Phrenic nerve pacing device

JP2024528254A5Pending Publication Date: 2025-08-08TEXAS MEDICAL CENT +1
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Patent Information

Application Number
JP2024506880
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-08-03
Filing Date
2022-08-02
Publication Date
2025-08-08

AI Technical Summary

Technical Problem

Existing methods for phrenic nerve stimulation in patients with central nervous system-induced respiratory failure are inadequate, particularly in the context of endotracheal stimulation systems that require improved electrode configurations and control mechanisms for effective pacing of the diaphragm.

Method used

An endotracheal stimulation system comprising a catheter with a distal portion featuring a bipolar or unipolar electrode pair, configured to fit within an endotracheal tube, and a guide sheath allowing axial translation, enabling constrained and unconstrained configurations for optimal phrenic nerve pacing.

Benefits of technology

The system effectively paces the phrenic nerve by ensuring comprehensive contact with the tracheal wall, facilitating diaphragm contraction and relaxation, thereby supporting inspiratory and expiratory phases of breathing.

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Abstract

In some embodiments, disclosed herein is an intratracheal stimulation platform, system, and method of using thereof for pacing the phrenic nerve, right phrenic nerve, and / or left phrenic nerve of a subject.In some embodiments, one or more electrode pairs are provided to contact a portion of the tracheal wall or trachea through an ET tube to enable phrenic nerve pacing.In some cases, one or more electrode pairs are configured to send electrical pulses that stimulate the phrenic nerve, thereby helping to promote the contraction and relaxation of diaphragm muscle.
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Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 228,939, filed August 3, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Phrenic nerve stimulation is a technique used to pace the diaphragm in patients with central nervous system etiologies of respiratory failure. Summary of the Invention

[0003] In a first aspect, the present invention provides an endotracheal stimulation system including a catheter, at least a distal portion of the catheter including an electrode pair including a proximal looped electrode and a distal looped electrode, the proximal looped electrode and the distal looped electrode being in electrical communication with a proximal portion of the system for connection to a control unit; and a guide sheath surrounding at least a portion of the catheter and having a lumen sized to fit within an endotracheal tube, the catheter being axially translatable relative to the endotracheal tube, the endotracheal stimulation system having a constrained configuration when at least a portion of the proximal looped electrode and the distal looped electrode are within the guide sheath, and an unconstrained configuration when at least a portion of the proximal looped electrode and the distal looped electrode extend outside the guide sheath and the electrode pair contacts a subject's trachea.

[0004] In some embodiments, the proximal loop electrode and the distal loop electrode are bipolar. In some embodiments, the proximal loop electrode and the distal loop electrode are monopolar. In some embodiments, the proximal loop electrode is coated with a proximal insulator, the distal loop electrode is coated with a distal insulator, or both. In some embodiments, the proximal loop electrode and the distal loop electrode are electrically insulated in the constrained configuration, the unconstrained configuration, or both. In some embodiments, the proximal point of the proximal loop electrode is closer to the proximal point of the distal loop electrode by an electrode offset in the constrained configuration, the unconstrained configuration, or both. In some embodiments, the electrode offset is measured as the distance between the distal point of the proximal loop electrode and the distal point of the distal loop electrode. In some embodiments, the electrode offset is about 0.25 cm to about 16 cm.

[0005] In another aspect, the invention provides an endotracheal stimulation system including a catheter, at least a distal portion of the catheter including an electrode pair, the electrode pair being in electrical communication with a proximal portion of the system for connection to a control unit, the distal portion of the catheter being biased to have a shape that is non-linear when in an unconstrained configuration, and a guide sheath surrounding at least a portion of the catheter and having a lumen sized to fit within an endotracheal tube, the catheter being axially translatable relative to the guide sheath, the endotracheal stimulation system having a constrained configuration when the distal portion of the catheter is within the guide sheath, the catheter axis and the guide sheath axis being axially aligned, and an unconstrained configuration when the distal portion of the catheter extends outside the guide sheath, at least a portion of the catheter axis and the guide sheath axis are angled such that the electrode pair contacts the trachea of ​​a subject.

[0006] In some embodiments, the electrode pair is bipolar. In some embodiments, the electrode pair is monopolar. In some embodiments, the distal portion of the catheter includes two or more electrode pairs. In some embodiments, the two or more electrode pairs are distributed along the length of the catheter. In some embodiments, each of the two or more electrode pairs is separated by an offset distance of about 0.25 cm to about 16 cm. In some embodiments, the catheter further includes a lumen. In some embodiments, the catheter is flexible, pliable, or both. In some embodiments, the catheter has a non-linear shape in the unconstrained configuration with a diameter of about 1 mm to about 35 mm. In some embodiments, the catheter has a non-linear shape in the unconstrained configuration with a minimum arc angle, average arc angle, or maximum arc angle of about 90 degrees to about 360 degrees.

[0007] In another aspect, the present invention provides an endotracheal stimulation system including a catheter at a distal end of the system configured to wrap around at least a portion of an endotracheal tube, the catheter including an electrode pair on an outer surface of the catheter, the electrode pair in electrical communication with a proximal portion of the system for connection to a control unit.

[0008] In some embodiments, the electrode pair is bipolar. In some embodiments, the electrode pair is unipolar. In some embodiments, the catheter includes two or more electrode pairs. In some embodiments, the two or more electrode pairs are evenly distributed along the length of the catheter.

[0009] In another aspect, the invention provides a method of pacing a subject, the method comprising: converting an endotracheal stimulation system from a constrained configuration to an unconstrained configuration by advancing a catheter out of a guide sheath to contact a wall of the trachea with an electrode pair, and powering the electrode pair in a pattern to pace the phrenic nerve of the subject. In some embodiments, the method further comprises bending the catheter, deforming the catheter, or both.

[0010] In another aspect, the invention provides a method of pacing a subject, the method including inserting a second system into a tracheal tube of the subject, converting the endotracheal stimulation system from a constrained configuration to an unconstrained configuration by advancing a catheter out of a guide sheath to contact a wall of the trachea with an electrode pair, and powering the electrode pair in a pattern to pace the subject's phrenic nerve. In some embodiments, the method further includes bending the catheter, deforming the catheter, or both.

[0011] In another aspect, the invention provides a method of pacing a subject, the method including inserting a third system into the trachea of ​​the subject, contacting a wall of the trachea with an electrode pair, and powering the electrode pair in a pattern to pace the phrenic nerve of the subject. In some embodiments, the method further includes bending the catheter, deforming the catheter, or both. [Brief description of the drawings]

[0012] The novel features of the present disclosure are set forth with particularity in the appended claims. The features and advantages of the present disclosure will be better understood by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings. [Figure 1] FIG. 1 is a diagram illustrating the location of the phrenic nerves of a subject, showing the oral cavity 001, trachea 010, left phrenic nerve 020, right phrenic nerve 030, spine 040, esophagus 050, bronchi 060, carina 065, left lung 070, right lung 080, and diaphragm 090. As shown, the left phrenic nerve 020 and right phrenic nerve 030 extend from the neck and branch off in parallel from either side of the spine at the C3, C4, and C5 cervical vertebrae, terminating at the diaphragm 090. [Diagram 2]FIG. 1 illustrates an exemplary endotracheal stimulation platform 1000. The system includes an endotracheal tube 200 configured to be inserted into a subject's trachea 010, and an endotracheal tube connector 300 that connects the endotracheal tube 200 to a ventilator 400 via a ventilator tube 410. The endotracheal tube connector 300 is also shown connecting the endotracheal tube 200 to a control unit 500 via two data cables 320. A sensor 310 is shown between the ventilator tube 410 and the endotracheal tube connector 300. The first endotracheal system 100 is shown in the exemplary form of two loop electrodes inside the subject's trachea 010. Anatomical landmarks such as the larynx 005, esophagus 050, and carina 065 are also illustrated. [Diagram 3] FIG. 1 illustrates a catheter 120 being introduced into the endotracheal tube connector 300 through the endotracheal tube connector port 340. The catheter 120 is shown traversing the guide sheath 110 through the guide sheath lumen. A locking mechanism 330 secures the data cable 320 to the endotracheal tube connector port 340. A ventilator tube 410 connects to the proximal end of the endotracheal tube connector 300. The distal end of the endotracheal tube connector 300 is configured to connect to the proximal end of the endotracheal tube 200. [Figure 4A] FIG. 1 is a side view of an exemplary first intratracheal stimulation system 100 in a restrained configuration. A catheter 120 and a guide sheath 110 are also shown. [Figure 4B] FIG. 1 is a side view of an exemplary first endotracheal stimulation system 100 between a constrained configuration and an unconstrained configuration. The distal loop electrode 130 is shown in an unconstrained configuration, while the proximal loop electrode 140 is shown in a constrained configuration. The distal and proximal catheter insulation 131, 141, and catheter 120 are shown near the opening at the distal end of the guide sheath 110. [Figure 4C]FIG. 1 is a side view of an exemplary first endotracheal stimulation system 100 in an unconstrained configuration. Distal loop electrode 130 and proximal loop electrode 140 are shown extending beyond an opening at the distal end of guide sheath 110 and unconstrained by guide sheath 110. Distal catheter insulation 131, proximal catheter insulation 141, and catheter 120 are also shown. [Figure 5A] FIG. 1 is a top view showing an exemplary first endotracheal stimulation system 100 in an unconstrained configuration, with the distal loop electrode 130 and the proximal loop electrode 140 in contact with the tracheal wall 015 of a subject. The distal loop electrode 130 and the proximal loop electrode 140 are physically separated from one another by an electrode offset 133. The distal catheter insulation 131, the proximal catheter insulation 141, the catheter 120, and the guide sheath 110 are shown extending through an opening at the distal end of the endotracheal tube 202. The endotracheal tube 200 is also shown to have a Murphy foramen 220 opening positioned near the opening 204 at the distal end of the endotracheal tube. The endotracheal tube cuff 210 is also shown in contact with the tracheal wall 015. The endotracheal tube lumen 205 is also shown. [Figure 5B] FIG. 1 illustrates a perspective view of an exemplary first endotracheal stimulation system 100 in an unconstrained configuration. Distal loop electrode 130 and proximal loop electrode 140 are physically separated from each other by an electrode offset 133. Distal catheter insulation 131 and proximal catheter insulation 141 are shown extending through an opening at the distal end of catheter 120. [Figure 6A] FIG. 6 illustrates a side view of an exemplary second endotracheal stimulation system 600 in a constrained configuration. A catheter 620 and a guide sheath 610 are shown extending through the distal opening 203 of the endotracheal tube 200. The endotracheal tube lumen 205 is also shown. [Figure 6B]FIG. 6 illustrates a side view of an exemplary second endotracheal stimulation system 600 in an unconstrained configuration. A catheter 620 is shown having multiple electrode pairs. Each of the illustrated electrode pairs 630 includes a distal electrode 631 and a proximal electrode 632. A guide sheath 610 is shown extending through an opening at the distal end of the endotracheal tube 200. [Figure 6C] 6 illustrates a top view of an exemplary distal region 625 of catheter 620 and four electrode pairs disposed along the length of catheter 620 in an unconstrained configuration. Catheter 620 is formed as a loop having an outer diameter 660 of the catheter. The distance from the outer edge of the first electrode pair 630 to the outer edge of the second electrode pair is shown as electrode outer diameter 670. The distance between distal electrode 631 and proximal electrode 632 along the length of catheter 620 is shown as electrode offset 633. The distance along the length of catheter 620 separating the first electrode pair from the second electrode pair is shown as electrode pair offset 635. Electrode length, electrode width 650, electrode outer edge 651, electrode inner edge 652, and electrode outer diameter 670 along the length of catheter 640 are also shown. [Figure 7] FIG. 7 illustrates a side view of a distal portion of an exemplary third endotracheal stimulation system 700. An endotracheal tube 200 is shown having an endotracheal tube cuff 210 at the distal end of the endotracheal tube 202 and an opening 204 at the distal end of the endotracheal tube. A helical catheter 720 is shown having a plurality of electrode pairs 730 and disposed along the length of the endotracheal tube 200. The helical catheter 720 wraps around the endotracheal tube 200 from the proximal end of the endotracheal tube 201 (not shown) to the distal end of the endotracheal tube 202. Each of the electrode pairs 730 includes a distal electrode 731 and a proximal electrode 732. The distal electrode 731 and the proximal electrode 732 are separated by a distance of an electrode offset 733 along the length of the helical shaped catheter 720. A pilot balloon line 215 is also shown. [Figure 8A]FIG. 7 illustrates a side view of a distal portion of a fourth endotracheal stimulation system 700. The illustrated endotracheal stimulation system has a collar-shaped catheter. The electrode pairs 730 are configured to wrap around the endotracheal tube 200. Each of the electrode pairs 730 includes a distal electrode 731, a proximal electrode 732, and a distance separating the distal electrode 731 from the proximal electrode referred to as the electrode offset 730. The endotracheal stimulation system 700 is also shown to have a gap 751, a protrusion 722, and an endotracheal tube 200 having a cuff 210 and a pilot balloon line 215. [Figure 8B] FIG. 7 illustrates a first collar-shaped catheter 750 of an exemplary third endotracheal stimulation system 700. A distal electrode 731, a proximal electrode 732, and an intermediate electrode 734 are shown at the distal end of the catheter. [Figure 8C] FIG. 7 illustrates a second collar-shaped catheter 751 of an exemplary third endotracheal stimulation system 700. Distal electrode 731 and proximal electrode 732 are shown at the distal end of catheter 720. Protrusions 722 and gaps 740 are also shown. The catheter is shown to have an electrode portion 735. [Figure 8D] FIG. 7 illustrates a third collar-shaped catheter 752 of the exemplary third endotracheal stimulation system 700. A plurality of distal electrodes 731 and proximal electrodes 732 are shown at the distal end of the catheter. Protrusions 722 and gaps 740 are also shown. [Figure 9A] FIG. 8 shows an exemplary fourth endotracheal stimulation system 800 having a catheter cuff 850 fitted over the endotracheal tube 200 in a restrained configuration. The endotracheal cuff 210 and pilot balloon line 215 are also shown. [Figure 9B] FIG. 8 shows an exemplary fourth endotracheal stimulation system 800 having a catheter cuff 850 in an unconstrained configuration. The catheter cuff 850 is shown superimposed with an endotracheal cuff (not shown). A plurality of cuff electrodes 830 are arranged circumferentially around the endotracheal tube 200 and separated from one another by cuff electrode offsets 833. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Provided herein are endotracheal stimulation platforms, systems, and methods of use thereof for pacing a subject's phrenic nerve, right phrenic nerve, and / or left phrenic nerve (FIG. 1). In some embodiments, one or more electrode pairs are provided to contact a portion of the tracheal wall or trachea through an ET tube to enable phrenic nerve pacing. For example, in some cases, one or more electrode pairs are configured to transmit electrical pulses that stimulate the phrenic nerve, thereby helping to promote diaphragm muscle contraction and relaxation. Such diaphragm muscle contraction and relaxation helps to promote the inhalation and exhalation phases of breathing.

