Retractable into the bone to enter the system

Abstract

The embodiments disclosed herein relate to a retractable intraosseous access system configured to switch between an active state and a folded or retracted state. In the folded state, the access component can pivot relative to the actuator to cause the access component to collapse against the handle. In the retracted state, the access component is slidably received within the housing of the actuator. Advantageously, the retractable intraosseous access system can provide an "integrated" design that eliminates the need to assemble separate components. Furthermore, the retractable intraosseous access system can provide a compact external profile that requires reduced storage space.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Patent Application No. 63 / 073,342, filed September 1, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to retractable intraosseous access systems. Background Technology

[0004] In emergency situations where rapid vascular access is required and direct venous access is difficult or impossible, an intraosseous (IO) access system is used. An IO access system may include an actuator configured to cause a needle to drill through the cortical layer of bone to access the medullary cavity. Fluid can then be delivered through the needle into the medullary cavity and into the patient's blood vessels.

[0005] Current methods for needle placement include providing a driver and an access component that includes the needle in a separately packaged form. However, this I / O access system must also be assembled before use by removing the needle from its packaging, removing the drill bit from the separate package, attaching the needle to the drill bit, and removing the needle cap before starting the procedure. These multi-step assembly processes consume valuable time. Furthermore, the separately packaged components may be lost or separated during transportation or storage, requiring additional logistical work to ensure that all individual components are properly stored and kept in a sterile environment.

[0006] Therefore, it is beneficial to provide an "integrated" intraosseous access system that requires fewer individual components for tracking and storage, and fewer assembly steps before use. Furthermore, the intraosseous access system offers a compact profile for easy storage and transport, and reduces packaging costs. The compact design is important because the IO access system can be used and stored by pre-admission users with limited space in kits or ambulances. Similarly, the IO access system is also used in space-constrained emergency rooms, trauma rooms, or intensive care unit (ICU) situations, such as on emergency trolleys. This document discloses a foldable, retractable intraosseous access system and related methods of use that address the aforementioned issues. Summary of the Invention

[0007] This document discloses a foldable intraosseous access system for accessing the medullary cavity, comprising: an actuator including a housing extending along a longitudinal axis; and an access assembly pivotally coupled to the actuator between a folded state and an active state, the access assembly including a needle extending parallel to the longitudinal axis in the active state and extending at an angle to the longitudinal axis in the folded state.

[0008] In some embodiments, the foldable intraosseous access system further includes a drive train configured to rotate the needle about a longitudinal axis in the active state and to disengage the access assembly in the folded state. In some embodiments, the needle in the folded state forms an angle between 50° and 180° with respect to the longitudinal axis. In some embodiments, the foldable intraosseous access system further includes a handle extending from the housing along a handle axis that extends at an angle relative to the longitudinal axis, with the needle extending parallel to the handle axis in the folded state. In some embodiments, the handle includes a handle recess configured to receive a portion of the access assembly therein in the folded state.

[0009] In some embodiments, the access component can also switch between a locked state and an unlocked state, with the locked state preventing the access component from switching between an active state and a folded state. In some embodiments, the foldable intraosseous access system also includes a cap configured to close the needle and retain it in a sterile environment or prevent accidental needlestick injury. In some embodiments, the housing also includes a distal opening through which the access component extends in both the folded and active states. In some embodiments, the drive system includes one of a gear mechanism, a drive spring, an electric motor, or a battery.

[0010] In some embodiments, the foldable intraosseous access system further includes a cam system comprising a cam that, in an operational state, slidably engages with a slot disposed in a housing. In some embodiments, the foldable intraosseous access system further includes a biasing member configured to actuate the cam to engage the slot in an operational state. In some embodiments, the foldable intraosseous access system further includes a connector disposed on the access assembly and slidably engaged with a receiver coupled to a drive system, the connector engaging the receiver when the access assembly is in an operational state. In some embodiments, the foldable intraosseous access system further includes a support mechanism comprising a first support and a second support, the first and second supports being slidably engaged relative to each other and configured to hold the cam between the first and second supports in one or more rest states to hold the access assembly in either a folded or operational state.

