Patent Description:
Embodiments described herein relate to systems, apparatus, and methods for delivering a medical device beyond a bifurcation in a body lumen. For example, embodiments described herein relate to systems, apparatus, and methods for translating a tube through an esophagus of the patient to a stomach of the patient.

Delivering a medical device to a location within a patient may include guiding the medical device through a bifurcated body lumen. Such procedures are sometimes performed blindly, risking misplacement of the medical device within the patient's body and/or injury to the patient's body. Furthermore, delivery of a medical device through a lumen of a patient can be even more difficult in high risk patients (e.g., sedated patients, endotracheally-intubated patients, and/or agitated patients). Additionally, while the position of a medical device within the patient can be confirmed via X-ray imaging, X-ray imaging carries the risk of radiation-induced injuries.

Thus, there is a need for systems, apparatus, and methods of delivering a medical device beyond a bifurcation in a body lumen which reduce risks to the patient and allow for the medical device to be quickly and easily placed in its intended location. <CIT> discloses a medical tube for insertion into the body of a patient. The medical tube includes a tube or device suitable for insertion into the patient's body, and a permanent magnet associated therewith. The magnet may be solid or non-solid, and may be rigid or non-rigid. In one embodiment, the magnet is hollow and associated with the medical tube such that the tube may be used for its intended purposes. In another embodiment, the magnet is solid and, after insertion into the body of the patient, is displaced such that it does not interfere with the intended use of the medical tube. In a further embodiment, the magnet is removable after placement of the medical tube.

Systems, apparatus, and methods for placing an elongated tube within a patient's body are described herein. The invention is defined by the appended claims and discloses an apparatus comprising an elongated tube, a magnetic tip, and an inflatable member. The elongated tube has a first end and a second end, and defines a first lumen and a second lumen. The first lumen extends from the first end to the second end. The magnetic tip is coupled to the first end of the elongated tube. The magnetic tip is tapered toward a distal end of the magnetic tip. An inflatable member is disposed within the elongated tube proximal of the tapered magnetic tip and fluidically coupled to the second lumen such that the inflatable member can receive fluid via the second lumen.

According to the invention, an apparatus includes an elongated tube, a magnetic tip, and an inflatable member. The elongated tube has a first end and a second end, and defines a first lumen and a second lumen. The first lumen extends from the first end to the second end. The magnetic tip is coupled to the first end of the elongated tube. The magnetic tip is tapered toward a distal end of the magnet tip. An inflatable member is disposed within the elongated tube proximal of the tapered magnetic tip and fluidically coupled to the second lumen such that the inflatable member can receive fluid via the second lumen.

In some embodiments, a system includes a magnetically responsive assembly and a magnetic member. The magnetically responsive assembly can include an elongated tube having a first end and a second end. The elongated tube can define a first lumen and a second lumen. The first lumen can extend from the first end to the second end. A magnetic tip generating a magnetic field can be coupled to the first end of the elongated tube. The magnetic tip can be tapered toward a distal end of the magnetic tip. The inflatable member can be disposed within the elongated tube proximal of the magnetic tip and fluidically coupled to the second lumen such that the inflatable member can receive fluid via the second lumen. The magnetic member can be configured to be disposed adjacent a surface of a patient and to apply a magnetic field such that, as the magnetic tip of the magnetically responsive assembly is translated through a first passageway toward an internal junction of the patient in which the first passageway, a second passageway, and a third passageway intersect, a magnetic force produced by the interaction of the magnetic field of the magnetic member and a magnetic field of the magnetic tip can urge the position of the magnetic tip to align the magnetic tip with the second passageway.

In some embodiments, a method includes introducing a magnetic tip of an elongated tube into an oropharynx region of a patient via one of a nasal cavity or an oral cavity of the patient. The magnetic tip can be tapered toward a distal end of the magnet tip. An external magnetic member can be applied to an external surface of the patient at a location corresponding to an internal junction of a hypopharynx of the patient and a larynx of the patient such that the external magnetic member applies a magnetic field to the internal junction. The magnetic tip can be translated through the hypopharynx, the magnetic field of the external magnetic member urging the magnetic tip toward a posterior wall of the hypopharynx as the magnetic tip is translated through the hypopharynx. The magnetic tip can be advanced through an esophagus of the patient to the stomach of the patient.

In some embodiments, a method includes disposing an external magnetic member on an external surface of a patient at a location corresponding to an internal junction of a first passageway, a second passageway, and a third passageway of the patient such that a first pole of the external magnetic member is oriented toward the external surface of the patient and a second pole of the external magnetic member is oriented away from the first pole such that the external magnetic member applies a magnetic field to the internal junction. The second pole can have an opposite polarity to the first pole. A magnetic tip of an elongated tube can be translated through an orifice of the patient, through the first passageway, through the internal junction, and into the second passageway, the magnetic tip being tapered toward a distal end of the magnet tip, the magnetic tip having a first pole oriented toward the external magnetic member and a second pole oriented away from the external magnetic member such that, as the magnetic tip is translated through the first passageway and the internal junction, the interaction of the first pole of the external magnetic member and the first pole of the magnetic tip shifts the magnetic tip into alignment with the second passageway.

Systems, apparatus, and methods described herein include the delivery of a medical device to locations within a patient's body. The medical device may include, for example, a tube such as a gastrostomy tube, a nasogastric tube, and/or a nasojejunal tube. The medical device may need to navigate or be guided beyond a bifurcation in a body lumen of the patient's body such that the medical device is advanced through an intended passageway and avoids an unintended route. Bifurcated body lumens may be encountered, for example, when a medical device is delivered to a patient's esophagus, stomach, trachea, or a particular lung.

