阅读说明：本技术 用于执行经皮气管切开术的系统、设备和方法 (Systems, devices, and methods for performing percutaneous tracheotomy ) 是由 S·P·德洛佩罗 H·卡罗兰 E·戈德瓦瑟 于 2019-05-31 设计创作，主要内容包括：本文描述了用于创建经皮气管切开术的设备、系统和方法。一种系统可以包括充胀组件和导丝组件。充胀组件可以包括细长管、可充胀构件和磁性构件。细长管可以具有第一端部和第二端部,并且可以限定管腔。可充胀构件可以联接至细长管的第一端部并且可以流体地联接至管腔,使得可充胀构件可以经由管腔接收流体。磁性构件可以联接至细长管的第一端部,使得磁性构件的运动可以引起细长管的第一端部的相对应运动。导丝组件的导丝的第一端部可以包括联接构件,该联接构件被配置为联接至可充胀构件,使得细长管的平移使导丝组件平移。(Devices, systems, and methods for creating a percutaneous tracheotomy are described herein. A 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 and 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 may 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 may cause corresponding movement of the first end of the elongate tube. The first end of the guidewire assembly may include a coupling member configured to be coupled to the inflatable member such that translation of the elongate tube translates the guidewire assembly.)

1. A system, comprising:

an inflation assembly including an elongate tube having a first end and a second end and defining a lumen, an inflatable member coupled to the first end of the elongate tube, the inflatable member fluidly coupled to the lumen such that the inflatable member is capable of receiving fluid via the lumen, a magnetic member coupled to the first end of the elongate tube such that movement of the magnetic member is capable of causing corresponding movement of the first end of the elongate tube, and a blocking member coupled to the inflatable member and configured to be more resistant to puncture than a sidewall of the inflatable member; and

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 be coupled to the inflatable member such that translation of the elongate tube translates the guidewire assembly.

2. The system of claim 1, wherein the lumen is a first lumen, and further comprising a needle defining a second lumen configured to receive the guidewire assembly.

3. The system of claim 1, further comprising a fluid configured to be disposed within the inflatable member via the lumen of the elongate tube such that a position of the inflatable member is visualized via ultrasound.

4. The system of claim 1, wherein the lumen is a first lumen, and further comprising a tubular member defining a second lumen configured to receive the inflation assembly such that the inflation assembly is translatable within the second lumen.

5. The system of claim 4, wherein the inflatable member is a first inflatable member, the tubular member including a second inflatable member configured to transition between an uninflated configuration and an inflated configuration, the second inflatable member configured to extend from an outer surface of the tubular member in the inflated configuration.

6. The system of claim 1, wherein the guidewire assembly comprises a shape memory material.

7. The system of claim 5, wherein the shape memory material is nitinol.

8. 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 in the first configuration than in the second configuration, the coupling member being biased toward the first configuration.

9. The system of claim 8, wherein the coupling member has a pigtail shape in the first configuration and an elongated shape in the second configuration.

10. The system of claim 8, wherein the coupling member is shaped as a straight line in the second configuration.

11. The system of claim 8, wherein the coupling member is configured to couple to the inflatable member via translation through a sidewall of the inflatable member at least partially within a lumen of a needle while the coupling member remains within the lumen of the needle in the second configuration, and transition to the first configuration when the coupling member translates out of the needle.

12. The system of claim 1, wherein the coupling member is coupleable to the inflatable member such that application of a first force on the elongate tube can translate the guidewire assembly in a first direction.

13. The system of claim 12, wherein applying a second force on the guidewire assembly greater than and opposite to the first force concurrent with applying the first force is configured to cause the coupling member to disengage from the inflatable member.

14. The system of claim 1, wherein the coupling member is disengageable from the inflatable member via at least partial transition from a first configuration to a second configuration, the first configuration having a greater lateral extent relative to a central axis of the guidewire than the second configuration.

15. The system of claim 1, wherein the inflatable member comprises polyurethane.

16. The system of claim 1, wherein the blocking member has a first durometer and the sidewall of the inflatable member has a second durometer, the first durometer being greater than the second durometer.

17. The system of claim 1, wherein a portion of the sidewall of the inflatable member has a first thickness and the blocking member has a second thickness, the second thickness being greater than the first thickness.

18. The system of claim 1, wherein the blocking member is coupled to the inflatable member such that the blocking member forms a portion of the inflatable member defining an interior of the inflatable member.

19. A system, comprising:

an inflation assembly comprising an elongate tube having a first end and a second end and defining a first lumen, an inflatable member coupled to the first end of the elongate tube, the inflatable member fluidly coupled to the first lumen such that the inflatable member is capable of receiving fluid via the first lumen, and a magnetic member coupled to the first end of the elongate tube such that movement of the magnetic member is capable of causing 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 be coupled to the inflatable member such that translation of the elongate tube translates the guidewire assembly; and

a tubular member defining a second lumen configured to receive the inflation assembly such that the inflation assembly is translatable within the second lumen.

20. The system of claim 19, wherein the inflatable member is a first inflatable member, the tubular member including a second inflatable member configured to transition between an uninflated configuration and an inflated configuration, the second inflatable member configured to extend from an outer surface of the tubular member in the inflated configuration.

21. A method, comprising:

translating a first end of an elongate tube through an aperture of a patient, through a cricoid ring of the patient, and into an upper trachea of the patient such that an inflatable member and a magnetic member coupled to the elongate tube are disposed in the upper trachea of the patient;

disposing an external magnetic assembly on a surface of the patient's anterior neck so as to urge the magnetic member of the elongate tube toward the patient's anterior neck and dispose the inflatable member against an inner surface of a tracheal 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 tracheal wall is disposed between the external magnetic assembly and the inflatable member with substantially no fluid gap;

inflating the inflatable member through the lumen of the elongate tube such that the inflatable member transitions from an uninflated configuration to an inflated configuration;

translating a coupling member of a guide wire assembly through the patient's anterior neck and into the patient's upper trachea, the guide wire assembly including a guide wire having a first end coupled to the coupling member and a second end disposed outside the patient's body, the guide wire extending through the patient's anterior neck;

coupling the coupling member to the inflatable member.

22. The method of claim 21, further comprising, prior to translating the first end of the elongate tube through the patient's aperture, translating a first end of a tubular member through the patient's aperture and through the patient's cricoid ring to position the first end of the tubular member in the patient's upper trachea.

23. The method of claim 22, wherein the inflatable member is a first inflatable member and the tubular member includes a second inflatable member configured to transition between an uninflated configuration and an inflated configuration, and further comprising:

inflating the second inflatable member such that the second inflatable member extends from an outer surface of the tubular member and is coupled to an inner surface of a tracheal wall of the patient.

24. The method of claim 22, further comprising, after coupling the coupling member to the inflatable member, translating the tubular member away from the inflatable member, through the cricoid annulus of the patient, and out of the orifice of the patient.

25. The method of claim 21, further comprising translating the elongate tube relative to an upper trachea of the patient such that the inflatable member translates the coupling member of the guidewire in a direction of translation of the elongate tube.

26. The method of claim 21, further comprising moving the external magnetic assembly over the surface of the patient's anterior neck such that the magnetic member of the elongate tube correspondingly moves along an inner surface of the upper trachea and the inflatable member is positioned between adjacent tracheal rings of the patient.

