Insertion device positioning guidance system and method

Abstract

The present application relates to an insertion device positioning guidance system and method. The present invention provides a system and method for guiding the insertion of a gastrointestinal tube, including: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, the electromagnetic field generator being outside the patient's body; a registration sensor configured to mark an anatomical position on the patient's torso; a gastrointestinal tube including a tip sensor configured to sense its positioning and / or orientation relative to the electromagnetic field generator; and a processing circuit configured to: calculate the orientation of the subject relative to the field generator based on the anatomical position marked by the registration sensor; load a predefined anatomical map representing the torso; align the map based on the anatomical position marked by the registration sensor, and display the path of the gastrointestinal tube insertion on the map, wherein the path is generated according to the change in the electromagnetic field strength sensed by the tip sensor during the insertion of the gastrointestinal tube, independent of the subject's movement and independent of the deviation in the positioning and / or orientation of the field generator.

Description

[0001] This application is a divisional application of an application with an application date of April 30, 2019, application number 2019103601281, and invention name “Insertion device positioning guidance system and method”. Field of the Invention

[0002] Embodiments of the present disclosure relate to insertion device positioning guide systems and methods. background

[0003] Enteral feeding is often used as nutritional support for patients who cannot be fed otherwise. Despite the many benefits associated with early initiation of enteral feeding, misplacement of feeding tubes is relatively common and can lead to patient discomfort and complications. Confirming the positioning of the tube only after it has been inserted delays the initiation of feeding and hydration or medication. Bedside electromagnetic (EM) systems for guided placement of nasoenteral feeding tubes are available and are used by medical personnel during treatment to avoid misplacement of feeding tubes. However, there remains a need for a reliable real-time tracking system that provides enhanced accuracy for positioning of critical tools during medical procedures.

[0004] The foregoing examples of the related art and limitations associated therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art by reading the specification and studying the drawings.

[0005] Overview

[0006] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are exemplary and illustrative, not limiting in scope.

[0007] One of the problems commonly associated with using an electromagnetic positioning guidance system to insert a feeding tube is that reliability is difficult to achieve in a patient environment that is often dynamic. For example, the patient often moves, and the bed is moved from one place to another. Therefore, an electromagnetic positioning guidance system is provided herein that can operate reliably regardless of the patient's motion or positioning, and does not require calibration.

[0008] According to some embodiments, an insertion device positioning guidance system is provided, which includes: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, wherein the electromagnetic field generator is outside the patient's body; a registration sensor configured to mark at least three anatomical locations on the patient's torso; a gastroenteral tube including a tip sensor configured to sense its position relative to the electromagnetic field generator; and a processing circuit configured to: calculate the orientation of the subject relative to the field generator based on the three anatomical locations marked by the registration sensor; load a predefined anatomical map representing the torso; and calculate the orientation of the subject relative to the field generator based on the at least three anatomical locations marked by the registration sensor, based on a positioning corresponding to or adjacent to a suprasternal notch, and based on an atomic position below the suprasternal notch. and displaying on the graph a path for gastrointestinal tube insertion, wherein the path is generated based on changes in electromagnetic field strength sensed by the tip sensor during insertion of the gastrointestinal tube while minimizing sensitivity to movement of the subject and / or deviations in positioning and / or orientation of the field generator.

[0009] According to some embodiments, the system further includes a reference sensor configured to be positioned on the torso of the subject within the treatment area, the reference sensor configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator.

[0010] In some embodiments, the reference sensor is configured to be positioned on one side of the patient's torso. In some embodiments, the anatomical view shows a frontal upper view of the subject substantially parallel to the patient's posture. In some embodiments, the anatomical view shows a side view of the subject. In some embodiments, the anatomical view shows an axial view of the subject.

[0011] In some embodiments, the system further comprises a monitor configured to display the anatomical view.

[0012] According to some embodiments, the term "anatomical diagram" 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" disclosed herein may refer to a set of diagrams (e.g., 2, 3, 4 or more), each diagram representing a different view (e.g., front view, front upper body view, side view, axial view).

[0013] In some embodiments, the registration sensor is a stylus configured to be manually operated.In some embodiments, the stylus comprises a 5DOF sensor at its distal end.

[0014] In some embodiments, the insertion device is a gastrointestinal tube.

[0015] In some embodiments, the at least three anatomical locations marked by the registration sensor include the xiphoid process and areas near the left and right clavicles. In some embodiments, the at least three anatomical locations marked by the registration sensor include the xiphoid process and areas near the left and right shoulders.

[0016] In some embodiments, determining / estimating the orientation of the subject includes defining a first vector between the xiphoid process and the left clavicle and a second vector between the xiphoid process and the right clavicle.

