Patent Description:
Traditionally, penetration of an invasive medical device such as a needle and catheter tubing through skin tissue to reach the vein during catheter insertion is invisible to clinicians. For this reason, clinicians must rely on their first-hand experience with needle insertion in combination with tactile sense to successfully identify the location of the vein. This may be a difficult task when attempting to access a small vein in a deep location under the skin, thereby increasing the risk of excess pain and/or injury to the patient. There are similar problems with insertion of other invasive medical devices such as guidewires, catheters, introducer needles, stylets, scalpel and guidewire with respect to the inability to precisely visualize the location of the invasive medical device.

Emerging procedural guidance systems utilize a combination of ultrasound and magnetic technologies to provide visualization of subdermal anatomy and device position in the in-plane and out-of-plane orientations. This combination of ultrasound and magnetic methods also allows for the projection or anticipation of the insertion device position relative to the patient's anatomy, and thereby improves the likelihood of successfully accessing the vascular and completing the invasive procedure. The ultra-sound and magnetic procedural guidance system technology requires that the invasive device have a sufficient magnetic field source that is maintained throughout the procedure.

In some current needle guidance systems, a magnetic field is generated just prior to insertion of the needle by magnetizing the needle by burying the metal cannula of the needle into a separate external needle magnetizer until the point of the needle hits a rubber stopping surface. <FIG> shows a perspective view of a currently available separate external needle magnetizer <NUM>. As shown in <FIG>, current practice uses an unprotected needle <NUM> that is placed within the separate external needle magnetizer <NUM> to a depth defined by the bottom of the magnetizer. The current devices for magnetizing a needle prior to insertion generally are not sterile and are not disposable.

In systems of the type shown in <FIG>, damage to the needle can occur that is not apparent to the user that can negatively affect the insertion process. Also, the step of the user actively magnetizing the metal cannula has some limitations and inherent risks as this approach does not guarantee consistent magnetization since variability in clinician procedures such as depth of insertion, speed of process, and centering of the needle in the magnetizer will result in different degrees of magnetization. Considering the potential inconsistency of a user fully inserting the needle to the bottom of the magnetizer <NUM>, the significant risk of damaging the needle tip, and the increased potential for contamination during this step, it would be advantageous to have a system that passively and consistently magnetizes the needle without introducing the aforementioned additional risks, such as needle tip damage and increased potential for contamination.

Thus, there is a need for a system that passively and consistently magnetizes invasive medical devices thereby reducing or eliminating risks, such as needle tip damage and needle contamination while providing magnetic shielding to minimizing any effects to the clinical environment from magnetic fields generated within the cover.

A cover for magnetizing a tissue-penetrating medical device having the features defined within the preamble of claim <NUM>, is described in <CIT>.

A cover for magnetizing a tissue-penetrating medical device according to the invention is defined by the features of claim <NUM>. Preferred embodiments are defined within the dependent claims.

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

In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.

Aspects of the disclosure pertain to a cover of a tissue-penetrating medical device with one or more magnets for passively magnetizing a portion of the tissue-penetrating medical device and a magnetic shield composed of one or more shielding materials associated with the cover that minimizes exposure of the clinical environment from magnetic fields generated from one or more magnets disposed within the cover and the magnetized portion of a tissue-penetrating medical device. The magnetic shield composed of one or more shielding materials also minimizes any adverse effects caused from exposure of the clinical environment to one or more permanent magnets disposed within the cover. Aspects of the disclosure pertain to an improved system that addresses the challenges to the existing technology and systems to passively magnetize an invasive medical device, such as a needle used with a peripheral intravenous (IV) catheter, while providing magnetic shielding to minimizing any effects to the clinical environment from magnetic fields generated within the cover from one or more permanent magnet disposed in the cover and the magnetized portion of the tissue-penetrating medical device.

