Multifunctional Newborn Garbage Tube

Abstract

An aspect of the invention relates to a multi-lumen tube including a plurality of channels having a proximal end, a distal end, and a length therebetween, the plurality of channels including a first channel forming a nutritional supply lumen and a second channel forming a monitoring lumen, each channel extending parallel to one another along at least a portion of the length of the tube, the proximal end being positioned outside the subject's body and the distal end being positioned within the subject's stomach.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 376,356, filed September 20, 2022, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] In preterm infants, an orogastric or nasogastric tube must be inserted to provide milk to infants who are unable to regulate feeding and swallowing independently. These infants often require a gas tube to drain the stomach of gas introduced into it by the respiratory support device. If this gas does not drain from the stomach, it can progress and cause abdominal distension ("CPAP belly"), which can interfere with breathing and feeding tolerance. Currently, feeding and venting needs are met with a single-lumen tube, which means that gas cannot be vented ("vented") while feeding. Because many extremely preterm infants have difficulty tolerating feedings, medical teams often decide to feed them more slowly through the tube, thereby limiting the time available for venting. In some cases, the insertion of a second tube allows for continuous feeding and continuous venting simultaneously. Summary of the Invention [Problem to be solved by the invention]

[0003] Therefore, there is a need in the art to develop a multi-function tube that allows for continuous feeding and evacuation to overcome a significant obstacle to optimal care of premature newborns. The present invention addresses this need. [Means for solving the problem]

[0004] An aspect of the invention relates to a garbage tube having a multi-lumen tube with a plurality of channels having a proximal end, a distal end and a length therebetween, the plurality of channels including a first channel forming a nutrient supply lumen and a second channel forming a monitoring lumen, the channels extending parallel to one another along at least a portion of the length of the tube, the proximal end being positioned outside the subject's body and the distal end being positioned within the subject's stomach.

[0005] In some embodiments, the multi-lumen tubing has an outer diameter in the range of 1.0 to 10.0 mm. In some embodiments, the multi-lumen tubing has an inner diameter in the range of 0.5 to 8.0 mm. In some embodiments, the outer surface of the multi-lumen tubing comprises a plurality of texture markings for enhanced visibility. In some embodiments, the first channel comprises an axial feed hole at the distal end of the channel.

[0006] In some embodiments, the first channel is fluidly connected to one selected from the group consisting of a pump and a syringe. In some embodiments, the first channel has a diameter in the range of 0.3 to 5.0 mm. In some embodiments, the plurality of channels comprises a third channel forming an exhaust lumen. In some embodiments, the third channel comprises a plurality of side exhaust holes penetrating a wall of the third channel and penetrating a wall of the multi-lumen tubing. In some embodiments, the plurality of side exhaust holes have a diameter in the range of 0.5 to 3.0 mm. In some embodiments, the plurality of side exhaust holes are disposed at the distal end of the multi-lumen tubing. In some embodiments, the plurality of side exhaust holes are disposed within the distal 2 cm of the multi-lumen tubing.

[0007] In some embodiments, the garbage tube further includes an exhaust chamber in fluid communication with a third channel disposed at the proximal end of the multi-lumen tube. In some embodiments, the exhaust chamber includes a first opening configured to be used for profiling gases in the stomach and an escape valve configured to allow gas outflow. In some embodiments, the escape valve is a one-way valve.

[0008] In some embodiments, the second channel further comprises a first side opening extending through the wall of the second channel, extending through the wall of the multi-lumen tubing, and positioned 3 to 20 cm from the distal end of the tubing. In some embodiments, the garbage tube further comprises at least one temperature sensor disposed at the first opening of the second channel. In some embodiments, the at least one temperature sensor may be selected from the group consisting of a thermocouple, a thermistor, a thermodiode, and combinations thereof. In some embodiments, the second channel further comprises a second side opening extending through the wall of the second channel, extending through the wall of the multi-lumen tubing, and positioned 3 to 7 cm from the distal end of the tubing. In some embodiments, the garbage tube further comprises a second pressure sensor disposed at the second side opening of the second channel.

[0009] In some embodiments, the garbage tube further comprises a plurality of electrode rings disposed on an outer wall of the multi-lumen tube and configured for use as an ECG or EMG sensor, the plurality of electrode rings being disposed along at least a portion of the length of the multi-lumen tube. In some embodiments, the plurality of electrode rings comprises 2 to 10 electrode rings. In some embodiments, the plurality of electrode rings comprises at least first, second, and third electrode rings, the first electrode ring being disposed 3 cm from the distal end of the multi-lumen tube, the second electrode ring being disposed 9 cm from the distal end of the multi-lumen tube, and the third electrode ring being disposed 10 cm from the distal end of the multi-lumen tube.

[0010] An aspect of the present invention relates to a method of providing nutrition to a subject, the method comprising: inserting a garbage tube through the nasal or oral cavity of the subject, the garbage tube comprising a multi-lumen tube having a plurality of channels having a proximal end, a distal end and a length therebetween, wherein a first channel forms a nutrition supply lumen having a proximal opening and a distal axial opening in the multi-lumen tube, and a second channel forms a monitoring lumen having a proximal opening and one or more lateral openings in the multi-lumen tube, with one or more sensors disposed at each opening, the channels extending parallel to each other along at least a portion of the length of the tube, the proximal end of the multi-lumen tube being positioned outside the subject's body and the distal end being positioned within the subject's stomach; providing nutrition through the nutrition supply lumen; and measuring at least one biological information of the subject using the one or more sensors during the process of providing nutrition through the nutrition supply lumen.

[0011] An aspect of the invention relates to a method of providing nutrition to a subject while simultaneously evacuating gas from the stomach of the subject, the method comprising inserting a garbage tube through the nasal or oral cavity of the subject, the garbage tube comprising a multi-lumen tube having a plurality of channels with a proximal end, a distal end and a length therebetween, wherein a first channel forms a feeding lumen having a proximal opening and a distal axial opening in the multi-lumen tube, a second channel forms a monitoring lumen having a proximal opening and one or more lateral openings in the multi-lumen tube with one or more sensors disposed at each opening, and a third channel forms a monitoring lumen having a proximal opening and one or more lateral openings in the multi-lumen tube with one or more sensors disposed at each opening. the gas supply lumen is adapted to supply nutrition through the gas supply lumen, the gas supply lumen being adapted to provide ...

[0012] In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a pressure sensor, an optical sensor, an infrared sensor, a humidity sensor, and a proximity sensor. In some embodiments, the garbage tube further comprises a plurality of electrode rings disposed on an outer surface of the multi-lumen tube configured to measure ECG or EMG signals from the subject, and the method further comprises measuring ECG or EMG signals from the subject using the plurality of electrode rings during the step of providing nutrition through the nutrition supply lumen.

[0013] The following detailed description of embodiments of the present invention will be better understood when read in conjunction with the accompanying drawings, It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings. [Brief explanation of the drawings]

