Injection patch for the skin to guide the administering of intramuscular injections

Abstract

An injection patch that can be used on a person's skin for administering intramuscular injections is provided. The injection patch has many advantageous features including comfort, flexibility, and durability. The injection patch provides landmarks on the skin and helps a health care provider or other immunizer to administer the injection to the correct site on the patient's skin. The injection patch contains at least one opening defining a visible injection field on the skin, wherein the injection can be administered. The injection patch is particularly effective for administering intramuscular vaccines.

Description

INJECTION PATCH FOR THE SKIN TO GUIDE THE ADMINISTERING OF INTRAMUSCULAR INJECTIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The application claims the benefit of U.S. Provisional Patent Application No. 63 / 572,192 filed March 30, 2024, the entire disclosure of which is hereby incorporated by reference.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present invention relates generally to an injection patch that can be used on a person’s skin for administering intramuscular injections. The injection patch provides landmarks on the surface of the patient’s skin and helps a health care provider to administer the injection into the correct area of the skin. The injection patch is particularly effective for administering intramuscular vaccines.Brief Review of the Related Art

[0003] Shoulder injuries related to vaccine administration (SIRVA) are an underdiagnosed, underreported, misunderstood, and preventable series of events caused by incorrect technique or landmarking for intramuscular deltoid injections. Many patients do not understand that SIRVA exists and do not report SIRVA because they feel that they are reacting to the injection or vaccine.

[0004] SIRVA can occur when an intramuscular deltoid injection is administered into the shoulder joint, too high in the arm, in the acromion or radial nerve, too low in the arm, or administered at an incorrect angle. Patients will often visit their physicians, days, weeks or months later, having been in persistent pain since about 24 hours or more after the injection, because they are not able to carry out daily tasks that were possible before the injection. These patients are often then diagnosed with inflammatory injuries such as bursitis, rotator cuff tears,and adhesive capsulitis, totally unrelated to the S1RVA. During an ultrasound scan, SIRVA will not appear to be any different from routine shoulder injuries.

[0005] In recent years, some injection patches have been developed for guiding needle injections into the skin of a person. F or example, Watson el al., U.S. Patent 5,728,071 discloses an injection patch for facilitating injection into a patient and for confining blood from the injection wound. An elastomeric, self-sealing membrane through which an injection needle can penetrate lies against the second surface of the pad and closes the central opening. A cover layer with a central opening overlies the membrane and exposes a central portion of it to identity the injection site. The patch is adhesively held to the patient’s skin. An injection can be made with a needle passed through the membrane and the patient's skin. Then, the needle is extracted while the membrane wipes the needle, reseals, and forms a cavity with the pad and the patient's skin. This seal helps to contain the blood within a specific area.

[0006] Watson, U.S. Patent 7,129,389 discloses an elastomeric puncture site patch. Hie patch is comprised of an elastomeric transparent self-sealing membrane and a spacer having an aperture. The spacer has an adhesive film on the surface opposite the membrane for adhering the patch to the skin. When the patch is applied to an area of the skin, a chamber is formed between the skin and the membrane and bounded by the spacer. Any blood from the needle injection is trapped in the chamber.

[0007] Bangera et al., U.S. Patent 9,205,204 discloses a wearable injection guide comprising a rigid material formed to substantially conform in shape to a person’s body region. For example, the injection guide can conform to a person’s face, torso, abdomen, head, neck, and the like. The rigid material is substantially impenetrable io an injection needle, and the rigid material includes one or more injection needle access regions arranged in a treatment pattern.

[0008] Rieck. U.S. Patent Application Publication 2023 / 0173134 discloses a plaster for use i n the context of an intramuscular injection, particularly a vaccination, having a patient side and an outer side, comprising: an adhesive layer on the patient side for attaching the plaster to the skin of a patient, an absorbent wound-covering on the patient side in the region of an intendedintramuscular injection site, the absorbent wound-covering having received a disinfectant, and an opening on the outer side in the area of the absorbent wound-covering of the patient side for the injection.

[0009] There are numerous vaccines recommended by the Center for Disease Control (CDC). For example, the CDC recommends CO VID-19 vaccines in addition to the over 15 other vaccines. Accordingly, there is an urgent need in the art for new products to address and / or to reduce the risk of SIRVA. There is a strong need for an injection patch that can help reduce the incidence of SIRVA.

