Insertion device positioning guide system and method

Abstract

To provide a device, a system, and a method for guiding insertion of an insertion tube into a patient implanted with an implantable device capable of interfering with an electromagnetic field generated over the torso of the patient.SOLUTION: A method includes: receiving signals relating to changes in an electromagnetic field, the changes caused by insertion of a gastro-enteral tube including an electromagnetic sensor; normalizing the received signals based on information on an implantable device and its interference with the electromagnetic field; and determining a position of the gastro-enteral tube based on the normalized signals.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Embodiments of the present disclosure relate to an apparatus, a system, and a method for guiding the positioning of a tube. Specifically, the present disclosure relates to an apparatus, a system, and a method for guiding the positioning of a tube based on detection of changes in an electromagnetic field generated, while taking into account the noise (disturbance) of the electromagnetic field generated by an implantable device.

Background Art

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

[0003] Guiding tube insertion can be particularly complex in patients with various types of implanted devices, such as assistive artificial hearts, as the implanted device may generate noise in the electromagnetic field used during insertion according to the guidance.

[0004] Therefore, a reliable real-time electromagnetic-based tracking system for accurately positioning important tools during medical procedures, while taking into account the noise induced into the electromagnetic field by implanted devices, is desired.

Summary of the Invention

[0005] One problem often associated with the insertion of feeding tubes using electromagnetic positioning guide systems is the difficulty in achieving reliability in the typically dynamic patient environment. This problem is further exacerbated when the patient has implanted devices that behave in a way that introduces noise into the electromagnetic field used to track the insertion.

[0006] According to some embodiments, a tube positioning device is provided comprising a processing circuit configured to track the insertion of an insertion tube (e.g., a feeding tube) based on changes in the electromagnetic field generated on the patient's body. The processing circuit discards changes caused by the operation of a medical device implanted in the patient. Thus, the devices disclosed herein can advantageously provide reliable and efficient guidance of insertion in patients with implanted medical devices that could interfere with the guidance.

[0007] According to some embodiments, the processing circuit is configured to receive information about an implanted device in the patient. The implanted device may interfere with the electromagnetic field generated on the patient's torso. The processing circuit is further configured to receive a signal related to a change in the electromagnetic field. This change in the electromagnetic field is caused by the insertion of a gastrointestinal tube equipped with an electromagnetic sensor. Based on the information about the implanted device and its interference with the electromagnetic field, the processing circuit further normalizes the received signal and determines the position of the gastrointestinal tube based on the normalized signal.

[0008] According to some embodiments, the implantable device is a ventricular assist device (VAD).

[0009] According to some embodiments, receiving information about an implanted device involves measuring a change in the electromagnetic field generated by the implanted device in the absence of a gastrointestinal tube, compared to a baseline electromagnetic field measured in the absence of the implanted device.

[0010] According to some embodiments, measuring changes in the electromagnetic field caused by an embedded device involves identifying one or more characteristics of the interference.

[0011] According to some embodiments, the embedded device is a device that operates periodically.

[0012] According to some embodiments, the processing circuit is configured to identify the operation of the embedded device based on one or more characteristics of the interference.

[0013] According to some embodiments, receiving information about an embedded device includes receiving information about the type of embedded device, and interference with the electromagnetic field of the embedded device is evaluated based on the type of embedded device.

[0014] According to some embodiments, a tube positioning device is provided comprising a processing circuit configured to receive signals related to changes in the electromagnetic field generated on the patient's torso. These changes are caused by the insertion of a gastrointestinal tube equipped with an electromagnetic sensor. The processing circuit normalizes the received signals based on interference with the electromagnetic field characteristic of the presence of the implantable device, and determines the position of the gastrointestinal tube based on the normalized signals.

[0015] According to some embodiments, the implantable device is a ventricular assist device (VAD).

[0016] According to some embodiments, a gastrointestinal tube positioning system is provided, comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area and positioned outside the patient's body; a positioning sensor configured to mark one or more anatomical locations on the patient's torso; a gastrointestinal tube equipped with an electromagnetic sensor configured to cause a change in the electromagnetic field; and a processing circuit.

