Patent Publication Number: US-2018042819-A1

Title: Systems and Methods for Self-Detection Positioning of Nasogastric Tubes, Feeding Tubes, or Other Tubes

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present application is based on, claims priority to, and incorporates herein by reference in its entirety, U.S. Provisional Patent Application No. 62/133,136, filed Mar. 13, 2015, and entitled “Systems and Methods For Self-Detection Positioning of Nasogastric Tubes, Feeding Tubes, Or Other Tubes.” 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH 
     Not Applicable. 
     BACKGROUND 
     The disclosure relates generally to medical devices used in conjunction with nasogastric, feeding, or other tubes and, more specifically, to a system and methods for self-detection positioning of such tubes. 
     Nasogastric (NG) tubes are a small plastic tube that can be inserted through the nares and ideally terminating in the stomach. NG tubes can be used to help decompress gas, to suction contents, to deliver medications, and for other therapeutic purposes. Similarly, feeding tubes are a small plastic tube, typically with a smaller diameter compared to NG tubes, inserted through the nares and ideally located in a post-pyloric position. Feeding tubes aim to deliver nutrition to patients that are not otherwise able to consume food through traditional means. 
     For both NG and feeding tubes, it is necessary to confirm that the tube is placed in the gastrointestinal tract (i.e., esophagus, stomach, intestines) as opposed to the pulmonary tract (i.e. trachea, bronchi). Aberrant, unintended placement in the lungs can cause considerable morbidity and possibly death. Unfortunately, incorrect placement of these tubes is a common and costly occurrence to both the patient and hospital system. 
     BRIEF SUMMARY 
     The present disclosure provides a systems and methods for detecting the position of a nasogastric (NG) tube, a feeding tube, or other tube within a patient. In particular, systems and methods are provided for a self-detection positioning system that is capable of acquiring data that distinguishes positioning of a medical tube in the lungs or the gastrointestinal tract of a patient. The system is also capable of determining a specific section of the gastrointestinal tract (for example, the stomach or the duodenum) in which the medical tube is placed. Upon detecting the medical tube is properly positioned in the patient, a notification may be communicated to a trained individual indicating the medical tube has been properly placed. 
     In one aspect, the present disclosure provides a self-detection positioning system for a medical tube. The self-detection positioning system includes a casing configured to receive a proximal end of the medical tube and thereby place a distal end of the medical tube in communication with one or more sensors mounted within the casing. The self-detection positioning system further includes a controller mounted within the casing and in communication with the one or more sensors. The controller is configured to determine a location of the distal end of the medical tube within a patient based on data received from the one or more sensors. 
     In another aspect, the present disclosure provides a method for determining a position of a medical tube within a patient. The method includes inserting a distal end of the medical tube into the patient and placing the proximal end of the medical tube in communication with one or more sensors by inserting the proximal end of the medical tube into an adapter. The adapter is configured to receive the proximal end of the medical tube. The method further includes determining a position of the distal end of the medical tube within the patient based on data from the one or more sensors. 
     The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The invention will be better understood and features, aspects and advantages other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such detailed description makes reference to the following drawings. 
         FIG. 1  is a schematic illustration of a self-detection positioning system in accordance with the present disclosure. 
         FIG. 2  shows a top view of the self-detection positioning system of  FIG. 1 . 
         FIG. 3  is a schematic illustration setting forth the steps for operating the self-detection positioning system of  FIG. 1 . 
         FIG. 4  illustrates one example of pressure data acquired by the self-detection positioning system of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     Currently, confirmation of proper placement of a nasogastric (NG) tube, a feeding tube, or other tubes can be obtained using a stethoscope-mediated method, pH testing of fluid, or radiography. The stethoscope-mediated and pH testing methods are both cumbersome and often inaccurate. Radiographs are extremely sensitive and currently the gold-standard technique for tube placement confirmation. However, each radiograph requires a technologist to first obtain the images then a radiologist to interpret it, and this process is repeated every time a tube is placed, exchanged, or suspected to be malpositioned or malfunctioning; the financial cost of this technique is thus enormous for hospitals given the ubiquity of NG, feeding, and other medical tubes. Furthermore, every radiograph subjects the patient to an additional dose of ionizing radiation. Lastly, radiographic studies take time to acquire and interpret, during which a tube cannot be used, resulting in delay of clinical care. Given that misplacement of NG tubes within the bronchial tree has the potential to decrease pulmonary function and even cause respiratory compromise in tenuous patients, the time delay necessitated by obtaining radiographs could potentially negatively impact patient care. 
