Bone penetrating manual driver and stabilizer assembly for intraosseous access

Abstract

A device is operable to provide access to a sternal intraosseous space in a first operating mode and is operable to provide access to a peripheral intraosseous space in a second operating mode. The device includes a manual driver and a stabilizer. The manual driver has a handle, an inner piercer hub, and an outer piercer hub. The stabilizer has a housing, an outer sleeve connected to the housing and configured to move from an extended position to a retracted position in a first operating mode, and a protective cover connected to the stabilizer housing and configured to move from an exposed position to a retracted position. The manual driver is securely engaged with the stabilizer in the first operating mode, and the manual driver is disengaged from the stabilizer in the second operating mode.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 865,175, filed on June 22, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to a medical device for positioning and accessing a space within a patient's bone. More specifically, the present disclosure relates to a bone penetrating manual driver and stabilizer assembly for placing a catheter into a space within a patient's bone. Background Art

[0004] Many life-threatening emergencies, including shock, trauma, cardiac arrest, drug overdose, diabetic ketoacidosis, cardiac arrhythmias, burns, and status epilepticus, to name a few, often result in unnecessary death due to the inability to promptly obtain intravenous (IV) access. An essential element in treating many life-threatening emergencies is the rapid establishment of IV access in order to administer medications and fluids directly into the patient's vascular system. Whether in an ambulance with a paramedic, an emergency room with an emergency specialist, or a battlefield with a military medic, the goal is the same - to quickly start an IV in order to administer life-saving medications and fluids to the patient. To a large extent, the ability to successfully treat most emergencies depends on the skill and luck of the operator in achieving vascular access. While it is relatively easy to start an IV for some patients, doctors, nurses, and paramedics may have difficulty establishing IV access for some patients. The success rate may be much lower on the battlefield, where injured soldiers are often repeatedly probed with sharp needles in an attempt to quickly establish IV access.

[0005] For patients with chronic illness or the elderly, available easily accessible veins may be few and far between. Other patients may have no available IV sites due to a lack of peripheral venous anatomy, obesity, extreme dehydration, or prior use of IV medications. For such patients, finding an appropriate site for life-saving therapy often becomes an arduous and frustrating task. As a result, patients with life-threatening emergencies may die when access to the vascular system for life-saving IV therapy is delayed or simply not possible.

[0006] In many cases, it is necessary to inject drugs or other fluids into the patient's bone marrow. For example, in the case of severe trauma or cardiac arrest, it may be impractical to deliver fluids by IV infusion. Intraosseous infusion may also be useful for newborns and young children who have difficulty accessing suitable blood vessels. Intraosseous infusion can be used to deliver fluids to the subject's sternum, humerus, femur, tibia or other bones. The advantage of intraosseous infusion is that an intraosseous infusion pathway can be established very quickly with appropriate technology. This can save lives in critical situations. Fluids can also be extracted or aspirated from the bone using an entrance in the bone.

[0007] The intraosseous (IO) space provides direct access to the patient's vascular system and offers an attractive alternative route to administer IV medications and fluids. Intraosseous administered medications rapidly enter the patient's circulatory system, so the bone marrow can function as a large, non-collapsible IV.

[0008] Proper placement of an intraosseous needle in a bone is critical. If a user attempts to insert a needle into the wrong location, the bone may be too thick, making it difficult for the needle to penetrate. Alternatively, the bone may be too thin, in which case the needle may penetrate completely through the anterior and posterior sides of the bone, thereby completely missing the intraosseous area. Additionally, placing the needle at an angle that is not substantially perpendicular to the surface of the bone can result in needle breakage or other complications. Moreover, certain powered drivers are unable to successfully penetrate a bone when their respective power sources are exhausted. Furthermore, a conventional driver assembly's sharp piercer tip can be dangerous if the user accidentally mishandles it prior to a planned insertion procedure. For example, without adequate sharps protection, a user could easily accidentally poke himself or someone else with the piercer.

[0009] Therefore, there is a need for a bone penetrating manual driver and stabilizer assembly that is operable to locate a suitable insertion site and provide a quick and simple guide to the intraosseous space within a patient's bone. There is also a 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. Summary of the invention

[0010] The implementation of a device for accessing an intraosseous space within a patient's bone according to the present disclosure meets the above needs. According to one aspect of the present disclosure, the device includes a manual intraosseous driver, the manual intraosseous driver including a handle and a piercer assembly, the piercer assembly having a sharp piercing end configured to penetrate the bone and associated bone marrow; and a stabilizer, the stabilizer including a retainer and a stabilizer housing; the retainer having a first retainer end, a second retainer end, and an internal channel extending from the first retainer end to the second retainer end, the internal channel being configured to removably receive a portion of the manual intraosseous driver; the stabilizer housing having a first housing end, a second housing end, and an internal housing portion configured to receive a portion of the retainer; wherein, when the manual driver is connected to the stabilizer in a first operating mode, the piercer assembly is operable to provide access to the sternal intraosseous space; and when the manual driver is separated from the stabilizer in a second operating mode, the piercer assembly is operable to provide access to the peripheral intraosseous space.

[0011] According to another aspect of the present disclosure, the stabilizer further includes a shield slidably disposed in an inner housing portion of the stabilizer housing, the shield being configured to move between an extended position and a retracted position in a first operating mode.

[0012] According to another aspect of the present invention, the extended position of the shield is operable to provide sharps protection against the sharp piercing end of the piercer assembly, while the retracted position of the shield is operable to expose the sharp piercing end of the piercer assembly to enable insertion of the piercer assembly into a bone and associated bone marrow.

[0013] According to another aspect of the present disclosure, the shield includes a first shield end slidably connected to a second retainer end of the retainer.

[0014] According to another aspect of the present disclosure, the stabilizer further includes a bone probe ring having a first ring end, a second ring end connected 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 the skin and subcutaneous tissue.

[0015] According to another aspect of the present disclosure, the shield includes a longitudinal channel configured to slidably receive a bone probe.

