Patent Description:
The present invention is directed to the magnetizing system and needle of claim <NUM>. The dependent claims refer to preferred embodiments.

Briefly summarized, the present disclosure is directed to a magnetizing system for use in selectively magnetizing a needle (or other cannula or magnetizable component for insertion into a patient) of a medical device. Once magnetized, the needle can be tracked by a needle guidance system, which assists the clinician placing the needle by visualizing the position and orientation of the needle after its insertion into a body of a patient. The image of the needle produced by the needle guidance system is superimposed in one embodiment atop an ultrasound image of an internal body portion, such as an imaged vein or other vessel, to enable the clinician to accurately place the needle in a desired location, such as within the lumen of the vein, for instance.

The disclosure is also directed to an orientation key system included with the magnetizing system to ensure the needle is positioned correctly in the magnetizing system. This in turn ensures that the needle is properly magnetized so as to be accurately tracked by the needle guidance system. In the invention a first key is associated with the magnetizer, and a needle cover is configured to removably cover the needle, the needle cover including a second key feature configured to fit with the first key feature, the first key feature and second key feature configured to guide a user so as to place the needle in a predetermined position with respect to the at least one permanent magnet when the needle is received at the needle receptacle. Various types of keys are disclosed herein.

These and other features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the present disclosure as set forth hereinafter.

It is appreciated that these drawings depict only typical embodiments and are therefore not to be considered limiting of its scope.

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present disclosure, and are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words "including," "has," and "having," as used herein, including the claims, shall have the same meaning as the word "comprising.

Embodiments herein are generally directed to a magnetizing system for use in selectively magnetizing a needle (or other magnetizable cannula, tissue-penetrating component, or medical component for insertion into a patient) of a medical device. Once magnetized, the needle can be tracked by a needle guidance system, which assists the clinician placing the needle by visualizing the position and orientation of the needle after its insertion into a body of a patient. The image of the needle produced by the needle guidance system is superimposed in one embodiment atop an ultrasound image of an internal body portion, such as an imaged vein or other vessel, to enable the clinician to accurately place the needle in a desired location, such as within the lumen of the vein, for instance.

Embodiments herein are also directed to an orientation key system included with the magnetizing system to ensure the needle is positioned correctly in the magnetizing system. This in turn ensures that the needle is properly magnetized so as to be accurately tracked by the needle guidance system. In one embodiment of the invention, a first key is associated with the magnetizer, and a needle cover is configured to removably cover the needle, the needle cover including a second key feature configured to fit with the first key feature, the first key feature and second key feature configured to guide a user so as to place the needle in a predetermined position with respect to the at least one permanent magnet when the needle is received at the needle receptacle. Various types of keys are disclosed herein.

As mentioned, the needle can be included as part of a medical device, such as a catheter insertion tool as described further below, though many other implementations with other types of medical devices are contemplated.

<FIG> depict various details of an insertion tool, or insertion device, <NUM> for assistance in inserting a catheter into a body of as patient, which also serves as an example of a medical device including a needle that can be magnetized with the present magnetizing system according to one embodiment. As shown in <FIG>, the insertion tool <NUM> includes top and bottom housing portions 12A, 12B of a housing <NUM>, from which extends a catheter <NUM> disposed over a needle <NUM>. Also shown is a finger pad <NUM> of a guidewire advancement assembly <NUM> slidably disposed in a slot <NUM> defined in the top housing portion 12A, and a portion of a handle assembly <NUM> of a catheter advancement assembly <NUM>. Further details are given below of the present insertion tool <NUM> and its various details in accordance with the present embodiment.

<FIG> show that the finger pad <NUM> as part of the guidewire advancement assembly <NUM> can be slid by a finger(s) of the user distally along the slot <NUM> in order to enable selective advancement of a guidewire <NUM> (initially disposed within a lumen of the needle <NUM>) out past a distal end 16B of the needle <NUM>. A proximal end of the guidewire <NUM> is attached to an interior portion of the top housing portion 12A such that a single unit of distal sliding advancement of the finger pad <NUM> results in two units of distal guidewire advancement. This is made possible by looping the guidewire <NUM> from its attachment point on the top housing portion 12A and through guide surfaces included on the guidewire lever <NUM> before extending into the lumen of the needle <NUM>. Note that in the present embodiment the guidewire lever <NUM> and finger pad <NUM> of the guidewire advancement assembly <NUM> are integrally formed with one another, though they may be separately formed in other embodiments. Note also that the guidewire <NUM> can be attached to other external or internal portions of the insertion tool <NUM>, including the bottom housing portion 12B, the needle hub <NUM>, etc..

<FIG> and <FIG> further show that the catheter advancement assembly <NUM> for selectively advancing the catheter <NUM> in a distal direction out from the housing <NUM> of the insertion tool <NUM> includes a handle assembly <NUM>, which in turn includes among other components two wings <NUM> that are grasped by the fingers of the user when the catheter is to be advanced. The wings <NUM> distally advance via the gap <NUM> defined between the top and bottom housing portions 12A, 12B.

