ROBOTIC SYSTEMS FOR DELIVERING INTRABronAL IMPLANTS AND

Abstract

The present technology relates to devices, systems and methods for improving lung function in a human individual. The technology includes a robotic system configured to assist in delivery and deployment of an implant in an airway of a patient. The robotic system may include a workstation to engage with and receive instructions from a therapy provider; and an arm in operable communication with the workstation. The arm may include an instrument driver and an articulatable instrument. The articulatable instrument may include an elongate member having a proximal end portion coupled to the instrument driver, a distal end portion configured for positioning in a bronchial airway of the human individual, and a working channel extending from the proximal end portion to the distal end portion. The working channel may be configured to receive a delivery system of an airway implant received therethrough.

Description

[0001] Cross-citation of related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 441,163, filed January 25, 2023, entitled “Robotic Systems for Delivering Endobronchial Implants and Related Technology,” the entire contents of which are incorporated herein by reference.

[0003] This application incorporates by reference the entire contents of the following applications: U.S. Patent Application No. TBD entitled “METHODS AND SYSTEMS FOR TREATING PULMONARY DISEASE” [Attorney’s No. APH.007WO], filed concurrently with this application; U.S. Provisional Application No. 63 / 441,167 entitled “METHODS AND SYSTEMS FOR TREATING PULMONARY DISEASE”, filed January 25, 2023; and PCT Application No. PCT / US22 / 73962 entitled “ENDOBRONCHIAL IMPLANTS AND RELATED TECHNOLOGIES”, filed July 20, 2022. Technical Field

[0004] This technology relates to robotic systems and related technologies for delivering intrabronchial implants. Background Technology

[0005] Chronic obstructive pulmonary disease (COPD) is a disease that impairs lung function. Symptoms of COPD include cough, wheezing, shortness of breath, and chest tightness. Smoking is the leading cause of COPD, but long-term exposure to other lung irritants (such as air pollution, chemical fumes, dust, etc.) can also cause or contribute to COPD. In most cases, COPD is a progressive disease that worsens over many years. Therefore, many people have COPD without realizing its progression. COPD is currently a leading cause of death and disability in the United States. Severe COPD can prevent patients from performing even basic activities such as walking, climbing stairs, or taking a bath. Unfortunately, there is no known cure for COPD. There is also no known medical technology that can reverse the lung damage associated with COPD.

[0006] In normal breathing, the act of inhalation draws air into the lungs through the nose or mouth and trachea. Within each lung, inhaled air enters a network of gradually narrowing airways branching into a network called bronchi, and then into the narrowest airways (called bronchioles). The bronchioles terminate in bundles of tiny, round structures called alveoli. Small blood vessels called capillaries run through the alveolar walls. As inhaled air reaches the alveoli, oxygen moves from the alveoli into the blood in the capillaries. Simultaneously, carbon dioxide moves in the opposite direction, from the blood in the capillaries into the alveoli. This process is called gas exchange. In healthy lungs, the airways and alveoli are elastic and flexible to accommodate inhaled air. When inhaling, the alveoli fill with air like tiny balloons. When exhaling, the alveoli contract. This expansion of the alveoli is a crucial part of effective gas exchange. Freely expanding alveoli exchange more gas than alveoli whose expansion is inhibited.

[0007] In lung tissue affected by COPD, less airflow passes through the airways for various reasons. Airways and / or alveoli may be relatively inelastic, the walls between alveoli may be damaged or destroyed, airway walls may be thickened or inflamed, and / or the airways may produce excessive mucus, leading to mucus buildup and airway obstruction. In typical cases of COPD, the disease does not affect all airways and alveoli in the lungs equally. Some areas of the lung may be more affected than others. In severe cases, airways and alveoli that are not adequate for effective gas exchange may account for 20% to 30% or more of the total lung volume.

[0008] The effects of COPD are often most pronounced when patients exercise or engage in other physical activities that would cause vigorous breathing in healthy individuals. Patients with COPD may be unable to breathe vigorously because the affected portion of their lungs traps air, preventing complete exhalation. This, in turn, inhibits the subsequent expansion of healthy lung tissue. Therefore, during exercise or other physical activity, the lungs of a COPD patient may be working in a state of dynamic hyperinflation, which impairs respiratory mechanics and increases the work of breathing. This hyperinflation can also hinder cardiac filling, leading to shortness of breath and / or reduced exercise performance. These and / or other harmful effects of COPD can cause a range of symptoms, ultimately impairing a patient's quality of life and increasing the risk of serious disability and death.

[0009] The term COPD encompasses both chronic bronchitis and emphysema. Approximately 25% of COPD patients also have emphysema. About 40% of these emphysema patients have severe emphysema. Furthermore, it is common for COPD patients to experience symptoms of both chronic bronchitis and emphysema simultaneously. In chronic bronchitis, the lining of the airways becomes inflamed, usually due to persistent irritation. This inflammation leads to thickening of the airway lining and the production of thick mucus that can coat and eventually block the airways. Conversely, emphysema is primarily a pathological diagnosis involving the abnormal and permanent enlargement of the air spaces distal to the terminal bronchioles. In emphysematous lung tissue, the small airways and / or alveoli typically lose their structural integrity and / or their ability to maintain their optimal shape. For example, damage or destruction of the alveolar walls can result in fewer but larger alveoli. This can severely impair normal gas exchange. Within the lungs, focal or “affected” areas of emphysematous lung tissue characterized by the lack of identifiable alveolar walls may be referred to as bullae. These relatively inelastic dead space sacs are typically larger than 1 cm in diameter and do not significantly contribute to gas exchange. Pulmonary bullae tend to retain air, thus creating overinflated lung slices that limit the ability of healthy lung tissue to fully expand upon inhalation. Therefore, in patients with emphysema, the diseased lung tissue not only ceases to contribute significantly to respiratory function but also impairs the function of healthy lung tissue.

[0010] Pharmacological treatment is typically prescribed for COPD. Treatment algorithms using bronchodilators, beta-2 agonists, muscarinic agonists, corticosteroids, or combinations thereof can provide short-term relief of COPD symptoms. However, these treatments do not cure COPD or significantly slow disease progression. Non-pharmacological management solutions (such as home oxygen therapy, non-invasive positive pressure ventilation, and pulmonary rehabilitation) are also common, but their therapeutic effects are limited. Another treatment option for patients with severe emphysema is lung volume reduction surgery (LVRS). This surgery involves removing the less functional portion of the lung (typically up to 20% to 25% of lung volume), thereby reducing the overall size of the lung and making more volume available in the thoracic cavity for expanding relatively healthy lung tissue. Because more volume is available for expansion, the remaining lung tissue after LVRS has an enhanced capacity for effective gas exchange. A significant drawback of LVRS is its highly invasive nature. Therefore, LVRS is generally considered a last resort, suitable only for a small percentage of patients with emphysema.

[0011] There are also procedures that reduce lung volume without surgical removal of diseased lung tissue. Examples include using coils or clamps to grasp and physically compact diseased lung tissue. These procedures reduce the overall lung volume, similar to LVRS. However, the potential of these procedures is limited because the proximal positioning of the coils or clamps tends to isolate not only the diseased portion of the lung but also the healthy portion. Furthermore, these procedures are often associated with serious complications, such as an increased risk of pneumothorax and chronic respiratory infections.

[0012] Another device-based treatment for COPD involves placing a one-way stent valve in the airway proximal to the emphysematous tissue. These valves allow air to flow out but not into the overinflated portions of the lung. This approach is recommended only for patients with little or no collateral ventilation (i.e., alveolar ventilation via a path that bypasses the normal airway). Unfortunately, less than 20% of patients with emphysema lack collateral ventilation. Therefore, one-way stent valves are not suitable for most patients with emphysema. Furthermore, similar to endobronchial coils and clips, the proximal positioning of one-way stent valves isolates not only the diseased portion of the lung but also the healthy portion.

[0013] Bronchoscopic thermal vapor ablation (BTVA) is another suboptimal treatment option for COPD. BTVA involves introducing heated steam into the diseased lung tissue. This produces a thermal response, leading to an initial local inflammatory response, followed by permanent fibrosis and atelectasis. Similar to thermal treatments like BTVA, biochemical treatments exist, which involve injecting glue or sealant into the diseased lung tissue. Both thermal and biochemical processes can accelerate remodeling, resulting in a reduction in tissue and air volume in the target area of ​​the overinflated lung. However, these processes are known to cause local toxicity and associated complications, undermining their potential efficacy.

[0014] Although stents are not routinely used to treat COPD, they are sometimes used in the lumen of central airways (i.e., trachea, main bronchus, lobar bronchus, and / or segmental bronchus) to temporarily improve the patency of these airways. For example, stents can be used to temporarily improve the patency of central airways affected by benign or malignant obstruction. Central airway stenting is not an effective treatment for emphysema because central airways have little or no effect on overall airway obstruction and / or airway stenosis associated with emphysema. Furthermore, when conventional stents are placed in the airway, they are plagued by occlusion problems, including granulation tissue formation and mucus impaction.

[0015] Some other known treatments for COPD involve bypassing the obstructed airway. For example, a perforation through the chest wall into the outer part of the lung can be used to create a direct connection between the diseased alveoli and the outside of the body (i.e., a bypass tract). Without further steps, these bypass tracts will close either through normal healing or through the formation of granulation tissue, thus eliminating the therapeutic effect. Placing a tubular prosthesis in the bypass tract can temporarily prolong the therapeutic effect. However, such prostheses eventually cause a foreign body reaction and accelerate granulation tissue formation. Furthermore, the formation of a bypass tract is often difficult and time-consuming. Once formed, the bypass tract can also be uncomfortable, inconvenient, and / or debilitating for the patient.

[0016] COPD is a major public health problem. In the United States alone, more than one million people suffer from severe emphysema and severe hyperinflation. The vast majority of these patients do not receive currently available treatments. The unmet clinical needs globally (including in countries with high rates of respiratory disease due to smoking) are many times greater than in the United States. As discussed above, conventional treatments for COPD are associated with serious complications, have limited effectiveness, are suitable only for a small subset of COPD patients, and / or have other significant drawbacks. Given the prevalence of this disease and the inadequacy of conventional treatments, innovation in this field is urgently needed. Summary of the Invention

[0017] For convenience, certain aspects of this technology are described in the content section of this invention as examples numbered (1, 2, 3, etc.). These are merely examples and are not intended to limit the technology.

[0018] 1. A robotic system for treating a human individual suffering from emphysema, the system comprising:

[0019] A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface;

[0020] An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes an extension member having a proximal portion coupled to the instrument driver, a distal portion configured for positioning in the bronchial airway of the human individual, and a working channel extending from the proximal portion to the distal portion.

[0021] An implant delivery system configured for intracavitary delivery via the working channel of the elongated member to a treatment site in the bronchial airway of the human individual, the implant delivery system comprising:

[0022] Implants, including:

[0023] A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and

[0024] A wire extending along a continuous wire path coaxially aligned with the longitudinal axis, wherein the wire path at an intermediate portion comprises at least three complete turns around the longitudinal axis.

[0025] A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once the implant is delivered to the treatment site;

[0026] The implant, when in the expanded deployment configuration, represents a tubular shape with a total surface area, and the wires are configured to occupy no more than 20% of the total surface area of ​​the tubular shape.

[0027] 2. The robot system according to Example 1, wherein the filament is configured to occupy no more than 5% of the total surface area of ​​the tubular shape.

[0028] 3. The robot system according to Example 1 or 2, wherein:

[0029] The articulated instrument further includes an elongated sheath defining a lumen configured to slidably receive the elongated component passing through it.

[0030] The instrument driver is the first instrument driver.

[0031] The arm in question is the first arm.

[0032] The robot system further includes:

[0033] Second arm,

[0034] A second instrument driver, configured to couple to the elongated sheath and the second arm.

[0035] Navigation system, which includes electromagnetic sensors, and

[0036] A camera, which is integrated with the elongated component and configured for optical pattern recognition.

[0037] 4. The robot system according to any one of Examples 1 to 3, wherein the arm is a single arm, and the elongated member (a) has an outer diameter of 3.5 mm, and (b) includes a multi-core fiber optic shape sensor for active control.

[0038] 5. The robotic system according to any one of Examples 1 to 4, wherein the arm is a single arm and the elongation member includes an integrated camera at its distal portion, and wherein the robotic system further includes a processor configured to cover the treatment location with real-time fluorescence fluoroscopic images and / or video.

[0039] 6. The robotic system according to any one of Examples 1 to 5, wherein the articulated instrument is a bronchoscope.

[0040] 7. The robotic system according to any one of Examples 1 to 6, further comprising a probe configured to be delivered to the airway via the working channel of the articulated instrument.

[0041] 8. The robotic system according to Example 7, wherein the probe is configured to apply suction to the airway.

[0042] 9. The robot system according to Example 8, wherein the probe includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

[0043] 10. The robot system according to any one of Examples 7 to 9, wherein the probe includes a camera at its distal end.

[0044] 11. The robot system according to any one of Examples 7 to 9, wherein the probe includes a flow sensor configured to measure airflow in the airway.

[0045] 12. The robot system according to any one of Examples 1 to 11, wherein:

[0046] The articulated instrument further includes an elongated sheath defining a lumen configured to slidably receive the elongated component passing through it.

[0047] The instrument driver is the first instrument driver.

[0048] The arm in question is the first arm.

[0049] The robot system further includes a second arm and a second instrument driver configured to couple to the elongated sheath and the second arm.

[0050] 13. The robot system according to Example 12, further comprising a probe configured to couple to the second instrument driver.

[0051] 14. The robotic system according to Example 12 or 13, wherein the probe is configured to apply suction to the airway.

[0052] 15. The robot system according to Example 14, wherein the probe includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

[0053] 16. The robotic system according to any one of Examples 12 to 15, wherein the probe includes a camera at its distal end.

[0054] 17. The robot system according to any one of Examples 12 to 16, wherein the probe includes a flow sensor configured to measure airflow in the airway.

[0055] 18. A method for improving lung function in a human individual, the method comprising:

[0056] Robotically moving an elongated component within the bronchial tree of the individual toward a treatment location adjacent to emphysematous tissue, wherein the elongated component defines a working channel, and wherein, as the elongated component is advanced, an implant is positioned in a low-profile state within the working channel, the implant comprising:

[0057] A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and

[0058] A wire extending along a continuous wire path coaxially aligned with the longitudinal axis, wherein the wire path at an intermediate portion comprises at least three complete turns around the longitudinal axis.

[0059] The implant is configured to allow mucociliary clearance from a position immediately adjacent to the distal end of the implant to a position immediately adjacent to the proximal end of the implant when the implant is deployed at the treatment site.

[0060] Transforming the implant from the low-profile state to an expanded deployment state at the treatment site, wherein transforming the implant includes expanding the implant to be juxtaposed with the airway wall at the treatment site.

[0061] 19. The method according to Example 18, wherein the proximal portion of the elongated member is coupled to an instrument driver of the robot system.

[0062] 20. The method according to Example 18 or 19, further comprising advancing the implant through the distal opening of the working channel of the elongated member via robot control.

[0063] 21. The method according to Example 18 or 19, further comprising manually advancing the implant through the distal opening of the working channel.

[0064] 22. The method according to Example 18, wherein:

[0065] During delivery, the implant is positioned on the actuating component, and both the implant and the actuating component are housed within a protective sheath.

[0066] The sheath is configured to be slidably positioned within the working channel, and

[0067] The method further includes robotically advancing the sheath and pushing components through the distal opening of the working channel under robot control.

[0068] 23. The method according to Example 22, further comprising, after robotically advancing the sheath and the actuating component, robotically retracting the sheath relative to the actuating component to deploy the implant.

[0069] 24. The method according to Example 18, wherein:

[0070] During delivery, the implant is positioned on the actuating component, and both the implant and the actuating component are housed within a protective sheath.

[0071] The sheath is configured to be slidably positioned within the working channel, and

[0072] The method further includes manually advancing the sheath and pushing components through the distal opening of the working channel under robot control.

[0073] 25. The method according to Example 24, further comprising, after manually advancing the sheath and the pushing member, manually retracting the sheath relative to the pushing member to deploy the implant.

[0074] 26. The method according to any one of Examples 17 to 25, wherein the elongated component includes a shape sensor configured to provide navigation guidance to a user.

[0075] 27. The method according to any one of Examples 17 to 26, wherein the elongating component includes an electromagnetic sensor.

[0076] 28. The method according to any one of Examples 17 to 27, wherein the elongated component comprises a multi-core optical fiber.

[0077] 29. The method according to any of Examples 17 to 28, wherein the elongating member includes a plurality of pull wires extending along the length of the elongating member, and wherein manipulation of the pull wires causes hinge of the distal portion of the elongating member.

[0078] 30. The method according to any one of Examples 17 to 29, wherein the elongated member includes an image sensor at its distal portion.

[0079] 31. The method according to any one of Examples 17 to 30, further comprising propelling the imaging device through the working channel of the elongated member.

[0080] 32. The method according to any one of Examples 17 to 31, further comprising advancing the restrained implant within the sheath up to 150 mm beyond the distal opening of the working channel.

[0081] 33. The method according to any of Examples 17 to 32, wherein the implant is placed on a pusher during delivery, and the implant and the pusher are placed within a sheath, wherein the sheath includes a visual marker indicating the proximal position of the implant housed in the sheath in a delivery state, the method further comprising positioning the visual marker proximal to a target airway location while viewing the visual marker via an imaging device.

[0082] 34. The method according to any of Examples 17 to 33, wherein during delivery the implant is placed on a pusher, and the implant and the pusher are placed within a sheath, wherein the sheath includes a visual marker positioned at a distance from the distal tip of an intermediate sheath, the distance corresponding to the working length of the working channel, and wherein the method includes advancing the delivery system through the working channel until the visual marker is aligned with the proximal end of the working channel, and then advancing the delivery system away from the working channel to an extension length, the extension length being at least the length of the delivery state.

[0083] 35. A method for improving lung function in a human individual, the method comprising:

[0084] Robotically moving an elongated component within the bronchial tree of the individual toward a treatment location near emphysematous tissue, wherein the elongated component defines a working channel, and wherein, as the elongated component is advanced, the implant is positioned in a low-profile state within the working channel; and

[0085] Transforming the implant from the low-profile state to an expanded deployment state at the treatment site, such that the distal end of the implant is deployed within an airway at least one generation larger than the airway in which the proximal end is deployed, and wherein transforming the implant includes expanding the implant to juxtapose it with the airway wall at the treatment site.

[0086] 36. The method according to Example 35, comprising propelling a probe through the working channel, wherein the probe includes at least one sensor.

[0087] 37. The method according to Example 36, further comprising identifying the treatment location at least in part based on information from the at least one sensor.

[0088] 38. The method according to Example 37, wherein the information indicates the disease state of the airway wall.

[0089] 39. The method according to any one of Examples 35 to 38, wherein the at least one sensor comprises one or more of a pressure sensor, an optical sensor, an image sensor, a flow sensor, a proximity sensor, a contact sensor, an ultrasonic sensor, a MEMS stiffness sensor, or an infrared sensor.

[0090] 40. A robotic system for treating a human individual suffering from emphysema, the system comprising:

[0091] A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface;

[0092] An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes an extension member having a proximal portion coupled to the instrument driver, a distal portion configured for positioning in the bronchial airway of the human individual, and a working channel extending from the proximal portion to the distal portion, wherein the working channel of the extension member is configured to accommodate a treatment location for intraluminal delivery of an implant delivery system into the bronchial airway of the human individual, the implant delivery system comprising:

[0093] Implants, including:

[0094] A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and

[0095] A wire extending along a continuous wire path, the wire having an untethered proximal end at the proximal portion and an untethered distal end at the distal portion; and

[0096] A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once the implant is delivered to the treatment site;

[0097] The implant, when in the expanded deployment configuration, represents a tubular shape with a total surface area, and the wires are configured to occupy no more than 20% of the total surface area of ​​the tubular shape.

[0098] 41. The system according to Example 40, wherein the wire comprises a single wire.

[0099] 42. The system according to Example 40 or 41, wherein the ratio of the radial spring constant to the longitudinal spring constant of the implant is between about 10:1 and about 80:1.

[0100] 43. The system according to any one of Examples 40 to 42, wherein the ratio of the radial spring constant of the implant, in Newton-meters, to the longitudinal shear modulus of the implant, in Pascals, is between about 0.005 and about 0.100.

[0101] 44. An implant delivery system configured for placement in the peripheral lung of a patient with emphysema via a robotic navigation system, the implant delivery system comprising:

[0102] Implants, including:

[0103] A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and

[0104] A wire extending along a continuous wire path, the wire having an untethered proximal end at the proximal portion and an untethered distal end at the distal portion; and

[0105] A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once it has been delivered to the treatment site.

[0106] The delivery system is sized and configured for delivery into the peripheral lung via a robotic navigation system, the robotic navigation system comprising:

[0107] A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface;

[0108] An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes a working channel configured to receive from the delivery system.

[0109] 45. The system according to Example 44, wherein the wire comprises a single wire.

[0110] 46. ​​The system according to Example 44 or 45, wherein the ratio of the radial spring constant to the longitudinal spring constant of the implant is between about 10:1 and about 80:1.

[0111] 47. The system according to any one of Examples 44 to 46, wherein the ratio of the radial spring constant of the implant, in Newton-meters, to the longitudinal shear modulus of the implant, in Pascals, is between about 0.005 and about 0.100.

[0112] 48. A diagnostic probe for accessing a patient's lung via a robotic navigation system to facilitate endobronchial treatment, the robotic navigation system comprising articulated instruments and instrument drivers, the diagnostic probe comprising:

[0113] An elongated member having a proximal portion coupled to the instrument driver and a distal portion configured to be received in the working channel of the articulated instrument; and

[0114] A sensor is disposed on the distal portion of the elongated member and configured to provide diagnostic information about the tissue of the lung.

[0115] 49. The diagnostic probe according to Example 48, wherein the probe is configured to apply suction to the airway of the lung.

[0116] 50. The diagnostic probe according to Example 49, wherein the sensor includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

[0117] 51. The diagnostic probe according to any of Examples 48 to 50, wherein the sensor includes one or more of a pressure sensor, an optical sensor, an image sensor, a flow sensor, a proximity sensor, a contact sensor, an ultrasonic sensor, a MEMS stiffness sensor, or an infrared sensor.

[0118] 52. A diagnostic probe according to any of Examples 48 to 51, wherein the probe is configured to measure one or more of the following: static ventilation / perfusion (VQ) ratio across different points of interest in the lung, dynamic VQ ratio across different points of interest in the lung, static airflow, dynamic airflow, static pressure, dynamic pressure, static airflow resistance, or dynamic airflow resistance.

[0119] 53. The diagnostic probe according to any of Examples 48 to 52, wherein the probe is configured to measure one or more pulmonary function test (PFT) measures from within the lung.

[0120] 54. A diagnostic probe according to any of Examples 48 to 53, wherein the probe is configured to apply virtual or physical tags to points of interest in the lung.

[0121] 55. The diagnostic probe according to Example 54, wherein the point of interest includes diseased tissue.

[0122] 56. The diagnostic probe according to any one of Examples 48 to 55, wherein the probe is configured to determine the proximal boundary of the emphysematous parenchyma in the lung.

[0123] 57. A diagnostic probe according to any one of Examples 48 to 56, wherein the probe is configured to generate a real-time mapping of the airway diameter in the lung. Attached Figure Description

[0124] Many aspects of this disclosure can be better understood by referring to the following figures. The components in the figures are not necessarily drawn to scale. Instead, the focus is on clearly illustrating the principles of this disclosure.

[0125] Figure 1 It is a schematic illustration of the bronchial tree within the thoracic cavity of a human individual.

[0126] Figure 2 It is a schematic illustration of the bronchial tree of an isolated human individual.

[0127] Figure 3 yes Figure 2 An enlarged view of the terminal portion of the bronchial tree shown in the image.

[0128] Figure 4 It is a table that shows examples of the size and algebra of different parts of the bronchial tree of an individual human.

[0129] Figure 5 It is a graph showing lung volume during periods of normal lung function.

[0130] Figure 6 It is a table showing the airway walls at different parts of the bronchial tree in a human individual.

[0131] Figure 7 It is an anatomical description of the airway walls at different parts of the bronchial tree in a human individual.

[0132] Figure 8 It is an anatomical illustration showing the narrowing of small airways in the lung tissue of emphysema.

[0133] Figure 9 It is an anatomical illustration showing alveolar wall damage in emphysematous lung tissue.

[0134] Figure 10 It is an anatomical illustration of normal airway patency during exhalation in healthy lung tissue.

[0135] Figure 11 It is an anatomical illustration of airway collapse during exhalation in emphysematous lung tissue.

[0136] Figure 12 It is an anatomical illustration showing normal acini.

[0137] Figure 13 It is an anatomical illustration of central acinar emphysema.

[0138] Figure 14 It is an anatomical illustration of panalveolar emphysema.

[0139] Figure 15 It is an anatomical illustration of paraseptal emphysema.

[0140] Figure 16 This is a perspective view of an implant according to at least some embodiments of the present technology.

[0141] Figure 17 yes Figure 16 The image shows a curved side view of the implant.

[0142] Figure 18 This is a side view of a heart shaft configured for use in the manufacture of implants, according to at least some embodiments of the present technology.

[0143] Figure 19 yes Figure 16 The image shows a perspective view of the implant in a radially compressed state around the delivery component.

[0144] Figure 20 yes Figure 16 The implant shown in the image is in Figure 19 The perspective view of the radial compression state shown in the figure highlights the portion of the implant for finite element analysis.

[0145] Figure 21 This is a perspective view of an implant according to at least some embodiments of the present technology.

[0146] Figure 22 This is a perspective view of a bronchoscope for use with an implant, according to at least some embodiments of the present technology.

[0147] Figure 23 and 24 This is a description illustrating different corresponding times during the deployment of implants according to at least some embodiments of the present technology.

[0148] Figure 25A This is a cross-sectional view of a delivery system according to at least some embodiments of the present technology.

[0149] Figure 25B It corresponds to Figure 25A Illustrations.

[0150] Figure 26A This is a perspective view of an implant in an unconstrained state according to at least some embodiments of the present technology.

[0151] Figures 26B to 26F It corresponds to Figure 26A Illustrations.

[0152] Figure 27Ayes Figure 26A The image shows an end view of the implant in an unconstrained state.

[0153] Figure 27B It corresponds to Figure 27A Illustrations.

[0154] Figure 28 yes Figure 26A The image shows a cross-sectional view of the implant in an unconstrained state.

[0155] Figure 29 yes Figure 26A The implant shown in the image is in an unrestrained state along... Figure 28 The cross-sectional view taken by line AA in the figure.

[0156] Figure 30 yes Figure 26A The implant shown in the image is in an unrestrained state along... Figure 28 The cross-sectional view taken by line BB in the middle.

[0157] Figure 31 yes Figure 26A The implant shown in the image is in an unrestrained state along... Figure 28 The cross-sectional view is taken by line CC in the image.

[0158] Figure 32 yes Figure 26A The implant shown in the image is in an unrestrained state along... Figure 28 The cross-sectional view taken by line DD in the middle.

[0159] Figure 33 This is a cross-sectional view of an implant in an unconstrained state according to at least some embodiments of the present technology, juxtaposed with a schematic diagram of a portion of the wire path at the middle part of the implant.

[0160] Figures 34A to 35B It is a display and Figure 33 The diagram shows the different corresponding angles related to the implant.

[0161] Figure 36 yes Figure 33 The image shows a cross-sectional view of the implant in its deployed state within the airway region.

[0162] Figure 37 This is a schematic diagram illustrating certain forces and dimensions related to an implant according to at least some embodiments of the present technology.

[0163] Figure 38 This is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of a simple coil.

[0164] Figure 39This is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of the implant according to at least some embodiments of the present technology.

[0165] Figure 40 This is an anatomical description of the airway region where an implant according to at least some embodiments of the present technology can be deployed.

[0166] Figures 41 to 46 Implants according to at least some embodiments of the present technology in Figure 40 The illustration shows partial schematics of the deployment process at different corresponding times in the airway area.

[0167] Figure 47 yes Figure 40 The anatomical illustration of the airway region shown in the figure indicates certain original and expanded dimensions.

[0168] Figure 48 This is a block diagram illustrating a method for improving lung function in a human individual according to at least some embodiments of the present technology.

[0169] Figure 49 A treatment system according to several embodiments of the present technology is shown.

[0170] Figure 50 A robot system according to several embodiments of the present technology is shown.

[0171] Figure 51A A hinged instrument according to several embodiments of the present technology is shown.

[0172] Figure 51B yes Figure 51A The cross-sectional view of the articulated instrument taken along line 51B-51B is shown in the figure.

[0173] Figure 52A A hinged instrument according to several embodiments of the present technology is shown.

[0174] Figure 52B and 52C They are Figure 52A The cross-sectional views of the articulated instrument taken along lines 52B-81B and 52C-52C are shown in the image.

[0175] Figure 53 A robot system according to several embodiments of the present technology is shown.

[0176] Figure 54A A hinged instrument according to several embodiments of the present technology is shown.

[0177] Figure 54B and 54C They are Figure 54AThe cross-sectional views of the articulated instrument taken along lines 54B-54B and 54C-54C are shown in the image.

[0178] Figure 55 A robot system according to several embodiments of the present technology is shown.

[0179] Figure 56A This is a cross-sectional view of an implant including an access window according to several embodiments of the present technology. Figure 56B and 56C They are Figure 56A The image shows a cross-sectional view of the implant taken along lines AA and BB.

[0180] Figure 57 This diagram illustrates the considerations for implants with variable chronic outward forces.

[0181] Figure 58A This is a perspective view of the instance delivery system. Figure 58B yes Figure 58A The image shows a detailed view of the delivery system.

[0182] Figure 59A and 59B These are the top view and the cross-sectional side view of the instance handle of the delivery system.

[0183] Figures 59C to 59F This is an illustrative diagram of an example embodiment of a user interface element on an example handle of a delivery system.

[0184] Figure 60A and 60B This is an illustrative diagram of an example sheath actuator in an implant delivery system.

[0185] Figure 61 This is an illustrative diagram of an example rack and pinion sheath actuator in an implant delivery system.

[0186] Figure 62A and 62B These are top and side views of an illustrative schematic diagram of a pulley-based sheath actuator, an example of an implant delivery system.

[0187] Figure 63 This is an illustrative diagram of an example telescopic sheath actuator in an implant delivery system.

[0188] Figure 64 This is an illustrative diagram of an example haptic feedback mechanism in an implant delivery system.

