Intraosseous sterile barrier and packaging

Abstract

An intraosseous access system having a sterile access assembly disposed within a sterile package. The access assembly can be sealed within the sterile package by a cover that allows gas sterilization. The sterile package provides mechanical protection and a sterile barrier during operation and transportation. In an embodiment, the disposable intraosseous access system is provided with an access assembly pre-attached to a driver and a sterile package or cap disposed thereon, the sterile package or cap being configured to provide mechanical protection and a sterile barrier during operation and transportation. In an embodiment, once the cap is removed, the access assembly extends from a retracted position within the driver to an expanded position. After use, the access assembly can be retracted to provide safe disposal. The system may further include an extension device, which is also disposed within the sterile environment provided by the driver or cap.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 907,446, filed September 27, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to intraosseous sterile barriers and packaging. Background Art Summary of the Invention

[0004] Briefly, embodiments disclosed herein relate to apparatus and methods for a sterile barrier and packaging assembly for an intraosseous access device. Currently, intraosseous needles and associated access assemblies are provided as individually packaged items, which require a protective covering and a separate sterile barrier disposed thereon. This requires the user to remove the access assembly from one or more outer packaging, secure the assembly to a drive mechanism, and then remove the cover before insertion. When deploying an intraosseous device in an emergency, these additional steps of removing the additional packaging take valuable time.

[0005] In some embodiments, disclosed herein are devices and methods that include both mechanical protection and a sterile barrier in a single packaged article, which is quick and easy to deploy. In some embodiments, the drive mechanism and access assembly are incorporated into a single disposable device. In addition, the access device can be retracted into a disposable driver, which reduces the overall size of the device. This provides a highly portable system that the user can readily use in an emergency. Furthermore, the steps and time required to unpack and assemble the device are reduced.

[0006] In some embodiments, disclosed herein is an intraosseous system comprising a sterile package for housing an access assembly of the intraosseous system, the sterile package comprising a cavity configured to receive the access assembly, a closed distal end, a proximal opening communicating with the cavity, and a lid arranged on the proximal opening to seal the access assembly in the cavity.

[0007] In some embodiments, the cover provides a sterile barrier to maintain the entry assembly in a sterile environment. The proximal opening is configured to receive the distal portion of the driver, which engages the entry assembly through the proximal opening. The cavity defines a first cross-sectional area and a second cross-sectional area larger than the first cross-sectional area, the first cross-sectional area being configured to receive the needle portion of the entry assembly, and the second cross-sectional area being configured to receive the hub portion of the entry assembly. The second cross-sectional area releasably engages the hub portion of the entry assembly with interference engagement, protrusion and locking engagement, threaded engagement, or glued engagement. The second cross-sectional area includes an O-ring configured to engage the hub portion of the entry assembly, which provides a seal between the distal portion of the cavity and the proximal portion of the cavity.

[0008] In some embodiments, the cover is made of a breathable organic material, a synthetic material, a woven material, a nonwoven material, a polymer, a copolymer, an olefin fiber, polyethylene, high density polyethylene ("HDPE"), or Formed. The cover provides a physical and sterile barrier, and allows EtO sterilization to be arranged in the cavity to enter the assembly. The cover is releasably connected to the proximal opening using one of heat sealing, bonding, bonding or welding. The cover includes one of a finger loop or a pull tab, which is configured to facilitate separation of the cover from the sterile package. The sterile package includes a flange extending radially from the proximal edge of the cap. The cover includes a tear line, which is configured to allow the first part of the cover to be separated from the second part of the cover and allow the entry assembly to pass through the proximal opening. The sterile package further includes fins extending longitudinally along its outer surface and configured to provide structural support.

[0009] Also disclosed is an intraosseous access device including a driver, an access assembly coupled to the driver, and a sterile package defining a cavity, the sterile package coupled to a portion of the driver and enclosing the access assembly to maintain the access assembly in a sterile environment.

[0010] In some embodiments, the proximal end of the sterile package is releasably fixed to the driver by heat sealing, bonding, bonding or welding. The proximal end of the sterile package is releasably fixed to the driver by the threaded engagement between the inner surface of the sterile package and the outer surface of the driver. The proximal end of the sterile package includes a tear-away strip that is configured to break away from one of the sterile package or the driver and release the sterile package from the driver. One of the sterile package or the driver includes an opening that is communicated with the cavity of the sterile package and includes a cover that is arranged thereon to maintain a sterile environment, the cover being formed by a material that is different from the sterile package or the driver.

[0011] In some embodiments, the cover is made of a breathable organic material, a synthetic material, a woven material, a nonwoven material, a polymer, a copolymer, an olefin fiber, polyethylene, high density polyethylene ("HDPE"), or The cover provides a physical and sterile barrier and allows for EtO sterilization of the access assembly disposed therein. The cover is coupled to the sterile packaging using one of heat sealing, bonding, adhesive bonding, or welding. The sterile packaging or actuator includes fins extending longitudinally along its outer surface and configured to provide structural support or a gripping feature for rotating the sterile packaging relative to the actuator. The access assembly is convertible between a retracted state and an extended state, wherein a portion of the access assembly is disposed within the actuator in the retracted state.