[0016] According to another aspect of the present disclosure, the bone probe tip of the bone probe is disposed in the longitudinal channel to provide sharps protection when the shield is in the extended position, and the bone probe tip of the bone probe extends from the longitudinal channel when the shield is in the retracted position.

[0017] According to another aspect of the present disclosure, the stabilizer further includes an outer sleeve slidably connected to the bone probe ring, the outer sleeve being operable to move from an undeployed position to a deployed position in a first operating mode.

[0018] According to another aspect of the present disclosure, the undeployed position of the outer cannula allows the piercer assembly to penetrate skin and subcutaneous tissue, and the deployed position of the outer cannula allows the piercer assembly to penetrate bone and associated bone marrow.

[0019] According to another aspect of the present disclosure, the outer sleeve includes a first pawl and a second pawl, and the first pawl is spaced apart from the second pawl.

[0020] According to another aspect of the present disclosure, the bone probe ring is configured to releasably engage the first pawl when the outer sleeve is in the undeployed position, and the bone probe ring is configured to releasably engage the second pawl when the outer sleeve is in the deployed position.

[0021] According to another aspect of the present disclosure, the first ring end of the bone probe ring includes a resilient arm including an outwardly projecting catch operable to engage a first pawl when the outer sleeve is in an undeployed position and operable to engage a second pawl when the outer sleeve is in a deployed position.

[0022] According to another aspect of the present disclosure, the stabilizer further includes a stabilizing base connected to the protective cover.

[0023] According to another aspect of the present disclosure, the stabilizing base includes a guide hole configured to guide the piercer assembly in the first operating mode.

[0024] According to another aspect of the present disclosure, the stabilizing base includes a through hole aligned with the longitudinal passage of the shield, the through hole being configured to allow a bone probe to pass through the base in the first operating mode.

[0025] According to another aspect of the present disclosure, the stabilizing base includes an alignment notch operable to indicate placement of the stabilizing base against a sternum of a patient in a first mode of operation.

[0026] According to another aspect of the present disclosure, the intrabone access device includes a safety latch operable to prevent the outer sleeve from moving from the undeployed position to the deployed position in the first operating mode and operable to prevent the shield from moving from the extended position to the retracted position in the first operating mode.

[0027] According to another aspect of the present disclosure, the first retainer end of the retainer is configured to releasably secure the manual intraosseous driver to the stabilizer.

[0028] According to another aspect of the present disclosure, the manual intrabone driver further comprises a starter, wherein the starter is operable to move to a locking position to lock the manual intrabone driver to a stabilizer so as to insert the puncture assembly intrabone in a first operating mode, and the starter is operable to move to an unlocking position to unlock the manual intrabone driver from the stabilizer so as to insert the puncture assembly intrabone in a second operating mode.

[0029] According to another aspect of the present disclosure, the manual intraosseous driver further includes a collar including a collar hole configured to partially receive the retaining member when the actuator is moved to the locked position.

[0030] According to another aspect of the present disclosure, the manual intraosseous driver further includes a biasing member configured to bias the actuator toward a locked position.

[0031] According to another aspect of the present disclosure, the piercer assembly includes an inner piercer hub having a first end and a second end, the first end of the inner piercer hub being connected to the handle, and the second end of the inner piercer hub being connected to the inner piercer; and an outer piercer hub having a first end and a second end, the first end of the outer piercer hub being releasably engaged to the second end of the inner piercer hub, and the second end of the outer piercer hub being connected to the outer piercer, the outer piercer defining a longitudinal hollow bore configured to slidably receive the inner piercer.

[0032] According to another aspect of the present disclosure, the inner piercer comprises a rigid stylet.

[0033] According to another aspect of the present disclosure, the outer piercer includes a flexible sleeve.

[0034] According to another aspect of the present disclosure, the handle includes an ergonomic grip suitable for grasping in the first and second operating modes.

[0035] According to another aspect of the present disclosure, the handle is configured to allow manual force to be applied during intraosseous insertion of the trocar assembly and to simultaneously allow rotation of the handle.

[0036] According to another aspect of the present disclosure, a method for accessing a patient's intrabone space includes providing an intrabone access device, the device including a manual intrabone driver connected to a stabilizer, the manual intrabone driver including a handle and a puncture assembly, the stabilizer including a retainer having an internal channel, and the puncture assembly slidably received in the internal channel and having a sharp puncture end configured to penetrate a bone and associated bone marrow; determining an operation mode of the intrabone access device based on the location of a target site for intrabone access; when the operation mode is a first operation mode, positioning the stabilizer on the patient's sternum and manually inserting the puncture assembly into the sternal intrabone space; when the operation mode is a second operation mode, separating the manual intrabone driver from the stabilizer, and manually inserting the puncture assembly into the peripheral intrabone space.

[0037] According to another aspect of the present disclosure, the stabilizer further comprises a shield movable between an extended position and a retracted position in a first operating mode, wherein the extended position of the shield provides sharps protection from a sharp piercing end, and the retracted position of the shield exposes the sharp piercing end of the piercer assembly to allow the piercer assembly to be inserted into a bone and associated bone marrow.

[0038] According to another aspect of the present disclosure, the stabilizer further comprises a bone probe ring comprising a bone probe having a bone probe tip operable to penetrate skin and subcutaneous tissue, wherein the protective cover provides protection against sharp objects of the bone probe tip when the protective cover is in an extended position, and exposes the bone probe tip of the bone probe when the protective cover is in a retracted position.

[0039] According to another aspect of the present disclosure, the stabilizer further comprises an outer sleeve slidably connected to the bone probe ring and movable from an undeployed position to a deployed position in a first operating mode, wherein the puncture assembly penetrates the skin and subcutaneous tissue when the outer sleeve is in the undeployed position and penetrates the bone and associated bone marrow when the outer sleeve is in the deployed position.

