Intrusive medical device cover with magnet

Abstract

A cover for magnetizing a shaft of a tissue-penetrating medical device is disclosed. The cover includes a sleeve member having a hollow body to form a protective enclosure over the shaft of the tissue-penetrating medical device. An open end of the hollow body provides a receiving space for receiving the shaft of the tissue-penetrating medical device. A magnet is disposed on the sleeve member. A medical device and a method of magnetizing the shaft of a tissue-penetrating medical device using the cover are also disclosed.

Description

[0001] This application is a divisional application of the invention patent application entitled "Invasive Medical Device Cover with Magnet", with an international filing date of May 8, 2017, international application number PCT / US2017 / 031566, and national application number 201780037032.0. Technical Field

[0002] Some aspects of the present invention relate to a shield for magnetizing tissue to penetrate a medical device. Background Technology

[0003] Traditionally, the penetration of invasive medical devices, such as needles and catheters, through the skin to reach blood vessels during catheter insertion is invisible to clinicians. For this reason, clinicians must rely on their first-hand experience with needle insertion combined with tactile sense to successfully identify the location of the vessel. This can be a difficult task when attempting to access small vessels deep beneath the skin, increasing the risk of unnecessary pain and / or injury to the patient. Similar problems exist regarding the insertion of other invasive medical devices (such as medical leads, catheters, guide needles, cannula needles, scalpels, and guidewires) because the location of the invasive medical device cannot be precisely visualized.

[0004] Emerging surgical guidance systems utilize a combination of ultrasound and magnetic technologies to provide visualization of subcutaneous anatomy and device placement, both in-plane and out-of-plane. This combination of ultrasound and magnetic methods also allows for the prediction or forecasting of the insertion device's position relative to the patient's anatomy, thereby increasing the likelihood of successful access to blood vessels and completion of invasive procedures.

[0005] One leading technology uses a portion of the device, inserted into the patient (e.g., a needle cannula), as the target part of the invasive device for magnetization, while another leading technology uses a permanent magnet located on the base of the device (e.g., a needle hub). Current needle guidance systems typically utilize a magnetic field generated by magnetizing the needle by embedding the needle into the magnetizer until the needle tip strikes a rubber stop surface. Figure 1 shows a perspective view of a currently available disposable needle magnetizer 11. As shown in Figure 1, current practice uses an unprotected needle 13, which is placed within an external disposable needle magnetizer 11 to a depth defined by the bottom of the magnetizer. Current devices for magnetizing the needle before insertion are typically not sterile, not disposable, and not electronic.

[0006] In systems of the type shown in Figure 1, damage to the needle that is not immediately apparent to the user may occur, potentially negatively impacting the insertion process. Furthermore, the user-initiated magnetization of the metal cannula has limitations and inherent risks, as this method does not guarantee consistent magnetization due to variations in clinical procedures. Variations in clinical procedures such as insertion depth, processing speed, and needle alignment within the magnetizer will result in different degrees of magnetization. Considering the potential inconsistencies in the user's complete insertion of the needle to the bottom of the magnetizer 11, the significant risk of needle tip damage, and the increased possibility of contamination during this step, a system that passively and consistently magnetizes the needle without introducing the aforementioned additional risks (such as needle tip damage and the possibility of increased contamination) would be advantageous. Therefore, there is a need for a system that passively and consistently magnetizes invasive medical devices while reducing or eliminating risks such as needle tip damage and needle contamination. Summary of the Invention

[0007] A first aspect of the invention relates to a cover for magnetizing a tissue-penetrating medical device. A first embodiment relates to a cover comprising a sleeve member having a hollow body having a distal end and a proximal end to form a protective encapsulation over a portion of the tissue-penetrating medical device (e.g., a shaft). In one or more embodiments, the sleeve member may have a length to cover the shaft of the tissue-penetrating medical device, and one or more magnets are disposed on the sleeve member. In one or more embodiments, an open end of the hollow tubular body provides a device receiving space for receiving at least a portion of the tissue-penetrating medical device (e.g., the shaft).

