Constant torque intraosseous access device and method thereof

Abstract

A constant torque intraosseous access device and method thereof are disclosed. The intraosseous access device may include a constant torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft, configured to provide intraosseous access to a patient's medullary cavity. Such a method of an intraosseous access device may include inserting a distal end of the intraosseous needle through the patient's skin at an insertion site; applying a force to the bone at the insertion site using the distal end of the intraosseous needle, which begins to wind a metal strip of the constant torque spring assembly from an output spool onto a storage spool, thereby initiating rotation of the intraosseous needle; and drilling through the bone until the intraosseous needle enters the patient's medullary cavity, thereby achieving intraosseous access using the intraosseous access device.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 907,454, filed on 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 a constant torque bone access device and method thereof. Background Art

[0004] Peripheral intravenous catheter ("PIVC") insertion is increasingly challenging in emergency situations where critically ill patients are deteriorating. Intraosseous ("IO") access is often the only means available to clinicians to increase the patient's chance of recovery, and even save the patient's life.

[0005] IO access can be obtained in as little as 2 to 5 seconds with a relatively high success rate. The most commercially advanced medical device for IO access is a small drill-like device built around a relatively primitive electric motor. The electric motor (e.g., as described above) provides sufficient means for drilling to achieve IO access, but such motors are not necessarily tuned to the needs of IO access. The infrastructure of such motors (e.g., batteries, cables, gear trains, gear reduction hardware, switches, etc.) is largely overbuilt relative to the drilling process of only 1-2 seconds. In addition, the drill-like device and its motor must be monitored and managed by a clinician in preparation for use, and there are requirements and regulations related to the disposal of the aforementioned medical devices. There is a need for a better tuned medical device that significantly reduces design and manufacturing complexity while optimizing the user experience.

[0006] A constant-torque IO access device and method thereof are disclosed herein that address the aforementioned drawbacks. Summary of the invention

[0007] Disclosed herein is an IO access device that, in some embodiments, includes a constant torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an IO needle coupled to the drive shaft. The drive shaft is coupled to the constant torque spring. The IO needle is configured to provide IO access to the medullary cavity of a patient.

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

[0009] In some embodiments, 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.

[0010] In some embodiments, the housing includes a housing teeth set around a hole in the housing, and the drive shaft extends from the hole. The drive shaft includes a complementary drive shaft teeth set around the drive shaft opposite to the housing teeth set. The housing teeth set and the drive shaft teeth set are engaged by a compression spring between the rear side of the drive shaft teeth set and the output spool in the inactive state of the IO access device.

[0011] In some embodiments, 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 IO needle simultaneously compresses the compression spring and inserts the drive shaft deeper into the axial channel. This causes the drive shaft teeth set to disengage from the housing teeth set and initiates the active state of the IO access device. In the active state of the IO access device, the output spool of the constant torque spring assembly on the drive shaft realizes the rotation of the IO needle.

[0012] In some embodiments, a combination of a molded piece within the housing and an extension pin disposed in the axial passage of the output spool between the drive shaft and the molded piece is configured to stop over insertion of the drive shaft into the axial passage of the output spool. Additionally, the combination of the extension pin and the molded piece is configured to decouple the force applied to the distal end of the IO needle from the constant torque spring assembly.

[0013] In some embodiments, the compression spring is configured to relax when the force applied to the distal end of the IO needle is removed. This allows the drive shaft teeth set to reengage with the housing teeth set and restart the IO into the inactive state of the device.

[0014] 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.

[0015] In some embodiments, the IO access device further comprises an interlock comprising a trigger and a locking pin disposed between the trigger and the output spool in an inactive state of the IO access device. The trigger is configured to release the locking pin, thereby allowing a force applied to the distal end of the IO needle to simultaneously compress the compression spring and insert the drive shaft deeper into the axial channel.

[0016] In some embodiments, the IO access device further comprises a braking system configured to act on the output spool to slow down the winding of the metal strip onto the storage spool.

[0017] In some embodiments, the IO needle is configured to be separated from the IO access device after IO access to the patient's intramedullary cavity is achieved.

[0018] In some embodiments, the IO needle includes an obturator removably disposed in a cannula. The cannula has an inner lumen configured for at least interosseous infusion when the obturator is removed.

