Insertion device positioning guidance system and method

Abstract

The present invention provides an insertion device positioning guidance system and method, the system comprising: an electromagnetic field generator, which is positioned outside the body of an object and is configured to generate an electromagnetic field covering a treatment area; an intestinal tube, comprising an electromagnetic sensor at the distal tip of the intestinal tube, the electromagnetic sensor being configured to sense the electromagnetic field; a registration sensor, which is configured to mark at least a first and a second anatomical position and / or orientation on the body of the object; and a processing circuit system, which is configured to: continuously obtain signals from the electromagnetic sensor, and based on the signals obtained from the electromagnetic sensor, continuously determine the position of the distal tip of the intestinal tube relative to the first and second anatomical positions marked by the registration sensor during the insertion of the intestinal tube; and display the path of the intestinal tube relative to the first and second anatomical positions during the insertion of the intestinal tube; wherein the path is generated based on the continuously determined position of the distal tip.

Description

[0001] This application is a divisional application whose applicant is Newchisell Limited Partnership, whose application date is August 17, 2017, whose application number is 201710706676.6, and whose invention name is "Insertion device positioning guidance system and method". Technical Field

[0002] Embodiments of the present disclosure relate to insertion device positioning guidance systems and methods. Background Art

[0003] Enteral feeding is commonly used as nutritional support for patients who cannot be fed in other ways. Although many benefits are associated with early initiation of enteral feeding, misplacement of feeding tubes is relatively common and can lead to patient discomfort and complications. Confirming the position of the tube only after it has been inserted delays the start of feeding and hydration or medication. Bedside electromagnetic (EM) systems for guiding the placement of nasoenteral feeding tubes are available and are used by medical staff during the procedure to avoid misplacement of feeding tubes. However, there is still a need for a reliable real-time tracking system that provides enhanced accuracy of important tool positioning during medical procedures.

[0004] The above examples of the related art and limitations related thereto are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art after reading this specification and studying the accompanying drawings. Summary of the invention

[0005] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are meant to be exemplary and illustrative, not limiting in scope.

[0006] One of the problems commonly associated with using an electromagnetic positioning guidance system to insert an esophageal tube is that it is difficult to obtain reliability in a patient environment that is often dynamic. For example, patients often move and beds are moved from one place to another. Therefore, an electromagnetic positioning guidance system is provided herein that is reliably operable and does not require calibration regardless of the patient's movement or position.

[0007] According to some embodiments, an insertion device positioning guidance system is provided, comprising: an electromagnetic field generator, the electromagnetic field generator being configured to generate an electromagnetic field covering a treatment area; a plate sensor, the plate sensor being configured to be positioned within the treatment area at a position defining an orientation of an object (specifically, a vector perpendicular to a chest of the object); a reference sensor, being configured to be positioned on the torso of the object within the treatment area, the reference sensor being configured to define a reference coordinate system representing the position and orientation of the torso of the object relative to the field generator; a registration sensor, the registration sensor being configured to mark at least a first and a second anatomical position relative to the reference coordinate system; and a processing circuit system, the The processing circuit system is configured to operate the field generator, read the signals obtained from the plate sensor, the reference sensor and the alignment sensor, and calculate their position and orientation relative to the field generator. The processing circuit system is further configured to generate an anatomical map representing the body of the object and the first and second anatomical positions. The processing circuit system is further configured to facilitate visualization of the position, orientation and path of the tip sensor located in the distal tip portion of the insertion device relative to the first and second anatomical positions on the 3D anatomical map independently of the movement of the object and independently of the deviation of the position and / or orientation of the field generator, thereby facilitating the determination of a successful medical procedure.

[0008] In some embodiments, the fiducial sensor is configured to be positioned on a side of the patient's torso such that the 3D anatomical map further depicts the body contour of the subject. In some embodiments, the 3D anatomical map shows a frontal upper view of the subject substantially parallel to the plate sensor. In some embodiments, the 3D anatomical map shows a side view of the subject substantially perpendicular to the plate sensor. In some embodiments, the 3D anatomical map shows an axial view of the subject.

[0009] In some embodiments, the system further comprises a monitor configured to display the 3D map.

