Aid for subcutaneous tissue injection and process of effecting the injection with the aid

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.

1 . A device for facilitating a subcutaneous injection into a human patient with a skin of normal thickness overlaying a subcutaneous layer comprising:
 a. one or more skin penetration plates that are able to penetrate without piercing into the unperturbed surface of the skin as far as the subcutaneous layer and also encompass an area of skin when pressed against the skin;   b. a central portion with a top and a bottom centered above the area of skin encompassed by the one or more skin penetration plates and having an aperture,   c. the aperture either having an injection needle affixed to it, facing toward the skin penetration plate or plates and of sufficient length to penetrate with piercing through the skin and into the subcutaneous tissue but not completely through this layer into the underlaying muscle tissue when the skin penetration plate or plates penetrate without piercing to the subcutaneous layer or being adapted to have such an injection needle affixed to it; and   d. support arms connecting the skin penetration plate or plates to the central portion and facilitating the penetration of the one or more skin penetration plates into the unperturbed surface of the skin as far as the subcutaneous layer.   
     
     
         2 . The device of  claim 1  wherein when the injection needle is affixed to the aperture it is held at an appropriate vertical distance from the skin penetration plate or plates to penetrate with piercing through the skin and into the subcutaneous layer when the one or more skin penetration plates penetrate without piercing into the unperturbed surface of the skin as far as the subcutaneous layer. 
     
     
         3 . The device of  claim 1  wherein penetration plate or plates encompass an area of about 10 cm 2  or greater. 
     
     
         4 . The device of  claim 3  wherein the encompassed area is between about 10 cm 2  and 20 cm 2 . 
     
     
         5 . The device of  claim 1  wherein there is more than one penetration plate and the maximum distance between such plates is between about 2 cm and 6 cm in the horizontal plane defined by the skin contacting surfaces of the penetration plates. 
     
     
         6 . The device of  claim 1  wherein the maximum distance across the area of skin encompassed by the skin penetration plate or plates is at least about 2 cm. 
     
     
         7 . The device of  claim 6  wherein the maximum distance across the area of skin encompassed by the skin penetration plate or plates is between about 2 cm and 6 cm. 
     
     
         8 . The device of  claim 1  wherein the minimum dimension of the penetration plate or plates in the horizontal plane defined by the skin contacting surface or surfaces of the penetration plate or plates is between about 1 mm and 3 mm. 
     
     
         9 . The device of  claim 1  wherein there are two about equal sized penetration plates whose midpoints are spaced 180° from each other and who do not touch each other in the horizontal plane defined by the skin contacting surfaces of the skin penetration plates. 
     
     
         10 . The device of  claim 9  wherein there is a gap between the skin penetration plates in the perimeter surrounding the encompassed area of skin in the horizontal plane defined by the skin contacting surfaces of the penetration plates sufficient to observe the injection needle penetrate the skin. 
     
     
         11 . The device of  claim 1  wherein penetration plate or plates describe a closed curve with a maximum diameter of between about 2 cm and 6 cm in the horizontal plane defined by the skin contacting surface or surfaces of the penetration plate or plates. 
     
     
         12 . The device of  claim 11  wherein the closed curve is a circle. 
     
     
         13 . The device of  claim 1  wherein the bottom of central portion will contact the skin and limit the downward motion of the device after penetration plate or plates penetrate to the subcutaneous layer. 
     
     
         14 . The device of  claim 1  wherein a projection of each of the support arms form an interior acute angle with the horizontal plane defined by the skin contacting surface or surfaces of the penetration plate or plates. 
     
     
         15 . The device of  claim 1  wherein the vertical distance between the skin contacting surface of one of the penetration plates and the lower end of the injection needle is between about 1 mm and 3 mm. 
     
     
         16 . The device of  claim 15  wherein the lower end of the injection needle is closer to the central portion than the penetration plate or plates. 
     
     
         17 . A process for administrating a subcutaneous injection comprising;
 a. obtaining a device for facilitating a subcutaneous injection into a human patient with a skin of normal thickness overlaying a subcutaneous layer comprising:
 i. one or more skin penetration plates that are able to penetrate without piercing into the unperturbed surface of the skin as far as the subcutaneous layer and also encompass an area of skin when pressed against the skin; 
 ii. a central portion with a top and a bottom centered above the area of skin encompassed by the one or more skin penetration plates and having an aperture, 
 iii. the aperture either having an injection needle affixed to it, facing toward the skin penetration plate or plates and of sufficient length to penetrate with piercing through the skin and into the subcutaneous tissue but not completely through this layer into the underlaying muscle tissue when the skin penetration plate or plates penetrate without piercing to the subcutaneous layer or being adapted to have such an injection needle affixed to it; and 
 iv. support arms connecting the skin penetration plate or plates to the central portion and facilitating the penetration of the one or more skin penetration plates into the unperturbed surface of the skin as far as the subcutaneous layer; 
   b. in the case in which the aperture does not already have the injection needle in place, affixing the injection needle in the aperture; and   c. pressing the device against the skin of the patient such that the injection needle penetrates with piercing through the skin into the subcutaneous tissue without penetrating into any muscle tissue.   
     
     
         18 . The process of  claim 17  wherein penetration plate or plates encompass an area of about 10 cm 2  or greater. 
     
     
         19 . The process of  claim 17  wherein the maximum distance across the area of skin encompassed by the skin penetration plate or plates is at least about 2 cm. 
     
     
         20 . The process of  claim 17  wherein a projection of each of the support arms form an interior acute angle with the horizontal plane defined by the skin contacting surface or surfaces of the penetration plate or plates.