Aspiration device for intraosseous access system

By designing a rotating linkage between the shell, needle assembly, and aspiration system of the intraosseous access system, the problems of difficulty in detecting the medullary cavity and inconvenience in replacing the needle assembly in existing technologies are solved, thereby improving surgical efficiency and safety.

CN114224425BActive Publication Date: 2025-11-04BARD ACCESS SYSTEMS INC
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Patent Information

Application Number
CN202111051846.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2020-09-09
Filing Date
2021-09-08
Publication Date
2025-11-04
Estimated Expiration
2041-09-08

AI Technical Summary

Technical Problem

Existing intraosseous access systems have difficulty detecting whether the needle has entered the medullary cavity, and may result in loss of positional openness during needle assembly replacement, affecting surgical efficiency and safety.

Method used

An intraosseous access system was designed, including a housing, a needle assembly, a suction system, and a transmission system. The transmission system enables the needle assembly and the suction system to rotate relative to each other. The suction system is used to confirm whether the needle has entered the medullary cavity, preventing the needle assembly from dislodging and ensuring stable positioning.

Benefits of technology

This allows for confirmation of medullary canal access without disassembling the needle assembly, improving surgical efficiency and safety, and reducing the risk of accidental needle puncture injury.

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Abstract

Embodiments disclosed herein relate to an aspiration device for an intraosseous access system. The system includes a driver housing, an access system including a drive train, a needle assembly rotatably coupled to the access system, and an aspiration system. The needle assembly can include a needle defining an internal lumen and an obturator disposed therein. The aspiration system can include a syringe or a vacuum coupled to the obturator. Sliding one of a plunger or a vacuum in a proximal direction can withdraw the obturator from the needle lumen and place a vacuum in fluid communication with the needle lumen to aspirate fluid flowing therethrough. A portion of the aspiration system can rotate with the needle assembly. Withdrawing the obturator can place the obturator within the syringe or vacuum, thereby mitigating needle stick injuries. The obturator can be placed back if the medullary cavity is not accessed.
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Description

[0001] Priority

[0002] This application claims priority to U.S. Patent Application No. 63 / 076,189, filed September 9, 2020, the entirety of which is incorporated by reference herein. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to an aspiration device for an intraosseous access system. BACKGROUND

[0004] Intraosseous (IO) access systems are configured to access the medullary cavity of a bone by drilling an access needle through the dense cortical bone and into the medullary cavity. Some IO access systems include a power drill or similar device configured to rotate a needle assembly at a high rotational speed to bore the access needle through the cortical bone. Detecting when the needle has entered the medullary cavity is challenging. For example, to confirm entry into the medullary cavity, the user must detach the drill from the needle assembly, withdraw a obturator from the needle’s internal lumen, attach a syringe to the access needle, and aspirate the needle internal lumen to observe the presence of bone marrow. Failure to aspirate bone marrow can mean that the access needle has not fully entered the medullary cavity and further drilling is required. However, with the needle assembly detached from the drill and the obturator withdrawn from the needle internal lumen, the needle cannot be reused, and the clinician must withdraw the needle, couple a new needle assembly to the drill, and continue drilling. Moreover, the patency of the original access site can be lost during needle replacement.

[0005] Disclosed herein are systems, devices, and methods aimed at addressing the above-mentioned problems. SUMMARY

[0006] Disclosed herein is an intraosseous access system comprising a housing, a needle assembly extending from a distal end of the housing and comprising an obturator extending along a longitudinal axis and disposed within an internal lumen of the needle, an aspiration system disposed within the housing and comprising one of a syringe or a vacuum aspirator, the aspiration system configured to slide the obturator relative to the needle and selectively provide a vacuum in fluid communication with the needle internal lumen, and a drive train disposed within the housing and configured to rotate one of the needle assembly and the syringe barrel or the vacuum aspirator canister about the longitudinal axis.