For example, an end of a tube may be delivered to a patient's stomach such that fluids can be delivered to the patient's stomach through the tube. <FIG> is a schematic illustration of a portion of a patient P. The patient P has an oral cavity Y, a nasal cavity C, a pharynx X. The patient P includes a nasal orifice N that provides access to the nasal cavity C and an oral orifice O that provides access to the oral cavity Y. The pharynx X includes a nasopharynx A, an oropharynx R, and a hypopharynx H. The patient P includes a junction J at which the pharynx X is coupled to a larynx L and an esophagus E. Specifically, the hypopharynx H is coupled to the larynx L at the junction J. The larynx L is connected to the trachea T. The patient P includes an epiglottis I, which is a flap of cartilage at the root of the tongue U of the patient P, which is depressed during swallowing to cover the opening to the larynx L. The larynx L also includes a glottis G, which is a slit-like opening between vocal cords of the patient P. Thus, a first pathway can include the nasal orifice N and nasal cavity C (or the oral orifice O and oral cavity Y), the nasopharynx A, the oropharynx R, and a first portion of the hypopharynx H. A second pathway can include a second portion of the hypopharynx H and the esophagus E. A third pathway can include the trachea T.

When a patient has difficulty swallowing food and/or liquid, a tube (e.g., a nasogastric tube) can be placed via an oral or nasal orifice and an esophagus of the patient such that nutrition can be provided directly through the tube to the stomach. <FIG> is a schematic illustration of a patient P having a nasal orifice N, a nasal cavity C, a pharynx X, an esophagus E, and a stomach S. As shown in <FIG>, an elongated tube <NUM> (e.g., a nasogastric tube) can be inserted through the nasal orifice N, through the nasal cavity C, through the pharynx X, through the esophagus E and into the stomach S. Thus, the elongated tube <NUM> can have a first end <NUM> disposed within the stomach and a second end <NUM> disposed outside of the patient P, with the elongated tube <NUM> passing through the patient's nasal orifice N. While the elongated tube <NUM> is shown as being disposed within the patient's nasal orifice N and nasal cavity C, in some embodiments the elongated tube <NUM> can be inserted via an oral orifice O of the patient, into the patient's oral cavity Y, into the pharynx X, through the esophagus E, and into the stomach S. Thus, the stomach S can be accessible from the nasal orifice N or the oral orifice O via the pharynx X and esophagus E.

Navigation of the elongated tube through the patient, however, can be challenging and pose risks to the patient. If the elongated tube is misplaced within the patient's body, such as within a patient's larynx, the elongated tube can injure the patient. For example, the elongated tube can cause pulmonary damage, pneumothorax, and/or hemodynamic collapse. In some embodiments, however, an elongated tube can include features to aid in navigating the first end of the elongated tube to the stomach of the patient. For example, <FIG> is a schematic representation of a system <NUM>. The system <NUM> includes an assembly <NUM>. The assembly <NUM> includes an elongated tube <NUM>, a magnetic feature <NUM>, and an echogenic member <NUM>. The elongated tube <NUM> can have a first end <NUM>, a second end <NUM>, and can define a feeding lumen <NUM>. In some embodiments, the system can optionally include an external magnetic member <NUM>.

In some embodiments, the first end <NUM> of the elongated tube <NUM> can be open such that fluid can flow through the second end <NUM>, through the feeding lumen <NUM>, through the first end <NUM>, and into the stomach. In some embodiments, the elongated tube <NUM> can define a number of fenestrations in a sidewall of the elongated tube <NUM> near the first end <NUM> such that fluid can flow through the second end <NUM>, through the feeding lumen <NUM>, out of the fenestrations, and into the stomach. In some embodiments, a cap or cover can be coupled to the first end <NUM> such that fluid communication between the feeding lumen <NUM> and the stomach is only via the one or more side openings. In some embodiments, the second end <NUM> is coupled to and/or includes a sump or feeding port.

In some embodiments, the magnetic feature <NUM> can include a magnetic tip of the elongated tube <NUM>. The magnetic feature <NUM> can be configured to apply a magnetic field to at least a portion of the patient's body. The magnetic tip can be coupled to the first end <NUM> of the elongated tube <NUM> and extend axially away from the first end <NUM> of the elongated tube <NUM>. In some embodiments, the magnetic tip can have a first end opposite a second end, the second end can be coupled to the first end <NUM> of the elongated tube <NUM>, and the magnetic tip can be tapered toward a first end of the magnetic tip. In some embodiments, the magnetic tip can be spatula-shaped. For example, the magnetic tip can include oppositely-disposed sidewalls and a bottom surface, the sidewalls tapered toward the bottom surface (e.g., relative to an axis coaxial with the first end <NUM> of the elongated tube <NUM>). In some embodiments, the oppositely-disposed sidewalls can each additionally or alternatively include at least a portion extending diagonally relative to (e.g., tapering toward) the axis coaxial with the first end <NUM> of the elongated tube <NUM>. For example, the magnetic tip can include a distal end having a straight edge disposed perpendicular to the coaxial axis, and the sidewalls of the magnetic tip can including portions that extend parallel to the coaxial axis and portions that taper diagonally from the parallel-extending portions to the straight edge. In some embodiments, the distal end of the magnetic tip may be curved from a first sidewall of the oppositely-disposed sidewalls to a second sidewall of the oppositely-disposed sidewalls.

In some embodiments, the magnetic tip can include an opening such that the feeding lumen <NUM> can be in fluidic communication with the stomach via the opening in the magnetic tip when the first end <NUM> of the elongated tube <NUM> is disposed within the stomach. In some embodiments, the magnetic tip can include a cap coupled to the first end <NUM> of the elongated tube <NUM>, one or more magnetic components disposed within the cap. In some embodiments, the magnetic feature <NUM> can include one or more magnetic components disposed within the elongated tube <NUM>. For example, the elongated tube <NUM> can include an end cap coupled to the first end <NUM>, and one or more magnetic components can be enclosed within the end cap and/or the elongated tube <NUM>. For example, in some embodiments, one or more spherical magnetic components (e.g., one, two, three, four, or more) can be disposed within the elongated tube <NUM> and/or an end cap coupled to the first end <NUM> of the elongated tube <NUM>.

