Cover for tissue penetrating device with integrated magnet and magnetic shielding - Patents.com

Abstract

To provide a system for performing magnetic shielding that minimizes any influence on a clinical environment caused by a magnetic field generated in a cover.SOLUTION: An assembly for magnetizing a tissue-penetrating medical device 10 comprises: a cover 12 including a sleeve member 14 having a hollow body 20 comprising an external surface, an internal surface, a proximal end 22, and a distal end 21 to form a protective closure over a shaft 34 of the tissue-penetrating medical device having a longitudinal axis, the proximal end of the hollow body providing a receiving space 40 for receiving at least the shaft of the tissue-penetrating medical device; one or more magnet collars that are effective for magnetizing the shaft, are disposed along the sleeve member, and surround the cover; and a magnetic shield composed of one or more shielding materials associated with the collars.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] Aspects of the present disclosure relate to a cover for passively magnetizing a tissue-penetrating medical instrument to enhance visualization during an invasive procedure while simultaneously shielding the clinical environment and equipment from exposure to magnetic fields generated within the cover when used in conjunction with a procedure guidance system that utilizes magnetic sensors to locate and predict the location of features on the tissue-penetrating medical instrument relative to a targeted anatomical structure. [Background technology]

[0002] Traditionally, during catheter insertion, a clinician cannot see an invasive medical instrument, such as a needle or catheter tube, penetrating the skin tissue to reach a vein. For this reason, clinicians must rely on their sense of touch to successfully identify the location of the vein, along with their own first-hand needle insertion experience. This can be a challenging task when attempting to access small veins in deep subcutaneous locations, thereby increasing the risk of undue pain and / or trauma to the patient. Insertion of other invasive medical instruments, such as guidewires, catheters, introducer needles, stylets, scalpels, and guidewires, has similar problems with the inability to accurately visualize the location of the invasive medical instrument.

[0003] Emerging procedure guidance systems utilize a combination of ultrasound and magnetic technologies to provide in-plane and out-of-plane visualization of subcutaneous anatomy and instrument location. This combination of ultrasound and magnetic techniques also allows for prediction or estimation of inserted instrument location relative to the patient's anatomy, thereby improving the likelihood of successful vascular access to complete the invasive procedure. Ultrasound and magnetic procedure guidance system technologies require the invasive instrument to have a sufficient magnetic field source that is maintained throughout the entire procedure.

[0004] In some current needle guidance systems, the magnetic field is generated by magnetizing the needle just prior to insertion by embedding the metal cannula of the needle in a separate external needle magnetizer until the tip of the needle hits a rubber stop surface. Figure 1 shows a perspective view of a currently available separate external needle magnetizer 11. As shown in Figure 1, current practice is to use an unprotected needle 13 and place it into the separate external needle magnetizer 11 to a depth defined by the bottom of the magnetizer. Current equipment for magnetizing the needle prior to insertion is generally non-sterile and non-disposable.

[0005] Systems of the type shown in FIG. 1 may cause damage to the needle that may adversely affect the insertion process, and this is not visible to the user. Additionally, the step of the user actively magnetizing the metal cannula has several limitations and inherent risks, as this approach does not guarantee uniform magnetization, as variations in the clinician's procedures, such as insertion depth, processing speed, and centering the needle within the magnetizer, will result in different degrees of magnetization. Considering the possibility that the user may be inconsistent in fully inserting the needle into the bottom of the magnetizer 11, the significant risk of damaging the needle tip, and the increased likelihood of contamination during this step, it would be advantageous to have a system that passively magnetizes the needle uniformly without introducing the additional risks mentioned above, such as increased likelihood of needle tip damage and contamination.

[0006] Therefore, there is a need for a magnetic shielding system that will passively and uniformly magnetize invasive medical instruments, thereby reducing or eliminating the risk of needle tip injury and needle contamination, while at the same time minimizing any impact on the clinical environment from the magnetic fields generated within the cover. Summary of the Invention [Means for solving the problem]

[0007] Aspects of the present disclosure relate to a cover for magnetizing a tissue-piercing medical instrument and for providing magnetic shielding to protect the magnetic charge carried by the instrument. A first embodiment relates to a cover comprising a sleeve member having a hollow body, the hollow body having an outer surface, an inner surface, a distal end, and a proximal end to provide a protective closure over a portion (e.g., shaft) of the tissue-piercing medical instrument, one or more magnets disposed along the sleeve member effective to magnetize the portion of the tissue-piercing medical instrument, and a magnetic shield of one or more shielding materials to minimize exposure of the clinical environment to magnetic fields emanating from the one or more magnets disposed along the sleeve member and the magnetized portion of the tissue-piercing medical instrument. In one or more embodiments, the sleeve member may have a length that covers the shaft of the tissue-piercing medical instrument, and there are one or more magnets disposed inside the sleeve member. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds the one or more magnets disposed inside the sleeve member. In one or more embodiments, the open end of the hollow tubular body provides a receiving space for receiving at least a portion (eg, a shaft) of a tissue-piercing medical instrument.

