Implantable artificial bronchus

Abstract

An implantable artificial bronchus, including a body having at least one fiber woven to form a lattice structure. The body includes a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, and the body at least partially tapering along a length of the body toward the distal lower opening. The body further includes a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening. A diameter of the proximal upper opening is larger than a diameter of the distal lower opening. The proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops. The number of distal loops is less than the number of proximal loops.

Description

TITLE

[0001] Implantable Artificial BronchusCROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 497,701 filed April 21, 2023 entitled “Implantable Artificial Bronchus”, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0003] The present disclosure 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

[0004] 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.

[0005] 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.

[0006] 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 therespiratory 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.BRIEF SUMMARY

[0007] Embodiments of the present disclosure are directed to an implantable artificial bronchus having a body comprised of at least one fiber woven to form a lattice structure, the 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 first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening. A diameter of the proximal upper opening is larger than a diameter of the distal lower opening and wherein the proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops, the number of distal loops being less than the number of proximal loops.

[0008] In some embodiments, the body includes a proximal portion, a first middle portion, a second middle portion, and a distal portion, the proximal portion being tapered radially inward 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 being proximate the proximal portion and the second middle portion being proximate the distal portion, the first middle portion having a first taper and the second middle portion having a second taper, the second taper being larger than the first taper.

[0009] In some embodiments, a diameter of the first middle portion is 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.

[0010] In some embodiments, the proximal portion flares out from the proximal upper opening to the first middle portion.

[0011] In some embodiments, the implantable artificial bronchus includes a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body. 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. The plurality of side openings may include a first side opening proximate the proximal upper opening and a second side opening proximate the distal lower opening, the first side opening having a first angle and the second side opening having a second angle less than the first angle.

[0012] In some embodiments, a length of the body is greater than 4 times a size of a largest diameter of the body.

[0013] In some embodiments, a maximum diameter of the body is greater than the diameter of the proximal upper opening. The body may have a maximum diameter of approximately 6 mm to approximately 12 mm.

[0014] In some embodiments, the body is a web comprised of the at least one fiber forming the lattice structure, the at least one fiber having ends woven together proximate a middle portion of the body. The body is a web comprised of a plurality of fibers forming the lattice structure.

[0015] In some embodiments, the diameter of the proximal upper opening is greater than twice the diameter of the distal lower opening.

[0016] In some embodiments, the at least one fiber is coated with at least one of silicone or polymer.

[0017] In some embodiments, in an implanted state the body is 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.

[0018] In some embodiments, the implantable artificial bronchus includes at least one radiopaque marker disposed on the body. The body may be comprised of PEEK. The body may be comprised of NiTiNOL.

[0019] In some embodiments, the at least one fiber is arranged in an alternating cross-weaving pattern to form the body.

[0020] In some embodiments, the implantable artificial bronchus does not include a valve or a nozzle coupled to the body.

[0021] In some embodiments, the body includes a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the first loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion.

[0022] Another embodiment of the present disclosure is directed to an implantable artificial bronchus including a body comprised of at least one fiber and having a proximal upper opening anda 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 first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the first loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion. A diameter of the proximal upper opening is larger than a diameter of the distal lower opening and the first portion has a greater density of portions of the fiber than the second portion.

[0023] In some embodiments, the implantable artificial bronchus includes a second loop disposed between the first loop and the distal lower opening, such that the body includes a third portion between the first loop and the second loop, and a fourth portion between the second loop and the distal lower opening, the fourth portion having the same or greater flexibility than the third portion, and the third portion having the same or greater flexibility than the first portion.

[0024] In some embodiments, the implantable artificial bronchus includes a central axis extending along the length of the body from the proximal upper opening to the distal lower opening, wherein the second portion is configured to bend away from the central axis more than the first portion.

[0025] Another embodiment of the present disclosure is directed to an implantable artificial bronchus including a body comprised of at least one fiber and 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 loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion. The body includes 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, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion. A diameter of the proximal upper opening is at least twice as large as a diameter of distal lower opening, and the diameter of the proximal upper opening is 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 is configured to curve in a first radial direction along a first length of thebody and a second radial direction opposite the first radial direction along a second length of the body.

[0026] In some embodiments, the implantable artificial bronchus promotes lung di sin sufflation. The implantable artificial bronchus is inserted into a catheter distally into a respiratory passageway of a patient’s lung, the catheter containing the implantable artificial bronchus disposed within the catheter in a compressed state, and withdrawing the catheter proximally relative to the implantable artificial bronchus causing the implantable artificial bronchus to unsheathe and naturally expand into an expanded state such that the implantable artificial bronchus remains disposed within the respiratory passageway. The implantable artificial bronchus is in the expanded state and disposed within the respiratory passageway results in at least a portion of the middle portion abutting an inner wall of the respiratory passageway and prevents the proximal upper opening from contacting the inner wall of the respiratory passageway.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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 disclosure is not limited to the precise arrangements and instrumentalities shown.

