding element shaft 225 is connected to a motion drive hub 187, the motion drive hub 187 is connected to a motor coupler 195, and the motor coupler 195 is connected to a motion drive handpiece 159. As shown, the motion drive handpiece 159 has a slider switch 160. The motion-driven handpiece 159 is connected to a battery 134 via a power cable 133 (or multiple power cables 133 connected via one or more connectors 150). The battery 134 functions to power the motion-driven handpiece 159. The wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cables 135 have or are connected by connectors 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 300 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges the battery 134 or directly powers the motion-driven handpiece 159. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces.

[0197] The vacuum hub 226 further has a seal 227. As shown, the grinding element shaft 225 extends through the seal 227 and the bearing 234. The grinding element shaft 225 is coupled to or fixed to the bearing 234. Thus, during operation, the grinding element shaft 225 and the bearing 234 are inserted into the vacuum hub until, for example, the bearing 234 contacts or approaches the proximal end of the catheter 238, and the seal 227 is positioned on the grinding element shaft 225 and coupled to the tip of the vacuum hub 226. The system 300 also has a filter 230 coupled to the vacuum hub 226 via a hose 229 and a Luer hub 228. As shown, the Luer hub 228 is coupled to the Luer taper connection 241 of the vacuum hub 226. The filter 230 may be connected to a vacuum source 233 via a hose 229 and a coupler 232. The filter 230 can hold the collected material 231. In some cases, the vacuum source 233 is operated by a physician or operator using a foot pedal.

[0198] During use, the tip 236 of the grinding element shaft 225 is positioned in the tip-side airway lumen 77, and suction is applied via the vacuum hub 226, causing the tip-side airway portion of the catheter 238 tip 239 to contract. As a result, the epithelium 83 is drawn to the raised edge 125 of the abrasive grain or grinding medium 82. The raised grinding edge 125 functions to contact and grind the airway wall epithelial layer 83. In this way, the epithelial layer 83 is peeled away from the airway lumen wall (shown here as an airway wall cross section 34), exposing the basement membrane 85. The operator controls the motion-driven handpiece 159 to rotate and / or translate the grinding element shaft 225 in an oscillating or oscillating manner, as described herein. In some examples, the frequency, amplitude, and / or direction of vibration, oscillation, or movement of the grinding element shaft 225 are adjusted by operating a button or slider 166. In some examples, the airway surface can be ground to a desired state simply by pulling the catheter 238 proximal, without the need to vibrate the grinding element shaft 225. By suction from the vacuum source 233, the ground epithelium enters the filter or filter trap 230 through the hollow catheter 238, vacuum hub 226 and hose 229, where it remains as a collection 231. In some examples, the vacuum source 233 is operated by a physician or operator using a foot pedal. As described herein (for example, with respect to Figures 27 and 28), in some examples, the system 300 has a foaming mechanism instead of, or in addition to, the grinding edge portion 125 and / or abrasive grains 82. In some examples, the grinding element shaft 225 may also be referred to as the elongated member. In some examples, the raised grinding edge portion 125 may also be referred to as the grinding feature portion.

[0199] Figure 15 shows an embodiment of a patient treatment system 300. The system 300 includes a treatment device 13 having a grinding catheter 250 and a motion-driven handpiece 159, a vacuum hub 226, and a filter 230. The grinding catheter 250 has a tip 251, a tip-side port 258, a raised grinding edge portion 125, a proximal-side port 257, a tip-side bearing 255, a hub port 259, a proximal-side bearing 254, a motion-driven shaft 253, a proximal end 252, and a motion-driven hub 187. The tip-side bearing 255 and the proximal-side bearing 254 function to prevent the treatment device 13 from detaching from the vacuum hub 226. The motion-driven hub 187 is connected to a motor coupler 195, which is connected to the motion-driven handpiece 159. As shown, the motion-driven handpiece 159 has a slider switch 160. The motion-driven handpiece 159 is connected to a battery 134 via a power cable 133 (or multiple power cables 133 connected via one or more connectors 150). The battery 134 functions to power the motion-driven handpiece 159. The wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cables 135 have or are connected by connectors 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 300 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges the battery 134 or directly powers the motion-driven handpiece 159. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces.

[0200] The vacuum hub 226 further has a seal 256 (e.g., an O-ring). As shown in the figure, the grinding element shaft 225 extends through the seal 256. The filter 230 is connected to the vacuum hub 226 via a hose 229 and a Luer hub 228. The filter 230 may be connected to a vacuum source 233 via a hose 229 and a coupler 232. The filter 230 can hold the collected material 231. In some examples, the vacuum source 233 is operated by a physician or operator using a foot pedal. When the grinding catheter 250 is pulled proximal or when the treatment device 13 is operating in any other state, the ground debris is removed from the airway and aspirated into the filter 230.

[0201] During use, the tip 251 of the grinding catheter 250 is positioned in the proximal airway lumen 77, and suction is applied via the vacuum hub 226, causing a portion of the airway to constrict towards the area between the proximal port 257 and the proximal port 258 of the grinding catheter 250. As a result, the epithelium 83 is drawn towards the raised edge 125 of the grinding catheter 250. The raised grinding edge 125 functions to contact and grind the airway wall epithelial layer 83. In this way, the epithelial layer 83 is peeled away from the airway lumen wall (shown here as an airway wall cross section 34), exposing the basement membrane 85. The operator controls the motion-driven handpiece 159 to rotate and / or translate the catheter 250 in an oscillating or oscillating manner, as described herein. In some examples, the frequency, amplitude, and / or direction of the vibration, oscillation, or movement of the catheter 250 are adjusted by operating a button or slider 166. In some examples, the airway surface can be ground to a desired state simply by pulling the catheter 250 proximal, without the need to vibrate the catheter 250. By suction from the vacuum source 233, the ground epithelium enters the filter or filter trap 230 through the grinding catheter 250, hub port 159, and hose 229, where it remains as a collection 231. In some examples, the raised grinding edge 125 includes a grinding edge formed by a cut or etched shape or pattern of the catheter 250. For example, the grinding shape or pattern of the grinding edge is formed by cutting or arc welding the catheter 250. In some examples, sharp indentations are formed on the catheter 250 by patterning or etching. By creating a gap between the proximal port 258 and the proximal port 257, the raised grinding edge 125 contacts and grinds the epithelial layer 83. Increasing the gap between the ports reduces the pressure, while decreasing the gap between the ports increases the pressure and grinding action. In some embodiments, the ports are spaced at least 0.01 mm to 50 mm apart from each other, and in exemplary embodiments, they are spaced at least 1 mm to 35 mm apart. The catheter may have 1 to 3000 ports. The diameter of the ports is 0.010 mm to 6 mm.In some cases, the catheter 250 may be referred to as the elongated member. In some cases, the raised grinding edge portion 125 may be referred to as the grinding feature portion.