[0008] In one or more embodiments, the device receiving space allows movement of the tissue through the medical device, into and out of the device receiving space. In one or more embodiments, the device receiving space allows movement of the tissue through the medical device in a direction parallel to the longitudinal axis of the tissue through the medical device.

[0009] In one or more embodiments, one or more magnets are disposed on one side of the device receiving space. In one or more embodiments, two or more magnets are disposed, wherein the two magnets are disposed around the device receiving space. According to one or more embodiments, the two or more magnets are disposed in a slot disposed around the sleeve member. In one or more embodiments, the slot disposed around the sleeve member surrounds the device receiving space.

[0010] In one or more embodiments, the cover may be sterile. In one or more embodiments, the cover may be disposable. In one or more embodiments, the cover may be both sterile and disposable. In one or more embodiments, the cover is made of plastic.

[0011] In one or more embodiments, the tissue-penetrating medical device may be a needle, cannula, catheter, scalpel, or guidewire. According to one or more embodiments, the cover passively magnetizes the tissue-penetrating medical device when it is removed from the cover. In a particular embodiment, the tissue-penetrating medical device is a needle that, when magnetized, is adapted for use with a surgical guidance system (which can locate and predict the needle's position during invasive medical procedures).

[0012] In one or more embodiments, the distal end of the tissue-penetrating medical device includes a notch to provide immediate confirmation of vascular access at the insertion point.

[0013] A second aspect of the invention relates to a medical device assembly comprising: a tissue-penetrating medical device; and a cover for magnetizing the tissue-penetrating medical device, the cover comprising a sleeve member having a hollow body having a distal end and a proximal end to form a protective encapsulation on at least a portion (e.g., a shaft) of the tissue-penetrating medical device. In one or more embodiments, one or more magnets may be disposed on the sleeve member. In one or more embodiments, the sleeve member has a length to cover the shaft of the tissue-penetrating medical device (e.g., a needle cannula). In one or more embodiments, an open end of the hollow tubular body provides a receiving space for receiving at least a portion of the tissue-penetrating medical device. In one or more embodiments, the tissue-penetrating medical device comprises a needle assembly including a needle and a shaft, and when the shaft is magnetized, the tissue-penetrating medical device is configured for use in a surgical guidance system to locate and anticipate the position of the shaft during invasive medical procedures. In one or more embodiments, the medical device assembly further includes: a catheter having a proximal end and a distal end; a catheter connector having a distal end, a proximal end, a total length extending from the distal end to the proximal end, an internal cavity, an upper portion, a lower portion, and a tip region having a distal opening having a periphery through which the catheter extends, the catheter connector being connected to the proximal end of the catheter; and a shaft having a proximal end and a distal end, and the needle assembly including a needle hub connected to the proximal end of the shaft, the needle hub including a seat magnet. In one or more embodiments, the catheter connector is connected to the proximal end of the shaft.

[0014] A third aspect of the invention relates to a method for magnetizing a tissue-penetrating medical device. The method comprises: placing the shaft of at least the tissue-penetrating medical device within a housing comprising a receiving space, the housing containing a magnet; and removing the tissue-penetrating medical device from the receiving space to magnetize the shaft of the tissue-penetrating medical device in the receiving space. The tissue-penetrating medical device is a needle, cannula, catheter, scalpel, or guidewire. In one or more embodiments, the magnet is a collar surrounding the housing. Alternatively, the housing contains at least two magnets. Attached Figure Description

[0015] Figure 1 shows a perspective view of a prior art disposable needle magnetizer;

[0016] Figure 2 A perspective view showing an embodiment of the needle cover of the present invention;

[0017] Figure 3A An embodiment of a tissue-penetrating medical device prior to insertion into the needle cap of the present invention is shown;

[0018] Figure 3B An embodiment of a tissue-penetrating medical device is shown, which is partially inserted into the needle cap of the present invention;

[0019] Figure 3C An embodiment of a tissue-penetrating medical device is shown, fully inserted into the needle cap of the present invention;

