SYSTEMS, APPARATUS, AND METHODS FOR PLACING AND/OR CONFIRMING A LOCATION OF AN END OF A NASOGASTRIC OR AN OROGASTRIC TUBE
Cross-Reference to Related Applications
[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63/297,457, filed January 7, 2022, entitled “Systems, Apparatus, and Methods for Placing and/or Confirming a Location of an End of a Nasogastric or an Orogastric Tube,” the entire contents of which are incorporated by reference herein for all purposes.
Background
[0002] Embodiments described herein relate to systems, apparatus, and methods for placing and/or confirming a location of an end of a nasogastric or an orogastric tube within a body cavity.
[0003] Delivering a medical device, such as an end of a nasogastric or an orogastric tube, to a location within a patient (e.g., a stomach) 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, after proper initial placement of an end of a nasogastric or an orogastric tube in a stomach of a patient, the nasogastric or orogastric tube may migrate relative to the patient’s stomach (e.g., into the patient’s esophagus or jejunum). Thus, caregivers, such as nurses, need to check the nasogastric or orogastric tube periodically (e.g., every four hours) to confirm that the end of the nasogastric or orogastric tube has not migrated unsafely.
[0004] One typical method of monitoring the location of the end of the nasogastric or orogastric tube includes marking and tracking a location of a portion of the tube external to the patient relative to a nasal or oral orifice through which the tube passes, but such a method may not indicate that the end has migrated into the esophagus (e.g., via being refluxed up) or traveled into the trachea, which could be catastrophic. Another method of monitoring the location of the end of the nasogastric or orogastric tube includes delivering a volume of air through the tube and into the stomach and listening for a gurgle sound (sometimes referred to as a “whoosh” or “blow” test), but such a gurgle sound is easily confused with other stomach noises. Another approach is to perform a pH test on aspirate fluid drawn through the tube using pH indicator paper to confirm that the aspirate fluid is stomach acid, but such an approach has been shown to be unreliable due to other substances in contact with the tube prior to and/or during insertion of the end of the tube into the stomach and/or user error. Another known approach includes using an enteral access system including electromagnetic sensors in a stylet for localization of a tip of a tube during tube insertion, but such an approach has been associated with pneumothorax events requiring urgent intervention (e.g., needle decompression or chest tube placement), and has sometimes been associated with cardiopulmonary arrest and patient death. While the location of the tube within the patient can be confirmed via X-ray imaging, X-ray imaging requires the use of additional equipment and the involvement of specialized clinicians to read the imaging and carries the risk of radiation-induced injuries.
[0005] Thus, there is a need for systems, apparatus, and methods for confirming delivery of an end of a nasogastric or orogastric tube beyond a bifurcation in a body lumen and confirming location of the end of the tube at periodic intervals, which reduce risks to the patient and allow for the medical device to be quickly and easily placed in its intended location.
Summary
[0006] Systems, apparatus, and methods for placing and/or confirming a location of an end of a nasogastric or an orogastric tube within a body cavity are described herein. In some embodiments, an apparatus includes an elongated tube and a position indicator. The elongated tube has a first end, a second end, and defines a lumen extending from the second end to a location at or near the first end of the elongated tube. The elongated tube defines at least one opening in fluid communication with the lumen such that, when the first end of the elongated tube is disposed in a cavity of a patient and the second end of the elongated tube is disposed outside of the patient, fluid can be delivered from the second end of the elongated tube into the cavity via the lumen and the at least one opening. The position indicator is coupled to the elongated tube and disposed sufficiently close to the first end such that, when the first end is properly disposed in the cavity of the patient, the position indicator is disposed in the cavity of the patient. The position indicator is configured to produce an indication perceivable outside of the patient that the position indicator is disposed in the cavity of the patient. The indication is an indication differentiable from a sound naturally generated by the cavity of the patient. Brief Description of the Drawings
[0007] FIG. 1 is a schematic illustration of a tube disposed in a patient, according to an embodiment.
[0008] FIG. 2 is a schematic illustration of a system, according to an embodiment.
[0009] FIGS. 3-11 are various views of a system and portions of the system, according to an embodiment.
[0010] FIGS. 12 and 13 are a perspective view and a side view of a system, according to an embodiment.
[0011] FIGS. 14-17 are various views of a portion of a system, according to an embodiment.
[0012] FIG. 18 is a flow chart illustrating a method of using any of the systems and/or assemblies described herein, according to an embodiment.
[0013] FIG. 19 is a flow chart illustrating a method of using any of the systems and/or assemblies described herein, according to an embodiment.
Detailed Description
[0014] Systems, apparatus, and methods for confirming placement and location of a medical device or a portion (e.g., an end) of a medical device in a location within a patient’s body are described herein. The medical device may include, for example, a tube such as a nasogastric tube and/or an orogastric tube. During delivery of the medical device to the location within the patient’s body, 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 through an esophagus to a patient’s stomach, avoiding the patient’s trachea and lungs. Additionally, after the initial placement of the medical device, confirmation of a location of a portion of the medical device (e.g., an end) can be performed at periodic intervals to ensure that the portion of the medical device has not migrated unsafely within the patient’s body. [0015] Systems, apparatus, and methods for placing and/or confirming a location of an end of a nasogastric or an orogastric tube within a body cavity are described herein. In some embodiments, an apparatus includes an elongated tube and a position indicator. The elongated tube has a first end, a second end, and defines a lumen extending from the second end to a location at or near the first end of the elongated tube. The elongated tube defines at least one opening in fluid communication with the lumen such that, when the first end of the elongated tube is disposed in a cavity of a patient and the second end of the elongated tube is disposed outside of the patient, fluid can be delivered from the second end of the elongated tube into the cavity via the lumen and the at least one opening. The position indicator is coupled to the elongated tube and disposed sufficiently close to the first end such that, when the first end is properly disposed in the cavity of the patient, the position indicator is disposed in the cavity of the patient. The position indicator is configured to produce an indication perceivable outside of the patient that the position indicator is disposed in the cavity of the patient. The indication is an indication differentiable from a sound naturally generated by the cavity of the patient.