[0007] In some embodiments, the drive train comprises one of a biasing member, an electric motor, or a battery. In some embodiments, the syringe comprises a plunger slidably engaged with the syringe barrel and the housing along the longitudinal axis, the syringe barrel rotatable relative to the plunger about the longitudinal axis. In some embodiments, the intraosseous access system further comprises a piston rotatably coupled to one of the plunger, the syringe barrel, or the obturator. In some embodiments, the intraosseous access system further comprises a handle connected to the plunger, a portion of the handle extending through a wall of the housing.

[0008] In some embodiments, the vacuum extractor includes a valve configured to selectively place a vacuum, disposed within the vacuum extractor tank in fluid communication with the needle lumen. In some embodiments, the vacuum extractor further includes an actuator configured to slide the tank along the longitudinal axis or actuate the valve between an open position and a closed position. In some embodiments, the housing further includes a viewing window configured to allow a user to view one of the syringe barrel or the vacuum extractor tank disposed thereunder. In some embodiments, one of the syringe barrel or the vacuum extractor tank can comprise a transparent material. In some embodiments, the biasing member is one of a flat spring, a coil spring, or a torsion spring. In some embodiments, the distal tip of the obturator is configured to retract into one of the syringe barrel or the housing 104 to mitigate accidental needle stick injuries.

[0009] A method for accessing the medullary cavity is also disclosed, the method comprising: actuating a drive train disposed within a housing, rotating a needle assembly coupled to the drive train and comprising an obturator disposed within a lumen of the needle, rotating one of a syringe barrel or a vacuum extractor tank relative to the housing about a longitudinal axis along which the needle extends, retracting the obturator from the needle lumen to provide fluid communication between the needle lumen and the one of the syringe barrel or the vacuum extractor tank, and returning the obturator within the needle lumen.

[0010] In some embodiments, the drive train comprises one of a biasing member, a flat spring, a coil spring, a torsion spring, an electric motor, or a battery. In some embodiments, the method further comprises sliding a handle coupled to one of a plunger or a vacuum extractor tank relative to the housing along the longitudinal axis, the handle being held in a rotatably fixed position about the longitudinal axis relative to the housing. In some embodiments, the handle extends through an aperture disposed in a wall of the housing. In some embodiments, the method further comprises rotating a piston coupled to a distal end of the plunger relative to one of the handle or the syringe barrel, the piston providing a fluid seal between a wall of the syringe barrel and the piston.

[0011] In some embodiments, the method further comprises confirming access to the medullary cavity by observing fluid flowing into one of the syringe barrel or the vacuum extractor via one or more viewing windows disposed in the housing. In some embodiments, the method further comprises decoupling the needle from the needle assembly. In some embodiments, the method further comprises disposing the obturator within one of the syringe barrel or the vacuum extractor tank to mitigate needle stick injuries.

[0012] These and other features of the concepts provided herein will become more apparent from the following detailed description in conjunction with the accompanying drawings, which are provided to assist in understanding the concepts and are not intended to limit the concepts in any way. BRIEF DESCRIPTION OF DRAWINGS

[0013] A more particular description of the disclosure will be presented through reference to specific embodiments thereof as illustrated in the appended drawings. It should be noted that these drawings are not to be considered limiting in scope, as the scope of the disclosure is defined by the appended claims. The illustrative embodiments of the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0014] Figure 1A A side view of an intraosseous access system including an aspiration system is shown in accordance with some embodiments.

[0015] Figure 1B A perspective view of an intraosseous access system including an aspiration system is shown in accordance with some embodiments.

[0016] Figure 2 A planar cutaway view of an intraosseous access system including an aspiration system with a syringe is shown in accordance with some embodiments.

[0017] Figure 3 A planar cutaway view of an intraosseous access system including an aspiration system with a vacuum is shown in accordance with some embodiments.