[0011] In some embodiments, the foldable intraosseous access system further includes a biasing member configured to bias the first and second supports toward each other. In some embodiments, the foldable intraosseous access system further includes a socket mechanism comprising a socket having a recess disposed on its distal surface and configured to engage a surface of a cam to hold the cam in one or more stationary states and the access assembly in one of a folded or active state. In some embodiments, the foldable intraosseous access system further includes a biasing member configured to bias the socket toward the cam.

[0012] Also disclosed is a retractable intraosseous access system for accessing the medullary cavity, comprising: an actuator including a housing extending along a longitudinal axis; and an access assembly slidably engaged with the actuator between a retracted state and an activated state, the access assembly including a needle extending parallel to the longitudinal axis, disposed within the housing in the retracted state, and extending from a distal opening of the housing in the activated state.

[0013] In some embodiments, the entry component can also switch between a locked state and an unlocked state, with the locked state preventing the entry component from switching between an active state and a retracted state. In some embodiments, the retractable intraosseous entry system also includes a drive system configured to rotate the needle about a longitudinal axis in the active state and configured to disengage the entry component in the folded state. In some embodiments, the drive system includes one of a gear mechanism, a drive spring, an electric motor, or a battery.

[0014] In some embodiments, the retractable intraosseous access system further includes a biasing member configured to bias the access component toward the operational state. In some embodiments, the retractable intraosseous access system further includes a catch mechanism configured to releasably engage the access component and hold it in the retracted state.

[0015] A method for accessing the medullary cavity is also disclosed, comprising: providing an intraosseous access system including a housing extending along a longitudinal axis and an access assembly coupled to the housing and including a needle; pivoting the access assembly from a retracted state in which the needle extends at an angle relative to the longitudinal axis to an operational state in which the needle extends parallel to the longitudinal axis; and activating a transmission system to rotate the needle about the longitudinal axis.

[0016] In some embodiments, the transmission system is configured to engage the entry assembly in the active state and disengage it in the retracted state. In some embodiments, the method further includes pivoting the needle relative to a longitudinal axis by an angle between 50° and 180°. In some embodiments, the method further includes pivoting the needle to extend parallel to the axis of the handle extending from the housing. In some embodiments, the method further includes arranging a portion of the entry assembly within a handle recess located on the handle when the entry assembly is in the retracted state.

[0017] In some embodiments, the method further includes switching the entry component between a locked state and an unlocked state, the locked state preventing the entry component from switching between an active state and a folded state. In some embodiments, the transmission system includes one of a gear mechanism, a drive spring, an electric motor, or a battery. In some embodiments, the method further includes sliding a cam along a longitudinal axis to engage a slot disposed in the housing when the entry component is in the active state.

[0018] A method for accessing the medullary cavity is also disclosed, comprising: providing an intraosseous access system including a housing extending along a longitudinal axis, and an access assembly slidably engaged with the housing and including a needle; sliding the access assembly along the longitudinal axis from a retracted state in which the needle is arranged within the housing to an active state in which the needle extends from the distal end of the housing; and activating a drive system to rotate the needle about the longitudinal axis.

[0019] In some embodiments, the drive system is configured to engage the entry component in an active state and disengage it in a retracted state. In some embodiments, the method further includes switching the entry component between a locked state and an unlocked state, the locked state preventing the entry component from switching between the active and retracted states.

[0020] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of such concepts in more detail. Attached Figure Description

[0021] A more specific description of the disclosure will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained using the accompanying drawings, with the aid of additional features and details, wherein:

[0022] Figure 1A A perspective view of a foldable intraosseous access system in a folded state according to some embodiments is shown.

[0023] Figure 1BA side view of a foldable intraosseous access system in operation, according to some embodiments, is shown.

[0024] Figure 1C Close-up details of the folding mechanism of a foldable intraosseous access system according to some embodiments are shown.

[0025] Figure 1D A schematic diagram of a foldable intraosseous access system in a folded state, according to some embodiments, is shown.

