FIELD OF INVENTION

Embodiments of the disclosure relate to insertion device positioning guidance systems and methods.

BACKGROUND

Enteral feeding is often used as nutritional support in patients unable to be fed otherwise. Although many benefits are associated with early initiation of enteral feeding, misplacement of feeding tubes is relatively common and can result in patient discomfort and complications. Confirming the position of the tube only after it is already inserted delays the feeding and the initiating of hydration or medication. Bedside electromagnetic (EM) systems for guided placement of feeding tubes are available and are utilized by medical staff during the procedure to avoid misplacement of feeding tubes. There is still a need, however, for reliable real-time tracking systems that provide enhanced accuracy for critical tool positioning during medical procedures.

The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY

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

One of the problems often associated with an insertion of a feeding tube using an electromagnetic positioning guidance system, is that reliability is difficult to obtain in the patient environment, which is typically dynamic. For example, the patient often moves and the bed is moved from one place to another. There is thus provided herein an electromagnetic positioning guidance system reliably operable regardless of the patient's movement or position and which requires no calibration.

According to some embodiments, there is provided a guidance system for positioning a enteral tube comprising: an electromagnetic field generator configured to be positioned externally to a subject's torso, said electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, an enteral tube comprising a sensor assembly removably positioned within the enteral tube, the sensor assembly comprising an electromagnetic sensor at a distal tip thereof, said electromagnetic sensor configured to sense and/or interfere with the electromagnetic field generated by the field generator, a reference sensor configured to be positioned, within the treatment area, on the subject's torso, the reference sensor is configured to define a reference coordinate system representing the position and orientation of the subject's torso relative to said electromagnetic field, wherein the reference sensor is configured to be positioned independently of the insertion of the enteral tube, a registration sensor configured to mark at least a first anatomic location relative to the reference coordinate system; and a processing circuitry configured to operate said field generator, read signals obtained from the reference sensor and the registration sensor, and calculate a position and orientation of said reference sensor and said registration sensor relative to said electromagnetic field, to generate a 3D anatomic map, representing the torso of the subject and the first anatomic location and a second anatomic location, and to visualize, on the 3D anatomic map, a position, orientation and path of the enteral tube, with respect to the first and second anatomic locations, independent of the subject's movement and independent of deviations in the position and/or orientation of said field generator.

According to some embodiments, the reference sensor is configured to be positioned on a side of the patient's torso, such that the 3D anatomic map further depicts a frontal body contour of the subject and wherein the registration sensor is further configured to mark a second anatomic location on the subject's torso.

According to some embodiments, the reference sensor comprises two reference sensors for positioning below the left and right claviculae respectfully, and wherein a distance between the first and second reference sensors is indicative of the width of the patient's torso. According to some embodiments, the processor is further configured to calculate the position of the second anatomic location (the xiphoid process) based on the position of the two reference sensors.

According to some embodiments, the processor is configured to visualize, on the 3D anatomic map, a position, orientation and path of the sensor or of the sensor assembly positioned within the enteral tube.

In some embodiments, the 3D anatomic map shows a frontal upper view of the subject. In some embodiments, the 3D anatomic map shows a side view of the subject. In some embodiments, the 3D anatomic map shows an axial view of the subject.

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

According to some embodiments, the term “anatomic map” as disclosed herein, may refer to one or more schematic maps, one or more 2D anatomic maps, one or more 3D anatomic maps or any combination thereof. According to some embodiments, the term “anatomic map” as disclosed herein, may refer to a group of maps (e.g., 2, 3, 4 or more) maps, each representing a different view (for example, frontal view, frontal upper view, side view, axial view).

In some embodiments, the plate sensor is configured to be positioned under the subject's upper torso and/or neck.

In some embodiments, the registration sensor is a stylus configured to be manually operated.

In some embodiments, the insertion device is a enteral tube. According to some embodiments, the enteral tube is a pediatric enteral tube. According to some embodiments, the enteral tube has outer diameter of 2 mm, 1.5 mm or less or 1 mm or less.

In some embodiments, the first anatomic location is the suprasternal notch and the second anatomic location is the xiphoid process, and wherein a path display of the enteral tube relative to the first and second anatomic locations is indicative of a successful insertion.

In some embodiments, a frontal view display of the path of the enteral tube relative to the first and second anatomic locations is indicative of a successful insertion. In some embodiments, the location where the displayed path (in frontal view) of the enteral tube crosses an axis between the first and second anatomic locations is indicative of a successful insertion. In some embodiments, the actual shape of the displayed path of the enteral tube is indicative of a successful insertion.