[0202] Figure 16 shows an embodiment of a system 300 for treating a patient. The system 300 includes a treatment device 13 having a grinding brush 270 and a motion-driven handpiece 159, a vacuum hub 226 connected to a hollow catheter 238, and a filter 230. The grinding brush 270 has a tip 272, grinding bristles 275, a base 271, and a motion-driven hub 187. As shown, the grinding brush 270 may include a wire having a twist 274 in the brush wire. The motion-driven hub 187 is connected to a motor coupler 195, which is connected to the motion-driven handpiece 159. As shown, the motion-driven handpiece 159 has a slider switch 160. The motion-driven handpiece 159 is connected to a battery 134 via a power cable 133 (or multiple power cables 133 connected via one or more connectors 150). Battery 134 functions to power the motion-driven handpiece 159. The wall outlet plug 136 is connected to battery 134 via one or more electrical cables 135. In some examples, the electrical cables 135 have or are connected by connectors 150. In some examples, battery 134 is a rechargeable battery. In some examples, system 300 has an AC / DC converter instead of battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges battery 134 or directly powers the motion-driven handpiece 159. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces.

[0203] The vacuum hub 226 further includes a seal 227, a seal bearing 273, and a bearing 234. The tip 239 of the catheter 238 is inserted into the proximal airway lumen 76, and the grinding brush 270 extends through the catheter 238 into the proximal airway lumen 76. The proximal end 240 of the catheter 238 is connected to the vacuum hub 226 via a coupling 237. As shown, the grinding brush 270 extends through the seal bearing 273 and the bearing 234. The filter 230 is connected to the vacuum hub 226 via a hose 229 and a Luer hub 228. The filter 230 may be connected to a vacuum source 233 via a hose 229 and a coupler 232. The filter 230 can hold the collected material 231. In some examples, the vacuum source 233 is operated by a physician or operator using a foot pedal.

[0204] During use, the tip 272 of the abrasive brush 270 is positioned in the tip-side airway lumen 77, and suction is performed via the vacuum hub 226, causing the tip-side airway portion of the catheter 238 tip 239 to constrict. As a result, the epithelium 83 is drawn towards the abrasive bristles 275. The abrasive bristles 275 function to contact and abrade the airway wall epithelial layer 83. In this way, the epithelial layer 83 is peeled away from the airway lumen wall (shown here as an airway wall cross section 34), exposing the basement membrane 85. Suction from the vacuum source 233 causes the abrasive epithelium to pass through the hollow catheter 238, vacuum hub 226, and hose 229 into the filter or filter trap 230, where it remains as a collection 231. In some examples, the vacuum source 233 is operated by a physician or operator using a foot pedal. In some examples, the abrasive brush 270 may also be referred to as a lengthwise member. In some cases, the grinding bristles 275 are sometimes referred to as the grinding feature section.

[0205] Figure 17 shows an embodiment of a system 300 for treating a patient. The system 300 includes a treatment device 13 having a grinding brush 270 and a motion-driven handpiece 159, and a brush guide catheter 305. In some embodiments, the system 300 includes a vacuum hub, a filter, and other related elements, as shown, for example, in Figure 15. The brush guide catheter 305 has a tip 301, a port 303, and a base end 302. The grinding brush 270 has a tip 272, grinding bristles 275, a base end 271, and a motion-driven hub 187. As shown, the grinding brush 270 may include a wire having a twist 274 in the brush wire. The motion-driven hub 187 is connected to a motor coupler 195, which is connected to the motion-driven handpiece 159. As shown, the motion-driven handpiece 159 has a slider switch 160. The motion-driven handpiece 159 is connected to a battery 134 via a power cable 133 (or multiple power cables 133 connected via one or more connectors 150). The battery 134 functions to power the motion-driven handpiece 159. The wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cables 135 have or are connected by connectors 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 300 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet charges the battery 134 or directly powers the motion-driven handpiece 159. In some examples, the handpiece 159 is gripped by the user to manually apply linear and / or rotational forces. In some examples, the treatment device 13 is configured such that the strands of the grinding bristles 275 extend radially beyond the outer circumference defined by the catheter 305. In some examples, the treatment device 13 is configured such that the strands of the grinding bristles 275 do not extend radially beyond the outer circumference defined by the catheter 305.

[0206] During use, the tip 301 of the brush guide catheter 305 is positioned in the tip-side airway lumen 77. The abrasive bristles 275 function to contact and abrade the airway wall epithelial layer 83. In this way, the epithelial layer 83 is peeled away from the airway lumen wall (shown here as an airway wall cross section 34), exposing the basement membrane 85. By suction from a vacuum source, the abrasive epithelium enters a filter or filter trap through the brush guide catheter 305, vacuum hub, and hose, where it remains as a collection, as shown in Figure 15, for example. As described herein (for example, with respect to Figures 27 and 28), in some examples, the system 300 has a foaming mechanism instead of or in addition to the abrasive bristles 275. In some examples, the abrasive brush 270 may also be referred to as an elongated member. In some examples, the abrasive bristles 275 may also be referred to as an abrasive feature.

