Patent Description:
The present invention relates generally to driver assemblies, such as those including a driver (e.g., manual or powered) and a drill bit, to drivers, to drill bits, and to methods of determining information when penetrating biological material, and more particularly, but not by way of limitation, to driver assemblies that include drivers and drill bits that can be used to determine information (e.g., voltages, voltage differences, impedances, changes in voltage differences, changes in impedances, and the like) about a target area in biological material (e.g., such as bone (and, more specifically, an intraosseous space within bone) or cerebrospinal fluid), to drill bits usable with such drivers and driver assemblies, to such drivers, and to methods of determining information, like penetrator (e.g., drill bit) position within biological material and voltage differences and/or impedances related to a target area (or a change in voltage differences and/or impedances from a reference location, voltage difference, or impedance in a target area) within biological material.

Patent Application Publication No. <CIT> describes systems and methods for safeguarding against nerve and muscle injury during surgical procedures, location and stimulation of nerves and muscles, identification and assessment of nerve and muscle integrity following traumatic injuries, and verification of range of motion and attributes of muscle contraction during reconstructive surgery.

A driver is further known from <CIT> from which the preamble of claim <NUM> derives.

According to the present invention there is provided a driver as defined in the appended independent claim <NUM>.

The term "embodiment" used in the present specification does not necessarily indicate ways of carrying out the invention claimed but also examples which aid understanding the invention.

Details associated with the embodiments described above and others are presented below.

This disclosure includes embodiments of driver assemblies comprising a driver having at least one sensor and a penetrator that are configured to permit the driver assembly to determine information about a target area within biological material, such as bone or cerebrospinal fluid. For example, embodiments of the present driver assemblies can be configured to display information relating to the voltage and/or electrical impedance of biological material. As another example, embodiments of the present driver assemblies can be configured to display information relating to the position of a penetrator within biological material. This disclosure also includes embodiments of penetrators, such as drill bits, that may be coupled to drivers and used to assist in determining such information. This disclosure also includes embodiments of methods of determining information (e.g., electrical impedance, voltage, voltage differences, changes in impedances and/or voltage differences, and the like) concerning a target area within biological material. Embodiments of the present driver assemblies, drill bits, and methods may be useful in procedures such as those that establish access to an intraosseous (IO) space, bone marrow biopsies, and craniotomies, to name a few.

Some embodiments of the present driver assemblies comprise a driver comprising a controller; a motor coupled to a power source and further coupled to the controller such that the controller can affect the motor's operation; a drive shaft coupled to the motor such that the motor can move the drive shaft; a trigger coupled to the controller and configured to activate the motor; and a first electrode configured to be coupled to the controller; and a drill bit configured to be coupled to the drive shaft and the controller, the drill bit comprising: an outer surface; a core disposed inside the outer surface; and an insulator disposed between the core and the outer surface configured to prevent electrical communication between the core and the outer surface; where the outer surface, the insulator, and the core cooperate to form at least one tip of the drill bit; and where the controller is configured to determine at least one of a voltage difference between the core and the first electrode and an impedance when the first electrode is coupled to the controller and at least when the driver assembly is used in a medical procedure. In some embodiments, a portion of the core is exposed at the tip of the drill bit.

Some embodiments of the present driver assemblies comprise a two-wire configuration. In some embodiments, the impedance is a normalized impedance when the controller determines an impedance. In some embodiments, the drill bit is configured to be coupled to the drive shaft by a commutating electrical connection. In some embodiments, the drill bit is configured to be coupled to the drive shaft by a gear box bearing, the gear box bearing configured to permit a commutating electrical connection between the drill bit and the drive shaft. In some embodiments, the controller is configured to pass an alternating current to the core.

Some embodiments of the present driver assemblies comprise a second electrode configured to be coupled to the controller, the controller configured to pass a current to the second electrode, when the first and second electrodes are coupled to the controller, to permit the controller to determine at least one of a voltage difference between the core and the first electrode and an impedance at least when the driver assembly is used in a medical procedure. In some embodiments, at least one of the first electrode and the second electrode comprises an adhesive configured to adhere at least one of the first electrode and the second electrode to skin. In some embodiments, the assemblies comprise a patch connector configured to couple at least one of the first electrode and the second electrode to the controller. In some embodiments, the assembly comprises at least a three-wire configuration. In some embodiments, the controller is configured to pass an alternating current to the core and the second electrode. In some embodiments, the controller comprises a current source configured to pass an alternating current to the core and the second electrode. In some embodiments, the alternating current passed to the core and the second electrode originates from the same current source. In some embodiments, the alternating current can comprise a frequency of <NUM> to <NUM>.

In accordance with the present invention, the controller of the driver is configured to determine a change in at least one of the impedance and the voltage difference when the drill bit moves through biological material. The controller is configured to compare the change in at least one of the impedance and the voltage difference to a threshold. In some embodiments, the controller comprises a threshold detector configured to compare the change in at least one of the impedance and the voltage difference to the threshold. In some embodiments, the threshold is adjustable. According to the invention, the controller is configured to deactivate the motor if the change in at least one of the impedance and the voltage difference meets or exceeds the threshold. Further according to the invention, the controller is configured to change a rotational speed of the motor if the change in at least one of the impedance and the voltage difference meets or exceeds the threshold.

In some embodiments of the present assemblies, the insulator comprises a non-conductive material. In some embodiments, the insulator comprises polytetrafluoroethylene. In some embodiments, the insulator comprises a thickness of <NUM> millimeters to <NUM> millimeters.

Some embodiments of the present assemblies comprise a display coupled to the controller and configured to display information relating to at least one of the impedance, the voltage between the core and the first electrode, and the change in at least one of the impedance and the voltage difference. In some embodiments, the display comprises at least one light emitting diode. In some embodiments, the display is configured to indicate information about a position of the drill bit based on the impedance, the voltage between the core and the first electrode, and the change in at least one of the impedance and the voltage difference.

Some embodiments of the present assemblies comprise a drill bit coupler configured to be coupled to the drill bit and to the drive shaft. In some embodiments, the drill bit coupler is insulated. In some embodiments, the drill bit coupler comprises an insulator.

Some embodiments of the present assemblies comprise at least one drill bit contact coupled to the drill bit and to the controller, the at least one drill bit contact configured to permit electrical communication between the controller and at least one of the core and the outer surface of the drill bit. In some embodiments, the drill bit contact is coupled to the drill bit by a commutating electrical connection. In some embodiments, the drill bit contact is slidably coupled to the drill bit. In some embodiments, the controller is configured to receive information from the core of the drill bit relating to at least one of current, voltage, impedance, and temperature. In some embodiments, the at least one drill bit contact is further configured such that the controller can receive information from the outer surface of the drill bit. In some embodiments, the information receivable from the outer surface relates to at least one of current, voltage, impedance, and temperature. In some embodiments, the drill bit contact comprises a non-conductive coating. In some embodiments, the drill bit contact comprises a dielectric.

Some embodiments of the present assemblies comprise a reference button coupled to the controller, the reference button being configured to set at least one of a reference impedance and a reference voltage difference, and the controller being configured to determine a change from at least one of the reference impedance and the reference voltage difference. In some embodiments, the reference button sets at least one of the reference impedance and the reference voltage difference when the reference button is engaged. In some embodiments, the controller is configured to set at least one of a reference impedance and a reference voltage difference automatically when the drill bit contacts a predetermined material within a target area. In some embodiments, the controller is configured to compare the change from at least one of the reference impedance and the reference voltage difference to a threshold. In some embodiments, the controller comprises a threshold detector configured to compare the change from at least one of the reference impedance and the reference voltage difference to the threshold. In some embodiments, the threshold is adjustable. According to the invention, the controller is configured such that if the change from at least one of the reference impedance and the reference voltage difference meets or exceeds the threshold, the controller will cause the display to indicate at least one of the impedance, the voltage between the core and the first electrode, and the change in at least one of the impedance and the voltage difference. Further according to the invention, the controller is configured to deactivate the motor if the change from at least one of the reference impedance and the reference voltage difference meets or exceeds the threshold. Still further according to the invention, the controller is configured to change a rotational speed of the motor if the change from at least one of the reference impedance and the reference voltage difference meets or exceeds the threshold.

In some embodiments, the present assemblies comprise an oscillator configured to produce a signal in the current. In some embodiments, the signal comprises a frequency of <NUM> to <NUM>. In some embodiments, the signal comprises a frequency of <NUM>. In some embodiments, the controller further comprises a differential amplifier coupled to the drill bit and to the first electrode, the differential amplifier configured to output a voltage difference between the drill bit and the first electrode. In some embodiments, the differential amplifier comprises a high common mode rejection differential input amplifier. In some embodiments, the controller further comprises a multiplier coupled to the oscillator and to the differential amplifier, the multiplier configured to multiply a signal received from the differential amplifier with a signal received from the oscillator to down convert the voltage difference to a baseband frequency. In some embodiments, the multiplier is configured to produce a direct voltage. In some embodiments, the controller further comprises a gain amplifier coupled to the multiplier and configured to increase a voltage of the baseband frequency produced by the multiplier. In some embodiments, the gain amplifier is configured to increase the voltage of the baseband frequency by a factor of <NUM>. In some embodiments, the gain amplifier is configured to increase the voltage of the baseband frequency by a factor of <NUM> to <NUM>,<NUM>. In some embodiments, the controller further comprises a low pass filter coupled to the gain amplifier and configured to attenuate a signal output by the gain amplifier that has a higher frequency than a cutoff frequency.