[0017] According to some embodiments, the processing circuit is configured to generate an anatomical map of the subject's torso based on at least one anatomical location marked by a registered sensor, or to match the subject's torso to a predetermined anatomical map, receive signals related to changes in the electromagnetic field, receive changes caused by the insertion of a gastrointestinal tube, normalize the received signals based on information about the implanted device in the subject and interference with the electromagnetic field of the implanted device, and show the path of gastrointestinal tube insertion on the map based on the changes in the normalized signal.

[0018] According to some embodiments, the processing circuit is configured to receive information about the patient's implanted device.

[0019] According to some embodiments, receiving information about an implanted device involves measuring a change in the electromagnetic field generated by the implanted device in the absence of a gastrointestinal tube, compared to a baseline electromagnetic field measured in the absence of the implanted device.

[0020] According to some embodiments, measuring changes in the electromagnetic field caused by an embedded device involves identifying one or more characteristics of the interference.

[0021] According to some embodiments, the embedded device is a device that operates periodically.

[0022] According to some embodiments, the processing circuit is configured to identify the operation of the embedded device based on one or more characteristics of the interference.

[0023] According to some embodiments, receiving information about an embedded device includes receiving information about the type of embedded device, and interference with the electromagnetic field of the embedded device is evaluated based on the type of embedded device.

[0024] According to some embodiments, one or more anatomical locations include the suprasternal notch and / or xiphoid process.

[0025] According to some embodiments, the implantable device is an auxiliary artificial heart.

[0026] According to some embodiments, a method for inserting a gastrointestinal tube into a subject, the method comprising: applying an electromagnetic field covering the subject's torso; using a registration sensor to utilize an external electromagnetic field generator for marking at least one anatomical location on the subject's torso; inserting an electromagnetic sensor configured to cause a change in the electromagnetic field into the subject; generating an anatomical map of the subject's torso based on at least one anatomical location marked by the registration sensor; matching the anatomical map of the subject's torso to a predefined anatomical map based on at least one anatomical location marked by the registration sensor; receiving a signal regarding a change in the electromagnetic field caused by the insertion of the gastrointestinal tube; normalizing the received signal based on information regarding the device implanted in the subject and the interference between the implantable device and the electromagnetic field; and indicating the path of the gastrointestinal tube insertion on the map based on the change in the normalized signal.

[0027] The method according to claim 22, wherein the processing circuit is further configured to receive information regarding the implantable device of the patient.

[0028] According to some embodiments, receiving information regarding the implantable device includes measuring a change in the electromagnetic field generated by the implantable device in the absence of the gastrointestinal tube, as compared to a baseline electromagnetic field measured in the absence of the implantable device.

[0029] According to some embodiments, measuring a change in the electromagnetic field caused by the implantable device includes identifying one or more characteristics of the interference.

[0030] According to some embodiments, the implantable device is a device that operates periodically.

[0031] According to some embodiments, the processing circuit is configured to identify the operation of the embedded device based on one or more characteristics of the interference.

[0032] According to some embodiments, receiving information about an embedded device includes receiving information about the type of embedded device, and interference with the electromagnetic field of the embedded device is evaluated based on the type of embedded device.

[0033] According to some embodiments, one or more anatomical locations include the suprasternal notch and / or xiphoid process.

[0034] According to some embodiments, the implantable device is a ventricular assist device (VAD).