[0019] Also disclosed is an IO access device, which in some embodiments includes a constant torque spring assembly arranged in a housing, a drive shaft extending from the housing, and an IO needle connected to the drive shaft, the IO needle being configured to provide IO access to the medullary cavity of a patient. The constant torque spring assembly includes a metal belt reversely wound on an output reel. The metal belt is configured to be wound on a storage reel from the output reel at a constant torque in the active state of the IO access device. The drive shaft is slidably arranged in the axial channel of the output reel. The force applied to the distal end portion of the drive shaft simultaneously compresses the compression spring and inserts the drive shaft deeper into the axial channel. This disengages the drive shaft tooth set around the drive shaft from the relative housing tooth set around the hole of the housing (the drive shaft extends from the hole) and starts the active state of the IO access device. The IO needle is configured to rotate in the active state of the IO access device, and provides IO access to the medullary cavity of the patient by means of drilling using the IO needle.

[0020] In some embodiments, the combination of the molding (which is within the housing) and the extension pin (which is disposed in the axial passage of the output spool between the drive shaft and the molding) is configured to stop over-insertion of the drive shaft into the axial passage of the output spool. In addition, the combination of the extension pin and the molding is configured to decouple the force applied to the distal portion of the drive shaft from the constant torque spring assembly.

[0021] In some embodiments, the compression spring is configured to relax when the force applied to the distal portion of the drive shaft is removed. This allows the drive shaft teeth set to reengage with the housing teeth set and restart the IO into the inactive state of the device.

[0022] 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 portion of the drive shaft.

[0023] A method for an IO access device is also disclosed, which in some embodiments includes an obtaining step of obtaining the IO access device. The IO access device includes a constant torque spring assembly disposed in a housing, a drive shaft coupled to the constant torque spring assembly and extending from the housing, and an IO needle coupled to the drive shaft. The method also includes an inserting step of inserting the distal end of the IO needle through the skin at an insertion site of the patient. The method also includes an applying step of applying a force to the bone at the insertion site using the distal end of the IO needle. The applying step begins winding a metal strip of the constant torque spring assembly from an output reel onto a storage reel, thereby starting rotation of the IO needle. The method also includes a drilling step of drilling through the bone until the IO needle enters the medullary cavity of the patient, thereby enabling the IO access device to achieve IO access to the medullary cavity of the patient.

[0024] In some embodiments, the applying step inserts the drive shaft deeper into the axial passage of the output spool of the constant torque spring assembly. The applying step also compresses the compression spring between the rear side of the drive shaft teeth set surrounding the drive shaft and the output spool. The applying step also disengages the drive shaft teeth set from the opposing housing teeth set surrounding the hole of the housing from which the drive shaft extends to initiate rotation of the IO needle.

[0025] In some embodiments, the method further comprises a stopping step of stopping the application of force to the bone using the distal end of the IO needle. The stopping step removes at least a portion of the drive shaft from the axial passage of the output spool, relaxes the compression spring, and reengages the drive shaft teeth set with the housing teeth set to stop the rotation of the IO needle.

[0026] In some embodiments, the stopping step is manually initiated by the clinician upon sensing a change in tissue density while entering the patient's medullary cavity.

[0027] In some embodiments, the stopping step is automatically initiated by the IO access device upon experiencing a change in tissue density while entering the patient's medullary cavity.

[0028] In some embodiments, the method further comprises a triggering step of triggering a trigger of an interlock of the IO access device. The triggering step releases a locking pin disposed between the trigger and the output spool, which allows a force to be applied to the bone at the distal end of the IO needle to initiate rotation of the IO needle.

[0029] In some embodiments, the method further comprises a separation step of separating the IO needle from the rest of the IO access device; a removal step of removing an obturator removably disposed in a cannula from the IO needle; a confirmation step of confirming that the cannula is disposed in the medullary cavity by aspirating bone marrow through a syringe; a securing step of securing the cannula to the patient; and a starting step of initiating an interosseous infusion as a bolus using the same or a different syringe.

[0030] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly depict certain embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A first IO access device is shown according to some embodiments.

[0032] Figure 2 A first IO access device is shown with one side of the housing removed according to some embodiments.

[0033] Figure 3 A second IO access device is shown according to some embodiments.

[0034] Figure 4 A second IO access device is shown with one side of the housing removed according to some embodiments.

[0035] Figure 5 A constant torque spring assembly is shown according to some embodiments.

