Magnetic signature identification of units of a tracking system

Abstract

Provided herein are magnetic signature elements configured to serve as identifiers for components of a magnetic surgical tracking system. The magnetic signature element includes one or more magnetic components arranged in a predetermined pattern that generates a detectable magnetic signature. The magnetic signature is indicative of one or more properties of the associated system component, thereby enabling secure, reliable, and automated identification of units within the magnetic tracking system.

Description

MAGNETIC SIGNATURE IDENTIFICATION OF UNITS OF A TRACKING SYSTEMFIEED OF THE INVENTION

[0001] The present invention, in some embodiments thereof, relates to magnetic signature element (identifier), for the secured identification of components of a magnetic surgical tracking system, and for facilitating secured operation thereof.BACKGROUND

[0002] Medical systems, such as tracking and navigating systems include various components, which need to operate in conjunction in order to function in an accurate and safe manner. For example, a magnetic tracking system may be used in an operating room, to provide the location of a surgical tool, by using magnetic sensors.

[0003] It is important to verify that all the components of the system match each other, to ensure the integrity of the system and in particular, the accurate measurement of the surgical tool location, which is critical for avoiding harmful operation.

[0004] Thus, there is a need in the art for unique magnetic signature identifiers, serving as identification means of units of a magnetic surgical tracking system, to facilitate secured identification and operation thereof.SUMMARY

[0005] There is provided, in accordance with some embodiments, advantageous magnetic signature elements (identifiers), which are used as identification means for units (components) of a surgical tracking system, whereby the magnetic signatures are indicative of one or more properties of the associated units. Advantageously, the use of such magnetic signature(s) enhance the secured and reliable operation of the system, by ensuring accuracy and maximal compatibility between various components (units) of the system.

[0006] According to some embodiments, the magnetic signature includes a unique or a predetermined arrangement (pattern) of magnetic elements (including, for example, permanent magnets, paramagnets and / or ferromagnets), associated with a functional unit ofthe tracking system. The unique pattern arrangement of the magnetic elements, once identified by corresponding magnetic sensor(s), as further detailed hereinbelow, is used as an identifying signature for the functional unit.

[0007] In some embodiments, the magnetic signature may be indicative of one or more properties / features of the functional unit, including, for example, but not limited to: type, class, manufacturer, manufacture date, size, orientation, and the like. In some embodiments, by determining the features of the functional unit, based on the magnetic signature, operation parameters of the system may be adjusted, to increase accuracy, reliability, safety, and the like.

[0008] In some embodiments, the MSE and systems disclosed herein advantageously facilitate faster calibration, a more robust detection vs external noise, unique identification of disposable cradle units, reduction of tracking errors due to drift, improvements in orientation registration / tool navigation precision, and the like.

[0009] In some embodiments, the tracking system is a magnetic tracking system which includes a tracking unit (also referred to herein as magnetic camera) having one or more magnetic sensors, and a cradle unit, configured to position or fix the tracking unit at / to a desired location (position and / or orientation) of a subject body, to thereby facilitate an accurate and reliable tracking and navigation during the medical procedure.

[0010] In some embodiments, the use of a magnetic signature associated with the cradle allows the tracking unit (directly or indirectly) to detect / determine the magnetic signature, and derive relevant features of the cradle unit, to ensure enhanced compatibility between the cradle unit and the tracking unit, and thereby enhance accuracy and general performance of the system.

[0011] According to some embodiments, accurate identification of system components may be of uttermost importance for ensuring correct, safe and accurate connection between the components.

[0012] In some embodiments, the magnetic signature may be used to ensure that the tracking system allows operation only when the correct components are associated. In some embodiments, the system may be configured such that it is deactivated, when the connected components are not compatible.

[0013] According to some embodiments, there is provided a magnetic signature element (MSE) for facilitating secured identification of one or more functional units of a tracking system, wherein the magnetic signature element includes one or more magnets, paramagnets and / or ferromagnets which are arranged in a predetermined pattern. The magnetic signature element is configured to be associated with the functional unit, and the pattern of the MSE is configured to be detectable by a corresponding tracking unit having one or more magnetic sensors. The MSE is indicative of one or more properties of the functional unit.

[0014] According to some embodiments, there is provided a magnetic signature element (MSE) for facilitating secured identification of a functional unit of a magnetic navigation system, by a tracking unit, the magnetic signature element may include one or more magnets, paramagnets and / or ferromagnets arranged in a predetermined pattern, wherein said magnetic signature element is configured to be associated with the functional unit and wherein the pattern of the MSE is detectable by the tracking unit, wherein the MSE is indicative of one or more properties of the functional unit.

[0015] According to some embodiments, the MSE may include one or more permanent magnets.

[0016] According to some embodiments, each of the one or more magnets, paramagnets and / or ferromagnets may include a predetermined shape, size and / or magnetic strength.

[0017] According to some embodiments, the MSE may be associated with a specific location / position on the functional unit.

[0018] According to some embodiments, one or more of the magnets, paramagnets and / or ferromagnets are positioned in a specific orientation in one or more specific locations on the functional unit.

[0019] According to some embodiments, one or more of the magnets are made of metal and may further function as radiopaque markers.

[0020] According to some embodiments, the MSE may include one or more magnets and one or more regions comprising paramagnetic regions and / or ferromagnetic regions.

[0021] According to some embodiments, the MSE may include one or more ferromagnets, the pattern of which is detectable upon application of an external magnetic field.

[0022] According to some embodiments, the MSE may include one or more paramagnets, whereby upon application of an alternating magnetic field, the pattern of said one or more paramagnets is detectable, wherein the pattern comprises a magnetic frequency that follows the frequency of the applied alternative magnetic field.