[0008] In one or more embodiments, the one or more magnets are fixed permanent magnets. In alternative embodiments, the one or more magnets include a magnetic collar.

[0009] In one or more embodiments, the instrument receiving space allows the tissue-piercing medical instrument to move into and out of the instrument receiving space, hi one or more embodiments, the instrument receiving space allows the tissue-piercing medical instrument to move in a direction parallel to the longitudinal axis of the tissue-piercing medical instrument.

[0010] In one or more embodiments, the two or more magnets are disposed within a groove positioned about the sleeve member. In one or more embodiments, the groove positioned about the sleeve member surrounds the instrument receiving space. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds a portion of the one or more magnets disposed inside the sleeve member. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds an outer surface of the sleeve member. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds an inner surface of the sleeve such that the one or more magnets disposed inside the sleeve member are exposed to the receiving space of the sleeve member.

[0011] In one embodiment, the shielding material may be a highly conductive material such as copper.

[0012] In another embodiment, the shielding material has a high magnetic permeability. The high magnetic permeability shielding material may be an alloy of nickel and iron metals. In a particular embodiment, the shielding material includes a ferromagnetic metal coating.

[0013] In yet another embodiment, the shielding material includes both a highly conductive material and a ferromagnetic metal cladding. The highly conductive material may be copper and the high permeability shielding material may be an alloy of nickel and iron metals.

[0014] In one or more embodiments, the cover of the needle subassembly takes the form of a needle cover, a catheter packaging, or a shipping container.

[0015] In one or more embodiments, the shielding material may be spray coated onto the inner or outer surface of the cover. In another embodiment, the shielding material may be spray coated onto the inner and outer surfaces of the cover.

[0016] In yet another embodiment, a magnetic shield made of one or more shielding materials may be insert molded into the cover.

[0017] In one or more embodiments, the tissue-penetrating medical instrument may be a needle, a cannula, a stylet, a catheter, a scalpel, or a guidewire. According to another embodiment, the cover passively magnetizes the tissue-penetrating medical instrument upon removal of the tissue-penetrating medical instrument from the cover. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a perspective view of a prior art disposable needle magnetizer. [Figure 2A] 1 is a perspective view of an embodiment of a needle cover having a magnetic shield of the present disclosure. [Figure 2B] 1 is a perspective view of an embodiment of a needle cover having a magnetic shield of the present disclosure. [Figure 3A] 1 illustrates an embodiment of a tissue penetrating medical instrument prior to insertion into a needle cover having a magnetic shield of the present disclosure. [Figure 3B] 1 illustrates an embodiment of a tissue-piercing medical instrument partially inserted into a needle cover having a magnetic shield of the present disclosure. [Figure 3C] 1 illustrates an embodiment of a tissue-piercing medical instrument fully inserted into a needle cover having a magnetic shield of the present disclosure. [Figure 4] 1 illustrates an embodiment of a tissue-piercing medical instrument that is fully magnetized after being removed from a needle cover having a magnetic shield of the present disclosure. [Diagram 5] 1A-1C illustrate an embodiment of a tissue penetrating medical device with a magnetic collar having a magnetic shield. [Figure 6A] FIG. 13 is a partial perspective view of the tip of a needle cover with an embedded magnet and magnetic shield of the present disclosure. [Figure 6B] FIG. 13 is an end view of a needle cover with one embedded magnet and magnetic shield of the present disclosure. [Figure 6C] FIG. 13 is an end view of a needle cover with two embedded magnets and a magnetic shield of the present disclosure. [Figure 7]1 illustrates an embodiment of a medical instrument with a cover having a magnetic shield of the present disclosure. [Figure 8] 8 is a partial exploded view of the embodiment of the medical device shown in FIG. 7, in which the magnetic field is contained within a cover having a magnetic shield. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Before describing certain exemplary embodiments of the present disclosure, it should be understood that the description is not limited to the details of construction or process steps set forth in the following description. The apparatus and methods described herein are capable of other embodiments and of being practiced or carried out in various ways.

[0020] In this disclosure, the convention is followed that the distal end of the instrument is the end closest to the patient and the proximal end of the instrument is the end away from the patient and closest to the practitioner.