[0189] Figure 65A This is an illustrative diagram of an example elongated component in an implant delivery system. Figure 65B yes Figure 65A Detailed schematic diagram of the elongated component shown in the figure.

[0190] Figure 66 This is an illustrative diagram of an example elongated component in an implant delivery system.

[0191] Figure 67A and 67B This is an illustrative diagram of an example elongation component and an example inner sheath in an implant delivery system.

[0192] Figure 68A This is an illustrative cross-sectional diagram of an example implant delivery system. Figure 68B yes Figure 68A A detailed schematic diagram of the delivery system shown in the figure.

[0193] Figure 69 This is an illustrative diagram of an implant delivery system having multiple segments of conformal material for attaching to the implant.

[0194] Figures 69A to 69 C is an illustrative cross-sectional diagram of different examples of an elongated component in an implant delivery system.

[0195] Figure 70 This is an illustrative cross-sectional diagram of an example implant delivery system.

[0196] Figure 71 This is an illustrative cross-sectional diagram of an example elongated component and an example inner sheath in an implant delivery system.

[0197] Figure 72 This is an illustrative diagram of an example elongated component in an implant delivery system.

[0198] Figure 73A This is an illustrative diagram of an example inner sheath in an implant delivery system.

[0199] Figure 73B This is an illustrative cross-sectional diagram of an example inner sheath in an implant delivery system.

[0200] Figure 74A and 74B This is an illustrative cross-sectional diagram of the inner sheath in various examples of implant delivery systems.

[0201] Figure 75 An example of the braided fabric and coil configuration of the structural reinforcement layer of the inner sheath in an implant delivery system is depicted.

[0202] Figure 76 This is an illustrative diagram of an example outer sheath in an implant delivery system.

[0203] Figure 77 This is an illustrative diagram of the visual markings on the implant delivery device relative to the bronchoscope.

[0204] Figures 78 to 84 This is an illustrative diagram of an example locking arrangement used to restrict the movement of an implant delivery system relative to a bronchoscope.

[0205] Figure 85 This is an illustrative diagram of an example locking arrangement that allows limited axial movement of the implant delivery system relative to the bronchoscope.

[0206] Figure 86A and 86B This is an illustrative diagram of an example locking arrangement that allows limited axial movement of the implant delivery system relative to the bronchoscope.

[0207] Figures 87A to 87D This is an illustrative diagram of an example sheath actuator in an implant delivery system.

[0208] Figure 88A and 88B These are illustrative diagrams of the example elongated components in the first and second configurations, respectively.

[0209] Figure 89A This is an illustrative diagram of an example guide sheath in an implant delivery system. Figure 89B This is an illustrative diagram of an example inner sheath and handle in an implant delivery system.

[0210] Figure 90 This is an illustrative diagram of an example implant delivery system including a guide sheath, inner sheath, and handle that operate in conjunction with a bronchoscope.

[0211] Figures 91A to 91C This is an illustrative diagram illustrating the operation of an example guide sheath in an implant delivery system.

[0212] Figures 92A to 92B This is an illustrative diagram illustrating the operation of an example implant delivery system.

[0213] Figure 93A and 93B This is an illustrative diagram illustrating the operation of an example airway and implant size adjustment device.

[0214] Figure 94A and 94B This is an illustrative diagram illustrating the operation of an example airway and implant size adjustment device.

[0215] Figures 95A to 95D This is an illustrative diagram of the markings on the example airway and implant size adjustment device.

[0216] Figure 96 This is an illustrative diagram of a medical device having a sensor configured to detect the distance between the medical device and the tissue wall.

[0217] Figure 97 This is an illustrative diagram of an example delivery system that uses a sheath to advance distally to facilitate implant deployment.

[0218] Figure 98 This is an illustrative diagram of an example delivery system that facilitates implant deployment by advancing the distal and proximal sheath portions distally and proximally, respectively. Detailed Implementation

[0219] I. Intrabronchial implants

[0220] As discussed above, existing methods for treating COPD are either highly invasive (e.g., lung volume reduction surgery), ineffective for most patients (e.g., one-way stent valves), have inappropriate effects on gas exchange in healthy lung tissue (e.g., endobronchial coils and clips), carry a high risk of complications (e.g., bronchoscopic steam ablation), or have poor long-term efficacy (e.g., bypass prostheses), and / or suffer from one or more other major limitations. Overcoming these limitations is a significant technical challenge. The inventors have developed novel methods for treating COPD that address at least some of the shortcomings of conventional methods. In at least some cases, these novel methods are surprisingly effective in establishing and maintaining airway patency. This is also expected in both emphysema patients without collateral ventilation and emphysema patients with collateral ventilation. Methods for treating COPD according to at least some embodiments of the present technology involve the use of robotic systems for delivering endobronchial implants. In addition to potential clinical benefits, these implants may have better delivery, retrieval, and / or safety characteristics compared to conventional devices. Given the prevalence and severity of COPD, innovative endobronchial implants and other aspects of COPD treatment based on various embodiments of this technology have great potential to have a meaningful positive impact on global public health.

[0221] At least some embodiments of this technology relate to establishing and maintaining patency in obstructed and / or narrowed portions of one or more airways in the lung. This is therapeutic for patients diagnosed with COPD (including those diagnosed with emphysema and / or chronic bronchitis). At least some of these therapeutic effects may be associated with promoting the release of air from overinflated and / or diseased lung portions and a corresponding increase in the volume of pleural contents available for gas exchange in other lung portions. Implants according to at least some embodiments of this technology are configured to be positioned within the airway lumen and expand against the airway wall, thereby expanding and / or enlarging the airway and increasing the cross-sectional area of ​​the airway lumen. The positioning of the implant within the bronchial lumen and / or the expansion of the implant against the airway wall can be achieved under robotic control. In at least some cases, the implant is configured to enlarge the airway beyond its normal size.

[0222] In at least some cases, implants according to embodiments of the present technology are configured to have relatively small (e.g., minimal) surface contact with the airway wall during respiration and / or maintain stable contact with the airway wall. These and other features disclosed herein can reduce or eliminate progressive airway obstruction caused by biological processes (e.g., inflammation, fibrosis, granulation, mucus impaction, etc.) that would otherwise limit the effectiveness of implants in treating COPD. An overview of the relevant lung anatomy and physiology, along with additional details regarding implants according to embodiments of the present technology, is discussed below.

[0223] This document discloses numerous specific details of apparatuses, systems, and methods according to various embodiments of the present technology. While these apparatuses, systems, and methods may be disclosed primarily or entirely in the context of treating COPD (and sometimes specifically emphysema), other contexts beyond those disclosed herein are also within the scope of the present technology. For example, suitable features of the described apparatuses, systems, and methods may be implemented in the context of treating tracheobronchospasm (TBM) or benign prostatic hyperplasia (BPH) and other instances. Furthermore, it should be understood that, in general, other apparatuses, systems, and methods besides those disclosed herein are also within the scope of the present technology. For example, apparatuses, systems, and methods according to embodiments of the present technology may have different and / or additional configurations, components, and processes than those disclosed herein. Moreover, those skilled in the art will understand that apparatuses, systems, and methods according to embodiments of the present technology may not have one or more of the configurations, components, and / or processes disclosed herein without departing from the present technology.

[0224] Anatomy and Physiology

[0225] Figure 1 This is a schematic illustration of the bronchial tree within the thoracic cavity of a human individual. For example... Figure 1As shown, the bronchial tree includes the trachea T, which extends downward from the nose and mouth and divides into the left main bronchus (LMB) and the right main bronchus (RMB). The left and right main bronchuses each branch to form the lobar bronchus (LB), segmental bronchus (SB), and subsegmental bronchus (SSB), which have successively smaller diameters and shorter lengths as they extend distally. Figure 2 This is a schematic illustration of an isolated bronchial tree. For example... Figure 2 As shown, the subsegmental bronchi continue to branch to form bronchioles (BO), conducting bronchioles (CBO), and finally terminal bronchioles (TBO), which are the smallest airways without alveoli. The terminal bronchioles branch into respiratory bronchioles (RBO), which are divided into alveolar ducts (AD). Figure 3 This is an enlarged view of the terminal portion of the bronchial tree. (Example) Figure 3 As shown, alveolar ducts terminate in blind outpouching, which contains two or more small clusters of alveolar A cells, called alveolar sacs (AS). Various individual alveoli can also be arranged along the length of the respiratory bronchioles.

[0226] The bronchi and bronchioles are the conduction airways that transport air to and from the alveoli. They do not participate in gas exchange. Instead, gas exchange occurs in the alveoli, located distal to the conduction airways, beginning at the respiratory bronchioles. Depending on the degree of branching in the proximal part of the airway, the various airways in the bronchial tree are usually referred to as "generations." For example, the trachea is called "generation 0" of the bronchial tree, the bronchioles of each order including the left and right main bronchioles are called "generation 1," the lobar bronchioles are called "generation 2," and the segmental bronchioles are called "generation 3." Furthermore, any airway extending from the trachea to the terminal bronchioles is usually called a "conduction airway." Figure 4 It is a table that indicates the size and algebra of different parts of the bronchial tree.

[0227] The respiratory bronchioles, alveoli, and alveolar sacs receive air and participate in gas exchange through the more proximal part of the bronchial tree to oxygenate the blood delivered to the lungs from the heart via the pulmonary artery, its branches, and capillaries. A thin, semi-permeable membrane separates the oxygen-deprived blood in the capillaries from the oxygen-rich air in the alveoli. Capillaries wrap around the alveoli and extend between them. Oxygen from the air diffuses through the membrane into the blood. Carbon dioxide from the blood diffuses through the membrane into the air in the alveoli. Then, fresh oxygen-rich blood flows from the alveolar capillaries through the branches of the pulmonary venous system to the heart. The heart pumps the oxygen-rich blood throughout the body. When the diaphragm and intercostal muscles relax and the lungs and chest wall return to their normal relaxed state, the oxygen-deprived air in the lungs is exhaled. In this way, air flows through the branching bronchioles, segmental bronchi, lobar bronchi, main bronchi, and trachea, and is finally expelled through the mouth and nose.

[0228] Figure 5This is a graph showing lung volume during normal lung function. Approximately one-tenth of total lung capacity is used at relaxation. More is used as needed (e.g., during exercise). Tidal volume (TV) is the volume of air inhaled and exhaled during conscious breathing. The additional volume of air that can be exhaled with maximal effort after a normal inspiration is the inspiratory reserve volume (IRV). The additional volume of air that can be forcibly exhaled after a normal exhalation is the expiratory reserve volume (ERV). The total volume of air that can be exhaled after a maximal inspiration is vital capacity (VC). VC equals the sum of TV, IRV, and ERV. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. The lungs can never be completely emptied. Total lung capacity (TLC) is the sum of VC and RV. Assessment of lung function can be used to determine a patient's eligibility for treatment and to evaluate the effectiveness of treatment.

[0229] Figure 6 It is a table showing the composition of the airway walls at different parts of the bronchial tree. Figure 7 It is an anatomical description of the airway walls at different parts of the bronchial tree. For example... Figure 6 and 7 As shown, the walls of the bronchi, bronchioles, alveolar ducts, and alveoli contain epithelium, connective tissue, goblet cells, mucous glands, rod cells, smooth muscle, elastic fibers, and hyaline cartilage, with nerves, blood vessels, and inflammatory cells scattered throughout. Most of the epithelium (from the nose to the bronchi) is covered by ciliated pseudostratified columnar epithelium, commonly known as respiratory epithelium. The cilia on these epithelium twitch in one direction, thus moving mucus and foreign objects (such as dust and bacteria) from more distal airways to more proximal airways, eventually reaching the throat, where mucus and / or foreign objects are cleared by swallowing or coughing. Moving downwards along the bronchioles, the cells become more cubic in shape but still have cilia.

[0230] The proportions and properties of the various components of the airway wall vary depending on their location within the bronchial tree. For example, mucous glands are abundant in the trachea and main bronchi, but absent from the bronchioles onward (e.g., around the 10th generation). In the trachea, cartilage is presented as C-rings of hyaline cartilage, while in the bronchi, it is presented as a scattered plate. As branches continue through the bronchial tree, the amount of hyaline cartilage in the wall decreases until it disappears in the bronchioles. Smooth muscle begins in the trachea, where it joins the C-rings of cartilage. It extends downward along the bronchi and bronchioles, completely encircling them. The bronchi and bronchioles are composed of elastic tissue, not hard cartilage. As cartilage decreases, the amount of smooth muscle increases. The mucosa also undergoes a transition from ciliated pseudostratified columnar epithelium to simple cuboidal epithelium to simple squamous epithelium.

[0231] Lung diseases

[0232] Figure 8It is an anatomical illustration showing the narrowing of small airways in the lung tissue of emphysema. Figure 9 It is an anatomical illustration showing alveolar wall damage in emphysematous lung tissue. Figure 10 It is an anatomical illustration showing normal airway patency during exhalation. Figure 11 This is an anatomical illustration of airway collapse during expiration in emphysematous lung tissue. COPD, and more specifically emphysema, is characterized by irreversible destruction of the alveolar walls, which contain elastic fibers that maintain radial-outward traction on the small airways and are used for both inspiration and expiration. Figures 8 to 11 As shown in the study, when these elastic fibers are damaged, the small airways are no longer subjected to radial outward traction and collapse, especially during expiration. Furthermore, emphysema damages the alveolar walls. (As illustrated...) Figure 9 As shown in the study, this results in a larger air cavity and a reduced surface area available for gas exchange. Consequently, the lungs are unable to exchange gases at a satisfactory rate, leading to a decrease in oxygenated blood. Furthermore, the large air cavity in the diseased lung, combined with airway collapse, causes lung overinflation (air trapping) and incomplete exhalation. In addition, the overinflated lung exerts continuous pressure on the chest wall, diaphragm, and surrounding structures, leading to shortness of breath and potentially hindering short-distance walking or the performance of daily tasks. Patients with advanced emphysema have extremely low quality of life and life expectancy; less than half survive for another five years.

[0233] There are three types of emphysema: central acinar type, panacinar type, and paraseptal type. Figure 12 It is an anatomical illustration showing normal acini. Figure 13 It is an anatomical illustration of central alveolar emphysema, involving alveoli and airways in the central alveoli, including the destruction of alveoli in the walls of the respiratory bronchioles and alveolar ducts. Figure 14 It is an anatomical illustration of panalveolar emphysema characterized by tissue destruction of the alveoli, alveolar ducts, and respiratory bronchioles. This produces fairly uniform airway enlargement throughout the acini and uniformly distributed emphysematous changes across the acini and secondary lobules. Figure 15 This is an anatomical illustration of paraseptal emphysema, characterized primarily by the enlargement of the air spaces around the alveoli due to the destruction of the alveoli and alveolar ducts. Paraseptal emphysema typically has a limited distribution and most commonly occurs along the posterior surface of the upper lung. It often coexists with other forms of emphysema.

[0234] Another aspect of the progression of emphysema and associated alveolar wall destruction is the increased airflow between adjacent alveoli (known as collateral ventilation or collateral airflow). Collateral ventilation severely impairs the clinical functionality of bronchial valves. As discussed above, these valves are designed to allow unidirectional air passage, leading to atelectasis in the affected lobe. However, collateral ventilation induces airflow in the lobe, thus preventing atelectasis.

[0235] Novel intrabronchial implants

[0236] This document describes devices, techniques, and methods for treating patients with lung diseases, such as severe emphysema. At least some embodiments of this technology involve robot-assisted endobronchial placement of an implant to establish or improve airway patency. The implant may be placed at a treatment location that includes a previously collapsed airway (e.g., a previously collapsed distal airway). Deployment of the implant may release air trapped in an overinflated portion of the lung and / or reduce or prevent subsequent air trapping in that portion of the lung. In at least some cases, it is desirable that the treatment location where the implant is deployed includes a fourth-generation or higher / deeper airway, such as (from distal to proximal) respiratory bronchioles, terminal bronchioles, conducting bronchioles, bronchioles, or subsegmental bronchi, and then extends proximally to a larger, more central airway (e.g., a sixth-generation or higher proximal / lower airway), such as (from distal to proximal) subsegmental bronchi, segmental bronchi, lobar bronchioles, and main bronchioles. A single implant can create a continuous path from distal to proximal to reliably create a channel for trapped air. In alternative embodiments, multiple discrete implants can be used instead of a single, longer implant. Multiple discrete implants can be placed in collapsed or at risk of collapse bronchial airways. Using multiple discrete implants at selected locations in the bronchial tree can have the advantage of using less material, thereby reducing contact stress and foreign body reactions (as discussed above), and allowing for greater flexibility and customization of treatment. For example, while a single implant embodiment may extend from a higher generation airway distally to a lower generation airway proximally, a system of multiple discrete implants allows for the placement of implants in multiple airways within the same generation.

[0237] The devices, systems, and methods described herein can be applied to different bronchospasms to release trapped air from regions of the lung in the safest and most efficient manner possible. For example, treatment of the left lung may involve one or more of the following segments: upper lobe (upper segment: apical-posterior segment, anterior segment; lingular segment: upper segment, lower segment); lower lobe: upper segment, anteromedial basal segment, lateral basal segment. Treatment of the right lung may involve one or more of the following segments: upper lobe: apical segment, anterior segment, posterior segment; middle lobe: medial segment, lateral segment; lower lobe: upper segment, anterior basal segment, lateral basal segment. The treatments described herein may involve robot-assisted placement of a single implant in a single lung (right or left), a single implant in each lung, or multiple implants in each lung. Treatment within a specific lung may involve using robot assistance to place an implant in a specific lobe (e.g., the upper lobe) and a specific segment within that lobe, or may involve placing at least one implant in multiple lobes, segments within lobes, or subsegments within segments. Clinical operators (e.g., pulmonologists or surgeons) can use imaging techniques (e.g., CT, ultrasound, radiography, or bronchoscopy) to identify which parts of the lung need to be treated, in order to assess the presence and pathology of the disease and its impact on lung function and airflow dynamics.

[0238] Modify airway walls

[0239] In some embodiments described herein, it may be advantageous for the expandable device to modify and / or alter the airway walls. In one example, the expandable device includes a self-expanding capability (e.g., a nitinol construction), whereby deployment of the expandable device results in a sustained outward force on the airway walls, leading to gradual enlargement of the airway walls and expansion of the airway lumen. In this example, the self-expanding of the expandable device will cause the airway walls to expand beyond their original diameter. Alternatively or additionally, expansion of the expandable device can be facilitated by a balloon configured to be inflated to force its expansion. Forcing the expandable device to expand via a balloon (integrated as part of or separate from the delivery system) may be advantageous because the size and pressure of the balloon can be adjusted to control the expansion of the expandable device.

[0240] Controlled expansion of the expandable device is desirable because such controlled expansion allows for controlled modification of the airway walls. In one instance, it may be desirable to cause enlargement of the airway walls to increase the cross-sectional area of ​​the airway lumen without causing substantial damage to the airway walls. The increase in cross-sectional area will improve expiratory flow, thereby providing therapeutic benefits to patients with emphysema. In other instances, it may be desirable to cause greater enlargement of the airway walls to create tears, perforations, and / or fenestrations within the airway walls. These tears, perforations, and / or fenestrations can form openings to other trapped air pockets within the diseased parenchyma adjacent to the airway, thereby improving expiratory flow and lung function. Furthermore, if these tears, perforations, and / or fenestrations are large enough in size and number, they can prevent occlusion that would otherwise lead to attempts to release trapped air. Thus, the expandable devices disclosed herein may have self-expanding and / or balloon-expandable features and capabilities to optimally achieve the desired modification of the airway walls.

[0241] An expandable device can be configured and positioned within the lumen of an airway, such that the expandable device increases the diameter of the lumen and thereby facilitates and / or improves gas transport through the airway. In some embodiments, the expandable device can be positioned within a collapsed, narrowed, or otherwise reduced-diameter airway lumen. The expandable device of this technology can have radial resistance (RRF) against compression by the airway wall and / or long-term outward force (COF) exerted by the expandable device on the airway wall. The RRF and / or COF of the expandable device can have large values, such that the expandable device is configured to maintain the minimum desired diameter of the airway lumen. The expandable device of this technology and / or one or more of its components may include a support, braid, mesh, textile, fabric, coil, tube, valve, and / or another suitable device configured and positioned within an anatomical passage, airway lumen, or blood vessel to provide support for the passage and / or other medical devices, and / or modify the biological tissue of the passage.

[0242] In some other applications, it may be desirable for expandable devices to be configured to contact a large surface area of ​​the channel wall. For example, coronary stents are typically designed such that they are configured to contact a large surface area of ​​the patient's coronary artery wall. Such a design may be advantageous for expandable devices configured to be positioned within the blood vessel to prevent or limit adverse outcomes associated with the interaction between the expandable device and the patient's blood (e.g., expandable device thrombosis, new atherosclerosis, etc.). However, since the airway is configured to transport air, not blood, there is no risk of clotting in the airway. Furthermore, although there is no risk of clotting in the airway, excessive granulation tissue may form in the airway due to the contact and / or relative movement between the expandable device and the airway wall. Such excessive granulation tissue can narrow the airway lumen and inhibit gas transport through the airway. Therefore, it may be advantageous to configure expandable devices configured to be positioned within the airway to contact a smaller surface area of ​​the airway lumen to prevent or limit granulation tissue formation, facilitate the removal of mucus from the airway, etc.

[0243] It should be understood that the purpose of expandable devices is not to eliminate granulation tissue formation, as some granulation tissue is expected to form in the presence of any foreign body in the airway, but rather to minimize any clinically significant obstruction caused by granulation tissue and / or mucus. Expandable devices with a significantly lower contact area are expected to experience a focal foreign body reaction (FBR) that will not lead to obstruction of the primary or distal airway. A certain amount of focal reaction may actually be beneficial, as partial or complete occlusion of the expandable device can provide stronger mechanical reinforcement of the airway lumen and / or help anchor the expandable device against movement caused by breathing or coughing.

[0244] COF can also help prevent migration of implanted expandable devices within a patient's airway. However, excessive COF can lead to increased mechanical stress at the implant-tissue interface, which in some cases may trigger severe FBR. This can result in occlusion and failure of the expandable device. Therefore, the desired COF parameter for an expandable device should be determined based on careful consideration to balance the risks (e.g., FBR) with the benefits (e.g., airway expansion).

[0245] like Figure 57As demonstrated, considering that the risk of airway and expandable device occlusion due to foreign body reaction to the implantation of an expandable device is generally greater at the distal end of an expandable device that contacts a smaller distal airway compared to the proximal end of an expandable device that contacts a larger proximal airway, even a moderate foreign body reaction can obstruct the small airway. Therefore, a higher COF is expected to result in increased expansion that is more beneficial to the distal airway. Furthermore, the increase in FBR in patients due to high COF may be less pronounced in the distal airway due to natural tissue damage (e.g., emphysema-related tissue damage). Therefore, in some embodiments, expandable devices with a gradual increase in COF from proximal to distal can optimize implant functionality while reducing the risk of FBR occlusion. Although Figure 57 This general trend is schematically illustrated as a linear relationship, but it should be understood that the expected rate of increase in COF from proximal to distal may not necessarily be linear and may depend at least in part on, for example, anatomical and / or tissue characteristics, such as airway size, mechanotactic properties, etc. Similarly, the risk of occlusion of the expandable device and / or the expected airway expansion may not necessarily follow a linear pattern. Figure 57 The linear relationship between the diameter of the airway and the diameter of the airway is shown in the figure.

[0246] For example, in some embodiments, the expandable device may include a variable COF along its length. For instance, the expandable device may include a first proximal implant portion and a second distal implant portion distal to the first implant portion, wherein the second distal implant portion is configured to provide a larger COF than the first proximal implant portion. Furthermore, the expandable device may include an intermediate portion between the first proximal implant portion and the second distal implant portion, wherein the intermediate portion is configured to apply a variable COF along its length (e.g., ranging between the first and second COFs).

[0247] For example, the range of variable COF can be between the COF applied by the first proximal implant portion and the COF applied by the second distal implant portion. In some embodiments, the second COF at the distal end can be between approximately 1.1 times and approximately 5 times the first COF at the proximal end. In some embodiments, the second COF at the distal end can be between approximately 2 times and approximately 4 times the first COF at the proximal end. For example, the COF at the distal end can be approximately 2 times, approximately 2.2 times, approximately 2.5 times, approximately 2.8 times, approximately 3 times, approximately 3.2 times, or approximately 3.5 times or approximately 3.8 times the first COF at the proximal end. For example, in some embodiments, the distal portion of the expandable device can apply a COF between approximately 0.20 N / mm (normalized over stent length) and approximately 0.35 N / mm, while the proximal portion of the expandable device can apply a COF between approximately 0.08 N / mm and approximately 0.14 N / mm. In one specific example, the distal portion of the expandable device may be subjected to a COF of approximately 0.32 N / mm, and the proximal portion of the expandable device may be subjected to a COF of approximately 0.08 N / mm.

[0248] It should be understood that in some embodiments, the radial resistance of the expandable device may also vary along its length to improve airway function. In other words, in some embodiments, the expandable device may include a variable RRF along its length. For example, the expandable device may include a first proximal implant portion and a second distal implant portion distal to the first implant portion, wherein the second distal implant portion is configured to provide a larger RRF than the first proximal implant portion. Furthermore, the expandable device may include an intermediate portion between the first proximal implant portion and the second distal implant portion, wherein the intermediate portion is configured to apply a variable RRF along its length (e.g., ranging between the first and second RRFs).

[0249] Figure 16 This is a perspective view of an expandable device 4600 configured according to several embodiments of the present technology. Figure 16In the diagram, device 4600 is shown in an expanded, unconstrained state. Device 4600 has a proximal portion 4600a, a distal portion 4600b, and a longitudinal axis L1 extending between the distal and proximal portions 4600a and 4600b. Device 4600 may include a generally tubular structure formed of wire 4601 wound around the longitudinal axis to form a series of strips 4602 (individually designated 4602a to 4602f), each strip comprising 360-degree turns of wire 4601. Device 4600 further includes a distal structure 4610 at the distal end of the distal strip 4602f and a proximal structure 4612 at the proximal end of the proximal strip 4602a. The wire 4601 undulates between the ends of a given strip 4602, such that each strip 4602 has a plurality of alternating peaks 4604 (individually labeled 4604a to 4604c) and valleys 4606 (individually labeled 4606a to 4606c), which are connected by struts 4608 (individually labeled 4608a to 4608f). Peaks 4604 may include bends within the given strip 4602 that are closer to and / or point towards the second end 4600b of the device 4600, and valleys 4606 may include bends within the given strip 4602 that are closer to and / or point towards the first end 4600b of the device 4600. The serpentine configuration of each turn of the wire 4601 facilitates easier radial compression of the device 4600 onto and / or into the delivery system, and facilitates more accurate deployment of the device 4600, as discussed in more detail below.

[0250] Each band 4602 may have first, second, and third peaks 4604a, 4604b, and 4604c; first, second, and third valleys 4606a, 4606b, and 4606c; and first, second, third, fourth, fifth, and sixth supports 4608a, 4608b, 4608c, 4608d, 4608e, and 4608f. The bands 4602 are connected end-to-end such that each band 4602 begins at the first valley 4606a and ends at the point where the sixth support 4608f meets the first valley 4606a of the next band 4602 (or, in the case of the sixth band 4602f, where the sixth support 4608f meets the first valley 4606a of the distal structure 4610). Starting at the first valley 4606a and moving distally in a clockwise direction, each band 4602 has a first pillar 4608a extending distally from the first valley 4606a to the first peak 4604a, followed by a second pillar 4608b extending proximally from the first peak 4604a to the second valley 4606b, then a third pillar 4608c extending distally from the second valley 4606b to the second peak 4604b, then a fourth pillar 4608d extending proximally from the second peak 4604b to the third valley 4606c, then a fifth pillar 4608e extending distally from the third valley 4606c to the third peak 4604c, and then a sixth pillar 4608f extending proximally from the third peak 4604 to the first valley 4606a of the next band 4602. Although Figure 46 The device 4600 shown includes three peaks and three valleys per turn, but in other embodiments, the device 4600 may have any number of peaks and valleys per turn. Furthermore, while all strips 4602 have the same number of peaks and valleys, in other embodiments, some or all of the strips 4602 within the same device may have different numbers of peaks and valleys.

[0251] Along the length of device 4600, and within a given strip 4602, wire 4601 has supports 4608 extending proximally and distally in the direction of the wire turn. For example, following wire 4601 in a clockwise direction around the turn, device 4601 has supports 4608 extending distally, then proximally, then distally, then proximally, and then distally again, thus forming multiple local V-shaped frames that support the airway walls and serve to open the airway lumen when placed within the airway. This contrasts with simple coils, in which the wire extends continuously distally as it winds around each turn. In some examples, such simple coils may have a greater risk of collapse or “pancaking” under radial forces exerted by the airway lumen compared to device 4600. In some embodiments, such as Figure 46As shown, the individual first and fifth pillars 4608a and 4608e may be longer than the individual second, third, fourth, and sixth pillars 4608b, 4608c, 4608d, and 4608f. In other embodiments, the pillars 4608 may have different lengths or configurations. The pillar length can be measured along the longitudinal axis of the wire 4601. Similarly, the individual second, third, and fourth pillars 4608b, 4608c, and 4608d may be longer than the sixth pillar 4608f. In some embodiments, the length of the pillar 4608 can be determined by the equation 3a-3b = 1 / pitch, where 'a' is the longer pillar and 'b' is the shorter pillar 4608.

[0252] As previously mentioned, the bands 4602 are connected to each other only by a single continuous wire. Advantageously, all peaks 4604 and valleys 4606 are free peaks and valleys, meaning that none of the peaks 4604 or valleys 4606 are connected to any peaks, valleys, or other portions of the longitudinally adjacent bands 4602. This lack of interconnectivity between axially adjacent structures provides enhanced axial flexibility and stretchability to the device 4600 compared to conventional supports that include one or more bridges or other links between longitudinally adjacent struts and / or apexes. This flexible configuration allows the device 4600 to stretch and bend with the airway in response to different loads (e.g., bending, torsion, tension) associated with various anatomical conditions (e.g., airway bifurcation, bending, etc.) and physiological conditions (e.g., breathing, coughing, etc.), thereby allowing the device to move with the airway to minimize relative motion while still maintaining a threshold radial force. In some embodiments, the device 4600 has a larger radial force to longitudinal stiffness ratio than conventional supports. This longitudinal and flexural flexibility, moving with the airway, also has the benefit of limiting the relative movement between the device 4600 and the airway wall during breathing and other movements (such as coughing). Relative movement between the device 4600 and the airway wall can cause inflammation and granulation tissue formation, which over time can partially or completely obstruct newly opened cavities, thereby blocking airflow and hindering the therapeutic objective. Without theoretical limitations, eliminating longitudinal links and / or closure units along the length of the device 4600 could help maintain perfusion of the therapeutic portion of the airway wall, as closure units can obstruct blood flow.