[0023] According to some embodiments, the functional unit may include a cradle unit, configured to be fixed at a desired position or orientation to a body of a subject, and may further be physically and / or functionally associated with the tracking unit.

[0024] According to some embodiments, the tracking unit includes an array of magnetic sensors, a communication module and / or a control module.

[0025] According to some embodiments, information obtained from the tracking unit may be used to generate, via an associated processing unit, one or more images of the predetermined pattern, and based thereon to detect the MSE.

[0026] According to some embodiments, information obtained from the tracking unit may be used to generate, via an associated processing unit, a set of images, corresponding to orthogonal axes locations of the functional unit.

[0027] According to some embodiments, information obtained from the tracking unit may be used to generate, via an associated processing unit, a single, combined image, the intensity of which is representative of orthogonal axes locations of the functional unit.

[0028] According to some embodiments, the one or more images may be compared to a database of images of pre-assigned magnetic signatures, to thereby allow determining or verifying one or more properties of the functional unit.

[0029] According to some embodiments, one or more features of the images may be compared to features of a preset database of pre-assigned magnetic signature images.

[0030] According to some embodiments, the magnetic navigation system may be configured to allow tracking and / or navigating a surgical tool within a body of a subject.

[0031] According to some embodiments, the ferromagnetic material may include Steel (Fe-alloy), Iron (Fe), Cobalt (Co), Nickel (Ni), Nickel-Iron Alloy (Ni-Fe), Stainless steel alloy, ferritic steel, martensitic steel, duplex steel or any combination thereof.

[0032] According to some embodiments, the paramagnetic material may include Aluminum (Al), Magnesium (Mg), Titanium (Ti), Tungsten (W), Platinum (Pt), Molybdenum (Mo), Chromium (Cr), Stainless steel alloy, austenitic steel, or any combination thereof.

[0033] According to some embodiments, there is provided a cradle unit of a magnetic navigation system, the cradle unit includes a magnetic signature indicative of one or more properties of the cradle unit, the magnetic signature is formed by one or more magnets, paramagnet(s) and / or ferromagnet(s), arranged in a predetermined pattern, wherein the predetermined pattern is identifiable by a tracking unit.

[0034] According to some embodiments, each of the one or more magnets, paramagnets and / or ferromagnets have a predetermined shape, size and / or magnetic strength.

[0035] According to some embodiments, one or more of the magnets, paramagnet(s) and / or ferromagnet(s), may be associated with a specific location / position on the cradle.

[0036] According to some embodiments, one or more of the magnets, paramagnet(s) and / or ferromagnet(s) are positioned in a specific orientation in one or more specific locations on the cradle.

[0037] According to some embodiments, one or more of the magnets of the cradle are made of metal and further function as radiopaque markers.

[0038] According to some embodiments, the cradle may include one or more magnets and one or more regions comprising paramagnetic regions and / or ferromagnetic regions, wherein the arrangement of the magnets and regions comprising paramagnetic regions and / or ferromagnetic regions form an identifiable magnetic signature.

[0039] According to some embodiments, the cradle may include one or more ferromagnets, the pattern of which is detectable upon application of an external magnetic field.

[0040] According to some embodiments, the cradle may include one or more paramagnets, whereby upon application of an alternating magnetic field, the pattern of said one or more paramagnets is detectable, wherein the pattern comprises a magnetic frequency that follows the frequency of the applied alternative magnetic field.

[0041] According to some embodiments, the external magnetic field may be generated by the tracking unit.

[0042] According to some embodiments, the cradle may further include one or more radiopaque markers for identification of position and / or orientation of the cradle relative to the body of the subject in imaging procedures.

[0043] According to some embodiments, the cradle unit may be configured to be fixed at a desired position or orientation to a body of a subject, and further be physically and / or functionally associated with the tracking unit, to thereby determine and fix the position and / or orientation of the tracking unit relative to the subject of the body.

[0044] According to some embodiments, the cradle may be disposable.

[0045] According to some embodiments, there is provided a system for tracking a surgical tool in a body of a subject, during a medical procedure, the system includes: the cradle unit having a magnetic signature as disclosed herein; a tracking unit including one or more magnetic sensors configured to detect the magnetic signature of the cradle; and a processing unit configured to identify the magnetic signature, and based thereon determine one or more properties of the cradle.

[0046] According to some embodiments, the tracking unit includes an array of magnetic sensors.

[0047] According to some embodiments, the system may further include a display configured to present to a user the magnetic signature of the cradle unit, an image of the magnetic signature, one or more features of the cradle unit, determined based on the magnetic signature, or any combinations thereof.

[0048] According to some embodiments, the system may further include a user interface, a memory, a database, a communication unit, or any combinations thereof.

[0049] According to some embodiments, there is provided a method for detecting a magnetic signature of a cradle unit, the method includes the steps of: providing or obtaining or providing the cradle having a magnetic signature as disclosed herein; detecting magnetic pattern associated with the magnetic signature of the cradle unit, by a tracking unit having one or more magnetic sensors; and generating, by a processing unit, based on the detected magnetic pattern one or more images, and determining, based on said images the magnetic signature; to thereby determine one or more properties of the cradle unit.

[0050] According to some embodiments, determining by the processing unit includes comparing the generated images to a database of images of pre-assigned magnetic signatures, to thereby allow determining or verifying one or more properties of the cradle unit.

[0051] According to some embodiments, determining may include comparing one or more features of the generated images to features of a pre-set database of pre-assigned magnetic signature images.

