Patent Publication Number: US-11654010-B2

Title: Implantable artificial bronchus

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 17/294,839 filed on May 18, 2021, which is a 371 national stage entry of International Patent Application No. PCT/US2019/062132 filed on Nov. 19, 2019, which claims the benefit of U.S. Provisional Patent Application No. 62/769,104 filed Nov. 19, 2018 entitled “Implantable Artificial Bronchus” and U.S. Provisional Patent Application No. 62/805,568 filed Feb. 14, 2019 entitled “Implantable Artificial Bronchus”, each of which is incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to an implantable artificial bronchus and methods of implanting the same for treatment of pulmonary emphysema and chronic obstructive pulmonary disease (COPD). 
     BACKGROUND OF THE INVENTION 
     Chronic obstructive pulmonary disease (COPD) can result in long-term breathing problems, poor airflow, shortness of breath, coughing, and sputum production. Pulmonary emphysema is a form of COPD and is experienced by a majority of individuals who suffer from COPD. 
     Pulmonary emphysema is characterized by the permanent enlargement of the gas exchange units in the lungs, acini, due to breakdown of the lung tissue and destruction of the alveolar walls. This gradual and irreversible degradation of the lung tissue leads to the loss of elastic capacity, lung recoil, expressed by the inability to expel inspired air. Further, the degradation of lung tissue contributes to the poor airflow, and thus, the poor absorption and release of respiratory gases. 
     Current treatments for pulmonary emphysema are limited and only provide symptomatic improvements. For example, a majority of current medications only treat the inflammatory component. Further, supplemental oxygen for hypoxic patients and pulmonary rehabilitation are the only medical treatments that have shown to improve mortality in severe cases of COPD. Surgical approaches, such as surgical lung volume reduction, is only indicated for a small proportion of patients and the procedure is invasive as it requires removing diseased, emphysematous lung tissue. Other methods, such as bronchoscopic techniques and stents, are currently being developed for treatment of severe COPD and have made progress over the past decade. However, these methods either do not allow bi-directional airflow, do not go deep enough within the distal levels of the respiratory bronchioles, or do not provide long term improvements to patients, for example, due to premature closing of the implanted stent or accelerating the damage to the patient. 
     Accordingly, there is a need for a more effective treatment for pulmonary emphysema and COPD which is minimally invasive, which includes bi-directional airflow, is able to go into deeper generations of respiratory bronchioles and does not result in more damage to the patient long term or trigger healing mechanisms within the lung. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention are directed to an implantable artificial bronchus, including a body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body. A length of the body is greater than 4 times the size of a largest diameter of the body and, a diameter of the proximal upper opening is larger than a diameter of the distal lower opening. 
     In some embodiments, the body may include a proximal portion, a first middle portion, a second middle portion, and a distal portion, the proximal portion being tapered towards a central axis of the body. The first middle portion and the second middle portion may be disposed between the proximal portion and the distal portion. The first middle portion may be proximate the proximal portion and the second middle portion being proximate the distal portion. The first middle portion may have a first taper and the second middle portion may have a second taper, the second taper may be larger than the first taper. 
     In some embodiments, a diameter of the first middle portion may be greater than a diameter of the proximal portion, a diameter of the second middle portion, and a diameter of the distal portion. The diameter of the distal portion may be less than the diameter of the proximal portion, the diameter of the first middle portion, and the diameter of the second middle portion. The diameter of the first middle portion may be equal to or less than the largest diameter of the body. The diameter of the second middle portion may constantly decreases along the length of the body from the first middle portion to the distal portion. The diameter of the distal portion may be substantially the same proximate the second middle portion and proximate distal lower opening. 
     In some embodiments, the proximal portion may flares out from the proximal upper opening to the first middle portion. 
     In some embodiments, a maximum diameter of the body may be greater than the diameter of the proximal upper opening. 
     In some embodiments, the body may be a web comprised of the single fiber forming a lattice structure, the single fiber may have ends woven together proximate a middle portion of the body. The single fiber may be coated with at least one of silicone or polymer. 
     In some embodiments, the diameter of the proximal upper opening is greater than twice the diameter of the distal lower opening. 
     In some embodiments, in an implanted state the body may be configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body. 
     In some embodiments, the plurality of side openings may include an angle ranging between approximately 130° proximate the proximal upper opening and 20° proximate the distal lower opening. 
     In some embodiments, the implantable artificial bronchus may include at least one retrieval loop coupled to the body at the proximal upper opening. The at least one retrieval loop may extend from the proximal upper opening in a direction substantially parallel to a central axis of the body. 
     In some embodiments, the implantable artificial bronchus includes at least one radiopaque marker disposed on the body. 
     In some embodiments, the body may have a maximum diameter of approximately 6 mm to approximately 12 mm. The body may be comprised of PEEK. The body may be comprised of NiTiNOL. Further, the body may include a single fiber arranged in an alternating cross-weaving pattern. 
     In some embodiments, the implantable artificial bronchus may not include a valve or a nozzle coupled to the body. 
     Another embodiment of the present invention may provide an implantable artificial bronchus including a body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the proximal upper opening tapering towards a central axis of the body. The body may constantly taper from a portion proximate the proximal upper opening toward a portion proximate the distal lower opening, and may have a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body. The body may include a proximal portion being tapered toward a central axis of the body, a first middle portion having a first middle taper, a second middle portion having a second middle taper larger than the first middle taper, and a distal portion having a constant distal diameter. The first middle portion and the second middle portion may be disposed between the proximal portion and the distal portion. A diameter of the proximal upper opening may be at least twice as large as a diameter of distal lower opening, and the diameter of the proximal upper opening may be less than a maximum diameter of the body, the maximum diameter of the body being proximate the proximal upper opening. In an implanted state the body may be configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body. 