[0036] Figure 6 An actuation mechanism according to some embodiments is shown. DETAILED DESCRIPTION

[0037] 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 distinguished from the specific embodiments and optionally combined with or replace any of the features of any of the many other embodiments disclosed herein.

[0038] 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 concepts provided herein.Ordinal numbers (e.g., 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", "third" features or steps do not need to appear in order, and the specific embodiments including these features or steps do not need to 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 marks are used to reflect, for example, relative position, orientation or direction.Unless the context clearly stipulates otherwise, the singular form "a kind of", "one" and "the" include plural references.

[0039] With regard to, for example, the "proximal side", "proximal portion" or "proximal end portion" of a catheter, the portion of the catheter intended to be close to the clinician's catheter when the catheter is used on the patient is included. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician's catheter when the catheter is used on the patient. For example, the "proximal end" of a catheter includes an end of the catheter intended to be close to the clinician's catheter when the catheter is used on the patient. The proximal portion, proximal portion or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal portion or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0040] About the "distal side", "distal portion" or "distal end portion" of, for example, a catheter, includes the portion of the catheter intended to be close to the patient or in the patient when the catheter is used on the patient. Similarly, the "distal length" of, for example, a catheter includes the length of the catheter intended to be close to the patient or in the patient when the catheter is used on the patient. For example, the "distal end" of a catheter includes an end of the catheter intended to be close to the patient or in the patient when the catheter is used on the patient. The distal portion, distal portion or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal portion or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal portion or distal length of a catheter is not the terminal portion or terminal length of a catheter.

[0041] 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.

[0042] As described above, PIVC insertion is increasingly challenging in emergency situations where critically ill patients are deteriorating. Intraosseous ("IO") access is often the only means available to clinicians to increase the patient's chance of recovery, or even save the patient's life. However, there is a need for better-adjusted medical devices that can significantly reduce design and manufacturing complexity while optimizing the user experience. This article discloses a constant torque IO access device and method thereof that addresses the aforementioned shortcomings.

[0043] IO access device

[0044] Figure 1 and 3 A first IO entry device 100 and a second IO entry device 300 are respectively shown according to some embodiments. Figure 2 and 4 A first IO access device 100 and a second IO access device 300 are respectively shown with one side of the housing 102 or 302 removed, according to some embodiments. Figure 5 A constant torque spring assembly 204 is shown according to some embodiments.

[0045] As shown, the IO access device 100 or 300 includes a constant torque spring assembly 204 or 404 disposed in a housing 102 or 302, a drive shaft 106 extending from the housing 102 or 302, and an IO needle 108 coupled to the drive shaft 106, the IO needle 108 being configured to provide IO access to the intramedullary cavity of a patient.

[0046] Housing 102 or 302 houses the components of IO access device 100 or 300. Although the components of IO access devices 100 and 300 are generally similar in function, the components may be physically different in order to accommodate a particular form factor. For example, IO access device 100 has a form factor for holding IO access device 100 in a manner that allows IO needle 108 to enter the medullary cavity of a patient with a stabbing motion. In contrast, IO access device 300 has a form factor for holding IO access device 100 in a manner that allows IO needle 108 to enter the medullary cavity of a patient with a more traditional drilling motion. Housing 102 or 302 is molded from a medically acceptable polymer so that a sagittal halve of housing 102 or 302 can be snapped or bonded together (e.g., mechanically fastened using fasteners, chemically bonded by adhesives, etc.) around the components of IO access device 100 or 300.

[0047] The constant torque spring assembly 204 or 404 includes a metal strip (e.g., a stainless steel strip) 210, at least a portion of which is reversely wound on an output spool 212 and correctly wound on a storage spool 214 relative to the bias of the metal strip 210. The metal strip 210 is configured to be wound on the storage spool 214 or into a storage cavity at a constant torque over a range of revolutions per minute ("RPM") when the output spool 212 is released, or otherwise allowed to do so.

[0048] The constant torque spring assembly 204 or 404 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. In addition, the metal ribbon 210 can be adjusted with respect to any characteristic selected from its thickness, width, number of windings around the output reel 212, etc., to configure the constant torque spring assembly 204 or 404 with optimal rotational motion of the IO needle for IO insertion.