[0052] According to some embodiments, the method may further include adjusting operating parameters of the tracking system, based on the determined / identified one or more properties of the cradle unit.

[0053] According to some embodiments, the method may further include registering the position and / or orientation of the cradle unit, to an imaging scan of the subject.

[0054] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.BRIEF DESCRIPTION OF THE FIGURES

[0055] Some exemplary implementations of the methods and systems of the present disclosure are described with reference to the accompanying drawings. In the drawings, like reference numbers indicate identical or substantially similar elements.

[0056] FIGs. 1A-1B show schematic perspective illustrations of a cradle unit having a magnetic signature, and a tracking unit components of a tracking system, according to some embodiments;

[0057] FIGs. 2A-2D show schematic illustrations of exemplary magnetic or magnetized elements forming magnetic signature(s), according to some embodiments;

[0058] FIGs. 3A-3C show images of exemplary magnetic signatures, according to some embodiments; and

[0059] FIG. 4 shows a flowchart of steps in a method for detecting a magnetic signature of a functional unit of a tracking system, according to some embodiments.DETAILED DESCRIPTION

[0060] According to an aspect of some embodiments there is provided an advantageous magnetic signature identifier, or a magnetic signature element (MSE), having a magnetic / magnetized pattern, generated by a combination of one or more magnets, ferromagnets and / or paramagnets. The magnetic signature can serve as an identifier or bar code, indicative of one or more features / parameters of the functional unit with which it is associated. The magnetic signature is capable of being identified by a corresponding tracking unit (for example, having one or more magnetometers / magnetic sensors). In some embodiments, the functional unit(s) are part of a magnetic tracking system for tracking and / or navigating a surgical tool during a medical procedure. As the tracking system includes various components, it is important to verify that all components match each other, to ensure the integrity of the system, and in particular, the accurate measurement / determination of the location (position and / or orientation) of the surgical tool, which is critical for the safety, reliability and overall successful completion of the procedure.

[0061] According to some embodiments, a magnetic signature element (MSE) refers to a structural assembly that is physically or functionally associated with a functional unit of a magnetic navigation system and includes one or more magnetic components such as magnets, ferromagnetic materials, and / or paramagnetic materials. The MSE is intentionally designed so that its components are positioned in a spatially predetermined arrangement that generates a characteristic magnetic response. This response forms a detectable magnetic signature that can be sensed and analyzed by a tracking unit. The MSE may be integrated into, mounted on, or embedded within the functional unit, and its purpose is to enable identification, verification, and / or characterization of the functional unit based on the detected magnetic signature.

[0062] In some embodiments, a predetermined pattern relates to the deliberate spatial arrangement, distribution, or configuration of magnetic components within the MSE. This may include the relative positions, orientations, material types, magnetic strengths, shapes, and / or sizes of the magnetic components. The pattern may be two-dimensional or three- dimensional and is selected such that it produces a unique and identifiable magnetic signature when sensed by the tracking unit. Different functional units may be assigned different predetermined patterns, enabling the system to distinguish among multiple units based on their magnetic signatures.

[0063] According to some embodiments, the system is for tracking a medical tool (e.g., a surgical tool) during a medical procedure. In some embodiments, the system includes a tracking unit having one or more magnetic sensors (or an array of such sensors) and a processing unit. The tracking unit is configured to detect change deformation / disturbance in the magnetic field affected by the movement of the tool and convey said information (readouts) to processor unit, which is configured to receive the detected change(s) and determine the spatial location (e.g. position and / or orientation) of the tool during or at the end of the medical procedure. The processor may further be configured to generate images, based on the readouts provided by the tracking unit.

[0064] In some embodiments, the determination of the spatial location of the tool may be based on one or more deep learning algorithm(s) correlating the change of the magneticfield with the spatial location of the magnet. In some embodiments, the determination is based on look-up tables, or other types of calculations or mathematical formulas.

[0065] According to some embodiments, there is provided herein a system for tracking a surgical tool, during a medical procedure, the system includes: a cradle having a magnetic signature; and a tracking unit including one or more magnetic sensors configured to detect magnetic field generated by the permanent magnet and / or changes to the magnetic field. The system further includes a processing unit configured to determine a position and / or orientation of the surgical tool, based on the detected magnetic field and / or changes thereto.

[0066] According to some embodiments, the system may further include a display configured to present to a user the position and / or orientation of the surgical tool, images related to the magnetic signature, parameters or features of the functional unit associated with the magnetic signature, and the like, or any combinations thereof. Each possibility is a separate embodiment.

[0067] According to some embodiments, the system may further include a user interface, a memory, a database, a communication unit, or any combinations thereof. Each possibility is a separate embodiment.

[0068] In some embodiments, the tracking unit may include one or more magnetic sensors. In some embodiments, the tracking unit may include an array of magnetic sensors. In some embodiments, the tracking unit may further include a controller module and / or a communication module (which may be wired or wireless). In some embodiments, in the presence of a magnetic field associated with a magnetic element (such a magnet (permanent magnet, electromagnet, etc.), or a magnetizable element (such as, ferromagnetic element, paramagnetic elements)), located in vicinity of the tracking unit, the magnetic sensors (magnetometers) readouts may be collected, in real time by the controller module and transmitted to a processing unit of the tracking system (for example, in the form of a computer (such as PC) station), via the communication module (by wired or wireless routes). In some embodiments, the processing unit may then arrange the received readouts in the form of an image, where each magnetometer is represented by a pixel in the generated image, with the direction (S / N) and magnitude of the magnetic field being represented by the pixel’s grayscale level.