[0014] Intratracheal Stimulation Platform In general, the endotracheal stimulation (ETS) platform of the present invention may include one or more endotracheal stimulation systems, one or more control units, and / or one or more ventilators functionally connected thereto. In some embodiments, the ETS platform 1000 includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 , 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 ETS systems. In some embodiments, the ETS systems are configured identically. In some embodiments, each ETS system is configured differently from other ETS systems in the ETS platform. In some embodiments, the ETS platform 1000 includes one or more ETS systems in any combination of configurations.

[0015] The ETS platform 1000 may include one or more control units 500 in some embodiments. The control unit 500 may be a hardware system, a software system, or a combination of hardware and software systems. In some embodiments, the control unit 500 is one or more computing devices. In some embodiments, the control unit 500 includes one or more data inputs and data outputs for unidirectional and / or multidirectional (e.g., bidirectional, between 3 or more devices, between 4 or more devices, between 5 or more devices, between 6 or more devices, between 7 or more devices, between 8 or more devices, between 9 or more devices, or between 10 or more devices) data transfer between the control unit 500 and any one or more components of the ETS platform 1000 (e.g., one or more ETS systems and / or ventilator systems). In some embodiments, the control unit 500 determines that the subject is in an inspiratory or expiratory cycle based on data measured by the sensor 310 and one or more patient monitoring devices, as described further below.

[0016] In some embodiments, the control unit 500 provides power to at least a portion of one or more electrode pairs for any of the intratracheal stimulation systems described herein. In some embodiments, the catheter 120 includes two or more of the electrode pairs, and the control unit 500 provides power to at least a portion of the two or more electrode pairs 150 based on the location of the two or more electrode pairs in the trachea 010 of the subject. In some embodiments, the control unit 500 controls the current provided to the one or more electrode pairs. In some embodiments, the control unit 500 is programmable to output power to the one or more electrode pairs 150 for controlled pacing. In some embodiments, the controlled pacing includes one or more controlled pacing parameters, such as intensity, frequency, and duration. In some embodiments, the intensity is based on current, voltage, or both. In some embodiments, the control unit 500 is programmable to output electricity to the one or more electrode pairs 150 based on data received by the sensor 310. In some embodiments, the control unit 500 uses machine learning algorithms and / or artificial intelligence to optimize the airflow rate of the subject. In some embodiments, the control unit 500 is further programmed to stop pacing and / or ventilation if one or more measured parameters of interest (e.g., blood pressure, blood oxygen content) exceed a set threshold.

[0017] In some embodiments, the ETS platform 1000 includes one or more ventilators. In some embodiments, the ventilator is any conventional device, apparatus, or system for delivering respiratory gas to a patient, such as a ventilator, a ventilator, a CPAP machine, or a BiPAP machine, among others. In some embodiments, the ventilator can provide a continuous mandatory ventilation (CMV) output, i.e., an output having parameters set by an operator without any feedback from the subject. In general, the ventilator periodically delivers respiratory gas at its output at a regulated pressure and frequency appropriate for ventilation of the subject. The present invention may be used with other sources of respiratory gas at a regulated pressure suitable for delivery to the subject, such as, for example, any device capable of providing a CPAP output. Some types of ventilators do not require a power source and are driven only by gas pressure derived from an oxygen cylinder or the like. Alternatively, the ventilator may be a simple electric ventilator with a compressor that fills a gas pressure vessel.

[0018] In some embodiments, the ETS platform 1000 includes one or more monitoring devices. In some embodiments, the one or more monitoring devices are functionally connected to other components of the ETS platform 1000 (e.g., the ventilator and / or the control unit). In some embodiments, the monitoring devices can collect and display (either on their own display or on another connected device having a display) information regarding one or more physiological parameters of the subject. In some embodiments, the physiological parameters that may be monitored include subject vital signs such as body temperature, pulse rate (or heart rate), blood pressure, oxygen saturation, respiratory rate, heart rate variability, pulse pressure strength, concentrations of substances in the blood and / or tissue, similar parameters indicative of the vitality of the human body, or any combination thereof. In some embodiments, the intratracheal stimulation platform 1000 further includes one or more subject sensors. In some embodiments, the one or more subject sensors include skin contact electrodes, accelerometers, thermometers, pressure sensors, air sensors 310, or any combination thereof. In some embodiments, as shown in FIG. 2, one or more target sensors are in wired and / or wireless communication with the control unit 500 (eg, as one or more data cables 320).

[0019] Intratracheal Stimulation System The endotracheal stimulation (ETS) system described herein generally includes a guide sheath, a catheter, an endotracheal (ET) tube, an ET tube connector, a sensor, and one or more electrode pairs. Exemplary embodiments of the ETS system of the present invention are further described below and in the drawings (FIGS. 2-9B).

[0020] The ETS system of the present invention is generally configured to be in electrical communication with the control unit 500 of the ETS platform 1000 (FIG. 2). In some embodiments, the electrical communication is wired, wireless, or both. In some embodiments, one or more wires extend through one or more data cables and are configured to connect to one or more electrodes of any one or more embodiments described herein. In some embodiments, the ETS system includes a locking mechanism 330 to ensure that electrical communication is maintained throughout operation. In some embodiments, the locking mechanism may be any reversible locking mechanism known in the art (e.g., a clutch lock, a cam lock, a shock lock, a spring button lock, or a swaging lock). In some embodiments, the locking mechanism secures the ETS system to the endotracheal tube connector port 340. In some embodiments, the locking mechanism 330 is used to ensure that the ETS system is coupled in place to the ET tube connector 300.

[0021] In some embodiments, one or more electrode pairs of the ETS system are configured to be positioned at an endotracheal stimulation site through the lumen of the ET tube 205 (FIGS. 2, 3, 4A-4C, 5A-5B, and 6A-6C). In some embodiments, one or more electrode pairs are configured to be positioned at an endotracheal stimulation site around the ET tube 200 (FIGS. 7, 8A-8D). In some embodiments, one or more electrode pairs are configured to be positioned at an endotracheal stimulation site around the ET tube cuff 210 (FIGS. 9A-9B).

[0022] In some embodiments, the ETS system includes one or more electrode pairs, each electrode pair including at least one distal electrode and at least one proximal electrode. In some embodiments, the distal electrode is positioned distal to the proximal electrode and near the distal end of the ETS system. The proximal-to-distal axis is generally used herein with respect to the longitudinal axis of the ET tube. For example, the distal electrode is positioned at least partially closer to the distal end of the proximal electrode of the ET tube. In some embodiments, the first electrode pair may be positioned distal to the second electrode pair. In some embodiments, multiple electrode pairs may be arranged along the longitudinal axis of the ET tube in a proximal-to-distal configuration. In some embodiments, the guide sheath, catheter, and / or one or more electrode pairs are translatable along the longitudinal axis, the longitudinal axis extending from the proximal end of the ET tube 200 to the distal end of the ET tube 200.

[0023] In some embodiments, the catheter 120 of any of the ETS systems described herein may include a catheter lumen. In some embodiments, the catheter is formed as a cylindrical rod having a lumen through which one or more electrode pairs can be inserted and delivered to the endotracheal stimulation system, as shown in Figures 2, 4A-4C, and 5A-5B. In some embodiments, the catheter 620 is a support configured to support one or more electrode pairs, as shown in Figures 6A-6C, 7, and 8A-8D. In some embodiments, the catheter is configured to be translatable along the length of the ET tube 200 through the ET tube lumen 205 (Figure 5A). In some embodiments, the catheter is formed to concentrically surround the ET tube (e.g., a collar configuration as shown in Figures 8A-8D and 9A-9B) and is configured to be translatable along the length of the ET tube 200.

[0024] In some embodiments, the ETS system includes an ET tube 200, as seen in Figure 7. In some embodiments, the ET tube includes an ET tube cuff 210, a Murphy hole 220, an ET tube proximal end 201, an ET tube distal end 202, an opening 203 at the ET tube proximal end, an opening 204 at the ET tube distal end, and an ET tube lumen 205.

[0025] First intratracheal stimulation system In a first aspect, the ETS platform 1000 includes a first ETS system 100 (FIGS. 2-5B). The first ETS system may include, in some embodiments, an ET tube 200, an ET tube connector 300, a guide sheath 110, a catheter 120, a sensor 310, and one or more electrode pairs 150 (FIGS. 4A-4C). FIG. 3 shows a catheter 120 being introduced into an endotracheal tube connector 300 through an endotracheal tube connector port 340. The catheter 120 is shown traversing the guide sheath 110 through the guide sheath lumen. A locking mechanism 330 secures a data cable 320 to the endotracheal tube connector port 340. A ventilator tube 410 connects with a proximal end of the endotracheal tube connector 300. A distal end of the endotracheal tube connector 300 is configured to connect with a proximal end of the endotracheal tube 200. In some embodiments, one or more components of the first ETS system are configured to be positioned within an ET tube 200, which is configured to be inserted into the trachea of ​​a subject. In some embodiments, the ETS system does not include a catheter 120, and the electrode pairs are supported by the ET tube.

[0026] electrode 4A-5B show a distal portion of a first ETS system, where an electrode pair 150 includes a distal electrode 130 and a proximal electrode 140. In some embodiments, the distal end of each electrode is formed into a loop (FIGS. 4A-5B). In some embodiments, the looped electrodes 130 and 140 are located at the distal end of the catheter 120. In some embodiments, the ETS system 100 has a constrained configuration (FIG. 4A) in which the electrodes 130, 140 are disposed within the guide sheath 110. In some embodiments, the ETS system has an unconstrained configuration (FIG. 4C) in which the electrodes 130, 140 extend from the distal end of the guide sheath 110. In some embodiments, the ability of the proximal electrode 140 and the distal electrode 130 to convert from the constrained configuration to the unconstrained configuration allows for a catheter 120 of reduced size to be used with the ETS system, which causes less stress on the trachea and / or other internal organs. In some embodiments, in the constrained configuration, at least a portion of the proximal electrode 140 and the distal electrode 130 are within the lumen of the guide sheath 110. In some embodiments, in the unconstrained configuration, at least a portion of the proximal electrode 140 and the distal electrode 130 extend outside of the guide sheath 110. In some embodiments, the proximal electrode 140 and the distal electrode 130 translate independently within the guide sheath 110. In some embodiments, in the constrained configuration, the proximal electrode 140 and the distal electrode 130 do not touch the ET tube 200 or the subject's trachea. In some embodiments, in the constrained configuration, the proximal electrode 140 and the distal electrode 130 are entirely within the ET tube 200. In some embodiments, the proximal electrode 140 and the distal electrode 130 are electrically isolated in the constrained configuration, the unconstrained configuration, or both.

[0027] In some embodiments, the ETS system includes a distal electrode 130 (FIGS. 4B-5B) and a proximal electrode 140 (FIGS. 4B-5B), where the distal electrode 130 is at least partially encased by a distal insulator 131 and the proximal electrode 140 is at least partially encased by a proximal insulator 141. Generally, the electrode pair 150 is translatable along a longitudinal axis, which extends from a proximal end of the ET tube 200 to a distal end of the ET tube 200. In some embodiments, the electrode pair 150 is translatable along the length of the ET tube 200.

[0028] In some embodiments, electrodes 130 and / or 140 are about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, Approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, approximately 35 cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm, approximately 48cm, Approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 60cm, approximately 61cm, approximately 62 cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, approximately 75cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm). In some embodiments, electrodes 130 and / or 140 have a length of 10 cm to 100 cm (e.g., 10 cm to 90 cm, 10 cm to 80 cm, 10 cm to 70 cm, 10 cm to 60 cm, 10 cm to 50 cm, 10 cm to 40 cm, 10 cm to 30 cm, 20 cm to 90 cm, 30 cm to 80 cm, 40 cm to 70 cm, or 50 cm to 60 cm). In some embodiments, electrodes 130 and / or 140 have a length of at least about 1 cm, 5 cm, 10 cm, 25 cm, or 50 cm. In some embodiments, electrodes 130 and / or 140 have a length of up to about 500 cm, 250 cm, 100 cm, 75 cm, 50 cm, 25 cm, or 10 cm.

[0029] In some embodiments, the loop of electrodes 130 and / or 140 has a diameter of about 1 mm to about 35 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, or about 35 mm). In some embodiments, the loops have a diameter of 1 mm to 35 mm (e.g., 2 mm to 35 mm, 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, 20 mm to 30 mm, or 25 mm to 35 mm). In some embodiments, the loops of electrodes 130 and / or 140 have a diameter of at least about 1 mm, 5 mm, 10 mm, 15 mm, or 20 mm. In some embodiments, the loops of electrodes 130 and / or 140 have a diameter of up to about 35 mm, 30 mm, or 25 mm.

[0030] In some embodiments, the loop of electrodes 130 and / or 140 may be between about 3 mm and about 110 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm , approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 7 2mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, approximately 77mm, approximately 78mm, approximately 79mm, approximately 80mm, approximately 81mm, approximately 82mm, approximately 83mm, approximately 84mm, approximately 85mm, approximately 86mm, approximately 87m m, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).In some embodiments, the loop of electrodes 130 and / or 140 has a circumference of 3 mm to 110 mm (e.g., 5 mm to 100 mm, 10 mm to 90 mm, 20 mm to 80 mm, 30 mm to 70 mm, 40 mm to 60 mm, 3 mm to 100 mm, 3 mm to 90 mm, 3 mm to 80 mm, 3 mm to 70 mm, 3 mm to 60 mm, 3 mm to 50 mm, 3 mm to 40 mm, 5 mm to 110 mm, 10 mm to 110 mm, 20 mm to 110 mm, 30 mm to 110 mm, 40 mm to 110 mm, 50 mm to 110 mm, 60 mm to 110 mm, 70 mm to 110 mm, 80 mm to 110 mm, 90 mm to 110 mm, or 100 mm to 110 mm). In some embodiments, the loops of electrodes 130 and / or 140 have a circumference of at least about 3 mm, 10 mm, 25 mm, 50 mm cm, or 75 mm. In some embodiments, the loops of electrodes 130 and / or 140 have a circumference of at most about 110 mm, 100 mm, 90 mm, or 80 mm.