[0010] According to some embodiments, the term "anatomical diagram" as disclosed herein may refer to one or more schematic diagrams, one or more 2D anatomical diagrams, one or more 3D anatomical diagrams, or any combination thereof. According to some embodiments, the term "anatomical diagram" as disclosed herein may refer to a set of diagrams (e.g., 2, 3, 4 or more diagrams), each diagram representing a different view (e.g., anterior view, frontal superior view, side view, axial view).

[0011] In some embodiments, the plate sensor is configured to be positioned under the upper torso and / or neck of the subject.

[0012] In some embodiments, the registration sensor is a stylus configured for manual operation.

[0013] In some embodiments, the insertion device is a gastrointestinal tube.

[0014] In some embodiments, the first anatomical location is the suprasternal notch and the second anatomical location is the xiphoid process. In some embodiments, a front view display of the path of the gastrointestinal tube relative to the first and second anatomical locations indicates successful insertion. In some embodiments, the location of the displayed path of the gastrointestinal tube (front view) across the axis between the first anatomical location and the second anatomical location indicates successful insertion. In some embodiments, the actual shape of the displayed path of the gastrointestinal tube indicates successful insertion.

[0015] According to some embodiments, a method for guiding an insertion device is provided, the method comprising: applying an electromagnetic field to a treatment area using an electromagnetic field generator; positioning a plate sensor within the treatment area at a position that defines the orientation of an object; positioning a reference sensor on the body of the object within the treatment area, the reference sensor defining a reference coordinate system that represents the position and orientation of the body of the object relative to the field generator; marking at least a first and a second anatomical position using a registration sensor; operating the field generator using a processing circuit system, reading signals obtained from the plate sensor, the reference sensor, and the registration sensor, calculating their positions and orientations relative to the field generator, and generating an anatomical map representing the body of the object and the first and second anatomical positions; and displaying the position, orientation, and / or path of the tip sensor of the insertion device relative to the first and second anatomical positions on the anatomical map, independent of movement of the object and independent of deviations in the position and / or orientation of the field generator.

[0016] In some embodiments, the method further comprises the step of displaying the path of the distal tip portion of the insertion device on the anatomical map and thereby facilitating the determination of a successful medical procedure.

[0017] In some embodiments, positioning the fiducial sensor includes positioning it on a side of the patient's torso such that the anatomical map further depicts a body contour of the subject.

[0018] In some embodiments, said positioning said plate sensor comprises positioning it beneath an upper torso and / or neck of said subject.

[0019] In some embodiments, the registration sensor is a manually operated stylus.

[0020] In some embodiments, the anatomical diagram shows a frontal superior view of the object substantially parallel to the plate sensor. In some embodiments, the anatomical diagram shows a side view of the object substantially perpendicular to the plate sensor. In some embodiments, the anatomical diagram shows an axial view of the object.

[0021] In some embodiments, the insertion device is a gastrointestinal tube.

[0022] In some embodiments, the first anatomical location is the suprasternal notch and the second anatomical location is the xiphoid process. In some embodiments, the path display of the gastrointestinal tube relative to the first and second anatomical locations indicates successful insertion. In some embodiments, the position of the displayed path of the gastrointestinal tube across the axis between the first anatomical location and the second anatomical location indicates successful insertion. In some embodiments, the actual shape of the displayed path of the gastrointestinal tube indicates successful insertion.

[0023] In some embodiments, the electromagnetic field generator does not make any physical contact with the patient. In some embodiments, the electromagnetic field generator is designed not to make physical contact with the patient. In some embodiments, the electromagnetic field generator is not designed to make direct or indirect physical contact with the patient.

[0024] In some embodiments, the processor / processing circuit system may include two units or two sub-units. The first unit is configured to control the entire tracking system (e.g., operate the field generator, read the signals obtained from the plate sensor, the reference sensor and the registration sensor and calculate their position and orientation relative to the field generator). The second unit is configured to receive the calculated position and orientation information from the first processor and use this information to generate a 3D anatomical map representing the body of the object and the first and second anatomical locations, and allow visualization of the position, orientation and / or path of the tip sensor relative to the first and second anatomical locations on the 3D anatomical map independent of the movement of the object and independent of deviations in the position and / or orientation of the field generator.

[0025] According to some embodiments, the tip sensor, which may also be referred to as a position sensor, is positioned at or adjacent to the distal end of the tube / catheter / probe and helps determine the position of the distal end of the tube / catheter / probe on the patient.