[0040] According to another aspect of the present disclosure, the stabilizer further comprises a stabilizing base for guiding the guide hole of the piercer assembly in the first operating mode.

[0041] According to another aspect of the present disclosure, the manual intrabone driver also includes a starter movable between a locked position and an unlocked position, wherein the locked position locks the manual intrabone driver to the stabilizer to facilitate the intrabone insertion of the puncture assembly in a first operating mode, and the unlocked position unlocks the manual intrabone driver from the stabilizer to facilitate the intrabone insertion of the puncture assembly in a second operating mode.

[0042] According to another aspect of the present disclosure, the piercer assembly includes an inner piercer hub having a first end and a second end, the first end of the inner piercer hub being connected to the handle, and the second end of the inner piercer hub being connected to the inner piercer; and an outer piercer hub having a first end and a second end, the first end of the outer piercer hub being releasably engaged to the second end of the inner piercer hub, and the second end of the outer piercer hub being connected to the outer piercer, the outer piercer defining a longitudinal hollow hole configured to slidably receive the inner piercer.

[0043] According to another aspect of the present disclosure, the inner piercer comprises a rigid stylet.

[0044] According to another aspect of the present disclosure, the outer piercer includes a flexible sleeve.

[0045] In order that the detailed description may be better understood, and that the present contribution to the art may be better appreciated, certain aspects of the disclosure have been outlined. Additional embodiments of the invention will be described hereinafter and form the subject of the appended claims.

[0046] In this regard, before explaining in detail at least one aspect of the intraosseous access device, it should be understood that the application of the device is not limited to the details of the structure and the arrangement of the components illustrated in the following specification or in the accompanying drawings. In addition to what is described, the intraosseous access device has other aspects and can be practiced and implemented in various ways. In addition, it should be understood that the phraseology and terminology employed herein and the abstract are for descriptive purposes and should not be regarded as limiting.

[0047] Therefore, those skilled in the art will appreciate that the concepts upon which the present disclosure is based can be readily used as a basis for designing other structures, methods and systems for achieving the multiple purposes of the intrabone access device. It is therefore important that the claims be regarded as including such equivalent constructions without departing from the spirit and scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to facilitate understanding of the present disclosure, various aspects of an intraosseous (IO) access device are shown by way of example in the drawings wherein like parts are designated by like reference numerals throughout.

[0049] Figure 1 A schematic diagram of a human chest cavity is shown.

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

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

[0052] Figure 4An exploded perspective view of an intraosseous device according to the present disclosure is shown.

[0053] Figure 5 A side view of an intraosseous device according to the present disclosure is shown.

[0054] Figure 6 A cross-sectional side view of an intraosseous device according to the present disclosure prior to use is shown.

[0055] Fig. 7A A perspective view of an embodiment of a bone probe according to the present disclosure is shown.

[0056] Figure 7B Shows Fig. 7A Side view of the bone probe.

[0057] Figure 7C A perspective view of another embodiment of a bone probe according to the present disclosure is shown.

[0058] Fig.7D Shows Figure 7C Side view of the bone probe.

[0059] Figure 8 A cross-sectional side view of an intraosseous device according to the present disclosure is shown in use in a first mode of operation.

[0060] Fig. 9 A cross-sectional side view of an intraosseous device according to the present disclosure is shown in use in a first mode of operation.

[0061] Fig.10 A cross-sectional side view of an intraosseous device according to the present disclosure is shown in use in a first mode of operation.

[0062] Fig.11 A cross-sectional side view of an intraosseous device according to the present disclosure is shown in use in a second mode of operation.

[0063] Fig.12 An exploded cross-sectional side view of an intraosseous device according to the present disclosure is shown in use in a second mode of operation, with the manual intraosseous driver assembly removed from the stabilizer assembly.

[0064] Fig.13 A perspective view of an intraosseous device according to the present disclosure is shown in use in a second mode of operation, wherein the manual intraosseous driver assembly is removed from the stabilizer assembly.

[0065] Fig.14 A perspective view of a manual driver assembly of an intraosseous device according to the present disclosure is shown for use in a second mode of operation. DETAILED DESCRIPTION

[0066] The present disclosure provides a bone penetrating manual driver and stabilizer assembly that is operable to locate a suitable insertion site and penetrate the underlying bone (e.g., the sternum of a human patient) to provide a quick and simple catheter to the intraosseous space within the bone for related medical procedures (including delivery of fluids and medications, aspiration and bone marrow biopsy, etc.).

[0067] Figure 1 A schematic diagram of a human thoracic cavity 10 is depicted. The sternum 2 is a flat, narrow bone between the ribs 6, and includes three parts: the manubrium, the body, and the xiphoid process. The sternum also includes a sternal notch 104 (also called a "suprasternal notch" or "jugular notch"), which is a U-shaped anatomical feature located above the sternum, below the throat, and between the clavicles. Figure 2 A cross-sectional view of a portion of a 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, which is bounded by anterior compact bone (i.e., anterior cortex) 15 and posterior compact bone (i.e., posterior cortex) 17. In other words, the intraosseous space 16 is the region in the bone between the anterior cortex and the posterior cortex. Bone marrow includes blood, hematopoietic cells, and connective tissue established within the intraosseous space.

[0068] In most adult patients, the anterior compact bone 15 and the posterior compact bone 17 are each approximately 2.0 millimeters (mm) thick, and the intraosseous space 16 is approximately 10.0 mm thick. Therefore, the total thickness of the 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 compact bone 15.

[0069] The intraosseous space 16 can be entered by an IO device, which may include but is not limited to a hollow needle, a hollow drill, a bone penetrator, a catheter, a cannula, a trocar, a stylet, an inner penetrator, an outer penetrator, a needle or a trocar, or other devices operable to provide access to the intraosseous space or the interior of the bone. Such an IO access device may be formed at least in part by a metal alloy, such as 304 stainless steel and other biocompatible materials associated with a needle and similar medical devices. A variety of IO access devices may be formed according to one or more teachings of the present invention. For example, during insertion at a selected insertion position, a variety of trocars, spindles and / or shafts may be provided in the cannula. The inner penetrator may include such trocars, shafts and rods, etc. In addition, the inner penetrator 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 the like). The outer penetrator may include a catheter, a cannula, a hollow needle and a hollow drill, 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.