[0012] In some embodiments, the sterile packaging is coupled to the access assembly and is configured to convert the access assembly from a retracted state to an expanded state when the sterile packaging is removed. In some embodiments, the intraosseous access device further includes an extension set that is releasably retained within a cavity defined by the sterile packaging to maintain the extension set within a sterile environment. In some embodiments, the intraosseous access device further includes an extension set that is releasably retained within a cavity defined by the body of the driver and includes a cover disposed over the opening of the cavity to provide a sterile barrier and maintain the extension set within the sterile environment.

[0013] Also disclosed is a method of preparing an intraosseous access device for use, comprising providing an access assembly disposed within a cavity of a sterile package, the access assembly including a cover disposed on a proximal opening communicating with the cavity to provide a sterile environment therein; pushing a coupling interface of an intraosseous driver through the proximal opening to engage a coupling interface of the access assembly; and withdrawing the sterile package distally to expose the access assembly.

[0014] In some embodiments, the method further includes disengaging a sleeve portion of the access assembly from an inner surface of the sterile package, the sleeve portion engaging the sterile package in an interference engagement, a protrusion and locking engagement, a threaded engagement, or a glued engagement. In some embodiments, the cavity includes an O-ring disposed on an inner surface thereof, the O-ring configured to engage the sleeve portion to provide a seal between the distal portion of the sterile package and the proximal portion of the sterile package. The cover is made of a breathable material, an organic material, a synthetic material, a woven material, a nonwoven material, a polymer, a copolymer, an olefin fiber, polyethylene, a high density polyethylene ("HDPE"), or form.

[0015] In some embodiments, the lid provides a physical and aseptic barrier, and allows EtO sterilization aseptic packaging and an access assembly arranged therein. The lid is connected to the aseptic packaging using a heat seal, bonding, adhesive bonding, or welding. In some embodiments, the method further includes removing the lid from the aseptic packaging before the coupling interface of the push driver passes through the proximal opening. In some embodiments, the method further includes pulling one of the finger ring or pull tabs coupled to the lid to separate the lid from the aseptic packaging. In some embodiments, the method further includes pushing the coupling interface of the driver through a tear line arranged in the lid, the tear line being configured to separate the first portion of the lid from the second portion of the lid to allow the coupling interface of the driver to pass therebetween. The aseptic packaging includes a flange extending radially from the proximal edge of the aseptic packaging.

[0016] A method of accessing a medullary cavity is also disclosed, comprising providing an intrabone driver comprising an access assembly extending from a distal portion thereof and a sterile package coupled to the distal portion and defining a cavity, the sterile package configured to enclose the access assembly within a sterile environment; removing the sterile package; and accessing the medullary cavity.

[0017] In some embodiments, the sterile package is releasably fixed to the distal portion of the intraosseous driver by heat sealing, bonding, gluing or welding. The sterile package is releasably fixed to the intraosseous driver by threaded engagement between the inner surface of the sterile package and the outer surface of the intraosseous driver. In some embodiments, the method further includes disengaging a tear-off strip, which is configured to disengage from one of the sterile package or the intraosseous driver and release the sterile package from the intraosseous driver. In some embodiments, one of the sterile package or the intraosseous driver includes an opening that is communicated with the cavity, and further includes a cover that is arranged on the opening to maintain a sterile environment, the cover being formed by a material different from that of the sterile package or the intraosseous driver.

[0018] The cover is made of breathable organic material, synthetic material, woven material, nonwoven material, polymer, copolymer, olefin fiber, polyethylene, high density polyethylene ("HDPE") or Formed. The cover provides a physical and sterile barrier, as well as allowing EtO sterilization of the access assembly disposed therein. The cover is coupled to the sterile packaging or the intraosseous driver using one of heat sealing, bonding, adhesive bonding, or welding. In some embodiments, the method further includes transitioning the access assembly from a retracted state to an expanded state, wherein a portion of the access assembly is disposed within the handle of the intraosseous driver in the retracted state. In some embodiments, removing the sterile packaging transitions the access assembly from the retracted state to the expanded state. In some embodiments, the method further includes removing an extension device releasably retained within a cavity defined by the sterile packaging, and coupling the extension device to a needle hub of the access assembly. In some embodiments, the method further includes removing a second cover disposed on the second opening (which is in communication with a second cavity defined by the intraosseous driver), and removing the extension device releasably retained therein and coupling the extension device to the needle hub of the access assembly.

[0019] Also disclosed is a method of sterilizing an intraosseous access system, comprising coupling an access assembly to a driver, enclosing the access assembly within an interior cavity of a sterile package, releasably coupling the sterile package to the driver, and sterilizing the intraosseous access system.

[0020] In some embodiments, one of the sterile packaging or the actuator includes an opening that communicates with the lumen of the sterile packaging and includes a cap disposed over the opening to maintain a sterile barrier and configured to allow EtO sterilization of the lumen. In some embodiments, the method further includes an extension device disposed in the lumen of the sterile packaging or the lumen of the actuator.