[0018] Figure 4 A flowchart of an exemplary method for an intraosseous access system is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0019] Before some embodiments are disclosed in more 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 the particular embodiments disclosed herein can have many applications and can be easily adapted for use with any number of other systems and methods for performing the functions disclosed herein.

[0020] With respect to the terms used herein, it is also to be understood that these terms are used for the purpose of describing certain embodiments and are not meant to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are used merely to identify different features or steps in a group of features or steps, and are not meant to designate a series or numeric limitation. For example, a “first,” “second,” “third” feature or step need not necessarily appear in that order and a particular embodiment including these features or steps need not necessarily be limited to these 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. Rather, such labels are used in connection with the orientation / fixed location relative to one another as illustrated in the drawings. “A,” “an,” and “the” as used herein mean “one or more” unless expressly specified otherwise.

[0021] For example, a “proximal,” “proximal portion,” or “proximal end portion” of a needle disclosed herein includes a portion of the needle intended to be proximate to a clinician when the needle is used on a patient. Likewise, for example, a “proximal length” of a needle includes a length of the needle intended to be proximate to a clinician when the needle is used on a patient. For example, a “proximal end” of a needle includes an end of the needle intended to be proximate to a clinician when the needle is used on a patient. A proximal portion, proximal end portion, or proximal length of a needle can include a proximal end of the needle; however, a proximal portion, proximal end portion, or proximal length of a needle need not include a proximal end of the needle. That is, unless the context indicates otherwise, a proximal portion, proximal end portion, or proximal length of a needle is not a distal portion or length of the needle.

[0022] For example, a “proximal,” “proximal portion,” or “proximal end portion” of a needle disclosed herein includes a portion of the needle intended to be proximate to a clinician when the needle is used on a patient. Likewise, for example, a “proximal length” of a needle includes a length of the needle intended to be proximate to a clinician when the needle is used on a patient. For example, a “proximal end” of a needle includes an end of the needle intended to be proximate to a clinician when the needle is used on a patient. A proximal portion, proximal end portion, or proximal length of a needle can include a proximal end of the needle; however, a proximal portion, proximal end portion, or proximal length of a needle need not include a proximal end of the needle. That is, unless the context indicates otherwise, a proximal portion, proximal end portion, or proximal length of a needle is not a distal portion or length of the needle.

[0023] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0024] Figure 1A A side view of an intraosseous (IO) access system (“system”) 100 including a suction system 110 is shown in accordance with some embodiments. Figure 1BA perspective view of an intraosseous access system 100 is shown, portions of which are shown in the line boxes.

[0025] The system 100 can generally include an access system 102 and an aspiration system 110. The access system 102 can include a drivetrain 106 coupled to a needle assembly 160. The drivetrain 106 can be configured to rotate the needle assembly 160 and drill the needle 162 through the bone cortex to access the medullary canal. The aspiration system 110 can be in fluid communication with the needle 162 of the needle assembly 160 and can confirm access to the medullary canal by aspirating bone marrow through the needle lumen 164. Advantageously, the intraosseous access system 100 can be configured to determine when the medullary canal has been accessed by aspirating through the needle 162 without disengaging the needle assembly 160 from the system 100.

[0026] In one embodiment, the intraosseous access system 100 can include a housing 104 including one or more of the access system 102, the aspiration system 110, or portions thereof disposed therein. The access system 102 can include a needle assembly 160 rotatably coupled to the drivetrain 106 and extending from a distal end of the housing 104. Optionally, the housing 104 can include a grip, such as a pistol grip 108 or similar structure, configured to facilitate grasping the housing 104 and advancing the needle 162 distally into the bone.

[0027] In one embodiment, the drivetrain 106 of the access system 102 can be configured to provide rotational motion to one or both of the aspiration system 110 and the needle assembly 160, as described in greater detail herein. In some embodiments, the access system 102 can be an automatic driver (e.g., a drill that achieves high rotational speeds). In one embodiment, the access system 102 can be an automatic driver including a drivetrain 106 having an electrical energy source (e.g., a battery) to provide power to a drilling mechanism (e.g., a motor or the like). In one embodiment, the system 100 can include an actuator, such as a button, switch, or the like, configured for actuating the drivetrain 106. In one embodiment, the drivetrain 106 can be actuated by axial pressure applied to a distal tip of the needle 162.