The top and bottom housing portions 12A, 12B are mated together via the engagement of four tabs <NUM> of the top housing portion with four corresponding recesses <NUM> located on the bottom housing portion. Of course, other mating mechanisms and schemes can be employed for joining the top and bottom housing portions together.

The exploded view of the insertion tool <NUM> in <FIG> shows that the handle assembly <NUM> includes a head portion <NUM> from which extend the wings <NUM>, and a tail portion <NUM>. Both the head portion <NUM> and the tail portion <NUM> are removably attached to the catheter hub <NUM>. Internal components of the insertion tool <NUM> that are disposed within the housing <NUM>, each of which is passed through by the needle <NUM> include a valve <NUM>, a safety housing <NUM> in which a carriage <NUM> and a needle safety component <NUM> is disposed, and a cap <NUM> of the safety housing. An O-ring <NUM> that is included with the needle safety component <NUM> is also shown, as is a needle hub <NUM>, which is secured to a proximal end of the needle <NUM> and is mounted to the housing <NUM> to secure the needle <NUM> in place within the insertion tool <NUM>. Note in <FIG> that, in one embodiment, the slot <NUM> in which the finger pad of the guidewire advancement assembly <NUM> is disposed includes a relatively wide portion to enable the guidewire lever <NUM> to be inserted therethrough in order to couple the guidewire advancement assembly to the housing <NUM>.

The insertion tool <NUM> is used by a clinician to insert the catheter <NUM> into the venous system (or other location) of a patient so as to enable fluids, medicaments, etc. to be infused into and/or removed from the patient. Though depicted here as a midline catheter, the catheter <NUM> can include a catheter of a variety of lengths, including relatively shorter peripheral catheters, peripherally inserted central catheters, CVCs, etc. Also, other elongate medical devices can be employed as benefit from the present disclosure, including solid and hollow needles and cannulae, blood-draw needles, biopsy needles, introducer needles, guidewires, stylets, tissue-penetrating medical components, etc. Further details regarding the insertion tool <NUM> and its operation can be found in <CIT>, titled "Catheter Placement Device Including Guidewire and Catheter Control Elements".

<FIG> and <FIG> depict various aspects of a ultrasound-based guidance system ("system"), generally designated at <NUM>, which serves as one example environment wherein principles of the embodiments described herein can be practiced, including the insertion of the catheter <NUM> using the insertion tool <NUM> shown in <FIG> and <FIG> as described further above.

In greater detail, the guidance system <NUM> is configured for locating and guiding a needle or other medical component, during ultrasound-based or other suitable procedures, in order to access a subcutaneous vessel of a patient, for instance. In one embodiment, the guidance system enables the position, orientation, and advancement of the needle to be superimposed in real-time atop the ultrasound image of the vessel, thus enabling a clinician to accurately guide the needle to the intended target. Furthermore, in one embodiment, the guidance system tracks the needle's position in five degrees of motion: X, Y, and Z spatial coordinate space, needle pitch, and needle yaw. Such tracking enables the needle to be guided and placed with relatively high accuracy.

As shown in <FIG> and <FIG>, the system <NUM> generally includes an ultrasound ("US") imaging portion including a console <NUM>, display <NUM>, and probe <NUM>, each of which is described in further detail below. It should be noted, however, that the ultrasound imaging portion can be configured in one of a variety of ways in addition to what is shown and described herein.

The ultrasound imaging portion of the system <NUM> is employed to image a targeted internal portion of a body of a patient prior to percutaneous insertion of a needle or other device to access the target. As described below, in one embodiment insertion of the needle is performed prior to the subsequent insertion of a catheter into a vein or other portion of the vasculature of the patient. It is appreciated, however, that insertion of a needle into the body of a patient can be performed for a variety of medical purposes in addition to catheter insertion.

<FIG> shows the general relation of the above-described components to a patient <NUM> during a procedure to ultimately place the catheter <NUM> (see <FIG> and <FIG>) into the patient vasculature through a skin insertion site <NUM>, according to one embodiment. <FIG> shows that the catheter <NUM> generally includes a proximal portion <NUM> that remains exterior to the patient and a distal potion <NUM> that resides within the patient vasculature after placement is complete. The system <NUM> is employed to ultimately position a distal tip 1176A of the catheter <NUM> in a desired position within the patient vasculature.

The catheter proximal portion <NUM> further includes a luer connector 1174A configured to operably connect the catheter <NUM> with an infusion apparatus. As mentioned, placement of a needle into the patient vasculature at the insertion site <NUM> is typically performed prior to insertion of the catheter, though it is appreciated that other placement methods can be employed. Further, it is appreciated that the above discussion is only one example for use of the system <NUM>; indeed it can be employed for a variety of uses, such as the placement of needles preparatory to insertion of a catheter as above, the insertion of a needle for other uses, or for the insertion of other medical components into the body of a patient, including x-ray or ultrasound markers, biopsy sheaths, ablation components, bladder scanning components, vena cava filters, etc..