[0069] According to some embodiments, in order to enhance accuracy of operation, the tracking unit position / location with respect of the subject body should be accurate and stable. To this aim, the system may further include a cradle unit.

[0070] According to some embodiments, the cradle unit is configured to be fixed to / associated with a body region, so as to allow accurate positioning thereof. In some embodiments, the fixing to the body region may be facilitated by various means, including, for example, stickers, tension bands, adhesive tapes, and the like.

[0071] In some embodiments, various cradle units may be used for various surgical applications, various body location, various subjects (children, adults, male, female, etc.), and the like. The various cradles may differ, for example, in, but not limited to: size, shape, form, composition, and the like. In some embodiments, the shape, size, composition, of the cradle may be determined or adjusted in accordance with the body region. For example, the cradle may be fitted to a vertebrae body part. For example, the cradle may be fitted to a spine body part. For example, the cradle may be fitted to a limb body part. For example, one cradle may be fitted to a thoracic body part. For example, the cradle may be fitted to an abdomen body part. For example, the cradle may be fitted to a skull body part. For example, the cradle may be fitted to a facial body part. For example, the cradle may be fitted to a pelvic body part.

[0072] According to some embodiments, information regarding one or more features / parameters of the cradle may be “encoded” / ” embedded” in the cradle in the form of a magnetic signature. The magnetic signature pattern may thus be indicative of such general or unique features of a cradle. Such information / features may include, for example, but not limited to: type of cradle, class of cradle, size of cradle, composition of cradle, manufacture date of the cradle, manufacturer of the cradle, intended use (i.e., to which body region it should fit, which subject, etc.), position and / or orientation of the cradle, and the like, or any combinations thereof. Each possibility is a separate embodiments.

[0073] According to some embodiments, based on the determined properties / parameters of the cradle, the tracking system may provide or adjust operating instructions. For example, if it is determined that the cradle unit is not suitable for the intended medical procedure, the procedure may be halted, until the cradle is replaced. For example, if it isdetermined that the cradle unit is not suitable for the intended subject, the procedure may be halted, until the cradle is replaced. For example, if it is determined that the cradle unit is not properly attached to the tracking unit, the procedure may be halted, until the attachment is adjusted.

[0074] According to some embodiments, the cradle unit may be configured to physically associate with the tracking unit. In some embodiments the tracking unit may fit tightly with the cradle unit. In some embodiments, the cradle may include a housing frame or other attachment means for associating with the tracking unit. In some embodiments, once associated / fixed, the tracking unit and the cradle unit may have a fixed, known and common coordinate system. According to some embodiments, the cradle may further serve as a sterile barrier to the tracking unit.

[0075] In some embodiments, the cradle may further allow a sterile wired connection between a processing unit and the tracking unit.

[0076] Reference is now made to Figs. 1A-B which shows schematic illustrations of a cradle unit and a tracking unit, according to some embodiments. Shown in Fig. 1A, is tracking unit 100 and cradle unit 110, each separate from each other. Tracking unit 100 includes one or more (or an array) of magnetic sensors (not shown). Additionally, in the example shown in Fig. 1A, tracking unit 100 may include one or more attachment latches / hinges, 104A-D, which may be used to associate / attach / fix tracking unit 100 to cradle unit 110. Cradle unit 110 includes a bottom face (surface) 112, configured to be in contact with / attach to / fixed to the subject body. The fixing to the subject body may be facilitated by any suitable means, including, for example, but not limited to: bands, stickers, adhesive, and the like. Upper surface (upper face) 114 is configured to associate with tracking unit 100. The upper surface may include a suitable frame, groove(s), hinges, or any other means structure that can accommodate / hold / secure the tracking unit. Additionally, cradle unit 110 includes or is associated with a magnetic signature 116. As detailed herein, the magnetic signature may include any pattern or distribution of magnetic / magnetized elements, which are detectable by the one or more sensors of the tracking unit. In some embodiments, magnetic signature 116 may be in the form of a magnetic signature element, associated (permanently or transiently) with the cradle unit. Insome embodiments, the magnetic signature elements may be associated / placed / deposited / patterned on the cradle unit, for example, on the upper face thereof, or any other spatial location. Fig. IB shows a schematic illustration of tracking unit 100 when attached to / associated with cradle unit 110. As shown in Fig. IB, latches 104A-D securely lock the tracking unit and the cradle unit, to prevent relative movement between the components. The attachment / association between the cradle unit and the tracking unit allows the two components to share a single coordinate system, which is highly important for the surgical procedure, as detailed herein.

[0077] According to some embodiments, obtaining the magnetic signature by the tracking unit may be performed prior to attachment of the cradle unit and the tracking unit. In some embodiments, obtaining the magnetic signature by the tracking unit may be performed after the attachment of the cradle unit and the tracking unit.

[0078] In some embodiments, the cradle may further include one or more radiopaque markers, for identification in images obtained from one or more imaging modalities (such as, fluoroscopy imaging), in particular, for the registration and determination of the location (position and / or orientation) of the cradle with respect of the respective body of the subject. Such markers may be used in various angular images (including, for example, anterior- posterior (AP) and lateral exposures). The markers are used for the registration of the imaging images to the coordinates of the magnetic tracking / navigating system. In some embodiments, prior to an intra operative 2D or 3D imaging, the cradle may be secured / fixed / attached to a body region of the subject, in close proximity to the operating area, and will steadily remain at that region for the duration of the surgical procedure. For example, for a spine surgery of L5-S1 discectomy, the cradle may be fixed on the subject’s skin above (superior to) the L5-S1 vertebra.