[0026] According to some embodiments, the systems and methods described herein may be applied using a sensor (e.g., a position sensor) such as a magnetic field sensor, an impedance-based sensor, or an ultrasonic sensor. According to some embodiments, the position sensor (e.g., a tip sensor) may refer to an element mounted on a tube / catheter / probe that causes the processing circuit system to receive a signal indicating the coordinates of the element. The position sensor may include a receiver that generates a position signal for a processing circuit system / control unit based on energy received by the sensor (e.g., from the field generator). According to some embodiments, communication between the sensor and the processing unit may be wireless.

[0027] Further details and features of the invention and its embodiments can be found in the present description and the accompanying drawings.

[0028] Unless otherwise limited, all technical terms and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar to or equivalent to the methods and materials described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In the event of a conflict, this patent specification (including definitions) shall prevail. In addition, materials, methods and examples are only illustrative and are not intended to be restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Exemplary embodiments are illustrated in the referenced drawings. Dimensions of components and features shown in the drawings are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The drawings are listed below.

[0030] Figure 1 is a block diagram of an insertion device positioning guidance system according to some embodiments.

[0031] Figure 2A An insertion device positioning guide system in a hospital setting is schematically illustrated according to some embodiments.

[0032] Figure 2B According to some embodiments Figure 2A An enlarged portion of the illustration.

[0033] Figure 2C According to some embodiments Figure 2A A side view of an illustration of a .

[0034] Figure 2D -E schematically illustrates an insertion device positioning guide system in a hospital setting according to some embodiments, showing anatomical locations marked using a stylus, fiducial sensors at different locations, and plate sensors.

[0035] Figure 3A A view showing a "real time" display of placement of an insertion device in accordance with some embodiments is shown.

[0036] Figure 3B A view of a "playback" display showing placement of an insertion device in accordance with some embodiments.

[0037] Figure 4 is a flow chart of steps of a method for guiding a location for insertion of a medical device according to some embodiments. DETAILED DESCRIPTION

[0038] Disclosed herein is a system and method for guiding the insertion of an insertable medical device, e.g., a tube such as a feeding tube. The disclosed system can be used as an insertion device positioning guidance system. The system can be used to track and indicate the position of an inserted medical device in real time during the insertion process. As an example, the system can track and indicate the position of the tip of a feeding tube as it is inserted into a subject's body. Advantageously, this makes the insertion process considerably easier and safer, ensuring that the tube is inserted at the correct location.

[0039] According to some embodiments, an insertion device positioning guidance system is provided, comprising: an electromagnetic field generator, the electromagnetic field generator being configured to generate an electromagnetic field covering a treatment area; a plate sensor, the plate sensor being configured to be positioned within the treatment area at a position defining an orientation of an object (specifically, a vector perpendicular to a chest of the object); a reference sensor, being configured to be positioned on a body of the object within the treatment area, the reference sensor being configured to define a reference coordinate system representing a position and orientation of the body of the object relative to the field generator; a registration sensor, the registration sensor being configured to mark at least a first and a second anatomical position relative to the reference coordinate system; and a treatment device. The system further comprises a processor / processing circuit system configured to operate the field generator, read the signals obtained from the plate sensor, the reference sensor and the registration sensor, calculate their position and orientation relative to the field generator, and generate an anatomical map representing the body of the subject and the first and second anatomical locations, the processor / processing circuit system further configured to facilitate visualization of the position, orientation and path of the tip sensor located in the distal tip portion of the insertion device relative to the first and second anatomical locations on the anatomical map independently of movement of the subject and independently of deviations in the position and / or orientation of the field generator, thereby facilitating determination of a successful medical procedure. Optionally, the system further comprises a monitor configured to display the map.

[0040] A plate sensor is configured to be positioned within the treatment area at a position that defines an orientation of a subject, specifically a vector perpendicular to a chest of the subject. The orientation of a subject, specifically a vector perpendicular to a chest of the subject, may be indicated by the plate sensor configured to be positioned within the treatment area. In a non-limiting example, the plate sensor is configured to be positioned under an upper torso and / or neck of the subject.

[0041] A reference coordinate system representing the position and orientation of the subject's body relative to the field generator can be indicated by a reference sensor configured to be positioned on the subject's body within the treatment area. The reference sensor can be positioned on one side of the patient's body so that the anatomical map further depicts the subject's body contour.

