Guidance system with clavicle position sensor

Abstract

To provide a device, system, and method for guiding tube positioning based on sensing of changes in an electromagnetic field using sensor positions on a subject's upper torso.SOLUTION: A tube positioning guidance system includes: an electromagnetic field generator 102 configured to generate an electromagnetic field 103a covering a treatment area; at least two reference sensors 104 configured for positioning on a subject's upper torso and to sense the electromagnetic field; a registration sensor configured to sense the electromagnetic field and, wherein the registration sensor is utilized to mark anatomic locations on the subject's torso; and a processing circuitry configured to determine a position, direction, and / or insertion path of an enteral tube relative to the subject's suprasternal notch and xiphoid process based on signals obtained from the sensors and changes in the strength of the electromagnetic field sensed by the enteral tube.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Embodiments of the present disclosure relate to an apparatus, system, and method for guiding the positioning of a tube, and more particularly, to an apparatus, system, and method for guiding the positioning of a tube based on detecting a change in an electromagnetic field using a sensor position on the upper torso of a subject.

Background Art

[0002] Enteral nutrition supplementation is often used as a means of nutritional supplementation for patients who cannot receive nutrition by other means. Although early initiation of enteral nutrition has many advantages, misplacement of the nutritional tube is relatively common and can cause discomfort and complications in patients. Confirming the position of the tube only after insertion is completed delays the start of nutritional and hydration or drug therapy. A bedside electromagnetic (EM) system for the guided placement of naso / enteral nutrition tubes is available and is used by medical staff during the procedure to avoid misplacement of the nutrition tube.

[0003] Therefore, there is a need for a reliable real-time electromagnetic-based tracking system to improve accuracy in the positioning of important tools during medical procedures.

Summary of the Invention

[0004] One common problem associated with the insertion of a nutrition tube using an electromagnetic positioning guidance system is that it is typically difficult to obtain reliability in a patient environment that is typically dynamic. This problem becomes even more severe when the patient is moving, sweating, and / or when there are special instructions that the caregiver should pay close attention to.

[0005] According to some embodiments, a tube positioning device is provided which includes a processing circuit configured to track the insertion of an insertion tube (e.g., a feeding tube) based on changes in an electromagnetic field occurring on a patient's body. The changes in the electromagnetic field are caused by electromagnetic sensors placed on the tube. The tube positioning device includes a pair of reference sensors for positioning on the subject's torso, for example, at or near the patient's clavicle.

[0006] Advantageously, by using alignment sensors to mark the sides of the torso, reference sensors placed on the sides of the subject's torso become unnecessary, as required in the aforementioned systems which tend to move due to patient movement or sweating.

[0007] In addition, the tube positioning device disclosed herein does not require the device's alignment sensor to be kept in a strictly upright position (90 degrees to the subject's torso) when marking the xiphoid process. Therefore, the possibility of errors occurring during anatomical position marking is much smaller.

[0008] Therefore, the devices disclosed herein have the advantage of minimizing the training required of the user and minimizing errors, while also providing reliable and efficient guidance during insertion into the patient.

[0009] According to several embodiments, an enteral tube positioning guidance system is provided. The system comprises an electromagnetic field generator located outside the patient and configured to generate an electromagnetic field covering a treatment area; at least two wired or wirelessly connected reference sensors configured to be positioned on the upper torso of the subject; a registration sensor configured to detect the electromagnetic field and transmit information indicating its position and / or orientation; and a processing circuit. The at least two reference sensors are configured to detect the electromagnetic field generated by the electromagnetic field generator. The registration sensor is used to mark at least the position of the xiphoid process and the side of the subject's torso. According to some embodiments, the marking of at least the position of the xiphoid process and / or the side of the subject's torso may be automatic.

[0010] According to some embodiments, the processing circuit is configured to calculate the width of the subject's torso based on the position of the xiphoid process marked by the alignment sensor and the side of the subject's torso, determine a plane defined by at least two reference sensors and the xiphoid process marked by the alignment sensor, calculate a vector N perpendicular to the plane, and generate a diagram of the subject's upper body showing the positions of the subject's xiphoid process and suprasternal notch. The diagram takes into account the calculated width of the subject's torso and the vector N.