[0028] In one embodiment, the drivetrain 106 can include a spring-driven drilling mechanism, such as a coil spring, flat spring, torsion spring, or similar biasing member, which can store potential mechanical energy and can be released upon actuation of the drivetrain 106. In one embodiment, the drivetrain 106 can further include one or more gear mechanisms, biasing members, bearings, bushings, or the like, configured to facilitate rotation of the needle assembly 160. In one embodiment, the access system 102 can be a manual driver, in which a clinician can use a handle, pistol grip 108, or similar structure to advance the needle assembly 160 through the bone cortex.

[0029] In one embodiment, a portion of the housing 104 may include a suction system 110 disposed therein. The housing 104 may include one or more viewing windows 120 configured to allow a user to view a portion of the suction system 110 disposed therein. In one embodiment, the viewing window 120 may define an opening extending through a wall of the housing 104. In one embodiment, the viewing window 120 may include a transparent or translucent portion of the housing 104. In one embodiment, the entire housing 104 may be formed of a translucent or transparent material configured to allow a user to view one or both of the suction system 110 and the entry system 102, or portions thereof disposed therein.

[0030] like Figures 1A-2 As shown, in one embodiment, the aspiration system 110 may include a syringe 130 having a barrel 132 and a plunger 134 slidably engaged therewith. The barrel 132 may be in fluid communication with the inner cavity 164 of the needle 162. Sliding the plunger 134 relative to the barrel 132 can create a vacuum within the barrel 132 and can draw fluid flow through the inner cavity 164 of the needle and into the barrel 132. In one embodiment, a portion of the barrel 132 may be formed of a translucent or transparent material. In use, a user can observe the fluid flow within the syringe barrel 132 through one of the viewing windows 120.

[0031] In one embodiment, the suction system 102 may include a vacuum pump or a similar structure configured to maintain a vacuum therein, as described in more detail herein. In use, a user may actuate a release mechanism, such as an actuator, valve, etc., to fluidly communicate the vacuum pump with the needle cavity 164 and draw fluid flow into the vacuum pump. A portion of the vacuum pump may be formed of a transparent or translucent material and is configured to allow the user to observe the fluid flow, as described herein.

[0032] In one embodiment, the aspiration system 110 may be coupled to the inlet system 102 or a portion thereof. In one embodiment, the aspiration system 110 may be coupled to the needle assembly 160 or a portion thereof. In one embodiment, one or both of the aspiration system 110 and the needle assembly 160 may be rotatable relative to the housing 104. In one embodiment, the drive system 106 may be configured to rotate the needle assembly 160 and the aspiration system 102 assembly about a central longitudinal axis 10.

[0033] In one embodiment, the distal end of the syringe barrel 132 can be coupled with the access system 102 or the needle assembly 160, or both. In one embodiment, the distal end of the syringe barrel 132 can be integrally formed with the access system 102. In one embodiment, the distal end of the syringe barrel 132 can be selectively coupled with the access system 102 using a threaded engagement system, an interference fit, a press fit engagement, a snap fit engagement, a luer lock, combinations thereof, or the like. In one embodiment, the distal end of the syringe barrel 132 can be coupled with the access system 102 using an adhesive, a bond, a weld, or the like.

[0034] In one embodiment, the syringe barrel 132 can be coupled with the needle assembly 160 and the drive train 106 and can rotate both the barrel 132 and the needle assembly 160 relative to the housing 104 about the central longitudinal axis 10. Further, the plunger 134 can remain substantially stationary relative to the housing 104 with respect to any rotational movement about the central longitudinal axis 10. Notably, the plunger 134 can still be slidably engaged with the syringe barrel 132 parallel to the longitudinal axis. Further, the plunger 134 can also slide along the longitudinal axis 10 relative to the housing 104.

