Patent Publication Number: US-2023145909-A1

Title: Configurable System and Method for Indicating Deviation from a Medical Device Placement Pathway

Description:
FIELD OF THE INVENTION 
     The subject matter of the present invention relates generally to a configurable system and method for indicating deviation from a medical device placement pathway. 
     BACKGROUND 
     Physicians and other health care providers frequently use catheters to treat patients. The known catheters include a tube which is inserted into the human body, with or without the aid of a guidewire or a stiffening stylet within. Certain catheters are inserted through the patient&#39;s nose or mouth for treating the gastrointestinal tract. These catheters, sometimes known as enteral catheters, typically include feeding tubes. The feeding tube lies in the stomach or intestines, and allow for the delivery of liquid nutrients, liquid medicines or a combination of the two to the patient; or for sampling from or decompressing the gastrointestinal tract (GIT) by allowing for passive or active drainage of contents (gas or liquid media). 
     Other types of catheters are inserted into the patient&#39;s veins or arteries for treating the cardiovascular system. These intravascular catheters include, among others, central venous catheters, peripheral venous catheters and the peripherally inserted central catheters. These catheters include a relatively small tube that passes through the patient&#39;s veins or arteries. Depending on the application, the health care provider can use an intravascular catheter to remove blood vessel blockages, place inserts into blood vessels and provide patients with injections of medications, drugs, fluids, nutrients, or blood products over a period of time, sometimes several weeks or more. 
     Catheters and larger tubes are used in other areas of the body too, for example, tubes in the trachea (Endotracheal Tubes) used to ventilate patients; urinary catheters (via the urethra or by a suprapubic vesicostomy procedure); wound drainage catheters; cerebrospinal fluid shunts; and the like. 
     When using any such catheters, it is important to place the end of the catheter at the proper location within the human body. Erroneous placement of the catheter tip may injure or harm the patient. For example, if the health care provider erroneously places an enteral catheter into the patient&#39;s lungs, this may damage or irritate the lungs, or liquid may be introduced into the lungs with harmful results. If the health care provider erroneously places an intravascular catheter into the wrong blood vessel of the cardiovascular system, the patient may experience injury or a harmful blockages or emboli. 
     With feeding tubes in particular, it is also prudent to check that the exit aperture of the feeding tube (typically located at or near to the distal end/tip of the tube) remains in its desired location over the period of treatment, e.g., feeding. Protocols that address this requirement in enteral feeding tubes include position verification by X-Ray or monitoring for the appropriate pH of fluids extracted from the feeding tube when not carrying nutritional liquids and careful patient monitoring to ensure nutritional uptake is as expected. 
     In some cases, health care providers use X-ray machines to gather information about the location of catheters within the body. There are several disadvantages with using X-ray machines. For example, these machines are relatively large and heavy, not always readily available, and are difficult to transport. This often leads to delays in initiating feeding if waiting for confirmation, which can be critical in malnourished infants for example. They also expose the patient to a relatively high degree of X-ray radiation and consume a relatively large amount of energy. These machines are typically not readily accessible for use because, due to their size, they are usually installed in a special X-ray room. This room can be far away from the patient&#39;s room. Therefore, health care providers can find it inconvenient to use these machines for performing catheter insertion procedures. Furthermore, it can be inconvenient to transport these machines to a patient&#39;s bedside, and they cannot be used at the patient&#39;s home for home care catheter procedures. Moreover, even X-rays are not necessarily conclusive as to the location of the catheter tip, as they are often misread by the ward staff rather than waiting for interpretation by a radiologist, and the natural and continuous movement of the internal organs can make it difficult for the physician interpreting the X-ray to be sure of the actual location of the distal end of the catheter. 
     Another existing catheter locating means involves using an electromagnetic coil positioned inside the catheter and an electromagnetic coil locating receiver outside of the patient&#39;s body. One or both such components are powered. The electromagnetic coil is generally incorporated into a stylet or guide wire which is inserted within the catheter. The coil locating receiver can be used to determine the distance the coil is from the receiver and its depth in the patient&#39;s body and can communicate with a display to show a reference image of a non-subject body and an image of the electromagnetic coil location and movement over time on the display with the reference image. However, these systems also have several disadvantages. For example, the coil locating receiver is a large device that must rest in a precise location outside the patient&#39;s body and does not permit for adjustments due to each individual patient&#39;s anatomical size or shape. Furthermore, health care providers can estimate the positioning of the catheter using the electromagnetic coil and coil locating receiver but cannot estimate or view the specific patient&#39;s anatomy. 
     During placement of tubes into the body their positions and pathway may be tracked in real time using electromagnetic or other tracking techniques, as described above. Such tubes may be placed into the GIT for feeding or the trachea for ventilation, as examples. For example, when considering feeding tubes that are designed to enter the esophagus, these may inadvertently enter the airway during placement, potentially causing significant morbidity (injuries may include pneumothorax (air leaking into and accumulating in the pleural space, i.e., between the lung and the chest wall), hemothorax (blood accumulating in the plural space), empyema (pus in the pleural space), pneumonia, aspiration, asphyxiation and potential death, amongst others). Electromagnetic tracking devices such as the CORTRAK* enteral access system (EAS) allow a clinician to visualize any pathway deviations from those expected. For example, a sharp turn to the left or the right when the tube tip is within the chest would indicate airway entry has occurred. The sooner this is recognized, and the tube is withdrawn, the more unlikely that any damage to the airways will occur. If the user does not recognize the deviation (e.g., if it is gentle initially, or they may be looking at the patient or away from the screen), the airway and lungs can be injured severely or even fed into and so “drowning” or infecting that portion of the lungs. 