[0014] [Figure 1A] 1A and 1B are perspective views of an exemplary garbage tube of the present invention. [Figure 1B] 1A and 1B are perspective views of an exemplary garbage tube of the present invention. [Figure 2A] 2A and 2B are side views of an exemplary garbage tube of the present invention. [Figure 2B] 2A and 2B are side views of an exemplary garbage tube of the present invention. [Figure 3A] 3A and 3B are cross-sectional views of a garbage tube of the present invention having a nutrient supply lumen, an exhaust lumen, and a monitoring lumen. [Figure 3B] 3A and 3B are cross-sectional views of a garbage tube of the present invention having a nutrient supply lumen, an exhaust lumen, and a monitoring lumen. [Figure 4] FIG. 4 is a side view of an exemplary exhaust chamber in fluid communication with an exhaust lumen. [Figure 5] FIG. 5 is a cross-sectional view of an exemplary monitoring lumen of the present invention. [Figure 6] FIG. 6 is a side view of an exemplary garbage tube having markings that allow for improved visibility during use. [Figure 7A] FIG. 7A is a flow chart illustrating an exemplary method of providing nutrition to a subject through a garbage tube according to an embodiment of the present invention. [Figure 7B] FIG. 7B is a flow chart illustrating an exemplary method for simultaneously evacuating gas from a subject's stomach and providing nutrition to the subject using a garbage tube according to an embodiment of the present invention. [Figure 8] FIG. 8 is a multiple view illustration of an exemplary garbage tube of the present invention. [Figure 9] FIG. 9 shows, from top to bottom, a cross-section, a top view, a front view, and a back view of an exemplary garbage tube of the present invention. [Figure 10]FIG. 10 shows various perspective views of an exemplary garbage tube of the present invention. [Figure 11A] 11A, 11B, and 11C illustrate pressure results of vital signs monitoring from an exemplary garbage tube (eg, Trinity Tube) of the present invention. [Figure 11B] 11A, 11B, and 11C illustrate pressure results of vital signs monitoring from an exemplary garbage tube (eg, Trinity Tube) of the present invention. [Figure 11C] 11A, 11B, and 11C illustrate pressure results of vital signs monitoring from an exemplary garbage tube (eg, Trinity Tube) of the present invention. [Figure 12A] 12A, 12B, and 12C illustrate temperature results of vital signs monitoring from an exemplary garbage tube of the present invention. [Figure 12B] 12A, 12B, and 12C illustrate temperature results of vital signs monitoring from an exemplary garbage tube of the present invention. [Figure 12C] 12A, 12B, and 12C illustrate temperature results of vital signs monitoring from an exemplary garbage tube of the present invention. [Figure 13] FIG. 13 shows an example of ECG results from vital signs monitoring from a garbage tube comparing chest and 3-7 combinations. [Figure 14] FIG. 14 shows a comparison of chest and 2-9 combination ECG results for vital signs monitoring from an exemplary garbage tube. [Figure 15] FIG. 15 is a diagram of a computing device in which the present invention can operate, in accordance with an embodiment of the present invention. [Figure 16] FIG. 16 is a side view of the EDI catheter. [Figure 17] FIG. 17 is a side view of an exemplary garbage tube according to an embodiment of the present invention. [Figure 18]FIG. 18 is an enlarged side view (left) and cross-sectional view (right) of the distal end of an exemplary garbage tube according to an embodiment of the present invention. [Figure 19] FIG. 19 is an enlarged side view (right) and cross-sectional view (right) of the proximal end of an exemplary garbage tube according to an embodiment of the present invention. [Figure 20] FIG. 20 is a diagram of various views of an exemplary garbage tube and garbage tube system according to an embodiment of the present invention. [Figure 21] FIG. 21 illustrates the results of pressure sensor calibration data for an exemplary garbage tube system. [Figure 22] FIG. 22 is a diagram illustrating the life support setup for the animal model. [Figure 23] FIG. 23 illustrates an exemplary garbage tube setup within an animal's body according to an embodiment of the present invention. [Figures 24A-24B] 24A, 24B, 24C, and 24D show ECG signal data at 13 cm generated by an exemplary garbage tube of the present invention. Fig. 24A shows data generated by ECG1. Fig. 24B shows data generated by ECG2. [Figures 24C-24D] Figures 24A, 24B, 24C, and 24D show data from ECG signals at 13 cm generated by an exemplary garbage tube of the present invention. Figure 24C shows data generated by ECG3. Figure 24D shows data generated by ECG4. [Figures 25A-25B] Figures 25A, 25B, 25C, and 25D show data from ECG signals at 8 cm generated by an exemplary garbage tube of the present invention. Figure 24A shows data generated by ECG1. Figure 24B shows data generated by ECG2. [Figures 25C-25D]Figures 25A, 25B, 25C, and 25D show data from an ECG signal at 8 cm generated by an exemplary garbage tube of the present invention. Figure 24C shows data generated by ECG3. Figure 24D shows data generated by ECG3. [Figure 26] FIG. 26 shows the ECG signal from selected electrodes (ECG3). [Figures 27A-27C] Figures 27A, 27B, and 27C show pressure and temperature data at 10 Hz and 60 BPM. Figure 27A shows pressure sensor 1 data at the tip, Figure 27B shows pressure sensor 2 data 5 cm from the tip, and Figure 27C shows esophageal temperature data. [Figures 28A-28C] Figures 28A, 28B, and 28C show pressure and temperature data at 10 Hz and 80 BPM. Figure 28A shows pressure sensor 1 data at the tip, Figure 28B shows pressure sensor 2 data 5 cm from the tip, and Figure 28C shows esophageal temperature data. [Figure 29A] 29A and 29B are diagrams of various views of an exemplary garbage tube with a first pressure sensor, a second pressure sensor, a temperature probe, and multiple ECG electrodes, according to an embodiment of the present invention. [Figure 29B] 29A and 29B are diagrams of various views of an exemplary garbage tube with a first pressure sensor, a second pressure sensor, a temperature probe, and multiple ECG electrodes, according to an embodiment of the present invention. [Figures 30A-30C] Figures 30A, 30B, and 30C illustrate data generated by an exemplary garbage tube: Figure 30A illustrates pressure data, Figure 30B illustrates temperature data, and Figure 30C illustrates ECG data. [Figure 31] FIG. 31 is a diagram illustrating placement of an exemplary garbage tube within a subject's body according to an embodiment of the present invention. [Figure 32] FIG. 32 is a diagram of various views of an exemplary garbage tube and garbage tube system according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] Detailed Description It should be understood that the figures and descriptions of the present invention are simplified to illustrate elements relevant to a clear understanding of the present invention, while excluding, for purposes of clarity, many other elements found in the field of garbage tubes. One skilled in the art may recognize that other elements and / or steps are desirable and / or necessary in implementing the present invention. However, because such elements and steps are well known in the art and do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

[0016] definition Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology is used:

[0017] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0018] The articles "a" and "an" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0019] As used herein, "about" when referring to a measurable value such as an amount, duration in time, etc., is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the stated value, where such variations are appropriate.

[0020] The terms "patient," "subject," "individual," and the like are used interchangeably herein and refer to any animal to which the systems, devices, and methods described herein are applicable. A patient, subject, or individual may be a mammal, and in some cases, may be a human.

[0021] Ranges: Throughout this disclosure, various aspects of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as a strict limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, and 3 to 6, as well as individual numerical values ​​within that range, e.g., 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the broadness of the range.

[0022] Multifunctional Newborn Garbage Tube The present invention generally relates to a multi-lumen neonatal gavage tube. In one embodiment, the gavage tube of the present invention includes a dedicated feeding lumen coupled to a dedicated exhaust lumen and a monitoring lumen, which together form a single tube. While some examples are described as having a dedicated exhaust lumen, it should be understood that the gavage tube of the present invention may include only a dedicated feeding lumen coupled to a dedicated monitoring lumen. In one embodiment, the gavage tube of the present invention is configured to allow continuous feeding and gastric evacuation. In one embodiment, the monitoring lumen allows for continuous monitoring of at least one parameter or signal, including, but not limited to, temperature, electrocardiogram (ECG), transdiaphragmatic pressure, pH, impedance, etc. In one embodiment, the gavage tube of the present invention allows for continuous monitoring of peristalsis. In one embodiment, the gavage tube of the present invention allows for quantification of work of breathing from transdiaphragmatic pressure. In one embodiment, the gavage tube of the present invention allows for correction of central venous pressure for intrathoracic pressure. In one embodiment, the garbage tube of the present invention allows for easy visualization by bedside ultrasound.

[0023] 1A, 1B, 2A, and 2B, an exemplary garbage tube 100 of the present invention is shown. Garbage tube 100 comprises a proximal end 102, a distal end 104, and a multi-lumen tube 106 therebetween.

[0024] As contemplated herein, the multi-lumen tube 106 can have an outer diameter ranging from 1.0 to 10.0 mm (3 to 30 French). In one embodiment, the multi-lumen tube 106 has an outer diameter of approximately 2.7 mm (8 French). In one embodiment, the multi-lumen tube 106 can have an inner diameter ranging from 0.5 to 8.0 mm. In one embodiment, the multi-lumen tube 106 has an inner diameter of approximately 2.1 mm. In one embodiment, the multi-lumen tube 106 has a wall thickness of approximately 0.3 mm. In one embodiment, the multi-lumen tube 106 can have a length ranging from 20 to 50 cm. In one embodiment, the distal end 104 of the multi-lumen tube 106 can be tapered. In one embodiment, the distal end 104 of the multi-lumen tube 106 can be flat. In one embodiment, the distal end 104 of the multi-lumen tube 106 can have any other suitable shape known to those of skill in the art. Although the exemplary dimensions of the multi-lumen tube 106 are provided sized for an infant-sized subject, the multi-lumen tube 106 may be sized for any intended subject, including but not limited to human infants.

[0025] In one embodiment, distal end 104 may be positioned within the stomach of a subject. In one embodiment, distal end 104 may be positioned beyond the stomach into the duodenum of a subject.

[0026] The multi-lumen tube 106 comprises a first channel forming the nutrient supply lumen 108 and a second channel forming the monitoring lumen 112. In some embodiments, the multi-lumen tube 106 further comprises a third channel forming the exhaust lumen 110. In some embodiments, the nutrient supply lumen 108 is separated from the exhaust lumen 110 and the monitoring lumen 112 by a central wall 113 (FIGS. 3A and 3B). In one embodiment, the central wall 113 may be as thick as the wall of the multi-lumen tube 106. In one embodiment, the central wall 113 is thicker than the wall of the multi-lumen tube 106. In one embodiment, the central wall 113 may be thinner than the wall of the multi-lumen tube 106. The relative thicknesses of the central wall 113 and the outer wall of the multi-lumen tube 106 may vary depending on the application and the materials used to construct the garbage tube 100. In some embodiments, the multi-lumen tube 106 comprises an outer surface with multiple markings for increased visibility. In some embodiments, the marking is a texture marking and / or a radiological marking.

[0027] The nutrient supply lumen 108 includes an axial nutrient supply hole 114 disposed at the distal end 104. In one embodiment, the nutrient supply hole 114 can have a diameter smaller than the diameter of the nutrient supply lumen 108. In one embodiment, the nutrient supply hole 114 can have the same diameter as the nutrient supply lumen 108. The nutrient supply lumen 108 can be connected to any suitable device configured to allow introduction of a nutrient supply material to the proximal end 102. In one embodiment, the nutrient supply lumen 108 can be connected to a syringe at the proximal end 102. In one embodiment, the nutrient supply lumen 108 can be connected to a pump at the proximal end 102. The pump can provide nutrient supply at a rate adjustable from 0.1 to 100 ml / hour. In one embodiment, the pump is configured to achieve standard NICU syringe driver pressures. In one exemplary embodiment, 100 ml / hour would provide a 2.5 kg baby with 160 ml / kg nutrition per day over 30 minutes every 3 hours.

[0028] The nutritional supply lumen 108 has a diameter ranging from 0.1 to 4.0 mm. In one embodiment, the nutritional supply lumen 108 has a diameter of approximately 0.5 mm. In one embodiment, the nutritional supply lumen 108 can have any cross-sectional shape, including, but not limited to, circular, oval, etc. In one embodiment, the nutritional supply lumen 108 can have a generally circular cross-section. While exemplary dimensions for the nutritional supply lumen 108 are provided sized for an infant-sized subject, the nutritional supply lumen 108 may be sized for any intended subject, including but not limited to a human infant.

