WO2021173134A1

WO2021173134A1 - Apparatus and methods for intraosseous device stabilization and fluid transfer

Info

Publication number: WO2021173134A1
Application number: PCT/US2020/019922
Authority: WO
Inventors: Lance Hopman; Richard Sims; Travis MCGOWAN
Original assignee: The Seaberg Company, Inc.
Priority date: 2020-02-26
Filing date: 2020-02-26
Publication date: 2021-09-02
Also published as: EP4110206A1; EP4110206A4

Abstract

Embodiments provide for an apparatus for supporting an intraosseous device disposed at a target site of a patient, and methods of use for the apparatus. In an example, the apparatus includes a cylindrical support structure with a hollow interior, the interior dimensions of the hollow interior greater than exterior dimensions of an intraosseous device. In this way, movement of the support structure may not be translated into movement of the intraosseous device, thereby reducing opportunity for dislodgement of the intraosseous device.

Description

APPARATUS AND METHODS FOR INTRAOSSEOUS DEVICE STABILIZATION AND FLUID TRANSFER

Technical Field

[0001] Embodiments herein relate to the field of intraosseus infusion, and more specifically, to assembly and stabilization of an intraosseus device.

Background

[0002] Rapid vascular access may be required for a variety of medical conditions, including but not limited to cardiac arrest, cardiac arrhythmias, myocardial infarctions, syncope, hypotension, anaphylactic shock, diabetes, and various other commonly occurring medical conditions. A common approach to establish vascular access is via intravenous (IV) infusion using a peripheral vein. However, there are established challenges to relying on intravenous infusion techniques, particularly in emergency settings where peripheral intravenous access is difficult because of issues such as edema, obesity, burns, and a history of intravenous drug abuse, among others.

[0003] A common alternative to intravenous infusion is central venous infusion. Yet, there are also drawbacks to central venous infusion including longer access times, increased costs, greater risk of complication, and high skill level required for proper insertion of a central line. For the above-mentioned reasons, in many pre-hospital and hospital environments, intraosseous (IO) infusion may be used as an alternative to intravenous infusion, rather than relying on central venous infusion. Intraosseous infusion is a process of injecting medication or fluid directly into the marrow of a bone. Any medication or fluid that can be administered via intravenous infusion can also be administered via intraosseous infusion, at approximately the same or an even faster rate. Thus, intraosseous infusion represents a quick and effective way in which to provide rapid vascular access for patients in which intravenous access is limited.

Brief Description of the Drawings

[0004] Embodiments will be readily understood by the following detailed description in conjunction with the accompanying drawings and the appended claims. Embodiments are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings.

[0005] FIG. 1 illustrates an example of an intraosseous (IO) needle embedded in a bone of a patient, and an extension set that mechanically couples to the IO needle in accordance with various embodiments;

[0006] FIG. 2 illustrates an example depiction of an IO stabilizer for use to practice various embodiments;

[0007] FIGS. 3A-3B illustrate an example where the IO stabilizer of FIG. 2 is used prior to mechanically coupling an IO needle to an extension set, in accordance with various embodiments;

[0008] FIG. 4 illustrates an example where the IO stabilizer of FIG. 2 is used subsequent to mechanically couple an IO needle to an extension set, in accordance with various embodiments;

[0009] FIG. 5A illustrates another perspective view of the IO stabilizer of FIG. 2, in the absence of an IO needle, in accordance with various embodiments;

[0010] FIG. 5B illustrates the perspective view of FIG. 5A of the IO stabilizer in the presence of an IO needle, in accordance with various embodiments;

[0011] FIGS. 6A-6B illustrate isolated perspective views of a cylinder of the IO stabilizer of FIG. 2 in the presence of an IO needle, in accordance with various embodiments; and

[0012] FIG. 7 illustrates a high-level example methodology for establishing IO access in a patient and for use of the stabilizer of FIG. 2, in accordance with various embodiments.

Detailed Description of Disclosed Embodiments [0013] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Therefore, the following detailed description is not to be taken in a limiting sense.

[0014] Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments; however, the order of description should not be construed to imply that these operations are order-dependent.

[0015] The description may use perspective-based descriptions such as up/down, back/front, and top/bottom. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of disclosed embodiments.

[0016] The terms “coupled” and “connected,” along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, “connected” may be used to indicate that two or more elements are in direct physical or electrical contact with each other. “Coupled” may mean that two or more elements are in direct physical or electrical contact. However, “coupled” may also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other. [0017] For the purposes of the description, a phrase in the form “A/B” or in the form “A and/or B” means (A), (B), or (A and B). For the purposes of the description, a phrase in the form “at least one of A, B, and C” means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C). For the purposes of the description, a phrase in the form “(A)B” means (B) or (AB) that is, A is an optional element.

[0018] The description may use the terms “embodiment” or “embodiments,” which may each refer to one or more of the same or different embodiments. Furthermore, the terms “comprising,” “including,” “having,” and the like, as used with respect to embodiments, are synonymous, and are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.).

[0019] With respect to the use of any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.

[0020] Embodiments herein provide an apparatus for supporting an IO device disposed at a target site in a patient, and methods of use for such an apparatus. As one example, such an apparatus may include a support structure having a hole formed therethrough. The support structure may have interior dimensions greater than exterior dimensions of the intraosseous device to maintain an absence of physical contact between an exterior surface of the intraosseous device and an inner wall of the support structure when the intraosseous device is positioned at least partially within the support structure and while embedded in a bone of the patient at the target site. In such an example, the support structure may be coupled to an outer surface of a base layer via a support structure base, the base layer including an adhesive on at least part of an inner surface of the base layer opposite the outer surface. The adhesive may be operable to releasably engage the apparatus to skin of the patient proximate the target site of intraosseous device insertion.