[0021] Aspects of the present disclosure relate to a cover for a tissue-penetrating medical instrument, the cover comprising one or more magnets for passively magnetizing a portion of the tissue-penetrating medical instrument, and a magnetic shield of one or more shielding materials associated with the cover that minimizes exposure of the clinical environment to magnetic fields generated from the one or more magnets disposed within the cover and the magnetized portion of the tissue-penetrating medical instrument. The magnetic shield of one or more shielding materials minimizes any adverse effects caused from exposing the clinical environment to one or more permanent magnets disposed within the cover. Aspects of the present disclosure relate to an improved system that addresses the challenges of existing techniques and systems of passively magnetizing an invasive medical instrument, such as a needle used with a peripheral intravenous (IV) catheter, while simultaneously providing magnetic shielding within the cover that minimizes any effects on the clinical environment from magnetic fields generated from the one or more permanent magnets disposed within the cover and the magnetized portion of the tissue-penetrating medical instrument.

[0022] One or more embodiments of the present disclosure relate to a cover for a tissue-penetrating medical instrument having an integrated magnet on or within the cover and a magnetic shield consisting of one or more shielding materials associated with the cover that minimizes any adverse effects on the clinical environment from the magnetic field generated within the cover. According to one or more embodiments, the cover of the present disclosure passively and uniformly magnetizes a portion (e.g., shaft) of the tissue-penetrating medical instrument. In one or more embodiments, the passive magnetization of the tissue-penetrating medical instrument is achieved without additional or new clinical steps because the invasive medical instrument already includes a cover covering the distal tip of the instrument. In one or more embodiments, the instruments and systems described herein provide more precise control of the location of the magnet relative to the instrument to be magnetized, resulting in a more consistent and predictable magnetic field being applied to the invasive medical instrument. In one or more embodiments, the instruments and methods described herein do not create additional risk of needle damage and do not incur additional risk of contamination compared to existing magnetizer devices.

[0023] 2A and 2B, an embodiment of the cover 12 of the present disclosure for magnetizing a tissue-piercing medical instrument 10 is shown, the cover 12 comprising a sleeve member 14 having a hollow body 20 with a distal end 21 and an open proximal end 22 forming a protective closure over the shaft 34 of the tissue-piercing medical instrument 30, one or more magnets 50, and a magnetic shield 60 associated with the cover 12. In one or more embodiments, the distal end 21 may be closed or open. In one or more embodiments, the magnetic shield 60 minimizes any impact on the clinical environment from magnetic fields emanating from the one or more magnets disposed within the cover and / or from the magnetized portion of the tissue-piercing medical instrument 10. In one or more embodiments, the magnetic shield 60 isolates the magnetized region of the tissue-piercing medical instrument 50 from any external magnetic and electromagnetic fields, thus maintaining the integrity of the magnetization of the magnetized region. In one or more embodiments, as shown in Figure 5, a magnetic shield 60 confines the magnetic field generated by the magnetized region within the confines of the cover 12 to prevent the magnetized tissue-piercing medical instrument 10 from causing magnetic interference to sensitive instruments and devices in a hospital environment. The magnetic shield 60 is comprised of one or more shielding materials that surround the magnetized region.

[0024] In one or more embodiments, the hollow body 20 can be tubular or any other suitable shape. In the illustrated embodiment, the tissue-piercing medical instrument 30 is shown as a needle assembly including a needle housing 32 and a needle shaft 34 having a sharpened distal tip 36. It will be understood that in FIGS. 2A and 2B, the sleeve member 14 is shown as transparent, allowing the shaft 34 of the tissue-piercing medical instrument 30 to be seen. The sleeve member 14 has a length L that covers the shaft 34 of the tissue-piercing medical instrument 30, including the sharpened distal tip 36 to prevent accidental needle sticks. The arrow shown in FIG. 2 for the length "L" also indicates the longitudinal axis of the shaft 34. The open proximal end 22 of the hollow body 20 provides an instrument receiving space 40 for receiving at least the shaft 34 of the tissue-piercing medical instrument 30. The cover 12 includes at least one magnet 50, and in the illustrated embodiment, at least two magnets 50, disposed on the sleeve member 14.

[0025] The instrument receiving space 40 is sized and shaped to allow the shaft 34 of the tissue-piercing medical instrument 30 to move into and out of the instrument receiving space 40. In one embodiment, the instrument receiving space 40 allows the shaft 34 of the tissue-piercing medical instrument 30 to move into the instrument receiving space 40 in a manner parallel to the longitudinal axis of the shaft 34 of the tissue-piercing medical instrument 30. One or more magnets 50 are disposed on the needle cover such that one face of the magnet is exposed to the interior of the receiving space 40 for magnetizing a portion of the tissue-piercing medical instrument 30, e.g., the shaft 34, while the opposite face of the magnet is exposed to a magnetic shield 60 associated with the cover 12 that prevents the magnetized portion of the tissue-piercing medical instrument, e.g., the shaft 34, from adversely affecting the clinical environment when the cover 12 is placed over the tissue-piercing medical instrument 30. The cover 12 passively magnetizes the shaft 34 of the tissue-piercing medical instrument 30 when the cover 12 is removed from the shaft 34 of the tissue-piercing medical instrument, thereby having a portion of the shaft 34 oriented to be exposed to the interior of the receiving space 40 or exposed to the magnet 50.