[0035] In one embodiment, the needle assembly 160 can include an obturator 166 disposed within the needle lumen 164 and configured to prevent tissue and bone fragments from entering and obturating the needle lumen 164. The proximal end of the obturator 166 can be connected to the plunger 134. In one embodiment, the obturator 166 can rotate relative to the plunger 134. For example, the obturator 166 can be coupled to the plunger 134 using a bearing 150. As used herein, the bearing 150 can include a ball bearing, a bushing, or a similar structure configured to facilitate rotational movement about an axis. In this way, as the needle assembly 160, including the needle 162 and the obturator 166, is rotated by the drive train 106, the obturator 166 can rotate relative to the plunger 134. Further, longitudinally sliding the plunger 134 relative to the housing 104 can cause the obturator 166 to slide relative to the needle 162.

[0036] In use, the rotating needle assembly 160 can drill the needle 162 through the bone cortex and into the medullary canal. In one embodiment, once the user believes that the medullary canal has been entered, the plunger 134 can be withdrawn proximally to create a vacuum within the barrel 132 and to remove the obturator 166 from the needle lumen 164 to place the barrel 134 in fluid communication with the needle lumen 164. If the medullary canal has been entered, bone marrow can be aspirated through the needle lumen 164. The user can view the bone marrow in the syringe barrel 132 through one or more viewing windows 120 to confirm that the medullary canal has been entered. Advantageously, the aspiration system 110 allows for confirmation of entry into the medullary canal by bone marrow aspiration without requiring disassembly of the needle assembly 160 from the intraosseous access system 100. In the event that the medullary canal has not been entered, i.e., no bone marrow is observed, the user can advance the plunger 134 distally, replace the obturator 166 within the needle lumen 164, and continue to drill the needle assembly 160 through the bone cortex.

[0037] Figure 2 A plan view cross-section of the intraosseous access system 100 is shown. In some embodiments, one or more viewing windows 120 can be located on the distal portion of the housing body 112 and can be configured to allow a user to view aspiration of fluid from the needle lumen 164.

[0038] In some embodiments, the plunger 132 can include a plunger shaft 146 that extends longitudinally through a portion of the syringe barrel 134. A proximal end of the plunger shaft 146 can be coupled to the plunger handle 142 that extends perpendicularly thereto. In one embodiment, the plunger handle 142 can be rotatably coupled to the plunger shaft 146 and can include a bearing 150 disposed therebetween. In this manner, in one embodiment, the transmission 106 can rotate one or more of the needle assembly 160, the syringe barrel 132, and the plunger shaft 146 about the central longitudinal axis 10, and the handle 142 can remain substantially stationary with respect to any rotational movement. In one embodiment, a portion of the plunger handle 142, such as a first portion 142A and a second portion 142B, can extend perpendicularly to the longitudinal axis from the plunger shaft 146. In one embodiment, a portion of the plunger handle 142 can extend perpendicularly to the longitudinal axis from the plunger shaft 146 to contact a wall of the housing 104.

[0039] In one embodiment, a portion of the plunger handle 142 can extend perpendicularly from the plunger shaft 146 and through a housing aperture 126 disposed in a wall of the housing 104. In one embodiment, a portion of the plunger handle 142 can engage the housing aperture 126 and stabilize the plunger 134 relative to the housing 104, for example, to prevent rotation of the handle 142 about the longitudinal axis 10 relative to the housing 104. For example, a first portion 142A can extend through a first housing aperture 126A and a second portion 142B can extend through a second housing aperture 126B. In one embodiment, the housing aperture 126 can define an elongated shape extending longitudinally. In use, a user can grasp a portion of the plunger handle 142 extending through the housing aperture 126 and can push the plunger 134 longitudinally relative to the housing 104.

