Patent Description:
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.

Embodiments of the present invention are directed to an implantable artificial bronchus according to claim <NUM>.

Also disclosed herein, 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.

Also disclosed herein, 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.

Also disclosed herein, the proximal portion may flares out from the proximal upper opening to the first middle portion.

Also disclosed herein, a maximum diameter of the body may be greater than the diameter of the proximal upper opening.

Also disclosed herein, 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.

Also disclosed herein, the diameter of the proximal upper opening is greater than twice the diameter of the distal lower opening.

Also disclosed herein, 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.

Also disclosed herein, the plurality of side openings may include an angle ranging between approximately <NUM>° proximate the proximal upper opening and <NUM>° proximate the distal lower opening.

Also disclosed herein, 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.

Also disclosed herein, the implantable artificial bronchus includes at least one radiopaque marker disposed on the body.

Also disclosed herein, the body may have a maximum diameter of approximately <NUM> to approximately <NUM>. 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.

According to the invention, the implantable artificial bronchus does not include a valve or a nozzle coupled to the body.

Also disclosed herein, 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.

Also disclosed herein, a method of promoting lung disinsufflation, the method including inserting a catheter distally into a respiratory passageway of a patient'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.

Also disclosed herein, the catheter may be a guide catheter and the implantable artificial bronchus may extend into a bronchiole passageway.

Also disclosed herein, 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.

Also disclosed herein, 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.

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.

Exemplary embodiments of the present invention provide an implantable artificial bronchus and methods of implanting the same. In use, implantable artificial bronchus <NUM> may facilitate the opening of airways within individuals with COPD and pulmonary emphysema. Specifically, implantable artificial bronchus <NUM> 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 <NUM> in the respiratory passageway may keep the walls of the bronchi and bronchioles from restricting thereby allowing airflow through the passageways. As shown in <FIG> and <FIG>, implantable artificial bronchus <NUM> includes body <NUM>, proximal upper opening <NUM>, distal lower opening <NUM>, wire or fiber <NUM>, and side openings <NUM>. Body <NUM> may be disposed between proximal upper opening <NUM> and distal lower opening <NUM>, and may be comprised of a fiber <NUM>. Implantable artificial bronchus <NUM> is at least partially tapered to allow for the insertion into the bronchi and penetration of implantable artificial bronchus <NUM> within distal bronchioles that increasingly become more narrow. For example, implantable artificial bronchus <NUM> may be deployed within the respiratory passageway such that proximal upper opening <NUM> is disposed within the bronchi, and distal lower opening <NUM> is able to reach as close as possible to respiratory bronchioles at levels <NUM> to <NUM> (terminal bronchioles).

