Magnetizer cap and magnetization system for maintaining sterility of a medical device while magnetizing the medical device

Abstract

The present application relates to a magnetizer cover and magnetization system for maintaining sterility of a medical device while magnetizing the medical device. The magnetizer cover includes a base, a funnel extending from the base, and a handle tab extending from the base. The base includes a medical device interface and a magnetizer interface opposite the medical device interface. The funnel includes a funnel stem configured to protect an elongate medical device from contacting a magnetizer when the elongate medical device is inserted into the funnel. The handle tab is configured for manipulating the magnetizer cover.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Patent Application No. 63 / 112,056, filed November 10, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to a magnetizer cover and magnetization system for maintaining the sterility of a medical device while magnetizing it. Background Technology

[0004] Ultrasound imaging is a widely accepted tool for guiding medical devices to target locations within blood vessels or organs in the body. Medical devices, such as needles, can be magnetized, inserted percutaneously, and tracked in real time before and after the puncture, allowing clinicians to determine the distance and direction of the needle to the target location and ensure successful insertion.

[0005] One problem that can arise when tracking or preparing to track medical devices is that the device may lose sterility due to contact with one or more contaminated surfaces. In fact, a medical device can be magnetized by moving through a magnetizer containing one or more magnetizing elements. However, while any contact between the medical device and the user with the device (e.g., via sterile gloves) can be sterilized, the magnetizing device and its components cannot be sterilized, resulting in the contamination of one or more surfaces. Exposure or contact with these contaminated surfaces by the medical device or user can lead to a loss of sterility. For example, contact between the medical device's or user's gloves and the magnetizer can cause contaminants on the magnetizer to contaminate the contact object.

[0006] What is needed are devices, systems, and methods for minimizing or preventing contamination of sterile medical devices during magnetization. Summary of the Invention

[0007] This document discloses a magnetizer cover for maintaining the sterility of a medical device while magnetizing it. The magnetizer cover includes a base, a funnel extending from the base, and a gripping tab extending from the base. The base includes a medical device interface and a magnetizer interface opposite to the medical device interface. The funnel includes a funnel stem configured to protect the medical device from contact with the magnetizer when an elongated medical device is inserted into the funnel. The gripping tab is configured to manipulate the magnetizer cover.

[0008] In some embodiments, at least the base includes one or more structural stability ridges incorporated therein. These one or more structural stability ridges provide additional structural stability to the magnetizer cover.

[0009] In some embodiments, the gripping tabs extend from the base in the same direction as the one or more structural stability ridges incorporated into the base.

[0010] In some implementations, the base and funnel are configured to be positioned between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

[0011] In some embodiments, the magnetizer cover also includes a side barrier orthogonal to the base. The side barrier is configured to be positioned between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

[0012] In some implementations, the gripping tabs extend from the base opposite to the side barrier.

[0013] In some implementations, the funnel extends from the magnetizer interface of the base, allowing the funnel rod to be inserted into the magnetizer orifice of the magnetizer.

[0014] In some implementations, the funnel also includes a funnel opening between the base and the funnel rod. The funnel opening is configured to guide the medical device into the funnel rod.

[0015] In some implementations, the length of the funnel is greater than the length of the magnetizable portion of the medical device.

[0016] In some implementations, the funnel rod has an open end opposite the base.

[0017] In some implementations, the funnel rod has a closed end opposite to the base.

[0018] In some embodiments, the funnel rod includes one or more inwardly facing prongs extending from the funnel opening into the funnel rod. The prongs are configured to engage the cap on the medical device when the medical device is inserted into the funnel and the medical device is fitted with a cap. The prongs are also configured to prevent the cap from retracting from the funnel when the medical device is withdrawn from the funnel.

[0019] In some implementations, the gripping tab includes multiple transverse ridges on the same plane as the medical device interface of the base.

[0020] In some implementations, the gripping tabs also include multiple transverse ridges located on the same plane as the magnetizer interface of the base.

[0021] This document also discloses a magnetization system for maintaining the sterility of a medical device while magnetizing it. The system includes a magnetizer and a magnetizer cover. The magnetizer includes a magnetizer orifice and a magnetization chamber. The magnetizer orifice is formed in the cover interface of the magnetizer. The magnetization chamber can be accessed through the magnetizer orifice. The magnetizer cover includes a base, a funnel extending from the base, and a gripping tab extending from the base. The base includes a medical device interface and a magnetizer interface opposite to the medical device interface. The funnel includes a funnel rod configured to protect the medical device from contact with the magnetizer when an elongated medical device is inserted into the funnel. The gripping tab is configured to manipulate the magnetizer cover.

[0022] In some embodiments, at least the base includes one or more structural stability ridges incorporated therein. These one or more structural stability ridges provide additional structural stability to the magnetizer cover.

[0023] In some embodiments, the gripping tabs extend from the base in the same direction as the one or more structural stability ridges incorporated into the base.

[0024] In some implementations, the base and funnel are configured to be positioned between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

[0025] In some embodiments, the magnetizer cover also includes a side barrier orthogonal to the base. The side barrier is configured to be positioned between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

[0026] In some implementations, the gripping tabs extend from the base opposite to the side barrier.

[0027] In some implementations, the funnel extends from the magnetizer interface of the base, allowing the funnel rod to be inserted into the magnetizer orifice of the magnetizer.

[0028] In some implementations, the funnel also includes a funnel opening between the base and the funnel rod. The funnel opening is configured to guide the medical device into the funnel rod.

[0029] In some implementations, the length of the funnel is greater than the length of the magnetizable portion of the medical device.

[0030] In some implementations, the funnel rod has an open end opposite the base.

[0031] In some implementations, the funnel rod has a closed end opposite to the base.