Some embodiments of the present methods comprise placing a first electrode of a driver assembly in or on a non-target area; moving a drill bit of the driver assembly through biological material toward a target area in biological material; and determining at least one of an impedance, a change in an impedance, a voltage difference, and a change in a voltage difference. In some embodiments, the methods comprise displaying a notification when at least one of the impedance, the change in an impedance, the voltage, and the change in a voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise changing or stopping a rotational velocity of the drill bit when at least one of the impedance, the change in an impedance, the voltage, and the change in a voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise placing a second electrode in or on the non-target area to form at least a three-wire configuration with the drill bit and the first electrode. In some embodiments, the methods comprise displaying a notification when at least one of an impedance, a change in a impedance, a voltage, and a change in a voltage meets or exceeds a threshold. In some embodiments, the methods comprise changing or stopping a rotational velocity of the drill bit when at least one of the impedance, the change in an impedance, the voltage, and the change in a voltage meets or exceeds a threshold. In some embodiments, the methods comprise removing the drill bit from the target area to permit access to the target area.

Some embodiments of the present methods (e.g., of determining at least one of a change in an impedance and a change in a voltage difference across biological material) comprise placing a first electrode of a driver assembly in or on a non-target area; moving a drill bit of the driver assembly through biological material toward a target area in biological material; setting at least one of a reference impedance and a reference voltage difference; and determining a change from at least one of the reference impedance and the reference voltage difference. In some embodiments, the methods comprise displaying a notification when the change from at least one of the reference impedance and the reference voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise changing or stopping a rotational velocity of the drill bit when the change from at least one of the reference impedance and the reference voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise placing a second electrode in or on the non-target area to form at least a three-wire configuration. In some embodiments, the methods comprise determining a change from at least one of the reference impedance and the reference voltage difference. In some embodiments, the methods comprise displaying a notification when the change from at least one of the reference impedance and the reference voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise changing or stopping a rotational velocity when the change from at least one of the reference impedance and the reference voltage difference meets or exceeds a threshold. In some embodiments, the methods comprise removing the drill bit from the target area to permit access to the target area.

Some embodiments of the present drivers comprise a controller configured to determine at least one of an impedance and a voltage difference; a motor coupled to a power source and further coupled to the controller such that the controller can affect the motor's operation; a drive shaft coupled to the motor such that the motor can move the drive shaft; a trigger coupled to the controller and configured to activate the motor; and a first electrode configured to be coupled to the controller; where the driver is configured to be coupled to an intraosseous (IO) device and used, with the IO device, to determine at least one of a change in an impedance and a change in a voltage difference across biological material. In some embodiments, the driver comprises a two-wire configuration. In some embodiments, the driver is configured to generate an alternating current.

Some embodiments of the present drivers comprise a second electrode configured to be coupled to the controller; where the controller can pass a current to the second electrode, when the first and second electrodes are coupled to the controller, to permit the controller to determine at least one of an impedance and a voltage difference at least when the driver is used with an IO device in a medical procedure. In some embodiments, the drivers comprise at least a three-wire configuration. In some embodiments, the driver is configured to generate an alternating current. In some embodiments, the alternating current can comprise a frequency of <NUM> to <NUM>.

In some embodiments of the present drivers, the controller is configured to determine at least one of an impedance, a change in an impedance, a voltage difference, and a change in a voltage difference between when the first and second electrodes are coupled to the controller and the driver is used with an IO device in a medical procedure. According to the invention, the controller is configured to compare at least one of the impedance, the change in an impedance, the voltage difference, and the change in a voltage difference to a threshold. In some embodiments, the controller comprises a threshold detector configured to compare at least one of the impedance, the change in an impedance, the voltage difference, and the change in a voltage difference to the threshold. In some embodiments, the threshold is adjustable. Further according to the invention, the controller is configured to deactivate the motor if at least one of the impedance, the change in an impedance, the voltage difference, and the change in a voltage difference meets or exceeds the threshold. Still further according to the invention, the controller is configured to change a rotational speed of the motor if at least one of the impedance, the change in an impedance, the voltage difference, and the change in a voltage difference meets or exceeds the threshold. In some embodiments, at least one of the first electrode and the second electrode comprises an adhesive configured to adhere at least one of the first electrode and the second electrode to skin. In some embodiments, a patch connector configured to couple at least one of the first electrode and the second electrode to the controller.

Some embodiments of the present drivers comprise a display coupled to the controller. In some embodiments, the display comprises at least one light emitting diode.

Some embodiments of the present drivers comprise a drill bit coupler configured to be coupled to a drill bit and to the drive shaft. In some embodiments, the drill bit coupler is insulated. In some embodiments, the drill bit coupler comprises an insulator.

Some embodiments of the present drivers comprise a reference button coupled to the controller, the reference button being configured to set at least one of a reference impedance and a reference voltage difference, and the controller being configured to determine at least one of a change in impedance from the reference impedance and a change in voltage difference from the reference voltage difference when the driver is coupled to an IO device and used during a medical procedure. In some embodiments, the reference button sets at least one of the reference impedance and the reference voltage difference when the reference button is engaged. In some embodiments, the controller is configured to set at least one of the reference impedance and the reference voltage difference automatically when a condition is met. According to the invention, the controller is configured to compare at least one of the change in impedance and the change in voltage difference to a threshold. In some embodiments, the controller comprises a threshold detector configured to compare at least one of the change in impedance and the change in voltage difference to the threshold. In some embodiments, the threshold is adjustable. In some embodiments, the controller is configured such that if at least one of the change in impedance and the change in voltage difference meets or exceeds the threshold, the controller will cause the display to change. Further according to the invention, the controller is configured to deactivate the motor if at least one of the change in impedance and the change in voltage difference meets or exceeds the threshold. Still further according to the invention, the controller is configured to change a rotational speed of the motor if at least one of the change in impedance and the change in voltage difference meets or exceeds the threshold.

In some embodiments of the present drivers, the controller comprises an oscillator configured to produce a signal in the current. In some embodiments, the signal comprises a frequency of <NUM> to <NUM>. In some embodiments, the signal comprises a frequency of <NUM>. In some embodiments, the controller further comprises a differential amplifier. In some embodiments, the differential amplifier comprises a high common mode rejection differential input amplifier. In some embodiments, the controller further comprises a multiplier coupled to the oscillator and to the differential amplifier, the multiplier configured to multiply a signal received from the differential amplifier with a signal received from the oscillator to down convert a voltage to a baseband frequency. In some embodiments, the multiplier is configured to produce a direct voltage. In some embodiments, the controller further comprises a gain amplifier coupled to the multiplier and configured to increase a voltage of the baseband frequency produced by the multiplier. In some embodiments, the gain amplifier is configured to increase the voltage of the baseband frequency by a factor of <NUM>. In some embodiments, the gain amplifier is configured to increase the voltage of the baseband frequency by a factor of <NUM> to <NUM>,<NUM>. In some embodiments, the controller further comprises a low pass filter coupled to the gain amplifier and configured to attenuate a signal output by the gain amplifier that has a higher frequency than a cutoff frequency.

Some embodiments of the present drill bits comprise an outer surface; a core disposed inside the outer surface; and an insulator disposed between the core and the outer surface configured to prevent electrical communication between the core and the outer surface, where the outer surface, the insulator, and the core cooperate to form at least one tip of the drill bit configured to penetrate bone, and where the drill bit is configured to be coupled to a driver and used to determine at least one of a change in impedance and a change in voltage difference across biological material during a medical procedure. In some embodiments, the drill bit is configured to be coupled to a drive shaft of a driver by a commutating electrical connection. In some embodiments, the drill bit is configured to be coupled to the drive shaft by a gear box bearing, the gear box bearing configured to permit a commutating electrical connection between the drill bit and a drive shaft of a driver. In some embodiments, the insulator comprises a non-conductive material. In some embodiments, the insulator comprises polytetrafluoroethylene. In some embodiments, the insulator comprises a thickness of <NUM> millimeters to <NUM> millimeters. In some embodiments, a portion of the core is exposed at the tip of the drill bit.

Any embodiment of any of the driver assemblies, drivers, drill bits, and methods can consist of or consist essentially of - rather than comprise/include/contain/have - any of the described elements, features, and/or steps. Thus, in any of the claims, the term "consisting of or "consisting essentially of can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.

The following drawings illustrate by way of example and not limitation. The figures illustrate the described elements using graphical symbols that will be understood by those of ordinary skill in the art. The embodiments of the present driver assemblies, drivers, drill bits, and their components shown in the figures are drawn to scale for at least the embodiments shown.

Further, a system (such as one of the present driver assemblies), a device (such as one of the present drivers or one of the present drill bits), or a component of a device (such as a controller or sensor of one of the present drivers) that is configured in a certain way is configured in at least that way, but can also be configured in other ways than those specifically described.

Various types of coupler assemblies incorporating teachings of the present disclosure may be satisfactorily used to releasably engage one end of a shaft extending from a driver with one end of an intraosseous device. For some embodiments, the powered driver may include a driveshaft having one end with a generally hexagonal cross section operable to be releasably engaged with a latch mechanism disposed in one end of a coupler assembly. For some embodiments, a coupler assembly incorporating teachings of the present disclosure may be referred to as a "hands free" coupler, a quick disconnect or quick release coupler and/or port assembly.

Embodiments of the present powered drivers may be used to insert an IO device into a selected target area or target site in ten seconds or less. However, various teachings of the present disclosure are not limited to use with powered drivers. Manual drivers and spring powered drivers may also be used with IO devices (such as embodiments of the present drill bits) incorporating teachings of the present disclosure.

Examples of manual drivers are shown in co-pending patent application serial No. <CIT> (published as <CIT>). The term "fluid" may be used in this application to include liquids such as, but not limited to, blood, water, saline solutions, IV solutions, plasma, or any mixture of liquids, particulate matter, dissolved medication, and/or drugs associated with biopsy or aspiration of bone marrow or communication of fluids with bone marrow or other target sites. The term "fluid" may also be used in this patent application to include any body fluids and/or liquids containing particulate matter such as bone marrow and/or cells which may be withdrawn from a target area.