[0031] In some embodiments, the electrode pair 150 (e.g., 130 and 140) is separated by an electrode offset distance 133 (FIG. 5A). In general, the electrode offset determines the radius of the electric field, which in turn determines the effectiveness of the phrenic nerve stimulation. In some embodiments, the offset 133 is generated when an operator or control unit translates one electrode of the electrode pair (e.g., 130 and 140) further distally than the other electrode. In some embodiments, the offset 133 is established during manufacture of the ETS system, and the electrode pair is fixed to each other at a predetermined offset before being inserted into the catheter lumen. In some embodiments, the offset is measured along the longitudinal axis of the catheter 120 (FIG. 5B) from the distal end of the proximal insulator 141 to the distal end of the distal insulator 131 (FIG. 5A). In some embodiments, the offset is measured from the distal end of the loop of the proximal electrode 140 to the distal end of the loop of the distal electrode 130 when the electrode pair 150 is in the unconstrained configuration (FIG. 5B). In some embodiments, the electrode offset 133 is measured in the constrained configuration. In some embodiments, the electrode offset 133 is measured in the unconstrained configuration. In some embodiments, the electrode offset 133 in the unconstrained configuration is approximately equal to the electrode offset 133 in the constrained configuration. In some embodiments, the electrode offset 133 in the unconstrained configuration is equal to the electrode offset 133 in the constrained configuration. In some embodiments, the electrode offset 133 in the unconstrained configuration is greater than the electrode offset 133 in the constrained configuration. In some embodiments, the electrode offset 133 in the unconstrained configuration is less than the electrode offset 133 in the constrained configuration. In some embodiments, the electrode offset is between about 0.25 cm and about 40 cm (e.g., about 0.25 cm, about 0.3 cm, about 0.4 cm, about 0.5 cm, about 0.6 cm, about 0.7 cm, about 0.8 cm, about 0.9 cm, about 1 cm, about 1.1 cm, about 1.2 cm, about 1.3 cm, about 1.4 cm, about 1.5 cm, about 1.6 cm, about 1.7 cm, about 1.8 cm, about 1.9 cm, about 2 cm, about 2.1 cm, about 2.2 cm, about 2.3 cm, about 2.4 cm, about 2.5 cm, about 2.6 cm, about 2.7 cm, about 2.8 cm, about 2.9 cm, about 3 cm, about 3.1 cm, about 3.2 cm, about 3.3 cm, about 3.4 cm, about 3.5 cm, about 3.6 cm, about 3.7 cm, about 3.8 cm, about 3.9 cm, about 4.1 cm, about 4.2 cm, about 4.3 cm, about 4.4 cm, about 4.5 cm, about 4.6 cm, about 4.7 cm, about 4.8 cm, about 4.9 cm, about 5.1 cm, about 5.2 cm, about 5.3 cm, about 5.4 cm, about 5.5 cm, about 5.6 cm, about 5.7 cm, about 5.8 cm, about 5.9 cm, about 6.1 cm, about 6.2 cm, about 6.3 cm, about 6.4 cm, about 6.5 cm, about 6.6 cm, about 6.7 cm, about 6.8 cm, about 6.9 cm, about 7.1 cm, about 7.2 cm, about 7.3 cm, about 7.4 cm, about 7.52 cm, approximately 3.3 cm, approximately 3.4 cm, approximately 3.5 cm, approximately 3.6 cm, approximately 3.7 cm, approximately 3.8 cm, approximately 3.9 cm, approximately 4 cm, approximately 4.1 cm, approximately 4.2 cm, approximately 4.3 cm, approximately 4.4 cm, approximately 4.5 cm, approximately 4.6 cm, approximately 4.7 cm, approximately 4.8 cm, approximately 4.9 cm, approximately 5 cm, approximately 5.1 cm, approximately 5.2 cm, approximately 5.3 cm, approximately 5.4 cm, approximately 5.5 cm, approximately 5.6 cm, approximately 5.7 cm, approximately 5.8 cm, approximately 5.9 cm, approximately 6 cm, approximately 6.1 cm, approximately 6.2 cm, approximately 6.3 cm, approximately 6.4 cm, approximately 6.5 cm, approximately 6.6 cm, approximately 6.7 cm, approximately 6.8 cm, approximately 6.9 cm, approximately 7 cm, approximately 7.1 cm, approximately 7.2 cm, approximately 7.3 cm, approximately 7.4 cm, approximately 7.5 cm, approximately 7.6 cm, approximately 7.7 cm, approximately 7.8 cm, approximately 7.9 cm, approximately 8 cm, approximately 8.1 cm, approximately 8.2 cm, approximately 8.3 cm, approximately 8.4 cm, approximately 8.5 cm, approximately 8.6 cm, approximately 8.7 cm, approximately 8.8 cm, approximately 8.9 cm, approximately 9 cm, approximately 9.1 cm, approximately 9.2 cm, approximately 9.3 cm, approximately 9.4 cm, approximately 9.5 cm, approximately 9.6 cm, approximately 9.7 cm, approximately 9.8 cm, approximately 9.9 cm, approximately 10 cm, approximately 10.1 cm, approximately 10.2 cm, approximately 10.3 cm, approximately 10.4 cm, approximately 10.5 cm, approximately 10.6 cm, approximately 10.7 cm, approximately 10.8 cm, approximately 10.9 cm, approximately 11 cm, approximately 11.1 cm, approximately 11.2 cm, approximately 11.3 cm, approximately 11.4 cm, approximately 11.5 cm, approximately 11.6 cm, approximately 11.7 cm, approximately 11.8 cm, approximately 11.9 cm, approximately 12 cm, approximately 12.1 cm, approximately 12.2 cm, approximately 12.3 cm, approximately 12.4 cm, approximately 12.5 cm, approximately 12.6 cm, approximately 12.7 cm, approximately 12.8 cm, approximately 12.9 cm, approximately 13 cm, approximately 13.1 cm, approximately 13.2 cm, approximately 13.3 cm, approximately 13.4 cm, approximately 13.5 cm, approximately 13.6 cm, approximately 13.7 cm, approximately 13.8 cm, approximately 13.9 cm, approximately 14 cm, approximately 14.1 cm, approximately 14.2 cm, approximately 14.3 cm, approximately 14.4 cm, approximately 14.5 cm, approximately 14.6 cm, approximately 14.7 cm, approximately 14.8 cm, approximately 14.9 cm, approximately 15 cm, approximately 15.1 cm, approximately 15.2 cm, approximately 15.3 cm, approximately 15.4 cm, approximately 15.5 cm, approximately 15.6 cm, approximately 15.7 cm, approximately 15.8 cm, approximately 15.9 cm, approximately 16 cm, approximately 16.1 cm, approximately 16.2 cm, approximately 16.3 cm, approximately 16.4 cm, approximately 16.5 cm, approximately 16.6 cm, approximately 16.7 cm, approximately 16.8 cm, approximately 16.9 cm, approximately 17 cm, approximately 17.1 cm, approximately 17.2 cm, approximately 17.3 cm, approximately 17.4 cm, approximately 17.5 cm, approximately 17.6 cm, approximately 17.7 cm, approximately 17.8 cm, approximately 17.9 cm, approximately 18 cm, approximately 18.1 cm, approximately 18.2 cm, approximately 18.3 cm, approximately 18.4 cm, approximately 18.5 cm, approximately 18.6 cm, approximately 18.7 cm, approximately 18.8 cm, approximately 18.9 cm, approximately 19 cm, approximately 19.1 cm, approximately 19.2 cm, approximately 19.3 cm, approximately 19.4 cm, approximately 19.5 cm, approximately 19.6 cm, approximately 19.7 cm, approximately 19.8 cm, approximately 19.9 cm, approximately 20 cm, approximately 20.1 cm, approximately 20.2 cm, approximately 20.3 cm, approximately 20.4 cm, approximately 20.5 cm, approximately 20.6 cm, approximately 20.7 cm, approximately 20.8 cm, approximately 20.9 cm, approximately 21 cm, approximately 21.1 cm, approximately 21.2 cm, approximately 21.3 cm, approximately 21.4 cm, approximately 21.5 cm, approximately 21.6 cm, approximately 21.7 cm, approximately 21.8 cm, approximately 21.9 cm, approximately 22 cm, approximately 22.1 cm, approximately 22.2 cm, approximately 22.3 cm, approximately 22.4 cm, approximately 22.5 cm, approximately 22.6 cm, approximately 22.7 cm, approximately 22.8 cm, approximately 22.9 cm, approximately 23 cm, approximately 23.1 cm, approximately 23.2 cm, approximately 23.3 cm, approximately 23.4 cm, approximately 23.5 cm, approximately 23.6 cm, approximately 23.7 cm, approximately 23.8 cm, approximately 23.9 cm, approximately 24 cm, approximately 24.1 cm, approximately 24.2 cm, approximately 24.3 cm, approximately 24.4 cm, approximately 24.5 cm, approximately 24.6 cm, approximately 24.7 cm, approximately 24.8 cm, approximately 24.9 cm, approximately 25 cm, approximately 25.1 cm, approximately 25.2 cm, approximately 25.3 cm, approximately 25.4 cm, approximately 25.5 cm, approximately 25.6 cm, approximately 25.7 cm, approximately 25.8 cm, approximately 25.9 cm, approximately 26 cm, approximately 26.1 cm, approximately 26.2 cm, approximately 26.3 cm, approximately 26.4 cm, approximately 26.5 cm, approximately 26.6 cm, approximately 26.7 cm, approximately 26.8 cm, approximately 26.9 cm, approximately 27 cm, approximately 27.1 cm, approximately 27.2 cm, approximately 27.3 cm, approximately 27.4 cm, approximately 27.5 cm, approximately 27.6 cm, approximately 27.7 cm, approximately 27.8 cm, approximately 27.9 cm, approximately 28 cm, approximately 28.1 cm, approximately 28.2 cm, approximately 28.3 cm, approximately 28.4 cm, approximately 28.5 cm, approximately 28.6 cm, approximately 28.7 cm, approximately 28.8 cm, approximately 28.9 cm, approximately 29 cm, approximately 29.1 cm, approximately 29.2 cm, approximately 29.3 cm, approximately 29.4 cm, approximately 29.5 cm, approximately 29.6cm, approximately 29.7cm, approximately 29.8cm, approximately 29.9cm, approximately 30cm, approximately 30.1cm, approximately 30.2cm, approximately 30.3cm, approximately 30.4cm, approximately 30.5cm, approximately 30.6cm, approximately 30.7cm, approximately 30.8cm, approximately 30. 9cm, approximately 31cm, approximately 31.1cm, approximately 31.2cm, approximately 31.3cm, approximately 31.4cm, approximately 31.5cm, approximately 31.6cm, approximately 31.7cm, approximately 31.8cm, approximately 31.9cm, approximately 32cm, approximately 32.1cm, approximately 32.2cm 32.3cm, 32.4cm, 32.5cm, 32.6cm, 32.7cm, 32.8cm, 32.9cm, 33cm, 33.1cm, 33.2cm, 33.3cm, 33.4cm, 33.5cm , approximately 33.6cm, approximately 33.7cm, approximately 33.8cm, approximately 33.9cm, approximately 34cm, approximately 34.1cm, approximately 34.2cm, approximately 34.3cm, approximately 34.4cm, approximately 34.5cm, approximately 34.6cm, approximately 34.7cm, approximately 34.8cm, Approximately 34.9cm, approximately 35cm, approximately 35.1cm, approximately 35.2cm, approximately 35.3cm, approximately 35.4cm, approximately 35.5cm, approximately 35.6cm, approximately 35.7cm, approximately 35.8cm, approximately 35.9cm, approximately 36cm, approximately 36.1cm, approximately 3 6.2cm, approximately 36.3cm, approximately 36.4cm, approximately 36.5cm, approximately 36.6cm, approximately 36.7cm, approximately 36.8cm, approximately 36.9cm, approximately 37cm, approximately 37.1cm, approximately 37.2cm, approximately 37.3cm, approximately 37.4cm, approximately 37 0.5 cm, about 37.6 cm, about 37.7 cm, about 37.8 cm, about 37.9 cm, about 38 cm, about 38.1 cm, about 38.2 cm, about 38.3 cm, about 38.4 cm, about 38.5 cm, about 38.6 cm, about 38.7 cm, about 38.8 cm, about 38.9 cm, about 39 cm, about 39.1 cm, about 39.2 cm, about 39.3 cm, about 39.4 cm, about 39.5 cm, about 39.6 cm, about 39.7 cm, about 39.8 cm, about 39.9 cm, or about 40 cm). In some embodiments, the electrode offset 133 is at least about 0.5 cm, 1 cm, 2 cm, or 5 cm. In some embodiments, the electrode offset 133 is at most about 10 cm, 7 cm, or 5 cm.

[0032] In some embodiments, the electrode pair 150 contacts the subject's trachea. In some embodiments, in the unconstrained configuration, the proximal electrode 140 and the distal electrode 130 contact the subject's tracheal wall 015 (FIG. 5A), thereby enabling phrenic nerve pacing as described herein. In some embodiments, in the unconstrained configuration, the proximal electrode 140 and the distal electrode 130 are configured to contact at least about 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 95% of the inner circumference of the subject's tracheal wall. In some embodiments, in the unconstrained configuration, the proximal electrode 140 and the distal electrode 130 contact the entire tracheal wall of the subject at a location along the proximal-distal axis of the trachea. In some embodiments, in the unconstrained configuration, at least a portion of the proximal electrode 140 and the distal electrode 130 contact the subject's tracheal tube.

[0033] In some embodiments, the proximal electrode 140 and the distal electrode 130 are made of the same conductive material. In some embodiments, the proximal electrode 140 and the distal electrode 130 are made of different conductive materials. In some embodiments, the conductive material is a material that is a conductor of electricity, including, but not limited to, pure metals or alloys commonly used in the art to make wire electrodes. In some embodiments, the conductive material is selected from silicon, platinum, iridium, polyimide, gold, ceramic, nickel, titanium, copper, iron, chromium, or alloys or combinations thereof.

[0034] In some embodiments, the proximal electrode 140 and the distal electrode 130 are bipolar. In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerves that run parallel to the trachea (e.g., the left phrenic nerve 020, the right phrenic nerve 030, or both). In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerves that run parallel to the trachea, regardless of the angular orientation of the catheter 120 relative to the trachea. In some embodiments, the proximal electrode 140 and the distal electrode 130 are unipolar. In some embodiments, in the unconstrained configuration, at least a portion of the proximal electrode 140 and the distal electrode 130 extend beyond the ET tube 200.