[0026] Figure 1E A schematic diagram of a collapsible intraosseous access system in an active unlocked state is shown according to some embodiments.

[0027] Figure 1F A schematic diagram of a foldable intraosseous access system in an active-locked state is shown according to some embodiments.

[0028] Figures 2A to 2C A schematic diagram of a foldable intraosseous access system including a scaffold folding mechanism is shown according to some embodiments.

[0029] Figures 2D to 2F A folding mechanism for a foldable intraosseous access system according to some embodiments is shown.

[0030] Figure 3A A perspective view of a retractable intraosseous access system according to some embodiments is shown.

[0031] Figure 3B A perspective view of a sliding intraosseous access system in operation according to some embodiments is shown.

[0032] Figure 4 A flowchart is shown illustrating an exemplary usage method for retractable or foldable I / O into a system according to some implementations. Detailed Implementation

[0033] Before disclosing certain specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and optionally combined with or substituted for any of the many other embodiments disclosed herein.

[0034] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide for sequential or numerical limitations. For example, the features or steps “first,” “second,” and “third” do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, fixed orientation, or fixed direction. Rather, such labels are used to reflect, for example, relative position, relative orientation, or relative direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0035] The terms "proximal," "proximal portion," or "proximal portion" of a needle, as disclosed herein, include the portion of the needle intended to be close to the clinician when used with a patient. Similarly, for example, the "proximal length" of a needle includes the length of the needle intended to be close to the clinician when used with a patient. For example, the "proximal end" of a needle includes the tip of the needle intended to be close to the clinician when used with a patient. The proximal portion, proximal portion, or proximal length of a needle may include the proximal end of the needle; however, the proximal portion, proximal portion, or proximal length of a needle does not necessarily include the proximal end of the needle. That is, unless the context otherwise suggests, the proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0036] The terms "distal," "distal portion," or "distal part" of a needle, as disclosed herein, include the portion of the needle intended to be close to or within the patient when used with the needle. Similarly, for example, the "distal length" of a needle includes the length of the needle intended to be close to or within the patient when used with the needle. For example, the "distal end" of a needle includes the tip of the needle that is close to or within the patient when used with the needle. The distal portion, distal part, or distal length of a needle may include the distal end of the needle; however, the distal portion, distal part, or distal length of a needle does not necessarily include the distal end of the needle. That is, unless the context otherwise suggests, the distal portion, distal part, or distal length of a needle is not the distal end portion or distal length of the needle.

[0037] To help describe the implementation scheme described in this article, such as Figures 1A to 1B As shown, the longitudinal axis extends substantially parallel to the axial length of the needle in the device in operation. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes. As used herein, the horizontal plane extends along both the lateral and longitudinal axes. The vertical plane extends perpendicular to the horizontal plane.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0039] Figures 1A to 1F Various views of the foldable or retractable intraosseous (IO) access system (“System”) 100 are shown. Figures 1A to 1B It shows the state of being retracted or folded. Figure 1A ) and active state ( Figure 1B A perspective view of a foldable or retractable intraosseous (IO) access system 100. In one embodiment, system 100 typically includes an actuator 110 and an access component 220. Actuator 110 may include a housing 112 defining a generally cylindrical shape extending longitudinally along a central longitudinal axis 90 between a distal end 116 and a proximal end 114, and may include a handle 120 extending therefrom. As will be understood, housing 112 may define various three-dimensional shapes without departing from the spirit of the invention. In one embodiment, handle 120 may extend from housing 112 along an axis 92 extending substantially perpendicular to the central longitudinal axis 90. However, it should be understood that the axis 92 of handle 120 may extend at other angles relative to the central longitudinal axis 90 without departing from the spirit of the invention. As will be understood, various numbers and configurations of housing 112 and handle 120 are contemplated to fall within the scope of the invention. Housing 112 may define an interior cavity 122 communicating with an opening 118 disposed at its distal end 116.

