System for improving airflow within the bronchial tree of an emphysematous lung

Abstract

The present application relates to a system for improving airflow within the bronchial tree of an emphysematous lung. The system comprises: a delivery device; and an implantable object comprising a distal end and a proximal end. The implantable object is configured to: place the implantable object through multiple generations of connected airways using the delivery device such that the distal end is placed in a first airway within a terminal portion of the bronchial tree and the proximal end is placed in a second airway within a mid-portion of the bronchial tree; and, when placing the implantable object through the multiple generations of connected airways, expand the implantable object such that at least a portion of the multiple generations of connected airways expands from (i) an initial diameter prior to placement of the implantable object to (ii) an expanded diameter that is greater than the initial diameter.

Description

[0001] Divisional application information

[0002] This application is a divisional application of the invention patent application with application date of September 13, 2016, application number 201680061529.1, and invention name “Improving Pulmonary Airflow”.

[0003] Cross-reference to related applications

[0004] This application claims priority to U.S. Non-Provisional Patent Application No. 14 / 852,609, filed September 13, 2015, entitled “Improving Pulmonary Airflow,” which is incorporated herein by reference in its entirety. Background Art

[0005] Obstructive lung diseases (including emphysema, chronic bronchitis, asthma, and others) can cause various obstructions and / or narrowing of the airways within the bronchial tree. Airways affected by obstructive lung disease may include, for example, any of the trachea, mainstem bronchi, lobar bronchi, segmental bronchi, subsegmental bronchi, bronchioles, conducting bronchioles, terminal bronchioles, and respiratory bronchioles. Airway obstruction may include mucus formation and / or scarring in the airways. Airway narrowing may be characterized by loss of radial tone, airway wall thickening, and / or bronchoconstriction, among other examples. Furthermore, obstructive lung disease may lead to rupture of alveolar walls.

[0006] When the airways or alveoli become damaged, it becomes increasingly difficult for a person to exhale. Patients with obstructive lung disease may also experience loss of muscle strength and difficulty performing daily activities, among other side effects. More detailed aspects of obstructive lung disease, including additional aspects of the lungs, bronchial tree, and airways, are discussed further below.

[0007] Many efforts have been made to heal and / or improve the damage to the bronchial tree caused by obstructive lung disease. Other efforts have been made to alleviate the obstruction and / or narrowing caused by obstructive lung disease. Still other efforts have been made to improve airflow in and out of the alveoli of the lungs. However, these efforts have currently encountered many challenges.

[0008] Some treatments involve placing prostheses (e.g., conventional stents) in the central airways (i.e., the trachea, mainstem bronchi, lobar bronchi, and / or segmental bronchi) in an attempt to maintain these airways open. Unfortunately, the central airways only account for a portion of the total airway obstruction and / or airway narrowing seen in patients with obstructive pulmonary disease. Furthermore, prostheses are subject to clogging issues, including the formation of granulation tissue and mucus impaction, when placed in the bronchial airways. Consequently, treatments involving the placement of conventional stents in the airways typically provide only short-term improvement in patients because the stents eventually become blocked.

[0009] Other treatments involve attempts to bypass the blocked bronchial airways by forming a perforation through the chest wall to the outer part of the lung, thereby forming a direct connection (i.e., a bypass) between the diseased alveoli and the outside of the body. If no other measures are taken, these bypasses will close due to normal healing or due to the formation of granulation tissue. The treating physician may attempt to extend the duration of non-closure by placing a tubular hollow prosthesis in the bypass. However, these prostheses can trigger a foreign body reaction and accelerate the formation of granulation tissue, thereby causing the bypass to eventually become blocked. In addition, this bypass surgical procedure is difficult to perform, is time-intensive, uncomfortable, inconvenient, and debilitating for the patient.

[0010] Other treatments involve forming perforations between selected central airways (e.g., main bronchus or lobar bronchus) and diseased alveoli in an attempt to bypass the blocked connecting airways. If no other measures are taken, the perforations will heal regularly, which will minimize the long-term effectiveness of these treatments. Attempts have been made to maintain the perforation from closing by placing a support stent in the lumen of the perforation. In addition, the stent can be covered with silicone and / or coated with antiproliferative drugs to minimize the normal healing response and / or foreign body reaction (including granulation tissue formation). However, unfortunately, these measures are generally insufficient and the support stent will also trigger a foreign body reaction that usually blocks the stent and causes the perforation to close, including granulation tissue formation. In addition, mucus produced from the glands in the central airways usually blocks the stent and causes the perforation to close.

[0011] These and other problems still affect existing treatments for obstructive lung disease, and reliable ways to avoid these problems have not yet been developed. It is therefore desirable to develop treatments for the problems caused by obstructive lung disease (for example, obstruction and narrowing of the airways of the bronchial tree) that more reliably avoid the problems encountered with existing treatments. Summary of the Invention

[0012] The present invention encompasses various devices, systems, and methods for improving airflow within the bronchial tree and / or into and out of the alveoli of the lungs. In some instances, airways connecting central airways to alveoli are enlarged to improve airflow between the central airways and the alveoli. In some instances, the connecting airways connecting the central airways to the alveoli can be enlarged beyond their normal size to further improve airflow. In other instances, when the airways are enlarged beyond their normal size, the walls of some airways can be punctured, thereby allowing additional alveoli adjacent to the connecting airways to communicate with the central airways.

[0013] A first aspect of the present invention relates to an open-ended stent that, when placed in a patient's lung, generally improves airflow to and / or from specific alveoli and more central airways, and also helps minimize and localize the formation of granulation tissue. Advantageously, the open-ended stent of the first aspect also utilizes collateral airflow between specific alveoli and surrounding alveoli typically present in the lung, which is prominent in obstructed lungs and even more pronounced in emphysematous lungs. Specifically, because the open-ended stent improves airflow between specific alveoli and more central airways, more collateral airflow is also able to enter the central airways.

[0014] A second aspect of the invention relates to an inflatable object that, when placed within a patient's lungs, can cause one or more airways to expand beyond their normal diameter. The expansion of the airway can create perforations or breaks in the airway wall, thereby creating direct communication between the airway and the surrounding alveoli, and can thereby increase airflow into and out of the airway not only from the alveoli normally connected to the airway, but also from the alveoli that surround the airway. In one example, the inflatable object is an inflatable balloon. In another example, the inflatable object is an inflatable cryoballoon. In another example, the inflatable object is a wire basket. In another example, the inflatable object is an open-type stent. Other examples exist.

[0015] A third aspect of the present invention relates to a method for treating a patient using a stent (in some instances, an open stent) and an expandable object. According to this method, an expandable object can be used to expand one or more obstructed airways and / or form perforations or ruptures (i.e., openings) in the walls of the airways, and the stent can then be placed within the airways to further promote airflow within the airways. The stent can be placed indefinitely or removed after a given period of time.

[0016] In some instances, a stent may be used to improve airflow without the use of an inflatable object. In other instances, an inflatable object may be used to improve airflow without the use of a stent.

[0017] As discussed in more detail below, the present invention also relates to other aspects, some of which include and / or incorporate the three aspects described above.

[0018] One exemplary embodiment includes a method for treating a subject. The method includes: (1) placing an inflatable object into one or more airways of a bronchial tree of the subject; (2) inflating the inflatable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is inflated; 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 inflated airways. In some examples, the method involves: (1) placing an inflatable object into two or more airways of the bronchial tree of the subject, wherein a first end of the inflatable object is located within a first airway of the bronchial tree and a second end of the inflatable object is located within a second airway of the bronchial tree; (2) inflating the inflatable object in 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 inflated; and (3) placing a stent in 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 inflated airways.