27. The method of claim 21, further comprising visualizing the position of the inflatable member via ultrasound.

28. The method of claim 21, further comprising inserting a first end of a needle into a trachea through a forward neck and through a sidewall of the inflatable member, the translation of the coupling member of the guidewire assembly being accomplished at least partially through a lumen of the needle.

29. The method of claim 28, wherein the coupling member is configured to transition between a first configuration in which the coupling member is pigtail-shaped and a second configuration in which the coupling member is straight, the coupling member being biased toward the first configuration, the coupling member being retained by the needle in the second configuration when the coupling member is disposed within the lumen of the needle,

wherein coupling of the coupling member to the inflatable member comprises translating the coupling member beyond the first end of the needle such that the coupling member at least partially transitions from the second configuration to the first configuration and withdrawing the needle relative to the coupling member such that the coupling member is retained by a sidewall of the inflatable member and the guidewire extends from the coupling member through the tracheal wall and through the anterior neck.

30. The method of claim 22, further comprising deflating the inflatable member after coupling the coupling member to the inflatable member.

Technical Field

Embodiments described herein relate to systems, devices, and methods for creating a percutaneous tracheotomy for accessing a patient's trachea via a path through the patient's neck.

Background

Some patients suffer from medical conditions that impair the patient's ability to breathe. In such patients, a tracheotomy may be beneficial. For some patients, percutaneous tracheotomy is a more desirable procedure than open surgical tracheotomy, because it is safer and less expensive than open surgical tracheotomy. Some percutaneous tracheotomy techniques include the Ciaglia technique (sequential or one-step dilation), the Griggs technique (wire clamp), and the translaryngeal tracheotomy (or Fantoni) technique. Typically, percutaneous tracheotomy requires safely puncturing the patient's anterior trachea and inserting a guidewire using a transfemoral procedure (Seldinger technique). Typically, the entry site for puncture and subsequent guidewire insertion is between the first tracheal ring and the second tracheal ring or between the second tracheal ring and the third tracheal ring.

However, identifying an ideal site for tracheal puncture can be challenging. Advanced tools such as bronchoscopy and ultrasound have been used to improve physical examination signs. Like many advanced procedural tools, bronchoscopes can be expensive, have sterility issues, can malfunction, and often lack immediate availability. While ultrasound, unlike bronchoscopy, can identify the tracheal ring, thyroid isthmus and proximal blood vessels to enable safer needle insertion, ultrasound alone lacks the ability to visualize the posterior trachea and thus the patient may be at risk of injury to the posterior wall of the trachea. The damaged posterior wall is inaccessible during a dilated percutaneous tracheotomy without bronchoscopy. In addition, standard bronchoscopes often inhibit adequate ventilation of the patient during the percutaneous tracheotomy procedure, thereby posing additional risks to the patient.

Accordingly, there is a need for systems, devices and methods for performing a percutaneous tracheotomy that reduce the risk to the patient and that allow the percutaneous tracheotomy to be performed quickly and easily.

Disclosure of Invention

Systems, devices, and methods for performing a percutaneous tracheotomy are described herein. In some embodiments, a 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 and 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 may 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 may 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 be coupled to the inflatable member such that translation of the elongate tube translates the guidewire assembly.

Drawings

Fig. 1 is a schematic view of a guidewire placement system according to an embodiment.

Fig. 2A and 2B are schematic illustrations of a front view and a cross-sectional side view, respectively, of a portion of the human anatomy.

Fig. 2C is a schematic diagram of a cross-sectional side view of a portion of human anatomy engaged with a portion of the guidewire placement system of fig. 1, in accordance with an embodiment.

Fig. 3A-3M are schematic views of a guidewire placement system in various stages of operation, according to an embodiment.

Fig. 4 is a schematic view of a guidewire placement system, under an embodiment.

Fig. 5 is a schematic view of a guidewire placement system, under an embodiment.

Fig. 6 is a schematic view of a guidewire placement system, under an embodiment.

Fig. 7 is a flow diagram of a method according to an embodiment.

Detailed Description

In some embodiments, a 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 and 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 may 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 may 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 be coupled to the inflatable member such that translation of the elongate tube translates the guidewire assembly.

In some embodiments, a method may include translating a tubular member through an aperture of a patient, through a cricoid ring of the patient, and into an upper trachea of the patient. The first end of the elongate tube may be translated through the lumen of the tubular member such that the inflatable member and the magnetic member of the elongate tube extend from the first end of the tubular member and are disposed in the upper trachea of the patient. An external magnetic assembly may be disposed on the patient's anterior neck to urge the magnetic member of the elongated tube toward the patient's anterior neck and to dispose the inflatable member against the inner surface of the upper airway. The inflatable member may then be inflated through the lumen of the elongate tube such that the inflatable member transitions from the uninflated configuration to the 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 guide wire assembly may include a guide wire having a first end coupled to the coupling member and a second end disposed outside the patient, the guide wire extending through the anterior neck of the patient. The coupling member may be coupled to the inflatable member.

Fig. 1 is a schematic diagram of a system 100. System 100 includes inflation assembly 110, guidewire assembly 120, and 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 inflatable member 114, and a magnetic member 115. Inflation assembly 110 may optionally include a blocking 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 mouth or nostrils of the patient to the trachea of the patient. The inflatable 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 inflatable member 114. In some embodiments, the inflation lumen 116 may be disposed within the elongate tube 112 and/or defined by the elongate tube 112.

In some embodiments, a light source 118 may be disposed on or near the first end 111 of the elongate tube 112. The light source 118 may generate sufficient light such that light may be emitted from the light source 118 through the tracheal wall to the surface of the neck and be visible to a user (e.g., a clinician). Accordingly, a user may be able to determine the position of the first end 111 of the elongate tube 112 based at least in part on the position of light emitted through the skin of the patient. In some embodiments, the light source 118 and the tubular member 150 may be configured such that light emitted by the light source 118 is partially or completely blocked by the tubular member 150 when the first end 111 of the elongate tube 112 is disposed within the tubular member 150 such that the light emitted by the light member is not visible on the skin of the patient or is darker on the skin of the patient than when the first end 111 of the elongate tube 112 is not within the tubular member 150. Thus, when the elongate tube 112 and the tubular member 150 are at least partially inserted into the patient, when the elongate tube 112 is translated relative to the tubular member 150 such that the first end 111 extends from the tubular member 150, the light emitted from the light source 118 may become visible or more visible as the first end 111 extends from the end of the tubular member 150. The light source 118 may be, for example, a Light Emitting Diode (LED).

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

In some embodiments, the inflatable member 114 may surround the elongate tube 112 in an inflated and/or uninflated configuration. In some embodiments, the inflatable member 114 may extend transversely from the elongate tube 112 in an inflated and/or uninflated configuration. In some embodiments, the inflatable member 114 may extend distally from the first end 111 of the elongate tube 112 in an inflated and/or uninflated configuration. In some embodiments, the inflatable member 114 may be disposed on the elongate tube 112 such that a portion of the elongate tube 112 extends distally of the inflatable member 114 when the inflatable member 114 is in the inflated and/or uninflated configuration. In some embodiments, the inflatable member 114 may have two ends (e.g., a cuff) and each end may be sealed to an outer surface of the elongate tube 112. The elongate tube 112 may define one or more inflation ports or apertures such that the inflation lumen 116 may be in fluid communication with the interior of the inflatable member 114 for transitioning the inflatable member 114 between the uninflated and inflated configurations. In some embodiments, the inflatable member 114 may be formed on or as part of a rigid subassembly, and the rigid subassembly may receive the elongate tube 112 within an aperture of the subassembly, and may then seal the elongate tube 112 to the subassembly.

