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.
Systems, apparatus, and methods for placing an elongated tube within a patient's body are described herein. In some embodiments, an apparatus includes an elongated tube, a magnetic tip, and an inflatable member. The elongated tube can have a first end and a second end, and can define a first lumen and a second lumen. The first lumen can extend from the first end to the second end. The magnetic tip 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. An inflatable member can be 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, an apparatus includes an elongated tube, a magnetic tip, and an inflatable member. The elongated tube can have a first end and a second end, and can define a first lumen and a second lumen. The first lumen can extend from the first end to the second end. The magnetic tip can be coupled to the first end of the elongated tube. The magnetic tip can be tapered toward a distal end of the magnet tip. An inflatable member can be 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.
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.
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,
In some embodiments, the first end 211 of the elongated tube 210 can be open such that fluid can flow through the second end 213, through the feeding lumen 212, through the first end 211, and into the stomach. In some embodiments, the elongated tube 210 can define a number of fenestrations in a sidewall of the elongated tube 210 near the first end 211 such that fluid can flow through the second end 213, through the feeding lumen 212, out of the fenestrations, and into the stomach. In some embodiments, a cap or cover can be coupled to the first end 211 such that fluid communication between the feeding lumen 212 and the stomach is only via the one or more side openings. In some embodiments, the second end 213 is coupled to and/or includes a sump or feeding port.
In some embodiments, the magnetic feature 220 can include a magnetic tip of the elongated tube 210. The magnetic feature 220 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 211 of the elongated tube 210 and extend axially away from the first end 211 of the elongated tube 210. 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 211 of the elongated tube 210, 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 211 of the elongated tube 210). 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 211 of the elongated tube 210. 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 212 can be in fluidic communication with the stomach via the opening in the magnetic tip when the first end 221 of the elongated tube 210 is disposed within the stomach. In some embodiments, the magnetic tip can include a cap coupled to the first end 211 of the elongated tube 210, one or more magnetic components disposed within the cap. In some embodiments, the magnetic feature 220 can include one or more magnetic components disposed within the elongated tube 210. For example, the elongated tube 210 can include an end cap coupled to the first end 211, and one or more magnetic components can be enclosed within the end cap and/or the elongated tube 210. 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 210 and/or an end cap coupled to the first end 211 of the elongated tube 210.
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 211 of the elongated tube 210 and a magnetic feature can be disposed on and/or within the elongated tube 210.
In some embodiments, the magnetic feature 220 (e.g., a magnetic tip) can be formed of any suitable type of magnet. For example, the magnetic feature 220 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 220 can include a temporary magnet. In some embodiments, the magnetic feature 220 can be an electromagnet, such as a solenoid. In some embodiments, the magnetic feature 220 can generate a magnetic field having an orientation (i.e., north (N) and south (S) poles). In other embodiments, the magnetic feature 220 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 220 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 220.
The echogenic member 230 is configured to be visualized via ultrasound such that the location of the echogenic member 230 (and, thus, the first end 211 of the elongated tube 210) within a patient can be verified. In some embodiments, the echogenic member 230 can be an inflatable member, such as an inflatable balloon. The system 200 can include an inflation lumen (not shown). In some embodiments, the inflation lumen can be separate from the elongated tube 210. In some embodiments, the inflation lumen can be defined by the elongated tube 210. For example, a central axis of the inflation lumen can extend parallel to a central axis of the feeding lumen 212. In some embodiments, the inflation lumen can include an inflation port on an end opposite the echogenic member 230. In some embodiments, the echogenic member 230 can be disposed on the elongated tube 210 such that the echogenic member 230 surrounds the elongated tube 210. In some embodiments, the echogenic member 230 can extend laterally from a side of the elongated tube 210 such that echogenic member extends asymmetrically relative to a central axis of the elongated tube 210. In some embodiments, the echogenic member 230 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 230), the echogenic member 230 extending to a greater lateral extent relative to a centerline of the elongated tube 210 in the inflated configuration. In some embodiments, the echogenic member 230 does not extend beyond an outer surface of the elongated tube 210 such that the assembly 213 has a smooth outer profile with a substantially continuous outer diameter through the portions including the elongated tube 210 and the echogenic member 230. In some embodiments, rather than having a separate echogenic member 230, a portion of the elongated tube 210, a cap coupled to the first end 211 of the elongated tube 210, and/or the magnetic feature 220 can have echogenic properties such that the assembly 202 can be visualized using ultrasound.
The external magnetic member 240 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 220 to generate a force on the magnetic feature 220. The external magnetic member 240 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 220 can be an electromagnet, such as a solenoid. In some embodiments, the magnetic feature 220 can generate a magnetic field having an orientation (i.e., north (N) and south (S) poles). In some embodiments, the external magnetic member 240 can be disposed within a strap assembly (not shown). The strap assembly can be configured to secure the external magnetic member 240 to a patient's body (e.g., a patient's neck).
