Abstract:
A perimeter fill syringe is disclosed, wherein the syringe includes a solid core, allowing fluid to fill an area around the perimeter of the syringe barrel, enabling a wider diameter for the barrel thus increasing the visibility of the markings and ease of handling by a user.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present patent application is related to and claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/126,028, filed Feb. 27, 2015, the contents of which is hereby incorporated by reference in its entirety into this disclosure. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure generally relates to syringes, and in particular to a syringe with a solid core, allowing fluid to fill an area around the perimeter of the syringe barrel, enabling a wider diameter for the barrel thus increasing the visibility of the markings and ease of handling by the patient. 
       BACKGROUND 
       [0003]    This section introduces aspects that may help facilitate a better understanding of the disclosure. Accordingly, these statements are to be read in this light and are not to be understood as admissions about what is or is not prior art. 
         [0004]    Health care providers administering medications to patients must exercise great care in determining the amount medication to inject into the patient&#39;s body. Similarly, for example, diabetic patients must likewise take great care to ensure the amount of insulin injected into their bodies is of the appropriate dosage. Unfortunately, however, many patients suffer ailments (e.g., failing eyesight) that make it difficult, and often dangerous, to adequately administer the required dosage of medication into their bodies. Such consequences can be extended to all drugs that must be administered via a syringe. Given that an improper dosage can result in serious consequences, it is critical that both health care providers and patients themselves be able to clearly and accurately determine the amount of medications loaded in a syringe prior to injection. 
         [0005]    Additionally, health care providers and patients themselves who must administer a drug via a syringe continually face the risk of accidental needle sticks. Even when cautious, there is always a chance that the person administering the drug via a needle syringe will slip and accidentally stick himself or another person. Every year in the United States, 44,000 to 98,000 people die as a result of medical error. Medication errors are a leading form of medical harm with over 1.5 million adverse drug events associated with medication use occurring every year. The medication use process is complex and difficult to navigate, even for trained professionals. Some medications are more prone to error than others for patients and professionals alike, and these medications earn the title high risk medications. Every year without fail, more errors associated with injectable insulin are reported than any other medication. This is exceptionally troubling given the nature of the medication insulin. It is an endogenous hormone in the human body that we supplement for patients with diabetes who do not synthesize sufficient quantities or for those who have developed an insensitivity to insulin in their body. Small volumes of insulin, measured and dosed to patients in terms of units of insulin, can have profound effects on our bodies. Volumes as small as 10 units or less can be enough to send someone into a state of hypoglycemia, a condition that if uncorrected can have dramatic effects and in some instances, if not reversed, be fatal. This range between where the medication is useful to patients and the point at which it becomes toxic is known as a therapeutic window. Insulin has one of the narrowest therapeutic windows but one of the widest ranges of dosing as patients can require as little as 2 units and some could require over 100 units. 
         [0006]    Combined with the narrow therapeutic window of insulin, we additionally complicate this process by manufacturing more than one concentration of insulin. Currently, 100 unit/mL and 500 unit/mL concentrations are readily available with a 200 unit/mL concentration available in the EU that may someday soon be available in the United States. Administering these doses requires drawing insulin up into an insulin syringe, which is a device specifically designed and marked for volumes of 100 unit/mL insulin. Therefore, a patient needing to administer 16 units could draw up precisely this amount into their syringe from a multi-dose vial and administer it to themselves. Patients that receive more than 200 units of insulin per day may elect to be placed on U500 (500 unit/mL insulin) to minimize the volume of fluid injected daily. In order to perform this process, these patients still must use a U100 (100 unit/mL) insulin syringe to accomplish this task. 
         [0007]    Thus, there remains an unmet need for syringes that enable safe, reliable administration of a drug to protect against both improper dosage and inadvertent needle sticks. 