[0253] As described in this paper, several aspects of the device contribute to minimizing granulation tissue formation. One aspect is the self-expanding structure and its excessive size relative to the airway diameter, which generates a long-term outward force against the airway wall, promoting wall adhesion and juxtaposition, thereby minimizing relative movement. A second aspect is the lack of interconnectivity with free peaks and valleys, which allows considerable flexibility, enabling the device to move with the airway and minimizing relative movement. A third aspect is the low material density and high porosity, resulting in a smaller surface area in contact with the airway wall, thus producing less tissue response. A fourth aspect is the absence of closure units in the wire pattern to maintain perfusion, thereby minimizing tissue necrosis and local inflammatory responses.

[0254] Another benefit of the lack of interconnectivity associated with the free peaks and valleys of the expandable device is the low tensile force required to detach the device from the airway wall. The tensile axial load (i.e., tension) applied to the filament will cause elongation, which reduces the diameter of each loop or band, thus moving each loop or band away from the airway wall. This separation from the airway wall facilitates device retrieval after implantation with minimal trauma or disturbance to the airway wall.

[0255] Placing the implant described herein in the distal airway of an emphysematous lung may be clinically advantageous. A historical challenge of conventional catheter delivery of implants (e.g., stents, braided structures) is shortening that occurs during deployment and implantation. This shortening can make accurate delivery of the implant to the intended treatment site challenging. Shortening is typically a result of the implant elongating into a reduced profile for minimally invasive delivery during radial compression. Elongation stems from the implant’s structural design and high material density (i.e., the implant cannot remain in the same axial plane during radial compression due to the structure and amount of material). In the device described herein, the lack of longitudinal bridges between axially adjacent structures and the relatively low material density (as described below) result in radial compression into a delivery configuration with little or no elongation (e.g., 0%, 5% or less, 10% or less), allowing the device 4600 to be deployed with minimal change in length. Therefore, unlike braids and certain stents, the device 4600 does not experience shortening during radial expansion. In a compressed delivery state (e.g., see...), Figure 49 The length of the 4600 device is approximately the same as the length of the device 4600 in its expanded, unconstrained state. As a result, the device 4600 can be deployed more predictably and with greater landing accuracy.

[0256] like Figure 16As shown, the device 4600 may have a turn density measured by the number of complete (i.e., 360-degree) turns along one inch of the device 4600. A sufficiently low turn density (e.g., adjacent turns are further apart longitudinally) to allow sufficient spacing between adjacent turns of the wire 4601 and / or between the strip 4602, such that the device 4600 can be compressed onto and / or into the delivery system, and a sufficiently low density to prevent adverse tissue reactions from the surface area contact generated along the length of the device 4600, may be advantageous. However, it may also be advantageous to have a sufficiently high turn density (e.g., adjacent turns are closer together longitudinally) to prevent sagging and / or indentation of the airway walls between adjacent turns (especially during expiratory flow, when the pressure around the outside of the airway is higher than the pressure inside the airway), and to ensure sufficient surface area contact to reduce and / or avoid relative movement and / or migration. Thus, the turn density of this technology can be optimized for delivery system loading capacity, minimal indentation of the airway walls between turns, minimal relative movement, and minimal local inflammatory response. In some embodiments, the device 4600 has a turn density of about 1 to about 4 turns per inch. In some embodiments, the device 4600 has a turn density of about 1.2 to about 3.5 turns per inch. In a particular embodiment, the device 4600 has a turn density of about 1.8 to about 3 turns per inch. Figure 16 In this device, the turn density is 3. Figure 21 The device 5100 is shown with a lower turn density of 1.8.

[0257] The expanded cross-sectional dimensions of device 4600 may be substantially constant or vary along the length of device 4600 and / or from ring to ring. For example, as discussed herein, device 4600 may have cross-sectional dimensions that vary along its length to accommodate different portions of the airway. For example, in some embodiments, device 4600 may have a diameter that decreases in the distal direction, thereby better approximating the natural distal narrowing of the airway lumen. The diameter may gradually increase in the distal direction along the length of device 4600, or device 4600 may have discrete portions having different diameters. For example, device 4600 may have a first portion and a second portion along its length. The first portion may have a first cross-sectional dimension and is configured to be positioned in a more distal portion of the airway (e.g., in the terminal bronchioles and / or emphysema regions of a damaged and / or collapsed airway). The second portion may have a second cross-sectional dimension larger than the first cross-sectional dimension and is configured to be positioned more proximally (e.g., in the primary bronchus and / or another uncollapsed portion). For example, the second part can be configured to be located in a portion of the airway that is less emphysematous than the collapsed distal portion and / or has cartilage (preferably cartilaginous rings rather than plates) in the airway wall, which can occur at the lobar (second generation) or segmental (third generation) level.

[0258] In some embodiments, device 4600 may have a diameter that increases in the distal direction. The diameter may gradually decrease in the proximal direction along the length of device 4600, or device 4600 may have discrete portions having different diameters. For example, device 4600 may have a generally uniform diameter over most of its length, and then a larger diameter in the most distal 1 to 3 turns (which may be band 4602 and / or distal structure 4610). In some embodiments, device 4600 has a first portion and a second portion along its length. The first portion may have a first cross-sectional size and is configured to be positioned in a more distal portion of the airway (e.g., in the terminal bronchioles and / or emphysema regions of a damaged and / or collapsed airway). The second portion may have a second cross-sectional size smaller than the first cross-sectional size and is configured to be positioned more proximally (e.g., in the primary bronchus and / or another uncollapsed portion). For example, the second portion may be configured to be positioned in a less emphysematous portion of the airway than the collapsed distal portion and / or have cartilage (preferably cartilaginous rings rather than plates) in the airway wall, which may occur at the lobar (second generation) or segmental (third generation) level. Having an enlarged diameter in the distal portion of device 4600 is beneficial for applying more radial force to the distal airway to produce greater expansion, or in some cases even for creating tearing in the airway wall. According to some embodiments, it may be advantageous for device 4600 to be configured to create tearing only along certain portions of the airway engaged by device 4600. Furthermore or alternatively, if the lung is particularly diseased, then distal enlargement may provide better access to the emphysematous lung and help anchor the device.

[0259] In some embodiments, the COF and / or RRF of different portions of the expandable device (e.g., proximal portion, intermediate portion, distal portion, etc.) can be configured as a result of any one or more of the various geometric features of the expandable device. For example, the diameter of the wire forming the expandable device can vary along the length of the device (e.g., the diameter of the wire can increase from the proximal end to the distal end of the device). As another example, the diameter of the expandable device can vary along the length of the device (e.g., the diameter of the device can increase from the proximal end to the distal end of the device) because segments of different wire diameters can have different resulting material properties when the wire is heat-set. As another example, the radius of curvature of the wire bend can vary along the length of the device (e.g., the radius of curvature of any one or more of the zigzag or peak / valley patterns of the device can decrease from the proximal end to the distal end of the device to increase the spring force applied by the device). As another example, the distal portion of the expandable device can include an additional zigzag repeating pattern (e.g., four repetitions instead of three). As another example, the heat treatment along the length of the implant can be varied to tune different strengths along the length of the implant. As another example, the distal portion of the expandable device may contain more turns of wire to increase the spring force applied by the device. Any one or more of these methods can be combined to configure a device with a variable COF and / or RRF along its length. However, embodiments featuring these device characteristics should be carefully considered for factors such as reducing foreign body reaction due to surface area contact between the device and the surrounding airway lumen, and reducing the risk of introducing excessive strain into the device when the expandable device is rolled into a radially compressed configuration (e.g., for loading onto a delivery device).

[0260] In some embodiments, wire 4601 has a circular cross-sectional shape. In other embodiments, wire 4601 may have other suitable cross-sectional shapes along its length (e.g., elliptical, rectangular, square, triangular, polygonal, irregular, etc.). In some embodiments, the cross-sectional shape of wire 4601 varies along its length. Changing the cross-sectional shape of wire 4601 may be advantageous for altering the mechanical properties of device 4600 along its length (e.g., radial strength changes from lower to higher from proximal to distal, or vice versa). Alternatively or additionally, different cross-sectional shapes allow for different distributions of contact forces on the airway walls. For example, a wire with an elliptical cross-sectional shape will have a larger contact area, a wider distribution of contact forces, and therefore lower contact stress at any point on device 4600 compared to a circular cross-section. Without being theoretically limited, it is believed that utilizing a cross-sectional shape with rounded edges may be advantageous, as rounded edges may present a smaller wound surface to the airway walls than straight edges. For example, while wires with rectangular cross-sectional shapes and linear corners can be used with this technology, in some cases, it may be advantageous to use rectangular wires with curved corners.

[0261] Wire 4601 may have a substantially constant cross-sectional area along its length, or it may have a varying cross-sectional area along its width. Changing the cross-sectional area of ​​wire 4601, for example, changing the radial force and / or flexibility of device 4600 along its length, may be advantageous. For example, device 4600 will have lower radial force and / or greater flexibility along a portion of wire 4601 where the cross-sectional area is smaller than along a portion of wire 4601 where the cross-sectional area is larger. In some embodiments, wire 4601 has a diameter not greater than 0.005 inches, not greater than 0.006 inches, not greater than 0.007 inches, not greater than 0.008 inches, not greater than 0.009 inches, not greater than 0.01 inches, not greater than 0.011 inches, not greater than 0.012 inches, not greater than 0.013 inches, not greater than 0.014 inches, and not greater than 0.015 inches.

[0262] In some embodiments, the expanded cross-sectional dimension of the device 4600 in an unconstrained expanded state (i.e., freed from the constraints of the delivery shaft and airway and resting on a table) may be excessively large relative to the diameter of the original airway lumen. For example, the expanded unconstrained cross-sectional dimension of the device 4600 may be at least 1.5 times the initial (uncollapsed) diameter of the airway lumen in which it is desired to be positioned. In some embodiments, the device 4600 has an expanded cross-sectional dimension that is approximately 1.5 times to 6 times, 2 times to 5 times, or 2 times to 3 times the diameter of the initial airway lumen. In some embodiments, expanding the airway lumen to the largest possible diameter may be clinically beneficial. A large airway diameter will allow for more efficient release of trapped air, thereby optimizing improvements in lung function (e.g., as measured by outflow, FEV1, etc.). In addition, the implantable device 4600 can perform controlled expansion of the airway wall with or without the aid of an expandable device (e.g., a balloon) to create one or more tears in the airway wall to further facilitate the release of air trapped in the lungs with peripheral emphysema, which may be clinically beneficial.

[0263] Given that the cartilaginous support in the bronchial airway tends to descend from proximal to distal, a device with a variable turn density may be advantageous, wherein the turn density in the distal portion of the device is greater than that in the proximal portion. This device configuration, with a greater turn density distally and a lower turn density proximally, may optionally include lower radial stiffness distally and greater radial stiffness proximally.

[0264] The distal structure 4610 is the first portion of the device 4600 to be deployed in the airway lumen. As a result, the distal structure 4610 may resemble the band 4602 but is adapted to provide greater circumferential force and a softer, non-invasive landing structure. For example, the final vertex 4616 of the filament 4601 may be angled to orient the distal end 4620 of the filament 4601 proximally and have a larger radius of curvature in its relaxed, unconstrained state than the other vertices, to provide a more rounded and softer bend for initial contact with the airway wall. In some embodiments, the distal vertex 4616 has approximately the same radius of curvature as the other vertices in its relaxed, unconstrained state. Furthermore or alternatively, the distal end 4620 of the filament 4601 may include, for example, a sphere (having a cross-sectional dimension only slightly larger than the cross-sectional dimension of the filament 4601) and / or other non-invasive elements of the looped portion of the filament 4601. In order to achieve a greater anchoring force at the distal portion 4600b of the device 4600, the third valley 4606c of the distal structure 4610 may have a larger radius of curvature so that the final vertex 4616 (which is the peak) is substantially aligned with the penultimate peak 4604b of the distal structure 4610.

[0265] The proximal portion 4600a of device 4600 may include a single proximal extension strut 4624 and a free proximal end 4622. Similar to the distal end 4620, the proximal end 4622 may extend in a proximal direction to limit trauma to the airway walls. The free proximal end may also be beneficial for retrieval of device 4600 if necessary.

[0266] Wire 4601 can be any elongating element, such as wire (e.g., having a circular or elliptical cross-sectional shape), coil, tube, filament, single interlaced elongating element, multiple braided and / or twisted elongating elements, ribbon (having a square or rectangular cross-sectional shape), and / or others. Thus, the term "wire" as used herein refers to wire (e.g., metal drawn into the form of a fine, flexible thread or rod) and other elongating elements described in detail herein, according to conventional definitions. Wire 4601 can be cut from a sheet of material and then wound around a mandrel in a three-dimensional configuration. In some embodiments, device 4600 is formed by cutting a tube such that only the remaining portion of the tubular sidewall comprises wire 4601. Sheets and / or tubes can be cut via laser cutting, electrical discharge machining (EDM), chemical etching, water jetting, air jetting, etc. Wire 4601 may also include a thin film formed via a deposition process. Elongated member 102 can be formed using materials such as nitinol, stainless steel, cobalt-chromium alloys (e.g., 35N). MP35N (Fort Wayne Metals, Fort Wayne, Indiana), Elgiloui nonmagnetic alloys, magnesium alloys, tungsten, tantalum, platinum, rhodium, palladium, gold, silver, or combinations thereof, or one or more polymers, or combinations of polymers and metals. In some embodiments, wire 4601 may comprise one or more drawn filled tube (“DFT”) wires, which include an inner material surrounded by different outer materials. For example, the inner material may be a radiopaque material, and the outer material may be a hyperelastic material.

[0267] The cross-sectional area of ​​the wire 4601 can be selected based on several factors, such as turn density, radial force, and radial compression capability for delivery. All other things being equal (e.g., turn density, wire length, wire material, etc.), a larger cross-sectional area of ​​the wire 4601 results in a greater radial force applied to the airway walls. However, a larger cross-sectional area of ​​the wire 4601 and the associated radial force make it more difficult to compress the device 4600 into and / or onto the delivery system. Therefore, the cross-sectional area of ​​the wire 4601 of this technology, together with its turn density, provides the device 4600 with sufficient radial force to maintain airway patency, resist strain and associated cyclic fatigue from anatomical loads during breathing and coughing, and reduce and / or eliminate relative motion, while still allowing the device 4600 to be compressed to a diameter of less than 3 mm, and in some cases less than 2 mm.

[0268] Having sufficiently high radial forces to resist migration, and reducing relative movement between device 4600 and the airway wall via improved wall juxtaposition, may be advantageous, as relative movement can irritate wall tissue and induce a foreign body reaction that could contribute to airway obstruction. The radial forces must also be sufficient to maintain airway patency, and in some cases, the airway may be enlarged to a diameter larger than its original diameter, for example, this could be 2 to 3 times larger. The radial forces exerted by device 4600 on the airway wall are determined at least in part by the turn density of device 4600 and the cross-sectional area of ​​wire 4601. For example, a larger cross-sectional area of ​​wire 4601 results in a larger radial force. A larger turn density of device 4600 results in a larger radial force. Similarly, a smaller cross-sectional area of ​​wire 4601 results in a smaller radial force. A smaller turn density of device 4600 results in a smaller radial force. The device 4600 of this technology may have a radial force per unit length not exceeding 7 g / mm, 6 g / mm, 5 g / mm, 4 g / mm, 3 g / mm, 2 g / mm, or 1 g / mm. In some embodiments, the device 4600 has a radial force per unit length of about 1 to about 5 g / mm. The radial force required to keep a collapsed airway open and patent during breathing is less than the radial force required for stents used to push or stop tumor growth or atherosclerosis. Such conventional stents typically have a radial force per unit length of about 10 g / mm or greater.

[0269] Device 4600 can be configured to have a minimal surface area in contact with the airway wall to reduce the amount of foreign body reaction (e.g., inflammation and granulation tissue) and the risk of airway obstruction. As used in this discussion, “contact surface area” refers to the surface area of ​​the portion of device 4600 that contacts the inner surface of the airway wall, which is less than the total surface area of ​​wire 4601. Minimizing the contact surface area of ​​device 4600 may also be beneficial for limiting and / or preventing obstruction of other distal branch openings and for achieving more effective mucociliary clearance. However, the contact surface area of ​​device 4600 also affects the device’s resistance to migration and relative movement. Therefore, device 4600 of this technology can be configured to have a contact surface area that is low enough to minimize (or position) adverse tissue reactions and allow sufficient mucociliary clearance, but high enough to provide good contact with the airway and resist movement. The device 4600 of this technology may have a contact surface area of, for example, no more than 20%, no more than 19%, no more than 18%, no more than 17%, no more than 16%, no more than 15%, no more than 14%, no more than 13%, no more than 12%, no more than 11%, no more than 10%, no more than 9%, no more than 8%, no more than 7%, no more than 6%, or no more than 5%. In other words, the porosity of the device 4600 may be at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, or at least 95%.

[0270] In some embodiments, regardless of whether the wire 4601 is made of and / or contains a radiopaque material, the device 4600 may include one or more radiopaque markers. For example, radiopaque markers may be placed at one or both ends of the device 4600 to facilitate accurate positioning and placement.

[0271] The device 4600 is configured such that, when implanted into the airway lumen to expand its cross-sectional area, the resulting airway lumen is as biomimetic as possible to a healthy airway lumen. For example, the device 4600 can be configured to sufficiently enlarge the airway lumen without giving it an overly artificial and / or unnatural shape (e.g., a straight or cylindrical airway lumen), allowing the treated airway lumen to retain, to some extent, the inherent curvature or tortuosity of the airway lumen's axis. Therefore, over a longer period (e.g., within three months, six months, one year, eighteen months, twenty-four months, etc.), the treated airway lumen can spontaneously reshape itself into a more natural, curved shape, resulting in improved clinical outcomes.

[0272] In some embodiments, the device 4600 is manufactured by winding a wire 4601 around a mandrel according to a predetermined winding pattern, and then heat-setting the wire 4601 while it is held in place on the mandrel, such that when the wire 4601 is removed from the mandrel, it substantially retains its shape on the mandrel. Figure 18 A mandrel 4800 configured for manufacturing this technology is shown. For example... Figure 18 As shown, the mandrel 4800 may be generally cylindrical and include a plurality of pillars 4802 extending radially away from the outer surface of the mandrel 4800. The pillars 4802 can be arranged to produce a pattern of desired winding geometry. For example, the radius of curvature of the pillars 4802 can determine the radius of curvature of the vertices. Figure 17 A portion of wire 4601 is shown wound around one of the pillars 302. Different vertices of the device 4600 may have the same radius of curvature or different radii of curvature.

[0273] In some cases, it may be beneficial to use a column with a radius of curvature very similar to the shape of the apex when the device 4600 is compressed downwards onto the delivery system and / or compressed into the delivery system. Figure 19 The device 4600 is shown in a radially compressed state, positioned on an elongated delivery member 4900. As the device 4600 is radially compressed, two pillars 4608 adjacent to any given peak 4604 or valley 4606 are compressed together, thereby applying strain at the attachment apex. For example, Figure 20 The finite element analysis performed on device 4600 is shown to calculate cyclic strain, as device 4600 will exhibit cyclic strain in the form of breathing, coughing, etc., during implantation. Figure 20 As shown, the strain amplitude peaks at the distal portion, where vertex 4616 is heat-set to have a larger radius of curvature than other vertices (e.g., peak 4604 and valley 4606). When forced into compression, vertices heat-set around a smaller diameter column (with a smaller radius of curvature) are expected to experience less strain and fatigue compared to the distal vertex 4616. Therefore, it is likely desirable for vertices to have an average radius of curvature no greater than 2.5 mm (e.g., 2.5 mm or less, 2 mm or less, 1 mm or less, 0.5 mm or less, or in the range of 0.35 mm to 0.60 mm).

[0274] The device 4600 can be configured for delivery via the working channel of a bronchoscope. Figure 22Example bronchoscope 5200 is shown. As shown, bronchoscope 5200 may have a handle with an eyepiece or camera 5202, a cable 5204 for a light source used for image processing, a suction section 5206, and a working channel port 5208. The bronchoscope includes an elongating shaft 5210 configured to be advanced through the patient's nose and down through the patient's trachea to the lungs. Shaft 5210 includes several lumens, including a lumen 5216 supporting a camera or fiber optic cable bundle, a lumen 5214 supporting a light source, and an outlet for the working channel 5212. The working channel lumen may have a diameter of about 3 mm or less.

[0275] like Figure 23 As shown, the elongation shaft 5210 of the bronchoscope 5200 can be advanced through the trachea and bronchial tree until the diameter of the elongation shaft 5210 approximately matches the diameter of the dilated airway and cannot be advanced further. The position where the elongation shaft 5210 stops advancing depends on the bronchoscope used. For typical bronchoscopes with a diameter of 5 to 6 mm, this will occur in the 3rd to 6th generation bronchi in most patients. The device 4600 can then be deployed in a distal to proximal direction. Figure 24 The device 4600 is shown after deployment. The distal portion 4600b of the device 4600 can be placed in a distal airway (e.g., generation 12 to 15, with an original diameter of 3 mm or less, and in some cases less than 1 mm), wherein the proximal portion 4600a of the device 4600 is positioned in a proximal airway (e.g., generation 2 to 4, with an original diameter of approximately 4 to 8 mm). In some embodiments, it may be advantageous to position the proximal portion 4600a of the device 4600 in a portion of an airway with more cartilage tissue (e.g., a cartilage-reinforced airway) for better anchoring. The device 4600 and / or the filament 4601 can be configured to self-expand to a preset configuration and / or diameter. In some embodiments, the filament 4601 is not heat-set and / or configured to self-expand. For example, in some embodiments, the device 4600 and / or the filament 4601 is balloon-expandable. In some embodiments, the device 4600 and / or the wire 4601 are balloon-expandable and self-expanding.

[0276] In some embodiments, the device 4600 may be deployed to discrete lengths (e.g., 20, 30, 40, 50, 60 cm, etc.), or, given the axial flexibility of the device 4600, the device 4600 and / or delivery system may be designed for variable-length deployment (e.g., each device may be designed to be deployed to + / - 5 cm of its nominal length) to accommodate variability in patient anatomy. According to some embodiments, the technology includes multiple devices 4600 delivered in tandem. The devices placed in tandem may have different lengths to accommodate and match different treatment lengths. Multiple devices may overlap, touch, or be spaced apart. If spaced apart, the devices may be spaced apart in the airway by no more than a predetermined distance (e.g., 5 mm, 1.0 cm, 1.5 cm, 2.0 cm).

[0277] Figure 25A The distal portion of a delivery system 5500 configured according to several embodiments of the present technology is shown. The delivery system 5500 may be configured for delivery through the working channel of a bronchoscope. One or more components of the delivery system 5500 and / or the bronchoscope may be coupled to a robotic system (including any and others of the components disclosed herein) that controls the movement of corresponding one or more components of the delivery system 5500 and / or the bronchoscope. In some embodiments, the delivery system 5500 has an outer diameter of no more than 3 mm. In some embodiments, the delivery system 5500 has an outer diameter of no more than 2 mm.

[0278] System 5500 may include an outer sheath 5502, an inner sheath 5508 configured to be slidably disposed within the outer sheath 5502, and an elongating shaft or other delivery component 5506 disposed within the inner sheath 5508. In some embodiments, system 5500 may not include an outer sheath. One, some, or all of the outer sheath 5502, inner sheath 5508, and elongating shaft 5506 may be coupled to an instrument actuator of a robotic system. Thus, rotation, translation, or other movement of one, some, or all of the outer sheath 5502, inner sheath 5508, and elongating shaft 5506 may be controlled by the instrument actuator and / or the robotic system. The outer sheath 5502 may be configured to enclose the entire delivery system and engage with the working channel 5212 of the bronchoscope 5200. For example, in some embodiments, the proximal end of the outer sheath 5502 is secured to a handle (not shown) of the delivery system 5500. The inner sheath 5508 is configured to retract to expose and deploy the device 4600. In at least some embodiments, the axial position of the delivery member 5506 relative to the axial position of the outer sheath 5502 is fixed. For example, the proximal end of the delivery member 5506 may be secured to the handle of the delivery system 5500. Furthermore, the entire delivery system 5500, except for the inner sheath 5508, may be secured to the bronchoscope 5200. In other embodiments, the corresponding delivery system may have other suitable combinations of movable and fixed components.

[0279] In some embodiments, system 5500 optionally includes a tapered, non-invasive tip 5512 at the distal end of the elongation member 5506. System 5500 may further include a proximal stop 5504 positioned around the elongation member 5506 and within an inner sheath 5508. The proximal stop 5504 may have a distally facing surface 5514 configured to abut the proximal end of device 4600. In some embodiments, system 5500 optionally includes a pad or other conformal member 5510 radially positioned between device 4600 and elongation member 5506. The conformal member 5510 may be more resilient than the elongation member 5506. When the conformal member 5510 is radially compressed, it can engage tightly with device 4600. For example, as... Figure 25B As shown, the conformal component 5510 can form a recess 5516 around the device 4600, which helps the device 4600 maintain its axial position. In this or another way, the device 4600 can be "pinned" into the conformal component 5510 to hold it in place until the inner sheath 5508 is fully retracted.

[0280] In at least some cases, the delivery system 5500 includes features that facilitate visualization during fluoroscopy and / or bronchoscopy of the implant 4600 during delivery and / or deployment. For example, the delivery system 5500 may include a first radiopaque mark 5518 located at the distal portion of the tip 5512 to indicate the distal feature of the delivery system 5500. The first radiopaque mark 5518 may be, for example, a cap or insert. The delivery system 5500 may further include a second radiopaque mark 5520 at the distal portion of the inner sheath 5508 to facilitate estimation of the distal position of the device 4600 during delivery and deployment. The second radiopaque mark 5520 may be, for example, an annular band. Alternatively or additionally, the delivery system 5500 may include a pad-printed line or other visual features (not shown) on the outer surface of the inner sheath 5508. These features facilitate visualization during bronchoscopy. For example, a line may be located at the proximal end of device 4600 to indicate where the proximal end of device 4600 will be positioned relative to the airway region after deployment. Furthermore, different indicators can be used to indicate the proximal end of devices of different lengths. For example, one circumferential line may indicate the proximal end of a 70mm device, two circumferential lines may indicate the proximal end of an 85mm device, three circumferential lines may indicate the proximal end of a 100mm device, and so on.

[0281] The elongation shaft 5210 of the bronchoscope 5200 can be advanced (e.g., manually or with robot assistance) through the trachea and bronchial tree until the diameter of the elongation shaft 5210 approximately matches the diameter of the dilated airway and cannot be advanced further. The location where the elongation shaft 5210 stops advancing can vary depending on the bronchoscope used. For typical bronchoscopes with a diameter of 5 to 6 mm, this will occur in the 3rd to 6th generation bronchi in most patients. The delivery system 5500 can then be advanced distally (e.g., manually or with robot assistance) through the distal opening of the working channel 5212, exposing the outer sheath 5502 within the airway lumen. The delivery system 5500 can be advanced distally until the distal portion of the outer sheath 5502 is positioned within the distal portion of the airway (e.g., in the terminal bronchioles and / or emphysema areas of a damaged and / or collapsed airway). With the outer sheath 5502 and the elongated delivery component 5506 in place, the inner sheath 5508 can (e.g., manually or with robot assistance) retract to expose and deploy the device 4600 at the desired location.

[0282] In some embodiments, only the bronchoscope is coupled to and controlled by the robotic system, while the delivery system remains under manual control. In some embodiments, only the delivery system is coupled to and controlled by the robotic system, while the bronchoscope remains under manual control. In several embodiments, both the bronchoscope and the delivery system are coupled to and controlled by the robotic system. In those embodiments where the delivery system is under robotic control, one, some, or all of the movable components of the delivery system may be coupled to and controlled by the robotic system. Movable components not under robotic control (if any) may be manually manipulated. The foregoing options apply to... Figure 55 The delivery systems disclosed in A and 55B, as well as any other delivery systems disclosed herein.

[0283] It should be understood that other delivery systems are also within the scope of this technology. For example, implants of this technology can be deployed via any of the delivery systems disclosed in U.S. Provisional Application No. 63 / 441,167, “Methods and Systems for Treating Pulmonary Dissease,” and PCT Application No. TBD [Agent No. APH.007WO], “Methods and Systems for Treating Pulmonary Dissease,” filed concurrently with this application, the entire contents of each of which are incorporated herein by reference. Similarly, the robotic system of this technology can be used to deliver any of the implants disclosed in U.S. Provisional Application No. 63 / 441,167, “Methods and Systems for Treating Pulmonary Dissease,” and in PCT Application No. TBD [Agent No. APH.007WO], “Methods and Systems for Treating Pulmonary Dissease,” filed concurrently with this application, the entire contents of each of which are incorporated herein by reference. Furthermore, the robotic system of this technology can be used with any of the delivery systems disclosed in U.S. Provisional Application No. 63 / 441,167, "Methods and Systems for Treating Pulmonary Diseases," and PCT Application No. TBD [Agent No. APH.007WO], "Methods and Systems for Treating Pulmonary Diseases," filed concurrently with this application, the entire contents of each of which are incorporated herein by reference. Additionally, the bronchoscope 5200 and delivery system 5500 can be used with any of the expandable devices disclosed herein.

[0284] Additional examples of expandable devices, systems, and methods for treating COPD and / or devices, systems, and methods for modifying airway walls may be found, for example, in U.S. Patent No. 9,592,138 entitled "Pulmonary Airflow," filed September 13, 2015; PCT Application No. PCT / US22 / 73962 entitled "Endobronchial Implants and Related Technologies," filed July 20, 2022; and U.S. Provisional Application No. 63 / 441,167 entitled "Methods and Systems for Treating Pulmonary Dissemination," filed concurrently with this application. The entire contents of each of the claims in PCT Application No. TBD of “DISEASE” [Agent’s Case No. APH.007WO] are hereby incorporated by reference.