[0016] In some embodiments, a method includes producing a fluid flow through a lumen of an elongated tube such that the fluid flow interacts with a position indicator coupled to the elongated tube and disposed within a patient. The method further includes determining whether the position indicator generated an indication that the position indicator is disposed within a target cavity of the patient in response to the fluid flow, the indication being an indication differentiable from a sound naturally generated by the cavity of the patient.
[0017] FIG. 1 is a schematic illustration of an elongated tube 110 partially disposed in a patient P. An end of the elongated tube 110 may be delivered to a patient’s stomach such that fluids can be delivered to a stomach S of the patient P through the elongated tube 110. As shown in FIG. 1, the patient P has an oral cavity Y, a nasal cavity C, a pharynx X, an esophagus E, the stomach S, and a small bowel including a duodenum D and a jejunum J. 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. Thus, a pathway to the stomach S can include the nasal orifice N and nasal cavity C (or the oral orifice O and oral cavity Y), the pharynx X, and the esophagus E.
[0018] When a patient P has difficulty swallowing food and/or liquid, the elongated tube 110 (e.g., a nasogastric or an orogastric tube) can be placed via the nasal orifice N or the oral orifice O and the esophagus E of the patient P such that nutrition and/or medication can be provided directly through the tube to the stomach S. For example, as shown in FIG. 1, the elongated tube 110 (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 110 can have the first end 111 disposed within the stomach S and a second end 113 disposed outside of the patient P, with the elongated tube 110 passing through the patient’s nasal orifice N. While the elongated tube 110 is shown as being disposed within the patient’s nasal orifice N and nasal cavity C, in some embodiments the elongated tube 110 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.
[0019] Navigation of the first end 111 of the elongated tube 110 through the patient P, however, can be challenging and pose risks to the patient P. If the first end 111 of the elongated tube 110 is misplaced within the patient’s body, such as within a patient’s larynx, trachea T, bronchi B (e.g., a patient’s bilateral primary bronchi), or lung L, the elongated tube 110 can injure the patient and/or fluid provided through the elongated tube 110 can cause injury to the patient. For example, the elongated tube 110 can cause pulmonary damage, pneumothorax, hemodynamic collapse, and/or pneumonia. Even worse events can occur if the elongated tube 110 is used to introduce medicine or food into the patient’s airway. Furthermore, after initial placement of the first end 111 of the elongated tube 110 within the stomach S, the elongated tube 110 may migrate such that the first end 111 is disposed within the duodenum D, the jejunum J, the esophagus E, the larynx, the trachea, or the lung of the patient P.
[0020] In some embodiments, an elongated tube can include or be coupled to features that aid in navigating a first end of the elongated tube to a stomach of a patient and/or that aid in confirming the location of the first end of the elongated tube within the patient. For example, FIG. 2 is a schematic representation of a system 200. The system 200 includes an elongated tube 210 having a first end 211 and a second end 213 and a position indicator 260 associated with the first end 211 of the elongated tube 210. The elongated tube 210 defines a lumen 212, which can be a feeding lumen. The lumen 212 can extend from the second end 213 to a location at or near the first end 211 of the elongated tube 210. The elongated tube 210 can define at least one opening 214 in fluid communication with the lumen 212 such that, when the first end 211 of the elongated tube 210 is disposed in a cavity of a patient (e.g., a stomach) and the second end 213 of the elongated tube 210 is disposed outside of the patient, fluid can be delivered from the second end 213 of the elongated tube 210 into the cavity via the lumen 212 and the at least one opening 214. In some embodiments, the opening 214 can be defined in the first end 211 of the elongated tube 210 such that fluid can flow through the second end 213, through the lumen 212, and out the opening 214 in the first end 211. In some embodiments, the elongated tube
210 can have one or more openings 214 (also referred to as fenestrations) that can be defined 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 lumen 212, and out of the one or more fenestrations. The fenestrations can be any suitable size or shape (e.g., rounded, rectangular). In some embodiments, the first end 211 can be closed (e.g., a cap or cover can be coupled to the first end 211) such that fluid communication between the lumen 212 and a body cavity (e.g., the stomach) within which the first end 211 is disposed is only via the one or more fenestrations in the sidewall.
[0021] The position indicator 260 can be disposed at or sufficiently close to the first end
211 such that, when the first end 211 of the elongated tube 210 is properly positioned in a stomach of the patient and the second end 213 is disposed outside of the patient (e.g., beyond the patient’s nose or mouth), the position indicator 260 is also positioned in the stomach of the patient. The position indicator 260 can be disposed distally to none, one, some, or all of the one or more openings 214 of the elongated tube 210 in communication with the lumen 212. In some embodiments, the position indicator 260 is fluidically isolated from fluid disposed within the lumen 212. In some embodiments, the position indicator 260 is in fluid communication with fluid disposed within the lumen 212. The position indicator 260 is configured to indicate to a user (e.g., a caregiver such as a healthcare practitioner) that the first end 211 of the elongated tube 210 is properly disposed in the stomach of the patient by producing an indication perceivable outside of the patient that the position indicator 260 is disposed in the stomach of the patient. The indication can be an indication differentiable from a sound naturally generated by the cavity of the patient such that the indication is not confused with naturally generated body noises (e.g., stomach or bowel sounds such as gurgling, bubbling, growling, and/or rumbling) and vice versa.
[0022] In some embodiments, the indication that can be produced by the position indicator 260 includes an audible indication that the position indicator 260, and thus the first end 211 of the elongated tube 210, is properly disposed in the patient’s stomach. The audible indication can be an audible indication that is not a natural sound passively produced by the patient’ s body (e.g., stomach or bowel sounds such as gurgling, bubbling, growling, and/or rumbling). For example, the audible indication can include a whistle, buzzer, duck call, ring, siren, and/or pop sound. In some embodiments, the position indicator 260 is configured to produce a tactile indication that the position indicator 260, and, thus the first end 211 of the elongated tube 210, is properly and/or improperly disposed in the patient’s stomach.