[0032] In some embodiments, the funnel rod includes one or more inwardly facing forks extending from the funnel opening into the funnel rod. The one or more forks are configured to engage the cap on the medical device when the medical device is inserted into the funnel and the medical device is fitted with a cap. The one or more forks are also configured to prevent the cap from retracting from the funnel when the medical device is withdrawn from the funnel.

[0033] In some implementations, the gripping tab includes multiple transverse ridges on the same plane as the medical device interface of the base.

[0034] In some implementations, the gripping tabs also include multiple transverse ridges located on the same plane as the magnetizer interface of the base.

[0035] This document also discloses a method for maintaining the sterility of an elongated medical device while magnetizing it. The method includes a magnetizer cap application operation, a medical device insertion operation, and a magnetization initiation operation. The magnetizer cap application operation includes inserting at least the funnel rod of the magnetizer cap's funnel into the magnetizer orifice of the magnetizer, thereby arranging the funnel rod in the magnetization chamber of the magnetizer. The medical device insertion operation includes inserting a magnetizable portion of the medical device into the funnel rod of the magnetizer cap. The funnel rod is configured to protect the magnetizable portion of the medical device from contact with the magnetizer. The magnetization initiation operation includes initiating the magnetization of the medical device.

[0036] In some embodiments, the magnetizable portion of the medical device includes a cap thereon. Additionally, the funnel rod includes one or more inward-facing forks extending from the funnel opening into the funnel rod. When the magnetizable portion of the medical device is inserted into the funnel rod, these one or more forks grip the cap during the insertion operation.

[0037] In some embodiments, the method further includes a medical device retraction operation. The medical device retraction operation includes withdrawing the medical device from the funnel rod after magnetization of the medical device is complete. The one or more forked caps are withdrawn from the funnel rod along with the medical device, thereby retaining the caps within the funnel rod.

[0038] These and other features of the concept provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail specific embodiments of such a concept. Attached Figure Description

[0039] Figure 1 A magnetization system including a magnetizer and a magnetizer cover is shown according to some embodiments.

[0040] Figure 2 A magnetizer cover according to some embodiments is shown.

[0041] Figure 3 A side view of a magnetization system according to some embodiments is shown.

[0042] Figure 4A A top view of a magnetizer cover according to some embodiments is shown.

[0043] Figure 4B A bottom view of a magnetizer cover according to some embodiments is shown.

[0044] Figure 5A An exploded view of the magnetization system and needle according to some embodiments is shown.

[0045] Figure 5B A perspective view of a magnetization system including a first needle cap removal feature according to some embodiments is shown.

[0046] Figure 5C A cross-sectional view is shown of a needle with a first needle cap inserted into a magnetization system, according to some embodiments.

[0047] Figure 5D A cross-sectional view is shown, according to some embodiments, of withdrawing the needle from the magnetization system while leaving the first needle cap therein.

[0048] Figure 5E The following are illustrated according to some implementation schemes. Figure 5C and Figure 5D A top view of the magnetization system.

[0049] Figure 5F A perspective view of a magnetization system including a second needle cap removal feature according to some embodiments is shown.

[0050] Figure 6 A method for magnetizing a system according to some embodiments is shown. Detailed Implementation Plan

[0051] 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 allow them to be readily separable from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0052] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented 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 for sequential or numerical limitations. For example, the features or steps “first,” “second,” and “third” do not necessarily have to appear in that order, and a particular embodiment including such features or steps does not necessarily have to be limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0053] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

[0054] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented 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 for any order or numerical limitation. For example, features or steps that are “first,” “second,” and “third” do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps does not necessarily have to be limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0055] The term "proximal" or "proximal portion" of a medical device, such as those disclosed herein, includes a portion of the medical device intended to be relatively closer to a designated location. Similarly, "proximal length" of a medical device includes the length of the medical device intended to be relatively closer to or at a designated location. For example, "proximal end" of a medical device includes the end of the medical device intended to be relatively closer to a designated location. A proximal portion, proximal portion, or proximal length of a medical device may include the proximal end of the medical device; however, a proximal portion, proximal portion, or proximal length of a catheter does not need to include the proximal end of the medical device. That is, unless the context otherwise suggests, a proximal portion, proximal portion, or proximal length of a medical device is not a distal portion or distal length of the medical device.

[0056] The term "distal" or "distal portion" of a medical device, such as that disclosed herein, includes a portion of the medical device intended to be relatively further away from the designated location. Similarly, the term "distal length" of a medical device includes the length of the medical device intended to be relatively further away from the designated location. For example, the term "distal end" of a medical device includes the end of the medical device intended to be relatively further away from the designated location. A distal portion, distal portion, or distal length of a medical device may include the distal end of the medical device; however, a distal portion, distal portion, or distal length of a medical device does not necessarily need to include the distal end of the medical device. That is, unless the context otherwise suggests, a distal portion, distal portion, or distal length of a catheter is not the distal portion or distal length of a medical device.

[0057] 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.

[0058] As mentioned above, there is a need for devices, systems, and methods to minimize or prevent contamination of sterile medical devices during magnetization. Such devices, systems, and methods are disclosed herein.

[0059] Magnetizer cover

[0060] refer to Figure 1The following embodiments illustrate a magnetization system 100 including a magnetizer 102 and a magnetizer cover 110. In some embodiments, the magnetizer 102 and the magnetizer cover 110 may be implemented using a magnetic medical device guidance system for inserting and detecting medical devices (e.g., a magnetic needle guidance system for inserting and detecting sterilized needles). Examples of magnetically based medical device guidance systems are disclosed in U.S. Patent Nos. 8,388,541, 8,781,555, 8,849,382, 9,456,766, 9,492,097, 9,521,961, 9,554,716, 9,636,031, 9,649,048, 10,449,330, 10,524,691, and 10,751,509, each of which is incorporated herein by reference in its entirety.