In some embodiments, rather than including a tapered or spatula-shaped magnetic tip as described above, a non-magnetic tapered or spatula-shaped tip can be coupled to the first end <NUM> of the elongated tube <NUM> and a magnetic feature can be disposed on and/or within the elongated tube <NUM>.

In some embodiments, the magnetic feature <NUM> (e.g., a magnetic tip) can be formed of any suitable type of magnet. For example, the magnetic feature <NUM> can 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 magnetic feature <NUM> can include a temporary magnet. In some embodiments, the magnetic feature <NUM> can be an electromagnet, such as a solenoid. In some embodiments, the magnetic feature <NUM> can generate a magnetic field having an orientation (i.e., north (N) and south (S) poles). In other embodiments, the magnetic feature <NUM> can be formed of 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 magnetic feature <NUM> can be formed of iron, and application of an external magnetic field can attract the iron toward the source of the field, applying a force to the magnetic feature <NUM>.

The echogenic member <NUM> is configured to be visualized via ultrasound such that the location of the echogenic member <NUM> (and, thus, the first end <NUM> of the elongated tube <NUM>) within a patient can be verified. In some embodiments, the echogenic member <NUM> can be an inflatable member, such as an inflatable balloon. The system <NUM> can include an inflation lumen (not shown). In some embodiments, the inflation lumen can be separate from the elongated tube <NUM>. In some embodiments, the inflation lumen can be defined by the elongated tube <NUM>. For example, a central axis of the inflation lumen can extend parallel to a central axis of the feeding lumen <NUM>. In some embodiments, the inflation lumen can include an inflation port on an end opposite the echogenic member <NUM>. In some embodiments, the echogenic member <NUM> can be disposed on the elongated tube <NUM> such that the echogenic member <NUM> surrounds the elongated tube <NUM>. In some embodiments, the echogenic member <NUM> can extend laterally from a side of the elongated tube <NUM> such that echogenic member extends asymmetrically relative to a central axis of the elongated tube <NUM>. In some embodiments, the echogenic member <NUM> is configured to transition between an uninflated configuration and an inflated configuration (e.g., due to echogenic fluid being introduced into an interior of the echogenic member <NUM>), the echogenic member <NUM> extending to a greater lateral extent relative to a centerline of the elongated tube <NUM> in the inflated configuration. In some embodiments, the echogenic member <NUM> does not extend beyond an outer surface of the elongated tube <NUM> such that the assembly <NUM> has a smooth outer profile with a substantially continuous outer diameter through the portions including the elongated tube <NUM> and the echogenic member <NUM>. In some embodiments, rather than having a separate echogenic member <NUM>, a portion of the elongated tube <NUM>, a cap coupled to the first end <NUM> of the elongated tube <NUM>, and/or the magnetic feature <NUM> can have echogenic properties such that the assembly <NUM> can be visualized using ultrasound.

The external magnetic member <NUM> can include any suitable magnet configured to apply a magnetic field to at least a portion of a patient's body that can interact with the magnetic field generated by the magnetic feature <NUM> to generate a force on the magnetic feature <NUM>. The external magnetic member <NUM> can include, for example, 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 magnetic feature <NUM> can be an electromagnet, such as a solenoid. In some embodiments, the magnetic feature <NUM> can generate a magnetic field having an orientation (i.e., north (N) and south (S) poles). In some embodiments, the external magnetic member <NUM> can be disposed within a strap assembly (not shown). The strap assembly can be configured to secure the external magnetic member <NUM> to a patient's body (e.g., a patient's neck).

In some embodiments, the external magnetic member <NUM> can be configured to be disposed on the surface of a patient's skin and can apply a magnetic field to at least a portion of a patient's body that can interact with the magnetic field generated by the magnetic feature <NUM> through various body tissue and organs disposed between the external magnetic member <NUM> on the surface of the patient's skin the magnetic feature <NUM> within the patient's body and across any suitable distance (e.g., about <NUM>, about <NUM>, and/or about <NUM>). For example, the external magnetic member <NUM> can be configured to be disposed on an anterior and/or posterior portion of a patient's neck. The interaction between the magnetic field generated by the external magnetic member <NUM> and the magnetic field generated by the magnetic feature <NUM> can produce a magnetic force that urges the position of the magnetic feature <NUM> in a direction toward or away from the external magnetic member <NUM>, and thus also urges the first end <NUM> of the elongated tube <NUM> relative to the external magnetic member <NUM>. In some embodiments, the external magnetic member <NUM> can have a first side and a second side, the second side disposed opposite of the first side. The external magnetic member <NUM> can have a first pole oriented in the direction the first side faces and a second pole oriented in the direction the second side faces, the first pole having an opposite polarity to the second pole. In some embodiments, the external magnetic member <NUM> can be configured to attract the magnetic feature <NUM> toward the external magnetic member <NUM> (e.g., if the external magnetic member <NUM> is disposed near the magnetic feature <NUM> with a first pole applying a magnetic force to the magnetic feature <NUM> of an opposite polarity as the magnetic feature <NUM> facing the external magnetic member <NUM>). In some embodiments, the external magnetic member <NUM> can be configured to repel the magnetic feature <NUM> away from the external magnetic member <NUM> (e.g., if the external magnetic member <NUM> is disposed near the magnetic feature <NUM> with a first pole applying a magnetic force to the magnetic feature <NUM> of the same polarity as the magnetic feature <NUM> facing the external magnetic member <NUM>). In some embodiments, the magnetic feature <NUM> (e.g., a magnetic tip) can be oriented such that the magnetic feature <NUM> can apply a force (e.g., a magnetic force) in a first direction lateral to a central axis of the elongated tube <NUM>, and the external magnetic member <NUM> can be oppositely polarized and disposed a distance from the magnetic feature <NUM> along the first direction such that the magnetic tip is moved in a second direction opposite the first direction. In some embodiments, the external magnetic member <NUM> can be arranged in a first configuration relative to the magnetic feature <NUM> (e.g., near a first side of the magnetic feature <NUM>) such that the a first pole (e.g., N) of the external magnetic member <NUM> faces a pole of the magnetic feature <NUM> having the same polarity and, thus, applies a repulsive force to the magnetic feature <NUM>. The external magnetic member <NUM> can be arranged in a second configuration relative to the magnetic feature <NUM> (e.g., near a second side opposite the first side) such that the first pole of the external magnetic member <NUM> faces a pole of the magnetic feature <NUM> having an opposite polarity (e.g., S), and thus, applies an attractive force to the magnetic feature <NUM>.