The terms "harvest" and "harvesting" may be used in this application to include bone and/or bone marrow biopsy and bone marrow aspiration. Bone and/or bone marrow biopsy (sometimes referred to as "needle biopsy") may be generally described as removing a relatively small piece or specimen of bone and/or bone marrow from a selected target area for biopsy purposes. Bone marrow aspiration (sometimes referred to as "bone marrow sampling") may be generally described as removing larger quantities of bone marrow from a selected target area. Relatively large quantities of bone marrow may be used for diagnostic, transplantation, and/or research purposes. For example some stem cell research techniques may require relatively large quantities of bone marrow.

The term "insertion site" may be used in this application to describe a location on a bone at which an intraosseous device may be inserted or drilled into the bone and associated bone marrow. Insertion sites are generally covered by skin and soft tissue. The term "target area" refers to any location on or within biological material, such as the biological material of a living human being.

The term "intraosseous (IO) device" may be used in this application to include, but is not limited to, any hollow needle, hollow drill bit, penetrator assembly, bone penetrator, catheter, cannula, trocar, stylet, inner penetrator, outer penetrator, IO needle, biopsy needle, aspiration needle, IO needle set, biopsy needle set or aspiration needle set operable to access or provide access to an intraosseous space or interior portions of a bone. Such IO devices may be formed, at least in part, from metal alloys such as <NUM> stainless steel and other biocompatible materials associated with needles and similar medical devices.

Embodiments of the present driver assemblies can be included in medical procedure trays such as those disclosed in International Patent Application No. <CIT> (published as <CIT>).

The devices and components shown in <FIG> are prior art devices and components, and the following description of them is provided to give the reader context for the types of devices and components that can be used consistently with embodiments of the present driver assemblies, drivers, and methods.

Referring now to the drawings, and more particularly to <FIG> , shown therein and designated by the reference numeral <NUM> is one embodiment of the present intraosseous (IO) needle sets or aspiration needle sets. Aspiration needle set <NUM> comprises a hollow outer penetrator or cannula 110a, a corresponding inner penetrator or stylet (or trocar) <NUM>, and a hub assembly 130a. In the embodiment shown, first end 111a of cannula 110a and first end <NUM> of stylet <NUM> are operable or configured to penetrate a bone and associated bone marrow. Various features of first end 111a of cannula 110a and first end <NUM> of stylet <NUM> are shown in more detail in <FIG>. First end <NUM> of IO needle set <NUM> corresponds generally with first end <NUM> a of cannula 110a and first end <NUM> of stylet <NUM>.

In the embodiment shown, cannula 110a includes a plurality of markings <NUM> disposed on exterior portions of the cannula. Markings <NUM> may be referred to as "positioning marks" or "depth indicators," and may be used to indicate the depth of penetration of needle set <NUM> into a bone and associated bone marrow. In some embodiments, cannula 110a may have a length of approximately sixty (<NUM>) millimeters and/or a nominal outside diameter of approximately <NUM> inches, <NUM>,<NUM>, (e.g., corresponding generally to the dimensions of a sixteen (<NUM>) gauge needle). Cannula 110a and/or stylet <NUM> may be formed from stainless steel or other suitable biocompatible materials. In some embodiments, markings <NUM> are spaced at one (<NUM>) centimeter intervals on exterior portions of cannula 110a. In some embodiments, one or more side ports <NUM> may be formed in exterior portions of cannula 110a spaced from first end 111a.

Hub assembly 130a may be configured and/or used to releasably dispose stylet <NUM> within the longitudinal bore or lumen of cannula 110a. In the embodiment shown, hub assembly 130a includes a first hub 140a and a second hub 150a. A second end of cannula 110a, opposite from first end 111a, may be securely engaged with hub 140a. The second end of stylet <NUM>, opposite from first end <NUM>, may be securely engaged with the first end of hub 150a. As shown in <FIG> , cannula 110a may extend longitudinally from first end <NUM> of hub 140a. Stylet <NUM> may also extend from the first end of hub 150a. The second end of hub 140a may include a standard Luer lock fitting which may be releasably engaged with a corresponding Luer lock fitting disposed within the first end of second hub 150a. The Luer lock fitting disposed on the second end of hub 140a may be in fluid communication with the bore or passage in cannula 110a, and may be operable to be releasably engaged with a standard syringe type fitting and/or a standard intravenous (IV) connection. In the embodiment shown, hub 150a includes second end <NUM> that generally corresponds with second end <NUM> of hub assembly 130a and second end <NUM> of IO needle set <NUM>. Hub 140a may include first end <NUM> which may generally correspond with first end <NUM> of hub assembly 130a. Cannula 110a may extend longitudinally from first end <NUM> of hub 140a and first end <NUM> of hub assembly <NUM>.

In the embodiment shown, the second end of a hub assembly may be operable to be disposed within a receptacle formed in a coupler assembly, as described in more detail below. One feature of the present disclosure may include forming a hub assembly which may be releasably engaged within a first receptacle disposed in a first end of a coupler assembly (e.g., receptacle <NUM> proximate first end <NUM> of elongated core <NUM> as shown in <FIG>). The dimensions and configuration of receptacle <NUM> may be selected to prevent rotation of hub 150a relative to hub 140a if hub assembly 130a is disposed in receptacle <NUM> (e.g., while inserting (rotating) an IO device into a bone and associated bone marrow). A powered driver may be releasably engaged with a second receptacle disposed in a second end of the coupler assembly (e.g., receptacle <NUM> proximate second end <NUM> of elongated core <NUM> as shown in <FIG>).

In the embodiment shown, intraosseous device or aspiration needle set 100a includes first end <NUM> of hub 150a spaced from second end <NUM> of hub 140a. Portions of stylet <NUM> extending from first end <NUM> of hub 150a are shown slidably disposed within lumen or longitudinal bore <NUM> of cannula 110a. Hub assembly 130a may include first end <NUM> which may correspond generally with first end <NUM> of hub 140a. Hub assembly 130a may also include second end <NUM> which may correspond generally with second end <NUM> of hub 150a and second end <NUM> of hub assembly 130a, as shown. Cannula 110a may be attached to and extend from first end <NUM> of hub 140a. Second end <NUM> of hub 140a may include one-half a typical Luer lock connection or fitting operable to be releasably engaged with corresponding portions of a Luer lock connection or fitting disposed in first end <NUM> of second hub 150a. For embodiments such as the one shown in <FIG> , first end <NUM> of hub assembly 130a may correspond with first end <NUM> of first hub 140a. Second end <NUM> of second hub 150a may correspond with second end <NUM> of hub assembly 130a and second end <NUM> of aspiration needle set 100a.

At least one portion of hub assembly 130a may have a generally hexagonal cross section operable to be received within the generally hexagonal cross section of receptacle <NUM> disposed proximate first end <NUM> of coupler assembly <NUM>, as shown in <FIG>. For some embodiments, portions of first hub 140a disposed adjacent to reduced outside diameter portion <NUM> may have generally hexagonal cross sections, as shown in <FIG>. In other embodiments, various cross sections other than hexagonal may be satisfactorily used to releasably engage a powered driver with one end of a coupler assembly and an intraosseous device with an opposite end of the coupler assembly. Aspiration needle sets may include a stylet, stylet or penetrator in combination with an associated cannula, catheter or outer penetrator. However, biopsy needles formed in accordance with teachings of the present disclosure may or may not include a stylet, stylet or inner penetrator.

Hub 140a may include second end <NUM> with opening <NUM> formed therein. A passageway may extend from second end <NUM> towards first end <NUM> of hub 140a, as illustrated in <FIG>. A passageway may be operable to communicate fluids with lumen <NUM> of cannula 100a. Second end <NUM> of hub <NUM> may include various features of a conventional Luer lock connection or fitting, including threads <NUM>, and corresponding threads <NUM> may be formed within first end <NUM> of hub 150a, as shown in <FIG>.

For some applications hub 140a and hub 150a may, for example, be formed using injection molding techniques. For such embodiments hub 140a may include reduced outside diameter portion <NUM> disposed between first end <NUM> and second end <NUM>. In a similar manner a plurality of void spaces or cutouts <NUM> may be formed in hub 150a adjacent to and extending from second end <NUM> in the direction of first end <NUM>. The configuration and dimensions of reduced diameter portion <NUM> and/or cutouts <NUM> may be varied to optimize associated injection molding techniques and at the same time provide required configurations, dimensions and material strength to allow associated hub assembly 130a to function as described in this disclosure.

In some embodiments, tip <NUM> of stylet <NUM> may be disposed relatively close to a tip of cannula 110a. For some applications, first end <NUM> of stylet <NUM> and first end 111a of cannula 110a may be ground at the same time to form adjacent cutting surfaces. Grinding ends 111a and <NUM> at the same time may result in forming a single cutting unit to form generally matching cutting edges. Other types of cutting surfaces formed in accordance with teachings of the present disclosure may be discussed later (e.g., as described with reference to FIGS.

<FIG> show a second example of cutting surfaces and tips which may be formed adjacent to the ends of a cannula and/or an associated stylet in the present embodiments. In the embodiment shown, outer penetrator or cannula <NUM> may include first end <NUM> having a plurality of cutting surfaces <NUM> formed adjacent to opening <NUM> in first end <NUM>. Opening <NUM> may communicate with and form a portion of an associated longitudinal bore or lumen <NUM>. For some applications cutting surfaces <NUM> may be formed using electrical discharge machining (EDM) techniques or otherwise, as described in <CIT>. In the embodiment shown, first end <NUM> has a generally tapered configuration or reduced outside diameter as compared with other portions of cannula <NUM> In other embodiments, first end <NUM> has an outside diameter that is equal to the outside diameter of other portions of cannula <NUM> (e.g., cannula <NUM> can have a constant outside diameter along the entire length of the cannula). Cutting surfaces <NUM> may, for example, be formed using machine grinding techniques. In some embodiments, such as the one shown, end <NUM> of cannula <NUM> may include six ground cutting surfaces <NUM> with respective crowns <NUM> therebetween. Forming a biopsy needle set and/or biopsy needle with tapered end <NUM> and a plurality of cutting surfaces <NUM> and crowns <NUM> may provide improved drilling performance (e.g., relative to others configurations) when the resulting biopsy needle set and/or biopsy needle is used with a powered driver in accordance with teachings of the present disclosure. For some applications, a helical groove <NUM> may be formed within longitudinal bore <NUM> proximate opening <NUM>. Helical groove <NUM> may assist with retaining a biopsy specimen or a bone marrow specimen within longitudinal bore <NUM>. For example, a single thread may be disposed within the longitudinal bore or lumen of the cannula such that the helical groove <NUM> is defined between turns of the thread. Various techniques and procedures may be satisfactorily used to place the single thread or otherwise form the helical groove, as described <CIT>.