[0019] Another exemplary embodiment includes a system for treating a subject. The system includes: (1) an inflatable object; (2) a stent; and (3) instructions for using the inflatable object and the stent to improve airflow in one or more airways of the subject's bronchial tree. The instructions for using the inflatable object and the stent to improve airflow in the airways of the subject's bronchial tree may include: in one example: (a) placing an inflatable object into one or more airways of the subject's bronchial tree; (b) inflating the inflatable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is inflated; and (c) placing the 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 inflated airways.

[0020] These and other embodiments, aspects, advantages and alternatives will become apparent to those skilled in the art by reading the following detailed description with reference, where appropriate, to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Several aspects of an example patient are presented.

[0022] Figure 2 Several aspects of the terminal portion of an example bronchial tree are shown.

[0023] Figure 3A Several aspects of an exemplary open stent are shown.

[0024] Figure 3B Several aspects of an exemplary open-ended stent within an airway are shown.

[0025] Figure 4A and 4B Several aspects of the airway are shown with an example open stent placed within the airway.

[0026] Figure 4C and 4D Several aspects of the airway are shown with an example closed stent placed within the airway.

[0027] Figure 5A and 5B Several aspects of an exemplary open stent are shown.

[0028] Figure 5C Several aspects of an exemplary open-ended stent within an airway are shown.

[0029] Figure 6A and 6B Several aspects regarding an example inflatable object are presented.

[0030] Figure 7A and 7B Several aspects of an inflatable object within an airway are shown.

[0031] Figure 7C Aspects of example inflatable objects are shown.

[0032] Figure 8 Example methods for improving airflow in an airway are presented.

[0033] Figure 9A 、 9B , 9C, 9D, 9E, 9F and 9G show several example aspects of the example method.

[0034] Figure 10A 、 10B , 10C, 10D, 10E, and 10F show example aspects of example methods.

[0035] Figure 11 Example methods for improving airflow in an airway are presented.

[0036] Figure 12 Example methods for improving airflow in an airway are presented.

[0037] Figure 13 Present example treatment options. DETAILED DESCRIPTION

[0038] In the following embodiments, reference is made to the accompanying drawings that form a part of the embodiments. In the drawings, similar symbols generally identify similar components unless the context dictates otherwise. The illustrative embodiments described in the embodiments, figures, and claims are not intended to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the various aspects of the present invention, as generally described herein and illustrated in the figures, may be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are encompassed herein.

[0039] The devices, systems, and methods described herein can be used to achieve the goal of improving airflow within the bronchial tree. More specifically, some of the devices, systems, and methods described herein include stents and expandable objects that can be used to improve airflow in the airways of a patient's bronchial tree. However, it should be understood that this application is not a specific application of the devices, systems, and methods described herein, and other applications are certainly possible.

[0040] Compared to other technologies, the devices, systems, and methods described herein can generally provide improved airflow in a relatively efficient, effective, and prolonged manner. As an example, the devices, systems, and methods described herein can minimize granulation and / or blockage issues associated with other known technologies that involve the use of foreign matter. The devices, systems, and methods described herein can also avoid some of the discomfort and inconvenience associated with some known technologies that involve the use of bypass pathways. Thus, many of the shortcomings of other technologies that attempt to improve airflow can be avoided.

[0041] 1. Example Patient

[0042] For example and illustration purposes, Figure 1 Several aspects of an example patient 100 are shown. As shown, within patient 100 are lungs 102. Typically, a treating physician can gain access to lungs 102 via the patient's trachea 104, perhaps using a bronchoscope, catheter, or other such delivery device introduced into the patient's trachea through the mouth or nose.

[0043] The patient's lungs contain a portion of the patient's bronchial tree 106. The bronchial tree 106 includes numerous airways, including central airways, such as the right and left mainstem bronchus; and lobar bronchi; intermediate airways, such as the numerous segmental and subsegmental bronchi; and non-central peripheral airways, such as bronchioles, conducting bronchioles, terminal bronchioles, and respiratory bronchioles, as discussed further below.

[0044] The exemplary bronchial tree shown also includes a diseased portion 108 located at a terminal point of the bronchial tree. In some exemplary cases, it is understood that the diseased portion 108 is affected by an obstructive lung disease (such as emphysema, among other examples).

[0045] The diseased portion is characterized by lesions that impair the passage of air between the airways and alveoli, and ultimately, the passage of air from outside the patient's body to and from the lungs and the patient's bloodstream. For example, certain airways within the diseased portion may be blocked, collapsed, and / or constricted. Also, the alveolar walls within the alveoli of the diseased portion may have deteriorated.

[0046] To more fully understand the harmful effects of obstructive lung disease, a brief discussion of the function of the lungs may be helpful. One function of the lungs is to allow the exchange of carbon dioxide from the blood by removing the two gases and replacing them with oxygen. To facilitate this gas exchange, the lungs move oxygen and carbon dioxide between the air outside the patient's body and the blood by bulk conduction through the bronchial tree to the alveoli and by diffusion across the blood-gas interface within the patient's alveoli.

[0047] Air is carried to the patient's alveoli via the airways of the patient's bronchial tree, which is contained within the patient's lungs. The bronchial tree contains several branching airways that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. As mentioned above, the trachea branches into the right and left main bronchi, which divide into multiple conducting airways: initially, the lobar bronchi; intermediate airways, such as the segmental and subsegmental bronchi; and peripheral airways, such as the bronchioles and conducting bronchioles; and finally, the terminal bronchioles.

[0048] Each of the terminal bronchioles gives rise to several respiratory bronchioles, which in turn divide into a number of alveolar ducts, typically ranging from two to eleven in number. Figure 2 Several aspects of the terminal portion of an example bronchial tree are shown, including examples of these smaller bronchioles.

[0049] The example bronchial tree 200 includes bronchioles 202 that divide into terminal bronchioles 204. The terminal bronchioles 204, in turn, divide into respiratory bronchioles 206. Also shown are example alveoli 208 containing alveolar sacs 210. As shown, individual alveoli 212 may also be present along the length of the respiratory bronchioles 206.

[0050] The terminal bronchioles 204 are the smallest airways and do not contain alveoli. The function of the bronchi and bronchioles is to provide conducting airways that move air to and from the alveoli. However, the conducting airways do not contain alveoli and gas exchange does not occur. Instead, gas exchange occurs in the alveoli, which are present at the distal ends of the conducting airways and begin at the respiratory bronchioles.

[0051] The various airways of the bronchial tree are often designated or otherwise characterized by "generations." For example, the trachea is referred to as "generation 0" of the bronchial tree. The various levels of the bronchi (including the left and right main bronchus) are referred to as "generation 1." The lobar bronchi are referred to as "generation 2." The segmental bronchi are referred to as "generation 3." The various bronchioles are referred to as "generations 4 through 19." For example, the terminal bronchioles are approximately "generations 14 through 18." For example, the respiratory bronchioles are approximately "generations 16 through 20." Furthermore, the airways extending from the trachea to the terminal bronchi are often referred to as "conducting airways."

[0052] Obstructive lung disease (specifically, such as emphysema) is characterized by irreversible damage to the alveolar walls containing elastic fibers, which maintain radially outward traction to the small airways and are used for inspiration and expiration. When these elastic fibers are damaged, these small airways are no longer under radially outward traction and may collapse during expiration, specifically. Thus, when these fibers are damaged, air may be trapped in the lungs and cannot be fully expelled during expiration. Emphysema causes the lungs to be overinflated (air trapped) and causes the person to be unable to exhale. In this case, the individual will become weak because the lungs cannot exchange gases at the required rate and the lungs are overinflated, and pressure is exerted on the chest wall, diaphragm, and surrounding structures.