<FIG> illustrate a system <NUM> and a method of using the system <NUM> to navigate an internal junction of a patient. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein, such as the system <NUM>. For example, as shown in <FIG>, the system <NUM> includes a magnetically responsive assembly <NUM> and an external magnetic member <NUM>. The assembly <NUM> includes an elongated tube <NUM> (e.g., a nasogastric tube), a magnetic tip <NUM>, and an echogenic member <NUM>. Each of the external magnetic member <NUM> and the magnetic tip <NUM> can be configured to apply a magnetic field to at least a portion of the patient's body. The elongated tube <NUM> can include a first end <NUM>, a second end opposite the first end <NUM>, and a feeding lumen. As shown, the magnetic tip <NUM> can be coupled to the first end <NUM> of the elongated tube <NUM> and can be tapered. For example, the magnetic tip <NUM> can have a first end <NUM> opposite a second end <NUM>. The second end <NUM> of the magnetic tip <NUM> can be coupled to the first end <NUM> of the elongated tube <NUM>, and the magnetic tip <NUM> can be tapered toward a first end <NUM> of the magnetic tip <NUM>. In some embodiments, the magnetic tip <NUM> can be spatula-shaped. For example, the magnetic tip <NUM> can include oppositely-disposed sidewalls and a bottom surface, the sidewalls tapered toward the bottom surface (e.g., relative to an axis coaxial with a central axis of the first end <NUM> of the elongated tube <NUM>). In some embodiments, the oppositely-disposed sidewalls can each additionally or alternatively include at least a portion extending diagonally relative to (e.g., tapering toward) the axis coaxial with the first end <NUM> of the elongated tube <NUM>. For example, the magnetic tip <NUM> can include a distal end having a straight edge disposed perpendicular to the coaxial axis, and the sidewalls of the magnetic tip <NUM> can including portions that extend parallel to the coaxial axis and portions that taper diagonally from the parallel-extending portions to the straight edge. In some embodiments, the distal end of the magnetic tip may be curved from a first sidewall of the oppositely-disposed sidewalls to a second sidewall of the oppositely-disposed sidewalls. In some embodiments, the magnetic tip <NUM> can include an opening such that the feeding lumen can be in fluidic communication with the stomach via the opening in the magnetic tip <NUM> when the first end <NUM> of the elongated tube <NUM> is disposed within the stomach. The system <NUM> can also include an inflation lumen <NUM> such that the echogenic member <NUM> can be filled with echogenic fluid via the inflation lumen <NUM>.

As shown in <FIG>, the assembly <NUM> can be disposed within a first passageway P1 of a patient. The first passageway P1 can be, for example, at least a portion of a pharynx of the patient. The assembly <NUM> can be translated into the first passageway P1 of the patient via, for example, an oral orifice or nasal orifice of the patient. The external magnetic member <NUM> can be disposed on a surface of the patient (e.g., on the patient's skin) near an internal junction J of the patient. The first passageway P1 can be coupled to a second passageway P2 and a third passageway P3 at the internal junction J such that the internal junction J forms the intersection of the first passageway P1, the second passageway P2, and the third passageway P3. The second passageway P2 can be, for example, a larynx of the patient. The third passageway P3 can be, for example, an esophagus of the patient. In some embodiments, the first passageway P1 can be a first portion of a hypopharynx of the patient, the second passageway P2 can be a second portion of the hypopharynx, the second portion of the hypopharynx coupled to an esophagus of the patient, and the third portion P3 can be a larynx of the patient.

The external magnetic member <NUM> can be aligned with the internal junction J and/or with a portion of the first passageway P1 near the internal junction J. In some embodiments, the external magnetic member <NUM> and the magnetic tip <NUM> can be arranged in the same plane as a central axis of the first passageway P1, a central axis of the second passageway P2, and a central axis of the third passageway P3. In some embodiments, the external magnetic member <NUM> has a first pole oriented toward the surface of the patient and a second pole oriented away from the first pole, the second pole having an opposite polarity to the first pole.

As shown in <FIG>, the assembly <NUM> can be translated toward the internal junction J. The external magnetic member <NUM> can be configured and disposed such that, as the magnetic tip <NUM> is translated through the first passageway P1 toward the internal junction J, the external magnetic member <NUM> can apply a magnetic field to the magnetic tip <NUM> to urge or shift the position of the magnetic tip <NUM> into alignment with the second passageway. Specifically, a magnetic force can be produced by the interaction of the magnetic field generated by the external magnetic member <NUM> and the magnetic field generated by the magnetic tip <NUM> that can urge or shift the position of the magnetic tip <NUM>. The magnetic tip <NUM> can have a first pole oriented toward the external magnetic member <NUM> and a second pole oriented away from the external magnetic member <NUM> such that, as the magnetic tip <NUM> is translated through the first passageway P1 and the internal junction J, the interaction of the first pole of the external magnetic member <NUM> and the first pole of the magnetic tip <NUM> shifts the magnetic tip into alignment with the second passageway P2. In some embodiments, the first pole of the magnetic tip <NUM> has the same polarity as the first pole of the external magnetic member <NUM> such that the magnetic tip <NUM> is repelled toward a wall W of the first passageway P1 by the external magnetic member <NUM> as the magnetic tip <NUM> is translated through the first passageway P1 and the second passageway P2. For example, as shown in <FIG>, the magnetic tip <NUM> can be urged against the wall W of the first passageway P1, the wall W disposed opposite the position of the external magnetic member <NUM>. In some embodiments, the external magnetic member <NUM> can be configured to maintain the magnetic tip <NUM> in contact with a posterior hypopharynx wall of the patient as the magnetic tip <NUM> is translated through the hypopharynx and into the esophagus of the patient.

