Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
  • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
  • A61M29/02—Dilators made of swellable material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00053—Mechanical features of the instrument of device
  • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
  • A61B2018/0022—Balloons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
  • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/958—Inflatable balloons for placing stents or stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/043—Bronchi
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
  • A61F2250/0048—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

• Obstructive lung disease including emphysema, chronic bronchitis, asthma and others, may lead to various obstructions and/or narrowing of airways within the bronchial tree.
• Airways that are affected by obstructive lung disease may include, for example, any of the trachea, main bronchi, lobar bronchi, segmental bronchi, sub-segmental bronchi, bronchioles, conducting bronchioles, terminal bronchioles and respiratory bronchioles.
• Airway obstructions may include the formation of mucous in the airways and/or scaring of the airways.
• Airway narrowing may be characterized by loss of radial tension of airways, thickening of the airway wall, and/or bronchoconstriction, among other examples.
• obstructive lung disease may lead to breakdown of alveolar walls.
• obstructive lung disease It becomes increasingly difficult for a patient to exhale as the airways or alveoli become damaged. Patients afflicted by obstructive lung disease may also face loss in muscle strength and an inability to perform common daily activities, among other ill effects. More detailed aspects of obstructive lung disease including additional aspects of the lungs, the bronchial tree, and airways are discussed further below.
• a prosthetic such as a conventional stent
• the central airways i.e., the trachea, main bronchi, lobar bronchi, and/or segmental bronchi
• the central airways only contribute a portion of the overall airway obstruction and/or airway narrowing seen in patients with obstructive lung disease.
• prosthetics when placed in the bronchial airways, are plagued by issues of occlusion including the formation of granulation tissue and mucous impaction. Accordingly, treatments that involve the placement of conventional stents in airways often result in only short term improved outcomes for patients because the stent is eventually occluded.
• This disclosure includes various devices, systems, and methods useful for improving airflow within a bronchial tree and/or into and out of the alveoli of the lung.
• the airways that connect central airways to alveoli are enlarged so as to improve airflow between the central airways and the alveoli.
• the connecting airways that connect the central airways to alveoli may be enlarged beyond their normal size to further improve airflow.
• the walls of some of the airways may become perforated allowing communication of additional alveoli that are adjacent to the connecting airways with the central airways.
• a first aspect of the disclosure involves an open form stent that, when placed within a lung of a patient, generally facilitates airflow to and/or from particular alveoli and more central airways, and also facilitates a minimization and localization of the formation of granulation tissue.
• the open form stent of the first aspect also makes use of collateral airflow between the particular alveoli and surrounding alveoli that is normally present in a lung, that is accentuated in an obstructed lung, and that is further accentuated in an emphysematous lung.
• the open form stent improves airflow between the particular alveoli and more central airways, more of the collateral airflow is able to make its way to the central airways as well.
• a second aspect of the disclosure involves an expandable object that, when placed within a lung of a patient, may expand one or more airway(s) beyond their normal diameter. Expansion of an airway may cause perforation(s) or tear(s) in the wall of the airway, thereby creating direct communications between the airway and surrounding alveoli, and may thereby increase airflow in and out of the airway not only from the alveoli normally connected to the airway but also from alveoli surrounding the airway.
• the expandable object is a dilatory balloon.
• the expandable object is a dilatory cryo balloon.
• the expandable object is a wire basket.
• the expandable object is the open form stent. Other examples exist.
• a third aspect of the disclosure involves a method for treating a patient using a stent (in some examples, an open-form stent) and an expandable object.
• the expandable object may be used to expand one or more obstructed airways and/or cause perforation(s) or tear(s) (i.e., openings) in the wall of the airway, and then the stent may be placed within the airway to further facilitate airflow within the airway.
• the stent may be placed for an indefinite period of time, or may be removed after a given period of time.
• a stent may be used to improve airflow without use of an expandable object.
• an expandable object may be used to improve airflow without use of a stent.
• One example embodiment includes a method for treating a subject.
• the method includes (1) placing an expandable object into one or more airways of the bronchial tree of the subject, (2) expanding the expandable object within at least one of the one or more airways such that at least a portion of the wall of the one or more airways is expanded, and (3) placing a stent in the one or more airways such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.
• the method involves (1) placing an expandable object into two or more airways of the bronchial tree of the subject, where a first end of the expandable object is situated within a first airway of the bronchial tree and a second end of the expandable object is situated within a second airway of the bronchial tree, (2) expanding the expandable object within at least two of the two or more airways such that at least a portion of a wall of the two or more airways is expanded, and (3) placing a stent within the at least two of the two or more airways such that a portion of the stent is adjacent to the portion of the wall of the two or more expanded airways.
• Another example embodiment includes a system used for treating a subject.
• the system includes (1) an expandable object, (2) a stent, and (3) instructions for improving airflow in one or more airways of a bronchial tree of a subject using the expandable object and the stent.
