Bone penetrating intraosseous access device

Abstract

An intraosseous access device is operable to provide access to a sternal intraosseous space in a first mode of operation and is operable to provide access to a peripheral intraosseous space in a second mode of operation. The device includes an outer cannula, an inner penetrator hub, and an outer penetrator hub. A guard is telescopically connected to the outer cannula. The guard is operable in the first and second modes of operation to move from an extended position to a retracted position. A bone probe ring is disposed within the guard and is configured to move between the extended and retracted positions in the first and second modes of operation. An actuator is operable to manually move the guard and the bone probe ring to the retracted position when in the second mode of operation.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 865,177, filed June 22, 2019, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention generally relates to a medical device for locating and accessing a patient's intraosseous space. More specifically, this invention relates to a bone-penetrating intraosseous access device for placing a catheter into an intraosseous space within a patient's bone. Background Technology

[0004] Many life-threatening emergencies, including shock, trauma, cardiac arrest, drug overdose, diabetic ketoacidosis, arrhythmia, burns, and status epilepticus, to name a few, often result in unnecessary death due to the inability to establish intravenous (IV) access in a timely manner. A fundamental element of treating many life-threatening emergencies is the rapid establishment of an IV line to deliver medications and fluids directly into the patient's vascular system. Whether in a paramedic's ambulance, an emergency room specialist's office, or on the battlefield with an Army medic, the goal is the same: to rapidly initiate an IV to administer life-saving medications and fluids. To a large extent, the ability to successfully treat most emergencies depends on the operator's skill and luck in establishing vascular access. While initiating an IV can be relatively easy on some patients, doctors, nurses, and caregivers may find it difficult to establish IV access in certain situations. Success rates on the battlefield can be much lower, with wounded soldiers often repeatedly probed with sharp needles in an attempt to establish IV access quickly.

[0005] For patients with chronic illnesses or the elderly, the availability of easily accessible veins may be exhausted. Other patients may lack available intravenous sites due to poor peripheral venous anatomy, obesity, severe dehydration, or a history of intravenous medication administration. For such patients, finding a suitable site for life-saving treatment often becomes a daunting and frustrating task. Therefore, patients in life-threatening emergencies may die when access to the vascular system for life-saving intravenous therapy is delayed or simply impossible.

[0006] In many situations, it is necessary to introduce medications or other fluids into the bone marrow of a subject. For example, in cases of severe trauma or cardiac arrest, intravenous (IV) infusion may be impractical. Intraosseous infusion can also be used to deliver fluids to newborns and young children where access to suitable blood vessels is difficult. Intraosseous infusion can be used to deliver fluids to the sternum, humerus, femur, tibia, or other bones of a subject. The advantage of intraosseous infusion is that, with appropriate techniques, an intraosseous infusion route can be established very rapidly. This can be life-saving in critical situations. Intraosseous access points can also be used to aspirate or aspirate fluids from within the bone.

[0007] Intraosseous (IO) space provides a direct channel to the patient's vascular system and offers an attractive alternative route for administering intravenous medications and fluids. Intraosseous drugs enter the patient's circulatory system rapidly, allowing the bone marrow to function as an indestructible large vein.

[0008] Proper placement of the intraosseous pin within the bone is crucial. If the user attempts to insert the pin in the wrong location, the bone may be too thick, making penetration difficult. Alternatively, the bone may be too thin, in which case the pin may penetrate completely through both the front and back of the bone, missing the entire intraosseous area. Furthermore, placing the pin at an angle substantially non-perpendicular to the bone surface can lead to pin breakage or other complications. Additionally, some powered drives fail to penetrate bone successfully when their respective power supplies are depleted. Moreover, the sharp penetrator tips of conventional drive components can be dangerous if the user accidentally mishandles them before the planned insertion procedure. For example, without sufficient protection from sharp points, the user could easily puncture themselves or another person with the penetrator.

[0009] Therefore, there is a need for a bone-penetrating manual actuator and stabilizer assembly that is operable to locate the appropriate insertion site and provides rapid and easy access to the intraosseous space within the patient's bone. There is also a need for a bone-penetrating manual actuator and stabilizer assembly having a first operating mode for sternal insertion and a second operating mode for peripheral insertion. Summary of the Invention

[0010] The aforementioned needs are met by an embodiment of the device according to the invention for accessing the intraosseous space within a patient's bone. According to one aspect of the invention, the device includes an intraosseous access device comprising a penetrator assembly having a sharp penetrating end operable to penetrate bone and associated bone marrow; a housing having an inner cavity and an outer sleeve defining a handle operable to manually drive the penetrator assembly into the bone and associated bone marrow; a retainer having a distal retainer end and a proximal retainer end slidably connected to the outer sleeve; and a protective shield having a distal shield end, a proximal shield end, and a longitudinally hollow channel extending between the distal and proximal shield ends, the protective shield being slidably connected to the outer sleeve; wherein, when the intraosseous access device is in a first operating mode, the penetrator assembly is operable to provide intraosseous access at a sternal insertion site; and wherein, when the intraosseous access device is in a second operating mode, the penetrator assembly is operable to provide intraosseous access at a peripheral insertion site.

[0011] According to another aspect of the invention, the penetrator assembly further includes an inner penetrator hub having a distal end and a proximal end, an inner penetrator extending from the distal end of the inner penetrator hub, an outer penetrator hub having a distal end and a proximal end, and an outer penetrator extending from the distal end of the outer penetrator hub, the outer penetrator being a longitudinal hollow aperture configured to slidably receive the inner penetrator.

[0012] According to another aspect of the invention, the proximal end of the outer penetrator hub is releasably engaged with the distal end of the inner penetrator hub.

[0013] According to another aspect of the invention, the housing core is fixedly disposed within the inner cavity of the housing, and the housing core includes a distal core end connected to the proximal end of the inner penetrator hub.

[0014] According to another aspect of the invention, the inner penetrator includes a rigid core needle, and the outer penetrator includes a flexible sleeve.

[0015] According to another aspect of the invention, the handle includes an ergonomic grip suitable for gripping during first and second operating modes.

[0016] According to another aspect of the invention, the handle is configured to allow the application of hand force during intraosseous insertion of the penetrator assembly during both first and second operating modes, and simultaneously allow rotation of the handle to rotate the penetrator assembly.

[0017] According to another aspect of the invention, the protective cover is configured to move between an extended position and a retracted position relative to the outer sleeve and the retainer during a first operating mode.

[0018] According to another aspect of the invention, the protective shield is configured to provide sharp-point protection against the sharp penetrating end of the penetrating device assembly when the shield is in an extended position during a first operating mode, and wherein the protective shield is configured to expose the sharp penetrating end of the penetrating device assembly when the shield is in a retracted position during the first operating mode, so as to allow the penetrating device assembly to be inserted into the bone and associated bone marrow.

[0019] According to another aspect of the invention, a first biasing member is provided between the retainer and the protective cover, the first biasing member being configured to bias the protective cover toward the extended position during a first operating mode.

[0020] According to another aspect of the invention, the first biasing member includes a compression spring.

[0021] According to another aspect of the invention, a bone probe ring is slidably connected to a retainer, the bone probe ring having a distal ring end and a proximal ring end.

[0022] According to another aspect of the invention, the bone probe extends from the distal end of the bone probe ring, and the bone probe includes a bone probe tip operable to penetrate the skin and subcutaneous tissue.

[0023] According to another aspect of the invention, the bone probe tip of the bone probe is disposed within the longitudinal channel of the protective cover to provide sharps protection when the protective cover is in the extended position during a first operating mode, and wherein the bone probe tip of the bone probe extends from the longitudinal channel of the protective cover when the protective cover is in the retracted position during the first operating mode.

[0024] According to another aspect of the invention, the bone probe ring is configured to move between a first position and a second position during a first operating mode, wherein when the bone probe ring is in the first position, it is closer to the distal end of the retainer than when it is in the second position.

[0025] According to another aspect of the invention, the distal end of the bone probe ring includes an inwardly projecting protrusion configured to engage a first pawl on a retainer to hold the bone probe ring in a first position during a first operating mode, and the protrusion is configured to engage a second pawl on the retainer to hold the bone probe ring in a second position during the first operating mode.

[0026] According to another aspect of the invention, the protrusion is operable to engage with a second pawl on the retainer.

[0027] According to another aspect of the invention, feedback is provided to the user when the protrusion engages with the second pawl on the retainer.

[0028] According to another aspect of the invention, the feedback includes at least one of an auditory response and a tactile response instructing the penetrator assembly to insert into the intraosseous space.

[0029] According to another aspect of the invention, a second biasing member is provided between the retainer and the bone probe ring, the second biasing member being configured to bias the bone probe ring toward a first position during a first operating mode.

