Retractable Intraosseous Access System
20220061887 · 2022-03-03
Inventors
Cpc classification
A61B17/3494
HUMAN NECESSITIES
A61B17/3476
HUMAN NECESSITIES
A61B2090/0801
HUMAN NECESSITIES
International classification
Abstract
Embodiments disclosed herein are directed to a retractable intraosseous access system configured to transition between an active state and one of a folded state or a retracted state. In the folded state, the access assembly can be pivoted relative to the driver to collapse the access assembly against a handle. In the retracted state, the access assembly is slidably received within a housing of the driver. Advantageously, the retractably intraosseous access system can provide an “all-in-one” design that does not require assembling separate components. Further the retractably intraosseous access system can provide a compact outer profile requiring reduced storage space.
Claims
1. A foldable intraosseous access system for accessing a medullary cavity, comprising: a driver including 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 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.
2. The foldable intraosseous access system according to claim 1, further including a drive train configured to rotate the needle about the longitudinal axis in the active state and configured to disengage the access assembly in the folded state.
3. The foldable intraosseous access system according to claim 1, wherein the needle in the folded state is angled between 50° and 180° relative to the longitudinal axis.
4. The foldable intraosseous access system according to claim 1, further including a grip extending from the housing along a grip axis extending at an angle relative to the longitudinal axis, the needle extending parallel to the grip axis in the folded state.
5. The foldable intraosseous access system according to claim 4, wherein the grip includes a grip recess configured to receive a portion of the access assembly therein, in the folded state.
6. The foldable intraosseous access system according to claim 1, wherein the access assembly is further transitionable between a locked state and an unlocked state, the locked state preventing the access assembly from transitioning between the active state and the folded state.
7. The foldable intraosseous access system according to claim 1, further including a cap configured to enclose a portion of the needle and maintain the needle within a sterile environment or prevent accidental needle stick injuries.
8. The foldable intraosseous access system according to claim 1, wherein the housing further includes a distal opening, the access assembly extending through the distal opening in both the folded state and the active state.
9. The foldable intraosseous access system according to claim 2, wherein the drive train includes one of a gear mechanism, a drive spring, an electric motor, or a battery.
10. The foldable intraosseous access system according to claim 1, further including a cam system, including a cam slidably engaged with a slot disposed in the housing in the active state.
11. The foldable intraosseous access system according to claim 10, further including a biasing member configured to urge the cam to engage the slot in the active state.
12. The foldable intraosseous access system according to claim 2, further including a coupler disposed on the access assembly and slidably engaged with a receiver coupled to the drive train, the coupler engaged with the receiver when the access assembly is in the active state.
13. The foldable intraosseous access system according to claim 1, further including a cradle mechanism including a first cradle and a second cradle slidably engaged relative to each other and configured to retain a cam therebetween in one or more resting states to maintain the access assembly in one of the folded state or the active state.
14. The foldable intraosseous access system according to claim 13, further including a biasing member configured to bias the first cradle and the second cradle towards each other.
15. The foldable intraosseous access system according to claim 1, further including a socket mechanism including a socket having a socket recess disposed on a distal surface thereof, and configured to engage a surface of a cam to retain the cam one or more resting states and to maintain the access assembly in one of the folded state or the active state.
16. The foldable intraosseous access system according to claim 15, further including a biasing member configured to bias the socket towards the cam.
17. A retractable intraosseous access system for accessing a medullary cavity, comprising: a driver including a housing extending along a longitudinal axis; and an access assembly slidably engaged with the driver between a retracted state and an active state, the access assembly including a needle extending parallel to the longitudinal axis and disposed within the housing in the retracted state and extending from a distal opening of the housing in the active state.
18. The retractable intraosseous access system according to claim 17, wherein the access assembly is further transitionable between a locked state and an unlocked state, the locked state preventing the access assembly from transitioning between the active state and the retracted state.
19. The retractable intraosseous access system according to claim 17, further including a drive train configured to rotate the needle about the longitudinal axis in the active state and configured to disengage the access assembly in the folded state.
20. The retractable intraosseous access system according to claim 19, wherein the drive train includes one of a gear mechanism, a drive spring, an electric motor, or a battery.
21. The retractable intraosseous access system according to claim 17, further including a biasing member configured to bias the access assembly towards the active state.
22. The retractable intraosseous access system according to claim 17, further including a catch mechanism configured to releasably engage the access assembly and retain the access assembly in the retracted state.
23-33. (canceled)
Description
DRAWINGS
[0019] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
[0020]
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[0030]
DESCRIPTION
[0031] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
[0032] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular 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 different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
[0033] With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near a clinician when the needle is used on a patient. Likewise, a “proximal length” of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient. A “proximal end” of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the needle can include the proximal end of the needle; however, the proximal portion, the proximal-end portion, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the needle is not a terminal portion or terminal length of the needle.
