Patent Description:
<CIT> and <CIT> disclose landmarking devices for intraosseous injection needles.

Some current practices for humeral intraosseous needle placement involve manual tactile land marking over the lateral upper arm to determine proper intraosseous needle insertion site. For proper humeral intraosseous needle placement, the intraosseous needle should be inserted into the humeral head. For patients with thick musculature or thick adipose tissue within this region, tactile land marking to identify the humeral head can be difficult and time consuming. Furthermore, tactile land marking can be difficult for new or infrequent intraosseous needle placement users or in critical time periods. It would be beneficial to the clinicians to be able to consistently, and with minimal effort, correctly identify the humeral head through landmarking the humeral region for proper intraosseous needle placement. Disclosed herein is an apparatus and a method that addresses the foregoing.

A humeral intraosseous landmarking apparatus according to the invention is defined in claim <NUM>. The dependent claims define preferred embodiments.

Disclosed herein is humeral intraosseous landmarking apparatus having a tab including an acromion placement circle, a band including a lateral epicondyle placement circle, where the lateral epicondyle placement circle and the acromion placement circle are separated by a fixed landmarking distance, and an intraosseous needle ring configured to landmark a humeral head, the intraosseous needle ring having a proximal end coupled to the tab and a distal end coupled to the band.

In some embodiments, the apparatus includes a top side and a bottom side.

In some embodiments, the tab includes a tab length and the band includes a band length and the length is greater than the tab length.

In some embodiments, the lateral epicondyle placement circle is located at a distal end of the band.

In some embodiments, the tab, the band and the intraosseous needle ring include an adhesive compound on the bottom side.

In some embodiments, the intraosseous needle ring includes a beveled edge, where the beveled edge includes an angle within the range of <NUM>°-<NUM>° in relation to the bottom side.

In some embodiments, the intraosseous needle ring includes an antimicrobial patch detachable coupled to the bottom side of the intraosseous needle ring.

In some embodiments, the apparatus includes a needle stabilizing device configured to fit within the intraosseous needle ring.

In some embodiments, the needle stabilizing device includes a needle stabilizing device lumen configured to receive an intraosseous needle and stabilize the intraosseous needle.

In some embodiments, the tab and the band include pressure paper configured to change from a first color to a second color with an increase in pressure upon the pressure paper by a hard surface.

In some embodiments, the tab includes a first score line configured to detach the tab from the proximal end of the intraosseous needle ring and the band includes a second score line configured to detach the band from distal end of the intraosseous needle ring.

Also disclosed herein is a method for landmarking the humeral region for intraosseous access, including configuring an arm of a patient for intraosseous needle placement, locating an acromion of the patient, overlaying an acromion placement circle of the intraosseous humeral landmarking apparatus over the acromion, locating a lateral epicondyle of the patient, overlaying the lateral epicondyle placement circle of the intraosseous humeral landmarking apparatus onto the lateral epicondyle, and inserting an intraosseous needle within an intraosseous needle ring of the intraosseous humeral landmarking apparatus.

In some embodiments, the intraosseous humeral landmarking apparatus includes a tab having the acromion placement circle , a band having a lateral epicondyle placement circle, where the lateral placement circle and the acromion placement circle are separated by a fixed landmarking distance, and the intraosseous needle ring configured to landmark a humeral head, the intraosseous needle ring having a proximal end coupled to the tab and a distal end coupled to the band.

In some embodiments, the intraosseous humeral landmarking apparatus includes a top side and a bottom side, where the bottom side includes an adhesive compound thereon.

In some embodiments, configuring includes adducting the patient's arm and configuring the patient's palm to be placed over a patient's umbilicus.

In some embodiments, locating the acromion includes using palpation, ultrasound imaging or infrared imaging for locating the acromion.

In some embodiments, overlaying includes adhering the acromion placement circle to the skin above the acromion.

In some embodiments, locating the lateral epicondyle includes using palpation, ultrasound imaging or infrared imaging for locating the lateral epicondyle.

In some embodiments, overlaying includes adhering the lateral epicondyle placement circle to the skin above the lateral epicondyle.

