Reusable push-to-start intraosseous access device

Abstract

Disclosed herein are push-to-start intraosseous (IO) access devices and methods thereof. Embodiments include replaceable rechargeable or non-rechargeable battery packs or spring driven devices. Intraosseous access devices typically require training to ensure proper placement of the access device. The user must coordinate the action of pulling the trigger proximally while simultaneously applying sufficient distal drive force to penetrate the bone. The devices disclosed herein include intuitive operation with one-way activation and drive force application. In addition, the trigger is automatically activated and deactivated to prevent premature activation and to prevent "posterior wall penetration." The devices include various indicators to further guide the user to place the device correctly with little or no training. The devices also include replaceable battery packs to ensure full charge availability when using the device and to provide a multiple use device that requires less storage.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 013,371, filed April 21, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a reusable push activated intraosseous access device. SUMMARY

[0004] Intraosseous access devices generally require training to ensure proper placement of the access device. The user must coordinate the opposing actions of pulling proximally on a trigger while simultaneously applying sufficient distal drive force to penetrate the bone. Too little distal drive force results in osteonecrosis, where the needle tip end rotates against the bone causing a friction burn rather than cutting into the bone as intended. Too much distal drive force can result in “back walling” of the needle through the far wall of the bone. Further complications can arise when accessing bones of different sizes and densities, depending on the age and health of the patient. Additionally, IO access devices are often used in emergency situations where delays can be fatal and it can be difficult to find a sufficiently trained user.

[0005] Embodiments disclosed herein relate to push activated intraosseous (IO) access devices and methods thereof. The push activated IO devices provide intuitive operation with unidirectional activation and drive force application. Additionally, the devices are both automatically activated and automatically deactivated to prevent premature activation, guide the correct amount of distal drive force, and prevent “back walling.” The devices include various indicators to further guide the user, who can be almost or not at all trained, to place the device correctly. The IO access devices disclosed herein further include replaceable battery packs, which can be rechargeable or non-rechargeable, to ensure the device is fully charged when it is used, and to provide a multi-use device that requires less storage space.

[0006] An intraosseous access device is disclosed herein, comprising a housing, a trigger, and a drive train assembly, a portion of which is slidably engaged with the housing and configured to transition between a distal position and a proximal position actuating the trigger.

[0007] In some embodiments, the portion of the drivetrain assembly that slidably engages the housing includes one of a motor, a gear assembly, a coupling structure, or an access assembly. The trigger is configured to connect the power source with the drivetrain assembly when the trigger is actuated. The power source is a battery pack disposed within the housing and is configured to be removable and replaceable from the housing, and wherein the battery pack is rechargeable or non-rechargeable. In some embodiments, the intraosseous access device further includes one of a force transducer, a speed sensor, a battery charge indicator, a timed stop sensor, or a trigger lock. The speed transducer is configured to vary the speed of the motor according to the amount of distal driving force applied to the intraosseous access device. The timed stop sensor is configured to stop the motor after a predetermined amount of time has elapsed. The trigger lock is convertible between a locked position and an unlocked position, when in the locked position the trigger lock prevents the portion of the drivetrain assembly from being converted to the proximal position.

[0008] In some embodiments, the intraosseous access device further includes a biasing member configured to bias the portion of the drivetrain assembly toward the distal position. A first force required to deform the biasing member and convert the portion of the drivetrain assembly from the distal position to the proximal position is greater than a second force required for the needle of the access assembly to penetrate the skin surface and less than a third force required for the needle to penetrate the bone cortex. In some embodiments, the intraosseous access device further includes a tensioning nut configured to adjust the tension of the biasing member. In some embodiments, the intraosseous access device further includes a force indicator configured to indicate the amount of force exerted on the biasing member. The force indicator includes one of a mechanical slider, a rotating dial, a series of scale markings, or a series of LED lights.

[0009] A method of placing an intraosseous access assembly is also disclosed, including: providing an intraosseous access device having a driver, a drivetrain assembly (a portion of the drivetrain assembly is convertible between a first position and a second position), an access assembly coupled to the drivetrain and including a needle; providing a first force to drive the access device distally until a tip of the needle penetrates a skin surface and contacts a bone cortex; providing a second force to drive the access device distally and convert the portion of the drivetrain assembly from the first position to the second position; rotating the access assembly; and drilling the needle through the bone cortex.

[0010] In some embodiments, the drive train includes one of a power source, an electronic control board, a motor, a gear assembly, or a coupling interface. The power source further includes a replaceable rechargeable or non-rechargeable battery pack. The drive train includes one of a drive spring, a drive shaft, a locking flange, or a coupling interface. In some embodiments, the method further includes an activation biasing member configured to bias a portion of the drive train assembly toward the first position, and wherein a force required to deform the activation biasing member is greater than the first force and less than the second force. In some embodiments, the method further includes a tensioning nut configured to adjust a tension of the activation biasing member. In some embodiments, the method further includes a timeout sensor configured to stop the rotation entry assembly after a predetermined amount of time has elapsed.

[0011] An entry device is also disclosed, including a driver housing, a drive shaft configured to rotate axially within the driver housing and configured to transition between a locked position and an unlocked position, a drive spring configured to rotate the drive shaft, and an entry assembly coupled to the drive shaft.