[0061] As shown in the figure, the magnetizer 102 may include a magnetization chamber 104, a cover interface 105, an open surface 107, and a magnetizing element 108, wherein the cover interface includes a magnetizer aperture 106 passing through it. The magnetizer cover 110 may include a base 112, a magnetizer interface 113, a gripping tab 114, a medical device interface 115, a funnel 116 including a funnel opening 118 and a funnel rod 119, and a side barrier 120.

[0062] It should be understood that medical devices made of magnetizable materials enable the magnetization of medical devices (e.g., needles). During ultrasound-based medical procedures, when the magnetized medical device is brought near a magnetic sensor (e.g., a magnetic sensor array) or inserted into the patient, the ultrasound imaging system can then track the medical device. This magnetic-based tracking of the magnetized medical device helps clinicians place the end of the medical device in a desired location (e.g., the lumen of a blood vessel) by superimposing a simulated needle image representing the real-time distance and orientation of the needle onto an ultrasound image of the patient's body approaching the magnetized medical device. Such a medical device can be, for example, stainless steel; however, other suitable needle materials capable of being magnetized can be used. With this configuration, the needle, etc., can generate a magnetic field or produce magnetic interference within a magnetic field, which can be detected as a magnetic signal by the magnetic sensor array of the ultrasound probe, allowing the distance and orientation of the magnetized medical device to be tracked by the ultrasound imaging system.

[0063] exist Figure 1In one embodiment, the magnetizer 102 includes a housing comprising a magnetization chamber 104 and multiple surfaces, including a cover interface 105 and an open surface 107. The magnetizer interface 113 of the magnetizer cover 110 is configured to contact the cover interface 105 of the magnetizer 102, as described below. The cover interface 105 includes a magnetizer orifice 106 through which a funnel 116 or its funnel rod 119 can be inserted. In one example, the magnetizer orifice 106 may be at least substantially circular, formed by the cover interface 105. The magnetizer orifice 106 allows the magnetizer cover 110, as described herein, to be at least partially inserted into the magnetization chamber 104 of the magnetizer 102, such that objects such as medical devices (e.g., sterilized needles) can be placed within the magnetizer cover 110 for magnetization while being protected from exposure to contaminants.

[0064] In one embodiment, the user positions the sterilized magnetizer cap 110 such that the funnel 116 or its funnel rod 119 engages within the magnetizer 102. For example, the funnel rod 119 of the magnetizer cap 110 can be inserted into the magnetization chamber 104 through a magnetizer orifice 106 formed by the cap interface 105. The magnetizer 102 may be unsterilized. The funnel rod 119 is configured to engage within the magnetizer orifice 106 such that the magnetizer cap 110 is stabilized and held by the magnetizer 102 without shifting or changing position. The user then moves a sterilized magnetizable medical device (e.g., a needle) through the funnel orifice 118 of the magnetizer cap 110, thereby causing or guiding the medical device into at least a portion of the funnel rod 119 (i.e., at least partially within the magnetizer cap 110), while the funnel rod 119 is inserted into the magnetizer 102. The medical device is then magnetized by the magnetizer 102. The user then removes the medical device from the magnetization system 100 for use with the ultrasound imaging system. Before, during, and after movement through the magnetizer 102, the sterilized medical device may come into contact with the sterilized magnetizer cover 110 without contacting the unsterilized magnetizer 102.

[0065] exist Figure 1 In one embodiment, the magnetizer cover 110 includes a gripping tab 114. A user can grip the gripping tab 114 to position the magnetizer cover 110 on the magnetizer 102 while maintaining the sterility of other surfaces. For example, a user can use the gripping tab 114 to hold, carry, or place the magnetizer cover 110. The gripping tab 114 may be integrated into a base 112 of the magnetizer 102 (e.g., the base 112 may include the gripping tab 114). The gripping tab 114 may extend or protrude from the base 112. As described below, the gripping tab 114 may include structures that further enable the user to manipulate the magnetizer cover 110.

[0066] Figure 1 The magnetizer cover 110 includes a base 112 having a magnetizer interface 113. Figure 1In one embodiment, the base 112 is at least partially planar. The magnetizer interface 113 is configured such that at least a portion of the magnetizer interface 113 can be positioned on at least a portion of the cover interface 105 of the magnetizer 102. For example, the magnetizer interface 113 may rest on the cover interface 105.

[0067] The magnetizer cap 110 allows a medical device (e.g., a needle) to be magnetized by the magnetizer 102 without exposing the device to potentially contaminated surfaces of the magnetizer 102. In examples, the magnetizer cap 110 may be a sheath, barrier, housing, envelope, packaging, or other structure to prevent or stop the surface of the magnetizer 102 from contacting objects inserted into it. The magnetizer cap 110 may be made of any suitable sterilizable material, such as, but not limited to, medical-grade plastics or silicone.

[0068] In some embodiments, the magnetizer interface 113 may be configured to securely engage or attach to the magnetizer 102 such that when the magnetizer interface 113 rests on the cover interface 105, the base 112, and more generally the magnetizer cover 110, does not shift or move. For example, the magnetizer interface 113 may include one or more rough portions that prevent the magnetizer cover 110 from moving when the magnetizer cover is positioned on the magnetizer 102. Furthermore, in some embodiments, the magnetizer cover 110 includes a sterilized structure that serves to stabilize or align the magnetizer cover 110. For example, in Figure 1 In one embodiment, the portion of the magnetizer cover 110 orthogonal to the base 112 forms a side barrier 120. The side barrier 120 may be configured to align with a portion of the magnetizer 102 or other structure, for example, by pressing against another object, thereby providing a barrier against other objects to maintain a sterile area around the medical device interface 115. Figure 1 As shown, one or more structural stability ridges 121 may be incorporated into at least the base 112 to provide additional stability to the magnetizer cover 110. Additionally, the one or more structural stability ridges 121 may be incorporated into the side barrier 120 such that the one or more structural stability ridges 121 extend along the base 112 and into the side barrier 120 to provide further stability to the magnetizer cover 110.

