Systems, devices and methods for performing percutaneous tracheotomy

Abstract

Described herein are devices, systems, and methods for providing percutaneous tracheotomy. In some embodiments, the system may include an inflation assembly and a guidewire assembly. The inflation assembly may include an elongate tube, an inflatable member, and a magnetic member. The elongate tube may have a first end, a second end, and may define a lumen. The inflatable member may be coupled to the first end of the elongate tube and fluidly coupled to the lumen, such that the inflatable member can receive fluid via the lumen. The magnetic member may be coupled to the first end of the elongate tube, such that movement of the magnetic member can cause corresponding movement of the first end of the elongate tube. The first end of a guidewire of the guidewire assembly may include a coupling member, the coupling member configured to couple to the inflatable member, such that translation of the elongate tube translates the guidewire assembly.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of International Patent Application PCT / US Patent Application Publication No. 19 / 34943, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," filed May 31, 2019, which claims priority to and benefit of U.S. Provisional Patent Application No. 62 / 679,282, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," filed June 1, 2018, and U.S. Provisional Patent Application No. 62 / 728,450, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," filed September 7, 2018, and which claims priority to and benefit of U.S. Provisional Patent Application No. This application is a continuation-in-part of, and claims priority to and benefit of, U.S. Patent Application Publication No. 17 / 108,200, entitled "Tracheostomy," the entire contents of each of which are expressly incorporated herein by reference for all purposes.

[0002]

[0002] U.S. Patent Application Publication No. 17 / 108,200 also claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 040,921, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," filed June 18, 2020, and U.S. Provisional Patent Application No. 63 / 112,921, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," filed November 12, 2020, the entire contents of each of which applications are expressly incorporated herein by reference for all purposes.

[0003]

[0003] This application is related to International Patent Application PCT / US Publication No. 19 / 29351, filed April 26, 2019, entitled "Systems, Apparatus, and Methods for Placing a Guidewire for a Gastrostomy Tube," International Patent Application PCT / US Publication No. 17 / 026141, filed April 5, 2017, entitled "Method and Apparatus for Coaptive Ultrasound Gastrostomy," and International Patent Application PCT / US Publication No. 14 / 34950, filed April 22, 2014, entitled "Coaptation Ultrasound Devices and Methods of Use," the entire contents of each of which are expressly incorporated herein by reference for all purposes.

[0004] background

[0004] The embodiments described herein relate to systems, devices and methods for performing a percutaneous tracheostomy to provide access to a patient's trachea via a pathway through the patient's neck. [Background technology]

[0005] Tracheotomy can be beneficial for patients suffering from medical conditions that impair their ability to breathe. Percutaneous tracheotomy is often preferred because it is safer and less expensive than open surgical tracheotomy procedures. Percutaneous tracheotomy generally requires puncturing the anterior portion of the patient's trachea and inserting a guidewire using the Seldinger technique. The entry site used for the puncture and subsequent guidewire insertion is usually between the first and second tracheal rings or between the second and third tracheal rings. To accomplish this, several percutaneous tracheotomy techniques have been developed, including the Ciaglia technique (continuous or single-stage dilation), the Griggs technique (wire clamp), and the translaryngeal tracheotomy ("TLT" or Fantoni) technique.

[0006]

[0006] Identifying the ideal site for tracheal puncture can be difficult, so clinicians often use advanced tools such as ultrasound and bronchoscopy to identify important anatomical landmarks to inform the ideal tracheal puncture location. Ultrasound can be used to identify the tracheal rings, proximal vessels, and thyroid isthmus, but ultrasound cannot visualize the posterior trachea, potentially placing patients undergoing tracheal puncture at risk for posterior tracheal wall injury. Bronchoscopy can potentially block the airway and impede airflow in patients with already compromised respiratory capacity. Bronchoscopy is also known to have issues with sterility, reliability, and ready availability, which can significantly increase the cost of percutaneous tracheotomy. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0007] Therefore, there is a need for systems, devices and methods for performing percutaneous tracheostomy that reduce risk to the patient and allow percutaneous tracheostomy to be performed quickly and easily. [Means for solving the problem]

[0008] overview

[0008] Systems, devices, and methods for performing percutaneous tracheotomy are described herein. In some embodiments, the system includes an inflation assembly and a guidewire assembly. The inflation assembly may include an elongate tube, an inflatable member, and a magnetic member. The elongate tube may have a first end, a second end, and may define a lumen. The inflatable member may be coupled to the first end of the elongate tube and may be fluidly coupled to the lumen such that the inflatable member can receive fluid via the lumen. The magnetic member may be coupled to the first end of the elongate tube such that movement of the magnetic member can cause corresponding movement of the first end of the elongate tube. The guidewire assembly may include a guidewire having a first end and a second end. The first end of the guidewire assembly may include a coupling member configured to couple to the inflatable member such that translation of the elongate tube translates the guidewire assembly. [Brief explanation of the drawings]

[0009] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] 1 is a schematic diagram of a guidewire placement system according to one embodiment. [Figure 2A]

[0010] FIG. 1 is a schematic diagram of a front view of a portion of the human anatomy. [Figure 2B]

[0010] FIG. 1 is a schematic diagram of a cross-sectional side view of a portion of the human anatomy. [Figure 2C]

[0011] 2 is a schematic diagram of a cross-sectional side view of a portion of the human anatomy engaged with a portion of the guidewire placement system of FIG. 1, according to one embodiment. [Figure 3A]

[0012] 1 is a schematic diagram of a guidewire placement system at a stage of operation, according to one embodiment. [Figure 3B] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3C]1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3D] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3E] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3F] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3G] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3H] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3I] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3J] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3K] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3L] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 3M] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 4]

[0013] 1 is a schematic diagram of a guidewire placement system according to one embodiment. [Figure 5]

[0014] 1 is a schematic diagram of a guidewire placement system according to one embodiment. [Figure 6]

[0015] 1 is a schematic diagram of a guidewire placement system according to one embodiment. [Figure 7]

[0016] 1 is a flowchart of a method according to one embodiment. [Figure 8]

[0017] FIG. 1 is a diagram of an endotracheal tube inserted between the vocal cords in a patient's trachea. [Figure 9]

[0018] 1 is a schematic diagram of an endotracheal tube placed in a patient's trachea. [Figure 10]

[0019] FIG. 1 is a schematic diagram of an endotracheal tube positioned in a patient's trachea, including a guidewire placement system delivered through the larynx by a paired delivery technique. [Figure 11]

[0020] 1 is a schematic diagram of a guidewire placement system according to one embodiment. [Figure 12A]

[0021] 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 12B]

[0021] FIG. 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 12C]

[0021] FIG. 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 12D]

[0021] FIG. 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 12E]

[0021] FIG. 1 is a schematic diagram of a guidewire placement system at one stage of operation, according to one embodiment. [Figure 13]

[0022] 1 is a flowchart of a method according to one embodiment. [Figure 14A]

[0023] FIG. 1 is a view of an inflamed larynx without an endotracheal tube inserted through the larynx. [Figure 14B]

[0023] FIG. 1 is a diagram of an inflamed larynx with an endotracheal tube inserted through the larynx. [Figure 15]

[0024] 1 is a table showing dimensions of different sized endotracheal tubes suitable for various patients. [Figure 16]

[0025] 1 is a schematic diagram of a guidewire placement system delivered through a patient's larynx relative to an endotracheal tube via a paired delivery technique, according to one embodiment. [Figure 17]

[0026] 1 is a schematic diagram of a guidewire placement system delivered through a patient's larynx relative to an endotracheal tube via a paired delivery technique, according to one embodiment. [Figure 18]

[0027] 1 is a schematic diagram of a portion of a guidewire placement system according to one embodiment. [Figure 19]

[0028] 1 is a schematic diagram of a portion of a guidewire placement system according to one embodiment. [Figure 20]

[0029] 1 is a schematic diagram of a side view of a guidewire placement system positioned within a patient's upper trachea at one stage of operation, according to one embodiment. [Figure 21]

[0029] FIG. 1 is a schematic diagram of a side view of a guidewire placement system positioned within a patient's upper trachea at one stage of operation, according to one embodiment. [Figure 22]

[0030] FIG. 22 is a cross-sectional view of the guidewire placement system of FIGS. 20 and 21. [Figure 23]

[0031] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 24]

[0032] FIG. 24 is a front view of the expansion assembly of FIG. 23. [Figure 25]

[0033] FIG. 24 is a cross-sectional view of the expansion assembly of FIG. 23. [Figure 26]

[0034] FIG. 24 is a cross-sectional perspective view of the expansion assembly of FIG. 23. [Figure 27]

[0035] FIG. 1 is a cross-sectional perspective view of an expansion assembly according to one embodiment. [Figure 28]

[0036] FIG. 28 is a side perspective view of the expansion assembly of FIG. 27. [Figure 29]

[0037] FIG. 28 is a front perspective view of the expansion assembly of FIG. 27. [Figure 30]

[0038] FIG. 28 is a rear cross-sectional perspective view of the expansion assembly of FIG. 27. [Figure 31]

[0039] FIG. 1 is a cross-sectional perspective view of an expansion assembly according to one embodiment. [Figure 32]

[0040] FIG. 32 is a cross-sectional view of the expansion assembly of FIG. 31. [Figure 33]

[0041] FIG. 32 is a cross-sectional perspective view of the expansion assembly of FIG. 31, without showing the inner tubular member of the expansion assembly. [Figure 34]

[0042] FIG. 32 is an end view of the expansion assembly of FIG. 31. [Figure 35]

[0043] FIG. 1 illustrates a front perspective view of an expansion assembly system according to one embodiment. [Figure 36]

[0044] FIG. 36 is a cross-sectional perspective view of the expansion assembly of FIG. 35. [Figure 37]

[0045] FIG. 36 is a side view of the expansion assembly of FIG. 35. [Figure 38]

[0046] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 39]

[0047] FIG. 39 is a first cross-sectional side view of the expansion assembly of FIG. 38. [Figure 40]

[0048] FIG. 39 is a second cross-sectional side view of the expansion assembly of FIG. 38. [Figure 41]

[0049] FIG. 39 is a cross-sectional perspective view of the expansion assembly of FIG. 38. [Figure 42]

[0050] FIG. 39 is a first cross-sectional top view of the expansion assembly of FIG. 38. [Figure 43]

[0051] FIG. 39 is a second cross-sectional top view of the expansion assembly of FIG. 38. [Figure 44]

[0052] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 45]

[0052] FIG. 1 is a top view of an expansion assembly according to one embodiment. [Figure 46]

[0052] FIG. 1 is a distal end view of an expansion assembly according to one embodiment. [Figure 47]

[0052] FIG. 1 is a side view of an expansion assembly according to one embodiment. [Figure 48]

[0053] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 49]

[0053] FIG. 1 is a top view of an expansion assembly according to one embodiment. [Figure 50]

[0053] FIG. 1 is a distal end view of an expansion assembly according to one embodiment. [Figure 51]

[0053] FIG. 1 is a side view of an expansion assembly according to one embodiment. [Figure 52]

[0054] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 53]

[0054] FIG. 1 is a top view of an expansion assembly according to one embodiment. [Figure 54]

[0054] FIG. 1 is a distal end view of an expansion assembly according to one embodiment. [Figure 55]

[0054] FIG. 1 is a side view of an expansion assembly according to one embodiment. [Figure 56]

[0055] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 57]

[0055] FIG. 1 is a top view of an expansion assembly according to one embodiment. [Figure 58]

[0055] FIG. 1 is a distal end view of an expansion assembly according to one embodiment. [Figure 59]

[0055] FIG. 1 is a side view of an expansion assembly according to one embodiment. [Figure 60]

[0056] FIG. 1 illustrates a perspective view of an inflation assembly according to one embodiment. [Figure 61]

[0056] FIG. 1 is a top view of an expansion assembly according to one embodiment. [Figure 62]

[0056] FIG. 1 is a distal end view of an expansion assembly according to one embodiment. [Figure 63]

[0056] FIG. 1 is a side view of an expansion assembly according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010] Detailed Description

[0057] In some embodiments, the system includes an expansion assembly and a guidewire assembly. The expansion assembly may include an elongate tube, an expandable member, and a magnetic member. The elongate tube may have a first end, a second end, and may define a lumen. The expandable member may be coupled to the first end of the elongate tube and fluidly coupled to the lumen, such that the expandable member can receive fluid through the lumen. The magnetic member may be coupled to the first end of the elongate tube, such that movement of the magnetic member can cause corresponding movement of the first end of the elongate tube. The guidewire assembly may include a guidewire having a first end and a second end. The first end of the guidewire assembly may include a coupling member configured to couple to the expandable member, such that translation of the elongate tube translates the guidewire assembly.

[0011]

[0058] In some embodiments, the method may include translating a tubular member through an opening in the patient, through the patient's cricoid cartilage, and into the patient's upper trachea. The first end of the elongate tube may be translated through the lumen of the tubular member such that the expandable member and magnetic member of the elongate tube extend from the first end of the tubular member and are positioned within the patient's upper trachea. The external magnetic assembly may be positioned on the patient's anterior neck such that the magnetic member of the elongate tube is biased toward the patient's anterior neck and the expandable member is positioned against the inner surface of the upper trachea. The expandable member may then be inflated through the lumen of the elongate tube such that the expandable member transitions from an uninflated configuration to an inflated configuration. The coupling member of the guidewire assembly may be translated through the patient's anterior neck and into the patient's upper trachea. The guidewire assembly may include a guidewire having a first end coupled to the coupling member and a second end positioned external to the patient, the guidewire extending through the patient's anterior neck. The coupling member may be coupled to the expandable member.

[0012]

[0059] FIG. 1 is a schematic representation of a system 100. The system 100 includes an inflation assembly 110, a guidewire assembly 120, and a tubular member 150. The system 100 may also optionally include an external magnetic assembly 140 and an ultrasound probe 160. The inflation assembly 110 may include an elongate tube 112, an expandable member 114, and a magnetic member 115. The inflation assembly 110 may optionally include a barrier member 195. The elongate tube 112 may have a first end 111 and a second end 113. In some embodiments, the elongate tube 112 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. The expandable member 114 and the magnetic member 115 may be coupled to the elongate tube 112 at or near the first end 111 of the elongate tube 112. The inflation assembly 110 may include an inflation lumen 116 in fluid communication with the expandable member 114. In some embodiments, the inflation lumen 116 may be disposed within and / or defined by the elongate tube 112 .

[0013]

[0060] In some implementations, the light source 118 can be positioned at or near the first end 111 of the elongated tube 112. The light source 118 can generate sufficient light such that it can be emitted from the light source 118 through the tracheal wall to the surface of the neck and be visible to an operator (e.g., a clinician). Thus, the operator can determine the location of the first end 111 of the elongated tube 112 based, at least in part, on the location of the light being emitted through the patient's skin. In some embodiments, the light source 118 and the tubular member 150 can be configured such that when the first end 111 of the elongated tube 112 is positioned within the tubular member 150, the light emitted by the light source 118 is partially or completely blocked by the tubular member 150, such that the light emitted by the light source 118 is not visible on the patient's skin or is dimmer than when the first end 111 of the elongated tube 112 is not within the tubular member 150. Thus, when elongate tube 112 and tubular member 150 are at least partially inserted into a patient's body, as elongate tube 112 translates relative to tubular member 150 such that first end 111 extends from tubular member 150, light emitted from light source 118 may become visible or become more visible as first end 111 extends from the end of tubular member 150. Light source 118 may be, for example, a light emitting diode (LED).

[0014]

[0061] The magnetic member 115 may be any suitable magnetic member configured such that movement of the magnetic member 115 results in corresponding movement of the first end 111 of the elongated tube 112. The magnetic member 115 may have any suitable shape. For example, in some embodiments, the magnetic member 115 may be in the shape of an elongated rectangle. In some embodiments, the magnetic member 115 may be in the shape of a cylinder. In some embodiments, the magnetic member 115 may be arcuate. In some embodiments, the magnetic member 115 is directly coupled to the elongated tube 112. In some embodiments, the magnetic member 115 is disposed within and at least partially surrounded by the expandable member 114. In some embodiments, the magnetic member 115 is directly coupled to the expandable member 114. In some embodiments, the system 100 includes two or more magnetic members 115.

[0015]

[0062] In some embodiments, the expandable member 114 can surround the elongate tube 112 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 114 can extend laterally from the elongate tube 112 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 114 can extend distally from the first end 111 of the elongate tube 112 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 114 can be positioned over the elongate tube 112 such that a portion of the elongate tube 112 extends distally of the expandable member 114 when the expandable member 114 is in the inflated and / or uninflated configuration. In some embodiments, the expandable member 114 can have two ends (e.g., cuffs), and each end can be sealed to the exterior surface of the elongate tube 112. The elongate tube 112 can define one or more inflation ports or holes such that the inflation lumen 116 can be in fluid communication with the interior of the expandable member 114 to transition the expandable member 114 between its uninflated and inflated configurations. In some embodiments, the expandable member 114 can be formed on or as part of a rigid subassembly that can receive the elongate tube 112 within an orifice of the subassembly, thereby sealing the elongate tube 112 to the subassembly.

[0016]

[0063] In some embodiments, the expandable member 114 can be formed from any suitable material, in any suitable shape, and at any suitable size. For example, the expandable member 114 can be oval, spherical, cylindrical, rectangular, teardrop-shaped, or any other suitable shape. In some embodiments, the shape can be selected based on the particular application of the system 100. For example, the shape of the expandable member 114 can be selected to facilitate ultrasound visualization in a particular region of the patient's body. Additionally, the expandable member 114 can be sized to facilitate engagement and retention of the expandable member 114 with the guidewire assembly 120.

[0017]

[0064] The expandable member 114 may be sufficiently flexible so that (e.g., when expanded) it can be punctured (e.g., by a needle) to define a pinhole in the wall of the expandable member 114 rather than rupturing or tearing as a result of the puncture. In some embodiments, the expandable member 114 may be formed from, for example, polyurethane, silicone, and / or polyvinyl chloride (PVC). In some embodiments, the expandable member 114 may have any suitable material properties, wall thickness, and / or outermost expanded diameter.

[0018]

[0065] In some embodiments, for example, the expandable member 114 can be oval in shape and formed from a low durometer urethane. The expandable member 114 can have an outermost diameter in the expanded configuration ranging from about 5 mm to about 30 mm and a length of about 20 mm. The wall thickness at the maximum balloon diameter in the expanded configuration can be about 0.029 mm to about 0.038 mm. The expandable member 114 can be filled with a maximum of, for example, about 5 ml to 10 ml of fluid in the expanded configuration.

[0019]

[0066] Guidewire assembly 120 may include a guidewire 122 having a first end 121 and a second end 123, and a coupling member 124 disposed at first end 121 of guidewire 122. Coupling member 124 may be configured to couple to expandable member 114, such that, when coupled, translation of expansion assembly 110 (e.g., translation of elongate tube 112 by pulling second end 113) can translate guidewire assembly 120. For example, if a force applied to elongate tube 112 causes expandable member 114 to move in a first direction, coupling member 124 to expandable member 114 can also move coupling member 124 and guidewire 122 in the first direction. Coupling member 124 may be configured to couple to expandable member 114, for example, by being captured by expandable member 114, being sandwiched within an interior region of the expandable member, or engaging a surface of the expandable member 114.

[0020]

[0067] In some embodiments, coupling member 124 can be separate from guidewire 122 and fixedly coupled (e.g., via an adhesive) to guidewire 122. For example, in some embodiments, coupling member 124 can include a first magnetic member configured to couple to a second magnetic member of expandable member 114.

[0021]

[0068] In some embodiments, guidewire 122 can include coupling member 124. For example, coupling member 124 can be monolithically formed with the shaft of guidewire 122 such that guidewire assembly 120 is a unitary structure. Similarly, in some embodiments, coupling member 124 and guidewire 122 can be formed from the same material or materials. In some embodiments, coupling member 124 can be shaped to engage at least a portion of the wall of expandable member 114. For example, coupling member 124 can have a planar or multi-planar shape and can be formed as a pigtail, hook, coil, or helical end to guidewire 122. Thus, in some embodiments, first end 121 of guidewire 122 can be held within or near expandable member 122 by coupling member 124 when coupling member 124 is disposed within expandable member 114. In some embodiments, coupling member 124 can be disposed outside of expandable member 114, and guidewire 122 passes through a first wall portion and an oppositely disposed second wall portion of expandable member 114 and is retained by expandable member 114 due to interaction between coupling member 124 and the first wall portion of expandable member 114. In some embodiments, coupling member 124 can be disposed partially within and partially outside of expandable member 114, and guidewire assembly 120 is coupled to expandable member 114 for translation of guidewire assembly 120 via movement of expansion assembly 110.

[0022]

[0069] In some embodiments, the coupling member 124 can be configured to transition between a first configuration for insertion and a second configuration for retention or coupling. For example, the coupling member 124 can have a smaller lateral extent (e.g., outermost diameter) relative to the central axis of the guidewire 122 in the first configuration than in the second configuration, such that the coupling member 124 can fit inside the lumen 135 of the needle 130 in the first configuration and expand to retain the guidewire 122 relative to the expandable member 114 in the second configuration. In some embodiments, the coupling member 124 can have a first shape in the first configuration and a second shape in the second configuration, such that the coupling member 124 can move through a hole in at least one sidewall of the expandable member 114 in the first configuration and engage with a sidewall of the expandable member 114 to be retained by the expandable member 114 in the second configuration. In some embodiments, the coupling member 124 can be biased toward the second configuration such that the coupling member 124 assumes the second configuration in the absence of an external force on the coupling member 124. In some embodiments, in a first configuration, coupling member 124 can be elongate, such as in the shape of a straight wire. The second configuration can correspond to the unbiased shape or configuration of the coupling member (e.g., a pigtail, hook, coil, or helix). In some embodiments, guidewire 122 and / or coupling member 124 can be formed from a shape memory material, such as, for example, Nitinol.

