US20230157725A1 - Powered driver actuated by force on driveshaft and related kits, components, and methods - Google Patents

Abstract

Powered drivers operable to insert an intraosseous device into a bone and associated bone marrow are disclosed. Some of the present powered drivers may include a housing having a distal end and a proximal end; a motor disposed in the housing; a driveshaft at the distal end of the housing; and a gearbox coupled to the motor and to the driveshaft. Activation of the motor causes rotation of the driveshaft. The housing may include a power source configured to power the motor. The driveshaft may be slidably disposed in the housing and configured such that, upon application of a threshold force on the driveshaft in the direction of the proximal end of the housing, the driveshaft will slide toward the proximal end of the housing to cause an electrical circuit between the motor and the power source to close.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation application of U.S. patent application Ser. No. 16/875,338 filed May 15, 2020, which is a continuation application of U.S. patent application Ser. No. 16/135,161 filed Sep. 19, 2018, now U.S. Pat. No. 10,653,448, which is a continuation application of U.S. patent application Ser. No. 14/624,219 filed Feb. 17, 2015, now U.S. Pat. No. 10,092,320, which claims priority from U.S. Provisional Patent Application No. 61/940,741 filed Feb. 17, 2014 and U.S. Provisional Patent Application No. 61/945,325 filed Feb. 27, 2014, the entire contents of which are incorporated herein by reference.
FIELD OF INVENTION
• The present invention is generally related to powered drivers and more particularly, but not by way of limitation, to powered drivers actuated by a force on a driveshaft (e.g., for inserting an intraosseous device into a patient's bone).
BACKGROUND
• Examples of powered drivers for inserting an intraosseous device are disclosed in U.S. patent application Ser. No. 12/025,580, which is published as Pub. No. US 2008/0221580.
SUMMARY
• Embodiments of the present drivers and kits can be configured to assist a user with inserting an intraosseous (IO) device into a patient's bone.
• Some embodiments of the present apparatuses or drivers comprise: a housing having a distal end and a proximal end; a motor disposed in the housing; a driveshaft extending outward from the distal end of the housing in a direction away from the proximal end; a gearbox coupled to the motor and to the driveshaft such that activation of the motor will cause rotation of the driveshaft; and a battery configured to power the motor; where the gearbox is slidably disposed in the housing and configured such that, upon application of a threshold force on the driveshaft in the direction of the proximal end of the housing, the driveshaft and gearbox will slide toward the proximal end of the housing and thereby close an electrical circuit between the motor and the battery. In some embodiments, the driveshaft is biased in the direction of the distal end of the housing (e.g., by a spring disposed between the gearbox and the distal end of the housing).
• Some embodiments of the present drivers further comprise: a switch coupled to the battery and the motor, the switch disposed between the proximal end of the housing and at least a portion of the gearbox; where the switch is configured to close the circuit upon application of the threshold force on the driveshaft. In some embodiments, the switch is disposed between the motor and the proximal end of the housing. In some embodiments, the switch comprises a base and plunger axially movable relative to the base. In some embodiments, the motor and gearbox are coupled in fixed axial relation to each other and are together slidable within the housing. In some embodiments, the motor and gearbox are biased in the direction of the distal end of the housing (e.g., by a spring disposed between the motor and the distal end of the housing).
• In some embodiments of the present drivers, the housing defines a primary portion extending between the distal end and the proximal end, and a handle portion extending laterally from the primary portion at a non-parallel angle relative to a longitudinal axis of the primary portion. In some embodiments, at least a portion of the driveshaft has an equilateral polygonal cross-sectional shape. In some embodiments, the at least a portion of the driveshaft has a pentagonal cross-sectional shape.
• Some embodiments of the present drivers further comprise: an electrical lockout comprising a strip configured to be removably inserted into the housing between two electrically conductive portions of the electrical circuit to prevent the apparatus from energizing during sterilization. In some embodiments, the strip comprises a polymer (e.g., Mylar).
• Some embodiments of the present drivers further comprise: a mechanical lockout including a tab configured to be removably inserted into the housing proximal to at least a portion of the driveshaft such that upon application of the threshold force on the driveshaft in the direction of the proximal end of the housing, the mechanical lockout prevents the driveshaft and gearbox from sliding toward the proximal end of the housing and thereby prevents the driveshaft and gearbox from closing the electrical circuit between the motor and the battery. In some embodiments, the mechanical lockout includes a needle cover. Some embodiments further comprise: an electrical lockout comprising a strip configured to be removably inserted into the housing between two electrically conductive portions of the electrical circuit to prevent the apparatus from energizing during sterilization; where the mechanical lockout is coupled to the electrical lockout.
• Some embodiments of the present kits comprise: an embodiment of the present apparatuses; and an intraosseous device comprising a connector configured to be coupled to the driveshaft of the driver. In some embodiments, the connector comprises a recess configured to receive a distal end of the driveshaft. In some embodiments, the intraosseous device comprises: a hub; a cannula extending from the hub to a distal end spaced from the hub; and a trocar extending from the connector to a distal end spaced from the connector; where the cannula is configured to be inserted into the cannula and the connector coupled to the hub to hold the trocar in fixed relation to the cannula. In some embodiments, connector is configured to be coupled to the hub by a Luer lock connector. In some embodiments, the connector comprises a female threaded portion surrounding a portion of the trocar, the hub comprises a male threaded portion extending away from the distal end of the cannula, and the male threaded portion is configured to be coupled to the female threaded portion to couple the connector to the hub.