[0011] According to some embodiments, the step of calculating width includes calculating the distance between a point on the side of the subject's torso (marked by a positioning sensor and / or automatically marked by a processor using one or more algorithms) and a line between the xiphoid process (marked by a positioning sensor) and the suprasternal notch (marked or determined as described further below).

[0012] According to some embodiments, the processing circuit is configured to determine the position, orientation, and / or path of the tip of the enteral tube in real time relative to one or both of a pair of reference sensors based on changes in the intensity of the electromagnetic field detected by the electromagnetic sensor, and to project the position, orientation, and / or path onto a figure using a vector N to determine the projection direction.

[0013] According to some embodiments, the enteral tube may be a gastrointestinal tube. According to some embodiments, the enteral tube may be a nasogastric enteral tube. According to some embodiments, the enteral tube may be an oral enteral tube. According to some embodiments, the enteral tube may be a nutritional tube.

[0014] According to some embodiments, the location on the upper torso of the subject where the reference sensor is placed is the subject's clavicle or near it.

[0015] According to some embodiments, the figures show a front top view, a side view, and / or an axial view of the subject's torso, calculated by tracking the position of the tip sensor, as well as the insertion path of the tube in each view.

[0016] According to some embodiments, the system further includes a monitor configured to display a figure. According to some embodiments, the figure may be displayed on a mobile device. According to some embodiments, the figure may be displayed on a monitor of another medical device, such as, but not limited to, a heart rate monitor or a capnograph monitor.

[0017] According to some embodiments, the registration sensor is incorporated into the tip of a stylus configured to be manually operated.

[0018] According to some embodiments, the alignment sensor is further configured to mark the suprasternal notch. Alternatively, the processing circuit may be configured to calculate the position of the suprasternal notch based on signals obtained from at least two reference sensors.

[0019] According to several embodiments, a method is provided for guiding the insertion of an enteral tube into a subject. The method includes: applying an electromagnetic field covering at least a portion of the subject's torso using an external electromagnetic field generator; positioning at least two wired or wirelessly connected reference sensors on the subject's upper torso; marking the position and sides of the subject's torso using registration sensors; calculating the width of the subject's torso based on the position of the xiphoid process and the sides of the torso marked by the registration sensors; determining a plane defined by signals obtained from at least two reference sensors and the xiphoid process marked by the registration sensors; calculating a vector N perpendicular to the plane; generating a diagram of the subject's upper body showing the positions of the subject's xiphoid process and suprasternal notch; inserting an enteral tube equipped with electromagnetic sensors into the subject; determining the position and orientation of the tip of the enteral tube relative to one or both of a pair of reference sensors in real time based on changes in the intensity of the electromagnetic field detected by the electromagnetic sensors; and projecting the insertion path onto the diagram using vector N to determine the projection direction.

[0020] According to some embodiments, the generated figure takes into account the calculated width of the subject's torso.

[0021] According to some embodiments, the method may also include the steps of marking a suprasternal notch and determining the orientation of the subject based on the marking. Alternatively, the position of the suprasternal notch may be calculated based on the positions of at least two reference sensors.

[0022] According to some embodiments, this method further includes displaying the figure on a monitor or on another display device such as a mobile phone or tablet.

[0023] According to some embodiments, the figures show a front top view of the subject's torso, a side view of the subject's torso, and / or an axial view of the subject's torso.

[0024] According to some embodiments, the position of a pair of reference sensors on the subject's upper torso is located at or near the subject's clavicle.

[0025] According to several embodiments, a processing circuit is provided. This processing circuit is a reference sensor positioned on the upper torso of a subject, which receives signals from at least two wired or wirelessly connected reference sensors exposed to an electromagnetic field, and receives indications of the position of at least the xiphoid process marked by the alignment sensor and the side of the subject's torso (e.g., the axilla). The alignment sensor is configured to transmit and receive electromagnetic signals when exposed to an electromagnetic field. The processing circuit further calculates the width of the subject's torso based on the position of the xiphoid process marked by the alignment sensor and the side of the subject's torso, determines a plane defined by the at least two reference sensors and the xiphoid process marked by the alignment sensor, calculates a vector N perpendicular to the plane, and generates a figure of the subject's upper body showing the positions of the subject's xiphoid process and suprasternal notch.