[0053] Another aspect of alveolar wall damage is increased airflow between adjacent air sacs (called collateral ventilation or collateral flow). However, this alone provides little or no benefit to the patient because air still cannot flow into and out of the lungs through the collapsed and obstructed airways.

[0054] Chronic bronchitis is characterized by excessive mucus production in the bronchial tree. Typically, the large bronchi are greatly enlarged (hypertrophy) and the small airways have chronic inflammatory changes. Excess mucus is present in the airways, and semisolid mucus plugs can block the small bronchi. Furthermore, the small airways often narrow and become inflammatory.

[0055] The devices, systems, and methods described herein can generally be used to improve airflow from hyperinflated alveoli within a diseased portion of the lung 108 affected by obstructive lung disease (e.g., emphysema and / or bronchitis) and into the central airways of the bronchial tree. Thus, the example stents and expandable objects described more fully below can be delivered to and placed within the airways connecting the central airways to the distal airways and alveoli of the diseased portion 108.

[0056] 2. Example Open-Type Stent

[0057] Figure 3ASeveral aspects of an exemplary open stent 300 are shown. As shown, the open stent may generally have an open configuration, in the form of a coil-like or spring-like structure. It will be understood that the coil is characterized by a continuous outer diameter. Herein, for purposes of example and explanation, the outer diameter of the coil may sometimes be referred to as an "open wall." Due to the open configuration of the stent, it will be understood that no portion of the open stent completely isolates a given area of ​​the open wall. In other words, the open wall comprises a continuously open spiral surface, which is described below in conjunction with Figure 4A and 4B Discuss in more detail.

[0058] Figure 3B Several aspects of an open-ended stent 352 are shown in an airway 350. Those skilled in the art will appreciate that the surface of airway 350 can be characterized by a mucociliary structure (or "levator") on its inner wall that is capable of clearing mucus from the airway. The mucociliary structure can include cilia that continuously move mucus along the airway and ultimately out of the airway. Because no portion of open-ended stent 350 completely isolates a given area of ​​the inner wall of airway 350, the natural mucociliary activity of the airway is generally unimpeded when the open-ended stent is in place.

[0059] As follows about Figure 4C and 4D Further discussing, conventional closed stents interrupt the function of the mucociliary structure by preventing mucus from being fully exposed to the mucociliary structure and / or isolating a given area of ​​the airway wall so that mucus may not be pushed further along the airway. Figure 3A and 3B The open-end stent shown in

[15] allows the airway wall to be exposed to the airway interior even when the stent is in place, and does not completely block the mucociliary structure in any one direction. Thus, even when the open-end stent is in place, the mucociliary structure can continue to promote mucus clearance along the spiral path extending through the center of the coil.

[0060] As another advantage, an open-ended stent can be characterized by a certain degree of flexibility and resilience, which minimizes mechanical toxicity within the airway, particularly when expanded across multiple airways. Due to the stent's flexibility, it can flex and move with the airway, thereby minimizing the foreign body reaction within the airway. Consequently, the open-ended stent minimizes inflammation and granulation tissue formation within the airway. Furthermore, any inflammation and granulation tissue that does form will be concentrated near the stent-wall interface, allowing air and / or mucus to still move along the airway within the stent's spiral open spaces.

[0061] As a further advantage, because the open stent is characterized by open walls that do not isolate the outside of the stent from the inside of the stent, the open stent can allow collateral airflow from side channels (e.g., alveoli or resulting perforations connecting to other surrounding alveoli) into the main lumen of the airway.

[0062] An open-ended stent can be formed from any suitable material. For example, an open-ended stent can be formed from a silicone polyester material. Examples include urethane, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and polyetheretherketone (PEEK). In other cases, an open-ended stent can be formed from a metallic material. Examples include stainless steel and nitinol. Other examples of suitable materials exist.

[0063] The open-end stent may be coated with one or more suitable coatings. In one example, the open-end stent may be coated with an antiproliferative agent, such as sirolimus, everolimus, zotarolimus, paclitaxel, taxotere, mitomycin-C, and others. In another example, the open-end stent may be coated with an anti-mucus agent, such as atropine, ipratropium, tiotropium, or a steroid. In yet another example, the open-end stent may be coated with a mucolytic material, such as N-acetylcystine or guaifenesin. In yet another example, the open-end stent may be coated with a hydrophilic material. Other examples of suitable coatings exist.

[0064] like Figure 3A , an exemplary open stent 300 has a given length 302, which can be any suitable length and can vary depending on the application, including the airway in which the open stent is ultimately placed. In one example, the length 302 can be between 2 cm long and 10 cm long. For example, the length 302 can be approximately 6 cm long. Other lengths may also be suitable.

[0065] Also like Figure 3A , an exemplary open stent 300 is shown having a given height or diameter 304. Diameter 304 can be any suitable diameter and can vary depending on the application, including the airway in which the open stent is ultimately placed. In one example, diameter 304 can be between 1 mm and 10 mm. For example, the diameter can be between 4 mm and 8 mm. In other cases, the diameter can be approximately 6 mm. Other diameters may also be suitable.

[0066] In addition, the exemplary open stent 300 may include a hook 306 on one or both ends. The hook may be looped back on itself to form a closed structure on one or both ends. Alternatively and / or in addition, the open stent 300 may include a smooth round ball at one or both ends. When the open stent is placed in the airway, structures such as hooks, loops or balls can be used to assist in the accessibility and / or maneuverability of the open stent. The use of such structures can further limit the trauma that the end of the open stent may cause to the tissue. For example, this structure can further limit the formation of granulation tissue, or can prevent the formation of pneumothorax when one end of the open stent is in contact with the visceral pleura, and / or can prevent pain when one end of the open stent is in direct or indirect contact with the parietal pleura.

[0067] Figure 4A Several aspects of an open stent 402 within an airway 400 are shown. Figure 4A The figure also depicts a continuous spiral path along the wall of the airway 400 when the open stent 402 is placed in the airway 400. Figure 4A As shown by the various arrows in FIG, a continuous spiral path exists along the open wall of the open stent, which allows for relatively uninterrupted traversal of the inner wall of the airway along the spiral path. As described above, mucus can be cleared along this spiral path by the mucociliary structure of the airway 400. Note that although the open stent 402 is shown as being located only in a single portion of the airway 400, it should be understood that the open stent 402 can extend into other portions of the airway 400 and / or can extend entirely into other airways.

[0068] Figure 4B Several aspects of an open stent 452 are shown within an airway 450. Similar to open stent 402, open stent 452 features a continuous spiral path along its open wall. Figure 4B Also depicted is granulation tissue along the open-ended stent structure 452, shown as individual X indicators along the open-ended stent. As shown, granulation tissue formation is confined to the open-ended stent structure itself. Thus, a continuous spiral pathway exists along the open-ended wall. Consequently, despite the formation of granulation tissue, the mucociliary structures of the airway 450 are not prevented from functioning to clear mucus from the airway, and an uninterrupted pathway for air movement exists along the airway.

[0069] Figure 4C Several aspects of a closed stent 462 within an airway 460 are shown, as is known in the art. Figure 4A and 4BIn contrast to the exemplary open stent shown in FIG, the closed stent 462 does not provide a continuous spiral path along the wall of the airway 460. Instead, the closed stent structure 462 (including its pervasive structure along its length) prevents traversal of the inner wall of the airway. Figure 4C While the specific example structure is shown in as a closed wire frame, those skilled in the art will appreciate that there are other known closed stents, including stents featuring solid (rather than wire frame) walls.