One or more embodiments of the present disclosure relate to a cover for a tissue-penetrating medical device, the cover having an integrated magnet on or within the cover and a magnetic shield composed of one or more shielding materials associated with the cover that minimizes any adverse effects to the clinical environment from magnetic fields generated within the cover. According to one or more embodiments, the cover of the present disclosure passively and consistently magnetizes a portion (e.g., a shaft) of a tissue-penetrating medical device. In one or more embodiments, passive magnetization of the tissue-penetrating medical device is achieved with no additional or new clinical steps because the invasive medical device already includes a cover that covers the distal tip of the device. In one or more embodiments, the devices and systems described herein provide more precise control of the location of the magnet relative to the device to be magnetized, resulting in a more consistent and predictable magnetic field applied to the invasive medical device. In one or more embodiments, the devices and methods described herein create no additional risk of needle damage and pose no additional risk for contamination when compared to existing magnetizer devices.

Referring now to <FIG>, one embodiment of a cover <NUM> of the present disclosure is shown for magnetizing a tissue-penetrating medical device <NUM>, the cover <NUM> comprising a sleeve member <NUM> having a hollow body <NUM> having a distal end <NUM> and an open proximal end <NUM> to form a protective closure over a shaft <NUM> of a tissue-penetrating medical device <NUM>, the cover having one or more magnets <NUM>, and a magnetic shield <NUM> associated with the cover <NUM>. In one or more embodiments, distal end <NUM> may be closed or open. In one or more embodiments, the magnetic shield <NUM> minimizes any effects to the clinical environment from magnetic fields generated within the cover from the one or more magnets disposed within the cover and/or from a magnetized portion of the tissue-penetrating medical device <NUM>. In one or more embodiments, the magnetic shield <NUM> isolates the magnetized region of the tissue-penetrating medical device <NUM> from any external magnetic and electromagnetic fields thus keep the integrity of the magnetization of the magnetized region. In one or more embodiments, as shown in <FIG>, the magnetic shield <NUM> contains the magnetic field generated by the magnetized region within the confines of the cover <NUM> to prevent the magnetized tissue-penetrating medical device <NUM> from causing magnetic interferences to sensitive equipment and devices in a hospital setting. The magnetic shield <NUM> would consist of one or more shielding material which would enclose the magnetized region.

In one or more embodiments, the hollow body <NUM> can be tubular or any other suitable shape. In the embodiment shown, the tissue-penetrating medical device <NUM> is shown as a needle assembly including a needle housing <NUM> and a shaft <NUM> of the needle having a sharp distal tip <NUM>. It will be appreciated that in <FIG>, the sleeve member <NUM> is shown as transparent and the shaft <NUM> of the tissue-penetrating medical device <NUM> is visible. The sleeve member <NUM> has a length L that covers the shaft <NUM> of the tissue-penetrating medical device <NUM>, including the sharp distal tip <NUM> to prevent accidental needle sticks. The arrows shown in <FIG> with respect to the length "L" also show the longitudinal axis of the shaft <NUM>. The open proximal end <NUM> of the hollow body <NUM> provides a device-receiving space <NUM> for receiving at least the shaft <NUM> of the tissue-penetrating medical device <NUM>. The cover <NUM> includes at least one magnet <NUM>, and in the embodiment show, at least two magnets <NUM> disposed on the sleeve member <NUM>.

The device-receiving space <NUM> is sized and shaped to permit movement of the shaft <NUM> of the tissue-penetrating medical device <NUM> into and out of the device-receiving space <NUM>. In one embodiment, the device-receiving space <NUM> permits movement of the shaft <NUM> of the tissue-penetrating medical device <NUM> into the device-receiving space <NUM> in a movement that is parallel to the longitudinal axis of the shaft <NUM> of tissue-penetrating medical device <NUM>. One or more magnets <NUM> are disposed on the needle cover such that one face of the magnet is exposed to the interior of the receiving space <NUM> in order to magnetize a portion, e.g. shaft <NUM> of the tissue-penetrating medical device <NUM>, while the opposite face of the magnet is exposed to the magnetic shield <NUM> associated with the cover <NUM> that prevents the magnetized portion, e.g. shaft <NUM>, of the tissue-penetrating medical device from adversely affecting the clinical environment when the cover <NUM> is placed over the tissue-penetrating medical device <NUM>. The cover <NUM> passively magnetizes the shaft <NUM> of the tissue-penetrating medical device <NUM> when the cover <NUM> is removed from the shaft <NUM> of the tissue-penetrating medical device thereby having a portion of shaft <NUM> being exposed to one or magnets <NUM> which are oriented to be exposed to the interior of the receiving space <NUM>.

