Magnetizer

Abstract

The utility model relates to a magnetizer. The magnetizer includes at least one magnetizing element and an illumination source. The housing defines a cavity in communication with the opening. By placing a medical device, such as a needle, into the cavity through the opening, it is exposed to the irradiation source while the needle is magnetized to imprint the magnetic feature. Optionally, the switching mechanism may be actuated when the needle passes through / engages the opening and actuates the illumination source and / or the magnetizing element. Advantageously, the needle can be sterilized while being magnetized. In addition, the cavity may be sterilized to prevent contamination of the needle during magnetization.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 195,018, filed on May 9, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to a magnetizer. Background Art

[0004] Magnetic tracking of medical devices has become an important tool for determining the position and orientation of medical devices within the body. Electromagnetic systems require a complex network of transmitters and detectors in order to track such medical devices using electromagnetic waves, and such systems can be bulky and expensive. Tracking static magnetic fields emitted by permanent magnets or magnetized medical devices can reduce the cost and overall size of the tracking system and the tracked medical device. In addition, some tracking systems imprint unique magnetic signatures onto magnetizable medical devices to allow static magnetic tracking systems to distinguish between two or more medical devices.

[0005] The process of imprinting magnetic features requires placing a magnetizable medical device (e.g., a needle formed of a magnetizable material) close to a magnetizing system that exposes the needle to a magnetic field. The magnetic field imprints a unique magnetic feature onto the needle. However, in this process, the sterility of the medical device may be compromised. For example, when the medical device is inserted into a magnetizer for magnetization, the medical device may contact the entrance of the magnetizer. Any exposure or contact of the medical device or user to an unsterilized magnetizing device may result in a loss of sterility. In addition, the sterilized magnetizer may contact an unsterilized surface (e.g., contact with a non-sterile skin surface) and thereby become contaminated.

[0006] Existing magnetizer systems are typically formed with a thin, deep well into which the medical device is placed (referred to as a "dip"), and which can be difficult to clean. As a result, existing magnetizer systems are typically single-use or may utilize a separate disposable piece that is first inserted into the magnetizer prior to dipping the needle, which can be expensive and / or generate excessive waste.

[0007] Therefore, there is a need for a system for imprinting magnetic features onto a medical device while maintaining the sterility of the medical device.Disclosed herein are systems and methods that address the aforementioned problems. Utility Model Content

[0008] Briefly summarized, embodiments disclosed herein relate to a magnetizer having: a housing defining a top surface, a bottom surface, and one or more side surfaces extending therebetween; a cavity disposed within the housing and communicating with an opening disposed in the top surface, the opening and the cavity being configured to receive a distal portion of a medical device therein; a magnetizing element disposed in a wall of the cavity; and an illumination source disposed in the wall of the cavity and configured to direct ultraviolet radiation into the cavity.

[0009] In some embodiments, the magnetized element is configured to be part of a magnetized medical device.

[0010] In some embodiments, the magnetized element is configured to imprint magnetic features onto the medical device.

[0011] In some embodiments, the illumination source is configured to emit electromagnetic radiation between a wavelength range of 100 nm to 280 nm.

[0012] In some embodiments, the radiation source is configured to emit one or more of UV-A, UV-B, and UV-C radiation.

[0013] In some embodiments, the illumination source is one of an LED bulb, a light bulb, an incandescent bulb, a fluorescent bulb, a fluorescent tube, or a low-pressure mercury-vapor gas-discharge lamp.

[0014] In some embodiments, the opening further includes a switching mechanism configured to transition one or both of the magnetized element and the illumination source between an activated state and a deactivated state.

[0015] In some embodiments, the opening further comprises one of a door or a flap configured to mitigate radiation from the illumination source from escaping the cavity.

[0016] In some embodiments, the medical device comprises one of a needle, a guidewire, or a stylet, the needle, the guidewire, or the stylet comprising a magnetizable material.

[0017] In some embodiments, the proximal portion of the medical device engages the opening to: i) align the distal portion of the medical device with the central axis of the cavity; ii) align the distal portion of the medical device at a predetermined distance from the illumination source; or iii) prevent the distal tip of the medical device from impacting the lower surface of the cavity.