[0049] Each of the output reel 212 and the storage reel 214 may optionally include a spindle co-incident with the axis of the reel for mounting the reel in the housing 102 or 302. Such a spindle may be on one side of the reel or on both sides of the reel. For example, the constant torque spring assembly 204 of the IO access device 100 includes the spindle 216 and the spindle 218 of the output reel 212 and the spindle 220 and the spindle 222 of the storage reel 214. Similarly, the constant torque spring assembly 404 of the IO access device 300 includes the spindle 416 and the spindle 418 of the output reel 212 and the spindle 420 and the spindle 422 of the storage reel 214.

[0050] As an alternative or in addition to the aforementioned main shaft, each of the output reel 212 and the storage reel 214 can optionally include an axial channel that is consistent with the axis of the reel, which can be used to mount the reel in the housing 102 or 302, drive another component of the IO access device 100 or 300 (e.g., the drive shaft 106), etc. Such an axial channel can be on one side of the reel, on both sides of the reel, or extend from one side of the reel to the other side of the reel. For example, the constant torque spring assembly 204 or 404 of the IO access device 100 or 300 includes an axial channel 524, which, at least in this case, includes a hexagonal shape to drive the hexagonal proximal portion of the drive shaft 106 (see Figure 5 and 6 If the output spool 212 or storage spool 214 includes a spindle on one side of the spool 212 or 214 and an axial channel in the same side of the spool 212 or 214, the spindle has an outer diameter large enough to accommodate the inner diameter of the axial channel, such as Figure 5 As shown by the main shaft 218 and the axial passage 524.

[0051] like Figure 5 As shown, the same side spindles, such as the spindles 218 and 222 of the output reel 212 and the storage reel 214, respectively, can be coupled together by at least one elastomeric ring 526 (e.g., an O-ring) to prevent any timing-related errors between the output reel 212 and the storage reel 214. Such timing-related errors are possible if the speed at which the metal strip 210 is wound onto the storage reel 214 is slower than the speed at which the metal strip 210 is wound off the output reel 212, or vice versa. As shown, the elastomeric ring 526 includes a half twist so that the elastomeric ring 526 crosses itself to match the rotational motion of both the output reel 212 and the storage reel 214.

[0052] Figure 6 An actuation mechanism 600 for actuating rotation of the IO needle 108 is shown in accordance with some embodiments.

[0053] As shown, the actuation mechanism 600 for actuating rotation of the IO needle 108 includes a drive shaft 106 slidably disposed in the axial channel 524 of the output reel 212, a drive shaft tooth set 628 surrounding the drive shaft 106, an opposing but complementary housing tooth set 630 surrounding the hole in the housing 102 or 302 (from which the drive shaft 106 extends), and a compression spring 632 between the rear side of the drive shaft tooth set 628 and the output reel 212.

[0054] In the inactive state of the IO access device 100 or 300, a spring force is applied on the rear side of the drive shaft teeth set 628 by the extension of the compression spring 632 between the rear side of the drive shaft teeth set 628 and the output spool 212. The extension of the compression spring 632 keeps the drive shaft 106 out of the axial channel 524, which also keeps its drive shaft teeth set 628 away from the output spool 212, so that the drive shaft teeth set 628 and the housing teeth set 630 engage with each other. Each of the drive shaft teeth set 628 and the housing teeth set 630 may include sawtooth-shaped teeth. When such teeth sets engage with each other in the inactive state of the IO access device 100 or 300, the rotation of the drive shaft 106 is prevented, and thus the rotation of the IO needle 108 is prevented.

[0055] In the active state of IO access device 100 or 300, the force applied to the distal end portion of drive shaft 106 by means of the distal end of IO needle 108 overwhelms the spring force applied on the rear side of drive shaft tooth set 628 by extension of compression spring 632. The compression of compression spring 632 keeps drive shaft 106 pushed into axial channel 524, which also keeps its drive shaft tooth set 628 close to output spool 212, so that drive shaft tooth set 628 and housing tooth set 630 are disengaged from each other. When such tooth sets are disengaged from each other in the active state of IO access device 100 or 300, rotation of drive shaft 106, and thus rotation of IO needle 108, is permitted.

[0056] In transitioning between the inactive state and the active state of IO access device 100 or 300, force applied to the distal portion of drive shaft 106 (by, for example, engaging bone with the distal end of IO needle 108) inserts drive shaft 106 deeper into axial passage 524 and simultaneously compresses compression spring 632 between the rear side of drive shaft teeth set 628 and output spool 212. Inserting drive shaft 106 deeper into the axial passage disengages drive shaft teeth set 628 from housing teeth set 630 to initiate the active state of IO access device 100 or 300, in which rotation of IO needle 108 is effected on drive shaft 106 by output spool 212 of constant torque spring assembly 204 or 404.