[0042] The first and second anatomical locations may be indicated by a registration sensor configured to mark at least the first and second anatomical locations relative to the reference coordinate system. Optionally, the registration sensor is a stylus configured to be manually operated. Optionally, the first anatomical location is the suprasternal notch and the second anatomical location is the xiphoid process, and the path of the gastrointestinal tube relative to the first and second anatomical locations is displayed to indicate successful insertion.

[0043] The electromagnetic field generator may be static throughout the duration of the process of placing the tube in the subject's body. In such a case, the area covered by the electromagnetic field is static / constant throughout the duration of the process of placing the tube in the subject's body. Advantageously, a static electromagnetic field may contribute to the accuracy of the display.

[0044] The anatomical view may show a frontal superior view of the object substantially parallel to the plate sensor and / or a side view of the object substantially perpendicular to the plate sensor and / or an axial view of the object.

[0045] An example of hardware suitable for use as the electromagnetic tracking system described above (including an electromagnetic field generator and one or more of the sensors) is the EM Tracking System from Northern Digital Inc of Ontario, Canada. system.

[0046] Throughout the following description, similar elements of different embodiments of the device are numbered with element numbers that differ by an integer multiple of 100. For example, Figure 1 The electromagnetic field generator is labeled with the number 102 and is Figure 1 The electromagnetic field generator of FIG. 2 corresponding to the electromagnetic field generator 102 is labeled with the number 202 .

[0047] Reference now Figure 1 , which is a block diagram of an insertion device positioning guidance system 100. The system 100 includes: an electromagnetic field generator 102, the electromagnetic field generator being configured to generate an electromagnetic field 103a covering at least a region of interest 103b (e.g., a treatment region (such as a patient's body)); a plurality of electromagnetic sensors (such as sensors 104, 106, and 108), the electromagnetic sensors being used to indicate an anatomical map (such as a tip sensor (located in a distal tip portion of an insertion device)) of the region of interest 103b (usually a subject's body); Figure 3A and Figure 3B ) on a position on a anatomical map. The system 100 further includes a processor 110, which is configured to operate the field generator, read the signals obtained from the plate sensor, the reference sensor and the registration sensor, calculate their position and orientation relative to the field generator, and generate the anatomical map representing the body of the object. The processor 110 is configured to facilitate visualization of the position and path of the tip sensor relative to a pre-specified anatomical position on the anatomical map independently of the movement of the object and independently of deviations in the position and / or orientation of the field generator 102. The system 100 further includes a monitor 112, which is operably connected to the processor 110 and is configured to display the position of the insertion device tip and the insertion site and / or the path from the insertion device tip to the insertion site on the anatomical map. In some embodiments, the monitor 112 can be integrated with the processor 110 (such as in the case of a stand-alone computer). Therefore, it is possible to determine a successful medical procedure (for example, inserting a feeding tube into the stomach as opposed to the lungs).

[0048] The sensor 108 is typically a plate sensor configured to be positioned in a position defining the orientation of the object within the treatment area. Optionally, the position indicates the posture of the object. The plate sensor 108 is optionally a 6-DOF (degree of freedom) electromagnetic sensor. The plate sensor 108 is optionally positioned on the bed of the object and is configured to mark the posture of the object by marking the position of the bed. Alternatively, the plate sensor 108 can be attached to the body of the object. Optionally, the plate sensor 108 is positioned under the back of the object. Optionally, the plate sensor 108 is positioned under the upper torso and / or neck of the object. In the case of keeping the plate sensor 108 adjacent to the back of the object, it can indicate whether the object is lying, lying in a manner of partially lifting its upper body, or sitting. The reference sensor 108 can, for example, be a 6-DOF electromagnetic sensor capable of determining 6 axes of its position (XYZ axes) and attitude (roll, yaw and pitch) relative to the field generator 102.

[0049] Sensor 104 is typically a reference sensor configured to be positioned on the subject's body. Reference sensor 104 is configured to define a reference coordinate system representing the position and orientation of the subject's body relative to the field generator. Alternatively, reference sensor 104 can be attached to the patient's skin, for example, on one side of the patient's body (such as under the patient's armpit). In such a case, the anatomical map further depicts the subject's body contour. Reference sensor 104 can, for example, be a 6-DOF electromagnetic sensor capable of determining its position (XYZ axes) and attitude (roll, yaw and pitch) relative to field generator 102 in 6 axes.

