Patent Description:
The individual performing the intramuscular injection, who is typically a health care practitioner such as a doctor, a nurse, a medical technician, a pharmacist, or other provider such as a family member, acquaintance or roommate of the patient, must be aware of the proper location for the injection and the neurovascular structures present within the region of the injection. For deltoid injections, the deltoid mass is relatively small compared to other intramuscular injection sites, and therefore, resulting in a small margin for error at the deltoid site.

The deltoid muscle is a generally accepted site for the injection of vaccines in children aged <NUM>-<NUM> months, older children and adults. It is extremely important to accurately identify the safe zone for injection. Upper arm injury can be a complication of an improper deltoid muscle injection. Problems with injection in the incorrect site of a deltoid injection include injection site reactions such as pain, erythema, induration and swelling at the injection site. Problems arise due to injection of the anatomical structures within or near the deltoid muscle, including the subdeltoid/subacromial bursa, anterior branch of the axillary nerve and the radial nerve. These issues are due to lack of awareness of these structures within and near the deltoid muscle.

Various methods exist to locate the safe zone for a deltoid injection, which can be found in medical and nursing textbooks, on the internet and in journals, but they all involve unacceptable variability and uncertainty. There is no universally accepted agreement on the particular location of the injection, and a variety of distances below the acromion have been recommended. <FIG> shows anatomical markers that may be used to determine the injection site for a deltoid injection. At least one author indicates that injection into the site midway between the acromion <NUM> and the deltoid tuberosity <NUM> is preferred to achieve injection in the deltoid muscle <NUM>. One method is for the practitioner giving the injection to draw an imaginary a safe zone square, which represents the safe zone of injection. The top of the square is about one or two finger widths below the acromion <NUM>, and the bottom of the deltoid is at the insertion of the deltoid muscle approximately from the fold of the axilla <NUM>. The optimal site of injection is at the middle portion of this square. Another way for an individual to determine the site of injection is to locate the acromion <NUM> and to draw a line laterally across the deltoid muscle from the apex of the axilla. Some medical literature has recommended visualizing the base <NUM> of a triangle <NUM> on the acromion <NUM>. However, other medical literature has recommended placing the base <NUM> of the triangle two to three finger breadths below the acromion <NUM> as shown in <FIG>. A practitioner can use their hand <NUM> as shown in <FIG> with the thumb <NUM> extended to form a partial outline of the imaginary triangle <NUM>. The injection site is the midpoint of the triangle.

The variety of techniques to locate a safe deltoid injection site leads to uncertainty and guesswork in making deltoid injections. For example, there is uncertainty with respect to where the practitioner is place their fingers. Many practitioners who administer immunization injections do not frequently administer deltoid injections and lack proficiency to determine the proper site of injection. In addition, variation in the size of hands and fingers of various practitioners can lead to further uncertainty in making proper deltoid injections. There is a need to provide a device that provides greater certainty and repeatability in determining the site of deltoid injections to reduce the frequency of problems such as injection of the subdeltoid/subacromial bursa, anterior branch of the axillary nerve and the radial nerve.

<CIT> discloses a multi-purpose drawing instrument.

<CIT> discloses an intramuscular painless spot positioning ruler.

<CIT> discloses a visual aid and manipulative for demonstrating geometric and trigonmetric functions.

<CIT> discloses a self-administered injection device.

One aspect of the present disclosure provides a device to locate an intramuscular site of an injection comprising a top element including a first end and a second end, and a top edge configured to be placed adjacent to a patient's acromion; a first leg pivotally attached to.

Another aspect of the disclosure pertains to an intramuscular injection kit comprising a hypodermic needle sized for intramuscular injection in a deltoid region of a patient; a syringe connectable to the hypodermic needle; and the device described herein.

One or more examples of the disclosure are directed to a method of locating the site of an intramuscular injection comprising: placing a top edge of a first element having a first end and a second end against the acromion of a patient; and positioning a first leg attached to the first end and a second leg attached to the second end in one of a first position and a second position to form a substantially triangular shaped region having a center, wherein when positioned in the first position, the center of the triangular region corresponds to the site of intramuscular injection for an adult patient's deltoid region, and when positioned in the second position, the center of the triangular region corresponds to the site of intramuscular injection for a child patient's deltoid region.