[0057] In transitioning between the active and inactive states of IO access device 100 or 300, the removal of force from the distal portion of drive shaft 106 (by, for example, disengaging the distal end of IO needle 108 from bone) allows compression spring 632 between the rear side of drive shaft teeth set 628 and output spool 212 to relax, which pushes drive shaft 106 out of axial passage 524 away from output spool 212. Pushing drive shaft 106 out of axial passage 524 reengages drive shaft teeth set 628 with housing teeth set 630 to initiate the inactive state of IO access device 100 or 300, in which rotation of IO needle 108 on drive shaft 106 by output spool 212 of constant torque spring assembly 204 or 404 is prevented.

[0058] The transition between the active state and the inactive state of IO access device 100 or 300 may be automatically initiated by IO access device 100 or 300. In such an IO access device, compression spring 632 is configured by means 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 may be applied by the bone marrow in the medullary cavity of the patient on the distal end of IO needle 108. The entry of IO needle 108 into the medullary cavity of the patient automatically replaces the force applied by the compact bone on the distal end of IO needle 108 (which is greater than the aforementioned spring force) with a force applied by the bone marrow in the medullary cavity on the distal end of IO needle 108 (which is less than the aforementioned spring force), thereby allowing compression spring 632 to push drive shaft 106 out of axial channel 524 away from output spool 212 to initiate the transition to the inactive state of IO access device 100 or 300. Nevertheless, the transition between the active state and the inactive state may be manually initiated by a clinician after sensing a change in tissue density when entering the medullary cavity from compact bone.

[0059] like Figure 2As shown, at least for the IO access device 100, the combination of the molding 236 (which is within the housing 102) and the extension pin 234 (which is disposed in the axial passage 524 of the output spool 212 between the drive shaft 106 and the molding 236) is configured to stop over-insertion of the drive shaft 106 into the axial passage 524 of the output spool 212 during transitions between the inactive state and the active state of the IO access device 100. In addition to stopping over-insertion of the drive shaft 106 into the axial passage 524 of the output spool 212, the combination of the extension pin 234 and the molding 236 is configured to decouple the force applied to the distal end of the IO needle 108 from the constant torque spring assembly 204. That is, any further force applied to the distal end of the IO needle 108 than that required for transitions between the inactive state and the active state of the IO access device 100 is applied to the molding 236 of the housing 102 by the extension pin 234 rather than the constant torque spring assembly 204. In effect, minimization of the bearing surface area and reduction of the extraneous moment arm length further decouples the forces applied to the distal end of the IO needle 108 from the constant torque spring assembly 204 .

[0060] like Figure 2 As shown, IO access device 100 also includes an interlock including a trigger 238 and a locking pin 240 disposed between trigger 238 and output spool 212 in an inactive state of IO access device 100. When pressed toward the housing, trigger 238 is configured to release locking pin 240, allowing force applied to the distal end of IO needle 108 to compress compression spring 632 and simultaneously insert drive shaft 106 deeper into axial passage 524.

[0061] like Figure 4 As shown, IO access device 300 also includes an interlock including a trigger 438 pivotally mounted on a laterally oriented pin 440 disposed between trigger 438 and output spool 212. Both trigger 438 and output spool 212 have interlocking teeth that interlock in an inactive state of IO access device 300. When pressed toward the housing, trigger 438 is configured to pivot about pin 440 and withdraw the interlocking teeth of trigger 438 from those of storage spool 214, allowing force applied to the distal end of IO needle 108 to compress compression spring 632 and simultaneously insert drive shaft 106 deeper into axial passage 524.

[0062] Although not shown, the IO access device 100 or 300 may further include a manually actuated 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 activated at any time when the metal strip 210 begins to be wound onto the storage spool 214 or throughout the winding.

[0063] IO needle 108 is configured to be separated from IO access device 100 or 300 after achieving IO access to the patient's medullary cavity. Although not shown, IO needle 108 includes an obturator removably disposed in a cannula. The cannula has an inner lumen configured for at least interosseous infusion when the obturator is removed.

[0064] method

[0065] The method of the IO entry device 100 or 300 includes at least a method of using the IO entry device 100 or 300 .