[0070] Figure 3 and 4 One embodiment of an intraosseous (IO) access device 20 and its components is depicted. In a first mode of operation, the IO access device is operable to help locate a suitable insertion site and manually penetrate an underlying bone, such as a patient's sternum, to quickly and easily provide access to an intraosseous space within the bone for related medical procedures (including delivery of fluids and medications, aspiration and bone marrow biopsy, etc.). 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.

[0071] For example, Figure 5 and Figure 6The intrabone access device 20 of the present disclosure is depicted in an initial position before use. The intrabone access device includes a manual intrabone driver assembly 100 removably connected to a stabilizer assembly 200. The manual IO driver assembly 100 includes a handle 110 connected to an inner puncture hub 108, which is attached to an inner puncture 111. The handle 110 may include a textured outer surface to provide a non-slip grip for the user. As previously discussed, the inner puncture 111 can, for example, take the form of any suitable stylet or trocar. The inner puncture 111 includes a distal end having a tip 102, which is operable to penetrate a bone and associated bone marrow. The inner puncture 111 also includes a proximal end, which may have a notch 112 configured to facilitate connecting the inner puncture hub 108 to the inner puncture 111. For example, inner piercer hub 108 may be overmolded over inner piercer 111 such that the material of the inner piercer hub may be molded to extend into recess 112. Inner piercer 111 extends from distal end 116 of inner piercer hub 108.

[0072] Manual intraosseous driver assembly 100 also includes an outer puncture hub 106 connected to an outer puncture 113. The distal end 116 of the inner puncture hub 108 is configured to releasably engage the outer puncture hub 106, which will be described in more detail in the following discussion. The outer puncture 113 can take the form of a hollow tube, such as a sleeve (e.g., a metal sleeve) or a hollow drill, and can be configured (e.g., with sufficient rigidity) so that when the outer puncture 113 is inserted through the anterior compact bone together with the inner puncture 111, the outer puncture 113 will not be bent or otherwise damaged. The outer puncture hub 106 includes a proximal end 107 and a distal end 109. The outer puncture 113 also includes a proximal end 118 and a distal end 117, and the proximal end 118 is connected to the outer puncture hub 106. The outer puncture distal end 117 includes a cutting surface that can be operated to penetrate the bone and the associated bone marrow. Outer piercer 113 extends from distal end 109 of outer piercer hub 106 .

[0073] The inner piercer hub 108 is configured to be removably attached to the outer piercer hub 106. More specifically, the proximal end 107 of the outer piercer hub 106 and the distal end 116 of the inner piercer hub 108 can be configured as complementary connectors (e.g., the distal end 116 is configured as a female Luer connector, and the proximal end 107 is configured as a male Luer connector, although these configurations can be reversed in other embodiments) to allow the handle 110 to be removably connected to the outer piercer 113. In addition, the distal end 116 of the inner piercer hub 108 may include a male protrusion that is tapered to match the inner tapered channel at the proximal end 107 of the outer piercer hub 106. In other embodiments, for example, the outer piercer hub 106 may include an inner or outer surface that is threaded and is an approximate channel that is in fluid communication with the channel of the outer piercer. The inner piercer hub 108 may include a complementary outer or inner surface that is threaded to cooperate with the corresponding threaded surface of the outer piercer hub 106.

[0074] Outer piercer 113 includes a longitudinal channel configured to slideably receive a portion of inner piercer 111 when inner piercer hub 108 is attached to outer piercer hub 106, thereby forming a piercer assembly. Handle 110 of the manual IO driver assembly is configured to manually drive the piercer assembly into the intraosseous space so that the handle has a shape suitable for gripping when the inner and outer piercers are manually inserted into the bone and associated bone marrow. Handle 110 is configured to allow manual force to be applied when inserting the piercer assembly into the IO space while allowing the handle to rotate.

[0075] When the inner piercer hub 108 and the outer piercer hub 106 are connected to each other, the inner piercer 111 is disposed within the channel of the outer piercer 113, and the inner piercer tip 102 extends beyond the distal end 117 of the outer piercer 113. Both the inner piercer tip 102 and the outer piercer distal end 117 are operable to penetrate the bone and associated bone marrow. More specifically, the inner piercer tip 102 and the outer piercer distal end 117 are configured as piercer assembly tips that cooperate with each other so that when the inner piercer hub 108 is attached to the outer piercer hub 106, the piercer assembly tip is operable to penetrate the bone and associated bone marrow.

[0076] The tip 102 of the inner puncture 111 is pointed and configured to allow the IO access device 20 to be driven into the intraosseous space, such as the intraosseous space 16. The inner puncture 111 fits tightly within the channel of the outer puncture 113 so that the inner puncture 111 prevents the outer puncture 113 from being blocked by tissue (e.g., skin, bone, bone marrow) when the IO access device is driven into the insertion site of the subject (e.g., patient). In some embodiments where both the inner puncture 111 and the outer puncture 113 include suitable metals, the inner puncture tip 102 and the outer puncture distal end 117 can be polished together to form corresponding cutting surfaces. In other embodiments, the inner puncture tip 102 and the outer puncture distal end 117 can be polished separately to form corresponding cutting surfaces configured to penetrate the bone and the associated bone marrow. Once the IO access device is properly positioned at the insertion site, the inner puncture hub 108 can be disengaged from the outer puncture hub 106, so that the proximal end 107 (which can take the form of a male Luer lock) is exposed and a conduit is formed from the outer puncture hub 106 through the outer puncture 113 to the intraosseous space. A fluid source can then be connected to the proximal end 107 of the outer puncture hub 106 to deliver the fluid through the outer puncture 113 into the intraosseous space.