In some embodiments, the inflatable member 114 may be formed in any suitable shape, in any suitable size, and in any suitable material. For example, the inflatable member 114 may be oval, spherical, cylindrical, rectangular, teardrop, or any other suitable shape. In some embodiments, the shape may be selected based on the particular application of the system 100. For example, the shape of the inflatable member 114 may be selected to improve ultrasound visualization in a particular region of the patient's body. Further, the inflatable member 114 may be sized for improved engagement and retention between the inflatable member 114 and the guidewire assembly 120.

The inflatable member 114 may be sufficiently flexible such that the inflatable member 114 (e.g., when inflated) may be pierced (e.g., by a needle) to define a needle hole in the wall of the inflatable member 114, rather than being ruptured or torn as a result of the piercing. In some embodiments, the inflatable member 114 may be formed of, for example, polyurethane, silicone, and/or polyvinyl chloride (PVC). In some embodiments, the inflatable member 114 may have any suitable material properties, wall thickness, and/or outermost diameter for inflation.

In some embodiments, for example, the inflatable member 114 may be oval in shape and formed of a low durometer polyurethane. The inflatable member 114 may have an outermost diameter in the range of about 40mm to about 55mm in the inflated configuration and a length of about 55 mm. The inflatable member 114 may have a diameter at each end in the range of about 5.46mm to about 5.72 mm. In the inflated configuration, the wall thickness at the maximum balloon diameter may be between about 0.029mm and about 0.038 mm. In the inflated configuration, the inflatable member 114 may be filled with up to, for example, about 50ml of fluid.

The 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 the first end 121 of the guidewire 122. The coupling member 124 may be configured to couple to the inflatable member 114 such that translation of the inflation assembly 110 (e.g., via translation of the elongate tube 112 caused by pulling the second end 113) may translate the guidewire assembly 120 when coupled. For example, if the inflatable member 114 moves in a first direction due to a force applied to the elongate tube 112, the coupling of the coupling member 124 with the inflatable member 114 may cause the coupling member 124 and the guidewire 122 to also move in the first direction. The coupling member 124 may be configured to couple with the inflatable member 114 via, for example, being captured by the inflatable member 114, being captured within an interior region of the inflatable member, or engaging a surface of the inflatable member 114.

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

In some embodiments, the guidewire 122 can include a coupling member 124. For example, the coupling member 124 may be integrally formed with the shaft of the guidewire 122 such that the guidewire assembly 120 is a one-piece structure. Similarly, in some embodiments, the coupling member 124 and the guidewire 122 can be formed from the same material or materials. In some embodiments, the coupling member 124 may be shaped such that the coupling member 124 may engage with at least a portion of the wall of the inflatable member 114. For example, the coupling member 124 may have a planar or multi-planar shape and may be formed as a pigtail (pigtail) shaped, hook shaped, coiled, or helical end of the guidewire 122. Thus, in some embodiments, when the coupling member 124 is disposed within the inflatable member 114, the first end 121 of the guidewire 122 may be held within or adjacent to the inflatable member 122 by the coupling member 124. In some embodiments, the coupling member 124 may be disposed outside of the inflatable member 114, with the guidewire 122 passing through a first wall portion and an oppositely disposed second wall portion of the inflatable member 114, such that the guidewire 122 is retained by the inflatable member 114 due to interaction between the coupling member 124 and the first wall portion of the inflatable member 114. In some embodiments, the coupling member 124 may be disposed partially inside the inflatable member 114 and partially outside the inflatable member 114 such that the guidewire assembly 120 is coupled to the inflatable member 114 for translating the guidewire assembly 120 via movement of the inflation assembly 110.

In some embodiments, the coupling member 124 may be configured to transition between a first configuration for insertion and a second configuration for retention or coupling. For example, the coupling member 124 may 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 may fit within the lumen 135 of the needle 130 in the first configuration and may expand to retain the guidewire 122 relative to the inflatable member 114 in the second configuration. In some embodiments, the coupling member 124 may have a first shape in the first configuration and a second shape in the second configuration, such that the coupling member 124 may travel through an opening in at least one sidewall of the inflatable member 114 in the first configuration and may engage the sidewall of the inflatable member 114 in the second configuration in order to retain the coupling member 124 by the inflatable member 114. In some embodiments, the coupling member 124 may be biased toward the second configuration such that the coupling member 124 will assume the second configuration in the absence of an external force acting on the coupling member 124. In some embodiments, in the first configuration, the coupling member 124 may be elongated such that the coupling member is shaped as a straight line. The second configuration may correspond to an unbiased shape or configuration of the coupling member (e.g., pigtail, hook, coil, or spiral). In some embodiments, the guidewire 122 and/or the coupling member 124 may be formed of a shape memory material such as nitinol.

In some embodiments, when the coupling member 124 is within the lumen 135 of the needle 130, the needle 130 can compress the coupling member 124 such that the coupling member is in the first configuration. Thus, the coupling member 124 has a smaller lateral extent (e.g., outermost diameter) relative to the central axis of the guidewire 122 when disposed within the lumen 135 of the needle 130 than when not within the lumen 135 of the needle 130. In some embodiments, lumen 135 and coupling member 124 may be configured and dimensioned such that coupling member 124 may be straight or substantially straight within lumen 135 of needle 130. For example, the inner diameter of the lumen 135 may be similar to the outer diameter of the coupling member 124 (e.g., the outer diameter of the wire forming the coupling member 124 portion of the guidewire assembly 120) such that the coupling member 124 may be laterally compressed into a shape having a smaller outer diameter and/or elongated within the lumen 135 of the needle 130. In some embodiments, the outer diameter of the wire forming coupling member 124 and the inner diameter of lumen 135 may be relatively sized such that the outer diameter of the wire forming coupling member 124 is slightly smaller than the inner diameter of lumen 135 and coupling member 124 and the inner surface of needle 130 defining lumen 130 may have a slip fit engagement. Thus, when coupling member 124 is screwed into lumen 135 of needle 130, the wire forming coupling member 124 is straightened to correspond to the shape of lumen 135. As the coupling member 124 translates out of the first end 131 of the needle 130, the coupling member 124 can transition from the first configuration to the second configuration. 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 as a result of being 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. When the coupling member 124 is completely outside of the needle 130, the coupling member 124 may be completely in the second configuration.

