Patent Description:
The present disclosure generally relates to a medical apparatus for locating and accessing an intraosseous space of a patient. More specifically, the present disclosure relates to a bone-penetrating manual driver and stabilizer assembly for placement of a conduit into the intraosseous space within a bone of a patient.

Many life-threatening emergencies, including shock, trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis, arrhythmias, burns, and status epilepticus, just to name a few, often unnecessarily result in death because intravenous (IV) access cannot be achieved in a timely manner. An essential element for treating many life threatening emergencies is the rapid establishment of an IV line in order to administer drugs and fluids directly into a patient's vascular system. Whether in an ambulance by paramedics, in an emergency room by emergency specialists or on a battlefield by an Army medic, the goal is the same--quickly start an IV in order to administer lifesaving drugs and fluids. To a large degree, ability to successfully treat most critical emergencies is dependent on the skill and luck of an operator in accomplishing vascular access. While relatively easy to start an IV on some patients, doctors, nurses and paramedics may nevertheless experience difficulty establishing IV access in some patients. The success rate on the battlefield may be much lower, in which wounded soldiers are often probed repeatedly with sharp needles in an attempt to quickly establish IV access.

In the case of patients with chronic disease or the elderly, availability of easily accessible veins may be depleted. Other patients may have no available IV sites due to anatomical scarcity of peripheral veins, obesity, extreme dehydration or previous IV drug use. For such patients, finding a suitable site for administering lifesaving therapy often becomes a monumental and frustrating task. As a result, patients with life threatening emergencies may die when access to the vascular system with lifesaving IV therapy is delayed or simply not possible.

There are various circumstances under which it is desirable to introduce drugs or other liquids into the marrow of a subject's bone. For example, in cases where a subject has suffered from serious trauma or cardiac arrest it may not be practical to deliver liquids by way of intravenous (IV) infusions. Intraosseous infusion may also be useful for delivering fluids to newborns and small children in which suitable blood vessels are difficult to access. Intraosseous infusion may be used to deliver fluids into a subject's sternum, humerus, femur, tibia, or other bone. Intraosseous infusion has the advantage that, with appropriate technology, a pathway for intraosseous infusion can be established very rapidly. This can save lives in critical situations. Portals in bone may also be applied to withdraw or aspirate fluid from within the bone.

The intraosseous (IO) space provides a direct conduit to a patient's vascular system and provides an attractive alternate route to administer IV drugs and fluids. Drugs administered intraosseously enter a patient's blood circulation system rapidly, thus bone marrow may function as a large non-collapsible vein.

Proper placement of an intraosseous needle in the bone is critical. If a user attempts to insert the needle in the wrong place, the bone might be too thick and therefore difficult for the needle to penetrate. Alternatively, the bone might be too thin, in which case the needle could completely penetrate the anterior and posterior sides of the bone, thus missing the intraosseous region entirely. Also, placing the needle at an angle that is not substantially perpendicular to the surface of the bone may lead to the needle breaking, or other complications. Furthermore, certain powered drivers are unable to successfully penetrate bone when their respective power source is depleted. Additionally, the sharp penetrator tips of conventional driver assemblies can be dangerous if they are accidentally mishandled by a user prior to a planned insertion procedure. For instance, without adequate sharps protection, the user is susceptible to accidentally poking himself or another individual with the penetrator.

Documents <CIT> and <CIT> disclose examples of intraosseus access devices in the prior art.

Therefore, a need exists for a bone-penetrating manual driver and stabilizer assembly operable to locate a suitable insertion site and provide a quick and easy conduit to an intraosseous space within a bone of a patient. There is a further need for a bone-penetrating manual driver and stabilizer assembly having a first mode of operation for sternal insertion, and a second mode of operation for peripheral insertion.

Claim <NUM> defines the invention and dependent claims disclose embodiments. No surgical methods are claimed. The foregoing needs are met by implementations of an apparatus for accessing an intraosseous space within a bone of a patient according to the present disclosure. According to one aspect of the disclosure, the apparatus comprises a manual intraosseous driver including a handle and a penetrator assembly, the penetrator assembly having a sharp penetrating end configured to penetrate a bone and associated bone marrow; and a stabilizer including a retainer and a stabilizer housing; the retainer having a first retainer end, a second retainer end, and an internal passageway extending from the first retainer end to the second retainer end, the internal passageway configured to removably receive a portion of the manual intraosseous driver; and the stabilizer housing having a first housing end, a second housing end, and an internal housing section configured to receive a portion of the retainer; where the penetrator assembly is operable to provide access to a sternal intraosseous space when the manual driver is coupled to the stabilizer in a first mode of operation; and where the penetrator assembly is operable to provide access to a peripheral intraosseous space when the manual driver is decoupled from the stabilizer in a second mode of operation.

According to another aspect of the disclosure, the stabilizer further comprises a protective shield slidably disposed in the internal housing section of the stabilizer housing, the protective shield configured to move between an extended position and a retracted position during the first mode of operation.

According to another aspect of the disclosure, the extended position of the protective shield is operable to provide sharps protection from the sharp penetrating end of the penetrating assembly, and the retracted position of the protective shield is operable to expose the sharp penetrating end of the penetrating assembly to permit insertion of the penetrating assembly into the bone and associated bone marrow.