[0069] In some embodiments, at least some components of the magnetizer cover 110 are sterilized. For example, the base 112, magnetizer interface 113, grip tab 114, medical device interface 115, funnel 116, and side barrier 120 may be sterilized. Therefore, a medical device moved or placed within the magnetizer cover 110 will only come into contact with the sterilized surfaces of the magnetizer cover 110, thus maintaining the sterility of the medical device. Furthermore, a user wearing sterile gloves can come into contact with the sterile surfaces of the magnetizer cover 110 without compromising the sterility of the gloves.

[0070] Figure 1 The base 112 includes a funnel 116 from which a funnel opening 118 and a funnel rod 119 extend. A medical device to be magnetized enters the magnetizer cover 110 through the funnel opening 118 and moves within the funnel rod 119. In some embodiments, the funnel rod 119 is at least as long as the medical device, thereby reducing the chance that the medical device will come into contact with the magnetizer 102.

[0071] The funnel rod 119 can be straight (e.g., at least substantially perpendicular to the base 112) or it can be angled. When angled, the funnel rod 119 can have angles such as 15°, 30°, 45°, 60°, 75°, 90°, etc. The funnel rod 119 can include an open end or a closed end. In embodiments where the funnel rod 119 has an open end, a sterilized end piece can be attached to the funnel rod to create a closed end. The closed end and the sterilized end piece each prevent the magnetizable medical device within the funnel rod 119 from contacting the magnetizer 102, and thus minimize the risk of contamination. In some embodiments, the sterilized end piece can be omitted. For example, in embodiments where the length of the funnel rod 119 is greater than the length of the needle, the needle can be magnetized without using the sterilized end piece. In some embodiments, the sterilized end piece can be removable.

[0072] In some embodiments, the funnel opening 118 may be a hole, orifice, gap, slot, or other opening formed in the base 112, allowing a medical device to enter and move through the magnetizer cover 110. The funnel rod 119 may include one or more of a tube, shaft, or hole. In some embodiments, the funnel opening 118 may have a receding, gradually sloping edge configured to guide the medical device into the funnel rod 119 and to center the medical device within the magnetizer cover 110. In other embodiments, the funnel opening 118 may not have a gradually sloping edge.

[0073] In some embodiments, the funnel opening 118 and the funnel rod 119 may have different shapes than those shown. For example, in one embodiment, the funnel rod 119 may be tapered. In another embodiment, the funnel rod 119 may be straight or substantially straight.

[0074] The funnel rod 119 may be shaped according to the shape of the corresponding medical device. For example, in an embodiment where the medical device is a needle, the funnel rod 119 may be shaped to facilitate movement of the needle into and out of the magnetizer cap 110 (e.g., cylindrical). However, the shape of each of the funnel opening 118 and the funnel rod 119 is not limited to the shapes shown. Instead, in some embodiments, the funnel opening 118 may have a rectangular opening, or the funnel rod 119 may be a rectangular prism (cubic prism).

[0075] In some implementations, the funnel rod 119 is hollow. For example, the funnel rod 119 may not have a structure that would obstruct the passage of a medical device (e.g., a needle).

[0076] The funnel opening 118 and funnel rod 119 of the funnel 116 of the magnetizer cover 110 can be configured according to various characteristics of the medical device being magnetized. For example, in an embodiment where the medical device to be magnetized is a needle, the width of the funnel opening 118 and the funnel rod 119 can each be at least equal to the width of the needle, allowing the needle to pass through. In some embodiments, each of the funnel opening 118 and the funnel rod 119 is wider than the needle, facilitating the movement of the needle into and out of the magnetizer cover 110. The funnel opening 118 and the funnel rod 119 can have different widths from each other. For example, the funnel opening 118 can be wider than the funnel rod 119, allowing the medical device to enter the magnetizer cover 110, but making it less likely to accidentally pass through.

[0077] exist Figure 1 In one embodiment, the magnetization chamber 104 includes multiple sides. At least a portion of one or more sides of the magnetization chamber 104 may have removed material to facilitate operation of the magnetizer 102. For example, as Figure 1 As shown in the embodiment, a portion of the side of the magnetization chamber 104 can be removed to provide an open surface 107. Through the open surface 107, the user can view the interior of the magnetizer 102 or its magnetizing element 108, clean the interior of the magnetizer 102 or its magnetizing element 108, view the magnetizer cover 110 and confirm its placement within the magnetizer 102, remove unwanted objects, or replace objects within the magnetizer 102.

[0078] refer to Figure 2 The magnetizer cap 110 typically includes a magnetizer interface 113, a gripping tab 114, a funnel 116 including a funnel opening 118 and a funnel rod 119, and a side barrier 120. In one embodiment, the user positions the magnetizer cap 110 in the desired position using the gripping tab 114, inserts the funnel 116 or its funnel rod 119 into the magnetizer 102, and inserts a magnetizable medical device into the funnel 116 through the funnel opening 118. The magnetizer cap 110 is held in the magnetizer 102 by the funnel rod 119 and gravity. The medical device is magnetized while in the funnel 116 and is then removed by the user.

[0079] In some embodiments, the magnetizer cap 110 may be configured to facilitate a user's insertion and removal of a medical device (e.g., a needle) into and from the magnetizer 102, as well as to facilitate the insertion and removal of any caps used for the medical device (e.g., needle cap 506 of needle 500). For example, the funnel opening 118 may have a width suitable for allowing a user to briefly insert and remove a needle with an immersion motion, and the funnel rod 119 may have a depth suitable for allowing a user to briefly insert and remove a needle with an immersion motion, thereby magnetizing the needle within the magnetizer 102. In another embodiment, the funnel opening 118 and the funnel rod 119 may have proportions suitable for inserting a needle or a needle with a needle cap. The magnetizer cap 110 can then be used even before the needle cap has been removed from the needle.