• the instructions for improving airflow in the airway of the bronchial tree of the subject using the expandable object and the stent may include, in one example: (a) placing an expandable object into one or more airways of the bronchial tree of the subject, (b) expanding the expandable object within at least one of the one or more airways such that at least a portion of the wall of the one or more airways is expanded, and (c) placing a stent in the one or more airways such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.
• FIG. 1 shows aspects of an example patient.
• FIG. 2 shows aspects of a terminal portion of an example bronchial tree.
• FIG. 3 A shows aspects of an example open-form stent.
• FIG. 3B shows aspects of an example open-form stent within an airway.
• FIGS. 4 A and 4B show aspects of an airway having an example open-form stent placed within the airway.
• FIGS. 4C and 4D show aspects of an airway having an example closed-form stent placed within the airway.
• FIGS. 5 A and 5B show aspects of an example open-form stent.
• FIG. 5C shows aspects of an example open-form stent within an airway.
• FIGS. 6 A and 6B show aspects on an example expandable object.
• FIGS. 7A and 7B show aspects of an expandable object within an airway.
• FIG. 7C shows aspects of an example expandable object.
• FIG. 8 shows an example method for improving airflow in an airway.
• FIGS. 9A, 9B, 9C, 9D, 9E, 9F, and 9G show example aspects of example methods.
• FIGS. 10A, 10B, IOC, 10D, 10E, and 10F show example aspects of example methods.
• FIG. 11 shows an example method for improving airflow in an airway.
• FIG. 12 shows an example method for improving airflow in an airway.
• FIG. 13 shows an example treatment protocol.
• the devices, systems, and methods described herein may be used for the purpose of improving airflow within a bronchial tree. More particularly, some devices, systems, and methods described herein include stents and expandable objects that may be used to improve airflow in airways of a patient's bronchial tree. However, it should be understood that such an application is but one particular application of the devices, systems, and methods described herein, and that other applications are certainly possible as well.
• the devices, systems, and methods described herein may generally provide for improved airflow in a manner that is relatively efficient, effective, and redundant when compared to other techniques.
• the devices, systems, and method described herein may minimize granulation and/or minimize occlusion issues associated with other known techniques that involve the use of foreign bodies.
• the devices, systems, and method described herein may also avoid some discomfort and inconvenience associated with some known techniques that involve the use of bypass paths. Therefore, many of the disadvantages of other techniques directed at attempts to improve airflow may be avoided.
• FIG. 1 shows aspects of an example patient 100.
• lungs 102 may generally be accessed by a treating physician via the patient's trachea 104, perhaps using a bronchoscope, catheter, or other such delivery device introduced to the patient's trachea through the mouth or nose.
• the patient's lungs contain a portion of the patient's bronchial tree 106.
• Bronchial tree 106 includes numerous airways including central airways such as the right and left main bronchus and the lobar bronchi, intermediary airways such as numerous segmental and sub-segmental bronchi, and non-central periphery airways such as the bronchioles, conducting bronchioles, terminal bronchioles and respiratory bronchioles., etc., discussed further below.
• central airways such as the right and left main bronchus and the lobar bronchi
• intermediary airways such as numerous segmental and sub-segmental bronchi
• non-central periphery airways such as the bronchioles, conducting bronchioles, terminal bronchioles and respiratory bronchioles., etc., discussed further below.
• the example bronchial tree shown also includes a diseased portion 108 located at a terminal point of the bronchial tree.
• diseased portion 108 may be understood to be affected by an obstructive lung disease such as emphysema, among other examples.
• the diseased portion may be characterized by damage that impairs the passage of air between airways and the alveoli, and therefore ultimately impairs the passage of gas from the air outside the patient to/from the lungs to/from the patient's blood stream.
• certain airways within the diseased portion may be occluded, collapsed, and/or otherwise constricted.
• alveolar walls within alveoli of the diseased portion may have deteriorated.
• a cursory discussion of the workings of the lungs may be beneficial.
• One function of the lungs is to permit the exchange of two gasses by removing carbon dioxide from blood and replacing it with oxygen.
• the lungs move oxygen and carbon dioxide between the air outside the patient's body and blood by bulk conduction through the bronchial tree to the alveoli and diffusion across a blood gas interface within the patient's alveoli.
• the air is brought to the patient's alveoli via airways of the patient's bronchial tree, housed within the patient's lungs.
• the bronchial tree includes branching airways that become narrower, shorter, and more numerous as they penetrate deeper into the lung.
• the trachea branches into the right and left main bronchus, which divide into a multitude of conducting airways starting with the lobar bronchi, intermediary airways such as segmental and sub-segmental bronchi, and periphery airways such as the bronchioles, conducting bronchioles, and finally terminal bronchioles.
• the terminal bronchioles each gives rise to several respiratory bronchioles, which go on to divide into multiple alveolar ducts, often ranging in number from two to eleven.
• FIG. 2 shows aspects of the terminal portion of the example bronchial tree, including examples of such smaller bronchioles.
• Example bronchial tree 200 includes bronchiole 202, which divides into terminal bronchioles 204. Terminal bronchiole 204 then divides into respiratory bronchioles 206. Also shown are example alveoli 208, containing alveolar sacs 210. As shown, various alveoli 212 may be present along the length of a respiratory bronchiole 206 as well. [0046] The terminal bronchioles 204 are the smallest airways that do not contain alveoli.