In some embodiments, if the translational force on the inflatable member 114 (e.g., the force translating on the inflatable member 114 and/or the force holding the inflatable member 114 stationary) is greater than the force on the coupling member 124 in the opposite direction to the translational force, the coupling member 124 may be configured to translate in the first direction through the inflatable member 114. The coupling member 124 and the inflatable member 114 may be configured to disengage if the force on the coupling member 124 opposes the translational force on the inflatable member 114 and is greater than the translational force on the inflatable member 114. For example, in some embodiments in which the coupling member 124 is a pigtail-shaped end of the guidewire 122, applying sufficient force to the coupling member 124 in a direction opposite to the force applied to the inflatable member 114 may cause the pigtail-shaped end to straighten the inflatable member 114 and disengage from the inflatable member 114. In some embodiments, applying sufficient force to the coupling member 124 in a direction opposite to the force applied to the inflatable member 114 may cause the coupling member to tear the sidewalls of the inflatable member 114, such that the inflatable member 114 and the coupling member 124 disengage. Thus, in some embodiments, the coupling member 124 and the inflatable member 114 may be disengaged via applying opposite direction pulling forces to each of the coupling member 124 and the inflatable member 114. In some embodiments, the coupling member 124 and the inflatable member 114 may be engaged such that the release force necessary to separate the coupling member 124 from the inflatable member 114 (e.g., via a pulling force in the opposite direction) is a force greater than the maximum force applied to the guidewire 122 (and thus to the coupling member 124) in the opposite direction from the inflatable member 114 during withdrawal of the coupling member 124 from the patient's body via pulling of the inflation assembly 110. Thus, the release force is high enough so that the inflatable member 114 and the coupling member 124 will not separate during inadvertent withdrawal of the coupling member 124 of the guidewire 122 during withdrawal, but the inflatable member 114 and the coupling member 124 may separate via, for example, pulling by a user when the inflatable member 114 and the coupling member 124 are outside of the patient's body. For example, in some embodiments, the release force may be at least about 0.25 pounds of force, at least about 0.5 pounds of force, or at least about 1.5 pounds of force. In some applications of the system 100, the release force may be greater or lesser depending on the resistance that may be experienced by the coupling member 124 and the guidewire 122 during withdrawal via the withdrawal force on the inflation assembly 110. In some embodiments, the coupling member 124 and the inflatable member 114 may be engaged such that the release force necessary to separate the coupling member 124 from the inflatable member 114 (e.g., via a pulling force in the opposite direction) is less than the force applied to the guidewire 122 (and thus to the coupling member 124) in a direction away from the patient (e.g., away from the patient's anterior neck) during withdrawal of the inflation assembly 110 from the patient's body via the patient aperture via pulling of the elongate tube 112. Thus, the release force may be low enough so that the inflatable member 114 and the coupling member 124 will not inadvertently separate during movement of the coupling member 124 of the guidewire 122 via movement of the inflatable member 114 within, for example, the trachea of a patient, but may separate via, for example, pulling of the elongate tube 112 and the guidewire 122 by a user. In some embodiments, a user may disengage the inflatable member 114 from the coupling member 124 by pushing the inflatable 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 created by the needle 130 while in the straight configuration or the non-straight configuration.

In some embodiments, the coupling member 124 may be configured to pierce the inflatable member 114 such that the coupling member 124 may be inserted into the inflatable member 114 and/or through the inflatable member 114. In some embodiments, the system 100 may optionally include a needle 130, the needle 130 having a first end 131, a second end 133, and defining a lumen 135. The first end 131 may have any suitable shape configured to pierce the inflatable member 114 and create a passageway to the inflatable member 114. For example, the first end 131 may have a sharp tip, which may be tapered. Lumen 135 may be sized such that coupling member 124 of guidewire assembly 120 may translate through second end 133, translate through lumen 135, and translate through first end 131 of needle 130. In some embodiments, the needle 130 may be inserted through the patient's anterior neck and tracheal wall and through the sidewall of the inflatable member 114. Then, a portion of the guidewire 122 and the coupling member 124 may be translated through the lumen 135 of the needle 130 such that at least one of the portion of the guidewire 122 and the coupling member 124 is at least partially disposed within the inflatable member 114. The needle 130 may then be removed from the inflatable member 114 via translating the needle 130 along the guidewire 122.

The optional blocking member 195 may be part of the 110 inflation assembly 110 that is more resistant to puncture or tearing (e.g., by a needle) than the inflatable member 114 or a portion of the inflatable member 114. In some embodiments, the blocking member 195 may be disposed in any suitable position relative to a portion of the inflatable member 114 intended to be pierced, in which position the blocking member may prevent the needle from passing through the inflatable member 114 and piercing the patient's posterior tracheal wall. In some embodiments, the blocking member 195 may form a portion of a sidewall of the inflatable member 114. In some embodiments, the blocking member 195 may be disposed on an outer surface of the inflatable member 114 and/or coupled to an outer surface of the inflatable member 114. In some embodiments, the blocking member 195 may be disposed within the inflatable member 114. For example, the blocking member 195 may be disposed on or coupled to an inner surface of the inflatable member 114 (e.g., opposite the surface of the inflatable member 114 intended to be pierced by the needle 130). In some embodiments, the blocking member 195 may be disposed on the elongate tube 112 or coupled to the elongate tube 112. In some embodiments, the blocking member 195 may be disposed at a location between the elongate tube 112 and the inner surface of the inflatable member 114.

Blocking member 195 may have any suitable shape. In some embodiments, the blocking member 195 may have a shape corresponding to the shape of the inner or outer surface of the inflatable member 114 and/or a shape corresponding to the shape of a plane through the inflatable member 114. For example, blocking member 195 may have an oval profile, a circular profile, or a rectangular profile.

In some embodiments, the blocking member 195 may be sufficiently puncture resistant and/or tear resistant such that if the force applied by the needle (e.g., needle 130) to the blocking member 195 is greater than the magnetic attraction exerted by the external magnetic assembly 140 (e.g., through the patient's skin and tracheal wall) on the magnetic member 115 of the inflation assembly 110, the needle will push the blocking member 195 toward the patient's posterior tracheal wall and thereby push the magnetic member 115 away from the patient's anterior tracheal wall, rather than the needle piercing the blocking member 195. Upon removal or reduction of the force exerted by the needle on blocking member 195 in the rearward direction, magnetic member 115 may be urged again toward the anterior wall of the trachea due to the magnetic attraction of external magnetic assembly 140.

In some embodiments, the blocking member 195 may be arranged relative to the magnetic member 115 such that when the magnetic member 115 is urged toward the external magnetic assembly 140, the blocking member 195 is disposed opposite the magnetic member 115 from the external magnetic assembly 140 (e.g., between the magnetic member 115 and the posterior tracheal wall of the patient). In some embodiments, blocking member 195 may include one or more magnetic elements. The one or more magnetic elements may have a polarity relative to the magnetic member 115 and/or the external magnetic assembly 140 such that the blocking member 195 is repelled by the magnetic member 115 and/or the external magnetic assembly 140 such that the blocking member 195 will be urged toward the patient's posterior tracheal wall and away from the patient's anterior tracheal wall. Blocking member 195 may be coupled or disposed relative to the portion of inflatable member 114 intended to be pierced such that when blocking member 195 is urged toward and away from the patient's posterior and anterior tracheal walls (e.g., via magnetic interaction with external magnetic assembly 140 and/or via magnetic interaction of external magnetic assembly 140 with magnetic member 1150), the portion of inflatable member 114 intended to be pierced is disposed adjacent or disposed adjacent the anterior tracheal wall. Accordingly, the blocking member 195 may be disposed between the interior of the inflatable member 114 and the posterior tracheal wall such that when the needle 130 is translated into the interior of the inflatable member 114, the blocking member 195 may prevent the needle 130 from extending into contact with the posterior tracheal wall because further translation of the needle 130 may translate the needle 130 into contact with the blocking member 195.