According to another aspect of the disclosure, the protective shield includes a first shield end slidably coupled to the second retainer end of the retainer.

According to another aspect of the disclosure, the stabilizer further comprises a bone probe ring having a first ring end, a second ring end coupled to the first housing end of the stabilizer housing, and a bone probe extending from the second ring end, the bone probe including a bone probe tip operable to penetrate skin and subcutaneous tissue.

According to another aspect of the disclosure, the protective shield includes a longitudinal channel configured to slidably receive the bone probe.

According to another aspect of the disclosure, the bone probe tip of the bone probe is disposed within the longitudinal channel to provide sharps protection when the protective shield is in the extended position, and wherein the bone probe tip of the bone probe extends from the longitudinal channel when the protective shield is in the retracted position.

According to another aspect of the disclosure, the stabilizer further comprises an outer sleeve slidably coupled to the bone probe ring, the outer sleeve operable to move from an undeployed position to a deployed position in the first mode of operation.

According to another aspect of the disclosure, the undeployed position of the outer sleeve permits the penetrator assembly to penetrate the skin and subcutaneous tissue, and where the deployed position of the outer sleeve permits the penetrator assembly to penetrate the bone and associated bone marrow.

According to another aspect of the disclosure, the outer sleeve includes a first detent and a second detent, the first detent spaced apart from the second detent.

According to another aspect of the disclosure, the bone probe ring is configured to releasably engage the first detent when the outer sleeve is in the undeployed position, and wherein the bone probe ring is configured to releasably engage the second detent when the outer sleeve is in the deployed position.

According to another aspect of the disclosure, the first ring end of the bone probe ring comprises a resilient arm including and outwardly protruding catch operable to engage the first detent when the outer sleeve is in the undeployed position and operable to engage the second detent when the outer sleeve is in the deployed position.

According to another aspect of the disclosure, the stabilizer further comprises a stabilizing base connected to the protective shield.

According to another aspect of the disclosure, the stabilizing base comprises a guide hole configured to guide the penetrator assembly during the first mode of operation.

According to another aspect of the disclosure, the stabilizing base comprises a through-hole aligned with the longitudinal channel of the protective shield, the through-hole configured to permit passage of the bone probe through the base during the first mode of operation.

According to another aspect of the disclosure, the stabilizing base comprises an alignment cutout operable to indicate placement of the stabilizing base against the patient's sternum during the first mode of operation.

According to another aspect of the disclosure, the intraosseous access devices comprises a safety latch operable to prevent the outer sleeve from moving from the undeployed position to the deployed position during the first mode of operation, and operable to prevent the protective shield from moving from the extended position to the retracted position during the first mode of operation.

According to another aspect of the disclosure, the first retainer end of the retainer is configured to releasably secure the manual intraosseous driver to the stabilizer.

According to another aspect of the disclosure, the manual intraosseous driver further comprises an activator, where the activator is operable to move to a locked position to lock the manual intraosseous driver to the stabilizer for intraosseous insertion of the penetrator assembly in the first mode of operation, and where the activator is operable to move to an unlocked position to unlock the manual intraosseous driver from the stabilizer for intraosseous insertion of the penetrator assembly in the second mode of operation.

According to another aspect of the disclosure, the manual intraosseous driver further comprises a collar including a collar aperture configured to partially receive a retention member when the activator is moved to the locked position.

According to another aspect of the disclosure, the manual intraosseous driver further comprises a biasing member configured to bias the activator toward the locked position.

According to another aspect of the disclosure, the penetrator assembly comprises an inner penetrator hub having a first end and a second end, the first end of the inner penetrator hub coupled to the handle, and the second end of the inner penetrator hub coupled to an inner penetrator; an outer penetrator hub having a first end and a second end, the first end of the outer penetrator hub releasably engaged to the second end of the inner penetrator hub, and the second end of the outer penetrator hub coupled to an outer penetrator defining a longitudinal hollow bore configured to slidably receive the inner penetrator.

According to another aspect of the disclosure, the inner penetrator comprises a rigid stylet.

According to another aspect of the disclosure, the outer penetrator comprises a flexible cannula.

According to another aspect of the disclosure, the handle includes an ergonomic grip suitable for grasping during the first and second modes of operation.

According to another aspect of the disclosure, the handle is configured to allow manual force to be applied and at the same time permit rotation of the handle during intraosseous insertion of the penetrator assembly.

According to another aspect of the disclosure, a method for accessing an intraosseous space of a patient comprises providing an intraosseous access device comprising a manual intraosseous driver coupled to a stabilizer, the manual intraosseous driver including a handle and a penetrator assembly, the stabilizer including a retainer having an internal passageway, and the penetrator assembly slidably received within the internal passageway and having a sharp penetrating end configured to penetrate a bone and associated bone marrow; determining a mode of operation of the intraosseous access device based on a location of a target site for intraosseous access; positioning the stabilizer over a patient's sternum and manually inserting the penetrator assembly into a sternal intraosseous space when the mode of operation is a first mode of operation; and decoupling the manual intraosseous driver from the stabilizer and manually inserting the penetrator assembly into a peripheral intraosseous space when the mode of operation is a second mode of operation.

According to another aspect of the disclosure, the stabilizer further comprises a protective shield movable between an extended position and a retracted position during the first mode of operation, where the extended position of the protective shield provides sharps protection from the sharp penetrating end of the penetrating assembly, and where the retracted position of the protective shield exposes the sharp penetrating end of the penetrating assembly to permit insertion of the penetrating assembly into the bone and associated bone marrow.