[0026] In one or more embodiments, the tissue-piercing instrument 30 is not magnetized prior to inserting the tissue-piercing instrument into the cover 12. When the tissue-piercing instrument 30 is inserted into the instrument receiving space 40 of the cover 12, any distal section of the tissue-piercing instrument 30 that passes under the influence of the magnets 50 becomes magnetized. In one or more embodiments, even if any section of the tissue-piercing instrument 30 has been demagnetized due to storage or exposure to an external magnetic field during storage, when the cover 12 is removed prior to use and portions of the tissue-piercing instrument 30 pass under one or more magnets 50 disposed within the instrument receiving space 40 of the cover 12, the portions of the tissue-piercing instrument 30 become re-magnetized.

[0027] According to one embodiment, a magnetic shield 60 of one or more shielding materials may be spray coated onto the outer surface of the cover as shown in FIG. 2A or onto the inner surface of the cover as shown in FIG. 2B such that at least one face of the magnet 50 is not coated with the shielding material, thereby allowing the uncoated face of the at least one magnet 50 to be exposed to a portion of the tissue-piercing medical device (e.g., shaft 34) when positioned within the receiving space 40. In another embodiment, the magnetic shield 60 of one or more shielding materials may be spray coated onto the inner and outer surfaces of the cover. In one or more embodiments, the magnetic shield 60 of one or more shielding materials may be spray coated onto the inner surface of the cover or onto the outer surface of the cover to a thickness of 1 / 1000 inch (0.00254 cm) to 1 inch (2.54 cm). The thickness of the magnetic shield may depend on the desired purpose or use of the medical device.

[0028] In another embodiment, the magnetic shield 60, which is made of one or more shielding materials, may be insert molded into the cover. Insert molding combines metallic and thermoplastic materials, or multiple combinations of materials and components, into a single unit. The insert molding process typically involves an injection molding method, where solid pellets of raw material are melted and extruded into a mold, the plastic then solidifies, and the molding machine then opens and the molded part is removed. The component to be insert molded is placed in the mold by hand or by automation before the material is injected into the mold. Then, when the material flows into the features in the insert, the insert is much more firmly secured than if it were assembled to a previously molded component.

[0029] According to one or more embodiments, the cover 12 may be molded from a plastic with a conductive or magnetic additive. In one embodiment, the cover 12 may be sterile and / or disposable.

[0030] In one or more embodiments, the shielding material may be a highly conductive material such as copper or copper spray. Highly conductive shielding materials function in the presence of high frequency electromagnetic fields. The changing magnetic field creates eddy currents in the conductor, which then cancel out the magnetic field, thereby preventing it from reaching magnetized areas and thus preventing possible demagnetization of the permanent magnets in the cover.

[0031] In one or more embodiments, the shielding material may have a high magnetic permeability. In one or more embodiments, the high magnetic permeability material may be iron, nickel, cobalt, or an alloy or compound containing one or more of these elements. In one or more embodiments, the high magnetic permeability material is comprised of an alloy of nickel metal and iron metal. The high magnetic permeability material may be Permalloy (a nickel-iron magnetic alloy, typically having about 80% nickel and about 15% iron and 5% molybdenum content), or a ferromagnetic metal coating. In one or more embodiments, the shielding material may be comprised of a nickel-iron alloy, having approximately 77% nickel, 16% iron, 5% copper, and 2% chromium or molybdenum. In yet another embodiment, the shielding material is comprised of approximately 80% nickel, 5% molybdenum, small amounts of various other elements such as silicon, and the remaining 12 to 15% iron. The high magnetic permeability shielding material functions well in the presence of a static external magnetic field. When an external static magnetic field is present near the magnetized area, the magnetic field lines are attracted to the magnetic shield due to its high magnetic permeability, thus preventing the magnetic field from reaching the magnetized area, thereby protecting the permanent magnet in the cover. Since the magnetic field generated by the permanent magnet in the cover and the magnetized needle is static, it is preferable to use a shielding material with high magnetic permeability to prevent the magnetized tissue-piercing medical instrument 10 from causing magnetic interference to sensitive equipment and devices in a hospital environment.