In some embodiments, the barrier member 195 may have increased echogenicity such that the barrier member 195 may be more easily visualized via ultrasound waves 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 surrounding portions of the patient. Due to the increased echogenicity, the user may be able to identify the position of the blocking member 195 via ultrasound imaging and interrupt the translation of the needle 130 before the needle reaches the blocking member 195 or before the needle passes the blocking member 195, such that the needle 130 may be prevented from advancing too far relative to the inflatable member 114 and/or the patient's trachea and the needle 130 from damaging the patient's posterior tracheal wall.

In some embodiments, blocking member 195 may be formed of any suitable material having increased puncture resistance to a needle (e.g., needle 130) used to pierce patient tissue and/or increased echogenicity. For example, barrier member 195 may be formed from a polymer or metal composite. In some embodiments, the barrier member 195 may include a thickened or reinforced portion of the sidewall of the inflatable member 114.

In some embodiments, the inflatable member 114 may be filled and/or inflated with a fluid (e.g., a liquid or gaseous fluid) after being disposed in the upper airway of the patient. For example, the inflatable member 114 may be filled and/or inflated with a fluid and/or contrast agent such that the inflatable member 114 defines an echogenic space that may be detected using ultrasound imaging. Inflating the inflatable member 114 may also increase the surface tension of the sidewall of the inflatable member so that the needle 130 and/or guidewire 122 may more easily pierce the sidewall. Further, inflation of the inflatable member 114 may create a larger interior space within which the coupling member 124 may expand and/or set. Inflation of the inflatable member 114 may also increase the target size of the inflatable member for visualization and targeting of the inflatable member 114 with the needle 130 and/or coupling member 124.

The tubular member 150 may have a first end 151 and a second end 153 opposite the first end 151. Tubular member 150 may define a lumen extending from first end 151 to second end 153. In some embodiments, tubular member 150 may include an inflatable member 152, the inflatable member 152 configured to extend from an outer surface of tubular member 150 to near first end 151. Inflatable member 152 may be configured to seal against an inner surface of the patient's trachea and/or stabilize tubular member 150 within the patient's trachea. Second end 153 of tubular member 150 may be configured to be coupled to a ventilation source such that when first end 151 of tubular member 150 is disposed within a patient's trachea, the patient may be ventilated via tubular member 150. In some embodiments, the tubular member 150 may be configured to be disposed within the trachea of a patient via translation of the first end 151 of the tubular member 150 through the nostril or orifice of the patient. In some embodiments, tubular member 150 may be an endotracheal tube. Tubular member 150 may be configured to receive at least a portion of inflation assembly 110 within a lumen of tubular member 150 such that inflation assembly 110 may translate 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 disposed within the lumen of tubular member 150 and translated relative to tubular member 150, tubular member 150 may 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 may be equal to or less than 50% of the inner diameter of tubular member 150. In some embodiments, inflation assembly 110 may be disposed in line with tubular member 150 so that the ventilator circuit does not break and airway pressure through the trachea may be maintained.

Fig. 2A and 2B are schematic illustrations of a front view and a cross-sectional side view of a portion of a patient P. As shown in fig. 2A and 2B, the patient P has an oral aperture O and nostrils S. An end of the tubular member (e.g., first end 151 of tubular member 150) may be inserted through the oral aperture O or nostril S and translated to the trachea W of the patient P. For example, tubular member 150 may be inserted through nostril S and translated through nasopharynx NP, oropharynx OP, through epiglottis EP, through laryngopharynx LP to bypass esophagus E, through larynx L, through thyroid cartilage TC, through cricoid ring C and into upper trachea U. The end of the tubular member may also be inserted through the oral aperture O and translated to the trachea W via the oropharynx OP.

The ultrasound probe 160 may be any suitable ultrasound probe configured for visualizing the inflatable member 114 within the patient's body and any intervening patient structures between the patient's skin and the inflatable member 114. For example, the ultrasound probe 160 may be used to visualize any intervening patient tissue or patient structure, such as, for example, the tracheal wall W, cartilage (e.g., thyroid cartilage TC), blood vessels (e.g., artery R and/or vein V), nerves (e.g., laryngeal nerve N), thyroid TG, a portion of thyroid TG (e.g., thyroid isthmus TI, parathyroid PG), and/or any other structure or tissue that may be disposed between the inflatable member 114 and the patient's skin. The external magnetic component 140 may be any suitable external magnetic component configured to urge the magnetic member 115 of the inflation component 110 towards the external magnetic component (e.g., via magnetic attraction) through patient tissue (e.g., through the patient's skin and tracheal wall). As shown in fig. 2C, the ultrasound probe 160 can be used to identify the location of a portion 110A of the inflation assembly 110 (e.g., the portion of the inflation assembly 110 that includes the inflatable member 114 and the magnetic member 115) within the body of the patient P relative to other tissues or structures of the patient P. For example, as shown in fig. 2C, where the inflation assembly 110 is disposed within the patient (e.g., the inflation assembly 110 is disposed within the patient's upper airway U, and the elongate tube 112 (not shown) extends from the portion 110A out of the oral aperture O through the larynx L, laryngo pharynx LP, oropharynx OP), the external magnetic assembly 140 may be coupled to an external surface of the patient (e.g., an anterior surface a of the patient's neck's skin) such that the magnetic member 115 (not shown in fig. 2C) of the portion 110A of the inflation assembly 110 is urged toward the external magnetic assembly 140 and the inflatable member 114 contacts a surface of the cavity's wall (e.g., a surface of the upper airway U's wall). The inflatable member 114 and the external magnetic assembly 140 may be disposed on opposite sides of the intervening tissue and/or structure such that substantially no fluid (e.g., air) gap is disposed between the inflatable member 114 and the external magnetic assembly 140. The surface of the wall of the cavity and the outer surface may be disposed on opposite sides of at least one tissue surface of the patient. The inflatable member 114 may be visualized within the lumen. For example, the inflatable member 114 may be echogenic and visualized via the ultrasound probe 160. 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 outer surface of the patient can be visualized by Ultrasound, a technique that may be referred to as adaptive Ultrasound (CU).

In some embodiments, the external magnetic component 140 may include a handle. In some embodiments, the external magnetic assembly 140 may include a magnetic element configured for magnetic interaction with the magnetic member 115. In some embodiments, the external magnetic assembly 140 may include any suitable number of magnetic elements (e.g., two magnetic elements) configured for magnetic interaction with the magnetic member 115. In some embodiments, as described above, the inflation assembly 110 may include a plurality of magnetic members 115 (e.g., two magnetic members) and the external magnetic assembly 140 may include a corresponding number of magnetic elements.

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

In use, tubular member 150 may be inserted through an orifice of a patient (e.g., a nostril or orifice of the patient), through the cricoid annulus of the patient, and into the upper trachea of the patient such that first end 151 of tubular member 150 and inflatable member 152 are disposed within the upper trachea. For example, the inflatable member 152 of the tubular member 150 may be disposed between the second and third tracheal rings of the patient. Inflation assembly 110 may 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 user may determine that the first end 111 of the elongate member 112 extends a particular distance beyond the first end 151 of the tubular member 150 based on the known relative lengths of the tubular member 150 and the elongate member 112 and/or a marker on at least one of the tubular member 150 or the elongate member 112.