[0285] Additional instances

[0286] Figure 26A , 27A 28 and 28 are perspective, end, and cross-sectional views of an implant 5600 according to at least some embodiments of the present technology, respectively. Figures 26B to 26F It corresponds to Figure 26A Illustrations. Figure 27B It corresponds to Figure 27A The illustration. Figures 26A to 28 In this context, implant 5600 is in an unconstrained state. This can be the state in which implant 5600 is presented without any external source of constraint (e.g., a sheath during delivery of implant 5600 or the walls of the bronchial tree after deployment of implant 5600). Unless otherwise specified, the characteristics of implant 5600 are described herein with respect to implant 5600 in this unconstrained state. See also: Figures 26A to 28The implant 5600 may extend about a longitudinal axis 5601. The implant 5600 may include a proximal portion 5602 and a distal portion 5603 spaced apart from each other along the longitudinal axis 5601. Between the proximal portion 5602 and the distal portion 5603 along the longitudinal axis 5601, the implant 5600 may include an intermediate portion 5604. The overall implant 5600 may be configured for deployment at a therapeutic site within the bronchial tree of a human individual. Aspects of examples of this deployment will be described in detail below. In at least some cases, the proximal portion 5602 and the distal portion 5603 are configured for deployment in different corresponding airways. For example, the proximal portion 5602 may be configured for deployment in a first airway, and the distal portion 5603 may be configured for deployment in a second airway that is a generation larger than the first airway. Depending on the characteristics of the length and diameter of, for example, implant 5600, the corresponding generations of the first and second airways can differ by 1, 2, 3, 4, 5, 6, or even more. The first airway may belong to the second generation or higher, such as 2, 3, 4, 5, or 6.

[0287] The implant 5600 may further include a wire 5605 extending along a wire path 5606. The wire path 5606 may extend between a first end 5607 at a proximal portion 5602 and a corresponding second end 5608 at a distal portion 5603. The wire path 5606 may be continuous between the first end 5607 and the second end 5608. Furthermore, the wire 5605 may include a first end 5609 at the first end 5607 and a second end 5610 at the second end 5608. The wire path 5606 may extend in a circumferential direction 5612 about a longitudinal axis 5601. Some, most, or all of the wire 5605 and the wire path 5606 may be within a tubular region 5611 coaxially aligned with the longitudinal axis 5601. In the illustrated embodiment, the tubular region 5611 has a circular cross-sectional shape perpendicular to the longitudinal axis 5601. In other embodiments, the counterpart to the tubular region 5611 may be oval, triangular with rounded corners, square with rounded corners, polygonal with rounded corners, or another suitable shape having a counterpart perpendicular to the longitudinal axis 5601. Furthermore, although the longitudinal axis 5601 and the tubular region 5611 are straight in the illustrated embodiments, in other embodiments, the longitudinal axis 5601 and the tubular region 5611 may be curved. For example, the counterpart to the implant 5600 may be curved, angled, serpentine, or have another suitable non-linear shape. For example, such a non-linear shape may be selected to correspond to the shape of the airway region in which the counterpart to the implant 5600 will be deployed.

[0288] Refer again Figures 26A to 28In the illustrated embodiments, the overall wire path 5606 between the first end 5607 and the second end 5608 comprises seven complete turns around the longitudinal axis 5601. In other embodiments, the counterpart of the wire path 5606 may comprise another suitable number of turns, for example, another suitable number of turns corresponding to the desired pitch and overall length of the counterpart of the implant 5600. In at least some embodiments, the wire path 5606 at the intermediate portion 5604 comprises three or more complete turns, such as four, five, six, or more turns. In these and other embodiments, the wire path 5606 at the proximal portion 5602 may comprise one complete turn closest to the first end 5607. Similarly, the wire path 5606 at the distal portion 5603 may comprise one complete turn closest to the second end 5608. The demarcation between the proximal portion 5602, the distal portion 5603, and the intermediate portion 5604 may be based on turns and / or on segments of the longitudinal axis 5601. For example, the proximal portion 5602 may extend along the nearest 10% of the longitudinal axis 5601, the distal portion 5603 may extend along the farthest 10% of the longitudinal axis 5601, and the intermediate portion may extend along the middle 80% of the longitudinal axis 5601. Alternatively, the proximal portion 5602 may extend along the nearest 15% of the longitudinal axis 5601, the distal portion 5603 may extend along the farthest 15% of the longitudinal axis 5601, and the intermediate portion may extend along the middle 70% of the longitudinal axis 5601. Other suitable demarcations are also possible.

[0289] Wire 5605 may include first legs 5614 (individually identified as first legs 5614a to 5614w) and second legs 5616 (individually identified as second legs 5616a to 5616w) alternately arranged along wire path 5606. The first legs 5614a to 5614w may extend distally in a circumferential direction 5612, while the second legs 5616a to 5616w may extend proximally in the circumferential direction 5612. In the illustrated embodiment, all first legs 5614a to 5614w and all second legs 5616a to 5616w have these specific orientations. In other embodiments, the counterparts of wire 5605 may include only some (e.g., most, all but one, all but two, etc.) of the counterparts of the first legs 5614a to 5614w and / or the counterparts of the second legs 5616a to 5616w having a specified orientation. For example, the counterparts of wire 5605 may include counterparts of the first legs 5614a to 5614w and the second legs 5616a to 5616w having a specified orientation only at the counterpart of the intermediate portion 5604 (rather than at the counterpart of the proximal portion 5602 and / or the counterpart of the distal portion 5603). Furthermore, in the illustrated embodiments and in at least some other embodiments, the first legs 5614a to 5614w and the second legs 5616a to 5616w and their counterparts may have any suitable features of the corresponding portions of other devices described herein.

[0290] Refer again Figures 26A to 28 The wire 5605 may include a first vertex portion 5618 (individually identified as first vertex portions 5618a to 5618w) disposed along the wire path 5606 at a corresponding first vertex 5619. The wire 5605 may also include a second vertex portion 5620 (individually identified as second vertex portions 5620a to 5620v) disposed along the wire path 5606 at a corresponding second vertex 5621. In at least some cases, the first legs 5614a to 5614w and the second legs 5616a to 5616w are alternately disposed along the wire path 5606. Furthermore, the first legs 5614a to 5614w and the second legs 5616a to 5616w may be distributed along the wire path 5606 between the first vertex portions 5618a to 5618w and the second vertex portions 5620a to 5620v. Figure 26AAs shown, the first vertex portions 5618a to 5618w may point towards the distal end (i.e., towards the distal portion 5603 rather than the proximal portion 5602 along the longitudinal axis 5601). Correspondingly, the portion of the wire 5605 closest to the first vertex portions 5618a to 5618w may extend proximally away from the first vertex portions 5618a to 5618w. Similarly, the second vertex portions 5620a to 5620v may point towards the proximal end (i.e., towards the proximal portion 5602 rather than the distal portion 5603 along the longitudinal axis 5601). Correspondingly, the portion of the wire 5605 closest to the second vertex portions 5620a to 5620v may extend distally away from the second vertex portions 5620a to 5620v. In the illustrated embodiments and in at least some other embodiments, the first vertex portions 5618a to 5618w and the second vertex portions 5620a to 5620v and their counterparts may have any suitable features of the corresponding portions of other devices described herein.

[0291] The overall implant 5600, proximal portion 5602, distal portion 5603, and / or intermediate portion 5604 may be substantially composed of wires 5605. Furthermore, the wires 5605 penetrating the implant 5600, at the proximal portion 5602, at the distal portion 5603, and / or at the intermediate portion 5604 may be substantially composed of various combinations of first legs 5614a to 5614w, second legs 5616a to 5616w, first apex portions 5618a to 5618w, and second apex portions 5620a to 5620v. In the illustrated embodiment, the proximal portion 5602 includes four of the first legs 5614 (first legs 5614a to 5614d), three of the second legs 5616 (second legs 5616a to 5616c), three of the first vertex portions 5618 (first vertex portions 5618a to 5618c), and three of the second vertex portions 5620 (second vertex portions 5620a to 5620c). These components correspond to a portion of the wire 5605 extending along the wire path 5606 closest to the first end 5607, but wherein the first leg 5614d extends slightly beyond this turn along the wire path 5606 toward the second end 5608. In the illustrated embodiment, the distal portion 5603 includes three of the first legs 5614 (first legs 5614u to 5614w), three of the second legs 5616 (second legs 5616u to 5616w), three of the first vertex portions 5618 (first vertex portions 5618u to 5618w), and two of the second vertex portions 5620 (second vertex portions 5620u to 5620v). These components correspond to a portion of the wire 5605 extending along the wire path 5606 closest to the second end 5608, except that the second leg 5616u extends slightly beyond this turn along the wire path 5606 toward the first end 5607. Finally, in the illustrated embodiment, the intermediate portion 5604 includes 16 of the first legs 5614 (first legs 5614e to 5614t), 17 of the second legs 5616 (second legs 5616d to 5616t), 17 of the first vertex portions 5618 (first vertex portions 5618d to 5618t), and 17 of the second vertex portions (second vertex portions 5620d to 5620t). These components correspond to a portion of the wire 5605 extending along the five full turns of the wire path 5606. In other embodiments, as discussed above, the counterparts of the proximal portion 5602, the distal portion 5603, and the intermediate portion 5604 may have other suitable demarcations. Furthermore, these counterparts may include other suitable numbers and / or types of components.

[0292] In at least some cases, the wire 5605 is unbranched throughout the wire path 5606. For example, the wire 5605 may lack branching, tri-branching, or other types of knots separating the wire 5605. Alternatively or concurrently, the wire 5605 may not be tethered along the entire wire path 5606. For example, the wire 5605 may lack bridging or other structural connections between different sections of the wire 5605 spaced apart from each other along the wire path 5606 and / or between the wire 5605 and other implant components. In a non-limiting manner, these features, alone or in combination with other features described herein, can be used to reduce foreign body reactions associated with the implant 5600, increase the longitudinal flexibility of the implant 5600, and / or for one or more other reasons. In other embodiments, the counterpart of the wire 5605 may be branched, tethered, and / or present with other implant components.

[0293] Refer again Figures 26A to 28 The first end 5609 and / or the second end 5610 may not be tethered. In contrast, the suture ends in conventional implants are typically tethered in some way, such as by fastening or otherwise attaching to other suture sections. This tethering is intuitive because untethered suture ends are generally more likely to cause trauma, migration, and / or exhibit other undesirable behaviors after implant deployment than tethered suture ends. See again Figures 26A to 27B The inventors recognized the potential benefits of leaving the first end 5609 and / or the second end 5610 untethered, and that associated problems could be mitigated or even eliminated by other implant features. One such benefit is support for mucociliary clearance. The inventors recognized that, as discussed above, the lack of branching and / or tethering at other portions of the filament 5605 and / or the absence of structures other than the filament 5600 of the implant 5600 could also support this purpose. Furthermore, without wishing to be limited to this theory, the inventors considered that mucociliary clearance could be used to support the long-term use of the implant 5600 without loss of airway patency due to mucus impaction or granulation tissue accumulation. Therefore, the implant 5600 can be configured to allow mucociliary clearance from the position immediately adjacent to the distal end of the implant 5600 to the position immediately adjacent to the proximal end of the implant 5600 when the implant 5600 is deployed at a treatment location within the bronchial tree.

[0294] like Figure 28As best illustrated, the first distal end 5609 may be located at the proximal end of the implant 5600. Correspondingly, the implant 5600 may include a given of a first leg 5614 at the first distal end 5607 of the wire path 5606. Furthermore, the pitch of the wire path 5606 at the proximal portion 5602 may be approximately the same as (e.g., within 10%) the pitch of the wire path 5606 at the intermediate portion 5604. These features, along with the absence of tethering at the first distal end, individually or in combination, may facilitate the retrievability of the implant 5600. For example, although the implant 5600 is intended for indefinite use, in some cases it may be useful to remove the implant 5600 from the treatment site after deployment. This may occur, for example, when a clinician improperly deploys the implant 5600, or when an unexpected and unusual biological process causes the airway area in which the implant 5600 is deployed to eventually lose patency. Retrieval of the implant 5600 may involve clamping the filament 5605 at or near the first end 5609 and pulling the filament 5605 proximally. The described features of the first end 5609 facilitate clamping access and can help guide the filament 5605 away from the airway wall in response to the pulling force. For example, the proximal portion 5602 of the implant 5600 may be configured to open and elongate during retrieval, rather than maintaining the same shape perpendicular to the longitudinal axis 5601. Therefore, the implant 5600 may tend to disengage inward and then move proximally during retrieval, rather than being dragged proximally across the airway wall. This reduces or eliminates excessive trauma.

[0295] Figure 29 , 30 31 and 32 are respectively along Figure 28 The image shows a cross-sectional view of the implant 5600 taken from lines AA, BB, CC, and DD. Figures 29 to 32 As shown, planes perpendicular to the longitudinal axis 5601 at different portions of the implant 5600 can intersect with more than one circumferentially spaced portion of the implant 5600. This contrasts with simple coils. The inventors have discovered that more than one circumferentially spaced portion contacting the wall of the airway region can be used to establish and maintain airway patency. The portions of the implant 5600 whose planes perpendicular to the longitudinal axis 5601 intersect can correspond to the portions of the implant 5600 that contact the wall of the airway region when the implant 5600 is deployed. Therefore, as Figures 28 to 32As shown, implant 5600 may contact three circumferentially spaced portions of the airway region wall at line A–A in a plane perpendicular to the longitudinal axis 5601, five such portions at line BB, three such portions at line CC, and six such portions at line DD. Lines AA, BB, and CC are at the intermediate portion 5604, while line DD is at the distal portion 5603. In at least some cases, any given plane perpendicular to the longitudinal axis 5601 at the middle 50% of the length of implant 5600 along the longitudinal axis 5601 intersects at at least three (e.g., from three to five) circumferentially spaced points along the wire path 5606.

[0296] like Figures 29 to 32 This indicates that the implant 5600 may be configured to contact a greater number of circumferentially spaced portions of the airway region wall at the distal portion 5603 in a plane perpendicular to the longitudinal axis 5601 than at the intermediate portion 5604 in a plane perpendicular to the longitudinal axis 5601. For example, the implant 5600 may be configured to intersect at least a first number of circumferentially spaced points along the wire path 5606 at any given plane at the middle 50% of the length of the implant along the longitudinal axis 5601 perpendicular to the length of the implant 5600, and at least a greater second number of circumferentially spaced points along the wire path 5606 at any given plane at the distal 5% of the length of the implant along the longitudinal axis 5601 perpendicular to the length of the implant 5600. In at least some cases, the second number of circumferentially spaced points is at least five. Furthermore, at any given plane that intersects the implant along the wire path 5606 at the furthest point of the longitudinal axis 5601 perpendicular to the length of the implant 5600, the maximum circumferential spacing between any pair of circumferentially adjacent points may not exceed 180 degrees, for example, not exceed 120 degrees. Conversely, for at least one pair of adjacent circumferentially separated points, there may be a minimum circumferential spacing of at least 60 degrees (e.g., at least 90 degrees, 120 degrees, or 150 degrees).

[0297] The inventors recognized that a relatively large number and / or relatively circumferentially balanced positioning of the contact points between the distal portion 5603 and the airway region could be useful in facilitating the deployment of the implant 5600. For example, in at least some cases, the implant 5600 is deployed by causing relative movement between the sheath and the implant 5600, thereby gradually exposing the implant 5600 and allowing radial expansion. In these and other cases, the distal portion 5603 may expand before other portions of the implant 5600. When this expansion begins, the distal portion 5603 may not have established a connection to the airway region. If the counterpart of the distal portion 5603 initiates and / or propagates a connection to the airway region at a single point, the force applied to the airway region at said point will potentially lead to asymmetrical expansion of the airway region. This, in turn, may potentially lead to unpredictable movement of the counterpart of the distal portion 5603 during deployment, resulting in potential trauma and / or suboptimal control of positioning. Conversely, refer again... Figure 32 The distal portion 5603 can be configured to apply force at a sufficient number of circumferentially spaced portions of the airway region (corresponding to arrow 5622) to cause relatively uniform expansion of the airway region, thereby reducing potential trauma and / or enhancing control over positioning. After its deployment, the distal portion 5603 can anchor the implant 5600 such that further radial expansion of the implant 5600 does not cause trauma or undue impairment of control over the positioning of the implant 5600, even if such further expansion propagates along a relatively small number of points and / or relatively circumferentially unbalanced points.

[0298] Implant geometry and contact density

[0299] Figure 33 This is a cross-sectional view of an implant 6300 in an unconstrained state according to at least some embodiments of the present technology, juxtaposed with a schematic diagram illustrating certain geometric aspects of the implant 6300. The implant 6300 is generally similar to the implant 5600 described above, except that the implant 6300 has fewer turns and different wire end features. (See also...) Figures 26A to 26FAnd 33, the implant 6300 may include or define a longitudinal axis 6301, a proximal portion 6302, a distal portion 6303, a middle portion 6304, a wire 6305, a wire path 6306, a circumferential direction 6312 (as indicated and bent into the page), a first leg 6314, a second leg 6316, a first vertex portion 6318, a first vertex 6319, a second vertex portion 6320, and a second vertex 6321, which at least substantially correspond to the longitudinal axis 5601, the proximal portion 5602, the distal portion 5603, the middle portion 5604, the wire 5605, the wire path 5606, the circumferential direction 5612, the first leg 5614, the second leg 5616, the first vertex portion 5618, the first vertex 5619, the second vertex portion 5620, and the second vertex 5621 of the implant 5600, respectively.

[0300] Now for reference Figure 33 The wire path 6306 is shown in a two-dimensional unfolded representation, where a portion of the wire path 6306 corresponds to three consecutive turns 6322 (individually identified as turns 6322a to 6322c) of the wire path 6306 at the middle portion 6304. The vertical axis in the diagram corresponds to the circumferential position and spacing in the circumferential direction 6312 around the longitudinal axis 6301. The horizontal axis in the diagram corresponds to the longitudinal position and spacing along the longitudinal axis 6301. The implant 6300 may define a length 6324 along the longitudinal axis 6301, a pitch 6326 along the longitudinal axis 6301, and a diameter 6328 perpendicular to the longitudinal axis 6301. In the diagram, the first segment 6330 of the wire path 6306 corresponds to the length of the first leg 6314. Similarly, the second segment 6332 of the wire path 6306 corresponds to the length of the second leg 6316. For simplicity, the first and second segments 6330 and 6332 are represented as straight lines between adjacent first and second vertices.

[0301] In the illustrated embodiment, the length 6324 is approximately 50 mm, the average pitch 6326 at the intermediate portion 6304 is approximately 8.1 mm, and the average diameter 6328 is approximately 10 mm. In other embodiments, these dimensions may be different. For example, the counterpart of the length 6324 may be in the range of 50 mm to 200 mm, such as from 70 mm to 200 mm or from 70 mm to 120 mm. Alternatively, the counterpart of the length 6324 may be less than 50 mm or greater than 200 mm. The counterpart of the average pitch 6326 at the intermediate portion 6304 may be in the range of 4 mm to 12 mm, such as from 6 mm to 12 mm or from 6 mm to 10 mm. Alternatively, the counterpart of the average pitch 6326 may be less than 4 mm or greater than 12 mm. The counterpart of the average diameter 6328 may be in the range of 2 mm to 20 mm, such as from 4 mm to 20 mm or from 5 mm to 15 mm. Alternatively, the counterpart of the implant 6328 with an average diameter may be less than 2 mm or greater than 20 mm. In other embodiments, the counterpart of the implant 6300 may also have other suitable dimensions.

[0302] Referring again to the illustrated embodiment, the average pitch 6326 at the distal portion 6303 may be smaller than the average pitch 6326 at the intermediate portion 6304, and smaller (e.g., 10% to 50% smaller) than the average pitch 6326 at the proximal portion 6302. This pitch difference may correspond to a greater number of circumferentially spaced portions of the filament 6305 along which the contact between the implant 6300 and the airway wall propagates during deployment of the distal portion 6303 than during deployment of the intermediate portion 6304. Alternatively, this pitch difference may correspond to a greater degree of circumferential balance among the portions of the filament 6305 along which the contact between the implant 6300 and the airway wall propagates during deployment of the distal portion 6303 than during deployment of the intermediate portion 6304. As discussed above, the number of contact portions and / or the circumferential balance of these contact portions can be used to reduce potential trauma during implant deployment and / or enhance control over positioning.

[0303] The interval 6326 may also be related to performance characteristics of the implant 6300, such as enhanced mucociliary clearance. In at least some cases, the implant 6300 is configured to define an unobstructed mucociliary clearance region when the implant 6300 is deployed at a treatment site within the bronchial tree of a human individual, extending along a continuous mucociliary clearance path 6334 from a position immediately adjacent to the distal end of the implant 6300 to a position immediately adjacent to the proximal end of the implant 6300. For example... Figure 33As shown, the mucociliary clearance path 6334 can extend between consecutive turns of the wire path 6306. The average width of the mucociliary clearance region parallel to the longitudinal axis 6301 can be significantly larger than the average cross-sectional diameter of the wire 6305 perpendicular to the wire path 6306. This can correspond to the synergistic combination of a relatively small contact area between the implant 6300 and the airway wall, resulting in a foreign body reaction and a relatively large area available for mucociliary clearance. These features, individually or together, can increase the time that the airway region in which the implant 6300 is deployed remains open (potentially indefinitely). In at least some cases, the average width of the mucociliary clearance region parallel to the longitudinal axis 6301 is at least 10 times (e.g., in the range of 10 to 20 times) the average cross-sectional diameter of the wire 6305 perpendicular to the wire path 6306. Additionally or alternatively, the average pitch 6326 can be in the range of 50% to 110% (e.g., from 70% to 90%) of the average diameter 6328. This could be the case, for example, at the middle portion 6304 and / or throughout the implant 6300.

[0304] The implant 6300 can be configured to flexibly transition from a low-profile delivery state to an expanded deployment state. The average diameter 6328 can differ significantly between these states. The inventors have found, through a non-limiting theoretical approach, that this feature has great potential to facilitate the establishment and maintenance of airway patency. Expansion of the airway far beyond its original diameter creates a relatively large free passage area that is less likely, or at least slower, to become obstructed due to mucus impaction or granulation tissue accumulation. In some embodiments, when the implant 6300 is in the deployment state, the average diameter 6328 is at least 3 times (e.g., at least 3.5 times, at least 4 times, at least 4.5 times, or at least 5 times) the average diameter 6328 when the implant 6300 is in the delivery state. In these and other embodiments, when the implant 6300 is in the illustrated unconstrained state, the average diameter 6328 is at least 4 times (e.g., at least 4.5 times, at least 5 times, at least 5.5 times, or at least 6 times) the average diameter 6328 when the implant 6300 is in the delivery state. Furthermore, the ratio of the average diameter 6328 to the length 6324 can be in the range of 1:5 to 1:30, for example, from 1:10 to 1:30.

[0305] In the illustrated embodiments, the diameter 6328 through length 6324 is consistent. In at least some cases, the diameter 6328 through length 6324 varies by no more than 5% or 10%. Relatedly, the average diameter 6328 at the proximal portion 6302 may differ from the average diameter 6348 at the distal portion 6303 by no more than 5% or 10%. This may be counterintuitive, as the distal portion 6303 is configured for deployment in a portion of the bronchial tree more distal than the portion where the proximal portion 6302 is deployed. The more distal airway regions of the bronchial tree are generally narrower than the more proximal portions. However, maintaining a relatively consistent diameter 6328 through length 6324 is beneficial for establishing and / or maintaining airway patency. For example, a relative overexpansion of the airway wall may be more advantageous distally than proximally. This is expected to be followed when deploying implants of consistent diameter in distally narrowed airway regions. Other advantages are also possible. Furthermore, in other embodiments, the counterpart of diameter 6328 may be inconsistent along the counterpart of length 6324. For example, the counterpart of diameter 6328 may increase or decrease along the counterpart of length 6324. In these cases, the average counterpart diameter 6328 corresponding to the proximal portion 6302 may be smaller or larger than the average counterpart diameter 6328 corresponding to the distal portion 6303.

[0306] Refer again Figure 33 A first apex portion 6318 at the intermediate portion 6304 defines a first helix 6336. Similarly, a second apex portion 6321 at the intermediate portion 6304 defines a second helix 6338. In at least some cases, the longitudinal axis 6301 is the axis of symmetry around which the first and second helices 6336, 6338 are wound. The implant 6300 may define a first helical band 6340 between the first helix 6336 and the second helix 6338. In the illustrated embodiment, successive turns of the first helical band 6340 are spaced apart from each other along the longitudinal axis 6301, such that the implant 6300 defines a second helical band 6342 interwoven with the first helical band 6340. In at least some cases, when the implant 6300 is in the deployed state, the average width of the first helical band 6340 is in the range of 30% to 75% of the average pitch 6326 at the intermediate portion 5604. When the implant 6300 transitions from a delivery state to a deployment state or an unconstrained state, the average width of the first spiral band 6340 parallel to the longitudinal axis 6301 may decrease, and the average width of the second spiral band 6342 parallel to the longitudinal axis 6301 may increase. Conversely, when the implant 6300 transitions from a deployment state or an unconstrained state to a delivery state, the average width of the first spiral band 6340 parallel to the longitudinal axis 6301 may increase, and the average width of the second spiral band 6342 parallel to the longitudinal axis 6301 may decrease.

[0307] In some cases, it is useful for the second spiral band 6342 to remain present when the implant 6300 is in the delivery state. In other words, in these cases, it is useful for the successive turns of the first spiral band 6340 to be spaced apart from each other along the longitudinal axis 6301 when the implant 6300 is in the delivery state. For example, this can be used to reduce or eliminate overlap of the wire path 6306 when the implant 6300 is in the delivery state. Overlap of the wire path 6306 can result in the implant 6300 being less compact in the delivery state than it would otherwise be. This can be disadvantageous because it may reduce the ability of the implant 6300 to be delivered within the lumen to a more distal airway. In other cases, the counterpart of the second spiral band 6342 can be eliminated when the counterpart of the implant 6300 is in the delivery state. In other words, in these other cases, the successive turns of the counterpart of the first spiral band 6340 can overlap when the counterpart of the implant 6300 is in the delivery state. In these cases, the circumferential alignment of features within the counterpart of the first helical band 6340 between its successive turns can affect whether the counterpart of the wire path 6306 overlaps. When the circumferential alignment of these features results in the counterparts of the wire path 6306 not overlapping, then it may be advantageous for the counterpart of the implant 6300 to overlap with the counterpart of the first helical band 6340 when it is in the delivery state. For example, such overlap can allow for more longitudinal expansion structures to exist in the same longitudinal space via nesting or crossing. However, as discussed below, the circumferential alignment of features within the first helical band 6340 may have other effects that may outweigh, conflict with, or complement this potential advantage.

[0308] like Figure 33 As shown, in the intermediate portion 6304, a given set of three elements at the corresponding adjacent turn 6322 of the wire path 6306, namely the first vertex 6319 and the corresponding first vertex portion 6320, can be circumferentially aligned with each other. For example, the given set of three elements at the first vertex 6319 and the corresponding first vertex portion 6320 can be within 5 degrees or 10 degrees of circumferential alignment with each other. Furthermore, such circumferential alignment can exist for one, some, or all of the first vertex 6319 and the corresponding first vertex portion 6320 at adjacent turns 6322. Figure 33Line 6344 indicates this circumferential alignment. In at least some cases, the circumferential alignment within the stated range persists as the implant 6300 transitions between a delivery state and a deployment state or between a delivery state and an unrestrained state. Therefore, when the implant 6300 is in the delivery state, deployment state, and unrestrained state, a given set of three elements—the first vertex 6319 at the corresponding adjacent turn 6322 of the wire path 6306 at the intermediate portion 6304 and the corresponding first vertex portion 6320—can be circumferentially aligned with each other. This persistence of circumferential alignment can have certain advantages, such as reducing or eliminating the tendency for the implant 6300 to shift after deployment at the treatment site. Such shift can increase foreign body reactions, increase airway erosion, and / or have other undesirable effects.

[0309] exist Figure 33 In the diagram, line segment 6346 represents the circumferential spacing between consecutive vertices of the first and second vertices 6319, 6321 along the wire path 6306 at the intermediate portion 6304. In at least some embodiments, the average value of this circumferential spacing is in the range of 35 degrees to 95 degrees, for example, from 55 degrees to 65 degrees. Similar to circumferential alignment, the average circumferential spacing persists as the implant 6300 transitions between a delivery state and a deployment state, or between a delivery state and an unconstrained state. In at least some cases, when the implant 6300 is in the delivery state, the average circumferential spacing between consecutive vertices of the first and second vertices 6319, 6321 along the wire path 6306 at the intermediate portion 6304 differs from that when the implant 6300 is in the deployment state by no more than 5% or no more than 10%. Similarly, when the implant 6300 is in the delivery state, this average circumferential spacing may differ from that when the implant 6300 is in the unconstrained state by no more than 5% or no more than 10%. Through a non-restrictive theoretical approach, the continued existence of this circumferential interval may have certain advantages, similar to those discussed above regarding the continued existence of circumferential alignment.

[0310] Figures 34A to 35B This diagram shows the different corresponding angles associated with the implant 6300. Specifically, Figure 34A and 34B This describes a portion of the wire path 6306 located on the opposite side of the given in the first vertex 6319, corresponding to the given in the first segment 6330 (corresponding to the given in the first leg 6314) and the given in the second segment 6332 (corresponding to the given in the second leg 6316). Similarly, Figure 35A and 35BThis indicates that when the implant 6300 is in both the unconstrained and delivered states, a portion of the wire path 6306 corresponding to the given in the first segment 6330 and the given in the second segment 6332 is located on the opposite side of the given in the second vertex 6321. For example... Figure 34A As shown, the first line 6348 between a pair of first vertices 6319 adjacent to each other along the wire path 6306 forms a first angle 6350 with the mediator in the second vertex 6321 along the wire path 6306. Figure 34A It also specifies the length 6352 of the given first segment 6330 located on the opposite side of the given first vertex 6319, and the length 6354 of the given second segment 6332. For example... Figure 35A As shown, a second line 6356 between a pair of adjacent second vertices 6321 along wire path 6306 forms a second angle 6358 with an intermediary in the first vertex 6319 along wire path 6306. In at least some cases, one or both of the first and second angles 6350, 6358 are in the range of -20 degrees to 20 degrees (e.g., from -20 degrees to 10 degrees) when implant 6300 is in the delivery state, and in the range of 20 degrees to 90 degrees (e.g., from 40 degrees to 90 degrees) when implant 6300 is in the deployment state. This angle can be negative when segments of wire path 6306 converge on opposite sides of the vertices and then diverge as they extend away from the vertices.