[0040] Access assembly 220 typically includes a needle 222 supported by a needle bushing 224 and defining a needle lumen 226. In one embodiment, access assembly 220 may also include an occluder (not shown) configured to engage within the needle lumen 226 and prevent tissue and bone fragments from obstructing the needle lumen 226 during placement. Access assembly 220 may also include a cap 228 configured to rest on at least a portion of the needle 222. Cap 228 may retain the needle 222 in a sterile environment during transport and storage and may prevent accidental needlestick injury. In one embodiment, access assembly 220 or a portion thereof may be rotatably coupled to actuator 110 and may rotate about a central longitudinal axis 90.

[0041] In one embodiment, the actuator 110 may further include a drive system 108 configured to rotate the entry assembly 220 and cause the needle 222 to drill through the bone cortex into the medullary cavity. Exemplary drive system 108 may include electrical, mechanical, electromechanical, dynamic, potential mechanisms, springs, biasing members, gear mechanisms, electric motors and power supplies (line power, battery power, etc.), combinations thereof, etc. Drive system 108 may be configured to provide rotational movement about a central longitudinal axis 90 to the entry assembly 220. In one embodiment, the actuator 110 may include an electric motor and battery pack or drive springs configured to rotate the entry assembly 220 and cause the needle 222 to drill into the bone into the medullary cavity.

[0042] In one implementation scheme, such as Figures 1A to 1B As shown, the entry component 220 is pivotally coupled to the driver 110 and can be in a retracted or folded position. Figure 1A ) and activity location ( Figure 1B Transitions between ( ). In one embodiment, access component 220 is pivotable through a vertical plane defined by a longitudinal axis and a transverse axis. However, it should be understood that access component 220 is pivotable through other planes in three-dimensional space. In one embodiment, access component 220 is pivotable relative to the central longitudinal axis 90 by an angle between 1° and 360°. In one embodiment, access component 220 is pivotable relative to the central longitudinal axis 90 by an angle between 50° and 180°. In one embodiment, access component 220 is pivotable relative to the central longitudinal axis 90 by an angle substantially 90°.

[0043] In one implementation, in the active location ( Figure 1B The axis 94 entering component 220 may extend parallel to the central longitudinal axis 90 of driver 110. In one embodiment, in the active position ( Figure 1B The axis 94 of the component 220 can be aligned with the central longitudinal axis 90 of the driver 110. In one embodiment, in the folded position ( Figure 1A The axis 94 entering component 220 may extend at an angle relative to the central longitudinal axis 90. In one embodiment, in the folded position ( Figure 1A The axis 94 of the entry component 220 may extend substantially parallel to the axis 92 of the handle 120. In one embodiment, in the folded position ( Figure 1A The axis 94 entering component 220 can extend at an angle between 1° and 360° relative to the central longitudinal axis 90. In one embodiment, in the folded position ( Figure 1A The axis 94 entering component 220 can extend at an angle between 5° and 180° relative to the central longitudinal axis 90. In one embodiment, in the folded position ( Figure 1AThe axis 94 of the component 220 can extend at an angle of approximately 90° relative to the central longitudinal axis 90.

[0044] In one implementation, the access component 220 can be in a folded state ( Figure 1A ) and active state ( Figure 1B The component 220 can pivot between one or more static states between a folded state and an active state. For example, the component 220 can pivot between one or more static states arranged in increments of 5° or 10°. However, it should be understood that these increments are exemplary and larger or smaller increments are also conceivable.

[0045] In one embodiment, the handle 120 may include a recess 192 extending along a portion thereof and configured to receive a portion of the entry component 220 therein when the system 100 is in a folded state. Advantageously, the handle recess 192 stabilizes the entry component 220 when the system 100 is in a folded state during transport and storage. Furthermore, by receiving at least a portion of the entry component 220 within the volume defined by the handle 120, the handle recess 192 provides a more compact overall profile.