     Another embodiment of the present invention may provide a method of promoting lung disinsufflation, the method including inserting a catheter distally into a respiratory passageway of a patient&#39;s lung, the catheter containing the implantable artificial bronchus compressed within the catheter, and withdrawing the catheter proximally relative to the implantable artificial bronchus, unsheathing the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the respiratory passageway, the implantable artificial bronchus configured to promote enlargement of the respiratory passageway. 
     In some embodiments, the catheter may be a guide catheter and the implantable artificial bronchus may extend into a bronchiole passageway. 
     Another embodiment of the present invention may provide a method of delivering the implantable artificial bronchus to an air passageway, the method including inserting the implantable artificial bronchus into a delivery device. The delivery device may include a handle having a proximal end, a distal end, an outer surface, and an actuator movable about the outer surface. The delivery device may further include a delivery portion including an outer sheath and a delivery wire, the outer sheath coupled to the actuator of the handle and extending out of the distal end of the handle, the outer sheath having a distal end and at least one slot, wherein the implantable artificial bronchus is inserted into the delivery device via the distal end. The delivery wire may be coupled to a proximal end of the handle and extending out of the distal end of the handle and into the outer sheath such that the delivery wire is disposed within the outer sheath, the delivery wire including a stopping member, wherein the stopping member is disposed proximate the implantable artificial bronchus after insertion of the implantable artificial bronchus into the delivery device. The method further includes inserting the delivery portion of the delivery device into a bronchoscope such that the outer sheath is disposed within a working channel of the bronchoscope, advancing the delivery portion through the bronchial passage via the bronchoscope, retracting the outer sheath, via the actuator, exposing the delivery wire and the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the bronchial passage, and removing the delivery device from the bronchial passage through the working channel of the bronchoscope. 
     In some embodiments, inserting the implantable artificial bronchus into the delivery device includes threading a suture through at least one proximal loop of the implantable artificial bronchus, pulling on the suture to cause the implantable artificial bronchus to collapse, inserting the suture and the implantable artificial bronchus through the distal end of the outer sheath, and removing the suture from the implantable artificial bronchus and the delivery device, via the at least one slot, such that the implantable artificial bronchus remains in the delivery device. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of embodiments of the implantable artificial bronchus, will be better understood when read in conjunction with the appended drawings of exemplary embodiments. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. 
         FIG.  1    is a perspective view of an exemplary implantable artificial bronchus in accordance with one embodiment of the present invention; 
         FIG.  2    is a side view of the implantable artificial bronchus shown in  FIG.  1   ; 
         FIG.  3    is an end view from a proximal end of the implantable artificial bronchus shown in  FIG.  1   ; 
         FIG.  4    is an end view from a distal end of the implantable artificial bronchus shown in  FIG.  1   ; 
         FIG.  5    is a close-up view of a distal end of the implantable artificial bronchus shown in  FIG.  1   ; 
         FIG.  6    is a side view of the implantable artificial bronchus of  FIG.  1    shown having a retrieval loop; 
         FIG.  7    is a perspective view the implantable artificial bronchus of shown in  FIG.  6   ; 
         FIG.  8    is an illustration of a lung showing compressed branches; 
         FIG.  9    is an illustration of an exemplary use of exemplary implantable artificial bronchus in accordance with one embodiment of the present invention; 
         FIG.  10    is an illustration of an exemplary use of exemplary implantable artificial bronchus in accordance with one embodiment of the present invention; 
         FIGS.  11 A-B  are illustrations of an exemplary measuring catheter in accordance with one embodiment of the present invention; and 
         FIGS.  12 A-D  are illustrations of an exemplary delivery device in accordance with one embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS OF THE INVENTION 
     Exemplary embodiments of the present invention provide an implantable artificial bronchus and methods of implanting the same. In use, implantable artificial bronchus  100  may facilitate the opening of airways within individuals with COPD and pulmonary emphysema. Specifically, implantable artificial bronchus  100  may allow for air trapped within the respiratory passageways, such as bronchi and bronchioles, to exit by opening up, and keeping open, the respiratory passageways. The implantation of implantable artificial bronchus  100  in the respiratory passageway may keep the walls of the bronchi and bronchioles from restricting thereby allowing airflow through the passageways. As shown in  FIGS.  1  and  2   , implantable artificial bronchus  100  may include body  102 , proximal upper opening  104 , distal lower opening  106 , wire or fiber  108 , and side openings  110 . Body  102  may be disposed between proximal upper opening  104  and distal lower opening  106 , and may be comprised of a fiber  108 . Implantable artificial bronchus  100  may be at least partially tapered to allow for the insertion into the bronchi and penetration of implantable artificial bronchus  100  within distal bronchioles that increasingly become more narrow. For example, implantable artificial bronchus  100  may be deployed within the respiratory passageway such that proximal upper opening  104  is disposed within the bronchi, and distal lower opening  106  is able to reach as close as possible to respiratory bronchioles at levels 9 to 15 (terminal bronchioles). 