• Some embodiments of the present methods comprise: disposing a distal end of an intraosseous (IO) device at a desired insertion site on a patient, the IO device coupled to the driveshaft of an embodiment of the present apparatuses; and applying a force to the distal end of the IO device via the housing of the driver such that the driveshaft of the driver slides toward the proximal end of the housing relative to the housing and activates the motor of the driver to rotate the driveshaft and IO device. In some embodiments, the force is applied until the IO device is inserted into a bone of the patient. In some embodiments, the desired insertion site is disposed over a proximal portion of the patient's humerus, a proximal portion of the patient's tibia, a distal portion of the patient's femur, a patient's clavicle, a patients iliac crest, or a patient's calcaneous. In some embodiments, the desired insertion site is disposed over the patient's sternum.
• Some embodiments of the present apparatuses or drivers comprise: a housing having a distal end and a proximal end; a motor disposed in the housing; a driveshaft extending outward from the distal end of the housing in a direction away from the proximal end; a gearbox coupled to the motor and to the driveshaft such that activation of the motor will cause rotation of the driveshaft; a battery configured to power the motor; and a mechanical lockout including a tab configured to be removably inserted into the housing proximal to at least a portion of the driveshaft such that upon application of a threshold force on the driveshaft in the direction of the proximal end of the housing, the mechanical lockout prevents the driveshaft and gearbox from closing an electrical circuit between the motor and the battery. In some embodiments, the mechanical lockout includes a needle cover:
• Some embodiments of the present apparatuses or drivers comprise: a housing having a distal end and a proximal end; a motor disposed in the housing; a driveshaft extending outward from the distal end of the housing in a direction away from the proximal end; a gearbox coupled to the motor and to the driveshaft such that activation of the motor will cause rotation of the driveshaft; a battery configured to power the motor; an electrical lockout comprising a strip configured to be removably inserted into the housing between two electrically conductive portions of an electrical circuit to prevent the apparatus from energizing during sterilization.
• The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are “coupled” may be unitary with each other. The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the terms “substantially,” “approximately,” and “about” may be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, 5, and 10 percent.
• Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
• The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, an apparatus that “comprises,” “has,” “includes,” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” “includes,” or “contains” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
• Any embodiment of any of the apparatuses, systems, and methods can consist of or consist essentially of—rather than comprise/include/contain/have—any of the described steps, elements, and/or features. 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 feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.
• Some details associated with the embodiments described above and others are described below.
BRIEF DESCRIPTION OF THE DRAWINGS
• The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The embodiments of the present assistive devices, coupler assemblies, drivers, intraosseous (IO) devices, and their components shown in the figures are drawn to scale for at least the embodiments shown.
• FIGS.1 and2 depict perspective views of a first embodiment of the present drivers.
• FIGS.3A and3B depict a cutaway perspective view and a side view, respectively, of the driver ofFIGS.1-2.
• FIG.4A depicts an exploded and partially cutaway side view of one example of an intraosseous needle set or penetrator assembly which may be inserted into a patient's bone and, thus, into a patient's vascular system using one of the present drivers and may be included in certain ones of the present kits.
• FIG.4B depicts a partial perspective view of a connector receptacle of the IO needle set ofFIG.4A that may be releasably engaged with embodiments of the present powered drivers.
• FIGS.5 and6 depict side views of a second embodiment of the present drivers with an IO needle set ofFIGS.4A-4B coupled to the driver.
• FIG.7 depicts a side cross-sectional view of the driver ofFIGS.5-6.
• FIG.8 depicts a cutaway perspective view of the driver ofFIGS.5-6.
• FIGS.9A-9C depict various views of another embodiment of the present drivers with a more ergonomic handle.
• FIG.10A depicts a perspective view of a mechanical lockout for use with the driver ofFIGS.9A-9C.
• FIGS.10B and10C depict side and perspective views, respectively, of the mechanical lockout ofFIG.10A and an electrical lockout in combination with the driver ofFIGS.9A-9C.
• FIG.11 depicts a cross-sectional view of the lockouts ofFIGS.10B and10C in combination with the driver ofFIGS.9A-9C.
• FIG.12A depicts a perspective view of a second embodiment of a mechanical lockout for use with the driver ofFIGS.9A-9C.
• FIG.12B depicts a side view of the mechanical lockout ofFIG.12A and an electrical lockout in combination with the driver ofFIGS.9A-9C.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
• Embodiments of the present powered drivers may be used to insert an IO device incorporating teachings of the present disclosure into a selected target area or target site (e.g., in ten seconds or less).
• Vascular system access may be essential for treatment of many serious diseases, chronic conditions, and acute emergency situations. Yet, many patients experience extreme difficulty obtaining effective treatment because of an inability to obtain or maintain intravenous (IV) access. An intraosseous (IO) space provides a direct conduit to a patent's vascular system and systemic circulation. Therefore, IO access is generally an effective route to administer a wide variety of drugs, other medications, and/or IV fluids. Rapid IO access or emergency vascular access (EVA) offers great promise for almost any serious emergency that requires vascular access to administer life-saving drugs, other medications, and/or fluids when traditional IV access is difficult or impossible.