The console <NUM> houses a variety of components of the system <NUM> and it is appreciated that the console can take one of a variety of forms. A processor <NUM>, including non-volatile memory such as EEPROM for instance, is included in the console <NUM> for controlling system function and executing various algorithms during operation of the system <NUM>, thus acting as a control processor. A digital controller/analog interface <NUM> is also included with the console <NUM> and is in communication with both the processor <NUM> and other system components to govern interfacing between the probe <NUM> and other system components.

The system <NUM> further includes ports <NUM> for connection with additional components such as optional components <NUM> including a printer, storage media, keyboard, etc. The ports in one embodiment are USB ports, though other port types or a combination of port types can be used for this and the other interfaces connections described herein. A power connection <NUM> is included with the console <NUM> to enable operable connection to an external power supply <NUM>. An internal battery <NUM> can also be employed, either with or exclusive of an external power supply. Power management circuitry <NUM> is included with the digital controller/analog interface <NUM> of the console to regulate power use and distribution.

The display <NUM> in the present embodiment is integrated into the console <NUM> and is used to display information to the clinician during the placement procedure, such as an ultrasound image of the targeted internal body portion attained by the probe <NUM>. In another embodiment, the display may be separate from the console. In one embodiment, a console button interface <NUM> and control buttons <NUM> (<FIG>) included on the probe <NUM> can be used to immediately call up a desired mode to the display <NUM> by the clinician to assist in the placement procedure. In one embodiment, the display <NUM> is an LCD device.

<FIG> further depicts a needle-based device, namely, the insertion device <NUM> depicted in <FIG> and <FIG>, used to gain initial access to the patient vasculature via the insertion site <NUM> and to deploy the catheter <NUM> into the patient <NUM>. As will be described in further detail below, the needle <NUM> of the insertion device <NUM> is configured to cooperate with the system <NUM> in enabling the system to detect the position, orientation, and advancement of the needle during an ultrasound-based placement procedure.

<FIG> and <FIG> also show that the system <NUM> includes a magnetizer <NUM>, described in greater detail further below, configured to magnetize all or a portion of the needle <NUM> of the insertion device <NUM> so as to enable the needle to tracked during the catheter placement procedure. The magnetizer <NUM> includes in the present embodiment an RFID reader <NUM> to enable it to read RFID tags included with the insertion device <NUM>, which enables the system <NUM>, among other things, to customize its operation to the particular size and type of needle included with the insertion device. More details regarding the RFID reader <NUM> are given further below.

The probe <NUM> is employed in connection with ultrasound-based visualization of a vessel, such as a vein, in preparation for insertion of the needle <NUM> and/or catheter <NUM> into the vasculature. Such visualization gives real time ultrasound guidance and assists in reducing complications typically associated with such introduction, including inadvertent arterial puncture, hematoma, pneumothorax, etc..

The handheld probe <NUM> includes a head <NUM> that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient's body when the head is placed against the patient's skin proximate the prospective insertion site <NUM> (<FIG>). The probe <NUM> further includes a plurality of control buttons <NUM> (<FIG>) for controlling the system, thus eliminating the need for the clinician to reach out of the sterile field, which is established about the patient insertion site prior to establishment of the insertion site, to control the system <NUM>.

As such, in one embodiment a clinician employs the ultrasound imaging portion of the system <NUM> to determine a suitable insertion site and establish vascular access, such as with the insertion tool needle <NUM>, prior to introduction of the catheter <NUM> (also included on the insertion tool) for ultimate advancement thereof through the vasculature toward an intended destination.

<FIG> shows that the probe <NUM> further includes a button and memory controller <NUM> for governing button and probe operation. The button and memory controller <NUM> can include non-volatile memory, such as EEPROM, in one embodiment. The button and memory controller <NUM> is in operable communication with a probe interface <NUM> of the console <NUM>, which includes a piezo input/output component 1144A for interfacing with the probe piezoelectric array and a button and memory input/output component 1144B for interfacing with the button and memory controller <NUM>.

Also as seen in <FIG>, the probe <NUM> includes a sensor array <NUM> for detecting the position, orientation, and movement of the insertion tool needle <NUM> during ultrasound imaging procedures, such as those described above. In the present embodiment, the sensor array <NUM> includes a plurality of magnetic sensors <NUM> embedded within or included on the housing of the probe. The sensors <NUM> are configured to detect a magnetic field associated with the needle <NUM> when it is magnetized and thus enable the system <NUM> to track the needle. Though configured here as magnetic sensors, it is appreciated that the sensors <NUM> can be sensors of other types and configurations, as will be described. Also, though they are described herein as included with the probe <NUM>, the sensors <NUM> of the sensor array <NUM> can be included in a component separate from the probe, such as a separate handheld device, in one embodiment. In one embodiment, the sensors <NUM> are disposed in an annular configuration about the head portion of the probe <NUM>, though it is appreciated that the sensors can be arranged in other configurations, such as in an arched, planar, or semi-circular arrangement.