[0030] According to another aspect of the invention, the second biasing member includes a compression spring.

[0031] According to another aspect of the invention, the stabilizer base is releasably connected to the distal end of the protective shield.

[0032] According to another aspect of the invention, the stabilizer base includes an alignment incision configured to align with the patient's sternal notch to indicate proper placement of the intraosseous access device at the sternal insertion site during a first operating mode.

[0033] According to another aspect of the invention, the stabilizer base also includes a guide hole configured to guide the penetrator assembly during a first operating mode.

[0034] According to another aspect of the invention, the outer tube further includes a longitudinal rail and a slider slidably connected to the longitudinal rail, the slider being operable to move the retainer and the protective cover between an deployed position and an undeployed position relative to the outer tube during a second operating mode.

[0035] According to another aspect of the invention, the protective shield is configured to provide sharp-point protection during a second operating mode when the shield is in the deployed position, preventing sharp-point penetration of the penetrator assembly; and wherein the protective shield is configured to expose the sharp-point penetration of the penetrator assembly during a second operating mode when the shield is in the undeployed position, to allow insertion of the penetrator assembly into the bone and associated bone marrow.

[0036] According to another aspect of the invention, the slider is configured to move between an engaged position with the housing core and a disengaged position with the housing core, wherein when in the engaged position the slider is prevented from moving along a longitudinal track, and wherein when in the disengaged position the slider is allowed to move along a longitudinal track.

[0037] According to another aspect of the invention, the outer sleeve further includes a sliding lock operable to move between a locked position and an unlocked position of the slider, the sliding lock being configured to secure the slider to the housing core in an engaged position when the sliding lock is in the locked position.

[0038] According to another aspect of the invention, a removable safety latch is also included, which is removably attached to the outer tube and configured to prevent the sliding member from being activated when the safety latch is attached to the outer tube.

[0039] According to another aspect of the invention, the outer tube also includes a safety button that, when activated during the first and second operating modes, is operable to prevent the protective cover from retracting into the outer tube.

[0040] According to another aspect of the invention, a method of accessing a patient's intraosseous space includes: providing an intraosseous access device comprising a penetrator assembly having a sharp penetrating end operable to penetrate bone and associated bone marrow, a housing having an inner cavity and a defining handle, a retainer slidably connected to the outer sleeve, a protective shield slidably connected to the outer sleeve, and a stabilizer base connected to the protective shield; determining an operating mode of the intraosseous access device based on the location of the target site of intraosseous access; when the operating mode is a first operating mode, positioning the stabilizer on the patient's sternum and manually driving the penetrator assembly into the intraosseous space of the sternum; when the operating mode is a second operating mode, manually retracting the protective shield and retainer relative to the outer sleeve and manually driving the penetrator assembly into the peripheral intraosseous space.

[0041] According to another aspect of the invention, the penetrator assembly includes an inner penetrator hub having a distal end and a proximal end, an inner penetrator extending from the distal end of the inner penetrator hub, an outer penetrator hub having a distal end and a proximal end, and an outer penetrator extending from the distal end of the outer penetrator hub, the outer penetrator being a longitudinal hollow hole configured to slidably receive the inner penetrator.

[0042] According to another aspect of the invention, the method further includes moving the protective cover relative to the outer sleeve and the retainer from an extended position to a retracted position during a first operating mode.

[0043] According to another aspect of the invention, the method further includes inserting a bone probe into the patient near the insertion site during a first operating mode until the tip of the bone probe contacts the bone.

[0044] According to another aspect of the invention, the method further includes separating the stabilizer base from the protective shield and removing the outer penetrator hub from the inner penetrator hub when the outer penetrator enters the intraosseous space during the first operating mode.

[0045] Therefore, certain aspects of the invention have been outlined to facilitate a better understanding of its detailed description and its contribution to the art. Additional embodiments of the invention exist, which will be described below and form the subject matter of the appended claims.

[0046] In this regard, before explaining at least one aspect of the intraosseous access device in detail, it should be understood that the device is not limited in its application to the structural details and arrangement of components set forth in the following description or shown in the accompanying drawings. In addition to those aspects described, the intraosseous access device can have other aspects and can be practiced and implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein, as well as the abstract, are for descriptive purposes and should not be considered limiting.

[0047] Therefore, those skilled in the art will understand that the concepts upon which this invention is based can be readily used as the basis for designing other structures, methods, and systems for achieving various purposes of intraosseous access devices. Therefore, it is important that the claims be considered to include such equivalent structures without departing from the spirit and scope of the invention. Attached Figure Description

[0048] To facilitate understanding of the invention, various aspects of the intraosseous (IO) access device are illustrated by way of example in the accompanying drawings, in which the same components are always indicated by the same reference numerals.

[0049] Figure 1 A schematic diagram of the human thoracic cavity is shown.

[0050] Figure 2 A cross-sectional view of the sternal region of a human is shown.

[0051] Figure 3 A perspective view of an intraosseous access device according to an embodiment of the present invention is shown.

[0052] Figure 4 It shows Figure 3 Front view of the intraosseous access device.

[0053] Figure 5 It shows along Figure 4 The cross-sectional view of the intraosseous entry device taken from line 5-5 in the figure.

[0054] Figure 6A A perspective view of an embodiment of the bone probe according to the present invention is shown.

[0055] Figure 6B It shows Figure 6A Side view of the bone probe.

[0056] Figure 6C A perspective view of another embodiment of the bone probe according to the present invention is shown.

[0057] Figure 6D It shows Figure 6C Side view of the bone probe.

[0058] Figure 7It is shown that during use in the first operating mode Figure 5 A cross-sectional side view of the intraosseous access device.

[0059] Figure 8 It is shown that during use in the first operating mode Figure 5 A cross-sectional side view of the intraosseous access device.

[0060] Figure 9 It is shown that during use in the first operating mode Figure 5 A cross-sectional side view of the intraosseous apparatus.

[0061] Figure 10 It is shown that during use in the first operating mode Figure 5 A cross-sectional side view of the intraosseous access device.

[0062] Figure 11 It is shown that during use in the second operating mode Figure 5 A cross-sectional side view of the intraosseous apparatus.

[0063] Figure 12 It is shown that during use in the second operating mode Figure 5 A cross-sectional side view of the intraosseous apparatus.

[0064] Figure 13 It is shown that during use in the second operating mode Figure 5 A cross-sectional side view of the intraosseous apparatus.

[0065] Figure 14 It is shown that during use in the second operating mode Figure 5 A cross-sectional side view of the intraosseous apparatus.

[0066] Figure 15 A safety latch is shown. Figure 3 A perspective view of the intraosseous access device.

[0067] Figure 16 It shows having Figure 15 A cross-sectional side view of the intraosseous device of the safety latch.

[0068] Figure 17 A perspective view of an intraosseous access device according to another embodiment of the present invention is shown.

[0069] Figure 18 It shows Figure 17 Front view of the intraosseous access device.

[0070] Figure 19 It shows along Figure 18 A cross-sectional view of the intraosseous access device taken from line 19-19.

[0071] Figure 20 It is shown that during use in the first operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0072] Figure 21 It is shown that during use in the first operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0073] Figure 22 It is shown that during use in the first operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0074] Figure 23 It is shown that during use in the second operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0075] Figure 24 It is shown that during use in the second operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0076] Figure 25 It is shown that during use in the second operating mode Figure 19 A cross-sectional side view of the intraosseous access device.

[0077] Figure 26 It is shown that during use in the second operating mode Figure 19 A cross-sectional side view of the intraosseous access device. Detailed Implementation

[0078] The present invention provides a bone penetration manual actuator and stabilizer assembly operable to position a suitable insertion site and penetrate underlying bone, such as the sternum or peripheral insertion site of a human patient, and provides a quick and easy catheter to the intraosseous space within the bone for related medical procedures, including delivery of fluids and drugs, aspiration and bone marrow biopsy, etc.

[0079] Figure 1 A schematic diagram of the human thoracic cavity 10 is depicted. The sternum 2 is a flat, narrow bone between the ribs 6, comprising three parts: the manubrium, the body, and the xiphoid process. The sternum also includes a sternal notch 104 (also known as a suprasternal notch or jugular notch), a U-shaped anatomical feature located above the sternum, below the pharynx, and between the clavicles.

[0080] Figure 2A cross-sectional view of a portion of the sternum 2 is shown. Skin 11 covers a layer of subcutaneous tissue 12, which in turn covers bone 14. Bone 14 includes an intraosseous space 16, defined by anterior dense bone (i.e., anterior cortex) 15 and posterior dense bone (i.e., posterior cortex) 17. The intraosseous space 16 is the region between the anterior and posterior cortices. Bone marrow includes blood, hematopoietic cells, and connective tissue formed within the intraosseous space. In most adult patients, the anterior dense bone 15 and posterior dense bone 17 are each approximately 2.0 mm thick, and the intraosseous space 16 is approximately 10.0 mm thick. Therefore, in most adult patients, the total thickness of bone 14 is approximately 14.0 mm. The target area within the intraosseous space 16 is the center, which in most adult patients is approximately 7.0 mm from the upper surface of the anterior dense bone 15.