[0021] Such an apparatus may in some examples include an adhesive backing proximate the inner surface. The adhesive backing may cover the adhesive included on at least part of the inner surface prior to the apparatus being releaseably engaged to the skin of the patient.

[0022] In some examples, the base layer of such an apparatus may include a void space or a hole having dimensions corresponding to the interior dimensions of the support structure. The void space may be aligned with the interior dimensions of the support structure. The interior dimensions of the support structure of the apparatus may be equal throughout an entirety of the support structure.

[0023] The base layer of such an apparatus may be of a generally equilateral triangular shape, although other shapes may be used as well. A support structure length extending from the support structure base to an outer rim of the support structure may be approximately or equal to one-third of a height of the generally equilateral triangular shape of the base layer.

[0024] The support structure of such an apparatus may be cylindrical, although other cross-sectional shapes may be used as well (e.g. square, rectangular, pentagonal, hexagonal, octagonal, trapezoidal, etc.). As an example where the support structure is cylindrical, a support structure diameter corresponding to the interior dimensions of the support structure may be larger than an intraosseous device diameter corresponding to the exterior dimensions of the intraosseous device. As a representative example, the interior dimensions (e.g., interior diameter) of the support structure may be greater than or equal to 1 .5x the exterior dimensions (e.g., outer diameter) of the IO device. As another example, the interior dimensions of the support structure may be greater than or equal to 2x the exterior dimensions of the IO device, but less than or equal to 3x the exterior dimensions of the 10 device. As another example, the interior dimensions of the support structure may be greater than or equal to 3x the exterior dimensions of the 10 device, but less than or equal to 4x the exterior dimensions of the 10 device. [0025] It may be understood that in most examples, the support structure may be expected to be approximately perpendicular to the skin surface when in use. In some examples it is herein recognized that the 10 device may be positioned in a manner not perpendicular to the skin surface (and thus at an angle with respect to the support structure).

[0026] In some examples, the support structure inner diameter minus the 10 device outer diameter may be greater than 7 mm but less than 14 mm. As another example, the support structure inner diameter minus the IO device outer diameter may be greater than 8 mm but less than 13 mm. As another example, the support structure inner diameter minus the IO device outer diameter may be greater than 9 mm but less than 12 mm. In one particular example, the support structure inner diameter minus the IO device outer diameter may be 11 mm. In the case where the support structure inner diameter minus the IO device outer diameter is 11 mm (and where both the support structure and the IO device are approximately cylindrical), it may be understood that when both the IO device and the support structure are positioned perpendicular to the skin, an amount of space between the inner walls of the support structure and the IO device exterior may be approximately 5.5 mm. [0027] Another example of an apparatus for supporting an intraosseous device disposed at a target site in a patient may comprise a hollow cylindrical support structure including a support structure base, the hollow cylindrical support structure and the support structure base coupled to an outer surface of a base layer, the base layer additionally having an inner surface with an adhesive included on at least a portion of the inner surface. The adhesive may be protected via removable adhesive backing. The base layer may include a hole with a hole diameter equal to an inner diameter of the hollow cylindrical support structure. The hole of the base layer may be flush with an inner wall of the hollow support structure. The inner diameter of the hollow cylindrical support structure may be at least 1 .5x an exterior diameter of the intraosseous device in order to maintain an absence of physical contact between the inner wall of the hollow support structure and the intraosseous device. As one representative example, the IO device outer diameter may be approximately 0.7”, and the inner diameter of the support structure or stabilizer may be approximately 1.13”. The apparatus may be configured to, when secured to skin of the patient via the adhesive, reduce or avoid movement of the intraosseous device in response to a lateral force applied to an external wall of the hollow cylindrical support structure.

[0028] For such an apparatus, a height of the hollow cylindrical support structure as measured from the support structure base to an outer edge of the hollow cylindrical support structure may be greater than an outer diameter of the hollow cylindrical support structure. Furthermore, the inner diameter of the hollow cylindrical support structure may be equal throughout an entirety of the hollow cylindrical support structure.

[0029] Discussed herein, a method for supporting an intraosseous device disposed at a target site in a patient may comprise embedding the intraosseous device in a bone of the patient at the target site. The method may include, in a first condition, mechanically coupling the intraosseous device to an extension set prior to positioning a supporting apparatus proximal to the target site. Alternatively, in a second condition, the method may include mechanically coupling the intraosseous device to the extension set subsequent to positioning the supporting apparatus proximal to the target site.

[0030] For such a method, the supporting apparatus may further comprise a supporting structure for surrounding at least a portion of the intraosseous device while the intraosseous device is disposed at the target site. Positioning the supporting apparatus in the first condition may include threading the extension set through the supporting structure, and then positioning the supporting apparatus to at least partially surround the intraosseous device. Alternatively, positioning the supporting apparatus in the second condition may include positioning the supporting structure to at least partially surround the intraosseous device, and then mechanically coupling the extension set to the intraosseous device while the supporting structure at least partially surrounds the intraosseous device. In both the first condition and the second condition, positioning the supporting device may include positioning the supporting structure so that no part of the intraosseous device is in physical contact with any aspect of the supporting structure.