[0070] Figure 4D Several aspects of a closed stent 472 are shown within an airway 470. Similar to closed stent 462, closed stent 472 does not provide a continuous helical pathway along the wall of airway 470. Figure 4D Also depicted in FIG. 4 is granulation tissue along the closed stent structure 472, which is shown as individual X indicators along the closed stent (representative granulation tissue is not shown along the entire closed stent structure). As shown, granulation tissue formation is localized along the closed stent structure, but because the closed stent includes a distributed structure along its length, granulation tissue formation occurs throughout the length of the closed stent. Thus, as in FIG. Figure 4A and 4B Unlike the case of the open stent shown in FIG, the formation of granulation tissue along the closed stent 472 further prevents the mucociliary structures of the airway 470 from functioning to clear mucus from the airway.

[0071] Figures 5A to 5C An alternative exemplary open-type stent is shown. Figure 5A An exemplary open stent 500 is shown, which has the same features as described above with respect to Figure 3A and 3B There are relatively few turns per unit length compared to the open-ended stent shown in In one embodiment, the coil structure of the open-ended stent 500 can be combined with at least one additional coil structure to form an open-ended stent featuring at least one double helix structure.

[0072] Figure 5BAn example of an exemplary double-helix open-ended stent 550 is shown in FIG. As shown, the exemplary open-ended stent is formed from a first coil structure 552 and a second coil structure 554. In some embodiments, the first coil structure 552 and the second coil structure 554 may be connected at one or both ends of the open-ended stent, thereby forming a loop. This loop facilitates placement and removal and also eliminates any potentially sharp ends of the first coil 552 and the second coil 554, thereby reducing the potential trauma of the open-ended stent to the airway and surrounding tissue. This double-helix open-ended stent creates the same stent-airway wall contact area as a single-coil open-ended stent, but with a lesser angle of the coil wire relative to the airway than a single-coil stent. Thus, the double-helix open-ended stent provides a more direct path for air and mucus to move along the airway. In practice, this double-helix open-ended stent can be placed in an airway of the bronchial tree to improve airflow.

[0073] like Figure 5C , for example, a double helix open-ended stent 582 is shown positioned in airway 580. Note that while open-ended stent 582 is shown positioned in only a single portion of airway 580, it should be understood that the open-ended stent may extend into other portions of airway 580 and / or may extend entirely into other airways.

[0074] 3. Example of balloon expansion

[0075] Figure 6A Several aspects of an example inflatable object 600 are shown. As shown, the inflatable object may generally be characterized as a resilient, flexible bulb or other open body enclosing an interior space.

[0076] The inflatable object 600 can have a closed first end 602 and an open second end 604. However, in another example, the first end can also be open. Either or both open ends can then be coupled to other extensions or connected objects (such as tubes) that allow fluids (such as gas and / or liquid) to be transferred into and out of the interior space of the inflatable object 600.

[0077] The inflatable object may be formed from any suitable material. For example, the inflatable object may be formed from one or more of the following: silicone, polyvinyl chloride (PVC), nylon, polyethylene terephthalate (PET), polyether block amide (PEBAX), polyester film, and / or latex. Other examples of suitable materials exist.

[0078] The expandable object may be coated with any suitable material. For example, the expandable object may be coated with an anti-proliferative agent (e.g., Taxotere, Paclitaxel, and / or Sirolimus, among others). Note that, typically through the use of an expandable object, this anti-proliferative agent may help maintain open any tears or perforations formed in the airway wall. In this way, this anti-proliferative agent may help ensure the effectiveness of the treatment, particularly when the treatment does not involve the placement of a stent. Additionally and / or alternatively, the expandable object may be coated with one or more of an anti-mucotic agent, a mucolytic agent, and a hydrophilic agent. Other examples of suitable coatings exist.

[0079] refer to Figure 6A , the inflatable object 600 is shown in a relaxed state where the inflatable object is not inflated. Figure 6B , an example inflatable object 650 is shown in an inflated state.

[0080] As discussed further below, in operation, an inflatable object may be placed in one airway or in multiple connected airways that form a pathway from a more central airway to more peripheral airways or alveoli, and then the inflatable object is inflated to also inflate the airway or airways. As such, the inflatable object may sometimes be referred to herein as a "dilution balloon."

[0081] In some applications, an expansion balloon can be used to intentionally expand an airway or portions of connected airways beyond their normal or natural diameter. In this case, the expansion balloon can pierce, puncture, or otherwise damage the wall of an airway or portions of connected airways. In some cases, the expansion of the expansion balloon will effectively create a generally longitudinal tear in the wall of the airway or portions of connected airways. Note that this longitudinal tear will tend to run generally parallel to the blood vessel, which itself tends to run along the length of the airway. Thus, trauma to the blood vessel itself will be minimized, and therefore bleeding will be minimized.

[0082] Figure 7A and 7B Demonstrates an example inflatable object within an airway. Figure 7A , showing an inflatable object 700 introduced into an airway 702 in a relaxed state. Figure 7B , showing inflatable object 700 in an inflated state within airway 702. As shown, inflatable object 700 has extended airway 702 beyond its normal size and has introduced openings 704 into the wall of airway 702. This effect can occur in the wall of a single airway or in one or more walls of connected airways. Note that while inflatable object 700 is shown as being located in only a single portion of airway 702, it should be understood that inflatable object 700 can extend into other portions of airway 702 and / or can extend entirely into other airways.

[0083] Although the example inflatable objects are shown in the figures as having regular shapes, other shapes are possible. For example, the size of the airbag can gradually decrease from one end to the other. As another example, the airbag can include a bulbous end that is relatively larger than another portion of the airbag body. As yet another example, the airbag can include two bulbous ends. As yet another example, the airbag can include one or more irregular features (such as ridges or other protrusions) on the outer surface that can concentrate the forces generated during pressurization and inflation of the airbag and enable the airbag to more easily pierce the airway wall when inflated. The irregular shape of the airbag can generally achieve the purpose of extending the airway in a desired manner so as to introduce the desired opening into the airway.

[0084] In some applications, the use of the dilation balloon described herein may differ from previous uses of inflatable objects within the bronchial tree, such as in bronchoplasty. For example, while in bronchoplasty applications, inflatable objects are typically placed in central airways, the dilation balloon described herein may be used in more peripheral airways, such as those described above with respect to Figure 2 As another example, although in bronchoplasty applications, inflatable objects are typically used to inflate obstructed airways to their normal size, the dilation balloons described herein can be used to inflate airways beyond their normal size and, in some instances, create openings in the airway wall or in one or more connected airways. Thus, the openings introduced into the airway wall can help improve airflow between the alveoli and other, more central airways.

[0085] Introducing openings (e.g., perforations and / or lacerations) into the surface of the airways can result in additional exposure of openings from the airways to the alveoli. In this way, airflow from the airways to the alveoli can be beneficially increased. Furthermore, since the peripheral airways are characterized by relatively little mucosa, blockage by perforations and / or lacerations will be minimized.

[0086] For this purpose, introduction of the dilating balloon into the peripheral airway can be accomplished using a relatively quick and efficient medical procedure in which the dilating balloon can be placed directly into the airway, through a bronchoscope placed in the trachea or other airway, through an endotracheal tube placed in the trachea, in a laryngeal mask airway placed in the hypopharynx, and other access methods. In some instances, the procedure can be accomplished as an off-patient surgical procedure. In this manner, the procedure can be significantly more convenient and significantly less invasive than other techniques for improving airflow.

[0087] In one example, the inflatable object may be in the form of a cryogenic balloon. Figure 7CSome aspects of an exemplary cryoballoon 780 are shown, which is coupled in fluid communication with a delivery conduit 782. As shown, conduit 782 may contain a fluid delivery channel 784 and a fluid extraction channel 786. Each of the walls of conduit 782, fluid delivery channel 784, and fluid extraction channel 786 may be made of materials known to those skilled in the art. Aspects of exemplary cryoballoon 780 have been simplified for purposes of example and explanation. Cryoballoon 780 may include other aspects understood by those skilled in the art.