[0026] According to some embodiments, the processing circuit is further configured to receive signals from an enteral tube equipped with an electromagnetic tip sensor, determine the position, orientation, and / or path of the tip of the enteral tube relative to one or both of the pair of reference sensors in real time based on changes in the intensity of the electromagnetic field detected by the electromagnetic sensor, and project its insertion path onto a diagram using a vector N to determine the projection direction.

[0027] According to some embodiments, the processing circuit is further configured to indicate and / or display the position and / or direction of the tip of the access tube with respect to the figure. According to some embodiments, the processing circuit is further configured to generate an insertion path. According to some embodiments, the processing circuit is further configured to determine and / or indicate the direction of the tip of the enteral tube. Thereby, it becomes possible to predict the direction in which the tip is facing.

[0028] According to some embodiments, the processing circuit further receives an indication of the position of the suprasternal notch marked by the alignment sensor. Alternatively, the processing circuit may be configured to calculate the position of the suprasternal notch based on signals obtained from at least two reference sensors.

[0029] According to some embodiments, the figure shows a front top view of the subject's torso, a side view of the subject's torso, and / or an axial view of the subject's torso.

[0030] According to some embodiments, the position on the upper torso of the subject is at or near the subject's collarbone.

[0031] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more technical advantages will be readily apparent to those skilled in the art from the drawings, description, and claims included herein. Further, while certain advantages are listed above, various embodiments may include all or some of the listed advantages, or none at all.

Brief Description of the Drawings

[0032] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. The description, together with the drawings, makes it clear to those skilled in the art how the disclosed embodiments can be implemented. The drawings are for illustrative purposes and no attempt has been made to show the details of the embodiments in more detail than is necessary for a basic understanding of the teachings of the present disclosure.

[0033] [Figure 1] This is a block diagram of an insertion device positioning guidance system according to several embodiments. [Figure 2] This is a flowchart of a method for guiding the insertion of an insertion tube in a patient, according to several embodiments. [Figure 3A] The sensor setup and registration process according to several embodiments is illustrated. [Figure 3B] The sensor setup and registration process according to several embodiments is illustrated. [Figure 3C] The sensor setup and registration process according to several embodiments is illustrated. [Figure 3D] The sensor setup and registration process according to several embodiments is illustrated. [Figure 3E] The sensor setup and registration process according to several embodiments is illustrated. [Modes for carrying out the invention]

[0034] The following description explains various aspects of the Disclosure. For explanatory purposes, and to provide a complete understanding of the different aspects of the Disclosure, specific configurations and details are described. However, it will also be apparent to those skilled in the art that the Disclosure can be implemented without the presentation of specific details herein. Furthermore, well-known features may be omitted or simplified in order to avoid ambiguity in the Disclosure.

[0035] According to several embodiments, an enteral tube positioning guidance system is provided. The system comprises an electromagnetic field generator located outside the patient and configured to generate an electromagnetic field covering a treatment area; at least two wired or wirelessly connected reference sensors configured to be positioned on the upper torso of the subject; a registration sensor configured to detect the electromagnetic field and transmit information indicating its position; and a processing circuit. The at least two reference sensors are configured to detect the electromagnetic field generated by the magnetic field generator. The registration sensor is used to mark at least the position of the xiphoid process and the side of the subject's torso.

[0036] According to some embodiments, the processing circuit calculates the width of the subject's torso based on the position of the xiphoid process and the side of the subject's torso marked by the alignment sensor, determines a plane defined by at least two reference sensors and the xiphoid process marked by the alignment sensor, calculates a vector N perpendicular to the plane, and displays a figure of the subject's upper body showing / determining the positions of the subject's xiphoid process and suprasternal notch. The figure takes into account the calculated width of the subject's torso.