[0028] Fig. l is a perspective view of an implantable artificial bronchus in accordance with a first exemplary embodiment of the present disclosure;

[0029] Fig. 2A is a side view of the implantable artificial bronchus of Fig. 1;

[0030] Fig. 2B is a side view of the implantable artificial bronchus of Fig. 1;

[0031] Fig. 3 is a side view of an implantable artificial bronchus in accordance with a second exemplary embodiment of the present disclosure;

[0032] Fig. 4 is a side view of an implantable artificial bronchus in accordance with a third exemplary embodiment of the present disclosure;

[0033] Fig. 5 is a rear end view from a proximal end of the implantable artificial bronchus of Fig. i;

[0034] Fig. 6 is a front-end view from a distal end of the implantable artificial bronchus of Fig. 1;

[0035] Fig. 7 is an illustration of a lung showing compressed bronchioles;

[0036] Fig. 8 is an illustration of implantation of the implantable artificial bronchus of Fig. 1 into a compressed branch of the lung of Fig. 7; and

[0037] Fig. 9 is an illustration of implantation of the implantable artificial bronchus of Fig. 1 into a compressed bronchiole of the lung of Fig. 7, where the implantable artificial bronchus is flexed.DETAILED DESCRIPTION

[0038] Exemplary embodiments of the present disclosure provide an implantable artificial bronchus and methods of implanting the same into a patient. 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. In some embodiments, implantable artificial bronchus 100 is configured to curve and bend to correspond with the shape of an individual patient’s passageways. For example, implantable artificial bronchus 100 may have a flexible distal end configured to bend and flex as implantable artificial bronchus 100 extends into deeper bronchioles. In some embodiments, the distal end of implantable artificial bronchus 100 has the same or greater flexibility has a proximal portion of implantable artificial bronchus 100 (e.g., proximal portion 120 and / or first middle portion 122).

[0039] As shown in Figs. 1-4, 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. In some embodiments, body 102 is comprised of more than one fiber. For example, body 102 may be comprised of two fibers, fiber 108a and fiber 108b. In some embodiments, fiber 108a and fiber 108b are separate fibers braided together to form body 102.

[0040] 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 narrower. 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). In some embodiments, a distal end of implantable artificial bronchus 100 is configured to flex and bend to match the contours of the bronchioles. For example, a distal end of implantable artificial bronchus 100 may be tapered toallow for implantable artificial bronchus 100 to reach deeper bronchioles and may also be flexible to allow for implantable artificial bronchus 100 to flex to match the contours of the deeper bronchioles.

[0041] As shown in Figs. 1-4, implantable artificial bronchus 100 may be comprised of body 102. In some embodiments, 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 D3, 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 124 being proximate distal portion 126.

[0042] 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. Proximal portion 120 tapering towards central axis A may prevent proximal portion 120 from abutting or contact the bronchial walls while implantable artificial bronchus 100 is disposed within a bronchiole. For example, proximal portion 120 tapering inward towards central axis A prevents proximal portion 120 from perforating, damaging, rubbing against, or scraping an inner wall of the respiratory passageway.

[0043] 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.

[0044] In some embodiments, implantable artificial bronchus 100 includes contacting portion 127, such as shown in Fig. 2A. Contacting portion 127 may be circumferentially disposed around body 102 between proximal portion 120 and first middle portion 122. In some embodiments, contacting portion 127 is disposed where body 102 transitions from slope 128 to slope 130.Contacting portion 127 may have a diameter of maximum diameter D3. For example, contacting portion 127 may be the widest (e.g., largest diameter) portion of body 102. Contacting portion 127 may be configured to allow implantable artificial bronchus 100 to be secured within a bronchiole by contact the bronchiole wall. In some embodiments, body 102 proximate contacting portion 127 is rounded (e.g., non-sharp, soft-contours) to prevent contacting portion 127 and implantable artificial bronchus 100 from damaging or perforating the bronchiole wall.

[0045] In some embodiments, the diameter of first middle portion 122 is substantially the same as maximum diameter D3. Maximum diameter D 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.

[0046] In some embodiments, distal portion 126 comprises the distal 25% of body 102. Distal portion 126 may comprise the distal 5% to 50%, 10% to 40%, or 15% to 30% of body 102. In some embodiments, distal portion 126 comprises the distal 10 mm to 20 mm of body 102. Distal portion 126 may comprise the distal 40 mm to 5 mm, 35 mm to 10 mm, or 25 mm to 15 mm of body 102.

[0047] In some embodiments, 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 D2 of distal lower opening 106. In some embodiments, 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 varybased 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.

[0048] In some embodiments, 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 (>15 levels), resulting in trapped air exiting the lower generations. In some embodiments, length L of body 102 is greater than 4 times maximum diameter D3 of body 102. For example, maximum diameter D3 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 D3 of body 102. Maximum diameter D3 of body 102 being 9 millimeters may allow for implantable artificial bronchus 100 to be deployed within 6 - 8 millimeter bronchi. Maximum diameter D3 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.

[0049] In some embodiments, maximum diameter D3 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 D3 may vary between 25-50% based on the breathing cycle, and dilation and constriction of the respiratory passageways. Maximum diameter D3 may also vary due the flexibility of implantable artificial bronchus 100. For example, maximum diameter D3 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.

[0050] In some embodiments, 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 isgreater 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 D3 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 D3 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.

[0051] In some embodiments, a kit may be provided which includes multiple implantable artificial bronchi 100 having various flexibility. For example, a kit may include one implantable artificial bronchus 100’ having minimal flexing (e.g., substantially rigid), a second implantable artificial bronchus 100” configured to flex more than implantable artificial bronchus 100’, and a third implantable artificial bronchus 100”’ configured to flex more than implantable artificial bronchus 100”. In some embodiments, a kit may be provided which includes multiple implantable artificial bronchi 100 having various locations of inflection (e.g., flexing) points. The kit may include one implantable artificial bronchus 100’ having an inflection point proximate distal lower opening 106, a second implantable artificial bronchus 100” having an inflection point proximate proximal upper opening 104 compared to implantable artificial bronchus 100’, and a third implantable artificial bronchus 100’” having an inflection point proximate proximal upper opening 104 compared to implantable artificial bronchus 100” and implantable artificial bronchus 100’.

[0052] In some embodiments, the diameter of body 102 decreases 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 D3 of body 102, which may be approximately 9.5 mm, to diameter D2 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 D3 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 longer. In some embodiments, body 102 has step-wise tapering. For example, body 102 may include a portion of tapering disposed between portions of no tapering.In some embodiments, body 102 includes a first portion of tapering at a first degree of tapering, a second portion tapering at a second degree of tapering, and a middle portion having no tapering disposed between the first portion of tapering and a second portion of tapering.