[0040] In one embodiment, a distal end of the plunger shaft 146 can be coupled to a piston 148. The piston 148 can be formed of a flexible material, for example, rubber or the like, and can engage an inner surface of the barrel 132 to provide a fluid seal therebetween. In use, withdrawing the plunger 134 proximally along the longitudinal axis can create a vacuum between a proximal surface of the piston 148 and a distal end of the barrel 132.

[0041] In one embodiment, the piston 148 can be rotatably coupled to the plunger shaft 146 by a bearing 150, bushing, or the like. In use, the drive train 106 can rotate the needle assembly 160, the syringe barrel 132, and the piston 148 about the longitudinal axis 10 while the plunger shaft 146 and the housing 104 can remain rotationally stationary relative to the longitudinal axis 10.

[0042] In one embodiment, the piston 148 can be in a fixed relationship relative to the plunger shaft 146. The piston 148 can then rotate relative to the syringe barrel 134 while maintaining a fluid seal therebetween. In use, the drive train 106 can rotate the needle assembly 160 and the syringe barrel 132 about the longitudinal axis 10 while the plunger shaft 146, the piston 148, and the housing 104 can remain rotationally fixed relative to the longitudinal axis 10.

[0043] In one embodiment, an obturator 166 can be disposed within the needle lumen 164. A proximal end of the obturator 166 can be coupled to the piston 148 of the plunger 134. In some embodiments, the obturator 166 can be coupled to the piston 148 by a snap fit, press fit, or interference fit engagement, or by an adhesive, weld, bond, combination thereof, or the like. In one embodiment, the obturator 166 can be coupled in a fixed relationship relative to the plunger 134. In one embodiment, the obturator 166 can be rotatably coupled to the plunger 134 by a bearing 150, bushing, or the like. In this manner, the obturator can rotate independently of the piston 148.

[0044] In some embodiments, the obturator 166 can be removed from the needle lumen 164 to provide fluid communication through the needle lumen 164 and into the syringe barrel 132. In one embodiment, retracting the plunger 134 can simultaneously create a vacuum within the syringe barrel 132 and at least partially remove the obturator 166 from the needle lumen 164.

[0045] In some embodiments, the plunger 134 can be advanced distally and the obturator 166 can be replaced into the needle lumen 164 without observing fluid flow. In one embodiment, the vacuum within the syringe barrel 132 can assist in advancing the obturator 166 distally, thereby replacing the obturator 166 into the needle lumen 164. The obturator 166 can then continue to prevent occlusion of the needle lumen 164 as the needle assembly 160 continues to penetrate the bone cortex. Advantageously, the obturator 166 can be withdrawn from the needle 162 and into the barrel 132 of the syringe 130. In this way, the barrel 132 can prevent accidental needle stick injuries from the distal end of the obturator 166.

[0046] In one embodiment, the drive train 106 can provide rotational motion to the needle assembly 160 in various ways. For example, where the aspiration system 110 is coupled to the needle assembly 160, the drive train 106 can rotate both the aspiration system 110 and the needle assembly 160. In some embodiments, the drive train 106 can rotate only the needle assembly 160, i.e., not the aspiration system 110. In some embodiments, the drive train 106 can rotate one or more components of the aspiration system 110 and / or the needle assembly 160 while keeping others stationary relative thereto.

[0047] In one embodiment, the drive train 106 can rotate the barrel 132 of the syringe 130 while keeping the plunger 134 stationary relative to any rotation about the longitudinal axis 10. In one embodiment, the plunger handle 142 can engage the housing aperture 126 to prevent the plunger 134 from rotating about the longitudinal axis 10 as the barrel 132 is rotated. In one embodiment, the plunger shaft 146 can be coupled to a bearing 150 sleeve or the like disposed within the piston 148. The bearing 150 is configured to allow rotational motion of the piston 148 about the central axis 10 while allowing the plunger shaft 146 to remain substantially stationary. In some embodiments, the syringe 130 is configured to receive a volume of fluid therein. In some embodiments, the capacity of the syringe can be between 1 ml and 10 ml. It will be appreciated that other capacities can also be contemplated.

