Various operating mechanisms and methods for intraosseous access medical devices

Abstract

Disclosed herein are intraosseous access devices having various operating mechanisms and methods of intraosseous access devices. For example, in some embodiments, the intraosseous access device includes a constant torque spring assembly, a drive shaft, an intraosseous needle, and an interlocking mechanism. The constant torque spring assembly is disposed in a housing, and the drive shaft extends from the housing. The drive shaft is coupled to the constant torque spring assembly. The intraosseous needle is coupled to the drive shaft. The intraosseous needle is configured to drill through bone and provide intraosseous access to the patient's medullary cavity. The interlocking mechanism is configured to prevent rotation of the intraosseous needle and the accompanying drilling thereof until the interlocking mechanism is disengaged.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 907,460, filed September 27, 2019, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present application relates to the field of medical devices, and more particularly to various operating mechanisms and methods for intraosseous access medical devices. Background Art

[0004] In emergency situations where critically ill patients are deteriorating, peripheral intravenous catheter ("PIVC") insertion is increasingly challenging. Intraosseous ("IO") access is often the only means available to clinicians to increase the patient's chance of recovery and even save their life. IO access can be obtained in as little as 2 to 5 seconds with a relatively high success rate.

[0005] The most advanced commercially available medical device for IO access is a small, drill-like device built around a relatively primitive electric motor that achieves IO access by drilling a hole using the needle assembly of the IO access medical device. Some medical devices for IO access utilize linear springs to provide the rotational energy for drilling, while some other IO access medical devices even rely on manual means to provide the rotational energy for drilling. Regardless of the drilling means a clinician uses for IO access, the clinician needs to be able to control the IO access medical device under all circumstances and be able to interrupt drilling at any time for any reason. Furthermore, it is necessary to prevent the IO access medical device from being accidentally triggered while being handled before the needle assembly of the IO access medical device is properly positioned for IO access, or even while the IO access medical device is stored, for example, in an emergency bag.

[0006] Various operating mechanisms and methods for IO access medical devices that meet the aforementioned needs are disclosed herein. Furthermore, a constant-torque IO access device and method are disclosed that significantly reduces the design and manufacturing complexity of the current state-of-the-art, small, drill-like devices used for IO access. Summary of the Invention

[0007] Disclosed herein is an IO access device that, in some embodiments, includes a constant torque spring assembly, a drive shaft, an IO needle, and an interlocking mechanism. The constant torque spring assembly is disposed within a housing, and the drive shaft extends from the housing. The drive shaft is coupled to the constant torque spring assembly. The IO needle is coupled to the drive shaft. The IO needle is configured to drill through bone and provide IO access to the patient's medullary cavity. The interlocking mechanism is configured to prevent rotation of the IO needle and associated drilling until the interlocking mechanism is disengaged.

[0008] In some embodiments, the constant torque spring assembly includes a metal strip that is reversely wound on an output spool having an axial channel. The metal strip is configured to be wound on a storage spool at a constant torque when the output spool is released.

[0009] In some embodiments, the spindles of the output spool and the storage spool are coupled together by at least one elastomeric ring to prevent any timing-related errors between the output spool and the storage spool.

[0010] In some embodiments, the interlock mechanism includes a trigger configured to release a locking pin disposed between the trigger and the output spool. The pressure-based trigger mechanism of the IO device is configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism for rotating the IO needle to rotate.

[0011] In some embodiments, the interlock mechanism includes a rotatable locking pin configured to block axial movement of an extension pin disposed in an axial passage of the output spool between the locking pin and the drive shaft. The pressure-based trigger mechanism of the IO device is configured to require disengagement of the interlock mechanism prior to actuating the pressure-based trigger mechanism for rotating the IO needle.

[0012] In some embodiments, the interlock mechanism includes a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those of the distal portion of the output spool. The pressure-based trigger mechanism of the IO device is configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism for rotating the IO needle.

[0013] In some embodiments, the interlock mechanism includes a spring-loaded trigger mounted in an outer channel of the housing, the spring-loaded trigger including an extension channel configured to allow the drive shaft to extend from the axial channel into the extension channel when the extension channel is aligned with the axial channel. The pressure-based trigger mechanism of the IO device is configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism for rotating the IO needle.

[0014] In some embodiments, the interlock mechanism includes a pressure-based trigger configured to release a detent from a bore of the output spool. The pressure-based trigger mechanism of the IO device is configured to allow the interlock mechanism to be disengaged before or after actuation of the pressure-based trigger mechanism for rotating the IO needle.

[0015] In some embodiments, the pressure-based trigger mechanism includes a housing tooth set surrounding an aperture in the housing from which the drive shaft extends, and a complementary drive shaft tooth set surrounding the drive shaft opposite the housing tooth set. The housing tooth set and the drive shaft tooth set are engaged in an inactive state of the 10 access device by a compression spring between a rear side of the drive shaft tooth set and the output spool.

[0016] In some embodiments, the drive shaft is slidably disposed within the axial channel of the output spool such that force applied to the distal end of the IO needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel. Force applied to the distal end of the IO needle disengages the drive shaft teeth from the housing teeth and activates the IO into an active state of the device, in which rotation of the IO needle on the drive shaft is achieved by the output spool of the constant torque spring assembly.

[0017] In some embodiments, the compression spring is configured to relax when the force applied to the distal end of the IO needle is removed. When the force applied to the distal end of the IO needle is removed, the drive shaft teeth reengage with the housing teeth and reactivate the IO into the inactive state of the device.

[0018] In some embodiments, the IO access device is configured such that entry of the IO needle into the patient's medullary cavity automatically removes the force applied to the distal end of the IO needle.

[0019] In some embodiments, the IO access further comprises a braking system. The braking system is configured to act on the output spool to slow down the metal strip being wound onto the storage spool.

[0020] In some embodiments, the IO needle is configured to be detached from the IO access device after IO access to the patient's medullary cavity is achieved.

[0021] In some embodiments, the IO needle includes an obturator removably disposed within a cannula having an inner lumen configured for at least IO infusion when the obturator is removed.