• Bone marrow typically includes blood, blood forming cells, and connective tissue disposed in an intraosseous space or cavity surrounded by compact bone. Long bones such as the tibia typically have an elongated central cavity filled with yellow bone marrow and adipose or connective tissue. Such cavities may also be referred to as a “medullary cavity,” “bone marrow cavity,” and/or “intraosseous space.”
• Compact bone disposed near an anterior or dorsal surface may be referred to as “anterior compact bone” or “anterior bone cortex.” Compact bone disposed farther from the dorsal or anterior surface may be referred to as “posterior compact bone” or “posterior bone cortex.”
• Examples of insertion sites for an IO device to establish access with a patient's vascular system include the upper tibia proximate a patient's knee, the humeral head proximate a patient's shoulder, and the patient's sternum. Availability of multiple intraosseous insertion sites and associated target areas in adjacent bone marrow have proven to be particularly important in applications such as emergency treatment of battlefield casualties or other mass casualty situations. Teachings of the present disclosure may be used to obtain intraosseous access at a wide variety of insertion sites and target areas.
• IO access may be used as a “bridge” for temporary fluid and/or drug therapy during emergency conditions until conventional IV sites can be found and used. Conventional IV sites often become available because fluids and/or medication provided via IO access may stabilize a patient and expand veins and other portions of a patient's vascular system. IO devices and associated procedures incorporating teachings of the present disclosure may become standard care for administering medications and fluids in situations when IV access is difficult or otherwise impossible.
• Intraosseous access may be used as a “routine” procedure with chronic conditions which substantially reduce or eliminate availability of conventional IV sites. Examples of such chronic conditions may include, but are not limited to, dialysis patients, patients in intensive care units, and/or epilepsy patients. Intraosseous devices and associated apparatuses incorporating teachings of the present disclosure may be quickly and safely used to provide IO access to a patient's vascular system in difficult cases, such as status epilepticus, to give medical personnel an opportunity to administer crucial medications and/or fluids. Further examples of such acute and chronic conditions are listed near the end of this written description.
• Apparatuses and methods incorporating teachings of the present disclosure may include using a first IO needle set having (e.g., a fifteen (15) gauge) cannula with a length of approximately fifteen (15) millimeters to establish vascular access for patients weighing between approximately three (3) kilograms and thirty nine (39) kilograms. A second IO needle set having a (e.g., a fifteen (15) gauge) cannula with an approximate length of twenty-five (25) millimeters may be used to establish vascular access for patients weighing forty (40) kilograms and greater. In other embodiments, a single size of IO needle set having a (e.g., a fifteen (15) gauge) cannula with an approximate length of twenty-five (25) millimeters may be used to establish vascular access for patients weighing three (3) kilograms and greater.
• The term “driver” may be used in this application to include any type of powered driver satisfactory for inserting an intraosseous (IO) device such as a penetrator assembly, a catheter, an IO needle, and/or an IO needle set into a selected portion of a patient's vascular system. Various techniques may be satisfactorily used to releasably engage or attach an IO device with a driver incorporating teachings of the present disclosure. A wide variety of connectors and associated connector receptacles, fittings, and/or other types of connections with various dimensions and configurations may be satisfactorily used to releasably engage an IO device with a driver. A battery powered driver incorporating teachings of the present disclosure may be used to insert an intraosseous device into a selected target area in ten (10) seconds or less. The reduced size and weight of drivers incorporating teachings of the present disclosure may accommodate use in emergency medical vehicles, in emergency crash carts at medical facilities and/or in carrying in backpacks of military personnel deployed for extended periods of time in remote locations.
• 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, any mixture of liquids, particulate matter, dissolved medication, and/or drugs associated with biopsy and/or aspiration of bone marrow, and/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 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 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, and/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 304 stainless steel and/or other biocompatible materials associated with needles and similar medical devices.
• For some applications an IO needle or IO needle set may include a connector with a trocar or stylet extending from a first end of the connector. A second end of the connector may be operable to be releasably engaged with a powered driver incorporating teachings of the present disclosure. An IO needle or IO needle set may also include a hub with a hollow cannula or catheter extending from a first end of the hub. A second end of the hub may include an opening sized to allow inserting the trocar through the opening and the attached hollow cannula. The second end of the hub may be operable to be releasably engaged with the first end of the connector. As previously noted, the second end of the connector may be releasably engaged with a powered driver. A wide variety of connectors and hubs may be used with an IO device incorporating teachings of the present disclosure. The present disclosure is not limited toconnector180 orhub200 as shown inFIGS.4A and4B.
• The IO device shown inFIGS.4A and4B is a prior art device, and the description of it is provided to give the reader context for the types of devices and components that can be used consistently with embodiments of the present drivers and kits.