[0035] In some embodiments, one or more electrode pairs are configured to pass through the lumen of the catheter 120. Generally, each electrode is configured to extend through at least a portion (e.g., about 1% to about 99% of the length of the electrode, e.g., about 10% to about 99%, about 20% to about 99%, 30% to about 99%, about 40% to about 99%, about 50% to about 99%, about 60% to about 99%, about 70% to about 99%, about 80% to about 99% of the length of the electrode) of the catheter 120. %, about 85% to about 99%, about 86% to about 99%, about 87% to about 99%, about 88% to about 99%, about 89% to about 99%, about 90% to about 99%, about 91% to about 99%, about 92% to about 99%, about 93% to about 99%, about 94% to about 99%, about 95% to about 99%, about 96% to about 99%, about 97% to about 99%, or about 98% to about 99%) is covered by the insulator. In some embodiments, each electrode has at least a portion where 1%-99% (e.g., 10%-99%, 20%-99%, 30%-99%, 40%-99%, 50%-99%, 60%-99%, 70%-99%, 80%-99%, 85%-99%, 86%-99%, 87%-99%, 88%-99%, 89%-99%, 90%-99%, 91%-99%, 92%-99%, 93%-99%, 94%-99%, 95%-99%, 96%-99%, 97%-99%, or 98%-99%) of the electrode's length is covered by the insulator. In some embodiments, the insulator resists current flow and / or provides a dielectric constant that is less than about 10%. 7 Ω m ~ approx. 10 15 Ω·m (e.g., about 10 8Ω m ~ approx. 10 15 Ω m, approximately 10 9 Ω m~10 14 Ω m, approximately 10 10 Ω m ~ approx. 10 13 Ω m, or approximately 10 10 Ω m ~ approx. 10 12 In some embodiments, the insulator is made of any material that has a resistivity of at least about 10 7 Ω m, 10 8 Ω m, 10 9 Ω m, 10 10 Ω m, 10 11 Ω m, 10 12 Ω m, 10 13 Ω m, 10 14 Ω m, or 10 15 In some embodiments, the insulator is made of any material that has a resistivity of at least about 10 10It is made of any material with a resistivity of Ω·m. Examples of suitable insulator materials may include, but are not limited to, polymeric insulators (such as silicone, polyurethane, polytetrafluoroethylene (e.g., TEFLON™), or other fluoropolymers), ceramic insulators, or glass insulators. The insulating coating allows for control, direction, and focus of the stimulation signal delivered by the electrode to the phrenic nerve. The insulating coating also allows for the electrode to be divided into multiple electrode stimulation regions to optimize stimulation location and / or to operate in multiple electrode configurations such as bipolar or tripolar electrodes. In some embodiments, electrode insulators 141 and / or 131 (FIG. 4C) are between about 0.5 mm and about 10 mm (e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4mm, approximately 2.5mm, approximately 2.6mm, approximately 2.7mm, approximately 2.8mm, approximately 2.9mm, approximately 3mm, approximately 3.1mm, approximately 3.2mm, approximately 3.3mm, approximately 3.4mm, approximately 3.5mm, approximately 3.6mm, approximately 3.7mm, approximately 3.8mm, approximately 3.9mm, approximately 4mm, approximately 4.1mm, approximately 4.2mm, approximately 4.3mm, approximately 4.4mm, approximately 4.5mm, approximately 4.6mm, approximately 4.7mm, approximately 4.8mm, approximately 4.9mm, approximately 5mm, approximately 5.1mm, approximately 5.2mm, approximately 5.3mm, approximately 5.4mm, approximately 5.5mm, approximately 5.6mm, approximately 5.7mm, approximately 5.8mm, approximately 5.9mm, approximately 6mm, approximately 6.1mm, approximately 6.2mm, approximately 6. 3mm, approximately 6.4mm, approximately 6.5mm, approximately 6.6mm, approximately 6.7mm, approximately 6.8mm, approximately 6.9mm, approximately 7mm, approximately 7.1mm, approximately 7.2mm, approximately 7.3mm, approximately 7.4mm, approximately 7.5mm, approximately 7. 6 mm, about 7.7 mm, about 7.8 mm, about 7.9 mm, about 8 mm, about 8.1 mm, about 8.2 mm, about 8.3 mm, about 8.4 mm, about 8.5 mm, about 8.6 mm, about 8.7 mm, about 8.8 mm, about 8.9 mm, about 9 mm, about 9.1 mm, about 9.2 mm, about 9.3 mm, about 9.4 mm, about 9.5 mm, about 9.6 mm, about 9.7 mm, about 9.8 mm, about 9.9 mm, or about 10 mm).

[0036] catheter In some embodiments, the catheter 120 is configured to pass through the lumen of the guide sheath 110. In some embodiments, the catheter 120 protrudes from the guide sheath 110. In some embodiments, the catheter 120 is longitudinally translatable relative to the ET tube 200. In some embodiments, the catheter 120 has an outer diameter of about 1.5 mm to about 20 mm (e.g., about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, the catheter 120 has a lumen and the lumen has a diameter of about 1.3 mm to about 19.8 mm (e.g., about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 19.5 mm, or about 19.8 mm).

[0037] In some embodiments, the catheter 120 is about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm, about 40 cm, about 41 cm, about 42 cm, about 43 cm, about 44 cm, about 45 cm, about 46 cm, about 47 cm, about 48 cm, about 49 cm, about 50 cm, about 51 cm, about 52 cm, about 53 cm, about 54 cm, about 55 cm, about 56 cm, about 57 cm, about 58 cm, about 59 cm, about 60 cm, about 61 cm, about 62 cm, about 63 cm, about 64 cm, about 65 cm, about 66 cm, about 67 cm, about 68 cm, about 69 cm, about 70 cm, about 71 cm, about 72 cm, about 73 cm, about 74 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, Approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm, approximately 48cm m, approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 60cm, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, approximately 75cm , about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm). In some embodiments, the catheter 120 has a length from proximal to distal end of 1 cm to 100 cm (e.g., 10 cm to 100 cm, 10 cm to 90 cm, 10 cm to 80 cm, 10 cm to 70 cm, 10 cm to 60 cm, 10 cm to 50 cm, 20 cm to 100 cm, 30 cm to 100 cm, 40 cm to 100 cm, 50 cm to 100 cm, 60 cm to 100 cm, 70 cm to 100 cm, 80 cm to 100 cm, or 90 cm to 100 cm). In some embodiments, the catheter 120 is flexible, pliable, or both. In some embodiments, the length of the catheter 120 maintains its length during use.

[0038] In some embodiments, the distal portion of the catheter 120 is biased to have a shape that is non-linear. In some embodiments, the catheter 120 is formed of a shape memory material (e.g., Nitinol) and the non-linear shape is achieved by actuating the shape memory material by electricity, heat, a chemical reaction, or any combination thereof.

[0039] In some embodiments, each electrode pair 150 is attached to a lumen of the catheter 120 and is translatable with the catheter 120 through the guide sheath 110. In some embodiments, each electrode pair 150 is not attached to a lumen of the catheter 120 and is translatable through the lumen of the catheter 120 along the longitudinal axis of the catheter 120.

[0040] Guide Sheath The guide sheath 110 is configured to pass through the lumen of the ET tube 200. In some embodiments, the guide sheath 110 is translatable along a longitudinal axis relative to the ET tube 200. In some embodiments, the guide sheath 110 has an outer diameter of about 1.5 mm to about 20 mm (e.g., about 1.5 mm to about 15 mm, about 1.5 mm to about 10 mm, about 1.5 mm to about 5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the guide sheath 110 has a lumen, and the lumen has a diameter of about 1.3 mm to about 19.8 mm (e.g., about 1.3 mm to about 15 mm, about 1.3 mm to about 10 mm, about 1.3 mm to about 5 mm, about 1.3 mm to about 2.5 mm, or 1.3 mm to about 2.2 mm). In some embodiments, the lumen of the guide sheath 110 surrounds at least a portion of the catheter 120.

[0041] In some embodiments, the electrode pair 150 translates together within the guide sheath 110. In some embodiments, the electrode pair 150 translates independently within the guide sheath 110. In some embodiments, the guide sheath 110 retracts from the electrode pair 150.

[0042] In some embodiments, the guide sheath 110 is about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm, about 40 cm, about 41 cm, about 42 cm, about 43 cm, about 44 cm, about 45 cm, about 46 cm, about 47 cm, about 48 cm, about 49 cm, about 50 cm, about 51 cm, about 52 cm, about 53 cm, about 54 cm, about 55 cm, about 56 cm, about 57 cm, about 58 cm, about 59 cm, about 60 cm, about 61 cm, about 62 cm, about 63 cm, about 64 cm, about 65 cm, about 66 cm, about 67 cm, about 68 cm, about 69 cm, about 70 cm, about 71 cm, about 72 cm, about 73 cm, about 74 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 8 cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, Approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm, approximately 48cm m, approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 60cm, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, approximately 75cm , about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm). In some embodiments, the guide sheath 110 has a length from the proximal end to the distal end of 1 cm to 100 cm (e.g., 10 cm to 100 cm, 10 cm to 90 cm, 10 cm to 80 cm, 10 cm to 70 cm, 10 cm to 60 cm, 10 cm to 50 cm, 20 cm to 100 cm, 30 cm to 100 cm, 40 cm to 100 cm, 50 cm to 100 cm, 60 cm to 100 cm, 70 cm to 100 cm, 80 cm to 100 cm, or 90 cm to 100 cm). In some embodiments, the length of the guide sheath 110 is longer than the length of the ET tube 200.

[0043] ET Tubes, ET Tube Connectors, and Sensors The ETS system generally includes an ET tube 200. The ET tube 200 is configured to be inserted into a subject's trachea 010 (FIG. 2). In some embodiments, inserting the ET tube into the subject's trachea 010 protects the subject's airway and provides ventilation while pacing the subject's phrenic nerve 020 and / or 030. In some embodiments, the ET tube is an oral ET tube 200. In some embodiments, the ET tube is a nasal ET tube. In some embodiments, the ET tube is a tracheotomy tube. In some embodiments, the ET tube is configured to function with all embodiments and / or variations of the guide sheath 110, catheter 120, ET tube connector 300, or one or more electrode pairs described herein.

[0044] In some embodiments, the ET tube 200 has an outer diameter of about 3 mm to about 20 mm (e.g., about 3 mm to about 18 mm, about 4 mm to about 16 mm, about 5 mm to about 14 mm, about 6 mm to about 13 mm, about 7 mm to about 12 mm, or about 8 mm to about 11 mm). In some embodiments, the ET tube 200 has an outer diameter of up to 20 mm (e.g., up to 15 mm, up to 10 mm, up to 5 mm). In some embodiments, the ET tube 200 has a lumen, and the lumen has a diameter of about 2.5 mm to about 19.8 mm (e.g., about 2.5 mm to about 15 mm, about 2.8 mm to about 12 mm, about 2.8 mm to about 10 mm, or about 5 mm to about 10 mm).

[0045] The ET tube 200, in some embodiments, has a length from the proximal end to the distal end of 12 cm to 40 cm (e.g., about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm).

[0046] In some embodiments, the ETS platform includes an ET tube connector 300. In some embodiments, the ET tube connector 300 bridges the proximal end of the ET tube and the distal end of the ventilator tubing circuit 410 (FIG. 2). In some embodiments, the ET tube connector 300 includes a port 340 (FIG. 3). In some embodiments, the port 340 provides an entry point for the guide sheath 110, catheter 120, and electrodes 150 to enter the ET tube 200 via the proximal end of the ET tube 200 (FIG. 3).

[0047] In some embodiments, the ET tube connector includes a sensor 310 (FIG. 2). In some embodiments, the sensor can measure one or more parameters including airflow, pressure, or temperature. In some embodiments, the control unit 500 is in electrical communication with the sensor 310.

[0048] Second Intratracheal Stimulation System In another aspect, the ETS platform 1000 provided herein includes a second ETS system 600 as shown in Figures 6A-6C. The second ETS system 600 may include, in some embodiments, an ET tube 200, an ET tube connector 300, a guide sheath 610, a catheter 620, and one or more electrode pairs 633. Figure 6A shows the exemplary second endotracheal stimulation system 600 in a constrained configuration. The catheter 620 and the guide sheath 610 are shown extending through a distal opening of the endotracheal tube 202.

[0049] In some embodiments, the second ETS system 600 is configured to engage one or more of the systems of the ETS platform 1000, including one or more data cables 320, the control unit 500, the ventilator 400, and the ventilator tube 410. In some embodiments, a locking mechanism 330 similar to that shown in FIG. 3 is configured to be used with the second ETS system 600 to secure the data cable 320 to the endotracheal tube connector via the endotracheal tube connector port 340. In some embodiments, one or more components of the second ETS system 600 are configured to be positioned within the lumen 205 ( FIG. 6A ) of the ET tube, and the ET tube 200 is configured to be inserted into the trachea of ​​a subject.

[0050] In some embodiments, the second ETS system 600 has a constrained configuration as shown in FIG. 6, where the catheter 620 is in an initial configuration useful for moving the catheter through the lumen of the ET tube 205 from the proximal end of the ET tube 200 to the distal opening of the ET tube 202 (FIG. 6A). In some embodiments, in the constrained configuration, a distal portion of the catheter 625 is within the guide sheath 610 (FIG. 6A). In some embodiments, the second ETS system 600 has an unconstrained or deployed configuration as seen in FIGS. 6B and 6C. In some embodiments, in the unconstrained configuration, a distal portion of the catheter 625 extends outside of the guide sheath 610 (FIG. 6B).

[0051] In some embodiments, the catheter 620 is configured to self-align into a predetermined shape once fully deployed through the ET tube 200.

[0052] electrode In some embodiments, at least a distal region of the catheter 620 includes one or more electrode pairs 630. In some embodiments, the electrode pairs 630 are in electrical communication with a proximal portion of the system 600. In some embodiments, the electrode pairs 630 include a distal electrode 631 and a proximal electrode 632. In some embodiments, the one or more electrode pairs 630 are in electrical communication with a proximal portion of the system 600 for connection to the control unit 500. In some embodiments, the electrical communication is wired, wireless, or both. In some embodiments, the wired electrical communication uses a locking mechanism 330 to ensure that electrical communication is maintained throughout operation of the ETS system 600.

[0053] FIG. 6B shows a side view of the exemplary second ETS system 600 in an unconstrained configuration. The catheter 620 is shown having a plurality of electrode pairs 630. Each of the illustrated electrode pairs 630 includes a distal electrode 631 and a proximal electrode 632. The guide sheath 610 is shown extending through an opening at the distal end of the endotracheal tube 200. In some embodiments, the one or more electrode pairs 630 are integral with the catheter 620. In some embodiments, the one or more electrode pairs are fixed to the catheter. In some embodiments, the one or more electrode pairs are disposed on an outer surface of the catheter 620 (FIGS. 6B-6C). In some embodiments, the catheter 620 is formed as a flexible cylindrical tube, and the one or more electrode pairs 630 completely surround separate portions of the catheter at various locations of the catheter, as shown in FIG. 6B.