[0035] Certain embodiments of this disclosure may include some, all, or any of the above-described advantages. One or more technical advantages will be readily apparent to those skilled in the art from the drawings, description, and claims contained herein. Furthermore, while certain advantages are listed above, various embodiments may include all or some of the listed advantages, or none at all. [Brief explanation of the drawing]

[0036] Several embodiments of this disclosure are described herein with reference to the accompanying drawings. The description, together with the drawings, will make it clear to those skilled in the art how some embodiments of the disclosure may be carried out. The drawings are for illustrative purposes only, and no attempt has been made to provide details of the embodiments beyond what is necessary for a basic understanding of the teachings of this disclosure. [Figure 1] This is a block diagram of an insertion device positioning guidance system according to several embodiments. [Figure 2] Figure 2 is a flowchart of a method for guiding the insertion of an insertion tube in a patient with an implanted device, according to several embodiments. [Figure 3]Figure 3 is a flowchart suitable for use in guiding the insertion of an insertion tube in a patient with an implanted device, according to several embodiments. [Modes for carrying out the invention]

[0037] 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.

[0038] A system and method for guiding the insertion of an insertable medical device (e.g., a tube such as a feeding tube) is disclosed herein. The disclosed system can be used as an insertion device positioning guidance system. This system can be used to track and indicate the position of the insertion medical device in real time during the insertion process. As an example, the system can track and display the position of the tip of a feeding tube while it is inserted into the body of a subject, taking into account devices (such as implantable devices) that interfere with or cause noise (disturbance) in the guidance of the feeding tube. Advantageously, this makes the insertion procedure considerably easier and safer and ensures that the tube is inserted in the correct position.

[0039] According to several embodiments, a positioning guidance system for an implantable device is provided. This positioning guidance system comprises an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area; a reference sensor configured to be positioned on the torso of the patient within the treatment area and configured to define a reference coordinate system representing the position and orientation of the patient's torso relative to the electromagnetic field generator; a registration sensor configured to mark at least four anatomical locations relative to the reference coordinate system; and a processing circuit. The processing circuit operates the electromagnetic field generator, reads signals from the reference sensor and the registration sensor, calculates the position and orientation relative to the electromagnetic field generator, and generates an anatomical map representing the patient's torso and first and second anatomical locations among the at least four anatomical locations. The processing circuit is further configured to visualize the position, orientation and path of a tip sensor located at the distal tip of the implantable device relative to the first and second anatomical locations on the anatomical map, regardless of the patient's movement and regardless of the displacement of the position and / or orientation of the electromagnetic field generator. This facilitates the successful determination of medical procedures. Optionally, the system may further include a monitor configured to display a map.

[0040] A reference coordinate system representing the position and orientation of the subject's torso relative to the electromagnetic field generator may be indicated by a reference sensor configured to be positioned within the treatment area on the subject's torso. The reference sensor may be positioned on the side of the patient's torso so that the anatomical map further depicts the subject's body contours.

[0041] The first and second anatomical locations can be indicated by a registration sensor configured to mark at least the first and second anatomical locations relative to a reference coordinate system. Optionally, the registration sensor is a stylus configured for manual operation. Optionally, the first anatomical location is the suprasternal notch, the second anatomical location is the xiphoid process, and the indication of the gastrointestinal tube's route relative to the first and second anatomical locations indicates successful insertion.

[0042] According to some embodiments, the first and / or second anatomical locations may be derived indirectly based on other anatomical locations marked by a registration sensor, and according to some embodiments, the other anatomical locations may be the left and right clavicles. According to some embodiments, the left and right clavicles together with the xiphoid process can be used to calculate the position, orientation, and / or posture of the subject. 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 and right clavicles 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 product of v1 and v2, where the third vector represents the cross-section, orientation, and / or posture of the subject.

[0043] According to some embodiments, the electromagnetic field generator may be located outside the patient. According to some embodiments, the electromagnetic field generator may be static for the entire duration of the procedure to place a tube inside the subject's body. In such cases, the area covered by the electromagnetic field is static / constant for the duration of the procedure to place a tube inside the subject's body. Advantageously, the electrostatic magnetic field may contribute to the accuracy of the display.

[0044] An anatomical map may show a frontal top view and / or a lateral view and / or an axial view of the subject.

[0045] 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.

[0046] Throughout the following description, similar elements of different embodiments of the apparatus will be 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.