[0207] Each embodiment shown in Figures 1 and 6 to 17 may incorporate any of the vibration control mechanism features shown in Figures 18 to 19. In some embodiments, the control mechanism or vibration control mechanism includes any one or more features disclosed herein with respect to the motor assembly or handpiece (e.g., motion-driven handpiece).

[0208] Figure 18 shows an embodiment of a system 400 for treating a patient. The system 400 includes a motor 325, a motor drive shaft 326, an eccentric drive hub 327 (such as a rotating disk), an eccentric drive pin 328, a rotary vibration hub 329, a rotary drive slot 330, an output shaft 331, a motion drive hub 187, and a rotary vibration coupler key 332. As shown, the system 400 further includes a power cable 133 positioned between the motor 325 and a slider switch 160. Furthermore, the system 400 also includes a battery 134 connected to the slider switch 160. In some examples, the slider switch 160 is connected to the battery 134 via the power cable 133 (or multiple power cables 133 connected via one or more connectors 150). The battery 134 functions to supply power to the motor 325. A wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cable 135 has a connector 150 or is connected by a connector 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 300 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet either charges the battery 134 or directly operates the motor 325. As shown in the figure, the operation of the motor 325 causes the rotary vibrating coupler key 332 to vibrate around the axis of rotation 333, as indicated by arrow A.

[0209] Figure 18A shows exemplary embodiments of the vibrational motion that can be produced by the motion-driven hub 187. As indicated by arrow A, the motion-driven hub 187 can rotationally vibrate over a range of motion of approximately 60 degrees. Similarly, as indicated by arrow B, the motion-driven hub 187 can rotationally vibrate over a range of motion of approximately 180 degrees. Furthermore, as indicated by arrow C, the motion-driven hub 187 can rotationally vibrate over a range of motion of approximately 350 degrees. The treatment system can be configured to set any value or range of values ​​for the rotational vibration. In some examples, the drive hub 187 (or grinding balloon or grinding instrument) vibrates over a range of rotation of 5 degrees. In some examples, the drive hub 187 (or grinding balloon or grinding instrument) vibrates over a range of rotation of 10 degrees. In some examples, the drive hub 187 (or grinding balloon or grinding instrument) vibrates over a range of rotation of 0 to 360 degrees. The grinding treatment device has the advantage of being able to grind controlled portions of the airway wall, ranging from a narrow area (for example, an area corresponding to the range of one degree of vibration) to the entire inner circumference of the airway wall (for example, an area corresponding to the range of 360 degrees of vibration), without requiring manual rotation of the treatment device itself, through the aforementioned vibration motion.

[0210] Figure 19 shows an embodiment of the system 400 for treating a patient. The system 400 includes a motor 325, a motor drive shaft 326, an eccentric drive hub 327, an eccentric drive pin 328, a vibration drive slide 336, a linear drive slot 337, an output shaft 331, a motion drive hub 187, and a linear vibration coupler key 338. As shown, the system 400 further includes a power cable 133 positioned between the motor 325 and a slider switch 160. Furthermore, the system 400 also includes a battery 134 connected to the slider switch 160. In some examples, the slider switch 160 is connected to the battery 134 via the power cable 133 (or multiple power cables 133 connected via one or more connectors 150). The battery 134 functions to supply power to the motor 325. A wall outlet plug 136 is connected to the battery 134 via one or more electrical cables 135. In some examples, the electrical cable 135 has a connector 150 or is connected by a connector 150. In some examples, the battery 134 is a rechargeable battery. In some examples, the system 300 has an AC / DC converter instead of a battery 134. When the wall outlet plug 136 is plugged into a wall outlet, the electricity from the wall outlet either charges the battery 134 or directly operates the motor 325. As shown in the figure, the operation of the motor 325 can cause the linear oscillating coupler key 338 to oscillate and linearly along the translation axis 334, as indicated in the direction of the motion arrow 335.

[0211] Therefore, considering Figures 18 and 19 individually or in combination, it can be seen that various vibrational motions are achievable. In some examples, rotational vibrational motion is realized using the elements of Figure 18. In some examples, linear translational vibrational motion is realized using the elements of Figure 19. In some examples, both rotational and linear translational vibrational motion are realized by using a combination of the elements of Figures 18 and 19. In some examples, these three options are combined with pulling and / or pushing the therapeutic device along the longitudinal axis of the airway. In the combined device, the components shown in Figure 18 are combined with the components shown in Figure 19. For example, a rotary drive motor (motor 325 in Figure 18, etc.) is placed on a linear drive slide (drive slide 336 in Figure 19, etc.). In this way, the rotary drive motor (and connected end-side components) can be made to vibrate linearly.

[0212] Note that Figures 6-19 may not be drawn to scale, and the tips and proximal ends of delivery devices and / or treatment devices or other system elements may be highlighted for focus and detail. Also, catheters and / or treatment devices are much longer than illustrated and are configured to advance through the bronchi into various airways, allowing them to progress along airways beyond the fourth generation. Similarly, airways are illustrated bisected to clearly show the devices and delivery devices positioned internally.

[0213] Figure 20 shows an embodiment of a system 500 for treating a patient. The system 500 comprises a lung treatment device 513 and a delivery device 501 such as a bronchoscope. The lung treatment device 513 is sized and configured to be delivered by the delivery device 501. The delivery device 501 is configured to be inserted into the lung. In some embodiments, the lung treatment device 513 is configured to be delivered through the lumen of the delivery device, for example, by pushing the treatment device through the lumen of a bronchoscope, catheter, introducer, sheath, sleeve, or similar device. In some embodiments, the treatment device 513 is inserted into a port 507, and the delivery device 501 is advanced through the bronchial tree to a target location in the lung. In some examples, the device 513 enters the bronchoscope port 507, with the tip 514 of the device 513 pointed towards the tip from the channel exit port 511, and the proximal end 515 of the device 513 extending proximal from the bronchoscope port 507.