[0018] In some embodiments, the proximal portion of the medical device engages the opening in a Luer lock engagement to provide a seal therebetween and prevent UV radiation from escaping the cavity.

[0019] In some embodiments, engaging the proximal portion of the medical device with the opening actuates the switching mechanism.

[0020] In some embodiments, the illumination source is disposed between an outer surface of the housing and an inner surface of the cavity, the inner surface of the cavity is transparent or translucent, and the outer surface of the housing is opaque.

[0021] The present invention also discloses a method for magnetizing and sterilizing a medical device, comprising: placing a portion of the medical device into a cavity defined by a shell, the shell defining a top surface, a bottom surface, and one or more side surfaces extending therebetween, the cavity being arranged within the shell and communicating with an opening arranged in the top surface; magnetizing the portion of the medical device using a magnetizing element arranged in a wall of the cavity; and sterilizing the portion of the medical device using an irradiation source arranged in the wall of the cavity and configured to direct ultraviolet radiation into the cavity.

[0022] In some embodiments, magnetizing a portion of the medical device includes imprinting a magnetic feature onto the medical device.

[0023] In some embodiments, the illumination source is configured to emit electromagnetic radiation between a wavelength range of 100 nm to 280 nm.

[0024] In some embodiments, the radiation source is configured to emit one or more of UV-A, UV-B, and UV-C radiation.

[0025] In some embodiments, the illumination source is one of an LED bulb, a light bulb, an incandescent bulb, a fluorescent bulb, a fluorescent tube, or a low-pressure mercury vapor gas discharge lamp.

[0026] In some embodiments, the method further includes transitioning one or both of the magnetized element and the illumination source between an activated state and a deactivated state via a switching mechanism operably coupled to the opening.

[0027] In some embodiments, the method further comprises closing a door or flap over the opening to mitigate radiation escaping from the cavity.

[0028] In some embodiments, the medical device comprises one of a needle, a guidewire, or a stylet, the needle, the guidewire, or the stylet comprising a magnetizable material.

[0029] In some embodiments, the method further includes engaging a proximal portion of the medical device with the opening to: i) align a distal portion of the medical device with a central axis of the cavity; ii) align the distal portion of the medical device at a predetermined distance from an illumination source; or iii) prevent the distal tip of the medical device from impacting a lower surface of the cavity.

[0030] In some embodiments, the method further includes engaging a proximal portion of the medical device with the opening in a Luer lock engagement to provide a seal therebetween and prevent UV radiation from escaping the cavity.

[0031] In some embodiments, engaging the proximal portion of the medical device with the opening actuates the switching mechanism.

[0032] In some embodiments, the illumination source is disposed between an outer surface of the housing and an inner surface of the cavity, the inner surface of the cavity is transparent or translucent, and the outer surface of the housing is opaque.

[0033] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly disclose specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Embodiments of the disclosure are illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements and in which:

[0035] Figure 1 A perspective view of a magnetizer system shown in cut away according to embodiments disclosed herein is shown.

[0036] Figure 2 A front view of a magnetizer system according to embodiments disclosed herein is shown in cross-section.

[0037] Figure 3 Shown is a top view of a magnetizer system according to embodiments disclosed herein.

[0038] Figure 4 A front view of a magnetizer system shown in cross-section according to embodiments disclosed herein is shown, the magnetizer system including a medical device.

[0039] Figure 5 A top view of a magnetizer system including a door is shown according to embodiments disclosed herein.

[0040] Figure 6 A top view of a magnetizer system including a fin is shown according to embodiments disclosed herein. DETAILED DESCRIPTION

[0041] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0042] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions.For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps.For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such labels are used to reflect, for example, relative position, orientation or direction.Singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly stipulates otherwise.

[0043] In the following description, the terms "or" and "and / or" as used herein should be interpreted as inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". An exception to this definition will only occur if the combination of elements, parts, functions, steps or actions are inherently mutually exclusive in some way.