[0023]

[0070] In some embodiments, when binding member 124 is within lumen 135 of needle 130, needle 130 can compress binding member 124 so that the binding member is in a first configuration. Thus, binding member 124 can have a smaller lateral extent (e.g., outermost diameter) relative to the central axis of guidewire 122 when disposed within lumen 135 of needle 130 than when not within needle 130. In some embodiments, lumen 135 and binding member 124 can be configured and sized such that binding member 124 can be straight or substantially straight within lumen 135 of needle 130. For example, lumen 135 can have an inner diameter similar to the outer diameter of binding member 124 (e.g., the outer diameter of the wire forming the binding member 124 portion of guidewire assembly 120), and binding member 124 can be laterally compressed and / or expanded within lumen 135 of needle 130 to a configuration with a smaller outer diameter. In some embodiments, the outer diameter of the wire forming the coupling member 124 and the inner diameter of the lumen 135 may be relatively sized such that the outer diameter of the wire forming the coupling member 124 is slightly smaller than the inner diameter of the lumen 135, allowing the coupling member 124 and the inner surface of the needle 130 that defines the lumen 135 to have a snug fit engagement. Thus, when the coupling member 124 is threaded into the lumen 135 of the needle 130, the wire forming the coupling member 124 is straightened to correspond to the shape of the lumen 135. The coupling member 124 may transition from a first configuration to a second configuration as it translates out of the first end 131 of the needle 130. For example, as the coupling member 124 extends from the first end 131 of the needle 130, the portion of the coupling member 124 extending from the first end 131 may transition toward the second configuration because it is biased toward the second configuration, while the portion of the coupling member 124 remaining within the lumen 135 of the needle 130 may remain in the first configuration. The coupling member 124 may be fully in the second configuration when it is completely outside the needle 130 .

[0024]

[0071] In some embodiments, the expandable member 114 can be configured to cause the coupling member 124 to translate in a first direction when a translational force on the expandable member 114 (e.g., a force causing the expandable member 114 to translate and / or a force holding the expandable member 114 stationary) is greater than a force on the coupling member 124 in a direction opposite the translational force. The coupling member 124 and the expandable member 114 can be configured to separate when the force on the coupling member 124 is opposite and greater than the translational force on the expandable member 114. For example, in some embodiments in which the coupling member 124 is a pigtail-shaped end to the guidewire 122, applying sufficient force to the coupling member 124 in a direction opposite the force applied to the expandable member 114 can cause the pigtail-shaped end to straighten and separate from the expandable member 114. In some embodiments, by applying sufficient force to the coupling member 124 in a direction opposite to the force applied to the expandable member 114, the coupling member can tear the sidewall of the expandable member such that the expandable member 114 and the coupling member 124 separate. Thus, in some embodiments, the coupling member 124 and the expandable member 114 can be separated by applying opposing pulling forces to each of the coupling member 124 and the expandable member 114. In some embodiments, the coupling member 124 and the expandable member 114 can be engaged such that the release force (e.g., by pulling in the opposite direction) required to separate the coupling member 124 from the expandable member 114 is greater than the maximum force applied to the guidewire 122 (and thus the coupling member 124) in the direction opposite the expandable member 114 during withdrawal of the coupling member 124 from the patient's body by pulling on the expansion assembly 110. Thus, the expandable member 114 and the coupling member 124 can be separated, for example, by a pull by the operator when the expandable member 114 and the coupling member 124 are outside the patient, but the release force is sufficiently high so that the coupling member 124 of the guidewire 122 is not inadvertently separated during withdrawal.For example, in some embodiments, the release force can be at least about 0.25 lbs of force, at least about 0.5 lbs of force, or at least about 1.5 lbs of force. In some applications of system 100, the release force may be greater or less, depending on the release force that coupling member 124 and guidewire 122 may experience through a withdrawal force on expansion assembly 110 during withdrawal. In some embodiments, coupling member 124 and expandable member 114 can be engaged such that the release force (e.g., by opposing pulling forces) required to separate coupling member 124 from expandable member 114 is less than the force applied to guidewire 122 (and thus coupling member 124) in a direction away from the patient (e.g., away from the patient's anterior neck) during withdrawal of expansion assembly 110 from the patient's body through an orifice in the patient by pulling elongate tube 112. Thus, the release force can be low enough so that the expandable member 114 and coupling member 124 do not inadvertently separate during movement of the coupling member 124 on the guidewire 122, e.g., due to movement of the expandable member 114 within the patient's trachea, but can be separated by, for example, the operator pulling on the elongate tube 112 and the guidewire 122. In some embodiments, the operator can separate the expandable member 114 from the coupling member 124 by pushing the expandable member 114 along the coupling member 124 toward the end of the coupling member 124 such that the coupling member 124 translates through the hole provided by the needle 130 while in a straight or non-straight configuration.

[0025]

[0072] In some embodiments, coupling member 124 can be configured to pierce expandable member 114 such that coupling member 124 can be inserted into and / or through expandable member 114. In some embodiments, system 100 can optionally include needle 130 having first end 131, second end 133, and defining lumen 135. First end 131 can have any suitable shape configured to pierce expandable member 114 and provide access to expandable member 114. For example, first end 131 can have a sharpened tip, which can be tapered. Lumen 135 can be sized to allow coupling member 124 of guidewire assembly 120 to be translated through second end 133, through lumen 135, and through first end 131 of needle 130. In some embodiments, needle 130 can be inserted through the anterior neck and tracheal wall of a patient and through a side wall of expandable member 114. Thus, coupling member 124 and a portion of guidewire 122 can be translated through lumen 135 of needle 130 such that at least one of coupling member 124 and a portion of guidewire 122 is at least partially disposed within expandable member 114. Needle 130 can therefore be removed from expandable member 114 by translating needle 130 along guidewire 122.

[0026]

[0073] The optional barrier member 195 may be a portion of the inflation assembly 110 that is more resistant to puncture or tearing (e.g., by a needle) than the expandable member 114 or a portion of the expandable member 114. In some implementations, the barrier member 195 may be positioned in any suitable location relative to the portion of the expandable member 114 intended to be pierced, where the barrier member may prevent the needle from penetrating the expandable member 114 and puncturing the posterior wall of the patient's trachea. In some implementations, the barrier member 195 may form a portion of the sidewall of the expandable member 114. In some implementations, the barrier member 195 may be positioned on and / or coupled to an outer surface of the expandable member 114. In some implementations, the barrier member 195 may be positioned within the expandable member 114. For example, the barrier member 195 may be positioned on or coupled to an inner surface of the expandable member 114 (e.g., opposite the surface of the expandable member 114 intended to be pierced by the needle 130). In some implementations, the barrier member 195 can be disposed on or coupled to the elongate tube 112. In some implementations, the barrier member 195 can be disposed at a location between the elongate tube 112 and the interior surface of the expandable member 114.

[0027]

[0074] The barrier member 195 may have any suitable shape. In some implementations, the barrier member 195 may have a shape that corresponds to the shape of an inner or outer surface of the expandable member 114 and / or a plane passing through the expandable member 114. For example, the barrier member 195 may have an oval, circular, or rectangular outline.

[0028]

[0075] In some implementations, the barrier member 195 may be sufficiently resistant to puncture and / or tearing such that if a needle (e.g., needle 130) applies a force to the barrier member 195 (e.g., through the patient's skin and tracheal wall) that is greater than the magnetic attraction force exerted by the external magnetic assembly 140 on the magnetic member 115 of the inflation assembly 110, the needle will urge the barrier member 195 toward the patient's posterior tracheal wall, and thus away from the patient's anterior tracheal wall, rather than piercing the barrier member 195. Removing or reducing the force of the needle on the barrier member 195 in the posterior direction can again urge the magnetic member 115 toward the posterior tracheal wall, due to the magnetic attraction force of the external magnetic assembly 140.

[0029]

[0076] In some implementations, the barrier member 195 can be positioned relative to the magnetic member 115 such that when the magnetic member 115 is biased toward the external magnetic assembly 140, the barrier member 195 is positioned on the opposite side of the magnetic member 115 from the external magnetic assembly 140 (between the magnetic member 115 and the patient's posterior tracheal wall). In some implementations, the barrier member 195 can include one or more magnetic elements that can have a polarity relative to the magnetic member 115 and / or the external magnetic assembly 140 such that the barrier member 195 is repelled by the magnetic member 115 and / or the external magnetic assembly 140, biasing the barrier member 195 toward the patient's posterior tracheal wall and away from the patient's anterior tracheal wall. When the barrier member 195 is biased (e.g., via magnetic interaction with the external magnetic assembly 140 and / or via magnetic interaction of the external magnetic assembly 140 with the magnetic member 1150) toward and away from the patient's posterior tracheal wall, the barrier member 195 can be coupled or positioned relative to the portion of the expandable member 114 that is intended to pierce such that the portion of the expandable member 114 that is intended to pierce is positioned near or adjacent to the anterior tracheal wall. Thus, the barrier member 195 can be positioned between the interior of the expandable member 114 and the posterior tracheal wall, and as the needle 130 translates into the interior of the expandable member 114, further translation of the needle 130 can cause the needle 130 to translate into contact with the barrier member 195, which can prevent the needle 130 from extending into contact with the posterior tracheal wall.

[0030]

[0077] In some implementations, the barrier member 195 may have a high echogenicity so that it can be more easily visualized via ultrasound than other portions of the inflation assembly 110 (e.g., the inflatable member 114 and / or the interior of the inflatable member 114) and / or the patient's surroundings. The high echogenicity may allow the surgeon to identify the location of the barrier member 195 via ultrasound imaging and stop translation of the needle 130 before the needle reaches or passes through the barrier member 195, preventing the needle 130 from advancing too far relative to the inflatable member 114 and / or the patient's trachea and causing damage to the patient's posterior tracheal wall.

[0031]

[0078] In some implementations, the barrier member 195 can be formed from any suitable material that is highly resistant to puncture by a needle (e.g., needle 130) used to pierce the patient's tissue and / or that is highly echogenic. For example, the barrier member 195 can be formed from a polymer or a metal composite. In some implementations, the barrier member 195 can include a thickened or reinforced portion of the sidewall of the expandable member 114.

[0032]

[0079] In some embodiments, the expandable member 114 can be filled and / or inflated with a fluid (e.g., a liquid or gaseous fluid) after being positioned in the patient's upper trachea. For example, the expandable member 114 can be filled and / or inflated with a fluid and / or contrast agent to define an echogenic space detectable using ultrasound imaging. Inflating the expandable member 114 can also increase the surface tension of the expandable member's sidewalls, allowing the needle 130 and / or guidewire 122 to more easily pierce the sidewalls. Furthermore, expansion of the expandable member 114 can provide a larger interior space into which the coupling member 124 can expand and / or be positioned. Inflating the expandable member 114, along with the needle 130 and / or coupling member 124, can also increase the target size of the expandable member for visualization and targeting of the expandable member 114.

[0033]

[0080] The tubular member 150 may have a first end 151 and a second end 153 opposite the first end 151. The tubular member 150 may define a lumen extending from the first end 151 to the second end 153. In some embodiments, the tubular member 150 may include an inflatable member 152 configured to extend from an outer surface of the tubular member 150 near the first end 151. The inflatable member 152 may be configured to seal against an inner surface of the patient's trachea and / or stabilize the tubular member 150 within the patient's trachea. The second end 153 of the tubular member 150 may be configured to be coupled to a ventilation source, such that the patient can be ventilated via the tubular member 150 when the first end 151 of the tubular member 150 is positioned within the patient's trachea. In some embodiments, the tubular member 150 may be configured to be positioned within the patient's trachea by translating the first end 151 of the tubular member 150 through the patient's nasal or mouth opening. In some embodiments, tubular member 150 can be an endotracheal tube (“ETT”). Tubular member 150 can be configured to receive at least a portion of inflation assembly 110 within a lumen of tubular member 150 such that inflation assembly 110 can be translated relative to first end 151 of tubular member 150. In some embodiments, tubular member 150 and inflation assembly 110 are configured such that when inflation assembly 110 is positioned within the lumen of tubular member 150 and translated relative to tubular member 150, tubular member 150 can continue to ventilate the patient (e.g., provide air to the patient's lungs via the patient's trachea). For example, in some embodiments, the outermost diameter or lateral extent of inflation assembly 110 can be 50% or less of the inner diameter of tubular member 150. In some embodiments, inflation assembly 110 can be positioned alongside tubular member 150 such that the ventilation circuit is not interrupted and air pressure through the trachea can be maintained.

[0034]

[0081] 2A and 2B are schematic diagrams of anterior and lateral cross-sectional views of a portion of a patient P. As shown in FIGS. 2A and 2B, the patient P has an oral opening O and a nasal opening S. An end of a tubular member, such as first end 151 of tubular member 150, can be inserted through either the oral opening O or the nasal opening S and translated into the trachea W of the patient P. For example, tubular member 150 can be inserted through the nasal opening S and translated through the nasopharynx NP, the oropharynx O, past the epiglottis EP, bypassing the esophagus E and through the larynx LP, through the larynx L, past the thyroid cartilage TC, and through the cricoid cartilage C into the upper trachea U. The end of the tubular member can also be inserted through the oral opening O and translated through the oropharynx OP to the trachea W.

[0035]

[0082] Ultrasound probe 160 may be any suitable ultrasound probe configured for visualization of expandable member 114 within the patient and any intervening patient structures between the patient's skin and expandable member 114. For example, ultrasound probe 160 may be used to visualize any intervening patient tissue or structure, such as the walls of the trachea W, cartilage such as thyroid cartilage TC, blood vessels such as artery R and / or vein V, nerves such as pharyngeal nerve N, thyroid gland TG, portions of the thyroid gland TG such as thyroid isthmus TI, parathyroid gland PG, and / or any other structure or tissue that may be located between expandable member 114 and the patient's skin. External magnetic assembly 140 may be any suitable external magnetic assembly configured to bias magnetic member 115 of inflation assembly 110 (e.g., via magnetic attraction) through patient tissue (e.g., through the patient's skin and tracheal wall) toward the external magnetic assembly. As shown in FIGURE 2C, ultrasound probe 160 can be used to identify the location of portion 110A of inflation assembly 110 (e.g., the portion of inflation assembly 110 including expandable member 114 and magnetic member 115) within patient P relative to other tissues or structures of patient P. For example, as shown in FIGURE 2C, with inflation assembly 110 positioned within the patient (e.g., elongated tube 112 (not shown) extending from portion 110A, through larynx L, laryngopharynx LP, oropharynx OP, and out the mouth opening O into the patient's upper trachea U), external magnetic assembly 140 can be coupled to an external surface of the patient (e.g., anterior surface A of the patient's neck skin), and magnetic member 115 (not shown in FIGURE 2C) of portion 110A of inflation assembly 110 can be urged toward external magnetic assembly 140, causing expandable member 114 to contact the surface of the wall of the cavity (e.g., the surface of the wall of the upper trachea U). The expandable member 114 and the external magnetic assembly 140 can be positioned on opposite sides of the intervening tissue and / or structure such that substantially no fluid (e.g., air) gap is disposed between the expandable member 114 and the external magnetic assembly 140. The cavity wall surface and the exterior surface can be positioned on opposite sides of at least one tissue surface of the patient. The expandable member 114 can be visualized within the cavity. For example, the expandable member 114 is echogenic and can be visualized via the ultrasound probe 160.This technique, in which an echogenic member is pressed against the surface of the wall of a body cavity and the echogenic member and all tissue planes between the echogenic member and the patient's exterior surface can be visualized by ultrasound, can be referred to as junctional ultrasound (CU).

[0036]

[0083] In some embodiments, external magnetic assembly 140 may include a handle. In some embodiments, external magnetic assembly 140 may include one magnetic element configured to magnetically interact with magnetic member 115. In some embodiments, external magnetic assembly 140 may include any suitable number of magnetic elements (e.g., two magnetic elements) configured to magnetically interact with magnetic member 115. In some embodiments, as described above, expansion assembly 110 may include multiple magnetic members 115 (e.g., two magnetic members), and external magnetic assembly 140 may include a corresponding number of magnetic elements.

[0037]

[0084] In some embodiments, the external magnetic assembly 140 and / or the magnetic member 115 can be formed from any suitable type of magnet. For example, the external magnetic assembly 140 and / or the magnetic member 115 can include permanent magnets such as neodymium iron boron (NdFeB) magnets, samarium cobalt (SmCo) magnets, aluminum nickel cobalt (AlNiCo) magnets, ceramic magnets, ferrite magnets, and / or any other suitable rare earth magnets. In some embodiments, the external magnetic assembly 140 and / or the magnetic member 115 can include temporary magnets. In some embodiments, the external magnetic assembly 140 and / or the magnetic member 115 can be electromagnets, such as solenoids. In some embodiments, the external magnetic assembly 140 and / or the magnetic member 115 can generate a magnetic field having an orientation (i.e., a north (N) pole and a south (S) pole). In other embodiments, the external magnetic assembly 140 and / or the magnetic member 115 can be formed from a ferromagnetic material that is not magnetized, i.e., does not generate its own magnetic field, but can be affected by an externally applied magnetic field. For example, the external magnetic assembly 140 and / or the magnetic member 115 can be formed from iron or steel, and application of an external magnetic field can attract the iron toward the magnetic field source, exerting a force on the external magnetic assembly 140 and / or the magnetic member 115.

[0038]

[0085] In use, tubular member 150 can be inserted through a patient's orifice (e.g., the patient's nose or mouth), through the patient's cricoid cartilage, and into the patient's upper trachea, with first end 151 of tubular member 150 and expandable member 152 positioned within the upper trachea. For example, expandable member 152 of tubular member 150 can be positioned between the patient's second and third tracheal rings. Inflation assembly 110 can then be translated through the lumen of tubular member 150 such that first end 111 of elongate tube 112 of inflation assembly 110 extends beyond first end 151 of tubular member 150. In some embodiments, the surgeon can determine that first end 111 of elongate tube 112 should extend a particular distance beyond first end 151 of tubular member 150 based on the known relative lengths of tubular member 150 and elongate tube 112 and / or markings on at least one of tubular member 150 or elongate tube 112.

[0039]

[0086] The external magnetic assembly 140 may then be placed on the anterior neck of the patient such that the magnetic member 115 of the inflation assembly 110 is urged toward the external magnetic assembly 140, urging the first end 111 of the elongated tube 112 into contact with the anterior wall of the upper trachea. The tubular member 150 may be translated relative to the first end 111 of the elongated tube 112 toward the cricoid cartilage, with the first end 111 remaining in place against the anterior wall of the upper trachea due to the magnetic interaction between the external magnetic assembly 140 and the magnetic member 115.

[0040]

[0087] Fluid can then be delivered to the expandable member 114 via the inflation lumen 116. As described above, the fluid can include a fluid and / or a contrast agent such that the expandable member 114 is detectable via imaging (e.g., ultrasound). The expandable member 114 can then be visualized (e.g., using an ultrasound probe 160) so that its location can be identified. The external magnetic assembly 140 can then be moved along the skin of the patient's anterior neck to urge the magnetic member 115 toward the desired tracheal puncture site. In some embodiments, the ultrasound probe 160 can be used to determine the tracheal puncture site between specific tracheal rings (e.g., between the patient's first and second tracheal rings or between the patient's second and third tracheal rings).

[0041]

[0088] While using the ultrasonic probe 160 to visualize the position of the expandable member 114, the guidewire assembly 120 can be inserted through the patient's anterior neck, into the patient's trachea, and coupled to the expandable member 114. For example, the needle 130 can be inserted through the patient's anterior neck and trachea and through a sidewall of the expandable member 114 so that the first end 131 (e.g., tip) of the needle 130 is disposed within the expandable member 114. During insertion of the needle 130, the ultrasonic probe 160 can be used to visualize the needle 130 and any intervening patient structures between the patient's skin and the expandable member 114. For example, the ultrasonic probe 160 can be used to identify the patient's thyroid isthmus and proximal vessels in real time during insertion of the needle 130 so that the thyroid isthmus and proximal vessels can be avoided. Additionally, the ultrasonic probe 160 can be used to confirm that the first end 131 of the needle 130 is disposed within the expandable member 114. Additionally or alternatively, echogenic fluid may be aspirated from the expandable member 114 through the needle 130 (e.g., into a syringe barrel) to confirm that the first end 131 of the needle 130 is positioned within the expandable member 114.

[0042]

[0089] With the first end 131 of the needle disposed within the expandable member 114, the coupling member 124 and a portion of the guidewire 122 can be inserted through the lumen 135 of the needle 130 and translated (pushed through) the lumen 135. The coupling member 124 can then be translated out of the first end 131 of the needle 130 so that the coupling member 124 is disposed within the expandable member 114. The translation of the needle 130 relative to the coupling member 124 and the guidewire 122 can then cause the needle 130 to be withdrawn from the patient, leaving the coupling member 124 within the expandable member 114 and the guidewire 122 extending through the wall of the expandable member 114. The external magnetic assembly 140 can then be removed from the patient so that the magnetic member 115 is no longer biased (e.g., via magnetic attraction) toward the anterior tracheal wall. The expandable member 114 can then be deflated.

[0043]

[0090] With guidewire assembly 120 extending through the patient's anterior neck and coupled to expandable member 114, any suitable percutaneous tracheotomy procedure can be performed using guidewire assembly 120 and a tract through the patient's anterior neck to the patient's trachea, where guidewire assembly 120 is located. For example, elongate tube 112 can be translated through tubular member 150 such that first end 111 of elongate tube 112 moves toward the patient's lower trachea and / or lungs. Thus, coupling member 124 of guidewire assembly 120 and guidewire 122 translate toward the patient's lower trachea and / or lungs. External dilation can then be performed, for example, via the Ciaglia or Griggs technique. In some embodiments, to prevent guidewire assembly 120 from separating from expandable member 114, it may be necessary to advance guidewire 122 through the puncture site in the patient's neck as elongate tube 112 is translated.

[0044]

[0091] As another example, the guidewire assembly 120 can be used to perform a translaryngeal tracheotomy (or Fantoni procedure). For example, the tubular member 150 and the elongated tube 112 can be translated such that the first end 111 of the elongated tube 112 moves through the patient's orifice (e.g., nose or mouth). Thus, the coupling member 124 of the guidewire assembly 120 and the guidewire 122 translate through the patient's orifice toward the patient's cricoid cartilage. In some embodiments, the tubular member 150 can be withdrawn from the patient's body through the patient's orifice before withdrawing the elongated tube 112. A tracheostomy tube can then be translated over the guidewire, through the patient's mouth, through the cricoid cartilage, and into the upper trachea, threaded so that it can engage a tract through the patient's tracheal wall and anterior neck.

[0045]

[0092] In some embodiments, to confirm that the guidewire coupling member 124 is positioned within the patient's trachea and engaged with the expandable member 114, the elongate tube 112 can be translated through the tubular member 150 such that the first end 111 of the elongate tube 112 moves through the patient's orifice (e.g., nose or mouth). Thus, the coupling member 124 of the guidewire assembly 120 and the guidewire 122 are translated through or near the patient's orifice toward the patient's cricoid cartilage. Engagement of the coupling member 124 with the expandable member 114 can then be confirmed. After confirmation, the guidewire 122 can be pulled through the patient's anterior cervical tract such that the coupling member 124 draws the expandable member 114 and elongate tube 112 into the upper trachea. Any suitable percutaneous tracheotomy can then be performed using the guidewire assembly 120.