[0034] With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near or in a patient when the needle is used on the patient. Likewise, a “distal length” of, for example, the needle includes a length of the needle intended to be near or in the patient when the needle is used on the patient. A “distal end” of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient. The distal portion, the distal-end portion, or the distal length of the needle can include the distal end of the needle; however, the distal portion, the distal-end portion, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the needle is not a terminal portion or terminal length of the needle.
[0035] To assist in the description of embodiments described herein, as shown in
[0036] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
[0037]
[0038] The access assembly 220 can generally include a needle 222 supported by a needle hub 224, and defining a needle lumen 226. In an embodiment, the access assembly 220 can further include an obturator (not shown) configured to fit within the needle lumen 226 and prevent tissue and bone fragments from occluding the needle lumen 226 during a placement event. The access assembly 220 can further include a cap 228 configured to be placed over at least a portion of the needle 222. The cap 228 can maintain the needle 222 within a sterile environment during transport and storage and can prevent accidental needle stick injuries. In an embodiment, the access assembly 220, or portions thereof, can be rotatably coupled with the driver 110 and can rotate about a central longitudinal axis 90.
[0039] In an embodiment, the driver 110 can further include a drive train 108 configured to rotate the access assembly 220 and drill the needle 222 through the bone cortex to access the medullary cavity. Exemplary drive trains 108 can include electrical, mechanical, electro-mechanical, kinetic, potential mechanisms, springs, biasing members, gear mechanisms, electric motors and power sources (mains power supply, battery power supply, or the like), combinations thereof, and the like. The drive train 108 can be configured to provide rotational motion to the access assembly 220 about the central longitudinal axis 90. In an embodiment, the driver 110 can include an electric motor and battery pack, or a drive spring, configured to rotate the access assembly 220 and drill the needle 222 into the bone to access the medullary cavity.
[0040] In an embodiment, as shown in
[0041] In an embodiment, in the active position (
[0042] In an embodiment, the access assembly 220 can transition between one or more resting states between the folded state (
[0043] In an embodiment, the grip 120 can include a recess 192 extending along a portion thereof and configured to receive a portion of the access assembly 220 therein, when the system 100 is in the folded state. Advantageously, the grip recess 192 can stabilize the access assembly 220 when the system 100 is in the folded state, during transport and storage. Further, the grip recess 192 can provide a more compact overall profile by receiving at least a portion of the access assembly 220 within a volume defined by the grip 120.
[0044] In an embodiment, as shown in
[0045] In an embodiment, the access assembly 220 can further include a coupler 140 disposed at a proximal end of the access assembly 220. The coupler 140 can be configured to selectively engage a receiver 142 that is coupled with the drive train 108. In an embodiment, the folding mechanism 200 in the unlocked position can disengage the coupler 140 from the receiver 142. In an embodiment, the folding mechanism 200 in the locked position can engage the coupler 140 with the receiver 142. In an embodiment, the folding mechanism 200 in the active and locked position can engage the coupler 140 with the receiver 142 and allow the drive train 108 to rotate the access assembly 220, or portions thereof. In an embodiment, the coupler 140 can define a substantially hexagonal cross-sectional shape, and can be configured to fit within a receiver recess 144 defining a similarly shaped, hexagonal cross-sectional shape. It will be appreciated, however, that other polygonal shaped coupler 140 and receiver recess 144, or “lock-and-key” type engagements, are also contemplated to fall within the scope of the present invention.
[0046] Advantageously, the folding mechanism 200 can be configured to only engage the coupler 140 with the receiver 142, when the access assembly 220 is in the active and locked state. This can prevent the drive train 108 from accidentally being activated and rotating the access assembly 220 prematurely, i.e. when the access assembly 220 is not positioned in the active state, i.e. during transport, storage, or assembly prior to use. In some embodiments, the drive train 108 of the driver 110 can be actuated by a pressure activated actuator such as a trigger, a button, or the like. In an embodiment, the drive train 108 can be activated by an axial pressure applied to the access assembly 220, or a portion thereof.
[0047] In an embodiment, the access assembly 220 can be selectively coupled with the folding mechanism 200 and allow a user to selectively attach, or selectively detach, the access assembly 220 therefrom. Advantageously, the selectively detachable access assembly 220 can allow a user to replace the access assembly 220 as desired either before or after a placement event in case of malfunction or misplacement of the needle 222. Further, a user can replace the access assembly 220 after use with a new access assembly and can transition the system 100 to the folded state ready for re-sterilization, storage, or reuse of the system 100.
[0048]
[0049] In an embodiment, the folding mechanism 200 can include a cam system 202, having one or more cams 214 that are laterally offset from the central longitudinal axis 90. For example, a first cam 214A may be disposed on a left side and a second cam 214B may be disposed on a right side of the folding mechanism 200. The cam 214 can define a regular or irregular, substantially oval, or elliptical shape and can include one or more facets. The cam 214 may be configured to slidably engage a slot 124 disposed in a side wall of the interior cavity 122, and extending longitudinally. For example, a first cam 214A can slidably engage a first slot 124A, and a second cam 214B can slidably engage a second slot 124B. In an embodiment, the slot 124 can define a width (w) extending substantially perpendicular to the central longitudinal axis 90.
