Systems, devices and methods for performing percutaneous tracheotomy

Abstract

To provide devices, systems, and methods for creating a percutaneous tracheostomy part.SOLUTION: A system includes an inflation assembly and a guidewire assembly. The inflation assembly can include an elongated tube, an inflatable member, and a magnetic member. The elongated tube can have a first end, a second end, and can define a lumen. The inflatable member can be coupled to the first end of the elongated tube and can be fluidically coupled to the lumen such that the inflatable member can receive fluid via the lumen. The magnetic member can be coupled to the first end of the elongated tube such that movement of the magnetic member can cause corresponding movement of the first end of the elongated tube. The first end of a guidewire of the guidewire assembly can include a coupling member, the coupling member configured to couple to the inflatable member such that translation of the elongated tube translates the guidewire assembly.SELECTED DRAWING: Figure 3F

Description

[Technical Field]

[0001]

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 679,282, filed June 1, 2018, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," and U.S. Provisional Patent Application No. 62 / 728,450, filed September 7, 2018, entitled "Systems, Apparatus, and Methods for Performing a Percutaneous Tracheostomy," the entire contents of each of which are expressly incorporated herein by reference for all purposes.

[0002] FIELD OF THE INVENTION

[0002] Embodiments described herein relate to systems, devices and methods for creating a percutaneous tracheostomy that provides access to a patient's trachea via a pathway through the patient's neck. [Background technology]

[0003]

[0003] Some patients suffer from medical conditions that impair their ability to breathe. For these patients, a tracheotomy procedure may be beneficial. For some patients, percutaneous tracheotomy is a preferred procedure because it is safer and less expensive than open surgical tracheotomy. Some percutaneous tracheotomy techniques include the Ciaglia technique (continuous or single-stage dilation), the Griggs technique (wire clamp), and translaryngeal tracheotomy (or Fantoni technique). Generally, percutaneous tracheotomy procedures require safely puncturing the anterior portion of the patient's trachea and inserting a guidewire using the Seldinger technique. Typically, the entry site used for puncture and subsequent guidewire insertion is between the first and second tracheal rings or between the second and third tracheal rings.

[0004] However, identifying the ideal site for tracheal puncture can be difficult. Advanced tools such as bronchoscopy and ultrasound have been used to improve physical examination landmarks. Like many advanced procedural tools, bronchoscopes are expensive, can have sterilization issues, can malfunction, and are often not readily available. Unlike bronchoscopy, ultrasound can identify the tracheal rings, thyroid isthmus, and proximal vessels to allow for safer needle insertion. However, ultrasound alone lacks the ability to visualize the posterior trachea, potentially placing the patient at risk for posterior tracheal wall injury. Without bronchoscopy, the damaged posterior wall cannot be accessed during extended percutaneous tracheotomy. Furthermore, standard bronchoscopes often prevent proper ventilation of the patient during percutaneous tracheotomy procedures, further increasing the risk to the patient.

[0005]

[0005] 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. Summary of the Invention

[0006]

[0006] 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 can include an elongate tube, an inflatable member, and a magnetic member. The elongate tube can have a first end, a second end, and can define a lumen. The inflatable member can be coupled to the first end of the elongate tube and can be fluidly coupled to the lumen such that the inflatable member can receive fluid through the lumen. The magnetic member can 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 can include a guidewire having a first end and a second end. The first end of the guidewire assembly can 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]

[0007] [Figure 1] 1 is a schematic diagram of a guidewire placement system, according to one embodiment. [Figure 2A]

[0008] FIG. 1 is a schematic diagram of a front view of a portion of the human anatomy. [Figure 2B]

[0008] FIG. 1 is a schematic diagram of a cross-sectional side view of a portion of the human anatomy. [Figure 2C]

[0009] 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]

[0010] 1A-1D are schematic diagrams of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3B] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3C]1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3D] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3E] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3F] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3G] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3H] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3I] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3J] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3K] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3L] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 3M] 1 is a schematic diagram of a guidewire placement system in various stages of operation, according to one embodiment. [Figure 4]

[0011] 1 is a schematic diagram of a guidewire placement system, according to one embodiment. [Figure 5]

[0012] 1 is a schematic diagram of a guidewire placement system, according to one embodiment. [Figure 6]

[0013] 1 is a schematic diagram of a guidewire placement system, according to one embodiment. [Figure 7]

[0014] 1 is a flowchart of a method according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0008]

[0015] In some embodiments, the system includes an expansion assembly and a guidewire assembly. The expansion assembly can include an elongate tube, an expandable member, and a magnetic member. The elongate tube can have a first end, a second end, and can define a lumen. The expandable member can be coupled to the first end of the elongate tube and can be fluidly coupled to the lumen such that the expandable member can receive fluid through the lumen. The magnetic member can 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 can include a guidewire having a first end and a second end. The first end of the guidewire assembly can include a coupling member configured to couple to the expandable member such that translation of the elongate tube translates the guidewire assembly.