As shown in <FIG> and <FIG>, implantable artificial bronchus <NUM> is comprised of body <NUM>. According to the invention, the body <NUM> is unobstructed and does not include a valve coupled to body <NUM>. Body <NUM> of implantable artificial bronchus <NUM> may be generally cylindrical towards proximal upper opening <NUM>, conical for a majority of body <NUM>, and generally cylindrical towards distal lower opening <NUM>. Body <NUM> may have maximum diameter D<NUM>, and may be tapered along length L of body <NUM> proximate proximal upper opening <NUM>, and between proximal upper opening <NUM> and distal lower opening <NUM>. For example, body <NUM> may include proximal portion <NUM>, first middle portion <NUM>, second middle portion <NUM>, and distal portion <NUM>. First middle portion <NUM> and second middle portion <NUM> may be disposed between proximal portion <NUM> and distal portion <NUM>, with first middle portion <NUM> being proximate proximal portion <NUM> and second middle portion being proximate distal portion <NUM>. Proximal portion <NUM> may taper towards central axis A and may have slope <NUM>, which may be between approximately <NUM> - <NUM> degrees relative to central axis A and may slope towards proximal upper opening <NUM>. First middle portion <NUM> may have a greater diameter than proximal portion <NUM> and may be generally cylindrical in shape. For example, first middle portion <NUM> may have a generally uniform diameter or may have a slight taper towards central axis A. First middle portion <NUM> may have slope <NUM>, which may be between approximately <NUM> - <NUM> degrees relative to central axis A and may slope towards distal lower opening <NUM>. First middle portion <NUM> having a greater diameter than proximal portion <NUM> allows first middle portion <NUM> to engage the walls of the bronchi, preventing them from collapsing, and securing implantable artificial bronchus <NUM>. For example, first middle portion <NUM> may allow implantable artificial bronchus <NUM> to be anchored proximally at levels <NUM> or <NUM> of the bronchi. In an embodiment, the diameter of first middle portion <NUM> may be substantially the same as maximum diameter D<NUM>. In another embodiment, maximum diameter D<NUM> may be disposed between proximal portion <NUM> and first middle portion <NUM>. Proximal portion <NUM> and first middle portion <NUM> may be disposed within the bronchi. Second middle portion <NUM> may be conical in shape. Second middle portion <NUM> may taper towards central axis A and may have a gradually decreasing diameter. Second middle portion <NUM> may have slope <NUM>, which may be between approximately <NUM> - <NUM> degrees relative to central axis A and may slope towards distal lower opening <NUM>. The diameter of second middle portion <NUM> may be less than the diameter of first middle portion <NUM> and may taper at a faster rate compared to first middle portion <NUM>. A section of second middle portion <NUM> proximate first middle portion <NUM> may be disposed in the bronchi. Second middle portion <NUM> may extend into the bronchioles and may taper until distal portion <NUM>. Distal portion <NUM> may be cylindrical in shape and may have a diameter less than second middle portion <NUM>, first middle portion <NUM>, and proximal portion <NUM>. Distal portion <NUM> may be disposed within the bronchioles. In an embodiment, distal portion <NUM> does not include any tapering such that the diameter of distal portion <NUM> proximate second middle portion <NUM> is the same as the diameter proximate distal lower opening <NUM>. For example, distal portion <NUM> may have an internal dimeter of approximately <NUM>, which may be substantially the same as diameter D<NUM> of distal lower opening <NUM>. In an embodiment, distal portion <NUM> tapers towards central axis A and may have slope <NUM>, which may be between approximately <NUM> - <NUM> degrees relative to central axis A and may slope towards distal lower opening <NUM>. In yet another embodiment, distal portion <NUM> may flare out, away from central axis A. For example, distal portion <NUM> may flare out to prevent inserting implantable artificial bronchus <NUM> too deeply within the bronchioles. Slopes <NUM>,<NUM>, <NUM>, and <NUM> may be between approximately <NUM> degrees and <NUM> degrees. Slopes <NUM>,<NUM>, <NUM>, and <NUM> may vary based on length L of body <NUM>. For example, slope <NUM> of second middle portion <NUM> may be approximately <NUM> degrees when length L is approximately <NUM> and may be approximately <NUM> degrees when length L is approximately <NUM>. In some embodiments, it is advantageous to have a greater degree of taper for slopes <NUM>,<NUM>, <NUM>, and <NUM> placed on the placement of implantable artificial bronchus.

In one embodiment, the shape and length of body <NUM> allows implantable artificial bronchus <NUM> to be inserted into a respiratory passageway to keep the respiratory passageways open in respiratory bronchioles beyond level <NUM>, close to alveoli (><NUM> levels), resulting in trapped air exiting the lower generations. According to an embodiment of the present invention, length L of body <NUM> may be greater than <NUM> times maximum diameter D<NUM> of body <NUM>. For example, maximum diameter D<NUM> of body <NUM> may be between <NUM> millimeters and <NUM> millimeters, and maximum length L of body <NUM> may be <NUM> millimeters or <NUM> millimeters. In some embodiments, length L of body <NUM> may be greater than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times maximum diameter D<NUM> of body <NUM>. Maximum diameter D<NUM> of body <NUM> being <NUM> millimeters may allow for implantable artificial bronchus <NUM> to be deployed within <NUM> - <NUM> millimeter bronchi. However, maximum diameter D<NUM> may be any size desired such as approximately <NUM>, approximately <NUM>, approximately <NUM>, approximately <NUM>, approximately <NUM>, or approximately <NUM>, and maximum length L of body <NUM> may be greater than <NUM> millimeters, less than <NUM> millimeters, or in between <NUM> and <NUM> millimeters. In one embodiment, maximum diameter D<NUM> of implantable artificial bronchus <NUM> is manufactured to be approximately <NUM>, which is reduced to approximately <NUM> or smaller upon deployment within the respiratory passageway. In use, maximum diameter D<NUM> may vary between <NUM>-<NUM>% based on the breathing cycle, and dilation and constriction of the respiratory passageways. Maximum diameter D<NUM> may also vary due the flexibility of implantable artificial bronchus <NUM>. For example, maximum diameter D<NUM> may increase or decrease based on changes of the diameter of the bronchus, such as during a breathing cycle. Maximum length L of body <NUM> may vary in length to be sized to fit within shorter or longer respiratory passageways. For example, maximum length L of body <NUM> 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 <NUM> having various maximum lengths L of body <NUM>. For example, a kit may include one implantable artificial bronchus <NUM> where maximum length L of body <NUM> is <NUM> millimeters, another implantable artificial bronchus <NUM> where maximum length L of body <NUM> is <NUM> millimeters, and a third implantable artificial bronchus <NUM> where maximum length L of body <NUM> is greater than <NUM> millimeters. A surgeon may choose one implantable artificial bronchus <NUM> from the kit having a specific maximum length L of body <NUM> based on the anatomy of a patient. Further, maximum diameter D<NUM> of body <NUM> may be located at a portion proximate to proximal upper opening <NUM> and may be sized to press against the bronchi walls of the upper levels of the respiratory passageways. Maximum diameter D<NUM> being located proximate to proximal upper opening <NUM> may prevent or reduce proximal upper opening <NUM> from contacting the bronchi walls, which may assist in the adjustment, retrieval, and removal of implantable artificial bronchus <NUM> via proximal upper opening <NUM>.