[0046]

[0093] In some embodiments, the expandable member 114 may define passageways (not shown) (also referred to as “vents”) extending from a first end to a second end of the expandable member 114 to allow fluid (e.g., air) to travel through the passageways when the expandable member 114 is in the expanded configuration. For example, in some embodiments, when the expandable member 114 is positioned within the trachea in the expanded configuration, each passageway may be bounded in part by the expandable member 114 and in part by the patient's tracheal wall. Thus, air may flow through the passageways between a portion of the trachea on a first side of the expandable member 114 (e.g., the region between the cricoid cartilage and the expandable member 114) and a portion of the trachea on a second side of the expandable member 114 (e.g., the region between the expandable member 114 and the patient's lungs) when the expandable member 114 is in the expanded configuration. In some embodiments, the expandable member 114 may define one or more entire outer boundaries of the passageways. The inflatable member 114 can be shaped to define any suitable number of passages (e.g., one, two, three, four, or more passages) in the expanded configuration. The passages can be defined at any suitable location on the inflatable member 114. In some embodiments, the inflatable member 114 can define a suitable number of passages having a suitable size (e.g., having a suitable combined cross-sectional area) such that when the inflatable member 114 is positioned within a patient's trachea and the outer surface of the inflatable member 114 contacts the inner wall of the patient's trachea, the patient can be properly ventilated through the passages (e.g., freely or via a ventilator). For example, the outer surface of the inflatable member 114 may contact the inner wall of the patient's trachea in a continuous manner such that air cannot flow between the outermost surface of the inflatable member 114 and the tracheal wall, or such that the rate at which air can flow between the outermost surface and the tracheal wall is insufficient for proper ventilation and oxygenation. In some embodiments, the combined cross-sectional area of ​​the passageways can be large enough to allow an air flow of about 40 to about 75 liters per minute through the passageways.Thus, with the inflatable member 114 deployed in the trachea, the patient can receive closed, continuous ventilation through the passageway, such as during ultrasound visualization (e.g., via junction ultrasound) of the inflatable member 114 and / or the tissue between the inflatable member 114 and the ultrasound probe.

[0047]

[0094] FIG. 7 is a flowchart of a method 200 according to one embodiment. Method 200 can be implemented using any of the systems or devices described herein, such as system 100 described above. Method 200 includes translating (202) a tubular member through a patient's opening, through the patient's cricoid cartilage, and into the patient's upper trachea. A first end of the elongate tube can be translated (204) through a lumen of the tubular member such that the expandable member and magnetic member of the elongate tube extend from the first end of the tubular member and are positioned within the patient's upper trachea. An external magnetic assembly can be positioned on the patient's anterior neck such that the magnetic member of the elongate tube is urged toward the patient's anterior neck and the expandable member is positioned against the anterior interior surface of the upper trachea (206). The expandable member can then be inflated (208) through the lumen of the elongate tube such that the expandable member transitions from an uninflated configuration to an inflated configuration. A coupling member of the guidewire assembly can be translated through the patient's anterior neck and into the patient's upper trachea (210). The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end disposed external to the patient, the guidewire extending through the patient's anterior neck. The coupling member can be coupled to the inflatable member (212).

[0048]

[0095] 3A-3M are schematic diagrams of system 300 at various stages of operation. System 300 may be the same or similar in structure and / or function to any of the systems or devices described herein, such as system 100 described above. For example, system 300 includes an expansion assembly 310, a guidewire assembly 320, and a tubular member 350. System 300 also includes an external magnetic assembly 340 and an ultrasound probe 360. Expansion assembly 310 may include an elongated tube 312, an expandable member 314, and a magnetic member 315. Elongated tube 312 may have a first end 311 and a second end 313. In some embodiments, elongated tube 312 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. Expandable member 314 and magnetic member 315 may be coupled to elongated tube 312 near first end 311 of elongated tube 312. Inflation assembly 310 includes an inflation lumen 316 defined by elongate tube 312 and in fluid communication with expandable member 314. Guidewire assembly 320 may include a guidewire 322 having a first end 321 and a second end 323, and a coupling member 324 disposed at first end 321 of guidewire 322. Tubular member 350 may have a first end 351 and a second end 353 opposite first end 351. Tubular member 350 may define a lumen extending from first end 351 to second end 353 and may include an expandable member 352 configured to transition from an uninflated configuration to an inflated configuration, wherein expandable member 352 extends from an outer surface of tubular member 350 near first end 351 and couples to an inner surface of a patient's tracheal wall.

[0049]

[0096] As shown in FIG. 3A , the tubular member 350 can be inserted through an orifice (not shown) of the patient P (e.g., the patient's nose or mouth) and into the patient P's upper trachea U through the patient P's cricoid cartilage C such that the first end 351 of the tubular member 350 and the expandable member 352 are positioned within the upper trachea U. After the expandable member 352 is inserted through the patient P's cricoid cartilage C, the expandable member 352 can be transitioned to an expanded configuration such that the expandable member 352 can secure the first end 351 within the upper trachea U and / or stabilize the first end 351 of the tubular member 350 against the inner surface of the tracheal wall (e.g., resist axial movement). For example, the expandable member 352 of the tubular member 350 can be positioned between the patient P's second tracheal ring T2 and the third tracheal ring T3 or between the patient P's first tracheal ring T1 and the second tracheal ring T2. The expandable member 352 may have any suitable shape. For example, the expandable member 352 may have a circular profile such that, in the expanded configuration, the central axis of the first end 351 of the tubular member 350 may be coaxial with the central axis of the upper trachea U.

[0050]

[0097] 3B, the expansion assembly 310 can then be translated through the lumen of the tubular member 350 so that the first end 311 of the elongated tube 312 of the expansion assembly 310 extends beyond the first end 351 of the tubular member 350. In some embodiments, the surgeon can determine that the first end 311 of the elongated tube 312 should extend beyond the first end 351 of the tubular member 350 a particular distance based on the known relative lengths of the tubular member 350 and the elongated tube 312 and / or markings on at least one of the tubular member 350 or the elongated tube 312.

[0051]

[0098] As shown in FIG. 3C , the external magnetic assembly 340 can then be placed on the patient's anterior neck A, and the magnetic member 315 of the inflation assembly 310 can be urged toward the external magnetic assembly 340, urging the first end 311 of the elongated tube 312 into contact with the anterior wall of the upper trachea U. The tubular member 350 can be translated relative to the first end 311 of the elongated tube 312 toward the cricoid cartilage C, with the first end 311 remaining in place against the anterior wall of the upper trachea U due to the magnetic attraction between the external magnetic assembly 340 and the magnetic member 315. For example, in some implementations, the first end 351 of the tubular member 350 can be translated toward the cricoid cartilage C with the inflatable member 352 inflated state by pulling the inflatable member 352 along the inner surface of the wall of the upper trachea U. In some implementations, the inflatable member 352 of the tubular member 350 can be partially or fully deflated before translation toward the cricoid cartilage C, and then re-inflated after translation. In some implementations, the tubular member 350 can remain in its initial position relative to the cricoid cartilage C (e.g., the inflatable member 352 can be initially inflated between the cricoid cartilage C and the first tracheal ring T1) rather than translating the first end 351 of the tubular member 350 toward the cricoid cartilage C before advancing.

[0052]

[0099] As shown in FIG. 3D , a fluid can then be delivered to the expandable member 314 via the inflation lumen 316 (e.g., via an inflation port coupled to the second end 313 of the elongate tube 312). As described above, the fluid can include a fluid and / or a contrast agent so that the expandable member 314 is detectable via imaging (e.g., ultrasound). An ultrasound probe 360 ​​can then be applied to the anterior neck A of the patient P so that the expandable member 314 and any intervening tissue and other structures between the expandable member and the surface of the anterior neck A can be visualized and the location of the expandable member 314 can be identified. The external magnetic assembly 340 can then be moved along the skin of the patient's anterior neck A to urge the magnetic member 315 toward the desired tracheal puncture site. In some embodiments, the ultrasound probe 360 ​​can be used to determine the tracheal puncture site between specific tracheal rings (e.g., between the first tracheal ring T1 and the second tracheal ring T2 of the patient P, or between the second tracheal ring T2 and the third tracheal ring T3 of the patient P).

[0053]

[0100] As shown in FIG. 3E , the needle 330 can be inserted through the anterior neck A of the patient P and into the patient's upper trachea U while using the ultrasound probe 360 ​​to visualize the position of the expandable member 314. The needle 330 can be further translated so that it is inserted through the sidewall of the expandable member 314 and the first end 331 (e.g., tip) of the needle 330 is disposed within the expandable member 314. During insertion of the needle 330, the ultrasound probe 360 ​​can be used to visualize the needle 330 and any intervening patient structures between the patient's skin and the expandable member 314. For example, the ultrasound probe 360 ​​can be used to identify the patient's thyroid isthmus and proximal vessels in real time during insertion of the needle 330 so that the thyroid isthmus and proximal vessels can be avoided. Additionally, the ultrasound probe 360 ​​can be used to confirm that the first end 331 of the needle 330 is disposed within the expandable member 314. Additionally or alternatively, echogenic fluid can be aspirated from the expandable member 314 (e.g., into a syringe barrel) through the needle 330 to confirm that the first end 331 of the needle 330 is positioned within the expandable member 314.

[0054]

[0101] 3F , with needle first end 331 disposed within expandable member 314, coupling member 324 and a portion of guidewire 322 can be inserted through lumen 335 of needle 330 and translated (e.g., pushed through) lumen 335. Coupling member 324 can then be translated out of first end 331 of needle 330 such that coupling member 324 is disposed within expandable member 314.

[0055]

[0102] 3G, translation of needle 330 relative to coupling member 324 and guidewire 322 may then cause needle 330 to be withdrawn from the patient, leaving coupling member 324 within expandable member 314 and guidewire 322 extending through the wall of expandable member 314. Further, external magnetic assembly 340 may be removed from the patient such that magnetic member 315 is no longer biased (e.g., by magnetic attraction) toward the anterior tracheal wall. Expandable member 314 may be deflated.

[0056]

[0103] With guidewire assembly 320 extending through the patient's anterior neck and coupled to expandable member 314, any suitable percutaneous tracheotomy procedure can be performed using guidewire assembly 320 and a tract through the patient's anterior neck to the patient's trachea, where guidewire assembly 320 is located. For example, it may be desirable to translate coupling member 324 of guidewire assembly 320 through tubular member 350 and out of the patient's mouth using inflation assembly 310 (e.g., to use guidewire 322 for airway control and reintroduction of an ETT if tubular member 350 is accidentally dislodged from the trachea). As shown in FIG. 3H , elongate tube 312 can be translated through tubular member 350 such that first end 311 of elongate tube 312 moves toward the patient P's lower trachea and / or lungs. Thus, coupling member 324 of guidewire assembly 320 and guidewire 322 translate toward the patient's lower trachea and / or lungs. External dilation can then be performed, for example, by the Ciaglia or Griggs technique. In some embodiments, the guidewire 322 must be advanced through the puncture site in the patient's neck as the elongate tube 312 translates to prevent the guidewire assembly 320 from separating from the expandable member 314. In some embodiments, the guidewire 322 can be pushed to cause the expandable member 314 to translate.

[0057]

[0104] As an example of the Ciaglia technique, FIG. 3I illustrates that a dilator 370 may be advanced over the guidewire 322 to externally dilate a tract through the anterior neck A to the upper trachea U. As shown in FIG. 3J, after external dilation, a tracheostomy tube 380 may be advanced over the guidewire 322 so that a first end of the tracheostomy tube 380 is positioned within the upper trachea U and a second end of the tracheostomy tube 380 is positioned external to the patient P (e.g., extending from the anterior neck A of the patient P). As shown in FIG. 3K, the guidewire assembly 320 may be separated from the expandable member 314. For example, sufficient force may be applied to the guidewire assembly 320 in a direction away from the patient P to cause the coupling member 324 to detach from the expandable member 314. The guidewire assembly 320 may then be translated through the tracheostomy tube 380 and removed from the patient P. The tracheostomy tube 380 may be coupled to a ventilator (not shown) such that the ventilator can force air into and draw air from the patient P's lungs (not shown) through the tracheostomy tube 380. After testing the ventilator and tracheostomy tube 380 combination to ensure that the ventilator is properly forcing air into and drawing air from the patient P's lungs through the tracheostomy tube 380, the inflation assembly 310 and tubular member 350 can be removed from the patient P's body. For example, the elongated tube 312 can be translated proximally through the tubular member 350, and the elongated tube 312 and tubular member 350 can be sequentially or simultaneously removed from the patient P's body through the opening in the patient P through which the tubular member 350 was inserted. For example, the inflatable member 352 can be fully or partially deflated, and the tubular member 350 can be translated proximally. As shown in FIG. 3L, a tracheostomy tube 380 can remain in place against the patient's anterior neck A and upper trachea U, providing fluid flow access to the patient's lungs.

[0058]

[0105] As another example, the guidewire assembly 320 can be used to perform a translaryngeal tracheotomy or Fantoni procedure. For example, as shown in FIG. 3M, the tubular member 350 can be withdrawn from the patient P's body through an orifice (e.g., the nose or mouth) of the patient P. The elongated tube 312 can be translated such that the first end 311 of the elongated tube 312 moves through the orifice of the patient P. Thus, the coupling member 324 of the guidewire assembly 320 and the guidewire 322 are translated through the cricoid cartilage C and out through the orifice of the patient P. The tracheostomy tube can then be threaded over the guidewire so that it can be translated through the patient's mouth, through the cricoid cartilage C, and into the upper trachea U, engaging a tract through the patient's tracheal wall and anterior neck A.

[0059]

[0106] In some embodiments, the external magnetic assembly and the expansion assembly may include any suitable number of magnetic elements configured to magnetically interact through the patient's tissue. For example, FIG. 4 is a schematic diagram of system 400. System 400 may be the same or similar in structure and / or function to any of the systems or devices described herein, such as system 100 and / or system 300 described above. For example, system 400 includes an expansion assembly 410, a guidewire assembly 420, and a tubular member 450. System 400 also includes an external magnetic assembly 440 and an ultrasound probe 460. The expansion assembly 410 may include an elongated tube 412 and an expandable member 414. The elongated tube 412 may have a first end 411 and a second end 413. In some embodiments, the elongated tube 412 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. The expandable member 414 and the magnetic member 415 can be coupled to the elongate tube 412 near the first end 411 of the elongate tube 412. The expansion assembly 410 includes an inflation lumen 416 defined by the elongate tube 412 and in fluid communication with the expandable member 414. The expansion assembly 410 can also include a first magnetic member 415A and a second magnetic member 415B. The guidewire assembly 420 can include a guidewire 422 having a first end 421 and a second end 423, and a coupling member 424 disposed at the first end 421 of the guidewire 422. The tubular member 450 can have a first end 451 and a second end 453 opposite the first end 451. The tubular member 450 may define an inner lumen extending from a first end 451 to a second end 453 and may include an inflatable member 452 extending from an outer surface of the tubular member 450 near the first end 451 and configured to couple to the inner surface of the patient's tracheal wall.

[0060]

[0107] The external magnetic assembly 440 may include a first magnetic element 442A, a second magnetic element 442B, and a handle 444. The first magnetic member 415A and the second magnetic member 415B of the expansion assembly 410 may be spaced apart along the elongated tube 412 such that the first magnetic member 415A is configured to magnetically interact with the first magnetic element 442A and the second magnetic member 415B is configured to magnetically interact with the second magnetic element 442B. During use of the system 400, an ultrasound probe 460 may be positioned between the first magnetic element 442A and the second magnetic element 442B to visualize the expandable member 414 of the expansion assembly 410. This embodiment allows for more precise control over the orientation of the first end 411 of the elongated tube 412 because the orientation of the first end 411 of the elongated tube 412 will match the orientation of the external magnetic assembly 440, i.e., the first magnetic element 442A and the second magnetic element 422B.

[0061]

[0108] In some embodiments, rather than having multiple magnetic members and / or elements, the expansion assembly 410 may include a disk-shaped magnetic member defining a through-hole, and the external magnetic assembly 440 may include a disk-shaped magnetic element defining a through-hole. The ultrasound probe 460 may be inserted through the through-hole of the disk-shaped magnetic element of the external magnetic assembly 440 and brought into contact with the patient P.

[0062]

[0109] In some embodiments, as described above, a light source can be positioned at or near the first end of the elongated tube, and the location on the patient's surface through which the light is emitted can identify the location of the first end of the elongated tube within the patient. For example, FIG. 5 is a schematic diagram of system 500. System 500 can be the same or similar in structure and / or function to any of the systems or devices described herein, such as system 100 and / or system 300 described above. For example, system 500 includes an inflation assembly 510 and a tubular member 550. Inflation assembly 510 can include an elongated tube 512 and an inflatable member 514. Elongated tube 512 can have a first end 511 and a second end 513. In some embodiments, elongated tube 512 can have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. Inflatable member 514 and magnetic member 515 can be coupled to elongated tube 512 near first end 511 of elongated tube 512. Inflation assembly 510 includes an inflation lumen 516 defined by an elongate tube 512 and in fluid communication with an inflatable member 514. A tubular member 550 may have a first end 551 and a second end 553 opposite the first end 551. Tubular member 550 may define a lumen extending from first end 551 to second end 553 and may include an inflatable member 552 extending from an outer surface of tubular member 550 near first end 551 and configured to couple to an inner surface of a patient's tracheal wall.

[0063]

[0110] 5, the light source 518 can be positioned at or near the first end 511 of the elongated tube 512. The light source can generate sufficient light such that it can be emitted from the light source through the tracheal wall onto the surface of the anterior neck A and be visible to an operator (e.g., a clinician). Thus, the operator can determine the location of the first end 511 of the elongated tube 512 based, at least in part, on the location of the light emitted through the anterior neck A of the patient P. The light source 518 can be, for example, a light emitting diode (LED).

[0064]

[0111] In some embodiments, as described above with respect to FIG. 1 , the inflation assembly can include a barrier member that prevents the needle from puncturing the posterior wall of the patient's trachea. For example, FIG. 6 is a schematic diagram of system 600. System 600 can be the same or similar in structure and / or function to any of the systems or devices described herein, such as system 100 and / or system 300 described above. For example, system 600 includes inflation assembly 660. System 600 also includes external magnetic assembly 640, ultrasound probe 660, and needle 630. Inflation assembly 610 can include elongate tube 612 and inflatable member 614. Elongate tube 612 can have a first end 611 and a second end (not shown). In some embodiments, elongate tube 612 can have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. Inflatable member 614 and magnetic member 615 can be coupled to elongate tube 612 near first end 611 of elongate tube 612. Inflation assembly 610 includes an inflation lumen defined by an elongate tube 612 and in fluid communication with an expandable member 614 .

[0065]

[0112] 6, a barrier member 695 can be coupled to or form part of a side wall of the expandable member 614. The barrier member 695 can be the same as or similar in structure and / or function to the barrier member 195 described above with respect to FIG. 1. For example, the barrier member 195 can have a shape that corresponds to the shape of the outer surface of the expandable member 614. The barrier member 195 can be configured to be positioned between the portion of the expandable member 614 intended to be pierced by the needle 630 and the posterior tracheal wall of the patient P. 6, when the needle 630 applies a force to the barrier member 695 that is greater than the magnetic attraction force applied by the external magnetic assembly 640 to the magnetic member 615 of the inflation assembly 610 (e.g., through the anterior neck A and tracheal wall of the patient P), the barrier member 695 may be sufficiently resistant to puncture and / or tearing such that the needle 630 may urge the barrier member 695 toward the posterior tracheal wall of the patient P, and thus urge the magnetic member 615 away from the anterior tracheal wall of the patient P, rather than piercing and / or penetrating the barrier member 695. Thus, when the needle 630 is urged against the barrier member 695 while the external magnetic assembly urges the magnetic member 615 toward the anterior neck A by magnetic attraction, a gap G may exist between the outer surface of the inflatable member 614 and the inner surface of the anterior tracheal wall of the patient P. When the force of the needle 630 in the posterior direction against the barrier member 695 is removed or reduced, the magnetic attraction of the external magnetic assembly 640 can again urge the magnetic member 615 towards the anterior neck A.

[0066]

[0113] In some implementations, the barrier member 695 can be disposed inside the expandable member 614 and coupled to an inner surface of the sidewall of the expandable member 614. In some implementations, the barrier member 695 can be disposed outside the expandable member 614 and coupled to an outer surface of the sidewall of the expandable member 614. In some implementations, the expandable member 614 can be formed in part from the barrier member 695. For example, the expandable member 614 can include a first sidewall portion and a second sidewall portion opposite the first sidewall portion. The first sidewall portion can be configured to penetrate and receive the needle 630, and the second sidewall portion can be configured to be more resistant to puncture by the needle 630 than the first sidewall portion. For example, the second sidewall portion can have a greater thickness and / or a greater hardness than the first sidewall portion.

[0067]

[0114] Additionally, in some implementations, the barrier member 695 may have a high echogenicity such that it may be more easily visualized by ultrasound than other portions of the inflation assembly 610 (e.g., the inflatable member 614 and / or the interior of the inflatable member 614) and / or surrounding portions of the patient P. The high echogenicity may allow the surgeon to identify the location of the barrier member 695 via ultrasound imaging and stop translation of the needle 630 before it reaches or penetrates the barrier member 695, preventing the needle 630 from advancing too far relative to the inflatable member 614 and / or the patient's trachea and causing damage to the patient's posterior tracheal wall.

[0068]

[0115] In some implementations, the barrier member 695 can be formed from any suitable material that is highly resistant to puncture by a needle (e.g., needle 630) used to pierce a patient's tissue and / or that is highly echogenic. For example, the barrier member 695 can be formed from a polymer or a metal composite. In some implementations, the barrier member 695 can be formed from the same or a different material as the expandable member 614 or the remainder of the expandable member 614. In some implementations, the barrier member 695 can include a thickened or reinforced portion of the sidewall of the expandable member 614. The barrier member 695 can have a high hardness (e.g., scratch hardness and / or indentation hardness) relative to the hardness of the expandable member 614 or the remainder of the expandable member 614.