[0009]

[0016] In some embodiments, the method can 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 can 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. 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 inner surface of the upper trachea. The expandable member can then be inflated 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 a guidewire assembly can be translated through the patient's anterior neck and into the patient's upper trachea. The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end positioned outside the patient's body, the guidewire extending through the patient's anterior neck. The coupling member can be coupled to the expandable member.

[0010]

[0017] 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 .

[0011]

[0018] In some implementations, the light source 118 can be disposed 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 disposed within the tubular member 150, the light emitted by the light source 118 is partially or completely blocked by the tubular member 150, and the light emitted by the light member 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, and elongate tube 112 is translated 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 once first end 111 extends from the end of tubular member 150. Light source 118 may be, for example, a light emitting diode (LED).

[0012]

[0019] 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 elongated and rectangular in shape. In some embodiments, the magnetic member 115 may be cylindrical in shape. In some embodiments, the magnetic member 115 may be arcuate in shape. 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.

[0013]

[0020] 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 disposed 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.

[0014]

[0021] In some embodiments, the expandable member 114 can be any suitable shape, any suitable size, and formed from any suitable material. 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.

[0015]

[0022] 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.

[0016]

[0023] In some embodiments, for example, the expandable member 114 may be oval in shape and formed from a low durometer urethane. The expandable member 114 may have an outermost diameter in the expanded configuration ranging from about 40 mm to about 55 mm and a length of about 55 mm. The expandable member 114 may have a diameter at each end ranging from about 5.46 mm to about 5.72 mm. The wall thickness at the maximum balloon diameter in the expanded configuration may be about 0.029 mm to about 0.038 mm. The expandable member 114 may be filled with up to, for example, about 50 ml of fluid in the expanded configuration.

[0017]

[0024] Guidewire assembly 120 can 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 can 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 cause coupling member 124 and guidewire 122 to move in the first direction. Coupling member 124 can 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 expandable member 114.

[0018]

[0025] In some embodiments, coupling member 124 may be separate from guidewire 122 and fixedly coupled (e.g., via an adhesive) to guidewire 122. For example, in some embodiments, coupling member 124 may include a first magnetic member configured to couple to a second magnetic member of expandable member 114.

[0019]

[0026] 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 of coupling member 124 with 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.

[0020]

[0027] 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, and the coupling member 124 can slide 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, and the coupling member 124 can move through an opening 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.

[0021]

[0028] 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 can 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 can 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 can 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 can remain in the first configuration. The coupling member 124 may be fully in the second configuration when it is completely outside the needle 130 .

[0022]

[0029] In some embodiments, the expandable member 114 can be configured to translate the coupling member 124 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 being 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 being 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's body, 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 can 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, e.g., a surgeon pulling on the elongate tube 112 and the guidewire 122. In some embodiments, the surgeon 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 opening provided by the needle 130 while in a straight or non-straight configuration.

[0023]

[0030] 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 sharp 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. The coupling member 124 and a portion of the guidewire 122 can then be translated through the lumen 135 of the needle 130 such that at least one of the coupling member 124 and the portion of the guidewire 122 is at least partially disposed within the expandable member 114. The needle 130 can then be removed from the expandable member 114 by translating the needle 130 along the guidewire 122.

[0024]

[0031] 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 a 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.

[0025]

[0032] The barrier member 195 can have any suitable shape. In some implementations, the barrier member 195 can 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 can have an oval, circular, or rectangular outline.

[0026]

[0033] 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 attractive force applied by the external magnetic assembly 140 to 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 against the barrier member 195 in the posterior direction can again urge the magnetic member 115 toward the posterior tracheal wall, due to the magnetic attractive force of the external magnetic assembly 140.

[0027]

[0034] 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. The one or more magnetic elements 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. The barrier member 195 can be coupled or positioned relative to a portion of the expandable member 114 that is intended to pierce such that when the barrier member 195 is urged (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 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 and contact the barrier member 195, thereby preventing the needle 130 from extending into contact with the posterior tracheal wall.

[0028]

[0035] In some implementations, the barrier member 195 can 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 allows the surgeon to identify the location of the barrier member 195 via ultrasound imaging and stop the 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.