[0046] In one implementation scheme, such as Figure 1C As shown, the actuator 110 may include a folding mechanism 200 disposed within the cavity 122 of the housing 112. The folding mechanism 200 may be configured to transition the entry component 220 between a folded state and an operational state, or between one or more stationary states between a folded state and an operational state, or a combination thereof. In one embodiment, the folding mechanism 200 may also be configured to transition the entry component 220 between a locked state and an unlocked state when the entry component 220 is in one or more of a folded state, an operational state, or one or more of a stationary state in between. In the locked state, the folding mechanism 200 prevents the entry component 220 from transitioning from its current position, i.e., the folded state, the operational state, or one or more of a stationary state in between. In the unlocked state, the folding mechanism 200 allows the entry component 220 to transition between one or more of a folded state, an operational state, or one or more of a stationary state in between.

[0047] In one embodiment, the access component 220 may further include a connector 140 disposed at the proximal end of the access component 220. The connector 140 may be configured to selectively engage a receiver 142 coupled to the drive system 108. In one embodiment, a folding mechanism 200 in the unlocked position disengages the connector 140 from the receiver 142. In one embodiment, a folding mechanism 200 in the locked position engages the connector 140 with the receiver 142. In one embodiment, a folding mechanism 200 in both the active and locked positions engages the connector 140 with the receiver 142 and allows the drive system 108 to rotate the access component 220 or a portion thereof. In one embodiment, the connector 140 may define a substantially hexagonal cross-sectional shape and may be configured to fit within a receiver recess 144 defining a similarly hexagonal cross-sectional shape. However, it should be understood that other polygonal connectors 140 and receiver recesses 144, or "lock and key" type engagements, are also considered to fall within the scope of the invention.

[0048] Advantageously, the folding mechanism 200 can be configured to engage the connector 140 with the receiver 142 only when the entry component 220 is in the active and locked state. This prevents the drive system 108 from being accidentally actuated and prematurely rotating the entry component 220, i.e., when the entry component 220 is not positioned in the active state, i.e., during assembly prior to transport, storage, or use. In some embodiments, the drive system 108 of the actuator 110 can be actuated by a pressure-activated actuator, such as a trigger, button, etc. In one embodiment, the drive system 108 can be actuated by axial pressure applied to the entry component 220 or a portion thereof.

[0049] In one embodiment, the entry component 220 is selectively coupled to the folding mechanism 200, allowing the user to selectively attach the entry component 220 to or selectively detach it from the folding mechanism. Advantageously, in the event of needle 222 failure or misalignment, the selectively detachable entry component 220 allows the user to replace the entry component 220 as needed before or after a placement event. Furthermore, the user can replace the entry component 220 with a new one after use, and the system 100 can be converted to a folded state ready for re-sterilization, storage, or reuse.

[0050] Figures 1C to 1FFurther details of the folding mechanism 200 are shown. In one embodiment, the distal portion of the housing 112 may include a distal opening 118 communicating with the interior cavity 122 of the housing 112. An access assembly 220 may extend through the distal opening 118 to engage one or more of the folding mechanism 200 or a drive system 108 disposed within the housing 112. In one embodiment, the access assembly 220 may extend through the distal opening 118 in both the folded and active states.

[0051] In one embodiment, the folding mechanism 200 may include a cam system 202 having one or more cams 214 laterally offset from the central longitudinal axis 90. For example, a first cam 214A may be arranged on the left side of the folding mechanism 200, and a second cam 214B may be arranged on the right side of the folding mechanism 200. The cams 214 may define a regular or irregular, substantially oval or elliptical shape, and may include one or more facets. The cams 214 may be configured to slidably engage slots 124 disposed in the sidewalls of the cavity 122 and extending longitudinally. For example, the first cam 214A may slidably engage a first slot 124A, and the second cam 214B may slidably engage a second slot 124B. In one embodiment, the slot 124 may define a width (w) extending substantially perpendicular to the central longitudinal axis 90.

[0052] In one embodiment, cam 214 may include a first diameter (d1) and a second diameter (d2) extending perpendicularly thereto. The first diameter (d1) may be larger than the second diameter (d2). In one embodiment, the first diameter (d1) may be larger than the width (w) of slot 124, and the second diameter (d2) may be smaller than the width (w) of slot 124. In one embodiment, the first diameter (d1) may be aligned parallel to the axis 94 of the entry assembly 220.