[0032] In cases where both high frequency electromagnetic fields and static external magnetic fields are expected to be present, the magnetic shield can be made of both highly conductive shielding material and highly permeable material to block the external magnetic fields from reaching the magnetized region. In a particular embodiment, the magnetic shield 60 includes a highly conductive material and a ferromagnetic metal cladding. The highly conductive material can be copper.

[0033] 3A to 3C show a medical instrument 100 including a tissue-penetrating medical instrument 130 and a cover 112 for magnetizing a shaft 134 of the tissue-penetrating medical instrument 130. The cover 112 includes a sleeve member 114 having a hollow tubular body 120 with a distal end 121 and an open proximal end 122 forming a protective closure over the shaft 134 of the tissue-penetrating medical instrument 130, the sleeve member 114 having a length L covering the shaft 134 of the tissue-penetrating medical instrument 130, the shaft 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 shaft 134 of the tissue-penetrating medical instrument 130. The cover 112 includes two magnets 150 and a magnetic shield 160 for minimizing any impact on the clinical environment due to the magnetic field generated from the two magnets 150 in the cover. Although two magnets 150 are shown, it will be understood that the instrument is not limited to a particular number of magnets or to magnets at a particular location around the sleeve member. The magnets 150 may be positioned in any position or orientation around the sleeve member. In one or more embodiments, a single magnet may be utilized to magnetize the shaft 134, or two or more magnets may be utilized. A magnetic shield 160 of one or more shielding materials may be spray coated onto the inner surface of the cover 112 or onto the outer surface of the cover 112 such that at least one face of the magnet 150 is not coated with the shielding material, thereby allowing an uncoated face of the at least one magnet 150 to be exposed to a portion of the tissue-piercing medical instrument 130 (e.g., the shaft 134) when positioned within the receiving space 140. In one or more embodiments, the magnetic shield 160 of one or more shielding materials may be spray coated onto the inner surface of the cover or onto the outer surface of the cover to a thickness of 1 / 1000 inch (0.00254 cm) to 1 inch (2.54 cm). The thickness of the magnetic shield 160, which is made of one or more shielding materials, may depend on the desired purpose or use of the medical device. In another embodiment, the magnetic shield 160 may be insert molded into the cover.

[0034] In embodiments where two magnets are utilized, the orientation of the magnetic fields of the two magnets may vary. One magnet may have north and south poles on axis with the shaft of the tissue-piercing medical instrument, while the second magnet may have north and south poles off-axis or perpendicular to the shaft of the tissue-piercing medical instrument. Alternatively, both magnets may have north and south poles off-axis with the shaft of the tissue-piercing medical instrument, or both magnets may have north and south poles on axis with the shaft of the tissue-piercing medical instrument.

[0035] FIG. 3A shows the tissue-penetrating medical instrument 130 prior to insertion into the cover 112 of the present disclosure. The tissue-penetrating medical instrument 130 includes a shaft 134 having a length L2 and a distal tip 136, the shaft 134 being attached to the housing 130 by a hub 152. In one or more embodiments, the hub 152 includes a hub magnet 155. In one or more embodiments, the hub magnet 155 is a permanent, fixed magnet. The hub magnet 155 may provide a fixed magnetic reference point when the tissue-penetrating needle is used to perform visualization of the subcutaneous anatomy and instrument location in conjunction with a combination of ultrasound and magnetic techniques. FIG. 3B shows the shaft 134 of the tissue-penetrating medical instrument 130 partially inserted into the cover 112 of the present disclosure. FIG. 3C shows the shaft 134 of the tissue-penetrating medical instrument 30 fully inserted into the cover 112 of the present disclosure. The medical instrument 100 shown in FIG. 3C may be packaged and ready for use in a medical procedure. The medical device 100 shown in Figure 3C can be packaged with other devices as part of a larger medical device assembly. Thus, Figure 3C shows a medical device 100 that is a needle subassembly having a cover 112 with at least one magnet 150 configured to magnetize the shaft 134 of the medical device 100 upon removal of the cover 112 from the shaft. The medical device 100 can also be packaged as part of a catheter assembly that includes a catheter adapter subassembly.

[0036] Depending on the area of ​​the medical implement to be magnetized, the magnetic shield may take the form of or be incorporated into a needle cover, a separate catheter enclosure, a catheter dispenser, product packaging, or a catheter shipper.

[0037] When a magnetic shield is incorporated into an individual medical device package, the entire package can be coated with magnetic shielding material. Alternatively, only the section of the package surrounding the magnetized area may contain magnetic shielding material. Such an approach facilitates ease of sterilization through the package.