[0031] For such a method, the supporting apparatus may further comprise a base layer with an outer surface and an inner surface, the inner surface including an adhesive layer protected by an adhesive backing. In such an example, in both the first condition and the second condition the method may include securing the supporting apparatus to skin of the patient by removing the adhesive backing while the supporting apparatus is positioned proximal to the target site, and may further include applying a force to the outer surface of the base layer to adhere the supporting apparatus to the skin of the patient.

[0032] For such a method, the first condition may in some examples include a situation where the patient is in need of resuscitation. Examples include but are not limited to cardiac arrest, near drowning, thoracic injuries, cerebral edema, etc.

[0033] For such a method, the first condition may further comprise providing a fluid, drug, and/or a type of medication to the patient by way of the extension set and the intraosseous device prior to positioning the supporting apparatus proximal to the target site.

[0034] As discussed above, the intraosseous (10) space provides for a direct pathway to the vascular system of a patient, and is thus an effective route for delivery of fluids, drugs, and other medications under conditions where intravenous (IV) access is not available or is not feasible. 10 infusion as discussed herein therefore refers to a process of injecting fluid, drugs, medications, etc., directly into the marrow of bone, thereby providing a non-collapsible entry point into a patient’s systemic venous system. Rapid 10 access may be readily achieved in emergency situations that require access to a patient’s vascular system. However, it may be understood that 10 access may not be used exclusively in emergency situations. For example, 10 access may be relied upon for chronic conditions for which IV access is compromised or unavailable. Examples of such chronic conditions include but are not limited to patients with epilepsy, patients in intensive care units, dialysis patients, etc.

[0035] As representative examples, 10 device insertion sites may include one or more of the upper tibia proximate a patient’s knee, the humeral head proximate a patient’s shoulder, and the sternum of a patient. It may be understood that the teachings of the present disclosure relate to any and all of the above-mentioned 10 device insertion sites, as well as other relevant 10 device insertion sites (e.g., manubrium, radius, ulna, proximal humerus, anterior and posterior pelvis, calcaneus, and clavicle).

[0036] Discussed herein, a driver may refer to any type of powered or manual actuator that can be used to install an 10 device in a patient at a predetermined insertion site. The drivers of the present disclosure may be directly coupled with an 10 device in some examples, whereas in other examples a type of connector (e.g., connector receptacles, fittings, etc.) may be used to releasably engage a driver to an 10 device.

[0037] Discussed herein, an 10 device may refer to any aspect of a penetrator assembly that is used to establish 10 access in a patient. Thus, an 10 device may refer to the entirety of a penetrator assembly in some examples. In other examples, an 10 device may refer to any aspect of a penetrator assembly, including but not limited to a hollow needle, a hollow drill bit, a catheter, a cannula, a trocar, an inner penetrator, an outer penetrator, an 10 needle, an 10 needle set, a bone penetrator, etc. Relevant to the present disclosure are a wide variety of trocars, spindles, and/or shafts disposed within a cannula during installation at a selected target area. Discussed herein, trocars, spindles, and shafts may be referred to as inner penetrators, while a cannula may be referred to as an outer penetrator.

[0038] Discussed herein, liquids including but not limited to water, saline solutions, IV solutions, plasma, blood, mixtures of liquids, particulate matter, dissolved drugs, and/or medications for injection into bone marrow or other target sites may be referred to as fluids. Fluids may in other examples also refer to bodily fluids (e.g., blood, bone marrow, and cells) withdrawn from a target site. For example, 10 access to bone and associated bone marrow may in some examples be used for procedures including, but not limited to, obtaining of biopsy specimens for analysis and research, bone marrow transplantation, stem cell research, etc.

[0039] As discussed above, 10 access may in some examples be preferable to IV access due to insertion sites and associated target areas for placement of an 10 device being larger than those for IV access. Yet there are challenges associated with maintaining an 10 device, including but not limited to 10 device dislodgement. [0040] Turning now to FIG. 1 , depicted is an example illustration 100 of an IO needle 102 that has been inserted into bone 103 of patient 104. While not explicitly illustrated, it may be understood that to insert IO needle 102 into bone 103, a driver (not shown) may be used to drive intraosseous needle 102 into bone 103 to a desired depth. Briefly, it may be understood that IO needle 102 may be a component of a penetrator set, which also includes a connector (not shown). The connector may be of a generally cylindrical nature defined by a first end and a second end. The first end of the connector may include an opening sized to receive portions of a drive shaft associated with a powered or manual driver, and the second end opposite the first end may include a trocar (not shown), also referred to herein as an inner penetrator or stylet. The inner penetrator may be selected to enable the inner penetrator to be slidably inserted into a longitudinal bore (not specifically shown) of outer penetrator 105, also referred to as cannula 105, of IO needle 102.

IO needle 102 may include hub 107 with first end 108 and second end 109. As depicted at FIG. 1 , outer penetrator 105 extends from second end 109 of hub 107. Extending from first end 108 of hub 107 are threads 110.

[0041] It may be understood that IO needle 102 may slidably receive the connector, in a manner such that the inner penetrator is inserted within an inner diameter of outer penetrator 105. In such a configuration, while not explicitly illustrated, it may be understood that an engagement mechanism may secure the connector to IO needle 102. As one non-limiting example, a male luer slip may be included as part of the connector and a female luer slip may be included as part of intraosseous needle 102, such that when the male and the female luer slips are engaged with one another, the connector is releasable secured to IO needle 102. [0042] With the connector and IO needle 102 releasably engaged, the driver may be releasably coupled to the first end 108 of the connector, to drive the penetrator set into bone 103 of patient 104. Subsequently, the connector may be slidably disengaged from IO needle 102, thereby exposing threads 110.