[0053] Referring to Figs 1 and 2A-3, 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 Di and distal lower opening 106 may have diameter D2. According to some embodiments, diameter Di of proximal upper opening 104 may be larger than diameter D2 of distal lower opening 106. For example, diameter Di of proximal upper opening 104 may be greater than twice diameter D2 of distal lower opening 106. In another example, diameter Di of proximal upper opening 104 may be approximately 7.5 mm and diameter D2 of distal lower opening 106 may be approximately 2 mm. diameter Di 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 D2 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 Di of proximal upper opening 104 and diameter D2 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, diameter D2 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, diameter D2 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.

[0054] As shown in Fig. 5, maximum diameter D3 of body 102 may be greater than diameter Di 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.

[0055] Referring to Figs. 2A-4, body 102 may be a lattice structure comprised of one or more woven wires or fibers 108 (e g., fibers 108 and 108b). In some embodiments, body 102 iscomprised of more than one fiber 108, such as fibers 108a and 108b. Fiber 108 may be arranged in a cross-weaving pattern to form a plurality of side openings 110. In some embodiments, the ends of the fiber 108 are disposed along body 102. The ends of fiber 108 may be connected and coupled together proximate the center of body 102 and the connection of fiber(s) 108 may be disposed within radiopaque marker 112. In some embodiments, the ends of one or more fibers 108 are woven together proximate the center of body 102. For example, the ends of the fibers 108 may be woven together and disposed along first middle portion 122 or second middle portion 124.

[0056] In some embodiments, to create the structure of body 102, one or more fibers 108 are 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 one or more fibers 108 (e.g., fiber 108 and 108b) in place. The tapered mandrel may have a small proximal diameter to form diameter Di and may include grooves for placement of fibers 108. Implantable artificial bronchus 100 may be manufactured by placing and weaving one or more fibers 108 (e.g., fiber 108a and fiber 108b) on the tapered mandrel to form body 102.

[0057] In some embodiments, the woven assembly of fibers 108 is placed in a furnace to heat fibers 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.

[0058] In forming the structure of body 102 using a tapered mandrel, one or more fibers 108 (e.g., fiber 108a and fiber 108b) are braided onto the outside of the mandrel such that one or more fibers 108 cross over each other or themselves to from a plurality of crossings 140 along body 102. For example, crossing 140 may be formed by fiber 108 (e.g., fiber 108a) crossing over or under itself or another fiber (e.g., fiber 108b). In some embodiments, the plurality of crossings 140 give body 102 a lattice shape. For example, the plurality of crossings 140, formed by one or more fibers 108, results in body 102 having side openings 110. Body 102 may include crossings 140 that are aligned (e.g., crossings 140a, 140b, 140c, etc.) formed by crossings 140 being aligned from proximal upper opening 104 to distal lower opening 106. Aligned crossings 140 (e.g., crossings 140a, 140b, 140c, etc.) may be crossings that extend down a single axis when body 102 is viewed from the side (e.g., Fig. 2B). In other words, aligned crossings 140 (e.g., crossings 140a, 140b, 140c, etc.) may be crossings that extend from proximal upper opening 104 to distal lower opening 106 along a single line such that the single line bifurcates each crossing 140 of the aligned crossings.In some embodiments, the aligned crossings include greater than ten crossings aligned with each other along a side of body 102. For example, as shown in Fig. 2B, body 102 may include ten to fifteen crossings.

[0059] In some embodiments, body 102 includes a plurality of loops 142 formed by looping of one or more fibers 108 during formation of body 102. Loop 142 may be formed by one or more fibers 108 extending from a first area along body 102 to a second area along body 102. In some embodiments, loops 142 form proximal upper opening 104 and distal lower opening 106. For example, due to one or more fibers 108 being braided to form body 102, one or more fibers 108 must be looped to form the structure of body 102, thereby forming loops 142 at the ends (e.g., proximal upper opening 104 and distal lower opening 106) of implantable artificial bronchus 100.

[0060] In some embodiments, one or more loops 142 are disposed along body 102. For example, loops 142 may be formed by looping one or more fibers 108 from an area proximate proximal upper opening 104 to an area of body 102 and then back to an area proximate upper opening 104, thereby creating loop 142 along body 102. In some embodiments, body 102 includes a plurality of loops 142 disposed along body 102. For example, body 102 may include a plurality of loops 142 that form distal lower opening 106 and / or proximal upper opening 104. In some embodiments, body 102 includes a plurality of loops 142 disposed between distal lower opening 106 and proximal upper opening 104.

[0061] In some embodiments, body 102 having loops 142 only at distal lower opening 106 and proximal upper opening 104 (e.g., not between proximal upper opening 104 and distal lower opening 106) and being tapered can cause distal portion 126 to have high density or concentration of fiber 108 (e.g., a greater number of crossings 140 in smaller volume of space). For example, distal lower opening 106 may have a high number of portions or segments of fiber 108 due to loops 142 only being present at distal lower opening 106 and proximal upper opening 104. The higher density of fiber 108 at distal portion 126 results in distal portion being rigid and less flexible than desired flexibility. For example, the increased density of distal portion 126 may result in distal portion 126 being less flexible than desired and / or other portions of body 102 (e.g., proximal portion 120, first middle portion 122, and / or second middle portion 124). In some embodiments, the increase in density of fiber 108 at the distal half of body 102 (e g., distal portion 126 and / or second middle portion 124) causes the degree of flexibility of the distal half to decrease along the length from the proximal upper opening 104 to distal lower opening 106. In some embodiments, the distal half of body 102 (e.g., distal portion 126 and / or second middle portion 124) includes the same number of loops 142 as the proximal half of body 102 (e.g., proximal portion 120 and / or first middle portion122), but the distal half of body 102 includes loops 142 in a smaller volume compared to the proximal half of body 102. This results in the distal half of body 102 having a greater stiffness (e.g., less flexibility) than the proximal half of body 102.