In one or more embodiments, tissue penetrating device <NUM> is not magnetized prior to placement of the tissue penetrating device into cover <NUM>. When the tissue penetrating device <NUM> is placed into the device-receiving space <NUM> of cover <NUM>, any distal section of the tissue penetrating device <NUM> that passes under the influences of the magnets <NUM> are magnetized. In one or more embodiments, portions of the tissue penetrating device <NUM> will be re-magnetized again when the cover <NUM> is removed prior to use and portions of the tissue penetrating device <NUM> pass under the one or more magnets <NUM> disposed within the device-receiving space <NUM> of cover <NUM>, even if some section of tissue penetrating device <NUM> were de-magnetized due to storage or exposure to external magnetic fields while in storage.

According to one embodiment, the magnetic shield <NUM> composed of one or more shielding material may be spray-coated onto an exterior surface of the cover, as shown in <FIG>, or onto an interior surface of the cover, as shown in <FIG>, such that at least one face of magnet <NUM> is not coated with shielding material to allow the un-coated face of at least one magnet <NUM> to be exposed to a portion (e.g., a shaft <NUM>) of a tissue-penetrating medical device when located in receiving space <NUM>. In another embodiment, the magnetic shield <NUM> composed of one or more shielding material may be spray-coated onto an interior surface and exterior surface of the cover. In one or more embodiments, the magnetic shield <NUM> composed of one or more shielding material may be spray-coated onto an interior surface of the cover or an exterior surface of the cover to a thickness of <NUM>,<NUM> to <NUM>,<NUM>. The thickness of the magnetic shield may depend on the desired purpose or application of the medical device.

In another embodiment, the magnetic shield <NUM> composed of one or more shielding material may be insert-molded into the cover. Insert molding combines metal and thermoplastic materials, or multiple combinations of materials and components into a single unit. Insert molding processes typically involve an injection molding process in which solid pellets of raw material are melted and extruded into a mold - the plastic is then solidified - and then the press opens and the molded parts are ejected. The component to be insert-molded is placed in the mold, either by hand, or by automation before the material is injected into the mold. Then, as the material flows into features in the insert, the insert is anchored much more securely than if it were assembled to a previously molded component.

According to one or more embodiments, the cover <NUM> may be molded from a plastic having conductive additives or magnetic additives. In one embodiment, the cover <NUM> may be sterile and/or disposable.

In one or more embodiments, the shielding material may be a highly conductive material, such as copper or copper spray. A highly conductive shielding material will work in the presence of high frequency electromagnetic field. The varying magnetic field will generate eddy current within the conductor which would then cancel the magnetic field, preventing the magnetic field from reaching the magnetized region, thus preventing the potential demagnetization of the permanent magnets in the cover.