[0021] These and other features of the concepts presented herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly disclose specific embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 shows an exploded view of an embodiment of an intraosseous access system according to embodiments disclosed herein, with the access assembly sub-device of the system depicted slightly enlarged and in elevation, and the automated driver component depicted in perspective;

[0023] Figures 2A-2B shows a perspective view of a sterile barrier and packaging assembly according to embodiments disclosed herein;

[0024] Figure 3 An intraosseous access device including a sterile barrier and packaging assembly according to embodiments disclosed herein is shown.

[0025] Figure 4 An intraosseous access device including a sterile barrier and packaging assembly according to embodiments disclosed herein is shown.

[0026] Figure 5 An intraosseous access device including a sterile barrier and packaging assembly according to embodiments disclosed herein is shown. DETAILED DESCRIPTION

[0027] Before providing some specific embodiments in more detail, it should be understood that the specific embodiments provided herein do not limit the scope of the concepts disclosed herein. It should also be understood that the features of the specific embodiments disclosed herein can be easily separated from the specific embodiments and optionally combined or substituted with the features of any one of the multiple other embodiments disclosed herein.

[0028] About the terms used herein, it should also be understood that the terms are for describing the purpose of some specific embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify the different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first," "second," and "third" features or steps do not necessarily need to appear in order, and the specific embodiment comprising such features or steps does not necessarily need to be limited to these three features or steps. Labels such as "left," "right," "up," "down," "front," "back," etc. are used for convenience and do not mean, for example, any specific fixed position, orientation, or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation, or direction. The singular "a," "an," and "the" include plural forms unless the context clearly indicates otherwise.

[0029] For example, with respect to a needle disclosed herein, the "proximal side," "proximal portion," or "proximal end portion" includes the portion of the needle that should be near the clinician when the needle is used on a patient. Similarly, for example, the "proximal length" of a needle includes the length of the needle that should be near the clinician when the needle is used on a patient. For example, the "proximal end" of a needle includes the end of the needle that should be near the clinician when the needle is used on a patient. The proximal portion, proximal end portion, or proximal length of a needle can include the proximal end of the needle; however, the proximal portion, proximal end portion, or proximal length of a needle need not include the proximal end of the needle. That is, unless the context indicates otherwise, the proximal portion, proximal end portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0030] For example, reference to the "distal side," "distal portion," or "distal end portion" of a needle disclosed herein includes the portion of the needle that should be near or in the patient when the needle is used on a patient. Similarly, for example, reference to the "distal length" of a needle includes the length of the needle that should be near or in the patient when the needle is used on a patient. For example, reference to the "distal end" of a needle includes the end of the needle that should be near or in the patient when the needle is used on a patient. The distal portion, distal end portion, or distal length of a needle can include the distal end of the needle; however, the distal portion, distal end portion, or distal length of a needle need not include the distal end of the needle. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of a needle is not the terminal portion or terminal length of the needle.

[0031] like Figure 1 As shown, to aid in describing the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle extending from the driver. The lateral axis extends orthogonal to the longitudinal axis, and the transverse axis extends orthogonal to both the longitudinal and lateral axes.

[0032] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0033] The present disclosure generally relates to intraosseous (IO) access devices, systems, and methods thereof. Specifically, embodiments disclosed herein include sterile barriers and packaging for components of IO devices.

[0034] Figure 1 An exploded view of an exemplary embodiment of an intraosseous access system 100 is shown, with some components shown in elevation and some components shown in perspective. The intraosseous access system 100 can be used to penetrate the skin and underlying bone for intraosseous access, such as via a pathway through the interior of a bone into the patient's bone marrow and / or vasculature.

[0035] In an embodiment, the system includes a driver 101 and an access assembly 109. Driver 101 can be used to rotate access assembly 109 into a patient's bone. In an embodiment, driver 101 can be automated or manual. In an embodiment, driver 101 is an automated driver 108. For example, automated driver 108 can be a drill that achieves high rotational speeds.

[0036] The intraosseous access system 100 may further include an obturator assembly 102, a shield 105, and a needle assembly 202, which may be collectively referred to as an access assembly 109. The access assembly 109 may also be referred to as an access system. For convenience, the obturator assembly 102 is referred to as such herein. In an embodiment, the obturator assembly 102 includes an obturator 104. However, in some embodiments, the obturator 104 may be replaced with a different elongated medical device. As used herein, the term "elongated medical device" is a broad term used in its ordinary sense, including devices such as needles, cannulas, trocars, obturators, stylets, etc. Therefore, the obturator assembly 102 may be more generally referred to as an elongated medical device assembly. In a similar manner, the obturator 104 may be more generally referred to as an elongated medical device.

[0037] In an embodiment, the obturator assembly 102 includes a coupling sleeve 103 attached to the obturator 104 in any suitable manner (e.g., one or more adhesives or overmolding). The coupling sleeve 103 can be configured to interface with the driver 101, as discussed further below. The coupling sleeve 103 can alternatively be referred to as an obturator sleeve 103, or more generally, as an elongated instrument sleeve 103.