     As shown in  FIGS.  1  and  2   , implantable artificial bronchus  100  may be comprised of body  102 . In one embodiment, body  102  is unobstructed and does not include a valve coupled to body  102 . Body  102  of implantable artificial bronchus  100  may be generally cylindrical towards proximal upper opening  104 , conical for a majority of body  102 , and generally cylindrical towards distal lower opening  106 . Body  102  may have maximum diameter D 3 , and may be tapered along length L of body  102  proximate proximal upper opening  104 , and between proximal upper opening  104  and distal lower opening  106 . For example, body  102  may include proximal portion  120 , first middle portion  122 , second middle portion  124 , and distal portion  126 . First middle portion  122  and second middle portion  124  may be disposed between proximal portion  120  and distal portion  126 , with first middle portion  122  being proximate proximal portion  120  and second middle portion being proximate distal portion  126 . Proximal portion  120  may taper towards central axis A and may have slope  128 , which may be between approximately 40-50 degrees relative to central axis A and may slope towards proximal upper opening  104 . First middle portion  122  may have a greater diameter than proximal portion  120  and may be generally cylindrical in shape. For example, first middle portion  122  may have a generally uniform diameter or may have a slight taper towards central axis A. First middle portion  122  may have slope  130 , which may be between approximately 2-4 degrees relative to central axis A and may slope towards distal lower opening  106 . First middle portion  122  having a greater diameter than proximal portion  120  allows first middle portion  122  to engage the walls of the bronchi, preventing them from collapsing, and securing implantable artificial bronchus  100 . For example, first middle portion  122  may allow implantable artificial bronchus  100  to be anchored proximally at levels 3 or 4 of the bronchi. In an embodiment, the diameter of first middle portion  122  may be substantially the same as maximum diameter D 3 . In another embodiment, maximum diameter D 3  may be disposed between proximal portion  120  and first middle portion  122 . Proximal portion  120  and first middle portion  122  may be disposed within the bronchi. Second middle portion  124  may be conical in shape. Second middle portion  124  may taper towards central axis A and may have a gradually decreasing diameter. Second middle portion  124  may have slope  132 , which may be between approximately 10-12 degrees relative to central axis A and may slope towards distal lower opening  106 . The diameter of second middle portion  124  may be less than the diameter of first middle portion  122  and may taper at a faster rate compared to first middle portion  122 . A section of second middle portion  124  proximate first middle portion  122  may be disposed in the bronchi. Second middle portion  124  may extend into the bronchioles and may taper until distal portion  126 . Distal portion  126  may be cylindrical in shape and may have a diameter less than second middle portion  124 , first middle portion  122 , and proximal portion  120 . Distal portion  126  may be disposed within the bronchioles. In an embodiment, distal portion  126  does not include any tapering such that the diameter of distal portion  126  proximate second middle portion  124  is the same as the diameter proximate distal lower opening  106 . For example, distal portion  126  may have an internal dimeter of approximately 2 mm, which may be substantially the same as diameter D 2  of distal lower opening  106 . In an embodiment, distal portion  126  tapers towards central axis A and may have slope  134 , which may be between approximately 1-3 degrees relative to central axis A and may slope towards distal lower opening  106 . In yet another embodiment, distal portion  126  may flare out, away from central axis A. For example, distal portion  126  may flare out to prevent inserting implantable artificial bronchus  100  too deeply within the bronchioles. Slopes  128 ,  130 ,  132 , and  134  may be between approximately 0 degrees and 15 degrees. Slopes  128 ,  130 ,  132 , and  134  may vary based on length L of body  102 . For example, slope  132  of second middle portion  124  may be approximately 4.3 degrees when length L is approximately 50 mm and may be approximately 2.7 degrees when length L is approximately 80 mm. In some embodiments, it is advantageous to have a greater degree of taper for slopes  128 ,  130 ,  132 , and  134  placed on the placement of implantable artificial bronchus. 
     In one embodiment, the shape and length of body  102  allows implantable artificial bronchus  100  to be inserted into a respiratory passageway to keep the respiratory passageways open in respiratory bronchioles beyond level 15, close to alveoli (&gt;15 levels), resulting in trapped air exiting the lower generations. According to an embodiment of the present invention, length L of body  102  may be greater than 4 times maximum diameter D 3  of body  102 . For example, maximum diameter D 3  of body  102  may be between 9.5 millimeters and 10.5 millimeters, and maximum length L of body  102  may be 50 millimeters or 80 millimeters. In some embodiments, length L of body  102  may be greater than 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 times maximum diameter D 3  of body  102 . Maximum diameter D 3  of body  102  being 9 millimeters may allow for implantable artificial bronchus  100  to be deployed within 6-8 millimeter bronchi. However, maximum diameter D 3  may be any size desired such as approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 10 mm, approximately 11 mm, or approximately 12 mm, and maximum length L of body  102  may be greater than 80 millimeters, less than 50 millimeters, or in between 50 and 80 millimeters. In one embodiment, maximum diameter D 3  of implantable artificial bronchus  100  is manufactured to be approximately 10.5 mm, which is reduced to approximately 8 mm or smaller upon deployment within the respiratory passageway. In use, maximum diameter D 3  may vary between 25-50% based on the breathing cycle, and dilation and constriction of the respiratory passageways. Maximum diameter D 3  may also vary due the flexibility of implantable artificial bronchus  100 . For example, maximum diameter D 3  may increase or decrease based on changes of the diameter of the bronchus, such as during a breathing cycle. Maximum length L of body  102  may vary in length to be sized to fit within shorter or longer respiratory passageways. For example, maximum length L of body  102  may be longer to penetrate to deeper, thinner respiratory bronchioles. 