According to an embodiment of the present invention, the diameter of body <NUM> may decrease from a portion of body <NUM> proximate proximal upper opening <NUM> to distal lower opening <NUM>. For example, body <NUM> may constantly taper from a portion proximate to proximal upper opening <NUM> toward the distal lower opening <NUM>. Body <NUM> may constantly taper from maximum diameter D<NUM> of body <NUM>, which may be approximately <NUM>, to diameter D<NUM> of distal lower opening <NUM>, which may be approximately <NUM>. In other embodiments, body <NUM> 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 <NUM> may constantly taper from maximum diameter D<NUM> to an area of body <NUM>, for example, located approximately <NUM> from distal lower opening <NUM>. Thereafter, body <NUM> may be flat, with no taper, for the rest of approximately <NUM> length. The rate of taper of body <NUM> may vary based on maximum length L of body <NUM>. For example, the rate of taper of body <NUM> may be greater if maximum length L of body <NUM> is lower.

Referring to <FIG> and <FIG>, proximal upper opening <NUM> is in fluid communication with distal lower opening <NUM> to allow for bi-directional airflow in and through implantable artificial bronchus <NUM>. Proximal upper opening <NUM> has diameter D<NUM> and distal lower opening <NUM> has diameter D<NUM>. Diameter D<NUM> of proximal upper opening <NUM> is larger than diameter D<NUM> of distal lower opening <NUM>. For example, diameter D<NUM> of proximal upper opening <NUM> may be greater than twice diameter D<NUM> of distal lower opening <NUM>. In another example, diameter D<NUM> of proximal upper opening <NUM> may be approximately <NUM> and diameter D<NUM> of distal lower opening <NUM> may be approximately <NUM>. However, diameter D<NUM> of proximal upper opening <NUM> may be between approximately <NUM> and <NUM>, between approximately <NUM> and <NUM>, between approximately <NUM> and <NUM>, between approximately <NUM> and <NUM>, or between approximately <NUM> and <NUM>. Further, diameter D<NUM> may be between approximately <NUM> and <NUM>, between approximately <NUM> and <NUM>, or between approximately <NUM> and <NUM>. In practice, diameter D<NUM> of proximal upper opening <NUM> and diameter D<NUM> of distal lower opening <NUM> 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<NUM> of distal lower opening <NUM> may be sized to be between approximately <NUM> and approximately <NUM> to fit within and reach respiratory bronchioles at level <NUM>, which have a diameter between approximately <NUM> and approximately <NUM>. Further, in another embodiment, diameter D<NUM> of distal lower opening may be smaller than approximately <NUM>, such as <NUM>, to fit within and reach deeper levels of respiratory bronchioles, such as respiratory bronchioles level <NUM>-<NUM>, which are approximately <NUM> to approximately <NUM> in diameter.

As shown in <FIG>, maximum diameter D<NUM> of body <NUM> may be greater than diameter D<NUM> of proximal upper opening <NUM>. Further, a portion of body <NUM> proximate to proximal upper opening <NUM> may taper towards central axis A of body <NUM> to allow for easy and efficient removal of implantable artificial bronchus <NUM> inside of the respiratory passageway. For example, a portion of body <NUM> proximate to proximal upper opening <NUM> being tapered towards central axis A of body <NUM> prevents any portion of body <NUM> proximate to proximal upper opening <NUM> from perforating lung tissue within a bronchi during insertion and placement of implantable artificial bronchus <NUM>.

Body <NUM> is a lattice structure comprised of woven wire or fiber. In one embodiment, body <NUM> is comprised of a single piece of wire or fiber <NUM>. The single piece of fiber <NUM> may be arranged in a cross-weaving pattern to form a plurality of side openings <NUM>. The ends of the single piece of fiber <NUM> may be connected and coupled together proximate the center of body <NUM> and the connection of the single piece of fiber <NUM> may be disposed within radiopaque marker <NUM>. In some embodiments, the ends of the single piece of fiber <NUM> may be woven together proximate the center of body <NUM>. For example, the ends of the single piece of fiber <NUM> may be woven together and disposed along first middle portion <NUM> or second middle portion <NUM>. However, the ends of the single piece of fiber <NUM> may be coupled together at any location of body <NUM> or in other manners. The ends of the single piece of fiber <NUM> may be woven side-by-side, and may be going in opposite directions when woven together.