[0022] Also disclosed herein is a method for inserting an IO access device, which, in some embodiments, includes a device acquisition step, an interlock disengagement step, a needle insertion step, a force application step, and a drilling step. The device acquisition step includes acquiring the IO access device. The interlock disengagement step includes disengaging an interlock mechanism configured to prevent rotation of the IO needle and associated drilling until the interlock mechanism is disengaged. The needle insertion step includes inserting the distal end of the IO needle through the skin at an insertion site of the patient. The force application step includes applying a force to the bone at the insertion site using the distal end of the IO needle. The force application step actuates a pressure-based trigger mechanism and begins winding a metal strip of a constant torque spring assembly from an output spool onto a storage spool. Winding the metal strip from the output spool onto the storage spool initiates rotation of the IO needle via a drive shaft coupled to the constant torque spring assembly. The drilling step includes drilling through the bone until the IO needle enters the patient's medullary canal. IO access is achieved when the patient's medullary canal is entered using the IO access device.

[0023] In some embodiments, the interlock disengaging step includes triggering a trigger to release a locking pin disposed between the trigger and the output spool.The pressure-based trigger mechanism is configured to require the interlock disengaging step prior to actuating the force applying step of the pressure-based trigger mechanism.

[0024] In some embodiments, the interlock disengaging step includes rotating a locking pin configured to block axial movement of an extension pin disposed in an axial passage of the output spool between the locking pin and the drive shaft. The pressure-based trigger mechanism is configured to require the interlock disengaging step prior to actuating the force applying step of the pressure-based trigger mechanism.

[0025] In some embodiments, the interlock disengaging step includes triggering a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those of the distal portion of the output spool. The pressure-based trigger mechanism is configured to require the interlock disengaging step prior to actuating the force applying step of the pressure-based trigger mechanism.

[0026] In some embodiments, the interlock disengaging step includes triggering a spring-loaded trigger mounted in an exterior passage of the housing, the spring-loaded trigger including an extension passage configured to allow the drive shaft to extend from the axial passage into the extension passage when the extension passage is aligned with the axial passage of the output spool. The pressure-based trigger mechanism is configured to require the interlock disengaging step prior to actuating the force applying step of the pressure-based trigger mechanism.

[0027] In some embodiments, the interlock disengaging step includes triggering a pressure-based trigger configured to release the stopper from the hole of the output spool. The pressure-based trigger mechanism is configured to require the interlock disengaging step before or after the force applying step of actuating the pressure-based trigger mechanism.

[0028] In some embodiments, the method further comprises a force stopping step. The force stopping step comprises stopping the application of force to the bone using the distal end of the IO needle. The force stopping step stops the rotation of the IO needle.

[0029] In some embodiments, the force stopping step is manually initiated by a clinician after sensing a change in tissue density while entering the patient's medullary cavity. Alternatively, the force stopping step is automatically initiated by a pressure-based trigger mechanism after a change in tissue density while entering the patient's medullary cavity.

[0030] In some embodiments, the method further comprises a needle separation step, an obturator removal step, a cannula confirmation step, a cannula securing step, and an infusion initiation step. The needle separation step comprises separating the IO needle from the rest of the IO access device. The obturator removal step comprises removing the obturator removably disposed in the cannula from the IO needle. The cannula confirmation step comprises confirming that the cannula is disposed in the medullary cavity by aspirating bone marrow through a syringe. The cannula securing step comprises securing the cannula to the patient. The infusion initiation step comprises initiating the IO infusion as a bolus using the same or a different syringe.

[0031] These and other features of the concepts presented herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly describe specific embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A first IO access device is shown according to some embodiments.

[0033] Figure 2 A first IO access device is shown with one side of the housing removed, according to some embodiments.

[0034] Figure 3 A cross-section of a first IO access device having a first interlock mechanism is shown, according to some embodiments.

[0035] Figure 4 A cross-section of a first IO access device with a second interlock mechanism is shown, according to some embodiments.

[0036] Figure 5 A second IO access device is shown according to some embodiments.

[0037] Figure 6 A second IO access device is shown with one side of the housing removed, according to some embodiments.

[0038] Figure 7 Shown is a cross-section of a second IO access device having an interlock mechanism, according to some embodiments.

[0039] Figure 8 A constant torque spring assembly is shown in combination with a pressure-based trigger mechanism, according to some embodiments.

[0040] Figure 9 Different states of a pressure-based trigger mechanism are shown according to some embodiments.

[0041] Figure 10 A constant torque spring assembly is shown according to some embodiments.

[0042] Figure 11 Shown is a cross section of a third IO access device according to some embodiments.

[0043] Figure 12 A cross-section of a third IO access device with a first interlock mechanism is shown, according to some embodiments.

[0044] Figure 13 A cross-section of a third IO access device with a second interlock mechanism is shown, according to some embodiments. DETAILED DESCRIPTION

[0045] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that are easily separated from the specific embodiments and optionally combined or substituted with the features of any one of the several other embodiments disclosed herein.

[0046] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concept provided herein. Ordinal numbers (for example, first, second, third, etc.) are generally used to distinguish or identify the different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not need to appear in order, and the specific embodiment including these features or steps need not be limited to these three features or steps. For convenience, use labels such as "left", "right", "up", "down", "front", "back" etc., and are not intended to imply for example any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect for example relative position, orientation or direction. The singular "a", "one" and "the" include plural references, unless context clearly indicates otherwise.

[0047] About " proximal ", for example, " proximal part " or " proximal end portion " of catheter comprises the part of catheter that should be close to clinician's catheter when catheter is used on patient. Similarly, for example, " proximal length " of catheter comprises the length of catheter that should be close to clinician's catheter when catheter is used on patient. For example, " proximal end " of catheter comprises the end of catheter that should be close to clinician's catheter when catheter is used on patient. Proximal part, proximal end portion or proximal length of catheter can comprise the proximal end of catheter; However, proximal part, proximal end portion or proximal length of catheter do not have to comprise the proximal end of catheter. That is, unless the context indicates otherwise, proximal part, proximal end portion or proximal length of catheter is not the terminal part or terminal length of catheter.