[0020] Figure 4 An embodiment of a tissue-penetrating medical device that is fully magnetized after being removed from the needle cap of the present invention is shown;

[0021] Figure 5 An embodiment of a tissue-penetrating medical device with a magnetic collar is shown;

[0022] Figure 6A A partial perspective view of the top of a needle cover with an embedded magnet is shown;

[0023] Figure 6B An end view of a needle cover with an embedded magnet is shown;

[0024] Figure 6C An end view of a needle cover with two embedded magnets is shown; and

[0025] Figure 7 An embodiment of the medical device is shown. Detailed Implementation

[0026] Before describing some exemplary embodiments of the present invention, it should be understood that the description provided is not limited to the construction or process details set forth in the following description. The apparatus and methods described herein can have other embodiments and can be practiced or performed in various ways.

[0027] In this invention, following convention, the distal end of the device is the end closest to the patient and the proximal end of the device is the end furthest from the patient and closest to the practicing physician.

[0028] This invention relates to an improved system that addresses the challenges of existing technologies and systems for passively magnetizing needles, such as those used with peripheral venous (IV) catheters. One or more embodiments of the invention relate to a tissue-penetrating medical device with a needle sheath having an integrated magnet on or within the sheath. According to one or more embodiments, the device and system of the present invention passively and consistently magnetize the needle. In one or more embodiments, passive magnetization of the invasive medical device is not required through additional or new clinical steps because the invasive medical device already includes a sheath covering the distal tip of the device. In one or more embodiments, the device and system described herein provide more precise control over the position of the magnet relative to the device to be magnetized, forming a more consistent and predictable magnetic field applied to the invasive medical device. In one or more embodiments, the device and method described herein do not present additional risks of needle damage or contamination compared to existing magnetizer devices.

[0029] Now for reference Figure 2 This illustrates one aspect of the invention, relating to a cover 12 for magnetizing a tissue-penetrating medical device 10, comprising a sleeve member 14 having a hollow body 20 having a distal end 21 and a proximal end 22 to form a protective encapsulation on the shaft 34 of the tissue-penetrating medical device 30. In one or more embodiments, the hollow body 20 may be tubular or any other suitable shape. In the illustrated embodiment, the tissue-penetrating medical device 30 is shown as a needle assembly comprising a needle housing 32 and a shaft 34 of the needle having a sharp distal tip 36. It should be understood that, in Figure 2 In this design, the sleeve member 14 is shown as transparent, and the axis 34 of the tissue-penetrating medical device 30 is visible. The sleeve member 14 has a length L that covers the axis 34 of the tissue-penetrating medical device 30, which includes a sharp distal tip 36, to prevent accidental needle puncture. Figure 2The arrow indicating the length "L" also shows the longitudinal axis of shaft 34. The open end 22 of the hollow body 20 provides a device receiving space 40 for receiving tissue penetrating the medical device 30, at least along shaft 34. The cover 12 includes at least one magnet 50. In the illustrated embodiment, at least two magnets 50 are disposed on the sleeve member 14.

[0030] The size and shape of the device receiving space 40 are configured to allow tissue to penetrate the medical device 30 and move into and out of the device receiving space 40. In one embodiment, the device receiving space 40 allows the axis 34 of the tissue to penetrate the medical device 30 to move into the device receiving space 40 in a motion parallel to the longitudinal axis of the axis 34 of the tissue penetrating the medical device 30. When the cover 12 is removed from the axis 34 of the tissue penetrating the medical device, the cover 12 passively magnetizes the axis 34 of the tissue penetrating the medical device 30.