In the present embodiment, each of the sensors <NUM> includes three orthogonal sensor coils for enabling detection of a magnetic field in three spatial dimensions. Such three dimensional ("<NUM>-D") magnetic sensors can be purchased, for example, from Honeywell Sensing and Control of Morristown, NJ. Further, the sensors <NUM> of the present embodiment are configured as Hall-effect sensors, though other types of magnetic sensors could be employed. Further, instead of <NUM>-D sensors, a plurality of one dimensional magnetic sensors can be included and arranged as desired to achieve <NUM>-, <NUM>-, or <NUM>-D detection capability.

In the present embodiment, five sensors <NUM> are included in the sensor array <NUM> so as to enable detection of the needle <NUM> in not only the three spatial dimensions (i.e., X, Y, Z coordinate space), but also the pitch and yaw orientation of the needle itself. Note that in one embodiment, orthogonal sensing components of two or more of the sensors <NUM> enable the pitch and yaw attitude of the needle <NUM> to be determined.

In other embodiments, fewer or more sensors can be employed in the sensor array. More generally, it is appreciated that the number, size, type, and placement of the sensors of the sensor array can vary from what is explicitly shown here.

It is appreciated that the needle <NUM> is composed of a magnetizable material to enable the needle to be magnetized by the below-described magnetizer and later be tracked by the guidance system <NUM> when the needle is percutaneously inserted into the body of the patient <NUM> during a procedure to insert the needle or an associated medical device into the body of the patient. In one embodiment, the needle <NUM> is composed of a stainless steel, such as SS <NUM> stainless steel, though other suitable needle materials that are capable of being magnetized can be employed. In one embodiment, the needle material is ferromagnetic. In another embodiment, the needle is paramagnetic. So configured, the needle <NUM> produces a magnetic field that is detectable by the sensor array <NUM> of the ultrasound probe <NUM> so as to enable the location, orientation, and movement of the needle <NUM> to be tracked by the system <NUM>, as described further below.

During operation of the system <NUM>, the head portion of the ultrasound probe <NUM> is placed against the patient skin and produces an ultrasound beam so as to ultrasonically image a portion of a vessel beneath the patient skin surface. The ultrasonic image of the vessel can be depicted on the display <NUM> of the system <NUM> (<FIG>, <FIG>).

As mentioned above, the system <NUM> in the present embodiment is configured to detect the position, orientation, and movement of the needle <NUM> of the insertion device <NUM> described above. In particular, the sensor array <NUM> of the probe <NUM> is configured to detect a magnetic field of the magnetized needle <NUM>. Each of the sensors <NUM> of the sensor array <NUM> is configured to spatially detect the magnetized needle in three dimensional space. Thus during operation of the system <NUM>, magnetic field strength data of the needle's magnetic field sensed by each of the sensors <NUM> is forwarded to a processor, such as the processor <NUM> of the console <NUM> (<FIG>), which computes in real-time the position and/or orientation of the needle <NUM>.

In light of the above, the position of the entire length of the needle <NUM> in X, Y, and Z coordinate space with respect to the sensor array <NUM> can be determined by the system <NUM> using the magnetic field strength data sensed by the sensors <NUM>. Moreover, the pitch and yaw of the needle <NUM> can also be determined. Suitable circuitry of the probe <NUM>, the console <NUM>, or other component of the system can provide the calculations necessary for such position/orientation. In one embodiment, the magnetic element <NUM> can be tracked using the teachings of one or more of the following <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>, each of which is cited herein for reference.

The above position and orientation information determined by the system <NUM>, together with the length of the needle <NUM>, as known by or input into the system, enable the system to accurately determine the location and orientation of the entire length of the needle, including its distal tip 16B, with respect to the sensor array <NUM>. This in turn enables the system <NUM> to superimpose an image of the needle <NUM> on to an image produced by the ultrasound beam <NUM> of the probe <NUM>, such as via a screenshot depicted on the display <NUM> (<FIG>, <FIG>), for instance. For example, the ultrasound image depicted on the display <NUM> can include depiction of the patient skin surface and a subcutaneous vessel to be accessed by the needle <NUM>, as well as a depiction of the needle <NUM> as detected by the system <NUM> and its position with respect to the vessel. The ultrasound image corresponds to an image acquired by the ultrasound beam of the probe <NUM>. In another embodiment, it is appreciated that only a portion of the length of the needle <NUM> is magnetized and thus tracked by the guidance system.

Note that further details regarding structure and operation of the above-described guidance system can be found in <CIT>, titled "Apparatus for Use with Needle Insertion Guidance System".

As mentioned above, in the present embodiment the needle <NUM> of the insertion tool <NUM> is magnetized so as to be trackable by the guidance system <NUM> when the needle is inserted into the body of the patient. Such magnetic-based tracking of the needle <NUM> assists the clinician in placing the distal tip 16B of the needle in a desired location, such as in the lumen of a vein, by superimposing a simulated needle image representing the real-time position and orientation of the needle over an ultrasound image of the internal area of the patient body being accessed by the needle.