[0029]

[0036] In some implementations, the barrier member 195 can be formed from any suitable material that is highly echogenic and / or highly resistant to puncture by a needle (e.g., needle 130) used to pierce the patient's tissue. 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.

[0030]

[0037] 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 can also increase the target size of the expandable member for visualization and targeting of the expandable member 114 along with the needle 130 and / or coupling member 124.

[0031]

[0038] The tubular member 150 can have a first end 151 and a second end 153 opposite the first end 151. The tubular member 150 can define a lumen extending from the first end 151 to the second end 153. In some embodiments, the tubular member 150 can 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 can 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 can be configured to be coupled to a ventilation source, and 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 can 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. 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.

[0032]

[0039] 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 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 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.

[0033]

[0040] Ultrasound probe 160 may be any suitable ultrasound probe configured for visualization of expandable member 114 within the patient and any intervening patient structure 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 disposed 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 FIG. 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 FIG. 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 exterior surface of the patient (e.g., anterior surface A of the patient's neck skin), and magnetic member 115 (not shown in FIG. 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 the echogenic member is pressed against the surface of the wall of the body cavity and the echogenic member and all tissue planes between the echogenic member and the exterior surface of the patient can be visualized by ultrasound, can be referred to as Coaptive Ultrasound (CU).

[0034]

[0041] In some embodiments, the external magnetic assembly 140 can include a handle. In some embodiments, the external magnetic assembly 140 can include one magnetic element configured to magnetically interact with the magnetic member 115. In some embodiments, the external magnetic assembly 140 can include any suitable number of magnetic elements (e.g., two magnetic elements) configured to magnetically interact with the magnetic member 115. In some embodiments, as described above, the expansion assembly 110 can include multiple magnetic members 115 (e.g., two magnetic members), and the external magnetic assembly 140 can include a corresponding number of magnetic elements.

[0035]

[0042] 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 to the magnetic field source, exerting a force on the external magnetic assembly 140 and / or the magnetic member 115.

[0036]

[0043] 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 member 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 member 112 should extend beyond first end 151 of tubular member 150 a particular distance based on the known relative lengths of tubular member 150 and elongate member 112 and / or markings on at least one of tubular member 150 or elongate member 112.

[0037]

[0044] The external magnetic assembly 140 can then be placed on the anterior neck of the patient, and 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 member 112 into contact with the anterior wall of the upper trachea. The tubular member 150 can be translated relative to the first end 111 of the elongated member 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.

[0038]

[0045] 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).

[0039]

[0046] The ultrasonic probe 160 can be used to visualize the location of the expandable member 114 while the guidewire assembly 120 is 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 so that the thyroid isthmus and proximal vessels can be avoided during insertion of the needle 130. 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 can 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.

[0040]

[0047] 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 through (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. Additionally, the external magnetic assembly 140 can 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. Additionally, the expandable member 114 can be deflated.

[0041]

[0048] 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 the pathway from the patient's anterior neck to the patient's trachea, where guidewire assembly 120 is positioned. For example, elongate member 112 can be translated through tubular member 150 such that first end 111 of elongate member 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 member 112 is translated.

[0042]

[0049] As another example, guidewire assembly 120 can be used to perform a translaryngeal tracheotomy (or Fantoni procedure). For example, tubular member 150 and elongate member 112 can be translated such that first end 111 of elongate member 112 moves through a patient's orifice (e.g., nose or mouth). Thus, coupling member 124 of guidewire assembly 120 and guidewire 122 translate through the patient's orifice toward the patient's cricoid cartilage. In some embodiments, tubular member 150 can be withdrawn from the patient's body through the patient's orifice before withdrawing elongate member 112. A tracheostomy tube can then be threaded over the guidewire, through the patient's mouth, through the cricoid cartilage, and into the upper trachea, engaging a path through the patient's tracheal wall and anterior neck.

[0043]

[0050] 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 member 112 can be translated through the tubular member 150 such that the first end 111 of the elongate member 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 toward the patient's cricoid cartilage and through or near the patient's orifice. 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 neck passage such that the coupling member 124 draws the expandable member 114 and elongate member 112 into the upper trachea. Any suitable percutaneous tracheotomy can then be performed using the guidewire assembly 120.

[0044]

[0051] 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 inner 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 positioned outside the patient's body, the guidewire extending through the patient's anterior neck. The coupling member can be coupled to the inflatable member (212).

[0045]

[0052] 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 can 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 can have a first end 351 and a second end 353 opposite first end 351. Tubular member 350 can define a lumen extending from first end 351 to second end 353 and can include an expandable member 352 configured to be capable of transitioning 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 the patient's tracheal wall.