According to some embodiments, there is provided a method for guiding an insertion device, the method comprising: utilizing an electromagnetic field generator, applying an electromagnetic field to a treatment area; positioning a reference sensor within the treatment area, on a subject's torso, the reference sensor defines a reference coordinate system representing the position and orientation of the subject's torso relative to the field generator; utilizing a registration sensor, marking at least a first anatomic location; utilizing processing circuitry to operate said field generator, read signals obtained from the reference sensor and the registration sensor, calculating a position and orientation thereof relative to said field generator, generating a 3D anatomic map representing the torso of the subject and the first and second anatomic locations; and displaying on the 3D anatomic map a position, orientation and/or path of a sensor assembly removably positioned within the insertion device, with respect to the first anatomic location and a second anatomic location, independent of the subject's movement and independent of deviations in the position and/or orientation of said field generator.

In some embodiments, the method further comprises displaying a current location, orientation and/or path of the distal tip section of the insertion device on the 3D anatomic map and thus facilitate determination of a successful medical procedure.

In some embodiments, positioning the reference sensor comprises positioning thereof on a side of the patient's torso, such that the 3D anatomic map further depicts a body contour of the subject. In some embodiments, the marking of at least a first and a second anatomic locations comprises utilizing a registration sensor.

In some embodiments, positioning the reference sensor comprises positioning two reference sensors below the left and right claviculae respectively and calculating the position of the second anatomic location based on the width of the subject's torso and the left and right claviculae.

In some embodiments, the method further comprises once a desired position of the insertion device is reached, removing the sensor assembly from the insertion device.

In some embodiments, the method further comprises the step of displaying the path of the distal tip section of the insertion device on the anatomic map and thus facilitates determination of a successful medical procedure. In some embodiments, the distal tip section of the insertion device may include the distal tip section of the sensor assembly, and/or the portion of the sensor assembly which comprises the electromagnetic sensor.

In some embodiments, the 3D anatomic map shows a frontal upper view of the subject. In some embodiments, the 3D anatomic map shows a side view of the subject. In some embodiments, the 3D anatomic map shows an axial view of the subject.

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

In some embodiments, the insertion device is a enteral tube. According to some embodiments, the enteral tube is a pediatric enteral tube. According to some embodiments, the enteral tube has outer diameter of 2 mm, 1.5 mm or less or 1 mm or less.

In some embodiments, the first anatomic location is the suprasternal notch, and the second anatomic location is the xiphoid process. In some embodiments, a path display of the enteral tube relative to the first and second anatomic locations is indicative of a successful insertion. In some embodiments, the location where the displayed path of the enteral tube crosses an axis between the first and second anatomic locations is indicative of a successful insertion. In some embodiments, the actual shape of the displayed path of the enteral tube is indicative of a successful insertion.

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. In some embodiments, the electromagnetic field generator is not designed to be in direct or indirect physical contact with the patient.

In some embodiments, the processor/processing circuitry may include two units or two sub-units. The first is configured to control the entire tracking system (e.g., operate the field generator, read signals obtained from the plate sensor, the reference sensor and the registration sensor and calculate a position and orientation thereof relative to said field generator. The second is configured to receive the calculated position and orientation information from the first processor, and use this information to generate a 3D anatomic map representing the torso of the subject and the first and second anatomic locations, and to allow visualization on the 3D anatomic map of a position, orientation and/or path of a tip sensor with respect to the first and second anatomic locations, independent of the subject's movement and independent of deviations in the position and/or orientation of the field generator.

According to some embodiments, the tip sensor, which may also be referred to as a position sensor, is positioned at or adjacent to the distal end of the tube/catheter/stylet and aids in determining the position of the distal end of the tube/catheter/stylet in a patient. According to some embodiments, the tip sensor may include the electromagnetic sensor positioned at the distal end of the sensor assembly. According to some embodiments, the tip sensor may include the electromagnetic sensor positioned at the distal end of the sensor assembly, which may be positioned at the distal end of the insertion device.

The systems and methods described herein may be applied, according to some embodiments, using sensors (e.g., position sensors) such as magnetic field sensors, impedance-based sensors or ultrasonic sensors. According to some embodiments, the position sensor (e.g., tip sensor) may refer to an element mounted on a catheter/tube/stylet, which causes the processing circuitry to receive signals indicative of the coordinates of the element. The position sensor may include a receiver, which generates a position signal to a processing circuitry/control unit based on energy received by the sensor (for example, from the field generator). According to some embodiments, the communication between the sensors and the processing unit may be wireless.

More details and features of the current invention and its embodiments may be found in the description and the attached drawings.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