[0062] Loops 142 may be placed along the length of body 102 (e.g., between proximal upper opening 104 and distal lower opening 106) to reduce the density of fiber 108 at distal lower opening 106 (and / or upper proximal opening 104) to allow for increased flexibility of body 102, such as at distal portion 126. For example, placing one or more loops 142 along body 102 allows for distal lower opening 106 to have less loops 142 and thus increasing the flexibility of distal portion 126 compared to when one or more loops 142 are not disposed along body 102. In some embodiments, increasing the flexibility of distal portion 126 results in distal portion 126 having at least the same degree of flexibility as other portions of body 102 (e.g., proximal portion 120, first middle portion 122, and / or second middle portion 124) and / or having increased flexibility compared to when no loops 142 are present along body 102. For example, the inclusion of one or more loops 142 may result in a distal half of body 102 (e.g., second middle portion 124 and / or distal portion 126) having substantially the same or greater flexibility than flexibility has a proximal half of body 102 (e g., proximal portion 120 and / or first middle portion 122) and / or distal portion 126 being more flexible than when body 102 does not include loops 142 along its length. In some embodiments, the inclusion of one or more loops 142 between proximal upper opening 104 and distal lower opening 106 results in a distal half of body 102 (e.g., second middle portion 124 and / or distal portion 126) having greater flexibility compared to configurations of body 102 that do not have any loops 142 disposed between proximal upper opening 104 and distal lower opening 106.

[0063] In some embodiments, body 102 includes loops 142 disposed between proximal upper opening 104 and distal lower opening 106 to reduce the number of loops 142 required at distal lower opening 106 thereby decreasing the density of fiber 108 at distal lower opening 106. For example, as illustrated in Figs. 2A-4, loops 142 may be disposed proximate first middle portion 122 and second middle portion 124 to reduce the number of loops 142 disposed at distal lower opening 106. In some embodiments, inclusion of one or more loops 142 between proximal upper opening 104 and distal lower opening 106 reduces the number of loops 142 required at distal lower opening 106 such that the number of loops 142 forming distal lower opening 106 is less than the number of loops 142 forming proximal upper opening 104.

[0064] In some embodiments, as illustrated in Figs. 2A-2B, a first exemplary embodiment of implantable artificial bronchus 100 is shown where body 102 includes one loop 142 proximate the eighth crossing from proximal upper opening 104 (e.g., proximate crossing 140h) and two loops 142proximate a twelfth crossing from proximal upper opening (e.g., proximate crossing 1401). This results in distal lower opening 106 having five loops. When no loops 142 are disposed along body between proximal upper opening 104 and distal lower opening 106, distal lower opening 106 may include eight loops.

[0065] Referring to Fig. 3, a second exemplary embodiment of implantable artificial bronchus 100 is shown substantially similar to the first embodiment except body 102 may include two loops 142 proximate the eighth crossing from proximal upper opening 104 (e.g., proximate crossing 140h) and two loops 142 proximate a twelfth crossing from proximal upper opening (e.g., proximate crossing 1401). In some embodiments, body 102 includes one or more loops 142 proximate an eighth crossing from proximal upper opening 104 (e.g., proximate crossing 140h) and / or one or more loops 142 proximate a twelfth crossing from proximal upper opening (e.g., proximate crossing 1401). As a result of the additional loop 142 of body 102 of Fig. 3 (first embodiment) compared to body 102 of Figs. 2A-2B, distal lower opening 106 of Fig. 3 (second embodiment) has a lower number of loops 142 (e.g., four) compared to distal lower opening 106 of Figs. 2A-2B (e.g., five). Body 102 may include any number of loops 142 disposed along body 102 between proximal upper opening 104 and distal lower opening 106. In some embodiments, due to the lower number of loops 142 at distal lower opening 106, distal portion 126 of body 102 of Fig. 3 is more flexible than distal portion 126 of body 102 of Figs. 2A-2B. One or more loops 142 disposed along body 102 instead of distal lower opening 106 results in greater flexibility to allow portions (e.g., distal portion 126) of body 102 to flex and bend (e.g., away from central axis A- A) to match the contours of deeper bronchioles when implanted.

[0066] When no loops 142 are disposed along body 102, distal lower opening 106 may be formed by eight loops 142 (e.g., distal loops). In some embodiments, three loops 142 may be disposed along body 102 between proximal upper opening 104 and distal lower opening 106 resulting in distal lower opening 106 including five loops 142 thereby reducing the density of fiber 108 at distal lower opening 106 causing distal portion 126 to having increased flexibility compared to distal lower opening 106 including eight loops 142. In some embodiments, body 102 includes inflection points along body 102. The inflection points may correspond to locations where body 102 includes one or more loops 142. For example, first middle portion 122 may include one loop 142 resulting in increased rigidity at that location thereby causing an inflection point where body 102 flexes or bends.