[0311] The average length 6352 of the first leg 6314 at the intermediate portion 6304 may differ from the average length 6354 of the second leg 6316 at the intermediate portion 6304. For example, the average length 6352 of the first leg 6314 at the intermediate portion 6304 may be greater than (e.g., 20% to 50% greater) the average length 6354 of the second leg 6316 at the intermediate portion 6304. Furthermore, the ratio of the average length 6352 of the first leg 6314 at the intermediate portion 6304 to the average length of the second leg 6316 at the intermediate portion 6304 may be greater than a threshold n / (n-1), where n is the average number of first legs 6314 per complete turn 6322 of the wire path around the longitudinal axis at the intermediate portion. For example, the ratio of the average length 6352 of the first leg 6314 at the intermediate portion 6304 to the average length of the second leg 6316 at the intermediate portion 6304 may be in the range of 80% to 99% of the threshold. This helps to avoid overlap of the wire path 6306 when the implant 6300 is in the delivery state without unduly damaging the implant support airway region and the degree of indentation of the airway region wall.

[0312] Implant 6300 can have an astonishingly low airway contact density. Generally, the amount of force required to dilate the airway region walls is relatively independent of the amount of contact between the implant and the airway region walls. Therefore, a lower airway contact density corresponds to a higher force density required. The inventors have discovered that the airways in the human bronchial tree can withstand remarkably high force densities. Therefore, airway contact density can be reduced without unduly impairing performance. Furthermore, low contact density is expected to have a beneficial effect on maintaining airway patency. For example, low contact density is expected to reduce foreign body reaction and promote mucociliary clearance. Moreover, as discussed further below, high force density can actually be beneficial by increasing stability. The airway-to-implant contact density is expected to correspond to the following Equation 1 (Equation 1):

[0313]

[0314] A i =Area supported by a single turn

[0315] A iw =Area of ​​a single turn

[0316] d w = Diameter of the implant

[0317] d a = Diameter of the airway

[0318] n = Number of bends per implant

[0319] In at least some embodiments, when the implant 6300 is in the deployed state, the implant 6300 is configured to occupy 5% to 30% of the total area of ​​the first spiral band 6340, for example 5% to 15%.

[0320] Implant stability

[0321] Figure 35 is a cross-sectional view of the implant 6300 in its deployed state within the airway region 6500. In this state, the radial forces on the implant 6300 and the airway region 6500 are expected to be balanced according to the following Equation 2 (Equation 2):

[0322] f ra +f alv =f re +f br (Equation 2)

[0323] f re =Radial expansion force of a single wire

[0324] f ra =Reaction force of the air passage in a single wire

[0325] f alv= The force exerted by alveolar pressure on a single wire turn

[0326] f br = The force exerted by bronchial pressure on a single wire coil

[0327] The diameter 6328 of the implant 6300 and the radial spring constant can be selected according to the following Equation 3 (Equation 3):

[0328]

[0329] f re =Radial expansion force of a single wire

[0330] k ir =Spring constant of the implant in the radial direction

[0331] k ar =Spring constant of the air passage in the radial direction

[0332] d in =Nominal diameter of the implant

[0333] d a = Diameter of the airway

[0334] d an = Nominal diameter of the airway

[0335] l p = Implant pitch length

[0336] P alv = Pressure in the alveoli

[0337] P br =Pressure in the bronchi

[0338] As discussed above, the inventors discovered that the airways in the human bronchial tree can withstand remarkably high force densities, which may be beneficial for enhancing implant stability and / or for other reasons. Therefore, the implant 6300 is configured to expand the diameter of the airway by many times (e.g., at least 2, 2.5, 3, 3.5, or 4 times) the nominal diameter of the airway.

[0339] Achieving stable contact between the implant and the airway wall can be challenging for at least two reasons. First, the relevant airway regions are typically tortuous, branching, and / or have widely varying diameters. Second, these airway regions often move significantly and unevenly during breathing, coughing, sneezing, etc. Relative movement between the airway regions and the implant can lead to or contribute to irritation, erosion, foreign body reactions, and / or other factors that tend to reduce long-term patency. In conjunction with or instead of high force density, the inventors recognized that relatively low resistance to longitudinal deformation, combined with relatively high resistance to radial deformation, can enhance implant stability.

[0340] Figure 36 This is a schematic diagram illustrating certain forces and dimensions related to an implant according to at least some embodiments of the present technology. Figure 36 The image shows two adjacent turns of the implant 6600 in its deployed state within airway region 6602. Both radial and longitudinal forces are identified. In at least some cases, the implant 6600 tends to remain stable during respiration when the force responding to elongation / shortening is less than the frictional force on the implant 6600. The radial and longitudinal spring constants of the implant 6600 can be selected according to the following Equation 4 (Equation 4):

[0341]

[0342] k ir =Spring constant of the implant in the radial direction

[0343] k il =Spring constant of the implant in the longitudinal direction

[0344] μ a-i = Coefficient of friction between the air passage and the spring

[0345] d a = Diameter of the airway

[0346] d in =Nominal diameter of the implant

[0347] l pn =Nominal implant pitch

[0348] l p2 = Distance between adjacent turns during lung movement

[0349] Implants according to at least some embodiments of the present technology have a ratio of radial spring constant to longitudinal spring constant in the range of 10:1 to 80:1 (e.g., from 15:1 to 80:1 or from 20:1 to 80:1).

[0350] A wire containing alternating first and second legs can support the air passage to a greater extent than a wire formed into a simple coil, even if the two wires have the same pitch. Figure 37 This is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of a simple coil. Figure 38 This is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of the implant according to at least some embodiments of the present technology. Figure 37 The maximum distance in the middle is represented by line 6700, and can be calculated using the following Equation 5 (Equation 5):

[0351]

[0352] l p = Implant pitch length

[0353] θ p = Implant pitch angle

[0354] exist Figure 38 In the diagram, a circle 6702 with a radius equal to the length of line 6700 is centered at a point on the line between adjacent turns along the wire path. The circle overlaps with the wire path, indicating that a portion of the air passage at this point is closer to the wire, and therefore... Figure 38 cable path and Figure 37 The cable path provides better support.

[0355] The inventors recognized that another implant feature potentially related to maintaining stable contact between the implant and the airway wall during respiration is resistance to flattening of tubular forms toward a flatter form. Some tubular structures have longitudinally distributed substructures (e.g., helical turns) that readily collapse into each other in a domino effect or other manner in response to shear stresses parallel to the longitudinal axis of the structure. This is problematic because this type of shear stress can occur in the airway during respiration. Airway expansion and contraction during respiration are significantly more pronounced than during pulsatile blood flow, both radially and longitudinally. Therefore, achieving adequate anti-flattening may be more challenging in the context of lung implants than in the context of vascular implants. Implants according to at least some embodiments of the present technology are well-suited for anti-flattening due to the structural features discussed below and / or for other reasons. For example, implants according to at least some embodiments of the present technology have a ratio of radial spring constant to longitudinal shear modulus suitable for anti-flattening. For example, this ratio may range from 0.005 to 0.100. Alternatively or concurrently, implants according to at least some embodiments of the present technology have a ratio of longitudinal spring constant to longitudinal shear modulus suitable for anti-flattening. For example, this ratio may be in the range of 0.5 to 5.0.

[0356] According to at least some embodiments of the present technology, the aforementioned and / or other properties that promote stable wall contact during respiration may be associated with certain structural features of the implant. One such feature is the complete or relative absence of rigid bridging between successive helical turns or other longitudinally distributed implant substructures. This feature promotes relatively low resistance to longitudinal deformation and relatively high resistance to radial deformation, as discussed above, which tends to promote stable contact between the implant and the airway wall during respiration. This feature may also increase the tendency of the implant to flatten from a tubular form towards a flatter form, as discussed above, which may have the opposite effect. However, the inventors have found that the latter effect can be at least partially mitigated by increasing the average spacing (e.g., pitch) between successive helical turns or other longitudinally distributed implant substructures. Furthermore, the complete or relative absence of rigid bridging between successive helical turns or other longitudinally distributed implant substructures and the increased spacing between these substructures synergistically help maintain improved airway patency. Both of these features tend to promote mucociliary clearance and / or reduce foreign body reaction. Implants according to at least some embodiments of the present technology include longitudinally distributed substructures (e.g., helical turns) within a first helical band extending about a longitudinal axis, and define an unobstructed second helical band between the windings of the first helical band. In at least some cases, this feature is present together when the pitch-to-diameter ratio is in the range of 0.3:1 to 1.5:1 (e.g., from 0.5:1 to 1.2:1).

[0357] Implant Deployment

[0358] Figure 40 This is an anatomical description of the airway region 6902 within the bronchial tree 6904 of a human individual. Figures 41 to 46 This is a partial schematic illustration of the different corresponding times during implantation at airway region 6902. It will now be mainly relative to implant 6300 ( Figure 33 ) and delivery system 5500 ( Figure 25A This document describes such a deployment. However, it should be understood that the deployment can be practiced with any suitable implant or delivery system described herein, including with the assistance of a robotic system (such as any or others disclosed herein). Furthermore, the implant 6300 and other implants described herein are compatible with other suitable types of deployment. See also: Figure 25A , 33From 40 to 46, the implant 6300 can be moved within the lumen of the bronchial tree 6904 at the airway region 6902 toward the treatment location. For example, the delivery system can be coupled to an instrument actuator of a robotic system and rotated, translated, and / or articulated within the bronchial tree 6904 via the actuator. The treatment location may include a first airway 6906 and a second airway 6908 located away from the first airway 6906. The generation of the second airway 6908 may be greater than that of the first airway 6906. For example, the generation of the second airway 6908 may be at least 1, 2, 3, 4, 5, or 6 greater than that of the first airway 6906. Furthermore, the generation of the first airway 6906 may be at least 3, 4, 5, 6, or even higher.

[0359] When the implant 6300 is in a low-profile delivery state, movement of the implant 6300 toward the treatment site may occur. For example, an inner sheath 5508 may extend around the implant 6300 and restrain radial expansion of the implant 6300 during movement within this lumen. Figure 40 and 41 As shown, the delivery system 5500 can be moved distally (e.g., manually or with robot assistance) until the tip 5512 reaches the limiting portion 6910 (e.g., bifurcation or trifurcation) of the bronchial tree 6904, which is too narrow to allow the delivery system 5500 to move further distally. In some cases, the tip 5512 expands a portion of the airway region 6902 at the limiting portion 6910. In other cases, the delivery system 5500 does not move distally sufficiently to cause this to occur. The interaction between the tip 5512 and the limiting portion 6910 can be discerned tactilely (e.g., a clinician may feel resistance when the tip 5512 reaches the limiting portion 6910), fluoroscopically (e.g., fluoroscopic imaging via a radiopaque marker (not shown) at the tip 5512), visually (e.g., via an endoscope camera (not shown) incorporated into the delivery system 5500), and / or in another suitable manner. In other cases, as described above... Figure 25A As described in the context, the delivery system 5500 can be deployed via the working channel of a bronchoscope. In these cases, the distal end of the bronchoscope (rather than the tip 5512) can interact with the limiting portion 6910 to limit the extent to which the implant 6300 can be advanced distally within the bronchial tree 6904. In these cases, a camera of the bronchoscope can be used to guide the positioning of the implant 6300. Movement of the bronchoscope and / or camera can be controlled manually or via a robotic system.

[0360] Once properly positioned, the implant 6300 can be transitioned from a delivery state (e.g., manually or via robot-assisted) to an expanded deployment state at the treatment site. Figure 43As shown, this may include causing relative movement between the implant 6300 and the inner sheath 5508. For example, the inner sheath 5508 may (e.g., manually or via robotic assistance) retract to gradually expose the implant 6300, starting from its most distal portion and moving proximally. Exposing the implant 6300 may allow for self-expansion of the implant. For example, exposing the implant 6300 may release at least some of the elastic bias of the implant 6300 until the implant 6300 reaches an equilibrium state in which the outward radial force from the implant 6300 is equal to the inward radial force from the airway region 6902. In at least some cases, the implant 6300 is more elastically biased at the first and second apex portions 6318, 6320 than at the first and second legs 6314, 6316. Therefore, implant 6300 can be considered to include springs at the first and second apex portions 6318, 6320 and connectors at the first and second legs 6314, 6316. In other embodiments, the springs and connectors may have other suitable forms. Furthermore, the springs may be replaced by a non-elastic expandable structure configured to expand via a mechanism other than elasticity (e.g., a balloon or other secondary structure within implant 6300).

[0361] During relative movement between the implant 6300 and the inner sheath 5508, the proximal stop 5504 inhibits proximal movement of the entire implant 6300, and the conformal component 5510 inhibits proximal movement of individual turns of the implant 6300. Therefore, the implant 6300 can be deployed in a controlled manner to maintain at least substantially its longitudinal positioning and configuration as it expands radially. In at least some cases, the length 6324 of the implant 6300 is approximately the same (e.g., differing by no more than 5% or 10%) immediately after the implant 6300 has been converted relative to when the implant 6300 was still within the inner sheath 5508. Conversion of the implant 6300 may begin with expansion of the distal portion 6303 at the second airway 6908. This may involve contacting the wall of the second airway 6908 and the untethered end of the filament 6305 at the most distal portion of the wall of the second airway 6908 near the implant 6300. Expanding the distal portion 6303 at the second airway 6908 may further include contacting the wall of the second airway 6908 and the recipient in the second leg 6316 at the end of the wire path 6306. Transformation of the implant 6300 may continue by expanding the intermediate portion 6304 and then expanding the proximal portion 6302 at the first airway 6906. Expanding the proximal portion 6302 at the first airway 6906 may include contacting the wall of the first airway 6906 and the untethered end of the wire 6305 at the proximal end of the implant 6300 at a portion of the wall of the first airway 6906. Expanding the proximal portion 6302 at the first airway 6906 may further include contacting the wall of the first airway 6906 and the recipient in the first leg 6314 at the end of the wire path 6306.

[0362] In at least some cases, during the expansion of different portions of the implant 6300, the contact between the wall of the airway region 6902 and the implant 6300 simultaneously propagates along different numbers of circumferentially spaced portions of the wall. For example, the contact between the wall and the implant 6300 may simultaneously propagate along a greater number of circumferentially spaced portions of the wall during deployment of the distal portion 6303 than during deployment of the intermediate portion 6304 or during deployment of the proximal portion 6302. In a particular instance, the contact between the wall and the implant 6300 simultaneously propagates along five or more circumferentially spaced portions of the wall during deployment of the distal portion 6303, and simultaneously propagates along three or more circumferentially spaced portions of the wall during deployment of the intermediate portion 6304 and the proximal portion 6302.

[0363] In at least some cases, during some expansion (e.g., by changing at least 50% or 75% of the diameter 6328) or full expansion of the implant 6300 at the treatment site, the average curvature of the wire path 6306 at the first and second apex portions 6318, 6320 increases, the width of the first spiral band 6340 parallel to the longitudinal axis 6301 decreases, the spiral length of the first spiral band 6340 increases, the width of the second spiral band 6342 parallel to the longitudinal axis 6301 increases, and the first apex at the corresponding adjacent turn 6322 of the wire path 6306... The given three points in point portion 6318 are kept within 5 degrees of each other's circumference alignment; the given three points in second vertex portion 6320 at the corresponding adjacent turn 6322 of wire path 6306 are kept within 5 degrees of each other's circumference alignment; the average circumferential spacing between consecutive vertices in the first and second vertices 6319 and 6321 along wire path 6306 is kept within the range of 35 degrees to 95 degrees; the average circumferential spacing between consecutive vertices is kept within the range of 55 degrees to 65 degrees; and / or the average circumferential spacing between consecutive vertices in degrees changes by no more than 5%.

[0364] like Figures 44 to 46 As shown, the conversion implant 6300 can release the implant from the conformal component 5510. The conformal component 5510 can then be withdrawn proximally along with the other parts of the delivery system 5500, leaving the implant 6300 in a deployed state at the treatment site. Immediately after conversion, the implant 6300 can apply a force, for example, at least 0.05 MPa, to the walls of the bronchial tree. The airway region 6902 can be extremely flexible, such that the conversion implant 6300 causes a portion of the wall of the bronchial tree 6904 to expand, the wall portion extending significantly beyond its original diameter along with the length 6324 of the implant 6300. Furthermore, the average diameter 6328 of the implant 6300 in the deployed state can be the same as or similar to the average diameter 6328 of the implant 6300 in the unconstrained state (e.g., from 70% to 100% or from 80% to 100%). Alternatively, the ratio of the average diameter 6328 of the implant 6300 immediately after the transformation to the average length 6324 of the implant 6300 immediately after the transformation may be in the range of 1:5 to 1:15.

[0365] Figure 47 This is an anatomical description of airway region 6902, indicating certain original and dilated dimensions. (See also...) Figure 25A , 33And 40 to 47, this may include expanding a first wall portion 7600, extending along the longitudinal axis 6301 and the distal 10% of the length 6324 of the implant 6300, from a first average original diameter 7602 to a first average expansion diameter 7604, and expanding a second wall portion 7606, extending along the longitudinal axis 6301 and the proximal 10% of the length 6324 of the implant 6300, from a second average original diameter 7608 to a second average expansion diameter 7610. In at least some cases, the average expansion diameter at the airway region 6902 extending through the length 6324 is at least 2, 2.5, 3, or 4 times the average original diameter at this portion of the airway region 6902. Additionally or alternatively, the ratio of the first average expansion diameter 7604 to the first average original diameter 7608 may be greater than (e.g., at least 4, 6, 8, or 10 times) the ratio of the second average expansion diameter 7610 to the second average original diameter 7608. Furthermore, the first average expansion diameter 7604 may differ relatively little from the second average expansion diameter 7610, for example, between 0% and 20%.

[0366] Although implant deployment is primarily described as being facilitated by the proximal retraction of the inner sheath, in some embodiments, movement of at least a portion of the inner sheath relative to the implant in other directions may additionally or alternatively facilitate implant deployment originating from other portions of the implant, enabling more accurate and / or precise placement of such portions. For example, implant deployment originating from distal expansion of the implant enables more accurate and / or precise placement of the distal portion of the implant. Implant deployment originating from proximal expansion of the implant enables more accurate and / or precise placement of the proximal portion of the implant. Implant deployment originating from the middle or central region of the implant enables more accurate and / or precise placement of the middle or central region of the implant.

[0367] For example, Figure 97This describes an example delivery system 8900 comprising a handle 8910 and an inner sheath 8930, wherein at least a portion of the inner sheath 8930 is advanceable distally to expose an implant 6300 and enable the implant 6300 to expand from a low-profile state starting proximally. For example, a user interface element 8912 on the handle 8910 may include a slider operatively coupled to the inner sheath 8930 (e.g., via a push rod 8921), which can be advanced or pushed distally within a slot to induce distal movement of the inner sheath 8930. Other user interface elements (such as those described herein) may additionally or alternatively be incorporated into the handle 8910 for controlling the inner sheath 8930. As another example, the inner sheath constraining the implant 6300 can be everted or can be everted to a configuration in which a proximal sheath portion is located within the implant 6300 and a distal sheath portion is arranged around the exterior of the implant 6300. In this example, the user interface element 8912 is operatively coupled to the proximal portion of the sheath 8930 such that retraction of the user interface element 8912 to the proximal end causes retraction of the proximal portion of the sheath 8930 to the proximal end, thereby pulling the distal portion of the sheath 8930 distally during eversion, which exposes and deploys the implant 6300 from the proximal end of the implant 6300.

[0368] In some embodiments, the implant may be deployed starting from the middle or central segment of the implant. For example... Figure 98 This describes an example delivery system 9000 comprising an inner sheath having a distal sheath portion 9030a and a proximal sheath portion 9030b. The distal and proximal sheath portions 9030a and 9030b can collectively constrain the implant 6300 in a low-profile state as the delivery system is advanced toward a target airway. To deploy the implant 6300, the distal sheath portion 9030a can be advanced distally, and the proximal sheath portion 9030b can be retracted proximally to expose the implant 6300 and allow it to expand from the middle segment of the implant. For example, the distal sheath portion 9030a can be advanced using any of the sheath actuation systems described above with respect to delivery system 8900, while the proximal sheath 9030a can be retracted using any of the sheath actuation systems described herein for retracting the inner sheath proximally. Actuation of the distal and proximal sheath portions can occur substantially simultaneously and / or at different times (e.g., sequentially).

[0369] Figure 48 This is a block diagram illustrating a method 7900 for improving lung function in a human individual according to at least some embodiments of the present technology. In at least some cases, the individual has been diagnosed with chronic obstructive pulmonary disease. Figure 48As shown, method 7900 may include determining the length of the target airway and / or implant (box 7902), and, while the implant is in a low-profile delivery state, moving the implant within the lumen of the individual's bronchial tree toward a treatment location within the bronchial tree (box 7904), changing the implant from the delivery state to an expanded deployment state at the treatment location (box 7906), and expanding the airway region at the treatment location (box 7908). Aspects of method 7900 are discussed above in detail in conjunction with various embodiments of the delivery system (including engagement of the outer sheath with the bronchoscope, operation of the guide sheath, and operation of the size adjustment device) and implant deployment. Method 7900 may further include deploying additional implants (box 7910). For example, the deployment process described above may be repeated with additional implants at different corresponding airway regions. For example, these airway regions may be associated with different bullae. The initial and subsequent deployment of implants may release trapped air and reduce or prevent further air trapping at these bullae.

[0370] Despite Figure 48 Not shown in the text, but in some cases, method 7600 may include further modification of the airway region where a given implant is deployed after implant deployment. When treatment involves the deployment of multiple implants, such further modification may occur at one, some, or all of the treatment sites. See above for reference. Figures 40 to 46 The discussed implant deployment can expand the walls of the airway region to a first average expansion diameter. Further modifications may include subsequently expanding the walls further to a second average expansion diameter greater than the first average expansion diameter. The balloon may be advanced into the treatment position within the lumen simultaneously with the implant or after the implant has been deployed and the delivery system has been removed. At the treatment position, the balloon may expand to expand both the walls and the implant to a larger second average expansion diameter. In at least some cases, the second average expansion diameter is greater than the average unconstrained diameter of the implant. Therefore, the balloon can be used for over-expansion implants. For example, this may be useful for creating and / or enlarging bronchial fenestrations in the walls. As discussed elsewhere in this disclosure, bronchial fenestrations may be therapeutically beneficial for releasing trapped air to improve airway patency and / or for one or more other reasons.

[0371] In at least some cases, the deployment of a first implant releases a first volume of trapped air, the placement of a second implant releases a second volume of trapped air, the placement of a third implant releases a third volume of trapped air, and so on. Implants may be deployed until a sufficient amount of trapped air is released and a sufficient degree of lung volume reduction is achieved to effectively treat COPD. In some cases, deployment of one implant may be sufficient. In other cases, two, three, four, five, six, or even more implants may be deployed. Furthermore, one, two, or another suitable first number of implants may be deployed at a time, and one, two, or another suitable second number of implants may be deployed a second time, hours, days, months, or even longer after the first deployment. In a particular instance, a first number of implants is deployed, followed by the collection of monitoring, testing, and / or patient-reported information during a testing period, and then a second number of implants is deployed based on the information and the effectiveness of the first number of implants in treating COPD symptoms. In yet another instance, additional implants may be deployed occasionally over months or years as COPD progresses and new bullae form.

[0372] Deploying an implant at the treatment site can cause the treatment site to change from poor or obstructed patency to therapeutically effective patency. In at least some cases, a portion of the bronchial tree distal to the treatment site has emphysema and collateral ventilation. In these and other cases, deployment of one or more implants can increase the forced expiratory volume in one second by at least 5% (e.g., at least 10%). Method 7600 may further include maintaining airway patency (box 7920). Method 7600 may include maintaining therapeutically effective patency at the treatment site throughout a continuous maintenance period while the implant 6300 is deployed at the treatment site. The maintenance period may be at least 3 months, 6 months, 9 months, or other suitable periods. During the maintenance period, a first region of the wall portion of the bronchial tree 6904, which extends along the longitudinal axis 6301 and the length 6324 of the implant 6300, may be in direct contact with the implant 6300, and a second region of the wall portion may not be in direct contact with the implant 6300. The second area may be at least 5, 8, 10, 12, 14 or more times the first area. Alternatively or additionally, during the retention period, the filament 6305 may occupy 5% to 30% (e.g., 5% to 15%) of the total area of ​​the first spiral band 6340. Furthermore, during the retention period, the maximum indentation of the wall portion at the second region may not exceed 50% of the average expansion diameter of the implant 6300. Maintaining airway patency may also include maintaining the mucociliary clearance area at the treatment position substantially free of granulation tissue and mucus impaction throughout the retention period. Alternatively or additionally, maintaining airway patency includes maintaining the mucociliary clearance area substantially free of one, some or all of the following: inflammation, inflammatory cells, granulation tissue, fibrosis, fibrotic cells, tissue hyperplasia, tissue necrosis, granulation tissue, and mucus impaction. The mucociliary clearance area may extend along a continuous mucociliary clearance path from a position immediately adjacent to the distal end of the implant 6300 to a position immediately adjacent to the proximal end of the implant 6300. In at least some cases, the mucus and cilia removal area is maintained at an average width parallel to the longitudinal axis 6301, which is at least 10, 12, 14, 16 or more times the average cross-sectional diameter of the wire 6305 perpendicular to the wire path 6306.

[0373] The airway patency maintenance component may reduce or eliminate excessive displacement of the implant 6300 during respiration. Relatedly, patency maintenance may include resisting elongation of the implant 6300 along its longitudinal axis throughout an individual's respiratory cycle at the treatment site with less resistance than the friction between the implant 6300 and the walls of the bronchial tree. This feature, alone or in conjunction with other features, may reduce or prevent airway irritation and associated granulation tissue formation and / or other responses that may reduce airway patency during the maintenance period. In at least some cases, the implant maintains airway patency and / or other desired levels of therapeutic performance described herein during the maintenance period, while no drug-eluting material is present between the expandable structure of the implant and the walls of the bronchial tree at the treatment site.

[0374] II. Delivery system

[0375] Expandable devices, such as any of the expandable devices described herein, can be deployed at the treatment site via a delivery system configured for use with a bronchoscope-navigable working channel. Although the delivery system is generally described herein as navigating through a bronchoscope, it should be understood that in some embodiments, the delivery system may additionally or alternatively navigate through other lumens of a suitable robotic system (e.g., a robotic catheter) or suitable device.

[0376] Figure 58A This is an illustrative diagram of a delivery system 2400 configured to deploy an expandable device at a treatment location. (See diagram for reference.) Figure 58A As shown, the delivery system 2400 includes a handle 2410 and a flexible component portion (also referred to herein as a shaft) that navigates through the working channel of the bronchoscope. For example, in some embodiments, the flexible component portion has an outer diameter of no more than 3 mm. In some embodiments, the flexible component portion has an outer diameter of no more than 2 mm. In some embodiments, the flexible component portion has an outer diameter of no more than about 1.8 mm.

[0377] Figure 58B This is a detailed view of the distal portion of the flexible component. (See attached image.) Figure 58BAs shown, the flexible component portion may include various components that are telescopically engaged and movable relative to each other. For example, the flexible component portion may include an elongated component 2420 having an implant mounting surface on which an expandable device can be mounted, and an inner sheath 2430 that at least partially covers the elongated component 2420. As described in further detail below, the inner sheath 2430 may be movable relative to the elongated component 2420 to selectively expose and / or cover the expandable device mounted on the elongated component 2420. For example, the inner sheath 2430 may be retracted proximally relative to the elongated component 2420 to expose the implant mounting surface and / or the expandable device that can be mounted on the implant mounting surface, thereby enabling the deployment of the expandable device. In some embodiments, the inner sheath 2430 may additionally or alternatively advance distally relative to the elongated component 2420 to cover the implant mounting surface and / or the expandable device that can be mounted on the implant surface. The handle 2410 may include an actuator 2412 coupled to the inner sheath 2430 so that the user can selectively retract and / or advance the inner sheath 2430 relative to the extension member 2420.

[0378] like Figure 58B As shown, the flexible component portion may further include an outer sheath 2440 that at least partially covers the inner sheath 2430. As described in further detail below, the outer sheath 2440 may be configured to engage with the working channel of the bronchoscope. For example, during the process of deploying the expandable device in a treatment position, the axial position of the outer sheath 2440 relative to the bronchoscope may be secured via manual locking (e.g., squeezing or otherwise holding the outer sheath in place relative to the bronchoscope) and / or physical locking components (e.g., as described below). In some embodiments, this interaction between the outer sheath 2440 and the bronchoscope can help stabilize the delivery system to the bronchoscope for predictable deployment. However, in some embodiments, the outer sheath 2440 may be omitted (e.g., to reduce the outer diameter of the flexible component portion).

[0379] As described further in detail herein, the flexible component can be navigated toward a treatment location by being advanced through a bronchoscope and / or along a guide wire already navigated to the treatment location. Additionally or alternatively, in some embodiments, the flexible component can be actively steered. For example, such active steer can provide additional control over the delivery system in areas of the target airway that may be difficult to navigate. Thus, actively steerable flexible components can help achieve more accurate placement of expandable devices and / or otherwise help improve access to certain target airways (e.g., for removing placed expandable devices). In some embodiments, the flexible component can be actively steered using an actuation system comprising one or more tethers (e.g., wires, fibers, etc.) that, when activated (e.g., pulled), can be shaped and / or otherwise guide the flexible component in certain directions. For example, the tethers can be embedded in the walls of the elongation component 2420, the inner sheath 2430, and the outer sheath 2440, between the elongation component 2420 and the inner sheath 2430, and / or between the inner sheath 2430 and the outer sheath 2440.

[0380] A. handle

[0381] The handle of the delivery system functions to enable a user to control the position of the flexible component portion (and the expandable device or implant mounted thereon) within the patient's body from a position outside the patient's body. In some embodiments, the handle may include a housing configured for handheld use and coupled to a proximal portion of the flexible component portion. The housing may include suitable features for controlling the flexible component portion, as further described below.

[0382] For example, such as Figure 59A and 59B As shown, the handle 2510 may include a housing 2510a and a sheath actuator 2511, which is operable to control the movement of the sheath 2430, the sheath being similar to... Figure 58B The inner sheath 2430 is shown in the image. The sheath actuator 2511 may include a user interface element 2512 coupled to a slider 2516, which is slidably engaged within a track 2514 in the housing 2510a. Figure 59B As shown, slider 2516 can be coupled to inner sleeve 2530 (e.g., via epoxy resin, welding, fasteners, mechanical interlocking, and / or other suitable attachment features or techniques) such that when slider 2516 moves within track 2514, inner sleeve 2530 moves in a corresponding manner. Figure 59A and 59B As shown, the track 2514 may be a longitudinal track substantially aligned with the longitudinal axis of the handle 2510 and the inner sheath 2530, such that the proximal movement of the user interface element 2512 along the track 2514 causes the proximal movement and retraction of the inner sheath 2530.