[0029] The exhaust lumen 110 includes a plurality of side vents 116 on the outer wall 117 of the exhaust lumen for venting the stomach. In one embodiment, the plurality of side vents 116 are located near the distal end 104. In one embodiment, the plurality of side vents 116 are located within the distal 2 cm of the exhaust lumen 110. In one embodiment, the plurality of side vents 116 may be arranged in any suitable configuration. In one embodiment, the plurality of side vents 116 may be arranged on at least one vertical line extending from the distal end 104 toward the proximal end 102. In one embodiment, the plurality of side vents 116 may be arranged on at least one horizontal line. In one embodiment, the plurality of side vents 116 may be arranged on at least one spiral line extending from the distal end 104 toward the proximal end 102 (FIG. 2). In one embodiment, the plurality of side vents 116 have a diameter in the range of 0.5 to 3.0 mm. The size, number, and placement of the vent holes may vary depending on the intended use of the garbage tube 100. For example, larger infants with larger stomachs may be accommodated with larger and more vent holes. In some embodiments, the multiple side vent holes 116 are evenly spaced on two different planes. In some embodiments, the multiple side vent holes 116 may be located at the 7 o'clock and 10 o'clock positions of the multi-lumen tube 106. In some embodiments, the multiple side vent holes 116 are a set of linear holes. In some embodiments, the multiple side vent holes 116 are three sets of linear holes. In some embodiments, the multiple side vent holes 116 are at least one hole in the multi-lumen tube 106 that is fluidly connected to the exhaust lumen 110. In some embodiments, the multiple side vent holes are located 2 cm distal to the second channel.

[0030] Exhaust lumen 110 is 1~6mm 2 In some embodiments, the total internal cross-sectional area is in the range of 3 mm 2A vent lumen 110 having a cross-sectional area of ​​1.5 mm and a length of 30 cm allows for an evacuation rate of approximately 180 ml / min from the stomach. In one embodiment, the vent lumen 110 has a generally crescent-shaped cross-section. While exemplary dimensions for the vent lumen 110 are provided sized for an infant-sized subject, the vent lumen 110 may be sized for any intended subject, including but not limited to human infants.

[0031] In one embodiment, the exhaust lumen 110 can be left open at the proximal end 102 for exhaust. In one embodiment, the exhaust lumen 110 can be fluidly connected to an exhaust chamber 118 at the proximal end 102 ( FIG. 4 ). The exhaust chamber 118 is configured to allow small amounts of gastric secretions and nutritional materials, including, but not limited to, milk, formula, or other liquid nutrients, to exit the exhaust lumen 110 upon vomiting or irritation and then gradually return to the child's stomach, maximizing nutritional tolerance. In one embodiment, the exhaust lumen 110 can be connected to the exhaust chamber 118 via any suitable mechanism known to those skilled in the art, including, but not limited to, tubing. The exhaust chamber 118 can have any suitable volume known to those skilled in the art for reflux and re-entry of milk in an enclosed space. In one embodiment, the exhaust chamber 118 has a chamber volume of 20 ml. In one embodiment, the exhaust chamber 118 has a volume greater than 20 ml. In one embodiment, the exhaust chamber 118 has a volume less than 20 ml.

[0032] The exhaust lumen 110 can be replaced periodically, for example, daily, while the garbage tube 100 remains in place. In some embodiments, the exhaust lumen 100 is replaced after a period of time, including, but not limited to, daily, every other day, every three days, every four days, three times a week, or once a week. In some embodiments, the exhaust chamber can be permanently attached to the exhaust lumen. In some embodiments, the exhaust chamber is removable so that the exhaust chamber can be replaced while the rest of the garbage tube remains in place.

[0033] The exhaust chamber 118 includes a first opening 120 and an escape valve 122. The first opening 120 can be located anywhere in the exhaust chamber 118 and is configured to be used for gastric gas profiling, including, but not limited to, CO2, metabolome, microbiome, etc. The escape valve 122 can be located anywhere in the exhaust chamber 118 and is configured to allow gas to escape. In one embodiment, the escape valve 122 can be a one-way valve. In one embodiment, the escape valve 122 can be any suitable valve known to one of skill in the art.

[0034] The multi-lumen tube 106 may include various openings to allow sensors to perform in-situ environmental measurements. Referring now to FIG. 1A , the multi-lumen tube 106 may include a first sensor opening 132 located near the distal end 104 and a second sensor opening 134 located near the proximal end 102. The first sensor opening 132 may house one or more sensors and form a fluid connection with the monitoring lumen 112. The second sensor opening 134 may house one or more sensors and form a fluid connection with the monitoring lumen 112. In one example, the multi-lumen tube 106 is described as having various sensors disposed within the tubes and lumens of the multi-lumen tube 106, but it should be understood that any sensor of the present invention may be configured and / or attached at any location outside of the individual tubes or outside of the multi-lumen tube 106 itself. It should also be understood that any sensor can be embedded in the wall of an individual tube or in the wall of the multi-lumen tube 106, and thus the sensors of the garbage tube 108 can be located inside, embedded in, or outside the tube and / or multi-lumen tube 106, any combination thereof is possible.

[0035] Referring now to FIG. 5 , an exemplary monitoring lumen 112 of the present invention is shown. The monitoring lumen 112 is configured to provide electrocardiogram (ECG), respiratory monitoring, temperature, and optional other monitoring functions. In one embodiment, the monitoring lumen 112 includes a temperature thermocouple 124 configured to provide reliable intraesophageal temperature without the need for a skin sensor. In one embodiment, the temperature thermocouple 124 is positioned at the distal end 104, extends toward the proximal end 102, and terminates approximately 3-7 cm from the distal end 104. In one embodiment, the temperature thermocouple 124 may terminate at any other suitable distance within the monitoring lumen 112. In one embodiment, the end of the temperature thermocouple 124 is integral with the wall of the monitoring lumen 112. In one embodiment, the end of the temperature thermocouple 124 is not integral with the wall of the monitoring lumen 112. In one embodiment, thermocouple 124 extends through monitoring lumen 112 and terminates at first sensor opening 132 to provide a temperature measurement within the gastric cavity. In one embodiment, thermocouple 124 extends through monitoring lumen 112 and terminates at first sensor opening 134 to provide a temperature measurement within the esophagus. In one embodiment, the temperature thermocouple may be any suitable thermocouple, including, but not limited to, a TE Micro Thermocouple Model 605, 0.08 x 0.16 mm size, 44 gauge. In one embodiment, any other temperature sensor may be used in place of the illustrated thermocouple, including, but not limited to, a thermistor, a thermodiode, etc.

[0036] In one embodiment, the monitoring lumen 112 further comprises a catheter 126 configured to measure diaphragmatic electrical activity (Edi) using neurally modulated assisted ventilation (NAVA) technology. For example, the catheter 126 may be a Getinge Edi NAVA catheter with 10 electrodes spaced 6 mm apart within a 6 Fr tube. In one embodiment, the electrodes may have a stainless steel coating. In one embodiment, the electrodes may have any other suitable coating known to those skilled in the art.

[0037] In some embodiments, the catheter 126 comprises at least one electrode wire configured to be connected to the at least one electrode ring 128. In some embodiments, the garbage tube 100 comprises at least one electrode disposed on the outside of the multi-lumen tube 106.

[0038] In one embodiment, the garbage tube 100 may further include a plurality of electrode rings 128 disposed on the outer wall of the multi-lumen tube 106 and contacting the subject's esophagus upon insertion. The plurality of electrode rings 128 are configured for use as an ECG sensor. The plurality of electrode rings 128 provide a reliable heart rate reading without the need for a skin sensor. In one embodiment, the garbage tube 100 may include at least two electrode rings 128. In one embodiment, the at least two electrode rings 128 may be positioned 5 to 15 mm apart from each other. In one embodiment, the garbage tube 100 may include three electrode rings 128. In one embodiment, the three electrode rings 128 are positioned 2 cm, 3 cm, and 4 cm from the distal end 104. In some embodiments, the garbage tube 100 has two electrode rings, three electrode rings, four electrode rings, five electrode rings, six electrode rings, seven electrode rings, eight electrode rings, nine electrode rings, ten electrode rings, eleven electrode rings, twelve electrode rings, thirteen electrode rings, fourteen electrode rings, or fifteen electrode rings. In some embodiments, the spacing between the electrode rings is, but is not limited to, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. In one embodiment, the plurality of electrode rings 128 can have a stainless steel coating. In another embodiment, the plurality of electrode rings 128 can have another suitable coating known to one of ordinary skill in the art.

[0039] In one embodiment, the monitoring lumen 112 further comprises at least one pressure sensor 130. In one embodiment, the monitoring lumen 112 has two pressure sensors, one located at the distal end 104 and one located 3-7 cm from the distal end 104. In one embodiment, the at least one pressure sensor 130 can be disposed within a catheter having a side hole for measuring esophageal pressure. In one embodiment, the pressure sensor 130 extends through the monitoring lumen 112 and terminates at a first sensor opening 132 to provide a pressure measurement within the gastric cavity. In one embodiment, the pressure sensor 130 extends through the monitoring lumen 112 and terminates at a first sensor opening 134 to provide a pressure measurement within the esophagus. In one embodiment, the at least one pressure sensor can be a microelectromechanical systems (MEMS) pressure sensor. In one embodiment, the MEMS pressure sensor can be 0.3 x 0.3 mm in size.

[0040] The monitoring lumen 112 has a diameter ranging from 0.3 to 1.5 mm. In one embodiment, the monitoring lumen 112 has a diameter of approximately 0.5 mm. In one embodiment, the monitoring lumen 112 can have any cross-sectional shape, including but not limited to, circular, oval, etc. In one embodiment, the monitoring lumen 112 has a diameter of 0.2 mm. 2 has a total internal cross-sectional area of

[0041] In one embodiment, garbage tube 100 may be a single-use device. In one embodiment, garbage tube 100 may be sterilized. In one embodiment, garbage tube 100 may be sterilized by any suitable method known to those of skill in the art, including, but not limited to, UV sterilization.

[0042] In one embodiment, the outer surface of the multi-lumen tubing 106 is printed with markings, including, but not limited to, measurement lines for positioning the tubing at the correct depth within the subject. In one embodiment, the outer surface of the multi-lumen tubing 106 may include one or more radiopaque markings, lines, spirals, etc. configured to be visible on a radiograph (X-ray), ultrasound, etc. (FIG. 6). In one embodiment, the outer surface of the tubing may include one or more radiopaque markings configured to be visible on a radiograph (X-ray). In one embodiment, the outer surface of the tubing is textured with lines, spirals, etc. configured to enhance visibility on ultrasound.