[0067] In some embodiments, body 102 includes one loop 142 disposed along body 102 between first middle portion 122 and second middle portion 124 and two loops 142 disposed alongbody between second middle portion 124 and distal portion 126. This 1-2 loop configuration results in second middle portion 124 having a lower density of crossings 140 (e.g., a lower number of crossings) and fiber 108 compared to body 102 being devoid of loops 142 between proximal upper opening 104 and distal lower opening 106, which causes second middle portion 124 to have increased flexibility compared to when body 102 is devoid of loops 142 along body 102. Further, two loops 142 disposed along body between second middle portion 124 and distal portion 126 results in distal portion 126 having a lower density of crossings 140 and fiber 108 compared to second middle portion 124, which causes distal portion 126 to have increased flexibility. In other words, the increase in the number of loops 142 along body 102 results in a decrease in the density of crossings 140 and fiber 108 between loops 142 and distal lower opening 106 causing the portion of body 102 between the most distal loop 142 and distal lower opening 106 to have increased flexibility compared to when body 102 does not contain any loops along its length. In some embodiments, the increase in the number of loops 142 along body 102 results in a decrease in the density of crossings 140 and fiber 108 between loops 142 and distal lower opening 106 causing the portion of body 102 between the most distal loop 142 and distal lower opening 106 to have substantially the same or greater flexibility compared to the portion of body 102 between proximal upper opening 104 and the most distal loop 142.

[0068] In some embodiments, the increase in the number of loops 142 along body 102 results in the portion of body 102 between the most distal loop 142 and distal lower opening 106 to have substantially the same or greater flexibility compared to the portion of body 102 between proximal upper opening 104 and the most distal loop 142. The increase in the number of loops 142 along body 102 may result in the portion of body 102 between the most distal loop 142 and distal lower opening 106 to have the substantially the same flexibility compared to the portion of body 102 between proximal upper opening 104 and the most distal loop 142. The increase in the number of loops 142 along body 102 may result in the portion of body 102 between the most distal loop 142 and distal lower opening 106 to having increased flexibility compared to body 102 having no loops 142 disposed along body 102.

[0069] In some embodiments, the increase in the number of loops 142 between proximal upper opening 104 and distal portion 126 results in distal portion 126 increasing in flexibility. For example, in the 1-2 configuration discussed above, distal portion 126 has a 27% greater flexibility compared to a configuration that does not have any loops 142 disposed along body 102 (e.g., all loops 142 being disposed at proximal upper opening 104 and distal lower opening 106). The addition of another loop 142 to the 1-2 configuration discussed above such that another loop 142 isdisposed along body 102 between first middle portion 122 and second middle portion 124 results in distal portion 126 having a 46% greater flexibility compared to a configuration that does not have any loops 142 disposed along body 102 (e.g., all loops 142 being disposed at proximal upper opening 104 and distal lower opening 106).

[0070] In some embodiments, the placement of loops 142 along body 102 determine which portions of body 102 have substantially the same or greater flexibility compared to other portions. For example, one or more loops 142 may be disposed along body 102 such that body 102 has a first portion between proximal upper opening 104 and the one or more loops 142 (e.g., the most distal loop 142) and a second portion between the one or more loops (e.g., the most distal loop 142) 142 and distal lower opening 106. The second portion may have substantially the same or an increased flexibility compared to the first portion to allow the second portion to flex and bend to match the contours of airways (e.g., bronchioles).

[0071] In some embodiments, a portion of body 102 having increased flexibility, due to the inclusion of loops 142 disposed along body 102, results in the portion of body 102 being able to flex or bend away from central axis A- A compared to when the portion of body 102 does not have loops 142 disposed along body 102 (e.g., loops 142 located only at proximal upper opening 104 and / or distal lower opening 106). In some embodiments, a portion (e.g., the second portion) of body 102 having substantially the same or greater flexibility compared to another portion (e.g., the first portion) of body 102 allows the portion of body 102 to flex or bend away from central axis A-A more than the other portion. For example, the second portion of body 102 may be configured to bend or flex away from central axis A-A the same amount or more than the first portion resulting in the second portion of body 102 having substantially the same or greater flexibility than the first portion. In some embodiments, the second portion of body 102 having substantially the same or greater flexibility than the first portion of body 102 allows the second portion to be similarly or more radially compressible or expandable compared to the first portion. In some embodiments, a portion of body 102 most distal to one or more loops 142 is has substantially the same or greater flexibility than any other portion of body 102. For example, a portion of body 102 most distal to one or more loops 142 may be configured to flex and / or bend away from central axis A-A the same amount or more than other portions of body 102.

[0072] In some embodiments, the flexibility of various portions of body 102 is measured by applying a load to the distal half (e.g., second middle portion 124 and / or distal portion 126) of body 102. For example, a load may be applied to a portion of body 102 between the most distal loop 142 and distal lower opening 106. The flexibility may be measured by comparing the slope of deflectionor flexing away of the distal half from central axis A-A in response to a load applied to the distal half of body 102. For example, a first configuration of body 102 may have greater flexibility than a second configuration of body 102 if the first configuration bends or flexes further away from central axis A-A when a load is applied to the distal half of the first configuration of body 102 compared to when the same load is applied to the distal half of the second configuration of body 102. In some embodiments where body 102 has a length of approximately 43 mm, the distal half of body 102 is the distal 27 mm of body 102. The distal half of body 102 may be the distal 45% to 65%. In some embodiments, the distal half of body 102 is the distal 10% to 75%, 15% to 70%, or 25% to 75%.

[0073] In some embodiments, body 102 includes a first loop 142 disposed along body 102 and a second loop disposed along body 102 such that body 102 has a first portion between proximal upper opening 104 and the first loop 142, a second portion between the first loop 142 and the second loop 142, and a third portion between the second loop 142 and distal lower opening 106. The third portion may have a decreased density of fiber 108 compared to the second portion, and the second portion may have a decreased density of fiber 108 compared to the first portion. This results in the third portion having substantially the same or greater flexibility than the second portion, and the second portion having substantially the same or greater flexibility than first portion. In some embodiments, first portion has an increased flexibility compared to when body 102 does not include any loops 142 along its length, second portion has an increased flexibility compared to when body 102 does not include any loops 142 along its length, and / or third portion has an increased flexibility compared to when body 102 does not include any loops 142 along its length.