       SUMMARY 
       [0008]    In one aspect, a perimeter fill syringe is presented. The perimeter fill syringe includes a top end, wherein the top end is configured to be coupled to a syringe needle, and a bottom end, wherein the bottom end is configured to be coupled to a plunger. The plunger is configured to be slidably coupled to the perimeter fill syringe. The perimeter fill syringe also includes an outer shell that is along the length between the top and the bottom end of the perimeter fill syringe. The perimeter fill syringe also includes a core that is encased within the outer shell. 
         [0009]    In another aspect, a method for reliably administering medication and dosage to a patient is presented. The method includes utilizing the presented perimeter fill syringe of a particular design to administer the medication. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0010]      FIG. 1  is an image of an insulin syringe in common use. 
           [0011]      FIG. 2A  is an image of one embodiment of the perimeter fill syringe that is cylindrical in shape. 
           [0012]      FIG. 2B  is an image of an embodiment of the top end of the outer shell of the perimeter fill syringe. 
           [0013]      FIG. 3A  is an image of one embodiment of the perimeter fill syringe that is rectangular in shape. 
           [0014]      FIG. 3B  is an image of the embodiment shown in  FIG. 3A  but also includes a cross-sectional view of the interior of the perimeter fill syringe. 
           [0015]      FIG. 4  is a cross-sectional view of an intermediate portion along the length of the perimeter fill syringe. 
           [0016]      FIG. 5A  shows an embodiment of the plunger that is configured to be inserted into a perimeter fill syringe that has a rectangular shape. 
           [0017]      FIG. 5B  is an image of the embodiment shown in  FIG. 5A  but also includes a cross-sectional view of the interior of the plunger. 
           [0018]      FIG. 6  is an image of an embodiment of the plunger that is configured to be inserted in to a perimeter fill syringe that has a cylindrical shape, such as that in  FIG. 2A . 
           [0019]      FIG. 7  shows separate images of the core and of the outer shell of an embodiment of the perimeter fill syringe. 
           [0020]      FIG. 8  shows an alternate embodiment of the perimeter fill syringe shown in  FIG. 7 , but in  FIG. 8 , the shape of the perimeter fill syringe is rectangular. 
           [0021]      FIG. 9A  shows an embodiment of the fully assembled perimeter fill syringe, wherein the core is partially slidably inserted into the outer shell. 
           [0022]      FIG. 9B  shows an image of an embodiment of a fully assembled perimeter fill syringe. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended. 
         [0024]    In response to the unmet need for a syringe design that enable safe, reliable administration of a drug to protect against both improper dosage and inadvertent needle sticks, such a novel syringe design is disclosed herein. For demonstration purposes, the herein described novel syringe design is an insulin syringe. However, it should be appreciated that the applications for the herein described novel syringe extends beyond insulin syringes and can apply to medications of all types that are to be administered via a syringe. 
         [0025]    Referring to  FIG. 1 , which is an image of an insulin syringe in common use, current syringes comprise a hollow barrel and a solid plunger used to push fluid out of a nozzle at the tip. There are numerous shortcomings in the current insulin syringe designs. First, the size of the syringe is quite small. It has a narrow diameter cylinder with markings that wrap almost completely around the barrel of the syringe. This small size can be difficult to handle for both health care providers and patients of all ages. Notably, complications of diabetes, specifically in those patients who may already have high insulin demand (in excess of 200 units per day), include blurred vision and neuropathy, or pain and loss of sensation in their fingers and toes. These patient conditions make the current syringe design far less than optimal for the safe, ergonomic handling of a device that is intended to inject a drug with a narrow therapeutic window. 
         [0026]    Second, these syringes can be used for both U100 and U500 concentrations. For example, if a health care provider drew up 100 units of U500 in one syringe and 20 units of U100 into separate syringes (same volumes of clear liquid) and walked away to attend to another task (e.g., answer a ringing phone), the syringes would be indistinguishable upon the health care provider&#39;s return. If the health care provider did not remember which was which, one represents a lethal dose for one patient while the other represents a dose far too low to combat the conditions of the other patient. Without any visual cues or “forcing functions” to indicate differently concentrated insulin doses is a formula for catastrophe. A forcing function would be any discernable difference between syringes such as shape, size, color, structure, or any other means of immediately noticing a difference beyond having to remember. 