According to another aspect of the disclosure, the stabilizer further comprises a bone probe ring including a bone probe having a bone probe tip operable to penetrate skin and subcutaneous tissue, wherein the protective shield provides sharps protection from the bone probe tip when the protective shield is in the extended position, and wherein the protective shield exposes the bone probe tip of the bone probe when the protective shield is in the retracted position.

According to another aspect of the disclosure, the stabilizer further comprises an outer sleeve slidably coupled to the bone probe ring and movable from an undeployed position to a deployed position in the first mode of operation, where the penetrator assembly penetrates the skin and subcutaneous tissue when the outer sleeve is in the undeployed position, and where the penetrator assembly penetrates the bone and associated bone marrow when the outer sleeve is in the deployed position.

According to another aspect of the disclosure, the stabilizer further comprises a stabilizing base including a guide hole for guiding the penetrator assembly during the first mode of operation.

According to another aspect of the disclosure, the manual intraosseous driver further comprises an activator movable between a locked position that locks the manual intraosseous driver to the stabilizer for intraosseous insertion of the penetrator assembly in the first mode of operation, and an unlocked position that unlocks the manual intraosseous driver from the stabilizer for intraosseous insertion of the penetrator assembly in the second mode of operation.

There has thus been outlined certain aspects of the disclosure in order that the detailed description thereof may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional implementations of the disclosure that will be described below and which form the subject matter of the claims appended hereto.

In this respect, before explaining at least one aspect of the intraosseous access device in detail, it is to be understood that the apparatus is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The intraosseous access device is capable of aspects in addition to those described, and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the intraosseous access device. The scope of the invention is solely defined by the claims.

In order that the disclosure may be readily understood, aspects of the intraosseous (IO) access device are illustrated by way of examples in the accompanying drawings, in which like parts are referred to with like reference numerals throughout.

The present disclosure provides a bone-penetrating manual driver and stabilizer assembly operable to locate a suitable insertion site and penetrate the underlying bone, such as a human patient's sternum, to provide a quick and easy conduit to an intraosseous space within the bone for associated medical procedures, including delivery of fluid and medication, aspiration, and biopsy of bone marrow, among others.

<FIG> depicts a schematic view of the ribcage of a human <NUM>. The sternum <NUM> is a flat, narrow bone between the ribs <NUM> comprising three segments: the manubrium, the body, and the xiphoid process. The sternum also comprises a sternal notch <NUM> (also called the "suprasternal notch" or the "jugular notch"), which is a U-shaped anatomical feature located above the sternum, below the throat, and between the clavicles. <FIG> shows a cross-sectional view of a portion of the sternum <NUM>. Skin <NUM> overlays a layer of subcutaneous tissue <NUM>, which in turn overlays bone <NUM>. Bone <NUM> includes an intraosseous space <NUM> bounded by anterior compact bone (i.e., anterior cortex) <NUM> and posterior compact bone (i.e., posterior cortex) <NUM>. Intraosseous space <NUM> is the region between the anterior and posterior cortex. Bone marrow includes blood, blood forming cells, and connective tissue found in the intraosseous space.

Anterior compact bone <NUM> and posterior compact bone <NUM> are each approximately <NUM> millimeters (mm) thick and intraosseous space <NUM> is approximately <NUM> thick in most adult patients. Thus, the total thickness of bone <NUM> is approximately <NUM>. The target zone within the intraosseous space <NUM> is the center, which is approximately <NUM> from the upper surface of anterior compact bone <NUM> in most adult patients.

The intraosseous space <NUM> may be accessed by an intraosseous (IO) access device, which may include, but is not limited to, a penetrator assembly comprising a hollow needle, hollow drill bit, bone penetrator, catheter, cannula, trocar, stylet, inner penetrator, outer penetrator, needle or needle set, or other device operable to provide access to an intraosseous space or interior portions of a bone. Such IO access 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. A wide variety of IO access devices may be formed in accordance with one or more teachings of the present disclosure. For instance, trocars, spindles, and/or shafts may be disposed within a cannula during insertion at a selected insertion site. Inner penetrators may include such trocars, spindles, and shafts, among others. Further, inner penetrators may comprise various lengths including, but not limited to, <NUM> to <NUM> millimeters (e.g., between <NUM> and <NUM>, <NUM>, and/or the like). Outer penetrators may include catheters, cannulas, hollow needles, and hollow drill bits, among others. In some implementations, the penetrator assembly may include a flexible outer penetrator and a rigid inner penetrator as disclosed in international patent application no.

<FIG> and <FIG> depict an implementation of an intraosseous (IO) access device <NUM> and its components. In a first mode of operation, the IO access device is operable to help locate a suitable insertion site and manually penetrate underlying bone, such as a patient's sternum, to quickly and easily provide a conduit to an intraosseous space within the bone for associated medical procedures, including delivery of fluid and medication, aspiration, and biopsy of bone marrow, among others. In a second mode of operation, the IO access device is operable for manual insertion into a patient's intraosseous space at a peripheral insertion site, such as a patient's humerus or tibia.