[0023] In some embodiments, the position indicator 260 can include a whistle feature. The whistle feature can be in fluid communication with a lumen defined by the elongated tube 210 such that gaseous fluid (e.g., air, nitrogen, carbon dioxide, and/or oxygen) flowing through the lumen can reach the whistle feature and cause the whistle feature to generate a whistle sound sufficiently loud to be audible outside the patient (e.g., using a stethoscope, or the unaided ear, applied to the surface of the patient’s body). In some embodiments, the elongated tube 210 can define a whistle lumen 215 in fluid communication with the whistle feature. The whistle feature can define an opening such that fluid can flow from the whistle lumen 215, into an interior of the whistle feature, and out of the opening, producing the whistle sound audible outside the patient. In some embodiments, the opening can be defined in or aligned with an opening in a sidewall of the elongated tube 210. In some embodiments, the opening can be defined within the whistle feature at an intersection between an entrance passageway, an interior chamber, and an exit passageway of the whistle feature (e.g., in a configuration similar to a Storm® whistle, or any of the embodiments of similar whistles disclosed in U.S. Patent No. 5,564,360, entitled “All Weather Safety Whistle and Sound Generator” (“the ‘360 Patent”), the disclosure of which is incorporated by reference herein. In some embodiments, the whistle feature can define an interior space in fluid communication with the whistle lumen 215, a closed distal end, and a projection (e.g., a bump) extending from an inner surface of the whistle feature toward the whistle opening. The whistle feature can be disposed at a distal end 216 of the whistle lumen 215. Thus, fluid can flow from the whistle lumen 215 into the open end of the whistle, flow into the interior space, accumulate beyond the projection in the interior space, and then flow out of the opening, producing a whistle sound resulting from interaction with the whistle feature. In some embodiments, the position indicator 260 can be formed similarly to a Storm® whistle (or other whistle disclosed in the ‘360 Patent) having an umbrella configured to define a chamber. In some embodiments, the position indicator 260 and/or a whistle lumen 215 can define a distal opening (e.g., through the first end 211 of the elongated tube 210) such that fluid pushed through the whistle lumen 215 and the position indicator 260 (e.g., the whistle feature) can travel through an exit passageway of the whistle feature and pass out the first end 211 of the elongated tube 210. In some embodiments, the whistle feature can be releasably couplable to the elongated tube 210.
[0024] In some embodiments, the system 200 can include an inflatable member 230 disposed on the elongated tube 210 and defining an interior in fluid communication with the whistle lumen 215 and an interior of the position indicator 260 (e.g., the whistle feature) to provide a gaseous space. The inflatable member 230 can be disposed such that the inflatable member 230 surrounds the position indicator 260 or a portion of the position indicator 260 defining an opening (e.g., a whistle opening) aligned with an opening of the elongated tube 210. In some embodiments, the inflatable member 230 can be inflated by gaseous fluid introduced into the whistle lumen 215 and through the position indicator 260. In some embodiments, the inflatable member 230 can surround a portion of the elongated tube 210. In some embodiments, the inflatable member 230 can be configured such that the inflatable member 230 is configured to transition between an unexpanded and an expanded configuration, and the inflatable member 230 has an outer diameter or maximum dimension perpendicular to a central axis of the elongated member 210 in the expanded configuration such that the inflatable member 230 cannot fully expand to the expanded configuration in a patient’s trachea, lungs, esophagus, and/or jejunum, but can fully expand to the expanded configuration in a patient’s stomach. In some embodiments, the inflatable member 230 is sized such that the inflatable member 230 cannot inflate to a sufficiently large volume (e.g., the expanded configuration) for the whistle feature to produce a sound, a sufficiently loud sound, or a sound of a sufficient duration in a patient’s trachea, lungs, esophagus, and/or jejunum, but can inflate to a sufficiently large volume (e.g., the expanded configuration) for the whistle feature to produce a sufficiently loud sound (i.e., sufficient decibels) and/or a sound of a sufficiently long duration when disposed in the patient’s stomach, to provide the desired indication. Thus, if the inflatable member 230 is disposed in a non-target location, such as a patient’s trachea, lungs, esophagus, and/or jejunum, the user can determine that the inflatable member 230 is in the nontarget location rather than in a target location (e.g., the stomach) because of a lack of audible indication or a change in the audible indication produced by the whistle feature when the inflatable member 230 is in the non-target location (due to the inflatable member 230 being prevented from inflating to the expanded configuration by the geometry of the non-target location). [0025] In some embodiments, the position indicator 260 can be electronic. The position indicator 260 can include a sensor configured to sense a characteristic of fluid in contact with the position indicator 260 and generate an indication based on a presence of the sensed characteristic. In some embodiments, the characteristic can be the presence of liquid fluid. In some embodiments, the characteristic can be an acidity of fluid contacting the sensor being within a particular range (e.g., the pH range associated with stomach acid). In some embodiments, the position indicator 260 can generate an indication in response to a signal transmitted to the position indicator 260, e.g., generated by a user. In some embodiments, the sensor can include a noise-generating component such as a speaker to generate the notification, which can include a sound like a buzzer or other alarm. In some embodiments, the sensor can include a transmitter and be configured to communicate a status of the sensor (e.g., a sensed characteristic or a determination based on the sensed characteristic) to a remote compute device such as a smartphone via, e.g., Bluetooth®.