[0048] About " distal ", for example, " distal portion " or " distal part " of catheter comprises the catheter part that should be near the patient or in the patient when catheter is used on the patient. Similarly, for example, " distal length " of catheter comprises the length of the catheter that should be near the patient or in the patient when catheter is used on the patient. For example, " distal end " of catheter comprises an end that should be near the patient or in the patient when catheter is used on the patient. The distal portion, distal portion or distal length of catheter can comprise the distal end of catheter; However, the distal portion, distal portion or distal length of catheter do not have to comprise the distal end of catheter. That is, unless the context indicates otherwise, the distal portion, distal portion or distal length of catheter is not the terminal portion or terminal length of catheter.

[0049] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0050] As described above, there is a need to prevent accidental triggering of an IO access medical device while handling the device before its needle assembly is properly positioned for IO access, or even while the device is stored, for example, in an emergency bag. Disclosed herein are various operating mechanisms for IO access medical devices and methods thereof that meet the aforementioned needs.

[0051] In addition to the foregoing, there is a need to significantly reduce the design and manufacturing complexity of the state-of-the-art, small, drill-like devices currently used for IO access. Also disclosed herein are constant torque IO access devices and methods thereof that significantly reduce the design and manufacturing complexity of the state-of-the-art, small, drill-like devices currently used for IO access.

[0052] The following will first describe various embodiments of the constant torque 10 entry device. Various operating mechanisms for the constant torque 10 entry device, such as a pressure-based trigger mechanism and a variety of different interlocking mechanisms, will then be described. Some of the various operating mechanisms are described below with respect to specific embodiments of the constant torque 10 entry device; however, this is for ease of explanation in conveying certain concepts of the various operating mechanisms. The specific operating mechanisms described with respect to specific embodiments of the constant torque 10 entry device should not be construed as being limited to the specific embodiments of the constant torque 10 entry device. Furthermore, while the various operating mechanisms are described in the context of the constant torque entry device, it should be understood that the various operating mechanisms are not limited thereto.

[0053] IO access device

[0054] Figure 1-4 A first IO entry device 100 is shown according to some embodiments. Figure 5-7 A second IO entry device 500 is shown according to some embodiments. Figure 11-13 A third IO entry device 1100 is shown according to some embodiments. Figure 10 A constant torque spring assembly 204 is shown according to some embodiments.

[0055] As shown, the IO access device 100, 500, or 1100 includes a constant torque spring assembly 204, 604, or 1104 disposed in a housing 102, 502, or 1102, a drive shaft 106 extending from the housing 102, 502, or 1102, and an IO needle assembly 108 coupled to the drive shaft 106, the IO needle assembly 108 being configured to provide IO access to the intramedullary cavity of a patient.

[0056] Housing 102, 502, or 1102 houses the components of IO access device 100, 500, or 1100. While the components of IO access devices 100, 500, and 1100 are generally functionally similar, the components may be physically different to accommodate a particular form factor. For example, IO access device 100 has a form factor for retaining IO access device 100 in a manner that allows IO needle assembly 108 to enter the patient's medullary canal with a puncturing motion. Conversely, IO access device 500 has a form factor for retaining IO access device 100 in a manner that allows IO needle assembly 108 to enter the patient's medullary canal with a more traditional drilling motion. Housing 102, 502, or 1102 is molded from a medically acceptable polymer so that the sagittal halves of housing 102, 502, or 1102 can be snapped or bonded (e.g., mechanically fastened using fasteners, chemically bonded with adhesives, etc.) around the components of IO access device 100, 500, or 1100.

[0057] The constant torque spring assembly 204, 604, or 1104 includes a metal strip (e.g., a stainless steel strip) 210, at least a portion of which is reverse wound on an output spool 212 and correctly wound on a storage spool 214 with respect to the bias of the metal strip 210. When the output spool 212 is released, the metal strip 210 is configured to be wound onto the storage spool 214 or into a storage cavity at a constant torque over a range of revolutions per minute ("RPM"), or otherwise allowed to do so.

[0058] The constant torque spring assembly 204, 604, or 1104 is unique in that the stress associated with the deflection of the metal ribbon 210 is not accumulated over the entire length of the metal ribbon 210. The stress is temporary and is applied only to a short length (e.g., the exposed length) of the metal ribbon 210 at any given time. Furthermore, the metal ribbon 210 can be adjusted with respect to any characteristic selected from its thickness, width, number of wraps around the output spool 212, etc., to configure the constant torque spring assembly 204, 604, or 1104 for optimal rotational motion of the IO needle for IO insertion.

[0059] Each of the output spool 212 and the storage spool 214 optionally includes a spindle co-incident with the axis of the spool for mounting the spool in the housing 102, 502, or 1102. Such a spindle can be on one side of the spool or on both sides of the spool. For example, the constant torque spring assembly 204 of the 10 access device 100 includes spindles 216 and 218 of the output spool 212 and spindles 220 and 222 of the storage spool 214. Similarly, the constant torque spring assembly 604 of the 10 access device 500 includes spindles 616 and 618 of the output spool 212 and spindles 620 and 622 of the storage spool 214. The constant torque spring assembly 1104 of the 10 access device 1100 also includes similar spindles; however, for clarity, the reference numerals for the spindles are omitted.

[0060] As an alternative to or in addition to the aforementioned main shaft, each of the output spool 212 and the storage spool 214 optionally includes an axial channel that is aligned with the axis of the spool, which can be used to mount the spool in the housing 102, 502, or 1102, drive another component of the 10 access device 100, 500, or 1100 (e.g., the drive shaft 106), etc. Such an axial channel can be on one side of the spool, on both sides of the spool, or extend from one side of the spool to the other side of the spool. For example, the constant torque spring assembly 204, 604, or 1104 of the 10 access device 100, 500, or 1100 includes an axial channel 1024 that, at least in this case, includes a hexagonal shape to drive the hexagonal proximal portion of the drive shaft 106 (see Figure 9 and Figure 10If the output spool 212 or storage spool 214 includes a main shaft on one side of the spool 212 or 214 and an axial channel in the same side of the shaft 212 or 214, the main shaft has an outer diameter large enough to accommodate the inner diameter of the axial channel, such as Figure 10 As shown in FIG. 1 , the main shaft 218 and the axial passage 1024 are connected.