<FIG> and <FIG>, for instance, depict an intraosseous access device <NUM> of the present disclosure in an initial position prior to use. The intraosseous access device comprises a manual intraosseous driver assembly <NUM> removably coupled to a stabilizer assembly <NUM>. The manual IO driver assembly <NUM> comprises a handle <NUM> connected to an inner penetrator hub <NUM>, which is attached to an inner penetrator <NUM>. The handle <NUM> may comprise a textured outer surface to provide an anti-slip grip for the user. The inner penetrator <NUM> may, for example, take the form of any suitable stylet or trocar, as previously discussed above. The inner penetrator <NUM> includes a distal end having a tip <NUM> operable to penetrate bone and associated bone marrow. The inner penetrator <NUM> further includes a proximal end that may have a notch <NUM> configured to assist in coupling the inner penetrator hub <NUM> to the inner penetrator <NUM>. For instance, the inner penetrator hub <NUM> may be overmolded over the inner penetrator <NUM> such that the material from the inner penetrator hub may be molded to extend into the notch <NUM>. The inner penetrator <NUM> extends from the distal end <NUM> of the inner penetrator hub <NUM>.

The manual intraosseous driver assembly <NUM> also includes an outer penetrator hub <NUM> that is coupled to an outer penetrator <NUM>. A distal end <NUM> of the inner penetrator hub <NUM> is configured to releasably engage the outer penetrator hub <NUM>, as will be discussed in further detail below. The outer penetrator <NUM> may, for example, take the form of a hollow tube, such as cannula (e.g., a metal cannula), or a hollow drill bit, and which may be configured (e.g., to possess sufficient rigidity) such that the outer penetrator <NUM> will not buckle or otherwise be damaged as it is inserted through anterior compact bone together with the inner penetrator <NUM>. The outer penetrator hub <NUM> includes a proximal end <NUM> and a distal end <NUM>. The outer penetrator <NUM> also includes a proximal end <NUM> and a distal end <NUM>, the proximal end <NUM> coupled to the outer penetrator hub <NUM>. The outer penetrator distal end <NUM> includes a cutting surface operable to penetrate bone and associated marrow. The outer penetrator <NUM> extends from the distal end <NUM> of the outer penetrator hub <NUM>.

The inner penetrator hub <NUM> is configured to removably attach to the outer penetrator hub <NUM>. More particularly, the proximal end <NUM> of the outer penetrator hub <NUM> and the distal end <NUM> of the inner penetrator hub <NUM> may be configured as complimentary connectors (with, for example, distal end <NUM> being configured as a female Luer connector and proximal end <NUM> being configured as a male Luer connector, though these configurations could be reversed in other implementations) to allow the handle <NUM> to be removably coupled to the outer penetrator <NUM>. Further, a distal end <NUM> of the inner penetrator hub <NUM> may include a male projection that is tapered to match an inwardly-tapered passageway at the proximal end <NUM> of the outer penetrator hub <NUM>. In other implementations, for example, the outer penetrator hub <NUM> may include an internal surface or an external surface that is threaded and that is proximate a passageway that is in fluid communication with the passageway of outer penetrator. The inner penetrator hub <NUM> may include a complimentary external surface or internal surface that is threaded to mate with the corresponding threaded surface of the outer penetrator hub <NUM>.

The outer penetrator <NUM> comprises a longitudinal passageway configured to slidably receive a portion of the inner penetrator <NUM> when the inner penetrator hub <NUM> is attached to the outer penetrator hub <NUM>, thus forming a penetrator assembly. The handle <NUM> of the manual IO driver assembly is configured to manually drive the penetrator assembly into an intraosseous space, such that the handle has a shape suitable for grasping during manual insertion of the inner and outer penetrators into the bone and associated bone marrow. The handle <NUM> is configured to allow manual force to be applied and at the same time permit rotation of the handle during insertion of the penetrator assembly into the IO space.

When the inner penetrator hub <NUM> and the outer penetrator hub <NUM> are coupled to each other, the inner penetrator <NUM> is disposed within the passageway of the outer penetrator <NUM>, and the inner penetrator tip <NUM> extends beyond the distal end <NUM> of the outer penetrator <NUM>. The inner penetrator tip <NUM> and the outer penetrator distal end <NUM> are each operable to penetrate bone and associated bone marrow. More particularly, the inner penetrator tip <NUM> and the outer penetrator distal end <NUM> are configured to cooperate with each other to form a penetrator assembly tip operable to penetrate bone and associated bone marrow when the inner penetrator hub <NUM> is attached to the outer penetrator hub <NUM>.

The tip <NUM> of the inner penetrator <NUM> is pointed and configured to allow the IO access device <NUM> to be driven into an intraosseous space, such as intraosseous space <NUM>. The inner penetrator <NUM> fits closely within the passageway of the outer penetrator <NUM> such that the inner penetrator <NUM> prevents the outer penetrator <NUM> from becoming clogged with tissue (e.g., skin, bone, marrow) as the IO access device is driven into an insertion site of a subject (e.g., a patient). The inner penetrator tip <NUM> and the outer penetrator distal end <NUM> may be ground together to form corresponding cutting surfaces in some implementations where both the inner penetrator <NUM> and the outer penetrator <NUM> comprise a suitable metal. In other implementations, the inner penetrator tip <NUM> and the outer penetrator distal end <NUM> may be ground separately to form corresponding cutting surfaces configured to penetrate bone and associated marrow. Once the IO access device is properly positioned at the insertion site, the inner penetrator hub <NUM> can be disengaged from the outer penetrator hub <NUM> such that the proximal end <NUM> (which may take the form of a male Luer lock) is exposed and a conduit is formed from the outer penetrator hub <NUM> through the outer penetrator <NUM> to the intraosseous space. A fluid source may then be coupled to the proximal end <NUM> of the outer penetrator hub <NUM> to deliver fluid through the outer penetrator <NUM> into the intraosseous space.

