WO2025088606A1

WO2025088606A1 - Magnetic surgical tools and uses thereof in medical procedures

Info

Publication number: WO2025088606A1
Application number: PCT/IL2024/051025
Authority: WO
Inventors: Daniel Messinger; Yoseph Weitzman
Original assignee: Epidutech Ltd
Current assignee: Epidutech Ltd
Priority date: 2023-10-25
Filing date: 2024-10-22
Publication date: 2025-05-01
Anticipated expiration: 2026-04-25

Abstract

Provided herein is a magnetic or magnetizable surgical tool, for use in medical procedures, as well as systems and methods for tracking the surgical tool during the procedures. Provided herein is a device for surgical procedures including a trackable magnetizable surgical tool having a paramagnetic and/or a ferromagnetic material, and a permanent magnet associated with the trackable surgical tool, facilitating tracking of the surgical tool by a magnetic sensing unit.

Description

MAGNETIC SURGICAL TOOLS AND USES THEREOF IN MEDICAL PROCEDURES

FIELD OF THE INVENTION

[0001] The present invention, in some embodiments thereof, relates to surgical tools having a magnetic signature, tracking systems and methods for tracking the position and/or orientation thereof in various medical procedures.

BACKGROUND

[0002] Surgical tools, such as guide wires (for example, Kirschner wires (K-wires)), needles or pins, are commonly used in medical procedures, (e.g., orthopedic procedures, such as, fixation pins for bone fragments, anchors for skeletal traction, temporary joint immobilization, guide wires for cannulated drills, screws, or other procedures, such as needles for biopsies, aspiration needles, neuro-modulation lead needles, and the like). The tools can have a variety of distal tips and may be driven into the target tissue, for example, to bones, to soft tissues, for the purpose of treatment, biopsy, ablation or any other purpose, through the skin to be positioned in a target region. Since the surgeon cannot maintain a line of sight with the tool and in order to track the location of the tool in the body, fluoroscopy or other type of imaging (e.g. CT scan, MRI, ultrasound, etc.) may be used, which is a cumbersome and costly procedure, and may be exposing the patient and the surgical team to undesired radiation.

[0003] Utilizing a magnet with a medical tool, for tracking the medical tool using a corresponding tracking system has been proposed, however, such magnets are usually relatively large and are not suitable for use with medical tools having a small diameter, such as wires or pins.

[0004] Thus, there is a need in the art for improved surgical tools having a magnetic region, that can be used with tracking systems and methods to allow a safe and accurate, reliable detection and tracking of the tools during medical procedures. SUMMARY

[0005] There is provided, in accordance with some embodiments, advantageous surgical tool, such as guidewire(s), needles, pins, and the like, for use in medical procedures, wherein the surgical tool includes or is associated with a magnet (which may be, for example, a permanent magnet, an electromagnet, or a ferromagnetic magnetizable material), such that a corresponding tracking system can track the spatial location (position and/or orientation) of the magnetic surgical tool, for example, in a body of a subject.

[0006] There is provided, in accordance with some exemplary embodiments, an advantageous magnetic surgical tool (e.g., K-wire, needle, pin) for use in orthopedic procedures, wherein the surgical tool includes or is associated with (for example, as an “addon”, or remotely) a magnet, such that a corresponding tracking system can track the spatial location of the magnetic surgical tool /needle in a body of a subject.

[0007] In some embodiments, the surgical tool disclosed herein may include a ferromagnetic magnetizable material. In some embodiments, at least a portion of the surgical tool may be made or include a ferromagnetic material.

[0008] In some embodiments, the surgical tool disclosed herein may include a paramagnetic magnetizable material. In some embodiments, at least a portion of the surgical tool may be made or include a paramagnetic material.

[0009] In some embodiments, the surgical tool disclosed herein may include a magnet (or a plurality of magnets) positioned between the distal end and the proximal end of the surgical tool, without otherwise affecting the hardness and/or size (e.g., diameter) of the wire.

[0010] In some embodiments, advantageously, the disclosed surgical tool may include a magnet (or a plurality of magnets, which may be arranged in a desired order), which has a diameter equal to or smaller than the external diameter of the wire, while advantageously, maintaining the hardness of the distal end or tip of the wire, to allow it to penetrate hard tissues. Furthermore, the disclosed tool overcomes technical hurdles of forming a functional tool (such as, a K-wire), which is made of non-magnetic materials (such as stainless steel), but nevertheless has a magnetic region disposed at the proximal end or between the distal end and the proximal region of the wire, while maintaining integrity, functionality as well as any other mechanical and physical properties of a standard K-wire.

[0011] According to some embodiments, advantageously, the disclosed magnetic tool (such as, K-wire) alleviates or reduces the need to use fluoroscopy imaging during a medical procedure (for example, during an orthopedic procedure), thereby increasing patient safety, while reducing costs and procedure length.

[0012] According to some embodiments, there is provided a system for tracking the magnetic/magnetized surgical tool during a medical procedure, the system includes: the tool, a permanent magnet, and an array of magnetic sensors, configured to detect a change/deformation/disturbance in magnetic field, generated (directly or indirectly) by the movement of the tool within the body; and a processor configured to receive the detected change in magnetic field and determine the spatial location (e.g. position and/or orientation) of the tool during or at the end of the medical procedure.

[0013] 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 magnetic field with the spatial location of the magnet.

[0014] According to some embodiments, the magnetic sensors may be in the form of an array of magnetic sensors that may be wirelessly associated with an at least one magnet associated (functionally and/or physically) with the tool, thereby enabling the user (for example, a physician/operator) to freely manipulate the tool, without physical limitations that would have been present if the magnetic sensors would have been mechanically coupled to the magnetic/magnetized tool.

[0015] In some embodiments, the array of magnetic sensors may be configured to detect a change in magnetic field generated by the movement of the disclosed magnetic/magnetized tool, thereby enabling the detection of the spatial location of the tool, optionally without a need to apply a magnetic field in the operation room, and thereby allowing the user to detect the location of the tool, without causing interference to other devices in the operation room during the medical procedure. [0016] According to some embodiments, there is provided herein a device for surgical procedures, the device includes: a trackable magnetizable surgical tool including a paramagnetic and/or a ferromagnetic material; and a permanent magnet associated with the trackable surgical tool. According to some embodiments, the paramagnetic and/or ferromagnetic material may be configured to be magnetized by the permanent magnet, thereby facilitating tracking of the surgical tool by a magnetic sensing unit.

[0017] According to some embodiments, the permanent magnet may be physically associated with the surgical tool.

[0018] According to some embodiments, the permanent magnet may be permanently attached to the surgical tool.

[0019] According to some embodiments, the permanent magnet may be removably attached to the surgical tool.

[0020] According to some embodiments, the permanent magnet may be positioned in proximity to the distal end of the surgical tool.

[0021] According to some embodiments, the permanent magnet may be remote from the surgical tool.

[0022] According to some embodiments, the permanent magnet may be stationary and remote from the surgical tool.

[0023] According to some embodiments, the permanent magnet may be remote from the surgical tool and wherein the surgical tool comprises ferromagnetic material. According to some embodiments, the ferromagnetic material may be magnetizable by the permanent magnet and may be configured to deform/change a magnetic field generated by the permanent magnet upon a change in position and/or orientation of the surgical tool.