In some embodiments, inserting an intraosseous needle ring includes inserting an intraosseous needle within the intraosseous needle ring into a humeral head.

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

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

<FIG> illustrates a perspective view of an arm including a humeral head. In placing an intraosseous needle within the humeral region of the arm <NUM> of a patient, a clinician must correctly identify the humeral head <NUM>. This process can be difficult if the patient has regions of thick musculature or excessive adipose tissue <NUM>. In identifying the humeral head <NUM>, the clinician may desire to use anatomical landmarks, to identify the humeral head <NUM> among the local anatomy of the humeral region. Two such anatomical landmarks may include the acromion <NUM>, located proximally on the arm <NUM> and the lateral epicondyle <NUM> located distally on the arm <NUM>. The distance between the acromion <NUM> and the lateral epicondyle <NUM> may be considered to be a fixed landmarking distance <NUM>, as the landmarking distance <NUM> is similar for most patients, providing consistent anatomical landmarks to help locate the humeral head <NUM>.

<FIG> illustrates a plan view of the intraosseous humeral land marking apparatus ("apparatus") <NUM>, in accordance with some embodiments. In some embodiments, the apparatus <NUM> may be used to quickly landmark and locate the humeral head for intraosseous needle placement and insertion. In some embodiments, the apparatus <NUM> includes a tab <NUM> and a band <NUM> coupled to an intraosseous needle ring <NUM>. The intraosseous needle ring <NUM> may include a proximal end, coupled to the tab <NUM> and a distal end, coupled to the band <NUM>. The intraosseous needle ring <NUM> may be configured to landmark a humeral head for the placement and insertion of an intraosseous needle when the apparatus <NUM> is deployed on a patient. The intraosseous needle ring <NUM> includes an intraosseous needle ring diameter <NUM>. The tab <NUM> includes an acromion placement circle <NUM> thereon. The acromion placement circle <NUM> may be configured to be placed over a patient's acromion during deployment of the apparatus <NUM>. The band <NUM> includes a lateral epicondyle placement circle ("distal placement circle") <NUM> thereon. The distal placement circle <NUM> may be configured to be placed over a patient's lateral epicondyle during deployment of the apparatus <NUM>. In some embodiments, the tab <NUM> includes a tab length <NUM> and the band <NUM> includes a band length <NUM> wherein the band length <NUM> is greater than the tab length <NUM>. In some embodiments, the acromion placement circle <NUM> includes an acromion placement circle diameter <NUM> and the distal placement circle <NUM> includes a distal placement circle diameter <NUM>. In some embodiments, the distal placement circle diameter <NUM> may be less than, greater than or equal to the acromion placement circle diameter <NUM>. In some embodiments, the distal placement circle <NUM> is located at a distal end of the band <NUM>. The acromion placement circle <NUM> and the distal placement circle <NUM> may be separated by a fixed landmarking distance <NUM>, as will be described in more detail herein. Advantageously with the fixed landmarking distance <NUM> separating the acromion placement circle <NUM> and the distal placement circle <NUM>, the intraosseous needle ring <NUM> may be configured to landmark the humeral head while avoiding thick musculature and adipose tissue in the humeral region.

<FIG> illustrated a side cross sectional view of the apparatus <NUM> including the intraosseous needle ring <NUM>, in accordance with some embodiments. In some embodiments, the apparatus <NUM> includes a top side and a bottom side, wherein when the apparatus is deployed, the bottom side is in physical contact with the arm and the top side is closest to the clinician. In some embodiments, the intraosseous needle ring <NUM> may protrude longitudinally from the apparatus <NUM>. In some embodiments, the intraosseous needle ring <NUM> may include a beveled edge <NUM> to help promote a specific intraosseous needle insertion angle as an intraosseous driver is perpendicular to the arm. For example, the beveled edge <NUM> may include an angle <NUM> within the range of <NUM>°-<NUM>° in relation to the bottom side, promoting an intraosseous needle insertion angle within the range of <NUM>°-<NUM>° in relation to the bottom side. In some embodiments, the intraosseous needle ring <NUM> may be constructed of the same material as the tab <NUM> and the band <NUM>. In some embodiments, the intraosseous needle ring <NUM> may be rigid and constructed of polymers or plastics (e.g., polyethylene terephthalate, polyvinyl chloride, polystyrene, polypropylene or the like).