[0037] According to some embodiments, indicating / determining the location of a subject's suprasternal notch is based on the location of the suprasternal notch marked by a positioning sensor. In addition, or alternatively, the location of the suprasternal notch may be determined / calculated based on a signal obtained from a reference sensor.

[0038] According to some embodiments, the position, orientation, and / or path of an enteral tube equipped with an electromagnetic sensor during insertion relative to the subject's suprasternal notch and xiphoid process can be determined based on a calculated vector N and changes in the intensity of the electromagnetic field detected by the electromagnetic sensor on the enteral tube.

[0039] The electromagnetic field generator may remain stationary throughout the entire procedure for placing the tube inside the subject's body. In such a case, the area covered by the electromagnetic field remains constant or unchanged throughout the procedure for placing the tube inside the subject's body. Advantageously, the electrostatic magnetic field may contribute to the accuracy of the display.

[0040] 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 the Aurora® system by Northern Digital, Inc. of Ontario, Canada.

[0041] Throughout the following description, similar elements of different embodiments of the apparatus are referred to by element numbers that differ by an integer multiple of 100. For example, the electromagnetic field generator in Figure 1 is referred to by number 102, and the electromagnetic field generator in Figure 2, which corresponds to electromagnetic field generator 102 in Figure 1, is referred to by number 202.

[0042] Refer here to Figure 1, a block diagram of the 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 (a treatment area such as the patient's torso), and a plurality of electromagnetic sensors, such as sensors 104 and 106. The system 100 further includes a processor 110 configured to operate the electromagnetic field generator, read signals from reference sensors 104 and 106, and generate an anatomical map representing the subject's torso. The processor 110 is configured to facilitate visualization of the position, orientation and / or path of the tip sensor on the map on the anatomical map, independently of the subject's movement and independent of deviations in the position and / or orientation of the magnetic field generator 102. The system 100 further includes a monitor 112 operably connected to the processor 110 and configured to display the position, orientation and / or path of the tip of the insertion device equipped with electromagnetic sensors on the anatomical map during its insertion. In some embodiments, the monitor 112 may be integrated with the processor 110, as in the case of an all-in-one computer or smartphone. Thus, it is possible to determine whether a medical procedure was successful (e.g., insertion of a feeding tube into the stomach instead of the lungs).

[0043] Sensors 104 and 106 are configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the electromagnetic field generator 102. Optionally, sensors 104 and 106 may be 6-degree-of-freedom electromagnetic sensors capable of determining their position (XYZ axes) and angle / orientation (roll, yaw, and pitch) along 6 axes relative to the electromagnetic field 103a generated by the electromagnetic field generator 102.

[0044] The guidance system also includes a positioning sensor (not shown) configured to mark at least one anatomical (chest) location on the subject's body, such as the lateral aspect of the subject's torso, the xiphoid process, and optionally the suprasternal notch. Different anatomical locations may be marked depending on the type of procedure used, the type of implantable medical device, etc. Marking of the anatomical location may be physical, such as by attaching a marker / reference (e.g., a sticker). Alternatively, marking of the anatomical location may be virtual, such as by aligning a virtual marker / reference. According to the embodiment, the marking can facilitate the identification or designation of an anatomical location inside or on the subject's body, such as the subject's suprasternal notch and / or the subject's xiphoid process, in non-limiting examples.

[0045] Optionally, the alignment sensor 107 may be a stylus sensor having a 3-degree-of-freedom sensor at its distal tip, and the stylus may be configured to be manually operated to mark anatomical locations on the subject's torso so as to be identified by the stylus operator. For example, once the stylus sensor 106 is positioned over / at a desired point on the patient's torso, marking can be performed by instructing the software (e.g., by pressing a GUI button or voice activation, but not limited to these). The marking can communicate with and be registered by the processor 110.

[0046] System 100 is configured to work in conjunction with an implantable medical device (not shown), such as a feeding tube. The implantable medical device may include one or more sensors to enable its tracking within the region of interest 103b. Preferably, the sensors are located at the tip of the implantable medical device. In such a case, the processor 110 and monitor 112 are configured to calculate and display the position, orientation, and / or advancement / path of the tip of the implantable medical device between designated anatomical locations leading to the insertion site / target region.