[0069]

[0116] For some patients, it may not be desirable to deliver any device through the ETT. Such delivery may expose healthcare providers to infectious respiratory pathogens, e.g., viruses such as COVID-19. Even if a patient is not known to have an infectious respiratory disease, as a precaution, healthcare providers may assume that any patient may be infectious during an epidemic, such as the COVID-19 outbreak. In such patients or situations, a brief apneic period during percutaneous tracheostomy may be acceptable (or even desirable). In such cases, the guidewire delivery system may preferably not be placed in-line with the ETT (i.e., through the lumen of the ETT). Rather, the system may be delivered outside the ETT, between the ETT and the vocal cords or vocal folds, in what is referred to herein as a "paired" approach.

[0070]

[0117] FIG. 8 is a diagram of a patient's larynx with the epiglottis retracted and the ETT positioned within the larynx between the vocal cords. As can be seen in FIG. 8, the ETT has a circumference substantially smaller than the circumference of the opening defined by the vocal cords, the minor cartilage, and the retracted epiglottis (e.g., glottis), thereby providing an opening through which a device, such as a guidewire delivery system, can be delivered into the larynx. For example, FIG. 14A illustrates a patient with an epiglottis shaped and positioned relative to the vocal cords such that both the ETT and a device can be delivered into the patient's larynx and trachea. FIG. 14B illustrates a patient with an ETT and an epiglottis shaped and positioned relative to the vocal cords such that delivery of a device outside of the ETT may not be feasible (e.g., because the glottal area is too small and / or distended). FIG. 9 is a schematic lateral view of a patient's larynx with an ETT positioned within the larynx. FIG. 10 illustrates a guidewire delivery system 800 delivered via a paired approach and positioned anteriorly between the ETT and the laryngeal wall.

[0071]

[0118] 11 is a schematic representation of system 800. System 800 includes an inflation assembly 810 and a guidewire assembly 820. System 800 may also optionally include an external magnetic assembly 840 and an ultrasound probe 860. Inflation assembly 810 may include an elongate tube 812, an expandable member 814, and optionally a magnetic member 815. Inflation assembly 810 may optionally include a barrier member 895. Elongate tube 812 may have a first end 811 and a second end 813. In some embodiments, elongate tube 812 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. Expandable member 814 and optionally magnetic member 815 may be coupled to elongate tube 812 at or near first end 811 of elongate tube 812. Inflation assembly 810 may include an inflation lumen 816 in fluid communication with expandable member 814. In some embodiments, the inflation lumen 816 can be disposed within and / or defined by the elongate tube 812 .

[0072]

[0119] Optional magnetic member 815 may be any suitable magnetic member configured such that movement of magnetic member 815 results in corresponding movement of first end 811 of elongated tube 812. Magnetic member 815 may have any suitable shape. For example, in some embodiments, magnetic member 815 may be in the shape of an elongated rectangle. In some embodiments, magnetic member 815 may be in the shape of a cylinder. In some embodiments, magnetic member 815 may be arcuate. In some embodiments, magnetic member 815 is directly coupled to elongated tube 812. In some embodiments, magnetic member 815 is disposed within and at least partially surrounded by expandable member 814. In some embodiments, magnetic member 815 is directly coupled to expandable member 814. In some embodiments, system 800 includes two or more magnetic members 815. In some embodiments, at least one magnetic member 815 can be disposed proximally of the expandable member 814, and / or at least one magnetic member 815 can be disposed distally of the expandable member 814. In some embodiments, each magnetic member 815 of a set of magnetic members 815 (e.g., two or more magnetic members 815) can be disposed within the expandable member 814, coupled to, disposed distally of, and / or disposed proximally of the expandable member 814.

[0073]

[0120] In some embodiments, the expandable member 814 can surround the elongate tube 812 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 814 can extend laterally from the elongate tube 812 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 814 can extend distally from the first end 811 of the elongate tube 812 in the inflated and / or uninflated configuration. In some embodiments, the expandable member 814 can be disposed on the elongate tube 812 such that a portion of the elongate tube 812 extends distally of the expandable member 814 when the expandable member 814 is in the inflated and / or uninflated configuration. In some embodiments, the expandable member 814 can have two ends (e.g., cuffs), and each end can be sealed to the exterior surface of the elongate tube 812. The elongate tube 812 can define one or more inflation ports or holes such that the inflation lumen 816 can be in fluid communication with the interior of the expandable member 814 to transition the expandable member 814 between its uninflated and inflated configurations. In some embodiments, the expandable member 814 can be formed on or as part of a rigid subassembly that can receive the elongate tube 812 within an orifice of the subassembly, thereby sealing the elongate tube 812 to the subassembly.

[0074]

[0121] In some embodiments, expandable member 814 can be formed from any suitable material, in any suitable shape, and at any suitable size. For example, expandable member 814 can be oval, spherical, cylindrical, rectangular, teardrop-shaped, or any other suitable shape. In some embodiments, the shape can be selected based on the particular application of system 800. For example, the shape of expandable member 814 can be selected to facilitate ultrasound visualization in a particular region of the patient's body. Additionally, expandable member 814 can be sized to facilitate engagement and retention of expandable member 814 with guidewire assembly 820.

[0075]

[0122] The expandable member 814 may be sufficiently flexible so that (e.g., when expanded) it can be punctured (e.g., by a needle) to define a pinhole in the wall of the expandable member 814 rather than rupturing or tearing as a result of the puncture. In some embodiments, the expandable member 814 may be formed from, for example, polyurethane, silicone, and / or polyvinyl chloride (PVC). In some embodiments, the expandable member 814 may have any suitable material properties, wall thickness, and / or outermost expanded diameter.

[0076]

[0123] Guidewire assembly 820 can include a guidewire 822 having a first end 821 and a second end 823, and a coupling member 824 disposed at first end 821 of guidewire 822. Coupling member 824 can be configured to couple to expandable member 814, and when coupled, translation of expansion assembly 810 (e.g., translation of elongate tube 812 by pulling second end 813) can translate guidewire assembly 820. For example, if a force applied to elongate tube 812 causes expandable member 814 to move in a first direction, coupling member 824 to expandable member 814 can also move coupling member 824 and guidewire 822 in the first direction. Coupling member 824 can be configured to couple to expandable member 814, for example, by being captured by expandable member 814, being sandwiched within an interior region of the expandable member, or engaging a surface of expandable member 814. In some embodiments, the coupling members 824 can be sized to form micropunctures in the sidewalls of the expandable member 814 .

[0077]

[0124] Similar to system 100, in some embodiments, coupling member 824 can be separate from guidewire 822 and fixedly coupled to guidewire 822 (e.g., via an adhesive). For example, in some embodiments, coupling member 824 can include a first magnetic member configured to couple to a second magnetic member of expandable member 814. Similar to system 100, in some embodiments, guidewire 822 can include coupling member 824. Similar to system 100, in some embodiments, coupling member 824 can be configured to transition between a first configuration for insertion and a second configuration for retention or coupling. Similar to system 100, in some embodiments, when coupling member 824 is within lumen 835 of needle 830, needle 830 can compress coupling member 824 such that the coupling member is in the first configuration. Similar to system 100, in some embodiments, expandable member 814 can be configured to cause coupling member 824 to translate in a first direction when a translational force on expandable member 814 (e.g., a force causing expandable member 814 to translate and / or a force holding expandable member 814 stationary) is greater than a force in a direction opposite the translational force on coupling member 824. When the force on coupling member 824 is opposite and greater than the translational force on expandable member 814, coupling member 824 and expandable member 814 can be configured to separate.

[0078]

[0125] Similar to system 100, in some embodiments, coupling member 824 can be configured to pierce expandable member 814 such that coupling member 824 can be inserted into and / or through expandable member 814. Similar to system 100, optional barrier member 895 can be a portion of inflation assembly 810 that is more resistant to puncture (e.g., by a needle) or tearing than expandable member 814 or portions of expandable member 814. Similar to system 100, in some embodiments, expandable member 814 can be filled and / or inflated with a fluid (e.g., a liquid or gaseous fluid) after being positioned in the patient's upper trachea. For example, expandable member 814 can be filled and / or inflated with a fluid and / or contrast agent such that expandable member 814 defines an echogenic space detectable using ultrasound imaging.

[0079]

[0126] In use, an end of the tubular member (e.g., an ETT) can be inserted through a patient's opening (e.g., the patient's nose or mouth), through the patient's cricoid cartilage, and beyond a target region of the patient's trachea so that the inflatable member of the tubular member is positioned between the target region of the trachea and the patient's carina. The target region of the trachea can include a desired tracheal puncture site (e.g., a location between the patient's second and third tracheal rings or a location between the patient's first and second tracheal rings). The inflatable member of the tubular member can be transitioned from an undeployed configuration to an expanded configuration so that it makes sealing contact with the patient's trachea such that air cannot flow between the patient's lungs and the patient's opening except through the lumen of the tubular member. The tubular member can be fluidly coupled to a ventilator so that the patient's lungs can be ventilated through the tubular member by the ventilator. Thus, the target region of the trachea outside the tubular member is fluidly isolated from a region of the airway opposite the location of the expanded inflatable member.

[0080]

[0127] The first end 811 of the elongated tube 812 of the inflation assembly 810 may then be inserted through a patient's orifice (e.g., the patient's nose or mouth) to a target area of ​​the patient's trachea between the cricoid cartilage and the outer surface of the tubular member such that the inflatable member 814 is positioned between the outer surface of the tubular member and the inner surface of the trachea. Thus, the elongated tube 812 is positioned adjacent to the tubular member through the patient's larynx and a portion of the trachea. In some embodiments, the surgeon can determine that the first end 811 of the elongated tube 812 should extend a particular distance into the trachea based on the known relative lengths of the tubular member 850 and the elongated tube 812 and / or markings on at least one of the tubular member 850 or the elongated tube 812.

[0081]

[0128] In some embodiments, the expandable member 814 can be translated through the patient to the target region of the trachea so as to be positioned in front of the tubular member (e.g., between the outer surface of the tubular member and the anterior wall of the upper trachea). For example, the elongated tube 812 can be manipulated during insertion to maintain the expandable member 814 in front of the tubular member. In some embodiments, one or more optional magnetic members 815 can be used to urge the expandable member 814 to a position in front of the tubular member. For example, an optional external magnetic assembly 840 can be positioned on the anterior neck of the patient such that one or more magnetic members 815 of the inflation assembly 810 are urged toward the external magnetic assembly 840 to urge the first end 811 of the elongated tube 812 and / or the expandable member 814 to a position in front of the tubular member (e.g., between the tubular member and the anterior wall of the upper trachea).

[0082]

[0129] Fluid can then be delivered to the expandable member 814 via the inflation lumen 816. As described above, the fluid can include a fluid and / or a contrast agent so that the expandable member 814 is detectable via imaging (e.g., ultrasound). In some embodiments, the expandable member 814 can be sized relative to the size (e.g., diameter) of the trachea and the size (e.g., diameter) of the tubular member such that expanding the expandable member 814 from the undeployed configuration to the expanded configuration causes a portion of the outer surface of the expandable member 814 to contact the anterior surface of the trachea, allowing ultrasound visualization of the contacting portion of the outer surface and all tissue planes between the expandable member 814 and the outer surface of the patient on which the ultrasound probe 860 is positioned (e.g., the ultrasound probe 860 is aligned with the expandable member 814). In some embodiments, in the expanded configuration, the expandable member 814 can exert a compressive force against tissue planes between the expandable member 814 and the outer surface of the patient. In some embodiments, the optional one or more magnetic members 815 can be used to bias the expandable member 814 against the front surface of the upper trachea. For example, an optional external magnetic assembly 840 can be placed on the anterior neck of the patient such that the one or more magnetic members 815 of the expansion assembly 810 are biased toward the external magnetic assembly 840, urging the expanded expandable member 814 into contact with the anterior wall of the upper trachea. In some embodiments, in the expanded configuration, the expandable member 814 can exert a compressive force against the tissue plane between the expandable member 814 and the external surface of the patient.

[0083]

[0130] The expandable member 814 can then be visualized (e.g., using an ultrasound probe 860) so that its location can be identified. If desired, the external magnetic assembly 840 can then be moved along the skin of the patient's anterior neck to bias one or more magnetic members 815 in the same direction, thereby urging the expandable member 814 toward the desired tracheal puncture site. In some embodiments, the ultrasound probe 860 can be used to determine the tracheal puncture site between specific tracheal rings (e.g., between the patient's first and second tracheal rings or between the patient's second and third tracheal rings). In some embodiments, instead of or in addition to using the external magnetic assembly 840 to bias the expandable member 814 toward the desired tracheal puncture site, the elongated tube 812 can be advanced or retracted relative to the patient (e.g., by pulling or pushing a portion of the elongated tube 812 outside the patient's body near the patient's head).

[0084]

[0131] While using the ultrasound probe 860 to visualize the position of the expandable member 814, the guidewire assembly 820 can be inserted through the patient's anterior neck, into the patient's trachea, and coupled to the expandable member 814. For example, a needle 830 can be inserted through the patient's anterior neck and trachea and through a sidewall of the expandable member 814 so that a first end 831 (e.g., a tip) of the needle 830 is disposed within the expandable member 814. During insertion of the needle 830, the ultrasound probe 860 can be used to visualize the needle 830 and any intervening patient structures between the patient's skin and the expandable member 814. For example, the ultrasound probe 860 can be used to identify the patient's thyroid isthmus and proximal vessels in real time during insertion of the needle 830 so that the thyroid isthmus and proximal vessels can be avoided. Additionally, the ultrasound probe 860 can be used to confirm that the first end 831 of the needle 830 is disposed within the expandable member 814. Additionally or alternatively, echogenic fluid may be aspirated from the expandable member 814 through the needle 830 (e.g., into a syringe barrel) to confirm that the first end 831 of the needle 830 is positioned within the expandable member 814.

[0085]

[0132] With first end 831 of needle 830 disposed within expandable member 814, coupling member 824 and a portion of guidewire 822 may be inserted through lumen 835 of needle 830 and translated (e.g., pushed through) through lumen 835. Coupling member 824 may then be translated out of first end 831 of needle 830 so that coupling member 824 is disposed within expandable member 814. Translation of needle 830 relative to coupling member 824 and guidewire 822 may then cause needle 830 to be withdrawn from the patient, leaving coupling member 824 within expandable member 814 and guidewire 822 extending through the wall of expandable member 814. Additionally, in embodiments in which an external magnetic assembly 840 is used, external magnetic assembly 840 may be removed from the patient such that one or more magnetic members 815 are no longer biased (e.g., via magnetic attraction) toward the anterior tracheal wall. Additionally, expandable member 814 may be deflated.

[0086]

[0133] With guidewire assembly 820 extending through the patient's anterior neck and coupled to expandable member 814, any suitable percutaneous tracheotomy procedure can be performed using guidewire assembly 820 and a tract through the patient's anterior neck to the patient's trachea in which guidewire assembly 820 is disposed. For example, elongate tube 812 can be translated such that first end 811 of elongate tube 812 moves out of the patient's orifice (e.g., nose or mouth). Thus, coupling member 824 of guidewire assembly 820 translates out of the patient's orifice through the cricoid cartilage, and guidewire 822 extends through the tracheal puncture site, through the larynx, and out of the patient's nasal or oral opening. A needle dilator can be translated over guidewire 822 to dilate the anterior tracheotomy tract in which guidewire 822 is disposed. A first end of a second guidewire can be translated through the needle dilator. The second guidewire can have a larger diameter than guidewire 822, for example. For example, in some embodiments, the second guidewire can be a 0.052-inch percutaneous tracheostomy guidewire. With the first end of the second guidewire positioned between the anterior surface of the trachea and the outer surface of the tubular member, the needle dilator can be removed. The ventilator coupled to the tubular member can be stopped, the inflatable member coupled to the tubular member can be deflated, and the tubular member can be removed from the patient's body through the opening through which it was inserted. By disconnecting from a functioning ventilator (e.g., the ventilator is stopped, the tubular member is removed, and the tracheostomy tube coupled to the ventilator is not still operably coupled to the tracheal puncture site), the guidewire 822 can remain extending through the tracheal puncture site and out the patient's mouth or nose while the patient is apneic (and viral aerosolization is minimized). Thus, if reintubation is required, a tubular member (e.g., an ETT) can be threaded over the guidewire 822 to rapidly return the patient to the ventilator. After the tubular member is removed, a tracheal dilator can be advanced over the second guidewire to dilate the tracheal passage outward through the anterior neck.After the dilator is removed, the tracheostomy tube may be advanced over the guidewire and through the patient's tracheal wall into engagement with the tracheal passage so that a first end of the tracheostomy tube is positioned within the upper trachea and a second end is positioned outside the patient (e.g., extending from the anterior neck of the patient). The second guidewire may be removed. A balloon cuff on the tracheostomy tube positioned within the trachea may be inflated to seal the trachea around the tracheostomy tube. A ventilator may be operably coupled to the tracheostomy tube so that air is provided to the patient's lungs via the tracheostomy tube, terminating the apneic period. The guidewire 822 may be removed from the patient (e.g., by cutting the coupling member 824 and pulling the end of the guidewire 822 so that it is removed from either the tracheal puncture site or an opening (e.g., nose or mouth)).

[0087]

[0134] In some embodiments, for example, the expandable member 814 can be oval in shape and formed from a low durometer urethane. The expandable member 814 can have an outermost diameter in the expanded configuration ranging from about 15 mm to about 55 mm and a length of about 55 mm. The wall thickness at the maximum balloon diameter in the expanded configuration can be about 0.029 mm to about 0.038 mm. The expandable member 114 can be filled with a maximum volume of fluid in the expanded configuration, for example, about 20 ml to about 40 ml.

[0088]

[0135] In some embodiments, the outer diameter of the expandable member 814 can be determined by the outer diameter of the tubular member (e.g., the ETT) and the inner diameter of the patient's trachea. For example, as shown in FIG. 15 , patients of different ages and developmental stages can tolerate different ETT sizes. Typical tracheal diameters range, for example, from about 15 mm to about 20 mm. Generally, older and / or larger patients can receive endotracheal tubes with larger outer diameters than younger and / or smaller patients. Thus, the outer diameter of the expandable member 814 in its expanded configuration can be selected depending on the outer diameter of the ETT placed in the patient's trachea and the inner diameter of the trachea, and the expandable member 814 can be movable relative to the ETT to compress against the anterior tracheal wall using the external magnetic assembly 850, or the expandable member 814 can expand sufficiently large to fill the space between the ETT and the anterior tracheal wall, exerting pressure on the anterior tracheal wall due to expansion of the expandable member 814 away from the anterior tracheal wall constrained by the ETT.

[0089]

[0136] In some embodiments, the expandable member 814 can be collapsed small enough in its undeployed configuration so that it can be translated through the lumen of a tubular member (e.g., an ETT) for in-line delivery (e.g., similar to that described with respect to system 300 shown in FIGS. 3A-3M above), and the expandable member 814 can be expandable to a large enough size in its expanded configuration so that the same expandable member 814 can be used for paired delivery and can expand in the space between the tubular member and the anterior tracheal wall to apply pressure against the anterior tracheal wall for coaptation and define an echogenic space that can be visualized via ultrasound. Thus, in some embodiments, the same inflation assembly 810 can be used for both in-line and paired delivery procedures (e.g., a clinician can determine which procedure is more appropriate for a patient based on the patient's anatomy and risk factors). For example, the size (e.g., maximum lateral extent or diameter) of the inflatable member 814 in the undeployed configuration can be small enough to pass through the lumen of an ETT having an inner diameter as shown in the chart of FIG. 15 , and the inflatable member 814 can be large enough in the deployed configuration to exert coaptation pressure against the patient's anterior tracheal wall by being constrained between the anterior tracheal wall and the ETT in the deployed configuration, the ETT having an outer diameter corresponding to the inner diameter as shown in the chart of FIG. 15 . In some embodiments, the inflatable member 814 used can have sizes in the undeployed and expanded configurations that depend on the inner and outer diameters of the associated ETT (an example of which is shown in FIG. 15 ) and the inner diameter of the patient's trachea. In some embodiments, a Foley catheter can be suitable for use as the inflation assembly 810 for delivery to the space in the upper trachea A outside a tubular member (e.g., an ETT), coaptation of the Foley catheter's balloon to the anterior tracheal wall, and ultrasound guidance.For example, a Foley catheter can be used as inflation assembly 810 for a patient having anatomical dimensions suitable for the shape and size of the balloon of the Foley catheter, and / or as part of a system having components (e.g., needle 830 and / or guidewire 822) configured to functionally operate as described herein in combination with the Foley catheter.

[0090]

[0137] In some embodiments, the expandable member 814 can be formed as a bilayer balloon, such as the balloon disclosed in International Patent Application PCT / US 17 / 026141, incorporated herein by reference above. For example, the expandable member 814 can include an inner balloon and an outer balloon, where the inner balloon is disposed inside the outer balloon. In some embodiments, the expandable member 814 can include a set of struts disposed between the inner and outer balloons to maintain a distance or space between the inner and outer balloons. The inner balloon can be fluidly coupled to a first inflation lumen (e.g., inflation lumen 816), and the outer balloon can be fluidly coupled to a second inflation lumen. Both the first and second inflation lumens can be contained within and / or defined by the elongate tube 812. To transition the bilayer inflatable member 814 from the undeployed configuration to the expanded configuration, the inner balloon can be inflated with a gaseous fluid (e.g., air) and the outer balloon can be inflated with a liquid fluid and / or contrast agent, such that the liquid fluid fills the space between the inner surface of the outer balloon and the outer surface of the inner balloon. The liquid fluid-filled space between the inner and outer balloons can be used as an echogenic window, with the pressure of the gaseous fluid in the inner balloon and the pressure of the liquid fluid in the outer balloon together pressing the outer surface of the outer balloon against the anterior tracheal wall, creating a coaptation.

[0091]

[0138] Because the bilayer inflatable member 814 has an inner balloon filled with a gaseous fluid, it can define an echogenic window using less liquid fluid than a single-layer inflatable member, thereby reducing the risk of a sufficient amount of fluid being expelled from the inflatable member 814 to injure the patient when the needle 830 passes through the outer and / or inner balloons, compared to a single-layer balloon filled with a liquid fluid. In some embodiments, the bilayer inflatable member 814 can include one or more spacers disposed between the inner and outer balloons to maintain a preferred distance between them (e.g., to prevent the outer balloon from contacting the inner balloon and thus eliminating the echogenic window). For example, the one or more spacers can include rivets located around the surface of the inner balloon. In some embodiments, the rivets can be positioned to maintain the distance between the inner and outer balloons in all directions. In some embodiments, the rivets can be positioned to maintain the distance between the inner and outer balloons in the region (e.g., central portion) of the inflatable member 814 where an echogenic window is desired.