<FIG> illustrates a perspective view of the apparatus <NUM> on an arm, in accordance with some embodiments. In some embodiments, a portion of or the entire tab <NUM> may be configured to include an adhesive compound on the bottom side, configured to adhere the tab <NUM> to an arm <NUM>. In some embodiments, the adhesive compound may be confined to the bottom side of the acromion placement circle <NUM>. In some embodiments, a portion of, or the entire band <NUM> may be configured to include the adhesive compound on the bottom side, configured to adhere the tab <NUM> to the arm <NUM>. In some embodiments, the adhesive compound may be confined to the bottom side of the distal placement circle <NUM>. In some embodiments, the apparatus <NUM> may be constructed of polycarbonate, polypropylene, polyethylene, laminated paper, or the like. In some embodiments, the tab <NUM> and the band <NUM> may be configured to include pressure paper. The pressure paper may be configured to change from a first color to a second color with an increase in pressure upon the pressure paper by a hard surface (e.g., humeral head, acromion, lateral epicondyle or the like). In an embodiment, the intraosseous needle ring <NUM> may include an antimicrobial patch, detachably coupled to the bottom side of the intraosseous needle ring <NUM> and extending along the intraosseous needle ring diameter <NUM>. In this embodiment, the antimicrobial patch may be configured to target and protect an intraosseous insertion area after the intraosseous needle is inserted therein. In some embodiments, the apparatus <NUM> may be used as a training device during clinician training to help clinicians quickly familiarize themselves with visual identification of the humeral region and identifying the humeral head.

<FIG> illustrate an exemplary method of landmarking the humeral region for intraosseous needle placement, in accordance with some embodiments. In some embodiments, as illustrated in <FIG>, the arm <NUM> of the patient is configured for landmarking by adducting the patient's arm <NUM> and placing the patient's palm over their umbilicus. Once the arm <NUM> of the patient is configured for landmarking, the apparatus <NUM> may be deployed on the patient's arm <NUM>. The acromion placement circle <NUM> may be placed upon the acromion <NUM> of the patient, as illustrated in <FIG>. With the acromion placement circle <NUM> placed upon the acromion <NUM>, the distal placement circle <NUM> may be placed upon the lateral epicondyle <NUM> as illustrated in <FIG>. With the acromion placement circle <NUM> placed upon the acromion <NUM> and the distal placement circle <NUM> placed upon the lateral epicondyle <NUM>, the intraosseous needle ring <NUM> is configured to indicate the location of the humeral head <NUM> for intraosseous needle insertion. A intraosseous access system including an intraosseous driver <NUM> having an intraosseous needle may be assembled for humeral intraosseous access within the intraosseous needle ring <NUM>, as illustrated in <FIG>. In some embodiments, a clinician may indicate the proper intraosseous needle area by tracing the intraosseous needle ring <NUM> with a marking device, before removing the apparatus <NUM> from the patient's arm <NUM>.

<FIG> illustrate a perspective view of an embodiment of the apparatus <NUM> in accordance with some embodiments. In this embodiment, as illustrated in <FIG>, the apparatus <NUM> may include a needle stabilizing device <NUM>, configured to fit within the intraosseous needle ring <NUM>, In this embodiment, the bottom side of the needle stabilizing device <NUM> may be configured to be coupled to the arm <NUM> by the adhesive compound. In this embodiment, the needle stabilizing device <NUM> may include a needle stabilizing device lumen <NUM> therethrough. The needle stabilizing device lumen <NUM> may be configured to allow and secure an intraosseous needle therethrough. In this embodiment, the needle stabilizing device <NUM> may indicate the proper location of humeral head <NUM> and also configure the intraosseous needle at an optimized angle for intraosseous access. In this embodiments, once the needle stabilizing device <NUM> is coupled to the arm <NUM>, the apparatus <NUM> may be removed from the arm <NUM>, as illustrated in <FIG>. In this embodiment, the needle stabilizing device <NUM> may be in the shape of a disc, a rectangular prism or the like.