Accordingly, it may be understood that illustration 100 depicts a situation where outer penetrator 105 of IO needle 102 has been driven into bone 103 of patient 104, and where the connector (and associated inner penetrator) has been disengaged from IO needle 102.

[0043] With threads 110 exposed via the disengagement of the connector from IO needle 102, first connector assembly 115 may be sealingly engaged with threads 110, to secure fluid tubing assembly 118 (also referred to herein as an extension set) to IO needle 102, as depicted illustratively by arrow 120. Specifically, first connector assembly 115 may include connector assembly threading (not visible at FIG. 1) capable of engaging with threads 110. It may be understood that FIG. 1 depicts just one example connector assembly and associated extension set, and a wide variety of other examples are within the scope of this disclosure. By securing first connector assembly 115 to threads 110, fluid may be enabled to flow from fluid tubing assembly 118 through intraosseous needle 102 and into bone 103. Additionally or alternatively, fluid may be enabled to flow in an opposite direction, specifically from bone 103, through intraosseous needle 102 and into extension set 118.

[0044] It may be understood that, while not explicitly illustrated, additional medical equipment may be compatible with the IO devices discussed herein. For illustrative purposes, extension set 118 includes second connector assembly 122. Second connector assembly 122 may be used to fluidically couple extension set 118 to one of a fluid bag, an ampule, a syringe (e.g., hypodermic syringe), etc. When a fluid bag is fluidically coupled to extension set 118 via second connector assembly 122, it may be understood that a bulb, pressure pump, or other means of increasing a pressure of fluid supplied to bone 103 by way of IO needle 102 may be utilized. [0045] Turning now to FIG. 2, depicted is an example illustration 200 of an isolated view of supporting structure 205, also referred to herein as stabilizer 205, or IO stabilizer 205, for use with an IO device such as the IO needle (e.g., intraosseous needle 102 at FIG. 1 ) depicted above at FIG. 1 . Supporting structure 205 will be discussed at FIG. 2 with respect to the x, y, and z axes depicted at inset 207. Supporting structure 205 includes base layer 210 extending at FIG. 2 along the x-z plane. Base layer 210 includes a first, outer surface 212, and a second, inner surface 214. Inner surface 214 may be understood to include an adhesive (not shown) along at least a portion of inner surface 214. The adhesive may be covered by adhesive backing 215, parts of which are visible at FIG. 2 as first adhesive backing tab 216 and second adhesive backing tab 217. While not explicitly illustrated, it may be understood that adhesive backing 215 may be comprised of two pieces that at least partially overlap one another, such that one portion of the adhesive on the second, inner surface 214 is exposed in response to first adhesive backing tab 216 being pulled along the z axis at FIG. 2 in the direction of arrow 220, and another portion of the adhesive is exposed in response to second adhesive backing tab 217 being pulled along the z-axis at FIG. 2 in the direction of arrow 221 . Exposing the adhesive on the second, inner surface 214 may enable supporting structure 205 to be secured to the skin of a patient. It may be understood that base layer 210 may be made of a thin, flexible material capable of conforming to the contours of a patient’s body.

[0046] Extending from the first, outer surface 212 along the y-axis is cylinder 225. Cylinder 225 may be secured to the first, outer surface by cylinder base 226. Cylinder 225 may be hollow, and open on both its first cylinder end 228 and second cylinder end 230. Furthermore, it may be understood that base layer 210 does not extend across first cylinder end 228, but rather base layer 210 includes a void or hole with dimensions corresponding to the dimensions of first cylinder end 228. As one example, cylinder 225 may be comprised of polycarbonate, and may be clear. [0047] Cylinder base 226 includes first straight edge 227 and second straight edge 228. Cylinder base 226 further includes first curved edge 229 and second curved edge 230. Dashed lines 235 are shown to illustrate that first straight edge 227 and second straight edge 228 approximately correspond to outer dimensions of wing 236 of base layer 210 from which second adhesive tab 217 extends therefrom. A first length 237 between first straight edge 227 and second straight edge 228 of cylinder base 226 may be understood to be substantially similar (e.g., within 5% or less) to a height 240 of cylinder 225 extending from cylinder base 226. Said another way, a ratio of first length 237 between first straight edge 227 and second straight edge 228 and height 240 of cylinder 225 may be approximately 1 .

[0048] Turning now to FIG. 3A, depicted is example illustration 300 showing IO needle 102 embedded in bone 103 of patient 104. Also depicted is supporting structure 205, which includes adhesive backing 215, visible as first adhesive backing tab 216 and second adhesive backing tab 217. Extending from outer surface 212 is cylinder 225, which as discussed is hollow. Dashed line 306 illustrates a desired positioning of supporting structure 305 on patient 104. Accordingly, arrow 307 is used to illustratively depict how supporting structure 205 may be positioned over IO needle 102, such that the portion of IO needle 102 not embedded in patient 104 may extend through cylinder 225. Thus, as will be elaborated in greater detail below, it may be understood that an inner diameter of cylinder 225 is greater than the external dimensions of the intraosseous needle, to enable IO needle 102 to extend through cylinder 225 in a manner such that inner walls 308 of cylinder 225 are not in physical contact with any portion of IO needle 102.