[0010] The present invention provides such an injection patch. The injection patch of the present invention has many features, benefits, and advantages as described further below.SUMMARY OF THE INVENTION

[0011] The present invention provides an injection patch that can be used on a person’s skin for correctly administering injections, particularly intramuscular vaccine injections. In one preferred embodiment, the injection patch comprises; a) an elongated body member comprising a first side segment and an opposing second side segment; b) a first end segment and a second end segment, the end segments being joined to the side segments to form a substantially rectangular injection patch; c) at least one transverse opening; the transverse opening extending substantially across the width of the injection patch, the transverse opening defining a visible injection field on the skin, wherein the injection can be administered.

[0012] Preferably, a first tab is attached to the first end segment of the injection patch, and a second tab is attached to the second end segment of the injection patch so the patch can be removed more easily from the skin. 1'he injection patch preferably contains a plurality of transverse openings. For example, the injection patch can contain a first transverse opening that defines a first Injection Field A on the skin; and a second transverse opening that defines a second Injection Field B on the skin, lin one example, Injection Field A is located above Injection Field B on the skin. The first and second transverse openings that define respective Injection Fields A and B preferably have a substantially rectangular shape. The injection patchcan have an outer surface and opposing inner surface, wherein the inner surface has a coating of medical adhesive for removably adhering the patch to the skin.

[0013] In one embodiment, the distance from the upper tab to the first Injection Field A is in the range of about 1 to about 2 inches; and the distance between Injection Field A and Injection Field B is about one inch. The injection patch provides landmarks on the skin surface and helps a health care provider or other immunizer to administer the injection to the correct site on the patient’s skin. The injection patch is particularly effective for administering intramuscular vaccines.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The novel features that are characteristic of the present invention are set forth in the appended claims. However, the preferred embodiments of the invention, together with further objects and attendant advantages, are best understood by reference to the following detailed description in connection with the accompanying drawings in which:

[0015] FIG. 1 is top view of one embodiment of the injection patch of the present invention;

[0016] FIG. 2 is a side perspective view of one embodiment of the injection patch of the present invention showing the injection patch being positioned on the arm of a patient; and

[0017] FIG. 3 is top view of another embodiment of the injection patch of the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0018] The present invention relates generally to an injection patch that can be used on the skin for administering intramuscular injections to patients. 'The injection patch provides landmarks on the surface of the skin and helps a health care provider or other immunizer to administer the injection to the correct site on the skin. The injection patch is particularly effective for administering intramuscular vaccines. Referring to the Figures, where like referencenumerals are used to designate like elements, and particularly FIG. 1, one embodiment of the injection patch (8) is generally shown.

[0019] As illustrated in FIG. 1, die injection patch (8) comprises: a) an elongated body member (10) comprising a first (left) side segment (12) and an opposing second (right) side segment (14); b) a first (top) end segment (16) and a second (bottom) end segment (18), the end segments (16, 18) being joined to the side segments (12, 14) to form a substantially rectangular injection patch; c) at least one transverse opening (20); the transverse opening extending across the width of the elongated member (10), wherein the transverse opening defines an injection field, where the injection can be administered. As shown in FIG. 1, in one preferred embodiment, there are two transverse openings (20A, 20B). A first injection field (A) is shown in the first transverse opening (20A). A second injection field (B) is shown in the second transverse opening (20B). The injection patch (8) includes an outer surface (22) and an opposing inner surface (not shown) that makes direct contact with the skin surface, allowing a person to wear the patch on their arm in a normal manner as discussed further below.

[0020] As discussed above, the injection patch (8) preferably has a plurality of transverse openings (20A, 20B). The first transverse opening (20A) and second transverse opening (20B) can have any suitable shape including, but not limited to, rectangular, circular, oval, triangular, square, diamond, pentagonal, hexagonal, heptagonal, and octagonal, and the like. Preferably, there are two substantially rectangular-shaped transverse openings (20A, 20B) as shown in FIG.1. The substantially rectangular-shaped transverse openings (20A, 20B) can have rounded comers. In one embodiment, the first transverse opening (20A) is located above the second transverse opening (20B).

[0021] As shown in FIG. 1, in one embodiment, the first transverse opening (20A) has an upper edge and a lower edge, and the second transverse opening (20B) has an upper edge and lower edge. The first and second transverse openings (20A, 20B) form a triangular-shaped area (30), wherein the base (32) of the triangle extends across the upper edge of the first transverse opening (20A) and the longitudinal sides (34) of the triangle extend from the base to an apex (36) located at the center point of the lower edge of the second transverse opening (20B). Thistriangular-shaped outline can be marked with adhesive strips of material to form a particularly preferred injection site within Injection Field A and Injection Field B that is clearly visible to the person giving the injection.