     Consequently, there is a need for a pathway deviation indicator to ensure more accurate catheter placement within a predetermined zone. In particular, a pathway deviation indicator that can be configurable by a user to define pathway boundaries would also be useful. 
     SUMMARY 
     Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention. 
     The present invention is directed to a medical device placement configurable pathway deviation indication system. The system includes a medical device comprising a proximal end and a distal end, wherein the distal end is configured to be inserted into a body of a patient; a location transmitter configured to transmit a signal related to a position of the distal end of the medical device; at least one detector device configured to receive information related to the patient&#39;s body and the location transmitter; and a configurable pathway deviation indication system operatively coupled to the location transmitter and the at least one detector device. The configurable pathway deviation indication system includes: a display, and a computing system comprising one or more processors and or more non-transitory computer-readable media that collectively store instructions that, when executed by the one or more processors, cause the computing system to perform operations. The operations include: providing a representation of anatomical landmarks of the patient&#39;s body; providing one or more pathway boundaries relative to a desired pathway in the representation of the anatomical landmarks; displaying, on the display, the position of the location transmitter of the medical device relative to the desired pathway; determining in real-time if the position of the location transmitter of the medical device approaches, reaches, and/or breaches any of the one or more pathway boundaries; and providing an indication when the location transmitter of the medical device approaches, reaches, and/or breaches any of the one or more pathway boundaries. 
     In one particular embodiment, the one or more boundaries can include at least one lateral boundary that is parallel to the desired pathway. Further, the at least one lateral boundary can include a left lateral boundary and/or a right lateral boundary, wherein each of the left lateral boundary and the right lateral boundary can be parallel to the desired pathway. 
     In another embodiment, the one or more boundaries can include a trajectory angle boundary of deviation from the desired pathway. 
     In an additional embodiment, each of the one or more boundaries can include a predefined maximum limit relative to the desired pathway, further wherein each of the one or more boundaries can include a user-defined adjustable limit that is less than the predefined maximum limit. Moreover, the one or more boundaries can include a default limit that is less than the predefined maximum limit. 
     In a further embodiment, the indication can be a visual indicator displayed on the display, an audible cue, and/or a haptic cue. Moreover, the visual indicator can include a graphic symbol and/or a change in a visual display of the one or more catheter placement pathway boundaries that has been approached, reached, and/or breached. 
     In yet another embodiment, a magnitude, frequency, shape, color, and/or pattern of the alert indication can increase or decrease. 
     In one more embodiment, the pathway deviation indication system can further include an input operatively coupled to the processor, wherein the input can be configured to enable a user to adjust the one or more pathway boundaries. 
     The present invention is further directed to a computer-implemented method for indicating deviation from a pathway during a medical device placement procedure. The method includes steps of: providing a representation of anatomical landmarks of a patient&#39;s body based on information received from at least one detector device; providing one or more pathway boundaries relative to a desired pathway in the representation of the anatomical landmarks; determining a position of a location transmitter of a medical device relative to the at least one detector device using information received from the detector device; displaying, on the display, the position of the location transmitter of the medical device relative to the desired pathway; determining if the position of the location transmitter of the medical device approaches, reaches, and/or breaches any of the one or more pathway boundaries; and providing an indication when the location transmitter of the medical device breaches and/or reaches and/or approaches any of the one or more pathway boundaries. 
     In one particular embodiment, the step of determining the position of the location transmitter relative to the at least one detector device can be conducted in real-time. 
     In another embodiment, the step of determining if the position of the location transmitter of the medical device approaches, reaches, and/or breaches any of the one or more pathway boundaries can be conducted in real-time. 
     In an additional embodiment, the method can further include a step of adjusting the one or more pathway boundaries using an input. 
     In yet another embodiment, the one or more boundaries can include at least one lateral boundary that is parallel to the desired pathway. Further, the at least one lateral boundary can include a left lateral boundary and/or a right lateral boundary, wherein each of the left lateral boundary and/or the right lateral boundary are parallel to the desired pathway. 
     In a further embodiment, the one or more boundaries can include a trajectory angle boundary of deviation from the desired pathway. 
     In still another embodiment, the step of providing an indication can include displaying a visual indicator on the display, initiating an audible cue, and/or generating a haptic cue. Further, a magnitude and/or frequency of the indication can increase or decrease. 
     In one more embodiment, the method can further include steps of: establishing a maximum pathway boundary; and establishing a default initial pathway boundary. 
     These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which: 
         FIG.  1    illustrates a block diagram of a catheter placement pathway deviation indication system according to one particular embodiment of the present invention; 
         FIG.  2    illustrates a front view of a detector apparatus positioned on a patient&#39;s body according to one particular embodiment of the present invention; 
         FIG.  3    illustrates an image generated by the system of  FIG.  1    according to one embodiment of the present invention; 
         FIG.  4    illustrates an image generated by the system of  FIG.  1    according to another aspect of the present invention in which a pathway boundary is breached and an indication is generated; 
         FIG.  5    illustrates an image generated by the system of  FIG.  1    according to another aspect of the present invention in which a pathway boundary is not reached or breached and therefore an alert indication is not generated; 
         FIG.  6    illustrates an image generated by the system of  FIG.  1    according to another aspect of the present invention in which the medical device has passed beyond the scope of the pathway boundary; 
         FIGS.  7 A and  7 B  illustrate images generated by the system of  FIG.  1    according to another aspect of the present invention when the pathway boundary is user-adjusted in real-time to be less restrictive (by offering wider limits); and 
         FIG.  8    illustrates a block diagram of a method implemented by the system of claim  1 . 
     
    
    
     DETAILED DESCRIPTION 
     Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents. 