[0088] In use, the cryo-balloon 780 can be placed within a desired airway or multiple connected airways in the bronchial tree. Coolant can then be released from a pressurized cartridge, container, and / or pump (not shown) through the fluid delivery channel 784 into the balloon to cool the airway at a rate appropriate for the application. In some cases, the coolant can be sprayed into the balloon via the fluid delivery channel 784, a separate sprayer, or other suitable element. The balloon can be inflated (e.g., with the coolant) to a desired pressure (corresponding to a desired size). As a result, the temperature of the airway can be reduced. The resulting temperature will be lower than body temperature, with potentially better results being below 0°C and even better results being significantly below 0°C. By reducing the temperature of the balloon to significantly below 0°C, the temperature of the surrounding tissue can also be reduced to significantly below 0°C. Reducing the temperature of the surrounding tissue to below 0°C dehydrates the tissue and stops blood flow in the surrounding blood vessels, thereby destroying mucus cells in the airway wall, reducing subsequent granulation tissue formation and minimizing bleeding. Then later, the coolant may be drained from the bladder through the fluid draw channel 786 .

[0089] The inflation fluid can be any suitable low-freezing-point liquid, such as an ethanol mixture or a saline mixture, or a liquefied gas, such as N2O or CO2. Liquid N2 can be used as a general coolant. When N2 is used, it can be delivered to the airbag in a liquid phase, where the liquid N2 evaporates at the inlet of the fluid delivery channel 784 and enters the airbag as a gas. Freon, N2O gas, and CO2 gas can also be used as coolants. Other coolants can be used, such as cold saline solution, Fluisol, or a mixture of saline solution and ethanol. Other examples of coolants exist.

[0090] While the above discussion discusses an example inflatable object in the form of an expansion balloon, this is not required. The inflatable object may also take other forms. In an alternative example, the inflatable object may take the form of a wire basket capable of decompression and compression. In addition to inflating the airway wall, this wire basket may also be well-suited for forming perforations and / or breaches in the airway wall.

[0091] 4. First Example Method

[0092] Figure 8An example method 800 for improving airflow within an airway is generally shown.

[0093] For the sake of clarity, this article can refer to the above figure for description Figure 8 . However, it should be understood that this is for example and illustration purposes only and that the operation of the method should not be limited by these figures. The method 800 may include one or more operations, functions, or actions illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in sequential order, these blocks may also be executed in parallel and / or in an order different from that described herein. Moreover, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired implementation.

[0094] Method 800 generally involves, at block 802, placing an inflatable object into one or more airways of a subject's bronchial tree. Block 804 includes inflating the inflatable object within the airway. And block 806 includes placing a stent in the airway. As shown, method 800 may additionally / optionally involve, at block 801, identifying a diseased area to be treated.

[0095] Each of these boxes is discussed in more detail below.

[0096] a. Identify the lesion area to be treated

[0097] Block 801 involves identifying a diseased area to be treated. According to block 801, the treating physician may identify a diseased area of ​​the bronchial tree using any suitable technique, including any such suitable technique known to those skilled in the art. In an example, the treating physician may identify, for example, Figure 1 The lesion area of ​​area 108 is shown in FIG.

[0098] b. Placement of an inflatable object into an airway of the subject's bronchial tree

[0099] Block 802 involves placing an inflatable object into one or more airways of a bronchial tree of a subject. According to block 802, the subject can be understood with respect to patient 100. In an example, the bronchial tree can be bronchial tree 106, and the one or more airways, or at least a portion thereof, can be airways or portions of connected airways within a lesion 108 of a lung. In an example, block 802 involves placing an inflatable object into the lesion identified with respect to block 801.

[0100] In some examples, placing the inflatable object may involve placing the inflatable object into two or more airways of the subject's bronchial tree, wherein a first end of the inflatable object is located within a first airway of the bronchial tree and a second end of the inflatable object is located within a second airway of the bronchial tree.

[0101] The inflatable object may be any suitable inflatable object, including but not limited to the inflatable objects described above. Figure 6A 、 6B , 7A, 7B and any of the example expandable objects discussed in 7C.

[0102] In one example, the inflatable object may include an expansion balloon. In some examples, the expansion balloon may be a cryoballoon. In one example, the expansion balloon may include a spherical object at its distal end. In another example, the expansion balloon may include at least a portion of its outer surface being non-uniform. For example, the outer surface may include ridges and / or other protrusions to assist with expansion and / or the formation of an opening in the airway wall.

[0103] In an example, placing the inflatable object may involve using a delivery device (e.g., a catheter, a guide wire, a bronchoscope, etc.) to place the inflatable object. In some examples, placing the inflatable object may further involve identifying a target area of ​​diseased lung and directing the inflatable object toward the identified area such that at least a portion of the inflatable object is proximal to the diseased portion of the lung. Those skilled in the art will appreciate that the inflatable object may be attached to the distal end of a delivery catheter. A treating physician may then introduce the inflatable object into the patient's trachea 104. Using the delivery catheter, the treating physician may then direct the inflatable object through the bronchial tree and into the peripheral airways of the bronchial tree. Ultimately, the distal end of the inflatable object may be delivered to the peripheral lesion 108 and into the respiratory bronchioles 206, while the proximal end of the inflatable object remains in a more proximal airway, such as a terminal bronchiole, conducting bronchiole, bronchioles, subsegmental bronchi, segmental bronchi, or lobar bronchi.

[0104] about Figure 9A and 9B Aspects of display box 802. Figure 9A , an inflatable object 900 is shown being introduced into an airway 902. Figure 9B , inflatable object 900 is shown as having been placed in a desired location in airway 902.

[0105] As discussed above and below with respect to Figure 9G Further discussed, alternative exemplary placement of the inflatable object may involve placing the inflatable object within the bronchial tree such that the inflatable object spans multiple types of airways. Figure 9G As shown in FIG, an inflatable object 912 is placed within the bronchial tree 910 such that the distal end of the inflatable object 912 is located within the respiratory bronchioles and such that the proximal end extends proximally into the larger, more central airways.

[0106] c. Inflate the inflatable object in the airway

[0107] Block 804 involves inflating the inflatable object within the airway, causing at least a portion of the airway or a portion of the connected airway to expand. In some cases, at least one opening is formed in the airway wall due to the expansion of the inflatable object.

[0108] In some examples, expanding the inflatable object may involve expanding the inflatable 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 expands.

[0109] As discussed above, an inflatable object can be inflated by introducing a fluid (e.g., liquid and / or gas) into the inflatable object. For example, in an example where the inflatable object is a cryogenic balloon, the cryogenic balloon can be inflated by introducing N2O into the cryogenic balloon.

[0110] about Figure 9C Aspects of the display block 804 are shown. Figure 9C , the inflatable object 900 has been inflated, causing the airway 902 to expand beyond its normal size. Thus, in the particular example shown, the inflatable object has caused the airway 902 to rupture, such that an opening now exists in the airway wall.

[0111] While a slit is shown as being formed in the airway 902, it should be understood that an opening need not be formed in all embodiments. In some embodiments, it may be desirable to dilate the airway without slitting it, and / or it may be sufficient.

[0112] Furthermore, while shown as forming a single breach in the airway 902, it should be understood that more than one breach may be formed. That is, block 804 may involve forming at least one opening in the airway wall.

[0113] In addition, refer again Figure 9G Inflatable object 912 may be inflated to dilate multiple segments of the airways of bronchial tree 910. Subsequently, ruptures and / or perforations may be formed in the multiple segments of the airways.