[0026] In some embodiments, the second end 213 of the elongated tube 210 can be coupled to and/or can include one or more pumps and/or sources of fluid. For example, a source of feeding fluid and/or an associated pump can be coupled to the lumen 212 to provide feeding fluid to the lumen 212. As shown in FIG. 2, a fluid and/or vacuum source 235 can be optionally included in the system 200 and can be fluidically coupled to the whistle lumen 215. In some embodiments, the fluid and/or vacuum source 235 can define a reservoir of gaseous fluid and can be manipulated (e.g., squeezed or pressed by a healthcare provider) to urge the gaseous fluid into the whistle lumen 215 and to the position indicator 260 including a whistle feature with a sufficient pressure and/or flow rate such that the position indicator 260 can generate an audible whistle. In some embodiments, the fluid and/or vacuum source 235 can include a flexible bulb defining a reservoir sealed to the elongated tube 210. The flexible bulb can be squeezed to push gaseous fluid (e.g., a bolus of gaseous fluid) into the whistle lumen 215 and can be biased toward an expanded configuration such that when the flexible bulb is released gaseous fluid (e.g., the gaseous fluid pushed out of the flexible bulb) is drawn into the flexible bulb. In some embodiments, the flexible bulb, the whistle lumen 215, the position indicator 260, and the inflatable member 230 can form a closed fluid system such that gaseous fluid can, upon squeezing the flexible bulb, be pushed from the flexible bulb into the whistle lumen 215, through the position indicator 260 to produce a whistle, and into the inflatable member 230, and then, upon releasing the flexible bulb, the flexible bulb expands to draw the fluid from the inflatable member 230, through the position indicator 260, through the whistle lumen 215, and into the flexible bulb. In some embodiments, rather than a flexible bulb, the fluid and/or vacuum source 235 can include a syringe defining a reservoir and couplable to the whistle lumen 215 such that the syringe can be manipulated to push fluid (e.g., a bolus) to the position indicator 260 via the whistle lumen 215 and draw fluid from the position indicator 260 via the whistle lumen 215. In some embodiments, due to the fluid and/or vacuum source 235, the whistle lumen 215, the position indicator 260, and the inflatable member 230 forming a closed fluid system, if the inflatable member 230 is disposed in a location (e.g., a trachea, esophagus, lung, or small bowel) that restrains the inflatable member 230 and does not allow the inflatable member 230 to fully expand to an expanded configuration, the fluid and/or vacuum source 235 will resist being fully pushed or depressed, providing feedback in the form of a tactile indication to the user that the inflatable member 230, and thus the first end 211 of the elongated member 210, is in the wrong location within the patient. In some embodiments, the user can determine that the inflatable member 230 is in the wrong location based on the resistance to pushing or squeezing the fluid source 235 (e.g., the flexible bulb or syringe) (e.g., based on being above a threshold resistance or based on a change in resistance partially through a push, squeeze, or depression) and/or based on a volume remaining in the fluid source 235 when the resistance increases or significantly increases (e.g., compared to a volume of fluid remaining in the fluid source 235 when the inflatable member 230 is unconstrained and in the expanded configuration). In response to the resistance or increase in resistance sensed by the user, the user can cease applying pressure to the fluid source 235 and manipulate (e.g., translate) the elongated tube 210 to move the inflatable member 230 and the first end 211 to a new location to test. In some embodiments, the system 200 can optionally include a pressure release valve fluidically coupled to the inflatable member 230 and the whistle lumen 215 and configured to release fluid when a fluid pressure within the inflatable member 230 and the whistle lumen 215 is above a threshold fluid pressure to prevent damage to the system 200 (e.g., to prevent bursting of the inflatable member 230). In some embodiments, the inflatable member 230 can be the position indicator 260, and the system 200 may not include an auditory feedback producing component (e.g., a whistle).
[0027] In some embodiments, the elongated tube 210 can define any suitable number of additional lumens. For example, as shown in FIG. 2, the elongated tube 210 can define an additional lumen 217. The lumen 217 can be in fluid communication with an opening 218 disposed in the first end 211 of the elongated tube 210. The lumen 217 can be used for fluid delivery and/or suction. In some embodiments, the lumen 212 can be the only lumen and/or can be in fluid communication with the position indicator 260 such that fluid traveling through the lumen 212 at a particular flow rate and/or pressure can activate the position indicator 260 (e.g., the whistle feature). For example, the lumen 212 can be used to provide fluid including nutrient and/or medication to a stomach of a patient during a first time period, then the lumen 212 can be cleared by pushing air through the lumen 212, and then the lumen 212 can be used as a whistle lumen to check the position of the position indicator 260. Additionally, although the stomach is described herein as the intended location of the first end 211 of the elongated tube 210, in some embodiments, the first end 211 of the elongated tube 210 can be configured to be placed distally of the stomach and disposed in the small bowel of the patient. In such embodiments, the elongated tube 210 can be longer and the inflatable member 230, the elongated tube 210, and the position indicator 260 (e.g., whistle feature) can each have a smaller maximum diameter than if the first end 211 is intended for placement in the stomach.
[0028] In some embodiments, the elongated tube 210 can optionally include one or more magnetic members 220 disposed near at or near the first end 211 of the elongated tube 210. In some embodiments, the one or more magnetic members 220 can be disposed distal to none, some, or all of the openings 214 (e.g., sidewall fenestrations) in fluid communication with the lumen 212. In some embodiments, the one or more magnetic members 220 can be 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 members 220 can be enclosed within a cavity or lumen of the elongated tube 210 bounded by the end cap. In some embodiments, the one or more magnetic members 220 can be formed in any suitable shape or size and can include any suitable number of magnetic members. For example, in some embodiments, the one or more magnetic members 220 can include one or more spherical magnetic components (e.g., one, two, three, four, or more) disposed within the elongated tube 210 and/or an end cap coupled to the first end 211 of the elongated tube 210 (e.g., in a line).
[0029] In some embodiments, the one or more magnetic members 220 can be formed of any suitable type of magnet. For example, the one or more magnetic members 220 can include a permanent magnet, such as a rare earth magnet (such as neodymium iron boron (NdFeB) or samarium cobalt (SmCo)), an aluminum nickel cobalt (AlNiCo) magnet, a ceramic / ferrite magnet, and/or any other suitable permanent magnet. In some embodiments, the one or more magnetic members 220 can include a temporary magnet. In some embodiments, the one or more magnetic members 220 can be an electromagnet, such as a solenoid (with or without a solid core). In some embodiments, the one or more magnetic members 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 one or more magnetic members 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 one or more magnetic members 220.