[0031] Figures 3A to 3C A medical device 100 is shown, comprising a tissue-penetrating medical device 130 and a cover 112 for magnetizing an axis 134 of the tissue-penetrating medical device 130. The cover 112 includes a sleeve member 114 having a hollow tubular body 120 having a distal end 121 and a proximal end 122 to form a protective encapsulation on the axis 134 of the tissue-penetrating medical device 130. The sleeve member 114 has a length L to cover the axis 134 of the tissue-penetrating medical device 130, the axis 134 having a length L2 and a distal tip 136. The open end 122 of the hollow tubular body 120 provides a receiving space 140 for receiving at least the axis 134 of the tissue-penetrating medical device 130. Two magnets 150 are disposed on the sleeve member 114. It should be understood that although two magnets 150 are shown, the device is not limited to a specific number of magnets or a specific position of the magnets around the sleeve member. Magnet 150 can be positioned or oriented around the sleeve member in any location. In one or more embodiments, a single magnet may be used to magnetize shaft 134, or two or more magnets may be used.

[0032] In embodiments using two magnets, the magnetic fields of the two magnets may be oriented differently. One magnet may have a north pole and a south pole on the axis of the tissue-penetrating medical device, while the second magnet may have a north pole and a south pole offset from or perpendicular to the axis of the tissue-penetrating medical device. Alternatively, both magnets may have north and south poles offset from the axis of the tissue-penetrating medical device, or both magnets may have north and south poles on the axis of the tissue-penetrating medical device.

[0033] Figure 3AA tissue-penetrating medical device 130 is shown before insertion into the housing 112 of the present invention. The tissue-penetrating medical device 130 includes a shaft 134 having a length L2 and a distal tip 136, and the shaft 134 is mounted to the housing 130 via a seat 152. In one or more embodiments, the seat 152 includes a seat magnet 155. In one or more embodiments, the seat magnet 155 is a fixed permanent magnet. When the tissue-penetrating needle is used in combination with ultrasound and magnetic technologies to provide visualization of subcutaneous anatomy and device placement, the seat magnet 155 provides a fixed magnetic reference point. Figure 3B The shaft 134 of the tissue-penetrating medical device 130, which is partially inserted into the cover 112 of the present invention, is shown. Figure 3C The shaft 134 of the tissue-penetrating medical device 130, which is fully inserted into the cover 112 of the present invention, is shown. Figure 3C The medical device 100 shown can be packaged and is ready for use in medical procedures. Figure 3C The medical device 100 shown can be packaged together with other devices as part of a larger medical device assembly. Therefore, Figure 3C A medical device 100 is shown as a needle assembly having a cover 112 having at least one magnet 150 configured to magnetize the shaft 134 of the medical device 100 when the cover 112 is removed from the shaft. The medical device 100 may further be packaged as part of a catheter assembly including a catheter connector subassembly.

[0034] Figure 4 This illustrates a tissue-penetrating medical device 130, wherein axis 134 has been removed from axis 134. Figure 3B-3C The needle cover shown is magnetized after removal. Figure 3B-3C As shown, two magnets 150 can be integrated into a cover 112 such that the cover 112 passively magnetizes the shaft 134 when the cover 112 is removed. Figure 3B-3C The illustrated embodiment shows two magnets 150 arranged around a cover 112. Such a cover can be easily integrated into existing catheter assemblies and other invasive medical devices (such as medical leads and catheter needles) to enable magnetization of the shaft of various invasive medical devices when the cover is removed to passively magnetize the shaft. The axial position of the magnets can be modified and positioned relative to the shaft length and the desired portion of the shaft to be magnetized. For example, in the case of a needle, the magnets can be specifically positioned according to the needle's specifications and length. Figure 3BAs shown, the positioning of the magnet will magnetize the shaft 134 from approximately position P shown in Figure 3 to the distal tip 136 of the shaft 134, because the portion of the shaft from position P to the distal tip 136 will move through the magnetic field provided by the magnet 150. This tissue-penetrating medical device 130 can now be used in conjunction with a surgical guidance system that uses a magnetic sensor as a means of measuring and predicting the position of the needle tip relative to a target anatomical structure. In one or more embodiments, the distal end of the tissue-penetrating medical device 130 includes a notch 137 located on the distal tip 136 of the shaft 134 to provide immediate confirmation of vascular access at the insertion point.