[0080] The magnetizer interface 113 of the magnetizer cover 110 may have a shape and size for placement on the magnetizer 102. In some embodiments, the magnetizer interface 113 may rest on the magnetizer 102 or its cover interface 105 after the funnel 116 or its funnel rod 119 is inserted through the magnetizer orifice 106, such that the magnetizer interface 113 contacts or touches the cover interface 105, while the medical device interface 115 does not contact or touch the magnetizer 102 in any way. The magnetizer cover 110 may be secured by inserting the funnel rod 119 of the funnel 116 into the magnetizer orifice 106 of the magnetizer 102, which minimizes movement and accidental removal of the magnetizer cover 110. In some embodiments, the magnetizer interface 113 may include further securing features (e.g., a latch, lock, or rim) to prevent movement of the magnetizer cover 110 when inserted into the magnetizer 102. In some embodiments, the cover interface 105 may include further securing features (e.g., a latch, lock, or rim) to prevent movement of the magnetizer cover 110 when inserted into the magnetizer 102. In some embodiments, a medical device may be inserted to fit snugly into the medical device interface 115 such that when the medical device is removed, the magnetizer cover 110 is also removed, while the medical device remains fitted within the medical device interface 115 (see [link to medical device interface 115]). Figures 5C to 5F ).

[0081] The gripping protrusion 114 may include gripping features 117. In Figure 2 In one embodiment, the gripping tab 114 is an extension of the base 112, and the shape of the gripping tab is adapted for the user to manipulate the magnetizer cover 110 in order to pick up the magnetizer cover 110 for insertion into the magnetizer 102. Although Figure 2The grip tab 114 is at least substantially coplanar with the base 112, but in some embodiments, the grip tab 114 may be angled, shaped, or have shape factors to allow a user to manipulate the magnetizer cover 110 without contacting any portion of it other than its grip tab 114 and grip feature 117. In some embodiments, the grip tab 114 may also include a handle; an extended tab; and / or a rod. The grip tab 114 may have a length extending a predetermined length above the edge of the magnetizer 102 such that the grip tab 114 can be gripped (e.g., between the thumb and forefinger) and the magnetizer cover 110 can be placed by the user without at least a portion of the grip tab 114 contacting the magnetizer 102.

[0082] The gripping feature 117 helps the user manipulate the magnetizer cover 110 by gripping the tab 114. For example, Figure 2 The grip feature 117 includes a plurality of straight, protruding ridges transverse to the grip tab 114, which improve the user's frictional grip on the grip tab 114. Although in Figure 2 In this embodiment, the grip feature 117 is located on the medical device interface 115, but in some implementations, the grip feature 117 may be located elsewhere. For example, the grip feature 117 may be arranged on the magnetizer interface 113 or on both the medical device interface 115 and the magnetizer interface 113 to further assist the user in holding the magnetizer cover 110. In practice, as... Figure 4A and Figure 4B As shown, the gripping feature 117 may include multiple ridges on both the medical device interface 115 and the magnetizer interface 113.

[0083] Although Figure 2 The grip feature 117 includes a set of ridges, but other patterns and forms of auxiliary devices may also be used. For example, the grip feature 117 may include a single ridge; multiple ridges forming a predetermined shape; or a dotted pattern. The grip feature 117 may also be angled to facilitate user control of the magnetizer cover 110.

[0084] The magnetizer cap 110 also includes a side barrier 120. The side barrier 120 may be positioned to abut a corresponding portion of the magnetizer 102 or other device, thereby stabilizing the magnetizer cap 110. In some embodiments, the magnetizer cap 110 may be manufactured for use with a corresponding magnetizer having a predetermined surface, and the side barrier 120 may have an angle, size, and shape corresponding to the predetermined surface of the corresponding magnetizer, such that the side barrier 120 abuts the magnetizer surface when the funnel rod 119 of the magnetizer cap 110 is inserted into the corresponding magnetizer. When the magnetizer cap 110 is inserted into the magnetizer 102 (e.g., via the funnel 116 or its funnel rod 119), the side barrier 120 may rest or rest against the magnetizer surface, thereby positioning itself between the medical device and the magnetizer to prevent unintentional contamination of the medical device by contacting the sterile side barrier 120 rather than the magnetizer 102. The magnetizer cap 110 is thus stabilized by the magnetizer surface and protects the medical device from unintentional contamination by the magnetizer. Although Figure 2 The side barrier 120 forms a curved edge with the base 112 and is at least substantially vertical and perpendicular to the base 112, but in some embodiments, the side barrier 120 may be at an angle relative to the base 112. In addition, in some embodiments, the side barrier 120 may form other types of edges with the base 112 (e.g., sharp edges).

[0085] In some embodiments, the magnetizer cap 110 and one or more of its components are sterilized. In some embodiments, the magnetizer cap 110 may be used with the magnetizer 102 when the magnetizer is not sterilized. A user may insert the magnetizer cap 110 into the unsterilized magnetizer 102, place an unmagnetized medical device (e.g., an unmagnetized needle) into the funnel opening 118 of the magnetizer cap 110, and thereby magnetize the medical device without potentially exposing the needle to the unsterilized magnetizer 102.

[0086] Any or all components of the magnetizer cap 110, such as the base 112, gripping tabs 114, gripping features 117, funnel 116, or side barriers 120, may be sterilized. For example, the side barrier 120 may be sterilized and used as a sterile barrier to protect the needle from the adjacent unsterilized surfaces of the magnetizer 102. In some embodiments, only the surfaces of the magnetizer cap 110 that will come into contact with the potentially contaminated magnetizer 102 will be those surfaces that the medical device will not contact or is unlikely to contact. Furthermore, the user may grasp the sterilized gripping tabs 114 to insert the magnetizer cap 110 into the magnetizer 102 to avoid contact with unsterilized portions of the magnetizer 102. For example, the magnetizer cap 110 may be manufactured for use with a corresponding magnetizer having a cap interface configured to receive the magnetizer cap 110, which rests on the cap interface after insertion. In some embodiments, the grip tab 114 may have a length extending beyond the surface of the magnetizer 102, allowing a user to use a sterile glove to grasp the portion of the grip tab 114 that does not contact the magnetizer 102 after the magnetizer cover 110 has been inserted, and thus avoid contaminating the sterile glove.