[0066] The method of using the IO entry device 100 or 300 includes at least an obtaining step of obtaining the IO entry device 100 or 300 .

[0067] The method may also include a preparation step of preparing the patient's skin at the patient's insertion site using an antimicrobial agent (eg, iodine povidone).The insertion site may be around the proximal tibia, distal tibia, or distal femur.

[0068] The method may also include the inserting step of inserting the distal end of the IO needle 108 through the skin at the insertion site.

[0069] The method may also include an applying step of applying a force to the bone at the insertion site using the distal end of the IO needle 108. In accordance with applying the force to the bone at the insertion site, the applying step includes inserting the drive shaft 106 deeper into the axial channel 524 of the output spool 212 of the constant torque spring assembly 204 or 404. The applying step also compresses the compression spring 632 between the rear side of the drive shaft tooth set 628 surrounding the drive shaft 106 and the output spool 212. The applying step also disengages the drive shaft tooth set 628 from the opposing housing tooth set 630 surrounding the hole of the housing 102 or 302 from which the drive shaft 106 extends to begin rotation of the IO needle 108. The applying step begins winding the metal strip 210 of the constant torque spring assembly 204 or 404 from the output spool 212 onto the storage spool 214, thereby starting rotation of the IO needle 108.

[0070] The method may further include a drilling step of drilling through the bone until the IO pin 108 enters the patient's medullary cavity, thereby enabling IO access to the patient's medullary cavity using the IO access device 100 or 300 .

[0071] The method may also include a stopping step of stopping the application of force to the bone using the distal end of the IO needle 108. The stopping step removes at least a portion of the drive shaft 106 from the axial channel 524 of the output spool 212, relaxes the compression spring 632, and reengages the drive shaft teeth set 628 with the housing teeth set 630 to stop the rotation of the IO needle 108. The stopping step may be automatically initiated by the IO access device 100 or 300 upon experiencing a change in tissue density (e.g., compact bone to bone marrow) while entering the patient's medullary cavity. The stopping step may alternatively be manually initiated by a clinician upon sensing a change in tissue density while entering the patient's medullary cavity.

[0072] The method may further include a triggering step of triggering an interlocked trigger 238 or 438 of IO access device 100 or 300. At least with respect to IO access device 100, the triggering step releases locking pin 240 disposed between trigger 238 and output spool 212, allowing force applied to the bone at the distal end of IO needle 108 to initiate rotation of IO needle 108.

[0073] The method may also include a separation step of separating the IO needle 108 from the rest of the IO access device 100 or 300 .

[0074] The method may further include a removal step of removing an obturator removably disposed in the cannula from the IO needle 108 .

[0075] The method may further include a confirming step of confirming that the cannula is disposed within the medullary cavity by aspirating bone marrow through the syringe.

[0076] The method may further include the step of securing the cannula to the patient using the dressing.

[0077] The method may also include the initial step of initiating the interosseous infusion as a bolus injection using the same or a different syringe.

[0078] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also included. Therefore, without departing from the scope of the concepts provided herein, it is possible to deviate from the specific embodiments disclosed herein.

Claims

1. An intraosseous access device, comprising: a constant torque spring assembly disposed in the housing, the constant torque spring assembly comprising a metal strip reversely wound on an output spool, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released, 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; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring; and An intraosseous needle is coupled to the drive shaft, the intraosseous needle being configured to provide intraosseous access to a patient's medullary cavity.

2. The intrabone access device according to claim 1, wherein the shell includes a shell tooth group surrounding a hole in the shell, the drive shaft extends from the hole, and the drive shaft includes a complementary drive shaft tooth group surrounding the drive shaft opposite to the shell tooth group, and the shell tooth group and the drive shaft tooth group are engaged with a compression spring between the rear side of the drive shaft tooth group and the output reel in an inactive state of the intrabone access device.

3. The intrabone access device according to claim 2, 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 rotation of the intrabone needle is achieved by the output reel of the constant torque spring assembly on the drive shaft.

4. An intrabone access device according to claim 3, wherein the combination of a molded part and an extension pin is configured to stop over-insertion of the drive shaft into the axial channel of the output reel and to decouple the force applied to the distal end of the intrabone needle from the constant torque spring assembly, wherein the molded part is within the housing and the extension pin is arranged in the axial channel of the output reel between the drive shaft and the molded part.

5. The intrabone access device of claim 3, 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 gear set with the housing gear set and re-activating the inactive state of the intrabone access device.