     Due to the current difficulties in cost consciously detecting proper placement of a nasogastric (NG) tube, a feeding tube, or other tube within the gastrointestinal tract of a patient, it would be desirable to have a low-cost, reusable, bedside, and self-detection positioning system that is capable of integration with current nasogastric (NG) tube, a feeding tube, or other tube. This would enable not only a physician, but also a nurse or other healthcare professional, to rapidly and reliably detect the position of a nasogastric (NG) tube, a feeding tube, or other tube at the bedside of a patient, obviating the need for the added expense, radiation dose, and delays associated with radiographs. Not only does the present disclosure provide such a system and method, but it does not require a proprietary tubing to operate and, thus, provides a cost-conscious solution to an enduring problem. 
       FIG. 1  shows a one non-limiting example of a self-detection positioning system  10  in accordance with the present disclosure. The self-detection system  10  includes a casing  12  which connects to a medical tube  14 . The medical tube  14  may be any tube configured for insertion into a human body and including a lumen. For example, the medical tube may be a orogastric tube, a endotracheal tube, a chest tube, a urinary catheter, a nasogastric (NG) tube, or a feeding tube, to name a few. The casing  12  includes a removable adapter  16  received by the casing  12  and an electrical control system  18  mounted within the casing  12 . The removable adapter  16  is configured to receive a proximal end  20  of the medical tube  14  and place one or more sensors  22  mounted within the removable adapter  16  in communication with a distal end (not shown) of the medical tube  14 . An exhaust port  21  extending from the removable adapter  16  to the casing  12  provides a vent to atmospheric conditions enabling fluid to flow through the medical tube  14  and past the one or more sensors  22 . As shown in the non-limiting example of  FIG. 1 , the removable adapter  16  protrudes from the casing  12 . In another non-limiting example, the removable adapter  16  may be mounted flush with the casing  12 . 
     The medical tube  14  can be a commercial nasogastric tube, a commercial feeding tube, or any other intubation tube known in the art. The proximal end  20  can be received by the removable adapter  14 , as described above, while the distal end is typically inserted through the nares of a patient. Therefore, the one or more sensors  22  can acquire data from a location within the patient where the distal end of the medical tube  14  is positioned. In one non-limiting example, the one or more sensors  22  can include a pressure sensor, a temperature sensor, a pH sensor, and a humidity sensor. In other non-limiting configurations, the one or more sensors  22  may include more or less sensors configured to measure any physical, chemical, and/or electrical property, as desired. 
     The electrical control system  18  includes a controller  24  in communication with the one or more sensors  22  and display  26  in communication with the controller  24 . The controller  24  can be reprogrammable to enable firmware updates to be installed on the controller  24 . Additionally or alternatively, the controller  24  can be configured to communicate with a remote processor to receive firmware updates, process data received from the one or more sensors  22 , and/or store data received from the one or more sensors  22 . The controller  24  is powered by a power supply  28  and can be configured to relay the power, if necessary, to the one or more sensors  22  and/or the display  26 . The power supply  28  can be a rechargeable battery, an AC to DC converter configured to receive wall power, or any other power supplying means known in the art. As shown in  FIG. 1  and  FIG. 2 , the display  26  may be mounted adjacent to the removable adapter  16  on the casing  12 . In other non-limiting configurations, the display  26  may be mounted anywhere on the casing  12 , or the display  26  may be mounted remotely from the casing  12 . 