[0054] In FIG. 6C, a top view of an exemplary distal region 625 of the catheter 620 and four electrode pairs 630 disposed along the length of the catheter 620 are shown in an unconstrained configuration. The catheter 620 is formed as a loop having an outer diameter 660 of the catheter. The distance from the outer edge of the first electrode pair 630 to the outer edge of the second electrode pair is shown as the outer diameter 670 of the electrodes. The distance between the distal electrode 631 and the proximal electrode 632 along the length of the catheter 620 is shown as the electrode offset 633. The distance along the length of the catheter 620 that separates the first electrode pair from the second electrode pair is shown as the electrode pair offset 635. In some embodiments, the distance between the distal electrode 631 and the proximal electrode 632 is less than the distance between the proximal electrode 632 and the distal electrode of the subsequent electrode pair. In some embodiments, the distance between the distal electrode 631 and the proximal electrode 632 is greater than the distance between the proximal electrode 632 and the distal electrode of the subsequent electrode pair.

[0055] In some embodiments, the electrode pair 630 extends along the length of the distal portion of the catheter 625, as shown in Figures 6B and 6C. In some embodiments, the electrode pair 630 extends along at most a portion of the distal portion of the catheter 625. In some embodiments, one or more electrodes are located at the tip of the catheter 620. In some embodiments, the electrode pair 630 is bipolar. In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerve, which runs parallel to the trachea 010. In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerve, which runs parallel to the trachea, regardless of the angular orientation of the catheter 620 relative to the trachea 010. In some embodiments, the electrode pair 630 is unipolar.

[0056] In some embodiments, each of the one or more electrode pairs 630 of the second ETS system 600 includes a distal electrode 631 (FIGS. 6B-6C) and a proximal electrode 632 (FIGS. 6B-6C), where the distal electrode 631 is positioned distal to the proximal electrode 632 along the length of the catheter 620 from the proximal end of the catheter to the distal region 625 of the catheter.

[0057] In some embodiments, each electrode of one or more electrode pairs 630 has a length 640 of about 1 mm to about 10 mm (e.g., about 1 mm to about 9 mm, about 1 mm to about 8 mm, about 1 mm to about 7 mm, about 1 mm to about 6 mm, or about 1 mm to about 5 mm). In some embodiments, each electrode in one or more electrode pairs 630 has a length of at least about 1 mm (e.g., at least about 2 mm, at least about 3 mm, at least about 4 mm, or at least about 5 mm) along the length of catheter 630 (FIG. 6C). In some embodiments, each electrode in one or more electrode pairs 630 has a length of up to about 10 mm (e.g., up to about 9 mm, up to about 8 mm, up to about 7 mm, up to about 6 mm, or up to about 5 mm) along the length of catheter 630 (FIG. 6C). In some embodiments, one or more electrode pairs have different lengths 640. In some embodiments, each electrode has a unique length 640.

[0058] In some embodiments, each electrode in one or more electrode pairs 630 has a width 650 of about 1 mm to about 10 mm (e.g., about 1 mm to about 9 mm, about 1 mm to about 8 mm, about 1 mm to about 7 mm, about 1 mm to about 6 mm, or about 1 mm to about 5 mm). In some embodiments, each electrode in one or more electrode pairs 630 has a width of at least about 1 mm (e.g., at least about 2 mm, at least about 3 mm, at least about 4 mm, or at least about 5 mm) along the width of the catheter 630 (FIG. 6C). In some embodiments, each electrode in one or more electrode pairs 630 has a width of up to about 10 mm (e.g., up to about 9 mm, up to about 8 mm, up to about 7 mm, up to about 6 mm, or up to about 5 mm) along the width of the catheter 630 (FIG. 6C). In some embodiments, one or more electrode pairs have different widths 650. In some embodiments, each electrode has a unique width 650. In some embodiments, one or more electrodes of the ETS 600 have substantially the same length 640 and width 650. In some embodiments, one or more electrodes of the ETS 600 have a length 640 that is longer than the width 650. In some embodiments, one or more electrodes of the ETS 600 have a length 640 that is shorter than the width 650.

[0059] In some embodiments, the distance between distal electrode 631 and proximal electrode 632 along the length of catheter 620, referred to herein as electrode offset 633 (FIG. 6C), is about 2 mm to about 10 mm (e.g., about 2 mm to about 8 mm, about 2 mm to about 6 mm, about 2 mm to about 4 mm, about 4 mm to about 8 mm, or about 6 mm to about 8 mm). In some embodiments, offset 633 is established during manufacture of the ETS system, and one or more electrode pairs 630 are fixed to catheter 620. In some embodiments, electrode offset is measured along the longitudinal axis of catheter 620 from the distal end of distal electrode 631 to the proximal end of proximal electrode 632. In some embodiments, electrode offset is measured along the longitudinal axis of catheter 620 from the proximal end of distal electrode 631 to the distal end of proximal electrode 632. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 620 from the distal end of the distal electrode 631 to the distal end of the proximal electrode 632. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 620 from the proximal end of the distal electrode 631 to the proximal end of the proximal electrode 632. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 620 from the center of the distal electrode 631 to the center of the proximal electrode 632.

[0060] In some embodiments, the distance from the first electrode pair to the second electrode pair along the length of the catheter 620, referred to herein as the electrode pair offset 635 (FIG. 6C), is between about 0.25 cm and about 16 cm (e.g., between about 0.5 cm and about 15 cm, between about 0.75 cm and about 10 cm, or between about 1 cm and about 5 cm). In some embodiments, the electrode pair offset is measured along the length of the catheter 620 from the distal end of the distal electrode 631 of the distal electrode pair to the proximal end of the proximal electrode 632 of the proximal electrode pair. In some embodiments, the electrode pair offset is measured along the length of the catheter 620 from the proximal end of the proximal electrode 631 of the distal electrode pair to the distal end of the distal electrode 632 of the proximal electrode pair. In some embodiments, the electrode pair offset is measured along the length of the catheter 620 from the distal end of the distal electrode 631 of the distal electrode pair to the distal end of the distal electrode 632 of the proximal electrode pair. In some embodiments, the electrode pair offset is measured along the length of the catheter 620 from the proximal end of the proximal electrode 631 of the distal electrode pair to the proximal end of the proximal electrode 632 of the proximal electrode pair. In some embodiments, the electrode pair offset is measured along the longitudinal axis of the catheter 620 from the center of the distal electrode pair to the center of the proximal electrode pair. In some embodiments, the multiple electrode pairs 630 are evenly spaced along the length of the distal region of the catheter 625. In some embodiments, the multiple electrode pairs 630 are not evenly distributed along the length of the distal region of the catheter 625.

[0061] In some embodiments, the proximal electrode 632 and / or the distal electrode 631 have a width that is greater than the width of the catheter 620 (FIG. 6C). In some embodiments, the greater width of the electrodes compared to the width of the catheter 620 results in the electrodes having an outer edge 651 and an inner edge 652 (FIG. 6C). In some embodiments, the diameter of the distal region 625 of the catheter is measured from the outer edge 651 of a first electrode to the outer edge of a second electrode positioned opposite the first electrode relative to the loop of the distal region 625 of the catheter (FIG. 6C). In some embodiments, the outer diameter 670 of the electrode is about 10 mm to about 40 mm (e.g., about 10 mm to about 30 mm, about 10 mm to about 20 mm, e.g., up to about 30 mm, up to about 25 mm, up to about 20 mm, up to about 15 mm).

[0062] In some embodiments, one or more electrode pairs 630 contact the trachea of ​​the subject. In some embodiments, in the unconstrained configuration, one or more electrode pairs 630 contact the tracheal wall 015 of the subject (FIG. 5A), thereby enabling phrenic nerve pacing as described herein. In some embodiments, in the unconstrained configuration, one or more electrode pairs 630 are configured to contact at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 95% of the inner circumference of the tracheal wall of the subject. In some embodiments, in the unconstrained configuration, the proximal electrode 632 and the distal electrode 631 contact the entire tracheal wall of the subject at a location along the proximal-distal axis of the trachea. In some embodiments, in the unconstrained configuration, at least a portion of one or more electrode pairs 630 contact the tracheal wall 015 of the subject.

[0063] In some embodiments, one or more electrode pairs 630 are made of the same conductive material. In some embodiments, one or more electrode pairs 630 are made of different conductive materials. In some embodiments, the conductive material is a material that is a conductor of electricity, and conductive materials include, but are not limited to, pure metals or alloys, commonly used in the art to make wire electrodes. In some embodiments, the conductive material is selected from silicon, platinum, iridium, polyimide, gold, ceramic, nickel, titanium, copper, iron, chromium, or alloys or combinations thereof.

[0064] In some embodiments, one or more electrode pairs 630 are bipolar. In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerve (e.g., the left phrenic nerve 020, the right phrenic nerve 030, or both) (FIG. 1) that runs parallel to the trachea 015. In some embodiments, the bipolar electrodes allow for pacing of the phrenic nerve that runs parallel to the trachea 015, regardless of the angular orientation of the catheter 620 relative to the trachea 015. In some embodiments, one or more electrode pairs 630 are unipolar. In some embodiments, in the unconstrained configuration, at least a portion of the proximal electrode 632 and the distal electrode 631 extend beyond the ET tube 200.

[0065] catheter In some embodiments, the catheter 620 is configured to pass through a lumen of the guide sheath 610. In some embodiments, the catheter 620 protrudes from the guide sheath 610. In some embodiments, the catheter 620 is longitudinally translatable relative to the ET tube 200. In some embodiments, the catheter 620 has an outer diameter of about 1 mm to about 35 mm (e.g., about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, or about 35 mm). In some embodiments, the catheter 620 has a lumen and the lumen has a diameter of about 1.3 mm to about 34.8 mm (e.g., about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 34.5 mm, or about 34.8 mm).

[0066] In some embodiments, the catheter 620 is about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm, about 40 cm, about 41 cm, about 42 cm, about 43 cm, about 44 cm, about 45 cm, about 46 cm, about 47 cm, about 48 cm, about 49 cm, about 50 cm, about 51 cm, about 52 cm, about 53 cm, about 54 cm, about 55 cm, about 56 cm, about 57 cm, about 58 cm, about 59 cm, about 60 cm, about 61 cm, about 62 cm, about 63 cm, about 64 cm, about 65 cm, about 66 cm, about 67 cm, about 68 cm, about 69 cm, about 70 cm, about 71 cm, about 72 cm, about 73 cm, about 74 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, Approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm, approximately 48cm m, approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 60cm, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, approximately 75cm , about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm). In some embodiments, the catheter 620 has a length from proximal to distal end of 1 cm to 100 cm (e.g., 10 cm to 100 cm, 10 cm to 90 cm, 10 cm to 80 cm, 10 cm to 70 cm, 10 cm to 60 cm, 10 cm to 50 cm, 20 cm to 100 cm, 30 cm to 100 cm, 40 cm to 100 cm, 50 cm to 100 cm, 60 cm to 100 cm, 70 cm to 100 cm, 80 cm to 100 cm, or 90 cm to 100 cm). In some embodiments, the catheter 620 is flexible, pliable, or both. In some embodiments, the length of the catheter 620 maintains its length during use.

[0067] The catheter 620 is configured to carry one or more wires that electrically connect the control unit 500 to one or more electrode pairs disposed at a distal portion 625 of the catheter.

[0068] In some embodiments, the catheter 620 is formed as a loop (FIGS. 6B-6C). In some embodiments, the catheter loop has a diameter 660 of 1.6 mm to 30 mm (e.g., about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm). In some embodiments, the catheter loop has a diameter 660 of at least about 1 cm, 5 cm, 10 cm, 15 cm, or 20 cm. In some embodiments, the catheter loop has a diameter 660 of up to about 35 cm, 30 cm, or 25 cm. In some embodiments, the catheter loop diameter 660 is measured from the outer edge of the loop to the opposite outer edge of the catheter loop (i.e., the outer diameter) (FIG. 6C). In some embodiments, the catheter loop diameter 660 is measured from the inner edge of the loop to the opposite inner edge of the catheter loop (i.e., the inner diameter) (FIG. 6C).

[0069] In some embodiments, the distal portion of the catheter 625 is biased to have a shape that is non-linear. In some embodiments, the catheter 620 is formed of a shape memory material (e.g., Nitinol) and the non-linear shape is achieved by actuating the shape memory material with electricity, heat, a chemical reaction, or any combination thereof. In some embodiments, the catheter 620, in the unconstrained configuration, can rotate in one or more directions from about 90 degrees to about 360 degrees (e.g., from about 100 degrees to about 360 degrees, from about 110 degrees to about 360 degrees, from about 120 degrees to about 360 degrees, from about 130 degrees to about 360 degrees, from about 140 degrees to about 360 degrees, from about 150 degrees to about 360 degrees, from about 160 degrees to about 360 degrees, from about 170 degrees to about 360 degrees, from about 180 degrees to about 360 degrees, from about 190 degrees to about 360 degrees, from about 200 degrees to about 360 degrees, from about 210 degrees to about 360 degrees, from about The non-linear shape has a minimum arc angle, average arc angle, or maximum arc angle of 220 degrees to about 360 degrees, about 230 degrees to about 360 degrees, about 240 degrees to about 360 degrees, about 250 degrees to about 360 degrees, about 260 degrees to about 360 degrees, about 270 degrees to about 360 degrees, about 280 degrees to about 360 degrees, about 290 degrees to about 360 degrees, about 300 degrees to about 360 degrees, about 310 degrees to about 360 degrees, about 320 degrees to about 360 degrees, about 330 degrees to about 360 degrees, about 340 degrees to about 360 degrees, or about 350 degrees to about 360 degrees). In some embodiments, the catheter has an arc angle of at least about 100 degrees, at least about 120 degrees, at least about 150 degrees, at least about 180 degrees, at least about 210 degrees, at least about 240 degrees, at least about 260 degrees, or at least about 300 degrees in one or more directions. In some embodiments, the catheter 620 has a non-linear shape in the unconstrained configuration with a minimum, average, or maximum arc angle of at least about 90 degrees, 120 degrees, 150 degrees, 180 degrees, 210 degrees, 240 degrees, 270 degrees, 300 degrees, or 330 degrees (including increments therein) in one or more directions.