[0046]

[0053] 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), through the patient P's cricoid cartilage C, and into the patient P's upper trachea U, with the first end 351 of the tubular member 350 and the expandable member 352 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, which can anchor 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 can have any suitable shape. For example, the expandable member 352 can have a circular profile such that, in the expanded configuration, the central axis of the first end 351 of the tubular member 350 can be coaxial with the central axis of the upper trachea U.

[0047]

[0054] 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 elongate member 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 elongate member 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 elongate member 312 and / or markings on at least one of the tubular member 350 or the elongate member 312.

[0048]

[0055] 3C , the external magnetic assembly 340 can then be placed on the patient's anterior neck A, and the magnetic member 315 of the expansion assembly 310 can be urged toward the external magnetic assembly 340, urging the first end 311 of the elongated member 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 member 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 expandable member 352 in an expanded state by pulling the expandable member 352 along the inner surface of the wall of the upper trachea U. In some implementations, the expandable member 352 of the tubular member 350 can be partially or fully deflated before being translated 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 expandable member 352 can initially be 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.

[0049]

[0056] 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 member 312). As described above, the fluid can include a fluid and / or a contrast agent such 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. An 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).

[0050]

[0057] As shown in FIG. 3E , while using the ultrasound probe 360 ​​to visualize the location of the expandable member 314, the needle 330 can be inserted through the anterior neck A of the patient P and into the patient's upper trachea U. The needle 330 can be further translated so that the needle 330 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 so that the isthmus and proximal vessels can be avoided during insertion of the needle 330. 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.

[0051]

[0058] 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 through (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.

[0052]

[0059] 3G, needle 330 can then be withdrawn from the patient's body due to translation of needle 330 relative to coupling member 324 and guidewire 322, leaving coupling member 324 within expandable member 314 and guidewire 322 extending through the wall of expandable member 314. Additionally, external magnetic assembly 340 can be removed from the patient so that magnetic member 315 is no longer biased (e.g., by magnetic attraction) toward the anterior tracheal wall. Expandable member 314 can be deflated.

[0053]

[0060] With the guidewire assembly 320 extending through the patient's anterior neck and coupled to the expandable member 314, any suitable percutaneous tracheotomy procedure can be performed using the guidewire assembly 320 and the pathway from the patient's anterior neck to the patient's trachea, where the guidewire assembly 320 is positioned. For example, as shown in FIG. 3H , the elongate member 312 can be translated through the tubular member 350 such that the first end 311 of the elongate member 312 moves toward the patient's lower trachea and / or lungs. Thus, the coupling member 324 of the guidewire assembly 320 and the guidewire 322 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 the guidewire assembly 320 from separating from the expandable member 314, the guidewire 322 must be advanced through the puncture site in the patient's neck as the elongate member 312 is translated. In some embodiments, the guidewire 322 can be pushed so that the expandable member 314 translates.

[0054]

[0061] As an example of the Ciaglia technique, FIG. 3I illustrates that a dilator 370 can be advanced over the guidewire 322 to externally dilate a pathway through the anterior neck A to the upper trachea U. As shown in FIG. 3J, after external dilation, a tracheostomy tube 380 can 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 outside the patient P (e.g., extending from the anterior neck A of the patient P). As shown in FIG. 3K, the guidewire assembly 320 can be separated from the expandable member 314. For example, sufficient force can 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 can then be translated through the tracheostomy tube 380 and removed from the patient P's body. The tracheostomy tube 380 can be coupled to a ventilator (not shown), which can push 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 pushing 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 elongate member 312 can be translated proximally through the tubular member 350, and the elongate member 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.

[0055]

[0062] 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 opening (e.g., the nose or mouth) of the patient P. The elongate member 312 can be translated such that the first end 311 of the elongate member 312 moves through the opening 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 opening 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 path through the patient's tracheal wall and anterior neck A.

[0056]

[0063] In some embodiments, the external magnetic assembly and the expansion assembly can 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 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 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 can include an elongated tube 412 and an expandable member 414. The elongated tube 412 can have a first end 411 and a second end 413. In some embodiments, the elongated tube 412 can 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.

[0057]

[0064] The external magnetic assembly 440 can 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 can be spaced apart along the elongate member 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 can 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 elongate tube 412 because the orientation of the first end 411 of the elongate 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.

[0058]

[0065] In some embodiments, rather than having multiple magnetic members and / or elements, the expansion assembly 410 can include a disk-shaped magnetic member defining a through-hole, and the external magnetic assembly 440 can include a disk-shaped magnetic element defining a through-hole. The ultrasound probe 460 can be inserted through the through-hole of the disk-shaped magnetic element of the external magnetic assembly 440 and made contact with the patient P.