[0024] According to some embodiments, the permanent magnet may be stationary.

[0025] According to some embodiments, the surgical tool includes one or more sections of paramagnetic and/or ferromagnetic material. Each possibility is a separate embodiment.

[0026] 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, and the like, or any combination thereof. Each possibility is a separate embodiment.

[0027] According to some embodiments, the paramagnetic material includes Aluminum (Al), Magnesium (Mg), Titanium (Ti), Tungsten (W), Platinum (Pt), Molybdenum (Mo), Chromium (Cr), Stainless steel alloy, austenitic steel, and the like, or any combination thereof. Each possibility is a separate embodiment.

[0028] According to some embodiments, the permanent magnet includes an array of electromagnets.

[0029] According to some embodiments, the device may be for use in navigation guided surgical procedures.

[0030] According to some embodiments, the guided surgical procedure may include biopsy, orthopedic procedure, tissue removal, tissue ablation, tissue manipulation, delivery of implants, delivery of electrodes for neural stimulation, and the like, or any combination thereof. Each possibility is a separate embodiment.

[0031] According to some embodiments, the surgical tool may be selected from a guidewire, a K (Kirschner)- wire, a needle, and/or a pin. In some embodiments, the surgical tool may include, for example, but not limited to: a tool for preparing a hole for a bone screw, a tool for delivering a bone screw into position, a tool for preparing a bony surface for fusion with another bony surface, a tool for preparing a bony surface for the placement or interface of an implant, a tool for delivering an implant to a desired location, a tool for injecting materials/substances into the body via a needle, a tool for utilizing a hollow tube that functions as a guide for the insertion of flexible tools into the body, and the like, or any combination thereof. Each possibility is a separate embodiment.

[0032] According to some embodiments, the surgical procedure may be an orthopedic procedure and the surgical tool may be a Kirschner wire (K-wire).

[0033] According to some embodiments, there is provided herein a system for tracking a surgical tool of a device for surgical procedures, during a medical procedure, the system includes: 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; and 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. In some embodiments, the tool is in the body of the subject. In some embodiments, the tracking is of the tool in the body of the subject. In some embodiments, the processing unit configured to determine a position and/or orientation of the surgical tool within the body of the subject.

[0034] According to some embodiments, the tracking unit includes an array of magnetic sensors.

[0035] According to some embodiments, determining the position and/or orientation of the surgical tool may be based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent magnet of the device, and/or of a surgical tool comprising a ferromagnetic material.

[0036] 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.

[0037] According to some embodiments, the system may further include a user interface, a memory, a data base, a communication unit, or any combinations thereof. Each possibility is a separate embodiment.

[0038] According to some embodiments, there is provided herein, a method for tracking a surgical tool in a body of a subject, during a medical procedure, the method includes: obtaining the device for surgical procedures; detecting magnetic field generated by the permanent magnet and/or changes/ disturbances/deformations in said magnetic field by a tracking unit comprising one or more magnetic sensors; and determining, based on the magnetic field and/or disturbances thereto, a position and/or orientation of the surgical tool within the body.

[0039] According to some embodiments, there is provided herein a method for tracking a surgical tool, during a medical procedure, the method includes: obtaining the device for surgical procedures; detecting magnetic field generated by the permanent magnet and/or changes/ disturbances/deformations in said magnetic field by a tracking unit comprising one or more magnetic sensors; and determining, based on the magnetic field and/or disturbances thereto, a position and/or orientation of the surgical tool. [0040] According to some embodiments, determining the position and/or orientation of the surgical tool may be based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent magnet and/or a surgical tool comprising a ferromagnetic material.

[0041] According to some embodiments, the method may further include registering the determined position and/or orientation of the magnetic tool, to an imaging scan of the subject.

[0042] According to some embodiments, there is provided herein a surgical tool including at least one magnet positioned between a distal end of the surgical tool and a proximal portion thereof. According to some embodiments the surgical tool includes: a guidewire, Kirschner wire (K- wires), a needle, a pin, or any combination thereof. Each possibility is a separate embodiment.

[0043] According to some embodiments, the at least one magnet may be positioned at or in proximity to the distal end of the tool.

[0044] According to some embodiments the magnet includes a plurality of magnets, arranged in a designated configuration.

[0045] According to some embodiments, the plurality of magnets may be arranged asymmetrically.

[0046] According to some embodiments, S-pole of a first magnet faces an S-pole of a second magnet.

[0047] According to some embodiments, the surgical tool includes an internal lumen, said at the least one magnet is positioned within the lumen.

[0048] According to some embodiments, the at least one magnet may be housed within a sleeve, said sleeve is physically associated with a proximal section of the distal end of the surgical tool, and to a distal section of the proximal portion of the tool, thereby forming a continuous tool.

[0049] According to some embodiments, the sleeve may be welded or glued to the distal end and the proximal portion of the surgical tool. [0050] According to some embodiments, the diameter of the magnet may be smaller than the external diameter of the surgical tool.

[0051] According to some embodiments, the length of the at least one magnet may be larger than external diameter thereof.

[0052] According to some embodiments, the distal end and the proximal portion of the tool may not be magnetic.

[0053] According to some embodiments, the surgical tool may be made or partially made of a ferromagnetic material and may be configured to be magnetized by an external magnetic field.

[0054] According to some embodiments, the surgical tool may be made or partially made of a ferromagnetic material and configured to be magnetized by an external magnetic field.

[0055] According to some embodiments, the surgical tool may be associated with a magnetic or ferromagnetic magnetizable add-on.

[0056] According to some embodiments, the surgical tool may be for use in navigation guided surgical procedures.

[0057] According to some embodiments, there is provided herein a system for tracking the surgical tool, in a body of a subject, during a medical procedure, the system includes: a tracking unit including one or more magnetic sensors configured to detect magnetic field generated by the magnetic tool and/or changes to the magnetic field; and a processing unit configured to determine the spatial location of the tool within the body, based on the detected magnetic field and/or changes thereto.

[0058] According to some embodiments, the tracking unit may include an array of sensors.

[0059] According to some embodiments, determining the spatial location may be based on deep learning algorithm(s) correlating a change of the magnetic field with the spatial location of the magnet of the surgical tool.

[0060] According to some embodiments, the system may further include a display configured to present to a user the spatial location of the tool. [0061 ] According to some embodiments, the system may further include a user interface, a memory, a data base, a communication unit, or any combinations thereof. Each possibility is a separate embodiment.

[0062] According to some embodiments, there is provided herein a method for tracking the surgical tool, in a body of a subject, during a medical procedure, the method includes: providing a tracking system including a tracking unit comprising one or more magnetic sensors configured to detect a magnetic field generated by the magnetic or magnetized tool, and/or changes to the magnetic field; and determining, utilizing a processor, the spatial location of the surgical tool within the body, based on the detected magnetic field and/or changes in the magnetic field.

[0063] According to some embodiments, determining the spatial location may be based on deep learning algorithm(s) correlating a change of the magnetic field with the spatial location of the magnet of the surgical tool.

[0064] According to some embodiments, the method may further include registering the determined spatial location of the magnetic tool within the body of the subject, to an imaging scan of the subject.

[0065] 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

[0066] 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.