[0017] In some embodiments, the location of the suprasternal notch is calculated based on the marked left and right clavicles.

[0018] In some embodiments, the registration sensor is configured to mark at least four anatomical locations, wherein a fourth anatomical location comprises a suprasternal notch of the patient.

[0019] In some embodiments, at least four anatomical locations include the suprasternal notch and the xiphoid process. In some embodiments, a front view display of the path of the gastrointestinal tube relative to the suprasternal notch and the xiphoid process indicates successful insertion. In some embodiments, the position of the displayed path of the gastrointestinal tube (in the front view) through the axis between the suprasternal notch and the xiphoid process indicates successful insertion. In some embodiments, the actual shape of the displayed path of the gastrointestinal tube indicates successful insertion.

[0020] According to some embodiments, the processing circuit may be configured to determine / calculate / draw a first vector (v1) extending between the xiphoid process and the left clavicle and a second vector (v2) extending between the xiphoid process and the right clavicle in a coordinate system based on the registration of the xiphoid process and the left clavicle with the right clavicle by the registration sensor. According to some embodiments, the processing circuit may be configured to determine / calculate / draw a third vector (v3) based on the first and second vectors (v1 and v2), for example, a cross product of v1 and v2, the third vector indicating the position, orientation and / or posture of the subject.

[0021] According to some embodiments, the system is configured to determine the path of the gastrointestinal insertion tube without the use of additional sensors.

[0022] According to some embodiments, a method for guiding an insertion device is provided, the method comprising: applying an electromagnetic field covering a treatment area using an external electromagnetic field generator; marking at least three anatomical locations on a subject's torso using a registration sensor; and utilizing a processing circuit to: calculate the orientation of the subject relative to the field generator based on the three anatomical locations marked by the registration sensor; load a predefined anatomical map representing the torso; align the map based on a positioning corresponding to the suprasternal notch or an area near the notch and an anatomical location below the suprasternal notch (for example, but not limited to the xiphoid process or the umbilicus) according to the at least three anatomical locations marked by the registration sensor; insert a gastrointestinal tube into the patient's body, the gastrointestinal tube comprising a tip sensor configured to sense its position relative to the electromagnetic field generator; and displaying a path of insertion of the gastrointestinal tube on a map, wherein the path is generated based on changes in electromagnetic field strength sensed by the tip sensor during insertion of the gastrointestinal tube, independent of the subject's movement and independent of deviations in the positioning and / or orientation of the field generator.

[0023] In some embodiments, the at least three anatomical locations marked by the registration sensor include the xiphoid process and the left and right clavicles.

[0024] In some embodiments, determining / estimating the orientation of the subject includes defining a first vector between the xiphoid process and the left clavicle and a second vector between the xiphoid process and the right clavicle.

[0025] In some embodiments, the location of the suprasternal notch is calculated based on the marked left and right clavicles.

[0026] In some embodiments, the registration sensor is configured to mark at least four anatomical locations, wherein a fourth anatomical location comprises a suprasternal notch of the patient.

[0027] According to some embodiments, calculating the position, orientation and / or posture of the subject may include determining / calculating / drawing a first vector (v1) extending between the xiphoid process and the left clavicle and a second vector (v2) extending between the xiphoid process and the right clavicle in a coordinate system based on the registration of the xiphoid process and the left clavicle with the right clavicle by the registration sensor. According to some embodiments, the processing circuit may be configured to determine / calculate / draw a third vector (v3) based on the first and second vectors (v1 and v2), for example by calculating the cross product of v1 and v2, the third vector indicating the position, orientation and / or posture of the subject.

[0028] In some embodiments, the method further comprises the step of displaying on the anatomical map the path of the distal tip portion of the insertion device and thereby aiding in determining a successful medical procedure.

[0029] In some embodiments, positioning the reference sensor includes positioning it on a side of the patient's torso.

[0030] In some embodiments, the registration sensor is a manually operated stylus.

[0031] In some embodiments, the anatomical diagram shows a front upper torso view of the subject. In some embodiments, the anatomical diagram shows a side view of the subject. In some embodiments, the anatomical diagram shows an axial view of the subject.

[0032] In some embodiments, the path display of the gastrointestinal tube relative to the first anatomical location and the second anatomical location indicates successful insertion. In some embodiments, the location of the displayed path of the gastrointestinal tube through the axis between the first anatomical location and the second anatomical location indicates successful insertion. In some embodiments, the shape of the displayed path of the gastrointestinal tube indicates successful insertion.

[0033] In some embodiments, the electromagnetic field generator is not in any physical contact with the patient. In some embodiments, the electromagnetic field generator is designed not to be in physical contact with the patient.