[0030] A position of the first end 211 within a cavity or passageway of a patient (e.g., a trachea, esophagus, and/or stomach) can be controlled by an external magnetic member disposed on a surface of a patient and configured to magnetically interact with the one or more magnetic members 220. An external magnetic member 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. The magnetic field of the external magnetic member can interact with the magnetic field generated by the one or more magnetic members 220 through various body tissue and organs disposed between the external magnetic member on the surface of the patient’s skin the one or more magnetic members 220 within the patient’s body and across any suitable distance (e.g., about 1 cm, 5 cm, 10 cm, about 15 cm, and/or about 20 cm). The interaction between the magnetic field generated by the external magnetic member and the magnetic field generated by the one or more magnetic members 220 can produce a magnetic force that urges the position of the one or more magnetic members 220 in a direction toward or away from the external magnetic member, and thus also urges the first end 211 of the elongated tube 210 relative to the external magnetic member. For example, the external magnetic member can be disposed on a front or back surface of a patient’s neck to urge the first end 211 of the elongated tube 210 toward the back of the patient’s throat and down the esophagus rather than the trachea of the patient as the first end 211 is translated through the patient. In some embodiments, the external magnetic member and/or the magnetic member(s) 220 can be the same or similar in structure and/or function to any of the external magnetic members or magnetic members disclosed in International 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,” published as International Publication Number WO 2019/213657, which is incorporated by reference herein in its entirety. [0031] In use, the first end 211 of the elongated tube 210 can be inserted through a nasal or oral orifice of the patient and translated relative to the orifice. . The first end 211 can be guided to and through the esophagus of the patient using any suitable method. For example, the first end 211 can be navigated beyond an internal junction of the patient to avoid the trachea and instead travel into the esophagus with the aid of an external magnetic assembly applied to the neck of the patient to urge the magnetic member(s) 220 posteriorly as the elongated tube 210 is translated. In some embodiments, the first end 211 can be translated into the patient blindly or with the aid of an endoscope. With the first end 211 of the elongated tube 210 disposed in a cavity or passageway of the patient, the location of the first end 211 can be verified to confirm that the first end 211 is disposed in a target cavity or location (e.g., the stomach), rather than in an unintended location such as the trachea, lungs, esophagus, and/or small bowel.
[0032] To identify the location of the first end 211 of the elongated tube 210 within the patient, the position indicator 260 can be used to provide any of the indications described above. For example, fluid flow through a lumen of the elongated tube 210 (e.g., the whistle lumen 215) can be produced such that the fluid flow interacts with a whistle feature of the position indicator 260. If the interaction between the fluid flow and the whistle feature produces a whistle sound indication audible outside of the patient to the user (e.g., a healthcare provider), the user can determine which portion of the patient’s body is the source of the whistle sound indication and thus can determine whether that portion is associated with the patient’ s stomach, small bowel, esophagus, etc. If the whistle sound indication is coming from the patient’s stomach, the user can then provide liquid fluid including nutrient and/or medication to the patient’s stomach via the elongated tube 210. If the whistle sound indication is coming from a location other than the patient’s stomach or no whistle sound indication is audible to the user (e.g., due to the inflatable member 230 being restrained from sufficiently expanding to provide a gaseous space for the whistle feature), the user can withdraw the elongated tube 210 and/or reposition the elongated tube 210 and recheck the location of the first end 211.
[0033] In some embodiments, instead of, or in addition to, listening for an audible indication, the fluid and/or vacuum source 235 can, in combination with the position indicator 260, which may include or be formed as the inflatable member 230, provide a tactile indicator to the user that the first end 211 of the elongated tube 210 is not disposed in the target cavity. For example, as described above, the fluid and/or vacuum source 235 can be manipulable to urge a bolus of gaseous fluid into a lumen of the elongated tube (e.g., the whistle lumen), into interaction with the position indicator, and into the interior of the inflatable member 230 to expand the inflatable member 230. If the user senses increased resistance to further manipulation of the fluid and/or vacuum source 235 before delivering the entire bolus (e.g., the fluid and/or vacuum source 235 becomes harder to squeeze), the increased resistance can be a tactile indicator that the inflatable member 230 is not disposed in the target cavity (e.g., the stomach) where the inflatable member 230 would be able to fully expand, and is instead located in an unintended location, such as the esophagus or trachea. If the tactile indication suggests that the inflatable member 230 is not disposed in the target cavity (e.g., due to the inflatable member 230 being restrained from fully expanding), the user can withdraw the elongated tube 210 and/or reposition the elongated tube 210 and recheck the location of the first end 211. If the user does not perceive a tactile indication that the inflatable member 230 is restrained from fully expanding (e.g., the user perceives that the full bolus is delivered without excessive force by the user, which can be a positive tactile indication), the user can provide liquid fluid through the lumen 212 of the elongated tube 210 to the target cavity (e.g., the stomach).
[0034] In some embodiments, after initially confirming that the first end 211 is disposed in the target cavity via the above steps or another suitable method (e.g., via X-ray imaging), any of the above steps can be used to confirm that the first end 211 of the elongated tube 210 has not migrated unsafely relative to the target cavity after a period of time. For example, the above steps can be used to confirm that the first end 211 of the elongated tube 210 has not migrated into the esophagus or small bowel. In some embodiments, the location of the first end 211 of the elongated tube 210 can be checked, for example, every four hours or before every administration of fluid via the elongated tube 210.
[0035] In some embodiments, as an alternative to, or in addition to, the position indicator 260 and the inflatable member 230 described above, the system 200 can include a first securing inflatable member and a second securing inflatable member (also referred to as balloons or cuffs) coupled to the elongated tube 210 and disposed proximally of the one or more openings 214 (e.g., proximal of any sidewall fenestrations). The first securing inflatable member and the second securing inflatable member can be coupled to the elongated member 210 such that the first securing inflatable member is disposed distally of the second securing inflatable member. In some embodiments, the first securing inflatable member and the second securing inflatable member can be coaxially arranged relative to each other and the elongated member 210. In some embodiments, no openings in a sidewall of the elongated member 210 are defined between the first securing inflatable member and the second securing inflatable member. In some embodiments, the first securing inflatable member and the second securing inflatable member can be fluidically isolated from each other and can each be fluidically coupled to respective inflation lumens. In some embodiments, rather than two distinct securing inflatable members, the system 200 can include a single securing inflatable member having a smaller diameter midportion separating the inflatable member into two separately inflatable portions (e.g., via a belt coupled to the midportion).