Before describing several exemplary embodiments and examples of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

The term "horizontal" as used herein is defined as a plane parallel to the plane or surface of a mask blank, regardless of its orientation. The term "vertical" refers to a direction perpendicular to the horizontal as just defined. Terms, such as "above", "below", "bottom", "top", "side" (as in "sidewall"), "higher", "lower", "upper", "over", and "under", are defined with respect to the horizontal plane, as shown in the figures.

The term "on" indicates that there is direct contact between elements. The term "directly on" indicates that there is direct contact between elements with no intervening elements.

Referring now to <FIG>, a first aspect of the present disclosure pertains to a device to aid in location of an intramuscular site of an injection. According to the invention, the device is configured to locate the intramuscular site of injection of a patient's deltoid region.

According to one or more embodiments, the device may be used by persons of any level of skill and experience in administering intramuscular injections. The device provides a universal standard for enabling those that are not experienced or proficient in administering intramuscular injections to the deltoid region. Intramuscular injections may also be performed in a doctor's office, a hospital, a clinic or other medical facility for a variety of reasons, such as for dispensing pain medication, immunizations or other medicaments. By providing a universal standard for locating the site of injection of the deltoid region, problems associated with errant injections are reduced and/or eliminated.

In particular, the device will aid in avoiding the incorrect site of a deltoid injection, which will reduce or prevent injection site reactions such as pain, erythema, induration and swelling at the injection site. Problems, which arise due to injection of the anatomical structures within or near the deltoid muscle, including the subdeltoid/subacromial bursa, anterior branch of the axillary nerve and the radial nerve, are reduced or prevented according to one or more embodiments described herein.

According to one or more embodiments, the device includes guidance information and clearly marked reference points to align anatomically with the patient and the provider to ensure proper identification of the proper area on the patient for immunization. In some embodiments, the device can be used as a training aid, a simulator or on actual patients to ensure the correct site to successfully administer an intramuscular injection in the deltoid muscle.

The device according to one or more embodiments takes the guess work away from the individual performing the injection as to where to place their fingers to obtain the proper alignment. Many people who administer intramuscular injections do not do so with a high degree of frequency or are not as skilled with respect to proper anatomical alignment to avoid mis-administration or negative outcomes. In some embodiments, the device can be used as a job aid or clinical reference tool for intramuscular injections of the deltoid region.

In one or more embodiments, a simple and reusable device is provided that can be used in teaching, simulation or on a patient. The device according to some embodiments provides a simple yet elegant solution to textbook and two-dimensional learning. According to some embodiments, the device will improve outcomes, minimize possible negative complications and develop confidence in individuals tasked with the perilous job of administering intramuscular injections. Embodiments provide a simple to use device that includes all of the anatomically correct alignments for both adult and children patients to allow intramuscular injections in the proper site.

Referring now to <FIG>, a first embodiment of the device <NUM> includes a top element <NUM> including a first end <NUM> and a second end <NUM>, and a top edge <NUM> configured to be placed adjacent to a patient's acromion. A person of ordinary skill in the art will understand that the acromion is a bony process on the scapula, commonly known as the shoulder blade. In some embodiments, acromion placement indicia <NUM> is located immediately below the top edge <NUM> of the device <NUM>. The acromion placement indicia <NUM> provides a visual marker corresponding to an anatomical reference point of a human patient so that the device is configured to locate the proper site of an intramuscular injection. The acromion indicia <NUM> can include words such as "TOP OF SHOULDER" as shown in <FIG> and <FIG>. Other suitable indicia can also be used to indicate where to place the device <NUM> for a deltoid injection.

In the embodiment shown, the device further comprises a first leg <NUM> pivotally attached to the first end <NUM> of the top element <NUM> such that the first leg <NUM> has an attached end 120a and a free end 120f. The device further comprises a second leg <NUM> pivotally attached to the second end <NUM> such that the second leg <NUM> has an attached end 130a and a free end 130f. The attached ends 120a and 130a can be attached to the top element <NUM> by any suitable attachment mechanism. For example, a rivet, a nut and bolt, or a fastening pin could be used with holes punched in the attached ends 120a and 130a and the first end <NUM> and the second end to aid in securing the legs 120a to the top element <NUM> so that the legs are pivotally attached to the top member. The legs <NUM> and <NUM> can swing freely and can be pivoted to form two different sized triangular regions, as will be described further below.