The external magnetic assembly 140 may then be placed on the patient's anterior neck to urge the magnetic member 115 of the inflation assembly 110 toward the external magnetic assembly 140 such that the first end 111 of the elongated member 112 is urged into contact with the anterior wall of the upper trachea. Tubular member 150 may be translated toward the cricoid annulus relative to first end 111 of elongated member 112, first end 111 of elongated member 112 being held in place against the anterior wall of the superior trachea due to the magnetic attraction between external magnetic assembly 140 and magnetic member 115.

The fluid may then be delivered to the inflatable member 114 via the inflation lumen 116. As described above, the fluid may include a fluid and/or contrast agent such that the inflatable member 114 is detectable via imaging (e.g., ultrasound). The inflatable member 114 may then be visualized (e.g., using the ultrasound probe 160) so that the location of the inflatable member 114 may be identified. The external magnetic assembly 140 may 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, ultrasound probe 160 may be used to determine a tracheal puncture site between particular tracheal rings (e.g., between a first tracheal ring and a second tracheal ring of a patient or between a second tracheal ring and a third tracheal ring of a patient).

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

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

With the guidewire assembly 120 extending through the patient's anterior neck and coupled to the inflatable member 114, any suitable percutaneous tracheotomy may be performed using the guidewire assembly 120 and a conduit (track) through the patient's anterior neck to the patient's trachea through which the guidewire assembly 120 is disposed. For example, the elongate member 112 may be translated through the tubular member 150 such that the first end 111 of the elongate member 112 moves toward the patient's lower trachea and/or lungs. Accordingly, the coupling member 124 and the guidewire 122 of the guidewire assembly 120 translate toward the patient's lower trachea and/or lungs. External dilation may then be performed via, for example, the Ciaglia technique or the Griggs technique. In some embodiments, as the elongate member 112 translates to prevent the guidewire assembly 120 from disengaging from the inflatable member 114, the guidewire 122 will need to be advanced through the puncture site in the patient's neck.

As another example, a trans-laryngeal tracheotomy (or Fantoni technique) may be performed using guidewire assembly 120. For example, the tubular member 150 and the elongate member 112 may translate such that the first end 111 of the elongate member 112 moves through an orifice (e.g., a nostril or an oral orifice) of the patient. Thus, the coupling member 124 and the guidewire 122 of the guidewire assembly 120 translate through the patient's orifice toward the cricoid ring. In some embodiments, tubular member 150 may be withdrawn from the patient's body via the patient's orifice prior to withdrawing elongate member 112. The tracheostomy tube may then be threaded over the guide wire such that the tracheostomy tube may be translated through the patient's mouth, translated through the cricoid ring into the upper trachea, and engaged with the tube through the patient's tracheal wall and anterior neck.

In some embodiments, to verify that the coupling member 124 of the guidewire is disposed within the trachea of the patient and engaged with the inflatable member 114, the elongate member 112 may be translated through the tubular member 150 such that the first end 111 of the elongate member 112 is moved through an orifice (e.g., a nostril or ostium) of the patient. Thus, the coupling member 124 and the guidewire 122 of the guidewire assembly 120 translate through or near the patient's orifice toward the cricoid ring. Engagement between the coupling member 124 and the inflatable member 114 may then be verified. After verification, the guidewire 122 can be pulled through the conduit in the patient's anterior neck such that the coupling member 124 pulls the inflatable member 114 and the elongate member 112 into the upper trachea. Any suitable percutaneous tracheotomy can then be performed using the guidewire assembly 120.

Fig. 7 is a flow diagram of a method 200 according to an embodiment. The method 200 may be implemented using any of the systems or devices described herein (e.g., the system 100 described above). The method 200 includes translating a tubular member through an orifice of a patient, through a cricoid ring of the patient, and into an upper trachea of the patient 202. The first end of the elongate tube may be translated 204 through the lumen of the tubular member such that the inflatable member and the magnetic member of the elongate tube extend from the first end of the tubular member and are disposed in the upper trachea of the patient. The external magnetic assembly can be disposed 206 on the patient's anterior neck such that the magnetic member of the elongated tube is urged toward the patient's anterior neck and the inflatable member is disposed against the inner surface of the upper airway. The inflatable member may then be inflated 208 through the lumen of the elongate tube such that the inflatable member transitions from the uninflated configuration to the inflated configuration. The coupling member of the guidewire assembly can be translated 210 through the patient's anterior neck and into the patient's upper trachea. The guide wire assembly may include a guide wire having a first end coupled to the coupling member and a second end disposed outside the patient, the guide wire extending through the anterior neck of the patient. The coupling member may be coupled 212 to the inflatable member.

Fig. 3A-3M are schematic diagrams of a system 300 in various stages of operation. The system 300 may be the same or similar in structure and/or function to any of the systems or devices described herein (e.g., the system 100 described above). For example, the system 300 includes an inflation assembly 310, a guidewire assembly 320, and a tubular member 350. The system 300 also includes an external magnetic assembly 340 and an ultrasound probe 360. The inflation assembly 310 may include an elongate tube 312, an inflatable member 314, and a magnetic member 315. Elongate tube 312 may have a first end 311 and a second end 313. In some embodiments, the elongate tube 312 may have a length sufficient to extend from at least the mouth or nostrils of the patient to the trachea of the patient. The inflatable member 314 and the magnetic member 315 may be coupled to the elongated tube 312 near the first end 311 of the elongated tube 312. The inflation assembly 310 includes an inflation lumen 316 defined by the elongate tube 312 and in fluid communication with the inflatable member 314. The 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 the first end 321 of the guidewire 322. The tubular member 350 may have a first end 351 and a second end 353 opposite the first end 351. The tubular member 350 may define a lumen extending from a first end 351 to a second end 353, and may include an inflatable member 352, the inflatable member 352 being configured to transition from an uninflated configuration to an inflated configuration in which the inflatable member 352 extends from an outer surface of the tubular member 350 near the first end 351 and is coupled to an inner surface of a tracheal wall of a patient.

As shown in fig. 3A, the tubular member 350 may be inserted through an orifice (not shown) of the patient P (e.g., a nostril or orifice of the patient), through the cricoid annulus C of the patient P, and into the superior trachea U of the patient P such that the first end 351 of the tubular member 350 and the inflatable member 352 are disposed within the superior trachea U. After the inflatable member 352 has been inserted through the annular ring C of the patient P, the inflatable member 352 may transition to the inflated configuration such that the inflatable member 352 may secure the first end 351 within the upper trachea U and/or such that the first end 351 of the tubular member 350 may be stabilized (e.g., against axial movement) relative to the inner surface of the tracheal wall. For example, the inflatable member 352 of the tubular member 350 may be disposed between the second and third tracheal rings T2, T3 of the patient P or between the first and second tracheal rings T1, T2 of the patient P. The inflatable member 352 may have any suitable shape. For example, the inflatable member 352 may have a circular profile in the inflated configuration such that a central axis of the first end 351 of the tubular member 350 may be coaxial with a central axis of the upper airway tube U.