[0044] With respect to, for example, the "proximal" or "proximal portion" of a medical device disclosed herein, it includes a portion of a medical device that is intended to be relatively closer to a specified location. Similarly, for example, the "proximal length" of a medical device includes the length of the medical device that is intended to be relatively closer to a specified location or placed in a specified location. For example, the "proximal end" of a medical device includes the end of the medical device that is intended to be relatively closer to a specified location. The proximal portion, proximal portion, or proximal length of a medical device may include the proximal end of the medical device; however, the proximal portion, proximal portion, or proximal length of a catheter need not include the proximal end of the medical device. That is, unless the context indicates otherwise, the proximal portion, proximal portion, or proximal length of a medical device is not the terminal portion or terminal length of the medical device.

[0045] With respect to, for example, the "distal" or "distal portion" of a medical device disclosed herein, it includes a portion of a medical device that is intended to be relatively further away from a specified location. Likewise, for example, the "distal length" of a medical device includes the length of the medical device that is intended to be relatively further away from a specified location. For example, the "distal end" of a medical device includes the end of the medical device that is intended to be relatively further away from a specified location. The distal portion, distal portion, or distal length of a medical device may include the distal end of the medical device; however, the distal portion, distal portion, or distal length of a medical device need not include the distal end of the medical device. That is, unless the context indicates otherwise, the distal portion, distal portion, or distal length of a catheter is not the terminal portion or terminal length of a medical device.

[0046] To aid in describing the embodiments described herein, a horizontal plane is defined by an axis from front to back and an axis from left to right. A vertical plane extends perpendicular to the horizontal plane.

[0047] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0048] Magnetizer system

[0049] Figures 1 to 6 An embodiment of a magnetizer system ("system") 100 for magnetizing a medical device 420 while maintaining sterility of the medical device 420 is shown. The exemplary medical device 420 includes a needle, a guidewire, a stylet, or a similar elongated medical device configured to be placed within a patient's body. In some embodiments, the magnetizer system 100 can be implemented using a magnetic-based guidance and tracking system for inserting and detecting medical devices (e.g., a magnetic-based needle guidance system for inserting and detecting a sterilized needle). Examples of magnetic-based equipment tracking and guidance systems are disclosed in U.S. Pat. No. 8,388,541, U.S. Pat. No. 8,781,555, U.S. Pat. No. 8,849,382, U.S. Pat. No. 9,456,766, U.S. Pat. No. 9,492,097, U.S. Pat. No. 9,521,961, U.S. Pat. No. 9,554,716, U.S. Pat. No. 9,636,031, U.S. Pat. No. 9,649,048, U.S. Pat. No. 10,449,330, U.S. Pat. No. 10,524,691, and U.S. Pat. No. 10,751,509, each of which is incorporated by reference in its entirety into this application.

[0050] In one embodiment, the medical device 420 includes a magnetizable material that enables the medical device (e.g., needle 420) to be magnetized and then can be tracked by a magnetic tracking system. An exemplary magnetic tracking system includes an ultrasound imaging system that includes one or more magnetic sensors. When the magnetized medical device 420 is brought into proximity with a magnetic sensor (e.g., a magnetic sensor array) and / or inserted into a patient during an ultrasound-based medical procedure, the magnetic tracking system distinguishes between two or more of such magnetized medical devices and determines the position and orientation of each magnetized medical device. By superimposing a simulated needle image representing the real-time position, distance, and orientation of the needle on an ultrasound image of the patient's body entered by the magnetized medical device, such magnetic-based tracking of the magnetized medical device helps clinicians place the end of the medical device in a desired location, such as in the lumen of a blood vessel.

[0051] In one embodiment, the magnetizable medical device 420 can be formed of stainless steel, however, other suitable magnetizable materials are contemplated to fall within the scope of the present invention. As configured, the magnetized needle 420 can generate a magnetic field or form a magnetic disturbance in a magnetic field that can be detected by a magnetic sensor array of a magnetic tracking system (e.g., an ultrasound probe) to enable the position, distance, and orientation of the magnetized medical device 420 to be tracked by the ultrasound imaging and magnetic tracking system.