The device <NUM> shown in <FIG> and <FIG> further comprise an end fastener pair including a first portion 151a attached adjacent to the free end 120f of the first leg <NUM> and a second portion 151b attached adjacent to the free end 130f of the second leg <NUM>, and an intermediate fastener pair including a first portion 150a attached on the first leg <NUM> between the first portion 151a of the end fastener pair and the attached end 120a of the first leg <NUM>, the intermediate fastener pair including a second portion 150b attached on the second leg <NUM> between the second portion 151b of the first fastener pair and the free end 130f of the second leg <NUM>.

According to the invention, , the top element <NUM>, the first leg <NUM> and the second leg <NUM> are sized such that when the end fastener pair is fastened together, the first leg <NUM>, the second leg <NUM> and the top element <NUM> form a substantially triangular region <NUM> having a center 180c, wherein the center 180c (shown in <FIG>) of the substantially triangular region <NUM> which corresponds to an intramuscular site of injection in the deltoid region for an adult patient when the top edge <NUM> of the top element <NUM> is place against an adult patient's acromion.

A person of ordinary skill in the art will understand that lines are drawn from each corner (or vertex) of a triangle to the midpoint of the opposite side of each vertex, then those three lines meet at a center, or centroid, of the triangle. The centroid is the triangle's center of gravity, where the triangle balances evenly. While drawing these lines is not necessary to utilize the device of the instant disclosure, this information may be useful to a user of the device to provide a visual aid in determining the proper site of intramuscular injection. There is some degree of freedom from the exact geometric center of the triangle, such that deviation from the exact geometric center will still result in a successful intramuscular injection without side effects discussed above. However, for training and explanation of the use of the device, the description of the true geometrical center of the triangle may be desired. "Substantially triangular region" refers to a region that generally corresponds to a triangle. As shown in <FIG> and <FIG>, the top element <NUM> has a slight degree of curvature.

According to the invention, the top element <NUM>, the first leg <NUM> and the second leg <NUM> are sized such that when the intermediate fastener pair is fastened together, the first leg <NUM>, the second leg <NUM> and the top element <NUM> form a substantially triangular region <NUM> having a center 180c, wherein the center 180c of the substantially triangular region corresponds to an intramuscular site of injection in the deltoid region for a child patient when the top edge of the top element is place against a child patient's acromion.

A person of ordinary skill in the art will recognize that a child patient has a smaller deltoid region than an adult patient. Therefore, the first leg <NUM> and the second leg <NUM> have a length and the end fastener pair first portion 151a and second portion 151b located adjacent to the free ends 120f, 130f of the first leg <NUM> and the second leg are positioned so that the triangle formed by fastening the end fastener pair together generally corresponds with the deltoid region of an average adult patient. Likewise, intermediate fastener pair first portion 150a and second portion 150b are so that that the triangle <NUM> formed by fastening the end fastener pair together generally corresponds with the deltoid region of an average child patient.

In some embodiments, the end fastener pair comprises a hook and loop closure system, which is also known as a VELCRO® brand fastener. In some embodiments, the fastener pair may comprise a snap, which can comprise a pair of interlocking discs. Other suitable fastener pairs may include cooperating adhesive surfaces. The intermediate fastener pair according to some embodiments can comprises a hook and loop closure system, a snap, or other suitable fastener pairs such as cooperating adhesive surfaces.

Referring to <FIG> and <FIG>, in some embodiments, the top element <NUM> comprises finger indicia <NUM> to indicate a location for an individual performing the intramuscular injection to place their index finger and middle finger on the top member. In the embodiment shown, an outline of the index and middle finger of a left hand are shown as the finger indicia <NUM>.

In some embodiments, the first leg <NUM> comprises right hand thumb indicia <NUM> to indicate a location for an individual performing the intramuscular injection to align a right thumb. The right hand thumb indicia <NUM> can comprise the words "ALIGN THUMB HERE (RH) or other suitable indicia.