[0074] Body 102 may include inflection points between the first portion and the second portion and the second portion and the third portion. The inflection points may be locations along body 102 where the density of fiber 108 changes resulting in body 102 flexing or bending at that point. In some embodiments, the inflection points are proximate loops 142. For example, the inflection point along body 102 may be at the point in which the flexibility of body 102 changes (e.g., due to one or more loops 142).

[0075] In some embodiments, one or more fibers 108 (e.g., fiber 108a and 108b) each 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. One or more fibers 108 may be arranged to be parallel to one another to comprise body 102. In some embodiments, one or more fibers 108 are braided together to comprise body 102. As shown in Figs. 1-4, one or more fibers 108 of body 102 may be arranged in an alternating cross-weaving pattern creating a web-like structure However, one or more fibers108 of body 102 may be arranged in any other manner desired. For example, one or more fibers 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. In some embodiments, fiber 108 has varying diameters. For example, a first portion of a single fiber 108 may have a first diameter and a second portion of the single fiber 108 may have a second diameter different than the first diameter.

[0076] Referring to Fig. 4, a third exemplary embodiment of implantable artificial bronchus 100 is shown substantially similar to the first embodiment and the second embodiment except body 102 has a shorten length compared to first embodiment of Figs. 2A-2B and second embodiment of Fig.3. Maximum diameter D3 of implantable artificial bronchus 100 of Fig. 4 may be from approximately 3.5 mm to approximately 5.0 mm. Distal lower opening 106 of Fig. 4 may have D2 of approximately 2.5 to approximately 3.0 mm. In some embodiments, body 102 of Fig. 4 has a length of approximately 37 mm when implanted. Body 102 of Fig. 4 may have a length of approximately 25 mm to approximately 45 mm, approximately 30 mm to approximately 42 mm, or approximately 30 mm to approximately 38 mm. Body 102 of Fig. 5 may have a length less than 50 mm when implanted.

[0077] In some embodiments, implantable artificial bronchus 100 of Fig. 4 is compressed when implanted within a patient’s bronchiole. In a compressed state, proximal upper opening 104 of Fig.4 may have Di of approximately 6.5 mm. In some embodiments, in a compressed state, proximal upper opening 104 of Fig. 4 has Di of approximately 3 mm to approximately 9 mm, approximately 4 mm to approximately 8 mm, or approximately 5 mm to approximately 7 mm. In a compressed state, distal lower opening 106 of Fig. 4 may have D2 of approximately 3.0 mm. In some embodiments, distal lower opening 106 of Fig. 4 has D2 of approximately 0.5 mm to approximately 6 mm, approximately 1 mm to approximately 5 mm, or approximately 2 mm to approximately 4 mm in a compressed state. In some embodiments, body 102 of Fig. 4 has a length of approximately 30.6 mm in a compressed state. In a compressed state, body 102 of Fig. 4 may have a length of approximately 25 mm to approximately 35 mm, approximately 27 mm to approximately 33 mm, or approximately 28 mm to approximately 32 mm. Body 102 of Fig. 5 may have a length less than 40 mm when compressed within a patient's bronchiole.

[0078] In some embodiments, implantable artificial bronchus 100 of Fig. 4 is compressed within a delivery catheter for implementation and placement within a patient’s bronchiole. When implantable artificial bronchus 100 of Fig. 4 is compressed within a delivery catheter, implantable artificial bronchus 100 of Fig. 4 may have a maximum diameter of 2.00 mm to 3.00 mm. In someembodiments, implantable artificial bronchus 100 of Fig. 4 has a diameter of approximately 2.31 mm when compressed within a delivery catheter.

[0079] In some embodiments, implantable artificial bronchus 100 of Fig. 4 is comprised of one fiber 108. In alternative embodiments, implantable artificial bronchus 100 of Fig. 4 is comprised of two fibers 108. Implantable artificial bronchus 100 of Fig. 4 may include one or more radiopaque markers. In some embodiments, implantable artificial bronchus 100 of Fig. 4 includes a first radiopaque marker disposed proximate upper proximal opening and a second radiopaque marker proximate distal lower opening 106.

[0080] Referring to Figs. 1-4, one or more fibers 108 may be comprised of a thermoplastic polymer, such as poly ether ether ketone (PEEK). One or more fibers 108 may be comprised of one or more of polymer, metal, metal alloy, or stainless steel. One or more fibers 108 of body 102 may be made of a metal alloy having shape memory effect, such as NiTiNOL. One or more fibers 108 may be fibers 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 some embodiments, each fiber 108 of body 102 is comprised of a single fiber of PEEK. In some embodiments, one or more fibers 108 of body 102 are comprised of PEEK and each have a diameter of approximately 0.25 mmm to approximately 0.35 mm. In some embodiments, body 102 is comprised of one or more PEEK fibers having a diameter of 0.28 mm or a diameter of 0.30 mm. Body 102 may be comprised of one or more fibers 108 of PEEK having a modulus of approximately 900 ksi. In some embodiments, body 102 is comprised of one or more fibers 108 of PEEK having a modulus of approximately 750 ksi to approximately 1,000 ksi, approximately 825 ksi to approximately 975 ksi, or approximately 850 ksi to approximately 950 ksi. One or more fibers 108 of body 102 may be made of a material having shape memory effect, such as PEEK. One or more fibers 108 may each have a diameter between approximately 0.15 and approximately 0.40 mm. In some embodiments, one or more fibers 108 each have a thickness of approximately 0.25 mm.

[0081] In some embodiments, one or more fibers 108 may each include a conformal coating 118. Coating 118 may be a coating material comprised of silicone or other polymers. One or more fibers 108 may be each 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.

[0082] With continued reference to Figs. 1-4, body 102 may include side openings 110. Side openings 110 may be created due to the interweaving of one or more fibers 108 (e.g., fiber 108a and fiber 108b). Body 102 may be formed by one or more fibers 108 and may only include side openings 110 disposed along the length L of body 102. In some embodiments, 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.