[0079] According to some embodiments, as detailed herein, the cradle may have a unique magnetic signature. Such magnetic signature may be recorded / detected by the tracking unit. To this aim, based on the readouts of the tracking unit, an image, or a set of images (for example, one for each readout of an orthogonal axes (X, Y, Z) of the tacking unit coordinate system) may be generated. In some embodiments, a combined image may be generated, theintensity of which is the resultant of the readouts of the orthogonal axes (X, Y, Z) of the tacking unit coordinate system.

[0080] According to some embodiments, after obtaining such images, the identification of the magnetic signature (i.e., the determination or identification of features of the cradle) may be determined, for example, by a processing unit of the system.

[0081] In some embodiments, the cradle unit is re-usable. In some embodiments, the cradle unit is disposable. In some embodiments, the cradle unit is sterile.

[0082] In some embodiments, in order to decipher / determine the signature, the obtained image may be compared to a library of pre-assigned images, that can be used as a reference. Once a match between a preassigned images and the obtained image is determined, it is indicative of the identity of the magnetic signature. In some embodiments, the library database may be located in a local server, a remote server, a cloud based server, on a local memory, and the like. In some embodiments, the library database may be updated periodically.

[0083] In some embodiments, in order to decipher / determine the signature, the obtained images is analyzed according to compliance with a set of (predetermined) rules / features / values, which are shared / common with a set / group of pre-approved images. Thus, the encryption of the signature may be facilitated. In some embodiments, the set of rules may be located in a local server, a remote server, a cloud based server, on a local memory, and the like. In some embodiments, the set of rules may be updated periodically.

[0084] According to some embodiments, the magnetic signature may be added to the functional unit (for example, the cradle) in the form of a magnetic signature element (SME). The SME may include one or more magnets, one or more paramagnets / paramagnetic regions and / or one or more ferromagnets / ferromagnetic regions arranged on the face thereof according to a predetermined pattern. In some embodiments, the SME may be associated with the function unit. In some embodiments, the association is permanent. In some embodiments, the SME may be formed with the functional unit. In some embodiments, the SME may be glued, adhered, welded, attached, secured, screwed, etc. to the functional unit.

[0085] In some embodiments, the magnetic signature may be directly placed / positioned / secured / deposited on or formed with the function unit.

[0086] In some embodiments, the magnetic signature may be formed (represented) by an arranged pattern of magnetic or magnetized elements.

[0087] In some embodiments, the magnetic signature may be formed by one or more magnets, one or more paramagnets, one or more ferromagnets, or any combinations thereof. Each possibility is a separate embodiment.

[0088] In some embodiments, the magnetic signature may be formed by one or more magnets having a desired shape, size and / or strength. Each possibility is a separate embodiment.

[0089] In some embodiments, the magnetic signature may be formed based on specific location / positioning (spatial location) of one or more magnets inside the function unit (e.g., a cradle) geometry.

[0090] In some embodiments, the magnetic signature may be formed based on specific orientation of one or more magnets inside the function unit (e.g., a cradle) geometry.

[0091] In some embodiments, the magnetic signature may be formed based on specific distribution (location and orientation) of one or more magnets inside the function unit (e.g., a cradle) geometry.

[0092] In some embodiments, when a plurality of magnets are used for forming a pattern, the magnets may be similar, identical or different with respect of size, shape, strength, and the like.

[0093] In some embodiments, the magnetic signature may be formed by one or more paramagnets having a desired shape, size and / or strength. Each possibility is a separate embodiment.

[0094] In some embodiments, the magnetic signature may be formed based on specific location / positioning (spatial location) of one or more paramagnets inside the function unit (e.g., a cradle) geometry.

[0095] In some embodiments, the magnetic signature may be formed based on specific orientation of one or more paramagnets inside the function unit (e.g., a cradle) geometry.

[0096] In some embodiments, the magnetic signature may be formed based on specific distribution (location and orientation) of one or more paramagnets inside the function unit (e.g., a cradle) geometry.

[0097] In some embodiments, when a plurality of paramagnets are used for forming a pattern, the paramagnets may be similar, identical or different with respect of size, shape, strength, and the like.

[0098] In some embodiments, the magnetic signature may be formed by one or more ferromagnets having a desired shape, size and / or strength. Each possibility is a separate embodiment.

[0099] In some embodiments, the magnetic signature may be formed based on specific location / positioning (spatial location) of one or more ferromagnets inside the function unit (e.g., a cradle) geometry.

[0100] In some embodiments, the magnetic signature may be formed based on specific orientation of one or more ferromagnets inside the function unit (e.g., a cradle) geometry.

[0101] In some embodiments, the magnetic signature may be formed based on specific distribution (location and orientation) of one or more ferromagnets inside the function unit (e.g., a cradle) geometry.

[0102] In some embodiments, when a plurality of ferromagnets are used for forming a spatial pattern, the ferromagnets may be similar, identical or different with respect of size, shape, strength, and the like.

[0103] According to some embodiments, the magnetic signature may include a combination of one or more permanent magnets (for example, small magnets), and a patterned spatial distribution of ferromagnetic material (ferromagnets), that collectively form a unique magnetic signature.

[0104] According to some embodiments, the magnetic signature may include a combination of one or more permanent magnets (for example, small magnets), and a patterned spatial distribution of paramagnetic material (paramagnets), that collectively form a unique magnetic signature.

[0105] According to some embodiments, the magnetic signature may include a combination of one or more permanent magnets (for example, small magnets), a patterned spatial distribution of paramagnetic material (paramagnets) and a patterned spatial distribution of ferromagnetic material (ferromagnets), that collectively form a unique magnetic signature.