[0114] In some embodiments, after the inflatable object is inflated, the inflatable object may then be removed. Figure 9D As shown, the expandable object 900 has returned to its relaxed state.The expandable object 900 can then be directed out of the airway, back through the bronchial tree, and out of the patient's trachea.

[0115] d. Place the stent in the airway

[0116] Block 806 involves placing the stent in the airway such that a portion of the stent is adjacent to a portion of the wall of the one or more expanded airways. In embodiments where the airway wall is dehiscent according to block 804, 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.

[0117] In some instances, placing the stent can involve placing the stent within at least two of the two or more airways such that a portion of the stent is adjacent to a portion of the two or more expanded airways.

[0118] The support may be any suitable support, including but not limited to the support described above. Figure 3A 、 3B , any of the open-type stents discussed in 4A, 4B, 5A, 5B and 5C.

[0119] For example, at least a portion of an open-ended stent may include a coil. In some cases, the stent may include both a first coil and a second coil.

[0120] In one example, an open stent has an open wall, as discussed above. In this example, for at least a certain length of the open stent, no portion of the open wall completely isolates a given area of ​​the open wall. Thus, the open wall can have a continuous open spiral surface along its length.

[0121] While the examples described herein include placement of an open stent, it will be appreciated that in some cases the method may be performed using a more traditional closed stent. In these cases, block 806 may involve placement of a closed stent.

[0122] about Figure 9E and 9F Aspects of display block 806. Figure 9E , an open-end stent 904 is shown being guided into airway 902. As shown, while guided into position, the open-end stent may be held in a compressed form to aid maneuverability through the bronchial tree. Figure 9E , an open stent 904 is shown as having been placed in a desired location in the airway 902 and permitted to expand. As shown, the open stent 904 has been placed adjacent to the opening in the airway 902.

[0123] The open stent 904 can then be left in the airway indefinitely and / or until the treating physician determines to remove the open stent. Alternatively, the open stent can be placed temporarily and removed after some predetermined amount of time. In this way, removal of the open stent will leave an open tissue tract between the central airway and the alveoli.

[0124] In the examples presented above, embodiments of method 900 are described in which the expandable object is removed from the airway prior to placing the stent in the airway. However, this is not required. In another embodiment of method 900, the expandable object may be placed together with the stent. Figure 10A 、 10B , 10C, 10D, 10E and 10F show example aspects of this embodiment.

[0125] As about Figure 10A As shown, prior to placement of the expandable object 1000, the stent 1002 can be positioned so as to surround at least a portion of the expandable object. In this manner, the expandable object 1000 and the stent 1002 form a package that can be introduced together into the airway.

[0126] about Figure 10B , the package of expandable object 1000 and stent 1002 can then be guided into airway 1004. Figure 10C As shown in FIG, the package of expandable object 1000 and stent 1002 has been placed in the desired location in the airway.

[0127] about Figure 10D , the expandable object 1000 may then be expanded. As shown, the stent 1002 may be arranged so that its size increases as the expandable object 1000 expands. After the expandable object 1000 is expanded, an opening is formed in the airway 1004.

[0128] about Figure 10E , the expandable object 1000 can then be returned to its relaxed state. Simultaneously, the open stent 1002 can be maintained in a decompressed form such that it now applies radial tension to the airway or portion of the connected airway. Figure 10E As shown in FIG, the open stent 1002 can apply this radial tension to the airway or portion of the connected airway adjacent to at least a portion of the at least one opening formed. After the expandable object 1000 returns to its relaxed state, the expandable object 1000 can then be guided out of the airway, back through the bronchial tree, and out of the patient's trachea.

[0129] about Figure 10F , after the expandable object 1000 is removed from the airway, the stent 1002 can remain in place within the airway 1004 or a portion of a connected airway. Furthermore, in some instances, the stent 1002 can remain in place within the bronchial tree, allowing the stent to span multiple types of airways. For example, Figure 9G In some ways similar to the expandable object 912 shown in FIG, the stent 1002 can be placed within the bronchial tree so that the distal end of the stent is located within the respiratory bronchioles and the proximal end extends proximally into the larger and more central airways.

[0130] 5. Second exemplary method

[0131] It should be understood that although the various functions described above are sometimes described as being performed as part of the same method, this is not required. For example, in some cases, a stent (such as the stents described herein) may be used without an expandable object. On the other hand, an expandable object (such as the expandable object described herein) may be used without a stent. Other examples may exist.

[0132] Figure 11 Another example method 1100 for improving airflow within a portion of an airway or a series of connected airways is generally shown.

[0133] For clarity, reference may be made to various other figures herein to describe the present invention. Figure 1 1100 is shown in the figure. However, it should be understood that this is for example and illustration purposes only and that the method operation should not be limited by these figures. The method 1100 may include one or more operations, functions, or actions illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in a sequential order, these blocks may also be executed in parallel and / or in an order different from that described herein. In addition, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired implementation.

[0134] Method 1100 generally involves sizing an open stent at block 1102. Block 1104 includes placing the open stent.

[0135] a. Set the size of the bracket

[0136] Block 1102 involves setting the size of the stent. The size of the stent can be characterized by estimates of both the diameter of the stent and the length of the stent.

[0137] The open stent may be any suitable stent, including but not limited to the stents described above. Figure 3A 、 3B , any of the open-type stents discussed in 4A, 4B, 5A, 5B and 5C.

[0138] According to block 1102, the stent may be sized according to any suitable technique.

[0139] In one example, the stent size can be set based on the approximate size of the airway where the stent will be placed. For example, a size corresponding to the average size of respiratory bronchioles can be used. As another example, a size corresponding to the diameter of the most proximal airway where the stent will be placed can be used.

[0140] In another example, the size of an open-end stent can be determined based on an image of a given patient's bronchial tree. For example, prior to stent placement, the patient's bronchial tree can be imaged using known imaging techniques, and the stent size can be determined based on the size indicated by the image. Alternatively, for example, the distance can be estimated during the actual surgical procedure based on an image of the patient's chest generated using known imaging techniques.

[0141] In yet another example, an inflatable object, such as those described elsewhere herein, can be used to set the size of a stent. For example, prior to placement of the stent, the inflatable object can be placed within the airway and inflated. The size of the inflatable object in the inflated state can then be used to infer the appropriate size of the stent. In one example, the pressure of the inflatable object can be measured while the inflatable object is in the inflated state. The pressure can be measured using a manometer located on the proximal end of a delivery system for the inflatable object. The measured pressure can be correlated with the appropriate size of the stent.

[0142] b. Placement of open stent

[0143] Block 1104 involves placing a stent in one or more airways. According to block 1104, the stent may be placed in any suitable manner. For example, the stent may be placed in accordance with the method described above. Figure 9E and 9F Associated description placement bracket.

[0144] 6. Third Example Method

[0145] Figure 12 Another example method 1200 for improving airflow within an airway is generally shown.

[0146] For clarity, reference may be made to various other figures herein to describe the present invention. Figure 12 . However, it should be understood that this is for example and illustration purposes only and the operation of the method should not be limited by these figures. The method 1200 may include one or more operations, functions, or actions illustrated by one or more of the blocks in each figure. Although the blocks are illustrated in sequential order, these blocks may also be executed in parallel and / or in an order different from that described herein. In addition, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired implementation.

[0147] Method 1200 generally involves, at block 1202, placing an inflatable object into one or more airways of a subject's bronchial tree. Block 1204 includes inflating the inflatable object from a relaxed state to an expanded state within at least one of the one or more airways. Block 1206 includes returning the inflatable object from the expanded state to a relaxed state. And block 1208 includes removing the inflatable object from the bronchioles.