[0052] Figure 1 A perspective view of a magnetizer system 100 is shown, shown in cut away. Figure 2 A front side view of a magnetizer system 100 shown in cross-section is shown. The magnetizer system 100 generally includes a housing 102, a magnetizing element 140, and an irradiation source 150, as described in more detail herein. The housing 102 includes a top surface 104, a bottom surface 110, and one or more side surfaces extending therebetween, such as a front surface 120, a rear surface, a left side surface 126, and a right side surface 128. As shown, the housing 102 defines a substantially rectangular parallelepiped shape, however, it should be understood that this is exemplary, and the housing 102 may define other regular or irregular three-dimensional shapes, such as a cylinder, a prism, a sphere, etc., and include one or more flat, concave, or convex facets, and / or one or more rounded, chamfered, or beveled edges, but is not limited thereto.

[0053] In one embodiment, the housing 102 defines an internal cavity ("cavity") 130. The cavity 130 is communicated with an opening 106 disposed on a surface (e.g., top surface 104) of the housing 102. The opening 106 also includes a curved portion 108 extending around the circumference of the opening 106 to define a chamfered or inclined entrance to the opening 106. The curved portion 108 is configured to facilitate guiding a portion of the medical device 420 through the opening 106 and into the cavity 130, as described in more detail herein. In some embodiments, the opening 106 can be a hole, an orifice, a gap, a slot, or other opening formed by the top surface 104, which allows the medical device 420 to enter and move through it. In one embodiment, the opening 106 defines a substantially circular orifice. However, this is not intended to be limiting, but in an embodiment, the opening 106 can define any closed curve, regular or irregular shape, such as a rectangle, an ellipse, etc.

[0054] In some embodiments, the opening 106 is configured to facilitate the user to insert and remove the medical device (e.g., needle) 420 into and from the cavity 130 of the magnetizer system 100. For example, the opening 106 can have a width suitable for enabling a user holding the needle 420 to briefly insert and remove the needle 420 with a dipping motion to magnetize the needle 420 within the magnetizer system 100. In one embodiment, the user can place the medical device 420 on the opening 106 and / or the curved portion 108 so that the medical device moves through the opening 106 in a controlled manner. In some embodiments, the curved portion 108 can include fillets and / or rounded portions. In other embodiments, the opening 106 can have a proportion suitable for inserting the needle 420 or the needle 420 with a needle cover. Then, even if the needle cover has not been removed from the needle 420, the magnetizer system 100 can still be used.

[0055] In some embodiments, the opening 106, the curved portion 108, the cavity 130, or a combination thereof can have a length extending toward the bottom surface 110 that is at least as long as the medical device 420. Such a length can reduce the likelihood that the medical device will contact the surface forming the cavity 130. In one embodiment, a user can magnetize the inserted medical device 420 by inserting the medical device 420 through the opening 106 until the medical device 420 contacts the bottom surface 110 of the cavity 130, and then remove the medical device 420 through the opening 106. However, the medical device does not need to contact the bottom surface 110 of the cavity 130. In some embodiments, the top surface 104, the opening 106, and / or the cavity 130 are at least substantially free of structures that will hinder the passage of the medical device 420 (e.g., a needle) therethrough. As shown, the opening 106 is positioned in the center of the top surface 104 to receive the medical device 420 for magnetization. However, it should be understood that the opening 106 may be positioned in a corner of the top surface 104 , on an edge of the top surface 104 , or in another location so that the medical device 420 may be received.

[0056] In one embodiment, the magnetizer system 100 also includes one or more magnetizing elements 140 (e.g., permanent magnets and / or electromagnets), which may be enclosed or packaged within the walls of the housing 102. For example, Figure 1 As shown, the first magnetized element 140A is disposed between the exterior left side 126 of the housing 102 and the interior left side of the cavity 130. Similarly, the second magnetized element 140B is disposed between the exterior right side 128 of the housing 102 and the interior right side of the cavity 130. It should be understood that the number, location, orientation, and configuration of the one or more magnetized elements 140 within the housing 102 are not intended to be limiting.