[0038] 4 shows the embodiment with the magnetized needle ready for insertion after the cover 112 has been removed, allowing the instrument to be used with a procedure guidance system that utilizes a magnetic sensor as a means of measuring and predicting needle tip location relative to the target anatomy.

[0039] As shown in FIG. 4, the tissue-piercing medical instrument 130 with the shaft 134 magnetized after it has been removed from the needle cover shown in FIGS. 3B-3C. As shown in FIGS. 3B-3C, two magnets 150 can be integrated into the cover 112 such that the cover 112 passively magnetizes the shaft 134 upon removal of the cover 112. The embodiment shown in FIGS. 3B-3C shows two magnets 150 positioned about the cover 112. Such a cover can be easily integrated into existing catheter assemblies and other invasive medical instruments such as guidewires and stylets to allow the shafts of various invasive medical instruments to be magnetized upon removal of the cover 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 based on the gauge and length of the needle. As shown in FIG. 3B, positioning the magnet in this manner results in the shaft 134 being magnetized from approximately position P shown in FIG. 3C to the distal tip 136 of the shaft 134 as the portion of the shaft from P to the distal tip moves through the magnetic field provided by the magnet 150. The tissue-penetrating medical instrument 130 can now be used with a procedure guidance system that utilizes a magnetic sensor as a means of measuring and predicting needle tip location relative to the targeted anatomical structure. In one or more embodiments, the distal end of the tissue-penetrating medical instrument 130 includes a notch 137 located on the distal tip 136 of the shaft 134 that allows for immediate confirmation of entry into the vessel at the insertion point. In one or more embodiments, the magnetized portion of the tissue-penetrating medical instrument may comprise a partial length of the tissue-penetrating medical instrument. In one or more embodiments, the magnetized portion of the tissue-penetrating medical instrument may comprise the distal tip of the tissue-penetrating medical instrument. In one or more embodiments, the magnetized portion of the tissue-penetrating medical instrument may comprise the entire length of the tissue-penetrating medical instrument.

[0040] 5 illustrates an embodiment of the tissue-piercing medical instrument 230 including a cover 212 having a magnetized collar 260, which may be a magnet that takes the shape of the collar 260 as shown. A magnetic shield 265 of one or more shielding materials may be spray coated onto the outer surface 261 of the collar 260 such that the inner surface 262 is not coated with the shielding material, thereby allowing the uncoated inner surface to be exposed to the portion of the tissue-piercing medical instrument 230 (e.g., shaft 234) located within the receiving space 240. In one or more embodiments, the magnetic shield 265 of one or more shielding materials may be spray coated onto the outer surface 261 of the collar 260 to a thickness of 1 / 1000 inch (0.00254 cm) to 1 inch (2.54 cm). The thickness of the magnetic shield 265 may depend on the desired purpose or use of the medical instrument. The cover 212 includes a sleeve member 214 having a hollow tubular body 220 with a distal end 221 and a proximal end 222 that forms a protective closure over the shaft 234 of the tissue-piercing medical instrument 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-piercing medical instrument 230. Although the magnetized collar 260 is shown as being separate from the cover 212, the magnetized collar 260 is variably positioned along the length L3 of the cover 212 relative to the shaft 234. The magnetized collar 260 can be used as a single-use disposable item, or the magnetized collar 260 can be reusable, as the needle cover remains in place during the magnetization step. Thus, according to one or more embodiments, the magnetized collar 260 is releasably attached to the cover 212. In an alternative embodiment, the magnetized collar 260 is permanently attached 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 is equal to the length L3 of the cover 212, as is the shaft 234 of the tissue-piercing medical instrument 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 substantially surrounds the periphery of a cover, or the magnetized collar 260 may be a cover made of plastic or other material with an array of magnets that substantially surrounds the periphery of the cover.

[0041] 6A-6C illustrate one way of integrating at least one magnet with a cover for a tissue-piercing medical instrument. According to one or more embodiments, as shown in FIG. 6A, the cover 312 may have a wall 360 made entirely of a magnetic shielding material, where one or more magnets 350 are disposed within a groove 362 positioned on an inner surface of the receiving space 340 around the sleeve member. In one or more embodiments, the groove 362 positioned around the sleeve member surrounds the instrument receiving space 340. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds a portion of the one or more magnets disposed inside the sleeve member. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds an outer surface of the sleeve member. In one or more embodiments, a magnetic shield of one or more shielding materials surrounds an inner surface of the sleeve such that one or more magnets disposed inside the sleeve member are exposed to the receiving space of the sleeve member.