[0012] In some embodiments, the entry device further includes an activation biasing member configured to bias the drive shaft to the locked position. A first force required to deform the activation biasing member and transition the drive shaft from the distal position to the proximal position is greater than a second force required for a needle of the entry assembly to penetrate a skin surface and less than a third force required for the needle to penetrate a bone cortex. The activation biasing member is a compression spring and the first force is between 2 pounds and 4 pounds. In some embodiments, the entry device further includes a tensioning nut threadedly engaged with the driver housing and configured to vary an amount of force required to deform the activation biasing member. The drive shaft further includes a locking flange configured to engage the driver housing and prevent axial rotation when the drive shaft is in the locked position. The locking flange engages the driver housing using one of a plurality of ratchet teeth, a lobe and detent, a frangible bridge, or a locking bar. The drive spring includes one of a torsion spring or a leaf spring. BRIEF DESCRIPTION OF DRAWINGS

[0013] A more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the application and are therefore not to be considered limiting of its scope. The application will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0014] Figure 1 An exploded view of an embodiment of an intraosseous access system according to embodiments disclosed herein is shown, with the access assembly sub-assembly of the system slightly enlarged and shown in elevation view, and the automatic driver components shown in perspective view;

[0015] Figure 2AA side view of an intraosseous access system is shown in accordance with embodiments disclosed herein;

[0016] Figure 2B A cross-sectional view of an intraosseous access system is shown in accordance with embodiments disclosed herein, with the access assembly in a first, distal position;

[0017] Figure 2C A cross-sectional view of an intraosseous access system is shown in accordance with embodiments disclosed herein, with the access assembly in a second, proximal position;

[0018] Figure 2D Close-up details of a device are shown in accordance with embodiments disclosed herein; Figure 2A

[0019] Figure 3 A cross-sectional view of an intraosseous access system is shown in accordance with embodiments disclosed herein;

[0020] Figure 4 A cross-sectional view of a spring-driven intraosseous access device is shown in accordance with embodiments disclosed herein;

[0021] Figures 5A-5H Close-up details of a spring-driven intraosseous access device are shown in accordance with embodiments disclosed herein; and

[0022] Figure 6A A cross-sectional view of a spring-driven intraosseous access device is shown in accordance with embodiments disclosed herein.

[0023] Figure 6B A schematic diagram of a spring-driven intraosseous access device is shown in accordance with embodiments disclosed herein. Figure 6A

[0024] Figures 6C-6D A cross-sectional view of a spring-driven intraosseous access device is shown in accordance with embodiments disclosed herein.

[0025] Figures 6E-6F A cross-sectional view of a geared spring-driven intraosseous access device is shown in accordance with embodiments disclosed herein. DETAILED DESCRIPTION

[0026] Before some embodiments are disclosed in more detail, it should be understood that the particular embodiments disclosed herein are not intended to limit the scope of the concepts provided herein. It should also be understood that the particular embodiments disclosed herein can have features that are readily separable from the particular embodiments, and that the features can be employed with any one or all of the many other embodiments disclosed herein or in combination with other steps, structures, features, etc.

[0027] ​​Regarding the terminology used herein, it should be understood that these terms are for describing specific embodiments and 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 group of features or steps and do not provide for a series or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in sequence, and the specific embodiments including these features or steps are not limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used and are not intended to imply, for example, any specific fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include plural references.

[0028] For example, the term "proximal," "proximal portion," or "proximal portion" of a needle disclosed herein includes the portion of the needle intended to be close to the clinician when the needle is used on a patient. Similarly, the term "proximal length" of a needle includes the length of the needle intended to be close to the clinician when the needle is used on a patient. For example, the term "proximal end" of a needle includes one end of the needle intended to be close to the clinician when the needle is used on 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 implies, the proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0029] For example, the term "distal," "distal portion," or "distal part" of a needle disclosed herein includes the portion of the needle intended to be near or within the patient when the needle is used on the patient. Similarly, the term "distal length" of a needle includes the length of the needle intended to be near or within the patient when the needle is used on the patient. For example, the term "distal end" of a needle includes the tip of the needle intended to be near or within the patient when the needle is used on the patient. 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 need to 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 portion or distal length of the needle.

[0030] like Figure 1 As shown, and to aid in describing the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle 204 extending from the driver 101. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0031] As used herein, the term "spring" is considered to include any type of spring or biasing member that can store potential mechanical energy. Exemplary biasing members can include compression springs, extension springs, torsion springs, constant force springs, leaf springs, flexible members, rubber rings, rubber bands, spring tabs, V-springs, cantilever springs, volute springs, butterfly springs, gas springs, gravity- propelled biasing members, combinations thereof, and the like, and are considered to fall within the scope of the present disclosure.

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

[0033] The present disclosure relates generally to bone marrow (IO) access devices, systems, and methods thereof. Figure 1 An exploded view of an exemplary intraosseous access system ("system") 100 is shown, with some of its components shown in front view and others in perspective view. In embodiments, the intraosseous access system 100 can be used to penetrate the skin and underlying hard bone ("cortical bone") in order to perform intraosseous access, for example, into a patient's bone marrow and / or vasculature via a passageway through the interior of the bone ("medullary cavity").

[0034] In embodiments, the system 100 includes a driver 101 and an access assembly 109. The driver 101 can be used to rotate the access assembly 109 and "drill" the needle 204 into a patient's bone. In embodiments, the driver 101 can be automated or manual. As shown, the driver 101 is an automated driver 101. For example, the automated driver 101 can be a drill that achieves high rotational speeds. In embodiments, the intraosseous access system 100 can also include an obturator assembly 102, a shield 105, and a needle assembly 202, which can be collectively referred to as the access assembly 109. The needle assembly 202 can include an access needle ("needle") 204 supported by a needle hub 203, as described in greater detail herein. In embodiments, the obturator assembly 102 includes an obturator 104. However, in some embodiments, the obturator 104 can be replaced with a different elongated medical instrument. As used herein, the term "elongated medical instrument" is a broad term that is used in its ordinary sense to include devices such as needles, cannulas, trocars, obturators, stylets, and the like. Thus, the obturator assembly 102 can be more generally referred to as an elongated medical instrument assembly. In a similar manner, the obturator 104 can be more generally referred to as an elongated medical instrument.

[0035] In embodiments, the obturator assembly 102 includes a coupling hub 103 that is attached to the obturator 104 in any suitable manner (e.g., one or more adhesives or overmolding). The coupling hub 103 can be configured to interface with the driver 101, as discussed further below. The coupling hub 103 can alternatively be referred to as an obturator hub 103, or more generally as an elongated instrument hub 103. In embodiments, a shield 105 is configured to couple with the obturator 104 to prevent accidental needle stick injuries when the obturator is removed after placement of the needle 204.