[0050] Sensor 106 is typically a registration sensor configured to be positioned on a subject's body (e.g., a subject's torso) and / or to mark at least a first and a second anatomical (thoracic) location on the body. Different anatomical locations may be marked based on the type of procedure used, the type of medical device inserted, etc. Marking the anatomical locations may be physical, such as attaching a marker / reference point (e.g., a sticker). Alternatively, marking the anatomical locations may be virtual, such as registering a virtual marker / reference point. According to an embodiment, the marking may facilitate identification or designation of anatomical locations within or on a subject's body (e.g., in a non-limiting example, the subject's suprasternal notch, and the subject's xiphoid process).

[0051] Optionally, the registration sensor 106 is a stylus sensor configured to be manually operated to mark at least first and second anatomical locations on the subject's body identified by an operator of the stylus. By way of example only, once the stylus sensor 106 is positioned over a desired point on the patient's body, the marking may be made by instructing the software (e.g., but not limited to, by pressing a GUI button or voice activation). The marking may be transmitted to and registered by the processor 110.

[0052] The system 100 is configured to work in conjunction with an inserted medical device (not shown) such as a feeding tube. The inserted medical device may include one or more sensors that allow it to be tracked within the region of interest 103b. Preferably, the sensor is located at the tip of the inserted medical device. In such a case, the processor 110 and monitor 112 are configured to calculate and display the position and / or advancement of the tip of the inserted medical device between designated anatomical locations leading to the insertion site / target area.

[0053] According to some embodiments, as used herein, the terms "insertion device" and "insertion medical device" may refer to any device / tool ​​adapted for insertion into the body. The insertion device may be any medical insertion device or medical surgical device. Non-limiting examples of insertion medical devices include feeding tubes (such as gastrointestinal tubes (e.g., nasoenteric feeding tubes), endotracheal tubes, tracheostomy tubes, gastric tubes, catheters, or cricothyrotomy tubes). Other examples of insertion devices are well known in the art.

[0054] According to some embodiments, the terms "processing circuitry" and "processor" may be used interchangeably.

[0055] In some embodiments, the insertion device is a tube. In some embodiments, the tube is a feeding tube. In some embodiments, the tube is a gastric / intestinal feeding tube, such as but not limited to a nasogastric feeding tube or a nasoenteric feeding tube. According to some embodiments, the feeding tube may have an electromagnetic sensor disposed therein and / or thereon (e.g., at its distal end).

[0056] Reference now FIG. 2A to FIG. 2E , which schematically illustrates an insertion device positioning guidance system 200 in a hospital setting according to some embodiments. Figure 2A schematically illustrates an insertion device positioning guidance system in a hospital environment according to some embodiments, Figure 2B According to some embodiments Figure 2A An enlarged portion of the diagram, Figure 2C According to some embodiments Figure 2A A side view of a diagram of Figure 2D and Figure 2E Schematically illustrates an insertion device positioning guidance system in a hospital setting according to some embodiments, showing anatomical locations marked with a stylus, reference sensors located at different locations (such as in FIG. 2A to FIG. 2C ) and board sensors shown in .

[0057] and Figure 1 Similar to system 100, system 200 includes an electromagnetic field generator 202 and a plurality of electromagnetic sensors 204, 206, and / or 208. Further, system 200 is configured to work in conjunction with an inserted medical device (not shown), which may include one or more electromagnetic sensors configured to sense and / or interfere with the electromagnetic field generated by field generator 202. Optionally, monitor 212 of system 200 is integrated with a computer corresponding to or including Figure 1 Processor 110.

[0058] According to some embodiments, the electromagnetic field generator 202 can be positioned at such an angle and position relative to the patient so that the generated electromagnetic field can cover the external and internal working areas, or in other words, the entire upper torso (at least from the nose area to the duodenal area). The reference sensor 204, the plate sensor 208, and the stylus sensor 206 are all covered under the field generated by the field generator 202. The tip sensor of the feeding tube is configured to move inside the digestive system, and its path can therefore be tracked. The reference sensor 204 can be attached to the patient's skin and / or thereon, for example, under the patient's armpit. Suitable means for attaching sensors (such as, for example, stickers, medical glue, etc.) are well known in the art. The reference sensor 204 can be used to detect the patient's position (XYZ axes) and attitude (roll, yaw, and pitch) relative to the field generator 202 based on the electromagnetic field (not shown) emitted by the field generator 202.