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 compounds containing one or more of these elements. In one or more embodiments, the high magnetic permeability material is comprised of an alloy of nickel and iron metals. The high magnetic permeability material may be Permalloy (a nickel-iron magnetic alloy, typically having about <NUM>% nickel and about <NUM>% iron and <NUM>% molybdenum content) or ferromagnetic metal coating. In one or more embodiments, the shielding material may be composed of a nickel-iron alloy having approximately <NUM>% nickel, <NUM>% iron, <NUM>% copper and <NUM>% chromium or molybdenum. In yet another embodiment, the shielding material maybe composed of approximately <NUM>% nickel, <NUM>% molybdenum, small amounts of various other elements such as silicon, and the remaining <NUM> to <NUM>% iron. A high magnetic permeability shielding material will work well in the presence of static external magnetic fields. When an external static magnetic field is present near the magnetized region, the magnetic field line is drawn within the magnetic shield due to its high permeability, thus preventing the magnetic field from reaching the magnetized region, protecting the permanent magnets in the cover. Because the magnetic field generated by the permanent magnets in the cover and the magnetized needle are static, it is preferable to use shielding material with high magnetic permeability to prevent the magnetized tissue-penetrating medical device <NUM> from causing magnetic interferences to sensitive equipment and devices in a hospital setting.

If both a high frequency electromagnetic field and static external magnetic fields are expected to be present, the magnetic shield can consist of both highly conductive shielding material and high magnetic permeability material to block the external magnetic field from reaching the magnetized region. In a specific embodiment, the magnetic shield <NUM> includes a highly conductive material and a ferromagnetic metal coating. The highly conductive material may be copper.

<FIG> show a medical device <NUM> including a tissue-penetrating medical device <NUM>, a cover <NUM> for magnetizing the shaft <NUM> of the tissue-penetrating medical device <NUM>. The cover <NUM> includes a sleeve member <NUM> having a hollow tubular body <NUM> having a distal end <NUM> and an open proximal end <NUM> to form a protective closure over the shaft <NUM> of the tissue-penetrating medical device <NUM>, the sleeve member <NUM> having a length L to cover the shaft <NUM> of the tissue-penetrating medical device <NUM>, the shaft <NUM> having a length L2 and a distal tip <NUM>. The open end <NUM> of the hollow tubular body <NUM> provides a receiving space <NUM> for receiving at least the shaft <NUM> of the tissue-penetrating medical device <NUM>. Cover <NUM> includes two magnets <NUM> and a magnetic shield <NUM> that minimizes any effects to the clinical environment from magnetic fields generated from the two magnets <NUM> within the cover. It will be understood that while two magnets <NUM> are shown, the device is not limited to a particular number of magnets or to a particular location of the magnets around the sleeve member. Magnets <NUM> may be positioned in any position or orientation around the sleeve member. In one or more embodiments, a single magnet can be utilized to magnetize the shaft <NUM>, or more than two magnets can be utilized. Magnetic shield <NUM> composed of one or more shielding materials may be spray-coated onto an interior surface of the cover <NUM> or an exterior surface of the cover <NUM> such that at least one face of magnet <NUM> is not coated with shielding material to allow the un-coated face of at least one magnet <NUM> to be exposed to a portion (e.g., a shaft <NUM>) of a tissue-penetrating medical device <NUM> when located in receiving space <NUM>. In one or more embodiments, the magnetic shield <NUM> composed of one or more shielding materials may be spray-coated onto an interior surface of the cover or an exterior surface of the cover to a thickness of <NUM>,<NUM> to <NUM>,<NUM>. The thickness of the magnetic shield <NUM> composed of one or more shielding materials may depend on the desired purpose or application of the medical device. In another embodiment, the magnetic shield <NUM> may be insert-molded into the cover.

In embodiments in which two magnets are utilized, the orientation of the magnetic fields of the two magnets can vary. One magnet can have north and south poles on axis with shaft of the tissue-penetrating medical device, while the second magnet can have north and south poles off-axis or perpendicular to the shaft of the tissue-penetrating medical device. Alternatively, the two magnets both can have north and south poles off axis with the shaft of the tissue-penetrating medical device, or the two magnets both can have north and south poles on axis with the shaft of the tissue-penetrating medical device.