Although <FIG> and <FIG> show fiber <NUM> being a single piece, fiber <NUM> may be composed of two or more strands of fiber. For example, body <NUM> may be comprised of two, three, four, or any number of fibers intertwined. Utilizing a plurality of fibers may increase the robustness of body <NUM> and reduce fatigue of body <NUM>. 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 <NUM> and first middle portion <NUM>, and a fiber with a thinner diameter may be used for second middle portion <NUM> and distal portion <NUM>. In an embodiment of the present invention, the multiple fibers may be arranged to be parallel to one another to comprise body <NUM>. In another embodiment, the multiple fibers may be braided together to comprise body <NUM>. As shown in <FIG> and <FIG>, fiber <NUM> of body <NUM> may be arranged in an alternating cross-weaving pattern creating a web-like structure However, fiber <NUM> of body <NUM> may be arranged in any other manner desired. For example, fiber <NUM> of body <NUM> may be arranged in a back braiding manner to provide a more rigid structure to maintain the shape of body <NUM>.

According to an embodiment of the present invention, fiber <NUM> may be comprised of a thermoplastic polymer, such as polyether ether ketone (PEEK). In other embodiments, fiber <NUM> is comprised of one or more of polymer, metal, metal alloy, or stainless steel. Fiber <NUM> of body <NUM> may be made of a metal alloy having shape memory effect, such as NiTiNOL. However, fiber <NUM> 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 <NUM> of body <NUM> is comprised of a single fiber of PEEK. In some embodiments, fiber <NUM> of body <NUM> is comprised of PEEK and has a diameter of <NUM>. In an embodiment, fiber <NUM> of body <NUM> is made of a material having shape memory effect, such as PEEK. Fiber <NUM> may have a diameter between approximately <NUM> and approximately <NUM>. In a preferred, embodiment, fiber <NUM> has a thickness of approximately <NUM>. In an embodiment of the present invention, to create the structure of body <NUM>, fiber <NUM> 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 <NUM> in place. The tapered mandrel may have a small proximal diameter to form diameter D<NUM> and may include grooves for placement of fiber <NUM>. Implantable artificial bronchus <NUM> may be manufactured by placing and weaving fiber <NUM> on the tapered mandrel to form body <NUM>. In an embodiment, the woven assembly of fiber <NUM> is placed in a furnace to heat fiber <NUM> to a first temperature of approximately <NUM>° and allowed to cool to set the shape of body <NUM> of implantable artificial bronchus <NUM>. Implantable artificial bronchus <NUM> may then be placed on a second shaping form, such as another mandrel, and heated to a second temperature of approximately <NUM>° to set the final shape of body <NUM>. The first temperature and second temperature may vary based on the materials used.

In an embodiment of the present invention, as shown in <FIG>, fiber <NUM> may include a conformal coating <NUM>. In one embodiment, coating <NUM> may be a coating material comprised of silicone or other polymers. Fiber <NUM> may be coated with coating <NUM> prior to formation of the final shape of implantable artificial bronchus <NUM>. Coating <NUM> may be configured to add protection to fiber <NUM>, aid in biocompatibility of fiber <NUM>, and reduce friction of fiber <NUM> against the lung tissue of the bronchi and bronchiole passageways to increase the ease of insertion of implantable artificial bronchus <NUM> within the respiratory passageway. Coating <NUM> may have a thickness between <NUM> and <NUM>.

With continued reference to <FIG> and <FIG>, body <NUM> includes side openings <NUM>. Side openings <NUM> may be created due to the interweaving of fiber <NUM>. Body <NUM> may be formed only by fiber <NUM> and may only include side openings <NUM> disposed along the length L of body <NUM>. In one embodiment of the present invention, side openings <NUM> may be in direct contact with the surrounding tissue. For example, body <NUM> and implantable artificial bronchus <NUM> may not include any coverings or sheaths disposed around it, allowing side openings <NUM> to directly contact the surrounding walls of the bronchi and bronchioles. In practice, side openings <NUM> are configured to allow air to enter and exit implantable artificial bronchus <NUM> through body <NUM>. Side openings <NUM> of implantable artificial bronchus <NUM> may allow access to other respiratory passageways that branch off of the main respiratory passageway where implantable artificial bronchus <NUM> is deployed. These other respiratory passageways may be created due to collateral ventilation. As shown in <FIG> and <FIG>, side openings <NUM> may be disposed along the entire length L of body <NUM>. Side openings <NUM> may be disposed on body <NUM> proximate proximal upper opening <NUM> and proximate distal lower opening <NUM>. Although <FIG> and <FIG> show side openings <NUM> being diamond shaped, side openings <NUM> may be any shape desired depending on the cross-weaving pattern of fiber <NUM>. In one embodiment, side opening <NUM> may include angles α and β created by the interweaving of fiber <NUM>. Angles α and β may be between approximately <NUM>° and approximately <NUM>°. Angle α may be disposed proximate proximal upper opening <NUM> and angle β may be disposed proximate distal lower opening <NUM>. Angle α may be greater than angle β. In some embodiments, angle α is less than <NUM>° and angle β is greater than <NUM>°. Angles α and β may decrease along length L of body <NUM> from proximal upper opening <NUM> to distal lower opening <NUM>. In one embodiment, angle α is approximately <NUM>° proximate to proximal upper opening <NUM> and angle β is approximately <NUM>° proximate to distal lower opening <NUM>. Decreasing angles α and β from proximal upper opening <NUM> to distal lower opening <NUM> results in body <NUM> being tapered along length L. In some embodiments, body <NUM> may include between <NUM> and <NUM> side openings <NUM> disposed along central axis A.