[0036] In use, after disposing the first end 211 of the elongated tube 210 in the stomach of the patient and with the elongated tube 210 extending through the patient’s esophagus and out of the patient’s nasal or oral orifice, the first securing inflatable member, which is disposed distally of the second securing inflatable member, can be expanded from an unexpanded to an expanded configuration (e.g., inflated). The elongated tube 210 can then be translated (e.g., pulled) proximally such that the first securing inflatable member is pulled against the esophageal sphincter of the patient and the second securing inflatable member is disposed within the esophagus of the patient. The second securing inflatable member can then be expanded from an unexpanded to an expanded configuration (e.g., inflated). Using an appropriate imaging device, such as an ultrasound probe, the system 200 can be visualized to confirm that the second securing inflatable member is disposed within the esophagus. Thus, the first securing inflatable member and the second securing inflatable member can be used to confirm the position of the first end 211 of the elongated tube 210 and to secure the first end 211 relative to the esophageal sphincter. Nutrient fluids and/or medication can then be delivered through the lumen 212 into the stomach.
[0037] In some embodiments, after disposing the first end 211 of the elongated tube 210 in the stomach of the patient and with the elongated tube 210 extending through the patient’s esophagus and out of the patient’s nasal or oral orifice, the second securing inflatable member can be expanded from an unexpanded to an expanded configuration (e.g., inflated). The first end 211 of the elongated tube 210 can then be urged distally into the small bowel (e.g., the duodenum) until the second securing inflatable member contacts the pylorus and the first securing inflatable member is disposed within the small bowel. The first securing inflatable member can then be expanded from an unexpanded to an expanded configuration (e.g., inflated) within the small bowel. Using an appropriate imaging device, such as an ultrasound probe, the system 200 can be visualized to confirm if the second securing inflatable member is in the small bowel. Thus, the first securing inflatable member and the second securing inflatable member can be used to confirm the position of the first end 211 of the elongated tube 210 and to secure the first end 211 relative to the pylorus. Nutrient fluids and/or medication can then be delivered through the lumen 212 into the small bowel. In some embodiments, the elongated tube 210 can define fenestrations proximal of the second securing inflatable member in fluidic communication with fenestrations distal of the first securing inflatable member.
[0038] FIGS. 3-11 are various views of a system 300, which can be the same or similar in structure and/or function to any of the systems described herein, such as the system 200. As shown in FIG. 3, which is a perspective view of the system 300, the system 300 includes an elongated tube 310 having a first end 311 and a second end 313, a position indicator 360 associated with the first end 311 of the elongated tube 310, and an inflatable member 330 coupled to the position indicator 360. The elongated tube 310, the position indicator 360, and the inflatable member 330 can be the same or similar in structure and/or function to any of the elongated tubes, position indicators, and inflatable members shown and described herein. FIGS. 4 and 5 are a top view and a perspective view, respectively, of a distal portion of the system 300. FIGS. 6, 7, and 8 are a perspective view, a bottom view, and a side view, respectively, of the distal portion of the system 300 with the inflatable member 330 not shown. FIGS. 9, 10, and 11 are a perspective view, atop view, and a cross-sectional view, respectively, of the position indicator 360.
[0039] The elongated tube 310 defines a feeding lumen 312 and a whistle lumen 315. The feeding lumen 312 extends from the second end 313 to a location near the first end 311 of the elongated tube 310. The elongated tube 310 can define a set of fenestrations 314 (also referred to as “openings”) defined in a sidewall of the elongated tube 310 in fluid communication with the lumen 312 such that, when the first end 311 of the elongated tube 310 is disposed in a cavity of a patient (e.g., a stomach) and the second end 313 of the elongated tube 310 is disposed outside of the patient, fluid can be delivered from the second end 313 of the elongated tube 310 into the cavity via the feeding lumen 312 and the set of fenestrations 314. As shown, the first end 311 of the elongated tube 310 is a closed end such that fluid communication between the feeding lumen 312 and a body cavity (e.g., the stomach) within which the first end 311 is disposed is only via the set of fenestrations 314 in the sidewall. [0040] As shown, the position indicator 360 is disposed sufficiently close to the first end 311 such that, when the first end 311 of the elongated tube 310 is properly positioned in a stomach of the patient and the second end 313 is disposed outside of the patient (e.g., beyond the patient’s nose or mouth), the position indicator 360 is also positioned in the stomach of the patient. The position indicator 360 is disposed proximal to the set of fenestrations 314 and within the whistle lumen 315. The position indicator 360 can be formed as or include a whistle feature in fluid communication with the whistle lumen 315 such that gaseous fluid (e.g., air, nitrogen, carbon dioxide, and/or oxygen) flowing through the whistle lumen 315 can reach the position indicator 360 and cause the position indicator 360 to generate a whistle sound indication audible outside the patient.
[0041] As shown in FIGS. 9-11, the position indicator 360 can include an open end 363 and a closed end 361 and can define an opening 362 such that fluid can flow from the whistle lumen 315, through the open end 363 into an interior space defined by the position indicator
360, and out of the opening 362 to produce a whistle sound audible outside the patient. The opening 362 can be aligned with an opening 314A defined in a sidewall of the elongated tube 310. The position indicator 360 can also include a projection 364 (e.g., a bump) extending from an inner surface of the position indicator 360 toward the whistle opening 362. Thus, when a bolus of gaseous fluid is delivered to the whistle lumen 315, fluid can flow from the whistle lumen 315 into the open end 363 of the position indicator 360, flow into the interior space, accumulate in the portion of the interior space between the projection 364 and the closed end
361, and then flow out of the opening 362, producing a whistle sound resulting from interaction with the position indicator 360. In some embodiments, if the opening 362 is obstructed (e.g., by body tissue, liquid fluid, or a sidewall portion of the optional inflatable member 330 in an unexpanded or not fully expanded configuration), the position indicator 360 will be prevented from producing the audible whistle sound indication or producing a whistle sound reaching a threshold decibel level.