<FIG> shows the tissue-penetrating medical device <NUM> prior to insertion into the cover <NUM> of the present disclosure. The tissue penetrating medical device <NUM> includes the shaft <NUM> having a length L2, a distal tip <NUM>, and the shaft <NUM> is mounted to the housing <NUM> by a hub <NUM>. In one or more embodiments, the hub <NUM> includes a hub magnet <NUM>. In one or more embodiments, hub magnet <NUM> is a permanent fixed magnet. Hub magnet <NUM> may provide for a fixed magnetic reference point when the tissue-penetrating needle is used with a combination of ultrasound and magnetic technologies to provide visualization of subdermal anatomy and device position. <FIG> shows the shaft <NUM> of the tissue-penetrating medical device <NUM> partially inserted into a cover <NUM> of the present disclosure. <FIG> shows the shaft <NUM> of the tissue-penetrating medical <NUM> device fully inserted into a cover <NUM> of the present disclosure. The medical device <NUM> as shown in <FIG> can be packaged and ready for use for a medical procedure. The medical device <NUM> shown in <FIG> can be packaged together with other devices as part of a larger medical device assembly. Thus, <FIG> shows a medical device <NUM> which is a needle subassembly having a cover <NUM> having at least one magnet <NUM> configured to magnetize shaft <NUM> of the medical device <NUM> upon removal of the cover <NUM> from the shaft. The medical device <NUM> could further be packaged as part of a catheter assembly including a catheter adapter subassembly.

Depending on the magnetized region of the medial device, the magnetic shield may be in the form of or incorporated into a needle cover, individual catheter wrapper, catheter dispenser, product packaging or a catheter shipper.

When the magnetic shield is incorporated into individual medical device packaging, the entire packaging can be coated with the magnetic shielding material. Alternatively, only the sections of the packaging enclosing the magnetized regions may contains the magnetic shielding material. Such approach would facilitate ease of sterilization through the packaging.

<FIG> shows an embodiment with a magnetized needle ready for insertion after cover <NUM> has been removed. This allows the device to be used with the procedural guidance systems that utilize magnetic sensors as a means of measuring and predicting needle tip location relative to the target anatomy.

As shown in <FIG>, the tissue-penetrating medical device <NUM> with the shaft <NUM> magnetized after the shaft <NUM> has been removed from the needle cover shown in <FIG>. As shown in <FIG>, two magnets <NUM> can be integrated into cover <NUM> so that the cover <NUM> passively magnetizes the shaft <NUM> upon removal of cover <NUM>. The embodiment shown in <FIG> shows two magnets <NUM> positioned around cover <NUM>. Such a cover could be easily integrated in existing catheter assemblies and other invasive medical devices such as guidewires and stylets to enable the magnetization of the shafts of various invasive medical devices 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>, the positioning of the magnets would result in the shaft <NUM> being magnetized from the approximately the position P shown in <FIG> to the distal tip <NUM> of the shaft <NUM> as the portion of the shaft from P to the distal tip will be moved through the magnetic field provided by the magnets <NUM>. This the tissue-penetrating medical device <NUM> can now be used with a procedural guidance system that utilize magnetic sensors as a means of measuring and predicting needle tip location relative to the target anatomy. In one or more embodiments, the distal end of the tissue penetrating medical device <NUM> includes a notch <NUM> located on the distal tip <NUM> of the shaft <NUM> to provide immediate confirmation of vessel entry at a point of insertion. In one or more embodiments, the magnetized portion of the tissue-penetrating medical device may comprise a partial length of the tissue-penetrating medical device. In one or more embodiments, the magnetized portion of the tissue-penetrating medical device may comprise a distal tip of the tissue-penetrating medical device. In one or more embodiments, the magnetized portion of the tissue-penetrating medical device may comprise an entire length of the tissue-penetrating medical device.