As shown in <FIG> , a biopsy needle set <NUM> may include cannula or outer penetrator <NUM> with stylet or inner penetrator <NUM> slidably disposed therein. The proximal ends of cannula <NUM> and stylet <NUM> may be similar to those of cannula 110a and stylet <NUM> depicted in <FIG> (e.g., may include hubs 140a and 150a, respectively). For some applications first end <NUM> of biopsy needle set <NUM> may minimize damage to skin and soft body tissue at an insertion site. For some applications inner penetrator or stylet <NUM> may include first end <NUM> having a plurality of cutting surfaces <NUM> and <NUM> formed on exterior portions thereof extending from associated tip <NUM> towards second end of stylet or inner penetrator <NUM>. For some applications one or more cutting surfaces <NUM> may be formed having length <NUM> extending from tip <NUM> to associated cutting surfaces <NUM> in associated cannula <NUM>. One or more cutting surfaces <NUM> may be formed adjacent to each cutting surface <NUM> with second length <NUM>. First length <NUM> may be greater than second length <NUM>. As shown, lengths <NUM> and <NUM> are measured parallel to the central longitudinal axis of stylet <NUM>. The ratio of first length <NUM> and second length <NUM> may be varied in accordance with teachings of the present disclosure to provide optimum performance for penetrating a selected bone and associated bone marrow. Additional details of some embodiments of first end <NUM> are described in <CIT>.

<FIG> depicts a cross-sectional view of one embodiment of a driver that can be used as an example for an embodiment of the present drivers with sensors and methods and kits comprising such drivers. In the embodiment shown, powered driver <NUM> may be used to insert intraosseous devices into a bone and associated bone marrow. Powered driver <NUM> may include housing <NUM> having a general configuration similar to a small pistol defined in part by handle <NUM>. Various components associated with powered driver <NUM> may be disposed within housing <NUM> (e.g., handle <NUM>). For example a power source such as battery pack <NUM> may be disposed within handle <NUM>. Housing <NUM> may be formed from relatively strong, heavy duty polymeric materials such as polycarbonate or other satisfactory materials. For some applications housing <NUM> may be formed in two halves (not expressly shown) which may be joined together with a fluid tight seal to protect various components of powered driver <NUM> disposed therein.

Motor <NUM> and gear assembly <NUM> may be disposed within portions of housing <NUM> adjacent to handle <NUM>. Motor <NUM> and gear assembly <NUM> may be generally aligned with each other. Motor <NUM> may be rotatably engaged with one end of gear assembly <NUM>. Drive shaft <NUM> may be rotatably engaged with and extend from another end of gear assembly <NUM> opposite from motor <NUM>. For some applications both motor <NUM> and gear assembly <NUM> may have generally cylindrical configurations. Distal end or first end <NUM> of housing <NUM> may include an opening with portions of drive shaft <NUM> extending through the opening, as shown. For some applications, end <NUM> or the portion of drive shaft <NUM> extending from first end <NUM> of housing <NUM> may have a generally hexagonal cross section with surfaces <NUM> disposed thereon. Receptacle <NUM> disposed in second end <NUM> of coupler assembly <NUM> may have a matching generally hexagonal cross section, as shown in <FIG>.

Surfaces <NUM> may extend generally parallel with each other and parallel with respect to a longitudinal axis or rotational axis of drive shaft <NUM>. One or more tapered surfaces <NUM> may also be formed on end <NUM> to assist with releasably engaging powered driver <NUM> with coupler assembly <NUM>. Embodiments of powered driver <NUM> include speed reduction ratios, for example, of between <NUM>:<NUM> and <NUM>:<NUM>, resulting in drive shaft RPMs that are reduced relative to motor RPMs. Coupler assemblies having corresponding openings or receptacles may be releasably engaged with end <NUM> extending from first end <NUM> of powered driver <NUM>. For example, end <NUM> extending from first end <NUM> of housing <NUM> may be releasably engaged with receptacle <NUM> disposed proximate second end <NUM> of coupler assembly <NUM>, as shown in <FIG>.

For some applications thrust bearing <NUM> may be disposed between first end or distal end <NUM> of housing <NUM> and adjacent portions of gear assembly <NUM>. Thrust bearing <NUM> may be disposed between second end or proximal end <NUM> of housing <NUM> and adjacent portions of motor <NUM>. Thrust bearings <NUM> and <NUM> may limit longitudinal movement of motor <NUM>, gear assembly <NUM> and drive shaft <NUM> within associated portions of housing <NUM>. Trigger assembly <NUM> may also be disposed within housing <NUM> proximate handle <NUM>. Trigger assembly <NUM> may include trigger or contact switch <NUM>. Motor <NUM> may be energized and deenergized by alternately depressing and releasing trigger <NUM>. Electrical circuit board <NUM> may also be disposed within housing <NUM>. Electrical circuit board <NUM> may be electrically coupled with trigger assembly <NUM>, motor <NUM>, power supply <NUM> and indicator light <NUM>. For some applications indicator light <NUM> may be a light emitting diode (LED) or a small more conventional light bulb. For some applications indicator light <NUM> may be activated when ninety percent (<NUM>%) of electrical storage capacity of battery pack <NUM> has been used. The configuration and dimensions of an intraosseous device formed in accordance with teachings of the present disclosure may vary depending upon respective intended applications for each intraosseous device. For example the length of a biopsy needle formed in accordance with teachings of the present disclosure may vary from approximately five (<NUM>) millimeters to thirty (<NUM>) millimeters.

Coupler assemblies incorporating teachings of the present disclosure may function as "quick release mechanisms" operable to engage and disengage an IO device from a powered driver (e.g., a driver disposed within a flexible containment bag or sterile sleeve). Such coupler assemblies may allow rotation of an IO device (e.g., biopsy needle or needle set) without damage to the flexible containment bag or sterile sleeve. One end of the coupler assembly may be operable to form a fluid seal or fluid barrier with adjacent portions of the containment bag or sterile sleeve. A coupler assembly incorporating teachings of the present disclosure may also be described as a port assembly attached to a containment bag. Such port assemblies may allow easy engagement or disengagement of a powered driver from an IO device and at the same time allow the powered driver to "power in and power out" an IO device from an insertion site.

<FIG> depict an example of a coupler assembly <NUM> suitable for some embodiments of the present assemblies and kits. <FIG> are perspective views showing various views of powered driver <NUM>, coupler assembly 250a, and intraosseous device 100b that is substantially similar to device 100a with the exception that device 100b does not include markings <NUM>. Coupler assembly 250a includes a first end <NUM> operable to be releasably engaged with one end of an intraosseous device such as, but not limited to, second end <NUM> of biopsy needle set 100b. Coupler assembly 250a also includes a second end <NUM> operable to be releasably engaged with a portion of a drive shaft extending from a powered driver, such as, but not limited to, end <NUM> of drive shaft <NUM> extending from first end <NUM> of housing <NUM> of powered driver <NUM>. Though not depicted here, second end <NUM> of coupler assembly <NUM> may be securely engaged with an opening in a containment bag or sterile sleeve, as described in <CIT>.

Coupler assemblies incorporating various teachings of the present disclosure may be placed in a medical procedure tray or kit with one end down and an opposite end looking up to allow "hands free" releasable engagement with a powered driver or a manual driver. For example, coupler assembly 250a may be disposed in medical procedure tray with first end <NUM> facing downward and second end <NUM> facing up such that end <NUM> of drive shaft <NUM> (of driver <NUM>) may be inserted into and releasably engaged with second end <NUM> of coupler assembly <NUM> without requiring an operator or user to physically contact or manipulate any portion of coupler assembly 250a. As described below, coupler 250a may include a "hands free" latching mechanism.

In the embodiment shown, coupler assembly 250a may include elongated core <NUM> with housing assembly <NUM> slidably disposed on exterior portions of elongated core <NUM>. Housing assembly <NUM>/270a may include first end <NUM> and second end <NUM> which may be generally aligned with respective first end <NUM> and respective second end <NUM> of elongated core <NUM>. For some applications, elongated core <NUM> may have a generally cylindrical configuration defined in first exterior portion 260a and second exterior portion 260b with various shoulders and/or recesses formed thereon. For some embodiments first exterior portion 260a may have a larger diameter than second exterior portion 260b. Housing assembly <NUM> may be described as having a generally hollow, cylindrical configuration defined in part by first housing segment <NUM> and second housing segment <NUM>. The first end of housing segment <NUM> may generally correspond with first end <NUM> of housing assembly <NUM>. The second end of second housing segment <NUM> may generally correspond with second end <NUM> of housing assembly <NUM>. First end <NUM> of second housing segment <NUM> may be described as having a generally cylindrical configuration with an outside diameter smaller than the adjacent inside diameter of second end <NUM> of first housing segment <NUM>. Second housing segment <NUM> may slide longitudinally from a first position ( <FIG>) to a second position ( <FIG>) within second end <NUM> of first housing segment <NUM> to release one end of a drive shaft engaged with second end <NUM> of coupler assembly <NUM>.