[0053] like Figure 1D As shown, in the folded state, the first diameter (d1) of the cam 214 is angled relative to the longitudinal axis of the slot 124, and is substantially parallel to the central longitudinal axis 90. When the assembly 220 transitions to the active state ( Figure 1E When the cam 214 is in the active position, the axis 94 of the cam 220 can be aligned parallel to the central longitudinal axis 90. Thus, the first diameter (d1) of the cam 214 can extend parallel to the axis of the slot 124, and the second diameter (d2) of the cam 214 can extend perpendicularly to it. In the active state, the cam 214 can be received within the slot 124 and can stabilize the cam 220 in the active state. The cam 214 can then be in the unlocked position of the active state. Figure 1E ) and the locked position of the action state ( Figure 1F Slide between ) . In the locked position of the active state ( Figure 1F The connector 140 can engage the receiver 142 of the drive system 108.

[0054] In one embodiment, the folding mechanism 200 may further include a biasing member configured to bias the entry assembly 220 toward a locked state. In use, a user can grasp the entry assembly 220 and transition it from a folded state to an unlocked state. The biasing member can then transition the entry assembly 220 from the unlocked state to the locked state by longitudinally pushing the cam 214 into the slot 124. Similarly, to transition the entry assembly 220 from an active locked state to a retracted folded state, the user can push the entry assembly 220 longitudinally distally to disengage the cam 214 from the slot 124 before pivoting the entry assembly 220 to the folded state.

[0055] In one embodiment, the folding mechanism 200 may further include a second biasing member configured to bias the entry component 220 toward the active state. A triggering mechanism may be configured to hold the entry component 220 in the folded state. In use, a user may actuate the triggering mechanism to release the entry component 220 and allow the second biasing member to transition the entry component 220 from the folded state to the active state. In one embodiment, a first biasing member may then transition the entry component 220 from an unlocked state to a locked state, as described herein. In one embodiment, a user may manually push the entry component 220 between one or more of the folded state, active state, unlocked state, or locked state, or combinations thereof. Advantageously, the foldable I / O entry system 100 may be configured to be fully assembled and packaged with the entry component 220 coupled to the driver 110. The system 10 may be stored in a storage state and quickly transitioned to an active state for use. Advantageously, the entry component 220 may be transitioned from the storage state to the active state and locked in the active state, ready for use. This prevents premature disengagement of the entry component 220 during use.

[0056] In one implementation scheme, such as Figures 2A to 2C As shown, the folding mechanism 200 may include a support mechanism 204. The support mechanism 204 may include a top support 184A and a bottom support 184B, which are configured to hold a cam 214 between them. As shown, the top support 184A and the bottom support 184B may be arranged along a transverse axis, with the cam 214 disposed between them. However, it should be understood that other configurations of the support mechanism 204 extending along other axes or at an angle relative to them are also considered to fall within the scope of the invention.

[0057] The top bracket 184A and the bottom bracket 184B can be in the first position along the lateral axis ( Figure 2A ) and second position ( Figure 2CSliding between ) . In the first position, the top support 184A and the bottom support 184B are arranged radially outward relative to the central longitudinal axis 90. In the second position ( Figure 2C The top support 184A and the bottom support 184B are arranged radially inward relative to the central longitudinal axis 90. The support mechanism 204 may also include an offset member configured to orient the top support 184A and the bottom support 184B toward a second position (…). Figure 2C Bias.

[0058] In use, the entry component 220 can switch between one or more of a folded state, an active state, or a static state in between. The support mechanism 204 holds the cam 214 between the top support 184A and the bottom support 184B. The facet of the cam 214 engages with the surface of either the top support 184A or the bottom support 184B, and holds the entry component 220 in the folded state. Figure 2A ), Operational state ( Figure 2C ) or one or more static states between them Figure 2B One or more of the following states: ) or combinations thereof. Advantageously, the support mechanism 204 can directly switch the entry component 220 from a folded state to a locked state, thereby accelerating the deployment of the IO entry system 100.