     In the following specification and the claims, reference will be made to a number of terms, which shall be defined to have the following meanings: 
     The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. 
     Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “substantially,” and “approximately,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise. Approximating language, when used to modify a value, indicates that the value can be raised or lowered by 10% and remain within the disclosed embodiment, and by as much as 20% when considering anatomical variabilities and remain within the disclosed embodiment. Further, when a plurality of ranges are provided, any combination of a minimum value and a maximum value described in the plurality of ranges are contemplated by the present invention. For example, if ranges of “from about 20% to about 80%” and “from about 30% to about 70%” are described, a range of “from about 20% to about 70%” or a range of “from about 30% to about 80%” are also contemplated by the present invention. 
     As used herein, the terms “processor” and “computer,” and related terms, e.g., “processing device,” “computing device,” and “controller” are not limited to just those integrated circuits referred to in the art as a computer, but broadly refers to a microcontroller, a microcomputer, a programmable logic controller (PLC), and application specific integrated circuit, and other programmable circuits, and these terms are used interchangeably herein. In the embodiments described herein, memory may include, but it not limited to, a computer-readable medium, such as a random-access memory (RAM), or a computer-readable non-volatile medium, such as a flash memory. Alternatively, a floppy disk, a compact disc-read only memory (CD-ROM), a magneto-optical disk (MOD), and/or a digital versatile disc (DVD) may also be used. Also, in the embodiments described herein, additional input channels may be, but are not limited to, computer peripherals associated with an operator interface such as a mouse and a keyboard. Alternatively, other computer peripherals may also be used that may include, for example, but not be limited to, a scanner, foot-pedal, headset, or the like. Furthermore, in the exemplary embodiment, additional output channels may include, but not be limited to, an operator interface monitor. 
     Further, as used herein, the terms “software” and “firmware” are interchangeable and include any computer program storage in memory for execution by personal computers, workstations, clients, and servers. 
     As used herein, the term “non-transitory computer-readable media” is intended to be representative of any tangible computer-based device implemented in any method of technology for short-term and long-term storage of information, such as, computer-readable instructions, data structures, program modules and sub-modules, or other data in any device. Therefore, the methods described herein may be encoded as executable instructions embodied in a tangible, non-transitory, computer-readable medium, including, without limitation, a storage device and/or a memory device. Such instructions, when executed by a processor, cause the processor to perform at least a portion of the methods described herein. Moreover, as used herein, the term “non-transitory computer-readable media” includes all tangible, computer-readable media, including, without limitation, non-transitory computer storage devices, including without limitation, volatile and non-volatile media, and removable and non-removable media such as firmware, physical and virtual storage, CD-ROMS, DVDs, and any other digital source such as a network or the Internet, as well as yet to be developed digital means, with the sole exception being transitory, propagating signal. 
     Furthermore, as used herein, the term “real-time” refers to at least one of the time of occurrence of the associated events, the time of measurement and collection of predetermined data, the time to process the data, and the time of a system response to the events and the environment. In the embodiments described herein, these activities and events occur substantially instantaneously. 
     Generally speaking, the present invention is directed to a medical device placement pathway deviation indication system that is configurable. The system can include a medical device comprising a proximal end and a distal end, wherein the distal end is configured to be inserted into a body cavity of a patient; a location transmitter configured to transmit a signal related to a position of the distal end of the medical device; and at least one detector device configured to receive information related to the patient&#39;s body and the location transmitter. The internal component device may generate the signal for detection by the external component device, or vice versa. The system further includes a configurable pathway deviation indication system operatively coupled to the location transmitter and the at least one detector device. The pathway deviation indication system includes a display, a computing system comprising one or more processors and or more non-transitory computer-readable media that collectively store instruction that, when executed by the one or more processors, cause the computing system to perform operations. The operations include: registering and providing a representation of anatomical landmarks of the patient&#39;s body; providing one or more pathway boundaries relative to the anatomical landmarks; displaying, on the display, the position of the location transmitter of the medical device relative to the desired pathway; determining in real-time if the position of the location transmitter of the medical device breaches any of the one or more pathway boundaries (e.g., perimeter boundaries or trajectory angle boundaries); and providing an indication when the location transmitter of the medical device breaches any of the one or more pathway boundaries. The present invention is further directed to at least one computer-implemented method for indicating deviation from a pathway during a medical device placement procedure. The present inventors have found that the pathway deviation indication system and method of the present invention can provide a configurable, e.g., self-adjustable aid for guidance during a medical device insertion procedure by providing at least one user-defined pathway boundary over the patient&#39;s anatomical landmarks and generating an alarm, alert, graphic, or other indication in real-time when the boundary has been breached. The user-customization of the pathway boundaries enables a user to configure the sensitivity of the pathway deviation indication system based on their own level of expertise, comfort, and desired utility of the system, and further enables the pathway boundaries or trajectory angle limit to be adjusted in real-time during the insertion procedure. 
     The specific features of the configurable pathway deviation indication system of the present invention may be better understood with reference to  FIGS.  1 - 8   . 
     Referring now to the drawings,  FIG.  1    illustrates a block diagram of one embodiment of a medical device placement pathway deviation indication system  100 . The medical device placement pathway deviation indication system  100  includes (a) a controller  102  which supports a processor  104  and a memory device  106  and can receive information from an input  110 ; (b) a display device  108 , which may optionally be enclosed in a housing  112  with the controller  102  as shown by dashed lines in  FIG.  1   ; (c) one or more non-invasive external detector devices  52  electronically coupled to the controller  102  by a wire, cable, signal data connection, signal carrier or wireless connection; and optionally (d) an invasive medical device, e.g., a catheter,  60  having a location transmitter  62  in communication with the one or more non-invasive external detector devices  52  and operatively coupled to the apparatus which, in turn, is operatively coupled to the controller  102 . 