Referring to <FIG>, side openings <NUM> may not be visible when implantable artificial bronchus <NUM> is viewed from a distal end. For example, side openings <NUM> may be arranged along body <NUM> in a manner such than when implantable artificial bronchus <NUM> is viewed from a distal end, side openings <NUM> may not be visible to prevent or limit side openings <NUM> from engaging with surrounding tissue during insertion and implantation of implantable artificial bronchus <NUM>.

Referring to <FIG>, implantable artificial bronchus <NUM> may include one or more radiopaque markers <NUM>. One or more radiopaque markers <NUM> may be disposed at various locations of implantable artificial bronchus <NUM>. For example, as shown in <FIG>, radiopaque marker <NUM> may be disposed on body <NUM> proximate proximal upper opening <NUM>. However, radiopaque marker <NUM> may be disposed anywhere along body <NUM>, such as proximal portion <NUM>, first middle portion <NUM>, second middle portion <NUM>, or distal portion <NUM>. Implantable artificial bronchus <NUM> may include any number of radiopaque markers <NUM> disposed along body <NUM>. For example, implantable artificial bronchus <NUM> may include one, two, three, four, five, six, or any number of radiopaque markers <NUM> desired. Radiopaque marker <NUM> may be used with known imaging techniques and may be used to determine the placement of implantable artificial bronchus <NUM> and may also aid in the retrieval or removal of implantable artificial bronchus <NUM>. In addition, radiopaque marker <NUM> may be used to determine the exact location of specific portions of implantable artificial bronchus <NUM> and body <NUM>. For example, radiopaque marker <NUM> disposed on body <NUM> proximate proximal upper opening <NUM> may indicate to a user the location of the proximal end of implantable artificial bronchus <NUM> to determine proper alignment and location of implantable artificial bronchus <NUM>. In an embodiment of the present invention, radiopaque marker <NUM> is disposed around fiber <NUM>. As shown in <FIG>, fiber <NUM> may be inserted through radiopaque marker <NUM>. However, radiopaque marker <NUM> may be disposed on fiber <NUM>, or underneath fiber <NUM>.

Referring to <FIG> and <FIG>, implantable artificial bronchus <NUM> may include one or more retrieval loops <NUM>. Retrieval loop <NUM> may aid in the retrieval and removal of implantable artificial bronchus <NUM> from the respiratory passageways. In an embodiment of the present invention, retrieval loop <NUM> is integrated into body <NUM>. For example, retrieval loop <NUM> may be configured to integrate into the cross-weaving pattern of fiber <NUM>. Retrieval loop <NUM> may be integrated into body <NUM> near proximal upper opening <NUM>. In another embodiment of the present invention, retrieval loop <NUM> is a separate structure coupled to body <NUM> as a secondary process. Retrieval loop <NUM> may be coupled to body <NUM> near proximal upper opening <NUM> or any other location along body <NUM>. Although <FIG> and <FIG> show implantable artificial bronchus <NUM> having one retrieval loop <NUM>, implantable artificial bronchus <NUM> may have any number of retrieval loops <NUM>. For example, implantable artificial bronchus <NUM> may have two, three, four or any number of retrieval loops <NUM> desired. Retrieval loop <NUM> may be made from a different material than fiber <NUM> of body <NUM> for increased robustness during retrieval and removal of implantable artificial bronchus <NUM>. For example, retrieval loop <NUM> may be made from materials such as MP35N, 35N LT, <NUM> Stainless Steel, Titanium, polymers, suture materials, polypropylene, nylon, or any other material desired. Further, retrieval loop <NUM> may vary in diameter compared to fiber <NUM>. In an embodiment, retrieval loop <NUM> may have a diameter of approximately <NUM>. However, retrieval loop <NUM> may have a diameter of any size desired. In an embodiment of the present invention, retrieval loop <NUM> includes handle <NUM>. Handle <NUM> may be configured to allow a user to easily retrieve or remove implantable artificial bronchus <NUM> via retrieval loop <NUM>. Handle <NUM> may be made of the same material as retrieval loop <NUM>, or may be made of different materials to increase the overall strength of retrieval loop <NUM>.