• a function of the bronchi and bronchioles is to provide conducting airways that lead air to and from the alveoli.
• the conducting airways do not contain alveoli and do not take park in gas exchange. Rather, gas exchange takes place in the alveoli that are found distal to the conducting airways, starting at the respiratory bronchioles.
• bronchial tree it is common to refer to, or otherwise characterize, the various airways of the bronchial tree according to “generations.” For instance, the trachea is referred to as “generation 0" of the bronchial tree. Various levels of bronchi, including the left and right main bronchi, are referred to as “generation 1.” The lobar bronchi are referred to as “generation 2.” The segmental bronchi are referred to as "generation 3.” Various bronchioles are referred to
• Terminal bronchioles for instance, are approximately “generation 14- 18.”
• Respiratory bronchioles for instance, are approximately “generation 16-20.” Further, it is common to refer to the airways extending from the trachea to the terminal bronchi as
• Obstructive lung disease such as emphysema in particular, is characterized by irreversible destruction of the alveolar walls that contain elastic fibers that maintain radial outward traction on small airways and are useful in inhalation and exhalation.
• these elastic fibers When these elastic fibers are damaged, these small airways are no longer under radial outward traction and can collapse, particularly during exhalation.
• air may be trapped in the lungs and not be able to be completely expelled during exhalation.
• Emphysema results in hyperinflation (air trapping) of the lung and an inability of the person to exhale. In this situation, the individual will be debilitated since the lungs are unable to perform gas exchange at a satisfactory rate and the lungs are hyperinflated and applying pressure to the chest wall, diaphragm, and surrounding structures.
• alveolar wall destruction is that the airflow between neighboring air sacs, known as collateral ventilation or collateral air flow, is increased.
• Chronic bronchitis is characterized by excessive mucous production in the bronchial tree. Usually there is a general increase in bulk (hypertrophy) of the large bronchi and chronic inflammatory changes in the small airways. Excessive amounts of mucus are found in the airways and semisolid plugs of the mucus may occlude small bronchi. Also, the small airways are usually narrowed and show inflammatory changes.
• the devices, systems, and methods described herein may generally be used to improve airflow out of hyperinflated alveoli within a diseased portion 108 of the lung that are affected by obstructive lung disease such as emphysema and /or bronchitis and into central airways of the bronchial tree. Accordingly, the example stents and expandable objects described more fully below may be delivered to and placed within airways that connect central airways to the distal airways and alveoli of diseased portion 108.
• FIG. 3A shows aspects of an example open-form stent 300.
• the open-form stent may generally have an open configuration, in the form of a coil-like or spring-like structure. It may be understood that the coil is characterized by a continuous outer diameter.
• the outer diameter of the coil may sometimes be referred to as an "open-form wall" for purposes of example and explanation.
• the open-form wall comprises a continuously open helical surface, discussed further below in connection with FIGS. 4A and 4B.
• FIG. 3B shows aspects of open-form stent 352 in airway 350.
• surface of airway 350 may be characterized by a mucociliary structure (or “elevator”) on its inner wall that is capable of clearing mucous within the airway.
• the mucociliary structure may include cilia that continuously move mucous along, and ultimately out of, the airway. Because no portion of open-form stent 350 entirely isolates a given area of the inner wall of airway 350, natural mucociliary processes of the airway may generally not be inhibited when the open-form stent is in place.
• the open-form stent may be characterized by a certain amount of flexibility and recoil, such that the open-form stent will minimize mechanical toxicity within the airway, especially when expanding across multiple airways.
• the open-form stent may bend and move with the airway, and thereby minimize foreign-body response within the airway.
• such an open-form stent will minimize inflammation and will minimize the formation of granulation tissue within the airway.
• what inflammation and granulation tissue that forms will be concentrated near the contact of the stent with the wall such that air and/or mucous may still move along the airway in the helical open space of the stent.
• the open-form stent is characterized by an open-form wall that does not close off the exterior of the stent from the interior of the stent, the open-form stent may allow for collateral airflow from side passages, such as alveoli or induced perforations connecting to other surround alveoli, into the main lumen of the airway.
• the open-form stent may be formed of any suitable material.
• the open-form stent may be formed of a silicone polyester material. Examples include urethane, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and polyetherether ketone (PEEK).
• the open-form stent may be formed of a metal material. Examples include stainless steel and nitinol. Other examples of suitable materials exist.
• the open-form stent may be coated in one or more suitable coatings.
• the open-form stent may be coated in an antiproliferative agent such as sirolimus, everolimus, zotarolimus, paclitaxel, taxotere, mitomycin-C, among others.
• the open-form stent may be coated in an antimucous agent such as atropine, ipratropium, tiotropium or a steroid.
• the open form stent may be coated in a mucolytic material such as N-acetylcystine or guifensin.
• the open- form stent may be coated in a hydrophilic material.
• suitable coatings exist.