[0383] As further described below regarding the elongation component, the handle 2510 can be coupled to the proximal end of the elongation component such that the handle restricts (e.g., fixes) the position and orientation of the elongation component relative to the handle 2510. This coupling can be achieved, for example, with epoxy resin, one or more suitable fasteners, and / or the like. For example, the handle housing 2510a (e.g., the proximal housing wall) can be coupled to the proximal end of the hypotube 2520. Thus, movement of the handle can cause a corresponding movement of the elongation component (and the expandable device mounted thereon on the implant mounting surface of the elongation component), for example, to position the expandable device within the airway.

[0384] Additionally or alternatively, as further described below with respect to the outer sheath, the handle 2510 may be coupled to the outer sheath 2540. The outer sheath 2540 may be coupled to the handle of the delivery device to fix the axial position of the outer sheath relative to the handle (and the inner sheath, the extension member, the expandable device, and other components arranged within the outer sheath), but allows the outer sheath 2540 to rotate relative to the handle (and the inner sheath, the extension member, the expandable device, and other components arranged within the outer sheath). Thus, coupling the outer sheath to the working channel port of the bronchoscope (as further described below) advantageously stabilizes (e.g., axially fixes) the position of the expandable device (loaded on the extension member) relative to the bronchoscope during deployment. In some embodiments, the delivery system may also include a strain relief portion 2550 (e.g., reinforcing material, flexural features, etc.) around the outer sheath 2540 after its connection to the handle 2510 to help reduce the risk of mechanical failure of the delivery system components.

[0385] The housing 2510a can be adjusted in size and shape to be held in the user's hand. For example, the housing 2510a can be generally elongated and may include ergonomic shapes (e.g., shaped contours to improve gripping stability, shaped contours specifically for holding with the left or right hand). Additionally or alternatively, the housing 2510a can be any suitable size (e.g., generally smaller to improve portability and / or reduce material costs, generally smaller to be held with a smaller hand, generally larger to be held with a larger hand, etc.). The handle may additionally or alternatively include textured features to improve gripping (e.g., ridges, rings, protrusions, high-friction materials, etc.). Furthermore, it should be understood that the user interface element 2512 can have any suitable shape. For example, Figures 59C to 59FVarious examples of user interface element 2512 are depicted, which may be considered comfortable to push and / or pull along the handle housing 2510a, such as a spherical or convex shape (e.g., a ball or sphere 2512a), a flat shape (e.g., a disc 2512b), or a contour shape having one or more concave surfaces for accommodating the thumb or other fingers (e.g., a squeeze shape 2512c or an L-shape 2512d). User interface element 2512 may additionally or alternatively include one or more tactile features to further assist the user in manually pushing and / or pulling the slider 2516, such as textured features (e.g., ridges, ribs) and / or other features for increasing friction (e.g., rubber or other relatively high-friction materials).

[0386] In some embodiments, the sheath actuator 2511 may include a suitable intermediate gear system between the user interface element 2512 and the slider 2516, which introduces a gear ratio that modifies the travel rate of the slider 2516 relative to the travel rate of the user interface element 2512. The gear ratio may be selected to increase or decrease the travel distance of the slider 2516 per unit travel distance of the user interface element 2512 (e.g., a gear ratio greater than or less than 1:1). In some embodiments, the gear ratio may be selected so that the deployment of the expandable device can be achieved by a selected number of operations (e.g., a stroke of the slider, rotation of a roller or knob, etc.). For example, the gear ratio may be selected so that the deployment of the expandable device can be achieved by a single stroke of the slider in a track (e.g., any of the slider mechanisms described below). Furthermore or alternatively, the gear ratio may be selected to change (e.g., reduce) the amount of force required to move the user interface element 2512, for example, to make it easier to overcome the static frictional forces at the initial actuation of the user interface element.

[0387] In some embodiments, the handle may include a lock that functions to selectively secure the axial and / or rotational position of the inner sheath relative to the extension member. For example, such a lock can help ensure that the user actively deploys the expandable device by selectively disengaging the lock and helps prevent accidental or premature deployment of the expandable device. Furthermore, when the lock is engaged during transport or other delivery of the delivery device, it can help prevent unwanted vibrations in components of the delivery system. Figure 59BAn example of a lock is shown, illustrating that a lock can be incorporated into the interaction between a user interface element 2512, a slider 2516, and a housing 2510. Specifically, the user interface element 2512 may be threadedly coupled to the slider 2516 on the opposite side of the housing wall (e.g., the user interface element 2512 has a threaded rod extending through a track opening and engaging a threaded hole in the slider 2516, or vice versa). The lock can be engaged by rotating the user interface element 2512 to tighten this threaded engagement, which causes the user interface element 2512 and the slider 2516 to move closer to each other on opposite sides of the handle housing wall, thereby fixing the axial position of the slider 2516 in the track and preventing movement of the inner sheath 2530. The lock can be disengaged by rotating the user interface element 2512 in the opposite direction and loosening the threaded engagement between the user interface element 2512 and the slider 2516 until the slider 2516 can move more freely within the track, thereby allowing movement of the inner sheath 2530 relative to the elongated member. In some embodiments, the lock can be repeatedly engaged and disengaged as needed.

[0388] although Figure 59A and 59B The diagram depicts a slider and track actuator system for actuating the inner sheath, but other handle embodiments may include other suitable actuator systems. For example, Figure 60A This is an illustrative schematic diagram of a syringe-based sliding actuator system 2611a, comprising a plunger 2622 and a body 2620 receiving the plunger 2622. The body 2620 may be directly or indirectly coupled to an inner sheath 2630 such that retraction of the body 2620 toward the plunger 2622 (or equivalently, actuation of the plunger 2622 into the body 2620) causes retraction of the inner sheath 2630. Alternatively, the plunger 2622 may be directly or indirectly coupled to the inner sheath 2630 such that retraction of the plunger away from the body causes retraction of the inner sheath 2630. In some embodiments, other suitable user interface elements may be combined with this mechanism. For example, as depicted in an alternative sliding actuator system 2611b. Figure 60B As shown, the distal finger hole 2624 can be incorporated into the body of the inner sheath 2630, while the proximal finger hole 2666 can be incorporated into a plunger-type mechanism.

[0389] In some embodiments, the sheath actuator system for actuating the inner sheath may include a mechanism different from the sliding mechanism described above. For example, the sheath actuator system may include a rack and pinion mechanism. Figure 61This is an illustrative schematic diagram of a rack and pinion system, comprising a gear 2720 meshing with a rack 2722. The gear 2720 may be coupled to a thumb roller or other suitable user interface element (not shown) on a housing, and the rack 2722 may be coupled to an inner sheath 2730. Rotation of the gear 2720 via the user interface element causes linear movement of the rack 2722, thereby causing linear movement of the inner sheath 2730. In some embodiments, the rack and pinion system may include a plurality of gears with a suitable gear ratio to adjust the travel rate of the rack 2722 (and the inner sheath 2730) relative to the rotational rate of the gear 2720 (and the user interface element). Similar to what has been described above with respect to sheath actuator 2511, the gear ratio may additionally or alternatively be selected to change (e.g., reduce) the desired amount of torque on the gear 2720 that moves the rack 2722.

[0390] As another example, the sheath actuator system may include a pulley-based system, which in some embodiments reduces the overall length of the handle required to deploy the expandable device. For example, Figure 62A and 62B This is an illustrative schematic diagram of a pulley system actuated by a user interface element (e.g., roller 2812) on a user-operable handle. When roller 2812 rotates, it actuates a gear system 2816 that is coupled via the pulley to wind a string 2818. The string 2818 is coupled to a block 2819 or other suitable anchor to which the inner sheath 2830 is coupled. Thus, rotation of roller 2812 causes the string 2818 to wind around the pulley, causing the block 2819 to retract relative to the extension member 2820, thereby causing axial movement (e.g., retraction) of the inner sheath 2830. It should be understood that other pulley-based sheath actuator embodiments may include other suitable gear system arrangements with details different from those described above. Figure 62A and 62B The details are depicted in the schematic diagram, but it operates on a similar principle. For example, the gear system 2816 can contain any suitable gear ratio.

[0391] As another example, the sheath actuator system may include a telescopic section in or as part of the handle, which in some embodiments may reduce the overall length of the handle required to deploy the expandable device. For example, Figure 63This is an illustrative schematic diagram of a handle 2910, which includes an arrangement having telescopic or nested segments 2914 actuated by user interface elements (e.g., roller 2912) on the user-operable handle 2910. When the roller 2912 rotates, it actuates a gear system 2916 that interacts with one or more of the segments 2914, at least one of which is coupled to an inner sheath 2930. Thus, rotation of the roller 2912 causes actuation of the gear system 2914, which causes the combined length of the segments 2914 to extend and / or collapse, thereby causing axial movement of the inner sheath 2930 relative to the extended member 2920. It should be understood that other embodiments of sheath actuators based on telescopic segments may include other suitable gear system arrangements with details different from those of the telescopic segment actuator. Figure 29 The details are depicted in the schematic diagram, but it operates on a similar principle. For example, gear system 2916 can contain any suitable gear ratio.

[0392] Alternatively, the sheath actuator system may include any suitable combination of user interface elements. For example, such as Figure 87A As shown, the sheath actuator system may include a user interface element 7912a (e.g., a sleeve) screwed onto a threaded mount on a handle and coupled to an inner sheath, such that rotation of the user interface element 7912a causes axial movement of the inner sheath (e.g., retraction proximally). As another example, such as... Figure 87B As shown, the sheath actuator system may include a user interface element 7912b comprising one or more buttons that, when pressed, disengage the axial lock between the inner sheath and the handle, thereby enabling axial movement of the inner sheath relative to the handle (e.g., retraction proximally). In some embodiments, the sheath actuator system may include multiple user interface elements, such as a first user interface element for disengaging the first axial lock between the sheath and the handle and / or providing a disengagement force overcoming the static friction of the inner sheath, and a second user interface element for controlling the range of axial movement of the inner sheath relative to the handle. For example, as... Figure 87C As shown, the sheath actuator system may include a first user interface element 7912c screwed onto a threaded mount on a handle and coupled to an inner sheath, and a second user interface element 7914c including one or more buttons operable similarly to user interface element 7912b. As another example, Figure 87D As shown, the sheath actuator system may include a first user interface element 7912d comprising a rotatable lever or knob coupled to the inner sheath, and a second user interface element 7914d comprising a slider (or button or other suitable user interface element) operable similarly to slider 2516. It should be understood that the sheath actuator system may include any suitable combination of mechanisms and user interface elements, such as those described herein.

[0393] In some embodiments, the handle may include one or more features configured to provide tactile feedback (e.g., tactile and / or auditory feedback) that conveys information about the deployment status (e.g., deployment rate, distance traveled by the inner sheath, etc.). For example, in some embodiments, the handle may include one or more interference mechanical components that engage on a periodic basis, such as... Figure 64 The interference mechanical components shown in the image. For example... Figure 64 As shown, the sheath actuator system may include a protrusion 3014 on a movable roller 3012. The movable roller 3012 may rotate in a manner corresponding to a user interface element (not shown). For example, the roller 3012 may share a rotation axis with a roller-based user interface element on a handle so as to rotate in conjunction with user operation of the user interface element, or it may share a rotation axis with a gear in a gear system of the sheath actuator system. The protrusion 3014 may periodically encounter mechanical interference with a second protrusion 3016 adjacent to another surface of the roller 3012, such that contact between the protrusions 3014 and 3016 results in tactile and / or auditory feedback (e.g., increased resistance, clicking, etc.). In some embodiments, the interference may additionally or alternatively trigger the emission of generated sounds (e.g., thuds, buzzes, tones, etc.) from a speaker device. The tactile feedback feature may be sized and / or shaped to provide suitable feedback at any suitable frequency (e.g., every 0.5 cm or 1 cm of inner sheath retraction / expandable device deployment, etc.). Alternatively, haptic feedback may be provided in response to information provided by a sensor. For example, a light source may be located on one side of the roller 3014, and a light sensor may be located on the opposite side of the roller 3014. The roller 3014 may include a window such that as the roller 3014 rotates, it periodically allows light to pass from the light source to the light sensor, which can detect and track the position of the roller.

[0394] Alternatively, the handle may be configured to substantially limit the movement of the inner sheath in one direction (e.g., in the proximal direction, for retracting the inner sheath). Thus, the handle helps provide better control over the deployment of the expandable device and / or substantially prevents attempts to re-insert the expandable device. For example, the sheath actuator system may include a ratchet mechanism that limits actuation in one direction (e.g., a ratchet mechanism attached to a slider, gear, pulley system, etc.).

[0395] In various embodiments, the handle may include any sheath actuator, not limited to those described herein. It should also be understood that in some embodiments, any of the sheath actuator systems described herein and / or other suitable sheath actuator systems may be combined in any suitable manner (e.g., a telescopic section operable by a pulley, a slider mechanism including a gear system, etc.). For example, various embodiments of the handle may include a suitable gear system for assisting in reducing the force applied by the user for deploying the expandable device (e.g., for overcoming the static fraction during the retraction of the inner sheath).

[0396] B. elongated parts

[0397] As described above, the elongated component in the delivery system functions at least partially to provide a structure on which an expandable device (implant) is mounted for delivery and placement within a patient. In some embodiments, a first portion (e.g., a proximal segment) of the elongated component may have a different structure than a second portion (e.g., a distal segment) of the elongated component. Typically, in some embodiments, the elongated component may include an implant mounting surface located on the distal portion of the elongated component for receiving the expandable device thereon.

[0398] Figure 65A A portion of an exemplary embodiment of the elongated member 3120 is depicted. For example... Figure 65A As shown, the extension member 3120 may include a thiocyanate tube 3128 that provides structural support for at least the proximal portion of the extension member 3120. For example, the thiocyanate tube 3128 may be coupled to a handle (not shown) and extend toward the distal end of the extension member 3120. The coupling of the thiocyanate tube 3128 to the handle limits (e.g., fixes) the position and orientation of the extension member 3120 relative to the handle. This fixing relationship is, for example, in… Figure 59B Shown in Figure 59B Depict the hyaluronic acid tube 2520 coupled to the handle 2510 (e.g., the proximal end of the hyaluronic acid tube is coupled to the handle housing 2510, for example, with epoxy resin, one or more suitable mechanical fasteners, etc.).

[0399] In some embodiments, such as Figure 65A and 65B As shown, the distal end of the hysteresis tube 3128 can be coupled (e.g., welded) to the coil 3124. The coil 3124 can have a close spacing and be compact enough to provide compression resistance to the flexible portion of the delivery system.

[0400] In some embodiments, the elongation member 3120 may further include an inner wire 3122 disposed within at least a portion of the hyaluronic acid tube 3128 and the coil 3124. The inner wire 3122 may be configured to increase the column strength of at least a portion of the elongation member 312. The inner wire 3122 may comprise, for example, a suitable cord. The distal end of the inner wire 3122 may be adjacent to or coupled to an implant mounting surface (further described below). In some embodiments, the proximal end of the inner wire 3122 may terminate in a solder ball 3126, such as... Figure 65B As shown in the diagram. The solder ball 3126 assists in removing the delivery system from the patient (e.g., after deployment of the delivery device). For example, the diameter of the solder ball 3126 may be larger than the inner diameter of the coil 3124, such that when the solder ball 3124 contacts the proximal end of the coil 3124, the coil 3124 provides a stop with sufficient mechanical interference to prevent the proximal end of the inner wire 3122 from completely passing through the coil 3124. When the delivery system is pulled proximally to remove it from the patient, the proximal movement of the handle may introduce tension, causing the coil 3124 to extend and thus hinder the removal of the delivery system. Figure 66 As shown, with coil 3124 extended, solder ball 3126 can abut against the opening of coil 3124, causing the handle to move proximally (in Figure 66 The inner wire 3122 is pulled downwards (as shown in the diagram), instead of the coil 3124. In other words, this interference limits the elongation of the coil and pulls the inner wire 3122 (along with the coil 3124). This limits the maximum length the overall elongation component can extend in response to the proximal withdrawal of the delivery system, thereby assisting in the removal of the entire delivery system.

[0401] The sodium hypotube 3128, coil 3124, inner wire 3122, and / or solder ball 3126 may comprise, for example, 304SS and / or other suitable materials. In some embodiments, the sodium hypotube 3128, coil 3124, inner wire 3122, and / or solder ball 3126 may comprise a radiopaque material to enable visualization of the elongated component under fluorescent light. The dimensions of the elongated component assembly may vary at least in part depending on the intended application. For example, in some embodiments, such as Figure 66 As shown, the relative dimensions of the solder ball 3126 and the inner diameter of the coil 3128 can be adjusted to increase their mechanical interference (e.g., the diameter of the coil 3128 can be reduced and / or the diameter of the solder ball 3126 can be increased). For example, this greater interference can help reduce the failure of the inner wire 3122 to the solder ball 3126 during removal by the delivery system.

[0402] In some embodiments, coil 3124 can be omitted from the elongation member, which can, for example, help reduce the overall outer diameter of the elongation member and the resulting outer diameter of the delivery system (e.g., for use with a bronchoscope having a smaller working channel). For example, as Figure 67A As shown, the elongated member 3320 may include a hysteresis tube 3328 (e.g., similar to the hysteresis tube 3128 described above) coupled to the inner wire 3322 (e.g., similar to the inner wire 3122 described above) by welding, wherein the absence of a coil can reduce the overall outer diameter of the elongated member 3320. Figure 67B As shown, in some embodiments without coils, the delivery device may include an inner sheath 3330 having a reduced profile around the inner wire 3332, such as a gradual decrease in the diameter of the inner sheath 3330 (or taper, etc.). This reduced diameter of the inner sheath 3330 in the region of the wire helps to reduce or prevent excessive bending of the inner wire 3332 (e.g., during the advancement of the delivery system and / or during the retraction of the inner sheath relative to the elongated member, each of which may have a tendency to bend the inner wire 3332 under compression).

[0403] In some embodiments, the elongated member includes an implant mounting surface on which an expandable device is mounted for delivery. For example, such as Figure 68A As shown, the elongated member 3420 may include an implant mounting surface 3423, said surface comprising a conformal material 3424 configured to adapt to the geometry of the expandable device I that radially collapses onto the implant mounting surface. For example, the conformal material 3424 may be adapted to one or more gap regions of the expandable device I (e.g., open helical regions between turns of the expandable device's wires, between the legs of the expandable device's wires, or other open spaces, etc.) such that when the device is radially compressed, the conformal material 3424 has a tight engagement with the expandable device. For example, as... Figure 34B As shown, the conformal material 3424 may form one or more recesses 3426 for receiving the wire of the expandable device, which helps the expandable device maintain its axial and / or rotational position on the elongation member 3420. Thus, the conformal material allows the expandable device to be "pinned" or otherwise held in place on the elongation member 3420 until the inner sheath 3430 retracts. In some embodiments, the conformal material may be sufficiently compressible and / or deformable such that the recesses 3426 allow the expandable device I to be sufficiently radially compressed until its outer diameter is substantially equal to or smaller than the outer diameter of the remainder of the implant mounting surface (or the remainder of the conformal material 3424). For example, when the expandable device is radially compressed and loaded onto the conformal material, the recesses 3426 in the conformal material may be adapted to a majority of the cross-sectional area of ​​the wire of the expandable device (e.g., as shown in the figure). Figure 68BAs shown, the cross-section of the circular wire is at least 180 degrees, or at least 150 degrees, or at least 120 degrees. In some embodiments, the implant mounting surface (e.g., a conformal material) may be generally smooth before the expandable device is received thereon, and after the expandable device is radially compressed onto the implant mounting surface, it is adapted to the shape of one or more gap regions of the expandable device.

[0404] The conformal material 3424 of the implant mounting surface can have several advantages. For example, when the expandable device is mounted on the elongation member 3420, the conformal material 3424 allows for greater tolerances in rotational and / or axial positioning of the expandable device. Because the conformal material 3424 allows the final placement of the expandable device within the implant mounting region of the elongation member to be more independent of rotation and / or axial orientation, the expandable device can be curled and constrained on the implant mounting surface in a more predictable manner. This results in greater control and consistency in the final radial compression form of the expandable device on the implant mounting surface, which in turn leads to greater control and predictability in the resulting deployment of the expandable device.

[0405] The conformal material 3424 may be in the form of, for example, a pad or coating on the inner wire of the elongated member, or a discrete segment of the elongated member adjacent to the inner wire. In various embodiments, the shape or distribution of the conformal material 3424 may vary in axial and / or radial dimensions. For example, in some embodiments, the conformal material 3424 may extend along the entire length of the implant mounting surface (e.g., at least as long as the expandable device I), such as... Figure 68A As shown in the illustration. In other embodiments, such as Figure 69 As shown, the elongated component may comprise multiple segments or sections of conformal material 3424 axially spaced across implant mounting surfaces along the longitudinal axis of the elongated component. These segments may be distributed equidistantly or unequally along the elongated component. Although Figure 69 The elongated member is depicted having three segments, but it should be understood that in other embodiments, the elongated member may comprise any suitable number (e.g., one, two, three, four, five or more) of conformal material segments.

[0406] Furthermore, in some embodiments, the conformal material 3424 may extend completely circumferentially around the elongated member (e.g., around the inner wire 3422), such as... Figure 69A The cross-sectional view is shown. However, in other embodiments, the conformal material 3424 may partially circumferentially surround the elongated member (e.g., around the inner wire 3422). For example, as Figure 69BAs shown, the conformal material 3424 can be wound around the circumference of the circular inner wire 3422 by less than 360 degrees (e.g., between about 180 degrees and about 360 degrees, or between about 180 degrees and about 270 degrees, etc.). Additionally or alternatively, in some embodiments, the elongated member may comprise two or more circumferential segments of the conformal material 3424 distributed around the elongated member. For example, as... Figure 69 As shown in C, the elongated member may comprise three segments of conformal material 3424 arranged circumferentially around the elongated member. The arc lengths of these multiple circumferential segments may be equal or unequal, and they may be distributed equidistantly or unequally around the elongated member. Although Figure 69 C depicts an elongated member having three circumferential segments of conformal material 3424, but it should be understood that in other embodiments, the elongated member may comprise any suitable number (e.g., one, two, three, four, five or more) of circumferential segments.

[0407] The conformal material 3424 may be selected to be sufficiently compressible and / or deformable, but sufficiently resilient to hold the expandable device in its axial and / or rotational position on the implant mounting surface. In some embodiments, the conformal material 3424 may comprise a thermoplastic, such as In some embodiments, the conformal material 3424 may comprise a flexible extruded material, such as Pebax. The conformal material may, for example, have a hardness between about 5A and about 75A, between about 15A and about 75A, between about 25A and about 55A, or about 5A, about 15A, about 25A, about 40A, about 55A, or about 75A. Additionally or alternatively, the conformal material may be selected based at least in part on the desired radial wall thickness, melting point or flow rate, adhesion properties to the inner wire 3422 and / or expandable device, tensile strength, plastic deformation, elongation, radiation impermeability, UV stability, biocompatibility, durability at temperature and / or humidity, and / or the like.

[0408] Figure 70 This is an illustrative schematic diagram depicting a portion of another example embodiment of a delivery system 3500 having an implant mounting surface comprising conformal material 3524 for receiving an expandable device (not shown). The delivery system includes an outer sheath 3540 and an inner sheath 3530 similar to those described herein, and an elongated member having an inner wire 3522 disposed within the inner sheath 3530. Figure 70 As shown, the conformal material 3524 can be disposed on the inner wire 3522 and coupled to the coil 3523 (or other suitable portion of the extension, such as the inner wire 3522 itself or the hyaluronic acid tube), for example with a suitable epoxy resin 3528. The spatial characteristics of the conformal material 3524 can vary across different embodiments, similar to those described above.

[0409] In some embodiments, the implant mounting surface may additionally (e.g., in combination with a conformal material) or alternatively include other features for engaging or otherwise securing the expandable device thereon. For example, in some embodiments, the implant mounting surface may include one or more bioadhesives (e.g., synthetic polymers, polysaccharides, cellulose, chitosan, fibrin, and / or other suitable bioadhesives). Furthermore or alternatively, in some embodiments, the implant mounting surface may include a textured surface, such as comprising one or more outward projections (e.g., ribs, protrusions, other uneven or rough surfaces, etc.) and / or a high-friction material (e.g., an elastomer).

[0410] In some embodiments, the implant mounting surface may additionally or alternatively include other features for receiving and positioning the expandable device on the elongated member. For example, the implant mounting surface may have one or more features that are complementary to or correspond to the overall shape or key geometry of the expandable device. In these embodiments, the implant mounting surface may comprise a material that is harder than the expandable device (e.g., a rigid or semi-rigid material). For example, Figure 71 This is an illustrative schematic diagram of an example embodiment of an elongated member 3620 having one or more incisions on an implant mounting surface having a shape corresponding to a radially constrained configuration of the expandable device I. In some embodiments, the incision 3624 may include a generally helical recess or channel matching the coiled shape of the expandable device I. Additionally or alternatively, in some embodiments, the implant mounting surface may include radially outwardly projecting protrusions or pins corresponding to certain peaks and / or valleys (e.g., apexes) of the expandable device. Such incisions and / or outwardly projecting features for receiving and positioning the expandable device may be molded, machined, or otherwise formed, for example, in any suitable manner.

[0411] As another example, the delivery system may additionally or alternatively include a proximal stop that functions to limit the proximal position of the expandable device I along the elongated member. For example, the delivery system may further include a proximal stop 3450 positioned around the elongated member 3420 and within an inner sheath 3430. The proximal stop 3450 may have a distally facing surface 3452 configured to abut the proximal end of the device I.

[0412] Furthermore, in some embodiments, the delivery system may include a non-invasive tip at the distal end of the extended component. For example, the non-invasive tip can help identify the location of the pleura during deployment. For example, as... Figure 70 As shown, the elongated component may include a rounded tip 3528, which in some embodiments may be coupled to the inner wire 3522 via epoxy resin or other suitable means. Figure 68AAnother example embodiment depicts an atraumatic tip 3490 that is more tapered than tip 3528. In some embodiments, the atraumatic tip may include one or more radiopaque markers (e.g., Figure 68A The marker 3492 shown in the figure is used to aid in visualizing the distal end of the delivery system under fluorescent fluoroscopy. For example, such visualization may help avoid unintentional trauma to the pleura during the deployment of an expandable device. As another example, the elongated component may include a flexible, wire-like tip configured to flex upon contact with soft tissue. Figure 72 This is an illustrative schematic diagram of an example of such a wire tip 3790 at the distal end of the elongated member 3720, wherein the wire tip 3790 is flexible and / or bent into a circular shape (e.g., a hook shape). Additionally or alternatively, to aid in determining the location of the pleura, in some embodiments, the delivery system may be compatible with a separate wire (e.g., "wire-on" technology) used to individually identify the location of the pleura. In some embodiments, the use of a wire-like tip and / or a separate wire can avoid the need for fluoroscopy during deployment to track the location of the delivery device.

[0413] In some embodiments, the elongation member may include one or more features that help prevent unintended engagement of the elongation member with surrounding features (e.g., the expandable device, patient anatomy, outer sheath, bronchoscope, etc.) during withdrawal of the elongation member after the expandable device has been deployed. For example, the elongation member may include a deformable distal portion that dynamically changes shape to avoid interfering with such surrounding features. In some embodiments, the elongation member may include a distal portion having a first configuration suitable for delivery of the expandable device and / or a second configuration suitable for retracting the elongation member after deployment of the expandable device. For example, Figure 88A and 88B This is an illustrative diagram of the distal portion of a delivery system 8000, including an inner sheath 8030 and an extension member 8020. Figure 88A In this configuration, the inner sheath 8030 extends over an expandable device (not shown) on the elongated member 8020. The elongated member 8020 may include a deformable tip 8022. In such a configuration... Figure 88A In the first configuration shown, the deformable tip 8022 can cover the distal opening of the inner sheath 8030 to provide a non-invasive tip for airway insertion. After the inner sheath 8020 retracts to deploy the expandable device, the delivery system (including the extension member 8020) can be withdrawn in a proximal direction for removal from the patient. Figure 88BDuring the withdrawal of the delivery system shown, the deformable tip 8022 can transform into a second configuration in which the deformable tip 8022 is in a low profile or other state that is unlikely to inadvertently become stuck on the surrounding feature when the delivery system is withdrawn. For example, the deformable tip 8022 can flip, fold (e.g., radially wrinkle), and / or radially collapse when the delivery system is withdrawn. The deformable tip 8022 can passively transform from the first configuration to the second configuration as it interacts with and responds to the surrounding feature, and / or can be actively controlled (e.g., with a pull wire or tether). In some embodiments, the deformable tip 8022 may comprise a flexible membrane and / or other suitable flexible material.

[0414] C. Inner sheath

[0415] The inner sheath of the delivery system functions to selectively cover and / or restrain the expandable device (implant) mounted on the elongation member. As described above, the inner sheath may be radially arranged on the elongation member and may retract to expose the expandable device and allow the expandable device to expand (e.g., by self-expansion) to a radially expanded configuration.

[0416] In some embodiments, the inner sheath may include a braided shaft comprising multiple layers of material. For example... Figure 73A and 73BThis is an illustrative schematic diagram of an example embodiment of an inner sheath 3830 comprising a liner 3832, a braid 3834, and an outer jacket extrusion 3838. The liner 3832, which may interface with elongated components and / or expandable devices in a delivery system, may contain a lubricating or low-friction material (e.g., PTFE) to help reduce friction when the inner sheath retracts. The braid 3834 functions to provide structural reinforcement to the inner sheath to maintain suitable flexibility. In some embodiments, the density of the braid (e.g., the warp and weft density) may vary with the length of the inner sheath to alter the degree of flexibility along its length. For example, in some embodiments, the warp and weft density may be higher for more distal regions of the inner sheath to allow the delivery device greater overall flexibility in its distal regions, for example, to better navigate through more tortuous anatomy. In some embodiments, for example, the fabric 3834 may include at least a distal fabric region having a first warp and weft density and a proximal fabric region having a second warp and weft density, wherein the first warp and weft density is higher than the second warp and weft density, such that the distal fabric region is more flexible than the proximal fabric region. In some embodiments, the fabric 3834 may have an intermediate fabric region having a gradually increasing warp and weft density from the proximal fabric region to the distal fabric region to provide a gradual transition in the flexibility of the inner sheath. However, in some embodiments, the fabric may have a uniform warp and weft density along its length. The outer sheath extrusion 3838 functions to cover the fabric 3834 and provide a smooth outer surface for the inner sheath. For example, the outer sheath extrusion 3838 may comprise a suitable thermosetting material (e.g., polyimide, nylon, Pebax, etc.) that maintains suitable flexibility and stiffness for the desired wall thickness. In some embodiments, different segments or portions of the outer sheath extrusion 3838 may comprise different materials with different hardnesses, such that different segments of the outer sheath extrusion 3838 may have different flexibility. For example, the varying flexibility of the outer jacket extruder 3838 along its length compared to the proximal portion of the delivery system can help introduce greater flexibility in the distal portion of the delivery system (e.g., for navigating smaller and / or more tortuous airways). For example, in some embodiments, the outer jacket 3838 may include nylon on its proximal end (to provide a stiffer proximal portion) and Pebax (e.g., 55D Pebax) on its distal end (to provide a more flexible distal portion).

