# US 10,500,351 B2 · Aid for subcutaneous tissue injection and process of effecting the injection with the aid

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- Number: US 10,500,351 B2
- Document ID: US10500351B2
- Status: Granted
- Kind: B2
- Application number: 15/261,955
- Filed: 2016-09-11
- Published: 2017-08-17
- Granted: 2019-12-10
- Earliest claimed: 2016-02-12
- Applicants: Shawn Michael Michels
- Inventors: Shawn Michael Michels
- Web page: https://patentgrep.com/patent/US10500351B2

## CPC

- A61M 5/46: having means for controlling depth of insertion
- A61M 5/3287: {Accessories for bringing the needle into the body; Automatic needle insertion (A61M5/20, A61M5/31525 take precedence)}
- A61M 5/425: {Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present disclosure is concerned with a device for facilitating a subcutaneous injection and a process for administering the subcutaneous injection. The device has a peripheral frame and an injection needle or an aperture in a central portion of the frame adapted to hold an injection needle. The peripheral frame has an arm or arms adapted to contact the skin at points distant enough from each other to allow the arms or arm to penetrate into the skin a distance greater than the thickness of the skin, a central portion which joins the arms above the terminal portions or portion and an injection needle affixed to the central portion, facing in the same direction as the penetration ends of the arms or an aperture in the central portion adapted to hold an injection needle facing in the same direction as the penetration ends of the arms.

## Claims

### Claim 1

A device for facilitating a subcutaneous injection into a patient comprising:
a. a peripheral frame having
i. two or more arms having penetration ends or a continuous arm having a penetration end adapted to contact skin of the patient at points distant enough from each other to allow the arms or arm to penetrate without piercing into the skin a distance, measured from the unperturbed surface of the skin, greater than the thickness of the skin; and
ii. a central portion which joins the arms or continuous arm at a vertical height above said penetration ends or end greater than the intended penetration distance of the arms or arm, wherein the central portion has a downward projection that is short enough to avoid preventing the arm or arms from penetrating the skin a thickness greater than the thickness of the skin; and
b. an injection needle having an upper end and a lower end affixed to the central portion, facing in the same direction as said the penetration ends or end and of sufficient length to penetrate with piercing through the skin and into the subcutaneous tissue when these ends penetrate without piercing into the skin,
wherein the vertical distance between one of said penetration ends and the exposed upper end of the injection needle is between about 3 mm and 11 mm, and the vertical distance between the said penetration end and the lower end of the injection needle is at least about 1 mm in order for the injection needle to penetrate with piercing through the skin into the subcutaneous tissue without penetrating into any muscle tissue.

### Claim 2 (depends on 1)

The device of claim 1 wherein the penetration ends of the arms form a closed polygon or curve.

### Claim 3 (depends on 2)

The device of claim 2 wherein there are two penetration arms with about equal sized penetration ends whose midpoints are spaced 180° from each other and whose edges are spaced from each other.

### Claim 4 (depends on 3)

The device of claim 3 wherein the edges of the penetration ends of each arm are spaced from the edges of the other penetration end by at least about the horizontal length of that penetration end.

### Claim 5 (depends on 1)

The device of claim 1 wherein the downward projection at least partially surrounds the upper end of the injection needle and limits the movement of the central portion toward the skin.

### Claim 6 (depends on 5)

The device of claim 5 wherein the projection terminates at about the same vertical height as the exposed upper end of the injection needle.

### Claim 7 (depends on 6)

The device of claim 6 wherein the projection is spaced from the upper end of the injection needle in the horizontal plane in which they both lie.

### Claim 8 (depends on 1)

The device of claim 1 wherein the patient is a human.

### Claim 9 (depends on 1)

The device of claim 1 wherein the vertical distance between the penetration end of one of the arms and the lower end of the injection needle is between about 1 mm and 3 mm.

### Claim 10 (depends on 1)

The device of claim 1 wherein the width of surface of the penetration arm or arms that contact the skin is between about 0.1 and 0.3 cm.

### Claim 11 (depends on 1)

The device of claim 1 wherein the horizontal distance between the penetration ends of the arms is between about 2 cm and 6 cm.