[0087] In some implementations, the funnel rod 119 is hollow. For example, the funnel rod 119 may have at least substantially no structures that would obstruct the passage of a medical device (e.g., a needle) therein.

[0088] refer to Figure 3 A side view of a magnetizer cover 110 having a magnetizer 102 according to some embodiments is shown. Figure 3 In one embodiment, the magnetizer cover 110 includes a funnel 116, the funnel rod 119 of which is inserted into the magnetizer 102 such that the funnel rod 119 is located in the magnetization chamber 104. A medical device (e.g., a needle) inserted into the funnel 116 is thus protected from contact with the magnetization chamber 104.

[0089] In addition, the magnetizer cover 110 includes a magnetizer interface 113 located on the magnetizer 102. The magnetizer interface 113 prevents the medical device from accidentally contacting the magnetizer 102 before and during insertion into the funnel 116.

[0090] exist Figure 3 In one embodiment, the grip tab 114 can be held by a user to position the magnetizer cap 110 on the magnetizer 102. The side barrier 120 extends from the medical device interface 115 to help the user position the magnetizer cap 110 and to protect nearby potentially contaminated surfaces (e.g., on the magnetizer 102).

[0091] refer to Figure 4AA top view of a magnetizer cap 110 according to some embodiments is shown. A gripping tab 114 includes gripping features 117 on a medical device interface 115 to assist a user in grasping the gripping tab 114. A funnel opening 118 is available for inserting a medical device for magnetization. A side barrier 120 extends to assist the user in positioning the magnetizer cap 110. A user wearing sterile gloves can grasp the gripping tab 114 to allow the magnetizer cap 110 to be placed inside the magnetizer 102 while maintaining glove sterility. Reference Figure 4B The image shows a bottom view of a magnetizer cover 110 according to some embodiments. The magnetizer cover 110 includes a magnetizer interface 113. As described above, a gripping tab 114 may also include a gripping feature 117 on the magnetizer interface 113 to further assist the user in grasping the gripping tab 114. A medical device can be magnetized by passing through a funnel rod 119.

[0092] refer to Figure 5A An exploded view of a needle according to some embodiments and a magnetization system 100 including a magnetizer cap 110 and a magnetizer 102 is shown. Additionally, Figure 5B The following are illustrated according to some implementation schemes. Figure 5A The magnetization system 100 includes a magnetizer cap 110 inserted into a magnetizer 102 and a needle inserted into a funnel rod 119 of a needle cap. The magnetization system 100 includes a magnetizer cap 110 and a magnetizer 102, wherein the magnetizer cap 110 is specifically configured to be inserted into an opening in the magnetizer 102, such that a funnel 116 (including its funnel rod 119) extends into the magnetizer 102. Furthermore, the funnel rod 119 is configured to receive a needle, for example... Figures 5A to 5B The needle 500 (which may include a magnetizable portion 502 and a non-magnetizable portion 504) advances or propels within the funnel rod 119 so as to be magnetized by the magnetizer 102.

[0093] In some embodiments, the magnetizer cover 110 includes a base 112 and a funnel 116, wherein the funnel 116 may include a tapered cylindrical portion extending away from the funnel opening 118, which is referred to herein as the funnel rod 119. Figure 5A In one embodiment, the funnel rod 119 can be inserted through the magnetizer aperture 106 of the magnetizer 102. The magnetizer cover 110 can be placed on the magnetizer 102 using a gripping tab 114. The magnetizer 102 then securely holds the magnetizer cover 110, as if... Figure 5B As shown. In some embodiments where the funnel rod 119 has a conical cylindrical structure, the diameter of the funnel rod 119 may be smaller than the diameter of the magnetizer orifice 106; therefore, the funnel rod 119 is configured to pass through it and be received by the magnetizer 102.

[0094] The magnetizer cover 110 includes a side barrier 120 that is aligned with the surface of the magnetizer 102. The side barrier 120 stabilizes the magnetizer cover 110 and prevents potentially contaminated portions of the magnetizer 102 from contacting portions of the magnetizer cover 110 that may come into contact with a magnetizable medical device.

[0095] In some implementations, each part and component of the magnetizer cover 110 can be sterilized. For example, in Figures 5A to 5B In this implementation, the gripper tab 114 can be sterilized so that a user wearing sterilized gloves will not be contaminated by contact with it. Furthermore, the interior of the funnel 116 (not shown) is sterilized so that any sterile medical device placed inside it will not be contaminated.

[0096] Now for reference Figures 5C to 5E The magnetizer cap 110 may include one or more inward-facing forks 510 within the funnel 116 or its funnel stem 119 near the funnel opening 118 or even extending from the funnel opening 118 into the funnel stem 119. It is advantageous to insert a needle 500, including a needle cap 506, into the magnetizer 102, for example, to maintain safety and sterility. The one or more forks 510 can be used to contact the needle cap 506, and once the needle cap 506 has been inserted through the one or more forks 510, the one or more forks hold the needle cap 506 and prevent the needle cap 506 from leaving the magnetizer cap 110 through the funnel opening 118. Thus, a clinician can insert a needle 500 with the needle cap 506 above it to magnetize the needle 500, and then remove the needle 500 while withdrawing it from the needle cap 506. In some embodiments, the funnel 116 may have an open end (e.g., an open end of the funnel rod 119 opposite the funnel opening 118), thereby enabling the removal of the needle cap 506. The open end may optionally include a removable cap as described above. In some embodiments, the magnetizer cap 110 may include the closed end of the funnel rod 119 and be disposed of together with the needle cap 506 after a single use.