[0106] According to some embodiments, the magnetic signature may include a combination of a patterned spatial distribution of one or more paramagnetic material (paramagnets) and a patterned spatial distribution of one or more ferromagnetic material (ferromagnets), that collectively form a unique magnetic signature.

[0107] In some embodiments, specific location / position refers to predetermined points or regions on the MSE, functional unit or cradle unit where magnetic components are placed. These locations are intentionally selected based on design criteria to form part of the predetermined pattern. Specific orientation refers to the angular alignment or directional positioning of magnetic components relative to a defined coordinate system of the functional unit, the cradle unit, or the tracking system. These orientations may include alignment along particular axes, tilt angles, or magnetization directions, and contribute to the uniqueness and detectability of the magnetic pattern.

[0108] In some embodiments, the magnet is a permanent magnet.

[0109] In some embodiments, the magnet may be made of metallic material (such as, neodymium) and may further be used as a radiopaque marker.

[0110] According to some embodiments, when ferromagnetic materials are used for the magnetic signature, an active magnetic element, such as, inductor may be used, to magnetize the ferromagnetic elements and to generate the detectable magnetic signature. In some embodiments, the inductor may be included with the tracking unit.

[0111] In some embodiments, when paramagnetic materials are used for the magnetic signature, an active magnetic element, such as, inductor may be used, to generate an alternating magnetic current (AC). The alternating magnetic current can in turn induce a corresponding magnetic response of the ferromagnetic elements, which follows the frequency of the applied alternating current. Such magnetic frequency changes can represent or be part of the magnetic signature.

[0112] According to some embodiments the ferromagnetic material may include, for example, but not limited to: Steel (Fe-alloy), Stainless steel alloy, ferritic (stainless) steel, martensitic (stainless) steel, duplex (stainless) steel, Iron (Fe), Cobalt (Co), Nickel (Ni), Nickel-Iron Alloy (Ni-Fe), or any combination thereof. According to some embodiments the ferromagnetic material may preferably include stainless steel alloys commonly used for surgical tools / devices, such as but not limited to, ferritic (stainless) steel, martensitic (stainless) steel, duplex (stainless) steel, or any combination thereof. Each possibility is a separate embodiment. Each possibility is a separate embodiment.

[0113] According to some embodiments the paramagnetic material may include, for example, but not limited to: Aluminum (Al), Magnesium (Mg), Titanium (Ti), Tungsten (W), Platinum (Pt), Molybdenum (Mo), Chromium (Cr), Stainless steel alloy, austenitic (stainless) steel, or any combination thereof. Each possibility is a separate embodiment. According to some embodiments the paramagnetic material may preferably include stainless steel alloys commonly used for surgical tools / devices, such as but not limited to, austenitic (stainless) steels.

[0114] Reference is now made to Figs. 2A-D, showing exemplary magnetic patterns forming a magnetic signature. As shown in Fig. 2A, a magnetic signature or SME 200, may include a combination of at least two permanent magnets, 202A-B. The magnets differ in their shape and size. In addition magnet 202A includes varying intensities. As shown in Fig. 2B, a magnetic signature or SME 210, may include a combination of a permanent magnet 212, and two ferromagnet 214A-B. The permanent magnet 212 and the ferromagnets differ in composition, size, shape and strength. As shown in Fig. 2C, a magnetic signature or SME 220, may include a combination of at least two permanent magnets, 222A-B and two paramagnets 226A-B. The magnets differ in their shape and size. Likewise, the paramagnets differ in size and shape. The magnets and paramagnets are positioned non-symmetrically, allowing determining orientation of the functional unit which is associated with the signature. As shown in Fig. 2D, a magnetic signature or SME 240, may include a combination of a permanent magnet, 232, a ferromagnet 234 and a paramagnet 236. The arrangement of the magnets and magnetized elements facilitate determining orientation of the functional unit which is associated with the signature.

[0115] Reference is now made to Figs. 3A-C, showing images of different magnetic signatures, according to some embodiments. As shown in the images presented at Figs. 3A- 3C, each image represent a different magnetic signature. Each of the magnetic signatures, 300A-C, are generated by a unique pattern of magnets and / or magnetizable elements, spatially distributed over a functional unit.

[0116] Reference is now made to Fig. 4, illustrating steps in a method for detecting and determining a magnetic signature of a functional unit, according to some embodiments. As shown in Fig. 4, method 400 includes at step 410 obtaining (or providing) the cradle unit having a magnetic signature, as disclosed herein. Next, at step 420, a magnetic pattern associated with the magnetic signature of the cradle unit is detected by a corresponding tracking unit. At step 430, a processing unit of the tracking system is configured to generate, based on the detected magnetic pattern of one or more corresponding images. At step 440, the processing unit is configured to determine, based on the generated images of the magnetic signature, one or more properties of the cradle unit (which are “encoded” by the magnetic signature). In some embodiments, the determination of the properties of the cradle unit, based on the interpretation of the magnetic signature may be facilitated, for example, based on comparison to a database of pre-assigned images, or according to a comparison to a pre-set of rules, as detailed above herein. At optional step 450, based on the determination of the one or more properties of the cradle unit, the processing unit may provide operating instructions (for example, to the tracking unit) if to proceed operation with the associated cradle unit, if to adjust one or more operating parameters, if to stop operation, and the like.

[0117] In some embodiments, the further instructions provided by the processing unit, based on the identification of the magnetic signature may be facilitated to as to enhance the safety and accuracy of the medical procedure. For example, if, based on the magnetic signature, it is determined that the cradle used is not suitable to the medical procedure (for example, the subject is a child and the cradle is designed for adults, for example, the medical procedure is a spine-related procedures, and the cradle is for limb-related procedure) or that the associating between the cradle unit and the tracking unit is not adequate, the processing unit may prevent or halt the procedure, until proper adjustments or replacement of the cradle unit is performed.