[0092]

[0139] In some embodiments, the bilayer inflatable member 814 can be large enough so that a magnet is not required to draw the bilayer inflatable member 814 against the anterior tracheal wall to effect coaptation and define an ultrasound-visible echogenic window. Instead, the bilayer inflatable member 814 can have a sufficiently large circumference (e.g., a sufficiently large diameter or cross-sectional area) in its expanded configuration so that the inflatable member 814 bridges the distance or gap between the tubular member (e.g., ETT) and the anterior tracheal wall and compresses both the tubular member and the anterior tracheal wall sufficiently to effect coaptation against the anterior tracheal wall and define an echogenic window. For example, the outer diameter of the tubular member in an adult patient can be in the range of 10-12 mm, and the inflatable member 814 can be sized such that, in its unconstrained, expanded configuration, it has an outer diameter that is greater than the inner diameter of the patient's trachea minus the outer diameter of the tubular member. In some embodiments, the system 800 may include a magnet associated with the expandable member 814 or the elongate tube 812 that is used only to position the bi-layer expandable member 814 in front of the tubular member before transitioning the bi-layer expandable member 814 from the undeployed configuration to the expanded configuration.

[0093]

[0140] In some embodiments, the expandable member 814 may define passageways (not shown) (also referred to as “vents”) extending from a first end to a second end of the expandable member 814 to allow fluid (e.g., air) to travel through the passageways when the expandable member 814 is in the expanded configuration. For example, in some embodiments, when the expandable member 814 is positioned within the trachea in the expanded configuration, each passageway may be bounded in part by the expandable member 814 and in part by the patient's tracheal wall. Thus, air may flow through the passageways between a portion of the trachea on a first side of the expandable member 814 (e.g., the region between the cricoid cartilage and the expandable member 814) and a portion of the trachea on a second side of the expandable member 814 (e.g., the region between the expandable member 814 and the patient's lungs) when the expandable member 814 is in the expanded configuration. In some embodiments, the expandable member 814 may define one or more entire outer boundaries of the passageways. The inflatable member 814 can be shaped to define any suitable number of passages (e.g., one, two, three, four, or more passages) in the expanded configuration. The passages can be defined in any suitable location on the inflatable member 814. In some embodiments, the inflatable member 814 can define a suitable number of passages having a suitable size (e.g., having a suitable combined cross-sectional area) such that when the inflatable member 814 is positioned within a patient's trachea and the outer surface of the inflatable member 814 contacts the inner wall of the patient's trachea, the patient can be properly ventilated through the passages (e.g., freely or via a ventilator). For example, the outer surface of the inflatable member 814 may contact the inner wall of the patient's trachea in a continuous manner such that air cannot flow between the outermost surface of the inflatable member 814 and the tracheal wall, or such that the rate at which air can flow between the outermost surface and the tracheal wall and / or tubular member 850 is insufficient for proper ventilation and oxygenation. In some embodiments, the combined cross-sectional area of ​​the passageways can be large enough to allow an air flow of about 40 liters per minute to about 75 liters per minute through the passageways.Thus, with the inflatable member 814 deployed in the trachea, the patient can receive closed, continuous ventilation through the passageway, such as during ultrasound visualization (e.g., via junction ultrasound) of the inflatable member 814 and / or the tissue between the inflatable member 814 and the ultrasound probe.

[0094]

[0141] In some embodiments, the expandable member 814 may comprise a single-layer balloon that is sufficiently large in the expanded configuration so that the expandable member 814 presses against the anterior tracheal wall and the tubular member (e.g., the ETT) when the expandable member 814 transitions from the undeployed configuration to the deployed configuration. Thus, in some embodiments, the system 800 may not include a magnet associated with the expandable member 814 or the elongated tube 812 because the expandable member 814 fills the gap between the tubular member and the anterior tracheal wall as it expands, pressing against the anterior tracheal wall to form an echogenic window. Instead, in some embodiments, the system 800 may include a magnet associated with the expandable member 814 or the elongated tube 812 that is used only to position the expandable member 814 in front of the tubular member before transitioning the expandable member 814 from the undeployed configuration to the expanded configuration. For example, FIG. 16 is a schematic diagram of a system 1100. The system 1100 may be the same or similar in structure and / or function as any of the systems described herein, such as the system 800. For example, system 1100 includes an inflation assembly 1110, a guidewire assembly 1120, and a needle 1130. System 1100 may also optionally include an ultrasound probe 1160. Inflation assembly 1110 may be the same as or similar in structure and / or function to any of the inflation assemblies described herein. Inflation assembly 1110 may include an elongate tube 1112 and an inflatable member 1114. As shown in FIG. 16 , inflatable member 1114 may include a single-layer balloon that is sufficiently large in its expanded configuration to compress against the anterior tracheal wall and tubular member 1150 (e.g., ETT) when inflatable member 1114 transitions from its undeployed configuration to its expanded configuration. Thus, when inflatable member 1114 expands, it fills the gap between tubular member 1150 and the anterior tracheal wall, forming an echogenic window by being pressed against the anterior tracheal wall. As shown in FIG. 17, the expandable member 1114 can then be pierced by a needle 1130 and a guidewire assembly 1120 can be coupled to the expandable member 1114 via the needle 1130 .

[0095]

[0142] In some embodiments, the inflatable member 814 may include a single-layer balloon, and the inflatable member 814 and / or the elongate tube 812 may include one or more magnetic members 815 such that the inflatable member 814 can be drawn toward or against the anterior tracheal wall by an external magnetic assembly. The single-layer balloon may be small enough that it is movable within the patient's trachea relative to the tubular member (e.g., the ETT) in its deployed configuration. For example, FIG. 17 is a schematic diagram of a system 1200. The system 1200 may be the same as or similar in structure and / or function to any of the systems described herein, such as system 800. For example, the system 1200 includes an inflation assembly 1210, a guidewire assembly 1220, and a needle 1230. The system 1200 may also optionally include an external magnetic assembly 1240 and an ultrasound probe 1260. The inflation assembly 1210 may be the same as or similar in structure and / or function to any of the inflation assemblies described herein. The inflation assembly 1210 may include an elongate tube 1212, an inflatable member 1214, and a magnetic member 1215. As shown in FIG. 17 , the inflatable member may include a single-layer balloon, and the inflatable member 1214 and / or the elongate tube 1212 may include one or more magnetic members 1215 such that the inflatable member 1214 can be drawn toward or against the anterior tracheal wall by an external magnetic assembly 1240. The single-layer balloon may be small enough so that in a deployed configuration it is movable within the patient's trachea relative to a tubular member 1250 (e.g., an ETT). As shown in FIG. 17 , the inflatable member 1214 may then be pierced by a needle 1230, and a guidewire assembly 1220 may be coupled to the inflatable member 1214 via the needle 1230.

[0096]

[0143] 12A-12E are schematic diagrams of guidewire placement system 900 at various stages of operation. Guidewire placement system 900 may be the same or similar in structure and / or function as guidewire placement system 800 described above. For example, system 900 includes an inflation assembly 910 and a guidewire assembly 920. System 900 also includes an ultrasound probe 960. Inflation assembly 910 may include an elongate tube 912 and an inflatable member 914. Elongate tube 912 may have a first end 911 and a second end 913. In some embodiments, elongate tube 912 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. Inflatable member 914 may be coupled to elongate tube 912 at or near first end 911 of elongate tube 912. Inflatable member 914 may be a dual-layer balloon-inflatable member having struts as described above. The inflation assembly 910 may include a first inflation lumen in fluid communication with an inner balloon of the expandable member 914 and a second inflation lumen in fluid communication with an outer balloon of the expandable member 914. In some embodiments, the inflation lumen 916 may be disposed within and / or defined by the elongate tube 912.

[0097]

[0144] A first end 951 of the tubular member 950 (e.g., an ETT) may be inserted through an orifice (e.g., the patient's nose or mouth) (not shown) of the patient P, through the patient P's cricoid cartilage C, and into the patient P's upper trachea U such that the first end 951 of the tubular member 950 and the inflatable member 952 are positioned between the patient's third tracheal ring T3 and the carina. For example, the first end 951 of the tubular member 950 may be advanced through the patient's body under direct or indirect laryngoscopy. The inflatable member 952 may be transitioned to an inflated configuration such that the inflatable member 952 can anchor the first end 951 within the trachea and / or stabilize the first end 951 of the tubular member 950 against the inner surface of the tracheal wall (e.g., resist axial movement). A second end 953 of the tubular member 950, positioned outside the patient P, may be operably coupled to a mechanical ventilator such that the patient's lungs can be ventilated by the ventilator via the tubular member 950. 12A for a period of time (e.g., hours, days) prior to delivery of elongated tube 912 to a desired tracheal puncture site in a target region of the trachea. The target region of the trachea exterior to tubular member 950 is fluidly isolated from the region of the airway (e.g., lung) opposite the location of expanded inflatable member 952.

[0098]

[0145] The first end 911 of the elongate tube 912 of the inflation assembly 910 may then be inserted through an opening in the patient P (e.g., the patient P's nose or mouth) to a target area of ​​the patient P's trachea between the cricoid cartilage and the outer surface of the tubular member 950 such that the inflatable member 914 is positioned between the outer surface of the tubular member 950 and the inner surface of the trachea. Thus, as shown in FIG. 12A , the elongate tube 912 is positioned adjacent to the tubular member 950 through the patient P's larynx and a portion of the trachea.

[0099]

[0146] A gaseous fluid can then be delivered to the inner balloon of the inflatable member 914 via the first inflation lumen, and a liquid fluid can be delivered to the outer balloon of the inflatable member 914 via the second inflation lumen. As shown in FIG. 12A , the inflatable member 914 can be sized relative to the size (e.g., diameter) of the trachea and the size (diameter) of the tubular member such that, by inflating the inflatable member 914 from the undeployed configuration to the expanded configuration, a portion of the outer surface of the outer balloon of the inflatable member 914 contacts the surface of the anterior wall of the trachea, allowing ultrasound visualization of the contacting portion of the outer surface and all tissue planes between the inflatable member 914 and the outer surface of the patient P on which the ultrasound probe 960 is positioned (e.g., the ultrasound probe 960 is aligned with the inflatable member 914). In some embodiments, in the expanded configuration, the inflatable member 914 can exert a compressive force against the tissue planes between the inflatable member 914 and the outer surface of the patient P. In some embodiments, in the expanded configuration, the expandable member 914 can then apply a compressive force against a tissue plane between the expandable member 914 and the outer surface of the patient P. The expandable member 914 can be visualized (e.g., using an ultrasound probe 960) so that the location of the expandable member 914 can be identified. In some embodiments, the ultrasound probe 960 can be used to determine the tracheal puncture site between specific tracheal rings (e.g., between the first tracheal ring T1 and the second tracheal ring T2 of the patient P or between the second tracheal ring T2 and the third tracheal ring T3 of the patient P). In some embodiments, the expandable member 914 can be urged to the desired tracheal puncture site by advancing or retracting the elongated tube 912 relative to the patient (e.g., by pulling or pushing a portion of the elongated tube 912 outside the patient's body near the patient's head).

[0100]

[0147] As shown in FIG. 12A , while using an ultrasound probe 960 to visualize the position of the expandable member 914, a needle 930 may be inserted through the anterior neck A of the patient P and into the side wall of the expandable member 914 so that a first end (e.g., tip) of the needle 930 is disposed within the expandable member 914. During insertion of the needle 930, the ultrasound probe 960 may be used to visualize the needle 930 and any intervening patient structures between the patient's skin and the expandable member 914. For example, the ultrasound probe 960 may be used to identify the patient's thyroid isthmus and proximal vessels in real time during insertion of the needle 930 so that the thyroid isthmus and proximal vessels can be avoided. Furthermore, the ultrasound probe 960 may be used to confirm that the first end of the needle 930 is disposed within the expandable member 914. Additionally or alternatively, echogenic fluid may be aspirated from the expandable member 914 through the needle 930 (e.g., into a syringe barrel) to confirm that the first end of the needle 930 is disposed within the expandable member 914.

[0101]

[0148] With a first end of the needle 930 disposed within the expandable member 914, the coupling member 924 and a portion of the guidewire 922 of the guidewire assembly 920 can be inserted into the lumen of the needle 930 and translated through (e.g., pushed through) the lumen. The coupling member 924 can then be translated out the first end of the needle 930 so that the coupling member 924 is disposed within the expandable member 914. The translation of the needle 930 relative to the coupling member 924 and guidewire 922 can then withdraw the needle 930 from the body of the patient P, leaving the coupling member 924 within the expandable member 914 and the guidewire 922 extending through the wall of the expandable member 914. Additionally, the expandable member 914 can be deflated by withdrawing the gaseous and liquid fluids from the expandable member 914.

[0102]

[0149] 12B , with guidewire assembly 920 extending through anterior neck A of patient P and coupled to expandable member 914, elongate tube 912 can be translated such that first end 911 of elongate tube 912 moves out of an orifice (e.g., nose or mouth) of patient P. Thus, coupling member 924 of guidewire assembly 920 translates such that guidewire 922 extends through the tracheal puncture site, through the larynx, and out of the patient's nasal or oral opening, through cricoid cartilage C, and out of the orifice of patient P. In some embodiments, guidewire 922 can be pushed while pulling elongate tube 912 such that expandable member 914 translates without becoming disengaged from coupling member 924.

[0103]

[0150] As shown in FIG. 12C , a needle dilator 972 can be translated over the guidewire 922 to dilate the anterior tracheostomy tract where the guidewire 922 is positioned. If a larger guidewire is desired for tracheal tract dilation, a first end of a second guidewire 974 can be translated through the needle dilator 972. The second guidewire 974 can have a larger diameter than the guidewire 922, for example. For example, in some embodiments, the second guidewire 974 can be a 0.052 inch percutaneous tracheostomy guidewire. With the first end of the second guidewire 974 positioned between the anterior surface A of the trachea and the outer surface of the tubular member 950, the needle dilator 972 can be removed. In some embodiments, the needle dilator 972 can define a first lumen configured to receive the guidewire 922 such that the needle dilator 972 can be passed over the guidewire 922. The puncture dilator 972 can define a second lumen configured to receive a second guidewire 974. In some embodiments, the second lumen can have a larger diameter than the first lumen.

[0104]

[0151] 12D , a ventilator coupled to tubular member 950 can be stopped, an inflatable member 952 coupled to tubular member 950 can be deflated, and tubular member 950 can be removed from patient P's body through the opening through which tubular member 950 was inserted. By disconnecting from a functioning ventilator (e.g., the ventilator is stopped, tubular member 950 is removed, and a tracheostomy tube coupled to the ventilator is not still operably coupled to the tracheal puncture site), guidewire 922 can remain extending through the tracheal puncture site and out of the patient's mouth or nose while the patient is apneic (and aerosolization of virus is minimized). Thus, if reintubation is necessary, a tubular member (e.g., an ETT) can be threaded over guidewire 922 to rapidly return the patient to the ventilator. After tubular member 950 is removed, a tracheal dilator 976 can be advanced over second guidewire 974 to dilate the tracheal passage outward through the anterior neck A.

[0105]

[0152] As shown in FIG. 12E , after the dilator 976 is removed, the tracheostomy tube 980 may be advanced over the second guidewire 974 and through the patient's tracheal wall into engagement with the tracheal passage so that a first end of the tracheostomy tube 980 is positioned within the upper trachea U and a second end is positioned external to the patient P (e.g., extending from the anterior neck A of the patient P). The second guidewire 974 may be removed. A ventilator may be operably coupled to the tracheostomy tube 980 so that air is provided to the patient's lungs via the tracheostomy tube 980, terminating the apneic period. The guidewire 922 may be removed from the patient (e.g., by cutting the coupling member 924 and pulling the end of the guidewire 922 so that it is removed from either the tracheal puncture site or the opening (e.g., nose or mouth)).

[0106]

[0153] Although not shown, in some embodiments, rather than passing the second guidewire 974 through the dilator 972 and then advancing the tracheal passage dilator 976 over the second guidewire 974, the tracheal passage dilator 976 can be advanced over the first guidewire 922 after removal of the dilator 972. Additionally, in some embodiments, the tracheostomy tube 980 can be advanced over the first guidewire 922. Thus, only one guidewire is required for dilating the tracheal passage through the anterior neck A and for engaging the tracheostomy tube 980 with the tracheal passage.

[0107]

[0154] FIG. 13 is a flowchart of a method 1000 according to one embodiment. Method 1000 can be implemented using any of the systems or devices described herein, such as system 800 or system 900 described above. Method 1000 includes translating 1002 a first end of an elongated tube through a patient's larynx between the outer periphery of the larynx and the exterior of an endotracheal tube. 1004 The first end of the elongated tube can extend into the space between the wall of the patient's trachea and the exterior of the endotracheal tube to a position distal to the patient's larynx and proximal to an inflatable member disposed on the endotracheal tube that occludes the space between the endotracheal tube and the wall of the patient's trachea. Optionally, an external magnetic assembly can be positioned on the patient's anterior neck such that a magnetic member coupled to the elongated tube is biased toward the patient's anterior neck, disposing the inflatable member between the interior surface of the anterior wall of the trachea and the endotracheal tube (1006). The expandable member is then inflated through the lumen of the elongate tube such that the expandable member transitions from an uninflated configuration to an inflated configuration, where the expandable member presses against the anterior wall of the trachea, facilitating ultrasound visualization of tissue between the patient's skin and the anterior wall of the trachea (1008). Optionally, an external magnetic assembly (such as the external magnetic assembly described in optional step 1006) may be positioned on the patient's anterior neck such that a magnetic member coupled to the elongate tube is urged toward the external magnetic assembly, increasing pressure of the expandable member against the anterior wall of the trachea (1010). The distal end of a guidewire assembly may be translated through the patient's anterior neck and into the patient's upper trachea (1012), the guidewire assembly including a guidewire having a first end and a second end disposed external to the patient, the guidewire extending through the patient's anterior neck. A coupling member on the first end of the guidewire may be coupled to the expandable member (1014).

[0108]

[0155] In some embodiments, a system, such as any of the systems described herein, can include a rigid or semi-rigid stylet configured to be removably received within a lumen of an elongate tube of an expansion assembly. For example, FIG. 18 is a schematic diagram of system 1300. System 1300 can be the same or similar in structure and / or function as any of the systems described herein, such as system 800. For example, system 1300 includes a tubular member 1350 and an expansion assembly 1310 including an elongate tube 1312. Although not shown, an expandable member, such as any of the expandable members described herein, can be coupled to the end of the elongate tube 1312. As shown in FIG. 18 , expansion assembly 1310 can include a stylet 1319. Stylet 1319 can be removably received within a lumen defined in elongate tube 1312. The stylet 1319 may be shaped to assist a physician in navigating through the patient P's anatomy to position the inflatable member of the inflation assembly 1310 in the intended portion of the upper trachea U (e.g., between the first tracheal ring T1 and the third tracheal ring (not shown)) during direct or indirect laryngoscopy. The stylet 1319, when positioned within the elongated tube 1312, can cause the elongated tube 1312 to conform to the shape of the stylet 1319. For example, the stylet 1319 may include a curved portion disposed between two substantially straight portions (e.g., a hockey stick shape), such that, with the stylet positioned within the lumen of the elongated tube 1312, the end of the elongated tube 1312 (and associated inflatable member) can be inserted through the patient P's glottis G (i.e., the opening between the patient's vocal cords) even if the glottis G is small and / or positioned very anteriorly in the patient's airway. Because the path between the patient's mouth and the glottis G may include an acute angle, the stylet may be formed to include a similar angle between two substantially straight portions to target the glottis. For example, the angle may be approximately 80 degrees to 110 degrees.In some embodiments, the stylet 1319 may be malleable so that the angle and curvature of the stylet 1319 can be adjusted to the size and anatomy of a particular patient.

[0109]

[0156] In some embodiments, such as when the glottal area is small, a guidewire can be placed through the glottis prior to introduction of the inflation assembly. For example, FIG. 19 is a schematic diagram of system 1400. System 1400 can be the same or similar in structure and / or function as any of the systems described herein, such as system 800. For example, system 1400 includes a tubular member 1450 and an inflation assembly 1410 including an elongated tube 1412. Although not shown, an inflatable member, such as any of the inflatable members described herein, can be coupled to the end of elongated tube 1412. As shown in FIG. 19, inflation assembly 1410 can include a guidewire 1317. Guidewire 1317 can be removably received within a lumen defined within elongated tube 1412. For example, during direct or indirect laryngoscopy, guidewire 1317 can be advanced through the glottis G of patient P until the end of the guidewire is positioned within the patient's upper trachea U. The tubular member 1412 can then be passed over the guidewire 1417 (e.g., in the direction of arrow AA) to position the inflatable member of the inflation assembly 1410 in the intended portion of the upper trachea U (e.g., between the first tracheal ring T1 and the third tracheal ring (not shown)). The guidewire 1417 can then be removed from the lumen of the tubular member 1412 by withdrawing the guidewire 1417 from the proximal end of the tubular member 1412.

[0110]

[0157] FIG. 20 is a schematic diagram of a system 1500 positioned within a patient's upper trachea U. The system 1500 includes an inflation assembly 1510. The system 1500 may optionally include a tubular member 1550, an external magnetic assembly 1540, and / or an ultrasound probe (not shown). The inflation assembly 1510 may be similar in structure and / or function to the inflation assembly 110 described above with respect to the system 100. For example, the inflation assembly 1510 may include an elongated tube 1512, an inflatable member 1514, and a magnetic member 1515. The elongated tube 1512 may have a first end 1511 and a second end 1513. In some embodiments, the elongated tube 1512 may have a length sufficient to extend from at least the patient's mouth or nasal openings to the patient's trachea. The inflatable member 1514 and the magnetic member 1515 may be coupled to the elongated tube 1512 at or near the first end 1511 of the elongated tube 1512. The inflation assembly 1510 may include an inflation lumen in fluid communication with the expandable member 1514 such that fluid can be delivered to or withdrawn from the expandable member 1514 via the inflation lumen to transition the expandable member 1514 between an unexpanded configuration (e.g., an unexpanded configuration) and an expanded configuration (e.g., an expanded configuration). In some embodiments, the inflation lumen can be disposed within and / or defined by the elongate tube 1512.