6. The intraosseous access device of claim 3, 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.

7. The intrabone access device according to claim 3 further includes an interlock, which includes a trigger and a locking pin, wherein the locking pin is arranged between the trigger and the output reel in the inactive state of the intrabone access device, and the trigger is configured to release the locking pin, thereby allowing the force applied to the distal end of the intrabone needle to compress the compression spring and simultaneously insert the drive shaft deeper into the axial channel.

8. The intrabone access device of claim 1, further comprising a braking system configured to act on the output spool to slow down winding of the metal ribbon onto the storage spool.

9. The intraosseous access device of claim 1, wherein the intraosseous needle is configured to be separated from the intraosseous access device after achieving intraosseous access to the patient's medullary cavity.

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

11. An intraosseous access device, comprising: a constant torque spring assembly disposed in the housing, the constant torque spring assembly comprising a metal strip reversely wound on an output reel, the metal strip being configured to be wound on a storage reel at a constant torque in an active state of the intrabone access device; a drive shaft extending from the housing, the drive shaft being slidably disposed in the axial passage of the output spool such that a force applied to a distal portion of the drive shaft compresses a compression spring and simultaneously inserts the drive shaft deeper into the axial passage, thereby disengaging a set of drive shaft teeth surrounding the drive shaft from an opposing set of housing teeth surrounding the aperture of the housing through which the drive shaft extends and activating the active state of the intrabone access device; and An intraosseous needle is coupled to the distal end portion of the drive shaft, the drive shaft being configured to rotate in an active state of the intraosseous access device and to provide intraosseous access to the medullary cavity of a patient by drilling with the intraosseous needle.

12. An intrabone access device according to claim 11, wherein the combination of a molded part and an extension pin is configured to stop over-insertion of the drive shaft into the axial channel of the output spool and to decouple the force applied to the distal portion of the drive shaft from the constant torque spring assembly, wherein the molded part is within the housing and the extension pin is arranged in the axial channel of the output spool between the drive shaft and the molded part.

13. The intrabone access device of claim 11, wherein the compression spring is configured to relax when the force applied to the distal portion of the drive shaft is removed, thereby reengaging the drive shaft teeth set with the housing teeth set and initiating an inactive state of the intrabone access device.

14. The intraosseous access device of claim 11, 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 portion of the drive shaft.

15. An intraosseous access device, comprising: a constant torque spring assembly disposed in the housing, the constant torque spring assembly comprising a metal strip reversely wound on an output spool, the metal strip being configured to be wound on a storage spool at a constant torque when the output spool is released; a drive shaft extending from the housing, the drive shaft coupled to the constant torque spring, wherein the housing includes a housing tooth set surrounding a hole in the housing, the drive shaft extends from the hole, and the drive shaft includes 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 being engaged by a compression spring between a rear side of the drive shaft tooth set and the output spool in an inactive state of the intrabone access device; and An intraosseous needle is coupled to the drive shaft, the intraosseous needle being configured to provide intraosseous access to the medullary cavity of a patient, wherein the drive shaft is slidably disposed in an axial channel of the output spool such that a force applied to the distal end of the intraosseous needle compresses the compression spring and simultaneously inserts the drive shaft deeper into the axial channel, thereby disengaging the drive shaft gear set from the housing gear set and initiating an active state of the intraosseous access device, in which active state rotation of the intraosseous needle is achieved by the output spool of the constant torque spring assembly on the drive shaft.

16. An intrabone access device according to claim 15, wherein the combination of a molded part and an extension pin is configured to stop over-insertion of the drive shaft into the axial channel of the output reel and to decouple the force applied to the distal end of the intrabone needle from the constant torque spring assembly, wherein the molded part is within the housing and the extension pin is arranged in the axial channel of the output reel between the drive shaft and the molded part.

17. The intrabone access device of claim 15, 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 gear set with the housing gear set and re-initiating the inactive state of the intrabone access device.

18. The intraosseous access device of claim 15, 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.

19. The intrabone access device according to claim 15, further comprising an interlock, the interlock comprising a trigger and a locking pin, the locking pin being arranged between the trigger and the output spool in the inactive state of the intrabone access device, the trigger being configured to release the locking pin, thereby allowing the force applied to the distal end of the intrabone needle to compress the compression spring and simultaneously insert the drive shaft deeper into the axial channel.

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