     As illustrated in  FIG.  2   , one or more of the non-invasive external detector devices  52  may be disposed in a detector apparatus housing  50 . The detector devices  52  may be operatively coupled to the controller  102  via a cable  51  or other wired or wireless connection. Each of the non-invasive external detector devices  52  are configured to be positioned a surface of a subject  2  (see  FIG.  2   ) which is a mammal, such as a human. Although the illustrated example depicts a human, it should be appreciated that medical device placement pathway deviation indication system  100  could be used with any mammals such as domestic animals. 
     The system  100  of the present invention may rely on “registered” anatomical reference points saved in the memory device  106  of the controller  102 . The “registered” anatomical reference points and sizes can be programmed in real-time for each patient&#39;s specific anatomy using a registration tool to capture the three-dimensional coordinates of each anatomical landmark in space and store these at the beginning of the tube placement procedure; or may be pre-programmed based on, e.g., average anatomical structure size and relative location of anatomical landmarks such as bony landmarks. Specifically, the memory device  106  can store algorithms defining a generally known pre-defined anthropometric relationship between anatomical landmarks. For instance, an average adult patient, an average pediatric patient of a particular age, etc. The “registered” anatomical reference points may additionally or alternatively be determined by using the non-invasive external detector devices  52  as registration tools, e.g., by positioning the non-invasive external detector devices  52  on known bony landmarks of the patient&#39;s body  2  and determining relative distances between each of the non-invasive external detector devices  52 . In some aspects of the present invention, a combination of average anatomical size for a patient population and individual patient data received from the non-invasive external detector devices  52  can be used to determine the “registered” anatomical reference points used by the configurable pathway deviation indication system  100 . 
       FIG.  2    further illustrates exemplary anatomical landmarks that may be relevant for placement of an invasive medical device such as a catheter, e.g., enteral feeding tube. The exemplary patient&#39;s body  2  may be generally bisected in the frontal plane by midline  10 . The midline  10  extends through the suprasternal (jugular) notch  4  of the sternum superiorly and the xiphoid process  8  inferiorly, i.e., the upper and lower landmarks of the sternum. The ribcage is denoted generally by reference numeral  6 . A registered height  12  of the chest of the exemplary patient&#39;s body  2  may extend along the length between the suprasternal notch  4  and the xiphoid process  8  parallel to the midline  10 . A registered width  14  of one side of the chest (a hemithorax) of the exemplary patient  2  may extend generally perpendicular to the midline  10  from the midline to a widest point on the ribcage  6 . For placement of an enteral feeding tube, a width  16  relevant to the placement procedure may be defined by about 50% of the registered width  14 . A right-side region of interest  18  may be defined as an area formed by the width  16  to the right of the patient&#39;s midline and the registered height  12  between the suprasternal notch  4  and the xiphoid process  8 . A left-side region of interest  20  may be defined as an area formed by the width  16  to the left of the patient&#39;s midline and the registered height  12  between the suprasternal notch  4  and the xiphoid process  8 . 
     The one or more non-invasive external detector devices  52  can be placed on particular bony landmarks of the patient&#39;s body  2  to orient and define a coordinate system for determining the location of the invasive medical device  60  within the patient&#39;s body  2 . For instance, for placement of an invasive medical device such as a catheter, e.g., enteral feeding tube, a detector device  52  can be placed at one or more of the suprasternal notch  4 , the xiphoid process  8 , and the patient&#39;s acromioclavicular joint(s) where the clavicle(s) end in the shoulder joint(s). 
     The anterior aspect of manubrium of the sternum (the upper bone of the sternum, of which the suprasternal notch  4  is part), appears to be an ideal point on the body for positioning of the detector apparatus  52  by clinicians as it is common to all humans and can be readily located visually or by palpitation regardless of the physical presentation of the patient. However, the use of the suprasternal notch  4  as a bony anatomy landmark is not the only bony point or region of the body that could be used for this purpose. There may be other points of the body to which the measuring equipment can be reliably co-located or located with a predetermined offset, such as over the xiphoid process or acromioclavicular joint(s). Such an arrangement allows the monitor to be used to display a reference point or object, preferably shaped and scaled in proportion with the parts of the body that will be useful to the clinician in the procedure they are performing. Such as when placing a catheter or guide wire or checking the location of a previously located catheter. 
     In some aspects of the present invention, one or more of the detector devices  52  may be disposed in a housing, e.g., a housing  50   a . A possible detector apparatus housing shape  50  is also shown in  FIG.  2   . The shape of the apparatus is of triangular form in plain view and is preferable for its use on the chest of a patient as described previously. This shape is convenient for the clinician to use because its apex  50   a  can be located on the at the suprasternal notch and its longitudinal axis made coincident with the midsagittal line  10  of the patient. However, any suitable shape for housing  50  may be used. The housing  50   a  can be affixed to the patient&#39;s body  2  by any suitable means, e.g., using a fixation device  54  such as adhesive tape or a clip interlocking onto an ECG electrode-type pad, to maintain a static point of reference on the patient&#39;s body  2 . Thus, even when there may be movement of the patient&#39;s body  2 , a static anatomical reference can be maintained. 
     The one or more non-invasive external detector devices  52  can use any suitable means to determine relative position and/or distance between each of the devices  52 . For instance, in one particular embodiment of the present invention, each of the detector devices  52  can include an electromagnetic transmitter and/or receiver configured to send and/or receive electromagnetic signals between the devices  52 , as controlled by the controller  102 , to determine the relative position and angular position of each of the detector devices  52 . However, the non-invasive external detector devices  52  may further use sound or ultrasound time-of-flight or any other suitable arrangement to determine relative position. 