[0070] In some embodiments, the catheter loop is about 3 mm to about 110 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about , about 28mm, about 29mm, about 30mm, about 31mm, about 32mm, about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 38mm, about 39mm, about 40mm, about 41mm, about 42mm , about 43mm, about 44mm, about 45mm, about 46mm, about 47mm, about 48mm, about 49mm, about 50mm, about 51mm, about 52mm, about 53mm, about 54mm, about 55mm, about 56mm, about 57mm, Approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, Approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, approximately 77mm, approximately 78mm, approximately 79mm, approximately 80mm, approximately 81mm, approximately 82mm, approximately 83mm, approximately 84mm, approximately 85mm, approximately 86mm, approximately 87mm, approximately In some embodiments, the loop has a circumference (e.g., from one end of the loop to the other end of the loop) of about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).In some embodiments, the catheter loop has a circumference of 3 mm to 110 mm (e.g., 5 mm to 100 mm, 10 mm to 90 mm, 20 mm to 80 mm, 30 mm to 70 mm, 40 mm to 60 mm, 3 mm to 100 mm, 3 mm to 90 mm, 3 mm to 80 mm, 3 mm to 70 mm, 3 mm to 60 mm, 3 mm to 50 mm, 3 mm to 40 mm, 5 mm to 110 mm, 10 mm to 110 mm, 20 mm to 110 mm, 30 mm to 110 mm, 40 mm to 110 mm, 50 mm to 110 mm, 60 mm to 110 mm, 70 mm to 110 mm, 80 mm to 110 mm, 90 mm to 110 mm, or 100 mm to 110 mm). In some embodiments, the catheter loop has a circumference of at least about 3 mm, 10 mm, 25 mm, 50 mm cm, or 75 mm, hi some embodiments, the catheter loop has a circumference of at most about 110 mm, 100 mm, 90 mm, or 80 mm.

[0071] Guide Sheath The guide sheath 610 is configured to pass through the lumen 205 of the ET tube, as seen in FIG. 6A. In some embodiments, the guide sheath 610 is translatable along the longitudinal axis relative to the ET tube 200. In some embodiments, the guide sheath 610 has an outer diameter of about 1.5 mm to about 20 mm (e.g., about 1.5 mm to about 15 mm, about 1.5 mm to about 10 mm, about 1.5 mm to about 5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the guide sheath 110 has a lumen, and the lumen has a diameter of about 1.3 mm to about 19.8 mm (e.g., about 1.3 mm to about 15 mm, about 1.3 mm to about 10 mm, about 1.3 mm to about 5 mm, about 1.3 mm to about 2.5 mm, or 1.3 mm to about 2.2 mm). In some embodiments, the lumen of the guide sheath 610 surrounds at least a portion of the catheter 620.

[0072] In some embodiments, the guide sheath 610 is about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, Approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm, approximately 48cm m, approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 60cm, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, approximately 75cm , about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm). In some embodiments, the guide sheath 610 has a length from the proximal end to the distal end of 1 cm to 100 cm (e.g., 10 cm to 100 cm, 10 cm to 90 cm, 10 cm to 80 cm, 10 cm to 70 cm, 10 cm to 60 cm, 10 cm to 50 cm, 20 cm to 100 cm, 30 cm to 100 cm, 40 cm to 100 cm, 50 cm to 100 cm, 60 cm to 100 cm, 70 cm to 100 cm, 80 cm to 100 cm, or 90 cm to 100 cm). In some embodiments, the length of the guide sheath 610 is longer than the length of the ET tube 200.

[0073] ET tubes, ET tube connectors and sensors An ETS system generally includes an ET tube 200. The ET tube 200 is configured to be inserted into a subject's trachea 010 (FIG. 2). In some embodiments, inserting the ET tube into the subject's trachea 010 protects the subject's airway and provides ventilation while pacing the subject's phrenic nerve 020 and / or 030. In some embodiments, the ET tube is an oral ET tube 200. In some embodiments, the ET tube is a nasal ET tube. In some embodiments, the ET tube is a tracheotomy tube. In some embodiments, the ET tube is configured to function with all embodiments and / or variations of the guide sheath 610, catheter 620, ET tube connector 300, or one or more electrode pairs 630 described herein.

[0074] In some embodiments, the ET tube 200 has an outer diameter of about 3 mm to about 20 mm (e.g., about 3 mm to about 18 mm, about 4 mm to about 16 mm, about 5 mm to about 14 mm, about 6 mm to about 13 mm, about 7 mm to about 12 mm, or about 8 mm to about 11 mm). In some embodiments, the ET tube 200 has an outer diameter of up to 20 mm (e.g., up to 15 mm, up to 10 mm, up to 5 mm). In some embodiments, the ET tube 200 has a lumen, and the lumen has a diameter of about 2.8 mm to about 19.8 mm (e.g., about 2.8 mm to about 15 mm, about 2.8 mm to about 10 mm, or 2.8 mm to about 5 mm).

[0075] The ET tube 200, in some embodiments, has a length from the proximal end to the distal end of 12 cm to 40 cm (e.g., about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm).

[0076] In some embodiments, the ETS platform includes an ET tube connector 300. In some embodiments, the ET tube connector 300 bridges the proximal end of the ET tube and the distal end of the ventilator tubing circuit 410 (FIG. 2). In some embodiments, the ET tube connector 300 includes a port 340 (FIG. 3). In some embodiments, the port 340 provides an entry point for the guide sheath 610, catheter 620, and one or more electrode pairs 630 to enter the ET tube 200 via the proximal end of the ET tube 200 (FIG. 3).

[0077] In some embodiments, the ET tube connector includes a sensor 310 (FIG. 2). In some embodiments, the sensor can measure one or more parameters including airflow, pressure, or temperature. In some embodiments, the control unit 500 is in electrical communication with the sensor 310.

[0078] Third intratracheal stimulation system In another aspect, the ETS platform 1000 provided herein includes a third ETS system 700 as shown in FIGS. 7-8D. The third ETS system 700 may include, in some embodiments, an ET tube 200, an ET tube connector 300, a catheter 720, and one or more electrode pairs 733. FIG. 7 illustrates an exemplary third ETS system 700, in which the endotracheal tube 200 includes an endotracheal tube cuff 210 at the distal end of the endotracheal tube 202, a Murphy hole 220, and an opening 204 at the distal end of the endotracheal tube. The catheter 720 formed as a spiral catheter is shown to have multiple electrode pairs 730. In FIG. 7, the catheter 720 is shown configured to wrap around the endotracheal tube 200 from the proximal end of the endotracheal tube 201 to the distal end of the endotracheal tube 202. Each of the electrode pairs 730 includes a distal electrode 731 and a proximal electrode 732. The distal electrode 731 and the proximal electrode 732 are separated by a distance of an electrode offset 733 along the length of the catheter 720. In some embodiments, the third ETS system includes a pilot balloon line 215 as shown in FIG.

[0079] In some embodiments, the third ETS system 700 is configured to engage one or more of the systems of the ETS platform 1000, including one or more data cables 320, the control unit 500, the ventilator 400, and the ventilator tube 410. In some embodiments, a locking mechanism 330 similar to that shown in FIG. 3 is configured to be used with the third ETS system 700 to secure the data cable 320 to the endotracheal tube connector via the endotracheal tube connector port 340. In some embodiments, one or more components of the third ETS system 700 are configured to be disposed about an outer surface of the ET tube 200 (FIGS. 7-8D), and the ET tube 200 is configured to be inserted into the trachea of ​​a subject.

[0080] electrode In some embodiments, at least a portion of the catheter 720 includes one or more electrode pairs 730. In some embodiments, the electrode pairs 730 are in electrical communication with a proximal portion of the ETS system 700. In some embodiments, the electrode pairs 730 include a distal electrode 731 and a proximal electrode 732, with the distal electrode 731 being disposed more distally relative to the proximal electrode 732 along the length of the catheter 720 from the proximal end of the catheter to the distal end of the catheter. In some embodiments, the one or more electrode pairs 730 are in electrical communication with a proximal portion of the system 700 for connection to the control unit 500. In some embodiments, the electrical communication is wired, wireless, or both. In some embodiments, the wired electrical communication uses a locking mechanism 330 to ensure that electrical communication is maintained throughout operation of the ETS system 700. In some embodiments, the catheter includes three electrode groups, as shown in FIG. 8B, with the distal electrode 731, the proximal electrode 732, and the intermediate electrode 734 disposed on the catheter 720.

[0081] In some embodiments, the one or more electrode pairs 730 are located on the outer surface of the catheter 720. In some embodiments, the electrode pairs 730 are bipolar. In some embodiments, the bipolar electrodes allow pacing of the phrenic nerve, which runs parallel to the trachea, regardless of the angular orientation of the inner catheter relative to the trachea 010. In some embodiments, the electrode pairs 730 are unipolar. In some embodiments, the one or more electrode pairs 730 are evenly distributed along the length of the electrode 720. In some embodiments, the one or more electrode pairs 730 are not evenly distributed along the length of the catheter 720. In some embodiments, the electrode pairs 730 are arranged longitudinally along the collar-shaped catheter along an axis parallel to the axis of the ET tube 200 (FIGS. 8A-8D).

[0082] In some embodiments, one or more electrode pairs 730 have a circular shape, as shown in Figure 7. In some embodiments, one or more electrode pairs are rectangularly shaped, as seen in Figures 8A-8D. In some embodiments, one or more electrode pairs have a circular, rectangular, triangular, oval, D-shaped, star-shaped, polygonal, or any combination or variation thereof.

[0083] In some embodiments, the one or more electrode pairs 730, when formed into a circular shape (FIG. 7), have a diameter of about 1 mm to 10 mm (e.g., about 2 mm to 10 mm, 3 mm to about 10 mm, about 4 mm to about 10 mm, about 5 mm to about 10 mm, or about 6 mm to about 10 mm). In some embodiments, the one or more electrode pairs 730 have a diameter of at least about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. In some embodiments, the one or more electrode pairs have a diameter of up to about 10 mm, about 9 mm, about 8 mm, about 7 mm, or about 6 mm.

[0084] In some embodiments, one or more electrode pairs 730, when formed in a rectangular configuration (FIGS. 8A-8B), have a length and a width, where the length is the dimension of the electrode extending around the circumference of the ET tube and the width is the dimension of the electrode from the proximal end of the ET tube to the distal end of the ET tube. In some embodiments, the length of the electrodes of one or more electrode pairs is about 3 mm to about 110 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, Approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38mm, approximately 39mm, approximately 40 mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69m m, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, approximately 77mm, approximately 78mm, approximately 79mm, approximately 80mm, approximately 81mm, approximately 82mm, approximately 83mm, approximately 8 4mm, about 85mm, about 86mm, about 87mm, about 88mm, about 89mm, about 90mm, about 91mm, about 92mm, about 93mm, about 94mm, about 95mm, about 96mm, about 97mm, about 98mm, about 99mm, about 100mm, about 101mm, about 102mm, about 103mm, about 104mm, about 105mm, about 106mm, about 107mm, about 108mm, about 109mm, about 110mm).

[0085] In some embodiments, the width of the electrodes of one or more electrode pairs 730 is about 1 mm to about 20 mm (e.g., about 2 mm to about 15 mm, or about 5 mm to about 10 mm). In some embodiments, the width of the electrodes of one or more electrode pairs 730 is at least about 1 mm, about 2 mm, about 5 mm, about 10 mm, or about 15 mm. In some embodiments, the width of the electrodes of one or more electrode pairs 730 is up to about 20 mm, about 15 mm, about 10 mm, or about 5 mm.

[0086] In some embodiments, the distance between the distal electrode 731 and the proximal electrode 732 is less than the distance between the proximal electrode 732 and the subsequent distal electrode 731. In some embodiments, the distance between the distal electrode 731 and the proximal electrode 732 is greater than the distance between the proximal electrode 732 and the subsequent distal electrode 731.

[0087] In some embodiments, the distance between distal electrode 731 and proximal electrode 732 along the length of catheter 720, referred to herein as electrode offset 733 (FIGS. 7 and 8A), is about 0.25 mm to about 16 mm (e.g., about 0.5 mm to about 15 mm, about 1 mm to about 14 mm, about 2 mm to about 13 mm, about 3 mm to about 12 mm, or about 4 mm to about 10 mm). In some embodiments, electrode offset 733 is at least about 0.25 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm, including increments therein. In some embodiments, the electrode offset 733 is up to about 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, or 16 mm, including increments therein. In some embodiments, the offset 733 is established during manufacturing of the ETS system, and one or more electrode pairs 730 are fixed to the catheter 720. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 720 from the distal end of the distal electrode 731 to the proximal end of the proximal electrode 732. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 720 from the proximal end of the distal electrode 731 to the distal end of the proximal electrode 732. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 720 from the distal end of the distal electrode 731 to the distal end of the proximal electrode 732. In some embodiments, the electrode offset 733 is measured along the longitudinal axis of the catheter 720 from the proximal end of the distal electrode 731 to the proximal end of the proximal electrode 732. In some embodiments, the electrode offset is measured along the longitudinal axis of the catheter 720 from the center of the distal electrode 731 to the center of the proximal electrode 732. In some embodiments, the offset 733 is measured along the length of the catheter 720, for example, along the helical shape of the catheter 720 that wraps around the ET tube 200 of FIG. 7. In some embodiments, the offset is measured around the collar shape of the catheter 720, as seen in FIGS. 8A-8D.In some embodiments, one or more electrode pairs 730 are positioned around the catheter as shown in FIG. 8D. In some embodiments, the catheter has an electrode portion 735 as shown in FIG. 8C. In some embodiments, the catheter has a catheter gap 740 (FIGS. 8A and 8D) that extends from the proximal end to the distal end of the catheter. In some embodiments, the catheter gap 740 has a width, the width being measured along the circumference of the catheter in a collar shape as in FIG. 8A-8D. In some embodiments, the catheter gap 740 has a width of 1 mm to about 10 mm (e.g., about 1 mm to about 9 mm, about 1 mm to about 8 mm, about 1 mm to about 7 mm, about 1 mm to about 6 mm, or about 1 mm to about 5 mm) in the collar shape configuration. In some embodiments, the catheter gap 740 has a width of up to about 10 mm (e.g., up to about 9 mm, up to about 8 mm, up to about 7 mm, up to about 6 mm, or up to about 5 mm) in the collar shape configuration. In some embodiments, the catheter gap 740 has a width in the collar shape configuration of at least 1 mm (eg, at least about 2 mm, at least about 3 mm, at least about 4 mm, or at least about 5 mm).

[0088] In some embodiments, the distance from the first electrode pair to the second electrode pair, measured along the helical shape of the catheter 760 ( FIG. 7 ), is between about 5 mm and about 110 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 8 mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38 mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53m m, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68m m, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, approximately 77mm, approximately 78mm, approximately 79mm, approximately 80mm, approximately 81mm, approximately 82mm, approximately 83mm , about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).