In some embodiments, the external magnetic member 240 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 220 through various body tissue and organs disposed between the external magnetic member 240 on the surface of the patient's skin the magnetic feature 220 within the patient's body and across any suitable distance (e.g., about 10 cm, about 15 cm, and/or about 20 cm). For example, the external magnetic member 240 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 240 and the magnetic field generated by the magnetic feature 220 can produce a magnetic force that urges the position of the magnetic feature 220 in a direction toward or away from the external magnetic member 240, and thus also urges the first end 211 of the elongated tube 210 relative to the external magnetic member 240. In some embodiments, the external magnetic member 240 can have a first side and a second side, the second side disposed opposite of the first side. The external magnetic member 240 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 240 can be configured to attract the magnetic feature 220 toward the external magnetic member 240 (e.g., if the external magnetic member 240 is disposed near the magnetic feature 220 with a first pole applying a magnetic force to the magnetic feature 220 of an opposite polarity as the magnetic feature 220 facing the external magnetic member 240). In some embodiments, the external magnetic member 240 can be configured to repel the magnetic feature 220 away from the external magnetic member 240 (e.g., if the external magnetic member 240 is disposed near the magnetic feature 220 with a first pole applying a magnetic force to the magnetic feature 220 of the same polarity as the magnetic feature 220 facing the external magnetic member 240). In some embodiments, the magnetic feature 220 (e.g., a magnetic tip) can be oriented such that the magnetic feature 220 can apply a force (e.g., a magnetic force) in a first direction lateral to a central axis of the elongated tube 210, and the external magnetic member 240 can be oppositely polarized and disposed a distance from the magnetic feature 220 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 240 can be arranged in a first configuration relative to the magnetic feature 220 (e.g., near a first side of the magnetic feature 220) such that the a first pole (e.g., N) of the external magnetic member 240 faces a pole of the magnetic feature 220 having the same polarity and, thus, applies a repulsive force to the magnetic feature 220. The external magnetic member 240 can be arranged in a second configuration relative to the magnetic feature 220 (e.g., near a second side opposite the first side) such that the first pole of the external magnetic member 240 faces a pole of the magnetic feature 220 having an opposite polarity (e.g., S), and thus, applies an attractive force to the magnetic feature 220.
As shown in
The external magnetic member 340 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 340 and the magnetic tip 320 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 340 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.
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Although the external magnetic member 340 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 340 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
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With at least the distal-most end of the assembly 402 (e.g., the first end 423 of the magnetic tip 420) aligned with the inferior portion of the oropharynx R and/or the esophagus E, the assembly 402 can be translated into the inferior portion of the oropharynx R. With the first end 423 of the magnetic tip 410 outside of the trachea T, as shown in
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,
The tapered portion 518 can have a first end 515 and a second end 517. The second end 517 can be coupled to the first end of any of the elongated tubes described herein. The first end 515 can have a larger inner diameter and outer diameter than the inner diameter and outer diameter of the second end 517. For example, the first end 515 can have an inner diameter larger than the outer diameter of the magnetic components 528. The second end 517 can have an inner diameter smaller than the outer diameter of the magnetic components 528. Thus, the magnetic components can be prevented from traveling through the second end 517 and into an elongated tube coupled to the second end 517 due to the elongated tube being of a larger diameter than the opening defined at the second end 517. Additionally, the cap 519 can be coupled to the first end 515 such that the magnetic components 528 are enclosed within the cap 519 and/or the tapered portion 518.
The distal subassembly 504 can be used the same or similarly to any of the magnetic features described herein, such as magnetic feature 220, magnetic tip 320, and/or magnetic tip 420. For example, an external magnetic member (e.g., the external magnetic member 240) can be used to shift or urge the magnetic components 528 (and, thus, the distal subassembly 504) relative to various internal passageways of a patient. With the distal subassembly 504 aligned with an intended passageway (e.g. an inferior portion of an oropharynx), the distal subassembly 504 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 504).
As shown, the tapered portion 718 can have a first end 715 and a second end 717. The second end 717 can be coupled to the first end of any of the elongated tubes described herein. The first end 715 can have a larger inner diameter and outer diameter than the inner diameter and outer diameter of the second end 717. For example, the first end 715 can have an inner diameter larger than the outer diameter of the magnetic components. The second end 717 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 717 and into the elongated tube 710 due to the magnetic components having a larger diameter than the opening defined at the second end 717. Additionally, the cap 719 can be coupled to the first end 715 such that the magnetic components 728 are enclosed within the cap 719 and/or the tapered portion 718. In some embodiments, the tapered portion 718 can be formed as a tube that tapers from a 16 Fr tube size at the first end 715 to a 12 Fr tube size at the second end 717.
The distal subassembly 704 can be used the same or similarly to any of the magnetic features described herein, such as magnetic feature 220 and/or magnetic tip 320. For example, an external magnetic member (e.g., the external magnetic member 240) can be used to shift or urge the magnetic components 728 (and, thus, the distal subassembly 704) relative to various internal passageways of a patient. With the distal subassembly 704 aligned with an intended passageway (e.g. an inferior portion of an oropharynx), the distal subassembly 704 can be advanced into the intended passageway (e.g., via advancing the elongated tube 710 coupled to the distal subassembly 704).
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.
Optionally, after advancing the magnetic tip through the internal junction and into the second passageway, 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 the second passageway, the magnetic tip can advanced farther beyond the internal junction. If the echogenic member or echogenic portion is visualized in an unintended location (e.g., within the first passageway), the magnetic tip may be retracted or withdrawn a distance (e.g., to a location prior to the internal junction), 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 and into the second passageway. The echogenic member or echogenic portion may be visualized again to confirm the location of the magnetic tip within the second passageway prior to further advancement.
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 methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.
This application is a continuation of International PCT Application No. PCT/US2019/030902, filed May 6, 2019, entitled “Systems, Apparatus, and Methods for Delivering a Medical Device Beyond a Bifurcation in a Body Lumen,” which claims priority to and the benefit of U.S. Provisional Application No. 62/667,132, filed May 4, 2018, entitled “Systems, Apparatus, and Methods for Placing a Gastrostomy Tube,” the entire contents of each of which are hereby expressly incorporated by reference for all purposes.
Number | Date | Country | |
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62667132 | May 2018 | US |
Number | Date | Country | |
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Parent | PCT/US2019/030902 | May 2019 | US |
Child | 17087150 | US |