[0047] According to some embodiments, the system may include non-temporary computer-readable storage media, i.e., memory modules. According to some embodiments, the memory modules may store on the memory modules one or more program codes configured to operate any one or more of the processor and / or field generators 102, any one or more of the reference sensors 104 and 106, the monitor 112, and / or other elements of the system 100.

[0048] According to some embodiments, program code, or one or more algorithms, may be executable by a processor to receive signals from any one or more of the reference sensors 104 and 106. According to some embodiments, program code, or one or more algorithms, may be executable by a processor to receive signals from the alignment sensors. According to some embodiments, one or more algorithms may include one or more preprocessing methods. According to some embodiments, one or more algorithms may be configured to apply one or more preprocessing methods to one or more signals received from any one or more of the reference sensors 104 and 106. According to some embodiments, one or more algorithms may be configured to apply one or more preprocessing methods to one or more signals received from the alignment sensors. According to some embodiments, one or more preprocessing methods may include any one or more of signal normalization, noise reduction, etc.

[0049] According to some embodiments, one or more algorithms may include one or more machine learning algorithms configured to identify the xiphoid process. According to some embodiments, one or more algorithms may include one or more machine learning algorithms configured to identify the suprasternal notch. According to some embodiments, the machine learning algorithms may be configured to identify a predetermined location on the upper torso of a patient in real time.

[0050] According to some embodiments, the machine learning algorithm may include supervised machine learning algorithms. According to some embodiments, the machine learning algorithm may include unsupervised machine learning algorithms. According to some embodiments, the training set for training the machine learning algorithm may include a dataset of images related to the upper torso of a patient, such as X-ray images, MRI images, and / or ultrasound images. According to some embodiments, the training set for training the machine learning algorithm may include a dataset of signals received from a positioning sensor and / or a reference sensor. According to some embodiments, the training set may include labels indicating the location of specified parts of the upper torso of a patient, such as the xiphoid process and / or the suprasternal notch.

[0051] Herein, we refer to Figures 2 and 3A–3E illustrating the steps of guiding the insertion of an enteral tube according to several embodiments. Those skilled in the art will understand that some steps are sequential, while others may be performed simultaneously or in a compatible order, and these options are within the scope of this disclosure.

[0052] Step 210 involves applying an electromagnetic field to the treatment area. Optionally, the electromagnetic field generator is positioned so that the electromagnetic field covers the treatment area. A pair of reference sensors are positioned on or near the patient's upper torso, e.g., on each of the patient's clavicles, as shown in Figure 3A. According to some embodiments, the reference sensors define a reference coordinate system representing the position and / or orientation of the subject's torso relative to the electromagnetic field generator (Step 220). In Step 230, as shown in Figure 3B, an alignment sensor (e.g., in the form of a manually operated stylus) is used to mark the xiphoid process and, optionally, the suprasternal notch. Alternatively, the position of the suprasternal notch may be calculated based on a pair of reference sensors positioned on or near the subject's clavicles (options not shown).

[0053] Next, as shown in Figure 3C, a diagram representing the subject's torso can be generated based on the signals obtained from a pair of reference sensors and the subject's width determined based on the markings on the side of the subject's torso by the alignment sensors (step 240).

[0054] Next, as shown in Figure 3D, a plane (tringle) interconnecting the xiphoid process and the two reference sensors can be generated / displayed (step 250).

[0055] Next, as shown in Figure 3E, a normal N to the plane may be calculated (N pointing in the same general direction as the registered sensor during setup). Then, using the normal N, assuming a fixed angle between the xiphoid process and the suprasternal notch, i.e., about 15 degrees, the position, orientation, and / or path of the tip sensor (placed at the tip of the enteral tube) is calculated (step 260).

[0056] Advantageously, the movement of one or more of a pair of reference sensors can be easily detected by a rapid change in the distance between the sensors.