<FIG> shows an embodiment of a tissue-penetrating medical device <NUM> including a cover <NUM> having a magnetizing collar <NUM>, which can be a magnet in the shape of the collar <NUM> as shown. Magnetic shield <NUM> composed of one or more shielding materials may be spray-coated onto an exterior surface <NUM> of the collar <NUM> such that the interior surface <NUM> is not coated with shielding material to allow the un-coated interior surface to be exposed to a portion (e.g., a shaft <NUM>) of a tissue-penetrating medical device <NUM> is located in receiving space <NUM>. In one or more embodiments, the magnetic shield <NUM> composed of one or more shielding materials may be spray-coated onto exterior surface <NUM> of the collar <NUM> to a thickness of <NUM>,<NUM> to <NUM>,<NUM>. The thickness of the magnetic shield <NUM> may depend on the desired purpose or application of the medical device. The cover <NUM> includes a sleeve member <NUM> having a hollow tubular body <NUM> having a distal end <NUM> and a proximal end <NUM> to form a protective closure over the shaft <NUM> of the tissue-penetrating medical device <NUM>. The open end <NUM> of the hollow tubular body <NUM> provides a receiving space <NUM> for receiving at least the shaft <NUM> of the tissue-penetrating medical device <NUM>. The magnetizing collar <NUM> is show as being disconnected from the cover <NUM>, but the magnetizing collar <NUM> is variably positioned along the length L3 of the cover <NUM> relative to the shaft <NUM>. The magnetizing collar <NUM> can be used as a single use disposable item, or the magnetizing collar <NUM> may be reusable since the needle cover stays in place during the magnetization step. Therefore, according to one or more embodiments, the magnetizing collar <NUM> is detachably mounted to the cover <NUM>. In alterative embodiments, the magnetizing collar <NUM> is permanently mounted to the cover <NUM>. The magnetizing collar <NUM> can be slidably moved along the length of the cover <NUM>. In other embodiments, the length L4 of the magnetizing collar <NUM> may be equal to the length L3 of the cover <NUM> such that the entire shaft <NUM> of the tissue-penetrating medical device <NUM>. In other embodiments, the length L4 of the magnetizing collar <NUM> is <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% or <NUM>% of the length L3 of the cover <NUM>. The magnetizing collar <NUM> can be a tubular magnet that substantially surrounds the periphery of the cover, or the magnetizing collar <NUM> can be a cover made of plastic or other material with an array of magnets substantially surrounding the periphery of the cover.

<FIG> show one way of integrating at least one magnet with a cover for a tissue-penetrating medical device. According to one or more embodiments, as shown in <FIG> the cover <NUM> may have a wall <NUM> made entirely of a magnetic shielding material wherein one or more magnets <NUM> are disposed in slots <NUM> positioned on the interior surface of the receiving space <NUM> around the sleeve member. In one or more embodiments, the slots <NUM> are positioned around the sleeve member surround the device-receiving space <NUM>. In one or more embodiments, the magnetic shield composed of one or more shielding material surrounds a portion of the one or more magnets disposed inside the sleeve member. In one or more embodiments, the magnetic shield composed of one or more shielding material surrounds the exterior surface of the sleeve member. In one or more embodiments, the magnetic shield composed of one or more shielding material surrounds the interior 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.

<FIG> shows a partial perspective view and <FIG> shows an end view of a cover <NUM> having an embedded magnetic <NUM> in the wall <NUM> of the cover <NUM> having a magnetic shield <NUM> comprised of magnetic material along the exterior surface of wall <NUM>. The magnet <NUM> is embedded in a slot <NUM>. The magnet <NUM> can be sized to be slidably mounted within the slot <NUM> and held in place by friction fit, or the magnet can be attached with an adhesive or other suitable ways. Alternatively, the magnet <NUM> could be integrally molded into the wall <NUM> during the forming process for the cover <NUM>. The length L5 of the magnet <NUM> shown in <FIG> is shown as being less than the length of the cover. According to one or more embodiments, the length L5 of the magnet <NUM> can be equal to the length of the cover, or <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% or <NUM>% of the length of the cover.