[0036] In embodiments, the needle assembly 202 includes a needle 204. However, in some embodiments, the needle 204 can be replaced with a different instrument, such as a cannula, tube, or sheath, and / or can be referred to using a different name, such as one or more of the foregoing examples. Thus, the needle assembly 202 can be more generally referred to as a cannula assembly or a tube assembly. In a similar manner, the needle 204 can be more generally referred to as a cannula.

[0037] In embodiments, the needle assembly 202 includes a needle hub 203 that is attached to the needle 204 in any suitable manner. The needle hub 203 can be configured to couple with the obturator hub 103, and can thereby be coupled to the driver 101, as discussed further below. The needle hub 203 can alternatively be referred to as a cannula hub 203. In embodiments, a cap 107 can be provided to cover at least a distal portion of the needle 204 and the obturator 104 prior to use of the access assembly 109. For example, in embodiments, a proximal end of the cap 107 can be coupled to the obturator hub 103.

[0038] With continued reference to Figure 1 , the driver 101 can take any suitable form. The driver 101 can include a handle 110 that can be held by a user in a single hand. In embodiments, the driver 101 further includes a coupling interface 112 formed as a socket 113 that defines a cavity 114. The coupling interface 112 can be configured to couple with the obturator hub 103. In embodiments, the socket 113 includes a sidewall that defines a substantially hexagonal cavity into which a hexagonal protrusion of the obturator hub 103 can be received. Other suitable coupling interfaces are also contemplated.

[0039] The driver 101 can include any suitable kind of energy source 115 configured to power rotational motion of the coupling interface 112. For example, in some embodiments, the energy source 115 can include one or more batteries that provide power to the driver 101. In some embodiments, the energy source 115 can include one or more springs (e.g., coil springs, leaf springs, etc.) or other biasing members that can store potential mechanical energy that can be released upon actuation of the driver 101.

[0040] The energy source 115 can be coupled with the coupling interface 112 in any suitable manner. For example, in embodiments, the driver 101 includes an electrical, mechanical, or electromechanical coupling 116 to the gear assembly 117. In some embodiments, the coupling 116 can include an electric motor that produces mechanical motion from electrical energy provided by the energy source 115. In other embodiments, the coupling 116 can include a mechanical link to the gear assembly 117. The driver 101 can include any appropriate kind of mechanical coupling to couple the gear assembly 117 with the coupling interface 112. In other embodiments, the gear assembly 117 can be omitted.

[0041] Further details and embodiments of the intraosseous access system 100 can be found in WO 2018 / 075694, WO 2018 / 165334, WO 2018 / 165339, US 2018 / 0116693, each of which is incorporated by reference in its entirety into the present application.

[0042] Figure 2A An embodiment of the intraosseous access device 100 is shown that includes a driver 101 that includes a replaceable battery pack energy source (“battery pack”) 115. In embodiments, the battery pack 115 is removable and replaceable with a similar battery pack. In embodiments, the battery pack 115 can be rechargeable or non-rechargeable. Advantageously, this allows the user of the system 100 to ensure that sufficient power is present when deploying the system in a placement event. Further, if the power of a first battery pack is depleted during a placement event, the user can replace the first battery pack with a second battery pack that is fully charged and continue the access procedure without having to wait for the first battery pack to charge. As discussed herein, intraosseous access devices are often used in emergency situations and, therefore, are stored for extended periods of time before being quickly deployed in a placement event. The replaceable battery pack 115 alleviates the user’s concern of having sufficient electrical energy during a placement event.

[0043] In embodiments, the driver 101 includes a battery charge indicator 170. In embodiments, the battery charge indicator 170 is disposed on the battery pack 115. The battery charge indicator 170 can include one or more LED lights, icons, or the like, which can turn on or off, change color, or a combination thereof, to indicate the charge level of the battery pack 115. In embodiments, the system 100 includes a charge indicator button 171 that a user can actuate to activate the battery charge indicator 170 and determine the charge level of the battery pack 115. Advantageously, the driver 101 and one or more replacement battery packs 115 can provide sufficient power for multiple uses while requiring less storage space than multiple single-use devices. Further, the overall cost is reduced by only needing to replace the battery pack rather than needing multiple single-use entry systems.

[0044] As shown in FIG. 1, in embodiments, the driver 101 includes a pressure activated trigger 111. The trigger 111 can be activated by axial pressure on the entry assembly 109. In embodiments, longitudinal pressure can depress the entry assembly 109 in a proximal direction and activate the trigger 111, which activates the motor 116 and causes the entry assembly 109 to rotate. Figures 2B-2C

[0045] As used herein, the battery pack 115 and any associated electronic control board 115A, motor 116, associated gear assembly 117, coupling structure 112, entry assembly 109, or combinations thereof can be collectively referred to as a drivetrain assembly (“drivetrain”) 118. In embodiments, the drivetrain 118, or a portion thereof, can be slidably engaged within the housing 108 of the driver 101. For example, as shown in FIG. 1, a portion of the drivetrain 118 (including the motor 116, coupling structure 112, and entry assembly 109) can be slidably engaged along a longitudinal axis between a first, distal position (A) and a second, proximal position (B). Figures 2B-2C Figure 2B Figure 2C

[0046] ​​​​However, it should be appreciated that any combination of components of the drive train 118 can be slidably engaged with the housing 108, while the remaining components of the drive train 118 remain stationary. For example, in embodiments, the portion of the drive train 118 that is slidably engaged with the housing 108 can include only the entry assembly 109, while the remaining components remain stationary. In embodiments, all components of the drive train 118 can be slidably engaged with the housing 108. In embodiments, the components of the drive train 118 can be further subdivided into a first portion that remains stationary and a second portion that is slidably engaged with the housing 108. For example, the coupling structure 112 can be made of a first piece that is slidably engaged with a second piece. As such, the portion of the drive train 118 that is slidably engaged with the housing 108 can include the entry assembly 109 and the second piece of the coupling structure 112. These and other combinations of drive train components 118 are considered to be within the scope of the present disclosure.