[0214] As illustrated, the treatment device 513 has a catheter 516 and a guidewire or dilator 517 is inserted to guide the catheter 516. This configuration prevents the catheter 516 from scraping the airway wall or lung tissue as it advances within the airway lumen. By positioning the guidewire or dilator 517, it becomes easier to guide the catheter 516 to a desired anatomical location, such as a specific branch, airway branch, or airway lumen. In some examples, the tip 518 of the guidewire or dilator 517 has a curved portion. In some examples, a rotational force can be applied to the curved portion to direct it into the branch, allowing the catheter 516 to advance into the branch. In some examples, the rounded end of the tip 518 helps to guide thicker tubes such as the catheter 516. In some examples, the tip 518 of the guidewire or dilator 517 has a radiopaque material. In some examples, the tip of the catheter has a radiopaque material.

[0215] In some examples, the treatment device 513 is introduced into patient P without the use of a bronchoscope, as shown in Figure 21. In some examples, the catheter 516 is introduced into patient P using a guidewire or dilator 517. In some examples, the catheter 516 is introduced into patient P without the use of a guidewire or dilator. Any of the treatment devices disclosed herein, such as the treatment device 513, may be delivered via a bronchoscope, or only using the lumen of an endotracheal tube (e.g., an endotracheal tube commonly used for patient ventilation or access into the patient's airway beyond the vocal cords), or guided only along a guidewire, or delivered without being guided by a tube or wire. In some examples, the rounded tip of the guidewire or dilator 517 is useful for guiding a thicker tube, such as the catheter 516.

[0216] Figure 22 shows an exemplary guidewire 617 according to an embodiment of the present invention. In some examples, the guidewire 617 includes a twisted cable wire, a braided wire, a reverse-twisted wire, or any combination thereof. In some examples, the diameter D of the wire 620 is in the range of about 1 mm to about 10 mm. The wire 620 may bend as it moves forward or backward within the patient's airway (e.g., at corners, other obstacles, or anatomical features), but in some examples, the wire 620 is configured so that there is no gap between each strand 621 of the wire 620 when it is bent. In this case, no gap is formed that could pinch tissue when the wire 620 is pulled back and straightened during a medical procedure. If a gap is formed between each strand 621 of the wire, there is a possibility of pinching tissue when the gap closes, the wire 620 may get caught on the patient, or tissue may be torn when the guidewire 617 is removed. In the continuous wire embodiment shown in Figure 22, the wire 620 does not open when bent. The gap described above is a drawback seen in some of the thinner guide wires of the core wire. In some examples, the diameter D of the wire 620 is approximately 1.5 mm. In some examples, the wire 620 is composed of multiple individual wire strands or wire cables 621. Such a wire structure with multiple strands or cables can form a very flexible and smooth wire. In some examples, the wire 620 consists of approximately 375 individual wire strands or cables 621. In some examples, the number of strands or cables 621 in the wire 620 or a portion thereof is reduced to increase compressibility. For example, the number of cables or strands in the base portion 622 of the wire 620 ranges from approximately 4 to approximately 50. In some examples, the number of strands or cables 621 in the wire 620 or a portion thereof is increased to increase flexibility. For example, the number of cables or strands in the tip portion 623 of the wire 620 ranges from approximately 50 to approximately 1000. Therefore, the guide wire 617 shown in Figure 22 has a hybrid configuration with two separate parts having different indentation / flexibility characteristics.The guide wire 617 has a base hub 618, a pushable base portion 622, a flexible tip portion 623, a connector 624 between the base portion 622 and the tip portion 623, and a tip end 625. In some examples, the connector 624 is a welded connector. In some examples, the tip end 625 is a tip welded end. In some examples, the tip end 625 is formed into a specific shape during welding. In some examples, the tip end 625 has a ball shape. In some examples, the diameter of the ball shape is approximately 2 mm. In some examples, the diameter of the ball shape is in the range of approximately 1 mm to approximately 10 mm. The wire 620 functions to transmit rotational force without causing twisting, which is a drawback seen in thin guide wires of the core wire. In some examples, the wire 620 is given rotational force by the hub 618. In some examples, the wire 620 is given rotational force from any part along the shaft of the wire 620. This differs from the thin guide wire of a core wire, where the outer coil floats away from the core and therefore rotational force must be applied from the hub. Wire 620 has the advantage that rotational force can be applied as needed, and the user does not need to return to the proximal end every time rotational force is needed on the wire. In some examples, the rounded end of the tip terminal 625 is useful for guiding thicker tubes such as catheters. In some examples, the tip terminal 625 has a radiopaque material.

[0217] Figure 23 shows an exemplary dilator 717 according to an embodiment of the present invention. In some embodiments, the dilator 717 is constructed as a solid plastic dilator. In some examples, the rounded end of the dilator 717 helps to guide a thicker tube, such as a catheter. Figure 24 shows an exemplary dilator 817 according to an embodiment of the present invention. As shown, the dilator 817 has a curved tip portion 823. In some examples, the rounded end of the dilator 817 helps to guide a thicker tube, such as a catheter. Figure 25 shows an exemplary dilator 917 according to an embodiment of the present invention. As shown, the dilator 917 has a curved tip portion 923 that curves in two directions on the same plane. In some examples, the rounded end of the dilator 917 helps to guide a thicker tube, such as a catheter.