As shown in fig. 3B, inflation assembly 310 may then be translated through the lumen of tubular member 350 such that first end 311 of elongate member 312 of inflation assembly 310 extends beyond first end 351 of tubular member 350. In some embodiments, the user may determine that the first end 311 of the elongate member 312 extends a particular distance beyond the first end 351 of the tubular member 350 based on the known relative lengths of the tubular member 350 and the elongate member 312 and/or a marker on at least one of the tubular member 350 or the elongate member 312.

As shown in fig. 3C, the external magnetic assembly 340 may then be placed on the patient's anterior neck a to urge the magnetic member 315 of the inflation assembly 310 toward the external magnetic assembly 340 such that the first end 311 of the elongated member 312 is urged into contact with the anterior wall of the upper airway U. The tubular member 350 may translate towards the annular ring C with respect to the first end 311 of the elongated member 312, said first end 311 of the elongated member 312 being held in position against the front 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 embodiments, first end 351 of tubular member 350 may be translated toward annular ring C, with inflatable member 352 being inflated by pulling tubular member 350 along the inner surface of the wall of upper airway U. In some embodiments, the inflatable member 352 of the tubular member 350 may be partially or fully deflated prior to translation toward the annular ring C, and then inflated after translation. In some embodiments, tubular member 350 may remain in its initial position relative to annular ring C, rather than translating first end 351 of tubular member 350 toward annular ring C prior to progression (e.g., inflatable member 352 may be initially inflated between cricoid ring C and first tracheal ring T1).

As shown in fig. 3D, fluid may then be delivered to the inflatable 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 may include a fluid and/or contrast agent such that the inflatable member 314 is detectable via imaging (e.g., ultrasound). An ultrasound probe 360 may then be applied to the front neck a of the patient P so that the inflatable member 314, and any intervening tissue or other structure between the inflatable member and the surface of the front neck a, may be visualized and the position of the inflatable member 314 may be identified. The external magnetic assembly 340 may 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 may be used to determine tracheal puncture sites 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).

As shown in fig. 3E, the needle 330 may be inserted into the patient's upper trachea U through the anterior neck a of the patient P while visualizing the position of the inflatable member 314 using the ultrasound probe 360. The needle 330 may be further translated such that the needle 330 is inserted through the sidewall of the inflatable member 314 such that a first end 331 (e.g., a tip) of the needle 330 is disposed within the inflatable member 314. During insertion of the needle 330, the ultrasound probe 360 may be used to visualize the needle 330 and any intervening patient structures between the patient's skin and the inflatable member 314. For example, the ultrasound probe 360 may be used to identify the patient's thyroid isthmus and proximal blood vessels in real time during insertion of the needle 330 so that the thyroid isthmus and proximal blood vessels may be avoided. In addition, the ultrasonic probe 360 may be used to confirm that the first end 331 of the needle 330 is disposed within the inflatable member 314. Additionally or alternatively, echogenic fluid may be drawn from the inflatable member 314 via the needle 330 (e.g., into a syringe needle barrel) to verify that the first end 331 of the needle 330 is disposed in the inflatable member 314.

As shown in fig. 3F, with the first end 331 of the needle disposed within the inflatable member 314, a portion of the guidewire 322 and the coupling member 324 can be inserted through the lumen 335 of the needle 330 and translated (e.g., pushed) through the lumen 335. The coupling member 324 may then be translated out of the first end 331 of the needle 330 such that the coupling member 324 is disposed within the inflatable member 314.

As shown in fig. 3G, the needle 330 can then be withdrawn from the patient's body via translation of the needle 330 relative to the coupling member 324 and the guidewire 322, leaving the coupling member 324 within the inflatable member 314 and the guidewire 322 extending through the wall of the inflatable member. Additionally, the external magnetic assembly 340 may be removed from the patient's body such that the magnetic member 315 is no longer urged toward the anterior wall of the trachea (e.g., via magnetic attraction). The inflatable member 314 may be deflated.

With the guidewire assembly 320 extending through the patient's anterior neck and coupled to the inflatable member 314, any suitable percutaneous tracheotomy may be performed using the guidewire assembly 320 and a conduit through the patient's anterior neck to the patient's trachea through which the guidewire assembly 320 is disposed. 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. Accordingly, the coupling member 324 and the guidewire 322 of the guidewire assembly 320 translate toward the patient's lower trachea and/or lungs. External dilation may then be performed via, for example, the Ciaglia technique or the Griggs technique. In some embodiments, as the elongate member 312 translates to prevent the guidewire assembly 320 from disengaging from the inflatable member 314, the guidewire 322 will need to be advanced through the puncture site in the patient's neck. In some embodiments, the guidewire 322 may be pushed such that the inflatable member 314 translates.

As an example of the Ciaglia technique, fig. 3I shows that dilator 370 may be advanced over guidewire 322 to externally dilate the tract passing through anterior neck a to upper trachea U. As shown in fig. 3J, after external dilation, the tracheostomy tube 380 can be advanced over the guidewire 322 such that a first end of the tracheostomy tube 380 is disposed within the upper trachea U and a second end of the tracheostomy tube 380 is disposed outside of 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 disengaged from the inflatable member 314. For example, a force sufficient to urge the coupling member 324 out of engagement with the inflatable member 314 may be applied to the guidewire assembly 320 in a direction away from the patient P. 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 may push air into the lungs (not shown) of the patient P and draw air from the lungs of the patient P via the tracheostomy tube 380. After testing the combination of the ventilator and tracheostomy tube 380 to ensure that the ventilator correctly pushes air into the lungs of patient P and draws air from the lungs of patient P via tracheostomy tube 380, inflation assembly 310 and tubular member 350 may be removed from patient P. For example, elongate member 312 can be translated proximally through tubular member 350, and elongate member 312 and tubular member 350 can be sequentially or simultaneously removed from patient P via proximal translation through the patient P's orifice through which tubular member 350 is inserted into patient P. For example, the inflatable member 352 may be fully or partially deflated and the tubular member 350 may be translated proximally. As shown in fig. 3L, the tracheostomy tube 380 may be held in position relative to the patient's anterior neck a and upper trachea U, providing a fluid flow path to the patient's lungs.

As another example, a trans-laryngeal tracheotomy or Fantoni technique may be performed using the guidewire assembly 320. For example, as shown in fig. 3M, the tubular member 350 may be withdrawn from the patient P through an orifice (e.g., a nostril or orifice) of the patient P. The elongated member 312 may translate such that the first end 311 of the elongated member 312 moves through the orifice of the patient P. Thus, the coupling member 324 and the guidewire 322 of the guidewire assembly 320 translate through the annular ring C and out through the orifice of the patient P. The tracheostomy tube may then be threaded over the guide wire so that it may be translated through the patient's mouth, translated through the cricoid ring C into the upper trachea U, and passed through the patient's tracheal wall and anterior neck a into engagement with the tube.