[0035] Figure 5 An embodiment of a tissue-penetrating medical device 230 is shown, comprising a cover 212 with a magnetized collar 260, the magnetized collar being a magnet in the shape of the collar 260 as shown. The cover 212 comprises a sleeve member 214 having a hollow tubular body 220 having a distal end 221 and a proximal end 222 to form a protective encapsulation on the shaft 234 of the tissue-penetrating medical device 230. The open end 222 of the hollow tubular body 220 provides a receiving space 240 for receiving at least the shaft 234 of the tissue-penetrating medical device 230. The magnetized collar 260 is shown separated from the cover 212, but the magnetized collar 260 is positioned variablely relative to the shaft 234 along the length L3 of the cover 212. The magnetized collar 260 can be used as a single-use, disposable item, or it can be reusable because the needle cover remains in place during the magnetization step. Therefore, according to one or more embodiments, the magnetized collar 260 is detachably mounted to the cover 212. In alternative embodiments, the magnetized collar 260 is permanently mounted to the cover 212. The magnetized collar 260 is slidably movable along the length of the cover 212. In other embodiments, the length L4 of the magnetized collar 260 may be equal to the length L3 of the cover 212, spanning the entire axis 234 of the tissue-penetrating medical device 230. In other embodiments, the length L4 of the magnetized collar 260 is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length L3 of the cover 212. The magnetized collar 260 may be a tubular magnet that generally surrounds the periphery of the cover, or the magnetized collar 260 may be a cover made of plastic or other materials, wherein the magnet array generally surrounds the periphery of the cover.

[0036] Figures 6A-6C This illustrates one method of integrating at least one magnet with a shroud for use in tissue-penetrating medical devices. Figure 6A Showing a partial 3D view and Figure 6BAn end view of a cover 312 is shown, the cover 312 having an embedded magnet 350 in a wall 360 of the cover 312. The magnet 350 is embedded in a slot 362. The magnet 350 may be sized to be slidably mounted within the slot 362 and held in place by frictional engagement, or the magnet may be attached by an adhesive or other suitable means. Alternatively, the magnet 350 may be integrally molded into the wall 360 during the forming process of the cover 312. Figure 6A The length L5 of the magnet 350 shown is less than the length of the cover. According to one or more embodiments, the length L5 of the magnet 350 may be equal to the length of the cover, or 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length of the cover.

[0037] Figure 6C An embodiment of a cover 412 is shown, the cover having a first magnet 450 in a first slot 462 in a wall 460 of the cover 412 and a second magnet 452 in a second slot 464 in the wall 460 of the cover. The first magnet 450 and the second magnet 452 are shown arranged, for example, 180 degrees apart from each other around the cover 412. It should be understood that the two magnets may be in other positions relative to each other. In addition, the cover 412 may contain more than two magnets. The first magnet 450 and the second magnet 452 may be slidably mounted in the corresponding first slot 462 and second slot 464 and held in place by frictional engagement, or they may be held in place by adhesive. In an alternative embodiment, the magnets may be integrally molded with the cover 412. Two or more magnets may have poles that are oriented in opposite directions.

[0038] In an alternative embodiment, a needle cover is provided with geometry that allows it to be placed inside an existing needle magnetization device while covering the needle's axis. The distal end of the needle cover can be used to limit the insertion depth by providing a stop that contacts the bottom of the needle magnetization device. Alternatively, features can be provided on the cover near the proximal portion of the needle cover to limit the insertion depth via a stop at the proximal opening of the needle magnetizer.

[0039] The covers described herein may have various properties. In one or more embodiments, the cover is formed of plastic. In one or more embodiments, the cover is sterile. In one or more embodiments, the cover is disposable. In other embodiments, the cover may be both sterile and disposable.

[0040] Tissue-penetrating medical devices can be needles, catheters, guide needles, cannula needles, scalpels, or guide wires. In one embodiment, the tissue-penetrating medical device is a needle that, when magnetized, can be used in conjunction with a surgical guidance system to locate and predict needle position during invasive medical procedures. Tissue-penetrating medical devices according to one or more embodiments comprise a magnetizable metallic material. In a particular embodiment, the magnetizable metallic material is magnetizable stainless steel.