<FIG> illustrate an exemplary method of landmarking the humeral region for proper intraosseous needle placement, in accordance with some embodiments. In an embodiment, as illustrated in <FIG>, the tab <NUM> may include a first score line <NUM> and the band <NUM> may include a second score line <NUM>. In this embodiment, a portion of the bottom side of the intraosseous needle ring <NUM> may include the adhesive compound configured to secure the intraosseous needle ring <NUM> to the arm <NUM>. In this embodiment, the first score line <NUM> may be located proximal the intraosseous needle ring <NUM> and the second score line <NUM> may be located distal the intraosseous needle ring <NUM>. The apparatus <NUM> may be placed on the arm <NUM> wherein the acromion placement circle <NUM> is over the acromion <NUM> and the distal placement circle <NUM> is over the lateral epicondyle <NUM>. The intraosseous needle ring <NUM> may then be secured to the arm <NUM>, as illustrated in <FIG>. In this embodiment, the tab <NUM> may be configured to separate from the intraosseous needle ring <NUM> along the first score line <NUM> and the band <NUM> may be configured to separate from the intraosseous needle ring <NUM> along the second score line <NUM> using a lateral tearing force. As illustrated in <FIG>, separating the tab <NUM> and the band <NUM> from the intraosseous needle ring <NUM> leaves the intraosseous needle ring <NUM> attached to the arm <NUM>, indicating the proper location for intraosseous needle placement in the humeral head <NUM>, as illustrated in <FIG>. In this embodiment, the intraosseous needle ring <NUM> may be configured to stabilize the intraosseous needle, once the intraosseous needle is inserted through the intraosseous needle ring <NUM>.

<FIG> illustrates a flow chart of the exemplary method <NUM> of landmarking the humeral region for intraosseous needle placement, in accordance with some embodiments. The method <NUM> includes configuring the patient's arm for intraosseous needle placement (block <NUM>). In some embodiments, configuring includes a clinician adducting the patient's arm and the patient's palm being placed over the patient's umbilicus. In some embodiments, the method <NUM> includes locating the acromion <NUM> (block <NUM>). In some embodiments, the clinician may locate the acromion <NUM> of the patient using palpation, ultrasound imaging, infrared imaging or the like. The method <NUM> further includes overlaying the acromion placement circle <NUM> of the apparatus <NUM> over the acromion (block <NUM>). In some embodiments, overlaying includes adhering the acromion placement circle <NUM> to the skin above the acromion <NUM>. The method <NUM> further includes locating the lateral epicondyle <NUM> (block <NUM>). In some embodiments, locating includes the clinician locating the lateral epicondyle <NUM> by palpation, ultrasound imaging, infrared imaging or the like. The method <NUM> further includes overlaying the distal placement circle <NUM> over the lateral epicondyle <NUM> (block <NUM>). In some embodiments, overlaying includes adhering the distal placement circle <NUM> to the skin above the lateral epicondyle <NUM>. The method <NUM> includes inserting an intraosseous needle within the intraosseous needle ring <NUM> (block <NUM>). In some embodiments, inserting includes inserting the intraosseous needle within the intraosseous needle ring <NUM> into a humeral head <NUM>.

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.

Claim 1:
A humeral intraosseous landmarking apparatus (<NUM>), comprising:
a tab (<NUM>) including an acromion placement circle (<NUM>);
a band (<NUM>) including a lateral epicondyle placement circle (<NUM>), wherein the lateral epicondyle placement circle (<NUM>) and the acromion placement circle (<NUM>) are separated by a fixed landmarking distance; and
an intraosseous needle ring (<NUM>) configured to landmark a humeral head, the intraosseous needle ring (<NUM>) having a proximal end coupled to the tab (<NUM>) and a distal end coupled to the band (<NUM>).