[0089] In some embodiments, the distance 770 ( FIG. 7 ) from the first electrode pair to the second electrode pair, measured along the length of the ET tube, is between about 5 mm and about 110 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 8 mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38 mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53m m, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68m m, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, approximately 77mm, approximately 78mm, approximately 79mm, approximately 80mm, approximately 81mm, approximately 82mm, approximately 83mm , about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).

[0090] In some embodiments, one or more electrode pairs 730 contact the trachea of ​​the subject. In some embodiments, one or more electrode pairs 730 contact the tracheal wall 015 of the subject, thereby enabling phrenic nerve pacing as described herein. In some embodiments, one or more electrode pairs 730 are configured to contact at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 95% of the inner circumference of the tracheal wall of the subject. In some embodiments, the proximal electrode 732 and the distal electrode 731 contact the entire tracheal wall of the subject at a location along the proximal-distal axis of the trachea 010. In some embodiments, at least a portion of one or more electrode pairs 730 contact the tracheal wall 015 of the subject.

[0091] In some embodiments, one or more electrode pairs 730 are made of the same conductive material. In some embodiments, one or more electrode pairs 730 are made of different conductive materials. In some embodiments, the conductive material is a material that is a conductor of electricity, including, but not limited to, pure metals or alloys, commonly used in the art to make wire electrodes. In some embodiments, the conductive material is selected from silicon, platinum, iridium, polyimide, gold, ceramic, nickel, titanium, copper, iron, chromium, or alloys or combinations thereof.

[0092] catheter In some embodiments, the catheter 720 of the third ETS system 700 is formed in a spiral shape, as shown in Figure 7. In some embodiments, the catheter 720 of the third ETS system 700 is formed in a collar configuration, as shown in Figures 8A-8D.

[0093] In some embodiments, the catheter 720 has a helical shape that twists around the ET tube 200 (FIG. 7). In some embodiments, the catheter 720 has a helical shape that twists about 0.5 turns to about 20 turns (e.g., about 0.5 turns, about 1 turn, about 1.5 turns, about 2 turns, about 2.5 turns, about 3 turns, about 3.5 turns, about 4 turns, about 4.5 turns, about 5 turns, about 6 turns, about 7 turns, about 8 turns, about 9 turns, about 10 turns, about 11 turns, about 12 turns, about 13 turns, about 14 turns, about 15 turns, about 16 turns, about 17 turns, about 18 turns, about 19 turns, or about 20 turns) around the ET tube. In some embodiments, the distance along the ET tube 200 that each turn covers from the proximal end of the ET tube to the distal end of the ET tube is from about 10 mm to about 40 mm (e.g., from about 10 mm to about 30 mm, or from about 10 mm to about 20 mm).

[0094] In some embodiments, the length of the catheter 720 along the ET tube 200 in a spiral configuration (FIG. 7) is from about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19cm, approximately 20cm, approximately 21cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, Approximately 33cm, approximately 34cm, approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm , about 47cm, about 48cm, about 49cm, about 50cm, about 51cm, about 52cm, about 53cm, about 54cm, about 55cm, about 56cm, about 57cm, about 58cm, about 59cm, about 60cm m, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74 cm, approximately 75cm, approximately 76cm, approximately 77cm, approximately 78cm, approximately 79cm, approximately 80cm, approximately 81cm, approximately 82cm, approximately 83cm, approximately 84cm, approximately 85cm, approximately 86cm, approximately 87cm, approximately 8 8cm, approximately 89cm, approximately 90cm, approximately 91cm, approximately 92cm, approximately 93cm, approximately 94cm, approximately 95cm, approximately 96cm, approximately 97cm, approximately 98cm, approximately 99cm, or approximately 100cm).

[0095] In some embodiments, the length of the catheter 720 along the ET tube 200 in the collar configuration (FIGS. 8A-8D) is from about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 20 cm, about 22 cm, about 24 cm, about 26 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm, about 40 cm, about 41 cm, about 42 cm, about 43 cm, about 44 cm, about 45 cm, about 46 cm, about 47 cm, about 48 cm, about 49 cm, about 50 cm, about 51 cm, about 52 cm, about 53 cm, about 54 cm, about 55 cm, about 56 cm, about 57 cm, about 58 cm, about 59 cm, about 60 cm, about 61 cm, about 62 cm, about 63 cm, about 64 cm, about 65 cm, about 66 cm, about 67 cm, about 68 cm, about 69 cm, about 70 cm, about 71 cm, about 72 cm, about 73 cm, about 74 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about cm, approximately 19cm, approximately 20cm, approximately 21cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32 cm, approximately 33cm, approximately 34cm, approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46 cm, approximately 47cm, approximately 48cm, approximately 49cm, approximately 50cm, approximately 51cm, approximately 52cm, approximately 53cm, approximately 54cm, approximately 55cm, approximately 56cm, approximately 57cm, approximately 58cm, approximately 59cm, approximately 6 0cm, approximately 61cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 7 4 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm).

[0096] In some embodiments, the width 725 of the catheter in the helical configuration (FIG. 7) is about 5 mm to about 15 mm (e.g., about 6 mm to about 14 mm, about 7 mm to about 13 mm, about 8 mm to about 12 mm, or about 9 mm to about 11 mm). In some embodiments, the width 725 of the catheter in the helical configuration (FIG. 7) is at least about 5 mm (e.g., at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, or at least about 10 mm). In some embodiments, the width 725 of the catheter in the helical configuration (FIG. 7) is up to about 15 mm (e.g., up to about 14 mm, up to about 13 mm, up to about 12 mm, up to about 11 mm, or up to about 10 mm).

[0097] In some embodiments, the catheter in the collar configuration wraps around at least a portion of the ET tube 200 as shown in Figures 8A-8D. In some embodiments, the catheter in the collar configuration wraps around an angular portion of the ET tube 200 at an angle of at least about 180 degrees, 270 degrees, or 360 degrees.

[0098] In some embodiments, the catheter 720 in the collar configuration wraps around at most a portion of the ET tube 200 as shown in FIGS. 8A-8D. In some embodiments, the catheter includes protrusions 722 to increase the strength of the connection of the catheter to the ET tube 200 (FIG. 8A). In some embodiments, the catheter 720 is configured to connect to the ET tube 200 by a snap-fit ​​or press-fit. In some embodiments, the collar-shaped catheter (FIG. 8A), the protrusions 722, or both, have gaps 740. In some embodiments, the size of the collar-shaped catheter and / or the gaps 740 are configured such that the collar-shaped catheter 720 (FIG. 8A) is securely fixed to the ET tube 200. In some embodiments, the collar-shaped catheter 720 is configured to connect to the ET tube 200 by an adhesive (FIG. 8B).

[0099] ET tubes, ET tube connectors and sensors An ETS system generally includes an ET tube 200. The ET tube 200 is configured to be inserted into a subject's trachea 010 (FIG. 2). In some embodiments, inserting the ET tube into the subject's trachea 010 protects the subject's airway and provides ventilation while pacing the subject's phrenic nerve 020 and / or 030. In some embodiments, the ET tube is an oral ET tube 200. In some embodiments, the ET tube is a nasal ET tube. In some embodiments, the ET tube is a tracheotomy tube. In some embodiments, the ET tube is configured to function with all embodiments and / or variations of the catheter 720, ET tube connector 300, or one or more electrode pairs 730 described herein.

[0100] In some embodiments, ET tube 200 has an outer diameter of about 3 mm to about 20 mm (e.g., about 3 mm to about 15 mm, about 3 mm to about 10 mm, or about 5 mm to about 10 mm). In some embodiments, ET tube 200 has a lumen and the lumen has a diameter of about 2.8 mm to about 19.8 mm (e.g., about 2.8 mm to about 15 mm, about 2.8 mm to about 10 mm, or 2.8 mm to about 5 mm).

[0101] The ET tube 200, in some embodiments, has a length from the proximal end to the distal end of 12 cm to 40 cm (e.g., about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm).

[0102] In some embodiments, the ETS platform includes an ET tube connector 300. In some embodiments, the ET tube connector 300 bridges the proximal end of the ET tube and the distal end of the ventilator tubing circuit 410 (FIG. 2). In some embodiments, the ET tube connector 300 includes a port 340 (FIG. 3).

[0103] In some embodiments, the ET tube connector includes a sensor 310 (FIG. 2). In some embodiments, the sensor can measure one or more parameters including airflow, pressure, or temperature. In some embodiments, the control unit 500 is in electrical communication with the sensor 310.

[0104] The fourth intratracheal stimulation system In another aspect, the ETS platform 1000 provided herein includes a fourth ETS system 800 as shown in FIG. 9A and FIG. 9B. The fourth ETS system 800 may include, in some embodiments, an ET tube 200, an ET tube connector 300, a catheter 820, and one or more electrode pairs 830. FIGS. 9A-9B show an exemplary fourth ETS system 800 including a catheter 820 in a collar configuration and a catheter cuff 850 disposed at a distal end of the catheter 820. In some embodiments, the catheter cuff 850 can have a non-expanded configuration as shown in FIG. 9A, and in some embodiments, the catheter cuff 850 can have an expanded configuration as shown in FIG. 9B. In some embodiments, the one or more electrode pairs 830 are disposed on the catheter cuff 850 as shown in FIG. 9B. In some embodiments, the catheter 820 is shown configured to wrap around the endotracheal tube 200 from the proximal end of the endotracheal tube 201 to the distal end of the endotracheal tube 202. In some embodiments, each electrode pair 830, including a, is positioned radially around the ET tube cuff 210 (FIG. 9B). In some embodiments, the ET tube 200 includes a pilot balloon line 215, as shown in FIG.

[0105] In some embodiments, the fourth ETS system 800 is configured to engage one or more of the systems of the ETS platform 1000, including one or more data cables 320, the control unit 500, the ventilator 400, and the ventilator tube 410. In some embodiments, a locking mechanism 330 similar to that shown in FIG. 3 is configured to be used with the fourth ETS system 800 to secure the data cable 320 to the endotracheal tube connector via the endotracheal tube connector port 340. In some embodiments, one or more components of the fourth ETS system 800 are configured to be disposed about an outer surface of the ET tube 200 (FIGS. 9A-9B), where the ET tube 200 is configured to be inserted into the trachea of ​​a subject.

[0106] electrode In some embodiments, at least a portion of the catheter 820 includes one or more electrode pairs 830. In some embodiments, the electrode pairs 830 are in electrical communication with a proximal portion of the ETS system 800. In some embodiments, the one or more electrode pairs 830 are in electrical communication with a proximal portion of the system 800 for connection to the control unit 500. In some embodiments, the electrical communication is wired, wireless, or both. In some embodiments, the wired electrical communication uses a locking mechanism 330 to ensure that electrical communication is maintained throughout operation of the ETS system 800.

[0107] In some embodiments, the one or more electrode pairs 830 are located on the outer surface of the catheter cuff 850 (FIG. 9B). In some embodiments, the electrode pair 830 is bipolar. In some embodiments, the bipolar electrodes allow pacing of the phrenic nerve, which runs parallel to the trachea, regardless of the angular orientation of the inner catheter relative to the trachea 010. In some embodiments, the electrode pair 830 is unipolar. In some embodiments, the one or more electrode pairs 830 are evenly distributed along a radial length around the catheter cuff 850. In some embodiments, the one or more electrode pairs 830 are not evenly distributed along the length of the catheter cuff 850. In some embodiments, the one or more electrode pairs 830 are disposed at least partially around the circumference of the catheter cuff 850 (FIG. 9B).

[0108] In some embodiments, one or more of the electrode pairs 830 have a circular shape. In some embodiments, one or more of the electrode pairs are formed into a rectangle. In some embodiments, one or more of the electrode pairs have a circular, rectangular, triangular, oval, D-shaped, star-shaped, polygonal, or any combination or variation thereof.

[0109] In some embodiments, the one or more electrode pairs 830, when formed into a circular shape (FIG. 7), have a diameter of about 1 mm to 10 mm (e.g., about 2 mm to 10 mm, 3 mm to about 10 mm, about 4 mm to about 10 mm, about 5 mm to about 10 mm, or about 6 mm to about 10 mm). In some embodiments, the one or more electrode pairs 830 have a diameter of at least about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. In some embodiments, the one or more electrode pairs have a diameter of up to about 10 mm, about 9 mm, about 8 mm, about 7 mm, or about 6 mm.

[0110] In some embodiments, one or more electrode pairs 830, when formed into a rectangular configuration, have a length and a width, where the length is the dimension of the electrode extending around the circumference of the ET tube and the width is the dimension of the electrode from the proximal end of the ET tube to the distal end of the ET tube. In some embodiments, the length of the electrodes of one or more electrode pairs is about 3 mm to about 20 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).

[0111] In some embodiments, the width of the electrodes of one or more electrode pairs 830 is from about 1 mm to about 10 mm (e.g., from about 2 mm to about 10 mm, or from about 5 mm to about 10 mm). In some embodiments, the width of the electrodes of one or more electrode pairs 830 is at least about 1 mm, about 2 mm, or about 5 mm. In some embodiments, the width of the electrodes of one or more electrode pairs 830 is up to about 10 mm, about, or about 5 mm.

[0112] In some embodiments, the distance between electrode pairs 830 along the circumference of the catheter cuff 850 in the expanded configuration, referred to herein as electrode offset 833 (FIG. 9B), is about 1 mm to about 10 mm (e.g., about 2 mm to about 10 mm, or about 5 mm to about 10 mm). In some embodiments, electrode offset 833 is at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 7 mm, 8 mm, 9 mm, or 10 mm, including increments therein. In some embodiments, electrode offset 733 is at most about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 7 mm, 8 mm, 9 mm, or 10 mm, including increments therein. In some embodiments, offset 833 is established during manufacture of the ETS system, and one or more electrode pairs 830 are fixed to the catheter 820. In some embodiments, electrode offset is measured along a radial axis around the catheter cuff 850 from the center of one electrode to the center of an adjacent electrode.

[0113] In some embodiments, one or more electrode pairs 830 contact the trachea of ​​the subject. In some embodiments, one or more electrode pairs 830 contact the tracheal wall 015 of the subject, thereby enabling phrenic nerve pacing as described herein. In some embodiments, one or more electrode pairs 830 are configured to contact at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 95% of the inner circumference of the tracheal wall of the subject. In some embodiments, at least a portion of one or more electrode pairs 830 contact the tracheal wall 015 of the subject.

[0114] In some embodiments, one or more pairs of electrodes 830 are made of the same conductive material. In some embodiments, one or more pairs of electrodes 830 are made of different conductive materials. In some embodiments, the conductive material is a material that is a conductor of electricity, including, but not limited to, pure metals or alloys, commonly used in the art to make wire electrodes. In some embodiments, the conductive material is selected from silicon, platinum, iridium, polyimide, gold, ceramic, nickel, titanium, copper, iron, chromium, or alloys or combinations thereof.