[0048] Figure 3Further details of an embodiment of an intraosseous access system 100 including an aspiration system 110 having a vacuum extractor 400 are shown. As described herein, the aspiration system 110 can be coupled to the access system 102. In one embodiment, the aspiration system 110 can include a vacuum extractor 400 configured to maintain a vacuum therein. The vacuum extractor 400 can include a canister 402 configured to maintain a vacuum therein, and a valve 404 configured to control fluid communication between the lumen 164 of the needle assembly 160 and the canister 402 vacuum extractor 400.

[0049] In one embodiment, the vacuum extractor 400 can further include a handle 442. In one embodiment, a portion of the handle 442 can extend through the housing aperture 126, as described herein. In use, a user can grasp the handle 442 and slide the vacuum extractor 400 longitudinally relative to the housing 104. In one embodiment, the vacuum extractor 400 can include bearings 150, bushings, or the like, configured to allow rotation of the canister 402 relative to the handle 442. In one embodiment, the proximal end of the obturator 166 can be coupled to the distal end of the vacuum extractor 400. In one embodiment, the vacuum extractor can further include bearings 150 configured to allow rotation of the obturator 166 relative to the vacuum extractor 400 or portions thereof, such as the canister 402 or the valve 404.

[0050] In one embodiment, the drive train 106 can rotate the vacuum extractor 400 and the needle assembly 160 about the central axis 10. When the user believes that the medullary cavity has been accessed, the user can grasp the handle 442 and slide the vacuum extractor 400 proximally to at least partially withdraw the obturator 166 from the lumen 164 of the needle. With the obturator 166 withdrawn, the user can actuate the valve 404 and provide fluid communication between the lumen 164 of the needle and the canister 402 of the vacuum extractor 400. The vacuum within the canister 402 can then draw a fluid flow through the lumen 164 of the needle. In one embodiment, a portion of the canister 402 can be formed of a transparent material, and the fluid flow within the canister 402 can be observed through one or more viewing windows 120.

[0051] If the medullary cavity has been entered, the user can observe bone marrow within the canister 402. If the medullary cavity has not been entered, for example if the distal tip of the needle 162 is still disposed within the cortical bone, no bone marrow will be observed. In this way, the user can close the valve 404 and slide the handle 442 distally to retract the obturator 166 within the needle lumen 162 and continue drilling the needle assembly 160 through the cortical bone. Advantageously, retracting the vacuum device 400 and obturator 166 assembly proximally can keep the tip of the obturator 166 within the housing 104 and mitigate accidental needle stick injuries. In one embodiment, the handle 442 can be configured to slide the evacuator 400 along the longitudinal axis and actuate the valve 404. In one embodiment, a separate actuator can be configured to actuate the valve 404 and transition the valve 404 between the open and closed positions.

[0052] In some embodiments, portions of the aspiration system 110 can be configured to be selectively decoupled from the access system 102. For example, in one embodiment, in the aspiration system 110, the syringe 130, the evacuator 400, or a combination thereof can be configured to be detachable and interchangeable. In one embodiment, sliding the syringe 130 or the evacuator 400 can be achieved by manual operation and a handle, as described herein. In one embodiment, the system 100 can further include a second transmission configured to be actuated by a user and slide the aspiration system 110 or portions thereof along the longitudinal axis.

[0053] Figure 4 An exemplary method 500 of use for the intraosseous access system 100, including the aspiration system 110, is shown. In one embodiment, the method 500 includes assembling the intraosseous access system 100 (block 502). In some embodiments, assembling the intraosseous access system 100 includes coupling the needle assembly 106 with the access system 102 of the system 100. The needle assembly 160 can be rotatably coupled to the system 100. In some embodiments, assembling the intraosseous access system 100 includes coupling the aspiration system 110 having the syringe 130 or the evacuator 400 with the system 100.