In one or more embodiments, the second leg <NUM> comprises left hand thumb indicia <NUM> to indicate a location for an individual performing the intramuscular injection to align their left thumb. The left hand thumb indicia <NUM> can comprise the words "ALIGN THUMB HERE (LH) or other suitable indicia. The right hand thumb indicia <NUM> and left hand thumb indicia <NUM> may be desirable as a training aid for those individuals who have been accustomed to or trained to use the technique for locating the site of injection using their hand. Therefore, this indicia provides a useful training aid and reference points for the individual providing the injection.

In some embodiments, the first leg <NUM> and second leg 130each comprises indicia <NUM>, <NUM> adjacent to the end fastener pair indicating fastening the device at the end fastener pair provides an injection site location for an adult patient. As shown in <FIG> and <FIG>, the second leg <NUM> includes indicia <NUM> in the form of a triangle marker and the word "Adult" adjacent to the intermediate fastener pair second portion 150b, and the first leg <NUM> includes indicial <NUM> in the form of a triangle mark and the word "Adult" adjacent to intermediate fastener first portion 150a.

In one or more embodiments the first leg <NUM> and second leg <NUM> each comprises indicia <NUM>, <NUM> adjacent to the intermediate fastener pair indicating that fastening the device at the end fastener pair provides an injection site location for a child patient. As shown in <FIG> and <FIG>, the first leg <NUM> includes indicia <NUM> adjacent to the first portion 150a of the intermediate fastener pair, and the second leg <NUM> includes indicia <NUM> adjacent to the second portion 150b of the intermediate fastener pair.

The device is configured and the indicia <NUM>, <NUM> on the first leg <NUM> and the indicia <NUM>, <NUM> on the second leg <NUM> are placed at a distance from the attached ends 120a, 130a of the respect first leg <NUM> and second leg <NUM> to provide anatomical reference points so that when the triangular region <NUM> is formed by fastening the intermediate fastener pair, the center 180c of the triangular region <NUM> is located at the proper site of injection for a child patient. Likewise, when the triangular region <NUM> is formed by fastening the end fastener pair, the center 180c of the triangular region <NUM> is located at the proper site of injection for a child patient. The device provides consistent and nonvariable reference points for any individual performing an intramuscular injection at the deltoid region of an adult or child patient. The guess work has been removed, and a person providing the injection can confidently inject a patient in the deltoid region with fear of causing upper arm pain or other complications associated with injection in the improper site.

In one or more embodiments, the device <NUM> is made from an opaque material such as paper, cardboard or paper. Thus, the top element <NUM>, the first leg <NUM> and the second leg <NUM> are made from an opaque material such as paper, cardboard or paper. In other embodiments, the device <NUM> is made from a transparent plastic or translucent plastic, which further enhances visualization when injecting the deltoid muscle. Examples of transparent plastics include, but are not limited to acrylics (e.g., polymethlamethacrylate), butyrates (e.g., cellulose acetate butyrate), polycarbonates (e.g., Lexan), and terphthalates (e.g., glycol modified polyethylene terphthalate (PETG)).

Referring now to <FIG>, another aspect of the disclosure provides an intramuscular injection kit <NUM>. The kit <NUM> comprises a hypodermic needle <NUM> sized for intramuscular injection in a deltoid region of a patient. In this regard, a second needle may be provided. Referring back to <FIG> and <FIG>, the device <NUM> can include needle indicia <NUM> indicating the appropriate sized needle for the injection. For example, the needle indicia <NUM> may state "Use <NUM> X <NUM>" or <NUM> by <NUM>/<NUM> needle" or other suitable indicia to advise the person providing the injection the proper size needle to use. The second leg <NUM> may include safety indicia <NUM> advising the individual using the device <NUM> to use the safety device after the injection. The safety indicia may include a message "Activate safety device after injection" or other indicia to provide for safe use of the device and the associated needle.

Referring back to <FIG>, the kit <NUM> may further comprise a syringe <NUM> connectable to the hypodermic needle <NUM>. The kit may further comprise a tray <NUM>, which may comprise thermoformed plastic. The syringe <NUM>, the hypodermic needle <NUM> and the device may all be placed in the tray <NUM>, which can be sealed. The kit <NUM> can include any or all of the features described above with respect to the device <NUM>.