[0115] catheter In some embodiments, the catheter 820 of the fourth ETS system 800 is formed as a collar with a catheter cuff 850 at the distal end of the catheter, as shown in FIGS. 9A-9B. In some embodiments, the catheter 820 is configured and dimensioned to translate along the ET tube 200 to the intratracheal stimulation site. In some embodiments, the catheter 820 is configured to translate along the length of the ET tube 200 with the catheter cuff 850 in a non-expanded configuration (FIG. 9A). In some embodiments, the catheter 820 is configured to position the catheter cuff 850 over the ET cuff 210 as shown in FIG. 9B. In some embodiments, the inflation state of the ET cuff 210 determines the configuration of the catheter cuff 850 from non-expanded to expanded. In some embodiments, the catheter cuff 850 is configured to slide over the ET cuff 210 and is configured to be expanded by either inflation of the ET cuff 210 or inflation of the catheter cuff 850.

[0116] In some embodiments, the catheter cuff 850 has one or more electrodes positioned radially around the ET tube 200. In some embodiments, each electrode of the catheter cuff is supported by an expandable scaffolding material (e.g., wire, net, mesh, or any variation and / or combination thereof). In some embodiments, the catheter cuff 850 has 1-20 electrodes (e.g., 1-18, 1-16, 1-14 electrodes, 1-12 electrodes, 1-10 electrodes, 1-8 electrodes, or 1-6 electrodes). In some embodiments, the catheter cuff has at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 electrodes. In some embodiments, the catheter cuff has up to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, or 2 electrodes.

[0117] In some embodiments, the length of the catheter 820 along the ET tube 200 is from about 1 cm to about 100 cm (e.g., about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, about 35 cm, about 36 cm, about 37 cm, about 38 cm, about 39 cm, about 40 cm, about 41 cm, about 42 cm, about 43 cm, about 44 cm, about 45 cm, about 46 cm, about 47 cm, about 48 cm, about 49 cm, about 50 cm, about 51 cm, about 52 cm, about 53 cm, about 54 cm, about 55 cm, about 56 cm, about 57 cm, about 58 cm, about 59 cm, about 60 cm, about 61 cm, about 62 cm, about 63 cm, about 64 cm, about 65 cm, about 66 cm, about 67 cm, about 68 cm, about 69 cm, about 70 cm, about 71 cm, about 72 cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm m, approximately 21cm, approximately 22cm, approximately 23cm, approximately 24cm, approximately 25cm, approximately 26cm, approximately 27cm, approximately 28cm, approximately 29cm, approximately 30cm, approximately 31cm, approximately 32cm, approximately 33cm, approximately 34cm, approximately 35cm, approximately 36cm, approximately 37cm, approximately 38cm, approximately 39cm, approximately 40cm, approximately 41cm, approximately 42cm, approximately 43cm, approximately 44cm, approximately 45cm, approximately 46cm, approximately 47cm , about 48cm, about 49cm, about 50cm, about 51cm, about 52cm, about 53cm, about 54cm, about 55cm, about 56cm, about 57cm, about 58cm, about 59cm, about 60cm, about 6 1cm, approximately 62cm, approximately 63cm, approximately 64cm, approximately 65cm, approximately 66cm, approximately 67cm, approximately 68cm, approximately 69cm, approximately 70cm, approximately 71cm, approximately 72cm, approximately 73cm, approximately 74cm, about 75 cm, about 76 cm, about 77 cm, about 78 cm, about 79 cm, about 80 cm, about 81 cm, about 82 cm, about 83 cm, about 84 cm, about 85 cm, about 86 cm, about 87 cm, about 88 cm, about 89 cm, about 90 cm, about 91 cm, about 92 cm, about 93 cm, about 94 cm, about 95 cm, about 96 cm, about 97 cm, about 98 cm, about 99 cm, or about 100 cm).

[0118] In some embodiments, the catheter wraps around at least a portion of the ET tube 200, as shown in Figures 9A-9B. In some embodiments, the catheter wraps around at least about a 180 degree, 270 degree, or 360 degree angular portion of the ET tube 200.

[0119] In some embodiments, the catheter includes protrusions to increase the strength of the connection of the catheter to the ET tube 200 (FIG. 8A). In some embodiments, the catheter 820 is configured to connect to the ET tube 200 via a snap or press fit.

[0120] ET tubes, ET tube connectors and sensors An ETS system generally includes an ET tube 200. The ET tube 200 is configured to be inserted into a subject's trachea 010 (FIG. 2). In some embodiments, inserting the ET tube into the subject's trachea 010 protects the subject's airway and provides ventilation while pacing the subject's phrenic nerve 020 and / or 030. In some embodiments, the ET tube is an oral ET tube 200. In some embodiments, the ET tube is a nasal ET tube. In some embodiments, the ET tube is a tracheotomy tube. In some embodiments, the ET tube is configured to function with all embodiments and / or variations of the catheter 820, ET tube connector 300, or one or more electrode pairs 830 described herein.

[0121] In some embodiments, the ET tube 200 has an outer diameter of about 3 mm to about 20 mm (e.g., about 3 mm to about 18 mm, about 4 mm to about 16 mm, about 5 mm to about 14 mm, about 6 mm to about 13 mm, about 7 mm to about 12 mm, or about 8 mm to about 11 mm). In some embodiments, the ET tube 200 has an outer diameter of up to 20 mm (e.g., up to 15 mm, up to 10 mm, up to 5 mm). In some embodiments, the ET tube 200 has a lumen, and the lumen has a diameter of about 2.8 mm to about 19.8 mm (e.g., about 2.8 mm to about 15 mm, about 2.8 mm to about 10 mm, or 2.8 mm to about 5 mm).

[0122] The ET tube 200, in some embodiments, has a length from the proximal end to the distal end of 12 cm to 40 cm (e.g., about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm).

[0123] In some embodiments, the ETS platform includes an ET tube connector 300. In some embodiments, the ET tube connector 300 bridges the proximal end of the ET tube and the distal end of the ventilator tubing circuit 410 (FIG. 2). In some embodiments, the ET tube connector 300 includes a port 340 (FIG. 3).

[0124] In some embodiments, the ET tube connector includes a sensor 310 (FIG. 2). In some embodiments, the sensor can measure one or more parameters including airflow, pressure, or temperature. In some embodiments, the control unit 500 is in electrical communication with the sensor 310.

[0125] How to pace a subject In another aspect, the invention provides a method of pacing a subject, the method including inserting one or more components of an ETS system into an ET tube 200 of a subject as described herein, transforming the first ETS system from a constrained configuration to an unconstrained configuration by advancing a catheter out of a guide sheath to contact a wall of the trachea with an electrode pair, and delivering power to the electrode pair in a pattern to pace the subject's phrenic nerve. In some embodiments, the method further includes bending the catheter, deforming the catheter, or both.

[0126] In some embodiments, inserting an ETS system, as described herein, into a subject's trachea comprises inserting an ET tube into the subject's trachea and inserting the ETS system into the ET tube. In some embodiments, inserting an ETS system herein into a subject's trachea comprises inserting an ET tube into the subject's trachea and inserting a catheter and a guide sheath together into the ET tube. In some embodiments, inserting an ETS system herein into a subject's trachea comprises inserting an ET tube into the subject's trachea, inserting a guide sheath into the ET tube, and inserting a catheter into the guide sheath.

[0127] In some embodiments, the method further includes intubating the subject with an ET tube and connecting the ET tube to a ventilator. In some embodiments, the method further includes bending and / or forming the catheter into a particular shape. In some embodiments, the method further includes confirming that the catheter is properly placed (e.g., near the carina) using an electrode pair and / or another sensing device.

[0128] In some embodiments, the ETS system does not include a catheter and the electrode pair is advanced out of the guide sheath. In some embodiments, the ETS system does not include a catheter and the electrode pair is bent, deformed, or both. In some embodiments, the ETS system does not include a catheter and the electrode pair and guide sheath enter the ET tube together.

[0129] In another aspect, the invention provides a method of pacing a subject, the method including inserting a second endotracheal system into the subject's ET tube as described herein, advancing the catheter out of the guide sheath to contact the wall of the trachea with the electrode pair to convert the ETS system from a constrained to an unconstrained configuration, and powering the electrode pair in a pattern to pace the subject's phrenic nerve. In some embodiments, the method further includes bending the catheter, deforming the catheter, or both.

[0130] In some embodiments, the ETS system does not include a catheter and the electrode pair is advanced out of the guide sheath. In some embodiments, the ETS system does not include a catheter and the electrode pair is bent, deformed, or both. In some embodiments, the ETS system does not include a catheter and the electrode pair and guide sheath enter the ET tube together.

[0131] In another aspect, the present invention provides a method of pacing a subject, the method comprising inserting a third endotracheal system herein into the trachea of ​​the subject, contacting a wall of the trachea with an electrode pair, and powering the electrode pair in a pattern to pace the subject's phrenic nerve. In some embodiments, the method further comprises placing the third endotracheal system over an ET tube.

[0132] In another aspect, the invention provides a method of pacing a subject, the method comprising inserting a fourth endotracheal system herein into the trachea of ​​the subject, contacting a wall of the trachea with an electrode pair, and powering the electrode pair in a pattern to pace the subject's phrenic nerve. In some embodiments, the method further comprises placing the fourth endotracheal system over an ET tube.

[0133] Terms and Definitions

[0134] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0135] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. References herein to "or" are intended to include "and / or" unless specifically stated otherwise.

[0136] As used herein, the term "about" refers to an amount that is approximately the recited amount, in some cases.

[0137] As used herein, the term "about" refers to an amount to the nearest 10%, 5%, or 1% of the recited amount, including increments therein.

[0138] As used herein, the term "about" in reference to percentages refers to amounts that are 10%, 5%, or 1% more or less than the recited percentage, including increments therein.

[0139] As used herein, the phrases "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive when used. For example, the phrases "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" respectively mean A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together. Terms such as "one or more," "at least one," and "two or more" mean at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 8 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64 , 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 1 07, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140 , 141, 142, 143, 144, 145, 146, 147, 148, 149 or 150, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000 or more, and any number in between.

[0140] The term "endotracheal stimulation platform" as used herein refers to one or more ETS systems and devices or systems functionally connected thereto. For example, an "endotracheal stimulation platform" may include any one or more ETS systems as described herein, one or more control units, and / or one or more ventilators.

[0141] As used herein, the term "distal" refers to the end furthest from the medical professional when introducing the device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing the device into a patient.

[0142] The term "longitudinal axis", as used herein, refers to the exact or approximate central axis of a device or component thereof along its larger dimension, i.e., along the length from its distal end to its proximal end, and vice versa, and is not limited to meaning a straight line; for example, if a catheter includes a helical shape as described herein, then "longitudinal axis" as used herein is intended to follow such helix.

[0143] As used herein, the term "expandable" refers to the ability to increase in diameter from a "collapsed" or "contracted" configuration to an "expanded" or "inflated" configuration. As used herein, "diameter" refers to the linear distance extending between two points and does not necessarily denote a particular shape.

[0144] The terms "constrained," "undeployed," "unexpanded," or variations thereof, as used herein, may be used interchangeably and are intended to refer to a collapsed or compressed configuration that has a reduced physical footprint compared to the "unconstrained" configuration.

[0145] The terms "unconstrained," "deployed," "extended," or variations thereof, as used herein, may be used interchangeably and are intended to refer to an enlarged and / or unfolded configuration having an increased physical footprint as compared to a "constrained" configuration.

[0146] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the present disclosure. It is to be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in implementing the present disclosure.

Claims

1. An intratracheal stimulation system, comprising: (a) a catheter, at least a distal portion of the catheter including an electrode pair, the electrode pair in electrical communication with a proximal portion of the endotracheal stimulation system for connection to a control unit, the distal portion of the catheter being biased to have a shape that is non-linear; (b) a guide sheath surrounding at least a portion of the catheter and having a lumen sized to fit within an endotracheal tube, the catheter being axially translatable relative to the guide sheath; The intratracheal stimulation system comprises: (c) a constraining configuration when the distal portion of the catheter is within the guide sheath, wherein an axis of the catheter and an axis of the guide sheath are axially aligned; (d) an unconstrained configuration when the distal portion of the catheter extends outside the guide sheath, wherein at least a portion of the axis of the catheter and the axis of the guide sheath are tilted so that the electrode pair contacts the trachea of the subject.

2. An intratracheal stimulation system as described in claim 1, wherein the electrode pair is bipolar.

3. An intratracheal stimulation system as described in claim 1, wherein the electrode pair is unipolar.

4. An intratracheal stimulation system as described in claim 1, wherein the distal portion of the catheter includes two or more electrode pairs.

5. An endotracheal stimulation system as described in claim 4, wherein the two or more electrode pairs are evenly distributed along the length of the catheter.

6. An intratracheal stimulation system as described in claim 4, wherein each of the two or more electrode pairs is separated by an offset distance of approximately 0.25 cm to approximately 16 cm.

7. The intratracheal stimulation system of claim 1, wherein the catheter further includes a lumen.

8. The intratracheal stimulation system of claim 1, wherein the catheter is flexible, pliable, or both.

9. An endotracheal stimulation system comprising a catheter at a distal end of the endotracheal stimulation system configured to wrap around at least a portion of an endotracheal tube, the catheter including an electrode pair on an outer surface of the catheter, the electrode pair in electrical communication with a proximal portion of the endotracheal stimulation system for connection to a control unit.

10. An intratracheal stimulation system as described in claim 9, wherein the electrode pair is bipolar.

11. An intratracheal stimulation system as described in claim 9, wherein the electrode pair is unipolar.

12. An intratracheal stimulation system as described in claim 9, wherein the catheter includes two or more electrode pairs.

13. An endotracheal stimulation system as described in claim 12, wherein the two or more electrode pairs are evenly distributed along the length of the catheter.

14. A method of pacing a subject, the method comprising: (a) inserting an endotracheal stimulation system into a tracheal tube of a subject, the endotracheal stimulation system comprising: (i) at least a distal portion comprising an electrode pair; (ii) a guide sheath surrounding at least a portion of the catheter and having a lumen sized to fit within an endotracheal tube, the catheter being axially translatable relative to the guide sheath; inserting the (b) advancing the catheter out of the guide sheath to contact the tracheal wall with the electrode pair, thereby converting the endotracheal stimulation system from a tethered configuration to an untethered configuration; (c) applying power to the electrode pair in a pattern to pace the subject's phrenic nerve.

15. The method of claim 14, further comprising bending the catheter, deforming the catheter, or both.