[0081] The intraosseous space 16 can be accessed via an intraosseous (IO) device, which may include, but is not limited to, a hollow needle, a hollow drill, a bone penetrator, a catheter, a cannula, a cannula needle, a core needle, an internal penetrator, an external penetrator, a needle, or a cannula needle, or other devices operable to provide access to the intraosseous space or the interior of the bone. Such an intraosseous access device may be at least partially formed of a metallic alloy, such as 304 stainless steel, and other biocompatible materials associated with needles and similar medical devices. Various intraosseous access devices can be formed according to one or more teachings of the present invention. For example, during insertion at a selected insertion site, a variety of cannula needles, spindles, and / or shafts may be disposed within the cannula. Internal penetrators may include such cannula needles, spindles, and shafts, etc. Furthermore, internal penetrators may include various lengths, including but not limited to 20 to 50 mm (e.g., between 35 and 40 mm, 38.5 mm, and / or similar). External penetrators may include catheters, cannulas, hollow needles, and hollow drills, etc. In some embodiments, the penetrator assembly may include a flexible outer penetrator and a rigid inner penetrator as disclosed in International Patent Application No. PCT / IB2019 / 053900, which is incorporated herein by reference in its entirety.

[0082] Figure 3 and 4 Embodiments of the intraosseous (IO) access device 100 and its components are described. In a first operating mode, the IO access device is operable to aid in locating a suitable insertion site and manually penetrating the underlying bone, such as a patient's sternum, to quickly and easily provide a conduit to the intraosseous space within the bone for related medical procedures, including the delivery of fluids and medications, aspiration, and bone marrow biopsy. In a second operating mode, the IO access device is operable for manually inserting into the patient's intraosseous space at a peripheral insertion site, such as the patient's humerus or tibia.

[0083] Figure 5 The intraosseous access device 100 of the present invention is depicted in its initial position or stationary state prior to use in a first or second operating mode. The intraosseous access device 100 includes a housing 105, a bone probe ring 120, a bone probe 130, a telescopic protective shield 150, a retainer 160, a stabilizer base 170, and a biasing member 180, as will be discussed in more detail below. The intraosseous access device 100 also includes an inner penetrator hub 108 attached to an inner penetrator 111. The inner penetrator 111 may take the form of any suitable core or cannula, as previously discussed. The inner penetrator 111 includes a distal end having a tip 102 operable to penetrate bone and associated bone marrow. The inner penetrator 111 also includes a proximal end, which may have a notch 112 configured to facilitate connection of the inner penetrator hub 108 to the inner penetrator 111. For example, the inner penetrator hub 108 may be overmolded on the proximal end of the inner penetrator 111, such that material from the inner penetrator hub can be shaped to extend into the notch 112. The inner penetrator 111 extends from the distal end 116 of the inner penetrator hub 108.

[0084] The manual intraosseous actuator assembly 100 also includes an outer penetrator hub 106 connected to the outer penetrator 113. The distal end 116 of the inner penetrator hub 108 is configured to releasably engage the proximal end of the outer penetrator hub 106, as will be discussed in more detail below. The outer penetrator 113 may be in the form of, for example, a hollow tube, such as a cannula (e.g., a metal cannula) or a hollow drill bit, and the outer penetrator 113 (e.g., having sufficient rigidity) may be configured such that it will not bend or otherwise damaged when inserted together with the inner penetrator 111 through anterior dense bone. In other embodiments, the outer penetrator 113 may be flexible, allowing it to be manipulated after insertion into the intraosseous space (i.e., by bending a portion of the outer penetrator to secure it together with the outer penetrator hub 106 to the patient's skin to provide a lower profile). The outer penetrator hub 106 includes a proximal end 107 and a distal end 109. The external penetrator 113 also includes a proximal end 118 and a distal end 117, with the proximal end 118 connected to the external penetrator hub 106. The distal end 117 of the external penetrator includes a cutting surface operable to penetrate bone and associated bone marrow. The external penetrator 113 extends from the distal end 109 of the external penetrator hub 106.

[0085] The inner penetrator hub 108 is configured to be removably attached to the outer penetrator hub 106. More specifically, the proximal end 107 of the outer penetrator hub 106 and the distal end 116 of the inner penetrator hub 108 can be configured as complementary connectors (e.g., the distal end 116 of the inner penetrator hub 108 is configured as a male Luer connector, and the proximal end 107 of the outer penetrator hub 106 is configured as a female Luer connector, although these configurations can be reversed in other embodiments, such that the distal end 116 of the inner penetrator hub 108 is configured as a female Luer connector and the proximal end 107 of the outer penetrator hub 106 is configured as a male Luer connector). Furthermore, the distal end 116 of the inner penetrator hub 108 may include a tapered protrusion to mate an inwardly tapering channel at the proximal end 107 of the outer penetrator hub 106.

[0086] The external penetrator 113 includes a longitudinal channel configured to slidably receive a portion of the internal penetrator 111 when the internal penetrator hub 108 is attached to the external penetrator hub 106, thereby forming a penetrator assembly. The intraosseous access device 100 is configured to manually drive the penetrator assembly into the intraosseous space. Specifically, the intraosseous access device 100 includes a housing 105 having an outer sleeve 110 defining a handle. The handle is shaped to be gripped when manually inserting the internal and external penetrators into the bone and associated bone marrow. The handle is also configured to allow manual force to be applied to the penetrator assembly while allowing rotation of the handle during insertion of the penetrator assembly into the intraosseous space. The handle may also include a textured outer surface to provide a non-slip grip for the user. The handle may also be ergonomically contoured to provide a comfortable grip for the user.

[0087] When the inner penetrator hub 108 and the outer penetrator hub 106 are connected to each other, the inner penetrator 111 is disposed within the channel of the outer penetrator 113, and the inner penetrator tip 102 extends beyond the distal end 117 of the outer penetrator 113. Both the inner penetrator tip 102 and the distal end 117 of the outer penetrator are operable to penetrate bone and associated bone marrow. More specifically, the inner penetrator tip 102 and the distal end 117 of the outer penetrator are configured to cooperate with each other to form a penetrator assembly tip that is operable to penetrate bone and associated bone marrow when the inner penetrator hub 108 is attached to the outer penetrator hub 106.

[0088] The tip 102 of the internal penetrator 111 is pointed and configured to allow the intraosseous access device 100 to be driven into, for example, the intraosseous space 16. The internal penetrator 111 fits tightly within the channel of the external penetrator 113 such that when the intraosseous access device is driven into the insertion site of the subject (e.g., a patient), the internal penetrator 111 prevents the external penetrator 113 from being blocked by tissue (e.g., skin, bone, bone marrow). In some embodiments, the tip 102 of the internal penetrator and the distal end 117 of the external penetrator may be ground together to form corresponding cutting surfaces, wherein both the internal penetrator 111 and the external penetrator 113 comprise suitable metal. In other embodiments, the tip 102 of the internal penetrator and the distal end 117 of the external penetrator may be ground separately to form corresponding cutting surfaces configured to penetrate bone and associated bone marrow, wherein the corresponding cutting surfaces of the internal and external penetrators mate with each other to penetrate bone and associated bone marrow. Once the intraosseous access device is properly positioned at the target insertion site and intraosseous access is achieved via the penetrator assembly, the inner penetrator hub 108 can disengage from the outer penetrator hub 106, exposing the proximal end 107 of the outer penetrator hub (which may be in the form of a convex or concave Luer lock) and forming a conduit from the outer penetrator hub 106 through the outer penetrator 113 to the intraosseous space. A fluid source can then be connected to the proximal end 107 of the outer penetrator hub 106 to deliver fluid through the outer penetrator 113 into the intraosseous space.

[0089] The housing 105 defines an inner cavity 114. The housing 105 also includes a housing core 115, such as a rod or column, disposed within the cavity 114. The proximal end 119 of the inner penetrator hub 108 includes a recess 104 configured to receive a distal portion of the housing core 115. The proximal portion of the housing core 115 is connected to the proximal end of the housing 105. In some embodiments, the housing core 115 may be integrally formed with the proximal end of the housing. The housing core 115 includes a narrow neck 124 configured to engage an actuator, such as a slider 190, which is operable to lock the retainer 160 in a first or extended position relative to the outer sleeve when the intraosseous access device 100 is in a first operating mode for positioning a suitable insertion site and manually penetrating the underlying bone, such as the patient's sternum, to quickly and easily provide conduit access to the intraosseous space within the bone. A sliding lock 192 is slidably connected to a longitudinal track or side channel 191 formed on the outer sleeve 110. When in the locked position, the sliding lock 192 abuts the tab portion of the slider 190. When in the unlocked position, the sliding lock 192 is operable to slide out of abutment with the tab portion of the slider. When the intraosseous access device is in a second operating mode for manually inserting the penetrator assembly into the patient's intraosseous space at the peripheral insertion site, the slider 190 is operable to disengage from the narrow neck 124 of the housing core 115 to allow the retainer 160 to move to a second or undeployed position relative to the outer sheath.