[0057] In some embodiments, opening 106 may include structure to facilitate passage of medical device 420 into cavity 130 and adjacent to or past magnetized element 140. For example, in Figure 1 In some embodiments, the opening 106 includes a curved portion 108 (e.g., rounded corners). In some embodiments, the opening 106 includes a curved conical tapered surface extending from the top surface 104 toward the cavity 130. For example, the opening 106 can be funnel-shaped, can be tapered or narrowed, and / or can have a conical shape so that the inserted medical device 420 is directed toward the center of the opening 106. In one embodiment, the opening 106 / curved portion 108 can include one or more grooves configured to direct a portion of the medical device 420 toward the center of the opening 106. In one embodiment, a user can "dip" the medical device by placing the medical device on the curved portion 108 so that the medical device moves toward the center of the opening 106, and then remove the medical device after the medical device has been magnetized.

[0058] The opening 106 having a tapered shape can guide the movement of the medical device 420 in an attempt to avoid contact between the medical device and other parts of the magnetizer system 100 (e.g., the cavity 130). For example, in an embodiment in which the medical device to be magnetized is a needle, the width of the opening 106 can be equal to or slightly greater than the width of the needle so that the needle 420 can pass therethrough. In some embodiments, the opening 106 is wider than the needle 420 to facilitate movement of the needle into and out of the magnetizer system 100. In some embodiments, a portion of the opening 106 can be narrower than the width of the cavity 130 so that the medical device 420 can be less likely to inadvertently contact the interior surface of the cavity 130.

[0059] In some embodiments, the opening 106 can be angled to accommodate a particular type of medical device. For example, the opening 106 and / or the curved portion 108 can be straight (e.g., at least substantially perpendicular to the top surface 104), or can be angled relative to the top surface 104, where the angle is, for example, 1°, 1.72°, 10°, 15°, 30°, 45°, 60°, 75°, 88.28°, 89°, etc. In an embodiment, the opening 106 and / or the curved portion 108 can include multiple angles, such as to accommodate curved devices.

[0060] In one embodiment, a distal portion of the medical device passes through the opening 106 and into the cavity 130, and a relatively proximal portion of the medical device is configured to engage the opening 106, for example, the curved portion 108. For example, the needle 420 is supported by a needle hub 410 located at the proximal end. The needle 420 passes through the opening 106 and into the cavity 130, and the needle hub 410 is configured to engage the opening 106 and / or the curved portion 108 in a friction fit, interference fit, Luer lock, or snap fit engagement.

[0061] Advantageously, the proximal portion (e.g., needle hub 410) engages opening 106 and seals the distal portion (e.g., needle 420) within the cavity. In addition, hub 410 engaging opening 106 aligns needle 420 with the central vertical axis of cavity 130. This places needle 420 equidistant from and / or at a predetermined distance relative to one or both of magnetizing element 140 and / or irradiation source 150. Advantageously, hub 410 and / or the proximal portion of needle 420 engaging opening 106 prevents further movement into cavity 130. As described above, the cavity defines a vertical length sufficient to receive needle 420 therein. Therefore, needle hub 410 engaging opening 106 prevents the distal end of needle 420 from colliding with the lower surface of cavity 130 and prevents needle 420 from becoming blunt or preventing damage to cavity 130.

[0062] In one embodiment, the cavity 130 includes one or more irradiation sources 150 configured to emit ultraviolet ("UV") radiation. Exemplary irradiation sources 150 may include LED bulbs, light bulbs, incandescent bulbs, fluorescent bulbs, fluorescent tubes, low-pressure mercury vapor gas discharge lamps, etc. In one embodiment, the irradiation source 150 is configured to emit electromagnetic radiation between a wavelength range of 10nm to 450nm. In one embodiment, the irradiation source 150 is configured to emit electromagnetic radiation between a wavelength range of 100nm to 400nm. In one embodiment, the irradiation source 150 is configured to emit electromagnetic radiation between a wavelength range of 100nm to 280nm. In one embodiment, the irradiation source 150 is configured to emit one or more of UV-A, UV-B, and UV-C radiation. However, it should be understood that other electromagnetic ranges are also contemplated. In one embodiment, the irradiation source 150 is configured to emit short-wave UV, germicidal UV, and / or ionizing radiation configured to sterilize the medical device 420 exposed to the radiation.