As shown in <FIG>, with the magnetic tip <NUM> aligned with the second passageway P2, the assembly <NUM> can be further translated relative to the internal junction J such that the magnetic tip <NUM> and/or the first end <NUM> of the assembly <NUM> is disposed within the second passageway P2. In some embodiments, the tapered shape of the magnetic tip <NUM> can assist in ensuring that the magnetic tip <NUM> is translated into the second passageway P2 rather than the third passageway P3. For example, if the magnetic tip <NUM> and the second passageway P2 are only partially aligned by the interaction between the external magnetic member <NUM> and the magnetic tip <NUM> prior to advancing the assembly <NUM> past the internal junction J, if the distal-most end (e.g., the portion of the magnetic tip <NUM> having the greatest length) is aligned with the second passageway P2 side of the internal junction J, the assembly <NUM> can be translated into the second passageway P2 by advancing the assembly <NUM> such that the tapered portion of the magnetic tip <NUM> engages a sidewall of the second passageway P2 and the translation of the magnetic tip <NUM> relative to the sidewall urges the magnetic tip <NUM> and the first end <NUM> of the elongated tube <NUM> into the second passageway P2.

As shown in <FIG>, an ultrasound probe <NUM> can be used to verify the location of the first end <NUM> of the assembly <NUM> within the patient. Specifically, the ultrasound probe <NUM> can be used to verify that the assembly <NUM> is disposed in an intended passageway (e.g., the second passageway P2) rather than an unintended passageway (e.g., the third passageway P3). As shown in <FIG>, after advancing the first end <NUM> of the elongated tube <NUM> relative to the internal junction J, the ultrasound probe <NUM> can be applied to the surface of the patient such that the location of the echogenic member <NUM> can be identified. In some embodiments, fluid can be delivered to the echogenic member <NUM> via the inflation lumen <NUM> such that the echogenic member <NUM> can be visualized via the ultrasound probe <NUM>. If the echogenic member <NUM> is verified as being disposed within the intended passageway (e.g., the second passageway P2), the first end <NUM> of the elongated tube <NUM> can be further advanced (e.g., through the esophagus and into the stomach of the patient). If the echogenic member <NUM> is visualized as being in an unintended passageway (e.g., the third passageway P3), the assembly <NUM> can be withdrawn such that the magnetic tip <NUM> and the first end <NUM> of the elongated tube <NUM> are disposed in the first passageway P1. In some embodiments, fluid can be removed from the echogenic member <NUM> prior to withdrawing the magnetic tip <NUM> and the first end <NUM> of the elongated tube <NUM>. The external magnetic member <NUM> and the magnetic tip <NUM> can then be manipulated (e.g., via moving the external magnetic member <NUM> and/or the magnetic tip <NUM>) to realign the magnetic tip <NUM> with the intended passageway (e.g. the second passageway). The assembly <NUM> can then be advanced again relative to the internal junction J (e.g., into the second passageway P2) and the position of the echogenic member <NUM> can be verified using the ultrasound probe <NUM> (e.g., fluid can be again introduced to the echogenic member <NUM> and viewed via the ultrasound probe <NUM>). If the echogenic member <NUM> is in the intended passageway (e.g., the second passageway P2), the first end <NUM> of the elongated tube <NUM> can be advanced (e.g., to the stomach). In some embodiments, the external magnetic member <NUM> and the magnetic tip <NUM> can be arranged such that a line passing through both the external magnetic member <NUM> and the magnetic tip <NUM> can intersect a central axis of the second passageway P2 and a central axis of the third passageway P3 when the magnetic tip is position in the second passageway P2.

Although the external magnetic member <NUM> is shown as being disposed on a side of the patient corresponding to the third passageway P3 (e.g., an anterior surface of the patient such as the front side of the patient's neck), in some embodiments, the external magnetic member <NUM> can be disposed on a side of the patient corresponding to the second passageway P2 (e.g., a posterior surface of the patient such as the back of the patient's neck). For example, as shown in <FIG>, which is an alternative arrangement of the system <NUM>, the external magnetic member <NUM> can be positioned on the side of the patient closer to the second passageway P2 than the third passageway P3 near the internal junction J. Thus, rather than repelling the magnetic tip <NUM> toward the posterior side of the first passageway P1, the external magnetic member <NUM> can attract the magnetic tip <NUM> toward the posterior side of the first passageway P1. For example, the external magnetic member <NUM> can be positioned on a surface of the patient (e.g., the skin) such that the second pole is oriented toward the magnetic tip <NUM> and the first pole is oriented away from the magnetic tip <NUM> and such that the magnetic tip <NUM> is attracted toward the second pole of the external magnetic member <NUM>.

<FIG> illustrate a portion of a system <NUM> and a method of using the system <NUM> to navigate an internal junction of a patient. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein, such as the system <NUM> and/or the system <NUM>. For example, as shown in <FIG> and <FIG>, the system <NUM> includes a magnetically responsive assembly <NUM>. <FIG> and <FIG> are a schematic illustration of a side view and a top view, respectively, of the magnetically responsive assembly <NUM>. The assembly <NUM> includes an elongated tube <NUM>, a magnetic tip <NUM>, and an echogenic member <NUM>. The elongated tube <NUM> can include a first end <NUM> and a second end (not shown) opposite the first end <NUM>. The elongated tube <NUM> can define a feeding lumen. The elongated tube <NUM> can define a number of fenestrations <NUM> such that the feeding lumen of the elongated tube <NUM> can be in fluid communication with a stomach of the patient via the fenestrations <NUM>. The feeding lumen can extend from the second end to the fenestrations <NUM> and/or the first end <NUM>. Although <FIG> shows the elongated tube <NUM> as defining three fenestrations <NUM>, the elongated tube <NUM> can define any suitable number of fenestrations. The system <NUM> can include an inflation lumen <NUM> such that the echogenic member <NUM> can be filled with echogenic fluid via the inflation lumen <NUM>.