[0049] Turning now to FIG. 3B, depicted is illustration 350, showing an example where supporting structure 205 has been placed over IO needle 102. It may be understood that no part of hub 107, or any other aspect of IO needle 102, is in physical contact with inner walls 308 of cylinder 225. In some examples, first end 108 of hub 107 may lie along approximately the same plane as an outer perimeter 352 of cylinder 225. In this way, threads 110 extending from first end 108 of hub 107 may extend past cylinder 225, for ease in engaging first connector assembly 115 with threads 110, as illustratively depicted via arrow 354. However, in other examples at least a portion, or an entirety, of threads 110 may not extend past cylinder 225 but instead may remain within the hollow portion of cylinder 225. In such examples, it may still be possible to readily engage first connector assembly 115 with threads 110 based on the dimensions of cylinder 225 with respect to IO needle 102 and first connector assembly 115.

[0050] Example illustration 350 shows supporting structure 205 with adhesive backing 215 not yet removed, as exemplified by first adhesive backing tab 216 and second adhesive backing tab 217 still being in place. It may be understood that with surface layer 210 placed upon skin of patient 104, the adhesive backing may be removed by pulling first adhesive backing tab 216 in the general direction exemplified by arrow 360, and by pulling second adhesive backing tab 217 in the general direction exemplified by arrow 362. Upon removal of the adhesive backing, supporting structure 210 may be firmly attached to the skin of patient 104 by application of pressure on outer surface 212 of base layer 210. In some examples, supporting structure 205 may be firmly attached to skin prior to engaging first connector assembly 115 with threads 110. However, it is also within the scope of this disclosure to, once supporting structure 205 is placed over IO needle 102, to first engage first connector assembly 115 with threads 110, and then to remove the adhesive backing to secure the supporting structure to the skin of patient 104. In either example, it may be understood that first connector assembly 115 may be securely engaged with threads 110 via a user relying on a single hand for the coupling, leaving another hand of the user free to, for example, hold down supporting structure 205 to the skin of patient 104.

[0051] Turning now to FIG. 4, depicted is another example illustration 400, showing an alternative manner in which supporting structure 205 may be used in accordance with the present disclosure. As illustrated, IO needle 102 is embedded in bone 103 of patient 104. Prior to applying supporting structure 205 to the skin of patient 104, first connector assembly 115 is sealingly engaged with threads (e.g., threads 110 at FIG. 1) associated with IO needle 102. With first connector assembly 115 engaged with threads 110 of IO needle 102, an entirety of extension set 118 including second connector assembly 122 may be threaded through cylinder 225, as exemplified illustratively by arrow 405. In this way, supporting structure 205 may be applied to skin of patient 104 while fluid tubing assembly 118 is already mechanically coupled to intraosseous needle 102. This may be advantageous for urgent cases (e.g., cases where the patient is in need of resuscitation) where infusion of drugs may otherwise be delayed by application of the stabilizer 205. In such an example, the stabilizer may be applied before patient transport, where its use is desired. As another related advantage, it may be understood that once the IO needle has been embedded in bone, there may be an open pathway for contamination. Thus, rapid application of the extension set 118 prior to application of IO stabilizer 205 may serve to reduce or avoid potential contamination once IO needle 102 is embedded in bone.

[0052] Turning now to FIG. 5A, depicted is an illustration 500 of support structure 205, as viewed from a top-down perspective, along the y-axis (refer to inset 505). Illustrated is outer surface 212 of support structure 205. Cylinder base 226 is adhered to outer surface 212. In some examples, cylinder 225 may be directly adhered to outer surface 212, without cylinder base 226. It may be understood that cylinder 225 or cylinder base 226 may be adhered to outer surface 212 by any effective means known in the art (e.g., gluing, welding, use of plastic agents which bond either through the evaporation of a solvent or through curing via heat, time, or pressure, etc.). Cylinder 225 extends outward (out of the page) along the y-axis from cylinder base 226. Further depicted is first adhesive backing tab 216 and second adhesive backing tab 217.

[0053] Support structure 205 has a generally equilateral triangular shape, with a first short edge 510, second short edge 512 and third short edge 514. First short edge 510 and second short edge 512 are connected via first long edge 516. Second short edge 512 and third short edge 514 are connected via second long edge 518. First short edge 510 and third short edge 514 are connected via third long edge 520. [0054] A first dashed line 522 is depicted as extending from a midpoint of first short edge 510 to a midpoint of second long edge 518. A second dashed line 524 is depicted as extending from a midpoint of first long edge 516 to midpoint of third short edge 514. A third dashed line 526 is depicted as extending from a midpoint of third long edge 520 to a midpoint of second short edge 512. It may be understood that a length (also referred to as “height”) of each of first dashed line 522, second dashed line 524, and third dashed line 526 may be the same, or substantially the same (e.g., not different by more than 1 -2%). As shown, each of first dashed line 522, second dashed line 524, and third dashed line 526 intersect at a center point 528 of cylinder 225.

[0055] Also depicted at FIG. 5A is first straight edge 227 and second straight edge 228 of cylinder base 226. Dashed lines 530 are shown to illustrate, as discussed above at FIG. 2, that a length 532 between first straight edge 227 and second straight edge 228 of cylinder base 226 is the same or substantially the same (e.g., not different by more than 1-2%) as a distance between where first long edge 516 meets second short edge 512 and where second short edge 512 meets second long edge 518. It may be understood that in some examples, a height of cylinder 225 may be the same, or substantially the same (e.g., not differing by more than 1 - 2%) as length 532, as discussed above. However, in other examples, a height of cylinder 225 may be different than length 532, without departing from the scope of this disclosure. For example, the height of cylinder 225 may be greater than length 532, or may be less than length 532, depending on the desired application.