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

The external magnetic assembly 440 may include a first magnetic element 442A, a second magnetic element 442B, and a handle 444. The first and second magnetic members 415A, 415B of the inflation assembly 410 may be spaced along the elongate member 412 such that the first magnetic member 415A is configured for magnetic interaction with the first magnetic element 442A and the second magnetic member 415B is configured for magnetic interaction with the second magnetic element 442B. During use of the system 400, the ultrasound probe 460 may be positioned between the first and second magnetic elements 442A, 442B to visualize the inflatable member 414 of the inflation assembly 410. This embodiment also enables more control over the orientation of the first end 411 of the elongate tube 412, as the orientation of the first end 411 of the elongate tube 412 will match the orientation of the external magnet assembly 440 (i.e., the first and second magnetic elements 422A, 422B).

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

In some embodiments, as described above, the light source may be disposed on or near the first end of the elongate tube such that the position of the first end of the elongate tube within the patient may be identified by a position on the emitted light surface of the patient. For example, fig. 5 is a schematic diagram of a system 500. System 500 may be identical or similar in structure and/or function to any of the systems or devices described herein (e.g., system 100 and/or system 300 described above). For example, system 500 includes inflation assembly 510 and tubular member 550. The inflation assembly 510 may include an elongate tube 512 and an inflatable member 514. The elongate tube 512 may have a first end 511 and a second end 513. In some embodiments, the elongate tube 512 may have a length sufficient to extend from at least the mouth or nostrils of the patient to the trachea of the patient. The inflatable member 514 and the magnetic member 515 may be coupled to the elongate tube 512 near the first end 511 of the elongate tube 512. The inflation assembly 510 includes an inflation lumen 516, the inflation lumen 516 being defined by the elongate tube 512 and being in fluid communication with the inflatable member 514. The tubular member 550 may have a first end 551 and a second end 553 opposite the first end 551. The tubular member 550 may define a lumen extending from the first end 551 to the second end 553, and may include an inflatable member 552, the inflatable member 552 configured to extend from an outer surface of the tubular member 550 near the first end 551 and couple to an inner surface of a tracheal wall of a patient.

As shown in fig. 5, the light source 518 may be disposed on or near the first end 511 of the elongate tube 512. The light source may generate sufficient light such that light may be emitted from the light source through the tracheal wall to the surface of the anterior neck a and be visible to a user (e.g., a clinician). Accordingly, a user may be able to determine the position of the first end 511 of the elongate tube 512 based at least in part on the position of light emitted through the front neck a of the patient P. The light source 518 may be, for example, a Light Emitting Diode (LED).

In some embodiments, as discussed above with respect to fig. 1, the inflation assembly may include a blocking member to prevent the needle from penetrating the patient's posterior tracheal wall. For example, fig. 6 is a schematic diagram of a system 600. System 600 may be identical or similar in structure and/or function to any of the systems or devices described herein (e.g., system 100 and/or system 300 described above). For example, the system 600 includes an inflation assembly 660. The system 600 also includes an external magnetic assembly 640, an ultrasound probe 660, and a needle 630. The inflation assembly 610 may include an elongate tube 612 and an inflatable member 614. The elongate tube 612 may have a first end 611 and a second end (not shown). In some embodiments, the elongate tube 612 may have a length sufficient to extend from at least the mouth or nostrils of the patient to the trachea of the patient. The inflatable member 614 and the magnetic member 615 may be coupled to the elongate tube 612 near the first end 611 of the elongate tube 612. The inflation assembly 610 includes an inflation lumen defined by an elongate tube 612 and in fluid communication with an inflatable member 614.

As shown in fig. 6, the blocking member 695 may be coupled to or form a portion of a sidewall of the inflatable member 614. The blocking member 695 may be identical or similar in structure and/or function to the blocking member 195 described above with respect to FIG. 1. For example, the blocking member 195 may have a shape that corresponds to the shape of the outer surface of the inflatable member 614. The blocking member 195 may be configured to be disposed between a portion of the inflatable member 614 intended to be pierced by the needle 630 and the tracheal posterior wall of the patient P. Furthermore, as shown in fig. 6, the blocking member 695 may be sufficiently resistant to puncture and/or tearing such that if the force exerted by the needle 630 against the blocking member 695 is greater than the magnetic attraction exerted by the external magnetic assembly 640 (e.g., through the anterior neck a and tracheal wall of the patient P) on the magnetic member 615 of the inflation assembly 610, the needle 630 may urge the blocking member 695 toward the posterior tracheal wall of the patient P and thereby urge the magnetic member 615 away from the anterior tracheal wall of the patient P, rather than the needle 630 piercing the blocking member 695 and/or passing through the blocking member 695. Thus, when the needle 630 is urged against the blocking member 695 while the external magnetic assembly urges the magnetic member 615 toward the front neck portion a via magnetic attraction, there may be a gap G between the outer surface of the inflatable member 614 and the inner surface of the tracheal anterior wall of the patient P. Upon removal or reduction of the force exerted by needle 630 on blocking member 695 in the rearward direction, magnetic member 615 may be urged again toward the anterior wall of the trachea due to the magnetic attraction of external magnetic assembly 640.

In some embodiments, the blocking member 695 may be disposed inside the inflatable member 614 and coupled to an inner surface of a sidewall of the inflatable member 614. In some embodiments, the blocking member 695 may be disposed outside of the inflatable member 614 and coupled to an outer surface of a sidewall of the inflatable member 614. In some embodiments, the inflatable member 614 may be partially formed by a blocking member 695. For example, the inflatable member 614 may include a first sidewall portion and a second sidewall portion opposite the first sidewall portion. The first sidewall portion may be configured to receive the needle 630 therethrough, and the second sidewall portion may be configured to be more resistant to penetration by the needle 630 than the first sidewall portion. For example, the second sidewall portion may have a greater thickness and/or a greater stiffness than the first sidewall portion.

Additionally, in some embodiments, the blocking member 695 may have increased echogenicity such that the blocking member 695 may be more easily visualized via ultrasound waves than other portions of the inflation assembly 610 (e.g., the inflatable member 614 and/or an interior of the inflatable member 614) and/or surrounding portions of the patient P. Due to the increased echogenicity, the user may be able to identify the position of the blocking member 695 via ultrasound imaging and interrupt the translation of the needle 630 before the needle reaches the blocking member 695 or before the needle passes the blocking member 695, such that it may be possible to prevent the needle 630 from advancing too far relative to the inflatable member 614 and/or the patient's trachea and prevent the needle 630 from damaging the patient's posterior tracheal wall.

In some embodiments, the blocking member 695 may be formed of any suitable material having increased puncture resistance to a needle (e.g., needle 630) used to pierce patient tissue and/or increased echogenicity. For example, the blocking member 695 may be formed of a polymer or metal composite. In some embodiments, the blocking member 695 may comprise a thickened or reinforced portion of the sidewall of the inflatable member 614. The blocking member 695 can have a hardness (e.g., scratch hardness and/or indentation hardness) that is increased relative to the hardness of the inflatable member 614 or the rest of the inflatable member 614.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where the above-described methods indicate certain events occurring in a certain order, the order in which certain events occur may be modified. Additionally, some of these events may be performed concurrently in a parallel process where possible and sequentially as described above.

Where the above-described schematic diagrams and/or embodiments indicate certain components arranged in certain orientations or positions, the arrangement of the components may be modified. While embodiments have been particularly shown and described, it will be understood that various changes in form and detail may be made. Any portions 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, features and/or properties of the different embodiments described.