[0059]

[0066] In some embodiments, as described above, a light source can be disposed 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 elongate tube 512 and in fluid communication with inflatable member 514. Tubular member 550 can have a first end 551 and a second end 553 opposite first end 551. Tubular member 550 can define a lumen extending from first end 551 to second end 553 and can include 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.

[0060]

[0067] 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).

[0061]

[0068] 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 elongate tube 612 and in fluid communication with expandable member 614 .

[0062]

[0069] 6, a barrier member 695 may be coupled to or form a portion of a side wall of the expandable member 614. The barrier member 695 may 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 may have a shape that corresponds to the shape of the outer surface of the expandable member 614. The barrier member 195 may 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, if 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, 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 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. 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.

[0063]

[0070] In some implementations, the barrier member 695 can be disposed inside the expandable member 614 and bonded 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 bonded 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.

[0064]

[0071] Additionally, in some implementations, the barrier member 695 may have a high echogenicity so 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.

[0065]

[0072] In some implementations, the barrier member 695 can be formed from any suitable material that is highly echogenic and / or highly resistant to puncture by a needle (e.g., needle 630) used to pierce the patient's tissue. For example, the barrier member 695 can be formed from a polymer or a metal composite. 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.

[0066]

[0073] 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 may be changed. Furthermore, some of the events may be performed sequentially, as described above, and may also be performed simultaneously in parallel processes where possible.

[0067]

[0074] 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. an inflation assembly including an elongate tube, an expandable member, and a magnetic member, the elongate tube having a first end, a second end, and defining a first lumen, the expandable member coupled to the first end of the elongate tube, the expandable member fluidly coupled to the first lumen such that fluid can be received through the first lumen, and the magnetic member 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; a guidewire assembly including a guidewire having a first end and a second end, the first end of the guidewire assembly including a coupling member configured to couple to the expandable member such that translation of the elongate tube causes translation of the guidewire assembly; a tubular member defining a second lumen, the second lumen configured to translatably receive the inflation assembly within the second lumen.

2. 2. The system of claim 1, wherein the expandable member is a first expandable member and the tubular member includes a second expandable member configured to transition between an unexpanded configuration and an expanded configuration, the second expandable member configured to extend from an outer surface of the tubular member in the expanded configuration.

3. The system of claim 2 , wherein the second inflatable member is configured to seal against an interior surface of the trachea in an inflated configuration.

4. The system of claim 1 , wherein a tubular member is configured to allow ventilation of a patient through the second lumen when the inflation assembly is disposed in the second lumen.

5. The system of claim 1 , wherein the outermost diameter of the expansion assembly is no greater than 50% of the inner diameter of the tubular member.

6. 10. The system of claim 1, wherein the inflation assembly includes a barrier member coupled to the inflatable member and positioned relative to the magnetic member so as to be positioned between the magnetic member and a posterior tracheal wall, and configured to be more resistant to puncture than a side wall of the inflatable member.

7. 7. The system of claim 6, wherein the barrier member has a first hardness and the sidewall of the expandable member has a second hardness, the first hardness being greater than the second hardness.

8. The system of claim 6 , wherein the portion of the sidewall of the inflatable member has a first thickness and the barrier member has a second thickness, the second thickness being greater than the first thickness.

9. 2. The system of claim 1, wherein the inflation assembly includes a barrier member, the barrier member forming a first portion of a sidewall of the inflatable member configured to be disposed between the magnetic member and a posterior tracheal wall, and configured to be more resistant to puncture than a second portion of the sidewall of the inflatable member.

10. 10. The system of claim 1, wherein the inflation assembly includes a barrier member coupled to the elongate tube so as to be positioned between the magnetic member and a posterior tracheal wall, and configured to be more resistant to puncture than a sidewall of the inflatable member.

11. The system of claim 1 , wherein the system further comprises a needle defining a third lumen, the third lumen configured to receive the guidewire assembly.

12. 10. The system of claim 1, further comprising a fluid configured to be disposed within the expandable member via the first lumen of the elongate tube so that the location of the expandable member can be visualized via ultrasound.

13. The system of claim 1 , wherein the coupling member comprises a shape memory material.

14. 2. The system of claim 1, wherein the coupling member is configured to transition between a first configuration and a second configuration, the coupling member having a greater lateral extent relative to a central axis of the guidewire when in the first configuration than when in the second configuration, and the coupling member is biased toward the first configuration.

15. The system of claim 14 , wherein the coupling member has a pigtail shape in the first configuration and an elongated shape in the second configuration.

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