[0067] FIG. 1 shows a schematic perspective illustration of a tool (in the form of a K- wire) having a magnet, according to some embodiments;

[0068] FIG. 2 shows a schematic perspective illustration of a tool (in the form of a K- wire) having a plurality of ordered magnets, according to some embodiments; [0069] FIG. 3 shows a schematic perspective view of system for tracking a magnetic K- wire in orthopedic procedure, according to some embodiments;

[0070] FIG. 4 schematically shows a perspective illustration of a device for surgical procedures having a surgical tool (which includes paramagnetic material) and a permanent magnet associated therewith, according to some embodiments;

[0071] FIG. 5 schematically shows a perspective illustration of a device for surgical procedures having a surgical tool (which includes a ferromagnetic material) and a permanent magnet attached thereto, according to some embodiments;

[0072] FIG. 6 schematically shows a perspective illustration of a device for surgical procedures having a surgical tool (which includes a ferromagnetic material) and a remote permanent magnet, according to some embodiments;

[0073] FIG. 7 schematically shows a perspective view of a system for tracking a surgical tool of a device for surgical procedures having a device for surgical procedure (e.g. the device of FIG. 4 or FIG. 5) and a magnetic tracking (sensing) unit, according to some embodiments;

[0074] FIG. 8 schematically shows a perspective view of a system for tracking a surgical tool of a device for surgical procedures having a device for surgical procedure which includes a remote permanent magnet (e.g. the device of FIG. 6) and a magnetic tracking (sensing) unit, according to some embodiments; and

[0075] FIG. 9 schematically shows a perspective view of system for tracking a surgical tool of device for surgical procedures in orthopedic procedure, having a surgical tool (which includes a ferromagnetic material), a remote array of permanent magnets attached to a patient’s body, and a mounted magnetic tracking (sensing) unit in a standoff position, according to some embodiments.

DETAILED DESCRIPTION

[0076] According to an aspect of some embodiments there is provided an advantageous magnetic or magnetized surgical tool (such as a guidewire, pin, needle, etc.), for use in medical procedures, as well as systems and methods for tracking thereof during the procedure.

[0077] According to some embodiments, and for simplicity of description, K-wire may be used herein an exemplary guidewire. However, other suitable guidewires and tools, such as needles and pins that can be associated with a magnet, can be utilized in the systems and methods disclosed herein.

[0078] According to an aspect of some embodiments there is provided an advantageous a magnetic/magnetized surgical tool for use in medical procedures. Further provided are systems and methods for tracking the surgical, for example, inside a subject's body, during the medical procedure.

[0079] According to some embodiments there is provided an advantageous K-wire for use in orthopedic procedures. Further provided are systems and methods for tracking K- wire inside a subject's body during the orthopedic procedure.

[0080] Reference is now made to Fig. 1, which shows a schematic perspective illustration of a K-wire having a magnet, according to some embodiments. As shown in Fig. 1, K-wire 100, includes a proximal portion 112 and a distal portion 114, having a distal tip 122. The distal tip may have any desired shape (such as, for example, but not limited to: pointed, arrowhead, diamond head, trocar, slotted trocar, notched trocar, Medin, etc.), in accordance with the target tissue and orthopedic procedure. The K-wire may be made of any suitable material (including, for example, stainless steel, titanium). K-wire 110 further includes magnet 116, which is located between the proximal portion 112 and distal portion 114. In some embodiments, the magnet may be positioned in close proximity to the distal end of the K-wire. Magnet 116 may be made of any suitable magnetic material (for example, Neodymium (Nd)) which can provide sufficient magnetic field for being detected by external sensors, while maintaining stiffness/hardness and having a diameter small enough, so as to fit with the K-wire body. Magnet 116 may be housed within housing 118 (for example, in the form of a sleeve). In some embodiments, Magnet 116 may be directly placed between the distal end and the proximal region of the K-wire. In some embodiments, Magnet 116 may fit into sleeve 118, and the housed magnet may then be attached to the K- wire, for example, by being attached at regions 120A-B of the wire. The association may be facilitated, for example, by welding, gluing, adhering, and the like. In some embodiments, magnet 116 may fit within hollow lumen of the K-wire. Magnet 116 may be positioned at any desired orientation, with respect of N or S poles. For example, as shown in Fig. 1, magnet 116 may be positioned/oriented such that North (N) pole is facing the distal end of the surgical tool and the South (S) pole is facing the proximal portion of the wire. The orientation of the poles may further aid in tracking the position/location/orientation of the magnetic K-wire, using a tracking system (having magnetic sensor(s)), as detailed below.

[0081] Reference is made to Fig. 2, which shows a schematic perspective illustration of a K-wire having a plurality of ordered magnets, according to some embodiments. As shown in Fig. 2, K-wire 200, includes a proximal portion 212 and a distal portion 214, having a distal tip 222. The distal tip may have any desired shape (such as, for example, but not limited to: pointed, arrowhead, diamond head, trocar, slotted trocar, notched trocar, Medin, etc.), in accordance with the target tissue and orthopedic procedure. The K-wire 200 may be made of any suitable material (including, for example, stainless steel, titanium). K-wire 200 further includes a plurality of magnets 216A-C, arranged in a desired order, and being, located between the proximal portion 212 and distal portion 214 of K-wire 200. Magnets 216A-C may each be made of any suitable magnetic material (for example, Neodymium (Nd)) which can provide sufficient magnetic field for being detected by external sensors, while maintaining stiffness/hardness and having a diameter small enough, so as to fit with the K-wire body. The plurality of magnets may be identical or different with respect to composition, size (length, diameter) and orientation. Each of magnets 216A-C may be housed within a respective housing 218A-C (for example, in the form of a sleeve). In some embodiments, Magnets 216A-C may be directly placed between the distal end and the proximal region of the K-wire. In some embodiments, Magnets 216A-C may each fit into respective sleeve 218A-C, and the housed magnets may then be orderly attached to the K- wire, to form an elongated sleeve, which is attached, at regions 220A-B of the wire. The association may be facilitated, for example, by welding, gluing, adhering, and the like. In some embodiments, the plurality of magnets 216A-C may all be fitted in a single housing, said housing is then attached to the wire. In some embodiments, magnets 216A-C may fit within hollow lumen of the K-wire. The organization/order of magnets 216A-C may be predetermined, and may advantageously include any order, even such in which similar poles (for example, S-S or N-N) are facing each other. Thus, magnets 216A-C may be positioned at any desired orientation, with respect of N or S poles. For example, as shown in Fig. 2, magnet 216A-C may be positioned/oriented such that a first North (N) pole (of magnet 216A) is facing the distal end of the surgical tool and the third South (S) pole (of magnet 216C) is facing the proximal portion of the wire. The second (middle) magnet 216B is positioned such that the S-pole thereof is facing the S-pole of magnet 216A, and the north pole thereof is facing the N-pole of magnet 216C. The ordering of the polarity of magnets/orientation of the poles may further aid in tracking the position/location/orientation of the magnetic K-wire. In some embodiments, different K-wires may have different order/organization/orientation of magnets, thereby enabling differentiation or distinguishing between different K-wires, even when used during the same procedure. In some embodiments, the orientation/ordering of the magnets may be used as an identification barcode of the respective K-wire.