[0047] In embodiments, a biasing member (e.g., the activation spring 190) can bias the slidable drive train 118, or a portion thereof, that is slidably engaged with the housing 108 toward the distal position. In embodiments, a biasing member (e.g., a spring) can be disposed between a first portion and a second portion of the drive train 118, for example between the second piece of the coupling structure 112 and the entry assembly 109, to bias a portion of the drive train 118 toward the distal position. These and similar combinations of slidable drive trains 118 are considered to be within the scope of the present disclosure.

[0048] In embodiments, the activation spring 190 can be a compression spring disposed within the driver 101 between a portion of the slidable drive train 118 and the distal end of the driver housing 108. However, as discussed herein, it will be appreciated that various other forms of biasing members can also be contemplated, including a compliant rubber disc, a flexible metal tab, or similar structure configured to bias the drive train 118 toward the distal position. In embodiments, the driver 101 further includes a tensioning nut 130. In embodiments, rotating the tensioning nut 130 can adjust the tension on the activation spring 190 and can change the amount of force required to compress the activation spring 190 and activate the device, as discussed in greater detail herein.

[0049] In embodiments, the force required to compress the activation spring 190 can be between 2 pounds and 4 pounds, although greater or lesser forces can also be contemplated. As discussed herein, the force required to compress the activation spring 190 can be adjusted by rotating the tensioning nut 130. Figure 2BAs shown, in one embodiment, the force required for the needle 204 to penetrate the skin tissue 70 can be less than the force required to compress the actuating spring 190. Accordingly, when the needle penetrates the skin tissue 70, the actuating spring 190 can hold the transmission system 118 in a proximal position. In another embodiment, the force required for the needle 204 to penetrate the cortical bone 80 can be greater than the force required to compress the actuating spring 190. Accordingly, when the needle tip 246 contacts the cortical bone 80, the user can apply an additional distal driving force to compress the actuating spring 190 and move the transmission system 118 from a distal position (…). Figure 2B ) shift to the proximal position ( Figure 2C ).

[0050] like Figure 2C As shown, in the proximal position, the drive system 118 contacts the trigger 111, which activates the motor 116 and rotates it into the assembly 109. The needle tip 246 then drills through the cortical bone 80 and into the medullary canal 90. The tissue density within the medullary canal 90 is less than that of the cortical bone 80. Therefore, the force required for the needle 204 to penetrate the tissue of the medullary canal 90 is less than the force required to compress the actuating spring 190. When the needle tip 246 enters the medullary canal 90, the force of the actuating spring 190 causes the drive system 118 to rotate back to the distal position. This disengages the trigger 111, stops the motor 116, and automatically stops any rotation into the assembly 109.

[0051] In one embodiment, the actuator 101 may further include a tension nut 130 configured to rotate and move the spring support 194 along a longitudinal axis. This adjusts the amount of force required to change the drivetrain 118 from a distal to a proximal position. Accordingly, the tension of the actuating spring 190 can be adjusted according to various factors, including the patient's age, the patient's health condition, the density of the cortical bone 80, the density of the tissue within the medullary cavity 90, and their combination.

[0052] In an exemplary method of use, an intraosseous access system 100 is provided, comprising a driver 101, an access component 109, and a replaceable battery 115, as described herein. In one embodiment, the access component 109 and / or the replaceable battery 115 are pre-loaded into the driver 101. In another embodiment, the access component 109 and / or the replaceable battery 115 are disposed separately, and the user can load the access component 109 and / or the replaceable battery 115 into the driver 101 prior to use. The user can check the charge level of the battery 115 using a battery power indicator 170. If necessary, the user can replace the battery 115 with a fully charged battery 115. In another embodiment, the system 100 may further include a cap 107 to protect the pin 204 of the access component 109.

[0053] The user can position the tip 246 of the needle 204 at the insertion site and apply a distal driving force to drive the driver 101 in the distal direction. As described herein, the launch spring 190 is configured to maintain the drive train 118 in a distal position as the needle 204 is driven through the skin surface tissue 70. The distal tip 246 of the needle 204 then contacts the hard cortical bone 80 which resists further distal advancement. The user continues to advance the driver 101 distally with sufficient force that is able to overcome the force of the launch spring 190. This causes the drive train 118 to slide proximally relative to the driver 101 and activates the trigger 111. The trigger 111 activates the motor 116 which rotates the entry assembly 109 and drills the needle 204 through the cortical bone 80. When the needle tip 246 penetrates the cortical bone 80 and enters the medullary canal 90, the launch spring 190 can transition the drive train 118 back to the distal position as the force of the launch spring is greater than the force required to penetrate the tissue of the medullary canal 90 by the needle 204. In the distal position, the trigger 111 is disengaged which causes the motor 116 to disengage and stop rotation of the entry assembly 109.

[0054] Advantageously, the system 100 provides an intuitive function of requiring only a unidirectional force to be applied to initiate the placement event (i.e., initiate drilling) as compared to pulling a "pistol grip" trigger in the proximal direction while simultaneously applying a driving force in the distal direction. Further, the launch spring 190 can be configured to automatically deform and activate the device 100 when the correct level of distal driving force is applied. The user can gradually increase the amount of distal driving force until the launch spring 190 compresses and activates the system 100, guiding the user towards the correct level of distal driving force.

[0055] Still further, the launch spring 190 can be configured to automatically deactivate the device 100 when the user removes the distal driving force or when the needle 204 enters the medullary canal 90. The automatic deactivation can indicate to the user that the placement was successful. This is particularly important to prevent "through the back wall" which can lead to various complications. Additionally, the automatic deactivation of the device can act as a safety feature to deactivate the device if the device is removed from the insertion site. In embodiments, the drive train 118 can also be configured to apply the correct torque and rotational speed to make the entry fast and effective.