[0022] lire transverse openings (20A, 20B) are cut-out areas so that when a person wears the patch (8), his / her skin is visible and a target injection site on the skin is provided. The health care provider or immunizer can see the patient’s skin through the openings (20A, 20B). For example, when the injection patch (8) is placed over the deltoid muscle (42) of the arm (40) of a patient, the upper tab (24) extends outwardly towards the top of the shoulder and does not adhere to the patient’s skin. This ensures the patch (8) is placed correctly on the surface of the skin. When the injection patch (8) is properly positioned on the skin as discussed in further detail below, the target injection site for administering the injection is readily visible.

[0023] In practice, a health care provider, following conventional care, wipes the region of the patient’s skin, where the injection will be administered, with alcohol or other antiseptic solution. Then, the health care provider removes the injection patch (8) from a sterile package (not shown) and positions the patch over the targeted injection site. As shown in FIG. 2, this step involves positioning the injection patch (8) in such a manner that the transverse openings (20A, 20B) are aligned with the target injection site(s) on the patient’s skin surface, for example, the patient’s left or right arm. In this way, the target injection site(s) on the skin surface are clearly visible to the health care provider; and he / she can properly administer the injection.

[0024] More particularly, the injection patch (8) is positioned such that a first injection is given in Injection Field A as defined by the first transverse opening (20A) and as shown in FIG.2. In one preferred embodiment, injection area A is the central and thickest portion of the deltoid muscle (42) in the arm (40). The injection area A is located above the armpit and approximately two (2) to three (3) centimeters below the acromion process (bony prominence above the deltoid muscle.) As shown in FIG. 2, the top end (16) of the injection patch (8) is adjacent to the acromion process. The top end (16) of the injection patch (8) preferably contains a small projecting tab or flap (24) that does not adhere to the patient’s arm, but the health care provider can pull on it to easily remove the patch from the arm. If a second injection is to be given, it ispreferably done in Injection Field B as defined by the second transverse opening (20B) and as also shown in FIG. 2. Preferably, the distance between Injection Field A and Injection Field B is about one inch. For an injection that is given in the arm, the bottom end (18) of the injection patch (8) is preferably adjacent to the axilla, humerus, and radial nerve. The bottom end (18) of the injection patch (8) can also contain a small projecting tab or flap (26) for removing the patch from the arm more easily.

[0025] In practice, the health care provider or immunizer grasps the injection patch (8) and places the patch on the arm of the patient as shown in FIG. 2. The inner surface of the injection patch (8) makes direct contact with the skin of the patient. The health care provider applies pressure downwardly on the injection patch (8) to removably seal the patch to the surface of the skin. Optionally, the inner surface of the injection patch (8) can contain a coaling layer of medical adhesive, but this is not necessary. The health care provider can apply pressure to the injection patch (8) with their fingers and thumb. As this pressure is applied, the injection patch (8) forms a detachable seal with the surface of the skin. The injection patch (8) is easy to apply, and the health care provider does not need to exert excessive strain on their outstretched hand to apply the patch.

[0026] Turning to FIG. 3, another embodiment of the injection patch (8) is shown, the injection patch (8) in FIG. 3 comprises: a) an elongated body member (10) comprising a first (left) side segment (12) and an opposing second (right) side segment (14); b) a first (top) end segment (16) and a second (bottom) end segment ( 18), the end segments ( 16, 18) being joined to the side segments (12, 14) to form a substantially rectangular injection patch; c) at least one annular-shaped secondary patch member (44A); the annular-shaped secondary patch member extending across the width of the elongated member (10), wherein the annular-shaped secondary patch member defines an injection field, where the injection can be administered. As shown in FIG. 3, in one preferred embodiment, there are two annular-shaped secondary patch members (44A, 44B). The annular-shaped secondary patch members (44A, 44B) can be made of any suitable material. A first injection field (A) is shown in the first secondary patch member (44A). A second injection field (B) is shown in the second secondary patch member (20B). The injection patch (8) includes an outer surface (22) and an opposing inner surface (not shown) thatmakes direct contact with the skin surface, allowing a person to wear the patch on their arm in a normal manner.