     Furthermore, the invasive medical device  60 , e.g., catheter, can include a location transmitter  62 . For instance, the location transmitter  62  can be disposed at a distal end of the catheter  60 . The location transmitter  62  can operatively communicate with one or more detector devices  52  in order to determine the location of the catheter, e.g., the distal end of the catheter  60 , relative to the one or more detector devices  52 . For instance, in one aspect of the present invention, the location transmitter  62  can be a coil disposed at the distal end of the catheter  60  and operatively coupled to the controller  102 , and the coil can generate an electromagnetic signal that can be detected by the detector devices  52 , not unlike that described in U.S. Pat. No. 8,265,732, which is hereby incorporated into this specification by reference. The incorporation of the above-mentioned patent does not and should not be construed as an admission of the content of the specification having entered the common general knowledge of those skilled in the art. Moreover, any suitable means can be used to determine a position of the invasive medical device, e.g., the position of the distal end of the catheter  60 , relative to the one or more non-invasive external detector devices  52 . 
     In use, detector devices  52  can be positioned on or near the patient&#39;s body  2  and initiated, e.g., activated or powered on. The processor  104  can receive information related to the relative position between the detector devices  52 . The memory device  106  can store image processing algorithms which the processor  104  can execute in order to visually render a graphical representation  126  of a skeletal anatomy scaled appropriately to the patient&#39;s torso, e.g., ribcage  6  and depict the rendered graphical representation of the anatomy as an image on a suitable monitor or display  108 , e.g., as illustrated in  FIG.  3   . Further, the memory device  106  can store image processing algorithms which the processor  104  can execute to visually render a graphical representation of the right-side area of interest  18  and the left side area of interest  20 , e.g., as an outlined or shaded region overlay as shown in  FIG.  3   , to illustrate the detection region  22 . 
     The image  120  shown on the display  108  can further include a vertical axis  122  (i.e., a y-axis) that can correspond to the midline  10  of the patient&#39;s body  2 . Further, the image  120  can include a horizontal axis  124  that is perpendicular to the vertical axis  122  and extends through a graphical representation of the xiphoid process  128  of the patient&#39;s body  2  as rendered on the graphical representation of the skeletal anatomy as described above. 
     The system  100  can further include a right-side “maximum boundary”  132  that extends parallel to a desired pathway for insertion of the medical device  60 , e.g., along the vertical axis  122 , on the right side of the patient&#39;s body, and a left side “maximum boundary”  134  on the left side of the patient&#39;s body. The right-side maximum boundary  132  and the left-side maximum boundary  134  may be graphically depicted in the image  120  as vertical lines, e.g., solid lines, or as a visible overlay representing the full detection region  130 . The right-side maximum boundary  132  may coincide with the outer right edge of the detection region  130 , e.g., at about 50% of the width of the right side of the patient&#39;s body  2 , otherwise known as the right “hemithorax”; or may be programmed to a portion of the hemithorax width, for e.g., about 50-70% of the hemithorax width during setup before a procedure starts. For instance, the right-side maximum boundary  132  may be a programmed value stored by the memory device  106 , or the right-side maximum boundary  132  may be calculated using one or more algorithms stored in the memory device  106  using information received from the detector devices  52 , or any combination thereof. Similarly, the left-side maximum boundary  134  may coincide with the outer left edge of the detection region  130 , e.g., at about 50% of the width of the left side of the patient&#39;s body  2 ; or may be programmed to a portion of the hemithorax width, for e.g., about 50-70% of the hemithorax width during setup before a procedure starts. For instance, the left-side maximum boundary  134  may be a programmed value stored by the memory device  106 , or the left-side maximum boundary  134  may be calculated using one or more algorithms stored in the memory device  106  using information received from the detector devices  52 , or any combination thereof. 
     Further, the system  100  can have “user-adjustable boundaries” set as lateral perimeter boundaries  136  and  138  that fall within the detection region  130  and can be adjustable by the user during use of the system  100 . For instance, a right lateral boundary  136  and a left lateral boundary  138  can be established and adjusted by a user as needed within the previously defined detection region  130  (within its maximum boundaries  134  and  132 ). The right lateral boundary  136  and the left lateral boundary  138  may be graphically depicted in the image  120  as vertical lines, e.g., solid lines or broken lines, parallel to the desired pathway along the vertical axis  122 . Each of the right and left lateral boundaries  136  and  138  may be user-adjustable relative to a distance between the desired pathway along the vertical axis  122  and the right and left-side maximum boundaries  132  and  134 . For instance, the right and left lateral boundaries  136  and  138  may be set as a percentage of the width from the desired pathway along the vertical axis  122  and the respective right and left-side maximum boundaries  132  and  134 , where 0% is along the desired pathway or vertical axis  122  and 100% coincides with the respective right and left-side maximum boundaries  132  and  134 . For instance, the right and left lateral boundaries  136  and  138  may be set in a range from 1% to 100%, such as from 5% to 100%, 10% to 100%, or 15% to 100%. The right and left lateral boundaries  136  and  138  may be set independently of each other, or the right and left lateral boundaries  136  and  138  may be set together in sync. This will allow the user to configure the sensitivity of the pathway deviation indicator system  100  to their own level of expertise and/or comfort with the insertion procedure, and the user&#39;s desired utility-level for the system  100  (e.g., if the user intends to rely heavily on the boundaries for guidance during the insertion procedure, the respective right and left lateral boundaries  136  and  138  may be relatively narrowly set). 