As shown in <FIG> and <FIG>, the magnetic tip <NUM> can be coupled to a first end <NUM> of the elongated tube <NUM> and can be tapered. For example, the magnetic tip <NUM> can have a first end <NUM> opposite a second end <NUM>. The second end <NUM> of the magnetic tip <NUM> can be coupled to the first end <NUM> of the elongated tube <NUM>, and the magnetic tip <NUM> can be tapered toward a first end <NUM> of the magnetic tip <NUM>. In some embodiments, the magnetic tip <NUM> can be spatula-shaped. For example, the magnetic tip <NUM> can include oppositely-disposed sidewalls and a bottom surface, the sidewalls tapered toward the bottom surface (e.g., relative to an axis coaxial with a central axis of the first end <NUM> of the elongated tube <NUM>). In some embodiments, the oppositely-disposed sidewalls can each additionally or alternatively include at least a portion extending diagonally relative to (e.g., tapering toward) the central axis of the first end <NUM> of the elongated tube <NUM>. For example, the second end <NUM> of the magnetic tip <NUM> can include a straight edge disposed perpendicular to the central axis, and the sidewalls of the magnetic tip <NUM> can including portions that extend parallel to the central axis and portions that taper diagonally from the parallel-extending portions to the straight edge. In some embodiments, the second end <NUM> of the magnetic tip may be curved from a first sidewall of the oppositely-disposed sidewalls to a second sidewall of the oppositely-disposed sidewalls. Additionally, as shown in <FIG>, the magnetic tip <NUM> can have a first side <NUM> and a second side <NUM>, the first side <NUM> having an opposite polarity from the second side <NUM>. In some embodiments, the magnetic tip <NUM> can include an opening such that the feeding lumen of the elongated tube <NUM> can be in fluidic communication with the stomach via the opening in the magnetic tip <NUM> when the first end <NUM> of the elongated tube <NUM> is disposed within the stomach. The magnetic tip <NUM> can be configured to apply a magnetic field to at least a portion of the patient's body.

As shown in <FIG>, a portion of the assembly <NUM> can be disposed within a superior portion of the oropharynx R of a patient. The first end <NUM> of the assembly <NUM> can be translated into the superior portion of the oropharynx R of the patient via, for example, an oral orifice or nasal orifice of the patient. An external magnetic member <NUM>, which can be the same or similar in structure and/or function to any of the external magnetic members described herein, can be disposed on a surface of the patient (e.g., on the patient's skin) near an internal junction J of the patient. For example, the external magnetic member <NUM> can be configured to apply a magnetic field to at least a portion of the patient's body. The trachea can be coupled to the superior portion of the oropharynx R via the glottis G. Similarly, the esophagus E can be coupled to the superior portion of the oropharynx R, for example, via an inferior portion of the oropharynx R.

As shown in <FIG>, the external magnetic member <NUM> can be aligned with the internal junction J and/or with a portion of the oropharynx R near the internal junction J. The external magnetic member <NUM> can have a first side <NUM> having a first pole and a second side <NUM> opposite the first side <NUM> having a second pole. Similarly, the magnetic tip <NUM> can have a first side <NUM> having a first pole and a second side <NUM> opposite the first side having a second pole. The first pole of the first side <NUM> of the external magnetic member <NUM> and the first pole of the first side <NUM> of the magnetic tip <NUM> can be the same polarity such that the external magnetic member <NUM> repels the magnetic tip <NUM> when the external magnetic member <NUM> and the magnetic tip <NUM> are arranged with the first side <NUM> of the magnetic tip <NUM> facing the first side <NUM> of the external magnetic member <NUM>. Thus, when the assembly <NUM> is disposed such that the magnetic tip <NUM> is disposed within the superior portion of the oropharynx R, the external magnetic member <NUM> can be arranged on the anterior portion of the patient's neck such that the interaction of the magnetic field of the external magnetic member <NUM> and the magnetic field of the magnetic tip <NUM> produces a magnetic force to the magnetic tip <NUM> (e.g., the external magnetic member <NUM> repels the first side <NUM> of the magnetic tip <NUM>), shifting the magnetic tip <NUM> and the first end <NUM> of the elongated tube <NUM> posteriorly. Although not shown, the external magnetic member <NUM> can alternatively be arranged on a posterior portion of the patient's neck with the first side <NUM> oriented toward the patient such that external magnetic member <NUM> attracts the second side <NUM> of the magnetic tip <NUM> posteriorly (the first side <NUM> of the external magnetic member <NUM> and the second side <NUM> of the magnetic tip <NUM> having opposite polarities).

With at least the distal-most end of the assembly <NUM> (e.g., the first end <NUM> of the magnetic tip <NUM>) aligned with the inferior portion of the oropharynx R and/or the esophagus E, the assembly <NUM> can be translated into the inferior portion of the oropharynx R. With the first end <NUM> of the magnetic tip <NUM> outside of the trachea T, as shown in <FIG>, further advancement of the assembly <NUM> will urge the assembly <NUM> toward the esophagus E rather than through the glottis G and into the trachea T due to the tapered shape of the magnetic tip <NUM>.