A proximal end <NUM> of the inner penetrator hub <NUM> includes a recess <NUM> configured to receive an activator <NUM>, such as a push button. The recess <NUM> at the proximal end <NUM> of the inner penetrator hub <NUM> is aligned with a through-hole <NUM> in a top surface of the handle <NUM> to provide access to the activator <NUM>. Activation of the activator <NUM> disengages the manual IO driver assembly <NUM> from the stabilizer assembly <NUM> to switch the IO access device to the second mode of operation in which the manual driver assembly is operable for manual insertion into a patient's intraosseous space at a peripheral insertion site, as will be further described in detail below.

The stabilizer assembly <NUM> comprises an outer sleeve <NUM> configured to slidably fit over a bone probe ring <NUM>. Both the outer sleeve <NUM> and the bone probe ring <NUM> have a generally cylindrical shape. An interior surface of the outer sleeve <NUM> includes a first annular detent <NUM> and a spaced apart second annular detent <NUM>. The bone probe ring <NUM> includes a first end <NUM> configured to releasably engage the first annular detent <NUM> when the outer sleeve is in a first or undeployed position, and releasably engage the second annular detent <NUM> when the outer sleeve is in a second or deployed position. In particular, the first end <NUM> includes a plurality of circumferentially spaced apart resilient arms <NUM>, each arm including an outwardly protruding catch <NUM> operable to engage the first annular detent <NUM> when the outer sleeve <NUM> is in the first position, and engage the second annular detent <NUM> when the outer sleeve is in the second position. The resiliency of the arms <NUM> allows the respective protrusions <NUM> to snap into engagement with the corresponding detents <NUM>, <NUM>. A first grip sleeve <NUM> may be fit over the outer sleeve to provide an anti-slip grip for the user.

The bone probe ring <NUM> further comprises a second end <NUM> including an inwardly extending flange having an underside with a plurality of openings from which respective bone probes <NUM> extend. For instance, the flange may include five openings corresponding to five bone probes, although other implementations may have more or less openings and corresponding bone probes. In some implementations, a single bone probe may be provided. In other implementations, a plurality of bone probes (for example <NUM> or <NUM> bone probes) may be provided. The bone probes may be arranged so that they stabilize the IO access device during insertion of a penetrator assembly into the intraosseous space at a desired location and orientation. For example, three bone probes may be arranged in a triangle surrounding the inner and outer penetrators.

As shown in <FIG>, each probe <NUM> comprises a pointed tip <NUM>, a plurality of circumferential grooves or notches <NUM>, and a proximal end <NUM>, where the annular notches <NUM> are closer to the proximal end <NUM> than to the tip <NUM>. The probes <NUM> may comprise stainless steel, though other suitable sterile or biocompatible materials (or materials capable of being made sterile before use on a patient) may be used. The proximal end <NUM> is configured to be inserted into the respective opening in the second end <NUM> of the bone probe ring <NUM>. In some implementations, the bone probes <NUM> may be fixed to the bone probe ring <NUM>, such as by being bonded using UV-curable adhesive applied to the annular grooves <NUM> and/or the proximal end <NUM> of the probe <NUM>. In other implementations, the bone probes <NUM> may be force fit through the respective openings such that they are held in place by an interference fit. In still other implementations, the probes <NUM> may be fixed to the bone probe ring <NUM> as part of an injection molding process or using epoxy. <FIG> depict another implementation of bone probes 230a that are suitable for use with the stabilizer assembly <NUM>. Each probe 230a comprises a pointed tip 232a, a groove or notch 234a, and a proximal end 236a, where the notch 234a is closer to the proximal end 236a than to the tip 232a. Each probe 230a may comprise stainless steel, though other suitable sterile or biocompatible materials (or materials capable of being made sterile before use on a patient) may be used. The proximal end 236a is configured to be inserted into the respective opening in the second end <NUM> of the bone probe ring <NUM>. Probes 230a may be fixed to the bone probe ring <NUM>, such as by being bonded using UV-curable adhesive applied to the notch 234a and/or the proximal end 236a of the probe 230a. In other implementations, the probe 230a may be force fit in the respective opening in the flange of the bone probe ring <NUM>, thus being held in place by an interference fit. In other implementations, the probes 230a may be fixed to the bone probe ring <NUM> as part of an injection molding process or using epoxy. Each probe <NUM>, 230a may comprise any of various lengths.

The second end <NUM> of the bone probe ring <NUM> is connected to a stabilizer housing <NUM>. A second grip sleeve <NUM> may be fit over the outer sleeve stabilizer housing <NUM> to provide an anti-slip grip for the user. The stabilizer housing <NUM> includes a first end <NUM> connected to the second end <NUM> of the bone probe ring. The stabilizer housing <NUM> further includes a second end <NUM> from which each bone probe <NUM> extends. The stabilizer housing <NUM> has an internal passageway <NUM> configured to slidably receive a protective shield <NUM>.