     The controller  102  can receive information from input  110  related to the user-adjustable boundaries. For instance, a user can input an initial right lateral boundary  136  and an initial left lateral boundary  138  prior to beginning an insertion procedure. The right lateral boundary  136  and the left lateral boundary  138  can be equal, or they can have different values. Moreover, the user can utilize the input  110  to adjust the right lateral boundary  136  and/or the left lateral boundary  138  in real-time during an insertion procedure. The right and left lateral boundaries  136  and  138  may be set independently by the input  110  and/or equally in sync. 
     The input  110  can be any suitable input such as a mouse, keyboard, scroll knob, scroll wheel, touch screen (e.g., a touch screen on the display  108  or an independent touch screen), a foot-pedal(s), a wired or wireless device such as a tablet, or any other input device configured to operatively connect with the controller  102 . 
     Using the information gathered from detector device(s)  52  and the location transmitter  62  regarding the relative position and orientation of the catheter tip  64 , when the insertion procedure is initiated, the relative position and direction of the catheter tip within the subject can be graphically represented in the image  120  on the display  108 . Moreover, in some aspects of the invention, the relative position and orientation data of the catheter tip  64  can indicate the relative positions of the tip  64  in three spatial dimensions: x (transverse across the body  2 ), y (longitudinal along the body  2 ) and z (depth within the body  2 ). 
     Specifically, the image  120  may illustrate a graphical representation  140  of the relative location of the distal tip  64  of the catheter  60 . The graphical representation  140  may be illustrated as a dot, an arrow, an icon, a shape, or any other suitable illustrative representation to indicate a current, real-time relative location (and or trajectory angle) of the distal tip  64  of the catheter  60 . Further, the image  120  may use all prior locations to illustrate a graphical representation  142  tracing the catheter&#39;s pathway  60  within the patient&#39;s body  2 . The graphical representation of the catheter tracing  142  can illustrate the position of the pathway of the catheter within the patient&#39;s body  2 , as shown in  FIG.  3   . The graphical representation of the catheter tracing  142  can be illustrated, e.g., as a solid, dotted or dashed line in a same color or different color than that of the graphical representation  140  of the position of the distal tip  64  of the catheter  60 . Moreover, the graphical representation of the catheter tracing  142  can have a different size/thickness, color, shape, pattern or appearance than the graphical representation of the tip  140 . For instance, as shown in  FIGS.  3 - 7   , the catheter tracing  142  can have a different graphical representation  140  of the distal tip of the catheter, and the graphical representation  140  of the distal tip of the catheter can have a thickness or width or color or shape that is different from that of the catheter tracing  142 . Such differences in size/thickness, color, shape, pattern or appearance, may be used to indicate a change in trajectory angle, depth or any other feature according to the tip&#39;s location. However, for the purpose of the present invention, the style of the graphical representation is not critical and any suitable graphical representation for the relative position of the catheter  60  within the patient&#39;s body  2  can be used. 
     During an insertion procedure, the right and left lateral user-adjustable boundaries  136  and  138 , respectively, may be shown on the image  120  as described above. As the catheter  60  is inserted into the patient&#39;s body  2 , the controller  102  can receive the information related to the relative position of the location transmitter  62  and compare to the right and left lateral boundaries  136  and  138  set by the user. If at any point the relative position of the location transmitter  62  approaches, reaches, or breaches the right lateral boundary  136  or the left lateral boundary  138 , the user may be notified. Specifically, image  120  may show the graphical representation  140  of the location transmitter and at least a portion of the graphical representation  142  of the catheter tracing nearing, crossing or positioned on the right lateral boundary  136  or the left lateral boundary  138  relative to the desired pathway, e.g., along the vertical axis  122 . 
     As used herein, the term “approach” or “approaching” the user-adjustable boundaries means that the relative position of the location transmitter  62  is within about 0-30% of the distance from a user-adjustable boundary to the desired pathway, e.g., the right lateral boundary  136  or the left lateral boundary  138 , within the region between the respective boundary and the desired pathway, e.g., vertical axis  22 . In this manner, a pathway deviation indicator  150  can be initiated as a caution alert to warn a user that the relative position of the location transmitter  62  may be nearing a particular user-defined boundary. In some aspects of the invention, the use of a caution alert can be configured by a user, e.g., to define the tolerance between about 0-30% of the distance from the respective boundary to the desired pathway at which the user would like to receive a caution alert. A tolerance of 0% for the caution alert would occur when the relative position of the location transmitter  62  reaches or is touching the respective boundary, e.g., one of the right lateral boundary  136  or the left lateral boundary  138 . A tolerance of 30% would provide a pathway deviation indicator  150  as a caution alert when the relative position of the location transmitter  62  is within 30% of the distance, e.g., width, between the respective boundary and the desired pathway. As an illustrative example only, if a distance between the vertical axis  22  and the right lateral boundary  136  is 10 cm, a caution alert can be initiated when the relative position of the location transmitter  62  approaches the right lateral boundary  136  within 3 cm if the caution alert tolerance is 30%. 
     Furthermore, one or more pathway deviation indicators  150  may be initiated to alert the user of a pathway deviation from, e.g., the relative position of the location transmitter  62  approaching, reaching, or breaching, the lateral user-adjustable boundaries. For instance, a visual warning graphic  152  may pop up on the image  120 , the graphical representation  140  of the location transmitter and/or the graphical representation  142  of the catheter tracing may change in size, color, and/or pattern (including but not limited to a flashing graphic), or any other visual alert may be initiated. Additionally or alternatively, the indicators  150  may include audible cues, such as an alert sound, and/or haptic cues, such as a vibration of the input  110  or other apparatus which a user may be in contact with. 