<FIG> is a schematic illustration of a cross-section of the patient taken along, for example, line A-A in <FIG> representing a cross-section of a patient at the junction of the patient's glottis G and trachea. As shown, the location of the assembly <NUM> can be verified relative to unintended pathways, such as a pathway including the patient's glottis G. As shown, the external magnetic member <NUM> can be disposed on a surface S of the patient while the location of the assembly <NUM> is verified using an ultrasound probe <NUM>. After advancing the first end <NUM> of the elongated tube <NUM> relative to the internal junction J, the ultrasound probe <NUM> can be applied to the surface of the patient such that the location of the echogenic member <NUM> can be identified. Fluid can be delivered the echogenic member <NUM> via the inflation lumen <NUM> such that the echogenic member <NUM> can be visualized via the ultrasound probe <NUM>. If the echogenic member <NUM> is verified as being disposed within the intended passageway (e.g., the inferior portion of the oropharynx R), the first end <NUM> of the elongated tube <NUM> can be further advanced (e.g., through the esophagus and into the stomach of the patient). If the echogenic member <NUM> is visualized as being in an unintended passageway (e.g., the trachea), the assembly <NUM> can be withdrawn such that the magnetic tip <NUM> and the first end <NUM> of the elongated tube <NUM> are disposed in the superior portion of the oropharynx R. The external magnetic member <NUM> and the magnetic tip <NUM> can then be manipulated (e.g., via moving the external magnetic member <NUM> and/or the magnetic tip <NUM>) to realign the magnetic tip <NUM> with the intended passageway (e.g. the inferior portion of the oropharynx R). The assembly <NUM> can then be advanced again relative to the internal junction J (e.g., into the second passageway P2) and the position of the echogenic member <NUM> can be verified using the ultrasound probe <NUM>. If the echogenic member <NUM> is in the intended passageway (e.g., the second passageway P2), the distal end <NUM> of the elongated tube <NUM> can be advanced (e.g., to the stomach).

In some embodiments, a system can include a distal subassembly coupled to a first end of an elongated tube, the distal subassembly including a magnetic feature. For example, <FIG> is an exploded perspective view of a distal subassembly <NUM>. The distal subassembly <NUM> can be coupled to the first end of any of the elongated tubes described herein. The distal subassembly <NUM> can include a tapered portion <NUM>, a cap <NUM>, and number of magnetic components <NUM>. For example, as shown, the distal subassembly <NUM> can include four spherical magnetic components <NUM>. In some embodiments, any suitable component of the distal subassembly <NUM> can be echogenic (e.g., be formed of an echogenic material or include an echogenic surface). For example, the tapered portion <NUM>, the magnetic components <NUM>, and/or the cap <NUM> can be echogenic. In some embodiments, the distal subassembly <NUM> can include an inflatable member which can be filled with echogenic fluid. In some embodiments, the spherical magnetic components <NUM> can be, for example, spherical <NUM>/<NUM>" N52 neodymium magnets.

The tapered portion <NUM> can have a first end <NUM> and a second end <NUM>. The second end <NUM> can be coupled to the first end of any of the elongated tubes described herein. The first end <NUM> can have a larger inner diameter and outer diameter than the inner diameter and outer diameter of the second end <NUM>. For example, the first end <NUM> can have an inner diameter larger than the outer diameter of the magnetic components <NUM>. The second end <NUM> can have an inner diameter smaller than the outer diameter of the magnetic components <NUM>. Thus, the magnetic components can be prevented from traveling through the second end <NUM> and into an elongated tube coupled to the second end <NUM> due to the elongated tube being of a larger diameter than the opening defined at the second end <NUM>. Additionally, the cap <NUM> can be coupled to the first end <NUM> such that the magnetic components <NUM> are enclosed within the cap <NUM> and/or the tapered portion <NUM>.

The distal subassembly <NUM> can be used the same or similarly to any of the magnetic features described herein, such as magnetic feature <NUM>, magnetic tip <NUM>, and/or magnetic tip <NUM>. For example, an external magnetic member (e.g., the external magnetic member <NUM>) can be used to shift or urge the magnetic components <NUM> (and, thus, the distal subassembly <NUM>) relative to various internal passageways of a patient. With the distal subassembly <NUM> aligned with an intended passageway (e.g. an inferior portion of an oropharynx), the distal subassembly <NUM> can be advanced into the intended passageway (e.g., via advancing an elongated tube such as any of the elongated tubes herein coupled to the distal subassembly <NUM>).

<FIG> is a perspective view of an external magnetic member <NUM> and a strap assembly <NUM>. The external magnetic member <NUM> can be the same or similar to any of the external magnetic members described herein. The strap assembly <NUM> can receive the external magnetic member <NUM> in a pouch of the strap assembly <NUM>. The external magnetic member <NUM> can be secured in the pouch of the strap assembly <NUM> using any suitable securement feature, such as, for example, a zipper or a hook-and-loop feature. In use, the strap assembly <NUM> can be coupled to a patient such that the external magnetic member <NUM> is held in place on the patient. For example, the strap assembly <NUM> can be coupled to a patient's neck such that the external magnetic member <NUM> is secured to an anterior skin portion or a posterior skin portion of the patient's neck. In some embodiments, the external magnetic member <NUM> can be, for example, a SuperMagnetMan <NUM>" by <NUM>" by <NUM>" N52 Magnetic Cube. In some embodiments, the strap assembly <NUM> can be, for example, an expandable sports belt.

<FIG> is a perspective view of a portion of an assembly <NUM>. The assembly <NUM> can be the same or similar in structure and/or function to any of the assemblies described herein. For example, the assembly <NUM> includes an elongated tube <NUM> and a distal subassembly <NUM>. The elongated tube <NUM> can have a first end <NUM>, a second end (not shown), and a feeding lumen <NUM>. The elongated tube <NUM> can define a fenestration <NUM> in a sidewall of the elongated tube <NUM> such that the feeding lumen <NUM> can be in fluid communication with, for example, a stomach of a patient, via the fenestration <NUM>. The distal subassembly <NUM> can include a tapered portion <NUM>, a cap <NUM>, and a number of magnetic components (not shown). For example, a number of spherical magnetic components can be enclosed within the tapered portion <NUM> and/or cap <NUM>. In some embodiments, the spherical magnetic components can be, for example, spherical <NUM>/<NUM>" N52 neodymium magnets. In some embodiments, any suitable member of the assembly <NUM> can be echogenic. For example, the tapered portion <NUM>, the magnetic components, and/or the cap <NUM> can be echogenic. In some embodiments, the assembly <NUM> can include an inflatable member which can be filled with echogenic fluid.