[0063] In one embodiment, one or more illumination sources 150 are disposed on a surface of the cavity 130, wherein one or both of the cavity 130 and the housing 102 are formed of an opaque material that prevents any UV or optical light from passing therethrough. In one embodiment, the housing 102 (i.e., its exterior face) is formed of an opaque material that prevents any UV or optical light from passing therethrough, and the interior walls of the cavity 130 are formed of a transparent or translucent material. In addition, the one or more illumination sources 150 are disposed between the opaque walls of the housing 102 and the transparent / translucent walls of the cavity 130, and are configured to direct illumination toward the central axis of the cavity 130. Advantageously, where the illumination sources are disposed between the walls of the cavity 130 and the walls of the housing 102, the surfaces of the housing 102 and / or the cavity 130 can be wiped clean using a cleaning solution while protecting the illumination sources 150 and the magnetizing source 140 from exposure to the cleaning solution.

[0064] It should be understood that the number, position, orientation, and configuration of the radiation sources 150 within the magnetizer system 100 can vary and are not intended to be limiting. In one embodiment, the one or more radiation sources 150 emit electromagnetic radiation into the cavity 130 and onto at least a portion of the medical device 420 disposed within the cavity 130. It should be understood that the number, position, and orientation of the one or more radiation sources 150 are configured to emit germicidal UV radiation onto a surface of the medical device 420 disposed within the cavity 130 to sterilize the medical device 420.

[0065] Advantageously, the magnetizer system 100 can simultaneously magnetize the medical device 420 to imprint the magnet features thereon while both the medical device 420 and the cavity 130 are sterilized or maintained sterile. For example, the magnetizer system 100 may accumulate contaminants on its surface while in use or storage. Sterilizing the cavity 130 prevents any contaminants from being transferred from the magnetizer system 100 to the medical device 420 while the medical device 420 is being magnetized. Furthermore, sterilizing the cavity 130 maintains the sterility of the cavity 130 during use. Additionally, if the sterility of the medical device 420 has been compromised while outside the magnetizer system 100, the irradiation source 150 can resterilize the medical device 420 prior to subsequently inserting it into a patient. Advantageously, the illumination source 150 allows a user to contact the medical device 420 with a surface of the magnetizer system 100 (eg, the curved portion 108 ) to allow the medical device 420 to be easily introduced into the cavity 130 without compromising the sterility of the medical device 420 .

[0066] In one embodiment, the irradiation source 150 can be activated or deactivated, that is, transitioned between an activated state or a deactivated state. In one embodiment, the irradiation source 150 can remain activated when the magnetizer system 100 and / or the magnetic tracking system are in use. In one embodiment, the irradiation source 150 can be activated when the medical device enters the cavity 130. In one embodiment, the magnetizer system 100 (e.g., the opening 106) includes a mechanical, optical, or acoustic switching mechanism, which is configured to determine the presence or absence of the medical device 420 in the cavity 130 or the insertion of the medical device 420 into the cavity or removal from the cavity. Then, the switching mechanism is configured to activate one or both of the magnetizing element 140 and the irradiation source 150 when the medical device 420 is placed in the cavity 130.

[0067] like Figure 5 to Figure 6 As shown, in one embodiment, the opening 106 may include a movable fixture configured to control access to the cavity 130. For example, Figure 5As shown, the opening 106 may include one or more doors 160 that are slidably or hingedly engaged with the magnetizer system 100 and can be opened to allow access to the cavity 130 and closed to prevent access to the cavity 130. The one or more doors 160 can mitigate the introduction of contaminants into the cavity 130 between uses. In one embodiment, the one or more doors 160 can be configured to close around a portion of the medical device 420 when the medical device 420 is engaged with the magnetizer system 100. In one embodiment, the one or more doors 160 can be operably coupled to a switching mechanism. Thus, closing the one or more doors 160 can activate the one or more irradiation sources 150 and / or the magnetizing element 140, as described herein. Advantageously, the one or more doors 160 can mitigate the escape of UV radiation from the cavity 130, thereby mitigating exposure to the user.