[0061] like Figure 10 As shown, the spindles on the same side of the constant torque spring assembly 204, such as the spindles 218 and 222 of the output spool 212 and the storage spool 214, respectively, can be coupled together by at least one elastomeric ring 1026 (e.g., an O-ring) to prevent any timing-related errors between the output spool 212 and the storage spool 214. Such timing-related errors are possible if the speed at which the metal strip 210 is wound onto the storage spool 214 is slower than the speed at which the metal strip 210 is wound off the output spool 212, or vice versa. As shown, the elastomeric ring 526 includes a half twist so that the elastomeric ring 526 crosses over itself to match the rotational motion of both the output spool 212 and the storage spool 214.

[0062] Although, as previously described, the constant torque spring assembly 204, 604, or 1104 can alternatively be configured as a constant force spring assembly including a constant force spring or a torsion spring assembly including a torsion spring, similar to the constant torque spring assembly 204, 604, or 1104, such a constant force spring assembly or torsion spring assembly can be disposed in the housing 102, 502, or 1102 for driving the drive shaft 106 coupled to the IO needle assembly 108 to provide IO access to the patient's intramedullary cavity.

[0063] The IO needle assembly 108 is configured to be separated from the IO access device 100, 500, or 1100 after achieving IO access to the patient's intramedullary cavity. Although not shown, the IO needle assembly 108 includes an obturator removably disposed within a cannula. The cannula has an inner lumen configured for at least IO infusion when the obturator is removed.

[0064] Pressure-based trigger mechanism

[0065] Figure 8 Shown is the constant torque spring assembly 204 in combination with a pressure-based trigger mechanism 800 for actuating rotation of the IO needle assembly 108, according to some embodiments. Figure 9 An inactive state and an active state of a pressure-based trigger mechanism 800 are shown, according to some embodiments.

[0066] As shown, the pressure-based trigger mechanism 800 for actuating rotation of the IO needle assembly 108 includes a drive shaft 106 slidably disposed in an axial channel 1024 of the output spool 212, a drive shaft teeth set 928 surrounding the drive shaft 106, an opposing but complementary housing teeth set 930 surrounding at least the aperture of the housing 102 from which the drive shaft 106 extends, and a compression spring 932 between a rear side of the drive shaft teeth set 928 and the output spool 212.

[0067] In at least the inactive state of 100, a spring force is applied to the rear side of drive shaft teeth set 928 by extending compression spring 932 between the rear side of drive shaft teeth set 928 and output spool 212. The extension of compression spring 932 holds drive shaft 106 out of axial channel 1024, which also holds its drive shaft teeth set 928 away from output spool 212, causing drive shaft teeth set 928 and housing teeth set 930 to engage with each other. Each of drive shaft teeth set 928 and housing teeth set 930 may include sawtooth-shaped teeth. When such teeth sets engage with each other in the inactive state of 100, rotation of drive shaft 106, and thus rotation of 100 needle assembly 108, is prevented.

[0068] In at least the active state of 10 access device 100, the force applied to the distal portion of drive shaft 106 by the distal end of 10 needle assembly 108 overwhelms the spring force applied to the rear side of drive shaft teeth set 928 by extension of compression spring 932. The compression of compression spring 932 keeps drive shaft 106 pushed into axial channel 1024, which also keeps its drive shaft teeth set 928 close to output spool 212, causing drive shaft teeth set 928 and housing teeth set 930 to disengage from each other. When such teeth sets are disengaged from each other in the active state of 10 access device 100, rotation of drive shaft 106, and thus rotation of 10 needle assembly 108, is permitted.

[0069] In transitioning between at least the inactive and active states of IO access device 100, a force applied to the distal portion of drive shaft 106, by, for example, engaging bone with the distal end of IO needle assembly 108, inserts drive shaft 106 deeper into axial passage 1024 and simultaneously compresses compression spring 932 between the rear side of drive shaft teeth set 928 and output spool 212. Inserting drive shaft 106 deeper into axial passage 1024 disengages drive shaft teeth set 928 from housing teeth set 930 to initiate the active state of IO access device 100, in which rotation of IO needle assembly 108 on drive shaft 106 is effected by output spool 212 of constant torque spring assembly 204.

[0070] In transitioning between at least the active and inactive states of IO access device 100, the force removed from the distal portion of drive shaft 106, by, for example, disengaging the distal end of IO needle assembly 108 from bone, allows compression spring 932 between the rear side of drive shaft teeth set 928 and output spool 212 to relax, which pushes drive shaft 106 out of axial channel 1024 away from output spool 212. Pushing drive shaft 106 out of axial channel 1024 reengages drive shaft teeth set 928 with housing teeth set 930 to initiate the inactive state of IO access device 100, in which rotation of IO needle assembly 108 on drive shaft 106, effected by output spool 212 of constant torque spring assembly 204, is prevented.

[0071] At least the transition between the active and inactive states of IO access device 100 can be automatically initiated by IO access device 100. In such an IO access device, compression spring 932 is configured, by virtue of its material, construction, or both, to have a spring constant and a compressible length proportional to a spring force that is greater than the average force that can be exerted by the bone marrow in the patient's medullary cavity on the distal end of IO needle assembly 108. Entry of IO needle assembly 108 into the patient's medullary cavity automatically replaces the force exerted by the compact bone on the distal end of IO needle assembly 108 (which is greater than the aforementioned spring force) with a force exerted by the bone marrow in the medullary cavity on the distal end of IO needle assembly 108 (which is less than the aforementioned spring force), thereby allowing compression spring 932 to push drive shaft 106 out of axial channel 1024 and away from output spool 212, thereby initiating the transition to the inactive state of IO access device 100. Nevertheless, the transition between the active and inactive states can be manually initiated by a clinician upon sensing a change in tissue density when entering the medullary cavity from compact bone.