[0111]

[0158] The expandable member 1514 can be the same or similar in structure and / or function to any of the expandable members described herein. For example, the expandable member 1514 can surround the elongate tube 1512 in the expanded and / or unexpanded configuration. In some embodiments, the expandable member 1514 can extend laterally from the elongate tube 1512 in the expanded and / or unexpanded configuration. In some embodiments, the expandable member 1514 can extend distally from the first end 1511 of the elongate tube 1512 in the expanded and / or unexpanded configuration. In some embodiments, the expandable member 1514 can be disposed over the elongate tube 1512 such that a portion of the elongate tube 1512 extends distally of the expandable member 1514 when the expandable member 1514 is in the expanded and / or unexpanded configuration. The elongate tube 1512 can define one or more inflation ports or holes so that the inflation lumen can be in fluid communication with the interior of the expandable member 1514 to transition the expandable member 1514 between an expanded configuration and / or an unexpanded configuration.

[0112]

[0159] In some embodiments, the expandable member 1514 may define a passageway 1517 (also referred to as an "air vent") to allow fluid (e.g., air) to travel through the passageway 1517 when the expandable member 1514 is in the expanded configuration. For example, FIG. 22 is a cross-sectional view of the expandable member 1514 in the expanded configuration. As shown in FIG. 22, the expandable member 1514 may define a first passageway 1517 and a second passageway 1517. Each of the first passageway 1517 and the second passageway 1517 may be bounded in part by the expandable member 1514 and in part by the patient's tracheal wall. Thus, air may flow through the passageway between a portion of the trachea on a first side of the expandable member 1514 (e.g., the region between the cricoid cartilage C and the expandable member 1514) and a portion of the trachea on a second side of the expandable member 1514 (e.g., the region between the expandable member 1514 and the patient's lungs) when the expandable member 1514 is in the expanded configuration.

[0113]

[0160] 22 , in some embodiments, the expandable member 1514 can include an upper portion 1514A (also referred to as a first portion) and a lower portion 1514B (also referred to as a second portion). In the expanded configuration, each of the upper portion 1514A and the lower portion 1514B can be shaped as a wedge. For example, the upper portion 1514A can have a first side 1581A, a second side 1581B, and an arcuate surface 1581C. The lower portion 1514B can have a first side 1583A, a second side 1583B, and an arcuate surface 1583C. The first passageway 1517 can be defined in part by the first side 1581A of the upper portion 1514A and the first side 1583A of the lower portion 1514B. The second passageway 1517 can be defined in part by a second side 1581B of the upper portion 1514A and a second side 1583B of the lower portion 1514B. Although the upper portion 1514A and the lower portion 1514B are referred to herein as the "upper portion" and the "lower portion," in some embodiments, either the upper portion 1514A or the lower portion 1514B can be shaped to be placed in contact with the anterior tracheal wall of the patient. For example, the inflatable member 1514 can be symmetrical about an axis that includes the central axis of the elongate tube 1512 in at least one of the expanded and unexpanded configurations.

[0114]

[0161] 22 as defining two passageways 1517, the expandable member 1514 may be shaped to define any suitable number of passageways 1517 in the expanded configuration (e.g., one, three, four, or more passageways 1517). In some embodiments, the expandable member 1514 may define a suitable number of passageways 1517 having a suitable size (e.g., having a suitable combined cross-sectional area) such that when the expandable member 1514 is positioned within a patient's trachea and the outer surface of the expandable member 1514 contacts the inner wall of the patient's trachea, the patient can be appropriately ventilated (e.g., freely or via a ventilator) through the passageways 1517. For example, the outer surface of the expandable member 1514 may contact the inner wall of the patient's trachea in a continuous manner such that air cannot flow between the arcuate surfaces 1581C and 1583C of the expandable member 1514 and the tracheal wall, or such that the rate at which air can flow between the arcuate surfaces 1581C and 1583C of the expandable member 1514 and the tracheal wall is insufficient for adequate ventilation and oxygenation. In some embodiments, the combined cross-sectional area of ​​the passageway 1517 can be large enough to allow an airflow of about 40 liters to about 75 liters per minute through the passageway 1517. Thus, with the expandable member 1514 deployed in the trachea, the patient can receive closed, continuous ventilation through the passageway 1517, such as during ultrasound visualization of the expandable member 1514 and / or tissue between the expandable member 1514 and an ultrasound probe. Although the inflatable member 1514 is shown as defining the boundary of the passageway 1517 in combination with the patient's tracheal wall, in some embodiments the inflatable member 1514 can define one or more entire outer boundaries of the passageway 1517. In some embodiments, the upper portion 1514A and the lower portion 1514B are in fluid communication with each other such that fluid can be provided to both the upper portion 1514A and the lower portion 1514B using the inflation lumen 1516. In some embodiments, the upper portion 1514A and the lower portion 1514B are fluidly isolated from each other such that separate inflation lumens and / or separate ports are used to provide fluid to both the upper portion 1514A and the lower portion 1514B.

[0115]

[0162] In some embodiments, the expandable member 1514 can be formed in any suitable shape, at any suitable size, and from any suitable material. In some embodiments, the shape can be selected based on the particular application of the system 1500. For example, the shape of the expandable member 1514 can be selected to facilitate ultrasound visualization in a particular region of the patient's body (e.g., a region other than the upper trachea U). Additionally, the expandable member 1514 can be sized to improve engagement and retention between the expandable member 1514 and any suitable component of a guidewire assembly, such as any of the guidewire assemblies described herein, which may optionally be included in the system 1500. For example, the expandable member 1514 can be sufficiently flexible so that the expandable member 1514 (e.g., when expanded) can be punctured (e.g., by a needle) to define a pinhole in the wall of the expandable member 1514 rather than rupturing or tearing as a result of the puncture. In some embodiments, the expandable member 1514 can be formed from, for example, polyurethane, silicone, and / or polyvinyl chloride (PVC). In some embodiments, the expandable member 1514 can have any suitable material properties, wall thickness and / or outermost expanded diameter.

[0116]

[0163] The magnetic member 1515 may be any suitable magnetic member configured such that movement of the magnetic member 1515 results in corresponding movement of the first end 1511 of the elongated tube 1512. The magnetic member 1515 may be the same or similar in structure and / or function as any of the magnetic members described herein. The magnetic member 1515 may have any suitable shape. For example, in some embodiments, the magnetic member 1515 may be in the shape of an elongated rectangular box. In some embodiments, the magnetic member 1515 may be in the shape of a cylinder. In some embodiments, the magnetic member 1515 may be arcuate. In some embodiments, the magnetic member 1515 is directly coupled to the elongated tube 1512. In some embodiments, the magnetic member 1515 is disposed within and at least partially surrounded by the expandable member 1514. 22, the magnetic member 1515 can be at least partially disposed within the expandable member 1514 (e.g., within an elongate tube 1512 within the expandable member 1514). In some embodiments, the magnetic member 1515 is directly coupled to the expandable member 1514. In some embodiments, the system 1500 includes two or more magnetic members 1515. In some embodiments, at least one magnetic member 1515 can be disposed proximal to the expandable member 1514 and / or at least one magnetic member 1515 can be disposed distal to the expandable member 1514. In some embodiments, each magnetic member 1515 of a set of magnetic members 1515 (e.g., two or more magnetic members 1515) can be disposed within the expandable member 1514, coupled to, disposed distal to, and / or disposed proximal to the expandable member 1514.

[0117]

[0164] In some embodiments, the magnetic member 1515 may not be included in the system 1500, and the expandable member 1514 may be shaped and sized such that, in the expanded configuration of the expandable member 1514, a first portion of the expandable member 1514 (e.g., one of the upper portion 1514A or the lower portion 1514B) can be positioned in contact with the anterior tracheal wall, and a second portion of the expandable member 1514 (e.g., the other of the upper portion 1514A or the lower portion 1514B) can be positioned in contact with the posterior tracheal wall, such that, upon being restrained by the posterior tracheal wall, the arcuate surface 1581C of the upper portion 1514A is urged against the anterior tracheal wall, exerting a coaptation pressure against the anterior tracheal wall, and an echogenic window defined by the expandable member 1514 is visible via ultrasound (e.g., coaptation ultrasound). In some embodiments, the magnetic member 1515 may not be included in the system 1500, and the expandable member 1514 may be shaped and sized such that, in the expanded configuration of the expandable member 1514, a first portion of the expandable member 1514 (e.g., one of the upper portion 1514A or the lower portion 1514B) can be positioned in contact with the anterior tracheal wall, and a second portion of the expandable member 1514 (e.g., the other of the upper portion 1514A or the lower portion 1514B) can be positioned in contact with a portion of the tubular member 1550, and the arcuate surface 1581C of the upper portion 1514A is restrained by the tubular member 1550 and is urged against the anterior tracheal wall, applying a coaptation pressure against the anterior tracheal wall, and an echogenic window defined by the expandable member 1514 is visible via ultrasound (e.g., coaptation ultrasound).

[0118]

[0165] In use, an end of the tubular member 1550 (e.g., an ETT) can be inserted through a patient's opening (e.g., the patient's nose or mouth) and through the patient's cricoid cartilage C to a position near a target area of ​​the patient's upper trachea U such that the expandable member and the end of the tubular member 1550 are positioned between the target area of ​​the trachea and the patient's cricoid cartilage C. The target area of ​​the upper trachea U can include a desired tracheal puncture site (e.g., a location between the patient's second tracheal ring T2 and third tracheal ring T3 or a location between the patient's first tracheal ring T1 and second tracheal ring T2). The expandable member of the tubular member 155 can be transitioned from an undeployed configuration to an expanded configuration such that the tubular member 155 is stabilized against the tracheal wall (e.g., resisting axial movement) and / or makes sealing contact with the patient's trachea U such that air cannot flow between the patient's lungs and the patient's opening except through the lumen of the tubular member 1550. In some embodiments, tubular member 1550 may be fluidly coupled to a ventilator such that the ventilator can ventilate the patient's lungs through tubular member 1550 .

[0119]

[0166] The first end 1511 of the elongated tube 1512 of the inflation assembly 1510 may be inserted through an orifice (e.g., the patient's nose or mouth) and translated through the lumen of the tubular member 1550 such that the first end 1511 of the elongated tube 1512 extends more than a certain distance from the first end 1511 of the elongated tube 1512. The certain distance may be based on the distance that the inflatable member 1514 and the magnetic member 1515 are positioned outside the tubular member 1550 and within the upper trachea U, beyond the end of the tubular member 1550. As shown in FIG. 20 , an external magnetic assembly 1540 may be positioned on the patient's anterior neck A such that magnetic interaction between the external magnetic assembly 1540 and the magnetic member 1515 urges the magnetic member 1514 toward (e.g., into contact with) the anterior wall of the upper trachea U. Thus, the external magnetic assembly 1540 may be used to align and / or orient the inflation assembly 1510 within the upper trachea U.

[0120]

[0167] 21 , a fluid can then be delivered to the expandable member 1514 via the inflation lumen of the inflation assembly 1510 to transition the expandable member 1514 from the unexpanded configuration to the expanded configuration. As described with respect to other embodiments herein, the fluid can include a fluid and / or a contrast agent such that the expandable member 1514 is detectable via imaging (e.g., ultrasound). In the expanded configuration, the expandable member 1514 can engage portions of the tracheal wall such that its position is fixed within the upper trachea U via pressure applied by the expandable member 1514 to the interior surface of the tracheal wall, including the anterior tracheal wall. Thus, in some embodiments, the expandable member 1514 can be secured within the upper trachea U and / or positioned in mating contact with the anterior tracheal wall to apply mating pressure to the anterior tracheal wall due to magnetic interaction between the external magnetic assembly 1540 and the magnetic member 1515 and / or engagement of the expandable member 1514 with the inner surface of the tracheal wall by constraining the expandable member 1514 between the anterior and posterior tracheal walls in the expanded configuration. As shown in FIG. 22 , when the expandable member 1514 is in the expanded configuration, a passageway 1517 defined by the expandable member 1514 and the tracheal wall allows ventilation through the upper trachea U. The passageway 1517 can be large enough to allow adequate ventilation of the patient during portions of the procedure (e.g., during tracheotomy creation). In some embodiments, an ultrasound probe can then be used to determine the tracheal puncture site between particular tracheal rings (e.g., between the first tracheal ring T1 and the second tracheal ring T2 of patient P, or between the second tracheal ring T2 and the third tracheal ring T3 of patient P). The expandable member 1514 can optionally be repositioned as described with respect to any of the other systems described herein. Once the expandable member 1510 is properly positioned against the anterior tracheal wall and the tracheal puncture site has been determined, the expandable member 1510 can be coupled to the guidewire assembly via operational steps that are the same as or similar to those described above with respect to any of the systems and methods described herein (e.g., the operational steps associated with system 100 and / or system 300).

[0121]

[0168] Although the inflation assembly 1510 is shown and described as being delivered to the upper trachea U using an in-line approach through the tubular member 1550, in some embodiments, the inflation assembly 1510 can be delivered and imaged using a paired approach, similar to that described above with respect to system 800. In some embodiments, the inflation assembly 1510 can be properly aligned and / or oriented with the anterior tracheal wall of the patient by inserting the inflation assembly 1510 in a particular directional orientation (e.g., with the upper portion 1514A facing upward) and maintaining the orientation of the elongated tube 1512 as the inflation assembly 1510 translates to the upper trachea U. In some embodiments, the orientation of the expandable member 1514 can be manipulated as needed within the upper trachea U (e.g., based on ultrasound imaging) to properly align the upper portion 1514A or lower portion 1514B with the anterior tracheal wall via manual manipulation (e.g., rotation) of the elongate tube 1512 and / or by using an external magnetic assembly 1540 to bias the inflation assembly 1510 toward a properly aligned orientation. In some embodiments, to prevent needle sticks of the posterior tracheal wall through the expandable member 1514, the lower portion 1514B can include or be coupled to a barrier member (not shown), and the upper portion 1514A can be configured to be aligned in contact with the anterior tracheal wall. The barrier member can be the same or similar in structure and / or function as the barrier member 195 and / or the barrier member 695 described above with reference to FIGS. 1 and 6, respectively.

[0122]

[0169] 23-26 are perspective, front, cross-sectional, and cross-sectional perspective views, respectively, of a portion of expansion assembly 1610 in an expanded configuration. Expansion assembly 1610 may be similar in structure and / or function to any of the expansion assemblies described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 1610 may include an elongate tube 1612, an expandable member 1614, and a magnetic member 1615. Elongate tube 1612 may define an inflation lumen 1616 in fluid communication with the interior of expandable member 1614 and may deliver and / or withdraw fluid from the interior of expandable member 1614 to transition expandable member 1614 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. As shown, the expandable member 1614 is disposed at the distal end of the elongate tube 1612, which includes an inner tubular member 1684 disposed within the elongate tube 1612 and the expandable member 1614, with the distal end of the expandable member 1614 coupled to the distal end of the inner tubular member 1684. In some embodiments, the inner tubular member 1684 can have a greater stiffness than the elongate tube 1612. The inner tubular member 1684 can define a central lumen in which the magnetic member 1615 can be disposed. In some embodiments, the magnetic member 1615 can be centered between the first and second ends of the expandable member 1614.

[0123]

[0170] As shown in Figures 25 and 26, the expandable member 1614 may define two passageways 1617 (also referred to as "vents") extending therethrough to allow fluid (e.g., air) to pass through the expandable member 1614 when the expandable member 1614 is positioned within a patient's trachea in the expanded configuration. Although Figures 23-26 depict the expandable member 1614 as defining two passageways 1617, the expandable member 1614 may define any suitable number of passageways 1617 (e.g., one, three, four, or more passageways 1617). Although the passageways 1617 are shown as being cylindrical, the passageways 1617 may have any suitable shape. In some embodiments, the inflatable member 1614 can define a suitable number of passageways 1617 having a suitable size (e.g., having a suitable combined cross-sectional area) so that when the inflatable member 1614 is positioned within a patient's trachea and the outer surface of the inflatable member 1614 contacts the inner wall of the patient's trachea (e.g., in a continuous manner such that air cannot flow along the outer surface of the inflatable member 1614, or the rate at which air can flow along the outer surface of the inflatable member 1614 is insufficient for adequate ventilation and oxygenation), the patient can be appropriately ventilated through the passageways 1617 (e.g., freely or via a ventilator). Although the passageways 1617 are shown as being positioned in a plane that includes and is equidistant from the central axis of the inflatable member 1614, the passageways 1617 can be positioned or defined at any suitable location relative to the central axis of the inflatable member 1614 (e.g., entirely on one side of a plane that includes the central axis and any suitable distance or distances from the central axis).

[0124]

[0171] In some embodiments, the expandable member 1614 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, the expandable member 1614 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, the magnetic member 1615 can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1515. For example, the magnetic member 1615 can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Furthermore, while the magnetic member 1615 is shown disposed within the inner tubular member 1684, it can be coupled to any suitable portion of the inflation assembly 1610 (e.g., directly to the expandable member 1614 and / or to the elongated tube 1612, such as along the outer surface of the inner tubular member 1684, the end and / or inner or outer surface of the expandable member 1614, etc.). Additionally, although the inflation lumen 1616 is shown as being defined by the elongate tube 1612, in some embodiments the inflation lumen can be defined between the inner tubular member 1684 and the elongate tube 1612 such that the inflation lumen surrounds the inner tubular member 1684. In use, the inflation assembly 1610 can operate in the same manner or similarly to that described with respect to other inflation assemblies described herein, such as the inflation assembly 1510.

[0125]

[0172] 27-30 are cross-sectional perspective, side perspective, front perspective, and rear cross-sectional perspective views, respectively, of expansion assembly 1710 in an expanded configuration. Expansion assembly 1710 may be similar in structure and / or function to any of the expansion assemblies described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 1710 may include an elongate tube 1712, an expandable member 1714, and a magnetic member 1715. Elongate tube 1712 may define (e.g., entirely or in combination with another component within elongate tube 1712, such as an inner tubular member) an inflation lumen in fluid communication with the interior of expandable member 1714 to deliver and / or withdraw fluid from the interior of expandable member 1714 to transition expandable member 1714 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. As shown, the expandable member 1714 can be positioned at or near the distal end of the elongate tube 1712. In some embodiments, not shown, the elongate tube 1712 can pass through the expandable member 1714 such that the expandable member 1714 surrounds a portion of the elongate tube 1712 and a portion of the elongate tube 1712 extends distally of the expandable member 1714.

[0126]

[0173] 27 and 28, the expandable member 1714 can be shaped to define a boundary for a first passageway 1717A and a boundary for a second passageway 1717B. For example, the expandable member 1714 can include an upper portion 1714A and a lower portion 1714B. The upper portion 1714A and the lower portion 1714B can collectively define an expandable interior of the expandable member 1714. The upper portion 1714A can have, for example, a semicircular cross-section or a wedge-shaped cross-section. The lower portion 1714B may have, for example, a non-semicircular cross-section (e.g., a substantially rectangular cross-section or a wedge-shaped cross-section excluding tapered transition edges as shown in FIGS. 27 and 28 ), such that a first portion of the outer surface of the upper portion 1714A and a first portion of the outer surface of the lower portion 1714B collectively define a first passageway 1717A, and a second portion of the outer surface of the upper portion 1714A and a second portion of the outer surface of the lower portion 1714B collectively define a second passageway 1717B. Thus, when the inflatable member 1714 is in the expanded configuration within the patient's upper trachea, the upper portion 1714 is positioned against the anterior wall of the patient's trachea, and air can flow through the first passageway 1717A defined by the inflatable member 1714 and the first portion of the patient's tracheal wall and the second passageway 1717B defined by the inflatable member 1714 and the second portion of the patient's tracheal wall. In some embodiments, when in the expanded configuration, the inflatable member 1714 can be shaped and sized such that the lower portion 1714B contacts and is constrained by the posterior tracheal wall, urging the upper portion 1714A against the anterior tracheal wall and applying coaptation pressure against the anterior tracheal wall.

[0127]

[0174] Although not shown in FIGS. 27 and 28 , the magnetic member 1715 (or two or more magnetic members 1715) can be coupled to or included in the expansion assembly 1710 at any suitable location. In some embodiments, the magnetic member 1715 may optionally not be included in the expansion assembly 1710, and the joining of the expandable member 1714 with the patient's anterior neck portion can be achieved solely through the pressure of the fluid inside the expandable member 1714. As shown in FIG. 30 , in some embodiments, the magnetic member 1715 can be positioned within the expandable member 1714 such that the magnetic member 1715 is not coaxial with the elongate tube. In some embodiments, the magnetic member 1715 can be secured within the lower portion 1714B of the expandable member 1714. For example, in some embodiments, the lower portion 1714B of the expandable member 1714 can define a first recess 1785A and a second recess 1785B on opposite sides of the lower portion 1714B, as shown in FIGS. 29 and 30 . The first and second recessed portions 1785A, 1785B can be configured to retain the magnetic member 1715 within a compartment defined between the first and second recessed portions 1785A, 1785B and the underside of the lower portion 1714B, as shown in Figure 30. An external magnetic assembly (such as external magnetic assembly 1540) can be used to orient the magnet 1715, for example, within the patient's trachea so that the upper portion 1714A of the inflatable member 1714 can be positioned against the anterior tracheal wall.

[0128]

[0175] In some embodiments, expandable member 1714 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, expandable member 1714 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, magnetic member 1715 can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1515. For example, magnetic member 1715 can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. 29 and 30 as being disposed within a section of expandable member 1714 defined by first recessed portion 1785A and second recessed portion 1785B, it may be coupled to any suitable portion of expansion assembly 1710 (e.g., directly to expandable member 1714, such as on the outer surface of elongate member 1712 inside and / or outside expandable member 1714, and / or along an end of expandable member 1714, and / or an inner or outer surface). In use, expansion assembly 1710 may operate in the same manner or similarly as described with respect to other expansion assemblies described herein, such as expansion assembly 1510.

[0129]

[0176] 31 , 32 , and 34 are a cross-sectional perspective view, a cross-sectional view, and an end view, respectively, of expansion assembly 1810 in an expanded configuration. FIG. 33 is a cross-sectional perspective view of expansion assembly 1810, with inner tubular member 1884 of expansion assembly 1810 not shown. Expansion assembly 1810 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 1810 may include elongate tube 1812, expandable member 1814, and magnetic member 1815. The elongate tube 1812 defines an inflation lumen 1816 in fluid communication with the interior of the expandable member 1814 to deliver fluid to and / or withdraw fluid from the interior of the expandable member 1814 to transition the expandable member 1814 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. As shown, the expandable member 1814 is disposed at a distal end of the elongate tube 1812, which includes an inner tubular member 1884 disposed within the elongate tube 1812 and within the expandable member 1814, the distal end of the expandable member 1814 being coupled to the distal end of the inner tubular member 1884. In some embodiments, the inner tubular member 1884 may have a greater stiffness than the elongate tube 1812. The inner tubular member 1884 may define a central lumen in which the magnetic member 1815 may be disposed. In some embodiments, the magnetic member 1815 can be centered between the first and second ends of the expandable member 1814 .