Another aspect of the disclosure pertains to a method of locating the site of an intramuscular injection. In one or more embodiments, the method includes placing a top edge <NUM> of a top element <NUM> having a first end <NUM> and a second end <NUM> against the acromion of a patient. The method further includes positioning a first leg <NUM> attached to the first end <NUM> and a second leg attached to the second end <NUM> in one of a first position and a second position to form a substantially triangular region <NUM> having a center 180c. When positioned in the first position, the center 180c of the triangular region <NUM> corresponds to the proper site of intramuscular injection for an adult patient's deltoid region. It will be appreciated with respect to <FIG> and <FIG>, the first position corresponds to the end fastener pair being fastened together. When positioned in the second position, the center 180c of the triangular region <NUM> corresponds to the site of intramuscular injection for a child patient's deltoid region. It will be appreciated with respect to <FIG> and <FIG> that the second position corresponds to the intermediate fastener pair being fastened together.

In some examples of the method, an individual administering the intramuscular injection places an index finger and a middle finger from a left hand or a right hand on finger indicia which indicates where to place the index finger and middle finger on the device, the finger indicia located on the top element <NUM>.

In some examples of the method, the individual providing the injection aligns their thumb of the hand from which the index finger and middle finger has been placed on the top element on one of the first leg or the second leg. For example, if the individual administering the intramuscular injection has placed their index finger and middle finger from their right hand on the indicia of the top element, the individual aligns their thumb from their right hand with the first leg <NUM>. Conveniently, the first leg <NUM> includes right hand thumb indicia <NUM> to aid the individual administering the injection in properly placing their thumb on the first leg <NUM>.

Alternatively, if the individual administering the intramuscular injection has placed their index finger and middle finger from their left hand on the indicia of the top element, the individual aligns their thumb from their left hand with the second leg. Conveniently, the second leg <NUM> includes left hand thumb indicia <NUM> to aid the individual administering the injection in properly placing their thumb on the second leg <NUM>.

In some examples, , the method includes fastening the first leg <NUM> and the second leg <NUM> in the first position, for example, with the end fastener pair fastened together. The device is now ready to be used to provide an intramuscular injection in the deltoid region to an adult patient.

For administering an injection to a child patient, method includes fastening the first leg <NUM> and the second leg <NUM> in the second position. This can be accomplished by fastening the intermediate fastener pair. The device is now ready to use to provide a child with an intramuscular injection in the deltoid region.

The method may further comprise the individual reading indicia on the device indicating a proper size hypodermic needle for the intramuscular injection and fastening the hypodermic needle to syringe.

Reference throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments" or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as "in one or more embodiments," "in certain embodiments," "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

Claim 1:
A device (<NUM>) to locate an intramuscular site of an injection of a patient, the device (<NUM>) comprising:
a top element (<NUM>)including a first end (<NUM>) and a second end (<NUM>), and a top edge (<NUM>) configured to be placed adjacent to a patient's acromion;
a first leg (<NUM>) pivotally attached to the first end (<NUM>) of the top element (<NUM>) such that the first leg (<NUM>) has an attached end (120a) and a free end (120f);
a second leg (<NUM>) pivotally attached to the second end (<NUM>) such that the second leg (<NUM>) has an attached end (130a) and a free end (130f); and
an end fastener pair including a first portion (151a) attached adjacent to the free end (120f) of the first leg (<NUM>) and a second portion (151b) attached adjacent to the free end (130f) of the second leg (<NUM>), and an intermediate fastener pair including a first portion (150a) attached on the first leg (<NUM>) between the first portion of the end fastener and the attached end (120a) of the first leg (<NUM>), the intermediate fastener pair including a second portion (150b) attached on the second leg between the second portion of the first fastener and the free end of the second leg
characterized in that
the first leg (<NUM>) and the second leg (<NUM>) have a length and the end fastener pair first portion (151a) and second portion (151b) located adjacent to the free ends (120f, 130f) of the first leg (<NUM>) and the second leg are positioned so that the triangle (<NUM>) formed by fastening the end fastener pair together generally corresponds with the deltoid region of an average adult patient and the intermediate fastener pair first portion (150a) and second portion (150b) are positioned so that that the triangle (<NUM>) formed by fastening the end fastener pair together generally corresponds with the deltoid region of an average child patient.