In some embodiments of the present invention, retrieval loop <NUM> include one or more radiopaque markers <NUM>. The presence of one or more radiopaque markers <NUM> with retrieval loop <NUM> may assist in determining the location of retrieval loop <NUM> and/or implantable artificial bronchus <NUM>, in addition to assisting in the retrieval of implantable artificial bronchus <NUM>. In an embodiment of the present invention, retrieval loop <NUM> may be configured to be interwoven into body <NUM> and compressed along with body <NUM>. Retrieval loop <NUM> being compressed allows for the entirety of implantable artificial bronchus <NUM> to be compressed for ease of insertion and implantation.

In use, implantable artificial bronchus <NUM> may be used to promote lung disinsufflation. As shown in <FIG>, lung <NUM> of an individual may include respiratory passageways <NUM> having walls <NUM>. Respiratory passageways <NUM> may be bronchi or bronchioles, and walls <NUM> may be bronchi walls or bronchiole walls depending on the depth within respiratory passageway <NUM>. In individuals with COPD and pulmonary emphysema, walls <NUM> of respiratory passageway <NUM> may be restricted limiting airflow, as denoted by the arrows in <FIG>. Implantable artificial bronchus <NUM>, as shown in <FIG>, may be used to keep walls <NUM> of respiratory passageway <NUM> from restricting, allowing for airflow as depicted by the arrows in <FIG>. Specifically, implantable artificial bronchus <NUM> may allow for air trapped within respiratory passageway <NUM> to exit by opening up, and keeping open, the bronchi and bronchioles.

Referring to <FIG>, in an embodiment, a surgeon places implantable artificial bronchus <NUM> into the respiratory passageway by inserting a catheter distally into a respiratory passageway of the lung. The catheter may contain implantable artificial bronchus <NUM> which may be compressed within the catheter. For example, implantable artificial bronchus <NUM> may be compressed radially toward central axis A reducing the diameter of implantable artificial bronchus <NUM> to fit implantable artificial bronchus <NUM> within the catheter during insertion and implantation. The catheter may be withdrawn proximally relative to implantable artificial bronchus <NUM>, unsheathing implantable artificial bronchus <NUM> and causing it to naturally expand and remain in the respiratory passageway. In another embodiment of the present invention, implantable artificial bronchus <NUM> is coupled to a bronchoscope for placement of implantable artificial bronchus <NUM> within respiratory passageways. In a preferred embodiment, implantable artificial bronchus <NUM> is composed of a material such as PEEK that allows implantable artificial bronchus <NUM> to expand to its original shape. As shown in <FIG>, implantable artificial bronchus <NUM> 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 <NUM> into respiratory passageway <NUM> is done with a channel bronchoscope. For example, a <NUM> channel bronchoscope may be used to assist with the insertion and implantation of implantable artificial bronchus <NUM> into respiratory passageway <NUM>. In an embodiment, the bronchoscope assists with delivering implantable artificial bronchus <NUM> to level <NUM> of the respiratory bronchioles. As implantable artificial bronchus <NUM> expands from its compressed state, implantable artificial bronchus <NUM> may be able to reach deeper respiratory bronchioles, such has levels <NUM>, <NUM>, or <NUM>. For example, implantable artificial bronchus <NUM> may be placed within the distal bronchus having a diameter between <NUM> - <NUM>, and maximum diameter D<NUM> of implantable artificial bronchus <NUM> may allow implantable artificial bronchus <NUM> to support bronchus wall <NUM> such that bronchus wall <NUM> does not collapse and close off the airway. Further, implantable artificial bronchus <NUM> may be inserted into respiratory passageway <NUM> 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 <NUM> in a compressed state. However, compressed implantable artificial bronchus <NUM> may be introduced directly by a guidewire.

Referring to <FIG>, implantable artificial bronchus <NUM> may be flexible to allow for body <NUM> of implantable artificial bronchus <NUM> to conform to the shape of a respiratory passageway. For example, implantable artificial bronchus <NUM> may be configured to weave back and forth as it enters distal bronchioles. In an embodiment, body <NUM> is configured to curve in a first radial direction along a first length of body <NUM> and a second radial direction opposite the first radial direction along a second length of body <NUM>. Implantable artificial bronchus <NUM> may be configured to be flexible due to the interweaving of fiber <NUM> of PEEK. For example, body <NUM> may be comprised of a single interweaving fiber <NUM>, which allows various segments of fiber <NUM> to cross and slide over one another during movement of implantable artificial bronchus <NUM>. In an embodiment, implantable artificial bronchus <NUM> does not include any element to couple the various segments of fiber <NUM>, thereby allowing them to move and slide over one another, increasing the flexibility of implantable artificial bronchus <NUM>. The flexibility of implantable artificial bronchus <NUM> and body <NUM> allow for implantable artificial bronchus <NUM> 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 <NUM> to be used in a longer respiratory passageway instead of using multiple implantable artificial bronchi. Further, the flexibility of implantable artificial bronchus <NUM> allows it to reach respiratory bronchioles beyond level <NUM>. Implantable artificial bronchus <NUM> may be configured to provide structure to bronchus wall <NUM> while allowing air trapped within in distal alveoli to exit via the central airway. The shape and flexibility of implantable artificial bronchus <NUM> allows implantable artificial bronchus <NUM> to reach as close as possible to distal respiratory bronchioles, such as respiratory bronchioles beyond level <NUM> and close to alveoli (><NUM> levels).