     The pathway deviation indicators  150  may be of varying and/or progressively changing frequencies or amplitudes. For instance, the colors, shapes, frequencies and/or amplitudes of the indicators  150  may increase or decrease, or the type of indicator  150  may change, if the indicator  150  is ignored by the user. Similarly, the colors, shapes, frequencies and/or amplitude of the indicators  150  may increase or decrease relative to, e.g., proportionally to, the amount or distance beyond the right or left lateral user-adjustable boundaries  136  and  138  that the path of the catheter has deviated. In the instance of a visual warning graphic  152 , the visual warning graphic  152  may increase or decrease in size, change color, flash on screen, or any combination thereof if the user does not respond to the indicators  150 . Similarly, the frequency and/or amplitude of audible or haptic cues may increase or decrease if the user does not respond to the indicator(s)  150 . It may be considered that an indicator  150  is ignored or not responded to by the user if the insertion procedure continues with the location transmitter  62  outside the lateral boundaries  136  or  138  without any course correction to bring the location transmitter  62  back within the lateral boundaries  136  or  138 , e.g., by removing some or all of the length of the catheter  60  from the patient&#39;s body  2 ; or by widening the user-adjustable boundaries to abort the alert. 
     As described above, the right lateral user-adjustable boundary  136  and/or left lateral user-adjustable boundary  138  can be adjusted by the user in real-time. For instance, if the system  100  detects that the location transmitter  62  has reached or crossed the right lateral boundary  136  and generates one or more pathway deviation indicators  150 , the user may widen the right lateral boundary  136  in real-time if the user does not believe the actual insertion path of the catheter  60  is in error. When the right lateral boundary  136  is widened in real-time such that the detected position of the location transmitter  62  is now considered to be in-bounds, the pathway deviation indicator(s)  150  may be inactivated or turned off. These adjustments may be made unilaterally, or bilaterally individually, or bilaterally in sync. 
     In some aspects of the present invention, the processor  104  may further utilize information gathered from detector device(s)  52  and the location transmitter  62  with algorithms stored in the memory device  106  to estimate an angle trajectory of the tip  64  of the catheter  60  within the patient&#39;s body  2 . A graphical representation  144  of the angle trajectory may be further generated and shown on the image  120 , e.g., as an arrow tip or a line extending from the graphical representation  140  of the position of the distal tip  64  of the catheter  60 . The graphical representation  144  of the angle trajectory may be visually represented as, e.g., an arrow, a solid line, dashed and/or dotted line, having a different color than one or more of the graphical representation(s)  140  of the distal tip of the catheter and the graphical representation(s) of the catheter tracing  142 . 
     The system  100  may further include a “trajectory angle boundary” which defines the maximum allowable angle of deviation relative to the desired pathway, e.g., along the patient&#39;s midline  10 , represented by the vertical axis  122  in the image  120  represented on the display  108 . During a procedure of insertion of a tube such as an enteral feeding tube, a sharp turn to the left or the right when the tube tip  64  is within the chest would indicate airway entry has occurred. The system  100 , in particular, the controller  102 , can compare the angle trajectory of the location transmitter  62  within the patient&#39;s body  2  with the trajectory angle boundary value which defines a maximum acceptable angle of deviation. When the trajectory angle is greater than the boundary angle of deviation, one or more pathway deviation indicators  150  may be initiated to alert the user of a pathway deviation beyond the boundary angle. The pathway deviation indicators  150  may function the same as described above with regard to touching or breaching the right and left lateral boundaries  136  and  138 . For instance, the pathway deviation indicators  150  may increase in frequency and/or amplitude if the boundary angle deviation indicators  150  are ignored. Additionally, the pathway deviation indicators  150  may increase in frequency and/or amplitude based on the amount beyond the boundary angle of deviation  146  that the trajectory angle has deviated. 
       FIGS.  4 - 7    will now be discussed in further detail to illustrate the use of the pathway deviation indication system  100  described above. 
       FIG.  4    shows an image  120  generated by the system  100  in a condition in which the right lateral user-adjustable boundary  136  is narrower than the left lateral user-adjustable boundary  138 . The graphical representation  140  of the position of the distal tip  64  of the catheter  60  shows that the right lateral user-adjustable boundary  136  has been breached. Multiple pathway deviation indicators  150  are shown in the image  120 . Specifically, the right lateral boundary  136  has changed from a dashed line (e.g., shown in  FIG.  3   ) to a solid line. Further, a visual warning graphic  152  is shown in the image  120 . 
       FIG.  5    shows an image  120  having a right lateral user-adjustable boundary  136  and left lateral user-adjustable boundary  138  having the same width settings as shown in  FIG.  4   . However, in  FIG.  5   , the pathway of the inserted catheter, i.e., the catheter tracing  142  and the distal tip  140  of the catheter as shown on the image  120 , remain in-bounds relative to both the right lateral user-adjustable boundary  136  and left lateral user-adjustable boundary  138 . The angle trajectory  144  shown in  FIG.  5    shows an anticipated pathway that may extend beyond the right lateral boundary  136 . Thus, the system  100  may optionally generate one or more pathway deviation indicators  150  which may change progressively as the catheter tip representation  140  approaches the user-adjustable boundary  136 . 
       FIG.  6    shows an image  120  in which the catheter tracing  142  and the graphical representation  140  of the real-time position of the location transmitter  62  has passed below the horizontal axis  124 , i.e., has extended below the patient&#39;s anterior chest. The image  120  appears to show that the catheter tracing  142  and the graphical representation  140  of the real-time position of the location transmitter  62  have extended beyond a width coinciding with the left lateral user-adjustable boundary  138 . However, in this case, the left lateral boundary  138  has not been reached or breached because the left lateral boundary  138  is not crossed above the horizontal axis  124 , i.e., in the patient&#39;s chest  2 . Thus, no pathway deviation indicators  150  are generated. 