[0218] Figure 26 shows an embodiment of system 1000 for treating a patient. System 1000 comprises a treatment device (not shown) and a vacuum hub 1226 connected to a catheter 1238. The treatment device may have features of any one or more of the treatment devices disclosed herein, such as the treatment devices shown in Figures 6-14, 16, 17, 27, and 28. The tip 1239 of the catheter 1238 is inserted into the airway lumen, and the treatment device extends through the catheter 1238 into the airway lumen. The proximal end 1240 of the catheter 1238 is connected to the vacuum hub 1226 via a connector 1237. System 1000 also has a filter connected to the vacuum hub 1226 via a hose 1229 and a vacuum source. Embodiments of the filter and / or vacuum source that can be incorporated into system 1000 are shown in Figures 14-16. During use, the treatment device is positioned inside the catheter 1238, and the lavage fluid is delivered from the lavage fluid source 1810 through the lavage fluid conduit 1820 and the port conduit 1892 of the lavage fluid port 1890 to the proximal end portion 1252 of the outer lumen 1250 of the catheter 1238 and exits from the anterior end portion 1254 of the outer lumen. This allows the lavage fluid to flow into the airway lumen L. To draw the lavage fluid into the inner lumen 1260 of the catheter 1238, suction is performed, for example, from a vacuum source 1133 via a hose 1229 and through a vacuum hub 1226. Furthermore, as previously mentioned, suction from the vacuum source 1133 can draw abrasive epithelium and / or other tissue or debris from the airway through the catheter inner lumen 1260 and hose 1229 into a filter or filter trap, where it can be retained as a collection. In some examples, the vacuum source 1133 is operated by a physician or operator using a foot pedal.

[0219] Thus, embodiments of the present invention encompass double-lumen or multi-lumen catheter configurations that enable suction and fluid delivery. Such embodiments allow a therapeutic device or treatment device to be delivered into the inner lumen 1260 (for example, through a seal 1227). In some examples, the seal 1227 functions to close the posterior opening or proximal portion 1262 of the inner lumen 1260 until the therapeutic device is introduced into the inner lumen 1260. In this way, lavage fluid can be injected through the fluid delivery port 1890 and the outer lumen 1250, and the lavage fluid can then be aspirated from the patient's body by action through the inner lumen 1260, the suction port 1241 of the vacuum hub 1226, the hose 1229, and the vacuum source 1133. In some embodiments, the system 1000 injects saline or other fluid to supply lavage fluid into the patient's airway. This cleaning fluid can be aspirated from the patient's body, for example, when creating a vacuum to draw airway tissue or walls toward the catheter 1238, or when aspirating debris from the airway lumen L.

[0220] In some embodiments, using a system such as system 2000, a fluid containing antibiotics, antifungals, or other agents can be injected into the lungs to minimize irritation to the airway walls and infections associated with mucus present in the airways. Other agents, such as steroids or wound-healing agents, can also be introduced into catheter 1238 (or secondary lumen 1250) to reduce or control the rate of inflammatory response to cutting, grinding, or treatment of the airway walls. Injecting such fluids or saline solution during suction makes it possible to create pathways for entering and leaving the patient's airways. This allows debris and other contaminants to be moved out of the airways, improving healing, tissue repair of the airway walls, and respiration. In some examples, the injected fluid has a desired or predetermined temperature. For example, the fluid may be heated to a specific temperature before injection or cooled to a specific temperature before injection.

[0221] Figures 27 and 28 show embodiments of the therapeutic device 2000 according to an embodiment of the present invention. As shown, the therapeutic device 2000 has an elongated element 2010 connected to a tip portion 2020. The therapeutic device 2000 is delivered via a catheter 3000 to a desired site in the patient, for example, into the airway lumen L of the patient's lung. In some embodiments, the tip portion 2020 includes or consists of an expandable and compressible material. For example, the tip portion 2020 has an expandable foam material. In exemplary embodiments, the tip portion performs a scraping function. In some examples, the tip portion performs a brushing function. In some examples, the tip portion 2020 has an expandable open-cell foam or scraping material, similar to a plastic dishwasher. In some examples, the tip portion is formed from a material having hardness capable of scraping epithelium. In some examples, the tip portion 2020 includes any of various silicones, nylons and / or other open-cell plastics. As shown in Figure 28, as the tip portion 2020 advances toward the tip end of the tip end opening 3010 of the catheter 3000, the size and / or diameter of the tip portion 2020 increases. For example, the amount of expansion of the tip portion diameter is in the range of approximately 2 mm to approximately 10 mm. During or after expansion, the tip portion 2020 is moved axially slowly or periodically, either manually or using a motor at a speed of 100 Hz, or a combination of both. The delivery catheter can perform aspiration simultaneously while the tip portion 2020 is scraping. Alternatively, the procedure can be performed to aspirate mucus before deploying the tip portion 2020 or scraping element, during scraping as needed, and then after removing the tip portion 2020 or scraping element from the catheter 3000 (e.g., after retracting toward the proximal end). In some examples, the elongated element 2010 may also be referred to as the elongated member. In some cases, the tip portion 2020 may be referred to as the grinding feature portion.

[0222] In some embodiments, the tip portion 2020 includes various expandable polymers, metal meshes of ferrous and non-ferrous metals, and / or composite materials of combinations of metals and polymers used as expandable elements. In some examples, the tip portion 2020 becomes expandable against the airway wall by advancing from the tip-side opening 3010 of the catheter, and is then used to scrape the airway to remove epithelium and goblet cells. Control of the depth of action can be achieved by controlling the grinding performance of the abrasive material according to a controlled motion pattern. In some examples, depth control can be achieved or adjusted by performing fine movements of the treatment device.

[0223] In some examples, the tip portion 2020 contains one of a variety of polymers, including any crystalline or amorphous form of thermoplastic, thermosetting, and elastomer materials. Exemplary materials that can be used to manufacture the tip portion 2020 include, but are not limited to, low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), nylon, nylon 6, nylon 6,6, Teflon® (polytetrafluoroethylene), thermoplastic polyurethane (TPU), silicone, vinylpolysiloxane (PVS), or natural polymers. Natural polymers may be made from proteins and nucleic acids found in the human body, such as cellulose, natural rubber, silk, wool, starch, and latex-derived natural rubber. In some examples, the material of the tip portion 2020 includes looped wires or filaments. In some examples, such looped wires or filaments form edges that enhance the abrasive effect of the tip portion. In exemplary embodiments, the tip portion 2020 is made of a material that allows fluid, structural particles, and / or debris to pass through. In some examples, the tip portion 2020 includes one or more types of abrasive material.