[0077] The proximal end 119 of the inner puncture hub 108 includes a recess 104 configured to receive an actuator 120 (e.g., a button). The recess 104 at the proximal end 119 of the inner puncture hub 108 is aligned with the through hole 103 in the top surface of the handle 110 to provide access to the actuator 120. Activation of the actuator 120 disengages the manual IO driver assembly 100 from the stabilizer assembly 200, thereby switching the IO access device to a second operating mode, wherein the manual driver assembly is operable for manual insertion into the patient's intraosseous space at a peripheral insertion site, as will be described in further detail below.

[0078] The stabilizer assembly 200 includes an outer sleeve 210 configured to be slidably mounted on a bone probe ring 220. The outer sleeve 210 and the bone probe ring 220 each have a generally cylindrical shape. The inner surface of the outer sleeve 210 includes a first annular detent 212 and a spaced second annular detent 214. The bone probe ring 220 includes a first end 222 configured to releasably engage the first annular detent 212 when the outer sleeve is in a first or undeployed position, and to releasably engage the second annular detent 214 when the outer sleeve is in a second or deployed position. In particular, the first end 222 includes a plurality of circumferentially spaced resilient arms 226, each arm including an outwardly protruding catch 228, which is operable to engage the first annular detent 212 when the outer sleeve 210 is in the first position, and to engage the second annular detent 214 when the outer sleeve is in the second position. The resiliency of the arms 226 allows the respective protrusions 228 to engage with the respective detents 212, 214. The first handle sleeve 211 may be mounted on the outer sleeve to provide a non-slip grip for the user.

[0079] The bone probe ring 220 also includes a second end 223, which includes a flange extending inwardly, and the flange has a bottom surface with multiple openings, and a corresponding bone probe 230 extends from the opening. For example, the flange can include five openings corresponding to five bone probes, although other embodiments can have more or less openings and corresponding bone probes. In some embodiments, a single bone probe can be provided. In other embodiments, multiple bone probes (such as 2 or 3 bone probes) can be provided. The bone probes can be arranged so that they stabilize the IO access device during the insertion of the puncture assembly into the bone space in a desired position and orientation. For example, three bone probes can be arranged in a triangle around the inner puncture and the outer puncture.

[0080] like Fig. 7A and 7B As shown, each probe 230 includes a tip 232, a plurality of circumferential grooves or notches 234, and a proximal end 236, wherein the annular notch 234 is closer to the proximal end 236 than the tip 232. The probe 230 may include stainless steel, although other suitable sterile or biocompatible materials (or materials that can be sterilized before use on a patient) may be used. The proximal end 236 is configured to be inserted into a corresponding opening in the second end 223 of the bone probe ring 220. In some embodiments, the bone probe 230 may be fixed to the bone probe ring 220, for example, by bonding using a UV-curing agent applied to the annular groove 234 and / or the proximal end 236 of the probe 230. In other embodiments, the bone probe 230 may be press-fit through the corresponding openings so that they are held in place by an interference fit. In other embodiments, the probe 230 may be fixed to the bone probe ring 220 as part of an injection molding process or using epoxy resin. Figure 7C and 7DAnother embodiment of a bone probe 230a suitable for use with a stabilizer assembly 200 is depicted. Each probe 230a includes a tip 232a, a groove or notch 234a, and a proximal end 236a, wherein the notch 234a is closer to the stabilizer assembly 200 than the proximal end 236a. Each probe 230a can include stainless steel, but other suitable sterile or biocompatible materials (or materials that can be sterilized before use on a patient) can also be used. The proximal end 236a is configured to be inserted into a corresponding opening in the second end 223 of the bone probe ring 220. The probe 230a can be fixed to the bone probe ring 220, for example, by bonding using a UV-curing agent applied to the annular groove 234a and / or the proximal end 236a of the probe 230a. In other embodiments, the probe 230a can be press-fit into a corresponding opening in the flange of the bone probe ring 220, thereby being held in place by an interference fit. In other embodiments, the probe 230a can be secured to the bone probe ring 220 as part of an injection molding process or using epoxy. Each probe 230, 230a can include any of a variety of lengths.

[0081] The second end 223 of the bone probe ring 220 is connected to the stabilizer housing 240. A second handle sleeve 241 can be mounted on the outer sleeve stabilizer housing 240 to provide a non-slip grip for the user. The stabilizer housing 240 includes a first end 242 connected to the second end 223 of the bone probe ring. The stabilizer housing 240 also includes a second end 243 from which each bone probe 230 extends. The stabilizer housing 240 has an internal passage 244 configured to slidably receive the protective cover 250.

[0082] The stabilizer assembly also includes a retainer 260 having a first end 262 fixedly disposed within the bone probe ring 220. A second end 263 of the retainer 260 is slidably connected to the shield 250. The shield 250 has an internal passage 254 configured to slidably receive a portion of the retainer 260. The retainer 260 has an internal passage 264 configured to removably receive a portion of the manual IO driver assembly 100. The first end 262 of the retainer 260 is configured to lock the manual IO driver assembly 100 to the stabilizer assembly 200. In particular, the first end 262 includes a pair of relatively spaced retaining seats 265. The first end 262 of the retainer 260 is configured to receive the inner puncture hub 108. In addition, the collar 105 is disposed between the inner puncture hub 108 and the retainer 260. A pair of retaining members (e.g., balls 124) are partially received in corresponding retaining seats 265 of the retainer. The balls 124 are used to connect the retainer 260 to the inner piercer hub 108 and the collar 105. The diameter of the balls 124 is slightly smaller than the retaining holes 125 of the inner piercer hub, but slightly larger than the corresponding collar holes 115 of the collar 105. Therefore, the balls 124 partially fit into the corresponding collar holes 115 of the collar so that they abut the retaining seats 265 of the retainer, connecting the inner piercer 108 to the retainer 260, thereby locking the manual IO driver assembly 100 to the stabilizer assembly 200. The second end 263 of the retainer includes a plurality of resilient fingers 266 that are annularly arranged along the circumference of the second end 263, each finger including a corresponding ridge or bump 267 that protrudes radially outward therefrom.