A biasing mechanism such as coiled spring <NUM> may be disposed around exterior portion 260a of generally elongated core <NUM>. First end <NUM> of coiled spring <NUM> may contact annular shoulder <NUM> formed on interior portions of first housing segment <NUM>. Second end <NUM> of coiled spring <NUM> may contact annular shoulder <NUM> disposed proximate first end <NUM> of second housing segment <NUM>. Coil spring <NUM>, annular shoulder <NUM> and annular shoulder <NUM> may cooperate with each other to generally maintain first housing segment <NUM> and second housing segment <NUM> in a first extended position relative to each other. Other biasing mechanisms such as, but not limited to, leaf springs and bellows (not expressly shown) may also be disposed between annular shoulder <NUM> and annular shoulder <NUM>. Annular shoulder <NUM>, associated with second end <NUM> of coiled spring <NUM>, may extend radially outward from generally cylindrical ring <NUM>. Generally cylindrical ring <NUM> may be slidably and rotatably disposed on exterior portion 260a of elongated core <NUM>. Annular shoulder <NUM> may be disposed on interior portions of generally cylindrical ring <NUM> and may extend radially inward toward adjacent portions of elongated core <NUM>. Annular shoulder <NUM> may be formed on exterior portion 260a of elongated core <NUM> intermediate first end <NUM> and second end <NUM>. The configuration and dimensions of annular shoulder <NUM> and annular shoulder <NUM> are selected to be compatible with each other such that engagement between annular shoulder <NUM> of generally cylindrical ring <NUM> with annular shoulder <NUM> of elongated core <NUM> may limit movement of second housing segment <NUM> longitudinally in the direction of second end <NUM> of elongated core <NUM>.

For some applications a plurality of flexible collets or fingers <NUM> may extend from generally cylindrical ring <NUM> opposite from annular shoulder <NUM>. Respective collet heads <NUM> may be formed on the end of each collet <NUM> opposite from annular shoulder <NUM>. The dimensions and configuration of collet heads <NUM> may be selected to be received within respective slots or openings <NUM> formed in second housing <NUM>. During manufacture of coupler assembly 250a, each collet head <NUM> may be disposed within respective slot or opening <NUM> to securely engage generally cylindrical ring <NUM> and annular shoulder <NUM> proximate first end <NUM> of second housing segment <NUM>. As a result, second housing segment <NUM> and annular shoulder <NUM> may generally move as a single unit relative to elongated core <NUM> and first housing segment <NUM>. During disengagement of an intraosseous device from first end <NUM> of coupler assembly 250a, first housing segment <NUM> may move or slide longitudinally toward second housing segment <NUM>. In a similar manner, second housing segment <NUM> may move or slide longitudinally toward first housing segment <NUM> during disengagement of a powered driver from second end <NUM> of coupler assembly 250a.

Annular shoulder <NUM> may be formed on exterior portions of elongated core <NUM> proximate first end <NUM>. Annular shoulder <NUM> may engage portions of first end <NUM> of housing <NUM> to limit longitudinal movement of first housing segment <NUM> during longitudinal movement of second housing segment <NUM> towards first end <NUM> of elongated core <NUM> during disengagement of a powered driver from second end <NUM> of coupler assembly 250a. As previously noted, annular shoulder <NUM> may be formed on exterior portions of elongated core <NUM> between first end <NUM> and second end <NUM>. Engagement between annular shoulder <NUM> and annular shoulder <NUM> of generally cylindrical ring <NUM> may limit movement of second housing segment <NUM> toward second end <NUM> of elongated core <NUM>. Contact between spring <NUM> and annular shoulder <NUM> and annular shoulder <NUM> of first housing segment <NUM> may limit the longitudinal movement of first housing segment <NUM> in the direction of second end <NUM> of elongated core <NUM> during disengagement of an intraosseous device from first end <NUM> of coupler assembly 250a.

Generally cylindrical ring <NUM> and attached annular shoulder <NUM> may slide longitudinally on exterior portions of annular core <NUM> between annual shoulder <NUM> and annular shoulder <NUM>. First housing segment <NUM> may move longitudinally toward second end <NUM> of elongated core <NUM> to release one end of intraosseous device from engagement with first end <NUM> of coupler assembly 250a. In a similar manner, second housing segment <NUM> may move longitudinally toward first end <NUM> of elongated core <NUM> to release one end of a drive shaft extending from a powered driver engaged with second end <NUM> of coupler assembly 250a. A wide variety of latches and latch mechanisms may be satisfactorily used to releasably engage one end of an intraosseous device within a first end of a coupler assembly incorporating teachings of the present disclosure. In a similar manner, a wide variety of latches and latch mechanisms may be satisfactorily used to releasably engage one end of a drive shaft extending from a powered driver or manual driver within a second end of the coupler assembly incorporating teachings of the present disclosure.

For embodiments represented by coupler assembly 250a, first latch <NUM> may be disposed on exterior portions of elongated core <NUM> proximate receptacle <NUM> adjacent to first end <NUM> to releasably engage one end of an IO device such as second end <NUM> of biopsy needle set 100b within receptacle <NUM> of coupler assembly 250a. Second latch mechanism <NUM> may be disposed on exterior portions of elongated core <NUM> proximate receptacle <NUM> adjacent to second end <NUM> to releasably engage one end of a drive shaft with second end <NUM> of coupler assembly 250a. Second latch <NUM> may be used to releasably engage one portion of a drive shaft such as end <NUM> of drive shaft <NUM> extending from powered driver <NUM> within second end <NUM> of coupler assembly 250a. Latch <NUM> may releasably engage an intraosseous device with first end <NUM> of coupler assembly 250a and substantially the same latch <NUM> may releasably engage a powered driver with second end <NUM> of coupler assembly 250a.

For some applications, latches <NUM> and <NUM> may have similar configurations such as a general "omega" shape (e.g., latch <NUM>). However, latch <NUM> may have larger dimensions corresponding generally with exterior portion 260a of elongated core <NUM>. Latch <NUM> may have smaller dimensions corresponding generally with exterior portion 260b of elongated core <NUM>. Various features of the present disclosure may be described with respect to latch mechanism <NUM> along with adjacent portions of second housing segment <NUM> and exterior portion 260b of elongated core <NUM>. Respective detents <NUM> and <NUM> may be formed on opposite ends of generally omega shaped latch <NUM>. In a similar manner, respective detents (not expressly shown) may be formed on the ends of generally omega shaped latch <NUM>. The configuration and dimensions of detents <NUM> and <NUM> may be compatible with placing each detent <NUM> and <NUM> in a respective slot or opening extending between exterior portion 260b of elongated core <NUM> to interior portions of receptacle <NUM> disposed proximate second end <NUM> of coupler assembly 250a. Latch <NUM> may have a first position in which portions of detents <NUM> and <NUM> may extend through the respective slots. The dimensions and configuration of detent <NUM> and <NUM> may be operable to be securely engaged with annular groove <NUM> formed in end <NUM> of powered driver <NUM>. In a similar manner, respective detents on associated latch <NUM> may be releasably engaged with annular groove <NUM> disposed in second end <NUM> of biopsy needle 100b. For some applications, a plurality of tapered surfaces <NUM> may be formed on exterior portions of hub 140a proximate first end <NUM> to radially expand detent mechanisms associated with omega shaped latch <NUM> radially outward while inserting second end <NUM> of biopsy needle 100b into first end <NUM> of coupler assembly 250a. The detent mechanism may "snap" into annular groove <NUM> when aligned therewith. In a similar manner, a plurality of tapered surfaces <NUM> may be formed on exterior portions of end <NUM> of drive shaft <NUM> extending from powered driver <NUM> to radially expand detent mechanisms <NUM> and <NUM> radially outward during the insertion of end <NUM> of powered driver <NUM> into second end <NUM> of coupler assembly 250a. Detent mechanisms <NUM> and <NUM> will "snap" into annular groove <NUM> when aligned therewith.

Engagement between detent mechanisms associated with latch <NUM> with annular groove <NUM> of hub assembly 130a will generally retain second end <NUM> of biopsy needle 100b securely engaged with first end <NUM> of coupler assembly 250a. This engagement may allow powered driver <NUM> to rotate or spin cannula or biopsy needle 110b while withdrawing cannula or biopsy needle 110b from an insertion site. In a similar manner, engagement between detent mechanisms <NUM> and <NUM> of omega shaped latch <NUM> and annular groove <NUM> of end <NUM> of powered driver <NUM> will generally retain second end <NUM> of coupler assembly 250a engaged with powered driver <NUM> during withdrawal of cannula 110b from an insertion site.

Biopsy needle set 100b may be released from first end <NUM> of coupler assembly 250a by sliding first housing segment <NUM> longitudinally toward second end <NUM> of elongated core <NUM>. Such movement of first housing segment <NUM> will result in interior tapered surface <NUM> contacting exterior portions of omega shaped latch <NUM> and compressing omega shaped latch <NUM> to radially expand associated detent mechanisms (not expressly shown) from engagement with annular groove <NUM> of hub assembly 130a. As a result, biopsy needle set 100b may be easily withdrawn from first end <NUM> of coupler assembly 250a. In a similar manner, longitudinal movement of second housing segment <NUM> toward first end <NUM> of coupler assembly 250a will result in interior tapered surface <NUM> contacting exterior portions of omega shaped latch <NUM> to compress generally omega shaped latch <NUM> and withdraw or retract detent mechanisms <NUM> and <NUM> from engagement with annular groove <NUM> of end <NUM>. As a result, powered driver <NUM> and second end <NUM> of coupler assembly 250a may be easily disconnected from each other.

