Patent ID: 12226124

DESCRIPTION

Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a catheter includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a catheter includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

As set forth above, PIVC insertions are increasingly challenging in emergency scenarios as critically ill patients deteriorate. Intraosseous (“IO”) access is often the only means available to clinicians to increase the patient's chances of recovery and even save the patients' lives. However, better tuned medical devices are needed that can significantly reduce design and manufacturing complexity while optimizing user experience. Disclosed herein are constant-torque IO access devices and methods thereof that address the forgoing shortcomings.

IO Access Devices

FIG.1andFIG.3respectively illustrate a first IO access device100and a second IO access device300in accordance with some embodiments.FIG.2andFIG.4respectively illustrate the first IO access device100and the second IO access device300with a side of housing102or302removed in accordance with some embodiments.FIG.5illustrates a constant-torque spring assembly204in accordance with some embodiments.

As shown, the IO access device100or300includes the constant-torque spring assembly204or404disposed in the housing102or302, a drive shaft106extending from the housing102or302, and an IO needle108coupled to the drive shaft106configured to provide IO access to a medullary cavity of a patient.

The housing102or302houses components of the IO access device100or300. While the components of the IO access devices100and300are largely the same in terms of function, the components can be physically different in order to accommodate a particular form factor. For example, the IO access device100has a form factor for holding the IO access device100in a way that permits the IO needle108to access a medullary cavity of a patient with a stabbing motion. In contrast, the IO access device300has a form factor for holding the IO access device100in a way that permits the IO needle108to access a medullary cavity of a patient with in a more traditional drilling motion. The housing102or302is molded of a medically acceptable polymer such that sagittal halves of the housing102or302can be snapped or bound (e.g., mechanically fastened with fasteners, chemically bonded by adhesive, etc.) together around the components of the IO access device100or300.

The constant-torque spring assembly204or404includes a metal ribbon (e.g., a stainless-steel ribbon)210, at least a portion of which is reversely wound onto an output spool212and correctly wound onto a storage spool214with respect to a bias of the metal ribbon210. The metal ribbon210is configured to wind onto the storage spool214or into a storage cavity with a constant torque across a range of revolutions-per-minute (“RPMs”) when the output spool212is released or otherwise allowed to do so.

The constant-torque spring assembly204or404is unique in that stresses associated with deflection of the metal ribbon210are not cumulative over an entire length of the metal ribbon210. The stresses are temporary and apply to only a short length (e.g., the exposed length) of the metal ribbon210at any given time. In addition, the metal ribbon210can be tuned with respect to any characteristic selected from its thickness, width, number of winds around the output spool212, and the like for configuration of the constant-torque spring assembly204or404with an optimal rotary action of the IO needle for IO insertion.

Each spool of the output spool212and the storage spool214optionally includes a spindle co-incident with an axis of the spool for mounting the spool in the housing102or302. Such a spindle can be on one side of the spool or both sides of the spool. For example, the constant-torque spring assembly204of the IO access device100includes spindle216and spindle218of the output spool212and spindle220and spindle222of the storage spool214. Likewise, the constant-torque spring assembly404of the IO access device300includes spindle416and spindle418of the output spool212and spindle420and spindle422of the storage spool214.

Alternatively or additionally to the foregoing spindles, each spool of the output spool212and the storage spool214optionally includes an axial channel co-incident with the axis of the spool, which can be for mounting the spool in the housing102or302, driving another component (e.g., the drive shaft106) of the IO access device100or300, etc. Such an axial channel can be in one side of the spool, both sides of the spool, or extending from one side of the spool to the other side of the spool. For example, the constant-torque spring assembly204or404of the IO access device100or300includes an axial channel524, which, in at least this case, includes a hexagonal shape to drive the hexagonal proximal-end portion of the drive shaft106. (SeeFIGS.5and6.) If the output spool212or the storage spool214includes a spindle on a side of the spool212or214and an axial channel in the same side of the spool212or214, the spindle has an outer diameter large enough to accommodate an inner diameter of the axial channel as shown inFIG.5by the spindle218and the axial channel524.

As shown inFIG.5, same-side spindles such as the spindles218and222respectively of the output spool212and the storage spool214can be coupled together by at least one elastomeric loop526(e.g., an ‘O’-ring) to prevent any timing-related errors between the output spool212and the storage spool214. Such timing-related errors are possible if the metal ribbon210winds onto the storage spool214more slowly than the metal ribbon210winds off the output spool212—or vice versa. As shown, the elastomeric loop526includes a half twist such that it crosses over itself to match the rotational motion of both the output spool212and the storage spool214.