[0027] The injection patch (8) is positioned such that a first injection is given in Injection Field A in the first opening as defined by the first annular-shaped secondary patch member (44A) as shown in FIG. 3. If a second injection is to be given, it is preferably done in Injection Field B in the second opening as defined by the second annular-shaped secondary patch member (44B).[0028) The injection patches (8) of the present invention is sufficiently rigid so that it will stay in place and yet the injection patch is not excessively tight. Different embodiments of the injection patch (8) can be used in accordance with the present invention as described above. The injection patch (8) has many advantages including comfort, flexibility, and durability. The injection patch (8) is relatively lightweight and provides the wearer with a complete range of motion. And yet, the injection patch (8) is sufficiently durable and provides a tight seal with the skin surface.

[0029] After the injection(s) have been given, the immunizer can apply conventional bandages to the injection site(s). The bandages can be applied to Injection Field A and Injection Field B to cover and protect the injection areas. Then, the health care provider can remove the injection patch (8) by pulling the top tab (24) while the bandage remains affixed to the skin. The patient can remove the bandage at their own discretion at a later point. By bandage, it is meant any strip of material used to bind a wound. Any suitable adhesive bandage can be used including, but not limited to, Band-Aid®, Nexcare™, Cured™, Welly Bravery™, and All-Health™ bandages.

[0030] The present invention provides a unique injection patch (8) that provides landmarks on the surface of the skin and helps a health care provider administer the injection to the correct area, The injection patch (8) can be used for administering any suitable injection, for example, intramuscular and subcutaneous injections. The injection patch (8) is particularly effective for administering intramuscular vaccines. For example, the injection patch can be used to administervaccine injections for COV1D-19, Influenza, Hepatitis, Meningococcal, Pneumococcal, Tetanus, diphtheria, or with pertussis (Tdap); measles, mumps, and rubella (MMR).

[0031] It should be understood that the terms, "first”, "second", "top", "bottom", "upper”, "lower", “upwardly”, "downwardly", “above” “below”, “right", "left", and the like are arbitrary terms used to refer to one position of an element based on one perspective and should not be construed as limiting the scope of the invention.

[0032] It also should be understood that the products, materials, constructions, and the like described and illustrated herein represent only some embodiments of the invention. It is appreciated by those skilled in the art that various changes and additions can be made to the products, materials, and constructions and the like without departing from the spirit and scope of this invention. It is intended that all such embodiments be covered by the appended claims.

Claims

ClaimsI claim:

1. An injection patch for contacting to skin so that an injection can be administered, comprising: a) an elongated body member comprising a first side segment and an opposing second side segment; b) a first end segment and a second end segment, the end segments being joined to the side segments to form a substantially rectangular injection patch; c) at least one transverse opening; the transverse opening extending substantially across the width of the injection patch, the transverse opening defining a visible injection field on the skin, wherein the injection can be administered.

2. The injection patch of claim 1, a first upper tab is attached to the first end segment and a second lower tab is attached to the second end segment.

3. The injection patch of claim 2, wherein the patch contains a plurality of transverse openings, where the injection can be administered.

4. The injection patch of claim 3, wherein the patch contains a first transverse opening defining a first Injection Field A; and a second transverse opening defining a second Injection Field B, where the injection can be administered.

5. The injection patch of claim .3, wherein Injection Field A is located above Injection Field B on the skin.

6. The injection patch of claim 3, wherein the distance from the first upper tab to the first Injection Field A is in the range of about 1 to about 2 inches.

7. The injection patch of claim 3, wherein the distance between the Injection Field A and Injection Field B is about one inch.

8. The injection patch of claim 3, wherein each transverse opening has a substantially rectangular shape.

9. The injection patch of claim 1, wherein the injection patch has an outer surface and opposing inner surface, the inner surface having a coating of medical adhesive for removably adhering the patch to the skin.

10. The injection patch of claim 1, wherein an intramuscular vaccine injection is administered.IL An injection patch for contacting to skin so that an injection can be administered, comprising: a) an elongated body member comprising a first side segment and an opposing second side segment; b) a first end segment and a second end segment, the end segments being joined to the side segments to form a substantially rectangular injection patch; c) at least one annular-shaped secondary patch member, the secondary patch member extending substantially across the width of the injection patch, the secondary patch member having an opening for defining a visible injection field on the skin, wherein the injection can be administered.

12. The injection patch of claim 11, wherein the patch contains a first annular-shaped secondary' patch member having an opening for defining a first Injection Field A; and a second annularshaped secondary patch member having an opening for defining a second Injection Field B, where the injection can be administered.

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