Flange <NUM> may be generally described as having an enlarged funnel shaped or bell shaped configuration. The dimensions and configuration of flange <NUM> may be selected to be compatible with end <NUM> of powered driver <NUM>. As previously noted, coupler assembly 250a may be securely engaged with an opening formed in a containment bag or sterile sleeve in accordance with teachings of the present disclosure. For embodiments such as the one shown, end <NUM> of housing <NUM> of coupler assembly 250a may include annular ring <NUM> operable to be securely engaged with adjacent portions of flange <NUM>. The outside diameter of annular ring <NUM> may generally correspond with the outside diameter of adjacent portions of flange <NUM>. The inside diameter of annular ring <NUM> may also generally correspond with the inside diameter of adjacent portions of flange <NUM>. For some embodiments a plurality of posts <NUM> and generally V shaped grooves <NUM> may be alternatingly disposed on the extreme end of flange <NUM>. Annular ring <NUM> may include a plurality of holes <NUM> sized to received respective posts <NUM> therein. Annular ring <NUM> may also include a plurality of generally V shaped projections <NUM> sized to be received within respective generally V shaped grooves <NUM> formed in adjacent portions of flange <NUM>. For embodiments such as the one shown, portions of a containment bag (e.g., around an opening) may be disposed between annular ring <NUM> and adjacent portions of flange <NUM>. For example, post <NUM> may be inserted through a corresponding hole in a containment bag adjacent to the perimeter of an opening in the containment bag. Holes <NUM> in annular ring <NUM> may be aligned with respective posts <NUM>. Other portions of a containment bag (e.g., adjacent to an opening) may be trapped between respective V shaped projections <NUM> and V shaped grooves <NUM>. Various welding techniques including, but not limited to, laser welding may be applied to posts <NUM> to bond annular ring <NUM> with adjacent portions of flange <NUM>. As a result, a perimeter of a containment bag around an opening in the containment bag may be securely engaged with second end <NUM> of coupler assembly 250a.

<FIG> show some examples of medical procedure trays and/or kits which may contain one or more intraosseous devices and/or other components incorporating teachings of the present disclosure. For example, medical procedure tray 20a as shown in <FIG> may include intraosseous needle set or aspiration needle set <NUM> incorporating various teachings of the present disclosure. Medical procedure tray 20b as shown in <FIG> may include intraosseous needle set or biopsy needle set 100b, ejector <NUM>, funnel <NUM> and/or containment bag or sterile sleeve <NUM>. Medical procedure tray 20c as shown in <FIG> may also include various IO devices and other components incorporating teachings of the present disclosure including, but not limited to, biopsy needle set 100b, coupler assembly <NUM>, containment bag <NUM>, ejector <NUM> and/or funnel 80a.

Medical procedure trays and/or kits formed in accordance with teachings of the present disclosure may provide a support or base for various components such as a coupler assembly, funnel, and/or sharps protector to allow an operator or user to perform various functions without requiring that the operator or user hold or manipulate the respective component. For example, medical procedure tray 20c as shown in <FIG> may position and support coupler assembly <NUM> such that one end of a powered driver may be inserted (pushed) into releasable engagement with second end <NUM> of coupler assembly <NUM>. The powered driver may then be used to withdraw coupler assembly <NUM> from medical procedure tray 20c without requiring an operator or user to directly hold or manipulate coupler assembly <NUM>.

Medical procedure trays 20a, 20b and/or 20c may also contain a wide variety of other components including, but not limited to, one or more sharps protectors <NUM> as shown in <FIG> and <FIG>. Sharps protectors <NUM> may include hard foam or claylike material <NUM> disposed therein. Intraosseous devices such as aspiration needle sets and biopsy needle sets typically have respective sharp tips and/or cutting surfaces operable to penetrate skin, soft tissue and bone. The sharp tips and/or cutting surfaces of such intraosseous devices may be inserted into hard foam or claylike material <NUM> after completion of a medical procedure using the respective intraosseous device.

<FIG> shows one procedure for placing a powered driver within a containment bag incorporating teachings of the present disclosure. Containment bag <NUM> may be formed from generally flexible, fluid impervious material which may also be sterilized using conventional sterilization techniques. Containment bag <NUM> may be used to prevent a non-sterile powered driver from contaminating a sterile intraosseous device and/or an injection site, particularly during a bone marrow biopsy procedure or a bone marrow aspiration procedure. Containment bag <NUM> may be operable to form a fluid barrier with adjacent portions of housing assembly <NUM>. At the same time, coupler assembly <NUM> may allow powered driver to rotate an intraosseous device releasably engaged with first end <NUM> of coupler assembly <NUM> without damage to containment bag <NUM>.

Referring now to <FIG> , designated by the reference numeral <NUM> is one embodiment of the present driver assemblies. Driver assembly <NUM> comprises driver <NUM> configured, for example, to rotate and/or move intraosseous needle sets and/or drill bits to penetrate a target area. Driver assembly <NUM> is configured to determine (and driver <NUM> is configured for use in determining), for example, a voltage and/or a voltage difference between a target area and another (e.g., non-target) area, an impedance at a target area, and/or determining a change in at least one of a voltage difference and/or an impedance. Embodiments of driver assembly <NUM> can comprise - but are not required to comprise - one or more components and/or characteristics of any of the other drivers and intraosseous devices described and depicted throughout this disclosure (e.g., <FIG>).

In the embodiment shown, driver <NUM> comprises housing <NUM>, which has a configuration similar to a pistol (e.g., having a barrel-shape, a handle, etc.). Various components associated with driver assembly <NUM>, and more specifically with driver <NUM>, are disposed within housing <NUM>. Housing <NUM> may comprise substantially rigid polymeric material (e.g., a polycarbonate) and, in some embodiments, housing <NUM> can comprise a single piece of material; in other embodiments, housing <NUM> can comprise more than one piece of material (e.g., two halves coupled with a fluid tight seal). In the embodiment shown, housing <NUM> includes handle <NUM>, which can have various configurations, including, for example, being configured to be gripped by a user.

According to the invention, driver <NUM>, and more specifically driver <NUM>, includes controller <NUM>. Controller <NUM> is configured to control various components (e.g., a motor) of driver <NUM>. Controller <NUM> is configured to determine various characteristics (e.g., voltage, voltage differences, impedances, changes in at least one of voltage differences and impedances, and the like) of a target and/or another (e.g., a non-target) area. The driver <NUM> also includes motor <NUM> coupled to power source <NUM> (e.g., a battery) and further coupled to controller <NUM>. Controller <NUM> is configured to activate and/or deactivate motor <NUM> (based on user input, position of an intraosseous device (such as a drill bit) within a target area, an impedance, a voltage difference, or a change in at least one of an impedance and a voltage difference).

Further according to the invention, driver <NUM> also includes drive shaft <NUM> coupled to motor <NUM> such that motor <NUM> can rotate drive shaft <NUM>. Drive shaft <NUM> can be configured similarly to other embodiments of drive shafts described and depicted throughout this disclosure (e.g., <FIG>). Drive shaft <NUM> is coupled to motor <NUM> by a gear assembly (e.g., gear assembly <NUM>, in previously described embodiments). In some embodiments, drive shaft <NUM> can have a substantially hexagonal cross-section (e.g., corresponding to the coupler assembly depicted in <FIG>). In other embodiments, drive shaft <NUM> can have a cross-section with any shape configured to be coupled to a corresponding intraosseous device, such as a drill bit or a needle set.

Further according to the invention, driver <NUM> includes trigger <NUM>, which is coupled to motor <NUM> and/or controller <NUM>. Trigger <NUM> is engaged to activate (and/or deactivate, in some embodiments) motor <NUM> to permit motor <NUM> to rotate drive shaft <NUM> and any coupled intraosseous device.

In the embodiment shown, driver assembly <NUM> also includes drill bit <NUM> ( <FIG>), which is configured to be coupled to driver <NUM>. In this disclosure, a first structure that is configured to be coupled to a second structure can be not coupled to the second structure or it can be coupled to the second structure (and, in either case, is still configured to be coupled to the second structure). Drill bit <NUM> includes an exposed portion (an exposed distal portion, in this embodiment) having a first end <NUM> and second end <NUM>. Drill bit <NUM> can be - but is not required to be - coupled to drive shaft <NUM> similarly to the ways in which other intraosseous devices (e.g., needle sets) discussed throughout this disclosure can be coupled to a drive shaft (e.g., via a coupler assembly having a hub). In the embodiment shown, for example, driver assembly <NUM> comprises drill bit coupler <NUM>, which can be part of drill bit <NUM> when an operator first obtains the drill bit for use, or which can be an element separate from and couplable to drill bit <NUM> when an operator first obtains the drill bit for use (such as either being a structure that can be coupled to driver <NUM> or that is coupled to driver <NUM> when an operator first obtains the driver for use). Drill bit coupler <NUM> includes first end <NUM> configured to be coupled (e.g., detachably) to second end <NUM> of drill bit <NUM>. Drill bit coupler <NUM> also includes second end <NUM> configured to be coupled (e.g., detachably) to drive shaft <NUM> (e.g., by a female hexagonal configuration corresponding to a male hexagonal configuration of drive shaft <NUM>). Drill bit coupler <NUM> can be insulated (such as, for example, by comprising an insulator (e.g., polytetrafluoroethylene)) to substantially prevent heat and/or electricity from drill bit <NUM> from passing beyond drill bit coupler <NUM>.

In the embodiment shown, second end <NUM> of drill bit <NUM> is further configured to be coupled to controller <NUM> by a commutating electrical connection (e.g., via a gear box bearing) to permit electrical communication between drill bit <NUM> and controller <NUM>. For example, in the embodiment shown, driver <NUM> has at least one drill bit contact <NUM> coupled (e.g., slidably) to drill bit <NUM> and to controller <NUM>. Drill bit contact <NUM> is configured to provide a commutating electrical connection between drill bit <NUM> and controller <NUM>. Drill bit contact <NUM> can comprise a non-conductive coating (e.g., a dielectric, such as polytetrafluoroethylene) configured to substantially prevent electricity from drill bit <NUM> from passing beyond drill bit contact <NUM>.