[0034] In some embodiments, the processor / processing circuit may include two units or two sub-units. The first unit or sub-unit is configured to control the entire tracking system (e.g., operate the field generator, read the signals obtained from the alignment sensor and optionally also from the reference sensor, and calculate its position and orientation relative to the field generator). The second unit or sub-unit is configured to receive the calculated positioning and orientation information from the first processor and use this information to generate an anatomical map representing the subject's torso and at least the first anatomical position and the second anatomical position, and allow visualization of the positioning, orientation and / or path of the tip sensor relative to the first anatomical position and the second anatomical position on the anatomical map, regardless of the subject's movement and regardless of deviations in the positioning and / or orientation of the field generator.

[0035] According to some embodiments, the tip sensor is positioned at or near the distal end of the tube / catheter / stylus and helps determine the position and orientation of the distal end of the tube / catheter / stylus within the patient.

[0036] According to some embodiments, the path of a gastrointestinal insertion tube may be determined without the use of additional sensors.

[0037] According to some embodiments, an insertion device positioning guidance system is provided, comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, the electromagnetic field generator being outside the patient's body; a registration sensor configured to mark a suprasternal notch and a xiphoid process on the patient's torso; a gastrointestinal tube comprising a tip sensor configured to sense its position relative to the electromagnetic field generator; and a processing circuit configured to: calculate the orientation of the subject relative to the field generator based on the suprasternal notch and the xiphoid process marked by the registration sensor, wherein calculating the orientation comprises determining and optionally correcting an angle of the registration sensor relative to the patient's torso; loading a predefined anatomical map representing the torso; an alignment map based on the marked suprasternal notch and xiphoid process; and displaying a path for insertion of the gastrointestinal tube on the map, wherein the path is generated based on changes in electromagnetic field strength sensed by the tip sensor during insertion of the gastrointestinal tube while minimizing sensitivity to movement of the subject and / or deviations in the positioning and / or orientation of the field generator.

[0038] According to some embodiments, the system is configured to determine the path of the gastrointestinal insertion tube without the use of additional sensors.

[0039] According to some embodiments, the system also includes a reference sensor configured to be positioned on the subject's torso within the treatment area, the reference sensor configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator.

[0040] In some embodiments, the reference sensor is configured to be positioned on a side of the patient's torso.

[0041] In some embodiments, the anatomical diagram shows a front upper body view of the subject in a posture substantially parallel to the patient. In some embodiments, the anatomical diagram shows a side view of the subject. In some embodiments, the anatomical diagram shows an axial view of the subject.

[0042] In some embodiments, the system further comprises a monitor configured to display the anatomical view.

[0043] According to some embodiments, the term "anatomical diagram" 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" disclosed herein may refer to a set of diagrams (e.g., 2, 3, 4 or more), each diagram representing a different view (e.g., front view, front upper body view, side view, axial view).

[0044] In some embodiments, the registration sensor is a stylus configured to be manually operated.In some embodiments, the stylus may include a 5DOF sensor at its distal end.

[0045] 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, a position sensor (e.g., a tip sensor) may refer to an element mounted on a catheter / tube / probe, which causes a processing circuit to receive a signal indicating the coordinates of the element. The position sensor may include a receiver that generates a positioning signal to a processing circuit / control unit based on energy received by the sensor (e.g., from a field generator). According to some embodiments, communication between the sensor and the processing unit may be wireless.

[0046] Further details and features of the invention and its embodiments can be found in the description and the accompanying drawings.

[0047] Unless otherwise limited, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the invention belongs. Although various methods and materials similar or equivalent to those described herein are used in experiments or tests 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, the materials, methods, and examples are exemplary only and are not intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Exemplary embodiments are illustrated in the reference 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. These drawings are listed below.

[0049] Figure 1 is a block diagram of an insertion device positioning guidance system according to some embodiments;

[0050] Figure 2A schematically illustrates an insertion device positioning guide system in a hospital setting according to some embodiments;

[0051] Figure 2B shows the Figure 2A an enlarged portion of the illustration;

[0052] Figure 2C shows the Figure 2A a side view of a diagram of;

[0053] Figure 2D-Figure 2E Schematic illustration of an insertion device positioning guidance system in a hospital setting showing anatomical locations marked using a stylus and reference sensors;

[0054] Figure 3AA view showing a "real time" display of placement of an insertion device according to some embodiments;

[0055] Figure 3B a view showing a "playback" display of placement of an insertion device according to some embodiments; and

[0056] Figure 4 is a flow chart of steps of a method for guiding positioning of an inserted medical device according to some embodiments;

[0057] Figure 5 schematically illustrates vectors used to calculate angles for registering sensors for marking the suprasternal notch and xiphoid process on a subject's torso and the subject's torso;

[0058] Fig. 6A and Figure 6B The schematic diagram shows the Figure 5 The calculated angle provides a left-right correction to the insertion path. Detailed Description

[0059] 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 the inserted medical device in real time during the insertion process. As an example, when the feeding tube is inserted into the body of a subject, the system can track and indicate the position of the tip of the feeding tube. Advantageously, this makes the insertion procedure very easy and safe, ensuring that the tube is inserted into the correct position.