The stabilizer assembly further comprises a retainer <NUM> having a first end <NUM> fixedly disposed within the bone probe ring <NUM>. A second end <NUM> of the retainer <NUM> is slidably coupled to the protective shield <NUM>. The protective shield <NUM> has in internal passageway <NUM> configured to slidably receive a portion of the retainer <NUM>. The retainer <NUM> has an internal passageway <NUM> configured to removably receive a portion of the manual IO drier assembly <NUM>. The first end <NUM> of the retainer <NUM> is configured to lock the manual IO driver assembly <NUM> to the stabilizer assembly <NUM>. In particular, the first end <NUM> includes a pair of oppositely spaced apart retention seats <NUM>. The first end <NUM> of the retainer <NUM> is configured to receive the inner penetrator hub <NUM>. Further, a collar <NUM> is disposed between the inner penetrator hub <NUM> and the retainer <NUM>. A pair of retention members, such as balls <NUM>, are partly received in the respective retention seats <NUM> of the retention member. The balls <NUM> serve to couple the retainer <NUM> to the inner penetrator hub <NUM> and collar <NUM>. The balls <NUM> are of a diameter slightly smaller than the retention aperture <NUM> of the inner penetrator hub, but are slightly larger than corresponding collar apertures <NUM> of the collar <NUM>. The balls <NUM> therefore fit partly in the respective collar apertures <NUM> of the collar such that they abut the retention seat <NUM> of the retainer, coupling the inner penetrator <NUM> to the retainer <NUM>, and thus locking the manual IO driver assembly <NUM> to the stabilizer assembly <NUM>. The second end <NUM> of the retainer includes a plurality of resilient fingers <NUM> annularly disposed along a circumference of the second end <NUM>, each finger including a respective ridge or nub <NUM> protruding radially outward therefrom.

The protective shield <NUM> includes a first end <NUM> having an inwardly extending annular flange <NUM>. The protective shield <NUM> is operable to move from a first or extended position to provide sharps protection from the distal ends of the inner and outer penetrators <NUM>, <NUM> as well as the bone probes <NUM>, and a second or retracted position to expose the respective inner and outer penetrators <NUM>, <NUM> and the bone probes <NUM> during an insertion procedure. The respective ridges or nubs <NUM> disposed on the resilient fingers <NUM> of the retainer <NUM> are operable engage the annular flange <NUM> of the protective shield <NUM> to limit how far the protective shield extends from the stabilizer housing <NUM> in the first or extended position. The protective shield <NUM> also includes a plurality of longitudinal channels <NUM> annularly disposed around the circumference of the shield, each channel <NUM> configured to slidably receive a corresponding bone probe <NUM>. When the protective shield is in a first or extended position, the tips <NUM> of each bone probe <NUM> are disposed within the respective channels <NUM> to provide sharps protection. When the protective shield is in a second or retracted position, the tips <NUM> of each bone probe <NUM> extend from the respective channels <NUM>. In some implementations, a portion of at least one of the channels <NUM> may include a safety clip assembly operable to secure the respective bone probe <NUM>.

A base <NUM> is connected to a second end <NUM> of the retractable shield <NUM>. The base comprises a guide hole <NUM> configured to guide the penetrator assembly during an insertion procedure. The base <NUM> also comprises a plurality of through-holes <NUM> corresponding to, and aligned with, the plurality of channels <NUM> of the protective shield <NUM>. The through-holes <NUM> are configured to permit passage of the respective bone probes through the base <NUM> during an insertion procedure. The base <NUM> may also comprise an alignment cutout <NUM>, such as an arc-shaped portion of the base. The alignment feature <NUM> is configured to approximate the shape of the sternal notch of a human patient and is operable to indicate proper placement of the base <NUM> against the patient. The stabilizer assembly <NUM> is properly located on the chest of a patient when the base <NUM> is placed over the sternum such that the sternal notch is visible and at least partially (and, preferably, completely) bounded by alignment cutout <NUM>. The second end <NUM> of the stabilizer housing <NUM> and/or the second grip sleeve <NUM> may have a shape similar to that of base <NUM>. This helps the user to quickly position the base <NUM> in appropriate alignment with a subject for insertion of a bone probe <NUM>.

A safety latch <NUM> is operable to prevent the stabilizer assembly <NUM> from moving from the first or extended position to the second or retracted position. In particular, the safety latch <NUM> includes a first end <NUM> configured to engage the outer sleeve <NUM> when the outer sleeve is in the first or extended position. Further, the safety latch <NUM> includes a second end <NUM> defining a pin portion configured to engage the protective shield <NUM> when the protective shield is in the first or extended position. The protective shield <NUM> includes a side aperture <NUM> configured to removably receive the pin portion of the second end <NUM> of the latch <NUM>. A user may remove the safety latch <NUM> from the stabilizer assembly <NUM> by pulling a tab <NUM> to disengage the second end <NUM> from the side aperture <NUM> of the protective shield <NUM>, thus permitting the stabilizer assembly <NUM> to move to the second or retracted position.