[0050] In an embodiment, the cam 214 can include a first diameter (d1) and a second diameter (d2) extending perpendicular thereto. The first diameter (d1) can be greater than the second diameter (d2). In an embodiment, the first diameter (d1) can be larger the width (w) of the slot 124, and the second diameter (d2) can be less than the width (w) of the slot 124. In an embodiment, the first diameter (d1) can be aligned parallel with an axis 94 of the access assembly 220.
[0051] As shown in
[0052] In an embodiment, the folding mechanism 200 can further include a biasing member configured to bias the access assembly 220 towards the locked state. In use, a user can grasp the access assembly 220 and transition the access assembly 220 from the folded state to the unlocked active state. The biasing member can then transition the access assembly 220 from the unlocked active state to the locked active state by urging the cams 214 longitudinally into the slots 124. Similarly, to transition the access assembly 220 from the active, locked state to the retracted, folded state, a user can urge the access assembly 220 longitudinally distally to disengage the cam 214 from the slot 124 before pivoting the access assembly 220 to the folded state.
[0053] In an embodiment, the folding mechanism 200 can further include a second biasing member configured to bias the access assembly 220 towards the active state. A trigger mechanism can be configured to retain the access assembly 220 in the folded state. In use, a user can activate the trigger mechanism to release the access assembly 220 and allow the second biasing member to transition the access assembly 220 from the folded state to the active state. In an embodiment, the first biasing member can then transition the access assembly 220 from the unlocked state the locked state, as described herein. In an embodiment, a user can manually urge the access assembly 220 between one or more of the folded state, active state, unlocked state, or locked state, or combinations thereof. Advantageously, the foldable 10 access system 100 may be configured to be packaged fully assembled with the access assembly 220 coupled to the driver 110. The system 10 can be stored in the storage state, and quickly transitioned to the active state ready for use. Advantageously, the access assembly 220 can be transitioned from the storage state to the active state and locked in the active state, ready for use. This can prevent premature disengagement of the access assembly 220 during usage.
[0054] In an embodiment, as shown in
[0055] The top cradle 184A and the bottom cradle 184B can be slidable along the transverse axis between a first position (
[0056] In use, the access assembly 220 can transition between one or more of the folded state, the active state, or one or more resting states therebetween. The cradle mechanism 204 can retain the cam 214 between the top cradle 184A and the bottom cradle 184B. A facet of the cam 214 can engage a surface of the top cradle 184A or the bottom cradle 184B and can maintain the access assembly 220 one or more of the folded state (
[0057] In an embodiment, as shown in
[0058] In use, the socket 324 can stabilize the cam 214 in the folded state (
[0059] In an embodiment, as shown in
[0060] In an embodiment, the system 100 can include a biasing member, configured to bias the sliding mechanism 208 and access assembly 220 towards the active state. In an embodiment, the system 100 can include a catch mechanism configured to retain the sliding mechanism 208 in the folded state. In use, a user can actuate the catch mechanism to release the access assembly 220. The biasing member can then transition the access assembly 220 towards the active state. In the active state, the user can then actuate the drive train 108 to rotate the access assembly 220 and drill the needle 22 into the bone, as described herein. Advantageously, the sliding mechanism 208 can allow for rapid deployment of the access assembly 220 by transitioning the access assembly 220 directly from the folded state to a locked active state. Further, the sliding mechanism 208 does not require a cap 228 since the access assembly 220 is stored within the housing 112. As such, in use a user does not have to perform a step of removing a cap 228 or similar shield from the needle 222, further expediting the deployment of the system 100.
[0061] In an embodiment, the access assembly 220 can be releasably attached to the sliding mechanism 208. Advantageously, after use, the access assembly 220, or portions thereof, can be detached from sliding mechanism 208 and disposed of Optionally a second access assembly can be coupled to the sliding mechanism 208. In an embodiment, the sliding mechanism 208 can then be transitioned from the active state to the folded state and stored ready for reuse.
[0062] Advantageously, embodiments of the IO access system 100 can provide a reduced, more compact overall profile when in a stored, folded, or folded state. As such, the system 100 require less room during storage and transport. Further, the system 100 can be provided with the access assembly 220 already coupled to the driver 110 as an “all-in-one” device reducing the number of separate components to track, unpackage and assembly, reducing the time required for assembly, reducing packaging, and reducing associated costs and complexity.
[0063]
[0064] The method 400 further includes transitioning the system 100 from the storage, folded, or folded state to the active state (block 404). The method 400 includes accessing the medullary cavity using the IO access system 100 (block 406). The method 400 further includes disposing of the IO access system 100 (block 408). In some embodiments, disposing of the IO access system 100 includes disengaging the access assembly 220 from the driver 110 and disposing of the access assembly 220. In some embodiments disposing of the IO access system 100 includes releasably attaching a second access assembly, and transitioning the system 100 from the active state to the storage, folded, or folded state and storing for reuse.
[0065] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.