[0060] According to some embodiments, an insertion device positioning guidance system is provided, comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area; a reference sensor configured to be positioned on a subject's torso within the treatment area, the reference sensor configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator; a registration sensor configured to mark at least four anatomical locations relative to the reference coordinate system; and a processing circuit configured to operate the field generator, read signals obtained from the reference sensor and the registration sensor, calculate their position and orientation relative to the field generator, generate an anatomical map representing the subject's torso and at least a first anatomical location and a second anatomical location of at least four anatomical locations, the processor / processing circuit also 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 anatomical location and the second anatomical location on the anatomical map, regardless of the subject's movement and regardless of deviations in the position and / or orientation of the field generator, thereby facilitating determination of a successful medical procedure. Optionally, the system also includes a monitor configured to display the map.

[0061] A reference coordinate system representing the position and orientation of the subject's torso relative to the field generators can be indicated by a reference sensor configured to be positioned on the subject's torso within the treatment area. The reference sensor can be positioned on one side of the patient's torso so that the anatomical map further depicts the subject's body contours.

[0062] The first anatomical location and the second anatomical location may be indicated by a registration sensor configured to mark at least the first anatomical location and the second anatomical location relative to a 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 anatomical location and the second anatomical location is displayed to indicate successful insertion.

[0063] The third anatomical position and the fourth anatomical position may be a left clavicle and a right clavicle. According to some embodiments, the left clavicle and the right clavicle and the xiphoid process may be used to calculate the subject's position, orientation and / or posture. According to some embodiments, calculating the subject's position, orientation and / or posture may include determining / calculating / drawing a first vector (v1) extending between the xiphoid process and the left clavicle and a second vector (v2) extending between the xiphoid process and the right clavicle in a coordinate system based on the registration of the xiphoid process and the left clavicle with the right clavicle by a registration sensor. According to some embodiments, the processing circuit may be configured to determine / calculate / draw a third vector (v3) based on the first and second vectors (v1 and v2), for example by calculating the cross product of v1 and v2, and the third vector indicates the subject's position, orientation and / or posture.

[0064] The electromagnetic field generator may be static during the entire process of placing the tube in the subject's body. In this case, the area covered by the electromagnetic field is static / constant throughout the process of placing the tube in the subject's body. Advantageously, a static electromagnetic field can aid in the accuracy of the display.

[0065] The anatomical view may show a frontal upper torso view of the subject and / or a side view of the subject and / or an axial view of the subject.

[0066] An example of hardware suitable for use as the electromagnetic tracking system described above, including an electromagnetic field generator and one or more sensors, is available from Northern Digital Inc., Ontario, Canada. system.

[0067] Throughout the following description, similar elements of different embodiments of the device are represented by element numbers that are distinguished by integer multiples of 100. For example, Figure 1 The electromagnetic field generator is indicated by numeral 102, and Figure 2A-2E The corresponding Figure 1 The electromagnetic field generator 102 of the present invention is indicated by the numeral 202. Now referring to Figure 1 , Figure 1 1 is a block diagram of an insertion device positioning guidance system 100. The system 100 includes an electromagnetic field generator 102 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 torso), an anatomical map ( Figure 3A-3B ) on a subject's torso. The system 100 also includes a processor 110 configured to operate the field generators, read the signals obtained from the sensors 104 and 106, and generate an anatomical map representing the subject's torso. The processor 110 is configured to facilitate visualization of the positioning and path of the tip sensor on the anatomical map, regardless of the subject's movement and regardless of deviations in the positioning and / or orientation of the field generator 102. The system 100 also includes a monitor 112, which is operably connected to the processor 110 and is configured to display the positioning and / or path of the insertion device tip during its insertion on the anatomical map. In some embodiments, the monitor 112 can be integrated with the processor 110, such as in the case of an all-in-one machine. Thus, it is possible to determine a successful medical procedure (e.g., inserting a feeding tube into the stomach rather than the lungs).