[0083] The shield 250 includes a first end 252 having an inwardly extending annular flange 257. The shield 250 is operable to move from a first or extended position to provide sharps protection to the distal ends of the inner and outer piercers 111, 113 and the bone probe 230, and a second or retracted position to expose the corresponding inner and outer piercers 111, 113 and the bone probe 230 during an insertion procedure. A corresponding ridge or bump 267 disposed on the resilient finger 266 of the retainer 260 is operably engaged with the annular flange 257 of the shield 250 to limit how far the shield extends from the stabilizer housing 240 in the first or extended position. The shield 250 also includes a plurality of longitudinal channels 256 annularly disposed around the circumference of the shield, each channel 256 being configured to slidably receive a corresponding bone probe 230. When the shield is in the first or extended position, the tip 232 of each bone probe 230 is disposed within a respective channel 256 to provide sharps protection. When the shield is in the second or retracted position, the tip 232 of each bone probe 230 extends from the corresponding channel 256. In some embodiments, a portion of at least one of the channels 256 can include a safety clip assembly operable to secure the corresponding bone probe 230.

[0084] The base 270 is connected to the second end 253 of the retractable shield 250. The base includes a guide hole 271 configured to guide the puncture assembly during the insertion procedure. The base 270 also includes a plurality of through holes 276 corresponding to and aligned with the plurality of channels 256 of the shield 250. The through holes 276 are configured to allow a corresponding bone probe to pass through the base 270 during the insertion procedure. The base 270 may also include an alignment notch 274, such as an arcuate portion of the base. The alignment notch 274 is configured to approximate the shape of the sternal notch of a human patient and is operable to indicate the correct placement of the base 270 against the patient. When the base 270 is placed on the sternum, the stabilizer assembly 200 is properly positioned on the patient's chest so that the sternal notch is visible and is at least partially (and preferably completely) defined by the alignment notch 274. The second end 243 of the stabilizer housing 240 and / or the second handle sleeve 241 may have a shape similar to the base 270. This helps the user quickly position the base 270 in alignment with the subject for insertion of the bone probe 230 .

[0085] The safety latch 280 is operable to prevent the stabilizer assembly 200 from moving from the first or extended position to the second or retracted position. In particular, the safety latch 280 includes a first end 282 configured to engage the outer sleeve 210 when the outer sleeve is in the first or extended position. In addition, the safety latch 280 includes a second end 283 defining a pin portion configured to engage the shield 250 when the shield is in the first or extended position. The shield 250 includes a side hole 258 configured to removably receive the pin portion of the second end 283 of the latch 280. The user can remove the safety latch 280 from the stabilizer assembly 200 by pulling the tab 284 to disengage the second end 283 from the side hole 258 of the shield 250, thereby allowing the stabilizer assembly 200 to move to the second or retracted position.

[0086] As previously described, the IO access device 20 can be used in a first mode of operation 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 catheter to the intraosseous space within the bone. Prior to use, in an initial position of this first mode of operation, the manual IO driver assembly 100 is attached to the stabilizer assembly 200. In addition, prior to use, the outer sleeve 210 and the protective cover 250 are both in their respective first or extended positions.

[0087] Prior to use, the user must first remove the safety latch 280 from the IO access device by pulling the tab 284, thereby disengaging the second end 283 from the side hole 258 of the shield 250. In particular, before the IO access device is used for an intraosseous insertion procedure, the pin portion of the safety latch 280 must be removed from the side hole 258 of the shield 250. The pin prevents operation of the IO access device when inserted into the hole 258 by preventing the shield 250 from being telescoped into the stabilizer housing 240. The locking pin can be inserted during the production of the IO access device or prior to use, and removed when the IO access device is ready for use.

[0088] The IO access device can be operated by placing the base 270 against the skin of the patient's bone where the trocar assembly is to be inserted. The base 270 has an arcuate alignment notch 274 that helps the user align the IO access device with the patient's sternal notch. In other embodiments, a guide feature can be provided to facilitate alignment with anatomical landmarks at other infusion sites. Figure 8 As shown, the user operates the IO access device by first pushing the handle 110. When the handle 110 is pushed, the shield 250 retracts into the stabilizer housing 240 to move from its first or extended position to its second or retracted position. When the shield 250 is retracted into the stabilizer housing 240, the puncture assembly 111, 113 and the surrounding bone probe 230 penetrate the patient's skin and underlying soft tissue. The base 270 helps to keep the IO access device 20 above the desired insertion site and in the desired direction. During use, the base 270 is substantially perpendicular to the puncture assembly and helps to introduce the inner puncture 111 and the outer puncture 113 directly into the patient's sternum.

[0089] When the tip 232 of the corresponding bone probe 230 contacts the bone, the first insertion depth of the inner and outer punctures 111, 113 is determined. At the first insertion depth, the inner and outer punctures 111, 113 are inserted the same distance as the bone probe 230, so the inner and outer punctures have not yet penetrated into the bone space. The inner and outer punctures 111, 113 are then inserted into the bone space by the user pushing the handle 110 again to slide the outer sleeve 210 over the bone probe ring 220 toward the stabilizer housing 240. In other words, as Fig. 9As shown, the outer sleeve 210 moves from its first or extended position to its second or retracted position, thereby deploying the inner puncture device 111 and the outer puncture device 113 into the bone intramedullary space. When the outer sleeve 210 moves from its first or extended position to its second or retracted position, the buckle 228 on each elastic arm 226 at the first end of the bone probe ring 220 disengages from the first annular pawl 212 of the outer sleeve to unlock the outer sleeve from its first or extended position. The buckle 228 then engages the second annular pawl 214 of the bone probe ring 220 to lock the outer sleeve 210 in its second or retracted position. Each buckle 228 may have a uniform but asymmetrical tooth shape with an inclination on at least one edge. Similarly, the first and second annular pawls 212, 214 may have a uniform but asymmetrical tooth shape with an inclination corresponding to the inclination of the teeth on at least one edge. When the outer sleeve 210 moves from its extended position to its retracted position, the buckle 228 of the bone probe ring 220 easily slides upward and over the gently inclined edges of the first and second annular pawls. When it passes the tip portion of each tooth, the resilient arm 226 forces the teeth of the pawl into the recess between the teeth of the pawl, thereby producing an audible click or click sound to indicate to the user that the outer sleeve is locked in its second position or retracted position. Because the lock buckle 228 is close to the steeply inclined edge of the second annular pawl 214, the outer sleeve is prevented from sliding back to its first or extended position, thereby locking the outer sleeve in the retracted position. In some embodiments, the handle 110 can be twisted to deploy the inner puncture device 111 and the outer puncture device 113 into the bone space.