     One non-limiting example of the operation of the self-detection positioning system  10  will be described with reference to  FIGS. 1-4 . In operation, the distal end of the medical tube  14  is inserted at step  30  into a patient, typically through the nares of the patient, by a trained individual. The trained individual may be a physician, nurse, MA, PA, or any other healthcare professional. Once the trained individual believes the distal end of the medical tube  14  is properly placed within the patient, the proximal end  20  of the medical tube  14  is inserted at step  32  into the removable adapter  16  thereby placing the distal end of the medical tube  14  in communication with the one or more sensors  22 . The controller  24  can then acquire data at step  34  from the one or more sensors  22 . In one non-limiting example, the controller  24  can acquire pressure data, temperature data, pH data, and humidity data from the one or more sensors  22 . The controller  24  can instruct the display  26  to display at step  36  the data acquired from the one or more sensors  22  for viewing by the trained individual. The trained individual can review the data and determine if the distal end of the medical tube  14  is properly placed within the patient. Additionally or alternatively, the controller  24  can be configured to detect at step  38  physiological rhythmic patterns  40 , as illustrated in two non-limiting examples of pressure data shown in  FIG. 4 . Upon detection of physiological rhythmic pressure patterns  40  indicated by arrow  42 , the controller  24  can determine at step  44  that the distal end of the medical tube  14  is located in a pulmonary tract of the patient and subsequently notify at step  46  the trained individual using the display  26  of this location. If rhythmic pressure patterns  40  are not detected indicated by arrow  48 , the controller  24  can determine at step  50  that the distal end of the medical tube  14  is located in a gastrointestinal tract of the patient and subsequently notify the trained individual using the display  26  of this location at step  52 . Alternatively or additionally, the controller  24  can be configured to detect at step  38  physiological patterns from any of the one or more sensors  22 . In some instances, the medical tube  14  can be placed into the patient by a first trained individual and placement of the medical tube  14  can be confirmed by a second trained individual. In this instance, the second trained individual will monitor the display  26  and determine the location of the distal end of the medical tube  14 , once the first trained individual believes the distal end of the medical tube  14  is properly placed within the patient. 
     In other non-limiting examples, the controller  24  can be configured to detect humidity, temperature, and/or pH data in combination with, or separately from, the pressure data to determine the location of the distal end of the medical tube  14 . For example, the controller  24  can detect no rhythmic pressure patterns  40  and elevated humidity and determine that the distal end of the medical tube  14  is located in the gastrointestinal tract of the patient. Alternatively or additionally, the controller  24  can be configured to determine a specific section of the gastrointestinal tract in which the distal end of the medical tube  14  is located, based on data from the one or more sensors  22 . For example, the controller  22  may be configured to detect whether the distal end of the medical tube is located within a duodenum or a stomach of the gastrointestinal tract of the patient. Furthermore, the controller  24  can be configured to detect any physical, chemical, and/or electrical data from the one or more sensors  22  to determine the location of the distal end of the medical tube  14 . 
     The notifications at steps  46  and  52  sent to the display  26  notifying the trained individual of the positioning of the distal end of the medical tube  14  may be in the form of a binary output, where one output signifies positioning in the pulmonary tract and the other output signifies positioning in the gastrointestinal tract. Alternatively or additionally, the display  26  may articulate the positioning of the distal end of the medical tube  14  to the physician. 
     Exemplary advantages of the above-described self-detection positioning system  10  or other medical systems designed or created using the above-described techniques or properties, will be described with reference to  FIGS. 1-4 . By no means is the following an exhaustive list of the numerous advantages provided by the invention, as will be understood by one of skill in the art. 
     The self-detection positioning system  10  provides quick and accurate determination of a position of a distal end of a medical tube  14  placed in a patient. The accuracy of the self-detection positioning system  10  may negate the need for a radiologist to confirm the placement of the medical tube  14 , and enable a less expensive medical professional, for example, a nurse, MA, PA, or other health care professional to confirm the placement of the medical tube  14 . 
     The components  16 ,  22 ,  24 ,  26 ,  28  mounted within or on the casing  12  can be easily configured to fit in a compact design enabling a physician to use the self-detection positioning system  10  in a point-of-care manner, or at the patient&#39;s bedside. Additionally, the removable adapter  16  received by the casing  12  is removable from the casing  12  enabling the self-detection positioning system  10  to be reusable and prevent cross-contamination between patients. 
     As described above, the self-detection positioning system  10  can use one or more sensors  22  to detect specific patterns in data to determine the position of the distal end of the medical tube  14 . Since the data measured by the one or more sensors  22  from within the patient will most likely be at substantially atmospheric conditions, the one or more sensors  22  can be low-cost and easily adapted to fit in a compact design. 
     Furthermore, the controller  24  can be reprogrammed enabling the controller  24  to adaptively learn. This adaptive learning could allow the self-detection positioning system  10  to more precisely determine the position of the distal end of the medical tube  14 . For example, the controller  24  could be configured to determine, based on the data from the one or more sensors  22 , whether the distal end of the medical tube  14  was positioned in a post-plyoric position within a gastrointestinal tract of a patient. 
     Although the above description generally relates to applying the self-detection positioning system  10  when inserting a nasogastric and/or feeding tube in a patient, they are but two non-limiting applications of the self-detection positioning system  10 . In other non-limiting applications, the self-detection positioning system  10  could be applied during any process of inserting a medical tube into a patient known in the art. 
     Thus, while the invention has been described above in connection with particular embodiments and examples, the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.