[0090] The outer tube 110, bone probe ring 120, and protective cover 150 all have a generally cylindrical or tubular shape. The outer surface of the outer tube 110 includes a longitudinal track 191 configured to guide the slider 190 from a first position in a first operating mode for intraosseous access of the sternum to a second position in a second operating mode for peripheral intraosseous access. The bone probe ring 120 includes a distal end 123 with an outwardly projecting annular flange 122. The bone probe ring 120 also includes a channel configured to slidably receive the distal portion of the retainer 160.

[0091] The distal end of the bone probe ring 120 also includes a plurality of circumferentially spaced openings from which corresponding bone probes 130 extend. For example, the distal end of the bone probe ring may include five openings corresponding to five bone probes, although other embodiments may have more or fewer openings and corresponding bone probes. In some embodiments, a single bone probe may be provided. In other embodiments, multiple bone probes may be provided (e.g., two or more bone probes, and preferably three bone probes). The bone probes may be arranged such that they can stabilize the intraosseous access device during insertion of the penetrator assembly into the intraosseous space at the desired location and orientation. For example, three bone probes may be arranged in a triangle around the inner and outer penetrators.

[0092] like Figure 6A and 6B As shown, each probe 130 includes a tip 132, a plurality of circumferential grooves or notches 134, and a proximal end 136, wherein the annular notches 134 are closer to the proximal end 136 than the tip 132. The probes 130 may comprise stainless steel, but other suitable sterile or biocompatible materials (or materials capable of being sterilized prior to use with a patient) may be used. The proximal end 136 is configured to insert into a corresponding opening in the distal end 123 of the bone probe ring 120. In some embodiments, the bone probes 130 may be secured to the bone probe ring 120, for example, by using a UV-curable adhesive applied to the annular grooves 134 and / or the proximal end 136 of the probes 130. In other embodiments, the bone probes 130 may be force-fitted by corresponding openings, such that they are held in place by interference fit. In other embodiments, the probes 130 may be secured to the bone probe ring 120 as part of an injection molding process or using epoxy resin. Figure 6C and 6DAnother embodiment of a bone probe 130a suitable for use with an intraosseous access device 100 is depicted. Each probe 130a includes a tip 132a, a notch or recess 134a, and a proximal end 136a, wherein the notch 134a is closer to the proximal end 136a than the tip 132a. Each probe 130a may comprise stainless steel, but other suitable sterile or biocompatible materials (or materials that can be made sterile prior to use with a patient) may be used. The proximal end 136a is configured to be inserted into a corresponding opening in the distal end 123 of a bone probe ring 120. The probe 130a may be secured to the bone probe ring 120, for example, by using a UV-cured adhesive applied to the notch 134a and / or the proximal end 136a of the probe 130a. In other embodiments, the probe 130a may be force-fitted in a corresponding opening in the flange of the bone probe ring 120, and thus held in place by interference fit. In other embodiments, probe 130a may be integral to the bone probe ring 120 as part of an injection molding process or by using epoxy resin. Each probe 130, 130a may include any of different lengths.

[0093] A bone probe ring 120 is slidably disposed within a protective cover 150. An inner cavity 114 is configured to slidably receive the protective cover 150. A retainer 160 includes a first retainer segment 161 threadedly engaged with a second retainer segment 162. A third retainer segment 163 is connected to the second retainer segment 162. The three retainer segments joined together form a three-piece chassis. The distal end of the second retainer segment 162 is slidably connected to the bone probe ring 120 and is configured to allow the bone probe ring to slidably move between a first extended position and a second retracted position. The retainer 160 has an internal channel 164 configured to receive an inner and outer penetrator hubs 108, 106. The proximal end of the third retainer segment 163 includes an outwardly projecting annular flange 168. The distal end of the second retainer segment 162 includes a plurality of resilient fingers 166 arranged in a ring around the circumference of the second retainer segment, each finger including a corresponding ridge or protrusion 167 projecting radially outward therefrom.

[0094] The protective shield 150 includes a proximal end having an annular inner shoulder 157. A biasing member is disposed between the protective shield shoulder 157 and the retainer flange 168, as will be discussed in more detail below. The protective shield 150 is operable to move between a first or extended position and a second or retracted position, in the first or extended position to provide protection against sharp edges of the distal ends of the inner penetrator 111, outer penetrator 113, and bone probe 130, and in the second or retracted position to expose the respective inner penetrator 111, outer penetrator 113, and bone probe 130 during insertion. A corresponding ridge or protrusion 167 disposed on the resilient finger 166 of the second retainer segment 162 is configured to engage the inwardly projecting annular flange of the bone probe ring 120 to limit how far the bone probe ring and the respective bone probe extend relative to the retainer and the protective shield. The distal end of the bone probe ring may include a radially outwardly projecting annular flange configured to engage an annular shoulder 157 of the protective shield 150 to limit how far the protective shield can extend from the outer sleeve 110 when the protective shield 150 is in the first or extended position. When the protective shield 150 is in the first or extended position, the tip 132 of each bone probe 130 is disposed within the internal space of the protective shield to provide sharps protection. When the protective shield is in the second or retracted position, the tip 132 of each bone probe 130 extends from the distal end of the protective shield.

[0095] The stabilizer base 170 is connected to the telescopic shield 150. The base 170 includes a guide hole 171 configured to guide the penetrator assembly during insertion. The base 170 also includes a plurality of through holes 176 corresponding to and aligned with the bone probe 130. The through holes 176 are configured to allow the corresponding bone probe 130 to pass through the base 170 during insertion. The base 170 may also include alignment features 174, such as an arcuate incision portion of the base. The alignment incision 174 is configured to approximate the shape of a sternal notch in a human patient and is operable to indicate proper placement of the base 170 against the patient. When the base 170 is placed on the sternum, for example during a first operating mode, the intraosseous access device 100 is suitably positioned on the patient's chest such that the sternal incision is visible and at least partially (and preferably completely) bounded by the alignment incision 174.

[0096] Reference Figure 15 and 16The intraosseous access device 100 may also include a removable safety latch 140 operable to prevent the protective shield 150 from moving from a first or extended position to a second or retracted position. Specifically, the safety latch 140 includes a first end 142 configured to engage the outer sleeve 110. Furthermore, the safety latch 140 includes a second end 143 configured to prevent the protective shield 150 from moving to its second or retracted position. The first end 142 of the latch 140 includes a pin 145 configured to insert into a longitudinal rail 191 to engage a side channel in the outer sleeve to prevent the slider 190 from sliding from the first position to the second position. The second end 143 of the latch 140 is configured to depress a safety button 194A to prevent the protective shield 150 from retracting telescopically into the outer sleeve 110 toward its second or retracted position, thereby maintaining protection against sharp elements of the penetrator assembly and bone probe. The user can remove the safety latch 140 from the intraosseous access device 100 by pulling the tab 144 to disengage the pin 145 from the side channel of the outer sleeve 110, thereby allowing the slider 190 to be actuated to manually retract the telescopic shield. Removal of the safety latch also prevents the first safety button 194A from being pressed to unlock the shield 150 from its extended position.

[0097] As previously described, the intraosseous access device 100 can be used in the first operating mode to help locate a suitable insertion site and manually penetrate the underlying bone (e.g., the patient's sternum) to quickly and easily provide a conduit to the intraosseous space within the bone. Prior to use, in the initial position of the first operating mode, the protective shield 150 is in its first or extended position, as... Figure 5 As shown. In operation, the user must first remove the safety latch 140 from the intraosseous access device by pulling the tab 144, thereby disengaging the pin 145 at the first end 142 from the side channel of the outer sleeve 110 before the intraosseous access device can be used for intraosseous penetration procedures. The pin prevents the intraosseous access device from operating in the insertion channel by preventing the protective cover 150 from retracting telescopically into the outer sleeve 150. The locking pin can be inserted during the manufacture of the intraosseous access device or before use and can be removed to prepare the intraosseous access device for use.