[0090] like Fig.10 As shown, once the inner puncture device 111 and the outer puncture device 113 penetrate the patient's bone to the desired depth, the release mechanism separates the base 270 from the protective cover. The outer puncture device hub 106 is also separated from the inner puncture device hub 108 (therefore the outer puncture device 113 is also separated from the inner puncture device 111). The depth is usually set to stop when the tips of the inner and outer puncture devices 111, 113 enter the patient's bone marrow. After the release mechanism is triggered, the manual drive and stabilizer assembly can be removed from the insertion site to leave the base 270, the outer puncture device hub 106 and the outer puncture device 113 in place. When the stabilizer assembly 200 is removed from the insertion site, the protective cover 250 is pushed outward from the stabilizer housing 240 back to its first or extended position to protect any user from accidentally contacting the bone probe 230. The base 270 can be adhered to the patient's skin to protect the infusion site and provide a strain relief anchor for any tubing that may be connected to the infusion tube assembly, or to provide strain relief for other tubing, catheters, etc. In addition, a flexible outer penetrator can be used so that it can be manipulated and secured to the patient to provide a lower profile after the stabilizer assembly is removed (i.e., by bending the outer penetrator downward to secure it to the skin).

[0091] In the second mode of operation, the IO access device is operable to be manually inserted into the intraosseous space of the patient at a peripheral insertion site. Prior to use, in an initial position of the second mode of operation, the manual IO driver assembly 100 is attached to the stabilizer assembly 200. In addition, prior to use, both the outer sleeve 210 and the protective cover 250 are in their respective first or extended positions. However, in this second mode of operation, the user is able to separate the manual IO driver assembly 100 from the stabilizer assembly 200 so that the manual IO driver assembly can be used without the stabilizer assembly at the peripheral insertion site.

[0092] To disengage the manual IO driver assembly 100 from the stabilizer assembly 200, the user must first remove the safety latch 280 from the IO access device by pulling the tab 284, thereby disengaging the second end 283 from the side hole 258 of the shield 250. Next, the user actuates the trigger 120 to begin the separation process. The trigger 120 includes a head 121 and a neck 122. The head 121 is disposed in the through hole 103 of the handle 110, and the neck 122 is disposed in the recess 104 of the inner piercer hub 108. Actuation of the trigger 120 includes the user pushing the head 121 downward, as shown in FIG. Fig.11 As shown. A biasing member (e.g., a compression spring) may be provided between the bottom surface of the recess 104 and the neck 122 of the actuator 120 to bias the actuator toward the locked position. When the head 121 is pushed downward against the biasing force of the biasing member, the neck 122 accordingly moves further downward into the recess of the inner piercer hub 108. As the thin neck 122 slides downward, it aligns with the retaining hole 125 and the collar hole 115, allowing the retaining ball 124 to move into the recess 104 of the inner piercer hub and out of the retaining seat of the retainer 260, thereby unlocking the inner piercer from the retainer. Once the inner piercer is unlocked from the retainer, the manual IO driver assembly 100 can be completely separated and removed from the stabilizer assembly 200 by pulling it out of the stabilizer, as shown in FIG. Fig.12 and 13 Thus, the manual IO driver assembly 100 can be used to peripherally insert the inner and outer puncture devices 111, 113 into the intraosseous space at the peripheral insertion site.

[0093] As mentioned above, once in the bone marrow, Fig.14 As shown, the user can further separate the outer puncture tool hub 106 from the inner puncture tool hub 108, thereby leaving the outer puncture tool in the intraosseous space. In addition, as described above, a flexible outer puncture tool can be used so that it can be manipulated and fixed to the patient after being inserted into the intraosseous space to provide a lower profile (i.e., by bending the outer puncture tool downward to fit the patient's skin).

[0094] Although 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. In addition, many features and advantages of the present disclosure are apparent from the detailed description, and therefore, the appended claims are intended to cover all such features and advantages of the present disclosure that fall within the spirit and scope of the present disclosure. In addition, it is not desired to limit the present disclosure to the exact construction and operation shown and described, and therefore, all suitable modifications and equivalent forms that may be adopted fall within the scope of the present disclosure. Therefore, the present disclosure should be considered illustrative rather than restrictive. Therefore, the present disclosure is intended to cover various modifications and similar structures included in the spirit and scope of the claims, which should be given the broadest interpretation to cover all such modifications and similar structures.

[0095] Although 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. In addition, many features and advantages of the present disclosure are apparent from the detailed description, and therefore, the appended claims are intended to cover all such features and advantages of the present disclosure that fall within the spirit and scope of the present disclosure. In addition, it is not desired to limit the present disclosure to the exact construction and operation shown and described, and therefore, all suitable modifications and equivalent forms that may be adopted fall within the scope of the present disclosure. Therefore, the present disclosure should be considered illustrative rather than restrictive. Therefore, the present disclosure is intended to cover various modifications and similar structures included in the spirit and scope of the claims, which should be given the broadest interpretation to cover all such modifications and similar structures.

