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EP-3861949-B1 - SYSTEM FOR CONSISTENT, REPEATABLE, AND SAFE CRYOSPRAY TREATMENT OF AIRWAY TISSUE

EP3861949B1EP 3861949 B1EP3861949 B1EP 3861949B1EP-3861949-B1

Inventors

  • MANERS, WENDELIN
  • HAWKE, Heather, V.
  • SHEETS, ELLEN
  • CORDERO, RAFAEL
  • DAVIDSON, MARC
  • FAN, WEI
  • SHERRILL, DAVID
  • HANLEY, BRIAN, M.
  • SARLI, Amy
  • GRIFFIN, STEPHEN

Dates

Publication Date
20260513
Application Date
20150604

Claims (14)

  1. A cryosurgery system (100) for treating a condition in an airway of a lung of a patient, comprising: (a) a catheter (1, 48) comprising an energy transfer distal end configured to advance to a target region in the airway, the target region comprising airway epithelial cells, the energy transfer distal end configured to direct cryospray to the target region; said energy transfer distal end terminating in a cylindrical segment including an atraumatic tip and, at the proximal part of the atraumatic tip, two rows of holes equally dispersed around the circumference of the shaft, each row containing 8 holes of 0.41 mm each, the first and second row being separated along the length of the shaft by a distance of 0.64mm measured from the centerline of the first row to the centerline of the second row, and wherein each hole is offset from adjacent holes of the other row by 20° to 25° and offset from adjacent holes of the same row by 45°, and (b) a computing device (700) configured to: calculate (635) a targeted amount of cryospray based on patient information and anatomical airway segment, the targeted amount being determined based on endoluminal diameter of the anatomical airway segment, wherein the targeted amount is configured to be passed through the atraumatic tip to ablate tissue in the target region to a depth between 0.1 and 0.5 mm from a surface of the airway while preserving an extracellular matrix of the airway epithelial cells; and automatically initiate (640) supply of the targeted amount of cryospray through the catheter.
  2. The cryosurgery system (100) of claim 1, wherein the airway comprises the trachea, the bronchus, the bronchiole, or the alveolus, or any combination thereof.
  3. The cryosurgery system (100) of any of claims 1 and 2, wherein the epithelial cells comprise ciliated cells or goblet cells, or both.
  4. The cryosurgery system (100) of any of claims 1-3, further comprising a flexible endoscope (40) insertable into the lung and wherein the energy transfer distal end is advanceable with or within the endoscope (40).
  5. The cryosurgery system (100) of any of claims 1-4, wherein the energy transfer distal end is advanceable to the target region through the airway utilizing a 3-D virtual map.
  6. The cryosurgery system (100) of any of claims 1-5, wherein the energy transfer distal end is advanceable to the lung according to a treatment map user interface (745).
  7. The cryosurgery system (100) of any of claims 1-6, wherein the energy transfer distal end is configured to direct cryospray to a mucosal layer or a layer of the epithelial cells of the airway at the target region.
  8. The cryosurgery system (100) of any of claims 1-7, further comprising a flexible endoscope (40) insertable into the lung and a braided polymer sheath (401) disposed about the endoscope (40).
  9. The cryosurgery system (100) of claim 1, wherein the condition to be treated comprises symptoms of chronic obstructive pulmonary disease (COPD).
  10. The cryosurgery system (100) of claim 9, wherein the epithelial cells comprise ciliated cells or goblet cells, or both.
  11. The cryosurgery system (100) of any of claims 9 and 10, wherein the one or more of the symptoms comprise one or more symptoms of chronic bronchitis.
  12. The cryosurgery system (100) of claim 1, wherein the condition in the airway is characterised by the hypersecretion of mucus.
  13. The cryosurgery system (100) of claim 12, further comprising a flexible endoscope (40) insertable into the lung and wherein the energy transfer distal end is advanceable with or within the endoscope (40).
  14. The cryosurgery system (100) of any of claims 12 and 13 wherein the epithelial cells comprise ciliated cells or goblet cells, or both.