[0098] The intraosseous access device can be operated by placing the stabilizer base 170 against the patient's skin on the bone, such as the sternum, where the penetrator assembly is to be inserted. The stabilizer base 170 has an arcuate alignment notch 174, which helps the user align the intraosseous access device with the patient's sternal notch. In other embodiments, one or more guiding features may be provided to facilitate alignment with anatomical locations of other infusion sites. Once the stabilizer base 170 is aligned with and placed against the insertion site, the user operates the intraosseous access device by first pushing down the handle 110, as... Figure 7As shown. When the handle 110 is pushed, the protective shield 150 retracts telescopically into the inner cavity 114 of the outer tube to move from its first or extended position to its second or retracted position. A biasing member 180 is disposed between a flange 168 at the proximal end of the third retainer section 163 and a shoulder 157 at the proximal end of the protective shield 150. The biasing member 180 (e.g., a compression spring) is operable to bias the protective shield toward its extended position. Thus, when the protective shield retracts into the inner cavity of the outer tube, the protective shield resists the biasing force of the biasing member 180. When the protective shield 150 retracts telescopically into the outer tube 110, the penetrator assemblies 111, 113 and the surrounding bone probe 130 protrude from the stabilizer base 170 to penetrate the patient's skin and underlying soft tissue. The stabilizer base 170 helps to hold the intraosseous access device 100 above the desired insertion site and in the desired orientation. During use, the stabilizer base 170 is substantially perpendicular to the penetrator assembly and facilitates the direct introduction of the inner penetrator 111 and the outer penetrator 113 into the patient's sternum.

[0099] When the tip 132 of the corresponding bone probe 130 contacts the bone, a first insertion depth of the inner penetrator 111 and the outer penetrator 113 is determined. At this first insertion depth, the inner penetrator 111 and the outer penetrator 113 are inserted the same distance as the bone probe 130, so that the inner and outer penetrators have not yet penetrated the intraosseous space. Then, the user pushes the handle 110 again to continue retracting the protective cover 150 into the outer tube 110, inserting the inner penetrator 111 and the outer penetrator 113 to a second insertion depth (e.g., into the intraosseous space), such that the surface of the base 170 can contact the bone probe ring 120 to correspondingly slide the bone probe ring 120 and the associated bone probe 130 into the lumen 114 of the outer tube 110, as... Figure 8 As shown. Furthermore, the retraction of the bone probe and bone probe ring into the outer sleeve is a result of the penetrator assembly further penetrating the intraosseous space, while the force applied by the bone probe to the anterior cortex of the bone causes the bone probe ring to slide upwards to its retracted position. In other words, the protective cover 150 moves from its first or extended position to its second or retracted position to unfold the inner penetrator 111 and the outer penetrator 113 into the intraosseous space. Additionally, the retainer 160 and the outer sleeve 110 are rotatable relative to the bone probe ring 120. Therefore, the user can also rotate the handle while pushing it to facilitate the penetrator assembly's penetration into the bone without interfering with the position of the bone probe ring or the placement of the bone probe.

[0100] As the bone probe ring 120 slides into the lumen of the outer sleeve 110, the inner annular flange 125 of the bone probe ring 120 no longer abuts the corresponding ridge or protrusion 167 projecting outward from the second retainer segment 162. The bone probe ring 120 is operable to retract into the lumen of the outer sleeve until the proximal end of the bone probe ring abuts the annular overhang of the first retainer segment 161, or until the inner annular flange 125 of the bone probe ring abuts the shoulder of the second retainer segment 162. Furthermore, the bone probe ring 120 may not be spring-loaded. Instead, the bone probe ring may be held in its distal position by pawls on the chassis, or more specifically, by a pair of pawls on the distal end of the second retainer segment 162. Once the bone probe abuts against the anterior cortex of the patient's sternum, the inner annular flange 125 of the bone probe ring is operable to overcome the first pawls to allow the bone probe ring to float until the penetrator assembly advances beyond the tip of the bone probe and into the intraosseous space a predetermined distance (i.e., approximately 10 mm). Once the bone probe ring has moved rearward a predetermined distance, the inner annular flange 125 engages with the second set of pawls to secure the bone probe. When the flange 125 engages with the second set of pawls, auditory and / or tactile feedback can be provided to the user. This feedback instructs the user to deploy the penetrator assembly into the intraosseous space.

[0101] Therefore, the bone probe ring is configured to move between a first position and a second position during a first operating mode, wherein when the bone probe ring is in the first position, it is closer to the distal end of the retainer than when it is in the second position. The distal end of the bone probe ring includes an inwardly projecting protrusion configured to engage a first pawl on the retainer to hold the bone probe ring in the first position during the first operating mode. During the first operating mode, the protrusion is configured to engage a second pawl on the retainer to hold the bone probe ring in the second position. The protrusion is operable to engage the second pawl on the retainer and provides feedback to the user when the protrusion engages the second pawl on the retainer. The feedback may include at least one of an auditory response and a tactile response to indicate that the penetrator assembly is inserted into the intraosseous space.

[0102] like Figure 9As shown, once the inner penetrator 111 and outer penetrator 113 have penetrated the patient's bone to the desired depth, a release mechanism separates the stabilizer base 170 from the protective shield 150. The release mechanism may include one or more flexible latches on the stabilizer base, each latch configured to releasably engage a corresponding latch at the distal end of the protective shield. The outer penetrator hub 106 also separates from the inner penetrator hub 108 (and thus the outer penetrator 113 similarly separates from the inner penetrator 111). The penetration depth is preferably set such that once the respective tips of the inner penetrator 111 and outer penetrator 113 enter the intraosseous space and are within the patient's bone marrow, their insertion will cease. After the release mechanism is triggered, the remainder of the intraosseous access device 100 can be withdrawn from the insertion site, leaving the stabilizer base 170, outer penetrator hub 106, and outer penetrator 113 at the insertion site.

[0103] like Figure 10 As shown, as the remainder of the intraosseous access device is removed from the insertion site, the biasing member 180 is operable to return the protective shield 150 from its retracted position to its extended position. Specifically, the biasing member 180, such as a compression spring, is positioned between a flange 168 on the third retainer section 163 and a shoulder 157 on the proximal end of the protective shield. The biasing member 180 pushes the protective shield back to its first or extended position to provide protection against sharp edges of the intraosseous probe tip 102 and the bone probe tip during removal from the insertion site.

[0104] Therefore, removing the intraosseous access device from the insertion site automatically moves the telescopic protective shield 150 from its second or retracted position within the cavity of the outer tube back to its first or extended position, protecting any user from accidental contact with the bone probe 130 and the sharp tip of the intraosseous penetrator. After the protective shield 150 is pushed back to its extended position, the user can press one or both of the safety buttons 194A, 194B operable to lock the protective shield in the extended position. Each of the safety buttons 194A, 194B has an extended portion configured to abut the inner shoulder 157 of the protective shield 150 when in the extended position to prevent the protective shield from telescopically retracting back into the cavity of the outer tube.

[0105] In some embodiments, the stabilizer base 170 can adhere to the patient's skin to protect the infusion site and provide strain relief anchors for any tubing that can be connected to the infusion tubing assembly, or for other tubing systems, catheters, etc. Additionally, a flexible external penetrator can be used to allow it to be manipulated and secured to the patient after the stabilizer assembly has been removed, in order to provide a lower profile (i.e., by bending the external penetrator downwards to secure it to the skin).

[0106] In the second operating mode, the intraosseous access device 100 is operable for manual insertion into the patient's intraosseous space at the peripheral insertion site. Prior to use, in the initial position of the second operating mode, the outer sheath 110 and the protective shield 150 are both in their respective first or extended positions, such as... Figure 11 As shown. In this second operating mode, the user can manually retract the protective cover 150 before intraosseous insertion, allowing the penetrator assembly to be manually driven into the intraosseous space at the peripheral insertion site.

[0107] In the second operating mode, the user must first remove the safety latch 140 in the same manner as described above for the first operating mode. Next, the user slides the sliding lock 192 out of the tab portion of the slider 190, thereby pressing the slider. Pressing the slider 190 aligns the slider hole with the neck 124 of the housing core 115, allowing the user to manually slide the retainer 160, the bone probe ring 120 with the bone probe, and the protective cover 150 into the retracted position within the inner cavity 114 of the outer sleeve 110, as described above. Figure 12 As shown. Therefore, the inner penetrator 111 and outer penetrator 113 protrude from the retracted stabilizer base 170, allowing the user to manually insert the penetrator assembly into the intraosseous space by applying force and twisting or rotating the handle 110 back and forth. Thus, the retainer 160, the bone probe ring 120 with the bone probe 103, and the protective cover 150 are manually retracted upward relative to the handle and inside the handle without applying any force to the biasing member 180 (i.e., without compressing the compression spring). Therefore, in the second operating mode, the manual intraosseous entry device 100 can be used to insert the inner and outer penetrators 111, 113 into the intraosseous space at the peripheral insertion site by manually pushing and twisting the handle.