Claims

1. An intraosseous access device, comprising: a manual intraosseous driver comprising a handle, an actuator, and a piercing assembly having a sharp piercing end configured to penetrate a bone and associated bone marrow; and A stabilizer, including a retainer and a stabilizer housing; The retainer has a first retainer end, a second retainer end, and an internal passage extending from the first retainer end to the second retainer end, the internal passage being configured to removably receive a portion of a manual intraosseous driver; and the stabilizer housing having a first housing end, a second housing end, and an inner housing portion configured to receive a portion of the retainer; wherein, in a first operating mode, the actuator is configured to move to a locked position to lock the manual intraosseous driver to the stabilizer for intraosseous insertion of the piercer assembly, and when the manual intraosseous driver is connected to the stabilizer in the first operating mode, the piercer assembly is operable to provide access to the intraosseous space of the sternum; and Wherein, in a second operating mode, the launcher is configured to move to an unlocked position to unlock the manual intraosseous driver from the stabilizer so as to insert the puncture assembly into the bone, and when the manual intraosseous driver is separated from the stabilizer in the second operating mode, the puncture assembly is operable to provide access to the surrounding intraosseous space.

2. The intrabone access device of claim 1, wherein the stabilizer further comprises a shield slidably disposed in the inner housing portion of the stabilizer housing, the shield being configured to be movable between an extended position and a retracted position in a first mode.

3. The intraosseous access device according to claim 2, wherein: The extended position of the shield is operable to provide sharps protection to the sharp piercing end of the piercer assembly, and wherein the retracted position of the shield is operable to expose the sharp piercing end of the piercer assembly to allow insertion of the piercer assembly into a bone and associated bone marrow.

4. The intrabone access device of any one of Claims 2 and 3, wherein the shield includes a first shield end slidably connected to a second retainer end of the retainer.

5. An intrabone access device according to any one of claims 2 and 3, wherein the stabilizer further comprises a bone probe ring having a first ring end, a second ring end connected to the first housing end of the stabilizer housing, and a bone probe extending from the second ring end, the bone probe comprising a bone probe tip operable to penetrate the skin and subcutaneous tissue.

6. The intrabone access device of claim 5, wherein the shield includes a longitudinal channel configured to slidably receive the bone probe.

7. The intrabone access device of claim 6, wherein the bone probe tip of the bone probe is disposed within the longitudinal channel to provide sharps protection when the shield is in the extended position, and the tip of the bone probe extends from the longitudinal channel when the shield is in the retracted position.

8. The intrabone access device of claim 5, wherein the stabilizer further comprises an outer sleeve slidably connected to the bone probe ring, the outer sleeve being operable to move from an undeployed position to a deployed position in a first mode of operation.

9. The intraosseous access device of claim 8, wherein the undeployed position of the outer cannula permits the piercer assembly to penetrate skin and subcutaneous tissue, and wherein the deployed position of the outer cannula permits the piercer assembly to penetrate bone and associated bone marrow.

10. The intrabone access device of claim 9, wherein the outer sleeve includes a first detent and a second detent, the first detent being spaced apart from the second detent.

11. The intrabone access device of claim 10, wherein the bone probe ring is configured to releasably engage the first detent when the outer sleeve is in an undeployed position, and wherein the bone probe ring is configured to releasably engage the second detent when the outer sleeve is in a deployed position.

12. The intrabone access device of claim 11, wherein the first ring end of the bone probe ring comprises a resilient arm, the resilient arm comprising an outwardly protruding buckle, the buckle being operable to engage the first pawl when the outer sleeve is in the undeployed position and being operable to engage the second pawl when the outer sleeve is in the deployed position.

13. The intrabone access device of any one of claims 2 and 3, wherein the stabilizer further comprises a stabilizing base connected to the shield.

14. The intrabone access device of claim 13, wherein the stabilizing base comprises a guide hole configured to guide the trocar assembly in the first mode of operation.

15. The intrabone access device of claim 6, wherein the stabilizer further comprises a stabilizing base connected to the shield, and the stabilizing base comprises a through hole aligned with the longitudinal channel of the shield, the through hole being configured to allow the bone probe to pass through the stabilizing base in the first operating mode.

16. The intraosseous access device of claim 13, wherein the stabilizing base includes an alignment notch operable to indicate placement of the stabilizing base against a sternum of a patient in the first mode of operation.

17. The intrabone access device of claim 8, further comprising a safety latch operable to prevent movement of the outer sleeve from the undeployed position to the deployed position in the first operating mode and operable to prevent movement of the shield from the extended position to the retracted position in the first operating mode.

18. The intraosseous access device of any one of claims 1-3, wherein the first retainer end of the retainer is configured to releasably secure the manual intraosseous driver to the stabilizer.

19. The intraosseous access device of claim 18, wherein the manual intraosseous driver further comprises a collar including a collar hole, the collar being configured to partially receive a retaining member when the actuator is moved to the locked position.

20. The intraosseous access device of claim 19, wherein the manual intraosseous driver further comprises a biasing member configured to bias the actuator toward the locked position.

21. The intraosseous access device of claim 1, wherein the trocar assembly comprises: an inner piercer hub having a first end and a second end, the first end of the inner piercer hub being connected to the handle and the second end of the inner piercer hub being connected to the inner piercer; An outer piercer hub having a first end and a second end, the first end of the outer piercer hub being releasably engaged to the second end of the inner piercer hub and the second end of the outer piercer hub being connected to an outer piercer defining a longitudinal hollow bore configured to slidably receive the inner piercer.

22. The intraosseous access device of claim 21, wherein the inner penetrator comprises a rigid stylet and the outer penetrator comprises a flexible cannula.

23. The intraosseous access device of claim 1, wherein: The handle includes an ergonomic grip suitable for grasping in the first and second modes of operation.

24. The intraosseous access device of claim 1, wherein the handle is configured to allow application of manual force and simultaneously allow rotation of the handle during intraosseous insertion of the trocar assembly.

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