[0083] As shown in Figs. 1-4, side openings 110 may be disposed along the entire length L of body 102. Side openings 110 may be disposed along body 102 from proximate proximal upper opening 104 to proximate distal lower opening 106. Although Figs. 1-4 show side openings 110 being diamond shaped, side openings 110 may be any shape desired depending on the crossweaving pattern of one or more fibers 108. In some embodiments, side opening 110 may include angles a and 13 created by the interweaving of fiber 108. Angles a and 13 may be disposed along central axis A-A. Angles a and 13 may be between approximately 130° and approximately 20°. For example, angles a and 13 may be between 135° and 15°, 110° and 40°, or 90° and 60°. Angle a may be greater than angle 13. In some embodiments, angle a is less than 22° and angle 13 is greater than 130°.

[0084] Angles a and 13 may each be formed due to side openings 110. In some embodiments, angles a and 13 are formed via the same manner at different locations along body 102. For example, angle a may transition to angle 13 along body 102. Angle a may be disposed proximate proximal upper opening 104 and angle 13 may be disposed proximate distal lower opening 106. Angles a and 13 may each decrease along length L of body 102 from proximal upper opening 104 to distal lower opening 106. In some embodiments, angle a is approximately 115° proximate to proximal upper opening 104 and angle 13 is approximately 22° proximate to distal lower opening 106. Decreasing angles a and 13 from proximal upper opening 104 to distal lower opening 106 results in body 102 being tapered along length L. Angles a and 13 may change as implantable artificial bronchus 100 is compressed. For example, during compression of implantable artificial bronchus 100, angle a maydecrease and angle 13 may increase. In some embodiments, body 102 may include between 15 and 35 side openings 110 disposed along central axis A.

[0085] Referring to Fig. 6, 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.

[0086] Referring to Figs. 1-6, 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. 1-5, 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 102. 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 some embodiments, radiopaque marker 112 is disposed around fiber 108. As shown in Fig. 5, fiber 108 may be inserted through radiopaque marker 112. However, radiopaque marker 112 may be disposed on fiber 108, or underneath fiber 108.

[0087] Implantable artificial bronchus 100 may include one or more retrieval loops to aid in the retrieval and removal of implantable artificial bronchus 100 from the respiratory passageways. In some embodiments, the retrieval loop is integrated into body 102. For example, the retrieval loop may be configured to integrate into the cross-weaving pattern of one or more fibers 108. The retrieval loop may be integrated into body 102 near proximal upper opening 104. In some embodiments, the retrieval loop is a separate structure coupled to body 102 as a secondary process. The retrieval loop may be coupled to body 102 near proximal upper opening 104 or any other location along body 102. Implantable artificial bronchus 100 may have any number of retrievalloops. For example, implantable artificial bronchus 100 may have two, three, four or any number of retrieval loops desired.

[0088] The retrieval loop 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, the retrieval loop may be made from materials such as MP35N, 35N LT, 316L Stainless Steel, Titanium, polymers, suture materials, polypropylene, nylon, or any other material desired. Further, the retrieval loop may vary in diameter compared to fiber 108. In some embodiments, the retrieval loop may have a diameter of approximately 0.381 mm. The retrieval loop may have a diameter of any size desired. In some embodiments, the retrieval loop includes a handle configured to allow a user to easily retrieve or remove implantable artificial bronchus 100 via the retrieval loop. The handle may be made of the same material as the retrieval loop, or may be made of different materials to increase the overall strength of the retrieval loop.

[0089] In some embodiments, the retrieval loop includes one or more radiopaque markers 112. The presence of one or more radiopaque markers 112 with the retrieval loop may assist in determining the location of the retrieval loop and / or implantable artificial bronchus 100, in addition to assisting in the retrieval of implantable artificial bronchus 100. The retrieval loop may be configured to be interwoven into body 102 and compressed along with body 102. The retrieval loop being compressed allows for the entirety of implantable artificial bronchus 100 to be compressed for ease of insertion and implantation.

[0090] Referring to Figs. 7-9, in use, implantable artificial bronchus 100 may be used to promote lung disinsufflation. As shown in Fig. 7, 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 pulmonary complications or diseases such as COPD and pulmonary emphysema, walls 204 of respiratory passageway 202 may be restricted limiting airflow, as denoted by the arrows in Figs. 7-9. For example, individuals with pulmonary complications or diseases may walls 204 that are radially compressed limiting the amount of airflow through respiratory passageway 202.

[0091] Referring to Fig. 8, implantable artificial bronchus 100 may be used to keep walls 204 of respiratory passageway 202 from restricting, allowing for airflow as depicted by the arrows. In some embodiments, implantable artificial bronchus 100 causes walls 204 to radially expand from a compressed state to allow more airflow through the respiratory passageway 202. Specifically, implantable artificial bronchus 100 may allow for air trapped within respiratory passageway 202 toexit by opening up, and keeping open, the bronchi and bronchioles (e.g., radially expanding the bronchi and bronchioles). In some embodiments, proximal upper opening 104 is tapered radially inwards towards central axis A-A to prevent proximal upper opening 104 from contact, abutting, rubbing, perforation, and / or damaging wall 204.

[0092] Referring to Fig. 9, due to one or more loops 142 being disposed along body 102 between proximal upper opening 104 and distal lower opening 106, a distal half (e.g., second middle portion 124 and distal portion 126) has substantially the same or greater flexibility than a proximal half (e.g., proximal portion 120 and first middle portion 122) of body 102. This allows body 102 to flex, bend, and curve to match the contours of respiratory passageways 202. In some embodiments, body 102 may flex, bend, and curve at one or more inflection points disposed along body 102. Further the flexing and tapering of body 102 allows implantable artificial bronchus 100 to be inserted into deeper bronchioles since body 102 is able to flex and bend thereby not causing damage to wall 204. In some embodiments, loops 142 are rounded at a distal point to prevent damage or perforation of walls 204 when body 102 is bent or flexed at the inflection point(s) (e.g., the location of loops 142).