[0042] FIG. 6A shows a partial perspective view and FIG. 6B shows an end view of the cover 312 with an embedded magnet 350 in the wall 360 of the cover 360, with a magnetic shield 365 of magnetic material along the outer surface of the wall 360. The magnet 350 is embedded in a groove 362. The magnet 350 can be sized to be slidably mounted in the groove 362 and held in place by a friction fit, or the magnet can be attached using an adhesive or other suitable method. Alternatively, the magnet 350 can be integrally molded into the wall 360 during the formation process of the cover 312. The length L5 of the magnet 350 shown in FIG. 6A is shown as being less than the length of the cover. According to one or more embodiments, the length L5 of the magnet 350 can be equal to the length of the cover or equal to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length of the cover.

[0043] FIG. 6C illustrates an embodiment of the cover 412 with a first magnet 450 in a first groove 462 in a wall 460 of the cover 412 and a second magnet 452 in a second groove 464 in the wall 460 of the cover. The first magnet 450 and the second magnet 452 are shown as being positioned around the cover 412, for example, 180 degrees from each other. It will be understood that the two magnets may be in other positions relative to each other. Additionally, the cover 412 may include more than one magnet. The first magnet 450 and the second magnet 452 may be slidably mounted in the corresponding first groove 462 and second groove 464, respectively, and held in place by a friction fit, or they may be held in place by an adhesive. In an alternative embodiment, the magnets may be integrally molded with the cover 412. The two or more magnets may have poles oriented in opposite directions. In the exemplary embodiment, a magnetic shield 465 made of a magnetic material is shown along the inner surface of first groove 462 and second groove 464 .

[0044] In an alternative embodiment, a needle cover is provided that has geometric dimensions that allow the needle cover to be placed inside an existing needle magnetization device while covering the shaft of the needle. The distal end of the needle cover may be used to limit the insertion depth by providing a stop that contacts the bottom of the needle magnetization device. Alternatively, features near the proximal portion of the needle cover may be provided on the cover to limit the insertion depth with a stop on the proximal opening of the needle magnetizer.

[0045] The covers described herein can have a variety of characteristics. In one or more embodiments, the cover is formed from plastic. In one or more embodiments, the cover is sterile. In one or more embodiments, the cover is disposable. In other embodiments, the cover can be both sterile and disposable.

[0046] The tissue-penetrating medical instrument may be a needle, a catheter, an introducer needle, a stylet, a scalpel, or a guidewire. In one embodiment, the tissue-penetrating medical instrument is a needle, which, when magnetized, can be used with a procedure guidance system to locate and predict the location of the needle during an invasive medical procedure. The tissue-penetrating medical instrument according to one or more embodiments includes a magnetizable metallic material. In a particular embodiment, the magnetizable metallic material is a magnetizable stainless steel.

[0047] The covers described herein may be incorporated into a vascular access device comprising a catheter, a catheter adapter subassembly, and a needle subassembly including an introducer needle, a needle hub connected to the proximal end of the introducer needle, and a needle cover according to any of the embodiments described herein. The needle cover may include a plastic sleeve member having a hollow tubular body that forms a protective closure over the introducer needle, as described herein, and two or more magnets disposed on the needle cover.

[0048] An example of a medical device assembly, specifically a vascular access device including a catheter according to any of the previous embodiments described above, is shown in Figure 7. The medical device assembly 500 shown in Figure 7 includes a tissue penetrating medical device in the form of a needle subassembly 514, a catheter adapter subassembly 512 including a catheter adapter body 516 and a catheter tube 518 and a permanent magnet element 532, and a cover 530 having embedded magnetic material 535 within a wall of the cover 530, which has a magnetic shield 565 of magnetic material along an outer surface of the wall. Figure 8 shows a partial exploded view of the embodiment of the medical device shown in Figure 7 with the magnetic field 515 contained within the cover having the magnetic shield 530. In one or more embodiments, the catheter adapter is connected to the proximal end of the shaft.

[0049] A permanent magnetic element located along the introducer needle may serve as an additional reference point when used in conjunction with ultrasound and magnetic techniques to visualize subcutaneous anatomy and instrument position. The needle 519 in the catheter tube 518 shows a cover 530, which is magnetized upon removal of the cap containing the magnet as described herein with respect to Figures 2-7. Magnetizing the needle with the cover as described herein creates a magnetic field within the magnetic field.

[0050] The medical device 500 may be a vascular access device that includes a lateral access port 556, which may be connected to a section of extension tubing 560 to establish fluid communication between an IV fluid source and the catheter tubing 518. In one or more embodiments, the extension tubing 560 is built-in to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more embodiments, the extension tubing 560 is compatible with high pressure infusion. In one or more embodiments, the extension tubing 560 allows for continuous confirmation of vascular access while the catheter is advanced into the patient's vein.