[0068] Sensor 104 is typically a reference sensor configured to be positioned on the torso of the subject. Reference sensor 104 is configured to define a reference coordinate system representing the positioning and orientation of the subject's torso relative to the field generator. Alternatively, reference sensor 104 can be attached to the patient's skin, such as on one side of the patient's torso, such as under the patient's armpit. In this case, the anatomical diagram also depicts the subject's body contour. Reference sensor 104 can be, for example, a 6-DOF electromagnetic sensor capable of determining its 6 axes of position (XYZ axes) and attitude (roll, yaw, and pitch) relative to field generator 102.

[0069] Sensor 106 is typically a registration sensor that is configured to be positioned at and / or mark at least four anatomical (chest) locations on the subject's body (e.g., the subject's torso). Different anatomical locations may be marked depending on the type of treatment used, the type of medical device inserted, etc. The marking of the anatomical location may be physical, such as an attached marker / benchmark (e.g., a sticker). Alternatively, the marking of the anatomical location may be virtual, such as recording a virtual marker / benchmark. According to an embodiment, the marking may help identify or specify anatomical locations within or on the subject's body, such as, in a non-limiting example, the subject's suprasternal notch and the subject's xiphoid process.

[0070] Optionally, the registration sensor 106 is a stylus sensor having a 3DOF sensor on its distal end, the stylus being configured to be manually operated to mark at least three 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 at the desired point on the patient's body, the marking may be made by indicating to the software (e.g., but not limited to, by pressing a GUI button or voice activation). The marking may be communicated to and recorded by the processor 110.

[0071] System 100 is configured to work in conjunction with an insertion medical device (not shown) such as a feeding tube. The insertion medical device may include one or more sensors to allow it to be tracked within the region of interest 103b. Preferably, the sensor is located at the tip of the insertion medical device. In this case, processor 110 and monitor 112 are configured to calculate and display the positioning and / or advancement of the tip of the insertion medical device between specified anatomical locations leading to the insertion site / target area.

[0072] According to some embodiments, as used herein, the terms "insertion device" and "insertion medical device" may refer to any device / tool ​​suitable 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.

[0073] According to some embodiments, the terms "processing circuitry" and "processor" may be used interchangeably.

[0074] 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 nasoenteral 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).

[0075] Reference now Figure 2A-2E , which schematically illustrates an insertion device positioning guide system 200 in a hospital setting according to some embodiments. Figure 2A schematically illustrates an insertion device positioning guide system in a hospital setting according to some embodiments; Figure 2B According to some embodiments Figure 2A an enlarged portion of the illustration; Figure 2C According to some embodiments Figure 2A a side view of a diagram of ; and Figure 2D-Figure 2E Schematically illustrates an insertion device positioning guidance system in a hospital environment according to some embodiments, showing the use of a stylus located at different positions, a reference sensor (such as Figure 2A-2C The anatomical locations marked by ) are shown.

[0076] Similar to Figure 1 The system 200 includes an electromagnetic field generator 202. The 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 the field generator 202. Optionally, the monitor 212 of the system 200 is integrated with a computer corresponding to or including Figure 1 Processor 110.

[0077] According to some embodiments, the electromagnetic field generator 202 can be positioned at such an angle and orientation relative to the patient 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 system 200 also includes a reference sensor 204 and a stylus sensor 206, which are configured to be covered by the field generated by the field generator 202 when in use. The tip sensor of the feeding tube is configured to move within the digestive system so that its path can be tracked. The reference sensor 204 can be attached to the patient's skin and / or on the patient's skin, for example, under the patient's armpit. Suitable devices for attaching sensors are well known in the art, such as stickers, medical glue, etc. 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.

[0078] The stylus sensor 206 can be manually operated to mark at least three anatomical locations on the patient's skin. For example, Figure 2D and Figure 2E Markings of four such anatomical locations (indicated as 206a, 206b, 206c, and 206d in these figures) on the patient's chest are shown. Anatomical location 206a is marked on the suprasternal notch, anatomical location 206b is marked on the xiphoid process, and anatomical locations 206c and 206d are marked in the region of the left and right clavicles, respectively. The markings may be communicated to and recorded by a computer.

[0079] Alternatively, only three anatomical locations may be marked, namely anatomical location 206b marking the xiphoid process and anatomical locations 206c and 206d marking the left and right clavicles. The location 206a of the suprasternal notch may then be calculated from anatomical locations 206c and 206d (eg, as their midpoints).

[0080] Optionally, the computer receives signals from reference sensor 204, and optionally also receives signals from registration sensor 206, and then aligns an anatomical map representing the subject's torso according to the marked anatomical locations and the signals of the registration sensors; thereafter, 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 signals and calculates the position of the sensor. Optionally, the computer receives the actual position and orientation of the sensor from a second processor that receives the signals from the sensors and calculates their physical positioning.