In an embodiment, side openings <NUM> of body <NUM> allow for air to enter body <NUM> while implantable artificial bronchus <NUM> is disposed within the respiratory passageway. For example, as denoted by the arrows in <FIG>, air may enter body <NUM> via side openings <NUM> from smaller side respiratory passageways. These smaller side respiratory passageways may be created due to collateral ventilation. This allows air to flow through body <NUM> from distal bronchioles while implantable artificial bronchus <NUM> is implanted in the respiratory passageway.

Referring to <FIG>, a measuring catheter <NUM> may be used prior to insertion of implantable artificial bronchus <NUM> into the respiratory passageway. Measuring catheter <NUM> may be inserted into a channel bronchoscope to determine the depth of the desired target site within the respiratory passageway. Measuring catheter <NUM> may be a steerable wire that may be inserted into the channel bronchoscope prior to delivery of implantable artificial bronchus <NUM>. For example, measuring catheter <NUM> may have a fixed diameter of about <NUM>. The diameter of measuring catheter may be approximately <NUM> to prevent insertion beyond bronchioles that have a diameter less than <NUM>. Measuring catheter <NUM> having a fixed diameter of approximately <NUM> allows measuring catheter <NUM> to measure the distance to where the bronchioles narrows to approximately <NUM>. Measuring catheter <NUM> may include distal <NUM>, proximal end <NUM>, and handle <NUM>. Distal end <NUM> and proximal end <NUM> may include markers <NUM>. Markers <NUM> 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 <NUM> within the respiratory passageway. In an embodiment, markers <NUM> at distal end <NUM> and the interval at which they are located are identical to markers <NUM> at proximal end <NUM>. This allows the user to determine the depth without solely relying on the camera since proximal end <NUM> may be located outside of the channel bronchoscope. Handle <NUM> may be a molded plastic handle and may be used for manipulating measuring catheter <NUM>. In an embodiment, handle <NUM> is glued in place by backfilling a hole within handle <NUM> with an adhesive.

Referring to <FIG>, a delivery device <NUM> may be used to delivery implantable artificial bronchus <NUM>. Once the depth is determined via measuring catheter <NUM>, delivery device <NUM> may be used to deliver implantable artificial bronchus <NUM> to the target site. Delivery device <NUM> may include delivery portion <NUM> and handle <NUM>. Delivery portion <NUM> may include outer sheath <NUM>, delivery wire <NUM>, and stabilizer <NUM>. Handle <NUM> may be coupled to delivery portion <NUM> at distal end <NUM> of handle <NUM>. Implantable artificial bronchus <NUM> may be inserted into delivery portion <NUM> and disposed within delivery device <NUM> for delivery to a target site within the respiratory passageway. For example, delivery device <NUM> may be inserted within a working channel of the bronchoscope. Delivery portion <NUM> may be inserted and advanced into the respiratory passageway. Once delivery portion <NUM> has reached the target site for delivering implantable artificial bronchus <NUM>, outer sheath <NUM> may be retracted to expose delivery wire <NUM> and implantable artificial bronchus <NUM>, allowing for the delivery of implantable artificial bronchus <NUM> at the target site. Delivery portion <NUM> may then be removed from the working channel of the bronchoscope.