[0068] In one embodiment, the magnetizer system 100 (e.g., the opening 106) can include a flexible flap 162, cover, or other barrier that mitigates the entry of contaminants into the cavity 130 via the opening 106, and / or mitigates the escape of UV radiation from the cavity 130 while allowing entry and exit of the medical device 420. For example, the flap 162 can be formed of rubber, silicone rubber, etc.

[0069] In one embodiment, a portion of the medical device 420 (e.g., a proximal portion of the needle 420) and / or the needle hub 410 engages the opening 106 and / or the curved portion 108 in a friction fit engagement, as described herein. Advantageously, the needle hub 410 seals the needle 420 within the cavity, thereby preventing any UV radiation from escaping. In one embodiment, the needle hub 410 engaging the opening 106 transitions the switching mechanism between an activated state and a deactivated state.

[0070] In one embodiment, if Figure 3 As shown, the magnetizer system 100 may include a bracket 310 configured to couple the magnetizer system 100 to a surface (e.g., a surface of a tracking system, an ultrasound system, etc.). In some embodiments, the magnetizer system 100 may be attached to a fixture, wherein the bracket 310 may slide on or slide through a fixture mounted to an ultrasound console. In such embodiments, a portion of the bracket 310 may abut the ultrasound console. In one embodiment, the bracket 310 may include a magnet, adhesive, snap fit, fixture, latch, keyhole socket, or similar mechanism configured to fix the magnetizer system 100 to a surface (e.g., a surface fixed to a magnetic tracking system and / or an ultrasound system).

[0071] Ultrasound imaging system

[0072] In some embodiments, the magnetic tracking system includes an ultrasound imaging system. In some embodiments, the ultrasound imaging system may include a console, a display screen, an ultrasound detector, and a magnetizer system 100. The ultrasound imaging system may be used to image the target before utilizing medical equipment 420 (e.g., a needle) to perform percutaneous puncture to insert the needle into a target (such as a blood vessel or organ in a patient's body) and enter the target. The ultrasound imaging system may be used together with various ultrasound-based medical procedures, such as used together with catheterization or used to perform a biopsy of a patient's tissue. During the use of the ultrasound imaging system, clinicians may need to reach outside the sterile area around the patient to control the ultrasound imaging system. In some embodiments, the display screen may be used to display the distance and orientation of a magnetized medical device (such as a needle). Distance and orientation data may be superimposed on the ultrasound image of the target in real time, thereby enabling clinicians to accurately guide the magnetized medical device 420 to the desired target.

[0073] In some embodiments, an ultrasound probe is coupled to a console. The probe can be placed against the skin surface to generate an ultrasound signal that enters the patient's body, receive a reflected ultrasound signal or ultrasound echo from the patient by reflection of the generated ultrasound pulse by the patient's body, and convert the reflected ultrasound signal into a corresponding electrical signal for processing into an ultrasound image by a console that is communicatively coupled to the ultrasound probe. In this way, a clinician can use an ultrasound imaging system to determine a suitable insertion site and establish vascular access using a needle or another medical device 420.

[0074] In some embodiments, the ultrasound probe may include a magnetic sensor array for detecting a magnetized medical device 420 (such as a needle) during an ultrasound-based medical procedure. The magnetic sensor array includes a plurality of magnetic sensors embedded in or included on the housing of the ultrasound probe. The magnetic sensor is configured to detect a magnetic field or interference in a magnetic field associated with the magnetized medical device when the magnetized medical device is close to the magnetic sensor array. The magnetic sensor is also configured to convert a magnetic signal from a magnetized medical device (e.g., a needle) into an electrical signal for processing by the console into position, distance, and orientation information of the magnetized medical device 420 relative to a predefined target, and for displaying an image representation of the magnetized medical device on a display screen. Therefore, the magnetic sensor array enables an ultrasound imaging system to track a needle, etc. The magnetic sensor may include three orthogonal sensor coils for realizing detection of a magnetic field in three spatial dimensions. In some embodiments, instead of a 3-D sensor, a plurality of 1-dimensional ("1-D") magnetic sensors may be included, and these sensors may be arranged as needed to realize 1-D, 2-D, or 3-D detection capabilities.