[0041] The shroud described herein can also be incorporated into a vascular access device including a catheter, a catheter connector assembly, and a needle assembly comprising a guide needle, a needle hub connected to a proximal end of the guide needle, and a needle shroud according to any of the embodiments described herein. The needle shroud may include a plastic sleeve member and two or more magnets disposed on the needle shroud as described herein, the plastic sleeve member having a hollow tubular body to form a protective encapsulation on the guide needle.

[0042] exist Figure 7 Examples of medical device components (particularly including vascular access devices for catheters according to any of the preceding embodiments described above) are shown. Figure 7 The medical device assembly 500 shown includes a tissue-penetrating medical device in the form of a needle assembly 514, and a catheter connector subassembly 512, which includes a catheter connector body 516, a catheter conduit 518, and a permanent magnet element 532. In one or more embodiments, the catheter connector is connected to the proximal end of a shaft.

[0043] When used in conjunction with ultrasound and magnetic techniques to provide visualization of subcutaneous anatomy and device location, the permanent magnet element 532 can serve as an additional reference point. The needle (not shown) within the catheter conduit 518 exhibits a magnetic portion 530, and as described herein, relative to... Figure 2-7 As described herein, the needle is magnetized when the cover containing the magnet is removed. The magnetization of the needle with the cover as described herein creates a magnetic field 515 in the magnetic portion 530.

[0044] The medical device 500 may be a vascular access device, including a lateral access port 556 and connectable to an extension tube 560 for establishing fluid communication between an IV fluid source and the catheter conduit 518. In one or more embodiments, the extension tube 560 is built-in to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more embodiments, the extension tube 560 is suitable for high-pressure injection. In one or more embodiments, the extension tube 560 provides continuous confirmation of vascular access during catheter advancement into the patient's blood vessel.

[0045] In one or more embodiments, the needle of the needle assembly 514 is inserted into the lumen of the conduit 518. The needle assembly 514 is shown to include a finger gripper 584 disposed on the side of the needle assembly 514 to facilitate various insertion techniques. In one or more embodiments, a protrusion may be present on the finger gripper to indicate where the user can grasp the device to remove the needle. In one or more embodiments, a finger pad 585 with a gently convex surface is disposed at the proximal end of the needle assembly 514. A flange 586 with a gently convex surface is disposed at the proximal end of the needle assembly 514 to provide a finger pad. The wing member 570, the finger pad 585, and the flange 586 can be utilized by the user during insertion, allowing the user to select which insertion technique to use.

[0046] In one or more embodiments, the needle assembly 514 includes a needle guard 580. The needle guard 580 may be designed to retain the needle tip within the guard after use. In one or more embodiments, the needle guard 580 may be passively activated. The needle tip is completely covered in a fixed position by the needle guard 580. In one or more embodiments, in some applications, a collar, pleats, or other structures may be included near the needle tip to engage with the needle guard.

[0047] A push-type tab 581 may be provided to facilitate catheter advancement during insertion. The push-type tab 581 also allows for advancement operated with one or both hands. In one or more embodiments, the push-type tab 581 is removed using a needle guard 580. A clip 582 may also be included on the extension tube to prevent blood flow when changing access ports.

[0048] In one or more embodiments, the vascular access device 500 further includes a first Luer passage 572 and a second Luer passage 573 in fluid communication with the extension tube 560, a blood control split diaphragm 574 associated with the first Luer passage 572, and a vent 576 associated with the second Luer passage 573. The split diaphragm 574 allows for reduction of catheter-related bloodstream infection (CRBSI) while providing unrestricted flow and a straight fluid path and acts as a blood control diaphragm. In one or more embodiments, the split diaphragm 574 may be located in the internal cavity of the catheter connector or on the distal end of the catheter connector. In yet another embodiment, the split diaphragm 574 may be located on the distal end of the extension tube 560. The vent 576 allows air to leak from the system during insertion, providing continuous confirmation of vascular access while preventing blood leakage from the system during insertion. In one or more embodiments, the vent 576 may be located at the distal end of the extension tube 560.