[0042] The inflatable member 330 can define an interior in fluid communication with the interior space of the position indicator 360 and the whistle lumen 315. The inflatable member 330 can be configured to transition between an unexpanded configuration and the expanded configuration shown in FIGS. 3-5 as a result of gaseous fluid being provided to the position indicator 360 via the whistle lumen 315 and passing from the opening 362 of the position indicator 360 into the interior space of the inflatable member 330. As shown in FIGS. 3-5, the inflatable member can fully surround a portion of the elongated member 310 in the expanded configuration. The inflatable member 330 can be configured to provide a gaseous space within a stomach of the patient fluidically coupled to the opening 362 such that the position indicator 360 produces an audible indication (e.g., a whistle sound) that is audible outside of the patient. If the inflatable member 330 is prevented from sufficiently expanding to or toward the expanded configuration, insufficient gaseous space will be available for the position indicator 360 to produce an audible indication that can be heard or heard sufficiently clearly outside the patient.
[0043] In some embodiments, as an alternative to or in addition to being coupled to one or more of the position indicators described herein, an elongated tube (e.g., a nasogastric tube) can be coupled to one or more inflatable members configured to fix the position of the elongated tube relative to a patient cavity and/or passageway. For example, FIGS. 12 and 13 are a perspective view and a side view of a system 400. The system 400 can be the same or similar in structure and/or function to any of the systems described herein. The system 400 includes an elongated tube 410 having a first end 411 and a second end 413, a first securing inflatable member 430, and a second securing inflatable member 432. The elongated tube 410, the first securing inflatable member 430, and the second securing inflatable member 432 can be the same or similar in structure and/or function to any of the elongated tubes and inflatable members shown and described herein.
[0044] The elongated tube 410 can define a feeding lumen and a set of fenestrations 414 (also referred to as “openings”) defined in a sidewall of the elongated tube 410 in fluid communication with the lumen such that, when the first end 411 of the elongated tube 410 is disposed in a cavity of a patient (e.g., a stomach) and the second end 413 of the elongated tube 410 is disposed outside of the patient, fluid can be delivered from the second end 413 of the elongated tube 410 into the cavity via the feeding lumen and the set of fenestrations 414.
[0045] The first securing inflatable member 430 and the second securing inflatable member 432 are coupled to the elongated tube 410 and disposed proximally of the set of fenestrations 414. The first securing inflatable member 430 and the second securing inflatable member 432 can be coupled to the elongated member 410 such that the first securing inflatable member 430 is disposed distally of the second securing inflatable member 432. As shown, the first securing inflatable member 430 and the second securing inflatable member 432 can be coaxially arranged relative to each other and the elongated member 410, and no openings are defined in the portion of the sidewall of the elongated member 410 extending between the first securing inflatable member 430 and the second securing inflatable member 432. The first securing inflatable member 430 and the second securing inflatable member 432 are fluidically isolated from each other and separately inflatable (e.g., via separate inflation lumens defined by the elongated member 410). In some embodiments, one or both of the first securing inflatable member 430 and the second securing inflatable member 432 can be coupled to, associated with, or include any of the position indicators described herein, such as, for example, a whistle feature. In some embodiments, the elongated tube 410 is not coupled to or associated with an audible indication generating position indicator.
[0046] In use, after disposing the first end 411 of the elongated tube 410 in the stomach of the patient and with the elongated tube 410 extending through the patient’s esophagus and out of the patient’s nasal or oral orifice, the first securing inflatable member 430, which is disposed distally of the second securing inflatable member 432, can be expanded from an unexpanded to an expanded configuration (e.g., inflated). The elongated tube 410 can then be translated (e.g., pulled) proximally such that the first securing inflatable member 430 is pulled against the esophageal sphincter of the patient and the second securing inflatable member 432 is disposed within the esophagus of the patient. The second securing inflatable member 432 can then be expanded from an unexpanded to an expanded configuration (e.g., inflated). Using an ultrasound probe, the system 400 can be visualized to confirm that the second securing inflatable member 432 is disposed within the esophagus. Thus, the first securing inflatable member 430 and the second securing inflatable member 432 can be used to confirm the position of the first end 411 of the elongated tube 410 and to secure the first end 411 relative to the esophageal sphincter. Nutrient fluids and/or medication can then be delivered through the lumen into the stomach.
[0047] In some embodiments, after disposing the first end 411 of the elongated tube 410 in the stomach of the patient and with the elongated tube 410 extending through the patient’s esophagus and out of the patient’s nasal or oral orifice, the second securing inflatable member 432 can be expanded from an unexpanded to an expanded configuration (e.g., inflated). The first end 411 of the elongated tube 410 can then be urged distally into the small bowel (e.g., the duodenum) until the second securing inflatable member 432 contacts the pylorus and the first securing inflatable member 430 is disposed within the small bowel. The first securing inflatable member 430 can then be expanded from an unexpanded to an expanded configuration (e.g., inflated) within the small bowel. Using an ultrasound probe, the system 400 can be visualized to confirm if the second securing inflatable member 432 is in the small bowel. Thus, the first securing inflatable member 430 and the second securing inflatable member 432 can be used to confirm the position of the first end 411 of the elongated tube 410 and to secure the first end 411 relative to the pylorus. Nutrient fluids and/or medication can then be delivered through the lumen 412 into the small bowel. In some embodiments, the elongated tube 410 can define fenestrations proximal of the second securing inflatable member 432 in fluidic communication with fenestrations distal of the first securing inflatable member 430.
[0048] FIGS. 14-17 are various views of a portion of a distal portion of a system 500. FIG. 14 is a perspective view of the distal portion of the system 500. FIGS. 15 and 16 are a side view and a top view, respectively, of the distal portion of the system 500. FIG. 17 is a cross- sectional view of the distal portion of the system 500. The system 500 can be the same or similar in structure and/or function to any of the systems described herein. For example, the system 500 includes an elongated tube 510 defining a lumen 512 and fenestrations 514 in fluid communication with the lumen 512 near a first end of the elongated tube 510. The elongated tube 510 also defines a cavity 519 bounded by the elongated tube 510 and a cap 511 A disposed on the distal end of the elongated tube 511. A set of magnetic members 520 is disposed in the cavity 519. The set of magnetic members 520 can be the same or similar in structure and/or function to any of the magnetic members described herein, such as the magnetic member(s) 220. Although four magnetic members 520 are shown, any suitable number of magnetic members 520 can be included in the set. Although the magnetic members 520 are shown as being spherical, the magnetic members 520 can have any suitable shape. The set of magnetic members 520 can be configured to magnetically interact with an external magnetic assembly such that the external magnetic assembly can be used to urge the magnetic members 520, and thus the first end 511 of the system 500, toward or away from the external magnetic assembly such that the first end 511 can be navigated through the patient (e.g., into the esophagus and into the stomach of the patient). After delivering the first end 511 to the stomach of the patient, fluid (nutrients and/or medication) can be delivered to the stomach via the lumen 512 and the fenestrations 514.