[0118] According to some embodiments, the method may further include registering the position and / or orientation of the cradle unit, to an imaging scan of the subject, prior to or after associating with the tracking unit.

[0119] According to some embodiments, the processor of the system may be in communication with the plurality of magnetic sensors. According to some embodiment, the processor may be configured to receive one or more signals from the plurality of sensors. According to some embodiments, the one or more signals may be associated with a change in the magnetic field due to movements of the magnet.

[0120] According to some embodiments, the processor may be configured to receive individual signals from individual sensors of the plurality of sensors. According to some embodiments, the processor may be configured to apply the received one or more signals to a deep learning algorithm stored in the memory module which then outputs the location of the magnetic tool, based, at least in part, on the received one or more signals.

[0121] According to some embodiments, the surgical procedure for use with the tracking system may include, for example, biopsy, orthopedic procedure, tissue removal, tissue ablation, tissue manipulation, delivery of implants, delivery of electrodes for neural stimulation, or any combination thereof. Each possibility is a separate embodiment.

[0122] The terms “cradle” and “cradle unit” may be used interchangeably.

[0123] In the description and claims of the application, the words “include” and “have”, and forms thereof, are not limited to members in a list with which the words may be associated.

[0124] 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 disclosure pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0125] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity,described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0126] Although stages of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described stages carried out in a different order. A method of the disclosure may include a few of the stages described or all of the stages described. No particular stage in a disclosed method is to be considered an essential stage of that method, unless explicitly specified as such.

[0127] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0128] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0129] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within thatrange, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0130] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In addition, where there are inconsistencies between this application and any document incorporated by reference, it is hereby intended that the present application controls.

[0131] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

CLAIMSWhat is claimed is:

1. A magnetic signature element (MSE) for facilitating secured identification of a functional unit of a magnetic navigation system, by a tracking unit, the magnetic signature element comprising one or more magnets, paramagnets and / or ferromagnets arranged in a predetermined pattern, wherein said magnetic signature element is configured to be associated with the functional unit and wherein the pattern of the MSE is detectable by the tracking unit, wherein the MSE is indicative of one or more properties of the functional unit.

2. The MSE according to claim 1, comprising one or more permanent magnets.

3. The MSE according to any one of claims 1 -2, wherein each of the one or more magnets, paramagnets and / or ferromagnets comprise a predetermined shape, size and / or magnetic strength.

4. The MSE according to any one of claims 1-3, wherein the MSE is associated with a specific location / position on the functional unit.

5. The MSE according to any one of claims 1-4, wherein one or more of the magnets, paramagnets and / or ferromagnets are positioned in a specific orientation in one or more specific locations on the functional unit.

6. The MSE according to any one of claims 1-5, wherein one or more of the magnets are made of metal and further function as radiopaque markers.

7. The MSE according to any one of claims 1 -6, comprising one or more magnets and one or more regions comprising paramagnetic regions and / or ferromagnetic regions.

8. The MSE according to any one of claims 1-7, comprising one or more ferromagnets, the pattern of which is detectable upon application of an external magnetic field.

9. The MSE according to any one of claims 1-8, comprising one or more paramagnets, whereby upon application of an alternating magnetic field, the pattern of said one or more paramagnets is detectable, wherein the pattern comprises a magnetic frequency that follows the frequency of the applied alternative magnetic field.

10. The MSE according to any one of claims 1-9, wherein the functional unit comprises a cradle unit, configured to be fixed at a desired position or orientation to a body of a subject, and further be physically and / or functionally associated with the tracking unit.

11. The MSE according to any one of claims 1-10, wherein the tracking unit comprises an array of magnetic sensors, a communication module and / or a control module.

12. The MSE according to any one of claims 1-11, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, one or more images of the predetermined pattern, and based thereon to detect the MSE.

13. The MSE according to claim 12, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, a set of images, corresponding to orthogonal axes locations of the functional unit.

14. The MSE according to claim 12, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, a single, combined image, the intensity of which is representative of orthogonal axes locations of the functional unit.

15. The MSE according to any one of claims 12-14, wherein the one or more images are compared to a database of images of pre-assigned magnetic signatures, to thereby allow determining or verifying one or more properties of the functional unit.

16. The MSE according to any one of claims 12-15, wherein one or more features of the images are compared to features of a preset database of pre-assigned magnetic signature images.

17. The MSE according to any one of claims 1-16, wherein the magnetic navigation system is configured to allow tracking and / or navigating a surgical tool within a body of a subject.

18. The MSE according to any one of claims 1-17, wherein the ferromagnetic material comprises Steel (Fe-alloy), Iron (Fe), Cobalt (Co), Nickel (Ni), Nickel-Iron Alloy (Ni- Fe), Stainless steel alloy, ferritic steel, martensitic steel, duplex steel or any combination thereof.

19. The MSE according to any one of claims 1-18, wherein the paramagnetic material comprising Aluminum (Al), Magnesium (Mg), Titanium (Ti), Tungsten (W), Platinum(Pt), Molybdenum (Mo), Chromium (Cr), Stainless steel alloy, austenitic steel, or any combination thereof.

20. A cradle unit of a magnetic navigation system, the cradle unit comprising a magnetic signature indicative of one or more properties of the cradle unit, the magnetic signature is formed by one or more magnets, paramagnet(s) and / or ferromagnet(s), arranged in a predetermined pattern, wherein the predetermined pattern is identifiable by a tracking unit.