[0081] The system 200 operates as follows:

[0082] The electromagnetic field generator 202 is activated to apply an electromagnetic field overlying the subject's torso to the treatment area;

[0083] A reference sensor 204 is positioned 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;

[0084] The registration sensor 206 is used to mark at least three anatomical locations on the subject's torso, preferably including the suprasternal notch, the xiphoid process, and the left and right clavicles;

[0085] Using the processor, an anatomical map representing the torso is aligned at anatomical locations (e.g., 206a and 206b derived from at least three anatomical locations marked by the registration sensor 206), and the anatomical map and the location and path of the tip sensor (of the feeding tube) are displayed on the monitor 212. The path of the tip sensor may be displayed relative to the anatomical locations 206a and 206b and / or relative to a longitudinal axis passing through the anatomical locations 206a and 206b and along the center of the torso.

[0086] Reference now Figure 3A , which shows a "real time" display of the placement of an insertion device according to some embodiments, and reference is made to Figure 3B , which shows a view of a "playback" display of the placement of an insertion device according to some embodiments. Such a display may be presented on a monitor such as monitor 212. The upper left corner includes general information and detailed information for the patient, as well as Figure 3B , along with playback controls.

[0087] The path of the tip is schematically drawn so that the caregiver can observe the entire insertion path of the tube until it reaches the desired location. Figure 3A and Figure 3B As shown, an arrow is near the end of the path to indicate the actual direction the tube is pointing. Such an arrow can help the user insert the tube correctly (or better understand where and in which direction the tube is moving). Figure 3A and Figure 3B The display of each monitor shows three views of the patient's body: a front view displayed at the upper right corner of the monitor, a lateral view displayed at the lower left corner of the monitor, and an axial view displayed at the lower right corner of the monitor. In some embodiments, different and / or additional views may be shown.

[0088] A caregiver inserting the medical device can manually manipulate the insertion tube into the patient's body while watching the indications on the monitor 212 to guide it to the desired location in the body. Figure 4 , Figure 4is a flow chart of steps of a method for guiding the positioning of an inserted medical device according to some embodiments. Step 420 includes applying an electromagnetic field to a treatment area. Optionally, an electromagnetic field generator (e.g., Figure 2A-2E The electromagnetic field generator 202 is positioned such that the electromagnetic field covers the treatment area. Optionally, a reference sensor (e.g. Figure 2A-2D A reference sensor 204 is positioned on the patient on the subject's torso within the treatment area, the reference sensor being configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator (step 422). Optionally, the reference sensor is positioned on one side of the patient's torso to indicate the subject's body contour / width. At least three anatomical locations are marked by utilizing the registration sensor (step 424). Optionally, a stylus sensor, such as Figure 2A-2D A stylus sensor 206 is provided, the stylus being configured to be manually operated to mark an anatomical location (e.g., anatomical locations 206a-206d). Optionally, one or more registration sensors may be positioned at at least three anatomical locations (option not shown). Optionally, the first anatomical location is the suprasternal notch, the second anatomical location is the xiphoid process, and the third and fourth anatomical locations are the left clavicle and the right clavicle, respectively. According to some embodiments, the positioning of the suprasternal notch may be calculated based on the marked left and right clavicles (e.g., the midpoint between them). Each of steps 420, 422, and 424 may be performed simultaneously or in an interchangeable order. An anatomical map representing the subject's torso may then be aligned to correspond to the marked anatomical locations, and optionally to the signal obtained from the reference sensor (step 426). The positioning and orientation of the tip sensor of the insertion device may then be displayed on the anatomical map relative to the first and second anatomical locations, independent of the subject's motion, and independent of deviations in the positioning and / or orientation of the field generator (step 428). This can be achieved when all sensors remain within the sensing volume of the field generator.

[0089] Optionally, the anatomical map displays a front upper body view of the subject, a side view of the subject, and an axial view of the subject. Optionally, the anatomical map can visualize the position of an insertion device (having an electromagnetic sensor configured to sense and / or interfere with an electromagnetic field generated by a field generator) within the subject by calculating and displaying the positioning of the insertion device relative to at least a first anatomical location 206a and a second anatomical location 206b. Optionally, the calculations can include normalizing positioning-based signals received from reference sensor 204 and / or anatomical locations 206c and 206d marked by registration sensor 206, optionally obtained continuously and / or in real time during treatment.

[0090] Reference now Figure 5 , Figure 5Vectors used to calculate the angle of a registration sensor (stylus) for marking a subject's torso and the suprasternal notch and xiphoid process on the subject's torso are schematically shown.