[0049] In one or more embodiments, the basic unit can be integrated into the ultrasound system, wherein the ultrasound processor and the magnetometer communicate directly with the ultrasound system via radio lines or using the same solid wire cable.

[0050] Another aspect of the invention relates to a method for magnetizing a tissue-penetrating medical device. An embodiment of the method includes placing the axis of the tissue-penetrating medical device within a shroud containing a device receiving space, the shroud containing at least one magnet; and removing the tissue-penetrating medical device from the device receiving space to magnetize the axis of the tissue-penetrating medical device.

[0051] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or simply "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the invention. Therefore, the appearance of phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification does not necessarily refer to the same embodiment of the invention. Furthermore, specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0052] While the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative examples of the principles and applications of the invention. Those skilled in the art will understand that various modifications and variations can be made to the methods and apparatus of the invention without departing from the spirit and scope of the invention. Therefore, the invention encompasses modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A medical device assembly comprising: Tissue-penetrating medical devices containing axes; as well as A removable cover for magnetizing the shaft of the tissue-penetrating medical device, the removable cover comprising a sleeve member having a hollow tubular body to form a protective encapsulation on the shaft of the tissue-penetrating medical device prior to use, the sleeve member having a length covering the shaft, and an open end of the hollow tubular body providing a receiving space for receiving at least the shaft of the tissue-penetrating medical device. as well as A magnetized collar, detachably mountable to the removable cover, the magnetized collar being in the form of a tubular magnet surrounding the outer periphery of the removable cover, the removable magnetized collar being configured to be variably positioned by sliding axially relative to the axis along the length of the removable cover to control the position of the magnetized collar relative to the axis of the tissue-penetrating medical device, the magnetized collar being configured to passively magnetize the desired portion of the axis relative to the position of the magnetized collar.

2. The medical device assembly according to claim 1, characterized in that, The tissue-penetrating medical device is a needle assembly, a cannula needle, a catheter, a guide needle, a scalpel, or a guide wire.

3. The medical device assembly according to claim 1, characterized in that, The tissue-penetrating medical device includes a needle assembly and a magnetized collar is used to magnetize the shaft when the shaft of the tissue-penetrating medical device is removed from the removable cover.

4. The medical device assembly according to claim 3, characterized in that, The tissue-penetrating medical device has a needle assembly comprising a needle and the shaft, and when the shaft is magnetized, the tissue-penetrating medical device is configured for use in a surgical guidance system to locate and anticipate the position of the shaft during invasive medical procedures.

5. The medical device assembly according to claim 4, further comprising: A catheter with a proximal end and a distal end; A catheter connector having a distal end, a proximal end, a total length extending from the distal end to the proximal end, an internal cavity, an upper portion, a lower portion, and a tip region having a distal opening with a periphery, through which the catheter extends, and the catheter connector being connected to the proximal end of the catheter; and The shaft has a proximal end and a distal end, and the needle assembly includes a needle seat connected to the proximal end of the shaft, the needle seat having one or more magnets thereon.

6. The medical device assembly according to claim 5, characterized in that, The one or more magnets include fixed permanent magnets.

7. The medical device assembly according to claim 5, characterized in that, The distal portion of the axis of the tissue-penetrating medical device includes a notch to provide immediate confirmation of blood vessel entry at the insertion point.

8. The medical device assembly according to claim 1, characterized in that, The length of the magnetized collar is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length of the removable cover.

9. A method for magnetizing a medical device component according to claim 1, comprising: The shaft of at least the tissue-penetrating medical device is placed in a magnetized collar; as well as The tissue-penetrating medical device is removed from the magnetized collar to magnetize the shaft of the tissue-penetrating medical device in the receiving space.

10. The method according to claim 9, characterized in that, The tissue-penetrating medical device is a needle, cannula, catheter, scalpel, or guidewire.

11. The method according to claim 9, characterized in that, The magnetized collar surrounds the removable cover.

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