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.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Applications Ser. Nos. 62/294,924 and 62/294,938, both filed 12 Feb. 2016 and both incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    Subcutaneous injection is a means of administering therapeutics that requires proper placement of the injection needle. The therapeutic needs to be injected beneath the skin but not into the underlying muscle tissue. The injection site is a substantial factor in controlling the rate of systemic disbursement of the therapeutic and the dosage regimens of a significant number of therapeutics are keyed to their administration to subcutaneous tissue. 
         [0003]    The proper placement of the injection needle is typically achieved by controlling the depth of its penetration beneath the skin and this in turn can be controlled by how far the needle is advanced into and through the skin and the angle between the needle and the skin. One approach has been to pinch the skin and underlying subcutaneous tissue and insert the injection needle into the gathered tissue. However, this approach requires the use of two hands. It also limits the injection sites to those where there is adequate tissue to be pinched. 
         [0004]    Commonly the injection needle is fitted to a syringe and the syringe is used to direct the placement of the injection needle. The proper placement of the injection needle with this mechanical arrangement can require considerable manual dexterity and may be particularly difficult in circumstances in which there is movement of the patient or the syringe, for instance when administration is attempted on a moving conveyance like a car or train. 
         [0005]    Typically the faster the injection needle is inserted into the tissue the less pain that is experienced. However, the insertion may be slower than optimum because of the mechanical arrangement. The insertion may proceed slowly out of a concern to achieve proper positioning of the injection needle. 
         [0006]    Some discomfort may be experienced if the injection needle moves after insertion and before the therapeutic is fully dispersed. The mechanical arrangement of the syringe located at a considerable distance from the end of the insertion needle being the sole means of controlling the ends location, enhances the probability of such movement and resultant discomfort. This in turn may cause a premature withdrawal of the injection needle before the therapeutic is fully administered. 
       SUMMARY 
       [0007]    The present invention involves a device for facilitating a subcutaneous injection into a patient and a process for administering a subcutaneous injection. The device may have 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 two or more arms or a continuous arm adapted to contact the skin of the patient 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 at a vertical height above the terminal portions or portion of the arms or arm adapted to contact the skin greater than the intended penetration distance of the arms and an injection needle affixed to the central portion, facing in the same direction as the penetration ends of the arms and of sufficient length to penetrate through the skin and into the subcutaneous tissue when these ends penetrate into the skin 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, the needle being of sufficient length and held an appropriate vertical distance from these ends to penetrate through the skin and into the subcutaneous tissue when these ends penetrate into the skin. 
         [0008]    The device may have 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 into the skin a distance greater than the thickness of the skin, a central portion centered above the encompassed area of skin, 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 into the skin or an aperture in the central portion adapted to hold an injection needle facing in the same direction as the penetration plate or plates, the needle being of sufficient length and held an appropriate vertical distance from this plate or these plates to penetrate through the skin and into the subcutaneous tissue when this plate or these plates penetrate into the skin; and support arms connecting the skin penetration plate or plates to the central portion. 
         [0009]    The process involves obtaining the device, in the case in which the central portion does not already have the injection needle in place, affixing the injection needle in the aperture and pressing the peripheral frame against the skin of a patient such that the injection needle penetrates through the skin into the subcutaneous tissue without penetrating into any muscle tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of a peripheral frame or device with a syringe mounted in it. 
           [0011]      FIG. 2  is a side elevation of the same peripheral frame or device with a syringe mounted in it. 
           [0012]      FIG. 3  is a cross-section along line  3  of  FIG. 1  of the peripheral frame or device interacting with the tissue of a patient. 
           [0013]      FIG. 4  is a side elevation of an alternative embodiment of the peripheral frame or device. 
           [0014]      FIG. 5  is a top view of the peripheral frame or device of  FIG. 4 . 
           [0015]      FIG. 6  is a side cross section of an alternative embodiment of the peripheral frame or device with an injection needle as an integral part. 
           [0016]      FIG. 7  is a side cross section of an alternative embodiment of the peripheral frame or device with a downward projection. 
           [0017]      FIG. 8  is a perspective view an alternative embodiment of the peripheral frame or device with a circular penetration end or plate. 
           [0018]      FIG. 9  is a perspective view of the peripheral frame or device of  FIG. 8  interaction with a syringe. 