• Referring now to the drawings, and more particularly toFIGS.1-3B, shown therein and designated by thereference numeral10 is one embodiment of the present apparatuses or powered drivers.Powered driver10 may be satisfactorily used to insert an intraosseous device at a desired insertion site adjacent to a bone and associated bone marrow.Powered driver10 may include one or more of the present features. One or more additional and/or alternative ones of the present features may also be included in or with powered driver10aofFIGS.5-8.
• In the embodiment shown, powereddriver10 includes ahousing14, amotor18, adriveshaft22, and agearbox26.Housing14 has adistal end30 and aproximal end34, andmotor18 is disposed within the housing withdriveshaft22 extending outwardly fromdistal end30 of the housing in a direction away fromproximal end34 such that adistal end38 of the driveshaft is spaced apart fromdistal end30 of the housing. In the embodiment shown,gearbox26 is coupled tomotor18 and to driveshaft22 such that activation of the motor will cause rotation of the driveshaft (suitable gearboxes described in more detail below). In this embodiment,driver10 also comprises a battery (e.g., twobatteries40, as shown) configured to power motor18 (e.g., through electrical communication betweenbatteries40 andmotor18, for example, through wiring, circuitry, and/or the like). In the embodiment shown,batteries40 comprise two 9-volt batteries which may be commercially available from a variety of suppliers and retail outlets. Other embodiments can include any suitable battery and/or combination of batteries that permit the function(s) described in this disclosure.
• In the depicted embodiment,driver10 does not include a “trigger” configured to be squeezed or otherwise depressed with a user's finger during use to activate the motor. Instead, in this embodiment,gearbox26 is slidably disposed inhousing14 and configured such that, upon application of a threshold force (e.g., a force at least large enough to move the driveshaft) ondriveshaft22 in direction42 (towardproximal end34 of the housing), the driveshaft and gearbox will slide toward the proximal end of the housing and thereby close an electrical circuit between the motor and the battery (and thus active the motor to rotate the driveshaft). For example, in the embodiment shown,driver10 further comprises a switch46 (e.g., having abody50 and a piston54 axially movable relative to the body, as shown) that is coupled to the battery and the motor (e.g., via wires or other conductors), where the switch is disposed betweenproximal end34 of the housing and at least a portion ofgearbox26. In this embodiment, switch46 is configured to close the circuit (e.g., between the battery and the motor upon application of the threshold force on the driveshaft). In this embodiment,motor18 andgearbox26 are coupled in fixed axial relation to each other and are together slidable within the housing (e.g., along axis58). In this embodiment, switch46 is disposed betweenmotor18 andproximal end34 of the housing.
• In some embodiments, gearbox26 (and driveshaft22) is biased in the direction of distal end30 (e.g., by aspring62 disposed between the gearbox and the distal end of the housing) such that in the absence of the threshold force on the driveshaft, the circuit remains open and the motor is not active. For example, in this embodiment,motor18 andgearbox26 are together biased in the direction ofdistal end30 of the housing by aspring62 disposed betweenbody50 of the switch (e.g., and/or one or more tabs orother portions66 ofhousing14 to which the body of the switch is mounted or otherwise supported, such as, for example, against axial movement) andmotor18. In this embodiment,housing14 includes one or more internal tabs orportions70 supporting motor18 (e.g., against lateral displacement relative to axis58) and permitting the motor to slide axially along axis58 (e.g., configured to supportmotor18 in coaxial alignment with axis58). In the embodiment shown,housing14 also includes one or more internal tabs orportions74 configured to limit the depth of slidable movement of motor18 (andgearbox26 and driveshaft22) indirection42. In this embodiment,tabs74 are disposed on opposite sides ofspring62 and extend within a cross-sectional perimeter of a proximal end ofmotor18 such thattabs74 physically limit movement ofmotor18 indirection42. In other embodiments, housing14 (including tabs orportions70 and/or74) can be provided in any structure or configuration that permits the operation describes in this disclosure (e.g., such that axial displacement ofmotor18,gearbox26, and/ordriveshaft22 is limitably permitted and lateral displacement ofmotor18,gearbox26, and/ordriveshaft22 is substantially restricted).
• Spring62 may be configured with a spring constant of between 1 and 6 pounds of force per inch (lbf/in). In various embodiments,spring62 may be configured differently for different applications. For example, in embodiments of the present drivers that are configured for pediatric use, the spring may be configured with a spring constant of between 1 and 4 lbf/in (e.g., 2-3 lbf/in); in embodiments of the present drivers that are configured for adult tibia and/or humerous insertion, the spring may be configured with a spring constant of between 2 and 6 lbf/in (e.g., 3-5 lbf/in); and, in embodiments of the present drivers that are configured for adult sternal insertions, the spring may be configured with a spring constant of between 1 and 4 lbf/in (e.g., 2-3 lbf/in).
• Motors and gear assemblies satisfactory for use with a powered driver incorporating teachings of the present disclosure may be obtained from various vendors. Such motor and gear assemblies are typically ordered as “sets” with one end of each motor securely attached to an adjacent end of an associated gear assembly. A driveshaft having various dimensions and/or configurations may extend from the gear assembly opposite from the motor. The gear assemblies may sometimes be referred to as “reduction gears” or “planetary gears.” The dimensions and/or configurations of an associated housing may be modified to accommodate an associated motor and gear assembly.