[0043] In one embodiment, the garbage tube 100 may be made of any suitable material known to those skilled in the art, including, but not limited to, soft, flexible plastics such as polymeric silicone (such as SILASTIC® manufactured by Dow Corning Corporation, Midland, Michigan, USA), polyurethane, silicone rubber, nylon, polyethylene terephthalate, latex, or combinations thereof.

[0044] In one embodiment, garbage tube 100 may be made from a single type of material. In one embodiment, garbage tube 100 may be made from multiple types of materials. In one embodiment, feeding tube 108 and exhaust tube 110 may be made from different types of materials. In one embodiment, feeding tube 108 and exhaust tube 110 may be made from a single type of material. In one embodiment, exhaust tube 110 may be made from a harder, less flexible material. In one embodiment, exhaust tube 110 may be made from a softer, more flexible material.

[0045] In one embodiment, the garbage tube 100 can be used with newborns, physically disabled infants, particularly premature infants, newborns with immature respiratory systems, and medically vulnerable infants. The example garbage tube 100 is provided for use by subjects up to one year of age, although examples also include infants and children up to and including two years of age. However, it should be noted that while the example garbage tube 100 provided is sized for an infant, the garbage tube 100 may be appropriately sized for any intended subject of any intended age, and the subject need not be human.

[0046] In one embodiment, the garbage tube 100 can further include a controller configured to monitor and store any data, including, but not limited to, feeding flow rate, feeding frequency, etc. The controller is further configured to receive data from the monitoring lumen 112 and the plurality of electrode rings 128. In some embodiments, the controller includes the computing device 1500 of FIG. 15. In some embodiments, the pressure within the subject is measured remotely using a membrane disposed at the distal end of the monitoring lumen. In this "remote sensing" approach, the inner diameter of the monitoring lumen 108 is 0.05-0.3 mm. The distal end of the monitoring lumen 108 opens into the esophagus. In some embodiments, the monitoring lumen includes one or more thin membranes surrounding the distal end of the lumen. In some embodiments, the proximal end of the monitoring lumen 108 is located outside the patient and is connected to any suitable sensor or pressure monitor.

[0047] Computing Devices In some aspects of the present invention, software executing the instructions provided herein can be stored on a non-transitory computer-readable medium, which when executed on a processor performs some or all of the steps of the present invention.

[0048] Aspects of the present invention relate to algorithms implemented in computer software. While particular embodiments may be described as being written in a particular programming language or running on a particular operating system or computing platform, it is understood that the systems and methods of the present invention are not limited to any particular computing language, platform, or combination thereof. Software executing the algorithms described herein can be written in, compiled, or interpreted in any programming language known in the art, including, but not limited to, C, C++, C#, Objective-C, Java, JavaScript, MATLAB, Python, PHP, Perl, Ruby, or Visual Basic. Furthermore, it is understood that elements of the present invention can be executed on any acceptable computing platform, including, but not limited to, a server, a cloud instance, a workstation, a thin client, a mobile device, an embedded microcontroller, a television, or any other suitable computing device known in the art.

[0049] Portions of the present invention are described as software running on a computing device. While the software described herein may be disclosed as running on a particular computing device (e.g., a dedicated server or workstation), it is also understood in the art that software is portable in nature, and that most software running on a dedicated server can, for purposes of the present invention, be run on any of a wide range of devices, including desktop or mobile devices, laptops, tablets, smartphones, watches, wearable electronics or other wireless digital / cellular telephones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

[0050] Similarly, portions of the present invention are described as communicating over various wireless or wired computer networks. For purposes of this invention, the terms “network,” “networked,” and “networking” are understood to encompass wired Ethernet, fiber optic connections, wireless connections including any of the various 802.11 standards, cellular WAN (wide area network) infrastructure such as 3G, 4G / LTE, or 5G networks, Bluetooth®, Bluetooth® Low Energy (BLE), or Zigbee® communication links, or any other manner in which one electronic device can communicate with another electronic device. In some embodiments, elements of the networked portions of the present invention may be implemented via a virtual private network (VPN).

[0051] 15 and the following discussion are intended to provide a brief, general description of a suitable computing environment in which the invention may be implemented. Although the invention has been described above in the general context of program modules executed in conjunction with application programs running on an operating system on a computer, those skilled in the art will recognize that the invention may also be implemented in combination with other program modules.

[0052] Generally, program modules include routines, programs, components, data structures, and other types of structures that perform particular tasks or implement particular abstract data types. Moreover, those skilled in the art will appreciate that the present invention may be practiced with other computer system configurations, including handheld (portable) devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers, etc. The present invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0053] Figure 15 illustrates an exemplary computer architecture of a computer 1500 for implementing various embodiments of the present invention. The computer architecture shown in Figure 15 represents a conventional personal computer including a central processing unit 1550 ("CPU"), a system memory 1505 including random access memory 1510 ("RAM") and read-only memory ("ROM") 1515, and a system bus 1535 coupling the system memory 1505 to the CPU 1550. A basic input / output system containing the basic routines that help to transfer information between elements within the computer, such as during start-up, is stored in the ROM 1515. The computer 1500 further includes an operating system 1525, applications / programs 1530, and a storage device 1520 for storing data.

[0054] Storage device 1520 is connected to CPU 1550 through a storage controller (not shown) connected to bus 1535. Storage device 1520 and its associated computer-readable media provide non-volatile storage for computer 1500. While descriptions of computer-readable media contained herein refer to storage devices such as hard disks or CD-ROM drives, those skilled in the art should understand that computer-readable media may be any available media that can be accessed by computer 1500.

[0055] By way of example, and not limitation, computer-readable media may include computer storage media, including volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data, including, but not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD or other optical storage devices, magnetic cassettes, magnetic tape, magnetic disk storage devices or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by a computer.

[0056] According to various embodiments of the present invention, computer 1500 may operate in a networked environment using logical connections to remote computers through a network 1540, such as a TCP / IP network such as the Internet or an intranet. Computer 1500 may connect to network 1540 via a network interface unit 1545 connected to bus 1535. It should be appreciated that network interface unit 1545 may also be utilized to connect to other types of networks or remote computer systems.

[0057] Computer 1500 may also include an input / output controller 1555 for receiving and processing input from a number of input / output devices 1560, including a keyboard, mouse, touchscreen, camera, microphone, controller, joystick, or other types of input devices. Similarly, input / output controller 1555 may provide output to a display screen, printer, speakers, or other types of output devices. Computer 1500 may connect to input / output devices 1560 via a wired connection, including, but not limited to, optical fiber, Ethernet, or copper wire, or via wireless means, including, but not limited to, Wi-Fi, Bluetooth, near field communication (NFC), infrared, or other suitable wired or wireless connection.

[0058] As briefly mentioned above, a number of program modules and data files, including an operating system 1525 suitable for controlling the operation of a networked computer, may be stored in the storage device 1520 and / or RAM 1510 of the computer 1500. The storage device 1520 and RAM 1510 may also store one or more applications / programs 1530. In particular, the storage device 1520 and RAM 1510 may store applications / programs 1530 for providing a variety of functions to a user. For example, the applications / programs 1530 may include many types of programs, such as word processing applications, spreadsheet applications, desktop publishing applications, database applications, gaming applications, Internet browsing applications, email applications, messaging applications, and the like. According to one embodiment of the present invention, the applications / programs 1530 comprise a multi-function software application for providing word processing functionality, slide presentation functionality, spreadsheet functionality, database functionality, and the like.

[0059] In some embodiments, computer 1500 may include various sensors 1565 for monitoring the ambient and internal environments of computer 1500. These sensors 1565 may include a global positioning system (GPS) sensor, a photosensitive sensor, a gyroscope, a magnetometer, a thermometer, a proximity sensor, an accelerometer, a microphone, a biometric sensor, a barometer, a pressure sensor, an ECG sensor, a humidity sensor, a radiation sensor, or any other suitable sensor.

[0060] Methods of Use: The present invention provides a method for continuously feeding a subject through a gavage tube while allowing for continuous evacuation of gas from the stomach. In one embodiment, the present invention provides a method for continuously monitoring at least one of the following: temperature, ECG, pressure, etc. In one embodiment, the present invention provides a method for continuously monitoring gastric peristalsis. In one embodiment, the present invention provides a method for measuring esophageal or airway pressure, which allows for adjustment of the gas flow rate delivered by a high-flow cannula to target a clinically desired pressure. In one embodiment, the present invention provides a method for quantifying the work of breathing from transdiaphragmatic pressure. In one embodiment, the present invention provides a method for correcting central venous pressure for intrathoracic pressure. In one embodiment, the present invention provides a method for easy visualization by bedside ultrasound. In one embodiment, the present invention provides a method for introducing a nutritional supply at any appropriate flow rate based on need. Furthermore, the present invention provides for data storage and program execution, as well as the transmission and reception of data over a network, as needed.

[0061] Referring now to FIG. 7A, an embodiment of the present invention relates to a method 200 of providing nutrition to a subject, the method 200 comprising the steps of: inserting (202) a garbage tube, the garbage tube comprising a multi-lumen tube with a plurality of channels having a proximal end, a distal end and a length therebetween, inserted through the nasal or oral cavity of the subject, a first channel forming a nutritional supply lumen having a proximal opening and a distal axial opening in the multi-lumen tube, and a second channel forming a nutritional supply lumen having a proximal opening and one or more lateral openings in the multi-lumen tube. The method includes inserting (202) a garbage tube having openings forming a monitoring lumen with one or more sensors disposed in each opening, each channel extending parallel to one another along at least a portion of the length of the tube, with the proximal end of the multi-lumen tube positioned outside the subject's body and the distal end positioned within the subject's stomach; providing nutrition through the nutrition supply lumen (204); and measuring at least one biological information of the subject using the one or more sensors during the process of providing nutrition through the nutrition supply lumen (206).