In the embodiment shown, drill bit <NUM> is configured to penetrate a target area (e.g., target area <NUM>). Drill bit <NUM> includes outer surface <NUM> extending from second end <NUM> to first end <NUM> of the exposed portion of drill bit <NUM>. Outer surface <NUM> has groove(s) <NUM> (e.g., thread(s)) that help enable drill bit <NUM> to penetrate biological material (e.g., bone) to reach a target area (e.g., an IO space within bone or cerebrospinal fluid within a subject's skull). In the embodiment shown, drill bit <NUM> also includes core <NUM> extending the length (also characterizable as the entire length) of drill bit <NUM>, from first end <NUM>, beyond second end <NUM>, and to the proximal end of the drill bit. In other embodiments, however, core <NUM> can extend less than the length of drill bit <NUM> (e.g., and be exposed to biological material at points along drill bit <NUM> other than at a tip of drill bit <NUM>). Core <NUM> can be disposed inside at least outer surface <NUM>. In the embodiment shown, drill bit <NUM> also includes insulator <NUM> (e.g., comprising a non-conductive material, such as polytetrafluoroethylene) extending from a location distal of the proximal end of the drill bit (and thus distal of the proximal end of core <NUM>), past second end <NUM>, to first end <NUM> of drill bit <NUM>. Insulator <NUM> can be disposed at least between core <NUM> and outer surface <NUM> to prevent electrical communication between core <NUM> and outer surface <NUM>. In some embodiments, insulator <NUM> has a thickness of <NUM> millimeters to <NUM> millimeters. In other embodiments, insulator <NUM> can have a thickness of less than <NUM> millimeters or more than <NUM> millimeters (e.g., depending on electricity flowing through core <NUM>).

In the embodiment shown, outer surface <NUM>, core <NUM>, and insulator <NUM> can be configured to cooperate to form at least one tip <NUM> at first end <NUM> of drill bit <NUM>. Tip <NUM> can be configured to penetrate a target area (e.g., target area <NUM>) in various ways (e.g., similarly to other intraosseous devices described and depicted throughout this disclosure (e.g., by having one or more cutting surfaces)). In the embodiment shown, a portion of core <NUM> is exposed at tip <NUM> to permit electrical communication between tip <NUM> and a target area. In the embodiment shown, drill bit contact <NUM> is configured to permit electrical communication between controller <NUM> and at least one of core <NUM> and outer surface <NUM>. For example, controller <NUM> can be configured to determine (e.g., through drill bit contact <NUM>) at least one of current, voltage, impedance, and temperature from outer surface <NUM> and/or core <NUM>.

In the embodiment shown (e.g., depicted in <FIG> , <FIG> , and <FIG>), driver assembly <NUM> (and, more specifically, driver <NUM>) also includes at least one first electrode <NUM> (e.g., forming a two-wire configuration with controller <NUM> as depicted in <FIG>). First electrode <NUM> can be placed (e.g., using an adhesive) in or on a non-target area (e.g., non-target area <NUM> comprising biological material, such as skin and/or tissue surrounding bone). Such non-target area may also be near (e.g., in proximity to) a target area (e.g., target area <NUM> comprising biological material, such as bone and/or bone marrow in the embodiment shown). In some embodiments, the closer the non-target area is to the target area, the more effective the driver assembly (and, more specifically, the driver) will be in determining the desired information (e.g., a voltage difference between core <NUM> and first electrode <NUM>, an impedance of biological material between core <NUM> and first electrode <NUM>, a change in the voltage difference between core <NUM> and first electrode <NUM>, and/or a change in the impedance of the biological material between core <NUM> and first electrode <NUM>). In other embodiments, the driver assembly (and, more specifically, the driver) will be more effective in determining the desired information where the non-target area is farther from the target area (e.g., to minimize voltage gradients at a target area caused by or resulting from first electrode <NUM>). As those of ordinary skill in the art will understand, the anatomy of interest for a procedure will impact the location or position of first electrode <NUM> with respect to a target area (e.g., one skilled in the art may avoid positioning time varying impedance artifacts (e.g., cardiac activity, respiration, etc.) between core <NUM> and first electrode <NUM>). First electrode <NUM> is configured to be coupled to controller <NUM>, for example, by patch connector <NUM>. In the embodiment shown, first electrode <NUM> is coupled (e.g., by a floating connection) to an inverting input of a differential amplifier (e.g., and thus coupled to controller <NUM>). Controller <NUM> can be configured to determine a voltage difference and/or an impedance between core <NUM> and first electrode <NUM>. Controller <NUM> can further be configured to determine a change in a voltage difference and/or a change in impedance (e.g., based on a previous voltage difference and/or impedance, a reference voltage difference and/or reference impedance, and the like). In some embodiments, an impedance and/or a voltage difference between core <NUM> and first electrode <NUM> can be substantially similar to an impedance and/or a voltage difference, respectively, at a target area (depending, for example, on the location of the target area and the position of core <NUM>). Various other configurations can be used to determine information about a target area, such as, for example, using a drill bit comprising a split ring electrode core, a three-wire configuration, a four-wire configuration, and the like.

In the embodiment shown, driver assembly <NUM> can further comprise at least one second electrode <NUM> coupled to controller <NUM>, such as by patch connector <NUM> (e.g., forming at least a three-wire configuration as depicted in <FIG>). In the embodiment shown, second electrode <NUM> can be placed (e.g., using an adhesive) in or on a non-target area (e.g., non-target area <NUM>). Second electrode <NUM> can be placed in various positions with respect to first electrode <NUM> and a non-target area, such as, for example, concentric with first electrode <NUM> (e.g., such that second electrode <NUM> encircles first electrode <NUM>). In other embodiments, however, second electrode <NUM> can comprise various other shapes (e.g., rectangular) and can be placed in various other positions with respect to first electrode <NUM> (e.g., parallel to first electrode <NUM>). In the embodiment shown, controller <NUM> can be configured to pass a current (e.g., an alternating current (e.g., at <NUM>)) to second electrode <NUM>, meaning the controller is involved in (or plays a role in) causing a current to pass to the second electrode. In some embodiments, controller <NUM> can be configured to pass the same current to core <NUM> and second electrode <NUM>. For example, controller <NUM> can pass a current to second electrode <NUM> having a frequency of <NUM> to <NUM>. In the embodiment shown, second electrode <NUM> is involved in (or plays a role in) permitting controller <NUM> to determine, for example, a voltage difference between first electrode <NUM> and core <NUM>, a change in such a voltage difference, an impedance in proximity to (or near) drill bit <NUM> and/or a target area (e.g., target area <NUM>), and a change in such an impedance. For example, second electrode <NUM> can assist in decreasing or minimizing interference (e.g., near field effects) from a non-target area when determining information (e.g., a voltage difference, a change in voltage difference, an impedance, and/or a change in impedance) related to a target area. As those of ordinary skill in the art will understand, the anatomy of interest for a procedure will impact the location or position of first electrode <NUM> and/or second electrode <NUM> relative to the location or position of a target area and/or a non-target area.

Controller <NUM> can be configured to determine information about a target area (e.g., a target area in biological material) in a variety of ways. In the embodiment shown, controller <NUM> is configured to determine a change in an impedance and/or a change in a voltage difference (e.g., between a target area and a non-target area) by, at least in part, reference to a point within the target area, an impedance, and/or a voltage difference. For example, driver <NUM> comprises reference button <NUM> coupled to controller <NUM>. Reference button <NUM> is configured to set (e.g., when a user engages reference button <NUM>) a reference point (e.g., marking a physical position within a target area), a reference impedance (e.g., marking an impedance at a point within a target area), and/or a reference voltage difference (e.g., marking a voltage difference (e.g., between a target area and a non-target area) at a point within a target area). In other embodiments, controller <NUM> can be configured to set a reference point, a reference impedance, and/or a reference voltage difference automatically when drill bit <NUM> contacts a predetermined point (e.g., a bone). If a reference point, a reference impedance, and/or a reference voltage difference is set (e.g., by a user engaging reference button <NUM>, automatically, etc.), controller <NUM> is configured to determine a change from the reference point, reference impedance, and/or reference voltage difference, respectively. Controller <NUM> can be configured to determine a change in impedance and/or a change in voltage difference by determining an impedance and/or voltage difference greater or less than the reference impedance and/or the reference voltage difference, respectively. In other embodiments, for example, controller <NUM> can be configured to determine a first impedance (e.g., an impedance of bone) and/or a first voltage difference (e.g., between a target and a non-target area) at a first depth within the target area and also determine a second impedance (e.g., an impedance of bone marrow) and/or a second voltage difference at a second depth within the target area. Controller <NUM> can also be configured to determine a change in impedance and/or a change in voltage difference between the first impedance and/or the first voltage difference and the second impedance and/or the second voltage difference, respectively. In other embodiments, controller <NUM> can be configured to determine a plurality (e.g., two or more) of impedances and/or voltage differences corresponding to a plurality of depths within a target area. Controller <NUM> can then be configured to determine a change in impedance and/or a change in voltage difference between the plurality of impedances and/or voltage differences, respectively.

In the embodiment shown, controller <NUM> can be configured to display information relating to a target area to a user. Driver assembly <NUM> (and, more specifically, driver <NUM>) can comprise display <NUM> (e.g., one or more light emitting diodes, a liquid crystal display, and/or noise indicators) configured to be coupled to controller <NUM> and configured to display information relating to at least one of an impedance, a change in an impedance, a voltage difference, and/or a change in a voltage difference. In the embodiment shown, display <NUM> comprises a plurality of light emitting diodes. In some embodiments, display <NUM> can be configured to display additional information, such as, for example, a position of a drill bit within a target area, or a depth of a drill bit within a target area (e.g., based on an impedance, a change in an impedance, a voltage difference, and/or a change in a voltage difference).

In the embodiment shown, controller <NUM> includes various components configured to permit controller <NUM> to determine information relating to a target area, display such information, and control a motor. For example, in the embodiment shown, controller <NUM> comprises current source <NUM> configured to produce a current to pass to second electrode <NUM> and core <NUM> of drill bit <NUM>. In the embodiment shown, current source <NUM> is configured to produce and/or pass a current (e.g., 100uA to 10mA) having a frequency of <NUM> to <NUM>. In other embodiments, current source <NUM> can be configured to produce and/or pass a current having a frequency of less than <NUM> and greater than <NUM> (depending, for example, on a location of a given target area, resistance in controller <NUM>, resistance in core <NUM>, and resistance in second electrode <NUM>).