[0082] According to some embodiments, the magnet may be positioned at or in close proximity to the proximal end of the K-wire. In some embodiments, the magnet may be positioned at essentially the middle portion of the K-wire.

[0083] According to some embodiments, the outer or inner diameter of the K-wire may be in the range of about 1 mm- 2 mm. In some embodiments, the length of K-wire may be about 200 mm-600 mm. In some exemplary embodiments, the inner diameter of the wire may be about 1.6mm, and the outer diameter of the K-wire may be about 1.7mm.

[0084] According to some embodiments, the diameter of the magnet may be, for example, in the range of about 1 -2 mm. In some embodiments, the diameter of the magnet may be in the range of about 1.1-1.9 mm. In some embodiments, the diameter of the magnet may be in the range of about 1.4-1.6 mm. In some exemplary embodiments, the diameter of the magnet may be about 1.5mm. In some embodiments, the diameter of the magnet is not larger than the diameter of the K-wire. In some embodiments, the diameter of the magnet is smaller than the diameter of the K-wire. In some embodiments, the length of the magnet is larger than the diameter of the magnet. In some embodiments, the ratio between the length and the diameter of the magnet is higher than 1 : 1. In some embodiments, the length of the magnet is in the range of about 10-50 mm. In some exemplary embodiments, the length of the magnet is about 30mm. In some embodiments, when a plurality of magnets are used, the total length thereof may be in the range of about 10-50mm. In some embodiments, the total length may be about 30mm.

[0085] In some embodiments, when the magnet is housed in a sleeve, the external or internal diameter of the sleeve may be in the range of about 1-2 mm. In some embodiments, the sleeve may be in the range of about 1.1-1.9 mm. In some embodiments the external diameter of the sleeve is essentially similar to the external diameter of the K-wire. In some embodiments the external diameter of the sleeve is essentially smaller than the external diameter of the K-wire. In some exemplary embodiments, the (external) diameter of the sleeve may be 1 ,7mm. In some embodiments, the length of the sleeve may be in the range of about 10-50 mm. In some exemplary embodiments, the length of the sleeve is about 30mm.

[0086] According to some embodiments, the disclosed K-wire may be used in various orthopedic procedures, including, for example, temporary bone fixation, definitive fixation of bone fracture fragments, intramedullary fixation of bones (such as the ulna), used as anchor for tension band wiring, form and maintain traction to a bone, used to guide cannulated screws to a precise location, and the like.

[0087] According to some embodiments, there is provided a system for tracking the magnetic K-wire during or after an orthopedic procedure. The system includes a tracking unit, which includes one or more sensors configured to detected/sense magnetic field generated by the magnetic K-wire, and a processing unit configured to determine the location of the K-wire within the patient’s body, based on the detected signal. According to some embodiments, the one or more signals may include a change in strength, direction, and/or flux of the magnetic field. According to some embodiments, the one or more signals may include a magnitude of the magnetic vector detected by one or more of the plurality of sensors.

[0088] According to some embodiments, the system is configured to track a plurality of K-wires, positioned/inserted/navigated in the patient body. In some exemplary embodiments, the system is configured to identify/detect each of the plurality of K-wires used in the procedure, wherein each of the K-wire has a similar or different arrangement of magnets (i.e., different “barcode”, as detailed above). Reference is now made to Fig. 3, which shows a schematic perspective view of system for tracking a magnetic K-wire in orthopedic procedure, according to some embodiments. As shown in Fig. 3, magnetic K- wire 300 includes a proximal portion 312 and distal portion 314, inserted into the target region in the subject body (for example, shown as lumbar bones 332). The K-wire further includes a magnet 316 positioned between the proximal region 312 and distal region 314. Further shown is external tracking unit 330, of tracking system, the tracking unit includes one or more magnetic sensors (shown as array of sensors), configured to detect magnetic signal generated by magnet 316 of K-wire 300. The detected signal can then be processed by a processing unit of the tracking system, to determine the spatial location/position/orientation of the K-wire within the body of the subject.

[0089] According to some embodiments the detection of the spatial location of the K-wire by the tracking system may be based on deep learning algorithms correlating the change of the magnetic field with the spatial location and/or orientation of the magnet. According to some embodiments, the tracking unit may include an array of magnetic sensors configured to be positioned near the patient during the orthopedic procedure, and to detect a change of the magnetic field of the magnet. According to some embodiments, the tracking system may include a processor in communication with the array of magnetic sensors and configured to apply one or more signals received from the array of magnetic sensors to one or more deep learning algorithms. According to some embodiments, the deep learning algorithms may be configured to identify the spatial location and/or orientation of the K- wire, based, at least in part, on the received one or more signals.

[0090] According to some embodiments there is provided a method for tracking a magnetic K-wire inside a patient’s body during an orthopedic procedure. According to some embodiments, the method may include receiving one or more signals from the array of magnetic sensors. According to some embodiments, the method may include applying the received one or more signals to one or more deep learning algorithms configured to determine the spatial location of the K-wire in relation to the array of sensors and/or within the body of the patient. According to some embodiments, the method may include registering the determined spatial location of the K-wire within the body to a scan of the patient in real time.

[0091] According to some embodiments, the processor may be in communication with the plurality of 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.

[0092] 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 K-wire based, at least in part, on the received one or more signals.

[0093] According to some embodiments, there is provided a method for fabricating a magnetic K-wire, the method includes a step of attaching a magnet, or a plurality of magnets between a distal end of a K-wire and a proximal portion of the K-wire. In some embodiments, the magnet is integrally formed with the K-wire. In some embodiments, the magnet is permanently associated with the K-wire. In some embodiments, the method may include a step of attaching a sleeve housing a magnet (or a plurality of magnets), between a distal end and a proximal portion of a K-wire. In some embodiments, the method may include a step of separating the K-wire at a location between the distal and a proximal end thereof, and welding magnet or a sleeve housing the magnet between the separation locations, to thereby form a continuous K-wire having a magnet.

[0094] According to some embodiments, the surgical tool (such as a guidewire e.g., K- wire, pin, or needle (such as a needle for direct injection or as a guide, e.g. Jamshidi), may be made (or partially made) of a ferromagnetic material and may be magnetized by an external magnetic field, thereby maintaining the functionality thereof as a guide wire (for example, allowing cannulated medical tools to be guided by the wire to a body location).

[0095] According to some embodiments, the K-wire, pin, needle, or any other suitable surgical tool may include or be associated with a magnetic add-on, that may be at any suitable geometrical shape or form, such as, for example, but not limited to: circular, ring, rectangular, oval, and the like. In some embodiments, the magnetic add-on may be mechanically attached/associated with the wire, needle or other surgical tool (surgical instrument). According to some embodiments, the magnetic add-on may be in the form of a sterile adhesive sticker that can be attached/adhered (reversibly or permanently) to any portion of a wire, needle or surgical instrument, including, for example, the distal region thereof (i.e., the region that is inserted into the surgical site in the subject’s body).

[0096] In some embodiments, using a calibration procedure as disclosed herein, the instrument (wire, needle, surgical tool etc.), which is associated with the magnetic add-on, may be navigated to a body location, based on its magnetic signature, by using a corresponding navigation or tracking computerized method, as disclosed herein.