     In an embodiment of the present invention, a kit may be provided which includes multiple implantable artificial bronchi  100  having various maximum lengths L of body  102 . For example, a kit may include one implantable artificial bronchus  100  where maximum length L of body  102  is 50 millimeters, another implantable artificial bronchus  100  where maximum length L of body  102  is 80 millimeters, and a third implantable artificial bronchus  100  where maximum length L of body  102  is greater than 80 millimeters. A surgeon may choose one implantable artificial bronchus  100  from the kit having a specific maximum length L of body  102  based on the anatomy of a patient. Further, maximum diameter D 3  of body  102  may be located at a portion proximate to proximal upper opening  104  and may be sized to press against the bronchi walls of the upper levels of the respiratory passageways. Maximum diameter D 3  being located proximate to proximal upper opening  104  may prevent or reduce proximal upper opening  104  from contacting the bronchi walls, which may assist in the adjustment, retrieval, and removal of implantable artificial bronchus  100  via proximal upper opening  104 . 
     According to an embodiment of the present invention, the diameter of body  102  may decrease from a portion of body  102  proximate proximal upper opening  104  to distal lower opening  106 . For example, body  102  may constantly taper from a portion proximate to proximal upper opening  104  toward the distal lower opening  106 . Body  102  may constantly taper from maximum diameter D 3  of body  102 , which may be approximately 9.5 mm, to diameter D 2  of distal lower opening  106 , which may be approximately 2 mm. In other embodiments, body  102  tapers slightly initially from the proximal end, more dramatically in the middle, and then slightly or not at all toward the distal end. For example, body  102  may constantly taper from maximum diameter D 3  to an area of body  102 , for example, located approximately 2 mm from distal lower opening  106 . Thereafter, body  102  may be flat, with no taper, for the rest of approximately 2 mm length. The rate of taper of body  102  may vary based on maximum length L of body  102 . For example, the rate of taper of body  102  may be greater if maximum length L of body  102  is lower. 
     Referring to  FIGS.  1  and  2   , proximal upper opening  104  may be in fluid communication with distal lower opening  106  to allow for bi-directional airflow in and through implantable artificial bronchus  100 . Proximal upper opening  104  may have diameter D 1  and distal lower opening  106  may have diameter D 2 . According to some embodiments, diameter D 1  of proximal upper opening  104  may be larger than diameter D 2  of distal lower opening  106 . For example, diameter D 1  of proximal upper opening  104  may be greater than twice diameter D 2  of distal lower opening  106 . In another example, diameter D 1  of proximal upper opening  104  may be approximately 7.5 mm and diameter D 2  of distal lower opening  106  may be approximately 2 mm. However, diameter D 1  of proximal upper opening  104  may be between approximately 5 mm and 14 mm, between approximately 6 mm and 13 mm, between approximately 7 mm and 12 mm, between approximately 8 mm and 11 mm, or between approximately 9 mm and 10 mm. Further, diameter D 2  may be between approximately 0 mm and 6 mm, between approximately 1 mm and 5 mm, or between approximately 2 mm and 4 mm. In practice, diameter D 1  of proximal upper opening  104  and diameter D 2  of distal lower opening  106  may be sized to fit within and reach various respiratory bronchi and bronchiole levels, such as distal bronchioles. For example, in one embodiment, diameter D 2  of distal lower opening  106  may be sized to be between approximately 2 mm and approximately 3 mm to fit within and reach respiratory bronchioles at level 15, which have a diameter between approximately 2.5 mm and approximately 3 mm. Further, in another embodiment, diameter D 2  of distal lower opening may be smaller than approximately 2 mm, such as 1.5 mm, to fit within and reach deeper levels of respiratory bronchioles, such as respiratory bronchioles level 16-18, which are approximately 1.5 to approximately 1 mm in diameter. 
     As shown in  FIG.  3   , maximum diameter D 3  of body  102  may be greater than diameter D 1  of proximal upper opening  104 . Further, a portion of body  102  proximate to proximal upper opening  104  may taper towards central axis A of body  102  to allow for easy and efficient removal of implantable artificial bronchus  100  inside of the respiratory passageway. For example, a portion of body  102  proximate to proximal upper opening  104  being tapered towards central axis A of body  102  prevents any portion of body  102  proximate to proximal upper opening  104  from perforating lung tissue within a bronchi during insertion and placement of implantable artificial bronchus  100 . 
     Body  102  may be a lattice structure comprised of woven wire or fiber. In one embodiment, body  102  is comprised of a single piece of wire or fiber  108 . The single piece of fiber  108  may be arranged in a cross-weaving pattern to form a plurality of side openings  110 . The ends of the single piece of fiber  108  may be connected and coupled together proximate the center of body  102  and the connection of the single piece of fiber  108  may be disposed within radiopaque marker  112 . In some embodiments, the ends of the single piece of fiber  108  may be woven together proximate the center of body  102 . For example, the ends of the single piece of fiber  108  may be woven together and disposed along first middle portion  122  or second middle portion  124 . However, the ends of the single piece of fiber  108  may be coupled together at any location of body  102  or in other manners. The ends of the single piece of fiber  108  may be woven side-by-side, and may be going in opposite directions when woven together. 
     Although  FIGS.  1  and  2    show fiber  108  being a single piece, fiber  108  may be composed of two or more strands of fiber. For example, body  108  may be comprised of two, three, four, or any number of fibers intertwined. Utilizing a plurality of fibers may increase the robustness of body  102  and reduce fatigue of body  102 . In an embodiment, each fiber of the plurality of fibers may have a different diameter. For example, a fiber with a thicker diameter may be used for proximal portion  120  and first middle portion  122 , and a fiber with a thinner diameter may be used for second middle portion  124  and distal portion  126 . In an embodiment of the present invention, the multiple fibers may be arranged to be parallel to one another to comprise body  102 . In another embodiment, the multiple fibers may be braided together to comprise body  102 . As shown in  FIGS.  1  and  2   , fiber  108  of body  102  may be arranged in an alternating cross-weaving pattern creating a web-like structure However, fiber  108  of body  102  may be arranged in any other manner desired. For example, fiber  108  of body  102  may be arranged in a back braiding manner to provide a more rigid structure to maintain the shape of body  102 . 