In the embodiment shown, controller <NUM> also includes oscillator <NUM> configured to produce a signal in the current produced by current source <NUM>, such as, for example, an alternating current. For example, in the embodiment shown, oscillator <NUM> can produce a signal having a frequency of <NUM> to <NUM>. In other embodiments, oscillator <NUM> can be configured to produce a signal having a frequency of less than <NUM> and greater than <NUM> (depending, for example, on a location of a given target area, resistance in controller <NUM>, resistance in core <NUM>, and resistance in first electrode <NUM>).

In the embodiment shown, controller <NUM> also includes differential amplifier <NUM>, which can be, for example, a high common mode rejection differential input amplifier. Differential amplifier <NUM> can be coupled to (e.g., electrically) and configured to receive a voltage from core <NUM> of drill bit <NUM>. Differential amplifier <NUM> can also be coupled to (e.g., electrically) and configured to receive a voltage from first electrode <NUM>. In the embodiment shown, differential amplifier <NUM> is configured to output a voltage difference between core <NUM> and first electrode <NUM> while a current is applied to second electrode <NUM> and core <NUM>. The output from differential amplifier <NUM> is a function of and/or correspond to, for example, an impedance at (or near) a target area (e.g., biological material in proximity to (or near) drill bit <NUM>). Core <NUM> and first electrode <NUM> can be coupled to the inputs of differential amplifier <NUM> in any configuration (e.g., based on a desired signal phase for the output).

In the embodiment shown, controller <NUM> also includes multiplier <NUM>, which can be coupled (e.g., electrically) to oscillator <NUM> and differential amplifier <NUM>. In the embodiment shown, multiplier <NUM> is configured to multiply a signal from differential amplifier <NUM> with a signal from oscillator <NUM> to down convert the voltage output from differential amplifier <NUM> to produce a baseband frequency (e.g., similarly to a lock-in amplifier). In the embodiment shown, multiplier <NUM> can produce a direct voltage as a function of and/or that corresponds to an impedance at (or near) a target area.

In the embodiment shown, controller <NUM> also comprises gain amplifier <NUM>, which can be coupled (e.g., electrically) to multiplier <NUM>. In the embodiment shown, gain amplifier <NUM> is configured to increase a voltage of a baseband frequency produced by multiplier <NUM>. For example, gain amplifier <NUM> can increase the voltage by a factor of <NUM>. In other embodiments, gain amplifier <NUM> can increase the voltage by a factor of <NUM> to <NUM>,<NUM> depending, for example, on a location of a given target area and/or resistance in controller <NUM>. A required system gain can be, for example, optionally distributed between differential amplifier <NUM> and gain amplifier <NUM>.

In the embodiment shown, controller <NUM> also includes low pass filter <NUM>, which can be coupled (e.g., electrically) to gain amplifier <NUM>. Low pass filter <NUM> is configured to receive a signal from gain amplifier <NUM> and attenuate a signal having a higher frequency than a predetermined cutoff frequency.

In the embodiment shown, driver assembly <NUM> (and, more specifically, driver <NUM>) is configured such that display <NUM> notifies a user if a change in an impedance and/or a change in a voltage difference meets or exceeds a threshold (e.g., a predetermined threshold, which can be positive or negative, and the exceeding of a negative threshold can be a negative value that is more negative than the negative threshold). Controller <NUM> includes threshold detector <NUM> coupled (e.g., electrically) to low pass filter <NUM>. Threshold detector <NUM> has a predetermined threshold (such as, for example, one that corresponds to a voltage difference, an impedance, or a current). In some embodiments, the predetermined threshold is adjustable, such that a user can set the threshold. In other embodiments, driver assembly <NUM> can permit a user to select from pre-programmed thresholds that, for example, correspond to various target areas (e.g., cranium, sternum, and the like). Low pass filter <NUM> can output a signal, and if the signal meets or exceeds a predetermined threshold of threshold detector <NUM>, controller <NUM> can cause display <NUM> to indicate, for example, at least one of an impedance, a change in an impedance, a voltage difference, a change in a voltage difference, a position of drill bit <NUM> within a target area, and any other relevant information related to impedance, voltage, and/or location of drill bit <NUM> within a target area.

In the embodiment shown, driver assembly <NUM> (and, more specifically, driver <NUM>) also includes motor controller <NUM>. Controller <NUM> is configured to permit motor controller <NUM> to deactivate (and/or activate, in some embodiments) motor <NUM> if a change in an impedance and/or a change in a voltage difference meets or exceeds a predetermined threshold. In other embodiments, controller <NUM> can be configured to permit motor controller <NUM> to change (e.g., increase and/or decrease) a rotational speed of motor <NUM> (e.g., and indirectly drill bit <NUM>) if a change in an impedance and/or a change in a voltage difference meets or exceeds a predetermined threshold.

The present drill bits, drivers, and driver assemblies may be used, for example, in any procedure in which it is desirable to identify (whether automatically or through a notification that can be recognized by a user) a change in the biological material through which an IO device (such as a drill bit or a needle set) is advancing. A craniotomy is one example of such a procedure. Another example is the placement of a needle set in an IO space within the sternum. Some embodiments of the present methods of determining an impedance, a change in an impedance, a voltage difference, and/or a change in a voltage difference relating to a target area and/or a non-target area with an embodiment of the present driver assemblies comprise placing a first electrode (e.g., first electrode <NUM>) of a driver assembly (e.g., driver assembly <NUM>) in or on a non-target area (e.g., non-target area <NUM>), moving a drill bit (e.g., drill bit <NUM>) of the driver assembly through biological material (e.g., skin and tissue) toward a target area (e.g., target area <NUM>, such as bone marrow or a location inside the skull (such as a location occupied by cerebrospinal fluid)) in biological material, and determining at least one of an impedance (e.g., at or near a target area), a change in an impedance, a voltage difference (e.g., between a target area and a non-target area), and a change in a voltage difference. In some embodiments, the method can further comprise placing a second electrode (e.g., second electrode <NUM>) in or on the non-target area (e.g., forming at least a three-wire configuration to minimize or decrease near field effects of a non-target area). Further, the method can comprise displaying a notification when at least one of the impedance, the change in an impedance, the voltage difference, and/or the change in a voltage difference meets or exceeds a threshold. As another example, the method can comprise changing and/or stopping a rotational velocity of the drill bit when at least one of the impedance, the change in an impedance, the voltage difference, and/or the change in a voltage difference meets or exceeds a threshold. The method can further comprise removing the drill bit from the target area, such as to permit access to the target area.

A method of determining an impedance, a change in an impedance, a voltage difference, and/or a change in a voltage difference with an embodiment of the present driver assemblies can comprise, for example, placing a first electrode (e.g., first electrode <NUM>) of a driver assembly (e.g., driver assembly <NUM>) in or on a non-target area (e.g., non-target area <NUM>), moving a drill bit (e.g., drill bit <NUM>) of the driver assembly through biological material toward a target area (e.g., target area <NUM>) in biological material, setting at least one of a reference impedance and a reference voltage difference, and determining a change from at least one of the reference impedance and the reference voltage difference such as in a manner described above. In some embodiments, the method can further comprise placing a second electrode (e.g., second electrode <NUM>) in or on the non-target area (e.g., to form at least a three-wire configuration to minimize or decrease near field effects of a non-target area). Further, the method can comprise displaying a notification when at least one of the impedance, the change in an impedance, the voltage difference, and/or the change in a voltage difference meets or exceeds a threshold. As another example, the method can comprise changing and/or stopping a rotational velocity of the drill bit when at least one of the impedance, the change in an impedance, the voltage difference, and/or the change in a voltage difference meets or exceeds a threshold. The method can also comprise removing the drill bit from the target area, such as to permit access to the target area.

Similarly to other embodiments of intraosseous devices (or components of intraosseous devices) described in this disclosure, embodiments of the present drivers, driver assemblies, and drill bits (and components of such embodiments) can also be included in one or more kits. A kit comprising one or more embodiments (or one or more components) of the present driver assemblies can comprise one or more IO devices (or one or more components of IO devices) of any of the kits described in this disclosure (e.g., as depicted in <FIG>). For example, a kit can comprise a driver (e.g., driver <NUM>) and an intraosseous device configured to be coupled to the driver (e.g., drill bit <NUM>). In some embodiments, a kit can also comprise at least one of a cannula and a stylet. In some embodiments, a kit can further comprise a coupler configured to couple the driver to the intraosseous needle set. In other embodiments, the kit can comprise an aspiration device configured to be coupled to a cannula. In some embodiments, a kit can comprise at least one sharps protector configured such that at least one of the cannula, the stylet, and the drill bit can be disposed in the sharps protector to prevent exposure of a cutting surface. In other embodiments, a kit can comprise a containment assembly configured to seal the driver inside the containment assembly to prevent desterilization of at least one of the intraosseous needle set and a target area.

Claim 1:
A driver comprising:
a controller (<NUM>) configured to determine at least one of an impedance and a voltage difference;
a motor (<NUM>) coupled to a power source (<NUM>) and further coupled to the controller (<NUM>) such that the controller can affect the motor's operation;
a drive shaft (<NUM>) coupled to the motor (<NUM>) such that the motor can move the drive shaft;
a trigger (<NUM>) coupled to the controller (<NUM>) and configured to activate the motor (<NUM>); and
a first electrode (<NUM>) configured to be coupled to the controller (<NUM>);
where the driver is configured to be coupled to an intraosseous device (<NUM>) and used, with the intraosseous device, to determine at least one of a change in an impedance and a change in a voltage difference across biological material;
characterised in that
the controller (<NUM>) is configured to compare at least one of the change in impedance and the change in voltage difference to a threshold; and
where the controller (<NUM>) is configured to deactivate the motor or change a rotational speed of the motor when at least one of the change in impedance and the change in voltage difference meets or exceeds the threshold.