[0062] Referring now to FIG. 7B, an embodiment of the present invention relates to a method 300 for simultaneously providing nutrition to a subject and evacuating gas from the stomach of the subject, the method 300 comprising the steps of: inserting (302) a garbage tube, the garbage tube comprising a multi-lumen tube with multiple channels having a proximal end, a distal end and a length therebetween, inserted through the nasal or oral cavity of the subject, a first channel forming a nutritional supply lumen in the multi-lumen tube having a proximal opening and a distal axial opening, a second channel forming a monitoring lumen in the multi-lumen tube having a proximal opening and one or more lateral openings, with one or more sensors disposed in each opening, and a third channel forming a monitoring lumen in the multi-lumen tube having a proximal opening and one or more lateral openings, with one or more sensors disposed in each opening. The method includes inserting (302) a garbage tube into a multi-lumen tube, the garbage tube forming an exhaust lumen having a proximal opening and a plurality of side exhaust holes, each channel extending parallel to one another along at least a portion of the length of the tube, the proximal end of the multi-lumen tube being positioned outside the subject's body and the distal end being positioned within the subject's stomach; providing nutrition through the nutrition supply lumen (304); during the step of providing nutrition through the nutrition supply lumen, causing the exhaust lumen to promote removal of gas from the subject's stomach (306); and during the step of providing nutrition through the nutrition supply lumen, measuring at least one biological information of the subject using one or more sensors (308).

[0063] In some embodiments, the one or more sensors are selected from the group consisting of a temperature sensor, a pressure sensor, an optical sensor, and an infrared sensor. In some embodiments, the garbage tube further comprises a plurality of electrode rings disposed on an outer surface of the multi-lumen tube and configured to measure ECG or EMG signals from the subject, and the method further comprises measuring ECG or EMG signals from the subject using the plurality of electrode rings during the step of providing nutrition through the nutrition supply lumen.

[0064] In steps 204 and 304, a nutritional supply material is provided through the nutritional supply lumen. In one embodiment, the nutritional supply material may include, but is not limited to, milk, powdered milk, or other liquid nutritional material known to those skilled in the art. In one embodiment, the nutritional supply lumen may be connected at its proximal end to a device, including, but not limited to, a syringe, pump, etc., to control the flow rate of the nutritional supply material to the subject. In one embodiment, the flow rate of the nutritional supply material may be in the range of 0.1 to 100 ml / hour. In step 206, the exhaust lumen is permitted to facilitate the removal of gas from the subject's stomach during the step of providing nutrition through the nutritional supply lumen. In one embodiment, the exhaust lumen is positioned beyond the stomach into the subject's duodenum.

[0065] In certain aspects, the methods are used to provide continuous nutrition and ventilation to an infant, such as a premature newborn, etc. In certain embodiments, the methods comprise inserting a garbage tube through the nasal or oral cavity of an infant subject, such as a newborn, a physically disabled infant, a premature newborn, a newborn with an immature respiratory system, a medically vulnerable infant, etc.

[0066] In certain embodiments, the method includes using a controller to monitor and store any data including, but not limited to, nutrient delivery rate, nutrient delivery frequency, etc. In certain embodiments, the method includes receiving data from a monitoring lumen and a plurality of electrode rings.

[0067] In some embodiments, the disclosed methods involve providing respiratory support that targets a specific positive end expiratory pressure (PEEP) and / or measuring PEEP. Subjects (e.g., infants) receiving a common form of respiratory support called high-flow nasal cannula (HFNC) receive some level of PEEP. The level of PEEP is critical to providing adequate respiratory support. By measuring the subject's internal airway pressure (PEEP), it is possible to adjust the amount of flow delivered through various devices (e.g., HFNC devices) to target the desired PEEP. This approach is defined herein as pressure-targeted high flow (PTHF) therapy.

[0068] In some embodiments, the disclosed methods include monitoring airway pressure at any distance along the length of the garbage tube, including not only the esophagus, but also the nasal cavity, oral cavity, nasopharynx, oropharynx (oropharynx), laryngopharynx, hypopharynx, or upper esophagus.

[0069] In some embodiments, the disclosed method involves placing any suitable sensor directly within the tube or channel forming the lumen of the garbage tube 100 of the present invention and monitoring pressure by inserting the garbage tube into the airway of a subject.

[0070] Experimental example The present invention will be described in more detail with reference to the following experimental examples. These examples are provided for illustrative purposes only and are not intended to be limiting unless otherwise specified. Therefore, the present invention should not be construed as being limited to the following examples in any way, but rather as embracing any variations that become apparent as a result of the teachings provided herein.

[0071] Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and use the present invention and practice the claimed methods. Therefore, the following examples are not to be construed as limiting in any way the remainder of the disclosure.

[0072] Experimental Example 1: Total length of feeding tube The inventors have collected data from clinical subjects suggesting that the overall length of feeding tubes placed in infants most frequently ranges from 12 to 20 cm. Therefore, a length of 20 to 50 cm is suggested to allow some length outside the infant for fixation and connection to the interface. This shorter length aids in gas evacuation, as resistance to gas flow increases proportionally with tube length.

[0073] Experimental Example 2: Feeding tube length below diaphragm level We have collected data from clinical subjects suggesting that the length of the feeding tube below the level of the diaphragm is most frequently in the range of 1.0 to 4.0 cm. Therefore, the placement of the proximal pressure and temperature sensors is estimated to be 5 cm (range 3 to 7 cm) from the distal tip.

[0074] Experimental Example 3: Maximum Nutrient Supply Flow Rate The inventors collected in vitro data from the vascular catheter, which suggested that continuous nutrition could be delivered through a 0.5 mm diameter lumen at flow rates up to 100 ml / hour without the need for excessive pressure.

[0075] Experimental Example 4: Minimum Nutrient Supply Flow Rate The inventors have collected in vitro data from a vascular catheter that suggests that continuous nutrition can be administered at flow rates as low as 1 ml / hour through a 0.5 mm diameter lumen without the lumen becoming occluded.

[0076] Experimental Example 5: Pressure Gradient and Cross-Sectional Area The inventors used a 30 cm long, 3 mm cross-sectional area 2 It was calculated that if there is a pressure gradient of 5 cmH2O across the tube, 160 ml of gas can be expelled from the stomach per minute.

[0077] Experimental Example 6: Vital Signs Monitoring from an Exemplary Garbage Tube (e.g., Trinity Tube) Below are experimental results of vital signs monitoring from an exemplary garbage tube (e.g., Trinity Tube) using an adult subject, demonstrating proof of concept of simultaneous acquisition of ECG, pressure, and temperature data from a single garbage tube.

[0078] 11A-11C, the results of pressure data generated by the Trinity Tube for quiet breathing (FIG. 11A), breath-holding (FIG. 11B), and the Valsalva maneuver (FIG. 11C) are shown.

[0079] Note that all pressure readings were likely taken with both pressure sensors in the esophagus, rather than the intended one in the esophagus and one in the stomach. Additionally, all pressure readings were positive, suggesting that a zero correction may be necessary before placing the sensors.

[0080] Referring to Figures 12E-12C, the subject's temperature results are shown. The initial temperature was recorded at 33.4°C, then gradually decreased to 30.8°C, and then increased again to 34.4°C. The subject drank cold water during the test, which may have lowered the body temperature. This data also suggests that in some cases the sensor may need to be calibrated before placement.

[0081] Referring now to Figures 13 and 14, the ECG results are shown. Chest leads were used for all recordings as a control. Initially, the EDI sensor was configured with the combinations 3-7, 4-8, and 5-9. The EDI sensor was then reset to the combinations 2-9, 3-8, and 4-7.

[0082] Experimental Example 7: Development and testing of a multifunctional gastric garbage tube capable of vital signs monitoring Extremely preterm infants face significant clinical and population health challenges. Advances in clinical monitoring may facilitate improved survival and long-term outcomes for this vulnerable population. In this study, a multifunction catheter equipped with ECG, pressure, and temperature sensors was developed, and its performance and ideal lead positioning were evaluated in a rat model. A modified multielectrode gastric gavage tube, equipped with one pressure sensor at the tip and another pressure and temperature sensor 6 cm from the tip, recorded ECG signals, transdiaphragmatic pressure, and core body temperature in rats.

[0083] ECG signals were obtained from esophageal electrodes in multiple positions, and the optimal electrode positions were ultimately identified as 4 cm and 6 cm from the tip of the feeding tube. Reliable pressure signals in the pressure range of 0–0.2 psi (0–14 cmH2O) were obtained from pressure sensors placed above and below the diaphragm. Temperature sensors recorded a core temperature of approximately 41°C, which was higher than the rectal temperature measurements due to the experimental setup used.

[0084] The disclosed multi-function catheter was proven to provide reliable, robust, high-resolution, low-noise ECG signals from esophageal electrodes in an animal model comparable in size to a preterm infant. Furthermore, all three sensors were housed within a tube less than 3 mm in diameter, commonly used in this population, and continuous pressure and temperature recordings were simultaneously extracted. Integrating these multiple components into a purely nutritional feeding tube, already commonly used in this population, would represent a significant advance in vital sign monitoring while mitigating risks to vulnerable preterm infants.

[0085] The long-term health of preterm infants is a major concern both nationally and internationally. More than 15 million infants are born preterm each year worldwide (JLECH MV Kinney, “March of Dimes, PMNCH, Save the Children, WHO. Born Too Soon: The Global Action Report on Preterm Birth,” World Health Organization, vol. 13, No. 5, pp. 1–126, 2012) and 350,000 in the United States (JA Martin, BE Hamilton, MJK Osterman, AK Driscoll, and TJ Mathews, “Births: Final data for 2015,” National Vital Statistics Reports, vol. 66, No. 1, pp. 1–70, January 2017). High-quality clinical research has led to significant advances in treatment, with interventions at gestational ages considered unviable just 20–30 years ago now becoming standard of care. Infants born at 22-23 weeks gestation and weighing 400-500g are now routinely admitted to many hospitals and receive intensive care interventions.