[0072] While pressure-based trigger mechanism 800 is described with respect to IO access device 100, it should be understood that any IO access device selected from IO access devices 100, 500, and 1100 can include a pressure-based trigger mechanism 800, optionally as part of an interlock mechanism. Notably, IO access devices 500 and 1100 do not show a drive shaft tooth set 928 or a complementary housing tooth set 930 with a pressure-based trigger mechanism 800. In the absence of such teeth, rotation of IO needle assembly 108 must be achieved by or in conjunction with another rotational actuation device proposed herein for actuating rotation of IO needle assembly 108. Nonetheless, compression spring 932 remains a useful component for the clinician to sense changes in tissue density as the distal end of IO needle assembly 108 passes from dense bone into the medullary cavity, thereby providing a signal indicating that drilling should be stopped. In fact, regardless of whether IO access device 500 or 1100 includes drive shaft teeth set 928 and housing teeth set 930, compression spring 932 is still configured to push drive shaft 106 out of axial channel 1024 and away from output spool 212 when the distal end of IO needle assembly 108 enters the medullary cavity from compact bone, which provides a directly perceptible signal to the clinician to stop drilling.

[0073] Force decoupling mechanism

[0074] like Figure 2 As shown, at least for IO access device 100, an extension pin 234 (which is disposed in the axial channel 1024 of the output spool 212 between the drive shaft 106 and the molding 236) in combination with the molding 236 located within the housing 102 is configured to stop over-insertion of the drive shaft 106 into the axial channel 1024 of the output spool 212 during transition between the inactive and active states of the IO access device 100. In addition to stopping over-insertion of the drive shaft 106 into the axial channel 1024 of the output spool 212, the extension pin 234 and the molding 236 provide a decoupling mechanism configured to decouple the force applied to the distal end of the IO needle assembly 108 from the constant torque spring assembly 204. That is, any further force applied to the distal end of the IO needle assembly 108, compared to at least the force required to transition the IO access device 100 between the inactive and active states, is applied to the molding 236 of the housing 102 via the extension pin 234 rather than the constant torque spring assembly 204. The minimization of the load-bearing surface area and the reduction of the extraneous moment arm length further decouple the force applied to the distal end of the IO needle assembly 108 from the constant torque spring assembly 204.

[0075] Interlocking mechanism

[0076] Figure 3 A cross-section of IO access device 100 is shown having a first interlock mechanism 338, according to some embodiments.

[0077] like Figure 3 As shown, the interlock mechanism 338 of the IO access device 100 includes a trigger 340 and a locking pin 342. In the inactive state of the IO access device 100, the locking pin 342 is disposed between the trigger 340 and the output spool 212. Before the pressure-based trigger mechanism 800 can be actuated to rotate the IO needle assembly 108, the interlock mechanism 338 must be disengaged, thereby providing a safety mechanism for the IO access device 100. The trigger 340 can be depressed using a clinician's finger, palm, or the like, such as by grasping the IO access device 100. When the trigger 340 is pressed toward the housing 102, the trigger 340 is configured to release the locking pin 342. Once released, the locking pin 342 is free to move proximally when a force is applied to the distal end of the IO needle assembly 108, which compresses the compression spring 932 and simultaneously inserts the drive shaft 106 deeper into the axial channel 1024.

[0078] Figure 4 A cross-section of IO access device 100 is shown having a second interlock mechanism 438, according to some embodiments.

[0079] As shown, the interlock mechanism 438 includes a locking pin 442 that is configured to rotate so that the locking pin 442 does not block the axial movement of the extension pin 234 in the axial channel 1024 of the output spool 212, thereby allowing actuation of the pressure-based trigger mechanism 800. Figure 4 , where the locking pin 442 is no longer engaged with the extension pin 234.

[0080] Figure 7 A cross-section of IO access device 500 is shown having an interlock mechanism 738, according to some embodiments.

[0081] like Figure 7As shown, the interlock mechanism 738 of the IO access device 500 includes a trigger 640 that is pivotally mounted on a laterally oriented pin 642 disposed within the housing 502 adjacent the output spool 212. The inner end portion of the trigger 640 and the distal end portion of the output spool 212 both have interlocking teeth that interlock in the inactive state of the IO access device 500. Before the pressure-based trigger mechanism 800 can be actuated to rotate the IO needle assembly 108, the interlock mechanism 738 must be disengaged, thereby providing a safety mechanism for the IO access device 500. When the outer end portion of the trigger 640 is pressed toward the housing 502, the trigger 640 is configured to pivot about the pin 642 and withdraw the interlocking teeth of the inner end portion of the trigger 640 away from the interlocking teeth of the output spool 212, thereby allowing the force applied to the distal end of the 10 needle assembly 108 to compress the compression spring 932 and simultaneously insert the drive shaft 106 deeper into the axial channel 1024 to rotate the 10 needle assembly 108.

[0082] Figure 12 A cross-section of a third IO access device 1100 is shown having a first interlock mechanism 1238, according to some embodiments.

[0083] like Figure 12 As shown on the left side of FIG, the pressure-based trigger mechanism 800 of the IO access device 1100 is actuated, but the stopper 1242 of the spring-mounted trigger 1240 coupled to the interlock mechanism 1238 engages the hole of the output spool 212, preventing rotation of the IO needle assembly 108. This is mechanically different from any of the interlock mechanisms 338, 438, and 738, which require disengagement of the interlock mechanism 338, 438, or 738 before the pressure-based trigger mechanism 800 can even be actuated. In fact, the IO access device 1100 is configured so that either the interlock mechanism 1238 or the pressure-based trigger mechanism 800 can be actuated first, but both the pressure-based trigger mechanism 800 and the interlock mechanism 1238 need to be actuated to rotate the IO needle assembly 108. When the trigger 1240 is pressed toward the housing 1102, the stopper 1242 is configured to withdraw from the aperture of the output spool 212, thereby allowing, if force has been applied to the distal end of the IO needle assembly 108, the applied force to compress the compression spring 932 and simultaneously insert the drive shaft 106 deeper into the axial channel 1024 to rotate the IO needle assembly 108. The IO access device is configured with an interlock mechanism so that rotation of the IO needle assembly 108 can be interrupted at any time by removing the pressure applied to the distal end of the IO needle assembly 108 or releasing the trigger 1240 (which relaxes the spring of the spring-loaded trigger 1240, returning the trigger to its default position).