[0097] Now for reference Figure 5F Similar to Figures 5C to 5E In one embodiment, the magnetizer cover 110 may include a continuous inwardly angled ring 512 within the funnel 116 or its funnel rod 119 but near the funnel opening 118. The ring 512 may be coupled with… Figures 5C to 5E The fork tooth implementation scheme operates in the same way.

[0098] Now for reference Figure 6 Method 600 may include maintaining the sterility of a slender medical device, such as a needle 500, while magnetizing the device. Method 600 includes... Figure 6The boxes illustrate multiple operations, one or more of which may be optional. Method 600 may begin when the magnetizer cap 110 is provided (box 602). Next, the magnetizer cap application operation (box 604) may include inserting at least a funnel rod 119 of the magnetizer cap 110 into a magnetizer aperture 106 of the magnetizer 102, thereby arranging the funnel rod 119 in the magnetization chamber 104 of the magnetizer 102. A subsequent medical device insertion operation (box 606) may include inserting a magnetizable portion of the medical device (e.g., a magnetizable portion 502 of the needle 500) into the funnel rod 119 of the magnetizer cap 110. As described herein, the funnel rod 119 is configured to protect the magnetizable portion of the medical device from contact with the magnetizer 102. The magnetization initiation operation includes initiating the magnetization of the medical device such that the magnetizable portion of the medical device (e.g., a magnetizable portion 502 of the needle 500) is magnetized by the magnetizer 102 (box 608).

[0099] Although not shown, method 600 may also include a medical device withdrawal operation. The medical device withdrawal operation includes withdrawing the medical device from the funnel rod 119 after magnetization of the medical device is complete. If the medical device includes a cap on top of it (e.g., a needle 500 with a needle cap 506), the one or more forks 510 or rings 512 grip the cap during the medical device insertion operation when the magnetizable portion of the medical device is inserted into the funnel rod. The one or more forks 510 or rings 512 also prevent the cap from being withdrawn from the funnel rod 119 along with the medical device, thereby retaining the cap in the funnel rod 119 after the medical device withdrawal operation. Regardless of the presence of the one or more forks 510 or rings 512 in the magnetizer cap 110, after the medical device withdrawal operation, the magnetized medical device (e.g., a magnetized needle 500) that remains sterile throughout method 600 can be inserted into the patient's body, where the insertion can be tracked, for example, by an ultrasound imaging system due to the magnetization of the medical device (box 610).

[0100] Ultrasonic imaging system

[0101] In some embodiments, the magneto-based device guidance system may be an ultrasound imaging system. In some embodiments, the ultrasound imaging system may include a console, a display screen, an ultrasound probe, and a magnetizer 102. In some embodiments, the ultrasound imaging system may also include a magnetizer cover 110. The ultrasound imaging system can be used to image a target before percutaneous insertion of a medical device (e.g., a needle) to insert the needle into a target (e.g., a blood vessel or organ in a patient's body) and before reaching that target. The ultrasound imaging system can be used with a variety of ultrasound-based medical procedures, such as catheter insertion or performing biopsies of patient tissue. During the use of the ultrasound imaging system, clinicians may need to reach outside the sterile area surrounding the patient to control the ultrasound imaging system. In some embodiments, the display screen may be used to display the distance and orientation of the magnetized medical device (e.g., a needle). Distance and orientation data can be overlaid on the ultrasound image of the target in real time, allowing clinicians to accurately guide the magnetized medical device to the intended target.

[0102] In some implementations, an ultrasound probe is coupled to a control console. The probe can be placed against the skin surface to generate ultrasound signals that enter the patient's body. The reflected ultrasound signals or echoes are received from the patient by the reflection of the generated ultrasound pulses by the patient's body, and the reflected ultrasound signals are converted into corresponding electrical signals for processing into an ultrasound image by a control console communicatively coupled to the ultrasound probe. In this way, clinicians can use an ultrasound imaging system to determine appropriate insertion sites and establish vascular access to a needle or another medical device.

[0103] In some embodiments, the ultrasound probe may include an array of magnetic sensors for detecting a magnetized medical device (e.g., a needle) during ultrasound-based medical procedures. The magnetic sensor array includes multiple magnetic sensors embedded within or included on the housing of the ultrasound probe. These magnetic sensors are configured to detect a magnetic field or interference in the magnetic field as a magnetic signal associated with the magnetized medical device when the magnetized medical device approaches the magnetic sensor array. These magnetic sensors are also configured to convert the magnetic signal from the magnetized medical device (e.g., a needle) into an electrical signal so that a console processes it into distance and orientation information of the magnetized medical device relative to a predetermined target, and to display an iconographic representation of the magnetized medical device on a display screen. Thus, the magnetic sensor array enables the ultrasound imaging system to track needles, etc. The magnetic sensors may include three orthogonal sensor coils to enable detection of magnetic fields in three spatial dimensions. In some embodiments, instead of 3-D sensors, multiple 1-dimensional (“1-D”) magnetic sensors may be included, and these sensors may be arranged as needed to achieve 1-D, 2-D, or 3-D detection capabilities.

[0104] During operation of an ultrasound imaging system, an ultrasound probe is placed against the patient's skin. An ultrasound beam is generated to image a portion of a target, such as blood vessels beneath the surface of the patient's skin. The ultrasound image of the blood vessels can then be drawn and stabilized on the ultrasound imaging system's display screen.

[0105] Ultrasound imaging systems can be configured to detect the distance and orientation of medical devices, for example, using magnetic sensors. By way of example, an array of magnetic sensors in an ultrasound probe is configured to detect the magnetic field of a magnetized medical device or interference in the magnetic field caused by the magnetized device. Each magnetic sensor in the array is configured to spatially detect the probe in three-dimensional space. Therefore, during operation of the ultrasound imaging system, magnetic field strength data of the medical device sensed by each magnetic sensor is forwarded to a processor in the control console, which 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 a screen.