[0038] In an embodiment, the guard 105 is configured to couple with the obturator 104. The coupling can allow relative longitudinal movement between the obturator 104 and the guard 105, such as sliding, translation, or other movement along the elongated axis (i.e., axial movement) when the guard 105 is in a first operating mode, and can prevent the same type of movement when the guard 105 is switched to a second operating mode. For example, when the obturator 104 maintains the guard 105 in an unlocked state, the guard 105 can couple with the obturator 104 in a manner that allows longitudinal translation, and when the obturator 104 moves to a position that no longer maintains the guard in the unlocked state, the guard 105 can automatically transition to a locked state in which little or no translational movement between the guard 105 and the obturator 104 is permitted. In other words, the guard 105 can be longitudinally locked to a fixed or substantially fixed longitudinal orientation relative to the obturator 104, at which longitudinal orientation the guard 105 resists or prevents inadvertent contact with the distal tip of the obturator, as discussed further below. In various embodiments, the guard 105 can be configured to rotate relative to the obturator 104 about the longitudinal axis of the obturator 104 in one or more of an unlocked or locked state.

[0039] Continue to refer to Figure 1For convenience, needle assembly 202 is referred to herein as such. In an embodiment, needle assembly 202 includes needle 204. However, in various other embodiments, needle 204 can be replaced with a different device, such as a cannula, tube, or sheath, and / or can be referred to by different names, such as one or more of the aforementioned examples. Therefore, needle assembly 202 can be more generally referred to as a cannula assembly or tube assembly. In a similar manner, needle 204 can be more generally referred to as a cannula.

[0040] In an embodiment, the needle assembly 202 includes a needle hub 203 attached to the needle 204 in any suitable manner. The needle hub 203 can be configured to couple with the obturator interface 103 and can thereby couple with the driver 101, as discussed further below. The needle hub 203 can also be referred to as a cannula hub 203.

[0041] In an embodiment, the guard 105 is configured to couple with the needle hub 203. The coupling can prevent relative axial or longitudinal movement, such as sliding, translation, etc., between the needle hub 203 and the guard 105 when the guard 105 is in a first operating mode, and can allow the guard 105 to be disengaged from the needle hub 203 when the guard 105 is transitioned to a second operating mode. For example, as discussed further below, when the obturator 104 maintains the guard 105 in an unlocked state, the guard 105 can be coupled with the needle hub 203 so as to be maintained at a substantially fixed longitudinal position relative to the needle hub, and when the obturator 104 moves to a position where the guard 105 is no longer maintained in the unlocked state, the guard 105 can automatically transition to a locked state relative to the obturator 104, in which the guard 105 is also disengaged from the needle hub 203.

[0042] In an embodiment, the shield 105 can be coupled to the obturator 104, the obturator 104 can be inserted with the needle 204, and the obturator hub 103 can be coupled to the needle hub 203 to assemble the access assembly 109. In an embodiment, a cap 107 can be provided to cover at least the distal portion of the needle 204 and the obturator 104 prior to use of the access assembly 109. For example, in an embodiment, the proximal end of the cap 107 can be coupled to the obturator hub 103.

[0043] Continue to refer Figure 1, the automatic drive 108 can take any suitable form. The drive 108 can include a handle 110 that the user can grasp with one hand. The drive 108 can further include an actuator 111 of any suitable type, via which the user can selectively actuate the drive 108 to achieve rotation of the coupling interface 112. For example, the actuator 111 can include a button, as shown, or a switch or other mechanical or electrical element for actuating the drive 108. In an embodiment, the coupling interface 112 is formed as a socket 113 defining a cavity 114. The coupling interface 112 can be configured to couple with the obturator bushing 103. In an embodiment, the socket 113 includes side walls that substantially define a hexagonal cavity, into which the hexagonal protrusion of the obturator bushing 103 can be accommodated. Other suitable connection interfaces can be envisioned.

[0044] The automated drive 108 can include any suitable type of energy source 115 configured to power the rotational movement of the coupling interface 112. For example, in one embodiment, the energy source 115 can include one or more batteries that provide power to the automated drive 108. In other embodiments, the energy source 115 can include one or more springs (e.g., coil springs) or other biasing members that can store potential mechanical energy that can be released when the actuator 111 is actuated.

[0045] The energy source 115 can be coupled to the coupling interface 112 in any suitable manner. For example, in an embodiment, the automatic drive 108 includes an electrical, mechanical, or electromechanical coupling 116 to the gear assembly 117. In some embodiments, the coupling 116 can include an electric motor that generates mechanical motion from the electrical energy provided by the power source 115. In other embodiments, the coupling 116 can include a mechanical linkage that mechanically transfers rotational energy from a mechanical (e.g., spring-based) energy source 115 to the gear assembly 117. The automatic drive 108 can include any suitable type of mechanical coupling 118 to couple the gear assembly 117 to the coupling interface 112. In other embodiments, the gear assembly 117 can be omitted.

[0046] In an embodiment, the automated drive 108 can rotate the coupling interface 112 and, thereby, the entry assembly 109 at a rotational speed significantly greater than that achievable by manually rotating the entry assembly 109. For example, in various embodiments, the automated drive 108 can rotate the entry assembly 109 at a speed of 200 to 3000 revolutions per minute (rpm). However, greater or lesser rotational speeds are also contemplated.

[0047] Further details and embodiments of the intraosseous access system can be found in WO 2018 / 075694, WO 2018 / 165334, WO 2018 / 165339 and US 2018 / 0116693, each of which is incorporated herein by reference in its entirety.