Embodiments described below provide apparatus and systems for magnetizing a needle, such as the needle <NUM> shown in <FIG> and1B, including needles and cannulae from a variety of medical devices, including needles themselves as the medical device. Thus, though dealing with magnetization of the needle <NUM> of the insertion tool <NUM> (<FIG> and <FIG>), the following discussion should not be considered as limiting.

<FIG> depict one example of an apparatus for magnetizing the needle <NUM> of the insertion tool <NUM> (<FIG>, <FIG>). As shown, a needle cover <NUM> is included, which is configured to fit on to and removably attach to the insertion tool <NUM> so as to cover the portion of the needle <NUM> and the catheter <NUM> that distally extend from the insertion tool housing <NUM>. The needle cover <NUM> defines a cavity <NUM> for receiving the needle <NUM> and catheter <NUM> therein and is sized as to removably engage with the distal portion of the housing <NUM> so as to protect the user from accidental needle sticks before use of the insertion tool <NUM>, as shown in <FIG>.

A cap <NUM> is permanently attached (such as via adhesive) to a distal end of the needle cover <NUM> and includes four slots <NUM> equally spaced apart about the outer perimeter of the cap. Within each slot <NUM> is disposed a magnetic element, such as a permanent magnet <NUM>. In the present embodiment, the permanent magnets <NUM> are configured as bar magnets 1408A sized to be permanently received within the slots <NUM> and held in place by an adhesive or other suitable mode. The poles of the permanent magnets <NUM> are aligned so as to correspond with the other magnets.

When the needle cover <NUM> is mated with the insertion tool <NUM> such that the distal portion of the needle <NUM> is disposed within the cavity <NUM> thereof (<FIG>), the magnets <NUM> disposed within the corresponding slots <NUM> are positioned proximate the distal portion of the needle. The needle cover is placed over the needle <NUM> in this manner after manufacture and remains in place during packaging, transport and storage until the insertion tool is accessed to be used by a clinician.

The proximate positioning of the magnets <NUM> to the needle <NUM> immediately magnetizes the distal portion of the needle. In one embodiment, the magnets <NUM> each have a longitudinal length of about <NUM> (<NUM> inch), sufficient to magnetize the distal portion of the needle <NUM>. It is appreciated, though, that other numbers, sizes, lengths, and magnetization lengths of the magnets and the needle are possible in other embodiments. For instance, three relatively shorter magnets could be included on the cap <NUM> in one embodiment. It is further appreciated that, though the permanent magnets <NUM> in the present embodiment are dipole magnets, in other embodiments each slot <NUM> could hold a plurality of magnets stacked end to end to form a multipole magnet arrangement. The permanent magnets <NUM> in one embodiment are rare-earth magnets such as neodymium magnets, though other suitable magnetic materials could be employed. These and other configurations are contemplated.

<FIG> depict details of the needle cover <NUM> according to another embodiment wherein the cap <NUM> is omitted and the permanent magnet <NUM> includes a single permanent, annular magnet 1408B, which is slid over the external surface of the needle cover so as to be disposed proximate the distal portion of the needle <NUM> residing on the needle cover cavity <NUM> when the needle cover is mated with the insertion tool <NUM>, similar to that shown in <FIG>. In this way, the needle <NUM> is magnetized by the annular magnet 1408B of <FIG> when the needle cover <NUM> is in place, thus enabling the needle to be tracked by a suitable needle tracking system.

<FIG> depict details of the needle cover <NUM> according to another embodiment wherein a key feature <NUM> is included therewith. The key feature <NUM> assists with positioning the needle <NUM> in a desired position and orientation with respect to a magnetizer (for magnetizing the needle) when the needle cover <NUM> is mated to the insertion tool <NUM> (similar to that shown in <FIG>) and the insertion tool is placed on or proximate to the magnetizer. An example of a similar magnetizer is shown in <FIG>, for instance, which, together with the needle cover of <FIG>, forms an embodiment of a magnetizing system according to the invention. In brief, the magnetizer is configured to immediately magnetize a predetermined segment of the distal portion of the needle <NUM> of the insertion tool <NUM> (<FIG> and <FIG>) when the insertion tool is placed on/proximate the magnetizer. To that end, the magnetizer includes one or more permanent magnets that are disposed and arranged to magnetize the needle when the needle <NUM> is positioned as discussed herein. For instance, in the present embodiment, five permanent magnets are located in the magnetizer and placed end-to-end in a multipole arrangement. This results in a multipole magnetization profile imparted to the distal portion of the needle <NUM>, which multipole profile can be then be detected and tracked by the guidance system <NUM> discussed above. Note that the multipole magnet arrangement assists in providing a robust magnetization to the needle <NUM>, rendering other residual magnetic fields that may be present on the needle unproblematic. It is appreciated that other magnetic sources, such as an electromagnet, can be employed to magnetize the needle, in other embodiments. As such, the embodiments described herein are not meant to be limiting. In the present embodiment, the magnetizer comprises part of the guidance system <NUM>, though in other embodiments it can be a separate component.