[0047] Herein, we refer to Figure 1, a block diagram of the implantation 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 area such as the patient's torso), and an electromagnetic sensor such as a sensor 104 located within / above the distal tip portion of the implantation tube in the region of interest 103b (typically the subject's torso). The system 100 further includes a processor 110 configured to operate the electromagnetic field generator, read signals from the sensor 104, and display the position and / or path of the implantation tube on a monitor 112 on an anatomical map representing the subject's torso, independently of the displacement of the electromagnetic field generator 102 and independent of the subject's movement, while correcting for errors caused by the presence of the implantation device 106.

[0048] In some embodiments, the monitor 112 may be integrated with the processor 110, as in the case of an all-in-one computer.

[0049] According to some embodiments, the processor 110 is configured to receive information about the presence and / or type of the implanted device 106, for example, by receiving signals from the implanted device, by detecting a medical device, and / or by obtaining input from, for example, a user interface. According to some embodiments, the calculation of the position and / or path of the insertion tube is based on the information received regarding the implanted device. In addition to or instead of this, the processing unit may be configured to discard and / or normalize the signals obtained from the sensor 104, with or without the presence of the implanted device.

[0050] According to some embodiments, the system further includes a reference sensor 108 configured to be positioned on the subject's torso. The reference sensor 108 is configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to the electromagnetic field generator. Optionally, the reference sensor 108 can be attached to the patient's skin, for example, to the side of the patient's torso, such as under the patient's armpit. In such cases, the anatomical map further depicts the subject's body contour. The reference sensor 108 may be a six-degree-of-freedom electromagnetic sensor capable of determining its six axes of position (XYZ axes) and orientation (roll, yaw, and pitch) relative to the electromagnetic field generator 102.

[0051] According to some embodiments, the system further includes a registration sensor 107 configured to be positioned and / or marked at an anatomical (chest) location on the subject's body (e.g., the subject's torso). Different anatomical locations may be marked depending on the type of procedure used, the type of implantable medical device, etc. The marking of the anatomical location may be physical, such as by attaching a marker / reference (e.g., a sticker). Alternatively, the marking of the anatomical location may be virtual, such as by aligning a virtual marker / reference. According to embodiments, the marking can facilitate the identification or designation of anatomical locations inside or on the subject's body, such as, in non-limiting examples, the subject's suprasternal notch and the subject's xiphoid process.

[0052] Optionally, the alignment sensor 107 is a stylus sensor having a 3-degree-of-freedom sensor at its distal tip, and the stylus is configured to be manually operated to mark at least three anatomical locations on the body of a subject identified by the stylus operator. For example, once the stylus sensor 107 is positioned over a desired point on the patient's body, marking may be performed by indicating it to the software, for example, 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.

[0053] According to some embodiments, as used herein, the terms “insertion device,” “insertion medical device,” and “insertion tube” may be interchangeable and may refer to any device / tool ​​adapted for insertion into the body. An 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., nasogastric feeding tubes), endotracheal tubes, tracheostomy tubes, gastric tubes, catheter tubes, or cricothyroidotomy tubes. Other examples of insertion devices are well known in other art fields.

[0054] According to some embodiments, the terms “processing circuit” and “processor” may be used interchangeably.

[0055] In some embodiments, the insertion device is a tube. In some embodiments, the tube is a feeding tube. In some embodiments, the tube is a gastrointestinal / enteral feeding tube, e.g., a nasogastric feeding tube or a nasoenteral feeding tube, but is not limited to these. According to some embodiments, an electromagnetic sensor may be placed inside and / or on the feeding tube, for example, at its distal end.

[0056] Herein, we refer to Figure 2, which is a flowchart of Method 200 for guiding the insertion of an insertion tube according to several embodiments.

[0057] Those skilled in the art will understand that at least the order of the following steps of this method can be changed and / or performed in parallel.

[0058] According to some embodiments, the method is implemented by a processing unit or a non-temporary computer-readable medium that stores software instructions causing the processor to perform the steps described herein when executed by the processor.