[0059] As discussed herein, the plate sensor 208 can be positioned at a location that defines the orientation of the subject (or at least the orientation of the body part being treated). For example, if a medical insertion procedure involves a patient's torso, the plate sensor 208 can be positioned on a portion of the patient's bed 215 that is parallel to the torso, such as at Figure 2D Alternatively, as shown in Figure 2E As shown in FIG. 2 , the plate sensor 308 is at least partially inserted between the patient's back and the bed 215 .

[0060] The stylus sensor 206 may be manually operated to mark one or more anatomical locations on the patient's skin. For example, Figure 2D and Figure 2E Two such anatomical locations are shown marked on the patient's chest (indicated as "206a" and "206b" in these figures). Anatomical location 206a is marked on the suprasternal notch, and anatomical location 206b is marked on the xiphoid process. The markings can be transmitted to a computer and registered thereby.

[0061] Optionally, the computer receives the position and posture signals of the reference sensor 204, the plate sensor 208, and the two marked anatomical locations 206a and 206b, and calculates anatomical landmarks representing the subject's body, after which the medical procedure can begin. In the exemplary case of guiding the insertion of a feeding tube, the tip of the feeding tube is equipped with a sensor. Optionally, the computer receives the actual position and orientation of the sensor from a second processor that receives the signal and calculates the position of the sensor. Optionally, the computer receives the actual position and orientation from a second processor that receives the signal from the sensor and calculates its physical position.

[0062] The system 200 is operated as follows:

[0063] activating the electromagnetic field generator 202 to apply an electromagnetic field to the treatment area, thereby covering the body of the subject;

[0064] Positioning the plate sensor 208 / 308 within a treatment area (e.g., on a bed beneath the subject's torso) at a location that defines the subject's orientation (or at least the orientation of the body part being treated);

[0065] Positioning a reference sensor 204 on the subject's torso (preferably on one side of the torso) within the treatment area. The reference sensor 204 defines a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator;

[0066] A registration sensor 206 is used to mark two anatomical locations on the subject's torso (e.g., the suprasternal notch and the xiphoid process);

[0067] Using the processor, an anatomical map representing the torso and the two anatomical locations is generated and displayed along with the location and path of the tip sensor (of the feeding tube) on the monitor 212. The tip sensor may be displayed relative to the two anatomical locations and / or relative to a longitudinal axis passing between the two anatomical locations and along the center of the torso.

[0068] Reference now Figure 3A , which shows a "real time" display of the placement of an insertion device according to some embodiments, and now refers to Figure 3B , which shows a view of a "playback" display of a placement insertion device according to some embodiments. Such a display may be presented on a monitor, such as monitor 212. The left corner includes general information and patient details, and Figure 3B The display also includes playback controls.

[0069] The path of the tip is schematically drawn so that the caregiver can visualize the entire insertion path of the tube until it reaches the desired location. Figure 3A and 3B As shown in , an arrow is near the tip of the path, indicating the actual direction the tube is pointing. (Multiple) such arrows can help the user insert the tube properly (or better understand where the tube is and which direction the tube is moving). Figure 3A and Figure 3B Both displays show three views of the patient's body: an anterior view shown at the top right of the monitor, a lateral view shown at the bottom left of the monitor, and an axial view shown at the bottom right of the monitor. In some instances, different and / or additional views may be shown.

[0070] While manually manipulating the medical implement into the patient's body, the caregiver inserting the medical device may view instructions on the monitor 212 to guide it to the desired location in the body.