           [0019]      FIG. 10  is a side cross section of the peripheral frame or device of  FIG. 8  with a syringe in place interacting with the tissue of a patient. 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    Referring to  FIG. 1 , a peripheral frame or device  100  is illustrated in combination with a syringe. The frame or device has arms  102  that terminate at one end in a common circular penetration end or plate  104 . It is also possible for each arm  102  to have its own penetration end or plate and it is also possible for there to be a single arm  102 . The arms  102  terminate at the other end in a central portion  106 . This central portion  106  has an aperture  107  into which the body  112  of a syringe has fixed such that the special relationship between the frame or device and the syringe is fixed. One skilled in the art will recognize that there are many ways or fixing the body  112  such as a rubber insert that frictionally engages both the aperture  107  and the body  112 . Such an insert might be knurled. Affixed to the terminal end of the body  112  is a syringe cap  110  that carries an injection needle  108  with a terminal end  109 . At the opposite end of the syringe body is a plunger  114  which may be activated to dispense a therapeutic retained in the interior of the body  112  through the injection needle  108 . The peripheral frame or device  100  is adapted to facilitate the proper placement of the injection needle  108  and especially its terminal end  109 . It is convenient to facilitate locating this end  109  in the subcutaneous tissue of a patient to whom the therapeutic is being administered or self-administered. 
         [0021]    Referring to  FIG. 2 , the syringe body  112  has been fixed to the central portion  106  of the frame or device  100  via the aperture  107  such that there is a fixed special relationship between the frame or device and the injection needle  108  and its terminal end  109 . Taking into account the relationship between the arms  102 , the penetration end or plate  104  and the central portion  106  that carries the aperture  107 , this means there is a fixed special relationship between the terminal end  109  of the injection needle  108  and the bottom  105  of the penetration end or plate  104 . It is convenient if the vertical distance between them is such that when the penetration ends have compressed the flesh of a patient utilizing the frame or device  100  the injection needle  108  penetrates into but not through the subcutaneous tissue of the patient. This is typically between about 1 mm and 3 mm. Because the penetration ends or plates typically need to be fairly rigid to achieve the desired penetration into the flesh, it may be advantageous to cover them with a cushioning material for the comfort of the patient. But in such cases an appropriate adjustment should be made to account for the compressed thickness of the cushioning material in establishing this vertical distance difference. In this regard, different cushioning materials could be used to adjust for patients with different skin and subcutaneous tissue characteristics such as the difference between adults and children. 
         [0022]    Referring to  FIG. 3 , the frame or device  100  has been pressed against the flesh of a patient utilizing the frame or device  100  such that the skin  200  has been compressed and the injection needle  108  has penetrated into the subcutaneous tissue  202  of the patient, but the terminal end  109  of this needle  108  has not penetrated into muscle tissue  204 , the syringe body  112  and the syringe cap  110  have acted to maintain a fixed special relationship between the injection needle  108  and the penetration end or plate  104 . The cap  110  is fixed on the terminal end of the body  112  and the mid-section of the body  112  is fixed to the central portion  106  (not shown in this FIG.) and the penetration end or plate  104  is also fixed to the central portion  106  via the arms  102 . 
         [0023]    Referring to  FIG. 4 , a different embodiment of the peripheral frame or device  100  is illustrated in combination with a syringe. In this embodiment each of the legs  102  terminates in its own penetration end or plate  104 . Unlike the embodiment illustrated in  FIG. 1-3 , the penetration ends  104  do not form a closed polygon, but rather are just two rectangles equally spaced from the injection needle  108 . However, they are spaced such that when the device  100  is pressed into the flesh of a patient the syringe body  112  and the syringe cap  110 , which is held in the aperture  107  of the central portion  106 , interact with these penetration ends  104  such that the injection needle  108  penetrates into the subcutaneous tissue of the patient without its terminal end  109  extending into the patients muscle tissue. 
         [0024]    Referring to  FIG. 5 , it can be seen that the central portion  106  of this embodiment with its aperture  107  and attached syringe cap  110  does not entirely surround any portion of the patient&#39;s flesh. 
         [0025]    Referring to  FIG. 6 , a different embodiment of the peripheral frame or device  100  is illustrated in combination with a modified syringe. This modified syringe has a cap  110  that carries threads  120  and a nose  118 . This allows it to interact with a central portion  106  that has an aperture  107  that carries threads  120 . This central portion  106  also carries the injection needle  108 . The relationship between the penetration end or plate  104  of the legs  102  is such that the terminal end  109  of the injection needle  108  will penetrate into the subcutaneous tissue of a patient without extending into the muscle tissue of the patient when the device  100  is pressed against the flesh of the patient. 
         [0026]    Referring to  FIG. 7 , a different embodiment of the peripheral frame or device  100  is illustrated in combination with a syringe. In this case the syringe body  112  is connected to the central portion  106  via its cap  110  using an aperture  107  that has a bottom wall  111  that assures the vertical positioning of the injection needle  108  relative to the penetration end or plate  104  or arm  102 . Thus when the device  100  is pressed against the flesh of the patient the terminal end  109  of the injection needle  108  will penetrate into the subcutaneous tissue of a patient without extending into the muscle tissue of the patient. 