[0130]

[0177] The expandable member 1814 defines passageways 1817 (e.g., first passageway 1817A and second passageway 1817B) that allow fluid (e.g., air) to travel through the passageways 1817 when the expandable member 1814 is in the expanded configuration. In the expanded configuration, when the expandable member 1814 is positioned in the patient's upper trachea, each of the first passageway 1817A and the second passageway 1817B can be partially bounded by the expandable member 1814 and partially bounded by the patient's tracheal wall. Thus, air can flow through the passageways 1817 between a portion of the trachea on a first side of the expandable member 1814 (e.g., the region between the patient's cricoid cartilage and the expandable member 1814) and a portion of the trachea on a second side of the expandable member 1814 (e.g., the region between the expandable member 1814 and the patient's lungs) to ventilate and oxygenate the patient through the passageways 1817 when the expandable member 1814 is in the expanded configuration.

[0131]

[0178] The expandable member 1814 can include an upper portion 1814A (also referred to as a first portion) and a lower portion 1814B (also referred to as a second portion). In the expanded configuration, each of the upper portion 1814A and the lower portion 1814B can be shaped as a wedge. For example, the upper portion 1814A can have a first side 1881A, a second side 1881B, and an arcuate surface 1881C. The lower portion 1814B can have a first side 1883A, a second side 1883B, and an arcuate surface 1883C. The first passageway 1817A can be defined in part by the first side 1881A of the upper portion 1814A and the first side 1883A of the lower portion 1814B. The second passageway 1817B can be defined in part by a second side 1881B of the upper portion 1814A and a second side 1883B of the lower portion 1814B. Although the upper portion 1814A and the lower portion 1814B are referred to herein as the "upper portion" and "lower portion," in some embodiments, either the upper portion 1814A or the lower portion 1814B can be shaped to be placed in contact with the anterior tracheal wall of a patient. For example, the inflatable member 1814 can be symmetrical about an axis that includes the central axis of the elongate tube 1812 and / or the inner tubular member 1884 in at least one of the expanded and unexpanded configurations. In some embodiments, when in the expanded configuration, the inflatable member 1814 can be shaped and sized such that the lower portion 1814B can contact and be restrained by the posterior tracheal wall, biasing the upper portion 1814A against the anterior tracheal wall to apply coaptation pressure thereagainst.

[0132]

[0179] 34 as defining two passageways 1817, the expandable member 1814 may be shaped to define any suitable number of passageways 1817 in the expanded configuration (e.g., one, three, four, or more passageways 1817). In some embodiments, the expandable member 1814 may define a suitable number of passageways 1817 having a suitable size (e.g., having a suitable combined cross-sectional area) such that when the expandable member 1814 is positioned within a patient's trachea and the outer surface of the expandable member 1814 contacts the inner wall of the patient's trachea (e.g., in a continuous manner such that air cannot flow along the outer surface of the expandable member 1814 or the rate at which air can flow along the outer surface of the expandable member 1814 is insufficient for adequate ventilation and oxygenation), the patient can be properly ventilated through the passageways 1817 (e.g., freely or via a ventilator). In some embodiments, the upper portion 1814A and the lower portion 1814B are in communication with each other such that fluid can be provided to both the upper portion 1814A and the lower portion 1814B using the inflation lumen 1816. In some embodiments, the upper portion 1814A and the lower portion 1814B are fluidly isolated from each other such that separate inflation lumens and / or separate ports are used to provide fluid to both the upper portion 1814A and the lower portion 1814B.

[0133]

[0180] In some embodiments, expandable member 1814 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, expandable member 1814 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, magnetic member 1815 can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1815. For example, magnetic member 1815 can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Furthermore, while magnetic member 1815 is shown disposed within inner tubular member 1884, it can be coupled to any suitable portion of inflation assembly 1810 (e.g., directly to expandable member 1814 and / or to elongate tube 1812, such as along the outer surface of inner tubular member 1884, the end and / or inner or outer surface of expandable member 1814, etc.). In some embodiments, magnetic member 1815 may optionally not be included in inflation assembly 1810, and engagement of inflatable member 1814 with the patient's anterior neck portion may be achieved solely under the pressure of fluid within inflatable member 1814. Additionally, while inflation lumen 1816 is shown as being defined by elongate tube 1812, in some embodiments, the inflation lumen may be defined between inner tubular member 1884 and elongate tube 1812, such that the inflation lumen surrounds inner tubular member 1884. In use, inflation assembly 1810 may operate in the same manner or similarly to that described with respect to other inflation assemblies described herein, such as inflation assembly 1510.

[0134]

[0181] 35-37 are a front view, a cross-sectional perspective view, and a side view, respectively, of an expansion assembly 1910. The expansion assembly 1910 may be the same as or similar in structure and / or function to any of the expansion systems or devices described herein, such as the above-described expansion assembly 110, expansion assembly 410, and / or expansion assembly 1510. For example, the expansion assembly 1910 may include an elongate tube 1912, an expandable member 1914, a first magnetic member 1915A, and a second magnetic member 1915B. The elongate tube 1912 defines an inflation lumen in fluid communication with a front portion of the expandable member 1914 and can deliver and / or withdraw fluid from the interior of the expandable member 1914 to transition the expandable member 1914 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. As shown, the expandable member 1914 is disposed near the distal end of the elongate tube 1912, and the elongate tube 1912 extends through the expandable member 1914 such that a portion of the elongate tube 1912 extends distally of the expandable member 1914. As shown in FIG. 35 , the elongate member 1912 can include a number of ports 1986 in fluid communication with the inflation lumen, allowing fluid to be transferred to and / or from the interior of the expandable member 1914 via the ports 1986.

[0135]

[0182] The first magnetic member 1915A can be coupled to (e.g., disposed on or inside a lumen of) a portion of the elongate tube 1912 extending distally of the expandable member 1914. The second magnetic member 1915B can be coupled to (e.g., disposed on or inside a lumen of) a portion of the elongate tube 1912 proximal to the expandable member 1914. In some embodiments, the first magnetic member 1915A and the second magnetic member 1915B can be positioned adjacent to and approximately equidistant from both ends of the expandable member 1914. As shown in FIG. 36 , the second magnetic member 1915B can define a lumen along a central axis of the second magnetic member 1915B, which is in fluid communication with the inflation lumen of the elongate tube such that fluid can be transported to and / or from the interior of the expandable member 1914 via the lumen of the second magnetic member 1915B.

[0136]

[0183] The expandable member 1914 can be formed to have any suitable shape having a passageway feature that allows fluid (e.g., air) to pass through the expandable member 1914 when the expandable member 1914 is positioned within a patient's trachea in the expanded configuration. For example, as shown in FIGS. 35 and 37 , the expandable member 1914 can include a flat surface 1987 that extends from the first end to the second end of the expandable member 1914. The remainder of the outer surface of the expandable member 1914 can be formed as a partial cylinder in the expanded configuration of the expandable member 1914. In some embodiments, when directed into the patient's trachea, the flat surface 1987 can be positioned opposite a surface of the expandable member 1914 that is configured to contact the patient's anterior tracheal wall. In some embodiments, when directed into the patient's trachea, the flat surface 1987 can be positioned at an angle relative to a surface of the expandable member 1914 that is configured to contact the patient's anterior tracheal wall, without the flat surface 1987 contacting the patient's anterior tracheal wall. Thus, because the inflatable member 1914 does not expand to form a perfect cylindrical shape, the flat surfaces 1987, in combination with the surface of the patient's tracheal wall, can collectively define a passageway through the patient's trachea. The flat surfaces 1987 can be wide enough so that when the inflatable member 1914 is placed in the patient's trachea in the expanded configuration, the passageway has a cross-sectional area large enough for the patient to be adequately ventilated and oxygenated.

[0137]

[0184] In some embodiments, expandable member 1914 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, expandable member 1914 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, first magnetic member 1915A and second magnetic member 1915B can each be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1515. For example, first magnetic member 1915A and second magnetic member 1915B can each be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Additionally, although each of the first magnetic member 1915A and the second magnetic member 1915B is shown as being disposed on the exterior of the expandable member 1914, the first magnetic member 1915A and / or the second magnetic member 1915B can be disposed on the interior of the expandable member 1914 and / or coupled to the exterior of the expandable member 1914. In use, the expansion assembly 1610 can operate in the same manner or similarly to that described with respect to other expansion assemblies described herein, such as the expansion assembly 1510.

[0138]

[0185] 38-43 are a perspective view, a first cross-sectional side view, a second cross-sectional side view, a cross-sectional perspective view, a first cross-sectional top view, and a second cross-sectional top view, respectively, of expansion assembly 2010. Expansion assembly 110 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 2010 may include an elongate tube 2012 and an expandable member 2014. While not shown, expansion assembly 2010 may include one or more magnetic members that are the same or similar in structure and / or function to any of the magnetic members described herein. Elongate tube 2012 defines first and second inflation lumens 2016A and 2016B. Expandable member 2014 defines first and second internal portions 2088 and 2089. The second internal portion 2089 may surround the first internal portion 2088 such that when the expandable member 2014 is placed in contact with a surface, such as a tracheal wall, the first internal portion 2088 is separated from the surface by the second internal portion 2089. The first inflation lumen 2016A is in fluid communication with the first internal portion 2088 to deliver fluid to and / or withdraw fluid from the first internal portion 2088 of the expandable member 2014 to transition the expandable member 2014 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. The second inflation lumen 2016B is in fluid communication with the second internal portion 2089 to deliver fluid to and / or withdraw fluid from the second internal portion 2089 of the expandable member 2014. Thus, first interior portion 2088 can be inflated (e.g., with air) to expand expandable member 2014, and second interior portion 2088 can be filled with a liquid fluid and / or contrast agent such that second interior portion 2088 is detectable via imaging (e.g., ultrasound). In some embodiments, the air and / or liquid fluid flowing through first and second inflation lumens 2016A and 2016B, respectively, are sufficiently different and / or provided at sufficiently different volumes and / or pressures such that first and second interior portions 2088, 2089 have different internal pressures.For example, the first inner portion 2088 may be inflated to a greater internal pressure than the second inner portion 2089 such that the first inner portion 2088 provides rigidity to the shape of the expandable member 2014, while the first inner portion 2089 has greater malleability or compliance for more consistent engagement with the anterior tracheal wall of the patient.

[0139]

[0186] The expandable member 2014 defines passageways 2017 (e.g., first passageway 2017A and second passageway 2017B) that allow fluid (e.g., air) to travel through the passageways 2017 when the expandable member 2014 is in the expanded configuration. In the expanded configuration, when the expandable member 2014 is positioned in the upper trachea of ​​a patient, each of the first passageway 2017A and the second passageway 2017B can be partially bounded by the expandable member 2014 and partially bounded by the patient's tracheal wall. Thus, air can flow through the passageways 2017 between a portion of the trachea on a first side of the expandable member 2014 (e.g., the area between the patient's cricoid cartilage and the expandable member 2014) and a portion of the trachea on a second side of the expandable member 2014 (e.g., the area between the expandable member 2014 and the patient's lungs) to ventilate and oxygenate the patient through the passageways 2017 when the expandable member 2014 is in the expanded configuration.

[0140]

[0187] For example, similar to expandable member 1814, expandable member 2014 can include an upper portion 2014A (also referred to as a first portion) and a lower portion 2014B (also referred to as a second portion). In the expanded configuration, upper portion 2014A and lower portion 2014B can each be formed as a wedge that includes a portion of first interior portion 2088 and a portion of second interior portion 2089. For example, upper portion 2014A can have a first side 2081A, a second side 2081B, and an arcuate surface 2081C. Lower portion 2014B can have a first side 2083A, a second side 2083B, and an arcuate surface 2083C. First passageway 2017A can be defined in part by first side 2081A of upper portion 2014A and first side 2083A of lower portion 2014B. The second passageway 2017B can be defined in part by a second side 2081B of the upper portion 2014A and a second side 2083B of the lower portion 2014B. Although the upper portion 2014A and the lower portion 2014B are referred to herein as the "upper portion" and "lower portion," in some embodiments, either the upper portion 2014A or the lower portion 2014B can be shaped to be placed in contact with the anterior tracheal wall of the patient. For example, the inflatable member 2014 can be symmetrical about an axis that includes the central axis of the elongate tube 2012 in at least one of the expanded and unexpanded configurations. In some embodiments, when in the expanded configuration, the inflatable member 2014 can be shaped and sized such that the lower portion 2014B can contact and be restrained by the posterior tracheal wall, biasing the upper portion 2014A against the anterior tracheal wall and applying coaptation pressure thereagainst.

[0141]

[0188] Although the expandable member 2014 is shown in FIG. 38 as defining two passageways 2017, it may be shaped to define any suitable number of passageways 2017 in the expanded configuration (e.g., one, three, four, or more passageways 2017). In some embodiments, the expandable member 2014 may define a suitable number of passageways 2017 having a suitable size (e.g., having a suitable combined cross-sectional area) such that when the expandable member 2014 is positioned within a patient's trachea and the outer surface of the expandable member 2014 contacts the inner wall of the patient's trachea (e.g., in a continuous manner such that air cannot flow along the outer surface of the expandable member 2014, or the rate at which air can flow along the outer surface of the expandable member 2014 is insufficient for adequate ventilation and oxygenation), the patient can be adequately ventilated (e.g., freely or via a ventilator) through the passageways 2017. In some embodiments, a portion of the upper portion 2014A of the first interior portion 2088 and a portion of the lower portion 2014B of the first interior portion 2088 are in fluid communication with each other (e.g., directly or via inflation lumen 2016A) such that the first inflation lumen 2016A can be used to provide fluid to both portions of the first interior portion 2088. In some embodiments, the portions of the first interior portion 2088 are fluidly isolated from each other such that separate inflation lumens and / or separate ports are used to provide fluid to both portions of the first interior portion 2088. In some embodiments, the portion of the second interior portion 2089 of the upper portion 2014A and the portion of the second interior portion 2089 of the lower portion 2014B are in fluid communication with each other (e.g., directly or via second inflation lumen 2016B) such that the second inflation lumen 2016B can be used to provide fluid to both portions of the second interior portion 2089. In some embodiments, the portions of the second internal portion 2089 are fluidly isolated from one another such that separate inflation lumens and / or separate ports are used to provide fluid to both of the portions of the second internal portion 2089.

[0142]

[0189] In some embodiments, the expandable member 2014 can be the same or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, the expandable member 2014 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, the joining of the expandable member 2014 to the anterior neck portion of the patient can be achieved solely under the pressure of a fluid within the expandable member 2014. Furthermore, although the first and second inflation lumens 2016A, 2016B are shown as being defined by the elongate tube 2012, in some embodiments, the first and / or second inflation lumens can be defined by another member (e.g., an inner tubular member, such as inner tubular member 1884) and the elongate tube 2012 or by another tube disposed within the elongate tube 2012. In use, expansion assembly 2010 may operate in the same manner or similarly to that described with respect to other expansion assemblies described herein, such as expansion assembly 1510.

[0143]

[0190] 44-47 are perspective, top, distal end, and side views, respectively, of expansion assembly 2110 in an expanded configuration. Expansion assembly 2110 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100, expansion assembly 1510 of system 1500, and / or expansion assembly 1810. For example, expansion assembly 2110 may include an elongate tube 2112 and an expandable member 2114. Elongate tube 2112 may define an inflation lumen in fluid communication with the interior of expandable member 2114 and may deliver and / or withdraw fluid from the interior of expandable member 2114 to transition expandable member 2114 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. The expandable member 2114 can be positioned along a portion of the elongate tube 2112 (eg, near the distal end of the elongate tube 2112).

[0144]

[0191] The expandable member 2114 defines passageways 2117 (e.g., first passageway 2117A and second passageway 2117B) that allow fluid (e.g., air) to travel through the passageways 2117 when the expandable member 2114 is in the expanded configuration. In the expanded configuration, when the expandable member 2114 is positioned within a patient's upper trachea, each of the first passageway 2117A and the second passageway 2117B can be bounded in part by the expandable member 2114 and in part by the patient's tracheal wall. Thus, air can flow through the passageways 2117 between a portion of the trachea on a first side of the expandable member 2114 (e.g., the region between the patient's cricoid cartilage and the expandable member 2114) and a portion of the trachea on a second side of the expandable member 2114 (e.g., the region between the expandable member 2114 and the patient's lungs), and can ventilate and oxygenate the patient through the passageways 2117 when the expandable member 2114 is in the expanded configuration.

[0145]

[0192] The expandable member 2114 can include an upper portion 2114A (also referred to as a first portion) and a lower portion 2114B (also referred to as a second portion). In the expanded configuration, each of the upper portion 2114A and the lower portion 2114B can be shaped as a wedge. For example, the upper portion 2114A can have a first side 2181A, a second side 2181B, and an arcuate surface 2181C. The upper portion 2114A can also have a distal end 2181D and a proximal end 2181E. The lower portion 2114B can have a first side 2183A, a second side 2183B, and an arcuate surface 2183C. The lower portion 2114B can also have a distal end 2183D and a proximal end 2183E. The first passageway 2117A can be defined in part by a first side 2181A of the upper portion 2114A and a first side 2183A of the lower portion 2114B. The second passageway 2117B can be defined in part by a second side 2181B of the upper portion 2114A and a second side 2183B of the lower portion 2114B. Although the upper portion 2114A and the lower portion 2114B are referred to herein as the "upper portion" and the "lower portion," in some embodiments, either the upper portion 2114A or the lower portion 2114B can be shaped to be placed in contact with the anterior tracheal wall of the patient. For example, the inflatable member 2114 can be symmetrical about an axis that includes the central axis of the elongate tube 2112 in at least one of the expanded and unexpanded configurations. In some embodiments, when in the expanded configuration, the inflatable member 2114 can be shaped and sized such that the lower portion 2114B contacts and is constrained by the posterior tracheal wall and the upper portion 2114A can be biased against the anterior tracheal wall to apply coaptation pressure thereto.

[0146]

[0193] In some embodiments, the upper portion 2114A and the lower portion 2114B are in fluid communication with each other such that fluid can be provided to both the upper portion 2114A and the lower portion 2114B using an inflation lumen in the elongated tube 2112. In some embodiments, the upper portion 2114A and the lower portion 2114B are fluidly isolated from each other such that separate inflation lumens and / or separate ports in the elongated tube 2112 are used to provide fluid to the upper portion 2114A and the lower portion 2114B.

[0147]

[0194] In some embodiments, the expandable member 2114 can be the same or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, the expandable member 2114 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. The expansion assembly 2110 can also include a magnetic member (not shown), which can be the same or similar in structure and / or function to any of the magnetic members described herein. For example, in some embodiments, the elongate member 2112 can define a central lumen in which the magnetic member can be disposed. In some embodiments, the magnetic member can be centered between the first and second ends of the expandable member 2114. In some embodiments, the magnetic member can be the same or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1815. For example, the magnetic member can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Further, in some embodiments, the magnetic member can be coupled to any suitable portion of the expansion assembly 2110 (e.g., directly to the expandable member 2114 and / or to the elongate tube 2112, such as on an outer surface of an inner tubular member disposed within the elongate tube 2112, along an end and / or inner or outer surface of the expandable member 2114, etc.). In some embodiments, the magnetic member may optionally not be included in the expansion assembly 2110, and the joining of the expandable member 2114 with the anterior neck portion of the patient can be achieved solely under the pressure of a fluid within the expandable member 2114. Further, in some embodiments, an inflation lumen can be defined between the inner tubular member (e.g., inner tubular member 1684) and the elongate tube 2112, such that the inflation lumen surrounds the inner tubular member. In use, the expansion assembly 2110 can operate in the same manner as or similar to that described with respect to other expansion assemblies described herein, such as the expansion assembly 1510 and the expansion assembly 1810.For example, when a portion of the expandable member 2114 is in abutting contact with the anterior tracheal wall of the patient, the expandable member 2114 can be visualized (e.g., via ultrasound) and a needle can pierce the expandable member 2114 so that the same or similar procedure as described with respect to Figures 3A-3M and / or 18-22 can be performed.

[0148]

[0195] 48-51 are perspective, top, distal end, and side views, respectively, of expansion assembly 2210 in an expanded configuration. Expansion assembly 2210 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 2210 may include elongate tube 2212 and expandable member 2214. Elongate tube 2212 may define an inflation lumen in fluid communication with the interior of expandable member 2214 and may deliver and / or withdraw fluid from the interior of expandable member 2214 to transition expandable member 2214 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. The expandable member 2214 can be positioned along a portion of the elongate tube 2212 (eg, near or at the distal end of the elongate tube 2212).

[0149]

[0196] The expandable member 2214 defines a passageway 2217 that allows fluid (e.g., air) to travel through the passageway 2217 when the expandable member 2214 is in the expanded configuration. In the expanded configuration, when the expandable member 2214 is positioned in the patient's upper trachea, the passageway 2217 may be bounded in part by the expandable member 2214 and in part by the patient's tracheal wall. Thus, air may flow through the passageway 2217 between a portion of the trachea on a first side of the expandable member 2214 (e.g., the area between the patient's cricoid cartilage and the expandable member 2214) and a portion of the trachea on a second side of the expandable member 2214 (e.g., the area between the expandable member 2214 and the patient's lungs), and may ventilate and oxygenate the patient through the passageway 2217 when the expandable member 2214 is in the expanded configuration.

[0150]

[0197] In the expanded configuration, the expandable member 2214 can be formed to have a horseshoe shape. For example, the expandable member 2214 can have an arcuate top surface 2281C, a first side surface 2281F, and a second side surface 2281G. The expandable member 2214 can also have a distal end 2281D and a proximal end 2281E. The expandable member 2214 can also have a first bottom surface 2281A and a second bottom surface 2281B. The passageway 2217 can be defined in part by the first bottom surface 2281A and the second bottom surface 2281B. In some embodiments, when in the expanded configuration, the expandable member 2214 can be shaped and sized such that a lower portion of the expandable member 2214 (e.g., the portion at the intersection of the first side surface 2281F and the second bottom surface 2281B and the portion at the intersection of the second side surface 2281G and the first bottom surface 2281A) contacts and is restrained by the posterior tracheal wall, and biases the arcuate upper surface 2281C against the anterior tracheal wall to apply coaptation pressure against the anterior tracheal wall.