[0084] Figure 13A cross-section of a third IO access device 1100 is shown having a second interlock mechanism 1338, according to some embodiments.

[0085] like Figure 13 As shown, the interlock mechanism 1338 of the IO access device 1100 includes a spring-loaded trigger 1340 slidably mounted within an exterior passageway of the housing 1102 proximal to the output spool 212. The trigger 1340 includes an extension passageway of the axial passageway 1024. When the trigger 1340 is actuated and properly aligned, upon application of force to the distal end portion of the drive shaft 106 pursuant to actuation of the pressure-based trigger mechanism 800, the drive shaft 106 can extend into the extension passageway of the trigger 1340. When the trigger 1340 is not actuated or properly aligned, the drive shaft 106 cannot extend into the extension passageway of the trigger 1340, thereby preventing actuation of the pressure-based trigger mechanism 800. That is, before the pressure-based trigger mechanism 800 can be actuated to rotate the IO needle assembly 108, the interlock mechanism 1338 must be disengaged, thereby providing a safety mechanism for the IO access device 1100.

[0086] As an additional preventative measure to the aforementioned interlock mechanisms 338, 438, 738, 1238, and 1338 for preventing accidental actuation of the pressure-based trigger mechanism 800 by dropping or gripping the IO access device, a needle shield may be included to cover the IO needle assembly 108. Although not shown, the needle shield is configured to cover the IO needle assembly 108 and prevent accidental actuation of the pressure-based trigger mechanism 800 by providing a buffer space around the IO needle assembly 108. The shield also prevents the clinician from contacting the IO needle assembly 108 before removing the needle shield from around the IO needle assembly 108, thereby enhancing the sterility of the IO needle assembly 108.

[0087] Braking mechanism

[0088] Although not shown, the IO access device 100, 500, or 1100 may also include a manual brake system configured to act on the output spool 212 to slow the winding of the metal strip 210 onto the storage spool 214. The brake system may be actuated when the metal strip 210 begins to be wound onto the storage spool 214 or at any time throughout the winding process.

[0089] method

[0090] The method of entering the IO into the apparatus 100 , 500 , or 1100 at least includes a method of entering the apparatus 100 , 500 , or 1100 using the IO.

[0091] The method of using IO to enter the device 100, 500 or 1100 includes at least a device acquisition step. The device acquisition step includes acquiring IO to enter the device 100, 500 or 1100.

[0092] The method may also include a skin preparation step. The skin preparation step includes preparing the patient's skin at the patient's insertion site using an antiseptic (e.g., povidone-iodine). The insertion site may be around the proximal tibia, distal tibia, or distal femur.

[0093] The method can also include an interlock disengagement step. The interlock disengagement step includes disengaging an interlock mechanism as described above, which is configured to prevent rotation of the IO needle and the accompanying drilling thereof until the interlock mechanism disengages. In one example, the interlock disengagement step can include triggering a trigger 340 to release a locking pin 342 disposed between the trigger 340 and the output spool 212. In another example, the interlock disengagement step can include rotating a locking pin 442, which is configured to block axial movement of an extension pin 234 disposed in the axial channel 1024 of the output spool 212 between the locking pin 442 and the drive shaft 106. In yet another example, the lock disengagement step can include triggering a trigger 640 pivotally mounted on a laterally oriented pin 642, the trigger 640 having trigger teeth that are configured to lock with those of the distal portion of the output spool 212. In yet another example, the interlocking disengagement step can include a trigger 1340 of a trigger-loaded spring installed in an external passage of the housing 1102, the trigger 1340 of the spring-loaded spring including an extension passage configured to allow the drive shaft 106 to extend from the axial passage 1024 into the extension passage when the extension passage is aligned with the axial passage 1024 of the output spool 212. The pressure-based trigger mechanism 800 is configured to require the interlocking disengagement step before actuating the force-applying step of the pressure-based trigger mechanism. In other words, the pressure-based trigger mechanism 800 can be configured to require the interlocking disengagement step before or after actuating the force-applying step of the pressure-based trigger mechanism. In practice, the interlocking disengagement step can include triggering the pressure-based trigger 1240, which is configured to release the stopper 1242 from the hole of the output spool 212.

[0094] The method may further include a needle insertion step. The needle insertion step includes inserting the distal end of the IO needle of the IO needle assembly 108 through the skin at the insertion site.

[0095] The method may also include a force application step. The force application step includes applying a force to the bone at the insertion site using the distal end of the IO needle of the IO needle assembly 108 to actuate the pressure-based trigger mechanism 800. According to the force application step, the drive shaft 106 is inserted deeper into the axial channel 1024 of the output spool 212 of the constant torque spring assembly 204, 604, or 1104, which compresses the compression spring 932 between the rear side of the drive shaft teeth set 928 and the output spool 212. Compression of the compression spring 932 disengages the drive shaft teeth set 928 from the opposing housing teeth set 930 surrounding the aperture of the housing 102, 502, or 1102. Further according to the force applying step, the metal ribbon 210 of the constant torque spring assembly 204, 604 or 1104 begins to be wound from the output spool 212 onto the storage spool 214, thereby rotating the IO needle assembly 108 and its IO needle by means of the drive shaft 106 coupled to the constant torque spring assembly 204, 604 or 1104.

[0096] The method may further include a drilling step. The drilling step includes drilling through the bone until the IO needle assembly 108 enters the patient's medullary cavity. IO access is achieved when the IO access device 100, 500, or 1100 is used to enter the patient's medullary cavity.