[0086] Preterm infants in neonatal intensive care units (NICUs) undergo numerous procedures. Most preterm infants are unable to properly coordinate feeding, swallowing, and breathing, and therefore require the insertion of a gastric tube for garbage feeding (L. Kristoffersen, E. Skogvoll, and M. Hafstroem, “Pain Reduction on Insertion of a Feeding Tube in Preterm Infants: A Randomized Controlled Trial,” Pediatrics, vol. 127, No. 6, pp. e1449-e1454, June 2011, doi: 10.1542 / PEDS.2010-3438). Specialized medical equipment is also available to monitor the physiological status of NICU patients, whose vital signs are unstable and fluctuating. The type of medical equipment employed is tailored to each patient's individual needs. Standard vital signs commonly monitored include heart rate (HR), respiratory rate (RR), blood pressure, temperature, and peripheral oxygen saturation (SpO2) (M. Villarroel et al., “Non-contact physiological monitoring of preterm infants in the Neonatal Intensive Care Unit,” npj Digital Medicine 2019 2:1, vol. 2, No. 1, pp. 1-18, Dec. 2019, doi: 10.1038 / s41746-019-0199-5).Body temperature is also an important vital sign for assessing illness (JL Leante-Castellanos, A. Martinez-Gimeno, M. Cidras-Pidre, G. Martinez-Munar, A. Garcia-Gonzalez, and C. Fuentes-Gutierrez, “Central-Peripheral Temperature Monitoring as a Marker for Diagnosing Late-Onset Neonatal Sepsis,” Pediatric Infectious Disease Journal, July 2017, doi: 10.1097 / INF.0000000000001688). An abnormal heart rate (very low or very high) may indicate an underlying condition such as infection, pain, or illness. Irregular breathing is often associated with hypoxemia (low blood oxygen levels), hypercapnia (high blood carbon dioxide levels), and acidosis (high blood acidity). Traditional vital sign monitoring methods require adhesive electrodes or transducers to be attached to the skin, which can be problematic for preterm infants, especially those born before 29 weeks of gestation, as they can damage the fragile, immature skin. (M. Villarroel et al., “Non-contact physiological monitoring of preterm infants in the Neonatal Intensive Care Unit,” npj Digital Medicine 2019 2:1, vol. 2, No. 1, pp. 1–18, Dec. 2019, doi: 0.1038 / s41746-019-0199-5) Any skin damage increases the risk of infection, a significant morbidity factor for these infants, whose immune systems are also immature.

[0087] Despite the introduction of oxygen saturation monitoring in the 1980s, respiratory failure remains a leading cause of mortality and morbidity in very preterm infants, and respiratory monitoring has not progressed. (LM Muhe et al., “Major causes of death in preterm infants in selected hospitals in Ethiopia (SIP): a prospective, cross-sectional, observational study,” Lancet Glob Health, vol. 7, No. 8, pp. e1130–e1138, Aug. 2019, doi: 10.1016 / S2214-109X(19)30220-7) Currently, clinical decisions regarding treatment escalation and de-escalation are based on quantitative indicators of gas exchange (CO2 and oxygen concentration), while assessment of work of breathing is entirely qualitative (e.g., subcostal retractions, auscultation for air inflow). Continuously quantified measures of the work of breathing can help predict clinical deterioration and assess the effectiveness of noninvasive ventilation strategies. Furthermore, continuous measures of intrathoracic pressure allow clinical care teams to combine the noninvasive use of high-flow therapy with the controlled pressure delivery of continuous positive airway pressure (CPAP), optimizing both respiratory support and infant comfort and skin integrity (A. Bernatzky and G. Mariani, “Nasal high flow therapy for primary respiratory support in preterm infants,” Arch Argent Pediatr, Vol. 115, No. 1, pp. e52–e53, Feb. 2017).Diaphragmatic activity can be quantified by the diaphragmatic pressure-time integral (PTPdi), which can be measured by placing pressure sensors directly above and below the diaphragm and is known as transdiaphragmatic pressure (T. Dassios, A. Vervenioti, S. Tzifas, S. Fouzas, and G. Dimitriou, “Validation of a non-invasive pressure-time index of the inspiratory muscles in spontaneously breathing newborn infants,” J Clin Monit Comput, vol. 37, No. 1, p. 221, Feb. 2023, doi: 10.1007 / S10877-022-00882-6).

[0088] The device disclosed herein, referred to in some embodiments as "Trinity Tube," integrates three functions: feeding milk to the stomach, removing excess gas (a by-product of non-invasive ventilation modes) from the stomach, and monitoring vital signs such as transdiaphragmatic pressure, heart rate, and temperature without the need for invasive skin-worn sensors. The structure of the Trinity Tube and the specifications of the animal model, as well as the experimental procedures and steps, are described below.

[0089] Materials and methods are now discussed.

[0090] Device Design: The Trinity Tube has undergone numerous refinements based on the distance from the infant's mouth to the esophagogastric junction (EGJ) and the length of the abdominal esophagus.

[0091] Feeding: Administering milk is crucial for the survival and growth of very preterm infants (L. Kristoffersen, E. Skogvoll, and M. Hafstroem, “Pain Reduction on Insertion of a Feeding Tube in Preterm Infants: A Randomized Controlled Trial,” Pediatrics, vol. 127, No. 6, pp. e1449-e1454, June 2011, doi: 10.1542 / PEDS.2010-3438). With the near-universal use of feeding pumps, even a 3 Fr (1 mm) inner diameter tube can deliver large amounts of milk.

[0092] Venting: Noninvasive venting can allow gas to reach the stomach, leading to abdominal distension and reduced respiratory function. (A. Priyadarshi, M. Hinder, N. Badawi, M. Luig, and M. Tracy, “Continuous Positive Airway Pressure Belly Syndrome: Challenges of a Changing Paradigm,” International Journal of Clinical Pediatrics, vol. 9, No. 1, pp. 9-15, 2020, doi: 10.14740 / IJCP352) Maximizing the size of the vent lumen in the disclosed device optimized gas evacuation from the stomach.

[0093] ECG (Electrocardiogram): The disclosed device consists of a 6 Fr (2 mm) Edi (Electrical Diaphragmatic Activity) polyurethane catheter (manufactured by Getinge, Germany) with 10 stainless steel electrodes arranged linearly at the distal end with 6 mm electrode spacing (Figure 17). The catheter has a single 0.8 mm diameter feeding lumen and can deliver milk up to 100 ml / h. Edi catheters are primarily used in neurally adjusted ventilatory assist (NAVA) to detect diaphragmatic electrical activity. When placed in the esophagus, the Edi catheter's electrodes can also be used to acquire ECG signals (P. Simmen et al., "Multichannel Esophageal Heart Rate Monitoring of Preterm Infants," IEEE Trans Biomed Eng, vol. 68, No. 6, pp. 1903-1912, June 2021, doi: 10.1109 / TBME.2020.3030162).

[0094] Pressure and Temperature: As shown in Figure 18, the Trinity Tube prototype contains two 1 French (0.33 mm) outer diameter MEMS pressure sensors (Millar, Texas) and one 0.13 mm outer diameter T-type thermocouple (Omega Engineering, Connecticut, 5SC-TT-36-36). To securely place the first pressure sensor at the tip of the Edi catheter, a polyimide guide tube (0.508 mm inner diameter, 0.6604 mm outer diameter, Nordson Medical, Ohio) is placed within the feeding lumen of the Edi catheter, and the pressure sensor is then inserted into the guide tube (Figure 19). Because the polyurethane feeding lumen of Edi has a high-friction surface, the guide tube greatly aids in the insertion and removal (for resterilization) of the pressure sensor.

[0095] A second polyimide guide tube and thermocouple are securely attached to the outer surface of the Edi catheter using FDA-compliant polyolefin heat shrink tubing with an inner diameter of 3 mm, 6 cm from the first pressure sensor. Similar to pressure sensor 1, pressure sensor 2 is also inserted into the second polyimide guide tube (Figure 20). With all sensors inside the heat shrink tubing, the final outer diameter is now 2.84 mm.

[0096] In the disclosed device, the feeding lumen of the Edi catheter was used to house the pressure sensor, but in other embodiments, the device may be used in conjunction with a 3mm 2 The device may have an exhaust lumen of 0.25 mm and a feeding lumen of 0.67 mm to 1.33 mm inner diameter. This exhaust lumen diameter allows for extraction of up to 140 ml of air from the stomach at a pressure gradient of 6 cmH2O (0.085 psi). Additionally, in some embodiments, the disclosed device may have fewer esophageal electrodes in positions that provide optimal and robust signals. Additionally, in some embodiments, a separate lumen is used to house all sensor wires. The dimensions and placement of all features are shown in Figure 20.

[0097] Data acquisition units (DAQ) were used to obtain precise and accurate data from the sensors and ECG electrodes. For ECG data collection, an ECG module (ECG Click, Mikro Elektronika, Belgrade, Serbia) equipped with low-pass and high-pass filters amplified the ECG signal and sent it to a high-precision, high-speed USB-connected DAQ unit (16-bit, up to 250,000 Hz, MCC USB-1608GX, Measurement Computing Corporation, Massachusetts). The signal data was then displayed and stored on a computer using MCC DAQami software.

[0098] Pressure and temperature data were collected directly from the sensors through a multifunction, high-precision, medium-speed USB DAQ (24-bit, 1000 Hz, OM-DAQ-USB-2400, Omega Engineering, Connecticut) and stored using Omega DAQ Central software (version 1.0.7, Omega Engineering, Connecticut). Both the ECG module and the pressure sensor were supplied with an input voltage of 5.00 V. The output voltage range of the ECG module was ±2.4 V, and the accuracy of the pressure sensor was 25 μV / mmHg (or 1.293 mV / psi).