[0059] In one implementation scheme, such as Figures 2D to 2F As shown, the folding mechanism 200 may include a bracket folding mechanism 206. The bracket folding mechanism 206 may include a bracket 324 disposed proximal to the cam 214 and include a recess 326 disposed on its distal surface. The recess 326 may be configured to receive a portion of the cam 214 therein and stabilize the cam 214 in one or more of a folded state, an engaged state, or a stationary state therein. In one embodiment, a facet of the cam 214 may engage the recess 326 to retain the cam 214 and the access assembly 220 coupled thereto in one or more of a folded state, an engaged state, or a stationary state therein. In one embodiment, the bracket 324 may include a biasing member configured to bias the bracket 324 toward the cam 214.

[0060] During use, the support 324 allows the cam 214 to remain stable in the folded state. Figure 2D The user can grasp the entry component 220 and push it into the operating state. The cam 214 engages the bracket 324, and the bracket is deflectable. Figure 2E This allows cam 214 to transition from the folded state to the active state. Figure 2FThe cam 214 may be switched to one or more static states in between. In one embodiment, in the active position, the cam 214 may include a notch or protrusion configured to engage and retain the cam 214 within the recess 236, and configured to prevent the cam 214 from disengaging from the recess 236. In this way, the cam 214 can be locked in the active position.

[0061] In one implementation scheme, such as Figures 3A to 3B As shown, system 100 may include a sliding mechanism 208 configured to cause needle assembly 220 or a portion thereof to be in a folded state. Figure 3A ) and extended state ( Figure 3B Slide between ) . For example Figure 3A As shown, the access component 220 or a portion thereof can be retained within the housing 112 and can be supported by a sliding mechanism 208. The sliding mechanism can slidably engage with the housing 112 along its central longitudinal axis 90 between a folded state and an operational state. For example, a cam 214 extending laterally from the sliding mechanism can slidably engage a slot 124 extending longitudinally and disposed in the sidewall of the cavity 122 of the housing 112. However, it should be understood that other configurations of the sliding mechanism 208 are contemplated. In the folded state, the access component 220 can be retained within the housing 112. Advantageously, the housing 112 can maintain the access component 220 in a sterile environment during transport and storage. Furthermore, the housing 112 protects against accidental needlestick injuries.

[0062] In one embodiment, system 100 may include a biasing member configured to bias the sliding mechanism 208 and the entry component 220 toward the operational state. In one embodiment, system 100 may include a holding mechanism configured to hold the sliding mechanism 208 in a folded state. In use, a user may actuate the holding mechanism to release the entry component 220. The biasing member may then switch the entry component 220 toward the operational state. In the operational state, the user may then actuate the drive system 108 to rotate the entry component 220 and insert the needle 22 into the bone, as described herein. Advantageously, the sliding mechanism 208 allows for rapid deployment of the entry component 220 by directly switching the entry component 220 from the folded state to the locked operational state. Furthermore, the sliding mechanism 208 does not require a cap 228 because the entry component 220 is stored within the housing 112. Thus, in use, the user does not have to perform the step of removing the cap 228 or a similar shield from the needle 222, thereby further accelerating the deployment of system 100.

[0063] In one embodiment, the access component 220 may be releasably attached to the sliding mechanism 208. Advantageously, after use, the access component 220 or a portion thereof can be detached from the sliding mechanism 208 and disposed of. Optionally, a second access component may be coupled to the sliding mechanism 208. In one embodiment, the sliding mechanism 208 can then be switched from an active state to a folded state and stored for reuse.

[0064] Advantageously, the implementation of the IO entry system 100 can provide a reduced, more compact overall profile when in a stored, folded, or collapsed state. This reduces the space required for storage and transport. Furthermore, the system 100 can be arranged with the entry component 220 already coupled to the drive 110 as an "integrated" device, thereby reducing the number of individual parts required for tracking, unpacking, and assembly, reducing assembly time, reducing packaging, and reducing associated costs and complexity.