[0071] Reference now Figure 4 , which is a flow chart of steps of a method for guiding the location of an insertion of a medical device according to some embodiments. Step 420 includes applying an electromagnetic field to a treatment area. Optionally, an electromagnetic field generator (such as electromagnetic field generator 202 of FIG. 2 ) is positioned so that the electromagnetic field covers the treatment area. A plate sensor (such as FIG. 2A to FIG. 2D The plate sensor 208 of the embodiment of the present invention is positioned at a position that defines the orientation of the subject (or at least the orientation of the body part being treated) (step 422). The reference sensor (such as FIG. 2A to FIG. 2D A reference sensor 204 (e.g., a reference sensor 204) is positioned on the patient (on the subject's torso) within the treatment area, the reference sensor defining a reference coordinate system representing the position and orientation of the subject's torso relative to the field generators (step 424). Optionally, the reference sensor is positioned on one side of the patient's torso, such as to indicate the subject's body contour. At least first and second anatomical locations are marked by utilizing a registration sensor (step 426). Optionally, a manually operated stylus sensor (e.g., FIG. 2A to FIG. 2D A stylus sensor 206 of the embodiment of the present invention is provided to mark the at least first and second anatomical locations (e.g., 206a and 206b). Alternatively, one or more registration sensors are positioned above the at least first and second anatomical locations. Optionally, the first anatomical location is the suprasternal notch and the second anatomical location is the xiphoid process. Each of the reference sensor 204, the plate sensor 208, and the two marked anatomical locations 206a and 206b is present within the region of interest. Each of steps 420, 422, and 424 may be performed simultaneously or in an interchangeable order. An anatomical map representing the subject's body and the first and second anatomical locations is generated by utilizing a processor (step 428). The anatomical map may be generated based on signals received from the reference sensor 204, the plate sensor 208, and the two marked anatomical locations 206a and 206b. The position and orientation of the tip sensor of the insertion device relative to the first and second anatomical locations is displayed on the anatomical map independent of the movement of the subject and independent of deviations in the position and / or orientation of the field generator (step 430). This can be done while all sensors remain within the sensing volume of the field generator.

[0072] Optionally, the anatomical map shows a front superior view of the subject substantially parallel to the plate sensor, a side view of the subject substantially perpendicular to the plate sensor, an axial view of the subject. Optionally, the anatomical map enables visualization of the position of an inserted device (having an electromagnetic sensor configured to sense and / or interfere with an electromagnetic field generated by a field generator) within the subject's body by calculating and displaying the position of the inserted device compared to the first anatomical location 206a and the second anatomical location 206b. Optionally, the calculating may include normalizing the position based at least in part on signals received from the reference sensor 204 and the plate sensor 208 and obtained continuously and / or in real time during the procedure.

[0073] The present invention may be a system, method and / or computer program product. The computer program product may include a computer-readable storage medium (or multiple computer-readable storage media) having computer-readable program instructions thereon for causing a processor to implement aspects of the present invention.

[0074] The computer-readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer-readable storage medium can be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the above. A non-exhaustive list of more specific examples of computer-readable storage media includes the following: a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), a static random access memory (SRAM), a portable compact disk read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanical encoding device having instructions recorded thereon, and any suitable combination of the above. As used herein, a computer-readable storage medium should not be interpreted as being a transient signal (such as a radio wave or other freely propagating electromagnetic wave), an electromagnetic wave propagated by a waveguide or other transmission medium (for example, a light pulse passing through an optical fiber cable), or an electrical signal transmitted by a wire. On the contrary, the computer-readable storage medium is a non-transient (i.e., non-volatile) medium.

[0075] The computer-readable program instructions described herein may be downloaded from a computer-readable storage medium to a corresponding computing / processing device or downloaded to an external computer or external storage device via a network (e.g., the Internet, a local area network, a wide area network, and / or a wireless network). The network may include copper transmission cables, optical transmission fibers, wireless transmissions, routers, firewalls, switches, gateway computers, and / or edge servers. The network adapter card or network interface in each computing / processing device receives the computer-readable program instructions from the network and forwards the computer-readable program instructions to be stored in a computer-readable storage medium in the corresponding computing / processing device.

[0076] The computer-readable program instructions for implementing the operation of the present invention can be assembly instructions, instruction set architecture (ISA) instructions, machine instructions, machine-related instructions, microcode, firmware instructions, state setting data, or source code or object code written in any combination of one or more programming languages, and the one or more programming languages ​​include object-oriented programming languages ​​(such as Java, Smalltalk, C++, etc.) and conventional procedural programming languages ​​(such as "C" programming languages ​​or similar programming languages). The computer-readable program instructions can be executed completely on the user's computer, partially on the user's computer, executed as an independent software package, partially on the user's computer, partially on a remote computer, or completely on a remote computer or server. In the latter context, the remote computer can be connected to the user's computer through any type of network (including local area network (LAN) or wide area network (WAN)), or can be connected to an external computer (for example, by using the Internet of an Internet service provider). In certain embodiments, the electronic circuit system including, for example, programmable logic circuit system, field programmable gate array (FPGA) or programmable logic array (PLA) can be executed by utilizing the state information of the computer-readable program instructions for personalized electronic circuit system to execute the computer-readable program instructions, thereby executing aspects of the present invention.