[0048] Figures 2A-2B Shown is an embodiment of the aseptic packaging (e.g., cap 207) in which exemplary entry assembly 109 is arranged. Cap 207 defines a substantially cylindrical cavity 210 extending from a distal end 214 to a proximal end 212 along a longitudinal axis and communicated with an opening 208 arranged at the proximal end 212. It should be noted that the distal end 214 of cap 207 is sealed and is formed as a single integral piece with cap 207. As shown, cavity 210 defines a substantially circular cross-sectional shape, but it is understood that other cross-sectional shapes are also contemplated and fall within the scope of the present invention. In an embodiment, cylindrical cavity 210 defines a substantially uniform cross-sectional area along its longitudinal length. In an embodiment, cylindrical cavity 210 comprises a part that limits different cross-sectional areas along its longitudinal length.

[0049] In an embodiment, the proximal opening 208 and the proximal portion of the cylindrical cavity 210 include a cross-sectional area sufficient to receive the coupling interface 112 of the driver 101, such that the distal portion of the driver 101 can be inserted through the opening 208 and the driver coupling interface 112 can engage the coupling interface 122 of the entry assembly 109.

[0050] In embodiments, the exemplary access assembly 109 is releasably secured within the cap 207 by means of a mechanical interference engagement, a protrusion and locking engagement, a threaded engagement, an adhesive, combinations thereof, or the like. For example, in embodiments, the obturator hub 103 further includes a pair of outward protrusions 136 that can engage an inner surface of the cap 207 and can assist in coupling the access assembly 109 to the cap 207. In embodiments, the cap 207, or a portion thereof, can define an inner diameter that is only slightly larger than an outer diameter of the skirt 130 of the hub 103. The outward protrusions 136 can slightly deform the proximal end of the cap 207 from a substantially cylindrical shape to a more elliptical shape, which can enhance the grip of the cap 207 on the skirt 130. Any other suitable connection arrangement for the cap 207 is also contemplated.

[0051] In an embodiment, the cap 207 can include a rubber O-ring 230, a grommet, or a similar structure disposed within the wall of the cap 207 and configured to engage a bushing of the access assembly 109, such as the obturator bushing 103, when the access assembly 109 is disposed within the cap 207. In an embodiment, the O-ring 230 can be configured to retain the access assembly 109 within the cap 207. In an embodiment, the O-ring 230 can provide a seal between the cap 207 and the access assembly 109 to maintain the needle 204, disposed distally of the O-ring 230, in a sterile environment, even when the proximal opening 208 is opened, as discussed in greater detail herein. Advantageously, the seal can maintain the needle 204 in a sterile environment even when the driver 101 is coupled to the access assembly 109 and maintain the needle 204 in a sterile environment until the moment of use, thereby reducing the introduction of pathogens and the like.

[0052] In an embodiment, the proximal end 212 of the cap 207 includes a flange 216 extending radially around the longitudinal axis from the proximal edge of the cap 207. In an embodiment, the flange 216 provides a distally facing surface that allows a user to grip the cap 207 and push the entry assembly 109 disposed therein proximally against the coupling interface 112 of the driver 101. This is particularly important when the user is wearing gloves or has limited grip or dexterity. In an embodiment, the flange 216 provides a proximally facing surface for a cover 220 to be coupled thereto, as discussed in more detail herein. In an embodiment, the cap 207 includes one or more fins 218 disposed on the outer surface of the cap 207, extending parallel to the longitudinal axis. The fins 218 provide mechanical strength for the cap 207, preventing deformation of the cap 207 and protecting the entry assembly 109 disposed therein from damage. In addition, the fins 218 provide a gripping feature that allows the user to securely grip the cap 207. It should be understood that the outer surface of the cap 207 may further include additional textured surfaces, additional materials including a high coefficient of friction, combinations thereof, etc. to improve the user's grip on the outer surface of the cap 207.

[0053] In an embodiment, cap 207 is formed by a substantially elastic material, such as metal, alloy, plastic, polymer, copolymer, thermoplastic, polypropylene, composite, carbon composite, a combination thereof, etc. In an embodiment, the material forming cap 207 can be substantially rigid and resistant to deformation. In an embodiment, the material forming cap 207 can form a sterile barrier, can be sterilized, or is airtight. Sterilization techniques contemplated herein include ethylene oxide sterilization ("EtO"), gamma ray ("Gamma") sterilization, electron beam ("E-Beam") sterilization, or similar sterilization techniques known in the art. In an embodiment, cap 207 also includes a cover 220 attached to the proximal end 212 of cap 207. Cover 220 can be coupled to cap 207 using heat sealing, bonding, gluing, welding, or similar suitable techniques that releasably fix cover 220 to cap 207. In an embodiment, cover 220 is attached to the proximal surface of flange 216.

[0054] In an embodiment, the cover 220 can be formed of breathable or non-breathable materials, organic or synthetic materials, woven or non-woven materials, including polymers, copolymers, olefin fibers, polyethylene, high density polyethylene ("HDPE"), combinations thereof, etc. The cover 220 can provide a physical and sterile barrier. In an embodiment, the cover 220 can be breathable to allow ethylene oxide ("EtO") sterilization of the cap 207 and any contents disposed therein when the cover 220 is disposed over the proximal opening 208 of the cap. In an embodiment, the cover 220 can provide a gas-impermeable barrier to provide a physical and sterile barrier, for example, when gamma ray or electron beam sterilization techniques are used.