[0049] FIG. 18 is a flow chart illustrating a method 600 of using any of the systems and/or assemblies described herein. The method 600 includes producing, at 602, a fluid flow through a lumen of an elongated tube such that the fluid flow interacts with a position indicator coupled to the elongated tube and disposed within a patient. The method 600 further includes determining, at 604, whether the position indicator generated an indication that the position indicator is disposed within a target cavity of the patient in response to the fluid flow, the indication being an indication differentiable from a sound naturally generated by the cavity of the patient. In some embodiments, the determining includes listening for whether an audible indication is emitted from a portion of a body of the patient associated with the target cavity. If no audible indication is emitted or no audible indication is emitted from the portion of the body of the patient associated with the target cavity, the position indicator can be determined to be not disposed in the target cavity. For example, no audible indication may be emitted because the position indicator is unable to generate the audible indication due to being disposed in a non-target cavity or passageway, such as because an inflatable member of the position indicator is unable to sufficiently inflate such that the audible indication can be produced. In some embodiments, no audible indication may be emitted from the portion of the body of the patient associated with the target cavity because the position indicator is disposed in a nontarget cavity or passageway and an audible indication is emitted from a portion of the body of the patient not associated with the target cavity. In some embodiments, the position indicator can include an inflatable member, and the producing can include applying pressure to a source of the fluid flow. The source of the fluid flow can be in fluid communication with the inflatable member via the lumen. The determining can include sensing a resistance of the source of the fluid flow to the applied pressure. For example, a resistance above a threshold resistance can be sensed (e.g., based on a resistance of a syringe plunger or a flexible bulb of the fluid source from being pressed to urge fluid into the inflatable member, or based on a volume of the syringe or bulb of the fluid source when the resistance increases signifying that the inflatable member is resistant to receiving additional fluid from the fluid source that the inflatable member would not be resistant or would be less resistant to receiving if the inflatable member were unconstrained). The resistance can be associated with the inflatable member being disposed within a non-target cavity or passageway that is not sufficiently large (e.g., lacks a sufficiently large cross-section) such that the inflatable member can expand to a particular diameter or volume (e.g., associated with the inflatable member when unconstrained and inflated within the target cavity and/or sufficiently large such that the indication can be produced). In some embodiments, upon determining that the position indicator is disposed in the target cavity, liquid fluid can be provided through a feeding lumen of the elongated tube to the target cavity. In some embodiments, upon determining that the position indicator is not disposed in the target cavity, the elongated tube can be manipulated (e.g., translated) to relocate the position indicator (e.g., from a non-target cavity or passageway to the target cavity). In some embodiments, the determining that the position indicator is not disposed in the target cavity includes determining that the indication was not produced.
[0050] FIG. 19 is a flow chart illustrating a method 700 of using any of the systems and/or assemblies described herein. The method 700 includes producing, at 702, a fluid flow through a lumen of an elongated tube such that the fluid flow interacts with an inflatable member coupled to the elongated tube and disposed within a patient. The inflatable member is configured to be inflated via the lumen. The method 700 further includes determining, at 704, whether the inflatable member is disposed within a non-target cavity or passageway of the patient based on a resistance of the inflatable member to the fluid flow. The producing can optionally include applying pressure to a source of the fluid flow, the source being in fluid communication with the inflatable member via the lumen. The determining can optionally include sensing a resistance of the source of the fluid flow to the applied pressure. For example, a resistance above a threshold resistance can be sensed (e.g., based on a resistance of a syringe plunger or a flexible bulb of the fluid source from being pressed to urge fluid into the inflatable member, or based on a volume of the syringe or bulb of the fluid source when the resistance increases signifying that the inflatable member is resistant to receiving additional fluid from the fluid source that the inflatable member would not be resistant or would be less resistant to receiving if the inflatable member were unconstrained). In some embodiments, upon determining that the inflatable member is not disposed in the non-target cavity or passageway, liquid fluid can be provided through a feeding lumen of the elongated tube to a target cavity. In some embodiments, upon determining that the inflatable member is disposed in the non- target cavity or passageway, the elongated tube can be manipulated to relocate the inflatable member. In some embodiments, the inflatable member is included in a position indicator, and the method can further include determining whether the position indicator generated an indication that the position indicator is disposed within a target cavity of the patient in response to the fluid flow. For example, upon determining that the inflatable member is not disposed in the non-target cavity or passageway (e.g., based on a lack of resistance to inflation of the inflatable member and/or the volume of fluid delivered to the inflatable member), the user can determine whether the position indicator generates an indication that the position indicator is disposed within the target cavity. The indication can be an indication differentiable from a sound naturally generated by the cavity of the patient. In some embodiments, the indication can be an audible indication and the determining can include listening for whether the audible indication is emitted from a portion of a body of the patient associated with the target cavity. For example, the position indicator can include a whistle feature and the user can deliver fluid through a whistle lumen and listen for a whistle to determine if the inflatable member is properly inflated (and thus disposed in a sufficiently large cavity such as the target cavity) and/or to determine if the position indicator is in the target cavity based the source of the audible indication relative to the patient’s body. Thus, in some embodiments, the placement of the distal end of an elongated tube can include a first step of confirming that an inflatable member of a position indicator is able to properly expand to an expanded configuration in a location, suggesting that the inflatable member is in a sufficiently large cavity that is likely to be the target cavity (e.g., the stomach) and not a non-target cavity or passageway (e.g., the esophagus, trachea, bronchi, or lungs), and a second step of confirming that an indication is able to be produced by the position indicator and/or that the indication is emitted from a portion of a patient’s body associated with (e.g., aligned with) the target cavity (e.g., the stomach).
[0051] 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.
[0052] 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.