In further detail, the key feature <NUM> of the cover <NUM> of <FIG> is configured to fit with a corresponding key structure on or associated with the magnetizer so that the needle <NUM> is placed in the desired position and orientation on the magnetizer. Thus, an orientation key system is established, with corresponding keys included on the needle cover <NUM> and the magnetizer. Upon being properly placed on the magnetizer, the distal portion of the needle <NUM> can then be magnetized by the multipole magnet arrangement described above.

In the present embodiment and as seen in <FIG>, the key feature <NUM> in the present embodiment includes a fin <NUM> extending from a bottom surface 1400B of the needle cover <NUM>. A corresponding slot can be included in the body of the magnetizer to receive the fin <NUM>, which causes the needle cover <NUM> and attached insertion tool <NUM> to be placed on the magnetizer in a specified, desired orientation. In turn, this causes the distal portion of the needle <NUM>, disposed within the needle cover <NUM>, to be placed in sufficient proximity, and in the proper desired orientation, to the set of magnets in the magnetizer so as to be magnetized thereby. Once magnetization occurs, which is substantially immediate, the insertion tool <NUM> can be removed from the magnetizer, the needle cover removed, and the insertion tool used to insert the needle and catheter into the body of the patient.

<FIG> depict various details of a magnetizing system according to one embodiment, including a magnetizer <NUM> and a tray <NUM> that is removably matable with the magnetizer. As shown in <FIG>, the magnetizer includes a body <NUM> that defines a receptacle <NUM> below which a plurality of permanent magnets <NUM> are linearly disposed in a multipole arrangement (<FIG>). Note that the one or more magnets could be arranged in other than a linear arrangement within the magnetizer, in other embodiments.

A first key feature <NUM> of an orientation key system <NUM> is included with the magnetizer body <NUM>. In particular, the first key feature <NUM> includes a recess <NUM> that is defined by a portion of the receptacle <NUM> and is sized to receive therein a corresponding key feature <NUM> of the tray <NUM>. The tray <NUM>, which includes a receptacle <NUM>, includes a protrusion <NUM> on a bottom surface thereof that serves as the second key feature <NUM>. The tray receptacle <NUM> is sized to be received within the receptacle <NUM> of the magnetizer body <NUM>. Correspondingly, the tray receptacle <NUM> is sized to receive therein the insertion tool <NUM> (or other suitable medical device) in a predetermined orientation. Further, the protrusion <NUM> is received into the correspondingly shaped recess <NUM> of the magnetizer receptacle <NUM> such that the needle is positioned accurately with respect to the magnets <NUM> when the insertion tool-laden tray <NUM> is inserted into the receptacle <NUM> of the magnetizer body <NUM>. Magnetization of the desired distal portion of the needle <NUM> of the insertion tool <NUM> (through the tray <NUM>) then immediately occurs.

It is thus seen that the first key feature <NUM> (i.e., the recess <NUM> of <FIG> in the present embodiment) and the second key feature <NUM> (i.e., the protrusion <NUM> in the present embodiment) cooperate to serve as an orientation key system to ensure correct positioning of the insertion tool <NUM> on the magnetizer <NUM> and, specifically, correct positioning of the needle <NUM> with respect to the permanent magnets <NUM> of the magnetizer. It is appreciated that the orientation key system can be configured in other ways as seen, for example, in the embodiments described further below.

<FIG> show the tray <NUM> configured to hold therein the insertion tool <NUM> including an <NUM> needle <NUM>, while <FIG> show the tray configured to hold the insertion tool with a <NUM> needle. As such, the protrusion <NUM> is positioned differently as part of the receptacle <NUM> to accommodate the differently sized needle in each case. These and other variations are contemplated.

<FIG> depict various details of a magnetizing system including the magnetizer <NUM> and the tray <NUM>, which is removably matable with the magnetizer, according to another embodiment. As shown, the magnetizer <NUM> includes the body <NUM> that defines the receptacle <NUM>. The receptacle <NUM> in the present embodiment includes a relatively wide first portion 1504A that is slightly concavely shaped, and a narrowed second portion 1504B. The plurality of permanent magnets <NUM> is linearly disposed within the magnetizer body <NUM> in a multipole arrangement and disposed beneath the surface of the receptacle second portion 1504B, as best seen in <FIG>.