[0417] In some embodiments, the inner sheath may further include reinforcing members embedded in the wall of the inner sheath to help reduce longitudinal stretching of the inner sheath. For example, such as Figure 73A As shown, the reinforcing member 3836 may extend along at least a portion of the length of the inner sheath. Figure 73BAs shown, the reinforcing member 3836 may be located above the braided layer 3834 (e.g., between the braided layer 3834 and the outer jacket extruder 3838), which may, for example, help keep the braided layer 3834 uniformly positioned around the inner shaft and reduce the overall outer diameter of the inner sheath (and thus the shaft of the delivery system). However, in other embodiments, the reinforcing member 3836 may be at least partially located between the braided layer 3834 and the inner linear element 3832 and / or the reinforcing member 3836 may be woven within the braided layer 3834. In some embodiments, the reinforcing member 3836 comprises fibers (e.g., aramid or para-aramid fibers, e.g., Materials such as steel and / or wire (e.g., stainless steel) may be used, but other suitable materials may be selected based on the desired tensile strength, reinforcement dimensions (e.g., thickness or cross-sectional dimensions), number of reinforcements, etc.

[0418] In some embodiments, reducing the overall outer diameter of the inner sheath to reduce the outer diameter of the delivery system (e.g., to be compatible with certain working channel sizes of a bronchoscope) may be advantageous. Individual components of the inner sheath can be modified to achieve a reduction in the inner sheath diameter. For example, the thickness of the liner, braid, reinforcing elements (e.g., fibers or wires), and / or the outer sheath extrusion can be reduced to decrease the overall outer diameter of the inner sheath. For example, the use of different braid patterns or the use of coils in the braid layers (e.g., as...) Figure 75 (As shown in the diagram) Replacing the woven fabric can result in a reduced thickness of the reinforcing layer between the inner liner and the outer jacket extrusion. Additionally or alternatively, such as Figure 74A As shown in the figure, replacing such as Figure 74B The single reinforcing member 3836 shown herein may be replaced by a plurality of smaller reinforcing members 3936 in some embodiments, which together enable the inner sheath 3930 to adequately resist tension under tensile loads while still having a small cross-sectional profile. For example, the inner sheath may contain two, three, four, five, six or more reinforcing members along at least a portion of its length. Such a plurality of reinforcing members may be equidistantly distributed around the circumference of the inner sheath (e.g., three reinforcing members arranged 120 degrees apart circumferentially, four reinforcing members arranged 90 degrees apart circumferentially, etc.), which can help maintain a balanced cross-sectional profile of the inner sheath in terms of resistance to longitudinal tension. However, in some embodiments, the plurality of reinforcing members may be unequally distributed around the circumference of the inner sheath (e.g., reinforcing members of different diameters and / or material properties with different resistance to longitudinal tension may be circumferentially distributed in a manner that effectively provides a balanced cross-sectional profile of the inner sheath in terms of resistance to longitudinal tension). Figure 74BAnother example illustrating a reduction in the overall outer diameter of a delivery system is that the outer diameter of the elongated components and / or the implant in its radially compressed configuration may be additionally or alternatively reduced (e.g., the implant may be rolled into a smaller radius), such that the layers of the inner sheath result in a reduction in the overall outer diameter of the delivery system. As another example, in some embodiments, one or more layers of the inner sheath (e.g., a liner) may be thickened to help reduce elongation, while omitting reinforcing components (e.g., fibers and / or filaments), which can help reduce the outer diameter of the inner sheath while improving the radial symmetry of the inner sheath.

[0419] D. outer sheath

[0420] The outer sheath of the delivery system functions to provide a surface for engagement with the bronchoscope. In some embodiments, the outer sheath can rotate independently of the inner sheath, which reduces the torque exerted on the inner sheath and / or the extension components (arranged within the outer sheath) during the delivery system's advancement and navigation through anatomical structures.

[0421] For example, such as Figure 59A As shown, the outer sheath 2540 can be coupled to the handle 2510. Figure 76 A detailed view of an outer sheath 4140, similar to an outer sheath 2540, is provided. The outer sheath 4140 is coupled to the handle of the delivery device via a rotatable anchor 4160 housed within the housing to fix the axial position of the outer sheath 4140 relative to the handle (and the inner sheath, extension member, expandable device, and other components arranged within the outer sheath 4140), but allows rotation of the outer sheath relative to the handle (and the inner sheath, extension member, expandable device, and other components arranged within the outer sheath 4140). Therefore, coupling the outer sheath 4140 to the working channel port of the bronchoscope (as further described below) advantageously stabilizes (e.g., axially fixes) the position of the extension member relative to the bronchoscope during deployment. In some embodiments, the delivery system may further include a strain relief portion 4150 (e.g., a reinforcing sleeve, flexure notch, etc.) in the area surrounding the connection between the outer sheath 4140 and the handle to help reduce the risk of failure due to fatigue and / or kinking when manipulating the delivery system. In some embodiments, the main body wall of the outer sheath may comprise at least two layers of material, including an inner liner (e.g., PTFE or other lubricating or low-friction material) and an outer jacket (e.g., Pebax, nylon) that provides a smooth outer surface for the outer sheath 4140.

[0422] In some embodiments, the outer sheath may extend along the entire length of the flexible shaft of the delivery system, or it may extend only along a portion of the shaft. For example, as Figure 58B As shown, the outer sheath 2440 may be shorter than the inner sheath 2430.

[0423] E. Guide sleeve

[0424] In some embodiments, the outer sheath may be decoupled and detached from the handle at least initially to serve as a guide sheath, through which the extension member and inner sheath may be introduced. The guide sheath may be similar to the outer sheath described herein, except that the guide sheath can navigate toward the treatment position through the target airway when detached from the handle of the delivery device. For example, Figure 89A This is an illustrative schematic diagram of a guide sleeve 8140 including an elongated shaft 8146. Typically, the guide sleeve 8140 can be formed in a similar manner to the outer sleeve 2540 and / or the outer sleeve 4140. For example, in some embodiments, the body wall of the guide sleeve 8140 may comprise at least two layers of material, including an inner liner (e.g., PTFE or other lubricating or low-friction material) and an outer jacket (e.g., Pebax, nylon) providing a smooth outer surface for the guide sleeve 8140. However, in some embodiments, the body wall of the guide sleeve 8140 may comprise a single layer of material (e.g., an outer jacket similar to that of the outer sleeve). Furthermore, the guide sleeve 8140 may include strain relief portions 8150 (e.g., reinforcing sleeves, flexural cutouts, etc.) in the region surrounding the connector 8142 to help reduce the risk of failure due to fatigue and / or kinking when manipulating the guide sleeve 8140. The guide sheath 8140 may include a lumen configured to receive a wire that can be used to provide further navigation control to the guide sheath 8140 (e.g., to access a specific distal airway), and / or at least a portion of the remainder of the delivery system, such as Figure 89B The inner sheath 8130 of the delivery system is shown in the figure. In some embodiments, the guide sheath may include a lumen for accommodating both the wires of the delivery system and the inner sheath 8130 (e.g., at different times), or the guide sheath may include different lumens to separately accommodate the inner sheath 8130 and the wires.

[0425] In some embodiments, the guide sleeve 8140 may be selectively coupled to the handle 8110 of the delivery system. For example, when the inner sleeve 8130 is advanced into the guide sleeve 8140, the guide sleeve 8140 may be coupled to the handle 8110 via a connector 8142 on the guide sleeve and an engagement of a corresponding connector 8118 on or coupled to the handle 8110, as shown below. Figure 90 As shown in the illustration. For example, connectors 8142 and 8118 may include threaded engagement, snap-fit ​​engagement and / or other suitable couplings (e.g., Luer lock).

[0426] In some embodiments, the guide sheath 8140 may be configured to measure the length of the target airway, which can help inform treatment planning and the selection of an appropriate implant length at the treatment location to be placed in the target airway. For example, the guide sheath 8140 may include one or more markers 8144 (e.g., radiopaque markers, markers visible via a bronchoscope camera, etc.) that can be visualized under fluoroscopy to measure the length of the target airway. In some embodiments, the markers 8144 may be evenly distributed (e.g., spaced 0.5 cm, 1 cm, 2 cm, etc.) to facilitate the measurement of the target airway in which the guide sheath 8140 is temporarily placed. Additionally or alternatively, at least a portion of the markers 8144 may be spaced apart by a distance corresponding to a predetermined available length of the expandable device to be deployed at the target airway to facilitate the selection of such predetermined lengths for treatment planning.

[0427] like Figure 91A As shown, during the delivery of the expandable device, the guide sheath 8140 can be advanced within the working channel of the bronchoscope 5200 (or robotic catheter or other robotic system) in the patient's target airway. In some examples, the lead can be advanced distally toward the treatment location, and the guide sheath 8140 can be advanced over the lead. For example, the lead can be advanced distally until it contacts the pleura within the patient's body. Figure 91B Furthermore, the guide sheath 8140 can be advanced distally along the guide wire to the pleura (e.g., Figure 91C In many examples, the lead wire 8310 and the guide sheath 8140 may extend beyond the distal end of the bronchoscope 5200, allowing certain radiopaque markings on the guide sheath 8140 to be visualized and used for measuring the target airway and / or selecting the length of the assistive implant. After an appropriate implant length has been selected, the guide sheath 8140 may be held such that its distal tip remains adjacent to the pleura. The lead wire 8310 may then be removed from the guide sheath 8140 while the guide sheath 8140 remains in place (e.g., manually held, locked to the bronchoscope, etc.).

[0428] like Figure 92A As shown, the inner sheath 8130 can be inserted into the guide sheath 8140 and advanced a predetermined or known distance, which helps to position the expandable device at a desired location relative to the guide sheath 8140. For example, in some embodiments, the inner sheath 8130 can be advanced until the distal tip of the inner sheath 8130 is approximately aligned with the distal tip of the guide sheath 8140, such as... Figure 92BAs shown in the diagram. This positioning of the inner sheath 8130 can, for example, help ensure that the inner sheath 8130 (and the expandable device housed within the inner sheath 8130) can track the same target airway region measured by the guide sheath 8140 for implant selection as the guide sheath 8140 guides the inner sheath 8130 distally to the pleura.

[0429] After the inner sheath 8130 (and the expandable device) is positioned at the target treatment location, the position of the inner sheath 8130 can be fixed relative to the treatment location (e.g., by manually holding the handle 8110, mechanically coupling the proximal region of the inner sheath 8130 to a fixing feature independent of the guide sheath 8140, etc.) to stabilize the position of the expandable device relative to the airway. Subsequently, the guide sheath 8140 can be retracted proximally, such that retraction or other axial movement of the inner sheath results in the exposure and deployment of the expandable device without interference from the guide sheath 8140. In some embodiments, the guide sheath 8140 can be coupled to the handle 8110 via one or more connectors (e.g., connectors 8142 and 8118), such that proximal movement of the handle 8110 results in proximal movement of the guide sheath 8140. In this coupling configuration, the guide sheath 8140 can function similarly to the outer sheath described elsewhere herein for deploying the expandable device. However, in some embodiments, the guide sheath 8140 can be completely withdrawn from the bronchoscope proximally before the deployment of the expandable device.

[0430] In some embodiments, after the deployment of the expandable device, the handle 8110 can be pulled proximally to remove the inner sheath 8130 and the guide sheath 8140 together from the patient. However, in some embodiments, the guide sheath 8140 can be reused to place additional expandable devices at a second target location. For example, the guide sheath 8140 can be decoupled from the handle 8110 of the first delivery system, the inner sheath 8130 of the first delivery system can be removed from the guide sheath 8140, and the guide sheath 8140 can be navigated to the second target location. When the guide sheath 8140 is positioned at the second target location, the deployment process described above can be repeated to deploy a second expandable device from the inner shaft of the second delivery system. Therefore, in some embodiments, the same guide sheath can be used to sequentially position and deploy two or more expandable devices. Alternatively, different guide sheaths can be positioned to help facilitate the positioning and deployment of multiple expandable devices.

[0431] F. Size adjustment device

[0432] In some embodiments, the delivery system may include a size adjustment device configured to help determine the appropriate length of the implantable expandable device to be used. For example, the size adjustment device may function to measure the length of a target airway corresponding to a desired treatment location. Typically, the size adjustment device may include an elongated portion with multiple markers to facilitate measurement of the target airway length. In some embodiments, the size adjustment device may include markers located at a distal portion of the size adjustment device that is advanced into the target airway, wherein the markers can be directly aligned with the area of ​​the target airway. Thus, as the size adjustment device is advanced through the bronchoscope to the target location, the depth of its advancement (and the length of the target airway) can be tracked by the markers on the distal portion of the size adjustment device. The elongated portion may be flexible to facilitate navigation through tortuous airways and / or other anatomical structures. In some embodiments, the distal tip of the elongated portion may be non-invasive (e.g., comprising a rounded tip, a ball welded to the distal tip, etc.) to help reduce the risk of tissue trauma caused by the interaction of the size adjustment device with tissue.

[0433] Alternatively, the resizing device may include a marking located on the proximal portion of the resizing device, which is visible outside the patient and outside the bronchoscope. For example, the resizing device may be advanced distally until the user feels the distal tip of the resizing device contacting the pleura via tactile feedback, and then the resizing device may be retracted proximally by a desired amount (e.g., until the distal tip of the resizing device is visible in the bronchoscope camera at the desired location proximal to the expandable device at the target airway). Once the resizing device has retracted by the desired amount, the desired length of the expandable device can be determined based on the marking exposed on the proximal end of the resizing device.

[0434] Markings on the size adjustment device can be configured to be visualized using one or more modes. For example, in some embodiments, the markings can be radiopaque (e.g., platinum-iridium, tungsten) and visualized under fluorescent light. The markings can be attached in various ways, including but not limited to forging, curling, and pad printing, and can be coupled to the external and / or internal surfaces of the size adjustment device (or embedded within the size adjustment device). Additionally or alternatively, the markings can be visible from a bronchoscope camera (or a camera inserted via a robotic system, etc.) for example, under white light imaging, and / or visible to the naked eye. Additionally or alternatively, in some embodiments, the markings can comprise discrete segments of the size adjustment device that are color-coded (or otherwise distinguished by texture, pattern, and / or the like). For example, Figure 95C The example of the resizing device 8700c includes color-coded segments 8710 corresponding to different predetermined lengths of expandable devices that may be placed therein.

[0435] In some embodiments, the markings may be equally spaced to provide scale measurement, as illustrated in the size adjustment device 8700a. Figure 95A As described herein. Alternatively, at least a portion of the marking may be located at an axial position corresponding to a predetermined potential length of the expandable device, such as... Figures 95B to 95D As shown in the figure (labeled "L1", "L2", "L3", "L4", etc.). In exemplary embodiments, "L1", "L2", "L3", and "L4" may correspond to expandable device lengths of 55 mm, 70 mm, 85 mm, and 100 mm, respectively, but the labels may alternatively correspond to any suitable predetermined length of the expandable device for implantation. In some embodiments, such as Figure 95D As shown, some of the markings 8710 are equidistant and function to provide a scale measurement of the target airway, while some of the markings may additionally or alternatively correspond to a predetermined potential length of the expandable device (in... Figure 95D (In the examples, they are labeled "L1" and "L2").

[0436] As described above, in some embodiments, the delivery system may include a guide sleeve 8140 including a marker 8144, such that the guide sleeve 8140 serves as a size adjustment device. The guide sleeve 8140 can be advanced into the target airway, and visualization of the marker can help facilitate measurement of the target airway and / or help inform the selection of the length of the expandable device to be placed in the target airway, as described above.

[0437] In some embodiments, the size adjustment device may include wires. For example, such as Figure 93A As shown, the lead 8510 may include multiple markers 8512 along its length, for example, at the distal and / or proximal portions of the lead 8510. The lead can be advanced through a bronchoscope or robotic system to a target airway, and observation of the marker positions relative to airway features can be used to measure the target airway length and / or determine the appropriate length of an expandable device for treatment planning. Subsequently, as Figure 93B As shown, the inner sheath 8530 (containing an expandable device of the desired length) can be advanced along the guide wire to the target position, ensuring that the inner sheath 8530 is in the same position measured by the adjusting device guide wire 8510. The guide wire 8510 can remain in place or be removed once the inner sheath 8530 and the expandable device are in the desired target position and ready for deployment of the expandable device.

[0438] In some embodiments, the size adjustment device may be a separate extension component (e.g., a probe) that can be inserted via a bronchoscope. For example, such as Figure 94AAs shown, probe 8610 or other elongated components may include multiple markers 8612 (e.g., marker strips) along its length, such as at the distal and / or proximal portions of probe 8610. Similar to the lead wire 8510 described above, probe 8610 can be advanced through a bronchoscope or robotic system to a target airway, and observation of the position of the markers relative to airway features can be used to measure the target airway length and / or determine the appropriate length of the expandable device for treatment planning. For example, probe 8610 may be advanced into the target airway until the distal tip of probe 8610 contacts the pleura, and then retracted to the desired distance corresponding to where the distal end of the expandable device will be placed. Figure 94B Therefore, once the probe 8610 is positioned at the desired target location, the location of the marker 8610 can be used to identify the appropriate length of the expandable device for the target airway.

[0439] In some embodiments, the delivery system may include various types of size adjustment devices whose measurement information can be combined (e.g., averaged or cross-checked in comparison) to improve measurement accuracy and thus improve treatment planning.

[0440] E. mark

[0441] In some embodiments, the delivery system may include features to facilitate fluoroscopy, bronchoscopy, and / or other visualization during delivery and / or deployment of the expandable device. The elongated component, inner sheath, and / or outer sheath may include suitable visual markings and / or radiopaque markings (e.g., straps, inserts).

[0442] For example, in some embodiments, such as Figure 68A As shown, the tip of the elongated component may include a radiopaque marker 3492 (which may be made of a material, either otherwise or alternatively, intended for visual identification beyond fluorescent transparency). As another example, such as... Figure 68A As shown, the distal end of the inner sheath may include markings 3432 (e.g., radiopaque markings and / or visual markings) to facilitate estimation of the distal end of the expandable device during delivery and deployment.

[0443] In some embodiments, the delivery system may additionally or alternatively include pad-printed lines or other visual features (not shown) on the outer surface of the inner sheath. These features facilitate visualization during bronchoscopy. The pad-printed lines may be printed with colors that strongly contrast with the color of the inner sheath (e.g., light lines against a dark sheath). For example, a line may be aligned with the proximal end of the expandable device to indicate where the proximal end of the expandable device will be positioned relative to the airway region after deployment. Furthermore, different indicators may be used to indicate the proximal end of devices of different lengths. For example, one circumferential line may indicate the proximal end of a 70 mm device, two circumferential lines may indicate the proximal end of an 85 mm device, three circumferential lines may indicate the proximal end of a 100 mm device, and so on.

[0444] As another example, in some embodiments, the proximal end of the shaft portion of the delivery device may include one or more features to indicate the extent of insertion of the delivery device through the working channel of the bronchoscope. For example, such as Figure 77 As shown, the delivery system may include one or more marking strips 4210 (e.g., pad printing strips) axially spaced along the longitudinal axis of the delivery system shaft, wherein each marking strip indicates a corresponding insertion depth distance. At least some of the marking strips 4210 may be equidistant (e.g., spaced 1 cm apart), and / or at least some of the marking strips 4210 may be unequally spaced (e.g., a series of markings, wherein adjacent pairs of markings are sequentially spaced 1 cm, 5 cm, and 10 cm apart). Additionally or alternatively, in some embodiments, the delivery system may include markings on the shaft indicating the alignment of the tip of the delivery system with the end of the bronchoscope.

[0445] H. sensor

[0446] In some embodiments, the delivery system may include one or more sensors that function to provide information about the distance between the distal end of the delivery system (e.g., the distal end of an outer sheath, inner sheath, or extension on which the implant is mounted) and the pleura or chest wall, to help prevent unintentional tissue damage as a result of pleural puncture during advancement of the delivery system. For example, the sensors may be configured to measure the distance between the distal end of the delivery system and the pleura and communicate this distance information to the user (e.g., distance measurement, or whether the distal end of the delivery system is within a predetermined distance from the pleura, such as 5 mm, 10 mm, 15 mm, or 20 mm). In some embodiments, such as Figure 96 As shown, the delivery system 8800 may include such a sensor 8832 located at a distal end of the delivery system (e.g., the distal end of the inner sheath 8830, the distal end of the outer sheath, the distal end of the extension member). Alternatively, such a sensor may be located at a distal end of an implantable expandable device in the delivery system.

[0447] In some embodiments, the sensor does not require physical contact between the delivery system and the pleura to determine the distance to the pleura, which can advantageously prevent damage or adverse events (e.g., infection, irritation, pneumothorax) that could result from such contact. For example, in some embodiments, the sensor may include a proximity sensor, such as an ultrasonic sensor, an infrared sensor, and / or a laser displacement sensor. In some embodiments, sensor information may be transmitted wirelessly (e.g., via Bluetooth) or via a wired connection and may be communicated to the user in a visual mode (e.g., displayed on a monitor display on a console, such as a robot system console), an auditory mode (e.g., emitted tones or voice indicating distance information), a tactile mode (e.g., tactile feedback conveyed through the handle of the delivery system), and / or any suitable manner.

[0448] In some embodiments where the delivery system includes or does not include distance sensors, other techniques for determining the distance between the distal end of the delivery system and the pleura may be additionally or alternatively utilized. For example, the tip of the delivery system (e.g., the distal end of the outer sheath, inner sheath, extension member, lead, and / or sizing device) may be advanced distally into the airway until it contacts the pleura, and then retracted to the desired target location for implant deployment. As another example, the airway and pleura can be visualized by imaging during the implant delivery process, which allows the user to obtain a better view of the delivery system relative to the pleura. For example, imaging properties may be adapted to improve visualization of the airway and pleura, and / or contrast agents may be introduced into the patient to improve airway illumination during imaging (e.g., during fluoroscopy). Furthermore or alternatively, other imaging techniques (e.g., cone-beam CT) may be used to facilitate 3D reconstruction of patient tissue including the airway and pleura, and sensors, software, and / or delivery system accessories may be used in combination with cone-beam CT to assist in treatment location identification, device navigation, device sizing, and / or device placement.

[0449] It should be understood that other delivery systems are within the scope of this technology. Furthermore, the delivery system can be used with any of the expandable devices disclosed herein.

[0450] III. Scope of participation

[0451] As described above, expandable devices (such as each of the expandable devices described herein) can be configured to deliver a working channel through the bronchoscope. Figure 22Example bronchoscope 5200 is shown. As shown, bronchoscope 5200 may have a handle with an eyepiece or camera head 5202, a cable 5204 for a light source for image processing, a suction section 5206, and a working channel port 5208. The bronchoscope includes an elongated shaft 5210 configured to advance downward through the trachea to the lungs. Shaft 5210 includes several lumens, including a lumen 5216 for supporting a camera or fiber optic cable bundle, one or more lumens 5214 for supporting a light source, and an outlet for a working channel 5212. In some embodiments, the working channel lumen may have a diameter of about 3 mm or less, or about 2 mm or less. In some embodiments of the bronchoscope, in addition to or as an alternative to lumens 5214 and / or lumens 5216 for supporting a separate light source and a separate camera, a light source and / or camera may be embedded (e.g., a "chip-on-tip" variant).

[0452] During deployment, the bronchoscope's elongation shaft can be advanced through the trachea and bronchial tree (e.g., until the diameter of the elongation shaft approximately matches the diameter of the dilated airway and cannot be advanced further, although the location where the elongation shaft stops advancing may vary depending on the bronchoscope used). For a typical bronchoscope with a diameter of 5 to 6 mm, the stopping point in most patients will occur in the 3rd to 6th generation bronchus. The delivery system can then be advanced distally through the distal opening of the bronchoscope's working channel until the distal portion is positioned within the distal portion of the airway near the treatment site (e.g., in the terminal bronchioles and / or in emphysematous regions of damaged and / or collapsed airways), at which point the expandable device (implant) can be deployed from the delivery system (e.g., any of the delivery systems described herein).

[0453] In some embodiments, during such deployment, a flexible component or shaft of the delivery system can be inserted through the working channel 5212 of the bronchoscope. The outer sheath of the delivery system can be held in place relative to the bronchoscope (e.g., manually), for example, in a position adjacent to the working channel port 5208. Alternatively, in embodiments where the outer sheath of the delivery system is omitted (e.g., to reduce the overall outer diameter of the shaft of the delivery system), the handle (or an accessory coupled to the handle) can be directly and manually contacted to hold the extension component (and the expandable device mounted thereon) in place relative to the bronchoscope. The expandable device can then be deployed as described elsewhere herein (e.g., advancing the extension component and expandable device to a treatment position, retracting and / or advancing the inner sheath to expose the expandable device, and allowing the expandable device to transition to a radial expansion configuration). After the expandable device is deployed, the delivery system can be withdrawn from the bronchoscope, and the bronchoscope can also be withdrawn from the patient.

[0454] In some embodiments, in addition to or as an alternative to the user manually holding the delivery system relative to the bronchoscope, one or more mechanisms may physically lock the delivery system in place. In some embodiments, the handle or delivery system shaft may include or be coupled to a first mating assembly, and the bronchoscope may include or be coupled to a second mating assembly, wherein the first and second mating assemblies are configured to engage with each other and selectively lock to axially and / or rotatably restrict movement of the delivery system relative to the bronchoscope when locked in place.

[0455] Figure 78 and 79 This is an illustrative schematic diagram of an example of a static lock, wherein when lock 4410 is engaged, lock 4410 restricts axial and rotational movement of the delivery system relative to bronchoscope 5200. Lock 4410 includes a first component 4412 coupled to or integrally formed with a shaft, handle, or other suitable assembly to the delivery system 4400, and a second component 4414 coupled to or integrally formed with the bronchoscope. The first component 4412 may be configured to threadedly engage with the second component 4414 to couple the delivery system 4400 to the bronchoscope 5200. For example, lock 4410 may include mating Luer lock assemblies.

[0456] Figure 80 The diagram is an illustrative illustration of an example of lock 4510a, which is similar to lock 4410, except that the first component 4512a (which is coupled to or integrally formed with a shaft, handle or other suitable component of the delivery system) and the second component 4514a (which is coupled to or integrally formed with a bronchoscope) are engaged via a ball joint.

[0457] Figure 81 This is an illustrative schematic diagram of an example of lock 4510b, which is similar to lock 4410, except that the first component 4512b (which is coupled to or integrally formed with a shaft, handle or other suitable component of the delivery system) and the second component 4514b (which is coupled to or integrally formed with a bronchoscope) are connected and engaged with each other using a Tuohy Borst adapter.

[0458] Figure 82This is an illustrative schematic diagram of an example of lock 4510c, which is similar to lock 4410 except that the first component 4512c (coupled to or integrally formed with a shaft, handle, or other suitable component of the delivery system) and the second component 4514c (coupled to or integrally formed with a bronchoscope) are engaged with each other by a biasing mechanism. For example, the second component 4514c may be inserted into a container (e.g., sleeve, or bore) of the first component 4512c (or vice versa) to engage the first and second components together, and such engagement may be biased by a spring or other suitable biasing element (e.g., by a downward force on the first component 4512c, such as...). Figure 82 (as shown in the figure) to facilitate engagement of the first and second components. In some embodiments, at least one of the first and second components may additionally be laterally movable, such that in order to disengage the lock, the laterally movable component must additionally laterally shift out of alignment with its mating component.

[0459] In some embodiments, the mechanism for locking the delivery system in place relative to the bronchoscope may be coupled to or integrally formed with a shaft (or the handle of the delivery system or other suitable component) and directly engage with the bronchoscope. For example, as Figure 83 As shown, the plug 4910 may be coupled to or integrally formed with the handle of the delivery system 4900 and coupled to the working channel port 5208 of the bronchoscope via mechanical interoperation (e.g., snap-fit). For example, the plug 4910 may include an annular lip or edge that clamps the wall of the working channel port 5208. Alternatively, the plug 4910 may include a washer or O-ring that clamps or fits tightly against the inner wall of the working channel port 5208. Alternatively, a similar plug may be coupled to or integrally formed with the working channel port 5208 and coupled to the shaft (or handle or other suitable component) of the delivery system 4900 in a similar manner.

[0460] In some embodiments, the lock may be configured to restrict axial movement of the delivery system relative to the bronchoscope, but allow rotational movement. For example, as Figure 84As shown, the lock 5010 may include a mating ring arrangement between a first component 5012 (coupled to or integrally formed with a shaft, handle, or other suitable component of the delivery system) and a second component 5014 (coupled to or integrally formed with a bronchoscope). For example, the first component 5012 may include an outwardly projecting ring 5013 (or ring segment) configured to mate with an annular channel 5015 on the second component 5014. Once mated, the ring 5013 can travel within the channel 5015, which acts as a track, thereby allowing relative rotation between the first component 5012 and the second component 5014, and thus relative rotation between the handle and the bronchoscope. However, the range of relative axial movement between the handle and the bronchoscope may be limited by the amount of clearance or the tightness of the fit between the two components in the axial direction. In some embodiments, the second component 5014 may include an outwardly projecting ring (or ring segment) configured to mate with the annular channel of the first component 5012.