[0056] In embodiments, the system 100 can be configured to vary the amount of torque and / or rotational velocity based on the amount of distal driving force applied. As such, the system 100 can be configured to guide the user to deliver the correct balance of distal driving force, torque, and rotational velocity in order to make intuitive, fast, and effective IO (intraosseous) access placement. As a result, the user needs little or no training to use the system 100. Of particular importance, intraosseous access devices are often used in emergency situations where placement speed is important and the user is not necessarily required to have any prior training.

[0057] In embodiments, the driver 101 can be configured in a variety of compact or ergonomic shapes. For example, a user-actuated trigger (i.e., a device selectively actuated by the user) can be limited to a pistol-grip configuration in order to position the trigger in an accessible location. An automatic pressure-activated trigger does not rely on such a configuration and can allow for a more compact or ergonomic configuration of the system 100. For example, as shown in FIG. 4, a cylindrical driver 101 A is provided that defines a generally tubular shape extending along a longitudinal axis. Such a design can provide a more compact driver 101 than a pistol-grip driver, resulting in greater efficiency in storage and transport of the device. These and other ergonomic or compact designs are also considered to fall within the scope of the present application. Figure 3

[0058] In embodiments, in addition to the activation spring 190, the driver 101 includes a force sensor (not shown) configured to automatically stop the driver 101 once the bone cortex 80 has been penetrated. In embodiments, the force sensor is a pressure transducer that detects the axial force applied to the needle tip 246. The force sensor can be configured to detect whether the axial force applied to the needle tip 246 is present or not. The system 100 can then determine when the needle tip 246 has penetrated the bone cortex 80 and entered the medullary space 90, and can deactivate the motor 116 to prevent further drilling. Advantageously, the force sensor provides an additional safety safeguard against penetrating the posterior wall. Further, the force sensor can allow the user to selectively activate or deactivate the driver 101 during a placement event by applying or removing the distal driving force.

[0059] ​In one implementation, the actuator 101 includes a speed sensor configured to adjust the speed of the motor 116 in proportion to the amount of distal driving force applied to the actuator 101. For example, the speed sensor is configured to detect the amount of force applied to the actuator 101 or the amount of deformation applied to the actuation spring 190. The speed sensor then increases the speed of the motor in proportion to the applied force or the detected deformation. Advantageously, the speed sensor balances the correct rotational speed with the amount of distal driving force applied to provide efficient intraosseous placement. This prevents osteonecrosis or perforation of the posterior wall, as discussed herein. Advantageously, during actuation, the actuator 101 can be configured to “ramp up” the motor speed to prevent sudden start-up, which could cause the needle tip 246 to travel away from the selected insertion site, resulting in incorrect placement of the insertion device. Furthermore, sudden start-up can startle the user and also lead to incorrect placement of the insertion device.

[0060] In one embodiment, the actuator 101 includes a timed stop sensor. The timed stop sensor provides automatic stopping after a set period of time since the device was started. In another embodiment, the timed stop sensor deactivates the motor between 3 and 59 seconds after the motor has started. Advantageously, the timed stop sensor provides protection against penetration through the posterior wall by deactivating the motor after a predetermined time, such as 2-3 seconds, or the time required for drilling through the cortical bone 80. Furthermore, the timed stop sensor also prevents accidental battery depletion, such as during accidental start-up events during storage or transport.

[0061] In one embodiment, the actuator 101 includes a trigger lock. The trigger lock may include a slide switch, an electronic switch, etc., configured to prevent premature activation of the trigger 111. For example, the trigger lock may be a slide switch configured to prevent the drive system 118 from transitioning from a distal position to an activated proximal position. During use, the user can release the trigger lock switch before initiating an event. Advantageously, the trigger lock prevents accidental activation of the actuator 101 before use, such as during transport or storage.

[0062] like Figure 2A , 2D As shown, in one embodiment, the actuator 101 includes a distal driving force indicator 310. The force indicator 310 may include a series of LEDs, mechanical sliders, a rotating dial, combinations thereof, etc., and includes scale markings 314. The force indicator 310 may include a mechanical or electronic transducer that detects the amount of distal driving force applied to the actuator 101 and indicates the amount of force required relative to the correct amount of force. For example, Figure 2DA close-up detail of a force indicator 310 that can be arranged on the outer surface of the drive 101 is shown. In an embodiment, a drivetrain 118 can be linked to a slider 312 arranged on the outer surface of the drive 101. As described herein, the drivetrain 118 can slide proximally relative to the drive 101 when a user applies a distal driving force. The slider 312, coupled to the drivetrain 118, can also slide proximally relative to the drive housing 108. A series of scale marks 314 arranged on the drive housing 108, together with the slider 312, can indicate to the user whether sufficient distal driving force has been applied, or whether too much force has been applied, or too little force has been applied. Advantageously, the force indicator 310 can further guide the user regarding the correct operation of the system 100, even if the user has little or no training. In an embodiment, the force indicator 310 includes a rotating dial that rotates about a series of scale marks to indicate the amount of force applied. In an embodiment, the force indicator 310 includes one or more LEDs that turn on and off and / or change color to indicate the amount of force applied. These and similar constructions of mechanical or electronic force indicators are considered to fall within the scope of protection of this invention.

[0063] like Figure 4 As shown, in an embodiment, the intraosseous access system 200 typically includes a spring-driven energy source 215 and a force-activated spring 290. The access system 200 includes an actuator 201 having an actuator housing 208 defining a substantially cylindrical shape, although other housing shapes are also contemplated. The access system 200 further includes the spring-driven energy source 215 and a drive shaft 220 disposed within the actuator housing 208. The drive shaft 220 is configured to rotate about a longitudinal axis of the actuator 201. The drive shaft 220 is further configured to slide along the longitudinal axis between a distal locked position and a proximal unlocked position, as described in more detail herein. The drive shaft 220 also includes a locking flange 222 configured to engage the actuator housing 208 when the drive shaft 220 is in the distal locked position and disengage from the actuator housing 208 when the drive shaft 220 is in the proximal unlocked position, as described in more detail herein.