[0055] In an embodiment, the cover 220 includes a gripping feature that allows a user to grasp a portion of the cover 220 and peel the cover 220 off the cap 207 to access the contents therein. In an embodiment, the gripping feature includes a tab, a finger ring, or a similar structure or a combination thereof. In an embodiment, the gripping feature includes a finger ring 222 extending from the proximal surface of the cover 220. In an embodiment, the gripping feature includes a tab 224 extending from the periphery of the cover 220. However, it will be understood that similar structures or combinations thereof are considered to fall within the scope of the present invention.

[0056] In an embodiment, the cover 220 includes a tear line 226. The tear line 226 can include a score line, a perforation, a laser cut line, or a similar weakening line that allows a portion of the cover 220 to be separated along it. In an embodiment, a user can push an object (e.g., a distal portion of the driver 101) through the tear line 226 of the cover 220 to access the access assembly 109 disposed therein. Advantageously, this speeds up the attachment of the access assembly 109 to the driver 101 by eliminating the need to first remove the cover 220. Instead, the user pushes the driver 101 through the cover 220, breaking the tear line 226, until the driver coupling interface 112 engages the access assembly coupling interface 122. The cap 207 can then be withdrawn distally, exposing the needle 204 ready for use.

[0057] In an embodiment, tear line 226 can facilitate removal of cover 220 before securing access assembly 109 to driver 101. For example, a user can pull on a gripping feature, such as finger ring 222 or tab 224, which can cause a portion of cover 220 to separate along tear line 226. With a portion of cover 220 removed, a proximal portion of access assembly 109 is exposed, allowing a user to couple a driver thereto, for example, by coupling driver interface 112 to access assembly coupling interface 122. It should be noted that an intact cover 220, including tear line 226, can still maintain a sterile barrier between cavity 210 and the surrounding environment.

[0058] Advantageously, the cap 207 allows the access assembly 109 to be individually wrapped and serves as both protection and a sterile barrier during transport and handling of the access assembly 109, and does not require the user to remove the device from a separate sterile barrier packaging. Although the embodiment of the cap 207 is shown as including an exemplary access assembly 109, it should be understood that this is not limited to the access assembly 109, and in some embodiments, the cap 207 may also include separate components or combinations thereof of the access assembly 109, or may include additional components of the intraosseous access system 100. In addition, the cap 207 allows the driver 101 or a similar placement device to approach the access assembly 109 without physically contacting the access assembly 109, thereby eliminating the risk of contamination and reducing the number of packaging components, such as additional Tyvek pouches, etc. Advantageously, the embodiments disclosed herein speed up the attachment of the access assembly 109 to the driver 101 while maintaining a sterile barrier until the moment of use.

[0059] like Figure 3As shown, in an embodiment, the intraosseous access system 100 includes sterile packaging, such as cap 307, which provides a disposable system in which the access assembly 109 is already coupled to the driver 101. The cap 307 provides both protection during shipping and operation and acts as a sterile barrier between the surrounding environment and the portion of the system 100 that contacts the patient.

[0060] In an embodiment, a cap 307 is provided that defines a substantially cylindrical cavity 310 extending along a longitudinal axis from a distal end 314 to a proximal end 312. The cap 307 is configured to house the access assembly 109 and includes features similar to those of the embodiments described herein. It should be understood that the access assembly 109 is exemplary, and one of ordinary skill in the art will appreciate that the cap 307 protects at least a portion of the intraosseous access system 100 that contacts the patient during use.

[0061] In an embodiment, the proximal end 312 of the cap 307 is configured to engage the distal portion of the driver 101, including the driver coupling interface 112. The proximal end 312 can be releasably secured to the driver 101, for example, by heat sealing, bonding, gluing, welding, or similar suitable techniques. In an embodiment, the cap 307 is coupled to the driver 101 by means of a threaded engagement between the inner surface of the cap 307 and the outer surface of the driver 101. In use, a user grasps the outer surface of the cap 307 and can rotate the cap 307 relative to the driver 101 about the longitudinal axis, twisting to break the releasable securing, threaded portion, or a combination thereof to release the cap 307 from the driver 101. In an embodiment, the cap 307 includes fins 318 that provide mechanical strength to the cap 307 and provide a gripping feature. It should be understood that the outer surface of the cap 307 can further include an additional textured surface, additional materials including a high coefficient of friction, combinations thereof, etc., to improve the user's grip on the outer surface of the cap 307.

[0062] In an embodiment, as described herein, the cap 307 includes a tear-off strip 326 defined by one or more tear lines and includes a gripping feature such as a tab or finger ring. In use, the user pulls on the gripping feature, which causes the tear-off strip 326 to separate from the intraosseous access system 100 and the cap 307 to separate from the driver 101. In an embodiment, the distal end 314 of the cap 307 is formed as a continuous sealed end to define the cavity 310 therein. In an embodiment, the cavity 310 and the access assembly 109 disposed therein are sterilized prior to assembly of the driver 101.