[0148] a. Place an inflatable object into an airway of the subject's bronchial tree

[0149] Block 1202 involves placing an inflatable object into one or more airways of the bronchial tree of a subject. The inflatable object may be placed using any suitable technique, including those described herein. For example, the inflatable object may be placed as described above with respect to Figure 9A and 9B or Figure 10B and 10C The inflatable object is placed as shown.

[0150] b. Inflate the inflatable object to its expanded state within the airway

[0151] Block 1204 involves inflating an inflatable object from a relaxed state to an inflated state within at least one of the one or more airways, such that the airway or at least a portion of the connected airways expands. In some cases, at least one opening is formed in the wall of the one or more airways due to the expansion of the inflatable object. Any suitable technique, including the techniques described herein, may be used to inflate the inflatable object within the airway. For example, the inflatable object may be inflated as described above with respect to Figure 9C and Figure 10D The expansion shown.

[0152] In some examples, the expandable object can be sized such that, when expanded, the expandable object exhibits an outer diameter similar to that described above with reference to stents.

[0153] c. Return the expandable object to its relaxed state

[0154] Block 1206 involves restoring the inflatable object from the inflated state to the relaxed state. The inflatable object may be restored to the relaxed state using any suitable technique, including the techniques described herein. For example, the inflatable object may be restored as described above with respect to Figure 9D and Figure 10E The demonstrated ground returns to a relaxed state.

[0155] d. Removal of inflatable objects from the airway

[0156] Block 1208 involves removing the inflatable object from one or more airways. The inflatable object may be removed using any suitable technique, including those described herein. For example, the inflatable object may be removed as described with respect to Figure 9D and Figure 10E The inflatable object is shown removed.

[0157] 7. Example treatment plan

[0158] Figure 13An example treatment regimen 1300 that can be used in conjunction with the various techniques described herein to improve airflow within an airway is generally shown. While certain functions are described with respect to treatment regimen 1300, it should be understood that additional and / or other functions can also be performed.

[0159] The treatment plan 1300 begins at block 1302 where a patient's lung history and physical exam are given. If the lung history (Hx) and / or physical exam indicate the possibility of lung disease, the plan continues to block 1304.

[0160] At block 1304, a pulmonary function test (PFT) is performed on the patient. The PFT may include a battery of tests including, but not limited to, spirometry, static lung volume measurement, diffusing capacity for carbon monoxide, airway resistance, respiratory muscle strength, and arterial blood gases, among other examples.

[0161] At block 1306, a determination is made as to whether the patient's ratio of forced expiratory volume in 1 second (FEV) to forced vital capacity (FVC) is greater than 0.7. If not, the protocol proceeds to block 1308, where the protocol ends. If yes, the protocol proceeds to block 1310. Note that other criteria may be used for the decision point at block 1306. For example, if there is evidence of severe hyperinflation (where the ratio of residual volume (RV) to total vital capacity (TLC) is greater than or equal to 0.65), the protocol may proceed to block 1310.

[0162] A CT scan is performed on the patient at block 1310. The treating physician then analyzes the CT scan images and data.

[0163] At block 1312, a determination is made as to whether the patient's CT scan indicates that the patient has lung disease (e.g., emphysema), whether homogeneous or heterogeneous. If not, the protocol proceeds to block 1314, where the protocol ends. If yes, the protocol proceeds to block 1316. In some cases, a further determination may be made as to whether there is no evidence of significant airway disease or no isolated airway disease and concurrent emphysema before proceeding to block 1316.

[0164] At block 1315, the treating physician identifies the diseased area to be treated. According to block 1315, the treating physician may use any suitable technique, including any such suitable technique known to those skilled in the art, to identify the diseased area of ​​the bronchial tree. In an example, the treating physician may identify the diseased area, e.g. Figure 1 The area 108 is shown in FIG.

[0165] At block 1316, the treating physician treats one or more airways within the patient's bronchial tree to improve airflow. The airways may be treated according to any of the methods described herein for improving airflow within an airway, including, for example, one or more of method 800, method 1100, and method 1200.

[0166] At block 1318, it is determined whether the treatment successfully improved airflow. If so, the protocol proceeds to block 1320 where it ends. If not, block 1316 is repeated to improve airflow.

[0167] 8. Example treatment plan

[0168] In embodiments, a system may be provided according to various methods described herein.The system may include one or more of an inflatable object, a stent, and instructions for improving airflow in an airway of a bronchial tree.

[0169] The stent may be any of the stents described herein, for example with respect to Figure 3A 、 3B , 4A, 4B, 5A, 5B and 5C. The expandable object can be any of the expandable objects described herein, such as Figure 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.

[0170] The system may further include other objects. One example includes a canister containing compressed and / or liquefied gas for inflating the inflatable object. Another example includes a manometer for monitoring the pressure within the inflatable object. Yet another example includes one or more delivery catheters for guiding the inflatable object and / or stent through the bronchial tree.

[0171] 9. Summary

[0172] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims

1. A system for improving airflow within the bronchial tree of an emphysematous lung, the system comprising: delivery device; as well as An implantable object comprising a distal end and a proximal end, wherein the implantable object is configured to: placing the implantable object through multiple generations of connected airways using the delivery device such that the distal end is placed in a first airway within a peripheral portion of the bronchial tree and the proximal end is placed in a second airway within a middle portion of the bronchial tree; and expanding the implantable object while placing the implantable object across the plurality of connected airways so that at least a portion of the plurality of connected airways expands from (i) an initial diameter prior to placement of the implantable object to (ii) an expanded diameter that is greater than the initial diameter, wherein the implantable object comprises an open wall having a spiral surface with continuous openings, wherein, when the implantable object is placed and expanded through the multiple generations of connected airways, the continuously open helical surface provides an uninterrupted pathway along the inner wall of the airway from the distal end of the implantable object to the proximal end of the implantable object.

2. The system of claim 1, wherein: The second airway within the middle portion of the bronchial tree comprises one of a lobar bronchus or a segmental bronchus; and The first airways within the peripheral portion of the bronchial tree include bronchioles.

3. A system according to claim 1 or 2, wherein the implantable object includes an expandable object, the expandable object is surrounded by a stent, and wherein the expandable object and the stent are configured to expand simultaneously in a coordinated manner with each other so that the portion of the multiple generations of connected airways expands from the initial diameter to the expanded diameter.

4. The system of claim 1 or 2, wherein the implantable object comprises a stent.

5. The system of claim 4, wherein the stent includes walls that do not isolate the exterior of the stent from the interior of the stent, thereby allowing airflow from the side channels into the main lumen of the airways when the stent is placed through the multiple generations of connected airways.

6. The system of claim 3, wherein the stent includes walls having a certain amount of flexibility so that when the stent is placed through the multiple generations of connected airways, it can bend and move with the airway.

7. The system of claim 3, wherein the stent comprises walls configured to allow exposure of the walls of the airways to the inside of the airways when the stent is placed through the multiple generations of connected airways.

8. The system of claim 3, wherein the stent comprises a coil-like or spring-like structure.

9. The system of claim 3, wherein the stent is configured to apply radial tension to the portion of the multiple generations of connected airways when the stent is expanded.

10. The system of claim 1, wherein the expanded diameter of the portion of the multiple generations of connected airways comprises a larger diameter compared to a normal, pre-lesion diameter of the portion of the multiple generations of connected airways.

11. The system of claim 1 , wherein the implantable object has an expanded diameter of between 1 mm and 10 mm.

12. The system of claim 1 , wherein the expanding of the implantable object such that the at least a portion of the plurality of generations of connected airways expands from the initial diameter to the expanded diameter comprises: The implantable object is expanded to an extent that causes at least one airway wall opening to be formed in the portion of the plurality of connected airways.