[0097] In some embodiments, the magnetic add-on disclosed herein may be sterilizable or packed in a sterile enclosure. In some embodiments, the magnetic add-on may be disposable. In some embodiments, the magnetic add-on may be for a single or multipleuse.

[0098] According to an aspect of some embodiments there is provided an advantageous device for surgical procedures, as well as systems and methods for tracking thereof during the procedure.

[0099] According to some embodiments, the device includes a trackable magnetizable surgical tool and a permanent magnet associated with the trackable surgical tool. According to some embodiments, the magnetizable surgical tool may include a paramagnetic and/or a ferromagnetic material. Each possibility is a separate embodiment. According to some embodiments, the paramagnetic and/or ferromagnetic material is configured to be magnetic magnetized by the permanent magnet, thereby facilitating tracking of the surgical tool by a magnetic tracking (magnetic sensing) unit.

[00100] According to some embodiments, the permanent magnet may be a material or object that produces a magnetic field. According to some embodiments, the permanent magnet may be an object made from a material that is magnetized and creates its own persistent magnetic field.

[00101] According to some embodiments, the surgical tool may be a guidewire (e.g. K (Kirschner)-wire), a needle, a pin, and the like for use in surgical procedures, or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the surgical tool may be any tool or combination of tools designed for, but not limited to, one or more of the following procedures: preparing a hole for a bone screw, delivering a bone screw into position, preparing a bony surface for fusion with another bony surface, preparing a bony surface for the placement or interface of an implant, delivering an implant to a desired location, injecting materials into the body via a needle, or utilizing a hollow tube that functions as a guide for the insertion of flexible tools into the body. Each possibility is a separate embodiment.

[00102] According to some embodiments, the surgical procedure may include 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. According to some embodiments, the surgical procedure is an orthopedic procedure.

[00103] As used herein the terms “magnetic tracking unit and “magnetic sensing unit“, may be used interchangeably and refer to a magnetic sensor or an array of magnetic sensors.

[00104] Reference is now made to FIGs. 4-6, which schematically show a perspective illustration of a device for surgical procedures having a surgical tool associated with a permanent magnet. In accordance with some embodiments, the association of the permanent magnet with the trackable surgical tool may be physical association (as shown in FIGs. 4- 5), remote association (as shown in FIG. 6), or a combination thereof. Each possibility is a separate embodiment. According to some embodiments, the trackable surgical tool which is physically associated with the permanent magnet (for example, as shown in Figs. 4-5) may include a ferromagnetic and/or a paramagnetic material. Each possibility is a separate embodiment. According to some embodiments, the trackable surgical tool which is remotely associated with the surgical tool (for example, as shown in Fig. 6) may include a ferromagnetic material.

[00105] FIG. 4 schematically shows a device for surgical procedure 400 which includes a surgical tool comprising paramagnetic material 410 and a permanent magnet 416 physically associated with the surgical tool 410. According to some embodiments surgical tool 410 may include one or more sections of paramagnetic material. According to some embodiments, surgical tool 410 is a paramagnetic material. According to some embodiments, the surgical tool 410 is made or partially made of a paramagnetic material. In some embodiments, the surgical tool 410 may be partially or transiently magnetized when subjected to the magnetic field of a permanent magnet 416. In some embodiments, this magnetization is temporary and may persist only in the presence of an external magnetic field such as the magnetic field of permanent magnet 416.

[00106] FIG. 5 schematically shows a device for surgical procedure 500 which includes a surgical tool comprising ferromagnetic material 510 and a permanent magnet 516 physically associated with the surgical tool 510. According to some embodiments surgical tool 510 may include one or more sections of ferromagnetic material. According to some embodiments, surgical tool 510 is a ferromagnetic material. According to some embodiments, surgical tool 510 is made or partially made of a ferromagnetic material and may be configured to be magnetized by an external magnetic field. The ferromagnetic material of surgical tool 510 is magnetized when subjected to the magnetic field of permanent magnet 516. This magnetization is not temporary and may remain even after removing an external magnetic field such as the magnetic field of permanent magnet 516.

[00107] As further shown in FIGs. 4-5, surgical tools 410 and 510 include a proximal portion (412 and 512, respectively) and a distal portion (414 and 514, respectively) having a distal tip (422 and 522, respectively). According to some embodiments, the permanent magnet, such as magnets 416 and 516, may be located/physically associated between the proximal portion (such as 412 and 512, respectively) and the distal portion (such as 414 and 514, respectively) of the surgical tool (such as 410 and 510, respectively). As depicted in FIG. 4 and FIG. 5, according to some embodiments, permanent magnets 416 and 516 may be positioned/physically attached in proximity to the distal ends of the distal portions (414 and 514, respectively) of surgical tools 410 and 510, respectively. According to some embodiments, the permanent magnet may be positioned/physically attached at the proximal end of the distal portion of the surgical tool

[00108] According to some embodiments, the distal tip, such as distal tips 422, 522 and 622, may have any desired shape such as, for example, but not limited to: pointed, arrowhead, diamond head, trocar, slotted trocar, notched trocar, Medin, etc., in accordance with the target tissue and surgical procedure (e.g. orthopedic procedure).

[00109] According to some embodiments, the permanent magnet, such as permanent magnets 416, 516 and 616, may be made of any suitable magnetic material (for example, Neodymium (Nd)) which can provide sufficient magnetic field for being detected by (external) magnetic sensors.

[00110] Although not shown, according to some embodiments, the physical association of the permanent magnet to the surgical tool (such as in devices 400 and 500) may be a permanent attachment or a removable attachment to the surgical tool. Each possibility is a separate embodiment.

[00111] According to some embodiments, the device for surgical procedure may include a permanent magnet permanently attached to a surgical tool which includes ferromagnetic material. According to some embodiments, the device for surgical procedure may include a permanent magnet permanently attached to a surgical tool which includes paramagnetic material. According to some embodiments, the device for surgical procedure may include a permanent magnet removably attached to a surgical tool which includes ferromagnetic material. According to some embodiments, the device for surgical procedure may include a permanent magnet removably attached to a surgical tool which includes paramagnetic material.

[00112] According to some embodiments, removably attached permanent magnet may be attached to the surgical tool by an attachment mechanism (not shown), which may provide a secure yet easily detachable connection with the permanent-magnet. According to some embodiments, the attachment mechanism ensures that removably attached permanent magnet remains firmly in place during operation (e.g. surgical procedure) while still being simple to detach from the surgical tool when necessary.

[00113] According to some embodiments, the attachment mechanism may include, for example but not limiting to, snap-fit connectors, mechanical fasteners, adhesive fasteners, stickers (e.g. magnetic stickers), clips, threaded connections, latches, or any combination thereof. Each possibility is a separate embodiment. [00114] According to some embodiments, the attached magnet may be in the form of a magnetic sticker, configured to be placed/adhered to the tool, at a desired location on the tool.

[00115] According to some embodiments, the association of the trackable surgical tool with the permanent magnet may be a remote association, in which both the tool and the permanent magnet are physically distant or not in direct contact (for example, as shown in FIG. 6). However, despite their separation, the surgical tool and the permanent magnet may interact or communicate via magnetic fields. According to some embodiments, when in remote association, the surgical tool includes a ferromagnetic material. Fig. 6 schematically shows a device for surgical procedure 600 which includes a surgical tool having a ferromagnetic material 610 and a remote permanent magnet 616. According to some embodiments, the remote permanent magnet may be stationary or mobile. Each possibility is a separate embodiment.