[0108] Once penetration into the bone marrow is achieved, the user can further separate the outer penetrator hub 106 from the inner penetrator hub 108, such as... Figure 13 As shown, the external penetrator is thus left within the intraosseous space, as described above. Furthermore, as previously mentioned, a flexible external penetrator can be used so that it can be manipulated and secured to the patient after insertion, providing a lower profile (i.e., by bending the external penetrator downwards to secure it to the patient's skin).

[0109] Reference Figure 14 The protective shield 150 is shown in its first or extended position, in which it is operable to provide sharp-piece protection against the penetrator assembly. The user can press one or both of the safety buttons 194A and 194B to lock the protective shield in the extended position. Each of the safety buttons 194A and 194B has an extended portion configured to abut against an inner shoulder 157 at the proximal end of the protective shield 150 when in the extended position to prevent the protective shield from unintentionally retracting into the cavity of the outer tube 150.

[0110] Figure 17 and 18 Another embodiment of the intraosseous (IO) access device 200 is depicted. Each embodiment of the intraosseous access device may include one or more components and / or features that are present throughout the other embodiments of the intraosseous access device described and depicted in this invention. In a first mode of operation, the intraosseous access device 200 is operable to aid in locating a suitable insertion site and manually penetrating the underlying bone, such as a patient's sternum, to quickly and easily provide a conduit to the intraosseous space within the bone for associated medical procedures, including the delivery of fluids and medications, aspiration, and bone marrow biopsy. In a second mode of operation, the intraosseous access device is operable for manually inserting into the patient's intraosseous space at a peripheral insertion site.

[0111] Figure 19 The intraosseous access device 200 of the present invention is depicted in its initial position or stationary state before use in a first or second operating mode. The intraosseous access device 200 includes a penetrator assembly as previously described in detail above. The intraosseous access device 200 also includes a housing 205, a bone probe ring 220, a bone probe 130 as previously described in detail above, a protective shield 250, a retainer 260, a stabilizer base 270, a first biasing member 280, and a second biasing member 282. The housing 205 includes an outer sleeve 210 defining a handle. The handle may include a textured outer surface to provide a non-slip grip for the user. The handle may also have an ergonomic profile to provide a comfortable grip for the user.

[0112] As previously described, the penetrator assembly includes an inner penetrator 111, an inner penetrator hub 108, an outer penetrator 113, and an outer penetrator hub 106. The proximal end 119 of the inner penetrator hub 108 includes a recess 104 configured to receive a distal portion of the housing core 215, such as a rod or post. The proximal portion of the housing core 215 is connected to the proximal end of the housing. The housing core 215 includes a narrow neck 224 configured to engage a slider 290 to lock the retainer 260 in a first or extended position when the intraosseous access device 200 is in a first operating mode. This first or extended position is used to locate the sternal insertion site and manually penetrate the underlying bone to quickly and easily provide a conduit to the intraosseous space within the bone. The slider 290 is configured to disengage from the narrow neck 224 of the housing core 215 to unlock the retainer 260 from its extended position. When the intraosseous access device is in the second operating mode for manually inserting the penetrator assembly into the patient's intraosseous space at the peripheral insertion site, disengaging the slider 290 from the housing core 215 further allows the user to manually slide the retainer to its undeployed position.

[0113] The outer tube 210, bone probe ring 220, and retainer 260 all have generally cylindrical or tubular portions. The outer surface of the outer tube 210 includes a longitudinal track 291 defining a longitudinal channel configured to guide the slider 290 from a first position to a second position, the first position being a position where the intraosseous access device is in a first operating mode for sternal intraosseous access, and the second position being a position where the intraosseous access device is in a first operating mode for peripheral intraosseous access. The bone probe ring 220 includes a distal end with an outwardly projecting annular flange 222. The bone probe ring 220 has a generally cylindrical shape and includes a channel configured to slidably receive the distal portion of the retainer 260.

[0114] The distal end of the bone probe ring 220 also includes a plurality of circumferentially spaced openings from which corresponding bone probes 130 extend. For example, the distal end of the bone probe ring may include five openings corresponding to five bone probes, although other embodiments may have more or fewer openings and corresponding bone probes. In some embodiments, a single bone probe may be provided. In other embodiments, multiple bone probes may be provided (e.g., two or more bone probes, and preferably three bone probes). The bone probes may be arranged such that they can stabilize the intraosseous access device during insertion of the penetrator assembly into the intraosseous space at the desired location and orientation. For example, three bone probes may be arranged in a triangle around the inner and outer penetrators.

[0115] A bone probe ring 220 is slidably disposed within a protective cover 250. An inner cavity 214 is configured to slidably receive the protective cover 250. The distal end of a retainer 260 is slidably connected to the bone probe ring 220 and is configured to allow the bone probe ring to slidably move between a first or extended position and a second or retracted position. The retainer 260 defines a one-piece chassis and has an internal channel 264 configured to receive an inner penetrator hub 108 and an outer penetrator hub 106. The proximal end of the retainer 260 includes an outwardly projecting annular flange 268. The distal end of the retainer 260 includes a plurality of resilient fingers 266 arranged circumferentially around the retainer, each finger including a corresponding ridge or protrusion 267 projecting radially outward therefrom.

[0116] The protective shield 250 includes a proximal end having an annular inner shoulder 257. A first biasing member 280 is disposed between the protective shield shoulder 257 and the retainer flange 268, and a second biasing member 282 is disposed between the proximal end of the bone probe 220 and the retainer flange 268, as will be discussed in more detail below. The protective shield 250 is operable to move between a first or extended position and a second or retracted position, in the first or extended position for providing sharp-feature protection from the distal ends of the inner penetrator 111, outer penetrator 113, and bone probe 130, and in the second or retracted position for exposing the respective inner penetrator 111, outer penetrator 113, and bone probe 130 during insertion. A corresponding ridge or protrusion 267 disposed on the resilient fingers 266 of the retainer 260 is configured to engage the inwardly projecting annular flange of the bone probe ring 220 to limit how far the bone probe ring and the respective bone probe can extend relative to the retainer and the protective shield. The distal end of the bone probe ring may include a radially outwardly projecting annular flange configured to engage an annular shoulder 257 of the protective shield 250 to limit how far the shield extends from the outer shell 210 when the shield is in the first or extended position. When the protective shield 250 is in the first or extended position, the tip 132 of each bone probe 130 is disposed within the internal space of the protective shield to provide sharps protection. When the protective shield is in the second or retracted position, the tip 132 of each bone probe 130 extends from the distal end of the protective shield.

[0117] The stabilizer base 270 is connected to the telescopic shield 250. The base 270 includes a guide hole 271 configured to guide the penetrator assembly during insertion. The base 270 also includes a plurality of through holes 276 corresponding to and aligned with the bone probes. The through holes 276 are configured to allow the corresponding bone probes to pass through the stabilizer base 270 during insertion. The base 270 may also include alignment features 274, such as an arcuate incision portion of the base. The alignment incision 274 is configured to approximate the shape of a sternal notch in a human patient and is operable to indicate proper placement of the base 270 against the patient. When the base 270 is placed on the sternum, for example during a first operating mode, the intraosseous access device 100 is suitably positioned on the patient's chest such that the sternal incision is visible and at least partially (and preferably completely) bounded by the alignment incision 274.

[0118] The intraosseous access device 200 may also include a safety latch 140 as described above to prevent the intraosseous access device from moving from a first or extended position to a second or retracted position. Specifically, the safety latch 140 includes a first end 142 configured to engage the outer sleeve 210. Furthermore, the safety latch 140 includes a second end 143 configured to prevent the protective shield 250 from moving to its second or retracted position. The first end 142 of the latch 140 includes a pin 145 configured to insert into the longitudinal rail 291 to engage a side channel in the outer sleeve, thereby preventing the slider 190 from sliding from the first position to the second position. The second end 143 of the latch 140 is configured to press a safety button 294A to prevent the protective shield 250 from retracting telescopically into the outer sleeve 210 toward its second or retracted position, thereby maintaining sharp-edged protection for the penetrator assembly and the bone probe. The user can remove the safety latch 140 from the intraosseous access device 200 by pulling the tab 144 to disengage the pin 145 from the side channel of the outer sleeve 210, thereby allowing the slider 290 to be actuated to manually retract the telescopic shield 250. Removal of the safety latch also prevents the first safety button 294A from being pressed to unlock the shield 250 from its extended position.