• example open-form stent 300 has a given length 302, which may be any suitable length and may vary depending on application including what airway(s) the open-form stent is to ultimately be placed. In one example, length 302 may be between 2cm to 10cm in length. For instance, length 302 may be approximately 6cm in length. Other lengths may be suitable as well.
• example open-form stent 300 has a given height, or diameter 304, which may be any suitable diameter and may vary depending on application including what airway(s) the open-form stent is to ultimately be placed. In one example, diameter 304 may be between 1mm to 10mm. For instance, the diameter may be between 4mm to 8mm. In other cases, the diameter may be approximately 6mm. Other diameters may be suitable as well.
• example open-form stent 300 may include a hook 306 on one or both ends.
• the hook may be looped back on itself so as to form a closed structure at one or both ends.
• the open-form stent 300 may include a smooth, rounded ball at one or both ends.
• Such structures as the hook, loop, or ball may be used when placing the open-form stent in an airway, to aid the accessibility and/or manipulability of the open-form stent. Use of such structures may further limit the trauma the ends of the open-stent may cause on tissue.
• such a structure may further limit the formation of granulation tissue or may prevent formation of a pneumothorax if an end of the open-form stent were to come into contact with the visceral pleura, and/or may prevent pain if an end of the open-form stent were to come into direct or indirect contact with the parietal pleura.
• FIG. 4A shows aspects of open-form stent 402 within airway 400. Also depicted in FIG. 4A is a continuous helical pathway along the wall of airway 400 that remains when open-form stent 402 is placed within airway 400. As shown by the various arrows in FIG.4A, a continuous helical pathway exists along the open-form wall of the open-form stent that permits relatively uninterrupted traversal of the inner wall of the airway along the helical pathway. As noted above, mucuous may be cleared along this helical pathway by the mucociliary structure of airway 400. Of note, although open-form stent 402 is shown within only a single portion of airway 400, it should be understood that open-form stent 402 may extend into other portions of airway 400 and/or may extend into other airways altogether.
• FIG. 4B shows aspects of open-form stent 452 within airway 450.
• open form-form stent 452 is characterized by a continuous helical pathway that exists along its open-form wall.
• granulation tissue along the structure of open-form stent 452 shown as various X indicators along the open-form stent.
• the granulation tissue formation is localized along the structure of the open-form stent itself.
• the continuous helical pathway along the open-form wall remains.
• the mucociliary structure of airway 450 is not prevented from functioning to clear mucous from the airway and an uninterrupted pathway for the movement of air along the airway remains.
• FIG. 4C shows aspects of closed-form stent 462 within airway 460, as known in the art.
• closed-form stent 462 does not provide a continuous helical pathway along the wall of airway 460. Instead, the structure of closed-form stent 462, including its pervasive structure along its length, prevents traversal of the inner wall of the airway. While a particular example structure is shown in FIG. 4C as a closed-form wire frame, those of skill in the art will appreciate that other known closed-form stents exist including stents characterized by solid (rather than wire-frame) walls.
• FIG. 4D shows aspects of closed-form stent 472 within airway 470. Like closed-form stent 462, closed-form stent 472 does not provide a continuous helical pathway along the wall of airway 470. Also depicted in FIG. 4D is granulation tissue along the structure of closed-form stent 472, shown as various X indicators along the closed-form stent
• FIGS. 5A-5C show an alternative example open-form stent.
• FIG. 5A shows an example open-form stent 500, characterized by relatively less turns per unit length than that shown above with respect to FIGS. 3A and 3B.
• the coil structure of open-form stent 500 may be combined with at least one additional coil structure to form an open-form stent that is characterized by at least a double helix structure.
• FIG. 5B An example of an example double helix open-form stent 550 is shown in FIG. 5B.
• example open-form stent is formed of a first coil structure 552 and a second coil structure 554.
• the first coil structure 552 and the second coil structure 554 may connect at one or both ends of the open-form stent thereby creating a loop.
• Such a loop may aid in placement or removal and may also eliminate any potential sharp ends of the first coil 552 and the second coil 554 thereby decreasing trauma that the open form stent may cause to the airway and surrounding tissues.
• This double coil open-form stent can produce the same area of stent-airway wall contact as a single coil open-form stent, but produce less angulation of the coil wires relative to the airway compared to that which is produced by a single coil stent.
• the double coil open-form stent may allow for a more direct pathway for the movement of air and mucous along the airway.
• such a double helix open-form stent may be placed in an airway of a bronchial tree to improve airflow.
• double helix open-form stent 582 is placed in airway 580.
• open-form stent 582 is shown within only a single portion of airway 580, it should be understood that open-form stent may extend into other portions of airway 580 and/or may extend into other airways altogether.
• FIG. 6A shows aspects of an example expandable object 600.
• the expandable object may generally be characterized by a resiliently flexible bulb, or other open body, that encloses an interior space.
• Expandable object 600 may have a first end 602 that is closed and a second end
• the first end may also be open. Either or both open ends may then be coupled to other extensions or connected objects, such as tubing, that permit communication of fluids such as gases and/or liquids into and out of the interior space of expandable object 600.