[00116] According to some embodiments surgical tool 610 may include one or more sections of ferromagnetic material. According to some embodiments, surgical tool 610 is a ferromagnetic material. The ferromagnetic material of surgical tool 610 is magnetized when subjected to the magnetic field of permanent magnet 616. According to some embodiments, the ferromagnetic material is magnetizable by the permanent magnet and is configured to deform the magnetic field generated by the permanent magnet upon a change in position and/or orientation of the surgical tool.

[00117] 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.

[00118] 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.

[00119] According to some embodiments, a remote permanent magnet, such as magnet 616 of device 600, advantageously, reduces sterility requirements for the magnet, decreases its manufacturing costs, and eliminates biocompatibility requirements thereof, since it (the magnet) may not have to be pre-included/pre-integrated/pre-attached to the surgical tool. Consequently, advantageously, a remote permanent magnet, such as magnet 616 of device 600, may be larger and/or stronger than physically attached permanent magnets, such as permanent magnets 416 and 516, depending on the procedure's requirements. Alternatively, the remote permanent magnet, such as magnet 616 of device 600, may be configured with varied dimensions, geometries, and magnetic strengths to suit specific operation requirements/needs. This adaptability advantageously allows precise customization, thereby enhancing the surgical tool’s functionality and versatility.

[00120] According to some embodiments, a remote permanent magnet, such as remote magnet 616 of device 600, may include one or more (permanent) magnets. According to some embodiments, a remote permanent magnet may be a remote array of (permanent) magnets. According to some embodiments, a remote permanent magnet may be a remote array of electromagnets.

[00121] According to some embodiments, the permanent magnet may be at any suitable geometrical shape or form, such as, for example, but not limited to: circular, ring, rectangular, oval, and the like. Each possibility is a separate embodiment.

[00122] It is noted that, according to some embodiments, the magnetic field of the permanent magnet may be tracked by a magnetic tracking (sensing) unit (such as, for example, units 730, 830, or 930 shown in FIGs. 7-9), accordingly the device for surgical procedure (such as device 400 or 500), in which the surgical tool is physically associated with the permanent magnet, may be also trackable by the tracking unit (such as, for example, units 730, 830, or 930 shown in FIGs. 7-9). According to some embodiments, the magnetic 1 field generated by the associated permanent magnet is altered/modified/deformed upon a change in position and/or orientation of the surgical tool, thereby enabling the surgical tool to be (magnetically) trackable.

[00123] As used herein, in accordance with some embodiments, the term “position and/or orientation” refers to the spatial location of the surgical tool within the operational environment.

[00124] According to some embodiments, a device for surgical procedure, such as but not limited to device 400, 500, or 600 may be used in navigation guided surgical procedure. Guided surgical procedure may include 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.

[00125] Reference is now made to FIG. 7 which schematically shows a perspective view of a system for tracking a surgical tool of a device for surgical procedures 700 having a device for surgical procedure 702 and a magnetic tracking (sensing) unit 730, according to some embodiments. According to some embodiments, the device for surgical procedure 702 may be the device of FIG. 4 or of FIG. 5 (device 400 or 500, respectively).

[00126] According to some embodiments the system for tracking a surgical tool of a device for surgical procedures, such as system 700, may be a system for tracking a surgical tool in a body of a subject during a medical procedure.

[00127] As shown in FIG. 7 the device for surgical procedures 702 includes a surgical tool 710 and a permanent magnet physically associated thereto 716. According to some embodiments, surgical tool 710 may include a ferromagnetic material and/or a paramagnetic material. Each possibility is a separate embodiment. According to some embodiments, the physically associated permanent magnet 716 is configured to generate a magnetic field and at least partially magnetize the paramagnetic and/or ferromagnetic material of surgical tool 710, thereby providing (to a tracking unit 730) an indication of the position and/or orientation of the surgical tool 710 during the surgical procedure. Each possibility is a separate embodiment. According to some embodiments, the generated magnetic field is influenced/dictated entirely by the permanent magnet 716. [00128] According to some embodiments, the physically associated permanent magnet 716 may be an array of permanent magnets. According to some embodiments, magnet 716 may be an array of electromagnets. According to some embodiments, the surgical tool 710 may include a paramagnetic and/or a ferromagnetic material. Each possibility is a separate embodiment.

[00129] As further shown in FIG. 7, tracking unit 730 includes one or more magnetic sensors (shown as an array of magnetic sensors), configured to detect magnetic (field) signal(s) generated by permanent magnet 716. The detected signal(s) may then be processed by a processing unit of the tracking unit (not shown), to determine a position and/or orientation of the surgical tool (e.g. surgical tool 710) based on the detected magnetic field and/or changes thereto. According to some embodiments, the detected signal(s) may then be processed by a processing unit of the tracking unit, to determine a position and/or orientation of the surgical tool (e.g. surgical tool 710) within a body, based on the detected magnetic field and/or changes thereto. According to some embodiments, the system for tracking a surgical tool of device for surgical procedures 700 may further include a display configured to present to a user the position and/or orientation of the surgical tool. According to some embodiments, the system for tracking a device for surgical procedures 700 may further include a user interface, a memory, a database, a communication unit, or any combinations thereof. Each possibility is a separate embodiment.

[00130] Reference is now made to FIG. 8, which schematically shows a perspective view of a system for tracking a surgical tool of a device for surgical procedures 800 having a device for surgical procedure 802 which includes a remote permanent magnet 816 (e.g. device 600 of FIG. 6), and a magnetic tracking (sensing) unit 830, according to some embodiments.

[00131] According to some embodiments a system for tracking a surgical tool of a device for surgical procedures, such as system 800, may be a system for tracking a surgical tool in a body of a subject during a medical procedure.

[00132] As shown in FIG. 8 the device for surgical procedure 802 includes a surgical tool 810 and a permanent magnet remotely associated thereto 816. According to some embodiments, the remotely associated permanent magnet 816 is configured to generate a magnetic field and magnetize the ferromagnetic material of surgical tool 810, thereby providing (to a tracking unit 830) an indicating of the position and/or orientation of the surgical tool 810 during the surgical procedure. It is noted that, the magnetizable ferromagnetic material of surgical tool 810 is configured to deform the magnetic field generated by the permanent magnet 816 upon a change in position and/or orientation of the surgical tool 810, and the deformed magnetic field may provide (to a tracking unit 830) an indicating of the position and/or orientation of the surgical tool 810 during the surgical procedure.

[00133] According to some embodiments, the indicating (or determining) of the position and/or orientation of the surgical tool may be based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent magnet of the device, and/or of a surgical tool comprising a ferromagnetic material.