[0097] The method may further include a force stop step. The force stop step includes stopping the use of the IO needle assembly 108 or the distal end of its IO needle to apply force to the bone. The force stop step removes at least a portion of the drive shaft 106 from the axial channel 1024 of the output spool 212, relaxes the compression spring 932, and reengages the drive shaft tooth set 928 with the housing tooth set 930 to stop the rotation of the IO needle assembly 108. The force stop step can be automatically initiated by the IO access device 100, 500, or 1100 after sensing a change in tissue density (e.g., compact bone to bone marrow) when entering the patient's medullary cavity. Alternatively, the force stop step can be manually initiated by a clinician after sensing a change in tissue density when entering the patient's medullary cavity.

[0098] The method may further include a needle separation step. The needle separation step includes separating the IO needle assembly 108 from the remainder of the IO access device 100 , 500 , or 1100 .

[0099] The method may further include an obturator removal step. The obturator removal step includes removing an obturator removably disposed in a cannula from the IO needle assembly 108.

[0100] The method may further include a cannula confirmation step. The cannula confirmation step includes confirming that the cannula is positioned in the medullary cavity by aspirating bone marrow through a syringe.

[0101] The method may further comprise a cannula securing step. The cannula securing step comprises securing the cannula to the patient using a dressing.

[0102] The method may further comprise an infusion initiation step. The infusion initiation step comprises initiating the IO infusion as a bolus using the same or a different syringe.

[0103] Although certain specific embodiments have been disclosed herein, and although some details of these specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and / or modifications may occur to those skilled in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, departures from the specific embodiments provided herein may be made without departing from the scope of the concepts disclosed herein.

Claims

1. An intraosseous access device, comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, The intraosseous needle is configured to be separated from the intraosseous access device after achieving intraosseous access to the patient's medullary cavity.

2. The intrabone access device of claim 1 , wherein the constant torque spring assembly comprises a metal ribbon reversely wound on an output spool having an axial channel, the metal ribbon being configured to be wound on a storage spool at a constant torque when the output spool is released.

3. The intraosseous access device of claim 2, wherein the main shafts of the output spool and the storage spool are coupled together by at least one elastomeric ring to prevent any timing-related errors between the output spool and the storage spool.

4. The intraosseous access device of claim 2 , wherein the interlock mechanism comprises a trigger configured to release a locking pin disposed between the trigger and the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

5. The intrabone access device of claim 2 , wherein the interlock mechanism comprises a rotatable locking pin configured to block axial movement of an extension pin disposed in the axial channel of the output spool between the locking pin and the drive shaft, and the pressure-based trigger mechanism of the intrabone access device is configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

6. The intraosseous access device of claim 2 , wherein the interlock mechanism comprises a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those teeth of the distal portion of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

7. The intrabone access device of claim 2 , wherein the interlock mechanism comprises a spring-loaded trigger mounted in an external channel of the housing, the spring-loaded trigger comprising an extension channel configured to allow the drive shaft to extend from the axial channel into the extension channel when the extension channel is aligned with the axial channel, the pressure-based trigger mechanism of the intrabone access device configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

8. The intraosseous access device of claim 2 , wherein the interlock mechanism comprises a pressure-based trigger configured to release a stopper from the hole of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to allow the interlock mechanism to be disengaged before or after actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

9. An intrabone access device according to any one of claims 4 to 8, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output spool.

10. The intrabone access device according to claim 9, wherein the drive shaft is slidably arranged in the axial channel of the output spool, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth set from the housing tooth set and starting the active state of the intrabone access device, in which the output spool of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

11. The intrabone access device of claim 9, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

12. The intraosseous access device of claim 9, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

13. The intraosseous access device of claim 2, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

14. The intraosseous access device of claim 1, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having an inner lumen configured for at least intraosseous infusion when the obturator is removed.

15. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, The intraosseous needle includes an obturator removably disposed in a cannula having an inner lumen configured for at least intraosseous infusion when the obturator is removed.

16. The intrabone access device of claim 15, wherein the constant torque spring assembly comprises a metal ribbon reversely wound on an output spool having an axial channel, the metal ribbon configured to be wound on a storage spool at a constant torque when the output spool is released.

17. The intrabone access device of claim 16, wherein the main shafts of the output spool and the storage spool are coupled together by at least one elastomeric ring to prevent any timing-related errors between the output spool and the storage spool.

18. The intraosseous access device of claim 16, wherein the interlock mechanism comprises a trigger configured to release a locking pin disposed between the trigger and the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

19. The intrabone access device of claim 16, wherein the interlock mechanism comprises a rotatable locking pin configured to block axial movement of an extension pin disposed in the axial channel of the output spool between the locking pin and the drive shaft, and the pressure-based trigger mechanism of the intrabone access device is configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

20. The intraosseous access device of claim 16, wherein the interlock mechanism comprises a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those teeth of the distal portion of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

21. The intrabone access device of claim 16, wherein the interlock mechanism comprises a spring-loaded trigger mounted in an external channel of the housing, the spring-loaded trigger comprising an extension channel configured to allow the drive shaft to extend from the axial channel into the extension channel when the extension channel is aligned with the axial channel, the pressure-based trigger mechanism of the intrabone access device configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

22. The intraosseous access device of claim 16, wherein the interlock mechanism comprises a pressure-based trigger configured to release a stopper from the hole of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to allow the interlock mechanism to be disengaged before or after actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

23. An intrabone access device according to any one of claims 18 to 22, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between a rear side of the drive shaft tooth set and the output spool.

24. The intrabone access device according to claim 23, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth set from the housing tooth set and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

25. The intrabone access device of claim 23, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

26. The intraosseous access device of claim 23, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

27. The intrabone access device of claim 16, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

28. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, The main shafts of the output spool and the storage spool are coupled together by at least one elastomeric ring to prevent any timing-related errors between the output spool and the storage spool.

29. The intraosseous access device of claim 28, wherein the interlock mechanism comprises a trigger configured to release a locking pin disposed between the trigger and the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

30. The intrabone access device of claim 28, wherein the interlock mechanism comprises a rotatable locking pin configured to block axial movement of an extension pin disposed in the axial channel of the output spool between the locking pin and the drive shaft, and the pressure-based trigger mechanism of the intrabone access device is configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

31. The intraosseous access device of claim 28, wherein the interlock mechanism comprises a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those teeth of the distal portion of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

32. The intrabone access device of claim 28, wherein the interlock mechanism comprises a spring-loaded trigger mounted in an external channel of the housing, the spring-loaded trigger comprising an extension channel configured to allow the drive shaft to extend from the axial channel into the extension channel when the extension channel is aligned with the axial channel, the pressure-based trigger mechanism of the intrabone access device configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intrabone needle.