[0063] In an embodiment, the cap 307 includes an opening 308 that communicates with the interior cavity 310 of the cap 307 and may include a cover 320 disposed thereon. In an embodiment, the opening 308 is disposed at the distal end 314 of the cap 307, but it is understood that the opening 308 can be disposed through the side wall of the cap 307. In an embodiment, the opening 308 can be disposed in the wall of the body of the driver 101 to communicate with the interior cavity of the body. It should be noted that the interior cavity of the body can communicate with the interior cavity 310 of the cap 307. It should be understood that other combinations of one or more openings 308 that communicate with the interior portion of the driver 101 or the cap 307 are also contemplated.

[0064] In an embodiment, the cover 320 can be formed of a gas-permeable material that allows EtO sterilization of the cavity 310 and any components disposed therein after the cap 307, access assembly 109, and driver 101 have been assembled. In an embodiment, the cover 320 can be gas-impermeable, for example, when using gamma ray or electron beam sterilization techniques. Although the outer surfaces of the cap 307 and driver 101 may not remain sterile during operation and transportation, the interior of the cavity 310 and any components disposed therein, i.e., those that come into contact with the patient, will remain sterile until the moment of use.

[0065] In an embodiment, the system 100 can further include an extension device 160 or similar medical device(s) configured to be coupled to the needle hub 203 once the needle is positioned to enter the intramedullary cavity. In an embodiment, the system 100 can include an access kit (not shown) that includes additional equipment needed to position and stabilize the access needle assembly 202. The access kit can include a dressing, a stabilization device, sterile wipes, gloves, combinations thereof, and the like. In an embodiment, the extension device 160 or access kit can be retained within a cavity defined by one of the driver body 101 or the cap 307. For example, as Figure 3 As shown, the handle of the driver 101 defines a cavity 170 configured to receive the extension member 160 disposed therein. The cavity 170 can be sealed using a cap 320 configured to allow the extension member 160 disposed within the cavity 170 to be sterilized, as described herein.

[0066] In an embodiment, the system 100 can be assembled with an access assembly 109 coupled to the driver 101 and having a cap 307 disposed thereon. The system 100 can further include an extension device 160 or access kit that is disposed within the driver 101 and sealed therein by a cap 320. The system 100 can then be sterilized by EtO sterilization, gamma sterilization, e-beam sterilization, or the like as described herein. Advantageously, this provides a readily available and sterile system 100 and maintains the patient-contacting portion in a sterile environment prior to use. Furthermore, the system 100 provides all of the components required to access the medullary cavity as a single, easily accessible system 100, accelerating the surgical procedure.

[0067] like Figure 4 As shown, in an embodiment, the intraosseous access system 100 includes sterile packaging, such as cap 407, provided as a disposable system. The access assembly 109 is provided already coupled to the driver 101 and arranged in a retracted state, wherein a portion of the access assembly 109 is arranged within the handle 110 of the driver 101. The handle 110 and the cap 407 define a cavity 410, and the access assembly 109 is arranged within the cavity 410. The cap 407 and the driver handle 110 maintain a sterile barrier between the surrounding environment and the portion of the system 100 that contacts the patient. In addition, the cap 407 and the driver handle 110 provide mechanical protection for the access assembly 109 arranged therein.

[0068] In an embodiment, access assembly 109, or components thereof, is disposed within driver 101 in a retracted state, with cap 407 covering an opening 413 disposed at the distal end of driver 101. When transitioning from the retracted state to the deployed state, access assembly 109 can pass through opening 413. In an embodiment, cap 407 is releasably attached to the distal end of driver 101 by heat sealing, bonding, gluing, welding, or similar suitable techniques. In an embodiment, cap 407 is coupled to driver 101 via a threaded engagement between an inner surface of cap 407 and an outer surface of driver 101. In use, a user grasps the outer surface of cap 407 and can rotate cap 407 relative to driver 101 to twist and break the releasable securing portion, threaded portion, or a combination thereof, thereby releasing cap 407 from driver 101. In an embodiment, cap 407 includes fins 418 that provide mechanical strength to cap 407 and provide a gripping feature. It should be understood that, as described herein, the outer surface of cap 407 may further include additional textured surfaces, gripping features, etc.

[0069] In one embodiment, as described herein, the cap 407 includes a tear-off strip 426 defined by one or more tear lines and includes a gripping feature, such as a tab or finger ring. In use, the user pulls on the gripping feature, which causes the tear-off strip 426 to separate from the intraosseous access system 100 and the cap 407 to separate from the driver 101.

[0070] In an embodiment, cap 407 can be set aside and access assembly 109 can be extended through opening 413 to an expanded state and locked in place, ready for insertion into the patient. In an embodiment, cap 407 can be coupled to access assembly 109 and used as a gripping feature to pull access assembly 109 through opening 413 to an expanded state while maintaining the sterility of access assembly 109. In an embodiment, once the user has finished using intraosseous access system 100, needle 204 can be retracted from the expanded state to the retracted state to accommodate needle 204 for disposal. Optionally, cap 407 can be placed over opening 413 again to fully accommodate needle 204 for disposal. Advantageously, this can prevent accidental needle sticks and contain any blood on the needle until the device can be safely disposed of.