• the expandable object may be formed of any suitable material.
• the expandable object may be formed of a one or more or silicone, polyvinyl chloride (PVC), nylon, polyethylene terephthalate (PET), polyether block amide (PEBAX), mylar, and/or latex.
• PVC polyvinyl chloride
• PET polyethylene terephthalate
• PEBAX polyether block amide
• mylar and/or latex.
• suitable materials exist.
• the expandable object may be coated in any suitable material.
• the expandable object may be coated in an antiproliferative agent (such as taxatore, paclitaxel, and/or sirolimus, among other examples).
• an antiproliferative agent such as taxatore, paclitaxel, and/or sirolimus, among other examples.
• such an antiproliferative agent may generally assist in maintaining the patency of any tear or perforation formed in the airway wall by use of the expandable object.
• such an antiproliferative agent may help ensure the effectiveness of a treatment, particularly when the treatment does not involve the placement of a stent.
• the expandable object may be coated in one or more of an antimucous agent, a mucolytic agent, and a hydrophilic agent. Other examples of suitable coatings exist.
• FIG. 6A With reference to FIG. 6A, the expandable object 600 is shown in a relaxed state where the expandable object is not expanded.
• example expandable object 650 is shown in an
• the expandable object in operation may be placed in an airway or multiple connected airways that form a pathway from more central airways to more peripheral airways or alveoli and then expanded so as to also expand the airway or airways.
• the expandable object may be referred to herein as a "dilatory balloon.”
• the dilatory balloon may be used to intentionally dilate an airway(s) or portion of connected airways beyond its normal or natural diameter. In such a situation, the dilatory balloon may perforate, puncture, or otherwise damage the wall of an airway or portion of connected airways. In some cases, expansion of the dilatory balloon will operate to form generally longitudinal tears in the wall of an airway or portion of connected airways. Notably, such longitudinal tears will tend to run largely parallel to blood vessels, which themselves tend to run along the length of airways. As a result, trauma to blood vessels themselves will be minimized, and so will bleeding be minimized.
• FIGS. 7A and 7B show an example expandable object within an airway.
• expandable object 700 is shown, in a relaxed state, introduced within airway 702.
• expandable object 700 is shown, in an expanded state, within airway 702.
• expandable object 700 has extended airway 702 beyond its normal size and has introduced opening 704 into the wall of airway 702. This effect may occur in the wall of a single airway or to one or more walls of connected airways.
• expandable object 700 is shown within only a single portion of airway 702, it should be understood that expandable object 700 may extend into other portions of airway 702 and/or may extend into other airways altogether.
• the balloon may taper in size from one end to the other.
• the balloon may include a bulbous end that is relatively larger than another portion of the balloon body.
• the balloon may include two bulbous ends.
• the balloon may include one or more irregular implements on its out surface such as a ridge or other obtrusion that may concentrate force generated during pressurization and expansion of the balloon and enable the balloon to more readily perforate an airway wall when expanded. Irregular shapes of the balloon may generally serve the purpose of extending the airway in desired ways so as to introduce desired openings into the airway.
• the use of the dilatory balloon described herein may differ from prior uses of expandable objects within the bronchial tree, such as dilatory balloons used in bronchoplasty.
• dilatory balloons used in bronchoplasty may be used in more periphery airways such as those described above with respect to FIG. 2.
• the dilatory ballon described herein may be used to expand the airway beyond its normal size and in some instances produce openings in an airway wall or in one or more connected airways. Openings introduced in the airway wall may therefore aid in improving airflow between alveoli and other more central airways.
• Introduction of the dilatory balloon into periphery airways for this purpose may be accomplished using a relatively quick and efficient medical procedure in which it may be placed directly into the airway, passed through a bronchoscope placed in the trachea or other airways, through a endotracheal tube placed in the trachea, a laryngeal mask airway placed in hypopharynx, among other access methods.
• the procedure may be
• the procedure may be significantly more convenient and significantly less intrusive than other techniques for improving airflow.
• the expandable object may take the form of a cryo balloon.
• cryo ballon 780 coupled, in fluid communication, with delivery catheter 782.
• catheter 782 may contain a fluid delivery passage 784 and fluid drain passage 786.
• Each of the walls of catheter 782, fluid delivery passage 784, and fluid drain passage 786 may be made from materials known to those skilled in the art.
• Aspects of example cryo balloon 780 have been simplified for purposes of example and explanation.
• Cryo balloon 780 may include other aspects as understood to those skilled in the art. [0082] In use, cryo balloon 780 may be placed within a desired airway or a multiple connected airways of the bronchial tree.
• Coolant may then be released into the balloon from a pressurized cartridge, container, and/or pump (not shown) through fluid delivery passage 784 to cool the airway at a rate appropriate for the application.
• coolant may be sprayed into the balloon through fluid delivery passage 784, a separate sprayer, or other suitable elements.
• the balloon may be inflated (e.g., by coolant) to a desired pressure (corresponding to a desired size).
• a desired pressure corresponding to a desired size
• the temperature of the airway may be dropped.