         [0027]    Referring to  FIG. 8 , a different embodiment of the peripheral frame or device  100  is illustrated in combination with a syringe. The syringe cap  110  is provided with a series of vertical protrusions  113  that mate with a series of vertical slots in the aperture  107  of the central portion. The aperture  107  of the central portion  106  is also provided with a downward protrusion  122 . There is essentially a single continuous arm  102  that terminates in a single penetration end or plate  104  that is in the form of a circle. The aperture  107  may alternatively have a rubber insert which securely holds the syringe cap  110  or the aperture  107  may have a smooth wall dimensioned to securely hold the syringe cap  110 . 
         [0028]    Referring to  FIG. 9 , the relationship of the syringe plunger  114 , the syringe body  112  and the syringe cap  110  to the frame or device is illustrated for the embodiment of  FIG. 8 . 
         [0029]    Referring to  FIG. 10 , a cross section along line  10  of  FIG. 9  illustrates the interaction of this embodiment with the flesh of a patient. The aperture  107  of the central portion  106  not only has a bottom wall  111  but also has a downward protrusion  122 . This protrusion  122  surrounds the connector  117  of the syringe cap  110  Thus it can act to control the depth of penetration of the injection needle  108 . The penetration end or plate  104  compresses the skin  200  and projects into the subcutaneous tissue  202 . This mechanically allows the central portion  106  to move toward the skin  200  and the injection needle  108  to penetrate through the skin  200  and into the subcutaneous tissue  202 . However, the frame or device  100  is designed such that the terminal end  109  of the injection needle  108  does not enter the muscle tissue  204 . As a result of the downward pressure of the penetration end or plate  104 , the skin does rise a bit in the area encompassed by the penetration end or plate  104  as indicated by the line  300 . Typically this rise is about 1 mm. It has been found convenient for the inside diameter of the penetration end or plate  104  to be about 4.1 cm and its width in the plane of the skin to be 0.2 cm. It is also convenient to use a 4, 5, 6, or 8 mm long injection needle  108  whose terminal end  109  is positioned about 1-3 mm higher than the bottom surface  105  of the penetration end  104 . 
         [0030]    Typical dimensions of the frame or device may relate to the dimensions of readily available injection needles and the need to encompass sufficient tissue to allow adequate penetration of the penetration ends or plates. It is convenient to allow between about 3 mm and 11 mm, preferably between about 5 mm and 9 mm between the penetration end of one of the arms and the upper end of the penetration needle. It is also convenient to provide a vertical distance between the penetration end of one of the arms and the lower end of the penetration needle between about 1 mm and 3 mm. It is also convenient to use penetration ends or plates that readily allow penetration and those with a width of surface that contact the skin is between about 0.1 and 0.3 cm are helpful. It is further helpful to have a horizontal distance between penetration ends or plates of between about 2 cm and 6 cm. Adequate penetration is also facilitated if the area encompassed by the penetration ends or plates is between about 10 cm 2  and 20 cm 2 . 
         [0031]    The figure formed by the penetration end or ends in the plane of the skin of a patient before pressure is applied is virtually unlimited. For manufacturing ease it may be any regular polygon such as an equilateral triangle, a square, a pentagon or a hexagon. It also may be a smooth curve such as an ellipse or a circle. Irregular shapes will function as well but the manufacturing of irregular shapes is more challenging, but provides no particular advantage. 
         [0032]    For ease of description reference has been made to a syringe or a modified syringe, but any device that can deliver a therapeutic to an injection needle at a gradual rate is suitable. In this regard, syringe has been used in a broad sense to include any device with a cylinder for holding a therapeutic that can be delivered through an injection needle associated with a plunger or activator that operates to drive the therapeutic through the injection needle. Typically the injection needle has a fluid tight direct connection with the holding cylinder of the syringe, although other fluid paths are possible, such as the modified syringe described in association with  FIG. 6 . Thus syringe has been used in a sense that encompasses an injection pen. Other delivery devices that can benefit from the frame or device of the present invention in administering subcutaneous injections include the auto injectors that can deploy or “fire” an injection needle upon activation such as that described in US Published Patent Application 2015/0258284. Typically the operation of such devices would be modified so as to rely the forward progress of the frame or device of the present invention for insertion of the injection needle into subcutaneous tissue. For instance, the auto injector could be first activated and then carried forward with the frame or device of the present invention when it is pressed against the flesh of a patient. 
         [0033]    The peripheral frame or device of the present invention can be applied to a wide variety of sites on the human body, virtually anywhere where there is an adequate area to accommodate it. However, it may be advantageous to apply it to tissue that shows crease lines when it is flexed, such as the abdomen, and, if the frame is constructed with parallel separate penetration end or plates, to align them parallel to these crease lines. 
         [0034]    The peripheral frame or device of the present invention can be beneficially used to aid the delivery of any fluid therapeutic that is to delivered by subcutaneous injection including insulin. It can be adapted to interact with any delivery device that relies upon an injection needle to assure placement of the delivery end of the injection needle in subcutaneous tissue. 
         [0035]    While only certain features of the invention have been illustrated and described herein, many modifications and changes will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.