[0151]

[0198] In some embodiments, expandable member 2214 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, expandable member 2214 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. Inflation assembly 2210 can also include a magnetic member (not shown), which can be the same as or similar in structure and / or function to any of the magnetic members described herein. For example, in some embodiments, elongate member 2212 can define a central lumen in which the magnetic member can be disposed. In some embodiments, the magnetic member can be centered between the first and second ends of expandable member 2214. In some embodiments, the magnetic member can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1815. For example, the magnetic member can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Further, in some embodiments, the magnetic member can be coupled to any suitable portion of the expansion assembly 2210 (e.g., directly to the expandable member and / or to the elongate tube 2212, such as along the outer surface of an inner tubular member disposed within the elongate tube 2212, along the end and / or inner or outer surface of the expandable member 2214, etc.). In some embodiments, the magnetic member may optionally not be included in the expansion assembly 2210, and the joining of the expandable member 2214 with the anterior neck portion of the patient can be achieved solely under the pressure of a fluid within the expandable member 2214. Further, in some embodiments, an inflation lumen can be defined between the inner tubular member (e.g., inner tubular member 1684) and the elongate tube 2212, such that the inflation lumen surrounds the inner tubular member. In use, the expansion assembly 2210 can operate in the same manner as or similar to that described with respect to other expansion assemblies described herein, such as the expansion assembly 1510 and the expansion assembly 1810.For example, when a portion of the expandable member 2214 is in abutting contact with the anterior tracheal wall of the patient, the expandable member 2214 can be visualized (e.g., via ultrasound) and a needle can pierce the expandable member 2214 so that the same or similar procedure as described with respect to Figures 3A-3M and / or 18-22 can be performed.

[0152]

[0199] 52-55 are perspective, top, distal end, and side views, respectively, of expansion assembly 2310 in an expanded configuration. Expansion assembly 2310 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 2310 may include elongate tube 2312 and expandable member 2314. Elongate tube 2312 may define an inflation lumen in fluid communication with the interior of expandable member 2314 and may deliver and / or withdraw fluid from the interior of expandable member 2314 to transition expandable member 2314 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. The expandable member 2314 can be positioned along a portion of the elongate tube 2312 (eg, near or at the distal end of the elongate tube 2312).

[0153]

[0200] The expandable member 2314 defines passageways 2317 (e.g., first passageway 2317A, second passageway 2317B, and third passageway 2317C) that allow fluid (e.g., air) to travel through the passageways 2317 when the expandable member 2314 is in an expanded configuration. In the expanded configuration, when the expandable member 2314 is positioned in a patient's upper trachea, each of the first passageway 2317A, second passageway 2317B, and third passageway 2317C can be bounded in part by the expandable member 2314 and in part by the patient's tracheal wall. In some embodiments, the elongate tube 2312 can define a portion of one or more of the first passageway 2317A, second passageway 2317B, and third passageway 2317C. Thus, air can flow through the passage 2317 between a portion of the trachea on a first side of the expandable member 2314 (e.g., the area between the patient's cricoid cartilage and the expandable member 2314) and a portion of the trachea on a second side of the expandable member 2314 (e.g., the area between the expandable member 2314 and the patient's lungs), and can ventilate and oxygenate the patient through the passage 2317 when the expandable member 2314 is in the expanded configuration.

[0154]

[0201] The expandable member 2314 can include an upper portion 2314A (also referred to as the first portion), a first lower portion 2314B (also referred to as the second portion), and a second lower portion 2314C (also referred to as the third portion). In the expanded configuration, each of the upper portion 2314A, the first lower portion 2314B, and the second lower portion 2314B can be shaped as a wedge. For example, the upper portion 2314A can have a first side 2381A, a second side 2381B, and an arcuate surface 2381C. The first lower portion 2314B can have a first side 2383A, a second side 2383B, and an arcuate surface 2383C. The second lower portion 2314C can have a first side 2382A, a second side 2382B, and an arcuate surface 2382C. The expandable member 2314 may also have a distal end 2381D and a proximal end 2381E.

[0155]

[0202] The first passageway 2317A can be defined in part by the first side surface 2381A of the upper portion 2314A and the first side surface 2383A of the first lower portion 2314B. The second passageway 2117B can be defined in part by the second side surface 2381B of the upper portion 2314A and the first side surface 2382B of the second lower portion 2114B. The third passageway 2117C can be defined in part by the second side surface 2382B of the first lower portion 2314B and the second side surface 2382B of the second lower portion 2314C. In some embodiments, when in the expanded configuration, the inflatable member 2314 can be shaped and sized such that the first lower portion 2314B and the second lower portion 2314C (e.g., the arcuate surface 2383C and the arcuate surface 2382C) contact and are constrained by the posterior tracheal wall, urging the upper portion 2314A against the anterior tracheal wall and applying coaptation pressure against the anterior tracheal wall.

[0156]

[0203] In some embodiments, the upper portion 2314A, the first lower portion 2314B, and the second lower portion 2314C are in fluid communication with one another such that fluid can be provided to all of the upper portion 2314A, the first lower portion 2314B, and the second lower portion 2314C using an inflation lumen in the elongate tube 2312. In some embodiments, the upper portion 2314A, the first lower portion 2314B, and the second lower portion 2314C are fluidly isolated from one another such that separate inflation lumens and / or separate ports in the elongate tube 2312 are used to provide fluid to the upper portion 2314A, the first lower portion 2314B, and the second lower portion 2314C.

[0157]

[0204] In some embodiments, the expandable member 2314 can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, the expandable member 2314 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. The expansion assembly 2310 can also include a magnetic member (not shown), which can be the same as or similar in structure and / or function to any of the magnetic members described herein. For example, in some embodiments, the elongate member 2312 can define a central lumen in which the magnetic member can be disposed. In some embodiments, the magnetic member can be centered between the first and second ends of the expandable member 2314. In some embodiments, the magnetic member can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1815. For example, the magnetic member can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Further, in some embodiments, a magnetic member can be coupled to any suitable portion of the expansion assembly 2310 (e.g., directly to the expandable member 2314 and / or to the elongate tube 2312, such as on an outer surface of an inner tubular member disposed within the elongate tube 2312, along an end and / or inner or outer surface of the expandable member 2314, etc.). In some embodiments, a magnetic member may optionally not be included in the expansion assembly 2310, and the joining of the expandable member 2314 with the patient's anterior neck portion can be achieved solely under the pressure of a fluid within the expandable member 2314. Further, in some embodiments, an inflation lumen can be defined between the inner tubular member (e.g., inner tubular member 1684) and the elongate tube 2312, such that the inflation lumen surrounds the inner tubular member. In use, the expansion assembly 2310 can operate in the same manner or similarly to that described with respect to other expansion assemblies described herein, such as the expansion assembly 1510 and the expansion assembly 1810.For example, when a portion of the expandable member 2314 (e.g., the arcuate surface 2381C of the upper portion 2314A) is in abutting contact with the anterior tracheal wall of the patient, the expandable member 2314 can be visualized (e.g., via ultrasound) and a needle can pierce the expandable member 2314 so that the same or similar procedure as described with respect to Figures 3A-3M and / or 18-22 can be performed.

[0158]

[0205] 56-59 are perspective, top, distal end, and side views, respectively, of expansion assembly 2410 in an expanded configuration. Expansion assembly 2410 may be similar in structure and / or function to any of the expansion assembly systems and devices described herein, such as expansion assembly 110 of system 100 and / or expansion assembly 1510 of system 1500. For example, expansion assembly 2410 may include an elongate tube 2412 and an expandable member 2414. Elongate tube 2412 may define an inflation lumen in fluid communication with the interior of expandable member 2414 and may deliver and / or withdraw fluid from the interior of expandable member 2414 to transition expandable member 2414 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. The expandable member 2414 can be positioned along a portion of the elongate tube 2412 (eg, near or at the distal end of the elongate tube 2412).

[0159]

[0206] The expandable member 2414 includes a first expandable member 2414A, a second expandable member 2414B, and a third expandable member 2414C. The first expandable member 2414A and the second expandable member 2414B define a first passageway 2417A, and the first expandable member 2414A and the third expandable member 2414C define a second passageway 2417B, and when the expandable member 2414 is in an expanded configuration, fluid (e.g., air) can move through the passageways 2417A, 2417B. In the expanded configuration, when the expandable member 2414 is positioned within a patient's upper trachea, each of the first passageway 2417A and the second passageway 2417B can be bounded in part by the expandable member 2414 and in part by the patient's tracheal wall. In some embodiments, the elongate tube 2412 can define a portion of one or more of a first passageway 2417A and a second passageway 2417B. Air can therefore flow through the passageways 2417A, 2417B between a portion of the trachea on a first side of the expandable member 2414 (e.g., the area between the patient's cricoid cartilage and the expandable member 2414) and a portion of the trachea on a second side of the expandable member 2414 (e.g., the area between the expandable member 2414 and the patient's lungs) to ventilate and oxygenate the patient through the passageways 2417A, 2417B when the expandable member 2414 is in the expanded configuration.

[0160]

[0207] The second and third expandable members 2414B and 2414C can be positioned below the first expandable member 2414A. In some embodiments, the central axes of the second and third expandable members 2414B and 2414C can be parallel to one another. In some embodiments, the central axes of the second and third expandable members 2414B and 2414C can be parallel to one another and positioned in a plane that includes the central axis of the elongate tube 2412 (e.g., equidistant from the central axis of the elongate tube 2412). In some embodiments, the first expandable member 2414A can be formed from a different material than the second and third expandable members 2414B and 2414C. For example, in some embodiments, the first expandable member 2414A can be formed from a material having different compliance and / or flexibility compared to the second and / or third expandable members 2414B and / or 2414C. For example, the first inflatable member 2414A can be formed from a material that has higher compliance and / or higher flexibility compared to the second inflatable member 2414B and / or the third inflatable member 2414C. Thus, as the first inflatable member 2414A, the second inflatable member 2414B, and the third inflatable member 2414C are inflated, after the second inflatable member 2414B and the third inflatable member 2414C are fully inflated, the first inflatable member 2414A can continue to expand, and the second inflatable member 2414B and the third inflatable member 2414C are restrained by the posterior tracheal wall, and the first inflatable member 2414A expands and is biased against the anterior tracheal wall, exerting coaptation pressure against the anterior tracheal wall.

[0161]

[0208] In some embodiments, the first inflatable member 2414A, the second inflatable member 2414B, and the third inflatable member 2414C are in fluid communication with one another such that fluid can be provided to all of the first inflatable member 2414A, the second inflatable member 2414B, and the third inflatable member 2414C using the inflation lumen of the elongate tube 2412. In some embodiments, the first inflatable member 2414A, the second inflatable member 2414B, and the third inflatable member 2414C are fluidly isolated from one another such that fluid can be provided to the first inflatable member 2414A, the second inflatable member 2414B, and the third inflatable member 2414C using separate inflation lumens and / or separate ports of the elongate tube 2412.

[0162]

[0209] In some embodiments, the expandable member 2414 (e.g., first expandable member 2414A) can be the same as or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1514. For example, the expandable member 2414 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. The expansion assembly 2410 can also include a magnetic member (not shown), which can be the same as or similar in structure and / or function to any of the magnetic members described herein. For example, in some embodiments, the elongate member 2412 can define a central lumen in which the magnetic member can be disposed. In some embodiments, the magnetic member can be centered between one or more first and second ends of the expandable member 2414. In some embodiments, the magnetic member can be the same as or similar in structure and / or function to any of the magnetic members described herein, such as magnetic member 1815. For example, the magnetic member can be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. Further, in some embodiments, the magnetic member can be coupled to any suitable portion of the expansion assembly 2410 (e.g., directly to the expandable member 2414 and / or to the elongate tube 2412, such as along an outer surface of an inner tubular member disposed within the elongate tube 2412, an end of the expandable member 2414, and / or one or more inner or outer surfaces). Further, in some embodiments, an inflation lumen can be defined between the inner tubular member (e.g., the inner tubular member 1684) and the elongate tube 2412 such that the inflation lumen surrounds the inner tubular member. In some embodiments, a magnetic member may optionally not be included in the expansion assembly 2410, and the joining of the first expandable member 2314A with the patient's anterior neck portion can be achieved solely under the pressure of the fluid within the expandable member 2414. In use, the expansion assembly 2410 can operate in the same manner or similarly to that described with respect to other expansion assemblies described herein, such as the expansion assembly 1510 and the expansion assembly 1810.For example, when a portion of the first expandable member 2414A is in abutting contact with the anterior tracheal wall of the patient, the first expandable member 2414A can be visualized (e.g., via ultrasound) and a needle can be pierced through the first expandable member 2414A so that the same or similar procedure as described with respect to Figures 3A-3M and / or 18-22 can be performed.

[0163]

[0210] 60-63 are perspective, top, distal end, and side views, respectively, of the expansion assembly 2510 in an expanded configuration. The expansion assembly 2510 may be similar in structure and / or function to any of the expansion assemblies described herein, such as the expansion assembly 110 of system 100 and / or the expansion assembly 1510 of system 1500. For example, the expansion assembly 2510 may include an elongate tube 2512 and an expandable member 2514. The elongate tube 2512 defines an inflation lumen in fluid communication with the interior of the expandable member 2514 and may deliver and / or withdraw fluid from the interior of the expandable member 2514 to transition the expandable member 2514 between an unexpanded or undeployed (e.g., uninflated) configuration and an expanded or deployed (e.g., inflated) configuration. As shown, the expandable member 2514 may be disposed on or near the distal end of the elongate tube 2512.

[0164]

[0211] As shown, the expandable member 2514 may have a toroidal shape and may define a passageway 2517 (also referred to as a "vent") extending therethrough to allow fluid (e.g., air) to pass through the expandable member 2514 when the expandable member 2514 is positioned in an expanded configuration within a patient's trachea. The diameter of the passageway 2517 may be large enough to allow the patient to be adequately ventilated (e.g., freely or via a ventilator) through the passageway 2517 when the expandable member 2514 is positioned within the patient's trachea and the outer surface of the expandable member 2514 contacts the inner wall of the patient's trachea (e.g., such that air cannot flow along the outer surface of the expandable member 2514, or in a continuous manner such that the rate at which air can flow along the outer surface of the expandable member 2514 is insufficient for adequate ventilation and oxygenation). In some embodiments, the central axis of the passageway 2517 may be coaxial with the central axis of the expandable member 2514. In some embodiments, the elongate tube 2512 can be positioned on a first side of the passageway 2517 and can have a central axis that is parallel to the central axis of the passageway 2517.

[0165]

[0212] 60-63 depict the inflatable member 2514 as defining one passageway 2517, the inflatable member 2514 may define any suitable number of passageways 2517 (e.g., two, three, four, or more passageways 2517). While the passageway 2517 is shown as cylindrical, the passageway 2517 may have any suitable shape. In some embodiments, the inflatable member 2514 may define a suitable number of passageways 2517 having a suitable size (e.g., having a suitable combined cross-section) such that when the inflatable member 2514 is positioned within a patient's trachea and the outer surface of the inflatable member 2514 contacts the inner wall of the patient's trachea (e.g., in a continuous manner such that air cannot flow along the outer surface of the inflatable member 2514 or the rate at which air can flow along the outer surface of the inflatable member 2514 is insufficient for adequate ventilation and oxygenation), the patient can be properly ventilated through the passageways 2517 (e.g., freely or via a ventilator).

[0166]

[0213] In some embodiments, the expandable member 2514 can be the same or similar in structure and / or function to any of the expandable members described herein, such as expandable member 1614. For example, the expandable member 2514 can be formed from any suitable material having the properties described with respect to the other expandable members described herein. In some embodiments, the inflation assembly 2510 does not include a magnetic member because the expandable member 2514 can be inflated to a sufficiently large size such that a lower portion of the expandable member 2514 (e.g., a portion of the outer surface of the expandable member opposite the passageway 2517 from the elongated tube 2512) can contact and be restrained by the posterior tracheal wall, urging an upper portion of the expandable member 2514 (e.g., a portion of the outer surface of the expandable member opposite the passageway 2517 from the elongated tube 2512) to apply coaptation pressure against the anterior tracheal wall.

[0167]

[0214] In some embodiments, the inflation assembly 2410 may optionally include a magnetic member (not shown), which may be the same or similar in structure and / or function as any of the magnetic members described herein. For example, in some embodiments, the elongate member 2512 may define a central lumen in which the magnetic member may be disposed. In some embodiments, the magnetic member may be centered between the first and second ends of the inflatable member 2514. In some embodiments, a magnetic member, such as magnetic member 1515, may be included, which may be the same or similar in structure and / or function as any of the magnetic members described herein. For example, the magnetic member may be configured to be biased toward an external magnetic assembly (such as external magnetic assembly 1540) when positioned within the patient's upper trachea. In some embodiments, the magnetic member may be coupled to any suitable portion of the inflation assembly 2510 (e.g., directly to the inflatable member 2514 and / or to the elongate tube 2512, such as along the outer surface of an inner tubular member disposed within the elongate tube 2512, along the ends and / or inner or outer surfaces of the inflatable member 2514). Further, in some embodiments, an inflation lumen can be defined between an inner tubular member (e.g., inner tubular member 1684) and elongate tube 2512 such that the inflation lumen surrounds the inner tubular member. In use, inflation assembly 2510 can operate in the same or similar manner as described with respect to other inflation assemblies described herein, such as inflation assembly 1510. For example, when a portion of inflatable member 2514 is in abutting contact with the anterior tracheal wall of the patient, inflatable member 2514 can be visualized (e.g., via ultrasound) and a needle can pierce inflatable member 2514 such that the same or similar procedure can be performed as described with respect to FIGS. 3A-3M and / or 18-22.

[0168]

[0215] While various embodiments have been described above, it should be understood that they are presented by way of example only, and not by way of limitation. While the methods described above show some events occurring in a particular order, the order of some events can be changed. Furthermore, some of the events can be performed sequentially, as described above, and, where possible, can be performed simultaneously in a parallel process.

[0169]

[0216] While the schematic diagrams and / or embodiments described above show some components arranged in some orientations or positions, the arrangement of the components may be varied. While embodiments have been particularly shown and described, it will be understood that various changes in form and detail may be made. Any portion of the apparatus and / or methods described herein may be combined in any combination except mutually exclusive combinations. The embodiments described herein may include various combinations and / or subcombinations of the functions, components, and / or features of the different embodiments described.

Claims

1. Long tube, an inflatable member coupled to an end of the elongate tube, the inflatable member configured to transition from an uninflated configuration to an inflated configuration, whereby in the inflated configuration, a first portion of the inflatable member compresses against an anterior wall of the trachea and a second portion of the inflatable member compresses against a posterior wall of the trachea to facilitate ultrasound visualization of tissue between the patient's skin and the anterior wall of the trachea, the inflatable member defining a passageway extending from the first end of the inflatable member to the second end of the inflatable member, whereby air can travel through the trachea via the passageway from a first region defined between the elongate tube and the trachea proximal to the inflatable member to a second region distal to the inflatable member when the inflatable member is in the inflated configuration and compressing against the anterior wall of the trachea and the posterior wall of the trachea. A system including:

2. The system described in claim 1, wherein the expandable member defines the entire outer boundary of the passage.

3. The system of claim 1 , wherein the passageway is defined in part by the inflatable member and in part by a portion of the wall of the trachea.

4. 2. The system of claim 1, wherein the passageway is a first passageway and the inflatable member defines a second passageway extending from the first end of the inflatable member to the second end of the inflatable member, whereby air can travel through the trachea via the second passageway when the inflatable member is in the inflated configuration and compressing the anterior wall of the trachea.

5. 10. The system of claim 1, further comprising a guidewire assembly including a guidewire and a coupling member configured to be translated through a foramen in the patient's anterior neck whereby the coupling member engages the expandable member and the guidewire extends through the anterior neck of the patient.

6. 2. The system of claim 1, wherein the inflatable member is configured to compress the anterior wall of the trachea in the expanded configuration when the inflatable member is positioned in a space between the anterior wall of the trachea and the exterior of an endotracheal tube to facilitate ultrasound visualization of tissue between the patient's skin and the anterior wall of the trachea.

7. 2. The system of claim 1, wherein the inflatable member is configured to compress the anterior wall of the trachea in the expanded configuration when the inflatable member is spaced beyond an end of an endotracheal tube to facilitate ultrasound visualization of tissue between the patient's skin and the anterior wall of the trachea.

8. 10. The system of claim 1, further comprising a magnetic member configured such that in response to positioning an external magnetic assembly on a surface of the patient's anterior neck, the expandable member can be urged against an inner surface of a wall of the upper trachea, such that any intervening structure between the surface of the patient's anterior neck and the inner surface of the wall of the upper trachea is positioned with substantially no fluid gap between the external magnetic assembly and the expandable member.

9. The system of claim 8 , wherein the magnetic member is disposed within the expandable member.

10. The system of claim 1 , wherein the passageway is non-coaxial with respect to a central axis of the elongate tube.

11. The system of claim 4 , wherein each of the first and second passageways is defined entirely by the inflatable member.

12. 5. The system of claim 4, wherein the first passageway is defined by the inflatable member and a first portion of the tracheal wall, and the second passageway is defined by the inflatable member and a second portion of the tracheal wall.

13. 2. The system of claim 1, wherein the passage is a first passage, the expandable member includes a first portion and a second portion, the first passage being defined in part by a first sidewall of the first portion and a first sidewall of the second portion, and the second sidewall of the first portion and a second sidewall of the second portion defining in part a second passage extending from the first end of the expandable member to the second end of the expandable member.

14. 14. The system of claim 13, wherein in the expanded configuration of the expandable member, the first portion has a first cross-sectional shape and the second portion has a second cross-sectional shape that is different from the first cross-sectional shape.

15. 14. The system of claim 13, wherein in the expanded configuration of the expandable member, the first portion has a first cross-sectional shape and the second portion has a second cross-sectional shape that is the same as the first cross-sectional shape.

16. 2. The system of claim 1, wherein the inflatable member defines a first inner portion and a second inner portion surrounding the first inner portion, and when the inflatable member is positioned in contact with the anterior wall of the trachea, the first inner portion is separated from the anterior wall of the trachea by the second inner portion.

Images