• Whiledriver10 is configured such thatmotor18,gearbox26, anddriveshaft22 are axially slidable together, other embodiments may be configured such that the motor is held in a fixed axial position relative to the housing and the gearbox and the driveshaft slide relative to the motor (e.g., along a stub shaft extending from the motor), or such that the motor and gearbox are held in a fixed axial position relative to the housing and the driveshaft slides relative to the motor and gearbox, to activate the motor and rotate the driveshaft. In some embodiments, the motor is configured to rotate at a satisfactory speed and a satisfactory torque such that the gearbox can be omitted and the motor can directly drive the driveshaft.
• In the embodiment shown,housing14 defines aprimary portion78 extending betweendistal end30 andproximal end34, and a handle portion82 (e.g., having a central longitudinal axis86) extending laterally fromprimary portion78 at a non-parallel angle84 (e.g., between thirty degrees (30°) and sixty degrees (60°), and in some embodiments, up to or greater than ninety degrees)(90°) relative to axis58 of the primary portion. In this embodiment,housing14 can be described has having the general configuration of a small pistol (e.g.,housing14 resembles a pistol-grip).Handle portion82 may be described as an elongated, hollow container sized to receivebatteries40, as shown.Housing14 may be formed from relatively strong, heavy duty polymeric material. For someapplications housing14 may be formed in two halves which are joined together to form a fluid tight seal with certain components ofdriver10 disposed in the housing, as shown. In some embodiments,batteries40 are not removable fromhousing14. For example, two halves of the housing may be glued or otherwise coupled (e.g., welded) together such that the housing generally cannot be reopened (e.g., to replace batteries) without damaging the housing. In other embodiments,batteries40 may be removable for replacement and/or recharging.
• In the embodiment shown,distal end30 ofhousing14 includes anopening90 with portions ofdriveshaft22 extending therethrough. In the embodiments showndriver10 further includes an O-ring (e.g., a resilient polymeric or rubber O-ring)94 disposed arounddriveshaft22 and betweengearbox26 anddistal end30 of the housing to sealopening90. In some embodiments, at least a portion (e.g., distal end38) ofdriveshaft22 has an equilateral polygonal cross-sectional shape. For example, in the embodiment shown, a portion of the driveshaft terminating indistal end38 has a pentagonal cross-sectional shape defined by fivesurfaces98. In some embodiments, such as the one shown, surfaces98 may be tapered and/or disposed at an angle relative to axis58 (e.g., an angle of three degrees)(3°±two degrees (2°) relative to axis58). In some embodiments, a magnet can be disposed on and/or indistal end38 of the driveshaft (e.g., ordistal end38 may otherwise be magnetic). Fittings and/or connectors with various dimensions and/or configurations other than the depicted configuration ofdistal end38 of the driveshaft may also be satisfactorily used with a powered driver incorporating teachings of the present disclosure (e.g., in the shown embodiment,distal end38 ofdriveshaft22 is configured to releasably secure IO needle set160, however, in other embodiments,driveshaft22 can be configured to releasably secure other IO needle sets and comprise any associated structure).
• In the embodiment shown,driveshaft22 includes anannular groove102 configured to receive O-ring94 whendriveshaft22 is pressed fully indirection42, such that O-ring94 will contract intogroove102 and preventdriveshaft22 from returning to its extended position. This is but one example of a way in whichdriver10 can be configured as a single-use driver (e.g., to permit the use of inexpensive batteries while preventing re-use to maintain efficacy and patient safety, such as, for example, where the batteries provide sufficient power to insert a single IO device but may not provide sufficient power to insert a second IO device). In other embodiments, switch46 may be configured as a single-use switch that prevents a second activation, such as, for example, with a fuse that terminates the functionality of the switch after a single use, or a simple timer circuit that terminates the functionality of the switch after a prescribe period of time (e.g., 10 seconds) that is sufficient to insert a single IO device but not sufficient to couple a second IO device to driveshaft22 and attempt to insert the second IO device. In other embodiments,spring62 may comprise a collapsible member and/or otherwise be configured to irreversibly yield after compression. In yet other embodiments, similar single-use structure can be provided (e.g., alone or in addition to the above) through collapsible internal support members (e.g., collapsible internal tabs orprotrusions66,70, and/or74). In further embodiments, the driver is configured to have sufficient power to insert and/or re-insert up to but not more than a threshold number (e.g., 3, 4, 5, or more) of IO devices such that a user can insert, adjust the depth of, and/or re-insert an IO device with a single driver. In other embodiments,driver10 can be configured to allow removal ofbatteries40 by pressing tabs or snaps incorporated intohousing14. These tabs or snap can be located in thehandle portion82, such as one tab or snap on each side ofhandle portion82. Pressing the tabs or snaps causesbatteries40 to be released from driver10b, such as from the bottom or back side ofhandle portion82, and can render the driver inoperable for future use.
• Intraosseous (IO) devices having corresponding tapered openings or connector receptacles may be releasably engaged withdistal end38 ofdriveshaft22. For example,distal end38 extending may be releasably engaged with a tapered opening (e.g.,186) in a connector (e.g.,180) as shown inFIGS.4A and4B, which depict an example of an IO device orpenetrator assembly160 that is usable withdriver10.