       FIGS.  7 A and  7 B  illustrate a scenario in which a user has adjusted the right lateral user-adjustable boundary  136  in real-time during an insertion procedure to make it wider (as seen from  FIG.  7 A  to  FIG.  7 B ). In particular,  FIG.  7 A  illustrates a similar condition to that as shown in  FIG.  4    above, in which the right lateral user-adjustable boundary  136  is breached and one or more pathway deviation indicators  150  are activated.  FIG.  7 B  illustrates that the right lateral user-adjustable boundary  136  is widened, i.e., moved laterally away from the desired pathway along the vertical axis  122  and toward the right maximum boundary  132 . With the right lateral boundary  136  augmented, the catheter tracing  142  is no longer out-of-bounds, and the pathway deviation indicators  150  can be turned off. 
     The present invention further contemplates additional mechanisms for setting the lateral boundaries. For instance, the system  100  can be configured to have customer-specific default and/or lateral maximum boundaries, where the customer is, for instance, a healthcare system, hospital, doctor&#39;s office, clinician, or other user. If desired, customer-specific maximum boundaries that are less than 100%, i.e., less than the hemithorax width for the right-side maximum boundary  132  and the left-side maximum boundary  134 . When customer-specific maximum boundaries are set, the user-adjustable right lateral boundary  136  and the left lateral boundary  138  may not exceed the customer-specific maximum boundaries. These adjustments to the maximum boundaries may be made unilaterally or bilaterally individually or bilaterally in sync, before a procedure begins. 
     Additionally, the system  100  may be configured with customer-specific default lateral user-adjustable boundaries as well. For instance, a particular customer or user may specify particular default starting points for the right lateral user-adjustable boundary  136  and the left lateral user-adjustable boundary  138 , within the limits of the right-side and left-side maximum boundaries  132  and  134 . When the user initiates the system  100  during an insertion procedure, the right lateral user-adjustable boundary  136  and the left lateral user-adjustable boundary  138  will initially be positioned at the specified default lateral user-adjustable boundaries. By way of example, one user may set their specific default starting lateral user-adjustable boundaries at 20% of maximum boundary width for the right lateral user-adjustable boundary  136  and at 40% of maximum boundary width for the left lateral user-adjustable boundary  138  (in recognition that tubes in the trachea may pass more easily into the right lung than the left one, due to the more obtuse main bronchus angle on the left-side from the presence of the heart predominantly on that side of the chest). 
     The present invention may be further directed to a computer-implemented method for indicating deviation from a pathway during a catheter placement. The computer-implemented method may be executed by the processor  104  and the memory device  106 , in conjunction with the display  108  and the input  110  described above. 
     At step  802 , the method includes providing a representation of anatomical landmarks of the patient&#39;s body based on information received from at least one detector device  52 . For instance, an image  120  as described above may be generated including the vertical midline  122  and representation of the xiphoid process  128 , among other anatomical landmarks if desired. 
     Next, at step  804 , the method includes providing one or more pathway boundaries relative to a desired pathway, e.g., along the vertical midline  122  in the representation of the anatomical landmarks, e.g., the image  120 . For instance, the right and left maximum boundaries  132  and  134  may be displayed on the image  120  as the pathway boundaries. Additionally or alternatively, the right and left pathway user-adjustable boundaries  136  and  138  may be provided on the image  120 . 
     Next, at step  806 , the method includes determining a position of a location transmitter of a medical device, e.g., the location transmitter  62 , relative to the at least one detector device, e.g., detector devices  52 , using information received from the detector device(s)  52 . 
     Next, at step  808 , the method includes displaying on the display, e.g., image  120 , the position of the location transmitter of the medical device relative to the desired pathway, e.g., along the vertical midline  122  and determining if the position of the location transmitter of the medical device reaches or breaches any of the one or more pathway boundaries. For instance, the image  120  may show if/when the position of the location transmitter  62  crosses one of the right or left pathway user-adjustable boundaries  136  or  138 , or if the trajectory  144  of the location transmitter  62  exceeds the angle of the trajectory angle boundary. 
     Then, at step  810 , the method includes providing an indication when the location transmitter of the medical device reaches or breaches any of the one or more pathway boundaries. For instance, the step  810  may include displaying a visual indicator on the display, initiating an audible cue, and/or generating a haptic cue. 
     The method steps  802 - 810  can be conducted in real-time, in particular the steps of determining the position of the location transmitter, e.g., transmitter  62 , relative to the detector device(s)  52  and the pathway boundaries. 
     Further, the method can include step(s) of adjusting the one or more pathway boundaries using an input, e.g., the input  110  as described above. 
     An exemplary technical effect of the methods, systems, and apparatus described herein includes at least one of, but are not limited to: a) improving medical device placement pathway accuracy and efficiency using existing hardware for medical device tracking, and b) reducing the likelihood of patient injury during medical device placement procedures. 
     Exemplary embodiments of medical device placement tracking systems that are configurable and include pathway deviation indicators are described above in detail. The medical device placement tracking systems, devices, and methods of using such systems and devices are not limited to the specific embodiments described herein, but rather, components of systems and/or steps of the methods may be utilized independently and separately from other components and/or steps described herein. For example, the methods may also be used in combination with other medical device tracking systems and are not limited to practice with only the medical device tracking systems, and methods as described herein. Rather, the exemplary embodiment can be implemented and utilized in connection with many other medical device tracking systems. 
     Although specific features of various embodiments of the disclosure may be shown in some drawings and not in others, this is for convenience only. In accordance with the principles of the disclosure, any feature of a drawing may be referenced and/or claimed in combination with any feature of any other drawing. 
     This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.