The tray <NUM>, which defines a receptacle <NUM>, is of a clamshell design in the present embodiment and thus includes a top portion 1510A and a bottom portion <NUM> B. The tray <NUM> in the present embodiment includes PETG, though other polyethylene, thermoplastic, or suitable materials can be employed. As in the previous embodiment, the tray receptacle <NUM> is sized to be removably received within the receptacle <NUM> of the magnetizer. <FIG> (showing the magnetizer body <NUM>) and 11A-11C (showing the tray <NUM>) illustrate that the tray receptacle <NUM> includes a relatively wider portion that is configured to be received into the first portion 1504A of the magnetizer receptacle <NUM> and a relatively narrow portion that is configured to be received into the second portion 1504B of the magnetizer receptacle. Correspondingly, the tray receptacle <NUM> is further sized to receive therein the insertion tool <NUM> in a predetermined orientation, as seen in <FIG>, such that the needle <NUM> is disposed in the narrow portion of the tray receptacle <NUM>, which correspondingly places the needle within the second portion 1504B of the magnetizer receptacle <NUM> and adj acent the permanent magnets <NUM>, thus allowing the needle to be magnetized thereby when the tray is placed on the magnetizer body <NUM>.

The magnetizer <NUM> and tray <NUM> further include an orientation key system <NUM> configured to ensure correct positioning of the insertion tool <NUM> on the magnetizer <NUM> and, specifically, correct positioning of the needle <NUM> with respect to the permanent magnets <NUM> of the magnetizer. In the present embodiment, the orientation key system <NUM> includes a first key feature <NUM>, namely, a plurality of posts <NUM> included on the magnetizer body <NUM>. As shown, two posts <NUM> are included in an offset configuration and disposed on either side of the second portion 1504B of the receptacle <NUM>. Each post <NUM> is sized differently in diameter from the other post.

Correspondingly, the orientation key system <NUM> includes a second key feature <NUM>, included on the tray <NUM>, which is configured to cooperatively interact with the first key feature <NUM> (i.e., the posts <NUM> in the present embodiment) in order to satisfy the purpose of the orientation key system <NUM>, that is, to provide for the correct positioning of the insertion tool needle <NUM> with respect to the permanent magnets <NUM>. In the present embodiment, the second key feature <NUM> includes two holes <NUM> defined through both the top and bottom portions 1510A, 1510B of the tray <NUM>. The holes <NUM> differ according to which tray portion they are defined through: a relatively larger, oblong hole 1534A is defined in two offset locations on the tray top portion 1510A, and a relatively smaller round hole 1534B is defined in two offset locations on the tray bottom portion 1510B so as to be aligned with the corresponding holes 1534A.

As best seen in <FIG>, the holes <NUM> are received into the correspondingly positioned posts <NUM> of the magnetizer body <NUM> when the tray is placed on the magnetizer body <NUM>. In turn, this places the needle <NUM> of the insertion tool <NUM> (disposed in the tray <NUM>) in the second portion 1504B of the magnetizer receptacle <NUM> and adjacent the permanent magnets <NUM>, thus allowing the needle to be magnetized thereby when the tray is placed on the magnetizer body <NUM>. In the present embodiment, the holes <NUM> and the posts <NUM> are positioned such that the distal tip 16B of the needle <NUM> is substantially co-terminal with the adjacent end-most permanent magnet <NUM>, as seen in <FIG>. This provides magnetization to the needle <NUM> beginning at the needle distal tip 16B and extending proximally therefrom, as is desired. In other embodiments, however, the holes, posts, and needle can be arranged in other positional configurations to provide a magnetization profile as may be desired.

Note that magnetization of the desired portion of the needle <NUM> substantially immediately occurs when the tray is placed on the magnetizer <NUM>. Thus, it is seen that the engagement of the tray holes <NUM> (as the second key feature <NUM>) with the posts <NUM> (as the first key feature <NUM>) of the magnetizer body <NUM> ensures that the needle <NUM> is positioned properly with respect to the magnets, thus ensuring that magnetization of the desired portion of the needle is achieved. Again note that, though in the present embodiment, multipole magnetization of the distal portion of the needle <NUM> extends proximally along the needle beginning at the distal tip thereof, in other embodiments magnetization of other portions of the needle (or other magnetizable medical component) can be performed.

As mentioned, the posts <NUM> are each differently sized in the present embodiment. In the present embodiment, the larger post <NUM> has a diameter of about <NUM> (<NUM> inch) while the relatively smaller posts has a diameter of about <NUM> (<NUM> inch), though other sizes are possible. The holes 1534B defined in the bottom portion 1510B of the tray <NUM> are also correspondingly sized so as to mate with the posts <NUM> in only one orientation, i.e., the orientation shown in <FIG>, which prevents misalignment of the needle <NUM> with the permanent magnets <NUM>.

Also, the posts <NUM> in the present embodiment extend a predetermined height above the magnetizer body <NUM>, which forces a user, when removing the tray <NUM> from the magnetizer after needle magnetization, to lift the tray vertically upward until the tray holes <NUM> clear the posts, which direction is orthogonal to the longitudinal length of the plurality of permanent magnets <NUM> included in the magnetizer body <NUM> (<FIG>). This ensures that the needle <NUM> is withdrawn from proximity with the permanent magnets <NUM> in a direction that will not re-write or distort the magnetic field on the needle imposed thereon by the magnets, as could be the case if the needle was slid laterally with respect to the permanent magnets at close distance. Note that the height of the posts can vary according to magnetic strength of the permanent magnets, etc. In the present embodiment, the posts are about <NUM> (<NUM> inch) high, though other heights are also possible. Note also that the tray can be sterilized during time of manufacture/packaging such that, after magnetization of the insertion tool contained therein, the tray may be opened and the insertion tool dropped from the package into a sterile field of the patient, thus preserving the sterility of the insertion tool and the field.