[0106] An ultrasound imaging system using magnetic field strength data sensed by magnetic sensors can determine the distance or orientation of any point in coordinate space along the entire length of a magnetized medical device relative to an array of magnetic sensors. Furthermore, the pitch and deflection of the needle can be determined. Appropriate circuitry in the ultrasound probe, console, or other components of the ultrasound imaging system can provide the necessary calculations for this distance or orientation.

[0107] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. 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 cap for maintaining the sterility of a medical device while magnetizing it, characterized in that, include: A base including a medical device interface and a magnetizer interface opposite to the medical device interface, the base including at least a planar portion; A funnel extending from the base, the funnel including a funnel rod configured to protect the medical device from contact with a magnetizer when an elongated medical device is inserted into the funnel, wherein the planar portion extends circumferentially around the funnel; and A gripping tab extends from the base and is configured to manipulate the magnetizer cover.

2. The magnetizer cover according to claim 1, characterized in that, At least the base includes one or more structural stability ridges incorporated therein to provide additional structural stability to the magnetizer cover.

3. The magnetizer cover according to claim 2, characterized in that, The gripping tabs extend from the base in the same direction as the one or more structural stability ridges incorporated into the base.

4. The magnetizer cover according to claim 1, characterized in that, The base and the funnel are configured between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

5. The magnetizer cover according to claim 1, characterized in that, Also includes: A side barrier, orthogonal to the base, is configured between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

6. The magnetizer cover according to claim 5, characterized in that, The gripping protrusions extend from the base opposite to the side barrier.

7. The magnetizer cover according to claim 1, characterized in that, The funnel extends from the magnetizer interface of the base, allowing the funnel rod to be inserted into the magnetizer orifice of the magnetizer.

8. The magnetizer cover according to claim 1, characterized in that, The funnel also includes a funnel opening between the base and the funnel rod, the funnel opening being configured to guide the medical device into the funnel rod.

9. The magnetizer cover according to claim 1, characterized in that, The length of the funnel is greater than the length of the magnetizable portion of the medical device.

10. The magnetizer cover according to claim 1, characterized in that, The funnel rod has an open end opposite to the base.

11. The magnetizer cover according to claim 1, characterized in that, The funnel rod has a closed end opposite to the base.

12. The magnetizer cover according to claim 1, characterized in that, The funnel rod includes one or more inwardly facing forks extending from the funnel opening into the funnel rod, the one or more forks being configured to: grip the cap on the medical device when the medical device is inserted into the funnel and the medical device is covered with a cap, and prevent the cap from being withdrawn from the funnel when the medical device is withdrawn from the funnel.

13. The magnetizer cover according to claim 1, characterized in that, The gripping protrusion includes a transverse ridge located on the same plane as the medical device interface of the base.

14. The magnetizer cover according to claim 13, characterized in that, The gripping tab also includes a transverse ridge located on the same plane as the magnetizer interface of the base.

15. A magnetization system for maintaining the sterility of a medical device while magnetizing it, characterized in that, The system includes: Magnetizer, the magnetizer comprising: Magnetizer orifice, which is formed in the cover interface of the magnetizer; and A magnetization chamber, accessible through the magnetizer aperture; and Magnetizer cover, the magnetizer cover comprising: A base including a medical device interface and a magnetizer interface opposite to the medical device interface, the base including at least a planar portion; A funnel extending from the base, the funnel including a funnel rod configured to protect an elongated medical device from contact with the magnetizer when inserted into the funnel, wherein the planar portion extends circumferentially around the funnel; and A gripping tab extends from the base and is configured to manipulate the magnetizer cover.

16. The magnetization system according to claim 15, characterized in that, At least the base includes one or more structural stability ridges incorporated therein to provide additional structural stability to the magnetizer cover.

17. The magnetization system according to claim 16, characterized in that, The gripping tabs extend from the base in the same direction as the one or more structural stability ridges incorporated into the base.

18. The magnetization system according to claim 15, characterized in that, The base and the funnel are configured between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

19. The magnetization system according to claim 15, characterized in that, Also includes: A side barrier, orthogonal to the base, is configured between the magnetizer and the medical device to prevent the medical device from contacting the magnetizer and contaminating the medical device.

20. The magnetization system according to claim 19, characterized in that, The gripping protrusions extend from the base opposite to the side barrier.

21. The magnetization system according to claim 15, characterized in that, The funnel extends from the magnetizer interface of the base, allowing the funnel rod to be inserted into the magnetizer orifice of the magnetizer.

22. The magnetization system according to claim 15, characterized in that, The funnel also includes a funnel opening between the base and the funnel rod, the funnel opening being configured to guide the medical device into the funnel rod.

23. The magnetization system according to claim 15, characterized in that, The length of the funnel is greater than the length of the magnetizable portion of the medical device.

24. The magnetization system according to claim 15, characterized in that, The funnel rod has an open end opposite to the base.

25. The magnetization system according to claim 15, characterized in that, The funnel rod has a closed end opposite to the base.

26. The magnetization system according to claim 15, characterized in that, The funnel rod includes one or more inwardly facing forks extending from the funnel opening into the funnel rod, the one or more forks being configured to: grip the cap on the medical device when the medical device is inserted into the funnel and the medical device is having a cap, and prevent the cap from being withdrawn from the funnel when the medical device is withdrawn from the funnel.

27. The magnetization system according to claim 15, characterized in that, The gripping protrusion includes a transverse ridge located on the same plane as the medical device interface of the base.

28. The magnetization system according to claim 27, characterized in that, The gripping tab also includes a transverse ridge located on the same plane as the magnetizer interface of the base.

Images