• the resultant temperature will be below body temperature and, with potentially improved results below 0 °C and even more potentially improved results significantly below 0 °C.
• the temperature of surrounding tissues may also be reduced significantly below 0 °C.
• the inflation fluid may be any suitable low freezing point liquid such as an ethanol mixture or saline mixture or a liquefied gas such as N 2 0 or C0 2 .
• Liquid N 2 can be used as a general purpose coolant. When N 2 is used, it can be transported to the balloon in the liquid phase where it evaporates at the exit of fluid delivery passage 784 and enters the balloon as a gas.
• Freon, N 2 0 gas, and C0 2 gas can also be used as coolants.
• Other coolants could be used such as cold saline solution, Fluisol, or a mixture of saline solution and ethanol. Other examples of coolants exist.
• the expandable object may take other forms as well.
• the expandable object may take the form of a wire basket that is capable of decompressing and compressing. Such a wire basket may be well suited for causing perforations and/or tears in an airway wall in addition to expanding the airway wall.
• FIG. 8 generally shows an example method 800 for improving airflow within an airway.
• Method 800 shown in FIG. 8 may be described herein with reference to the above figures. It should be understood, however, that this is for purposes of example and explanation only and that the operations of the methods should not be limited by these figures.
• Method 800 may include one or more operations, functions, or actions as illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.
• Method 800 generally involves, at block 802 placing an expandable object into one or more airways of a bronchial tree of a subject.
• Block 804 includes expanding the expandable object within the airway.
• block 806 includes placing a stent in the airway.
• method 800 may additionally/optionally involve, at block 801 identifying a diseased area to be treated.
• Block 801 involves identifying a diseased area to be treated.
• a treating physician may identify the diseased area of a bronchial tree using any suitable technique including any such suitable technique known to those of skill in the art.
• the treating physician may identify a diseased area such as area 108 shown in FIG. 1.
• Block 802 involves placing an expandable object into one or more airways of a bronchial tree of a subject.
• the subject may be understood with respect to patient 100.
• the bronchial tree may be bronchial tree 106, and the one or more airways, or at least a portion thereof, may be an airway or portion of connected airways within diseased region 108 of the lung.
• block 802 involves placing the expandable object into the diseased area identified with respect to block 801.
• placing the expandable object may involve placing the expandable object into two or more airways of the bronchial tree of the subject. In such a situation, a first end of the expandable object is situated within a first airway of the bronchial tree and a second end of the expandable object is situated within a second airway of the bronchial tree.
• the expandable object may be any suitable expandable object including, but not limited to, any one of the example expandable objects discussed above with respect to FIGS. 6A, 6B, 7A, 7B, and 7C.
• the expandable object may include a dilatory balloon.
• a dilatory balloon may, in some instances, be a cryo ballon.
• the dilatory balloon may include a bulbous form on a distal end.
• the dilatory balloon may include at least a portion of its outer surface that is non-uniform.
• the outer surface may include a ridge and/or other obtrusion to aid in the expansion and/or formation of openings in an airway wall.
• placing the expandable object may involve placing the expandable object using a delivery device such as a catheter, guide wire, bronchoscope and the like.
• placing the expandable object may additionally involve identifying the targeted area of a diseased lung, and directing the expandable area towards the identified area such that at least a portion of the expandable object is near the diseased portion of the lung.
• the expandable object may be affixed to a distal end of the delivery catheter.
• a treating physician may then introduce the expandable object into the trachea 104 of the patient.
• the treating physician may then guide the expandable object through the bronchial tree and into a peripheral airway of the bronchial tree.
• the distal end of the expandable object may ultimately be delivered to a peripheral diseased region 108, and into a respiratory bronchiole 206 while the proximal end of the expandable object remains in a more proximal airway such as a terminal bronchiole, conducting bronchiole, bronchiole, sub- segmental bronchus, segmental bronchus or lobar bronchus.
• FIGS. 9 A and 9B Aspects of block 802 are shown with respect to FIGS. 9 A and 9B.
• expandable object 900 is shown as being guided into airway 902.
• FIG. 9B expandable object 900 is shown as having been placed in a desired location of airway 902.
• an alternative example placement of an expandable object may involve placing the expandable object within the bronchial tree such that the expandable object spans multiple types of airways.
• expandable object 912 is placed within bronchial tree 910 such that the distal end of expandable object 912 is situated within a respiratory bronchiole and such that the proximal end is extending proximally into larger and more central airways.
• Block 804 involves expanding the expandable object within the airway such that at least a portion of the airway or a portion of connected airways is expanded. In some cases, at least one opening is formed in a wall of the airway as a result of the expansion of the expandable object.
• expanding the expandable object may involve expanding the expandable object within at least two of two or more airways such that at least a portion of a wall of the two or more airways is expanded.
• the expandable object may be expanded by introducing fluid such as liquid and/or gas, into the expandable object.
• fluid such as liquid and/or gas
• the cryo balloon may be expanded by introducing N 2 0 into the cryo balloon.
• FIG. 9C Aspects of block 804 are shown with respect to FIG. 9C.