• Penetrator assembly160 as shown inFIGS.4A and4B may includeconnector180, associatedhub200,outer penetrator210, andinner penetrator220.Penetrator assembly160 may include an outer penetrator such as a cannula, a hollow tube or hollow drill bit, and an inner penetrator such as a stylet or trocar. Various types of stylets and/or trocars may be disposed within an outer penetrator. For some applications, outer penetrator orcannula210 may be described as a generally elongated tube sized to receive inner penetrator orstylet220 therein. Portions ofinner penetrator220 may be disposed withinlongitudinal passageway184 extending throughouter penetrator210. The outside diameter ofinner penetrator220 and the inside diameter oflongitudinal passageway184 may be selected such thatinner penetrator220 may be slidably disposed withinouter penetrator210.
• Metallic disc170 may be disposed withinopening186 for use in releasably attachingconnector180 with a magnet disposed ondistal end38 of driveshaft22 (e.g., or an otherwise magnetic driveshaft22).End223 ofinner penetrator220 may be spaced frommetallic disc170 with insulating or electrically nonconductive material disposed therebetween. In some embodiments,metallic disc170 may be magnetic and thedistal end38 ofdriveshaft22 and/ordriveshaft22 may comprise metallic materials configured to releasably attach to the magnetic metallic disc ofconnector180.
• Tip211 ofouter penetrator210 and/or tip222 ofinner penetrator220 may be operable to penetrate bone and associated bone marrow. The configuration oftips211 and/or222 may be selected to penetrate a bone or other body cavities with minimal trauma. First end or tip222 ofinner penetrator220 may be trapezoid shaped and may include one or more cutting surfaces. In one embodiment,outer penetrator210 andinner penetrator220 may be ground together as one unit during an associated manufacturing process. Providing a matching fit allowsrespective tips211 and222 to act as a single drilling unit which facilitates insertion and minimizes damage as portions ofpenetrator assembly160 are inserted into a bone and associated bone marrow.Outer penetrator210 and/orinner penetrator220 may be formed from stainless steel, titanium, and/or other materials of suitable strength and durability to penetrate bone.
• Hub200 may be used to stabilizepenetrator assembly160 during insertion of an associated penetrator into a patient's skin, soft tissue, and adjacent bone at a selected insertion site.First end201 ofhub200 may be operable for releasable engagement or attachment with associatedconnector180.Second end202 ofhub200 may have a size and configuration compatible with an associated insertion site forouter penetrator210. The combination ofhub200 withouter penetrator210 may sometimes be referred to as a “penetrator set” or “intraosseous needle.”
• Connector180 and attachedinner penetrator220 may be releasably engaged with each other by Luer type fittings, threaded connections, and/or other suitable fittings formed onfirst end201 ofhub200.Outer penetrator210 extends fromsecond end202 ofhub200.
• For someapplications connector180 may be described as a generally cylindrical tube defined in part byfirst end181 andsecond end182. The exterior ofconnector180 may include an enlarged tapered portion adjacent to end181. A plurality oflongitudinal ridges190 may be formed on the exterior ofconnector180 to allow an operator to grasp associatedpenetrator assembly160 during attachment with a driveshaft.Longitudinal ridges190 also allowconnector180 to be grasped for disengagement fromhub200 whenouter penetrator210 has been inserted into a bone and associated bone marrow.
• Second end182 ofconnector180 may include opening185 sized to receivefirst end201 ofhub200 therein.Threads188 may be formed inopening185 adjacent tosecond end182 ofconnector180.Threads188 may be used in releasably attachingconnector180 with threaded fitting208 adjacent tofirst end201 ofhub200.
• First end201 ofhub200 may include a threadedconnector208 and/or other suitable fittings formed on the exterior thereof.First end201 may have a generally cylindrical pin-type configuration compatible with releasably engaging second end orbox end182 ofconnector180.
• For some applications end202 ofhub200 may have the general configuration of a flange. Angular slot or groove204 sized to receive one end of protective cover orneedle cap234 may be formed inend202. Slot or groove204 may be used to releasable engage needle cover234 (shown inFIG.5) withpenetrator assembly160.
• For some applications a penetrator assembly may include only a single, hollow penetrator. For other applications a penetrator assembly may include an outer penetrator such as a cannula, a hollow needle or hollow drill bit, and an inner penetrator such as a stylet, trocar or other removable device disposed within the outer penetrator.Penetrator210 is one example of a single, hollow penetrator or cannula.
• The size of a penetrator may vary depending upon the intended application for the associated penetrator assembly. Penetrators may be relatively small for pediatric patients, medium size for adults, and large for oversize adults. By way of example, a penetrator may range in length from five (5) mm to thirty (30) mm. The diameter of a penetrator may range from eighteen (18) gauge to ten (10) gauge. The length and diameter of the penetrator used in a particular application may depend on the size of a bone to which the apparatus may be applied. Penetrators may be provided in a wide variety of configurations depending upon intended clinical purposes for insertion of the associated penetrator. For example, there may be one configuration for administering drugs and/or fluids to a patient's bone marrow and an alternative configuration for sampling bone marrow and/or blood from a patient. Other configurations may be appropriate for bone and/or tissue biopsy.