     According to an embodiment of the present invention, fiber  108  may be comprised of a thermoplastic polymer, such as polyether ether ketone (PEEK). In other embodiments, fiber  108  is comprised of one or more of polymer, metal, metal alloy, or stainless steel. Fiber  108  of body  102  may be made of a metal alloy having shape memory effect, such as NiTiNOL. However, fiber  108  may be a fiber of any other type of material such as a polymer, metal mesh, or any other type of material and may include a covering, such as silicone. In a preferred embodiment, fiber  108  of body  102  is comprised of a single fiber of PEEK. In some embodiments, fiber  108  of body  102  is comprised of PEEK and has a diameter of 0.30 mm. In an embodiment, fiber  108  of body  102  is made of a material having shape memory effect, such as PEEK. Fiber  108  may have a diameter between approximately 0.15 and approximately 0.40 mm. In a preferred, embodiment, fiber  108  has a thickness of approximately 0.25 mm. In an embodiment of the present invention, to create the structure of body  102 , fiber  108  is woven over a tapered mandrel, which may be made of titanium, ceramic, tool steel, or stainless steel. The tapered mandrel includes a series of pins to hold fiber  108  in place. The tapered mandrel may have a small proximal diameter to form diameter D 1  and may include grooves for placement of fiber  108 . Implantable artificial bronchus  100  may be manufactured by placing and weaving fiber  108  on the tapered mandrel to form body  102 . In an embodiment, the woven assembly of fiber  108  is placed in a furnace to heat fiber  108  to a first temperature of approximately 140° and allowed to cool to set the shape of body  102  of implantable artificial bronchus  100 . Implantable artificial bronchus  100  may then be placed on a second shaping form, such as another mandrel, and heated to a second temperature of approximately 170° to set the final shape of body  102 . The first temperature and second temperature may vary based on the materials used. 
     In an embodiment of the present invention, as shown in  FIG.  5   , fiber  108  may include a conformal coating  118 . In one embodiment, coating  118  may be a coating material comprised of silicone or other polymers. Fiber  108  may be coated with coating  118  prior to formation of the final shape of implantable artificial bronchus  100 . Coating  118  may be configured to add protection to fiber  108 , aid in biocompatibility of fiber  108 , and reduce friction of fiber  108  against the lung tissue of the bronchi and bronchiole passageways to increase the ease of insertion of implantable artificial bronchus  100  within the respiratory passageway. Coating  118  may have a thickness between 0.05 mm and 0.1 mm. 
     With continued reference to  FIGS.  1  and  2   , body  102  may include side openings  110 . Side openings  110  may be created due to the interweaving of fiber  108 . Body  102  may be formed only by fiber  108  and may only include side openings  110  disposed along the length L of body  102 . In one embodiment of the present invention, side openings  110  may be in direct contact with the surrounding tissue. For example, body  102  and implantable artificial bronchus  100  may not include any coverings or sheaths disposed around it, allowing side openings  110  to directly contact the surrounding walls of the bronchi and bronchioles. In practice, side openings  110  may be configured to allow air to enter and exit implantable artificial bronchus  100  through body  102 . Side openings  110  of implantable artificial bronchus  100  may allow access to other respiratory passageways that branch off of the main respiratory passageway where implantable artificial bronchus  100  is deployed. These other respiratory passageways may be created due to collateral ventilation. As shown in  FIGS.  1  and  2   , side openings  110  may be disposed along the entire length L of body  102 . Side openings  110  may be disposed on body  102  proximate proximal upper opening  104  and proximate distal lower opening  106 . Although  FIGS.  1  and  2    show side openings  110  being diamond shaped, side openings  110  may be any shape desired depending on the cross-weaving pattern of fiber  108 . In one embodiment, side opening  110  may include angles α and ß created by the interweaving of fiber  108 . Angles α and ß may be between approximately 130° and approximately 20°. Angle α may be disposed proximate proximal upper opening  104  and angle ß may be disposed proximate distal lower opening  106 . Angle α may be greater than angle ß. In some embodiments, angle α is less than 22° and angle ß is greater than 130°. Angles α and ß may decrease along length L of body  102  from proximal upper opening  104  to distal lower opening  106 . In one embodiment, angle α is approximately 115° proximate to proximal upper opening  104  and angle ß is approximately 22° proximate to distal lower opening  106 . Decreasing angles α and ß from proximal upper opening  104  to distal lower opening  106  results in body  102  being tapered along length L. In some embodiments, body  102  may include between 15 and 35 side openings  110  disposed along central axis A. 
     Referring to  FIG.  4   , side openings  110  may not be visible when implantable artificial bronchus  100  is viewed from a distal end. For example, side openings  110  may be arranged along body  102  in a manner such than when implantable artificial bronchus  100  is viewed from a distal end, side openings  110  may not be visible to prevent or limit side openings  110  from engaging with surrounding tissue during insertion and implantation of implantable artificial bronchus  100 . 