As previously described, the IO access device <NUM> may be used in a first mode of operation to help locate a suitable insertion site and manually penetrate underlying bone, such as a patient's sternum, for quickly and easily providing a conduit to an intraosseous space within the bone. Prior to use, in an initial position of this first mode of operation, the manual IO driver assembly <NUM> is attached to the stabilizer assembly <NUM>. Further, both the outer sleeve <NUM> and the protective shield <NUM> are in their respective first or extended positions prior to use.

Prior to use, the user first must remove the safety latch <NUM> from the IO access device by pulling on the tab <NUM>, thereby disengaging the second end <NUM> from the side aperture <NUM> of the protective shield <NUM>. In particular, the pin portion of the safety latch <NUM> must be removed from the side aperture <NUM> of the shield <NUM> before the IO access device can be used in an intraosseous insertion procedure. The pin prevents operation of the IO access device when inserted into the aperture <NUM> by blocking the shield <NUM> from telescoping into the stabilizer housing <NUM>. The locking pin may be inserted during manufacture or before use of IO access device, and removed to prepare the IO access device for use.

The IO access device may be operated by placing the base <NUM> against the skin of a patient over a bone into which it is desired to insert the penetrator assembly. The base <NUM> has an arc-shaped alignment cutout <NUM> that helps a user align the IO access device with a patient's sternal notch. In other implementations, guide features may be provided to facilitate alignment with anatomical landmarks at other infusion sites. The user operates the IO access device by first pushing on the handle <NUM>, as depicted in <FIG>. As the handle <NUM> is pushed, the shield <NUM> telescopes into the stabilizer housing <NUM> to move from its first or extended position to its second or retracted position. As the shield <NUM> telescopes into the stabilizer housing <NUM>, the penetrator assembly <NUM>, <NUM>, as well as the surrounding bone probes <NUM>, penetrate the patient's skin and underlying soft tissue. The base <NUM> assists in keeping the IO access device <NUM> over the desired insertion site and in the desired orientation. During use, the base <NUM> is substantially perpendicular to the penetrator assembly and assists in introducing the inner and outer penetrators <NUM>, <NUM> straight into the patient's sternum.

A first depth of insertion of the inner and outer penetrators <NUM>, <NUM> is determined when the tips <NUM> of the respective bone probes <NUM> contact the bone. At this first depth of insertion, the inner and outer penetrators <NUM>, <NUM> are inserted the same distance as the bone probes <NUM>, and therefore the inner and outer penetrators do not yet penetrate into the intraosseous space. Insertion of the inner and outer penetrators <NUM>, <NUM> into the intraosseous space is then carried out by the user pushing the handle <NUM> again to slide the outer sleeve <NUM> over the bone probe ring <NUM> toward the stabilizer housing <NUM>. In other words, the outer sleeve <NUM> is moved from its first or extended position to its second or retracted position, as depicted in <FIG>, to deploy the inner and outer penetrators <NUM>, <NUM> into the intraosseous space. As the outer sleeve <NUM> is moved from its first or extended position to its second or retracted position, the catch <NUM> on each resilient arm <NUM> at the first end of the bone probe ring <NUM> disengages the first annular detent <NUM> of the outer sleeve to unlock the outer sleeve from its first or extended position. The catch <NUM> then engages the second annular detent <NUM> of the bone probe ring <NUM> to lock the outer sleeve <NUM> in its second or retracted position. Each catch <NUM> may have a uniform but asymmetrical tooth shape having a slope on at least one edge. Similarly, the first and second annular detents <NUM>, <NUM> may have a uniform but asymmetrical tooth shape having a slope on at least one edge corresponding to that of the teeth. When the outer sleeve <NUM> is moved from its extended position to its retracted position, the catch <NUM> of the bone probe ring <NUM> easily slide up and over the gently sloped edges of the first and second annular detents. The resilient arms <NUM> force the teeth of the catch into the depression between the teeth of the detents as it passes the tip portion of each tooth, thus resulting in an audible snap or click indicating to the user that the outer sleeve is locked in its second or retracted position. The outer sleeve is prevented from sliding back to its first or extended position because the catch <NUM> abuts against the steeply sloped edge of the second annular detent <NUM>, thereby locking the outer sleeve in the retracted position. In some implementations, the handle <NUM> may be twisted to deploy the inner and outer penetrators <NUM>, <NUM> into the intraosseous space.

As shown in <FIG>, once the inner and outer penetrators <NUM>, <NUM> have penetrated the patient's bone to a desired depth, a release mechanism uncouples the base <NUM> from the protective shield. The outer penetrator hub <NUM> is also uncoupled form the from the inner penetrator hub <NUM> (and thus the outer penetrator <NUM> is likewise uncoupled from the inner penetrator <NUM>). The depth is typically set so that the insertion of the inner and outer penetrators <NUM>, <NUM> will stop when their tip are in the patient' bone marrow. After the release mechanism is triggered, the manual driver and stabilizer assembly may be withdrawn from the insertion site to leave in place the base <NUM>, the outer penetrator hub <NUM>, and the outer penetrator <NUM>. As the stabilizer assembly <NUM> is removed from the insertion site, the protective shield <NUM> is urged outwardly from the stabilizer housing <NUM> back to its first or extended position so as to protect any users from inadvertent contact with the bone probes <NUM>. The base <NUM> may be adhered to the patient's skin to protect the infusion site and to provide an anchor for strain relief for any tubing that may be coupled to the infusion tube assembly, or to provide strain relief for other tubing systems, catheters, or the like. Further, a flexible outer penetrator may be utilized so that it may be manipulated and fixed to the patient after the stabilizer assembly is removed in order to provide a lower profile (i.e., by bending the outer penetrator down to secure it against the skin).