[0077] Aspects of the present invention are described herein with reference to flowchart illustrations and / or block diagrams of methods, devices (systems) and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart illustration and / or block diagram and the combination of blocks in the flowchart illustration and / or block diagram can be implemented by computer-readable program instructions.

[0078] These computer-readable program instructions may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device to produce a machine, such that the instructions executed by the processor of the computer or other programmable data processing device create a means for implementing the functions / actions specified in one or more blocks of the flowchart and / or block diagram. These computer-readable program instructions may also be stored in a computer-readable storage medium, which may direct a computer, a programmable data processing device, and / or other device to function in a particular manner, such that the computer-readable storage medium in which the instructions are stored includes an article of manufacture, which includes instructions for implementing aspects of the functions / actions specified in one or more blocks of the flowchart and / or block diagram.

[0079] Computer-readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device, so that a series of operating steps are performed on the computer, other programmable apparatus, or other device to produce a computer-implemented process, so that the instructions executed on the computer, other programmable apparatus, or other device implement the functions / actions specified in one or more boxes of the flowchart and / or block diagram.

[0080] The flow chart and block diagram in the accompanying drawings show the architecture, function and operation of the possible implementation of the system, method and computer program product according to various embodiments of the present invention. In this regard, each square block in the flow chart or block diagram can represent a module, a fragment or a part of an instruction including one or more executable instructions for implementing (multiple) specified logical functions. In some alternative implementations, the functions marked in the square blocks may not occur in the order marked in the accompanying drawings. For example, in fact, the two boxes shown in succession can be performed substantially at the same time, or these boxes can sometimes be performed in reverse order, depending on the functions involved. It will also be noted that each square block in the block diagram and / or the flow chart diagram and the combination of the square blocks in the block diagram and / or the flow chart diagram can be implemented by a system based on special hardware that performs a specified function or action or implements a combination of special hardware and computer instructions.

[0081] The description of the various embodiments of the present invention has been presented for the purpose of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terms used herein are selected to best explain the principles of the embodiments, the practical application of the technology found in the marketplace or technical improvements to the technology, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A guiding system for locating an intestinal tube, comprising: an electromagnetic field generator positioned external to the subject's body, the electromagnetic field generator configured to generate an electromagnetic field covering a treatment area; a bowel tube comprising an electromagnetic sensor at a distal tip of the bowel tube, the electromagnetic sensor being configured to sense the electromagnetic field; a reference sensor configured to be positioned on the subject's body within the treatment area, the reference sensor configured to define a reference coordinate system representing the position and orientation of the subject's body relative to the electromagnetic field generator; a registration sensor configured to annotate at least first and second anatomical locations and / or orientations on a body of the subject; as well as processing circuitry configured to: reading signals obtained from the reference sensor and the registration sensor and calculating the position and orientation of the subject's body relative to the electromagnetic field generator and generating an anatomical map representing the body and the first and second anatomical locations marked by the registration sensors based on the signals obtained from the reference sensor and the registration sensor; Continuously obtain a signal from the electromagnetic sensor, continuously determining during insertion of the bowel tube a position of a distal tip of the bowel tube relative to the first and second anatomical locations marked by the registration sensor based on signals obtained from the electromagnetic sensor; A path of the bowel tube relative to the first and second anatomical locations is displayed during insertion of the bowel tube; wherein the path is generated based on the continuously determined position of the distal tip.

2. The system of claim 1, wherein: The processing circuit system is further configured to determine whether insertion of the enteral tube was successful based on the displayed path.

3. The system of claim 1, wherein: The registration sensor is incorporated into the tip of a stylus configured for manual operation.

4. The system of claim 1, wherein: The first anatomical location is the suprasternal notch and the second anatomical location is the xiphoid process.

5. The system of claim 1, wherein: The intestinal tube is a feeding tube.

6. The system of claim 1, wherein the electromagnetic sensor is a separate unit configured to be movably positioned inside or on the intestinal tract.

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