[00134] As further shown in FIG. 8, tracking unit 830 includes one or more magnetic sensors (shown as an array of magnetic sensors), configured to detect magnetic signal(s) generated by permanent magnet 816 and consequently deformed by the magnetized ferromagnetic material of surgical tool 810. The detected signal(s) may then be processed by a processing unit of the tracking unit (not shown), to determine a position and/or orientation of the surgical tool (e.g. surgical tool 810) based on the detected deformed magnetic field and/or changes thereto. According to some embodiments, the detected signal(s) may then be processed by a processing unit of the tracking unit, to determine a position and/or orientation of the surgical tool (e.g. surgical tool 810) within a body, based on the detected deformed magnetic field and/or changes thereto. According to some embodiments, the system for tracking a surgical tool of a device for surgical procedures 800 may further include a display configured to present to a user the position and/or orientation of the surgical tool. According to some embodiments, the system for tracking a surgical tool 800 may further include a user interface, a memory, a data base, a communication unit, or any combinations thereof. Each possibility is a separate embodiment.

[00135] Remote permanent magnets, such as magnet 816, may be configured with varied dimensions, geometries, and magnetic strengths to suit specific operation requirements/needs/environment. According to some embodiments, remote permanent magnet, such as magnet 816, may be stationary or mobile.

[00136] In accordance with some embodiments, remote permanent magnet 816 may be an array of permanent magnets. In accordance with some embodiments, remote permanent magnet 816 may be a remote electromagnet.

[00137] In accordance with some embodiments, the remote electromagnet may be configured to generate magnetic signal(s) at a predetermined location (or position) and frequency (or at an encrypted frequency using a set of frequencies), selected to ensure it is distinguishable from common electromagnetic interference (EMI) present in the operational/surgical environment (e.g. operation room). By operating at this predetermined or encrypted frequency, the electromagnet maintains optimal performance while minimizing interference from external electromagnetic sources (electromagnetic noise). According to some embodiments, the remote electromagnet may be configured to generate magnetic signal(s) at a predetermined location (or position) and frequency, selected to ensure it is distinguishable from a specific electromagnetic interference present in the operational/surgical environment (e.g. operation room).

[00138] In accordance with some embodiments, remote permanent magnet 816 may be a remote array of electromagnets. In accordance with some embodiments, the remote electromagnet array may be configured to generate magnetic signal(s) at a specified combination of location (or position) and frequency (thereby providing a more specified electromagnetic pattern), designed to be distinguishable from surrounding interference. Advantageously, this tailored combination enhances the system's ability to operate reliably in environments with high levels of electromagnetic noise, such as in an operating room, ensuring optimal performance and reducing the impact of external electromagnetic disturbances. In accordance with some embodiments, the remote electromagnet array may be configured to generate a desir ed/selected magnetic signal(s), by predetermining a combination of location (or position) and frequency of the array, such that optimize the interaction between the magnetic field and the surgical tool in its momentary location (e.g. during operation). [00139] Reference is now made to FIG. 9, which schematically shows a perspective view of system for tracking a device for surgical procedures in orthopedic procedure 900, having a surgical tool (which includes a ferromagnetic material) 910, a remote array 916 of permanent magnets 917-923 attached to a patient’s body 950 positioned on a surgical table 940, and a mounted magnetic tracking (sensing) unit 930 in a standoff position, according to some embodiments.

[00140] According to some embodiments, the array of permanent magnets 916 may be an array of electromagnets. According to some embodiments, magnets 917-923 of array of magnets (or electromagnets) 916 may be attached/positioned on the patient’s body 950 individually or collectively (e.g. by being mounted on an adhesive sheath). According to some embodiments, the magnetic tracking (sensing) unit 930 includes one or more magnetic sensors (shown as an array of magnetic sensors), configured to detect magnetic signal(s) generated by permanent magnet 916 and consequently deformed by the magnetized ferromagnetic material of surgical tool 910. According to some embodiments, the magnetic tracking (sensing) unit 930 may be further configured to detect movements of the patient’s body during the operation (e.g. for alerting about registration changes).

[00141] According to some embodiments, the array of permanent magnets 916 may be made of, or be joined to, radiopaque markers thereby participating in the image registration process. Each possibility is a separate embodiment. Without bounding to any theory, due to their composition of a dense metal (such as neodymium), the magnets can effectively absorb radiation from a fluoroscopy imaging device, resulting in a high-contrast visibility in the acquired images. When the same magnet is identified in both fluoroscopic and magnetic modalities and corresponds to the same location within each respective coordinate system, it can be utilized to register or align the coordinate systems. This registration allows correlating images from different imaging modalities.

[00142] Advantageously, according to some embodiments positioning the mounted magnetic tracking (sensing) unit 930 in a standoff position is configured to clear the way for the surgeon, enabling unobstructed access to the desired anatomical site for surgical procedures, mounted magnetic tracking (sensing) unit 930 in a standoff position facilitates optimal working conditions for the surgeon, ensuring a clear operating field. [00143] According to some embodiments, positioning the mounted magnetic tracking (sensing) unit 930 in a standoff position is configured to keep tracking (sensing) unit away from the surgical site, thus preventing its exposure to radiation when fluoroscopic imaging is required. This configuration ensures that the magnetic tracking (sensing) unit remains protected from radiation during imaging while maintaining operational efficiency.

[00144] According to some embodiments, there is provided herein a method for tracking a surgical tool, the method includes: obtaining a device for surgical procedure (e.g. device 400, 500 or 600), detecting magnetic field generated by the permanent magnet and/or changes/disturbances/deformations in the magnetic field by a tracking unit comprising one or more magnetic sensors, determining, based on the magnetic field and/or disturbances thereto, a position and/or orientation of the surgical tool.

[00145] As used herein the terms “changes”, “disturbances”, and “deformations", with respect to magnetic field, may be interchangeably used and refer to any alteration, disruption, or modification in the intensity, direction, or uniformity of the magnetic field as a result of internal or external factors.

[00146] According to some embodiments, the method for tracking a surgical tool may be in a body of a subject, during a medical procedure (e.g. orthopedic procedure/operation). According to some embodiments, determining the position and/or orientation of the surgical tool may be within the body.

[00147] According to some embodiments, determining the position and/or orientation of the surgical tool is based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent and/or a surgical tool including a ferromagnetic material.

[00148] According to some embodiments, the method further includes registering the determined position and/or orientation of the magnetic tool to an imaging scan. According to some embodiments, the method further includes registering the determined position and/or orientation of the magnetic tool within the body of the patient, to an imaging scan of the subject.

[00149] In some embodiments, the terms “tool”, “surgical tool”, “instrument”, “surgical instrument” and “medical tool” may be used interchangeably. The terms include any type of surgical tool configured for use in a medical procedure. In some embodiments, the surgical tool is inserted into a body of a subject. In some embodiments, the surgical tool may be selected from, but not limited to: a pin, a needle (for example, guiding needle, Jamshidi, biopsy needle), a guidewire (for example, a k-wire), and the like, or any combinations thereof. In some embodiments, the term “surgical tool” or “surgical tools” may refer to any surgical tool aimed to any specific target anatomy and/or to implants.

[00150] In some embodiments, the term “magnetic surgical tool” or “magnetic surgical tools” may refer to any surgical tool and/or to implant aimed to any specific target anatomy that has a magnetic signature (e.g., magnetic, magnetizable, magnetizable component, addon), that is trackable by a magnetic sensor.

[00151] 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.

[00152] 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.

[00153] 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.

[00154] 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. [00155] 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.

[00156] 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.

[00157] 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 that range, 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.

[00158] 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.