[0056] As another example relating to the height of cylinder 225, the height defined as a length extending from the cylinder base to an outer rim or edge of cylinder 225, may be approximately one-third of the length of first dashed line 522, second dashed line 524, and third dashed line 526.

[0057] As yet another example relating to the height of cylinder 225, the height may be understood to be greater than an outer diameter of cylinder 225, but less than twice the outer diameter. However, in other examples the height of cylinder 225 may be equal to or less than the outer diameter of cylinder 225, without departing from the scope of this disclosure.

[0058] Turning now to FIG. 5B, example illustration 550 is shown, depicting a same view of support structure 205 (refer to inset 555) as that depicted at FIG. 5A.

In this example illustration 550, also depicted is IO needle 102, including threads 110 and hub 107. Cylinder 225 has inner walls 308, and as depicted, no aspect of IO needle 102 is in physical contact with inner walls 308 of cylinder 225. Double-sided arrow 560 is shown to illustrate a distance between an outer or external surface of IO needle 102 and inner walls 308 of cylinder 225. In one example, the distance represented by arrow 560 may be greater than 0.5 cm but less than 0.7 cm. It may be understood that the distance as represented by double-sided arrow 560 may differ in some examples, depending on the IO needle selected for use. [0059] Turning now to FIG. 6A, depicted is an example illustration 600 of an isolated perspective view (refer to inset 605) of cylinder 225 and cylinder base 226 of a stabilizer (e.g., stabilizer 205 at FIG. 2). Shown also is a portion of IO needle 102. While not explicitly illustrated, it may be understood that cannula 105 is embedded in bone of a patient. Cylinder 225 is moved in the general direction of arrow 607, in order to enable cylinder 225 to surround an entirety of intraosseous needle 102. At FIG. 6A, hub 107 and threads 110 are not extended through second end 230 of cylinder 225, but rather, are wholly within or surrounded by cylinder 225.

Specifically, at FIG. 6A, hub 107 and threads 110 of IO needle 102 remain wholly within cylinder 225 when the base layer (e.g., base layer 210 at FIG. 2) contacts, and is adhered to, skin of a patient. In another example, such as that depicted at FIG. 6B (refer to example illustration 650), cannula 105 is driven to a different depth than that depicted at FIG. 6A. FIG. 6B shows the same perspective view (refer to inset 655) as that depicted at FIG. 6A. The differing cannula depth at FIG. 6B as compared to FIG. 6A may be due to, for example, a differing amount of soft tissue over the bone. Thus, in the example depicted at FIG. 6B, at least a portion (e.g., threads 110) of IO needle 102 extends through second end 230 of cylinder 225.

[0060] As mentioned above, it may be understood that an advantage of using the IO stabilizer of the present disclosure is that lateral force or pressure, as depicted illustratively at FIG. 6B by arrow 657 (e.g., externally applied force or tissue movement that results in cylinder movement) may not be translated into movement of the IO needle. In other words, movement of the IO needle responsive to lateral force applied to the cylinder may be reduced or substantially avoided as compared to a situation where the IO needle included at least some physical contact with the cylinder or related supporting structure. It may be understood that tissue movement may still result in some force applied to the IO needle, however such translational force may be applied at a base of the IO needle, represented by arrow 658, as opposed to a top or upper portion of the IO needle (e.g., hub 107). This may serve to reduce a potential for the IO needle to be dislodged from bone.

[0061] Turning now to FIG. 7, depicted is a high-level example method 700 for obtaining IO access, and for stabilizing an IO needle, also referred to herein as a catheter. For obtaining IO access, an IO system may be used, the system including but not limited to a driver, a needle assembly (e.g., penetrator assembly), and an extension set. It may be understood that method 700 may be used to obtain IO access any time in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases.

[0062] Method 700 begins at 705, and includes selecting a desired insertion site for IO access. Selecting a desired insertion site may include one or more of an indication that a particular site is not associated with a bone fracture, that IO catheter placement for a particular location has not been conducted within a predetermined amount of time (e.g., 48 hours), that there has not been previous, significant orthopedic procedure(s) at a particular site, that there is not an infection at a particular site, and/or that there is not excessive tissue or an absence of anatomic landmarks at a particular site.

[0063] Selecting a desired anatomical insertion site at 705 may additionally include considerations regarding needle length, patient age, and patient physiology. As non-limiting examples, preferred anatomical sites for adult patients may include proximal humerus, proximal tibia, and distal tibia. Similar sites may be preferred for pediatric patients, with the addition of distal femur. As discussed above, other relevant target sites are within the scope of this disclosure. Once selected, the desired insertion site may be cleaned in accordance with institutional protocol or policy.

[0064] With the desired insertion site and desired needle length (e.g., 15mm, 25mm, 45mm, etc.) determined, method 700 proceeds to 710. At 710, method 700 includes attaching the needle assembly to the driver, and removing a safety cap from the needle assembly. While not explicitly shown, other additional steps may be conducted at step 710, including but not limited to priming the extension set.

[0065] Continuing to 715, method 700 includes inserting the needle assembly through the skin and adipose tissue of the patient. It may be understood that a tip of the needle assembly may come to rest against targeted periosteum/bone. Furthermore, it may be desirable to ensure that at least 5 mm of the catheter is visible above the skin of the patient. Such a determination may be achieved based on depth indicators on the catheter, for example.