FIG.6illustrates an activation mechanism600for activating rotation of the IO needle108in accordance with some embodiments.

As shown, the activation mechanism600for activating rotation of the IO needle108includes the drive shaft106slideably disposed in the axial channel524of the output spool212, a set of drive-shaft teeth628around the drive shaft106, a set of opposing but complementary housing teeth630around an aperture of the housing102or302from which the drive shaft106extends, and a compression spring632between a back side of the set of drive-shaft teeth628and the output spool212.

In an inactive state of the IO access device100or300, a spring force is exerted on the back side of the set of drive-shaft teeth628by extension of the compression spring632between the back side of the set of drive-shaft teeth628and the output spool212. Extension of the compression spring632keeps the drive shaft106pushed out of the axial channel524, which also keeps the set of drive-shaft teeth628thereof away from the output spool212such that the set of drive-shaft teeth628and the set of housing teeth630are engaged with each other. Each set of teeth of the set of drive-shaft teeth628and the set of housing teeth630can include sawtooth-shaped teeth. When such sets of teeth are engaged with each other as in the inactive state of the IO access device100or300, rotation of the drive shaft106and, thus, the rotation of the IO needle108is prevented.

In an active state of the IO access device100or300, the spring force exerted on the back side of the set of drive-shaft teeth628by the extension of the compression spring632is overwhelmed by force applied to a distal-end portion of the drive shaft106by way of a distal end of the IO needle108. Compression of the compression spring632keeps the drive shaft106pushed into the axial channel524, which also keeps the set of drive-shaft teeth628thereof close to the output spool212such that the set of drive-shaft teeth628and the set of housing teeth630are disengaged with each other. When such sets of teeth are disengaged with each other as in the active state of the IO access device100or300, rotation of the drive shaft106and, thus, the rotation of the IO needle108is allowed.

In a transition between the inactive state and the active state of the IO access device100or300, force applied to the distal-end portion of the drive shaft106by way of, for example, engaging bone with the distal end of the IO needle108, simultaneously inserts the drive shaft106deeper into the axial channel524and compresses the compression spring632between the back side of the set of drive-shaft teeth628and the output spool212. Inserting the drive shaft106deeper into the axial channel disengages the set of drive-shaft teeth628from the set of housing teeth630to initiate the active state of the IO access device100or300, in which state rotation of the IO needle108is effectuated by the output spool212of the constant-torque spring assembly204or404on the drive shaft106.

In a transition between the active state and the inactive state of the IO access device100or300, force removed from the distal-end portion of the drive shaft106by way of, for example, disengaging the distal end of the IO needle108from bone, allows the compression spring632between the back side of the set of drive-shaft teeth628and the output spool212to relax, which pushes the drive shaft106out of the axial channel524away from the output spool212. Pushing the drive shaft106out of the axial channel524reengages the set of drive-shaft teeth628with the set of housing teeth630to initiate the inactive state of the IO access device100or300, in which state rotation of the IO needle108is by the output spool212of the constant-torque spring assembly204or404on the drive shaft106is prevented.

The transition between the active state and the inactive state of the IO access device100or300can be automatically initiated by the IO access device100or300. In such an IO access device, the compression spring632is configured by way of its material, construction, or both to have a spring constant and a compressible length proportional to a spring force greater than an average force that can be applied on the distal end of the IO needle108by marrow in a medullary cavity of a patient. Entry of the IO needle108into the medullary cavity of the patient automatically replaces the force applied on the distal end of the IO needle108by compact bone, which force is greater than the foregoing spring force, with the force applied on the distal end of the IO needle108by the marrow in the medullary cavity, which force is less than the foregoing spring force, thereby allowing the compression spring632to push the drive shaft106out of the axial channel524away from the output spool212to initiate the transition to the inactive state of the IO access device100or300. Notwithstanding the foregoing, the transition between the active state and the inactive state can be manually initiated by a clinician after feeling a change in tissue density upon entering the medullary cavity from compact bone.

As shown inFIG.2for at least the IO access device100, a combination of a molded piece236within the housing102and an extension pin234disposed in the axial channel524of the output spool212between the drive shaft106and the molded piece236is configured to stop over insertion of the drive shaft106into the axial channel524of the output spool212during the transition between the inactive state and the active state of the IO access device100. In addition to stopping the over insertion of the drive shaft106into the axial channel524of the output spool212, the combination of the extension pin234and the molded piece236is configured to decouple the force applied to the distal end of the IO needle108from the constant-torque spring assembly204. That is, any further force applied to the distal end of the IO needle108than that needed for the transition between the inactive state and the active state of the IO access device100is applied to the molded piece236of the housing102by the extension pin234instead of the constant-torque spring assembly204. Indeed, minimization of bearing surface area and reduction of extraneous moment arm lengths further decouple the force applied to the distal end of the IO needle108from the constant-torque spring assembly204.