<FIG> shows an embodiment of a cover <NUM> with a first magnet <NUM> in a first slot <NUM> of the wall <NUM> of the cover <NUM>, and a second magnet <NUM> in a second slot <NUM> in the wall <NUM> of the cover. The first magnet <NUM> and second magnet <NUM> are shown as being positioned around the cover <NUM>, for example, <NUM> degrees from each other. It will be understood that the two magnets can be in other positions with respect to each other. Additionally, the cover <NUM> can include more than two magnets. The first magnet <NUM> and second magnet <NUM> can be slidably mounted in the respective first slot <NUM> and the second slot <NUM> and held in place by friction fit, or they could be held in place by adhesive. In alternative embodiments, the magnets can be integrally molded with the cover <NUM>. The two or more magnets may have oppositely oriented poles. As an exemplary embodiment, magnetic shield <NUM> is shown comprised of magnetic material along the interior surface of first slot <NUM> and the second slot <NUM>.

In alternative embodiments, a needle cover is provided that has geometric dimensions that permit the needle cover to be placed inside existing needle magnetizing devices while the needle cover is covering the shaft of the needle. The distal end of the needle cover may be used to limit the depth of insertion by providing a stop to contact the bottom of the needle magnetizing device. Alternatively, a feature near the proximal portion of the needle cover can be provided on the cover to limit the depth of insertion by a stop on the proximal opening of the needle magnetizer.

The covers described herein can have a variety of properties. In one or more embodiments, the covers are formed from plastic. In one or more embodiments, the covers are sterile. In one or more embodiments, the covers are disposable. In other embodiments, the covers may be both sterile and disposable.

The tissue-penetrating medical device may be a needle, catheter, introducer needle, stylet, scalpel or guidewire. In one embodiment, the tissue-penetrating medical device is a needle, which when magnetized can be used with a procedural guidance system to locate and project the position of the needle during an invasive medical procedure. The tissue-penetrating medical device according to one or more embodiments is includes a magnetizable metallic material. In a specific embodiment, the magnetizable metallic material is magnetizable stainless steel.

The covers described herein may also 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 to form a protective closure over the introducer needle, and two or more magnets disposed on the needle cover as described herein.

An example of a medical device assembly, specifically a vascular access device including a catheter according to any of the foregoing embodiments described above is illustrated in <FIG>. The medical device assembly <NUM> shown in <FIG> comprises a tissue penetrating medical device in the form of a needle subassembly <NUM>, and a catheter adapter subassembly <NUM> including a catheter adapter body <NUM> and a catheter tubing <NUM> and a permanent magnet element <NUM>, a cover <NUM> having an embedded magnetic <NUM> in the wall of the cover <NUM> having a magnetic shield <NUM> comprised of magnetic material along the exterior surface of wall. <FIG> shows a partial exploded view of the embodiment of a medical device shown in <FIG> having a magnetic field <NUM> contained within the cover having a magnetic shield <NUM>. In one or more embodiments, the catheter adapter is connected to the proximal end of the shaft.

A permanent magnet element located along the introducer needle may serve as an additional reference point when used in combination with ultrasound and magnetic technologies to provide visualization of subdermal anatomy and device position. A needle <NUM> within the catheter tubing <NUM> shows a cover <NUM>, and the needle has been magnetized upon removal of a cap including a magnet as described with respect to <FIG> herein. Magnetizing the needle with the cover as described herein creates a magnetic field in the magnetic region.

The medical device <NUM> may be a vascular access device which includes a lateral access port <NUM> and may be connected to a section of an extension tube <NUM> for establishing fluid communication between an IV fluid source and the catheter tubing <NUM>. In one or more embodiments, the extension tube <NUM> is built-in to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more embodiments, the extension tube <NUM> is compatible with high pressure injection. In one or more embodiments, the extension tube <NUM> provides continuous confirmation of vessel access during advancement of the catheter into the patient vein.