[0066] With the tip of the needle assembly resting against the targeted periosteum/bone, method 700 proceeds to 720. At 720, method 700 includes actuating the driver in order to achieve controlled entry of the needle into the bone of the patient. Responsive to the controlled entry, method 700 at step 720 includes advancing the needle assembly to a desired position. [0067] Continuing to 725, method 700 includes removing a stylet component of the needle assembly by stabilizing the needle assembly hub (e.g., hub 107 at FIG. 1) while retracting (lifting off) and disconnecting the driver from the needle assembly hub. It may be understood that during the retracting, the stylet component may remain attached to the driver. Responsive to the stylet component being dissociated from the needle assembly hub, the stylet may be removed from the driver and placed into an appropriate sharps containment device.

[0068] Proceeding to 730, method 700 includes determining whether it is desirable to connect the catheter (e.g., same as IO needle 102 at FIG. 1) to the extension set prior to the use of the stabilizer (e.g., stabilizer 205 at FIG. 2). As mentioned above, there may be circumstances where it may be desirable to connect the catheter to the extension set prior to the use of the stabilizer because of a desire to provide fluids (e.g., fluids including resuscitative drugs or medications) without delay. One such example includes cardiac arrest. In other examples, it may be desirable to connect the catheter to the extension set prior to the use of the stabilizer in order to ensure a reduction or avoidance of potential contamination that may otherwise occur with the catheter in place in the absence of the connected extension set.

[0069] If, at 730, it is determined that connection of the catheter to the extension set prior to the use of the stabilizer is not desired, then method 700 proceeds to 735. At 735, method 700 includes placing the stabilizer over the catheter and against the patient’s skin, similar to that discussed in detail above at FIG. 3A. Continuing to 740, method 700 includes connecting the catheter to the extension set while holding the stabilizer in place against the skin of the patient, similar to that discussed above with regard to FIG. 3B.

[0070] Returning to 730, in a case where it is determined to be desirable to connect the catheter to the extension set prior to the use of the stabilizer, method 700 proceeds to 745. At 745, method 700 includes connecting the catheter to the extension set in a manner as discussed above with regard to FIG. 4. With the catheter connected to the extension set, it may be understood that drugs or other medications may be delivered to the patient in the absence of the stabilizer. When it is determined that use of the stabilizer is desired, for example responsive to the patient being transported from one location to another, method 700 proceeds to 750. At 750, method 700 includes feeding or threading the extension set through the cylinder (e.g., cylinder 225 at FIG. 2) of the IO stabilizer, and then guiding the stabilizer over the catheter such that the base layer (e.g., base layer 210 at FIG. 2) rests against the patient’s skin and the catheter is surrounded by the cylinder.

[0071] Whether the stabilizer is used prior to connecting the catheter to the extension set, or subsequent to connecting the catheter to the extension set, method 700 proceeds to 755. At 755, method 700 includes securing the stabilizer to the patient’s skin. Specifically, securing the stabilizer to the patient’s skin may include pulling on the adhesive backing tabs (e.g., first adhesive backing tab 216 and second adhesive backing tab 217 at FIG. 2) to remove the adhesive backing from the IO stabilizer, thereby exposing the adhesive layer of the stabilizer to the skin of the patient. The IO stabilizer apparatus may be secured to the skin by pressing down on the outer surface (e.g., outer surface 212 at FIG. 2) of the IO stabilizer base layer (e.g., base layer 210 at FIG. 2) to adhere the inner surface (e.g., inner surface 214 at FIG. 2) of the stabilizer base layer to the skin of the patient.

[0072] While the discussion above focused on the use of the IO stabilizer subsequent to an IO needle (e.g., IO needle 102 at FIG. 1) being embedded in a bone of a patient, it is herein recognized that in some alternative examples, the IO stabilizer may be adhered to the skin of a patient prior to the IO needle being embedded in bone. For example, because the cylinder (e.g., cylinder 225 at FIG. 2) is hollow, it may be possible to first position (and adhere) the IO stabilizer proximal to a target location, and then once placed, the driver and needle assembly may be used to embed the IO needle into the bone of the patient. An advantage to such methodology may be to avoid an extra step of positioning the IO stabilizer subsequent to the placement of the IO needle at the target site. For example, an experienced technician may secure the IO stabilizer to the patient while another experienced technician prepares the driver and needle assembly. This may improve a speed at which fluids can be provided to the patient, while additionally ensuring that the IO needle is effectively supported throughout an entirety of the IO infusion process.

[0073] In this way, use of the IO stabilizer of the present disclosure may improve operational aspects related to IO infusion. In particular, use of the IO stabilizer as discussed herein may reduce opportunity for the IO needle to become dislodged to at least some extent, or fully, from the patient. Because IO infusion may be used in emergency situations where time is critical for positive patient outcome, reducing any opportunity for IO needle dislodgement may improve patient survival rates.

[0074] The technical effect of having a support structure (e.g., cylinder 225 at FIG. 2) be of a hollow nature with dimensions (e.g., interior diameter) greater than corresponding dimensions (e.g., exterior diameter) of an IO needle is that lateral force applied to the cylinder may not be transferred to the IO needle, which may reduce overall movement of the IO needle, thereby enabling the needle to be maintained more firmly embedded in the bone of a patient, as compared to other support structures in which the support structure is at least partially physically coupled to the IO needle. The technical effect of having the support structure of the IO stabilizer of the present disclosure be hollow, with an interior diameter that is the same throughout an entirety of the support structure, is that it may be possible to mechanically couple an IO needle to an extension set prior to positioning the IO stabilizer over the IO needle (and associated extension set). This may enable fluids including drugs and/or medications to be delivered to a patient without a delay associated with application of the stabilizer, and then the IO stabilizer may be positioned when it is needed, for example during transport of the patient. A still further technical effect of having the support structure of the IO stabilizer of the present disclosure be hollow is that it may in some examples be possible to position the IO stabilizer prior to driving an IO needle into bone (through the hollow cylinder). [0075] Although certain embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a wide variety of alternate and/or equivalent embodiments or implementations calculated to achieve the same purposes may be substituted for the embodiments shown and described without departing from the scope. Those with skill in the art will readily appreciate that embodiments may be implemented in a very wide variety of ways. This application is intended to cover any adaptations or variations of the embodiments discussed herein. Therefore, it is manifestly intended that embodiments be limited only by the claims and the equivalents thereof.