[0059] In step 210, information is received regarding implanted devices in the patient that may interfere with and / or cause noise in the electromagnetic field generated on the patient's torso. According to some embodiments, receiving the information may include receiving it as an input instruction (e.g., via a user interface), receiving a signal from the implanted device, and / or deriving the presence and / or type of the implanted device based on one or more signature parameters, the signature parameters of which are optionally related to the type of interference / noise caused in the electromagnetic field. According to some embodiments, the information regarding the implanted device may take into account the type of implanted device. According to some embodiments, the information regarding the implanted device may relate the type, degree, or pattern of noise caused by the implanted device to the electromagnetic field. According to some embodiments, the implanted device is a device that operates periodically.

[0060] In step 220, a signal relating to a change in the electromagnetic field is received. According to some embodiments, at least a large portion of the change in the electromagnetic field is caused by the insertion of an insertion tube (e.g., a gastrointestinal tube) into the patient's gastrointestinal system, and the insertion tube is characterized by including an electromagnetic sensor at its distal end, for example.

[0061] In step 230, the received signal is normalized based on information about the embedded device and interference with the electromagnetic field. According to some embodiments, normalization includes the step of identifying the intensity and / or pattern (also referred to herein as the noise / interference signature) of the noise / interference. According to some embodiments, the identification of the noise / interference signature may include applying a pattern recognition algorithm. According to some embodiments, normalization includes estimating the changes in the electromagnetic field caused by the embedded device. According to some embodiments, identification and / or normalization may include the application of a machine learning algorithm. According to some embodiments, normalization removes noise. According to some embodiments, normalization reduces noise. According to some embodiments, normalization includes the step of identifying the operation of the embedded device based on one or more characteristics of the interference.

[0062] In step 240, the position of the gastrointestinal tube is determined based on the normalized signal.

[0063] Herein, we refer to Figure 3, which is a flowchart of Method 300 for guiding the insertion of an insertion tube according to several embodiments.

[0064] Those skilled in the art will understand that at least the order of the following steps of this method can be changed and / or performed in parallel.

[0065] According to some embodiments, the method is implemented by a processing unit or non-temporary computer-readable medium that stores software instructions causing the processor to perform the steps described herein when executed by the processor.

[0066] In step 310, a signal related to the change in the electromagnetic field is received. According to some embodiments, at least a large portion of the change in the electromagnetic field is caused by the insertion of an insertion tube (e.g., a gastrointestinal tube) into the patient's gastrointestinal system, and the insertion tube is characterized by including an electromagnetic sensor at its distal end, for example.

[0067] In step 320, the received signal is normalized based on informational noise / interference that would typically occur if an embedded device were present. According to some embodiments, identification and / or normalization involves the application of a machine learning algorithm. According to some embodiments, normalization eliminates noise from the embedded device, if present. According to some embodiments, normalization reduces noise from the embedded device, if present. According to some embodiments, normalization has minimal impact on the signal if no embedded device is present.

[0068] In step 330, the position of the gastrointestinal tube is determined based on the normalized signal.

[0069] 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.

[0070] 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. The computer-readable storage media used herein 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, a computer-readable storage medium is a non-transient (i.e., non-volatile) medium.

[0071] 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 them for storage on a computer-readable storage medium within the respective arithmetic / processing unit.

[0072] 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 can be executed on the user's computer, as a standalone software package, partly on the user's computer, partly 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 to personalize the electronic circuit in order to perform embodiments of the present invention.

[0073] 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.

[0074] 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, the computer-readable storage medium having instructions stored therein comprises a product containing instructions that implements a mode of function / operation specified in one or more blocks of a flowchart and / or block diagram.

[0075] 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.

[0076] The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products 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 that comprises 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.

[0077] The descriptions of various embodiments of the present invention are presented for illustrative purposes only and are not intended to be exhaustive or limitful to 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 terminology used herein has 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.

[0078] While several exemplary embodiments and designs have been described above, those skilled in the art will understand their specific modifications, additions, and subcombinations. Therefore, the following claims are intended to be construed as encompassing all such modifications, additions, and subcombinations as they fall within their true spirit and scope.