[0119] Furthermore, as previously mentioned, the intraosseous access device 200 can be used in the first operating mode to help locate a suitable insertion site and manually penetrate the underlying bone, such as the patient's sternum, to quickly and easily provide a conduit into the intraosseous space within the bone. Prior to use, in the initial position of the first operating mode, the protective shield 250 is in its first or extended position, as... Figure 19 As shown. In operation, the user must first remove the safety latch 140 from the intraosseous access device by pulling the tab 144, thereby disengaging the pin 145 at the first end 142 from the side channel of the outer tube 210 before the intraosseous access device can be used for intraosseous penetration procedures. The pin prevents the intraosseous access device from operating in the insertion channel by preventing the protective cover 250 from retracting telescopically into the outer tube 250. The locking pin can be inserted during the manufacture of the intraosseous access device or before use, and can be removed to prepare the intraosseous access device for use.

[0120] The intraosseous access device 200 can be operated by placing the stabilizer base 270 against the patient's skin on the bone, such as the sternum, where the penetrator assembly is to be inserted. The base 270 has an arcuate alignment notch 274, which helps the user align the intraosseous access device with the patient's sternal notch. In other embodiments, guiding features may be provided to facilitate alignment with anatomical landmarks at other infusion sites. Once the stabilizer base 270 is aligned with and against the insertion site, the user operates the intraosseous access device by pushing down the handle 210. As the handle 110 is pushed, the shield 250 retracts telescopically into the lumen 214 of the outer cannula to move from its first or extended position to its second or retracted position. A first biasing member 280 is disposed between a flange 268 at the proximal end of the retainer 260 and a shoulder 257 at the proximal end of the shield 250. The first biasing member 280 (e.g., a compression spring) is operable to bias the shield toward its extended position. Therefore, when the protective shield retracts into the inner cavity of the outer tube, it resists the biasing force movement of the first biasing member 280. As the protective shield 250 retracts telescopically into the outer tube 210, the penetrator assemblies 111, 113 and the surrounding bone probe 130 extend from the stabilizer base 270 to penetrate the patient's skin and underlying soft tissue. The stabilizer base 270 helps to hold the intraosseous access device 200 above the desired insertion site and in the desired orientation. During use, the base 270 is substantially perpendicular to the penetrator assemblies and facilitates the direct introduction of the inner penetrator 111 and the outer penetrator 113 into the patient's sternum.

[0121] When the tip 132 of the corresponding bone probe 130 contacts the bone, a first insertion depth of the inner penetrator 111 and the outer penetrator 113 is determined. At this first insertion depth, the inner penetrator 111 and the outer penetrator 113 are inserted the same distance as the bone probe 130, such as... Figure 20 As shown, the inner and outer penetrators have not yet penetrated into the intraosseous space. The user then pushes the handle 210 again to continue retracting the protective cover 250 into the outer tube 210, inserting the inner penetrator 111 and outer penetrator 113 to a second insertion depth (e.g., into the intraosseous space), thereby making the surface of the base 270 contact the bone probe ring 220, so that the bone probe ring 220 and the associated bone probe 130 slide accordingly into the cavity 214 of the outer tube 210, as shown. Figure 21 As shown. Furthermore, this retraction of the bone probe ring into the outer sheath is a result of the penetrator assembly further penetrating the intraosseous space, while the force applied by the bone probe to the anterior cortex of the bone causes the bone probe ring to slide upwards to its retracted position. In other words, the protective shield 250 moves from its first or extended position to its second or retracted position to deploy the inner penetrator 111 and the outer penetrator 113 into the intraosseous space.

[0122] A second biasing member 282 is disposed between the flange 268 at the proximal end of the retainer 260 and the proximal end of the bone probe ring 220. The second biasing member 282 (e.g., a compression spring) is operable to bias the bone probe ring and is directed toward the corresponding bone probe in the extended position. Therefore, when the bone probe ring retracts into the lumen of the outer sleeve, the biasing force of the second biasing member 282 pushes the bone probe ring. The biasing force applied to the bone probe ring by the second biasing member 282 ensures that the individual bone probes are properly positioned against the anterior cortex of the bone before the penetrator assembly is advanced into the intraosseous space. Furthermore, the retainer 260 and the outer sleeve 210 are rotatable relative to the bone probe ring 220. Therefore, the user can also rotate the handle while pushing it to facilitate penetration of the penetrator assembly into the bone without interfering with the position of the bone probe ring or the position of the bone probe inserted into the skin and underlying tissue.

[0123] When the bone probe ring 220 slides into the inner cavity of the outer sleeve 210, the inner annular flange 225 of the bone probe ring 220 no longer abuts the corresponding ridge or protrusion 267 projecting outward from the distal end of the retainer 260. The bone probe ring 220 is operable to retract into the inner cavity of the outer sleeve until the proximal end of the bone probe ring abuts the annular protrusion of the retainer 260, or until the inner annular flange 225 abuts the shoulder of the retainer.

[0124] like Figure 22 As shown, once the inner penetrator 111 and outer penetrator 113 have penetrated the patient's bone to the desired depth, the release mechanism separates the base 270 from the protective shield 250. For example, the retainer can be configured to allow the bone probe ring to slide approximately 10 mm, such that the penetrator assembly is inserted into the bone to a depth of approximately 10 mm. The release mechanism may include one or more flexible latches on the stabilizer base, each latch being configured to releasably engage a corresponding latch at the distal end of the protective shield. The outer penetrator hub 106 is also separated from the inner penetrator hub 108 (and thus the outer penetrator 113 is also separated from the inner penetrator 111). The penetration depth is preferably set such that insertion of the inner penetrator 111 and outer penetrator 113 will stop when their tips enter the patient's bone marrow. After the release mechanism is triggered, the remainder of the intraosseous access device 200 can be withdrawn from the insertion site to leave the stabilizer base 270, outer penetrator hub 106, and outer penetrator 113 at the insertion site.

[0125] When the handle of the intraosseous access device is lifted away from the insertion site, the first biasing member 280 is operable to return the protective shield 250 from its retracted position to its extended position. Specifically, as previously described, the first biasing member 280 (e.g., a compression spring) is disposed between a flange at the proximal end of the retainer 260 and a shoulder 257 at the proximal end of the protective shield 250. Thus, the first biasing member 280 pushes the protective shield back to its first or extended position to provide protection against sharpness of the intraosseous probe tip 102 and the bone probe tip during removal from the insertion site. A second biasing member 282 (e.g., a compression spring) is disposed in the annular space of the retainer 260, and more specifically, between a flange 268 at the proximal end of the retainer 260 and the proximal end of the bone probe assembly 220 to push the bone probe assembly back to its extended position after the penetration procedure.

[0126] Therefore, removing the intraosseous access device 200 from the insertion site automatically moves the telescopic protective shield 250 from its second or retracted position within the cavity of the outer sheath back to its first or extended position, protecting any user from unintentional contact with the bone probe 130 and the sharp tip of the internal penetrator. After the protective shield 250 is pushed back to its extended position by the first biasing member 280, and the bone probe ring 220 is similarly pushed back to its extended position by the second biasing member 282, the user can press a pair of safety buttons 294A, 294B operable to lock the protective shield in the extended position. Each of the safety buttons 294A, 294B has an extended portion configured to abut against the annular inner shoulder 257 of the protective shield 250 when it is in the extended position, preventing the protective shield from telescopically retracting back into the cavity of the outer sheath.

[0127] In some implementations, the base 270 can adhere to the patient's skin to protect the infusion site and provide strain-relieving anchors for any tubing that can be connected to the infusion tubing assembly, or for other tubing systems, catheters, etc. Additionally, a flexible external penetrator can be used to allow it to be manipulated and secured to the patient after the stabilizer assembly has been removed, providing a lower profile (i.e., by bending the external penetrator downwards to secure it to the skin).

[0128] In the second operating mode, the intraosseous access device 200 is operable for manual insertion into the patient's intraosseous space at the peripheral insertion site. Prior to use, in the initial position of the second operating mode, the outer sheath 210 and the protective shield 250 are both in their respective first or extended positions, such as... Figure 23As shown. In this second operating mode, the user can manually retract the protective shield 250 before intraosseous penetration, allowing the penetrator assembly to be manually driven into the intraosseous space at the peripheral insertion site. For example, in the second operating mode, the user must first remove the safety latch 240 in the same manner as described above with respect to the first operating mode. Next, the user presses the slider 290 inward to align the slider orifice with the neck 224 of the housing core 215, allowing the user to then manually move the slider 290 towards the proximal end of the housing, correspondingly sliding the retainer 260, bone probe ring 220, and protective shield 250 together to the retracted position into the cavity of the outer sheath 210, as... Figure 24 As shown. Therefore, the inner penetrator 111 and the outer penetrator 113 extend from the retracted stabilizer base 270, allowing the user to manually insert the penetrator assembly into the intraosseous space by applying force and twisting or rotating the handle 210 back and forth. Thus, the retainer 260, the bone probe ring 220 with the bone probe 103, and the protective cover 250 are manually retracted upward relative to the handle and the handle interior without applying any force to the first and second biasing members 280, 282 (i.e., without compressing their respective compression springs).