Claims

CLAIMS What is claimed is:

1 . An apparatus for supporting an intraosseous device disposed at a target site in a patient, comprising: a support structure having a hole formed therethrough, the support structure having interior dimensions greater than exterior dimensions of the intraosseous device to maintain an absence of physical contact between an exterior surface of the intraosseous device and an inner wall of the support structure when the intraosseous device is positioned at least partially within the support structure while embedded in a bone of the patient at the target site; the support structure coupled to an outer surface of a base layer via a support structure base, the base layer including an adhesive on at least part of an inner surface of the base layer opposite the outer surface; and wherein the adhesive is operable to releasably engage the apparatus to skin of the patient proximate the target site.

2. The apparatus of claim 1 , further comprising an adhesive backing proximate the inner surface, the adhesive backing covering the adhesive included on at least part of the inner surface prior to the apparatus being releaseably engaged to the skin of the patient.

3. The apparatus of claim 1 , wherein the base layer includes a void space having dimensions corresponding to the interior dimensions of the support structure; and wherein the void space is aligned with the interior dimensions of the support structure.

4. The apparatus of claim 1 , wherein the interior dimensions of the support structure are equal throughout an entirety of the support structure.

5. The apparatus of claim 1 , wherein the base layer is of a generally equilateral triangular shape; and wherein a support structure length extending from the support structure base to an outer rim of the support structure is approximately one-third of a height of the generally equilateral triangular shape of the base layer.

6. The apparatus of claim 1 , wherein the support structure is cylindrical; and wherein a support structure diameter corresponding to the interior dimensions of the support structure is at least 1.5x an intraosseous device diameter corresponding to the exterior dimensions of the intraosseous device.

7. A method for supporting an intraosseous device disposed at a target site in a patient, comprising: embedding the intraosseous device in a bone of the patient at the target site; in a first condition, mechanically coupling the intraosseous device to an extension set prior to positioning a supporting apparatus proximal to the target site; and in a second condition, mechanically coupling the intraosseous device to the extension set subsequent to positioning the supporting apparatus proximal to the target site.

8. The method of claim 7, wherein the supporting apparatus further comprises a supporting structure for surrounding at least a portion of the intraosseous device while the intraosseous device is disposed at the target site; wherein positioning the supporting apparatus in the first condition includes threading the extension set through the supporting structure and then positioning the supporting apparatus to at least partially surround the intraosseous device; and wherein positioning the supporting apparatus in the second condition includes positioning the supporting structure to at least partially surround the intraosseous device, and then mechanically coupling the extension set to the intraosseous device while the supporting structure at least partially surrounds the intraosseous device.

9. The method of claim 8, wherein positioning the supporting apparatus in both the first condition and the second condition further comprises: positioning the supporting structure so that no part of the intraosseous device is in physical contact with any aspect of the supporting structure.

10. The method of claim 7, wherein the supporting apparatus further comprises a base layer with an outer surface and an inner surface, the inner surface including an adhesive layer protected by an adhesive backing; and wherein both the first condition and the second condition include securing the supporting apparatus to a skin of the patient by removing the adhesive backing while the supporting apparatus is positioned proximal to the target site, and applying a force to the outer surface of the base layer to adhere the supporting apparatus to the skin of the patient.

11. The method of claim 7, wherein the first condition includes a situation where the patient is in need of resuscitation.

12. The method of claim 7, wherein the first condition further comprises providing a fluid to the patient by way of the extension set and the intraosseous device prior to positioning the supporting apparatus proximal to the target site.

13. An apparatus for supporting an intraosseous device disposed at a target site in a patient, comprising: a hollow cylindrical support structure including a support structure base, the hollow cylindrical support structure and the support structure base coupled to an outer surface of a base layer, the base layer additionally having an inner surface with an adhesive included on at least a portion of the inner surface, the adhesive protected via removable adhesive backing; the base layer including a hole with a hole diameter equal to an inner diameter of the hollow cylindrical support structure, the hole of the base layer flush with an inner wall of the hollow support structure; the inner diameter of the hollow cylindrical support structure minus the exterior diameter of the intraosseous device is greater than 8 mm but less than 13 mm to maintain an absence of physical contact between the inner wall of the hollow support structure and the intraosseous device; the apparatus configured to, when secured to a skin of the patient via the adhesive, reduce or avoid movement of the intraosseous device in response to a lateral force applied to an external wall of the hollow cylindrical support structure.

14. The apparatus of claim 13, wherein a height of the hollow cylindrical support structure as measured from the support structure base to an outer edge of the hollow cylindrical support structure is greater than an outer diameter of the hollow cylindrical support structure.

15. The apparatus of claim 13, wherein the inner diameter of the hollow cylindrical support structure is equal throughout an entirety of the hollow cylindrical support structure.