[0064] The spring-driven energy source (“drive spring”) 215 may include a torsion spring configured to store rotational potential energy. However, it should be understood that other biasing members may also be considered. The drive spring 215 may be coupled to both the actuator housing 208 and the drive shaft 220 in a tensioned state. Accordingly, when the locking flange 222 disengages from the actuator housing 208, allowing the drive shaft 220 to rotate freely, the drive spring 215 causes the drive shaft 220 to rotate about its longitudinal axis.

[0065] In embodiments, the driver 201 further includes a coupling interface 212 disposed at a distal end of the drive shaft 220 and configured to engage the access assembly 109 as described herein. As described herein, rotation of the drive shaft 220 can cause the access assembly 109 to rotate and cause the needle 204 to drill through the cortical bone 80 and into the medullary canal 90. As used herein, the drive spring 215, the drive shaft 220, the locking flange 222, the coupling interface 212, or combinations thereof can be collectively referred to as a drive train assembly.

[0066] In embodiments, the driver housing 208 includes a tension nut 230 threadably engaged with the driver housing 208. Rotating the tension nut 230 about the longitudinal axis can cause the nut 230 to move relative to the driver housing 208 along the longitudinal axis. In embodiments, the driver 201 includes a force activation spring 290 annularly disposed about the drive shaft 220 between the tension nut 230 and the coupling interface 212. In embodiments, the activation spring 290 is a compression spring configured to resist a compression force prior to deformation. In embodiments, the compression force required to deform the spring is between 2-4 pounds of force, although greater or lesser forces can also be contemplated. In embodiments, rotating the tension nut 230 can vary the amount of compression force required to deform the activation spring 290. In embodiments, the activation spring 290 is configured to bias the drive shaft 220 toward a distal locked position. When a proximal force is applied to the needle tip 246 sufficient to compress the activation spring 290, the drive shaft 220 can move to a proximal unlocked position, activating the device.

[0067] In embodiments, the coupling interface 212 is threadably engaged with the drive shaft 220 such that rotating the coupling interface 212 about the longitudinal axis causes the coupling interface 212 to move longitudinally relative to the drive shaft 220. As such, rotating the coupling interface 212 can vary the tension of the activation spring 290 disposed between the coupling interface 212 and the driver housing 208 or the tension nut 230.

[0068] In embodiments, the locking flange 222 can include one or more locking features configured to allow the locking flange 222 to selectively engage or disengage the driver body 208. Figures 5A-5H Some example embodiments of locking features are shown. In embodiments, the flange 222 can include a first flange locking feature (e.g., flange ratchet teeth 224) configured to selectively engage a second driver locking feature (e.g., housing ratchet teeth 234) to selectively resist relative motion therebetween.

[0069] As Figures 5A-5BAs shown, in one embodiment, the locking flange 222 includes a plurality of ratchet teeth 224 configured to engage with a plurality of housing ratchet teeth 234 arranged on the housing 208, the tension nut 230, or a combination thereof. The flange ratchet teeth 224 and the housing ratchet teeth 234 are configured to engage to prevent the drive shaft 222 from rotating about its longitudinal axis in a first direction (e.g., clockwise) and are configured to allow progressive rotation in the opposite second direction (e.g., counterclockwise). Advantageously, this allows the drive spring 215 to be tensioned by rotating the drive shaft 220 in the second direction. The system 200 maintains tension by engaging the flange ratchet teeth 224 with the housing ratchet teeth 234, preventing rotation in the first direction. In one embodiment, when a proximal force sufficient to overcome the compressive force of the actuating spring 290 is applied to the needle tip 246, the shaft 220 and the locking flange 222 move proximally and disengage the flange ratchet teeth 224 from the housing ratchet teeth 234, thereby allowing the shaft 220 to rotate freely. Then, the drive spring 215 causes the drive shaft 220 to rotate as described herein.

[0070] like Figures 5C-5D As shown, in one embodiment, the drive shaft 220 includes one or more lugs 226 that engage one or more stops 236 disposed within the housing 208, the tension nut 230, or a combination thereof. Figure 5C As shown, lug 226 engages stop 236 and prevents rotational movement of drive shaft 220. In an embodiment, when a proximal force sufficient to overcome the compressive force of actuation spring 290 is applied to needle tip 246, shaft 220 and locking flange 222 move proximally and disengage lug 226 from stop 236, thereby allowing shaft 220 to rotate freely. Drive spring 215 then rotates drive shaft 220 as described herein.

[0071] like Figures 5E-5FAs shown, in one embodiment, the locking flange 222 includes a fragile bridge 228 formed between the locking flange 222 and the housing 208, the tension nut 230, or a combination thereof. The fragile bridge 228 may include a tear line, such as a scribing, laser-cut line, or perforation, configured to break upon application of a predetermined force, thereby allowing the locking flange 222 to separate from the housing body 208 or the tension nut 230. For example, when a proximal force sufficient to overcome the force required for tear line separation is applied to the needle tip 246, the fragile bridge 228 detaches from the housing 208 / tension nut 230, thereby allowing the shaft 220 and the locking flange 222 to move proximally and allowing the shaft 220 to rotate freely. The drive spring 215 then rotates the drive shaft 220 as described herein. In one embodiment, the fragile bridge 228 may be used in place of the actuation spring 290 to prevent proximal movement until a sufficient proximal force is applied. In the implementation, in addition to the starting spring 290, a fragile bridging member 228 may be used to prevent proximal movement until sufficient proximal force is applied.

[0072] like Figures 5G-5H As shown, in one embodiment, the actuator 201 includes a locking lever 240 configured to engage a locking flange 222, a drive shaft 220, or a combination thereof to prevent rotation of the drive shaft 220. In one embodiment, the outer surface of the locking flange 222 includes one or more locking teeth. The locking lever 240 engages the locking teeth and prevents rotation of the drive shaft 220. In one embodiment, the shaft 220 moves proximally when a proximal force sufficient to overcome the compressive force of the actuation spring 290 is applied to the needle tip 246. Figure 5H As shown, a portion of the locking lever 240 is actuated by proximal movement of the drive shaft 220, causing the locking lever 240 to pivot and disengage from the locking flange 222, thereby allowing the shaft 220 to rotate freely. The drive spring 215 then rotates the drive shaft 220 as described herein.