[0065] Figure 4 A block diagram of a method 400 for accessing the medullary cavity using an embodiment of the foldable I / O access system 100 disclosed herein is shown. Method 400 includes obtaining the I / O access system 100 as described herein (block 402). In some embodiments, obtaining the foldable I / O access system includes the system 100 in a single-use package, wherein the system 100 is fully assembled and includes, for example, a folding mechanism 200 configured for a storage state. In the storage state, the system 100 may be configured to prevent premature deployment of the access component 220 and / or actuation of the drive system 108 of the actuator 110.

[0066] Method 400 also includes transitioning system 100 from a stored, folded, or collapsed state to an operational state (block 404). Method 400 includes using I / O to access the medullary cavity via system 100 (block 406). Method 400 also includes disposing of I / O access system 100 (block 408). In some embodiments, disposing of I / O access system 100 includes disengaging access component 220 from driver 110 and disposing of access component 220. In some embodiments, disposing of I / O access system 100 includes releasably attaching a second access component and transitioning system 100 from an operational state to a stored, folded, or collapsed state and storing it for reuse.

[0067] Although certain specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Therefore, changes can be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A collapsible intraosseous access system for accessing a medullary cavity, characterized by, Comprising: a driver comprising a housing extending along a longitudinal axis; an access assembly pivotably coupled to the driver between a folded state and an active state, the access assembly comprising a needle that extends parallel to the longitudinal axis in the active state and at an angle to the longitudinal axis in the folded state; and a ratchet mechanism comprising a first ratchet and a second ratchet slidably engaged relative to one another and configured to hold a cam therebetween in one or more static states to hold the access assembly in one of the folded state or the active state. Further comprising a transmission system configured to rotate the needle about the longitudinal axis in the active state and configured to disengage the access assembly in the folded state.

2. The collapsible intraosseous access system of claim 1, wherein, The needle is angled between 50° and 180° relative to the longitudinal axis in the folded state.

3. The collapsible intraosseous access system of claim 1, wherein, Further comprising a handle extending from the housing along a handle axis that extends at an angle relative to the longitudinal axis, the needle extending parallel to the handle axis in the folded state.

4. The collapsible intraosseous access system of claim 1, wherein, The handle comprises a handle recess configured to receive a portion of the access assembly therein in the folded state.

5. The collapsible intraosseous access system of claim 4, wherein, The access assembly is further transitionable between a locked state that prevents the access assembly from transitioning between the active state and the folded state and an unlocked state.

6. The collapsible intraosseous access system of claim 1, wherein, Further comprising a cap configured to enclose a portion of the needle and to maintain the needle within a sterile environment or to prevent accidental needle stick injuries.

7. The collapsible intraosseous access system of claim 1, wherein, The housing further comprises a distal opening through which the access assembly extends in both the folded state and the active state.

8. The collapsible intraosseous access system of claim 1, wherein, The transmission system comprises one of a gear mechanism, a drive spring, an electric motor, or a battery.

9. The collapsible intraosseous access system of claim 2, wherein, Further comprising a cam system comprising a cam that slidably engages a slot disposed in the housing in the active state.

10. The collapsible intraosseous access system of claim 1, wherein, Further comprising a biasing member configured to urge the cam to engage the slot in the active state.

11. The collapsible intraosseous access system of claim 10, wherein, Further comprising a coupler disposed on the access assembly and slidably engaged with a receiver coupled to the transmission system, the coupler engaging the receiver when the access assembly is in the active state.

12. The collapsible intraosseous access system of claim 2, wherein, Further comprising a biasing member configured to bias the first ratchet and the second ratchet toward one another.

13. The collapsible intraosseous access system of claim 1, wherein, Further comprising a cradle mechanism comprising a cradle having a cradle recess disposed on a distal surface thereof and configured to engage a surface of a cam to hold the cam in one or more static states and to hold the access assembly in one of the folded state or the active state.

14. The collapsible intraosseous access system of claim 1, wherein, Further comprising a biasing member configured to bias the cradle toward the cam.

15. The collapsible intraosseous access system of claim 14, wherein, ​

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