BACKGROUND

The continuation of unsafe injection practices in healthcare applications puts patients and healthcare providers in hospitals, clinics, practices and elsewhere at risk for largely preventable negative health effects. For example, a common procedure is a deltoid intramuscular injection, which can be conducted in various locations such as in pharmacies, clinics, physicians' offices and hospitals. Other sites for intramuscular injections include the vastus lateralis (thigh) muscle, ventrogluteal site (hip), and the dorsogluteal site (buttock). Muscles have larger and more blood vessels than subcutaneous tissue and injections here usually have faster rates of absorption than subcutaneous injections or intradermal injections.

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 12-18 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.1shows 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 acromion50and the deltoid tuberosity52is preferred to achieve injection in the deltoid muscle54. McGarvey MA, Hooper AL. The deltoid intramuscular injection site in the adult—current practice among general practitioners and practice nurses. Ir Med J. 2005; 98:105-7. 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 acromion50, and the bottom of the deltoid square is at the insertion of the deltoid muscle approximately from the fold of the axilla56. 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 acromion50and to draw a line laterally across the deltoid muscle from the apex of the axilla. Some medical literature has recommended visualizing the base57of a triangle58on the acromion50. However, other medical literature has recommended placing the base57of the triangle two to three finger breadths below the acromion50as shown inFIG. 1. A practitioner can use their hand60as shown inFIG. 1with the thumb62extended to form a partial outline of the imaginary triangle58. 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 and a method 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.

SUMMARY OF THE DISCLOSURE

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 second leg pivotally attached to the first end of the top element such that the first leg has an attached end and a free end; a second leg pivotally attached to the second end such that the first leg has an attached end and a free end; an end fastener pair including a first portion attached adjacent to the free end of the first leg and a second portion attached adjacent to the free end of the second leg, and an intermediate fastener pair including a first portion attached on the first leg between the first portion of the end fastener and the attached end of the first leg, the intermediate fastener pair including a second portion attached on the second leg between the second portion of the end fastener pair and the attached end of the second leg.

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 embodiments 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.