[0073] In an exemplary method of use, a spring driven intraosseous access system 200 as described herein is provided, including a coiled drive spring 215 and a launch spring 290. The user advances the driver 201 distally until the needle tip 246 penetrates the skin surface 70. Note that the resistance of the needle 204 to penetrate the skin tissue 70 is less than the force required to deform the launch spring 290. As such, the drive shaft 220 and access assembly 190 remain in a distally locked position. The needle tip 246 then contacts the bone cortex 80 and the user can continue to advance the driver 201 distally with sufficient force to deform the launch spring 290 by pressing the access assembly 109 into the bone cortex 80. The access assembly 109 and drive shaft 220 slide proximally relative to the driver housing 208, compressing the launch spring 290 between the coupling interface 212 and the tension nut 230 portion of the driver housing 208. The locking flange 222 coupled to the drive shaft 220 disengages from the driver housing 208, allowing the drive shaft 220 to rotate. The drive spring 215 rotates the drive shaft 220 and access assembly 109, drilling the needle 204 into the bone cortex 80 and into the medullary canal.

[0074] As Figures 6A-6B shown, in an embodiment, an intraosseous access system 300 is provided including a flat drive spring 315. The access system 300 includes a driver 301 having a driver body 308 with a flat drive spring 315 disposed therein, a drive shaft 320, and a collector shaft 321.

[0075] In the tensioned state, the drive spring 215 is coiled around the drive shaft 220. Upon transitioning of the drive spring between the tensioned state and the untensioned state, the leaf spring unwinds from the drive shaft 320, rotates the drive shaft, and is coiled on the collector shaft 321. Figure 6B A plan view of the drive shaft 320, the collector shaft 321, and the flat drive spring 315 extending therebetween is shown, including the relative rotational direction of each of the drive shaft 320 and the collector shaft 321. Advantageously, the flat drive spring provides a more constant torque and a more constant rotational speed upon transitioning of the spring between the tensioned state and the untensioned state.

[0076] In an embodiment, the drive shaft 320 and the collector shaft 321 are held in a longitudinally fixed position relative to the drive body 208. In an embodiment, the coupling interface 312 is slidably engaged with the drive shaft 320 along the longitudinal axis. The coupling interface 312 is also coupled with the drive shaft 320 such that any rotational movement of the drive shaft 320 causes the coupling interface 312 and the access assembly 109 to rotate.

[0077] In embodiments, the driver 301 includes a launch spring 390 disposed within the drive shaft 320 and biased to hold the coupling interface 312 in a distal position. When a force is exerted on the needle tip 246 in the proximal direction sufficient to overcome the force of the launch spring 390, the launch spring 390 is able to deform and allow the coupling interface 312 to slide longitudinally. The coupling interface can further include a locking flange, as described herein. When the coupling interface 312 transitions from the distal position to the proximal position, the locking flange can disengage, allowing the coupling interface 312 and the drive shaft 320 to rotate. The coupling interface 312 and the locking flange can include various ratchet teeth, lugs and detents, frangible bridges, locking bars, combinations thereof, and the like, as described herein, to selectively prevent rotation of the coupling interface 312 and drive shaft 320 assembly until launched.

[0078] In embodiments, the driver 301 further includes a tension nut 330 threadably engaged with the driver housing 208. As such, rotating the tension nut 330 about the longitudinal axis can change the tension of the launch spring 390, which can change the amount of force needed to longitudinally move the entry assembly 109 and the trigger device 300.

[0079] In an exemplary method of use, a spring-driven intraosseous access system 300 as described herein is provided, including a flat drive spring 315 and a launch spring 390. The user advances the driver 301 distally until the needle tip 346 penetrates the skin surface 70. Note that the resistance of the needle 304 to penetrate the skin tissue 70 is less than the force needed to deform the launch spring 390. As such, the launch spring 390 holds the coupling interface 312 and the entry assembly 190 in a distal, locked position. The needle tip end 246 then contacts the bone cortex 80, at which point the resistance of the needle penetration is greatly increased. The user can continue to advance the driver 301 distally with sufficient force to deform the launch spring 390 by pressing the entry assembly 109 into the bone cortex 80. The entry assembly 109 and the coupling interface 312 slide proximally relative to the driver housing 308, compressing the launch spring 390 between the coupling interface 312 and the tension nut 330. The locking feature is configured to prevent rotation of the coupling interface 312. The locking feature disengages from the driver housing 308, allowing the coupling interface 312 and the entry assembly 109 to rotate, drilling the needle 304 into the bone cortex 80 and into the medullary canal 90.

[0080] Advantageously, the drive springs disclosed herein, such as drive springs 215 and 315, can maintain stored energy without depletion over an extended period of time. Further, the drive springs include an inherent time-stop feature to prevent penetration through the posterior wall, as described herein. Specifically, drive spring 215 can be configured to provide sufficient rotation to the entry assembly to drill through the cortical bone before reaching a de-tensioned state and to stop further drilling. In embodiments, the drive spring is configured to provide rotation between 10 and 20 revolutions to provide sufficient drilling to penetrate the cortical bone and enter the medullary cavity without penetrating the posterior wall. However, it should be understood that the drive spring can also be configured to provide fewer or more revolutions.