33. The intraosseous access device of claim 28, wherein the interlock mechanism comprises a pressure-based trigger configured to release a stopper from the hole of the output spool, the pressure-based trigger mechanism of the intraosseous access device being configured to allow the interlock mechanism to be disengaged before or after actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

34. An intrabone access device according to any one of claims 29 to 33, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output spool.

35. An intrabone access device according to claim 34, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

36. The intrabone access device of claim 34, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

37. The intraosseous access device of claim 34, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

38. The intraosseous access device of claim 28, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

39. The intraosseous access device of claim 28, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

40. The intraosseous access device of claim 28, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

41. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, The interlock mechanism includes a trigger configured to release a locking pin disposed between the trigger and the output spool, and the pressure-based trigger mechanism of the intraosseous access device is configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

42. An intrabone access device according to claim 41, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output reel.

43. An intrabone access device according to claim 42, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

44. The intrabone access device of claim 42, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

45. The intraosseous access device of claim 42, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

46. The intrabone access device of claim 41, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

47. The intraosseous access device of claim 41, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

48. The intraosseous access device of claim 41, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

49. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, The interlocking mechanism includes a rotatable locking pin configured to block axial movement of an extension pin disposed in the axial channel of the output spool between the locking pin and the drive shaft, and the pressure-based trigger mechanism of the intraosseous access device is configured to require the interlocking mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

50. An intrabone access device according to claim 49, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, and the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output spool.

51. An intrabone access device according to claim 50, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

52. The intrabone access device of claim 50, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

53. The intraosseous access device of claim 50, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

54. The intrabone access device of claim 49, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

55. The intraosseous access device of claim 49, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

56. The intraosseous access device of claim 49, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

57. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, wherein the interlock mechanism comprises a trigger pivotally mounted on a transversely oriented pin, the trigger having trigger teeth configured to interlock with those teeth of the distal portion of the output spool, and the pressure-based trigger mechanism of the intraosseous access device is configured to require the interlock mechanism to be disengaged prior to actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

58. An intrabone access device according to claim 57, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output reel.

59. An intrabone access device according to claim 58, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

60. The intrabone access device of claim 58, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

61. The intraosseous access device of claim 58, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

62. The intrabone access device of claim 57, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

63. The intraosseous access device of claim 57, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

64. The intraosseous access device of claim 57, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

65. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, wherein the interlock mechanism comprises a spring-loaded trigger mounted in an external channel of the housing, the spring-loaded trigger comprising an extension channel, the extension channel being configured to allow the drive shaft to extend from the axial channel into the extension channel when the extension channel is aligned with the axial channel, and the pressure-based trigger mechanism of the intraosseous access device being configured to require the interlock mechanism to be disengaged before actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

66. An intrabone access device according to claim 65, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output reel.

67. An intrabone access device according to claim 66, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

68. The intrabone access device of claim 66, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and reactivating the intrabone access device into the inactive state.

69. The intraosseous access device of claim 66, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

70. The intrabone access device of claim 65, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

71. The intraosseous access device of claim 65, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

72. The intraosseous access device of claim 65, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

73. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, wherein the interlock mechanism comprises a pressure-based trigger configured to release a stopper from the aperture of the output spool, and wherein the pressure-based trigger mechanism of the intraosseous access device is configured to allow the interlock mechanism to be disengaged before or after actuating the pressure-based trigger mechanism to rotate the intraosseous needle.

74. An intrabone access device according to claim 73, wherein the pressure-based trigger mechanism includes a housing tooth set and a complementary drive shaft tooth set opposite to the housing tooth set, the housing tooth set surrounding the orifice of the housing, the drive shaft extending from the orifice, the drive shaft tooth set surrounding the drive shaft, the housing tooth set and the drive shaft tooth set being engaged in an inactive state of the intrabone access device by a compression spring between the rear side of the drive shaft tooth set and the output reel.

75. An intrabone access device according to claim 74, wherein the drive shaft is slidably arranged in the axial channel of the output reel, so that the force applied to the distal end of the intrabone needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft tooth group from the housing tooth group and starting the active state of the intrabone access device, in which the output reel of the constant torque spring assembly realizes the rotation of the intrabone needle on the drive shaft.

76. An intrabone access device according to claim 74, wherein the compression spring is configured to relax when the force applied to the distal end of the intrabone needle is removed, thereby reengaging the drive shaft tooth set with the housing tooth set and reactivating the intrabone access device into the inactive state.

77. The intraosseous access device of claim 74, wherein the intraosseous access device is configured such that entry of the intraosseous needle into the patient's medullary cavity automatically removes a force applied to the distal end of the intraosseous needle.

78. The intrabone access device of claim 73, further comprising a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

79. The intraosseous access device of claim 73, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

80. The intraosseous access device of claim 73, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

81. An intraosseous access device comprising: a constant torque spring assembly disposed in the housing; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring assembly; an intraosseous needle coupled to the drive shaft, the intraosseous needle configured to drill through bone and provide intraosseous access to the patient's medullary cavity; and an interlock mechanism configured to prevent rotation of the intraosseous needle and concomitant drilling thereof until the interlock mechanism is disengaged, wherein the constant torque spring assembly comprises a metal strip reversely wound on an output spool having an axial channel, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, and The intraosseous access device further includes a braking system configured to act on the output spool to slow the winding of the metal ribbon onto the storage spool.

82. The intraosseous access device of claim 81, wherein the intraosseous needle is configured to be detached from the intraosseous access device after intraosseous access to the patient's medullary cavity is achieved.

83. The intraosseous access device of claim 81, wherein the intraosseous needle comprises an obturator removably disposed in a cannula having a lumen configured for at least intraosseous infusion when the obturator is removed.

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