• expandable object 900 has been expanded such that airway 902 is expanded beyond its normal size.
• the expandable object has caused airway 902 to tear such that an opening is now present in the airway wall.
• a tear is shown as formed in airway 902, it should be understood that it is not necessary to form an opening in all implementations. In some implementations it may be desirable and/or sufficient to dilate the airway without tearing the airway.
• block 804 may involve forming at least one opening in the airway wall.
• expandable object 912 may be expanded such that multiple sections of airways of bronchial tree 910 are expanded.
• tears and/or perforations may be formed within multiple sections of airways.
• the expandable object may then be removed. As shown with respect to FIG. 9D, expandable object 900 has been returned to a relaxed state. Expandable object 900 may then be guided out of the airway, back through the bronchial tree, and out of the patient's trachea.
• Block 806 involves placing a stent in the airway such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.
• placing the stent may involve placing the stent in the airway such that a portion of the stent is adjacent to at least a portion of the opening in the wall of the airway.
• placing a stent may involve placing the stent within at least two of two or more airways such that a portion of the stent is adjacent to a portion of two or more expanded airways.
• the stent may be any suitable stent including, but not limited to, any one of the open-form stents discussed above with respect to FIGS. 3 A, 3B, 4A, 4B, 5A, 5B, and 5C.
• the open form stent may include a coil.
• the stent may include both a first coil and a second coil.
• the open form stent has an open form wall, as discussed above.
• no portion of the open-form wall entirely isolates a given area of the open-form wall.
• the open-form wall may have a continuously open helical surface along its length.
• block 806 may involve placing a closed form stent.
• open-form stent 904 is shown as being guided into airway 902. As shown, while being guided into place, open-form stent may be held in a compressed form to aid in maneuverability through the bronchial tree. With respect to FIG. 9E, open-form stent 904 is shown as having been placed in a desired location of airway 902 and permitted to expand. As shown, open-form stent 904 has been placed adjacent to the opening in airway 902.
• Open-form stent 904 may then be left in the airway indefinitely and/or until a treating physician determines to remove the open-form stent.
• the open-form stent may be placed temporarily and removed after some predetermined amount of time. In this way, removal of the open-form stent will leave an open tissue conduit between central airways and the alveoli.
• the expandable object may be placed together with the stent.
• Example aspects of such an embodiment are shown with respect to FIGS 10A, 10B, IOC, 10D, 10E, and 10F.
• the stent 1002 may be positioned so as to encompass at least a portion of the expandable object. In this way, the expandable object 1000 and stent 1002 form a package that may together be guided into an airway.
• the package of expandable obj ect 1000 and stent 1002 may then be guided into airway 1004. As shown in FIG. IOC, the package of expandable object 1000 and stent 1002 has been placed in a desired location of the airway.
• the expandable object 1000 may then be expanded.
• stent 1002 may be arranged so that it increases in size as expandable object 1000 expands.
• an opening in airway 1004 is formed.
• the expandable object 1000 may then be returned to a relaxed state.
• open-form stent 1002 may maintain a decompressed form, such that it now exerts radial tension on the airway or portion of connected airways.
• open-form stent 1004 may exert such radial tension on the airway or portion of connected airways adjacent to at least a portion of the at least one opening that was formed.
• stent 1002 may remain in place within airway 1004 or portion of connected airways. Further, in some examples stent 1002 may remain in place within the bronchial tree such that the stent spans multiple types of airways. For instance, in some ways similar to expandable object 912 shown in FIG. 9G, stent 1002 may be placed within a bronchial tree such that the distal end of the stent is situated within a respiratory bronchiole and such that the proximal end is extending proximally into larger and more central airways.
• FIG. 11 generally shows another example method 1100 for improving airflow within an airway or portion of a series of connected airways.
• Method 1100 shown in FIG. 11 may be described herein with reference to various other figures. It should be understood, however, that this is for purposes of example and explanation only and that the operations of the methods should not be limited by these figures.
• Method 1100 may include one or more operations, functions, or actions as illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.
• Method 1100 generally involves, at block 1102, sizing an open-form stent.
• Block 1104 includes placing the open form stent
• Block 1102 involves sizing a stent.
• the size of the stent may be characterized by estimates of both diameter of the stent and length of the stent.
• the open-form stent may be any suitable stent including, but not limited to, any one of the open-form stents discussed above with respect to FIGS. 3A, 3B, 4A, 4B, 5A, 5B, and 5C.
• the stent may be sized according to any suitable technique.
• the stent may be sized based on an approximated size of an airway that the stent is to be placed into. For instance, a size corresponding to an average size of a respiratory bronchiole may be used. As another example, a size corresponding to the diameter of the most proximal airway in which the stent is to be placed may be used.
• the open-form stent may be sized based on an image of a given patient's bronchial tree.
• the patient's bronchial tree may be imaged prior to placement of the stent using known imaging techniques and the stent may be sized according to a size indicated by the image.
• distances can be estimated from images generated using known imaging techniques of the patient's chest during the actual procedure.