[0091] It should be understood that if the registration sensor is perpendicular to the subject's torso, the subject's orientation (head-legs and left-right) can be determined directly based on the angle of the registration sensor. However, if the registration sensor is tilted toward the subject's head, legs, left or right, the angle of the registration can be determined and corrected.

[0092] The calculation of the angle is based on two initial assumptions:

[0093] 1. The line connecting the marked points A and B and the head-leg axis alignment.

[0094] 2. In The angle α between the lens and the patient's back is predefined (17°).

[0095] Based on these assumptions, the up-vector can be calculated and corrected as follows:

[0096] represents the orientation of the registration sensor, is perpendicular to and The vector of the created plane. Then we rotate around the axis BD (to obtain ) such that the angle between the patient's posterior plane and AB is α, thereby obtaining a corrected up vector.

[0097] After the up vector is calculated, it may still be tilted to one side (left or right).

[0098] This left-right tilt can be corrected by the user after placement of the GI tube has begun and enough 3D path data points have been collected (until a point between point A and point B). Since the user expects that in the frontal view, the path between data points is vertical (when the esophagus is straight down, parallel to the ), if the obtained line is not as Fig. 6A The straight line shown gives the user the option to "realign" the path.

[0099] In this case, the processing circuitry may be configured to surround Iterates over different angles of the axis and recalculates the path to minimize The angle between and the regeneration path (so as to obtain an angle that makes the front path as perpendicular as possible). Once minimized (e.g. using a gradient descent technique), Figure 6B The up vector obtained to obtain correction in all directions (head-leg, right-left) is shown in .

[0100] 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 media) having computer-readable program instructions thereon for causing a processor to perform various aspects of the present invention.

[0101] A computer-readable storage medium may be a tangible device that can retain and store instructions for use by an instruction execution device. A computer-readable storage medium may 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 devices. 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 disc read-only memory (CD-ROM), a digital optical drive (DVD), a memory stick, a floppy disk, a mechanical encoding device having instructions recorded thereon, and any suitable combination of the above. The computer-readable storage medium used herein should not be interpreted as a temporary signal itself, such as a radio wave or other freely propagating electromagnetic wave, an electromagnetic wave propagated by a waveguide or other transmission medium (e.g., a light pulse transmitted by an optical fiber cable), or an electrical signal transmitted by a wire. In contrast, a computer-readable storage medium is a non-transient (i.e., non-volatile) medium.

[0102] The computer-readable program instructions described herein can 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 can 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.

[0103] The computer-readable program instructions for performing the operations of the present invention may be assembly instructions, instruction set architecture (ISA) instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state setting data, or source code or object code written in any combination of one or more programming languages, including object-oriented programming languages ​​(such as Java, Smalltalk, C++, etc.), and traditional procedural programming languages ​​(such as "C" programming language or similar programming languages). The computer-readable program instructions may be executed entirely on the user's computer as a stand-alone software package, partially on the user's computer, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider). In some embodiments, an electronic circuit including, for example, a programmable logic circuit, a field programmable gate array (FPGA), or a programmable logic array (PLA) may execute the computer-readable program instructions by personalizing the electronic circuit using the state information of the computer-readable program instructions so as to perform various aspects of the present disclosure.

[0104] Various aspects of the present invention are described herein with reference to the flowchart illustrations and / or block diagrams of the methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each block in the flowchart illustration and / or block diagram and the combination of the blocks in the flowchart illustration and / or block diagram can be implemented by computer-readable program instructions.

[0105] These computer program instructions may be provided to a processor of a general purpose computer, a special purpose computer, or other programmable data processing device for producing a machine, such that instructions executed via the processor of the computer or other programmable data processing device create instructions for implementing the functions / actions specified in the flowchart and / or in one or more blocks of the block diagram. These computer readable program instructions may also be stored in a computer readable medium, which may direct a computer, a programmable data processing device, and / or other device to function in a particular manner, such that a computer readable storage medium having instructions stored therein includes an article of manufacture including instructions for implementing various aspects of the functions / actions specified in one or more blocks of the flowchart and / or block diagram.

[0106] Computer-readable program instructions may also be downloaded to a computer, other programmable data processing device, or other apparatus to cause a series of operational steps to be performed on the computer, other programmable device, or other apparatus to produce a computer-implemented process, so that the instructions executed on the computer, other programmable device, or other apparatus implement the functions / actions specified in one or more blocks in the flowchart and / or block diagram.