[0461] Alternatively, the lock may be configured to limit the axial movement of the delivery system relative to the bronchoscope to a certain range of axial movement, thereby enabling “fine-tuning” of the axial position of the expandable device mounted in the delivery system. For example, this can be useful for allowing the user to make some linear adjustments to the position of the expandable device even after the delivery device has been locked to the bronchoscope. For instance, in some embodiments, as the shaft of the delivery system extends through the working channel of the bronchoscope, the user can view one or more markings (e.g., visual marking strips) on the shaft via a bronchoscope examination camera, where one or more markings indicate the position of the implant (e.g., the proximal end of the implant). Once the delivery system is locked to the bronchoscope, it may be advantageous to allow the user to adjust the axial position of the extension within a certain linear range until one or more visual markings (and the implant) are located at the desired treatment position.

[0462] For example, such locks can contain any suitable mating components or features (e.g., similar to those mentioned above). Figures 78 to 84 Any one or more of the locks described, except that the lock may include an inner sheath coupled to the delivery device and a slider, knob, or other user interface element that travels within a longitudinal track whose length corresponds to the permissible range of axial travel adjustment. Figure 85 , 86A As shown in 86B, lock 5110 may contain, for example, similar to Figure 80The ball-and-socket connection arrangement shown includes, except for the user interface element 5116, which travels within a track 5114 of the first component (which is coupled to or integrally formed with the delivery device shaft). Axial movement of the user interface element 5116 causes axial movement of the delivery device shaft, and correspondingly causes axial adjustment of the visual marking 5122 on the inner shaft 5120, visible through a bronchoscope camera, indicating axial adjustment of the position of the implant I. Figure 86A and 86B yes Figure 85 The various side views of the locking arrangement depicted in the figure show that the user interface element 5116 can slide within a track 5114 on the first component 5112. Alternatively, the user interface element 5116 and the track 5114 may be located on a component (not shown) coupled to or integrally formed with the bronchoscope working channel port 5208.

[0463] Although the above-described coupling arrangements are primarily concerned with coupling the outer sheath to the bronchoscope, it should be understood that these coupling arrangements may also be included in embodiments in which the outer sheath is a guide sheath that can be selectively detached from the handle of the delivery system. For example, any of the features described above for achieving a fixed and / or adjustable engagement between the outer sheath and the bronchoscope may be incorporated or suitably modified to achieve a fixed and / or adjustable engagement between the guide sheath and the bronchoscope.

[0464] In additional configurations, the kit or fully integrated system may include an implant (e.g., as described elsewhere herein) loaded within a delivery system and a single-use, disposable bronchoscope (or robotic system). The bronchoscope may include many of the features described above, including a tip articulation (e.g., 90 to 180 degrees) and a working channel (e.g., having a diameter between approximately 2.0 mm and 2.8 mm), and may primarily consist of plastic and polymer components that allow for efficient disposal. The delivery system may be packaged together with the disposable bronchoscope or may be supplied separately.

[0465] In some embodiments, the delivery system (e.g., an inner sheath and / or an outer sheath) may be approximately matched in length to a disposable bronchoscope or robotic system such that, when the delivery system is fully inserted into the disposable bronchoscope or robotic catheter, the distal portion of the delivery system may be coupled to the distal portion of the disposable bronchoscope or robotic catheter, and the proximal portion of the delivery system may be coupled to the proximal portion of the disposable bronchoscope or robotic catheter (e.g., at the biopsy port or opening of the working channel). For example, the length of the inner sheath and / or outer sheath may be adapted to the length of the disposable bronchoscope (or robotic catheter) such that the proximal end of the implant is adjacent to the distal end of the distal end of the disposable bronchoscope (or robotic catheter). The inner or outer sheath of the delivery system may be coupled via a suitable connector (e.g., a Luer connector or other suitable mechanical fastener) to form a connection between the delivery system and the disposable bronchoscope or robotic system during implant deployment. Therefore, the delivery system and the disposable bronchoscope or robotic system can be manipulated together, allowing the user to operate the two components as a single system, which helps improve the deployment accuracy and predictability of the expandable device. In some embodiments, the coupler may allow a range of relative axial movement to allow for some adjustments to the implant position relative to the distal end of the disposable bronchoscope or robotic catheter prior to implant deployment. For example, a coupler connecting the delivery system to the disposable bronchoscope or robotic catheter may be similar to any of the couplers herein relating to coupling the outer sheath to the bronchoscope (e.g., regarding...). Figures 78 to 86B (As described).

[0466] In additional configurations, the kit or fully integrated system may include an implant loaded within an inner sheath coupled to the handle (e.g., as described elsewhere herein), and a guide sheath (e.g., as described elsewhere herein) selectively and / or removably coupled to the handle. The guide sheath may be packaged together with the inner sheath, handle, and implant, or may be supplied in a separate package. In some embodiments, the kit may further include a single-use disposable bronchoscope having many of the features described above, including a tip articulation (e.g., 90 to 180 degrees) and a working channel (e.g., having a diameter between about 2.0 mm and 2.8 mm), and may primarily comprise plastic and polymer components that allow for efficient disposal. The disposable bronchoscope may be packaged together with its implant-loaded delivery system, or may be supplied in a separate package.

[0467] refer to Figures 56A to 56CIn some embodiments, the implant may include a minimal wire support with a curved shape that positions the support at radially opposing surfaces and has a wireless access window. The access window can be used for diagnostic or therapeutic interventions to access tissue through the access window. For example, a patient may have a collapsed airway in an area where a physician expects to obtain tissue samples to diagnose a nodule; or to perform a cancer intervention, such as ablation. In other embodiments, the implant is used to stabilize a narrowed or constricted airway during preparation for treatment. For example, in other pathologies of COPD (e.g., bronchitis), the airway diameter may be narrowed and / or highly variable due to inflammation, wall thickening, and / or smooth muscle contraction. The implant can be used to support portions of the airway targeted for COPD treatment (e.g., thermal lung denervation, pulsed field ablation, etc.).

[0468] The access window may be located in the middle section of the implant, with the distal and proximal sections having scaffold wires arranged to contact radially opposing surfaces. The proximal and distal sections help maintain patency of the lumen surrounding the middle section, facilitating tissue access through the access window. Alternatively, the access window may be located in the proximal section of the implant, with only the distal section having scaffold wires arranged to contact radially opposing surfaces. This design can offer the advantage of maintaining patency in some cases while providing a larger access window. Alternatively, the access window may be located in the distal section of the implant, with only the proximal section having scaffold wires arranged to contact radially opposing surfaces. This design can offer the advantage of maintaining patency in some cases while providing a larger access window. Alternatively, the access window may be the same length as the implant, i.e., the implant may not have a fully circumferential proximal or distal section.

[0469] Implants have features designed to enhance medical imaging, such as echogenic or radiopaque coatings or markings.

[0470] The implant can be resized to enlarge the airway in the target airway location to facilitate access to the surface of the airway and thus to tissue on or beneath the surface. By enlarging the airway, the surface of the airway can be moved closer to the target tissue that is not on the surface, which can facilitate diagnosis or treatment of the target tissue.

[0471] The implant may be doped with a drug intended to treat the target tissue. The drug may be designed for slow release over time.

[0472] An implant with an access window may have a longitudinal segment containing the access window and a longitudinal segment without the access window. The implant may have a filament that is elastically resilient and shaped to conform to the inner surface of a cylinder. In the longitudinal segment without the access window, the filament may conform to radially opposite points around the circumference of the cylinder. In the longitudinal segment with the access window, the filament may conform to points around a portion of the circumference of the cylinder. The access window may be a space defined by the filament formed as the implant, wherein the space occupies the surface of the cylinder in the portion without the filament. The access window may have a length along the longitudinal axis ranging from 10 mm to 30 mm, and an arc ranging from 25% to 50% as part of the circumference.

[0473] An implant with an access window can be delivered via a delivery sheath having a delivery lumen for receiving the implant in a contractile delivery configuration, wherein the delivery sheath has an indicator of the implant's rotational orientation. The indicator may indicate the radial direction the access window will face when deployed from the delivery sheath. The indicator may be a visual marker, visible through direct visualization via a bronchoscope camera or via a camera on a robotic delivery scope; for example, the visual marker may be visually distinguishable from the rest of the delivery sheath's surface (e.g., different color, different physical profile, protrusion, notch). The indicator may be detected by a sensor, allowing the robotic system to detect the rotational orientation. For example, the sensor may be an electrical sensor containing rotationally distinguishable electrical signals, such as a capacitor plate, which may be capable of very fine resolution (e.g., resolution of one degree of rotation, or one-tenth of a degree of rotation). The electrical sensor may interface with the robotic system, allowing the robot to precisely control the rotational orientation of the delivery sheath. The robotic system may have a user interface displaying relative rotational orientation, where the user can select a desired change in rotational orientation (e.g., a defined amount of clockwise or counterclockwise rotation, or rotation to a defined angle relative to the current rotational orientation). The robotic system may be adapted to accurately rotate the distal region of the delivery sheath by an amount defined by the user or by a target algorithm to radially position the access window toward the target tissue. The robotic system can rotationally orient the distal region of the delivery sheath by manipulating the proximal region of the delivery sheath and algorithmically taking into account curvature within the sheath. Alternatively or further, the robotic system can rotationally orient the distal region of the delivery sheath by manipulating the distal region of the sheath relative to the proximal region of the sheath.

[0474] Methods using implants with access windows may include manual delivery and deployment, such as via a bronchoscope. Alternatively or additionally, robotic systems may be used for delivery and deployment of implants, which may offer certain benefits as discussed herein. Method steps may include:

[0475] In vitro medical imaging is used to identify target tissue located at or near the target airway. This step may include in vivo diagnostic procedures, such as robotically delivered devices, to assess direct vision, ultrasound, or gas analysis.

[0476] The implant with an access window is delivered to the target airway location, optionally using a robot-assisted delivery system, such as the robot-assisted delivery system disclosed herein;

[0477] The implant is rotated and oriented prior to deployment, for example, to position the access window in the radial direction of the target tissue. This may include a distal region of a rotational delivery sheath to guide the deployment of the implant, such that the access window faces the target tissue (e.g., by a user, by a robotic system, or by a robotic system using a delivery sheath adapted for rotational orientation).

[0478] Deploying the implant from the delivery sheath transforms the implant from a contractile delivery configuration to an expanded deployment configuration, wherein the access window is guided radially toward the target tissue, and the implant expands the airway to facilitate access to the access window.

[0479] Delivering diagnostic devices (such as biopsy devices or cell brushes) to the target airway location can be accomplished via a delivery sheath positioned appropriately. The delivery sheath can be a robot-controlled sheath.

[0480] Before deploying the biopsy needle, confirm the deployment trajectory of the biopsy device, for example, by using the navigation features of the robotic system;

[0481] Deploying diagnostic devices (e.g., biopsy needles) into target tissue;

[0482] Remove tissue samples obtained from the diagnostic device;

[0483] When evaluating tissue samples, leave the implant in the appropriate location as a baseline marker;

[0484] If the tissue sample is benign, it can be returned to the implanted device to retrieve it from the patient (e.g., this can be done by a robotic system that can store the target location or path in its memory and use robotic control to return to the location based on the stored location or path), or left in place, which can improve the patient's breathing ability.

[0485] If the tissue sample is malignant, then the treatment is returned to the implanted implant (e.g., robotically) to provide treatment to the target tissue, such as tissue ablation, drug injection, or other means of treating the disease, where treatment can be delivered through an access window, which can facilitate the process by maintaining or enlarging the airway, exposing the target tissue, or reducing the distance between the airway surface and the target tissue.

[0486] Following tissue treatment, the delivery sheath can be removed from the patient, and the implant can remain in place, which can be used to deliver medication to the area for an extended period (e.g., weeks, months), such as to further treat malignant tissue or treat postoperative complications (e.g., infection). The implant can be used as a reference marker for later return to the target location to reassess the tissue (e.g., a robotic system can be used to deliver a diagnostic device to the target location) or to retrieve the implant. Alternatively, the implant can be removed from the patient after tissue treatment, while the delivery sheath (e.g., a robotic delivery sheath) remains in the patient's body.

[0487] IV. Robotic system for delivering intrabronchial implants

[0488] Traditional bronchoscopy methods are insufficient to reach and diagnose most regions of interest located in the peripheral airways. In contrast, robotic bronchoscopy provides physicians with a degree of precision and control, enabling visualization and access to such distal portions of the lung that were previously inaccessible. As detailed below, this technology includes a robotic system configured for use with the delivery systems and implants disclosed herein.

[0489] Figure 49 A robotic system 100 according to several embodiments of the present technology is illustrated. The robotic system 100 can be used with any of the delivery systems disclosed herein to deliver and deploy one or more implants of the present technology to a treatment site within the peripheral airway. Figure 49 As shown in the illustrations, in some embodiments, the robot system 100 includes one or more bases 110, a display 120, a user interface 130, one or more positioning arms 140, one or more instrument drivers 150, and articulated instruments 160. The robot system 100 may optionally include one or more probes 180, as detailed herein.

[0490] The base 110 of the robotic system 100 may include a power supply, processor, memory, and other control circuitry and electronics. In some embodiments, the arm 140 is directly coupled to and extends from the base 110, and in other embodiments, the arm 140 is coupled to a separate console and / or support structure. For those embodiments in which the arm 140 is coupled to the base 110, the base 110 may include a power supply, actuators, and / or motors configured to power and drive the arm 140. In some embodiments, the base 110 may be movable (e.g., mounted on wheels) and configured to move via the wheels to a desired location near the patient. The base 110 may be positioned in different locations within the operating room depending on space requirements and the need to facilitate the proper placement and movement of the articulated instrument 160 relative to the patient.

[0491] Display 120 can be configured to convey various information to a user, such as navigation information, robot system status, endoscopic views of the lungs, etc. Display 120 can be mounted to base 110 or detached from base 110. In some embodiments, user interface 130 is disposed on display 120. In other embodiments, user interface 130 is detached from display 120. Display 120 may be a touchscreen or not. Display 120 may be a light-emitting diode (LED) screen, an organic light-emitting diode (OLED) screen, a liquid crystal display (LCD) screen, a plasma screen, or any other type of screen.

[0492] User interface 130 enables the user to control various components of the robot system, such as the arm 140 (if under robot control), instrument actuator 150, and / or the movement of articulated instrument 160. For example, user interface 130 may be a handheld controller, a wheel, a ball, a joystick, a button, a touchscreen, etc.

[0493] The positioning arm 140 is configured to movably support the instrument driver 150 to provide convenient access to the desired portion of the patient's body (e.g., peripheral airway) and to provide a means of locking the instrument driver 150 into place after preferred placement. The arm 140 can be moved manually, via robot-assisted movement, or both. In some embodiments, the arm 140 includes a series of rigid links coupled by electronically actuated joints that prevent joint movement when powered and allow joint movement when energized by a control system (e.g., a switch or computer interface). In some embodiments, the rigid links are coupled by mechanically lockable joints that can be manually locked and unlocked using, for example, locking pins, screws, or clamps. The robot system 100 may include a single arm or multiple arms (e.g., two arms, three arms, etc.). In some variations, the arm 140 is mounted on a base 110. In other variations, the arm 140 is mounted on a separate base and / or other console. In still other embodiments, the arm 140 may be mounted on a tabletop or to a ceiling, sidewall, or other suitable support surface.

[0494] Instrument driver 150 may be located at the distal portion of arm 140 and configured to be releasably coupled to articulated instrument 160 to drive, support, position, and / or control the movement and / or operation of one or more components of articulated instrument 160 and / or one or more instruments delivered via the working channel of articulated instrument 160 (e.g., any of the delivery systems disclosed herein). For example, instrument driver 150 may be configured to control the rotation, translation, and / or articulation of one or more components of articulated instrument 160 and / or via the delivery system received therefrom. In some embodiments, instrument driver 150 includes one or more actuators (e.g., rotary actuators, linear actuators, belt and pulley systems, magnetic actuators, harmonic actuators, gear actuators, etc.) configured to be operatively coupled directly or via mechanical linkage to the proximal portion of articulated instrument 160. In any case, the articulated instrument 160 can be articulated 130 to 180 degrees in any direction via actuation of the instrument driver 150 and / or any associated linkage.

[0495] The articulated instrument 160 may include an extension portion having a proximal portion configured to couple to an instrument driver 150 and a distal portion configured to be positioned within a peripheral portion of the bronchial tree. The extension portion may include a working channel extending therethrough, the working channel being configured to receive one or more components of a delivery system of the present technology. For example, the working channel may be configured to receive an inner sheath of an implant delivery system (e.g., delivery system 2400, or other variations of implant delivery systems such as those described herein), and in some cases, to receive all or part of an outer sheath of the implant delivery system. As another example, the working channel may be configured to receive a guide sheath (e.g., guide sheath 8140, or other variations of guide sheaths such as those described herein), and / or an airway or implant size adjustment device (e.g., size adjustment device 8510 or size adjustment device 8610, or other variations of size adjustment devices such as those described herein). In some embodiments, the articulated instrument 160 includes a single elongated member, and in some embodiments, the articulated instrument 160 includes two or more elongated members. For example, the articulated instrument 160 may include first and second elongated members. The first elongated member may define a lumen therethrough, and the second elongated member may be configured to be slidably received within the lumen of the first elongated member. The second elongated member may define a working channel. The first and second elongated members may be coupled to the same instrument driver 150 or different instrument drivers 150. In some embodiments, in addition to the working channel, the articulated instrument 160 and / or the elongated members further include one or more lumens.

[0496] In some embodiments, the articulated instrument 160 may include one or more sensors embedded or otherwise at least partially disposed within the elongated member. The sensors may be configured to obtain data indicating the position of the elongated member relative to an anatomical structure. In some embodiments, the sensors are disposed only at the distal portion of the elongated member. Alternatively, the sensors may be disposed in other areas of the elongated member. The sensors may include, for example, one or more electromagnetic (EM) sensors, one or more multi-core fiber optic shape sensors, one or more ultrasonic sensors, etc. The articulated instrument 160 may incorporate image sensors (e.g., cameras for HG-level imaging, CCDs (charge-coupled devices), and CMOS (complementary metal-oxide-semiconductor), whether integrated with the elongated member or including separate image sensors that can be inserted through a working channel or other lumen of the articulated instrument 160. According to some embodiments, in addition to or instead of embedded sensors, the articulated instrument 160 may include one or more sensors disposed on the outer s...

Claims

1. A robotic system for treating a human individual suffering from emphysema, the system comprising: A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface; An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes an extension member having a proximal portion coupled to the instrument driver, a distal portion configured for positioning in the bronchial airway of the human individual, and a working channel extending from the proximal portion to the distal portion. An implant delivery system configured for intracavitary delivery via the working channel of the elongated member to a treatment site in the bronchial airway of the human individual, the implant delivery system comprising: Implants, including: Proximal portion; distal portion, which is spaced apart from the proximal portion along the longitudinal axis of the implant; and The middle portion, which is located along the longitudinal axis between the proximal portion and the distal portion; and A wire extending along a continuous wire path coaxially aligned with the longitudinal axis, wherein the wire path at an intermediate portion comprises at least three complete turns around the longitudinal axis. A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once the implant is delivered to the treatment site; The implant, when in the expanded deployment configuration, represents a tubular shape with a total surface area, and the wires are configured to occupy no more than 20% of the total surface area of ​​the tubular shape.

2. The robot system of claim 1, wherein the filament is configured to occupy no more than 5% of the total surface area of ​​the tubular shape.

3. The robot system according to claim 1 or 2, wherein: The articulated instrument further includes an elongated sheath defining a lumen configured to slidably receive the elongated component passing through it. The instrument driver is the first instrument driver. The arm in question is the first arm. The robot system further includes: Second arm, A second instrument driver, configured to couple to the elongated sheath and the second arm. Navigation system, which includes electromagnetic sensors, and A camera, which is integrated with the elongated component and configured for optical pattern recognition.

4. The robot system according to any one of claims 1 to 3, wherein the arm is a single arm, and the elongation member (a) has an outer diameter of 3.5 mm, and (b) includes a multi-core fiber optic shape sensor for active control.

5. The robotic system according to any one of claims 1 to 4, wherein the arm is a single arm, and the elongation member includes an integrated camera at its distal portion, and wherein the robotic system further includes a processor configured to cover the treatment location with real-time fluorescence fluoroscopic images and / or video.

6. The robotic system according to any one of claims 1 to 5, wherein the articulated instrument is a bronchoscope.

7. The robotic system according to any one of claims 1 to 6, further comprising a probe configured to be delivered to the airway via the working channel of the articulated instrument.

8. The robotic system of claim 7, wherein the probe is configured to apply suction to the airway.

9. The robot system of claim 8, wherein the probe includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

10. The robot system according to any one of claims 7 to 9, wherein the probe includes a camera at its distal end.

11. The robot system according to any one of claims 7 to 9, wherein the probe includes a flow sensor configured to measure airflow in the airway.

12. The robot system according to any one of claims 1 to 11, wherein: The articulated instrument further includes an elongated sheath defining a lumen configured to slidably receive the elongated component passing through it. The instrument driver is the first instrument driver. The arm in question is the first arm. The robot system further includes a second arm and a second instrument driver configured to couple to the elongated sheath and the second arm.

13. The robot system of claim 12, further comprising a probe configured to be coupled to the second instrument driver.

14. The robotic system of claim 12 or 13, wherein the probe is configured to apply suction to the airway.

15. The robotic system of claim 14, wherein the probe includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

16. The robotic system according to any one of claims 12 to 15, wherein the probe includes a camera at its distal end.

17. The robotic system according to any one of claims 12 to 16, wherein the probe includes a flow sensor configured to measure airflow in the airway.

18. A method for improving lung function in a human individual, the method comprising: Robotically moving an elongated component within the bronchial tree of the individual toward a treatment location adjacent to emphysematous tissue, wherein the elongated component defines a working channel, and wherein, as the elongated component is advanced, an implant is positioned in a low-profile state within the working channel, the implant comprising: A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and A wire extending along a continuous wire path coaxially aligned with the longitudinal axis, wherein the wire path at an intermediate portion comprises at least three complete turns around the longitudinal axis. The implant is configured to allow mucociliary clearance from a position immediately adjacent to the distal end of the implant to a position immediately adjacent to the proximal end of the implant when the implant is deployed at the treatment location, and to transform the implant from the low-profile state to an expanded deployment state at the treatment location, wherein transforming the implant includes expanding the implant to be juxtaposed with the airway wall at the treatment location.

19. The method of claim 18, wherein the proximal portion of the elongated member is coupled to an instrument driver of the robot system.

20. The method of claim 18 or 19, further comprising advancing the implant through a distal opening of the working channel of the elongated member via robot control.

21. The method of claim 18 or 19, further comprising manually advancing the implant through the distal opening of the working channel.

22. The method of claim 18, wherein: During delivery, the implant is positioned on the actuating component, and both the implant and the actuating component are housed within a protective sheath. The sheath is configured to be slidably positioned within the working channel, and The method further includes robotically advancing the sheath and pushing components through the distal opening of the working channel under robot control.

23. The method of claim 22, further comprising, after robotically advancing the sheath and the actuating component, robotically retracting the sheath relative to the actuating component to deploy the implant.

24. The method of claim 18, wherein: During delivery, the implant is positioned on the actuating component, and both the implant and the actuating component are housed within a protective sheath. The sheath is configured to be slidably positioned within the working channel, and The method further includes manually advancing the sheath and pushing components through the distal opening of the working channel under robot control.

25. The method of claim 24, further comprising, after manually advancing the sheath and the pushing member, manually retracting the sheath relative to the pushing member to deploy the implant.

26. The method according to any one of claims 17 to 25, wherein the elongated member includes a shape sensor configured to provide navigation guidance to a user.

27. The method according to any one of claims 17 to 26, wherein the elongating member comprises an electromagnetic sensor.

28. The method according to any one of claims 17 to 27, wherein the elongated component comprises a multi-core optical fiber.

29. The method according to any one of claims 17 to 28, wherein the elongating member comprises a plurality of pull wires extending along the length of the elongating member, and wherein manipulation of the pull wires causes hinge of the distal portion of the elongating member.

30. The method according to any one of claims 17 to 29, wherein the elongated member includes an image sensor at its distal portion.

31. The method according to any one of claims 17 to 30, further comprising propelling the imaging device through the working channel of the elongated member.

32. The method according to any one of claims 17 to 31, further comprising advancing the restrained implant within the sheath up to 150 mm beyond the distal opening of the working channel.

33. The method of any one of claims 17 to 32, wherein the implant is placed on a pusher during delivery, and the implant and the pusher are placed within a sheath, wherein the sheath includes a visual marker indicating the proximal position of the implant housed in the sheath in a delivery state, the method further comprising positioning the visual marker proximal to a target airway location while viewing the visual marker via an imaging device.

34. The method of any one of claims 17 to 33, wherein during delivery the implant is positioned on a pusher, and the implant and the pusher are positioned within a sheath, wherein the sheath includes a visual marker positioned at a distance from the distal tip of an intermediate sheath, the distance corresponding to the working length of the working channel, and wherein the method includes advancing the delivery system through the working channel until the visual marker is aligned with the proximal end of the working channel, and then advancing the delivery system away from the working channel to an extension length, the extension length being at least the length of the delivery state.

35. A method for improving lung function in a human individual, the method comprising: Robotically moving an elongated component within the bronchial tree of the individual toward a treatment location near emphysematous tissue, wherein the elongated component defines a working channel, and wherein, as the elongated component is advanced, the implant is positioned in a low-profile state within the working channel; and Transforming the implant from the low-profile state to an expanded deployment state at the treatment site, such that the distal end of the implant is deployed within an airway at least one generation larger than the airway in which the proximal end is deployed, and wherein transforming the implant includes expanding the implant to juxtapose it with the airway wall at the treatment site.

36. The method of claim 35, further comprising propelling a probe through the working channel, wherein the probe includes at least one sensor.

37. The method of claim 36, further comprising identifying the treatment location at least in part based on information from the at least one sensor.

38. The method of claim 37, wherein the information indicates the disease state of the airway wall.

39. The method according to any one of claims 35 to 38, wherein the at least one sensor comprises one or more of a pressure sensor, an optical sensor, an image sensor, a flow sensor, a proximity sensor, a contact sensor, an ultrasonic sensor, a MEMS stiffness sensor, or an infrared sensor.

40. A robotic system for treating a human individual suffering from emphysema, the system comprising: A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface; An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes an extension member having a proximal portion coupled to the instrument driver, a distal portion configured for positioning in the bronchial airway of the human individual, and a working channel extending from the proximal portion to the distal portion, wherein the working channel of the extension member is configured to accommodate a treatment location for intraluminal delivery of an implant delivery system into the bronchial airway of the human individual, the implant delivery system comprising: Implants, including: Proximal portion; distal portion, which is spaced apart from the proximal portion along the longitudinal axis of the implant; and The middle portion, which is located along the longitudinal axis between the proximal portion and the distal portion; and A wire extending along a continuous wire path, the wire having an untethered proximal end at the proximal portion and an untethered distal end at the distal portion; and A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once the implant is delivered to the treatment site; The implant, when in the expanded deployment configuration, represents a tubular shape with a total surface area, and the wires are configured to occupy no more than 20% of the total surface area of ​​the tubular shape.

41. The system of claim 40, wherein the wire comprises a single wire.

42. The system of claim 40 or 41, wherein the ratio of the radial spring constant to the longitudinal spring constant of the implant is between about 10:1 and about 80:

1.

43. The system according to any one of claims 40 to 42, wherein the ratio of the radial spring constant of the implant, in Newton-meters, to the longitudinal shear modulus of the implant, in Pascals, is between about 0.005 and about 0.

100.

44. An implant delivery system configured for placement in the peripheral lung of a patient with emphysema via a robotic navigation system, the implant delivery system comprising: Implants, including: A proximal portion; a distal portion spaced apart from the proximal portion along the longitudinal axis of the implant; and an intermediate portion located between the proximal and distal portions along the longitudinal axis; and A wire extending along a continuous wire path, the wire having an untethered proximal end at the proximal portion and an untethered distal end at the distal portion; and A delivery system configured to hold the implant in a low-profile configuration and to convert the implant into an expanded deployment configuration once it has been delivered to the treatment site. The delivery system is sized and configured for delivery into the peripheral lung via a robotic navigation system, the robotic navigation system comprising: A workstation for engaging with and receiving instructions from a treatment provider, wherein the workstation includes a display and a user interface; An arm operably communicating with the workstation, the arm including an instrument driver and an articulated instrument, wherein the articulated instrument includes a working channel configured to receive from the delivery system.

45. The system of claim 44, wherein the wire comprises a single wire.

46. ​​The system of claim 44 or 45, wherein the ratio of the radial spring constant to the longitudinal spring constant of the implant is between about 10:1 and about 80:

1.

47. The system according to any one of claims 44 to 46, wherein the ratio of the radial spring constant of the implant, in Newton-meters, to the longitudinal shear modulus of the implant, in Pascals, is between about 0.005 and about 0.

100.

48. A diagnostic probe for accessing a patient's lung via a robotic navigation system to facilitate endobronchial treatment, the robotic navigation system comprising articulated instruments and instrument drivers, the diagnostic probe comprising: An elongated member having a proximal portion coupled to the instrument driver and a distal portion configured to be received in the working channel of the articulated instrument; and A sensor is disposed on the distal portion of the elongated member and configured to provide diagnostic information about the tissue of the lung.

49. The diagnostic probe of claim 48, wherein the probe is configured to apply suction to the airway of the lung.

50. The diagnostic probe of claim 49, wherein the sensor includes a flow sensor, and wherein the flow sensor is configured to measure airflow when suction is applied in the airway.

51. The diagnostic probe according to any one of claims 48 to 50, wherein the sensor comprises one or more of a pressure sensor, an optical sensor, an image sensor, a flow sensor, a proximity sensor, a contact sensor, an ultrasonic sensor, a MEMS stiffness sensor, or an infrared sensor.

52. The diagnostic probe according to any one of claims 48 to 51, wherein the probe is configured to measure one or more of the following: static ventilation / perfusion (VQ) ratio across different points of interest in the lung, dynamic VQ ratio across different points of interest in the lung, static airflow, dynamic airflow, static pressure, dynamic pressure, static airflow resistance, or dynamic airflow resistance.

53. The diagnostic probe according to any one of claims 48 to 52, wherein the probe is configured to measure one or more pulmonary function test (PFT) measures from within the lung.

54. The diagnostic probe according to any one of claims 48 to 53, wherein the probe is configured to apply virtual or physical tags to points of interest in the lung.

55. The diagnostic probe of claim 54, wherein the point of interest includes diseased tissue.

56. The diagnostic probe according to any one of claims 48 to 55, wherein the probe is configured to determine the proximal boundary of emphysematous parenchyma in the lung.

57. The diagnostic probe according to any one of claims 48 to 56, wherein the probe is configured to generate a real-time mapping of the airway diameter in the lung.

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