13. The system of claim 12 , wherein the implantable object is configured such that, after the implantable object is expanded to such an extent that at least one airway wall opening will be formed in the portion of the multiple generations of connected airways, no portion of the implantable object protrudes through the at least one airway wall opening in the portion of the multiple generations of connected airways.

14. The system of claim 1, wherein the delivery device is a bronchoscope.

15. The system of claim 1, wherein the implantable object is comprised of a single wire extending about a longitudinal axis extending between the distal end and the proximal end of the implantable object.

16. A system for improving airflow within the bronchial tree of an emphysematous lung, the system comprising: delivery device; as well as An implantable object comprising an expandable object surrounded by a stent, wherein the implantable object is configured to: placing the implantable object within one or more airways of the bronchial tree using the delivery device; and When the implantable object is placed within the one or more airways of the bronchial tree, the expandable object and the stent are simultaneously expanded in a coordinated manner such that at least a portion of the one or more airways expands from (i) an initial diameter prior to placement of the implantable object to (ii) an expanded diameter that is greater than the initial diameter, wherein the stent comprises an open wall having a spiral surface with continuous openings, Wherein, when the stent is placed and expanded through multiple generations of connected airways, the continuously open helical surface provides an uninterrupted path along the inner wall of the airway over the entire length of the stent.

17. The system of claim 16, wherein the one or more airways comprises a plurality of airways extending from a middle portion of the bronchial tree to a peripheral portion of the bronchial tree.

18. The system of claim 17, wherein the plurality of airways comprises: a first airway within the mid-portion of the bronchial tree, the first airway comprising one of a lobar bronchus or a segmental bronchus; and A second airway within the peripheral portion of the bronchial tree, the second airway comprising a bronchiole.

19. The system of claim 16, wherein the expandable object and the stent are configured for simultaneous expansion in a coordinated manner with one another such that the portion of the one or more airways expands from the initial diameter to the expanded diameter.

20. The system of claim 16, wherein the implantable object comprises a stent.

21. The system of claim 19, wherein the stent includes walls that do not isolate the exterior of the stent from the interior of the stent, thereby allowing airflow from the side channels into the main lumen of the airways when the stent is placed across the multiple generations of connected airways.

22. The system of claim 19, wherein the stent comprises walls having a certain amount of flexibility such that the stent can flex and move with the airway when positioned across the plurality of connected airways.

23. The system of claim 19, wherein the stent comprises walls configured to allow exposure of the walls of the airways to the inside of the airways when the stent is placed through the multiple generations of connected airways.

24. The system of claim 19, wherein the stent comprises a coil-like or spring-like structure.

25. The system of claim 16, wherein the stent is configured to apply radial tension to the portions of the multiple generations of connected airways when the stent is expanded.

26. The system of claim 16, wherein the expanded diameter of the portion of the multiple generations of connected airways comprises a larger diameter compared to a normal, pre-lesion diameter of the portion of the multiple generations of connected airways.

27. The system of claim 16, wherein the expandable object has an expanded diameter between 1 mm and 10 mm.

28. The system of claim 16, wherein the expanding of the implantable object such that the at least a portion of the plurality of generations of connected airways expands from the initial diameter to the expanded diameter comprises: The implantable object is expanded to an extent that causes at least one airway wall opening to be formed in the portion of the plurality of connected airways.

29. The system of claim 28, wherein the implantable object is configured such that, after the implantable object is expanded to such an extent that at least one airway wall opening will be formed in the portion of the multiple generations of connected airways, no portion of the implantable object protrudes through the at least one airway wall opening in the portion of the multiple generations of connected airways.

30. The system of claim 16, wherein the delivery device is a bronchoscope.

31. A system for improving airflow within the bronchial tree of an emphysematous lung, the system comprising: delivery device; An expandable object, wherein the expandable object is configured to: placing the inflatable object within two or more connected airways of the bronchial tree using the delivery device such that a distal end of the inflatable object is positioned within a first airway of the bronchial tree and a proximal end of the inflatable object is positioned within a second airway of the bronchial tree, wherein the second airway is an airway of a lower level within the bronchial tree than the first airway; and When the inflatable object is placed within the two or more airways, inflating the inflatable object to a degree that results in at least one airway wall opening being formed in at least a portion of the two or more airways; as well as The stent, wherein the stent is configured to: The stent is placed within the two or more connected airways of the bronchial tree using the delivery device such that no portion of the stent protrudes through the at least one airway wall opening in the portions of the two or more connected airways.

32. The system of claim 31 , wherein the inflatable object is a balloon.

33. The system of claim 31 or 32, wherein the stent is a coil.

34. A balloon for use in a system for improving airflow within the bronchial tree of an emphysematous lung, characterized in that: The balloon is coupled to a distal portion of the delivery device, wherein the balloon is configured to: placing the balloon within two or more connected airways of the bronchial tree using the delivery device, the two or more connected airways comprising a first airway and a second airway, wherein the second airway is an airway of a lower generation within the bronchial tree than the first airway; and When the balloon is positioned within the two or more airways, the balloon is inflated to a degree that results in at least one airway wall opening being formed in at least a portion of the first and second airways.

35. A coil for use in a device for improving airflow within the bronchial tree of an emphysematous lung, characterized in that: The coil comprises a distal end and a proximal end, wherein: The coil is configured to be placed through multiple generations of connected airways such that the distal end is positioned within a first airway in a peripheral portion of the bronchial tree and the proximal end is positioned within a second airway in a middle portion of the bronchial tree; and The coil is further configured to expand to a diameter that forces at least a portion of the multiple generations of connected airways to expand from an initial diameter prior to placement of the coil to an expanded diameter that is greater than the initial diameter, wherein the coil comprises an open wall having a spiral surface with continuous openings, wherein, when the coil is placed and expanded across the multiple generations of connected airways, the continuously open helical surface provides an uninterrupted pathway along the inner wall of the airway from the distal end of the coil to the proximal end of the coil.

36. The device of claim 35, wherein the coil is configured to apply radial tension to the multiple generations of connected airways.

37. The device of claim 35 or 36, wherein the coil comprises a wall configured to allow exposure of the wall of the airway to the inside of the airway when the coil is placed through the plurality of connected airways.

38. The device of claim 35, wherein the coil has an expanded diameter of between 1 mm and 10 mm.

39. The apparatus of claim 35, wherein: The second airway within the middle portion of the bronchial tree comprises one of a lobar bronchus or a segmental bronchus; and The first airways within the peripheral portion of the bronchial tree include bronchioles.

40. A system for improving airflow within a bronchial tree, the system comprising: delivery device; An implantable object, wherein the implantable object is configured to: placing a first end of the implantable object within a first airway of the bronchial tree using the delivery device; placing the second end of the implantable object within a second airway of the bronchial tree using the delivery device, the second airway being adjacent to the first airway such that the implantable object is simultaneously placed within two or more connected airways, the two or more connected airways including the first airway and the second airway; as well as expanding the implantable object within at least two of the two or more connected airways when the implantable object is simultaneously placed within the two or more connected airways such that at least a portion of the two or more connected airways expands, wherein when the implantable object is expanded, the implantable object comprises a diameter that is larger than a normal diameter of the at least a portion of the two or more connected airways prior to expansion of the at least a portion of the two or more connected airways, wherein the implantable object comprises an open wall having a spiral surface with continuous openings, wherein, when the implantable object is placed and expanded through multiple generations of connected airways, the continuously open helical surface provides an uninterrupted pathway along the inner wall of the airway from the first end of the implantable object to the second end of the implantable object.

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