[0099] Benchtop experiments were conducted to calibrate the sensors, reduce electrical noise, and confirm that ECG signals could be obtained successfully. For example, ECG data was successfully received from an adult subject using three chest electrodes. Furthermore, calibration of the MEMS pressure sensors was performed using a 120 cm high water column. First, the sensor output signal was measured at room temperature (1 atm). Then, each sensor was inserted into the water column and pressure signals (mV) were collected at depth markings spaced 10 cm apart using a high-resolution DAQ unit. The results (Figure 21) showed that the pressure sensor output signal was linear with an offset equal to the room pressure. Furthermore, consistent temperature data was collected from the thermocouple using the Omega DAQ, and the sensors were calibrated at 0°C and 100°C.

[0100] Animal Model Description: Rats have been used as an animal model for preterm birth research due to their short gestation period, low cost, and ease of handling. While no animal model perfectly mimics the human condition, rats have been shown to develop symptoms and complications similar to those of preterm infants, making them a useful tool for investigating the mechanisms and complications of preterm birth (H. Hagberg, C. Mallard, and B. Jacobsson, “Role of cytokines in preterm labor and brain injury,” BJOG, vol. 112, No. SUPPL. 1, pp. 16–18, Mar. 2005, doi: 10.1111 / J.1471-0528.2005.00578.X).

[0101] Adult female Sprague-Dawley rats (722 g) were used for this experiment. Before weighing, rats were anesthetized with 2%–3% isoflurane gas in 100% oxygen. The trachea was cannulated and mechanical ventilation was performed (Harvard Apparatus). The right jugular vein and one carotid artery were cannulated (PE-50) for fluid / drug administration and blood pressure monitoring, respectively. The carotid artery catheter was connected to a pressure transducer (CWE DTX-1), and heart rate (HR) was calculated beat-to-beat from pulsatile blood pressure using Spike 2 software (CED, Cambridge).

[0102] The life support tubing setup and Trinity tubing attached to the animals are shown in Figures 22 and 23. At the end of the experiment, rats were euthanized by intravenous injection of saturated potassium chloride (>200 mg / kg).

[0103] Equipment Setup: An electronics box containing the DAQ, four ECG modules, sensor connection ports, circuit boards, and power supply was prepared for easy portability and enhanced protection of the electronics. The standard sensor connection ports on the electronics box allowed for convenient and reliable connection of the Edi catheter, pressure sensor, and thermocouple cable during experiments. The Edi catheter included a male 14-pin cable connector, with its 10 active pins connected to the stainless steel electrodes on the tubing. This Edi connector was then attached to a female port on the electronics box, where it split into 10 independent single-pin connectors, allowing for the connection of the leads to each ECG amplifier module. Each ECG module required at least three electrodes, two of which were used as bipolar leads and one as a ground lead to minimize ECG artifacts. A total of four ECG modules were used to simultaneously receive signals from multiple electrodes. Therefore, if a ground was shared, at least nine electrodes were required to receive four separate signals.

[0104] Methods: The experiment was conducted in two stages, the first stage focused on ECG data collection, and the second stage focused on pressure and temperature data collection.

[0105] ECG: In the first stage, a total of 10 experiments were conducted while the animals were receiving respiratory support. A sample rate of 1000 Hz was used for data acquisition. In the first five experiments, the most proximal electrode (electrode number (#) 10) was used as the ground, and the remaining electrodes (electrodes number 2 to number 9) were used as bipolar leads. The most distal electrode (electrode number 1) was expected to be located within the stomach without contacting the esophageal wall, so it was left disconnected. Table 1 shows the configuration of the electrodes and ECG module. In the first experiment, the tube was inserted 13 cm into the animal's esophagus, so that the first pressure sensor was located below the diaphragm in the stomach, and signals were collected. The tube was then retracted to 12 cm, 11 cm, 10 cm, and 8 cm, and ECG signals were collected, respectively (Table 2). During these five experiments, the animals were receiving respiratory support at 60 breaths per minute (BPM). [Table 1] [Table 2]

[0106] In the latter five experiments, the tube was inserted 12 cm and only three electrodes and one ECG module were used. The optimal placement at 12 cm insertion was based on ultrasound images showing the tube tip 2 cm below the diaphragm and the signals obtained in the first five cases and is described in the Results section. Table 3 shows the electrode configuration at a respiratory rate of 60 BPM (breaths per minute). [Table 3]

[0107] Pressure and temperature: In the second stage, pressure and temperature data were received at two respiratory rates of 60 BPM and 80 BPM, with data acquisition (DAQ) sample rates of 4, 10, and 20 Hz. The reason for using multiple sample rates was to find the highest possible sample rate that provided an acceptable waveform of intrathoracic pressure while optimizing the signal-to-noise ratio.

[0108] The results are now discussed.

[0109] Electrocardiogram: Figures 24A, 24B, 24C, and 24D show electrocardiogram signals received from the electrodes for 3 seconds with the tube inserted 13 cm.

[0110] Figures 24A-24D show depolarization signals from ECG modules 1-4. Module 1 has a stronger signal (up to 2.2V) than the others, but is noisy due to poor contact with the esophageal surface. This suggests that electrode 2 is inside the stomach and not making contact with the esophageal wall. Module 2 exhibits decreasing noise as electrode 3 moves further from the catheter tip. ECGs 3 and 4 show clearer signals with less noise due to the electrodes being closer together, but the signal strength is decreasing.

[0111] In Figures 24A-24D, in addition to the ECG signal, a strong negative deflection is observed every second, reflecting the periodic breathing effect of the mechanical ventilator. To confirm that the source of noise in ECG1 was due to poor contact, the catheter was pulled back at 1 cm intervals and the ECG signal was observed. As a result, it was found that once the catheter tip was removed from the stomach and all electrodes were inside the esophagus, the noise was significantly reduced and a clearer signal could be received.

[0112] Figures 25A-25D show the signals from the electrodes when the tube was inserted 8 cm. These results demonstrate that reliable, strong, high-resolution, and low-noise ECG signals can be obtained depending on the location of the esophageal electrodes within the esophagus and their spacing relative to one another. It is also important to ensure that the tip of the catheter, where the first pressure sensor is located, remains within the esophagus to obtain valid pressure measurements. A handheld ultrasound imager was used to track the tip of the catheter as it was pulled back. The imager indicated that the tip of the catheter was located 2 cm away from the stomach. Thus, at a 12 cm insertion depth, the majority of the esophageal electrodes exhibited strong, low-noise signals, while the first pressure sensor was still confirmed to be within the stomach.

[0113] For the remaining experiments, as previously mentioned, three electrodes were used interchangeably, with different spacing and ground electrodes according to Table 3, to find the strongest signal with the least noise. After considering all five experiments, electrodes 4 and 7 were selected as bipolar leads, and electrode 10 was selected as ground. The resulting ECG signal for this selection is shown in Figure 26.

[0114] Pressure and Temperature: Esophageal and gastric pressure and temperature were first measured at a respiratory rate of 60 BPM with the DAQ sampling rates set to 4 Hz, 10 Hz, and 20 Hz. The data received from the DAQ indicated that a sampling rate of 10 Hz was slow enough to provide accurate data as well as good resolution. Further pressure and temperature values ​​were then obtained at 80 BPM based on this sample rate. The pressure and temperature measurements at 10 Hz at respiratory rates of 60 BPM and 80 BPM are shown in Figures 27 and 28, respectively.

[0115] The results in Figures 27 and 28 demonstrate stable, high-resolution pressure sensing above and below the diaphragm. Because there is no voluntary effort in this anesthetized animal, pressures on both sides of the diaphragm vary in parallel, while subdiaphragmatic pressure is attenuated by static diaphragmatic resistance. Pressure fluctuations of 0 to 0.2 psi (0 to 14 cmH2O) are readily apparent, consistent with pressure levels expected in rat models and human neonates. Pressure waveforms readily distinguish between ventilator rates of 60 and 80 breaths per minute.

[0116] The diaphragmatic pressure-time integral (PTPdi) is a clinically validated index of the work of breathing calculated by simultaneously measuring pressure above and below the diaphragm in spontaneously breathing human infants (G. Dimitriou, A. Tsintoni, A. Vervenioti, D. Papakonstantinou, and T. Dassios, “Effect of prone and supine positioning on the diaphragmatic work of breathing in convalescent preterm infants,” Pediatr Pulmonol, vol. 56, No. 10, pp. 3258–3264, October 2021, doi: 10.1002 / PPUL.25594). Clinical teams can apply this index to guide escalation and de-escalation of ventilatory support and for early detection of clinical adverse events such as pneumothorax.

[0117] Furthermore, continuous monitoring of intrathoracic pressure allows for adjustment of gas flow during high-flow nasal cannula therapy to target desired end-expiratory pressures and optimize lung recruitment while preventing the need for transition to more invasive modes of support.

[0118] Temperature measurements were stable, ranging from 41.0 to 41.5°C. Simultaneously measured rectal temperatures were between 37.0 and 37.5°C. However, it should be noted that the experimental setup positioned the animal's chest directly under the heat lamp, potentially resulting in significant local heating.

[0119] In an animal model comparable in size to extremely preterm infants, ECG signals were obtained from esophageal electrodes. Continuous recordings of pressure and temperature were simultaneously extracted, with all three sensors housed within a tube less than 3 mm in diameter, similar to the one routinely used in this population. In summary, integrating multiple components into feeding tubes already used for nutritional support in this population represents a major advance in vital sign monitoring while simultaneously reducing risks to vulnerable preterm infants.

[0120] Experimental Example 8: Development and Testing of a Multifunctional Feeding Tube Capable of Respiration, Cardiac, and Temperature Monitoring Respiratory support for preterm infants is increasingly being provided noninvasively. Continuous positive airway pressure (CPAP) delivers positive end-expiratory pressure (PEEP) to the lungs but requires careful positioning and intensive nursing care. High-flow nasal cannulas (HFNC) are easier to position but deliver less consistent PEEP. All neonates requiring CPAP / HFNC have a gavage tube attached for routine clinical care. Placing a pressure sensor in the gavage tube would allow continuous PEEP monitoring and potentially allow adjustment of PEEP while on HFNC support. Additional sensors could quantify the work of breathing (transdiaphragmatic pressure gradient) and monitor heart rate and temperature.