In one or more embodiments, a needle of a needle subassembly <NUM> is inserted into a lumen of the catheter tubing <NUM>. The needle subassembly <NUM> is shown as including finger grips <NUM> positioned at the sides of the needle subassembly <NUM> to facilitate various insertion techniques. In one or more embodiments, bumps may be present on the finger grip to indicate where to the user may grip the device for needle removal. In one or more embodiments, a thumb pad <NUM>, having a gently convex surface, is provided at the proximal end of the needle subassembly <NUM>. A flange <NUM>, having a gently convex surface, is provided at the proximal end of the needle subassembly <NUM> to provide a finger pad. A wing member <NUM>, thumb pad <NUM> and flange <NUM> may be utilized by the user during insertion, permitting the user to elect which insertion technique to employ.

In one or more embodiments, the needle subassembly <NUM> includes a needle shield <NUM>. The needle shield <NUM> may be a design adapted to secure the tip of the needle within the shield after use. In one or more embodiments, the needle shield <NUM> may be activated passively. The needle tip is completely covered by the needle shield <NUM> in a fixed position. In one or more embodiments, a ferrule, crimp or other structure may be included near the tip for engagement with a needle shield in certain applications.

A push tab <NUM> may be provided to facilitate catheter advancement during insertion. The push tab <NUM> also allows for one-handed or two-handed advancement. In one or more embodiments, the push tab <NUM> is removed with the needle shield <NUM>. A clamp <NUM> may also be included on the extension tubing to prevent blood flow when replacing the access port.

In one or more embodiments, the vascular access device <NUM> further includes a first luer access <NUM> and a second luer access <NUM> in fluid communication with the extension tube <NUM>, a blood control split septum <NUM> associated with the first luer access <NUM>, and an air vent <NUM> associated with the second luer access <NUM>. Split septum <NUM> allows for a reduction in catheter-related bloodstream infection (CRBSI) while providing unrestricted flow and a straight fluid path and functions as a blood control septum. In one or more embodiments, the split septum <NUM> may be located in an internal cavity of the catheter adapter or on the distal end of the catheter adapter. In yet another embodiment, the split septum <NUM> may be located on a distal end of the extension tube <NUM>. The air vent <NUM> allows air to escape from the system during insertion, providing continuous confirmation of vascular access while preventing leakage of blood from the system during insertion. In one or more embodiments, the air vent <NUM> may be at the distal end of extension tube <NUM>.

In one or more embodiments, the base unit can be integrated into the ultrasound system with the ultrasound processor and a magnetometric detector being in direct communication with the ultrasound system either via wireless link or using the same physical cable.

Another aspect of the disclosure pertains to a method of magnetizing a tissue-penetrating medical device. Embodiments of the method include positioning a shaft of the tissue-penetrating medical device into a cover having a device-receiving space, at least one magnet disposed within the device-receiving space, and a magnetic shield composed of one or more shielding materials associated with the cover; and subsequently removing the tissue-penetrating medical device from the device-receiving space to magnetize the shaft of the tissue-penetrating medical device.

Reference throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments" or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as "in one or more embodiments," "in certain 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, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

Claim 1:
A cover (<NUM>,<NUM>,<NUM>) for magnetizing a tissue-penetrating medical device comprising:
a sleeve member (<NUM>,<NUM>,<NUM>) having a hollow body with an exterior surface, an interior surface, a proximal end, and a distal end to form a protective closure over a shaft (<NUM>,<NUM>,<NUM>) of a tissue-penetrating medical device having a longitudinal axis, the proximal end of the hollow body providing a receiving space for receiving at least a shaft of the tissue-penetrating medical device;
characterized in that
one or more magnets (<NUM>,<NUM>,<NUM>) disposed along the sleeve member effective to magnetize the shaft; and
a magnetic shield (<NUM>,<NUM>,<NUM>);
the magnetic shield composed of one or more shielding materials spray-coated onto the exterior surface of the sleeve member, a first face of the one or more magnets being exposed to the receiving space and an opposite face of the one of one or more magnets being oriented towards the magnetic shield.