Description

Field of the Invention The present invention relates to medical devices for treating pulmonary diseases, more specifically to cryospray devices. Cross-Reference to Related Applications This application claims priority under 35 U.S.C. §119 to United States Provisional Patent Application no. 62/007,518 by Maners, et al. titled "Method and System For Consistent, Repeatable, and Safe Cryospray Treatment of Airway Tissue" and filed June 4, 2014 and to United States Provisional Patent Application No. 62/047,936 by Hanley et al. titled "Bronchoscopic Sheath For Measuring or Spacing" and filed September 9, 2014. Conversion Table for Non-SI Units The present patent application uses the Non-SI Units psi and inch. The Equivalent SI Units are respectively kPa and mm and the Conversion Factors are as follows: 1 psi = 6.89476 kPa1 inch = 25.4 mm. Background of the Invention The conducting airways of humans are lined by a superficial layer of epithelial cells which comprise an important primary line of defense to the entire respiratory tract. This superficial cellular layer consists primarily of mucus-producing (goblet) cells and ciliated cells. These cells function in a coordinated fashion to entrap inhaled biological and inert particulates and remove them from the airways. While this "mucociliary escalator" functions with great efficiency in the face of potentially injurious stimuli, it is a delicately balanced system relying on maintenance of appropriate complements of ciliated and mucus-producing cells and the normal functioning of those cells to accomplish effective clearance. Perturbations in epithelial cell type distribution and function can lead to adverse health effects. Ciliated cells represent approximately 80% of the epithelial cells residing on luminal borders of the large airways. While they are the most prevalent epithelial cell type lining the airways, many studies suggest that they also are among the most vulnerable to injury by infection, irritant, and pollutant exposure. The identifying characteristic of ciliated cells, are the highly organized appendages of the cell, i.e., the cilia which cover the luminal border. Mucus and other non-ciliated cells represent approximately 20% of the epithelial cells lining the luminal borders of the large airways. Mucus cells often are distended with secretory product and exhibit a characteristic "goblet" shape. Together with the submucosal glands, goblet cells secrete high molecular weight mucus glycoproteins (mucins). Goblet cells are thought to have the potential to produce markedly more mucus than do the glands, especially in response to injury such as environmental pollutants and other noxious elements such as tobacco/cigarette smoke. Other non-ciliated cells with fewer or no granules also may be present along the luminal border. These may represent mucus cells which have emptied their contents onto the luminal surface or cells which have not yet differentiated. The entire epithelial layer sits on a basement lamina comprised of collagen and connective tissue. All the cells of the epithelial layer are anchored to this "basement membrane." Chronic bronchitis is a non-infectious inflammatory disease typically resulting from airway injury due to a noxious element (usually smoking). It is defined by cough with productive sputum of three months duration for two consecutive years. It is further characterized by excess mucus (mucus hyperactivity/hypersecretion/hyperplasia of goblet cells) in the bronchi, damage to cilia and loss of ciliated cells. Noxious stimuli lead to airway inflammation with swelling of the lamina propria leading to thickening of the airway wall, and this functional narrowing causes shortness of breath. More specifically, this injury causes over-proliferating goblet cells to overproduce a thick viscous, acidic mucus which is difficult to clear due to cilia dysfunction. The acidic mucous in chronic bronchitis leads to inflammation of the airway wall and varies in viscosity. Asthma is a chronic respiratory disease characterized by bronchial inflammation, increased airway smooth muscle and airway hyper-responsiveness, in which airways narrow (constrict) excessively or too easily in response to a stimulus. Asthma episodes or attacks cause narrowing/constriction of the airways, which makes breathing difficult. Asthma attacks may occur at irregular intervals and be triggered by allergens or irritants that are inhaled into the lungs or by stress, cold air, viral infections or other stimuli. Asthma is sometimes, but not always, associated with mucus hyperactivity. Airway hypersecretion is a feature of other airway diseases as well, including chronic obstructive pulmonary disease (COPD), cystic fibrosis, viral bronchitis, and bronchiolitis. In an individual suffering from hypersecretion, mucus accumulates in the airways and may cause airway obstruction. Airway submucosal glands and goblet cells lining the airway epithelium secrete mucus, an adhesive, viscoelas