[0224] In some examples, the treatment device 2000 and / or catheter 3000 are introduced into patient P using a guidewire or dilator. In some examples, the treatment device 2000 and / or catheter 3000 are introduced into patient P without using a guidewire or dilator. Any of the treatment devices disclosed herein may be delivered via a bronchoscope, or solely using the lumen of an endotracheal tube (e.g., a bronchial tube commonly used for patient ventilation or access into the patient's airway beyond the vocal cords), or guided solely along a guidewire, or delivered without being guided by a tube or wire. In some examples, the treatment device 2000 is introduced into the patient's airway using only catheter 3000. In some examples, catheter 3000 is connected to or introduced by a bronchoscope. In some examples, the treatment device 2000 is introduced into the patient's airway using only a bronchoscope, without the use of a catheter.

[0225] In some examples, the diameter of the inner lumen of the catheter 2000 ranges from approximately 6 mm to approximately 10 mm. All catheters or flexible bodies of the embodiments disclosed herein may have inner lumen dimensions similar to those of the catheter 2000.

[0226] In some examples, the tip portion 2020 has a cylindrical shape or profile. In some examples, the tip portion 202 has a spherical shape or profile. In some examples, the tip portion 2020 has a conical shape or profile. In some examples, the tip portion has a larger diameter and cross-section at the tip end and a smaller diameter and cross-section at the base end.

[0227] In some examples, the expansion ratio of the tip portion is approximately 10:1 (for example, by comparing the dimensions in the uncompressed state shown in Figure 28 with the dimensions in the compressed state shown in Figure 27). In some examples, the elongated element 2010 is a twisted cable, a braided cable, or any embodiment described herein with reference to Figure 22. In some examples, the tip portion 2020 is located closer to the base or central portion of the elongated element, for example, near or to the connector 624 shown in Figure 22. In some examples, the tip portion 2020 is bonded to the elongated element 2010. In some examples, the tip portion of the elongated element 2010 has a radiopaque material.

[0228] In some embodiments, the foam (e.g., the inflatable foam material of the tip portion 2020) is manufactured to have open-cell pores with diameter values ​​ranging from about 10 μm to about 5 mm. In some examples, the open-cell pores have one or more dimensions (e.g., width, length, or height) with diameter values ​​ranging from about 10 μm to about 5 mm.

[0229] In some examples, a densely compressed foam or coarse sponge structure (e.g., Figure 27) can be expanded to a less compressed or uncompressed foam or coarse sponge structure (e.g., Figure 28). As can be seen from Figure 27, the foam or coarse sponge is held in a compressed state by being confined inside the catheter 3000. As shown in Figure 28, the foam structure of the tip portion 2020 has a mesh structure in which a fully expanded loop (or circle) is connected to the central or internal region, with cut wires or edges protruding from the outer edge or outer surface of the foam structure. The cut wires act as bristles and can provide an additional abrasive effect. The exposed edges of the loops or circles located on the outer surface of the tip portion 2020 (e.g., defining open-cell pores) can also provide an abrasive effect.

[0230] In some examples, the foam element or tip portion 2020 is formed from or contains strands of ribbon intertwined in aligned or unaligned bundles. The ribbon contains, is manufactured from, or is plated from, any of a variety of materials, such as stainless steel, aluminum, tantalum, tungsten, silver (or other bacteriostatic or bactericidal materials), gold (or other highly radiopaque materials), iron or non-ferrous metal alloys such as titanium, nitinol or other similar memory shape alloys, carbon, polymers, synthetic or natural fibers such as silk, or any combination of the above. In some embodiments of the ribbon bundle, the bundle is bent within the range of elastic deformation of any material (e.g., the material used to manufacture the ribbon), and when the bundle is released from the lumen of the catheter 3000, the bundle expands from a first diameter to a second diameter. In some examples, after the bundle is released from the lumen of the catheter, the bundle expands from a diameter of 2 mm to a diameter of 15 mm or more within the guide catheter.

[0231] Some embodiments of the present invention are configured to address very large tissue damage in patients with severe COPD, and can provide treatment methods and devices specifically designed to treat such patients and particularly damaged lung tissue within their bodies. Such tissue damage is often not identified or recognized in prior treatment plans, leading to inadequate treatment or undesirable outcomes. In particular, the present invention determines the extent of tissue damage and the location of the damage in one or more lung lobes in determining the treatment plan. The extent and distribution of tissue damage are used to determine the optimal location for performing the treatment. These data are also used to evaluate the patient over time to determine whether treatment should be performed at the same location targeted in the previous treatment to enhance or restore the improvement obtained from the initial treatment, or to determine whether it is best to perform the treatment at a new, previously untreated location to restore the effects obtained from the original treatment.

[0232] Overall, patients often experience improvement in various symptoms. Examples of these improvements include reduced cough (e.g., cough due to trapped air and mucus), increased ability to clear mucus by opening the airway wider and for longer periods, improved mobility (e.g., measured by the current standard 6-minute walk test), reduced respiratory effort, reduced mood swings, decreased respiratory rate, reduced glottal closure reflex (reduced inflammation and cough due to mucus removal), a reduced incidence of respiratory failure, and an extended interval between COPD exacerbations.

[0233] Embodiments of lung therapy devices have various features and design elements to achieve the above-mentioned therapeutic effects and clinical objectives. Furthermore, various modifications can be constructed from these features and design elements, some of which are described herein.