[0057] The present invention may be a system, method, and / or a computer program product. The computer program product may include a computer-readable storage medium having computer-readable program instructions for causing a processor to perform an aspect of the present invention.

[0058] A computer-readable storage medium may be a tangible device capable of holding and storing instructions used by an instruction execution device. A computer-readable storage medium may be, but is not limited to, electronic storage devices, magnetic storage devices, optical storage devices, electromagnetic storage devices, semiconductor storage devices, or any suitable combination thereof. A non-exhaustive list of more specific examples of computer-readable storage media includes portable computer diskettes, hard disks, random access memory, read-only memory, erasable programmable read-only memory, static random access memory, portable compact disk read-only memory, digital general-purpose disks, memory sticks, floppy disks, mechanically encoded devices on which instructions are recorded, and any suitable combination thereof. As used herein, computer-readable storage media should not be interpreted as being transient signals in themselves, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., light pulses through optical fiber cables), or electrical signals transmitted through wires. Rather, computer-readable storage media are non-transient (i.e., non-volatile) media.

[0059] The computer-readable program instructions described herein can be downloaded to an external computer or external storage device from a computer-readable storage medium or via a network, such as the Internet, a local area network, a wide area network, and / or a wireless network, to the respective arithmetic / processing unit. The network may include copper transmission cables, optical transmission fibers, wireless transmissions, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface within each arithmetic / processing unit receives computer-readable program instructions from the network and transfers the computer-readable program instructions for storage in a computer-readable storage medium within the respective arithmetic / processing unit.

[0060] The computer-readable program instructions for performing the operations of the present invention may be assembler 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, and C++, and conventional procedural programming languages ​​such as the "C" programming language or similar programming languages. The computer-readable program instructions may run on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer, 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 wide area network (WAN), or it may be connected to an external computer (for example, via the Internet using an Internet service provider). In some embodiments, for example, an electronic circuit including a programmable logic circuit, a field-programmable gate array (FPGA), or a programmable logic array (PLA) can execute computer-readable program instructions by utilizing state information of computer-readable program instructions that personalize the electronic circuit in order to carry out embodiments of the present invention.

[0061] Aspects of the present invention are described herein with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It should be understood that each block in a flowchart and / or block diagram, as well as any combination of blocks in a flowchart and / or block diagram, can be implemented by computer-readable program instructions.

[0062] These computer-readable program instructions are provided to the processor of a general-purpose computer, a dedicated computer, or other programmable data processing device so that the machine can generate means for instructions executed via the processor of the computer or other programmable data processing device to perform functions / operations specified in one or more blocks of a flowchart and / or block diagram. These computer-readable program instructions may also be stored in a computer-readable storage medium that can instruct a computer, a programmable data processing device, and / or other device to function in a particular way, and as a result, a computer-readable storage medium having instructions stored therein comprises a product containing instructions that implements modes of functions / operations specified in one or more blocks of a flowchart and / or block diagram.

[0063] Computer-readable program instructions can also be loaded onto a computer, other programmable data processing device, or other device to generate a computer implementation process by causing the computer, other programmable device, or other device to execute a series of action steps so that the instructions executed on the computer, other programmable device, or other device implement the functions / operations specified in one or more blocks of a flowchart and / or block diagram.

[0064] The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of the system, method, and computer program product according to various embodiments of the present invention. In this regard, each block in a flowchart or block diagram may represent a module, segment, or part of an instruction comprising one or more executable instructions for implementing a specified logical function. In some alternative implementations, the functions described in a block may occur outside the order shown in the figure. For example, two blocks shown consecutively may actually be executed substantially simultaneously, or sometimes in reverse order depending on the function the block contains. It should also be noted that each block in a block diagram and / or flowchart, as well as combinations of blocks in a block diagram and / or flowchart, may be implemented by a special-purpose hardware-based system that performs a specified function or operation, or a combination of special-purpose hardware and computer instructions.

[0065] The descriptions of various embodiments of the present invention are presented for illustrative purposes only and are not intended to be exhaustive or to limit the disclosed embodiments. It will be apparent to those skilled in the art that many modifications and variations are possible without departing from the scope and spirit of the described embodiments. The terms used herein have been selected to best describe the principles of the embodiments, their practical application to market-available technologies or technical improvements, or to enable those skilled in the art to understand the embodiments disclosed herein.