• For someapplications connector180 may be described as having a generally cylindrical configuration defined in part byfirst end181 andsecond end182. Exterior portions ofconnector180 may include an enlarged tapered portion adjacent to end181. A plurality oflongitudinal ridges190 may be formed on the exterior ofconnector180 to allow an operator to grasp associatedpenetrator assembly160 during attachment with a drive shaft.Longitudinal ridges190 also allowconnector180 to be grasped for disengagement fromhub200 whenouter penetrator210 has been inserted into a bone and associated bone marrow.
• First end181 of connector of180 may include opening186 sized to receive portions driveshaft22 therein. A plurality ofwebs136 may extend radially outward fromconnector receptacle186.Webs136 may cooperate with each other to form a plurality ofopenings138 adjacent tofirst end181.Opening186 andopenings138 may cooperate with each other to form portions of a connector receptacle operable to receive respective portions of a connector (not expressly shown) therein.
• Referring now toFIGS.5-8;FIGS.5 and6 depict side views of a second embodiment10aof the present drivers with an IO needle set160 (FIGS.4A-4B) coupled to the driver (e.g., withdistal end38 ofdriveshaft22 disposed in a receptacle orrecess186 of the IO needle set);
• FIG.7 depicts a side cross-sectional view of driver10a; andFIG.8 depicts a cutaway perspective view of driver10a. Driver10ais substantially similar todriver10 with the primary exception thathousing14aof driver10ais not configured with a pistol-grip design (e.g., does not include a handle portion that is disposed at a non-parallel angle to rotational axis58 of the driveshaft. As such, similar reference numerals are used to designate components and assemblies that are similar and/or may even be identical (e.g.,driveshaft22 ofdriver10 anddriveshaft22 of driver10a) and dissimilar reference numerals are used to designate components and assemblies that necessarily differ (e.g.,driver10 and driver10a,housing14 andhousing14a).
• As noted, driver10aprimarily differs fromdriver10 in that handle portion82aofhousing14ais not disposed at a non-parallel angle relative toprimary portion78a; instead, handle portion82ais parallel to (and, in the depicted embodiment, coaxial with)primary portion78a. In this embodiment, driver10acomprises aswitch mount106 having aproximal end110, ashelf114 spaced fromproximal end110, and a pair of stepped motor guides118 extending to adistal end122 and including steps126. In the depicted embodiment,shelf114 is configured to be coupled tobody50 ofswitch46, andproximal end110 is configured to contactbatteries40 to prevent axial movement of the switch body when driver10ais assembled. In this embodiment, motor guides118 extend parallel to planar sides ofmotor18 and steps126 limit axial movement ofmotor18 relative to housing14a(e.g., similar to as described above fortabs74 of driver10). In this embodiment,housing14aincludes an openproximal end34aand anend cap130 is configured enclose the open proximal end (e.g., as shown). In the embodiment shown,end cap130 includesbarbed tabs134 configured to extend into corresponding openings inhousing14ato resist separation ofend cap130 fromhousing14a. In some embodiments,end cap130 is additionally or alternatively coupled tohousing14awith adhesive, welds, and/or the like such thatend cap130 is not removable fromhousing14awithoutdamaging end cap130 and/orhousing14a.
• In operation, an IO needle set160 can be coupled to driveshaft22 (e.g., withneedle cover234 disposed overcannula210 andtrocar220 and received inannular groove204, which is then removed prior to positioning the needle set for use). A distal end of the IO needle set can then be disposed at a desiredinsertion site142 on a patient and a force applied to the distal end of the IO device via the housing of the driver such that the driveshaft of the driver slides towardproximal end34 of the housing relative to the housing (as illustrated by the change indimension144 betweenFIGS.5 and6) and activates the motor of the driver (e.g., via operation of switch46) to rotate the driveshaft and IO device. As illustrated, the needle set may punctureskin146 andsoft tissue150 such that the force may be applied to the IO needle set and driveshaft by a layer ofcortical bone154 responsive to the force applied by a user on the housing in the direction of the insertion site. Alternatively, the threshold force required to movedriveshaft22 towardproximal end34 may be low enough (e.g.,spring62 may be weak enough), thatdriveshaft22 begins to move before the skin is punctured or before all ofsoft tissue150 is penetrated. While described with reference to driver10a, the function ofdriver10 is substantially similar in that application of a threshold force tohousing14 in the direction of an insertion site will cause motor activation via operation ofswitch46, and thus rotation of the driveshaft and IO device.
• Embodiments of the present kits can comprise an embodiment of the present drivers (e.g.,10,10a) and an IO device (e.g.,160). Some embodiments of the present kits are sterile.