As shown inFIG.2, the IO access device100further includes an interlock including a trigger238and a lock pin240disposed between the trigger238and the output spool212in the inactive state of the IO access device100. When pressed toward the housing, the trigger238is configured to release the lock pin240allowing the force applied to the distal end of the IO needle108to simultaneously compress the compression spring632and insert the drive shaft106deeper into the axial channel524.

As shown inFIG.4, the IOaccess device300further includes an interlock including a trigger438pivotally mounted on a transversely oriented pin440disposed between the trigger438and the output spool212. Both the trigger438and the output spool212have interlocking teeth that are interlocked in the inactive state of the IOaccess device300. When pressed toward the housing, the trigger438is configured to pivot about the pin440and withdraw the interlocking teeth of the trigger438from those of the storage spool214allowing the force applied to the distal end of the IOneedle108to simultaneously compress the compression spring632and insert the drive shaft106deeper into the axial channel524.

While not shown, the IOaccess device100or300can further include a hand-actuated braking system configured to act on the output spool212to slow the metal ribbon210from winding onto the storage spool214. The braking system can be initiated at a start of the winding of the metal ribbon210onto the storage spool214or at any time throughout the winding.

The IO needle108is configured to separate from the IO access device100or300subsequent to achieving IO access to a medullary cavity of a patient. While not shown, the IO needle108includes an obturator removably disposed in a cannula. The cannula has a lumen configured for at least interosseous infusion upon removal of the obturator.

Methods

Methods of the IO access device100or300include at least a method of using the IO access device100or300.

A method of using the IO access device100or300includes at least an obtaining step of obtaining the IO access device100or300.

The method can also include a preparing step of preparing skin of the patient with an antiseptic (e.g., iodopovidone) at an insertion site of a patient. The insertion site can be about the proximal tibia, the distal tibia, or the distal femur.

The method can also include an inserting step of inserting the distal end of the IO needle108through the skin at the insertion site.

The method can also include an applying step of applying force to bone at the insertion site with the distal end of the IO needle108. In accordance with applying the force to the bone at the insertion site, the applying step includes inserting the drive shaft106deeper into the axial channel524of the output spool212of the constant-torque spring assembly204or404. The applying step also compresses the compression spring632between the back side of the set of drive-shaft teeth628around the drive shaft106and the output spool212. The applying step also disengages the set of drive-shaft teeth628from the opposing set of housing teeth630around the aperture of the housing102or302from which the drive shaft106extends to start the rotation of the IO needle108. The applying step starts winding the metal ribbon210of the constant-torque spring assembly204or404from the output spool212onto the storage spool214, thereby starting rotation of the IO needle108.

The method can also include a drilling step of drilling through the bone until the IO needle108enters a medullary cavity of the patient, thereby achieving IO access to the medullary cavity of the patient with the IO access device100or300.

The method can also include a ceasing step of ceasing to apply the force to the bone with the distal end of the IO needle108. The ceasing step removes at least a portion of the drive shaft106from the axial channel524of the output spool212, relaxes the compression spring632, and reengages the set of drive-shaft teeth628with the set of housing teeth630to stop the rotation of the IO needle108. The ceasing step can be automatically initiated by the IO access device100or300after experiencing a change in tissue density (e.g., compact bone to marrow) upon entering the medullary cavity of the patient. The ceasing step can alternatively be manually initiated by a clinician after feeling the change in tissue density upon entering the medullary cavity of the patient.

The method can also include a triggering step of triggering the trigger238or438of the interlock of the IO access device100or300. With respect to at least the IO access device100, the triggering step releases the lock pin240disposed between the trigger238and the output spool212allowing the force applied to the bone at the distal end of the IO needle108to start the rotation of the IO needle108.

The method can also include a detaching step of detaching the IO needle108from a remainder of the IO access device100or300.

The method can also include a removing step of removing from the IO needle108the obturator removably disposed in the cannula.

The method can also include a confirming step of confirming the cannula is disposed in the medullary cavity by aspirating bone marrow through a syringe.

The method can also include a securing step of securing the cannula to the patient with a dressing.

The method can also include a starting step of starting interosseous infusion as boluses with a same or different syringe.

While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.