[0121] To develop a multifunctional garbage tube capable of simultaneously monitoring pressure, temperature, and ECG, and to demonstrate its feasibility in an animal model of the same size as a preterm newborn.

[0122] A 1 Fr (0.33 mm) pressure sensor (Millar, Texas) was inserted into the lumen of a 6 Fr (2 mm) neurally modulated ventilatory assist (NAVA) catheter (Getinge, Sweden) using a polyamide guide tube. A second 0.33 mm pressure sensor and a 0.13 mm thermocouple (Omega Engineering, Connecticut) were attached to the outer surface of the catheter 6 cm from the tip using heat shrink tubing (Figures 29A and 29B). The total diameter of the device was 2.84 mm. ECG signals were obtained from an indwelling sensor positioned 2–7 cm from the tip (Figure 29A). With IACUC approval, the device was placed in an adult (722 g) Sprague-Dawley rat (Charles River Laboratories, Malvern, PA) under isoflurane anesthesia. The tip of the tube was confirmed by ultrasound to be 2 cm below the diaphragm. Pressure and temperature were recorded at a frequency of 10 Hz, and electrocardiograms were recorded at 250 Hz. After the experiment, the rats were euthanized by injection of potassium chloride.

[0123] Pressure sensors placed above and below the diaphragm provided reliable pressure signals in the range of 0–14 cmH2O (0–0.2 psi) (Figure 30A). A core temperature of approximately 41°C was recorded (Figure 30B). Optimal ECG signals were obtained in the voltage range of 0–2 mV from esophageal electrodes placed 4 cm and 6 cm from the tube tip, with a ground electrode placed 9 cm away (Figure 30C).

[0124] The disclosed multifunction catheter provided continuous, reliable, high-resolution monitoring of esophageal pressure, temperature, and ECG in an animal model comparable in size to a preterm infant, with all sensors housed within a tube less than 3 mm in diameter, as is routinely used in preterm infants. In some embodiments, an exemplary garbage tube of the invention can comprise any of these elements within a device less than 3 mm in diameter (Figure 29B).

[0125] Experimental Example 9: Trinity Tube It is a minimally invasive device for NICU (neonatal intensive care unit) nurses and neonatologists that maintains skin integrity, provides adequate nutrition, expels excess gas, provides airway pressure feedback, and wirelessly monitors vital signs.

[0126] Figure 31 illustrates placement of an exemplary garbage tube within a subject according to an embodiment of the present invention. Figure 32 illustrates various views of an exemplary garbage tube and garbage tube system according to an embodiment of the present invention.

[0127] The following publications are incorporated herein by reference in their entirety:

[0128] Roberts, CT, et al. (2016). “Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants.” N Engl J Med 375(12): 1142-1151.

[0129] Dimitriou, G., et al. (2021). “Effect of prone and supine positioning on the diaphragmatic work of breathing in convalescent preterm infants.” Pediatr Pulmonol 56(10): 3258-3264.

[0130] Simmen, Patrizia et al. (2021). “Multichannel Esophageal Heart Rate Monitoring of Preterm Infants.” IEEE transactions on bio-medical engineering vol. 68,6: 1903-1912.

[0131] The disclosures of each patent, patent application, and publication cited herein are each incorporated herein by reference in their entirety. While the present invention has been disclosed with reference to specific embodiments, it will be apparent that other embodiments and variations of the present invention may be devised by those skilled in the art without departing from the true spirit and scope of the invention. It is intended that the appended claims be construed to include all such embodiments and equivalent variations.

Claims

1. a garbage tube; a multi-lumen tube having a plurality of channels, the multi-lumen tube having a proximal end, a distal end, and a length therebetween; the plurality of channels comprising a first channel forming a nutrient delivery lumen and a second channel forming a monitoring lumen, each channel extending parallel to one another along at least a portion of the length of the tube; A garbage tube, wherein the proximal end is positioned outside the subject's body and the distal end is positioned within the subject's stomach.

2. The garbage tube of claim 1 , wherein the multi-lumen tube has an outer diameter in the range of 1 to 10 mm.

3. The garbage tube of claim 1 or 2, wherein the multi-lumen tube has an inner diameter in the range of 0.5 to 8.0 mm.

4. 10. The garbage tube of claim 1, wherein the outer surface of the multi-lumen tube comprises a plurality of texture markings for enhanced visibility.

5. The garbage tube of claim 1 , wherein the first channel includes an axial feed hole at a distal end of the channel.

6. 10. The garbage tube of claim 1, wherein the first channel is in fluid communication with one selected from the group consisting of a pump and a syringe.

7. 10. The garbage tube of claim 1, wherein the first channel has a diameter in the range of 0.3 to 5.0 mm.

8. The garbage tube of any one of claims 1 to 7, wherein the plurality of channels comprises a third channel forming an exhaust lumen.

9. 9. The garbage tube of claim 8, wherein the third channel includes a plurality of side vents that extend through a wall of the third channel and through a wall of the multi-lumen tube.

10. 10. The garbage tube of claim 9, wherein the plurality of side vent holes have a diameter in the range of 0.5 to 3.0 mm.

11. The garbage tube of claim 9 , wherein the plurality of side vents are located at a distal end of the multi-lumen tube.

12. 10. The garbage tube of claim 9, wherein the plurality of side vents are located 2 cm distal to the multi-lumen tube.

13. 10. The garbage tube of claim 9, further comprising an exhaust chamber in fluid communication with the third channel disposed at a proximal end of the multi-lumen tube.

14. 14. The garbage tube of claim 13, wherein the exhaust chamber comprises a first opening configured to be used for profiling stomach gases and an escape valve configured to allow gases to escape.

15. 15. The garbage tube of claim 14, wherein the escape valve is a one-way valve.

16. 10. The garbage tube of claim 1, wherein the second channel further comprises a first side opening that penetrates a wall of the second channel, penetrates a wall of the multi-lumen tube, and is positioned 3 to 20 cm from the distal end of the tube.

17. 17. The garbage tube of claim 16, further comprising at least one temperature sensor disposed in the first opening of the second channel.

18. 18. The garbage tube of claim 17, wherein the at least one temperature sensor can be selected from the group consisting of a thermocouple, a thermistor, a thermodiode, and combinations thereof.

19. 19. The garbage tube of claim 18, wherein the second channel further comprises a second side opening extending through a wall of the second channel, extending through a wall of the multi-lumen tube, and positioned 3 to 7 cm from the distal end of the tube.

20. 20. The garbage tube of claim 19, further comprising a second pressure sensor disposed at the second side opening of the second channel.

21. 20. The garbage tube of claim 1 or 17, further comprising a plurality of electrode rings disposed on an outer wall of the multi-lumen tube and configured for use as an ECG or EMG sensor, the plurality of electrode rings being disposed along at least a portion of the length of the multi-lumen tube.

22. 22. The garbage tube of claim 21, wherein the plurality of electrode rings comprises between 2 and 10 electrode rings.

23. 22. The garbage tube of claim 21, wherein the plurality of electrode rings comprises at least first, second, and third electrode rings, the first electrode ring being positioned 3 cm from the distal end of the multi-lumen tube, the second electrode ring being positioned 9 cm from the distal end of the multi-lumen tube, and the third electrode ring being positioned 10 cm from the distal end of the multi-lumen tube.

24. 1. A method of providing nutrition to a subject, comprising: inserting a garbage tube through the nasal or oral cavity of the subject, the garbage tube comprising a multi-lumen tube comprising a plurality of channels having a proximal end, a distal end and a length therebetween, wherein a first channel forms a feeding lumen having a proximal opening and a distal axial opening in the multi-lumen tube, and a second channel forms a monitoring lumen having a proximal opening and one or more lateral openings in the multi-lumen tube with one or more sensors disposed at each opening, the channels extending parallel to one another along at least a portion of the length of the tube, and the proximal end of the multi-lumen tube being disposed outside the body of the subject and the distal end being disposed within the stomach of the subject; providing nutrients through said nutrient supply lumen; measuring at least one biological information of the subject using the one or more sensors during the step of providing nutrition through the nutrition supply lumen; A method comprising:

25. 1. A method of providing nutrition to a subject while simultaneously evacuating gas from the stomach of said subject, comprising: inserting a garbage tube through the nasal or oral cavity of the subject, the garbage tube comprising a multi-lumen tube comprising a plurality of channels having a proximal end, a distal end and a length therebetween, wherein a first channel forms a feeding lumen having a proximal opening and a distal axial opening in the multi-lumen tube, a second channel forms a monitoring lumen having a proximal opening and one or more lateral openings in the multi-lumen tube, with one or more sensors disposed in each opening, and a third channel forms an evacuation lumen having a proximal opening and multiple lateral openings in the multi-lumen tube, each channel extending parallel to one another along at least a portion of the length of the tube, and wherein the proximal end of the multi-lumen tube is positioned outside the subject's body and the distal end is positioned within the subject's stomach; providing nutrients through said nutrient supply lumen; enabling the exhaust lumen to facilitate removal of gas from the stomach of the subject during the step of providing nutrition through the nutrition supply lumen; measuring at least one biological information of the subject using the one or more sensors during the step of providing nutrition through the nutrition supply lumen; A method comprising:

26. 26. The method of claim 24 or 25, wherein the one or more sensors are selected from the group consisting of a temperature sensor, a pressure sensor, an optical sensor, and an infrared sensor.

27. 26. The method of claim 24 or 25, wherein the garbage tube further comprises a plurality of electrode rings disposed on an outer surface of the multi-lumen tube configured to measure ECG or EMG signals from the subject, the method further comprising measuring ECG or EMG signals from the subject using the plurality of electrode rings during the step of providing nutrition through the nutrition supply lumen.

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