Note that in the present embodiment, the magnetizer body receptacle <NUM> and the tray receptacle <NUM> are also configured such that the tray may be received into the magnetizer body receptacle in only one desired orientation. Thus, the configuration of the magnetizer body and tray receptacles <NUM>, <NUM> serves as an additional key feature to ensure proper needle-to-magnet positioning and prevent backwards, upside-down, etc. positioning of the tray on the magnetizer.

Note that the two holes/two post embodiment of <FIG> is but one example of an orientation key system. It is appreciated that the size, number, shape, position, and other configuration of the posts and holes can vary from what is described herein. Indeed, more than two posts can be employed, as is seen in the embodiment of the magnetizer body <NUM> of <FIG>, wherein three posts <NUM> are included. In other embodiments, differently shaped features other than posts can be disposed on magnetizer body and/or tray to operate as key features. In one embodiment, the posts can be included on the tray while corresponding holes are included on the magnetizer body. In another embodiment, a mixed combination of posts and holes are included on both the magnetizer and the tray. In yet another embodiment, a component other than a tray can be used to hold the insertion tool/needle and mate with the magnetizer. In light of the above discussion, it is appreciated that the orientation key system further serves as a visual cue for enabling the clinician to understand the proper mode for placing the tray (or medical device) on the magnetizer.

In the present embodiment, an RFID tag <NUM>, or other mode of identification, can be attached to the tray <NUM>, such as is seen in <FIG> and <FIG>. A corresponding RFID reader <NUM> can be positioned under the first portion 1504A of the magnetizer body receptacle <NUM> (<FIG>) to read the RFID tag <NUM> of the tray <NUM> when it is positioned on the magnetizer body <NUM>. The RFID reader <NUM> includes an interface, such as a USB interface <NUM> to enable it to be powered by and operably connect with the system <NUM> (see also <FIG>). In this way, the guidance system <NUM> (<FIG>, <FIG>) - of which the magnetizer <NUM> is a part in the present embodiment - can read the information encoded on the tray RFID tag <NUM> to identify the insertion tool <NUM> and determine such characteristics as the size, length, type, material, etc. of the insertion tool or its needle <NUM> (including needle length, gauge, etc.) (or other medical device) disposed therein. This in turn enables the guidance system <NUM> to configure itself for specific use with the insertion tool <NUM> and needle <NUM> corresponding to the information included on the RFID tag <NUM>.

Such an RFID system can also prevent unauthorized components from being usable with the guidance system <NUM> by locking out operation of the needle tracking system when no RFID tag is detected upon tray mating with the magnetizer body, for instance, or when the tag has previously been read by the RFID reader <NUM> a predetermined number of times.

<FIG> depicts another system for identifying the insertion tool <NUM>/medical device, including a barcode <NUM> disposed on the tray <NUM> and a barcode scanner <NUM> positioned on a support arm <NUM> to read the barcode when the tray is placed on the magnetizer <NUM>. <FIG> depict another variation, wherein a window <NUM> is included in the magnetizer body receptacle <NUM>. The barcode scanner <NUM> is disposed below the window <NUM>. A bottom surface of the tray <NUM> includes the barcode <NUM> thereon. The barcode <NUM> is positioned such that it aligns with the window <NUM> when the tray is received into the magnetizer body receptacle <NUM>, thus allowing the barcode scanner <NUM> to read the barcode and identify the insertion tool/medical device disposed in the tray. It is appreciated that various other barcode configurations can be included with the magnetizer, as well as other identification schemes.

Note that, though permanent magnets are depicted and discussed herein, other magnetic components can be employed in other embodiments, including an electromagnet, etc. Also note that further details regarding the sensor array and the guidance system employed to detect the magnetic field of the magnetized needle/medical device can be found in the following <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; and<CIT>.

Claim 1:
A magnetizing system for magnetizing a needle, and a needle (<NUM>), the system comprising:
a magnetizer (<NUM>) including at least one permanent magnet (<NUM>) and a body (<NUM>); the at least one permanent magnet (<NUM>) disposed within the body (<NUM>), the body (<NUM>) defining a needle receptacle (<NUM>) included with the magnetizer, the needle receptacle configured to receive the needle (<NUM>);
a first key feature (<NUM>, <NUM>) associated with the magnetizer (<NUM>); and
a needle cover (<NUM>) configured to removably cover the needle, the needle cover including a second key feature (<NUM>) configured to fit with the first key feature, the first key feature and second key feature configured to guide a user so as to place the needle in a predetermined position with respect to the at least one permanent magnet when the needle is received at the needle receptacle.