     Referring to  FIGS.  1 - 4   , implantable artificial bronchus  100  may include one or more radiopaque markers  112 . One or more radiopaque markers  112  may be disposed at various locations of implantable artificial bronchus  100 . For example, as shown in  FIGS.  1 - 3   , radiopaque marker  112  may be disposed on body  102  proximate proximal upper opening  104 . However, radiopaque marker  112  may be disposed anywhere along body  102 , such as proximal portion  120 , first middle portion  122 , second middle portion  124 , or distal portion  126 . Implantable artificial bronchus  100  may include any number of radiopaque markers  112  disposed along body  100 . For example, implantable artificial bronchus  100  may include one, two, three, four, five, six, or any number of radiopaque markers  112  desired. Radiopaque marker  112  may be used with known imaging techniques and may be used to determine the placement of implantable artificial bronchus  100  and may also aid in the retrieval or removal of implantable artificial bronchus  100 . In addition, radiopaque marker  112  may be used to determine the exact location of specific portions of implantable artificial bronchus  100  and body  102 . For example, radiopaque marker  112  disposed on body  102  proximate proximal upper opening  104  may indicate to a user the location of the proximal end of implantable artificial bronchus  100  to determine proper alignment and location of implantable artificial bronchus  100 . In an embodiment of the present invention, radiopaque marker  112  is disposed around fiber  108 . As shown in  FIG.  3   , fiber  108  may be inserted through radiopaque marker  112 . However, radiopaque marker  112  may be disposed on fiber  108 , or underneath fiber  108 . 
     Referring to  FIGS.  6  and  7   , implantable artificial bronchus  100  may include one or more retrieval loops  114 . Retrieval loop  114  may aid in the retrieval and removal of implantable artificial bronchus  100  from the respiratory passageways. In an embodiment of the present invention, retrieval loop  114  is integrated into body  102 . For example, retrieval loop  114  may be configured to integrate into the cross-weaving pattern of fiber  108 . Retrieval loop  114  may be integrated into body  102  near proximal upper opening  104 . In another embodiment of the present invention, retrieval loop  114  is a separate structure coupled to body  102  as a secondary process. Retrieval loop  114  may be coupled to body  102  near proximal upper opening  104  or any other location along body  102 . Although  FIGS.  6  and  7    show implantable artificial bronchus  100  having one retrieval loop  114 , implantable artificial bronchus  100  may have any number of retrieval loops  114 . For example, implantable artificial bronchus  100  may have two, three, four or any number of retrieval loops  114  desired. Retrieval loop  114  may be made from a different material than fiber  108  of body  102  for increased robustness during retrieval and removal of implantable artificial bronchus  100 . For example, retrieval loop  114  may be made from materials such as MP35N, 35NLT, 316L Stainless Steel, Titanium, polymers, suture materials, polypropylene, nylon, or any other material desired. Further, retrieval loop  114  may vary in diameter compared to fiber  108 . In an embodiment, retrieval loop  114  may have a diameter of approximately 0.381 mm. However, retrieval loop  114  may have a diameter of any size desired. In an embodiment of the present invention, retrieval loop  114  includes handle  116 . Handle  116  may be configured to allow a user to easily retrieve or remove implantable artificial bronchus  100  via retrieval loop  114 . Handle  116  may be made of the same material as retrieval loop  114 , or may be made of different materials to increase the overall strength of retrieval loop  114 . 
     In some embodiments of the present invention, retrieval loop  114  include one or more radiopaque markers  112 . The presence of one or more radiopaque markers  112  with retrieval loop  114  may assist in determining the location of retrieval loop  14  and/or implantable artificial bronchus  100 , in addition to assisting in the retrieval of implantable artificial bronchus  100 . In an embodiment of the present invention, retrieval loop  114  may be configured to be interwoven into body  102  and compressed along with body  102 . Retrieval loop  114  being compressed allows for the entirety of implantable artificial bronchus  100  to be compressed for ease of insertion and implantation. 
     In use, implantable artificial bronchus  100  may be used to promote lung disinsufflation. As shown in  FIG.  8   , lung  200  of an individual may include respiratory passageways  202  having walls  204 . Respiratory passageways  202  may be bronchi or bronchioles, and walls  204  may be bronchi walls or bronchiole walls depending on the depth within respiratory passageway  202 . In individuals with COPD and pulmonary emphysema, walls  204  of respiratory passageway  202  may be restricted limiting airflow, as denoted by the arrows in  FIG.  8   . Implantable artificial bronchus  100 , as shown in  FIG.  9   , may be used to keep walls  204  of respiratory passageway  202  from restricting, allowing for airflow as depicted by the arrows in  FIG.  9   . Specifically, implantable artificial bronchus  100  may allow for air trapped within respiratory passageway  202  to exit by opening up, and keeping open, the bronchi and bronchioles. 
     Referring to  FIGS.  9 - 10   , in an embodiment, a surgeon places implantable artificial bronchus  100  into the respiratory passageway by inserting a catheter distally into a respiratory passageway of the lung. The catheter may contain implantable artificial bronchus  100  which may be compressed within the catheter. For example, implantable artificial bronchus  100  may be compressed radially toward central axis A reducing the diameter of implantable artificial bronchus  100  to fit implantable artificial bronchus  100  within the catheter during insertion and implantation. The catheter may be withdrawn proximally relative to implantable artificial bronchus  100 , unsheathing implantable artificial bronchus  100  and causing it to naturally expand and remain in the respiratory passageway. In another embodiment of the present invention, implantable artificial bronchus  100  is coupled to a bronchoscope for placement of implantable artificial bronchus  100  within respiratory passageways. In a preferred embodiment, implantable artificial bronchus  100  is composed of a material such as PEEK that allows implantable artificial bronchus  100  to expand to its original shape. As shown in  FIG.  9   , implantable artificial bronchus  100  within the respiratory passageways may be configured to promote enlargement of the bronchial passageway and in turn cause lung deflation. 