[0054] In one embodiment, the method 500 includes actuating the access system 102 to rotate the needle assembly 160, the aspiration system 110, or components thereof, to drill the needle 162 through the cortical bone to enter the medullary cavity (block 504). In one embodiment, when the user believes that the medullary cavity has been entered, the user can confirm entry into the medullary cavity by retracting the obturator 166 from the needle lumen 164 (block 506). By providing a vacuum in fluid communication with the needle lumen 164, a fluid flow can be drawn through the needle lumen 164 (block 508). The vacuum can be provided by retracting the plunger 134 from the syringe barrel 132, or by actuating the valve to place the evacuator 400 in fluid communication with the needle lumen 164, or a combination thereof. (block 508).

[0055] In one embodiment, the user can then determine whether the medullary cavity has been entered by observing the flow of fluid (block 510). If entry into the medullary cavity has been confirmed, the user can detach the system 100 from the needle 162 (block 512). If entry into the medullary cavity has not been confirmed, the user places the obturator 166 back within the needle lumen 164 (block 514) and continues drilling through the bone cortex (return to block 504).

[0056] While certain specific embodiments have been disclosed herein, and while the detailed description has focused on particular embodiments, the particular embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications of the specific embodiments can occur to those in the art upon reading this disclosure, and such adaptations and / or modifications are intended to fall within the scope of the concepts provided herein. Accordingly, the specific embodiments disclosed above are illustrative, and not limiting, of the scope of the concepts provided herein.

Claims

1. An intraosseous access system, comprising: comprising: a housing; a needle assembly extending from a distal end of the housing and including a needle and an obturator, the obturator extending along a longitudinal axis and disposed within a needle lumen of the needle; a suction system disposed within the housing and including one of a syringe or a vacuum aspirator, the suction system configured to slide the obturator relative to the needle and selectively provide a vacuum in fluid communication with the needle lumen; and a drive train disposed within the housing and configured to rotate the needle assembly and one of a syringe barrel or a vacuum aspirator canister about the longitudinal axis.

2. The intraosseous access system of claim 1, wherein, The drive train includes one of a biasing member, an electric motor, or a battery.

3. The intraosseous access system of claim 1, wherein, The syringe includes a plunger slidably engaged with the syringe barrel and the housing along a longitudinal axis, the syringe barrel being rotatable about the longitudinal axis relative to the plunger.

4. The intraosseous access system of claim 3, wherein, Further including a piston rotatably coupled to one of the plunger, the syringe barrel, or the obturator.

5. The intraosseous access system according to claim 3, wherein, Further including a handle coupled to the plunger, a portion of the handle extending through a wall of the housing.

6. The intraosseous access system of claim 1, wherein, The vacuum aspirator includes a valve configured to control fluid communication between the vacuum aspirator canister and the needle lumen to selectively apply the vacuum to the needle lumen.

7. The intraosseous access system according to claim 6, characterized in that The vacuum aspirator further includes an actuator configured to slide the vacuum aspirator canister along a longitudinal axis or actuate the valve between an open position and a closed position.

8. The intraosseous access system of claim 1, wherein, The housing further includes a viewing window configured to allow a user to view one of the syringe barrel or the vacuum aspirator canister disposed therebelow.

9. The intraosseous access system of claim 1, wherein, One of the syringe barrel or the vacuum aspirator canister can include a transparent material.

10. The intraosseous access system of claim 2, wherein, The biasing member is one of a flat spring, a coil spring, or a torsion spring.

11. The intraosseous access system of claim 1, wherein, A distal tip of the obturator is configured to be withdrawn into one of the syringe barrel or the housing to mitigate accidental needle stick injuries.

Citation Information

Patent Citations

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