[0093] In some embodiments, 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 inward 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 some embodiments, implantable artificial bronchus 100 is coupled to a bronchoscope for placement of implantable artificial bronchus 100 within respiratory passageways. In some embodiments, 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 Figs. 7-9, implantable artificial bronchus 100 within the respiratory passageways may be configured to promote enlargement of the bronchial passageway and in turn cause lung deflation.

[0094] In some embodiments, 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 some embodiments, the bronchoscope assistswith 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 D3 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.

[0095] Referring to Fig. 9, due to the placement of loops 142 along body 102, 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 due to being able to flex and bend. In some embodiments, due to loops 142 being disposed between proximal upper opening 104 and distal lower opening 106, 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. In some embodiments, implantable artificial bronchus 100 does not include any element to couple the various segments of one or fibers 108, thereby allowing each fiber 108 to move and slide over one another, increasing the flexibility of implantable artificial bronchus 100.

[0096] The increased flexibility caused by loops 142 being disposed along body 102 (e.g., between proximal upper opening 104 and distal lower opening 106) 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 reachas close as possible to distal respiratory bronchioles, such as respiratory bronchioles beyond level 15 and close to alveoli (>15 levels).

[0097] In some embodiments, 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. 9, 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.

[0098] 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 to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways.

[0099] 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. 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”. Finally, unless specifically set forth herein, a disclosed or claimed method 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 performed in any practical order.

Claims

CLAIMSWhat is claimed is:

1. An implantable artificial bronchus, comprising: a body comprised of at least one fiber woven to form a lattice structure, the 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 first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening , wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening, wherein the proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops, the number of distal loops being less than the number of proximal loops.

2. The implantable artificial bronchus of claim 1, wherein the body includes a proximal portion, a first middle portion, a second middle portion, and a distal portion, the proximal portion being tapered radially inward towards a central axis of the body.

3. The implantable artificial bronchus of claim 2, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion, the first middle portion being proximate the proximal portion and the second middle portion being proximate the distal portion, the first middle portion having a first taper and the second middle portion having a second taper, the second taper being larger than the first taper.

4. The implantable artificial bronchus of claim 2, wherein a diameter of the first middle portion is greater than a diameter of the proximal portion, a diameter of the second middle portion, and a diameter of the distal portion.

5. The implantable artificial bronchus of claim 4, wherein the diameter of the distal portion is less than the diameter of the proximal portion, the diameter of the first middle portion, and the diameter of the second middle portion.

6. The implantable artificial bronchus of claim 4, wherein the diameter of the first middle portion is equal to or less than the largest diameter of the body.

7. The implantable artificial bronchus of claim 4, wherein the diameter of the second middle portion constantly decreases along the length of the body from the first middle portion to the distal portion.

8. The implantable artificial bronchus of claim 4, wherein the diameter of the distal portion is substantially the same proximate the second middle portion and proximate distal lower opening.

9. The implantable artificial bronchus of claim 2, wherein the proximal portion flares out from the proximal upper opening to the first middle portion.

10. The implantable artificial bronchus of claim 1 further comprising: a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body.

11. The implantable artificial bronchus of claim 10, wherein the plurality of side openings include an angle ranging between approximately 130° proximate the proximal upper opening and 20° proximate the distal lower opening.

12. The implantable artificial bronchus of claim 10, wherein the plurality of side openings include a first side opening proximate the proximal upper opening and a second side opening proximate the distal lower opening, the first side opening having a first angle and the second side opening having a second angle less than the first angle.

13. The implantable artificial bronchus of claim 1, wherein the body is a web comprised of the at least one fiber forming the lattice structure, the at least one fiber having ends woven together proximate a middle portion of the body.

14. The implantable artificial bronchus of claim 1, wherein in an implanted state the body is 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.

15. The implantable artificial bronchus of claim 1, wherein the body includes a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the first loop, and a second portion between the first loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion.

16. An implantable artificial bronchus, comprising: a body comprised of at least one fiber and 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 loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion, wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening.

17. The implantable artificial bronchus of claim 16, wherein the first portion has a greater density of portions of the fiber than the second portion.

18. The implantable artificial bronchus of claim 16, wherein the loop is a first loop and further comprising: a second loop disposed between the first loop and the distal lower opening, such that the body includes a third portion between the first loop and the second loop, and a fourth portion between the second loop and the distal lower opening, the fourth portion having the same or greater flexibility than the third portion, and the third portion having the same or greater flexibility than the first portion.

19. An implantable artificial bronchus, comprising: a body comprised of at least one fiber and 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 loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion, the body comprising: 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, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion, wherein a diameter of the proximal upper opening is at least twice as large as a diameter of distal lower opening, and the diameter of the proximal upper opening is less than a maximum diameter of the body, the maximum diameter of the body being proximate the proximal upper opening, and wherein in an implanted state the body is 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.

20. A method of promoting lung disinsufflation, the method comprising: inserting a catheter distally into a respiratory passageway of a patient’s lung, the catheter containing the implantable artificial bronchus of claim 1 disposed within the catheter in a compressed state; and withdrawing the catheter proximally relative to the implantable artificial bronchus causing the implantable artificial bronchus to unsheathe and naturally expand into an expanded state such that the implantable artificial bronchus remains disposed within the respiratory passageway, wherein the implantable artificial bronchus being in the expanded state and disposed within the respiratory passageway results in at least a portion of the body abutting an inner wall of the respiratory passageway and prevents the proximal upper opening from contacting the inner wall of the respiratory passageway.

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