     In an embodiment of the present invention, the insertion of implantable artificial bronchus  100  into respiratory passageway  202  is done with a channel bronchoscope. For example, a 2.8 mm channel bronchoscope may be used to assist with the insertion and implantation of implantable artificial bronchus  100  into respiratory passageway  202 . In an embodiment, the bronchoscope assists with delivering implantable artificial bronchus  100  to level 15 of the respiratory bronchioles. As implantable artificial bronchus  100  expands from its compressed state, implantable artificial bronchus  100  may be able to reach deeper respiratory bronchioles, such has levels 17, 18, or 19. For example, implantable artificial bronchus  100  may be placed within the distal bronchus having a diameter between 2-2.5 mm, and maximum diameter D 3  of implantable artificial bronchus  100  may allow implantable artificial bronchus  100  to support bronchus wall  204  such that bronchus wall  204  does not collapse and close off the airway. Further, implantable artificial bronchus  100  may be inserted into respiratory passageway  202  located in distal portions via access through the central airway. The implant path may be initially identified with a malleable metal guide. A subsequent catheter passage may be done to guide implantable artificial bronchus  100  in a compressed state. However, compressed implantable artificial bronchus  100  may be introduced directly by a guidewire. 
     Referring to  FIG.  10   , implantable artificial bronchus  100  may be flexible to allow for body  102  of implantable artificial bronchus  100  to conform to the shape of a respiratory passageway. For example, implantable artificial bronchus  100  may be configured to weave back and forth as it enters distal bronchioles. In an embodiment, body  102  is configured to curve in a first radial direction along a first length of body  102  and a second radial direction opposite the first radial direction along a second length of body  102 . Implantable artificial bronchus  100  may be configured to be flexible due to the interweaving of fiber  108  of PEEK. For example, body  102  may be comprised of a single interweaving fiber  108 , which allows various segments of fiber  108  to cross and slide over one another during movement of implantable artificial bronchus  100 . In an embodiment, implantable artificial bronchus  100  does not include any element to couple the various segments of fiber  108 , thereby allowing them to move and slide over one another, increasing the flexibility of implantable artificial bronchus  100 . The flexibility of implantable artificial bronchus  100  and body  102  allow for implantable artificial bronchus  100  to conform and be secured within a respiratory passageway without causing damage to the surrounding tissues. In addition, the flexibility allows for a single implantable artificial bronchus  100  to be used in a longer respiratory passageway instead of using multiple implantable artificial bronchi. Further, the flexibility of implantable artificial bronchus  100  allows it to reach respiratory bronchioles beyond level 15. Implantable artificial bronchus  100  may be configured to provide structure to bronchus wall  204  while allowing air trapped within in distal alveoli to exit via the central airway. The shape and flexibility of implantable artificial bronchus  100  allows implantable artificial bronchus  100  to reach as close as possible to distal respiratory bronchioles, such as respiratory bronchioles beyond level 15 and close to alveoli (&gt;15 levels). 
     In an embodiment, side openings  110  of body  102  allow for air to enter body  102  while implantable artificial bronchus  100  is disposed within the respiratory passageway. For example, as denoted by the arrows in  FIG.  10   , air may enter body  102  via side openings  110  from smaller side respiratory passageways. These smaller side respiratory passageways may be created due to collateral ventilation. This allows air to flow through body  102  from distal bronchioles while implantable artificial bronchus  100  is implanted in the respiratory passageway. 
     Referring to  FIGS.  11 A-B , a measuring catheter  400  may be used prior to insertion of implantable artificial bronchus  100  into the respiratory passageway. Measuring catheter  400  may be inserted into a channel bronchoscope to determine the depth of the desired target site within the respiratory passageway. Measuring catheter  400  may be a steerable wire that may be inserted into the channel bronchoscope prior to delivery of implantable artificial bronchus  100 . For example, measuring catheter  400  may have a fixed diameter of about 2 mm. The diameter of measuring catheter may be approximately 2 mm to prevent insertion beyond bronchioles that have a diameter less than 2 mm. Measuring catheter  400  having a fixed diameter of approximately 2 mm allows measuring catheter  400  to measure the distance to where the bronchioles narrows to approximately 2 mm. Measuring catheter  400  may include distal  406 , proximal end  404 , and handle  402 . Distal end  406  and proximal end  404  may include markers  403 . Markers  403  may be located at pre-defined intervals and may be visualized using a camera of the channel bronchoscope to determine the depth and space available to implant implantable artificial bronchus  100  within the respiratory passageway. In an embodiment, markers  403  at distal end  406  and the interval at which they are located are identical to markers  403  at proximal end  404 . This allows the user to determine the depth without solely relying on the camera since proximal end  404  may be located outside of the channel bronchoscope. Handle  402  may be a molded plastic handle and may be used for manipulating measuring catheter  400 . In an embodiment, handle  402  is glued in place by backfilling a hole within handle  402  with an adhesive. 