• the stent may be sized using an expandable object such as an expandable object described elsewhere herein.
• an expandable object such as an expandable object described elsewhere herein.
• the expandable object prior to placement of the stent, the expandable object may be placed within the airway and expanded. Then, a size of the expandable object in the expanded state may be used to infer an appropriate size for the stent.
• a pressure of the expandable object may be measured when the expandable object is in the expanded state. The pressure may be measured using a pressure gauge located on the proximal end of a delivery system for the expandable object. The measured pressure may be correlated to an appropriate size for the stent.
• Block 1104 involves placing the stent in one or more airways.
• the stent may be placed in any suitable manner.
• the stent may be placed in accordance with the description above associated with FIGS. 9E and 9F.
• FIG. 12 generally shows another example method 1200 for improving airflow within an airway.
• Method 1200 shown in FIG. 12 may be described herein with reference to various other figures. It should be understood, however, that this is for purposes of example and explanation only and that the operations of the methods should not be limited by these figures.
• Method 1200 may include one or more operations, functions, or actions as illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.
• Method 1200 generally involves, at block 1202, placing an expandable object into one or more airways of a bronchial tree of a subject.
• Block 1204 includes expanding the expandable object from a relaxed state to an expanded state within at least one of the one or more airways .
• Block 1206 includes returning the expandable object from the expanded state to the relaxed state.
• block 1208 includes removing the expandable object form the bronchiole.
• Block 1202 involves placing an expandable object into one or more airways of a bronchial tree of a subject.
• the expandable object may be placed using any suitable technique including those described herein. For instance, the expandable object may be placed as shown above with respect to FIGS. 9 A and 9B or FIGS. 10B and IOC.
• Block 1204 involves expanding the expandable object from a relaxed state to an expanded state within at least one of the one or more airways such that at least a portion of the airway or connected airways is expanded.
• at least one opening is formed in a wall of the one or more airways as a result of the expansion of the expandable object.
• the expandable object may be expanded within the airway using any suitable technique including those described herein. For instance, the expandable object may be expanded as shown above with respect to FIG. 9C and FIG. 10D.
• the expandable object may be sized such that the expandable object, when expanded, assumes an outer diameter similar to that described above with reference to the stents.
• Block 1206 involves returning the expandable object from the expanded state to the relaxed state.
• the expandable object may be returned to the relaxed state using any suitable technique including those described herein. For instance, the expandable object may be returned to the relaxed state as shown above with respect to FIG. 9D and FIG. 10E.
• Block 1208 involves removing the expandable object from the one or more airways
• the expandable object may be removed using any suitable technique including those described herein. For instance, the expandable object may be removed as shown with respect to FIG. 9D and FIG. 10E.
• FIG. 13 generally shows an example treatment protocol 1300 that may be used in conjunction with the various techniques described herein for improving airflow within an airway.
• treatment protocol 1300 While certain functions are described with respect to treatment protocol 1300, it should be understood that additional and/or other functions may be performed as well.
• Treatment protocol 1300 begins at block 1302, where a patient is given a pulmonary history and physical. If the pulmonary history (Hx) and/or physical indicate that there is a possibility of lung disease, the protocol continues to block 1304.
• the patient is given a pulmonary function test (PFT).
• PFT may include a battery of tests including but not limited to spirometry, static lung volume measurement, diffusing capacity for carbon monoxide, airways resistance, respiratory muscle strength, and arterial blood gases, among other examples.
• the patient is given a CT scan.
• the CT scan image and data is then analyzed by the treating physician.
• the protocol proceeds to block 1314, where it ends. If yes, the protocol proceeds to block 1316. In some situations, it may further be determined that there exists no evidence of significant airway disease or no isolated airway disease without concurrent emphysema before proceeding to block 1316.
• the treating physician identifies a diseased area to be treated.
• a treating physician may identify the diseased area of a bronchial tree using any suitable technique including any such suitable technique known to those of skill in the art.
• the treating physician may identify a diseased area such as area 108 shown in FIG. 1.
• the treating physician treats one or more airways within the patient's bronchial tree so as to improve airflow.
• the airway may be treated in accordance to any method for improving airflow within an airway described herein including, for example, one or more of method 800, method 1100, and method 1200.
• a system may be provided in accordance with the various methods described herein.
• the system may include one or more of an expandable object, a stent, and instructions for improving airflow in an airway of a bronchial tree.
• the stent may be any of the stents described herein such as those described with respect to FIGS. 3A, 3B, 4A, 4B, 5A, 5B, and 5C.
• the expandable object may be any of the expandable objects described herein such as those described with respect to FIGS. 6A, 6B, 7A, 7B, and 7C.
• the instructions for improving airflow may correspond to any of the example methods for improving airflow described herein such as any of methods 800, 1100, and 1200.
• the system may further include other objects.
• One example includes a cartridge containing compressed and/or liquefied gas used for expanding the expandable object.
• Another example includes a pressure gauge used for monitoring the pressure within the expandable object.
• Yet another example includes one or more delivery catheter used for guiding the expandable object and/or the stent through the bronchial tree.

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