[0051] In one or more embodiments, the needle of the needle subassembly 514 is inserted into the lumen of the catheter tube 518. The needle subassembly 514 is shown as including finger grips 584 positioned on either side of the needle subassembly 514 to facilitate various insertion techniques. In one or more embodiments, there may be a bump on the finger grip to indicate where the user may grip the instrument to remove the needle. In one or more embodiments, a thumb pad 585 having a gently convex surface is provided at the proximal end of the needle subassembly 514. A flange 586 having a gently convex surface is provided at the proximal end of the needle subassembly 514 to provide a finger pad. The wing members 570, thumb pad 585, and flange 586 may be utilized by the user during insertion to allow the user to select which insertion technique to use.

[0052] In one or more embodiments, the needle subassembly 514 includes a needle shield 580. The needle shield 580 may be of a design adapted to secure the tip of the needle within the shield after use. In one or more embodiments, the needle shield 580 may be passively actuated. The needle tip is completely covered in a fixed position by the needle shield 580. In one or more embodiments, a ferrule, crimp, or other structure near the tip may be included to allow engagement with the needle shield in some applications.

[0053] A push tab 581 may be provided to facilitate advancement of the catheter during insertion. The push tab 581 also allows for one-handed or two-handed advancement. In one or more embodiments, the push tab 581 is removed along with the needle shield 580. A clamp 582 may be included on the extension tube to prevent blood flow when replacing the access port.

[0054] In one or more embodiments, the vascular access device 500 further includes a first luer access 572 and a second luer access 573 in fluid communication with the extension tube 560, a blood control split septum 574 associated with the first luer access 572, and an air vent 576 associated with the second luer access 573. The split septum 574 functions as a blood control septum, allowing for a reduction in catheter-related bloodstream infections (CRBSIs) while providing unrestricted flow and a straight fluid path. In one or more embodiments, the split septum 574 may be located within an internal cavity of the catheter adapter or on the distal end of the catheter adapter. In yet another embodiment, the split septum 574 may be located on the distal end of the extension tube 560. The air vent 576 allows air to escape the system during insertion while preventing blood from leaking out of the system during insertion, allowing for continuous confirmation of vascular access. In one or more embodiments, the air vent 576 may be at the distal end of the extension tube 560 .

[0055] In one or more embodiments, the base unit can be integrated into an ultrasound system with an ultrasound processor and a magnetometric detector that communicates directly with the ultrasound system, either via a wireless link or using the same physical cable.

[0056] Another aspect of the present disclosure relates to a method of magnetizing a tissue-piercing medical instrument, the method embodiment including positioning a shaft of the tissue-piercing medical instrument within a cover having an instrument receiving space, at least one magnet disposed within the instrument receiving space, and a magnetic shield consisting of one or more shielding materials associated with the cover, thereafter removing the tissue-piercing medical instrument from the instrument receiving space, and magnetizing the shaft of the tissue-piercing medical instrument.

[0057] References throughout this specification to "one embodiment," "some embodiments," "one or more embodiments," or "embodiments" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "some embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0058] Although the disclosure herein has been described in terms of specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the disclosure. Therefore, it is intended that the disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. An assembly for magnetizing a tissue-penetrating medical instrument, comprising: a cover having a hollow body with an outer surface, an inner surface, a proximal end, and a distal end forming a protective closure over a shaft of a tissue-piercing medical instrument having a longitudinal axis, the cover having a sleeve member not in contact with the shaft, the proximal end of the hollow body providing a receiving space for receiving at least the shaft of the tissue-piercing medical instrument; one or more magnetic collars releasably attached to said cover and slidable along said sleeve member effective to magnetize said shaft; a magnetic shield covering an exterior surface of the magnetic collar, the magnetic shield being made of one or more shielding materials; Equipped with An assembly wherein said cover remains in place during the magnetization step and said magnetic collar is reusable.

2. The assembly of claim 1 , wherein the magnetic collar is movable along the shaft.

3. The assembly of claim 1 , wherein the one or more shielding materials are highly conductive materials.

4. The assembly of claim 3 , wherein the one or more shielding materials include copper.

5. The assembly of claim 1 , wherein the one or more shielding materials have a high magnetic permeability.

6. The assembly of claim 5 , wherein the one or more shielding materials include an alloy of nickel and iron metals.

7. The assembly of claim 6 , wherein the one or more shielding materials include a ferromagnetic metallic coating.

8. The assembly of claim 1 , wherein the one or more shielding materials include a highly conductive material and include a ferromagnetic metallic coating.

9. The assembly of claim 8 , wherein the highly conductive material comprises copper.

10. The assembly of claim 1 , wherein the one or more shielding materials are spray coated onto an exterior surface of the collar.

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