[0071] In an embodiment, the cap 407, the driver 101, or a combination thereof includes an opening 408 that communicates with the cavity 410. For example, Figure 4 As shown, opening 408 is arranged in distal end 414 of cap 407. Opening 408 includes a cover 420 attached thereto. In an embodiment, cover 420 can be formed of a breathable material that allows EtO sterilization of cavity 410 and any components disposed therein (e.g., access assembly 109) after cap 407, access assembly 109, and driver 101 have been assembled. In an embodiment, cover 420, cap 407, driver 101, access assembly 109, combinations thereof, etc. can be configured to be gamma-ray or electron beam sterilized before or after assembly. Although the outer surfaces of cap 407 and driver 101 may not maintain a sterile state during operation and transportation, the interior of cavity 410 and associated components will maintain a sterile state until use.

[0072] Advantageously, Figure 4 The illustrated embodiment of the intraosseous access system 100 defines a compact form factor that is easily stored, transported, and operated. This is particularly important for emergency services personnel, who may have limited carrying capacity and where rapid deployment is crucial. The system 100 maintains the sterility of patient-contacting surfaces until use and rapidly converts from a retracted, transportable configuration to a deployable configuration, ready for insertion into a patient.

[0073] Figure 5An embodiment of an intraosseous access system 100 is shown that includes a manual driver 101, an access assembly 109 coupled thereto, and sterile packaging disposed thereon, such as a cap 507. In an embodiment, the cap 507 can define a cavity 510 configured to receive the access assembly 109 and an extension device 160 or an access kit therein. In an embodiment, one of the body of the driver 101 or the cap 507 can include an opening 508 that communicates with the cavity 510 of the cap 507. The opening 508 can be covered by a cover 520 that is configured to facilitate sterilization of the access assembly 109 and extension device 160 disposed within the cavity 510 of the cap 507 after the system 100 has been assembled, as described herein.

[0074] In an embodiment, the cap 507 can include a support structure 522 configured to releasably secure a portion of the extension device 160 and retain the extension device within the cap 507. Advantageously, the support structure 522 can prevent the extension device from falling out of the cap when the cap 507 is removed and the needle 204 is placed. Instead, the extension device 160 remains in a sterile environment within the cap 507 until removed by the user and attached to the needle hub 203.

[0075] Advantageously, the system 100 can provide the fully assembled driver 101 and access assembly 109, along with the extension device 160, etc., in a sterile environment until use without requiring any additional packaging. The extension device 160 disposed within the cap 507 is readily available and can be retrieved without requiring any additional steps, speeding up the needle placement process.

[0076] Although some specific embodiments have been disclosed herein, and although some details of specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those of ordinary skill in the art and are encompassed in the broader aspects. Therefore, departures may be made from the specific embodiments provided herein without departing from the scope of the concepts disclosed herein.

Claims

1. An intraosseous access device, comprising: Driver; an access assembly coupled to the driver; and a sterile package defining a cavity, coupled to a portion of the driver, and enclosing the access assembly to maintain the access assembly in a sterile environment, wherein the proximal end of the sterile package includes a tear strip configured to detach from one of the sterile package or the actuator and release the sterile package from the actuator, wherein the access assembly is convertible between a retracted state and a deployed state, wherein a portion of the access assembly is disposed within the actuator in the retracted state, The sterile packaging is coupled to the access assembly and is configured to transition the access assembly from the retracted state to the deployed state when the sterile packaging is removed. 2 . The intraosseous access device of claim 1 , wherein the proximal end of the sterile package is releasably secured to the driver by heat sealing, bonding, adhesive bonding, or welding.

3. The intrabone access device of claim 1 or 2, wherein the proximal end of the sterile package is releasably secured to the driver by threaded engagement between an inner surface of the sterile package and an outer surface of the driver.

4. The intraosseous access device of claim 1 , wherein one of the sterile package or the driver comprises an opening communicating with the cavity of the sterile package and comprising a cover disposed thereon to maintain the sterile environment, the cover being formed of a material different from that of the sterile package or the driver.

5. The intraosseous access device of claim 4, wherein the cover is made of a breathable organic material, a synthetic material, a woven material, a non-woven material, a polymer, a copolymer, an olefin fiber, polyethylene, high-density polyethylene, or form.

6. The intraosseous access device of claim 4, wherein the cover provides a physical and sterile barrier and allows for EtO sterilization of the access assembly disposed therein.

7. The intraosseous access device of claim 4, wherein the cover is coupled to the sterile packaging using one of heat sealing, bonding, adhering, or welding.

8. The intraosseous access device of claim 1, wherein the sterile packaging or the driver includes fins extending longitudinally along an outer surface thereof, and the fins are configured to provide structural support or provide gripping features for rotating the sterile packaging relative to the driver.

9. The intraosseous access device of claim 1, further comprising an extension member releasably retained within the cavity defined by the sterile packaging to maintain the extension member within a sterile environment.

10. The intraosseous access device of claim 1, further comprising an extension member releasably retained within the cavity defined by the body of the driver, and a cover disposed over the opening of the cavity to provide a sterile barrier and maintain the extension member within a sterile environment.

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