As shown, the tapered portion <NUM> can have a first end <NUM> and a second end <NUM>. The second end <NUM> can be coupled to the first end of any of the elongated tubes described herein. The first end <NUM> can have a larger inner diameter and outer diameter than the inner diameter and outer diameter of the second end <NUM>. For example, the first end <NUM> can have an inner diameter larger than the outer diameter of the magnetic components. The second end <NUM> can have an inner diameter smaller than the outer diameter of the magnetic components. Thus, the magnetic components can be prevented from traveling through the second end <NUM> and into the elongated tube <NUM> due to the magnetic components having a larger diameter than the opening defined at the second end <NUM>. Additionally, the cap <NUM> can be coupled to the first end <NUM> such that the magnetic components <NUM> are enclosed within the cap <NUM> and/or the tapered portion <NUM>. In some embodiments, the tapered portion <NUM> can be formed as a tube that tapers from a <NUM> Fr tube size at the first end <NUM> to a <NUM> Fr tube size at the second end <NUM>.

The distal subassembly <NUM> can be used the same or similarly to any of the magnetic features described herein, such as magnetic feature <NUM> and/or magnetic tip <NUM>. For example, an external magnetic member (e.g., the external magnetic member <NUM>) can be used to shift or urge the magnetic components <NUM> (and, thus, the distal subassembly <NUM>) relative to various internal passageways of a patient. With the distal subassembly <NUM> aligned with an intended passageway (e.g. an inferior portion of an oropharynx), the distal subassembly <NUM> can be advanced into the intended passageway (e.g., via advancing the elongated tube <NUM> coupled to the distal subassembly <NUM>).

<FIG> is an example of an ultrasound image of a distal end of a magnetically-responsive assembly, such as any of the assemblies described herein, within a patient. Specifically, a portion <NUM> of an assembly can be seen in the area identified by box <NUM>. The portion <NUM> can include, for example, an echogenic member, such as any of the echogenic members described herein.

<FIG> is a flow chart illustrating a method <NUM> of using any of the systems and/or assemblies described herein. The method <NUM> includes introducing <NUM> a magnetic tip of an elongated tube into an oropharynx region of a patient via one of a nasal cavity or an oral cavity of the patient. The magnetic tip can be tapered toward a distal end of the magnet tip. An external magnetic member can be applied <NUM> to an external surface of the patient at a location corresponding to an internal junction of a hypopharynx of the patient and a larynx of the patient such that the external magnetic member applies a magnetic field to the internal junction. The magnetic tip can be translated <NUM> through the hypopharynx, the magnetic field of the external magnetic member urging the magnetic tip toward a posterior wall of the hypopharynx as the magnetic tip is translated through the hypopharynx. The magnetic tip can be advanced <NUM> through an esophagus of the patient to the stomach of the patient.

Optionally, prior to advancing the magnetic tip through the esophagus and to the stomach of the patient, an echogenic member or an echogenic portion coupled to the elongated tube can be visualized (e.g., via ultrasound) to verify the location of the magnetic tip within the patient. For example, an inflatable member (e.g., a balloon member) coupled to the elongated tube may be filled with an echogenic fluid and an ultrasound probe may be placed on a surface of the patient such that the inflatable member can be visualized using the ultrasound probe. If the echogenic member or echogenic portion is visualized in an intended location (e.g., within the esophagus), the magnetic tip can then be advanced to the stomach. If the echogenic member or echogenic portion is visualized in an unintended location (e.g., within a patient's larynx), the magnetic tip may be retracted or withdrawn a distance (e.g., to a location prior to the internal junction of the hypopharynx and the larynx), the external magnetic member may be repositioned relative to the patient, and the magnetic tip may be again translated beyond the internal junction of the patient, through the hypopharynx, and into the patient's esophagus. The echogenic member or echogenic portion may be visualized again to confirm the location of the magnetic tip within the hypopharynx beyond the internal junction prior to advancement into the patient's esophagus.

<FIG> is a flow chart illustrating a method <NUM> of using any of the systems and/or assemblies described herein. The method <NUM> can include disposing <NUM> an external magnetic member on an external surface of a patient at a location corresponding to an internal junction of a first passageway, a second passageway, and a third passageway of the patient such that a first pole of the external magnetic member is oriented toward the external surface of the patient and a second pole of the external magnetic member is oriented away from the first pole such that the external magnetic member applies a magnetic field to the internal junction. The internal junction, the first passageway, and the second passageway may be any suitable internal junction, first passageway, and second passageway of a patient. The second pole can have an opposite polarity to the first pole. A magnetic tip of an elongated tube can be translated <NUM> through an orifice of the patient, through the first passageway, through the internal junction, and into the second passageway. The magnetic tip can be tapered toward a distal end of the magnet tip. The magnetic tip can have a first pole oriented toward the external magnetic member and a second pole oriented away from the external magnetic member such that, as the magnetic tip is translated through the first passageway and the internal junction, the interaction of the first pole of the external magnetic member and the first pole of the magnetic tip shifts the magnetic tip into alignment with the second passageway.

Claim 1:
An apparatus, comprising:
an elongated tube (<NUM>) having a first end (<NUM>), a second end (<NUM>), and defining a first lumen (<NUM>) and a second lumen, the first lumen (<NUM>) extending from the first end to the second end;
a magnetic tip coupled to the first end (<NUM>) of the elongated tube (<NUM>), the magnetic tip being tapered toward a distal end of the magnetic tip; and
an inflatable member disposed within the elongated tube (<NUM>) proximal of the tapered magnetic tip and fluidically coupled to the second lumen such that the inflatable member can receive fluid via the second lumen.