In a second mode of operation, the IO access device is operable for manual insertion into a patient's intraosseous space at a peripheral insertion site. Prior to use, in an initial position of the second mode of operation, the manual IO driver assembly <NUM> is attached to the stabilizer assembly <NUM>. Further, both the outer sleeve <NUM> and the protective shield <NUM> are in their respective first or extended positions prior to use. In this second mode of operation, however, the user is able to detach the manual IO driver assembly <NUM> from the stabilizer assembly <NUM> so that the manual IO driver assembly can be used without the stabilizer assembly at a peripheral insertion site.

To disengage the manual IO driver assembly <NUM> from the stabilizer assembly <NUM>, the user first must remove the safety latch <NUM> from the IO access device by pulling on the tab <NUM>, thereby disengaging the second end <NUM> from the side aperture <NUM> of the protective shield <NUM>. Next, the user actuates the activator <NUM> to begin the decoupling process. The activator <NUM> includes ahead portion <NUM> and a neck portion <NUM>. The head portion <NUM> is disposed in the through-hole <NUM> of the handle <NUM>, and the neck portion <NUM> is disposed in the recess <NUM> of the inner penetrator hub <NUM>. Actuation of the activator <NUM> includes a user pushing down on the head portion <NUM>, as shown in <FIG>. A biasing member, such as a compression spring, may be provided between a bottom surface of the recess <NUM> and the neck portion <NUM> of the activator <NUM> to bias the activator toward a locked position. As the head portion <NUM> is pushed down against the biasing force of the biasing member, the neck portion <NUM> correspondingly moves downward further into the recess of the inner penetrator hub <NUM>. The thin neck portion <NUM> aligns with the retention apertures <NUM> and the collar apertures <NUM> as it is slid downward, allowing the retention balls <NUM> to move into the recess <NUM> of the inner penetrator hub and out of the retention seat of the retainer <NUM>, thus unlocking the inner penetrator from the retainer. Once the inner penetrator is unlocked from the retainer, the manual IO driver assembly <NUM> may be completely detached and removed from the stabilizer assembly <NUM> by pulling it out of the stabilizer, as illustrated in <FIG> and <FIG>. Consequently, the manual IO driver assembly <NUM> may be used for peripheral insertion of the inner and outer penetrators <NUM>, <NUM> into an intraosseous space at a peripheral insertion site.

Once access to the bone marrow is achieved, the user may further detach the outer penetrator hub <NUM> from the inner penetrator hub <NUM> as shown in <FIG>, thus leaving the outer penetrator within the intraosseous space, as previously described above. Also, as previously described above, a flexible outer penetrator may be utilized so that it may be manipulated and secured to the patient after insertion within the intraosseous space in order to provide a lower profile (i.e., by bending the outer penetrator down to secure it against the patient's skin).

While the intraosseous access device has been described in terms of what may be considered to be specific aspects, the present disclosure is not limited to the disclosed aspects. Moreover, the many features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the disclosure which fall within the scope of the disclosure. Further, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure. Accordingly, the present disclosure should be considered as illustrative and not restrictive. As such, this disclosure is intended to cover various modifications and similar arrangements included within the scope of the claims, which should be accorded their broadest interpretation so as to encompass all such modifications and similar structures.

While the intraosseous access device has been described in terms of what may be considered to be specific aspects, the present disclosure is not limited to the disclosed aspects. Moreover, the many features and advantages of the disclosure are apparent from the detailed specification.

Claim 1:
An intraosseous access device comprising:
a manual intraosseous driver (<NUM>) including a handle (<NUM>), an activator (<NUM>), and a penetrator assembly (<NUM>,<NUM>), the penetrator assembly having a sharp penetrating end configured to penetrate a bone and associated bone marrow; and
a stabilizer (<NUM>) including a retainer (<NUM>) and a stabilizer housing (<NUM>);
the retainer (<NUM>) having a first retainer end (<NUM>), a second retainer end (<NUM>), and an internal passageway (<NUM>) extending from the first retainer end (<NUM>) to the second retainer end (<NUM>), the internal passageway (<NUM>) configured to removably receive a portion of the manual intraosseous driver (<NUM>); and
the stabilizer housing (<NUM>) having a first housing end (<NUM>), a second housing end (<NUM>), and an internal housing section configured to receive a portion of the retainer (<NUM>);
where the activator (<NUM>) is configured to move to a locked position to lock the manual intraosseous driver (<NUM>) to the stabilizer (<NUM>) for intraosseous insertion of the penetrator assembly in a first mode of operation, and the penetrator assembly is operable to provide access to a sternal intraosseous space when the manual driver (<NUM>) is coupled to the stabilizer (<NUM>) in the first mode of operation; and
where the activator (<NUM>) is configured to move to an unlocked position to unlock the manual intraosseous driver (<NUM>) from the stabilizer (<NUM>) for intraosseous insertion of the penetrator assembly in a second mode of operation, and the penetrator assembly is operable to provide access to a peripheral intraosseous space when the manual driver (<NUM>) is decoupled from the stabilizer (<NUM>) in the second mode of operation.