[0234] This specification provides a more detailed description of various embodiments of lung therapy devices. While various embodiments and features are described, it should be understood that embodiments of the device may have any combination of these embodiments and features. Similarly, some embodiments may not include all of the embodiments and features described.

[0235] In some embodiments, one or more components of a therapeutic system are configured to provide controlled delivery of an active substance, such as a drug. In some examples, such delivery reduces the rates of wound healing, tissue repair, inflammation, granulation tissue formation, hyperplasia, and the like.

[0236] This specification describes various approaches. For example, the treatment device may be introduced through the lumen of the delivery device (e.g., the device itself is pushed and pulled within the lumen, placed within an introducer, or attached to an additional device such as a catheter or guidewire that can advance within the lumen). Alternatively, the treatment device may be attached to the outer portion of the delivery device (e.g., on the tip of a bronchoscope insertion cord or on a catheter) and introduced. The treatment device may be pushed and pulled from its attachment point by an inner or outer sleeve or device.

[0237] The guide wire has a configuration suitable for advancement within lung tissue and is specifically configured to contact the lung tissue in a state where an accident or damage can be suppressed or prevented. In some embodiments, the guide wire includes a wire cable, a wire bundle, a continuous braid, a twisted wire, a twisted wire bundle shaft structure, etc., which have a blunt tip (generally formed by crimping, adhering or welding the tip of the guide wire shaft structure). In some embodiments, the diameter of the guide wire ranges from 0.0127 cm to 0.254 cm (0.005 to 0.100 inches), preferably about 0.0457 cm to 0.1778 cm (0.018 to 0.070 inches). Usually, the guide wire blocks the lumen of the catheter so that when the guide wire curves or bends during delivery, no gap or only a very small gap is left. In some embodiments, the guide wire is configured such that when a bend with a radius of 1.27 cm (0.5 inches) or less occurs to suppress tissue from getting caught in the gap, the gap that opens in the portion of the guide wire contacting the tissue does not exceed 0.0762 cm (0.030 inches), more preferably, it is in the range of 0 to 0.0508 cm (0.020 inches).

[0238] Aspects of the above and related guide wire features can be further understood by referring to any one or more of the embodiments of the guide wire disclosed herein (e.g., FIGS. 6, 7A - 7D, 8A - 8B, 9, 10, 11 and 20 - 25). In some examples, the guide wires described herein include any of a variety of materials such as iron or non - ferrous metal alloys like stainless steel, aluminum, tantalum, tungsten, silver (or other bacteriostatic or bactericidal materials), gold (or other highly radiopaque materials), titanium, nitinol or other similar shape - memory alloys, carbon, polymers, synthetic or natural fibers such as silk, or any combination of the above, or are manufactured from such materials or are coated with such materials.

[0239] Medical imaging can be used to visualize the delivery or operation of any of the embodiments of the systems or devices disclosed herein. Medical imaging includes the use of any form of equipment that enables real-time imaging, recording, or computer processing to visualize devices, organs, or tissues within the human body using the line of sight of the human eye without exposing these devices, organs, or tissues. Such medical imaging techniques generally utilize the emission of electromagnetic energy or acoustic energy from low frequencies to high frequencies, and for example, one or more video cameras equipped in a bronchoscope, a computed tomography device, a biplane imaging device, a fluoroscopy device, an ultrasonic device, or a standard planar X-ray device, etc. are used. In some embodiments, the lung treatment device is placed into the lung by surgical techniques such as video-assisted minimally invasive skin incision surgery or laparotomy. Many of the lung treatment devices described herein can be placed further into any lung, lung lobe, main stem segment, segment, sub-segment, or bronchial tree. Similarly, many of the devices can be inserted directly into the lung through the chest wall and can also reach pockets of damaged parenchyma by being inserted through the wall of the main bronchus. Many of the devices can be implanted by thoracotomy or any type of endoscope. The respiratory function tests described herein are excellent indicators showing good and proper responses.

[0240] All features of the described systems and devices are applicable to the described methods by making necessary modifications, and vice versa. Embodiments of the present invention include kits having one or more components of the treatment systems disclosed herein. In some embodiments, the kit includes one or more treatment systems or one or more components of one or more treatment systems, and instructions for using the system according to any of the methods disclosed, for example, herein.

[0241] Preferred embodiments of the present invention have been described, but these embodiments are merely illustrative. Those skilled in the art will be able to make numerous modifications, changes, and substitutions without departing from the present invention. Various alternatives to the embodiments of the present invention described herein can be employed in the implementation of the present invention. The scope of the present invention is defined by the following claims. Methods and structures within these claims, as well as their equivalents, are included within the claims.

Claims

1. A tissue therapy device for detaching and removing some mucus-secreting cells from the airway walls of a patient's lungs, A long, rectangular member, An expandable grinding feature portion disposed on the elongated member, wherein the expandable grinding feature portion includes at least one strand, and the at least one strand includes a member selected from the group consisting of metal wire, fiber, and braid, A control mechanism that is interlocked with the elongated member, the control mechanism is configured to expand the expandable grinding feature until it contacts the airway wall of the lung, the airway wall including the basement membrane, smooth muscle layer and cartilage layer, and the control mechanism Removal means and, The at least one strand of the expandable grinding feature is configured to detach some mucus-secreting cells from the airway wall of the patient's lung without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall when the expandable grinding feature is expanded by the control mechanism. A tissue therapy device comprising a removal means configured to remove some of the detached mucus-secreting cells from the patient's lung while maintaining the state in which the smooth muscle layer of the airway wall is supported by the cartilage layer of the airway wall.

2. The apparatus according to claim 1, wherein the removal means includes a vacuum source that functions to pull the airway wall toward the expandable grinding feature.

3. The apparatus according to claim 2, wherein the vacuum source functions to remove some of the detached mucus-secreting cells from the patient's lungs.