• FIGS.9A-9C depict various views of another embodiment of driver10b. Driver10bis substantially similar in many respects todriver10, with the primary exceptions that: (1)handle portion82bis shaped for improved ergonomics, (2) housing14bincludesslot300 configured to receive a portion of a mechanical lockout to prevent accidental activation of driver10bfor increased safety when handling driver10b, and (3) housing14bincludes aslot304 inhandle portion82bconfigured to receive a portion of an electrical lockout for increased safety when handling driver10b. In this embodiment,slot300 is sized and positioned to allow a portion of a mechanical lockout to be inserted into housing14bto prevent rearward movement ofdriveshaft22 and thereby prevent closing of the electrical circuit that activates driver10b. Similarly, in the depicted embodiment,slot304 is sized and positioned to allow a portion of an electrical lockout to be inserted into housing14bto prevent the electrical circuit from being closed and thereby energizing driver10b(e.g., to prevent activation of the driver during sterilization, packaging, transportation, or the like).
• Referring now toFIGS.10A-10C,FIG.10A depicts a perspective view of a first embodiment ofmechanical lockout400 for use with driver10bofFIGS.9A-9C. In this embodiment,mechanical lockout400 is configured to be coupled to driver10bto prevent accidental activation of driver10b(e.g., for increased safety when handling driver10b, such as during sterilization or transportation).FIGS.10B and10C depict side and perspective views, respectively, ofmechanical lockout400 ofFIG.10A, and an embodiment of anelectrical lockout500, in combination with driver10bofFIGS.9A-9C. As shown,mechanical lockout400 is removably engaged with driver10bwithtab404 of the mechanical lockout be removably inserted intoslot300 in housing14bproximal to at least a portion ofdriveshaft22.
• For example, as illustrated inFIG.11,tab404 extends intoslot300 and is shaped to extend around and receive a reduced-diameter part of driveshaft22 (e.g., in a recess, as shown) to physically impede rearward movement ofdriveshaft22 andgearbox26. In other embodiments,slot300 could be located in housing14bcloser to proximal end34bof housing14band still physically impede rearward movement to prevent accidental activation. For instance, slot300 can be located proximal to a portion (e.g., all) ofgearbox26, or a portion (e.g., all) ofmotor18. In the embodiment illustrated inFIG.11, upon application of a threshold force ondriveshaft22 in the direction of proximal end34bof housing14b,mechanical lockout400 preventsdriveshaft22 andgearbox26 from sliding toward proximal end34bof housing14b, which preventsdriveshaft22 andgearbox26 from closing the electrical circuit betweenmotor18 andbattery40. In this embodiment,mechanical lockout400 also includesneedle cover408.
• FIG.11 depicts a cross-sectional view of the lockouts ofFIGS.10B and10C in combination with driver10b.FIG.11 depicts an embodiment ofelectrical lockout500 for increased safety when handling driver10b, such as during sterilization.Electrical lockout500 comprisesflexible strip504 that is removably inserted intoslot304 in housing14binhandle portion82bbetween two electrically conductive portions of the electrical circuit to prevent driver10bfrom energizing during sterilization. In this embodiment,strip504 can comprise a polymer, such as Mylar, and/or other non-conductive material.Electrical lockout500 can be used with driver10bin conjunction with any embodiment of the present mechanical lockouts (e.g.,mechanical lockout400 ormechanical lockout400a). As shown,electrical lockout500 can be coupled tomechanical lockout400. Coupling can be achieved, for example, by attachingstrip504 tomechanical lockout400, such as at the proximal end ofmechanical lockout400, so thatstrip504 andelectrical lockout500 can be removed in a single pull when removingmechanical lockout400.
• FIG.12A depicts a perspective view of a second embodiment ofmechanical lockout400afor use with driver10bto prevent accidental activation of driver10b(e.g., for increased safety when handling driver10b, such as during sterilization, transportation, or when applying a needle set160 to driver10b).Mechanical lockout400ais similar tomechanical lockout400, but does not include a needle cover.FIG.12B depicts a side view ofmechanical lockout400aofFIG.12A andelectrical lockout500 in combination with driver10b. In other embodiments,mechanical lockout400acan also be used with driver10bwithout an electrical lockout. As depicted inFIG.12B,mechanical lockout400ais removably engaged with driver10b.Mechanical lockout400aincludes tab404a, and similar toFIG.11, tab404acan be removably inserted intoslot300 in housing14bproximal to at least a portion ofdriveshaft22. Similar toFIG.11, upon application of a threshold force ondriveshaft22 in the direction of proximal end34bof housing14b,mechanical lockout400apreventsdriveshaft22 andgearbox26 from sliding toward proximal end34bof housing14b, which preventsdriveshaft22 andgearbox26 from closing the electrical circuit betweenmotor18 andbattery40.
• The above specification and examples provide a complete description of the structure and use of illustrative embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the methods and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than the one shown may include some or all of the features of the depicted embodiment. For example, elements may be omitted or combined as a unitary structure, and/or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and/or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments.
• The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.

Claims (1)

1. A powered driver for inserting an intraosseous device into a bone and associated bone marrow, the powered driver comprising:

a housing having a distal end and a proximal end;

a driveshaft at the distal end of the housing, the driveshaft configured to releasably connect to a portion of the intraosseous device;

a motor disposed in the housing and operable to rotate the driveshaft; and

a power source disposed in the housing and operable to power the motor through an electrical communication between the power source and the motor;

wherein the driveshaft is configured to move toward the proximal end of the housing upon application of a threshold force on the driveshaft in the direction of the proximal end of the housing to cause the electrical communication between the power source and the motor to close.

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