Handle <NUM> may include actuator <NUM>, stabilizer <NUM>, proximal end <NUM>, distal end <NUM>, anchor <NUM>, and outer surface <NUM>. Actuator <NUM> may be disposed on outer surface <NUM>. In an embodiment, actuator <NUM> may be disposed within slot <NUM> on outer surface <NUM>. Actuator <NUM> may be actuated via a thumb of a user to slide actuator <NUM> from proximal end <NUM> to distal end <NUM>. Actuator <NUM> may be coupled to outer sheath <NUM> and may be configured to retract outer sheath <NUM> into handle <NUM> to expose delivery wire <NUM>. For example, actuator <NUM> may be coupled to a portion of outer sheath <NUM> disposed within handle <NUM>, thereby resulting in outer sheath <NUM> being retracted into handle <NUM> when actuator <NUM> is moved towards proximal end <NUM>. Outer sheath <NUM> may pass through stabilizer <NUM> to assist in securing outer sheath <NUM> to handle <NUM>. In an embodiment, outer sheath <NUM> is movable relative to stabilizer <NUM> and handle <NUM>. Outer sheath <NUM> may include distal end <NUM>, slot <NUM>, and marker <NUM>, and may be coupled to distal end <NUM> of handle <NUM>. Marker <NUM> may be used to help determine various locations of outer sheath <NUM> within the respiratory passageway. Delivery wire <NUM> may be disposed within outer sheath <NUM> and may be comprised of a rigid material. Delivery wire <NUM> may extend from proximal end <NUM> of handle <NUM> to distal end <NUM> of outer sheath <NUM>. Delivery wire <NUM> may be anchored to proximal end <NUM> at anchor <NUM> of handle <NUM>. Anchor <NUM> may be configured to secure delivery wire <NUM> such that outer sheath <NUM> may be movable relative to delivery wire <NUM>. Delivery wire <NUM> may include stopper <NUM>, which may be disposed at the end of delivery wire <NUM>. Stopper <NUM> may be disposed within outer sheath <NUM> proximate to slot <NUM>.

In an embodiment, implantable artificial bronchus <NUM> is inserted into distal end <NUM> of outer sheath <NUM>, proximate to slot <NUM>, which is proximate stopper <NUM> of delivery wire <NUM>. Slot <NUM> may be located proximate distal end <NUM> of outer sheath <NUM>. Implantable artificial bronchus <NUM> may be inserted into distal end <NUM> by threading a suture through a loop of proximal upper opening <NUM>. The ends of the suture may pass through a funnel, into outer sheath <NUM>, and out of slot <NUM>. Implantable artificial bronchus <NUM> is inserted into distal end <NUM> of outer sheath <NUM> by pulling on the ends of the suture, which pull implantable bronchus <NUM> through the funnel resulting in collapsing implantable artificial bronchus <NUM>. Continued pulling of the ends of the suture pulls collapsed implantable artificial bronchus <NUM> into distal end <NUM> of outer sheath <NUM>. The suture is pulled until implantable artificial bronchus <NUM> reaches slot <NUM>, which is proximate stopper <NUM> of delivery wire <NUM>. The suture may then be pulled through slot <NUM> and removed from implantable artificial bronchus <NUM>. Once implantable artificial bronchus <NUM> is inserted into outer sheath <NUM>, implantable artificial bronchus <NUM> may expand. For example, body <NUM> of implantable artificial bronchus <NUM> having length L of approximately <NUM> may expand to have length L of approximately <NUM> within outer sheath <NUM>. By way of another example, body <NUM> of implantable artificial bronchus <NUM> having length L of approximately <NUM> may expand to have length L of approximately <NUM> within outer sheath <NUM>. During initial insertion, implantable artificial bronchus <NUM> may reduce down to its intended length. Once implantable artificial bronchus <NUM> is inserted into outer sheath <NUM> of delivery portion <NUM>, outer sheath <NUM> may be inserted into a working channel of the bronchoscope. Delivery portion <NUM> may be inserted into the respiratory passageway and advanced to the target site. Once the target site has been reached, actuator <NUM> may be moved towards proximal end <NUM> of handle <NUM>, thereby retracting outer sheath <NUM> into handle <NUM> and exposing delivery wire <NUM>, stopper <NUM>, and implantable artificial bronchus <NUM>. Retracting of outer sheath <NUM> does not cause movement of implantable artificial bronchus <NUM> towards handle <NUM> due to delivery wire <NUM> and stopper <NUM> exerting a force on implantable artificial bronchus <NUM> preventing movement of implantable artificial bronchus <NUM>. Once outer sheath <NUM> has been retracted and implantable artificial bronchus <NUM> is exposed, implantable artificial bronchus <NUM> may expand to its original position within the respiratory passageway. Delivery portion <NUM> of delivery device <NUM> 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 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".

Claim 1:
An implantable artificial bronchus (<NUM>), comprising:
a body (<NUM>) having a proximal upper opening (<NUM>) and a distal lower opening (<NUM>) in fluid communication with the proximal upper opening (<NUM>), to allow for bi-directional airflow in and through the implantable artificial bronchus (<NUM>), the body (<NUM>) at least partially tapering along a length of the body (<NUM>) toward the distal lower opening (<NUM>) and having a plurality of side openings (<NUM>) configured to allow air to enter into and exit the implantable artificial bronchus through the body,
wherein a length of the body (<NUM>) is greater than <NUM> times the size of a largest diameter of the body(<NUM>),
wherein a diameter of the proximal upper opening (<NUM>) is larger than a diameter of the distal lower opening (<NUM>);
wherein the body (<NUM>) is a lattice structure comprised of woven wire or fiber (<NUM>); and
wherein the implantable artificial bronchus (<NUM>) does not include a valve or a nozzle coupled to the body.