Claims

1. An insertion tube positioning device configured to determine the position of an insertion tube in a patient, wherein the insertion tube is equipped with an electromagnetic sensor, and the insertion tube positioning device, Equipped with a processing circuit, The aforementioned processing circuit is Receiving information about the implanted device in the patient, which causes interference in the electromagnetic field generated on the patient's torso, characterized by a pattern created by the operation of the implanted device in the patient. The system receives signals related to changes in the electromagnetic field caused by the insertion of the aforementioned insertion tube into the patient's body. Based on the information regarding the implanted device and the pattern characterizing the interference with the electromagnetic field generated by the operation of the implanted device, the received signal relating to the change in the electromagnetic field caused by the insertion of the insertion tube in the patient's body is normalized. Based on the normalized signal, the position of the insertion tube is determined, Insertion tube positioning device.

2. The insertion tube positioning device according to claim 1, wherein the implanted device is an artificial heart assist device.

3. The insertion tube positioning device according to claim 1, wherein the reception of information regarding the implanted device includes measuring a change in the electromagnetic field generated by the implanted device in the absence of the insertion tube, compared to a baseline electromagnetic field measured in the absence of the implanted device.

4. The insertion tube positioning device according to claim 3, wherein the measurement of the change in the electromagnetic field caused by the embedded device includes identifying one or more characteristics of the interference.

5. The insertion tube positioning device according to claim 4, wherein the embedded device is a device that operates periodically.

6. The insertion tube positioning device according to claim 4, wherein the processing circuit is configured to identify the operation of the embedded device based on one or more characteristics of the interference.

7. The insertion tube positioning device according to claim 1, wherein the reception of information regarding the embedded device includes receiving information regarding the type of the embedded device, and interference with the electromagnetic field of the embedded device is evaluated based on the type of the embedded device.

8. An insertion tube positioning system, An electromagnetic field generator configured to generate an electromagnetic field covering the treatment area, A positioning sensor configured to mark one or more anatomical locations on the patient's torso, An insertion tube equipped with an electromagnetic sensor configured to cause a change in the aforementioned electromagnetic field, Equipped with a processing circuit, The aforementioned processing circuit is Based on at least one anatomical location marked by a registered sensor, an anatomical map of the patient's torso is generated, or the patient's torso is matched to a predetermined anatomical map. The system receives signals related to changes in the electromagnetic field caused by the insertion of an insertion tube into the patient's body. Receiving information about a device implanted in the patient, which generates interference in the aforementioned electromagnetic field characterized by a pattern generated by the operation of the implanted device, Based on information regarding the device implanted in the subject and the pattern that characterizes the interference related to the change in the electromagnetic field caused by the insertion of the insertion tube in the patient's body, the received signal related to the change in the electromagnetic field caused by the insertion of the insertion tube in the patient's body is normalized. A system configured to map the path of an insertion tube based on the normalized changes in the aforementioned signal.

9. The system according to claim 8, wherein the processing circuit is configured to receive information about the patient's implanted device.

10. The system according to claim 9, wherein the reception of information about an implanted device includes measuring a change in the electromagnetic field generated by the implanted device in the absence of an insertion tube, compared to a baseline electromagnetic field measured in the absence of the implanted device.

11. The system according to claim 10, wherein measuring the change in the electromagnetic field caused by the embedded device includes identifying one or more characteristics of the interference.

12. The system according to claim 8, wherein the embedded device is a periodically operating device, and the processing circuit is configured to identify the operation of the embedded device based on one or more characteristics of the interference.

13. The system according to claim 9, wherein receiving information about an implanted device includes receiving information about the type of the implanted device, and interference with the electromagnetic field of the implanted device is evaluated based on the type of the implanted device.

14. The system according to any one of claims 8 to 13, wherein one or more anatomical locations include the suprasternal notch and / or the xiphoid process.

15. The system according to any one of claims 8 to 14, wherein the implanted device is an artificial heart assist device.

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