[0075] During operation of the ultrasound imaging system, an ultrasound probe is placed against the patient's skin. An ultrasound beam is generated to ultrasound image a portion of a target, such as a blood vessel beneath the surface of the patient's skin. The ultrasound image of the blood vessel can be depicted and stabilized on a display screen of the ultrasound imaging system.

[0076] The ultrasound imaging system can be configured to detect the distance and orientation of the medical device, such as by a magnetic sensor. By way of example, the magnetic sensor array of the ultrasound probe is configured to detect the magnetic field of the magnetized medical device or the disturbance in the magnetic field caused by the magnetized medical device. Each of the magnetic sensors in the magnetic sensor array is configured to spatially detect the needle in 3-dimensional space. Therefore, during the operation of the ultrasound imaging system, the magnetic field strength data of the magnetic field of the medical device sensed by each of the magnetic sensors is forwarded to the processor of the console, and the processor calculates the distance and orientation of the magnetized medical device in real time. The distance and orientation of the magnetized medical device are also used for graphical display on the display screen.

[0077] The magnetic field strength data sensed by the magnetic sensor can be used by the ultrasound imaging system to determine the distance or orientation of any point along the entire length of the magnetized medical device relative to the magnetic sensor array in coordinate space. In addition, the pitch and yaw of the needle 420 can also be determined. Suitable circuitry of the ultrasound probe, console, or other components of the ultrasound imaging system can provide the calculations necessary for such distances or orientations.

[0078] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A magnetizer, characterized in that: include: a housing defining a top surface, a bottom surface, and one or more side surfaces extending therebetween; a cavity disposed within the housing and in communication with an opening disposed in the top surface, the opening and the cavity being configured to receive a distal portion of a medical device therein; a magnetized element disposed in a wall of the cavity; and An illumination source is disposed in the wall of the cavity and is configured to direct ultraviolet radiation into the cavity.

2. The magnetizer according to claim 1, characterized in that The magnetizing element is configured to magnetize a portion of the medical device.

3. The magnetizer according to claim 1, characterized in that The magnetized element is configured to imprint a magnetic feature onto the medical device.

4. The magnetizer according to claim 1, characterized in that The illumination source is configured to emit electromagnetic radiation between a wavelength range of 100 nm to 280 nm.

5. The magnetizer according to claim 1, characterized in that The radiation source is configured to emit one or more of UV-A, UV-B, and UV-C radiation.

6. The magnetizer according to claim 1, characterized in that The illumination source is one of an LED bulb, a light bulb, an incandescent bulb, a fluorescent bulb, a fluorescent tube or a low-pressure mercury vapor gas discharge lamp.

7. The magnetizer according to claim 1, characterized in that The opening further includes a switching mechanism configured to transition one or both of the magnetized element and the illumination source between an activated state and a deactivated state.

8. The magnetizer according to claim 1, characterized in that The opening also includes one of a door or a flap configured to mitigate radiation from the illumination source from escaping the cavity.

9. The magnetizer according to claim 1, characterized in that The medical device includes one of a needle, a guidewire, or a stylet, wherein the needle, the guidewire, or the stylet includes a magnetizable material.

10. The magnetizer according to claim 1, characterized in that The proximal portion of the medical device engages the opening to: i) aligning a distal portion of the medical device with a central axis of the cavity; ii) aligning the distal portion of the medical device at a predetermined distance from the illumination source; or iii) preventing the distal tip of the medical device from impacting the lower surface of the cavity.

11. The magnetizer according to claim 7, characterized in that The proximal portion of the medical device engages the opening in a Luer lock engagement to provide a seal therebetween and prevent UV radiation from escaping the cavity.

12. The magnetizer according to claim 11, characterized in that Engaging the proximal portion of the medical device with the opening actuates the switching mechanism.

13. The magnetizer according to claim 1, characterized in that The illumination source is arranged between the outer surface of the shell and the inner surface of the cavity, the inner surface of the cavity is transparent or translucent, and the outer surface of the shell is opaque.

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