[0107] 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 block in the flow chart or block diagram can represent a part of a module, segment or instruction, which includes one or more executable instructions for realizing a specified logical function.In some optional implementations, the function marked in the block may not occur in the order marked in the accompanying drawings.For example, the two blocks shown continuously can in fact be performed substantially simultaneously, or the block can sometimes be performed in reverse order, depending on the function involved.It should also be noted that the combination of each block in the block diagram and / or the flow chart illustration and the block diagram and / or the flow chart illustration can be realized by a system based on dedicated hardware that performs a specified function or action or performs a combination of dedicated hardware and computer instructions.

[0108] The description of the various embodiments of the present invention is presented for illustration and 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, practical applications, or technical improvements to technologies found on the market, or to enable those of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A gastrointestinal tube positioning and guiding system, comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, wherein the electromagnetic field generator is external to the subject; a registration sensor configured to mark the subject's xiphoid process, left clavicle, and right clavicle on the subject's torso; a gastrointestinal tube comprising a tip sensor configured to be tracked within a treatment region relative to the electromagnetic field generator; and A processing circuit, the processing circuit being configured to: calculating an orientation of the subject relative to the electromagnetic field generator based on the xiphoid process, the left clavicle, and the right clavicle marked by the registration sensor; loading a predefined anatomical diagram representing a torso; The anatomical diagram is aligned based on positioning corresponding to: a first location on the subject's upper torso derived from the xiphoid process marked by the registration sensor; and a second position on the subject's upper torso derived from the left clavicle and the right clavicle marked by the registration sensor, and displaying a path of insertion of the gastrointestinal tube on the anatomical map, wherein the path is generated based on changes in the intensity of the electromagnetic field sensed by the tip sensor during insertion of the gastrointestinal tube; wherein calculating the orientation of the subject includes defining a first vector between the xiphoid process and the left clavicle and a second vector between the xiphoid process and the right clavicle; Wherein the processing circuit is configured to calculate a third vector based on the first vector and the second vector, wherein the third vector is a cross product of the first vector and the second vector, and the third vector indicates a position, orientation and / or posture of the subject.

2. The system of claim 1 further comprising a reference sensor configured to be positioned on the subject's torso within the treatment area and to define a reference coordinate system representing the position and orientation of the subject's torso relative to the electromagnetic field generator.

3. The system according to claim 1, wherein: The registration sensor is incorporated into the tip of the stylus.

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

5. The system according to claim 1, wherein: The system is configured to determine the path of a gastrointestinal insertion tube without the use of additional sensors.

6. An insertion device positioning guidance system, comprising: an electromagnetic field generator configured to generate an electromagnetic field covering the treatment area, the electromagnetic field generator being external to the subject; a registration sensor configured to mark the suprasternal notch and the xiphoid process on the torso of the subject; a gastrointestinal tube comprising a tip sensor configured to sense a position of the tip sensor relative to the electromagnetic field generator; a reference sensor configured to be positioned on the subject's torso within the treatment area and to define a reference coordinate system representing the position and orientation of the subject's torso relative to the electromagnetic field generator; and A processing circuit, the processing circuit being configured to: calculating an orientation of the subject relative to the electromagnetic field generator based on the suprasternal notch and the xiphoid process marked by the registration sensor, wherein calculating the orientation includes determining and correcting an angle of the registration sensor relative to the subject's torso; loading a predefined anatomical diagram representing a torso; Aligning the anatomical diagram based on the marked suprasternal notch and xiphoid process, and displaying on the anatomical map a path for insertion of the gastrointestinal tube, wherein the path is generated based on changes in the strength of the electromagnetic field sensed by the tip sensor during insertion of the gastrointestinal tube while minimizing sensitivity to motion of the subject and / or deviations in positioning and / or orientation of the electromagnetic field generator; wherein calculating the orientation of the subject includes defining a first vector between the xiphoid process and a left clavicle and a second vector between the xiphoid process and a right clavicle; Wherein the processing circuit is configured to calculate a third vector based on the first vector and the second vector, wherein the third vector is a cross product of the first vector and the second vector, and the third vector indicates a position, orientation and / or posture of the subject.

7. The system according to claim 6, wherein: The anatomical view shows a frontal upper body view of the subject and / or a side view of the subject and / or an axial view of the subject.

8. The system of claim 6, further comprising a monitor configured to display the anatomical view.

9. The system according to claim 6, wherein: The registration sensor is incorporated into the tip of a stylus configured to be manually operated.

10. The system according to claim 6, wherein: The registration sensor is configured to mark at least four anatomical locations, a fourth anatomical location comprising a suprasternal notch of the subject.

11. The system according to claim 6, wherein: The system is configured to determine the path of a gastrointestinal insertion tube without the use of additional sensors.

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