[0129] Therefore, in the second operating mode, the manual intraosseous access device 200 can be used to insert the inner penetrator 111 and the outer penetrator 113 into the intraosseous space at the peripheral insertion site. Once bone marrow access is achieved, the user can further separate the outer penetrator hub 106 from the inner penetrator hub 108, such as... Figure 25 As shown, the external penetrator is thus left within the intraosseous space, as described above. The external penetrator can be a flexible cannula so that it can be manipulated and secured to the patient after insertion to provide a lower profile (i.e., by bending the external penetrator downwards to secure it to the patient's skin).

[0130] exist Figure 26 In this configuration, the protective shield 250 is shown retracted to its first or extended position, in which it is operable to provide sharp-point protection for the sharp-penetrating assemblies and bone probe. The user can press one or both of safety buttons 294A and 294B to lock the shield in the extended position. Each of safety buttons 294A and 294B has an extended portion configured to abut against an inwardly projecting shoulder 257 at the proximal end of the protective shield 250 when in the extended position to prevent the shield from inadvertently retracting into the inner cavity of the outer sheath.

[0131] Although specific aspects of the intraosseous access device have been described, the invention is not limited to those disclosed. Furthermore, many features and advantages of the invention will be apparent from the detailed description, and therefore the appended claims are intended to cover all such features and advantages of the invention that fall within the spirit and scope of the invention. Moreover, the invention is not limited to the exact construction and operation shown and described; therefore, all suitable modifications and equivalents that may be employed fall within the scope of the invention. Thus, the invention should be considered illustrative rather than restrictive. In this way, the invention is intended to cover various modifications and similar constructions included within the spirit and scope of the claims, and should be interpreted in the broadest possible way to cover all such modifications and similar structures.

Claims

1. An intraosseous access device, comprising: A penetrator assembly having a sharp penetrating end operable to penetrate bone and associated bone marrow; A housing having an inner cavity and an outer sleeve defining a handle operable to manually drive the penetrator assembly into the bone and associated bone marrow; A retainer having a distal retainer end and a proximal retainer end, the retainer being slidably connected to the outer sleeve; and A protective cover having a distal end, a proximal end, and a longitudinal hollow channel extending between the distal end and the proximal end, the protective cover being slidably connected to the outer sleeve; When the intraosseous access device is in a first operating mode, the penetrator assembly is operable to provide intraosseous access at the sternal insertion site, wherein the retainer is locked in the deployed position; and When the intraosseous access device is in the second operating mode, the penetrator assembly is operable to provide intraosseous access at the peripheral insertion site, wherein the retainer is unlocked from the deployed position and manually slid to the undeployed position.

2. The intraosseous access device according to claim 1, wherein, The penetrator assembly further includes an inner penetrator hub having a distal end and a proximal end, an inner penetrator extending from the distal end of the inner penetrator hub, an outer penetrator hub having a distal end and a proximal end, and an outer penetrator extending from the distal end of the outer penetrator hub, the outer penetrator being a longitudinal hollow aperture configured to slidably receive the inner penetrator.

3. The intraosseous access device according to claim 2, wherein, The proximal end of the outer penetrator hub can be releasably engaged with the distal end of the inner penetrator hub.

4. The intraosseous access device according to any one of claims 2 and 3, further comprising a housing core fixedly disposed within the inner cavity of the housing, the housing core including a distal core end connected to the proximal end of the inner penetrator hub.

5. The intraosseous access device according to claim 2, characterized in that, The inner penetrator includes a rigid core needle, and the outer penetrator includes a flexible sleeve.

6. The intraosseous access device according to claim 1, wherein, The handle includes an ergonomic grip suitable for holding during the first and second operating modes.

7. The intraosseous access device according to claim 1, wherein, The handle is configured to allow manual force to be applied during intraosseous insertion of the penetrator assembly during the first and second operating modes, and simultaneously allow rotation of the handle to rotate the penetrator assembly.

8. The intraosseous access device according to claim 1, wherein, The protective cover is configured to move between an extended position and a retracted position relative to the outer tube and the retainer during the first operating mode.

9. The intraosseous access device according to claim 8, wherein, The protective shield is configured to provide sharp-point protection against the sharp penetrating end of the penetrating device when the shield is in the extended position during the first operating mode, and wherein the protective shield is configured to expose the sharp penetrating end of the penetrating device when the shield is in the retracted position during the first operating mode to allow the penetrating device to be inserted into the bone and associated bone marrow.

10. The intraosseous access device of claim 9, further comprising a first biasing member disposed between the retainer and the protective shield, the first biasing member being configured to bias the protective shield toward the extended position during the first operating mode.

11. The intraosseous access device according to claim 10, wherein, The first biasing member includes a compression spring.

12. The intraosseous access device of claim 8, further comprising a bone probe ring slidably connected to the retainer, the bone probe ring having a distal end and a proximal end.

13. The intraosseous access device of claim 12, further comprising a bone probe extending from the distal end of the bone probe ring, the bone probe including a bone probe tip operable to penetrate skin and subcutaneous tissue.

14. The intraosseous access device according to claim 13, wherein, The bone probe tip is disposed within the longitudinal channel of the protective cover to provide sharps protection when the protective cover is in the extended position during the first operating mode, and wherein, when the protective cover is in the retracted position during the first operating mode, the bone probe tip extends from the longitudinal channel of the protective cover.

15. The intraosseous access device according to any one of claims 13-14, wherein, The bone probe ring is configured to move between a first position and a second position during the first operating mode, wherein when the bone probe ring is in the first position, it is closer to the distal end of the retainer than when the bone probe ring is in the second position.

16. The intraosseous access device according to claim 15, wherein, The distal end of the bone probe ring includes an inwardly projecting protrusion configured to engage a first pawl on the retainer to hold the bone probe ring in a first position during the first operating mode, and the protrusion is configured to engage a second pawl on the retainer to hold the bone probe ring in a second position during the first operating mode.

17. The intraosseous access device according to claim 16, wherein, The protrusion is operable to engage with the second pawl on the retainer.

18. The intraosseous access device according to claim 17, wherein, Feedback is provided to the user when the bump engages with the second pawl on the retainer.

19. The intraosseous access device according to claim 18, wherein, The feedback includes at least one of an auditory response and a tactile response instructing the penetrator assembly to insert into the intraosseous space.

20. The intraosseous access device of claim 15, further comprising a second biasing member disposed between the retainer and the bone probe ring, the second biasing member being configured to bias the bone probe ring toward the first position during the first operating mode.

21. The intraosseous access device according to claim 20, wherein, The second biasing member includes a compression spring.

22. The intraosseous access device of claim 1, further comprising a stabilizer base releasably connected to a distal end of the protective shield.

23. The intraosseous access device according to claim 22, wherein, The stabilizer base includes an alignment incision configured to align with the patient's sternal notch to indicate proper placement of the intraosseous access device at the sternal insertion site during the first operating mode.

24. The intraosseous access device according to claim 23, wherein, The stabilizer base also includes a guide hole configured to guide the penetrator assembly during the first operating mode.

25. The intraosseous access device according to claim 1, wherein, The outer tube also includes a longitudinal rail and a slider slidably connected to the longitudinal rail, the slider being operable to move the retainer and the protective cover between the deployed position and the undeployed position relative to the outer tube during a second operating mode.

26. The intraosseous access device according to claim 25, wherein, The protective shield is configured to provide sharp-point protection against the sharp penetrating ends of the penetrating device when the shield is in the deployed position during the second operating mode; and wherein the protective shield is configured to expose the sharp penetrating ends of the penetrating device when the shield is in the non-deployed position during the second operating mode, to allow the penetrating device to be inserted into the bone and associated bone marrow.

27. The intraosseous access device according to any one of claims 25 and 26, wherein, The slider is configured to move between an engaged position with the housing core and a disengaged position with the housing core, wherein when in the engaged position the slider is prevented from moving along the longitudinal track, and wherein when in the disengaged position the slider is allowed to move along the longitudinal track.

28. The intraosseous access device according to claim 27, wherein, The outer sleeve also includes a sliding lock operable to move between a locked position and an unlocked position of the slider, the sliding lock being configured to secure the slider to the housing core in an engaged position when the sliding lock is in the locked position.

29. The intraosseous access device of claim 25 further includes a removable safety latch, the safety latch being removably attached to the outer sleeve and configured to prevent activation of the slider when the safety latch is attached to the outer sleeve.

30. The intraosseous access device according to claim 1, wherein, The outer tube also includes a safety button, which, when activated during the first and second operating modes, is operable to prevent the protective cover from retracting into the outer tube.

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