21. The cradle unit according to claim 20, wherein each of the one or more magnets, paramagnets and / or ferromagnets comprise a predetermined shape, size and / or magnetic strength.

22. The cradle unit according to any one of claims 20-21, wherein one or more of the magnets, paramagnet(s) and / or ferromagnet(s), are associated with a specific location / position on the cradle.

23. The cradle unit according to any one of claims 20-22, wherein one or more of the magnets, paramagnet(s) and / or ferromagnet(s) are positioned in a specific orientation in one or more specific locations on the cradle.

24. The cradle unit according to any one of claims 20-23, wherein one or more of the magnets are made of metal and further function as radiopaque markers.

25. The cradle unit according to any one of claims 20-24, comprising one or more magnets and one or more regions comprising paramagnetic regions and / or ferromagnetic regions, wherein the arrangement of the magnets and regions comprising paramagnetic regions and / or ferromagnetic regions form an identifiable magnetic signature.

26. The cradle unit according to any one of claims 20-25, wherein the ferromagnetic material comprises Steel (Fe-alloy), Iron (Fe), Cobalt (Co), Nickel (Ni), Nickel-Iron Alloy (Ni-Fe), Stainless steel alloy, ferritic steel, martensitic steel, duplex steel or any combination thereof.

27. The cradle unit according to any one of claims 20-26, wherein the paramagnetic material comprising Aluminum (Al), Magnesium (Mg), Titanium (Ti), Tungsten (W),Platinum (Pt), Molybdenum (Mo), Chromium (Cr), Stainless steel alloy, austenitic steel, or any combination thereof.

28. The cradle unit according to any one of claims 20-27, comprising one or more ferromagnets, the pattern of which is detectable upon application of an external magnetic field.

29. The cradle unit according to any one of claims 20-28, comprising one or more paramagnets, whereby upon application of an alternating magnetic field, the pattern of said one or more paramagnets is detectable, wherein the pattern comprises a magnetic frequency that follows the frequency of the applied alternative magnetic field.

30. The cradle unit according to any one of claims 28-29, wherein the external magnetic field is generated by the tracking unit.

31. The cradle unit according to any one of claims 20-30, comprising one or more radiopaque markers for identification of position and / or orientation of the cradle relative to the body of the subject in imaging procedures.

32. The cradle unit according to any one of claims 20-31, wherein the cradle unit is configured to be fixed at a desired position or orientation to a body of a subject, and further be physically and / or functionally associated with the tracking unit, to thereby determine and fix the position and / or orientation of the tracking unit relative to the subject of the body.

33. The cradle unit according to any one of claims 20-32, wherein the tracking unit comprises on or more magnetic sensor, an array of magnetic sensors, a communication module and / or a control module.

34. The cradle unit according to any one of claims 20-33, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, one or more images of the predetermined pattern, and based thereon detect the magnetic signature.

35. The cradle unit according to claim 34, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, a set of images, corresponding to orthogonal axes locations of the cradle unit.

36. The cradle unit according to claim 34, wherein information obtained from the tracking unit is used to generate, via an associated processing unit, a single, combined image, the intensity of which is representative of orthogonal axes locations of the cradle unit.

37. The cradle unit according to any one of claims 34-36, wherein the one or more images are compared to a database of images of pre-assigned magnetic signatures, to thereby allow determining or verifying one or more properties of the cradle unit.

38. The cradle unit according to any one of claims 34-37, wherein one or more features of the images are compared to features of a preset database of pre-assigned magnetic signature images.

39. The cradle unit according to any one of claims 20-38, wherein the cradle is disposable.

40. The cradle unit according to any one of claims 20-39, wherein the magnetic navigation system is configured to allow tracking and / or navigating a surgical tool within a body of a subject.

41. A system for tracking a surgical tool in a body of a subject, during a medical procedure, the system comprising: the cradle unit according to any one of claims 20-40; a tracking unit comprising one or more magnetic sensors configured to detect the magnetic signature of the cradle; and a processing unit configured to identify the magnetic signature and based thereon determine one or more properties of the cradle.

42. The system according to claim 41, wherein the tracking unit comprises an array of magnetic sensors.

43. The system according to any one of claims 41-42, further comprising a display configured to present to a user the magnetic signature of the cradle unit, an image of the magnetic signature, one or more features of the cradle unit, determined based on the magnetic signature, or any combinations thereof.

44. The system according to any one of claims 41-43, further comprising a user interface, a memory, a data base, a communication unit, or any combinations thereof.

45. A method for detecting a magnetic signature of a cradle unit, the method comprising:obtaining or providing the cradle of any one of claims 20-40; detecting magnetic pattern associated with the magnetic signature of the cradle unit, by a tracking unit comprising one or more magnetic sensors; and generating, by a processing unit, based on the detected magnetic pattern one or more images, and determining, based on said images the magnetic signature; to thereby determine one or more properties of the cradle unit.

46. The method according to claim 45, wherein the determining by the processing unit comprises comparing the generated images to a database of images of pre-assigned magnetic signatures, to thereby allow determining or verifying one or more properties of the cradle unit.

47. The method according to any one of claims 45-46, wherein determining comprises comparing one or more features of the generated images to features of a pre-set database of pre-assigned magnetic signature images.

48. The method according to any one of claims 45-47, further comprising adjusting operating parameters of the tracking system, based on the determined one or more properties of the cradle unit.

49. The method according to any one of claims 45-48, further comprising registering the position and / or orientation of the cradle unit, to an imaging scan of the subject.

Images