     Referring to  FIGS.  12 A-D , a delivery device  300  may be used to delivery implantable artificial bronchus  100 . Once the depth is determined via measuring catheter  400 , delivery device  300  may be used to deliver implantable artificial bronchus  100  to the target site. Delivery device  300  may include delivery portion  301  and handle  310 . Delivery portion  301  may include outer sheath  302 , delivery wire  304 , and stabilizer  308 . Handle  310  may be coupled to delivery portion  301  at distal end  313  of handle  310 . Implantable artificial bronchus  100  may be inserted into delivery portion  301  and disposed within delivery device  300  for delivery to a target site within the respiratory passageway. For example, delivery device  300  may be inserted within a working channel of the bronchoscope. Delivery portion  301  may be inserted and advanced into the respiratory passageway. Once delivery portion  301  has reached the target site for delivering implantable artificial bronchus  100 , outer sheath  302  may be retracted to expose delivery wire  304  and implantable artificial bronchus  100 , allowing for the delivery of implantable artificial bronchus  100  at the target site. Delivery portion  301  may then be removed from the working channel of the bronchoscope. 
     Handle  310  may include actuator  312 , stabilizer  308 , proximal end  311 , distal end  313 , anchor  316 , and outer surface  317 . Actuator  312  may be disposed on outer surface  317 . In an embodiment, actuator  312  may be disposed within slot  319  on outer surface  317 . Actuator  312  may be actuated via a thumb of a user to slide actuator  312  from proximal end  311  to distal end  313 . Actuator  312  may be coupled to outer sheath  302  and may be configured to retract outer sheath  302  into handle  310  to expose delivery wire  304 . For example, actuator  312  may be coupled to a portion of outer sheath  302  disposed within handle  310 , thereby resulting in outer sheath  302  being retracted into handle  310  when actuator  312  is moved towards proximal end  311 . Outer sheath  302  may pass through stabilizer  308  to assist in securing outer sheath  302  to handle  310 . In an embodiment, outer sheath  302  is movable relative to stabilizer  308  and handle  310 . Outer sheath  302  may include distal end  315 , slot  307 , and marker  318 , and may be coupled to distal end  313  of handle  310 . Marker  318  may be used to help determine various locations of outer sheath  302  within the respiratory passageway. Delivery wire  304  may be disposed within outer sheath  302  and may be comprised of a rigid material. Delivery wire  304  may extend from proximal end  311  of handle  310  to distal end  315  of outer sheath  302 . Delivery wire  304  may be anchored to proximal end  311  at anchor  316  of handle  310 . Anchor  316  may be configured to secure delivery wire  304  such that outer sheath  302  may be movable relative to delivery wire  304 . Delivery wire  304  may include stopper  305 , which may be disposed at the end of delivery wire  304 . Stopper  305  may be disposed within outer sheath  302  proximate to slot  307 . 
     In an embodiment, implantable artificial bronchus  100  is inserted into distal end  315  of outer sheath  302 , proximate to slot  307 , which is proximate stopper  305  of delivery wire  304 . Slot  307  may be located proximate distal end  315  of outer sheath  302 . Implantable artificial bronchus  100  may be inserted into distal end  315  by threading a suture through a loop of proximal upper opening  104 . The ends of the suture may pass through a funnel, into outer sheath  302 , and out of slot  307 . Implantable artificial bronchus  100  is inserted into distal end  315  of outer sheath  302  by pulling on the ends of the suture, which pull implantable bronchus  100  through the funnel resulting in collapsing implantable artificial bronchus  100 . Continued pulling of the ends of the suture pulls collapsed implantable artificial bronchus  100  into distal end  315  of outer sheath  302 . The suture is pulled until implantable artificial bronchus  100  reaches slot  307 , which is proximate stopper  305  of delivery wire  304 . The suture may then be pulled through slot  307  and removed from implantable artificial bronchus  100 . Once implantable artificial bronchus  100  is inserted into outer sheath  302 , implantable artificial bronchus  100  may expand. For example, body  102  of implantable artificial bronchus  100  having length L of approximately 50 mm may expand to have length L of approximately 80 mm within outer sheath  302 . By way of another example, body  102  of implantable artificial bronchus  100  having length L of approximately 80 mm may expand to have length L of approximately 128 mm within outer sheath  302 . During initial insertion, implantable artificial bronchus  100  may reduce down to its intended length. Once implantable artificial bronchus  100  is inserted into outer sheath  302  of delivery portion  301 , outer sheath  302  may be inserted into a working channel of the bronchoscope. Delivery portion  301  may be inserted into the respiratory passageway and advanced to the target site. Once the target site has been reached, actuator  312  may be moved towards proximal end  311  of handle  310 , thereby retracting outer sheath  302  into handle  310  and exposing delivery wire  304 , stopper  305 , and implantable artificial bronchus  100 . Retracting of outer sheath  302  does not cause movement of implantable artificial bronchus  100  towards handle  310  due to delivery wire  304  and stopper  305  exerting a force on implantable artificial bronchus  100  preventing movement of implantable artificial bronchus  100 . Once outer sheath  302  has been retracted and implantable artificial bronchus  100  is exposed, implantable artificial bronchus  100  may expand to its original position within the respiratory passageway. Delivery portion  301  of delivery device  300  may then be withdrawn from the respiratory passageway via the working channel of the bronchoscope. 
     It will be appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventive concepts thereof. It is understood, therefore, that this invention is not limited to the exemplary embodiments shown and described, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the claims. For example, specific features of the exemplary embodiments may or may not be part of the claimed invention and various features of the disclosed embodiments may be combined. The words “proximal”, “distal”, “upper” and “lower” designate directions in the drawings to which reference is made. Unless specifically set forth herein, the terms “a”, “an” and “the” are not limited to one element but instead should be read as meaning “at least one”. 
     It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein. 
     Further, to the extent that the methods of the present invention do not rely on the particular order of steps set forth herein, the particular order of the steps should not be construed as limitation on the claims. Any claims directed to the methods of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the steps may be varied and still remain within the spirit and scope of the present invention.