[0081] In the implementation plan, such as Figures 6C-6D As shown, the drivetrain may include a drive shaft 320, a drive spring 315, a collector shaft 321, and an entry assembly 109. The drivetrain may be slidably engaged relative to the housing 308 along a longitudinal axis, as described herein. An actuation spring 390 may be arranged between the drivetrain (e.g., drive shaft 320) and the housing 308 and may bias the drivetrain toward a distal position. Figure 6C In an embodiment, one of the drive shaft 320 or the collector shaft 321 may include a locking engagement feature as described herein, configured to selectively prevent rotation of the drive shaft 320. For example, as Figure 6C As shown, the drive shaft may include a first set of ratchet teeth 324 arranged on the drive shaft 320, which are configured to engage, at a distal position, a second set of ratchet teeth 334 arranged on the housing 308. Figure 6D As shown, the axial force applied to the entry assembly 109 can compress the actuation spring 390, thereby allowing the drivetrain to shift to a proximal position. This, in turn, allows the first set of ratchet teeth 324 to disengage from the second set of ratchet teeth 334 and allows the drive shaft 320 to rotate, as described herein.

[0082] In the implementation plan, such as Figures 6E-6F As shown, the transmission system may include a drive shaft 320, a drive spring 315, a collector shaft 321, and an entry assembly 109, and may further include a gear mechanism 317. The gear mechanism 317 can be "accelerated" or "decelerated" to change one of the speed or torque of the entry assembly 109 relative to the rotational speed of the drive shaft 320. The gear mechanism 317 may include spur gears, planetary gears, helical gears, bevel gears, square gears, worm gears, spiral gears, combinations thereof, etc.

[0083] In embodiments, the gears within the gear mechanism 317 can slide relative to one another along the longitudinal axis. As such, when an axial force is applied to the entry assembly 109, the entry assembly 109 and the gear 317B coupled to the entry assembly 109 can slide longitudinally from a distal position to a proximal position. The drive shaft 320 and the gear 317A coupled thereto remain stationary relative to the longitudinal position. The movement of the entry assembly 109 and the gear 317B can disengage the locking features (e.g., ratchet teeth 324, 334) and can allow the gear mechanism 317, the drive shaft 320, and the entry assembly 109 to rotate, as described herein. The system 300 can further include an activation spring 390 configured to bias the entry assembly 109 and the gear 317B toward the distal locked position. In embodiments, the locking features can be configured to engage the drive gear 317A coupled to the drive shaft 320.

[0084] In embodiments, the gear ratio between the drive shaft 320 and the entry assembly 109 can be greater than 1.0. Further, the locking features can be configured to engage the driven gear 317B coupled to the entry assembly 109. Advantageously, with a gear ratio greater than 1.0, the force required for the locking features to engage and block movement of the driven gear 317B can be less than the force required to engage and block movement of the drive gear 317A.

[0085] While some specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in detail, the specific 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 skilled in the art (given the benefit of this disclosure) and are also intended to fall within the scope of the concepts provided herein. Therefore, embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the concepts disclosed herein are intended to be reservoir.

Claims

1. An intraosseous access device, comprising: comprises: a housing; a trigger; a drive train assembly, a portion of which is slidably engaged with the housing and configured to transition between a distal position and a proximal position in which the trigger is actuated; and a biasing member configured to bias the portion of the drive train assembly toward the distal position, wherein a first force required to deform the biasing member and transition the portion of the drive train assembly from the distal position to the proximal position is greater than a second force required for a needle of an access assembly to penetrate a skin surface and less than a third force required for the needle to penetrate a bone cortex.

2. The intraosseous access device of claim 1, wherein, The portion of the drive train assembly that is slidably engaged with the housing comprises one of a motor, a gear assembly, a coupling structure, or an access assembly.

3. The intraosseous access device of claim 1, wherein, The trigger is configured to connect a power source with the drive train assembly when the trigger is actuated.

4. The intraosseous access device of claim 3, wherein, The power source is a battery pack disposed within the housing, the battery pack configured to be removable and replaceable from the housing, and wherein the battery pack is one of a rechargeable or a non-rechargeable battery pack.

5. The intraosseous access device of claim 2, wherein, Further comprising one of a force translator, a speed sensor, a battery charge indicator, a timed stop sensor, or a trigger lock.

6. The intraosseous access device of claim 5, wherein, The speed sensor is configured to vary a speed of the motor according to an amount of distal drive force applied to the intraosseous access device.

7. The intraosseous access device of claim 5, wherein, The timed stop sensor is configured to stop the motor after a predetermined amount of time has elapsed.

8. The intraosseous access device of claim 5, wherein, The trigger lock is transitionable between a locked position and an unlocked position, when in the locked position the trigger lock prevents the portion of the drive train assembly from transitioning to the proximal position.

9. The intraosseous access device of claim 1, wherein, Further comprising a tension nut configured to adjust a tension of the biasing member.

10. The intraosseous access device of claim 1, wherein, Further comprising a force indicator configured to indicate an amount of force exerted on the biasing member.

11. The intraosseous access device of claim 10, wherein, The force indicator comprises one of a mechanical slider, a rotating dial, a series of scale markings, or a series of LED lights.

12. An intraosseous access system, comprising: comprises: a driver housing; a drive shaft configured to rotate axially within the driver housing and configured to transition between a locked position and an unlocked position; a drive spring configured to rotate the drive shaft; an access assembly coupled to the drive shaft; and an activation biasing member configured to bias the drive shaft to the locked position, wherein a first force required to deform the activation biasing member and transition the drive shaft from the locked position to the unlocked position is greater than a second force required for a needle of the access assembly to penetrate a skin surface and less than a third force required for the needle to penetrate a bone cortex.

13. The intraosseous access system according to claim 12, characterized in that The activation biasing member is a compression spring and the first force is between 2 pounds and 4 pounds of force.

14. The intraosseous access system of claim 12, wherein, Further comprising a tension nut threadably engaged with the driver housing and configured to vary an amount of force required to deform the activation biasing member.

15. The intraosseous access system of claim 12, wherein, The drive shaft further comprises a locking flange configured to engage the driver housing and prevent axial rotation when the drive shaft is in the locked position.

16. The intraosseous access system according to claim 15, characterized in that The locking flange engages the driver housing using one of a plurality of ratchet teeth, lugs and detents, frangible bridges, or locking bars.

17. The intraosseous access system of claim 12, wherein, The drive spring comprises one of a torsion spring or a leaf spring.

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