[00159] 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

CLAIMS What is claimed is:

1. A device for surgical procedures, the device comprising: a trackable magnetizable surgical tool comprising a paramagnetic and/or a ferromagnetic material; and a permanent magnet associated with the trackable surgical tool, wherein the paramagnetic and/or ferromagnetic material is configured to be magnetized by the permanent magnet, thereby facilitating tracking of the surgical tool by a magnetic sensing unit.

2. The device according to claim 1, wherein the permanent magnet is physically associated with the surgical tool.

3. The device according to claim 2, wherein the permanent magnet is permanently attached to the surgical tool.

4. The device according to claim 2, wherein the permanent magnet is removably attached to the surgical tool.

5. The device according any one of claims 1-4, wherein the permanent magnet is positioned in proximity to the distal end of the surgical tool.

6. The device according to claim 1, wherein the permanent magnet is remote from the surgical tool.

7. The device according to claim 1, wherein the permanent magnet is stationary and remote from the surgical tool.

8. The device according to claim 1, wherein the permanent magnet is remote from the surgical tool and wherein the surgical tool comprises ferromagnetic material, wherein the ferromagnetic material is magnetizable by the permanent magnet and is configured to deform/change a magnetic field generated by the permanent magnet upon a change in position and/or orientation of the surgical tool.

9. The device according to claim 8, wherein the permanent magnet is stationary.

10. The device according to any one of claims 1-9, wherein the surgical tool comprises one or more sections of paramagnetic and/or ferromagnetic material.

11. The device according to any one of claims 1-10, wherein the ferromagnetic material comprising 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.

12. The device according to any one of claims 1-10, 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.

13. The device according to any one of claims 1-12, wherein the permanent magnet comprises an array of electromagnets.

14. The device according to any one of claims 1-13, for use in navigation guided surgical procedures.

15. The device according to claim 14, wherein the guided surgical procedure comprises: biopsy, orthopedic procedure, tissue removal, tissue ablation, tissue manipulation, delivery of implants, delivery of electrodes for neural stimulation, or any combination thereof.

16. The device according to any one of claims 1-15, wherein the surgical tool comprises a guidewire, a needle and/or a pin.

17. The device according to any one of claims 1-16, wherein the surgical procedure is an orthopedic procedure and the surgical tool is a Kirschner wire (K-wire).

18. A system for tracking the surgical tool of the device according to any one of claims 1- 17, in a body of a subject, during a medical procedure, the system comprising: a tracking unit comprising one or more magnetic sensors configured to detect magnetic field generated by the permanent magnet and/or changes to the magnetic field; and a processing unit configured to determine a position and/or orientation of the surgical tool within the body, based on the detected magnetic field and/or changes thereto.

19. The system according to claim 18, wherein the tracking unit comprises an array of magnetic sensors.

20. The system according to any one of claims 18-19, wherein determining the position and/or orientation of the surgical tool is based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent magnet of the device, and/or of a surgical tool comprising a ferromagnetic material.

21. The system according to any one of claims 18-20, further comprising a display configured to present to a user the position and/or orientation of the surgical tool.

22. The system according to any one of claims 18-21, further comprising a user interface, a memory, a data base, a communication unit, or any combinations thereof.

23. A method for tracking a surgical tool in a body of a subj ect, during a medical procedure, the method comprising: obtaining the device any one of claims 1-13; detecting magnetic field generated by the permanent magnet and/or changes/ disturbances/deformations in said magnetic field by a tracking unit comprising one or more magnetic sensors; and determining, based on the magnetic field and/or disturbances thereto, a position and/or orientation of the surgical tool within the body.

24. The method according to claim 23, wherein determining the position and/or orientation of the surgical tool is based on deep learning algorithm(s) correlating a change of the magnetic field with the position and/or orientation of the permanent magnet and/or a surgical tool comprising a ferromagnetic material.

25. The method according to any one of claims 23-24, further comprising registering the determined position and/or orientation of the magnetic tool within the body of the subject, to an imaging scan of the subject.

26. A surgical tool comprising at least one magnet positioned between a distal end of the surgical tool and a proximal portion thereof, wherein the surgical tool comprises a guidewire, Kirschner wire (K-wires), a needle and/or a pin.

27. The surgical tool according to claim 26, wherein the at least one magnet is positioned in proximity to the distal end of the tool.

28. The surgical tool according to any one of claims 26-27, wherein the magnet comprises a plurality of magnets, arranged in a designated configuration.

29. The surgical tool according to claim 28, wherein the plurality of magnets are arranged asymmetrically.

30. The surgical tool according to any one of claims 28 or 29, wherein S-pole of a first magnet faces an S-pole of a second magnet.

31. The surgical tool according to any one of claims 26-30, wherein the surgical tool comprises an internal lumen, said at the least one magnet is positioned within the lumen.

32. The surgical tool according to any one of claims 26-31, wherein the at least one magnet is housed within a sleeve, said sleeve is physically associated with a proximal section of the distal end of the surgical tool, and to a distal section of the proximal portion of the tool, thereby forming a continuous tool.

33. The surgical tool according to claim 32, wherein the sleeve is welded or glued to the distal end and the proximal portion of the surgical tool.

34. The surgical tool according to any one of claims 26-33, wherein the diameter of the magnet is smaller than the external diameter of the surgical tool.

35. The surgical tool according to any one of claims 26-34, wherein the length of the at least one magnet is larger than external diameter thereof.

36. The surgical tool according to any one of claims 26-35, wherein the distal end and the proximal portion of the tool are not magnetic.

37. The surgical tool according to any one of claims 26-36, made or partially made of a ferromagnetic material and configured to be magnetized by an external magnetic field.

38. The surgical tool according to any one of claims 26-37, associated with a magnetic or ferromagnetic magnetizable add-on.

39. The surgical tool according to any one of claims 26-38, for use in navigation guided surgical procedures.

40. A system for tracking the surgical tool according to any one of claims 26-38, in a body of a subject, during medical procedure, the system comprising: a tracking unit comprising one or more magnetic sensors configured to detect magnetic field generated by the magnetic tool and/or changes to the magnetic field; and a processing unit configured to determine the spatial location of the tool within the body, based on the detected magnetic field and/or changes thereto.

41. The system according to claim 40, wherein the tracking unit comprises an array of sensors.

42. The system according to any one of claims 40-41, wherein determining the spatial location is based on deep learning algorithm(s) correlating a change of the magnetic field with the spatial location of the magnet of the surgical tool.

43. The system according to any one of claims 41-42, further comprising a display configured to present to a user the spatial location of the tool.

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 tracking the surgical tool according to any one of claims 26-38, in a body of a subject, during a medical procedure, the method comprising: providing a tracking system comprising a tracking unit comprising one or more magnetic sensors configured to detect a magnetic field generated by the magnetic or magnetized tool, and/or changes to the magnetic field; and determining, utilizing a processor, the spatial location of the surgical tool within the body, based on the detected magnetic field and/or changes in the magnetic field.

46. The method according to claim 45, wherein determining the spatial location is based on deep learning algorithm(s) correlating a change of the magnetic field with the spatial location of the magnet of the surgical tool.

47. The method according to any one of claims 45-46, further comprising registering the determined spatial location of the magnetic tool within the body of the subject, to an imaging scan of the subject.