4. The apparatus according to claim 1, wherein the elongated member includes an expandable mechanism, and the expandable grinding feature portion is arranged on the expandable mechanism.

5. The apparatus according to claim 1, wherein the control mechanism is configured to generate linear motion in the expandable polishing feature portion.

6. The apparatus according to claim 3, wherein the removal means further comprises a filter trap configured to receive some of the detached mucus-secreting cells.

7. The apparatus according to claim 1, further comprising a guide wire, wherein the expandable grinding feature is attached to the guide wire.

8. The apparatus according to claim 7, wherein the guide wire includes a blunt tip.

9. The apparatus according to claim 7, wherein the guide wire includes a wire cable.

10. The apparatus according to claim 1, wherein the removal means comprises a catheter, a suction source, and a filter trap, the suction source being configured to generate suction that draws the detached mucus-secreting cells through the catheter into the filter trap.

11. The apparatus according to claim 1, further comprising a catheter, wherein the expandable grinding feature is connected to the catheter.

12. The apparatus according to claim 11, wherein the expandable grinding feature is configured to expand to its maximum extent without requiring rotation of the elongated member and the expandable grinding feature relative to the catheter.

13. The apparatus according to claim 1, wherein the at least one strand includes the metal wire.

14. The apparatus according to claim 1, wherein the at least one strand includes a plurality of strands.

15. The apparatus according to claim 1, wherein the at least one strand contains nitinol.

16. The apparatus according to claim 1, wherein the expandable grinding feature portion includes a shape memory material.

17. The apparatus according to claim 1, wherein the expandable grinding feature is operable to expand and press against the airway wall of the lung.

18. The apparatus according to claim 1, wherein the expandable grinding feature portion is operable to be expanded by operation of the control mechanism.

19. The apparatus according to claim 1, wherein the expandable grinding feature is operable to be expanded by operating a pull wire of the control mechanism.

20. The apparatus according to claim 1, further comprising a bronchoscope having a flexible body and a working channel outlet port, wherein the working channel outlet port of the bronchoscope is configured to receive the elongated member, and the bronchoscope is maneuverable.

21. The apparatus according to claim 20, wherein the bronchoscope is operable by an electric drive mechanism.

22. The apparatus according to claim 1, wherein the expandable grinding feature is operable to be expanded by operating the handle of the control mechanism.

23. The apparatus according to claim 1, wherein the expandable grinding feature portion is operable to be expanded by operation of the motor drive mechanism of the control mechanism.

24. The apparatus according to claim 1, wherein the expandable grinding feature is operable to be expanded via robotic operation of the control mechanism.

25. The apparatus according to claim 1, wherein the expandable grinding feature is operable to move along or within the airway wall via robotic operation of the control mechanism.

26. The apparatus according to claim 1, wherein the expandable grinding feature is operable to expand or move along or within the airway wall via the operation of a robotic motor or magnetic actuator of the control mechanism.

27. The apparatus according to claim 1, wherein the at least one strand has at least one etched surface.

28. The apparatus according to claim 1, wherein the control mechanism includes an electrically operated drive mechanism.

29. The apparatus according to claim 1, wherein the expandable grinding feature is operable to expand when driven by accumulated strain energy.

30. The apparatus according to claim 1, wherein the at least one strand is a component of a wire basket made of nitinol.

31. The apparatus according to claim 1, further comprising a connector hub and a tip, wherein the at least one strand is connected and arranged between the connector hub and the tip.

32. A tissue therapy device that enables the detachment and removal of some mucus-secreting cells from the airway walls of a patient's lungs, A long, rectangular member, An expandable grinding feature portion disposed on the elongated member, wherein the expandable grinding feature portion comprises at least one strand, and the at least one strand includes a member selected from the group consisting of metal wire, fiber, and braid, A control mechanism that is interlocked with the elongated member, the control mechanism is configured to expand the expandable grinding feature until it contacts the airway wall of the lung, and the airway wall includes a basement membrane, a smooth muscle layer, and a cartilage layer, comprising the control mechanism, The at least one strand of the expandable grinding feature is configured to detach some mucus-secreting cells from the airway wall of the patient's lung without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall, and without requiring rotation of the elongated member, when the expandable grinding feature is expanded by the control mechanism. A tissue treatment device wherein, when removed from the patient, the at least one strand of the expandable grinding feature is configured to remove a first portion of some detached mucus-secreting cells from the lung while maintaining the state in which the smooth muscle layer of the airway wall is supported by the cartilage layer of the airway wall.

33. The apparatus according to claim 32, further comprising a low-pressure source that operates to remove a second portion of the detached mucosecreting cells while maintaining the state in which the smooth muscle layer of the airway wall is supported by the cartilage layer of the airway wall.

34. A tissue therapy device that enables the detachment and removal of some mucus-secreting cells from the airway walls of a patient's lungs, A long, rectangular member, An expandable grinding feature portion disposed on the elongated member, wherein the expandable grinding feature portion comprises at least one strand, and the at least one strand includes a member selected from the group consisting of metal wire, fiber, and braid, A control mechanism that is interlocked with the elongated member, the control mechanism is configured to enable the expansion of the expandable grinding feature until it contacts the airway wall of the lung, and the airway wall includes a basement membrane, a smooth muscle layer, and a cartilage layer, comprising the control mechanism, A tissue treatment device wherein at least one strand of the expandable grinding feature is configured to detach some mucosecting cells from the airway wall of the patient's lung without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall when the expandable grinding feature is expanded to contact the airway wall of the lung, and the detached mucosecting cells can be removed from the lung while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall.

35. The apparatus according to any one of claims 1, 32, and 34, wherein the expandable grinding feature is configured to expand to its maximum extent without requiring rotation of the elongated member, and the at least one strand of the expandable grinding feature is configured to detach some mucosecting cells from the airway wall of the patient's lung without requiring rotation of the elongated member when the expandable grinding feature is expanded by the control mechanism.

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