Claims

1. An enteral tube positioning guidance system, An electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, wherein the electromagnetic field generator is located outside the patient's body, An electromagnetic tip sensor positioned at the tip of the enteral tube, At least two wired or wirelessly connected reference sensors configured to be positioned on the upper torso of the subject, and configured to detect the electromagnetic field generated by the electromagnetic field generator, A positioning sensor configured to detect an electromagnetic field and transmit information indicating its location, and used to mark at least the position of the xiphoid process and a point on the side of the subject's torso, Equipped with a processing circuit, The aforementioned processing circuit is Based on the position of the xiphoid process and the points on the side of the subject's torso marked by the alignment sensor, the width of the subject's torso is calculated. Determine the plane defined by at least two reference sensors and the xiphoid process marked by the alignment sensor. A vector N perpendicular to the aforementioned plane is calculated, A diagram of the subject's upper body showing the positions of the subject's xiphoid process and suprasternal notch, displaying a diagram that takes into account the calculated width of the subject's torso and the position of one or both of a pair of reference sensors. A system configured to determine the position, orientation, and / or insertion path of the tip of an enteral tube in real time relative to one or both of a pair of reference sensors based on changes in the intensity of the electromagnetic field detected by the tip sensor, and to project the position, orientation, and / or insertion path onto a diagram using a vector N to determine the projection direction.

2. The system according to claim 1, wherein the alignment sensor is further configured to mark the suprasternal notch.

3. The system according to claim 1 or 2, wherein the figures show a front top view of the subject's torso, a side view of the subject's torso, and / or an axial view of the subject's torso, and the position, direction, and / or insertion path of the tip of the enteral tube in each view, calculated by tracking the position of the tip sensor.

4. The system according to any one of claims 1 to 3, further comprising a monitor configured to display the aforementioned figure.

5. The system according to any one of claims 1 to 4, wherein the alignment sensor is incorporated into the tip of a stylus configured to be operated manually.

6. The system according to any one of claims 1 to 5, wherein the processing circuit is further configured to calculate the position of the suprasternal notch based on signals obtained from the at least two reference sensors.

7. The system according to any one of claims 1 to 6, wherein the position on the upper torso of the subject is near the subject's clavicle.

8. A processing circuit, It receives signals from at least two wired or wirelessly connected reference sensors positioned on the upper torso of the subject and exposed to an electromagnetic field. The system receives instructions for at least the position of the xiphoid process and a point on the side of the subject's torso marked by an alignment sensor configured to detect an electromagnetic field generated by an electromagnetic field generator. Based on the position of the xiphoid process and the points on the side of the subject's torso marked by the alignment sensor, the width of the subject's torso is calculated. Determine the plane defined by at least two reference sensors and the xiphoid process marked by the alignment sensor. A vector N perpendicular to the aforementioned plane is calculated, Create a schematic diagram of the subject's upper body showing the location of the subject's xiphoid process and suprasternal notch. Receiving signals from an enteral tube containing an electromagnetic tip sensor, A processing circuit configured to determine the position, orientation, and / or insertion path of the tip of an enteral tube in real time relative to one or both of a pair of reference sensors based on changes in the intensity of the electromagnetic field detected by the tip sensor, and to project the position, orientation, and / or insertion path onto a diagram using a vector N to determine the projection direction.

9. The processing circuit according to claim 8, further configured to receive an indication of the position of the suprasternal notch marked by the alignment sensor.

10. The processing circuit according to claim 8 or 9, wherein the figure shows a front top view of the subject's torso, a side view of the subject's torso, and / or an axial view of the subject's torso.

11. The processing circuit according to any one of claims 8 to 10, further configured to calculate the position of the suprasternal notch based on signals obtained from at least two of the reference sensors.

12. The processing circuit according to any one of claims 8 to 11, wherein the position on the upper torso of the subject is the subject's clavicle or near it.

Images