### Claim 12 (depends on 1)

The device of claim 1 wherein the area within the penetration ends or end of the arms or arm is between about 10 cm2 and 20 cm2.

### Claim 13 (depends on 1)

The device of claim 1 wherein the relationship between the injection needle and the penetration end or ends of the arm or arms is such that the needle does not penetrate beyond the subcutaneous tissue when the device is applied to a typical adult human.

### Claim 14 (depends on 1)

The device of claim 1 wherein the central portion has an aperture.

### Claim 15 (depends on 1)

The device of claim 1 wherein the injection needle is designed to penetrate with piercing more than 3 mm.

### Claim 16

A device for facilitating a subcutaneous injection into a patient comprising:
a. one or more skin penetration plates that both have a sufficiently small skin contacting area and encompass a sufficient area of skin within their perimeter to allow the plates to penetrate without piercing into the skin a distance, measured from the unperturbed surface of the skin, greater than the thickness of the skin;
b. a central portion centered above the encompassed area of skin, wherein the central portion has a downward projection that is short enough to avoid preventing the arm or arms from penetrating the skin a thickness greater than the thickness of the skin;
c. an injection needle affixed to the central portion, facing toward the skin penetration plate or plates and of sufficient length to penetrate through the skin and into the subcutaneous tissue when this plate or these plates penetrate without piercing into the skin; and
d. support arms connecting the skin penetration plate or plates to the central portion,
wherein the vertical distance between said skin penetration plate and the exposed upper end of the injection needle is between about 3 mm and 11 mm, and the vertical distance between the said skin penetration plate and the lower end of the injection needle is at least about 1 mm in order for the injection needle to penetrate with piercing through the skin into the subcutaneous tissue without penetrating into any muscle tissue.

### Claim 17 (depends on 16)

The device of claim 16 wherein:
a. the one or more skin penetration plates is a single skin penetration plate which has a central aperture of sufficient size to allow the plate to penetrate without piercing into the skin a distance greater than the thickness of the skin;
b. the downward projection at least partially surrounds the upper end of the injection needle and limits the movement of the central portion toward the skin;
c. the device is designed to be used with a human patient; and
d. the relationship between the injection needle and the penetration plate or plates is such that the needle does not penetrate beyond the subcutaneous tissue when the device is applied to a typical adult human.

### Claim 18 (depends on 17)

The device of claim 17 wherein the support arms join the central portion at an acute angle.

### Claim 19 (depends on 16)

The device of claim 16 wherein the injection needle is designed to penetrate with piercing more than 3 mm.

### Claim 20

A process for administering a subcutaneous injection to a human patient comprising:
a. obtaining a peripheral frame having
i. two or more arms having penetration ends or a continuous arm having a penetration end adapted to contact skin of the patient at points distant enough from each other to allow the arms or arm to penetrate without piercing into the skin a distance, measured from the unperturbed surface of the skin, greater than the thickness of the skin;
ii. a central portion which joins the arms or continuous arm at a vertical height above said penetration ends or end greater than the intended penetration distance of the arms or arm, wherein the central portion has a downward projection that is short enough to avoid preventing the arm or arms from penetrating the skin a thickness greater than the thickness of the skin; and
iii. an aperture in the central portion adapted to hold an injection needle facing in the same direction as said penetration ends or end,;
b. affixing an injection needle in the aperture, the needle being of sufficient length and held an appropriate vertical distance from these ends to penetrate with piercing through the skin and into the subcutaneous tissue when these ends penetrate or this end penetrates without piercing into the skin; and
c. pressing the peripheral frame against the skin of a patient such that the injection needle penetrates with piercing through the skin into the subcutaneous tissue without penetrating into any muscle tissue,
wherein the vertical distance between one of said penetration ends and the exposed upper end of the injection needle is between about 3 mm and 11 mm, and the vertical distance between the said penetration end and the lower end of the injection needle is at least about 1 mm in order for the injection needle to penetrate with piercing through the skin into the subcutaneous tissue without penetrating into any muscle tissue.