         [0027]    Third, the current U100 syringes require computations to be made in order to achieve the correct dose. In order for a health care provider or a patient to achieve a 100 unit dose of U500 insulin, they would need 0.2 mL of insulin at this concentration to achieve this. However, 0.2 mL in a U100 syringe is labeled on the barrel as only being 20 units. Such requirements are accompanied by risk that errors can be made in the computations and can thus lead to disastrous results, should an error be made. 
         [0028]    To address the above concerns, a novel design for a syringe, hereinafter referred to as a “perimeter fill syringe” is disclosed. Referring to  FIGS. 2A and 2B , in one embodiment, the perimeter fill syringe  100  is cylindrical in shape. In another embodiment, referring to  FIGS. 3A and 3B , the perimeter fill syringe  100  is of a rectangular shape. It should be appreciated that although for demonstration purposes of this disclosure a cylindrical and rectangular shape for the perimeter fill syringe  100  are described, such descriptions are not intended to be limiting, and rather, any shape can be used. Referring to  FIG. 4 , which is a cross-sectional view of an intermediate portion  200  along the length of the perimeter fill syringe  100 , the perimeter fill syringe  100  and has a core  201 . Still referring to  FIG. 4 , an outer shell  203  encases the core  201 . In between the outer shell  203  and the core  201  is a fluid space  205  for the medication or fluid to be placed. Referring to  FIGS. 5A and 5B , a plunger  301  is configured to be inserted into the fluid space  205 .  FIGS. 5A and 5B  show an embodiment of the plunger  301  that is configured to be inserted into a perimeter fill syringe  100  that has a rectangular shape.  FIG. 6  shows an embodiment of the plunger  301  that is configured to be inserted in to a perimeter fill syringe  100  that has a cylindrical shape. 
         [0029]    Referring to  FIG. 2B , an image of an embodiment of the top end  204  of the outer shell  203  of the perimeter fill syringe  100  is shown, of which the plunger  301  shown in  FIG. 6  can be inserted. The fluid space  205  is no longer along the shape of a ring at the top end  204  of the outer shell  203  to allow for minimal waste of the medication or fluid traveling through the fluid space  205 . 
         [0030]    Referring to  FIG. 7 , which shows separate images of the core  201  and of the outer shell  203  of an embodiment in which the perimeter fill syringe  100  is in cylindrical in shape, the top end  204  of the outer shell  203  can be configured to have a syringe needle inserted thereon. Still referring to  FIG. 7 , the core  201  can have a bottom end  207  that is configured to be coupled to a plunger that can facilitate the core  201  being inserted into the outer shell  203  to thereby administer the medication through the fluid space  205 . A space for the plunger needs to be configured into the design of the perimeter fill syringe  100 , an example of which is shown at the top of  FIGS. 3A and 3B .  FIG. 8  similarly shows an alternate embodiment of the perimeter fill syringe  100  shown in  FIG. 7 , but in  FIG. 8 , the shape of the perimeter fill syringe  100  is rectangular.  FIG. 4  shows an alternate view of the embodiment of the perimeter fill syringe  100  of  FIG. 8 . Referring to  FIG. 4 , the fluid can be inserted into the fluid space  205  can be seen to form the shape of a ring along a bottom portion  209  of the perimeter fill syringe  100 . Still referring to  FIG. 4 , the top end  211  of the core  201  is configured to be inserted into the bottom portion  209  to fill the fluid space  205 . 
         [0031]      FIGS. 9A and 9B  show an embodiment of the fully assembled perimeter fill syringe  100 , wherein the core  201  is partially slidably inserted into the outer shell  203 . Referring to  FIG. 9B , drawing back the core  201  allows the fluid space  205  to fill with fluid medication. Such a thin perimeter geometry enables a wider syringe design that is easier to grasp for patients and health care providers, especially those with lessening of motor function or dexterity. The wider diameter on the perimeter fill syringes  100  also enables markings to appear more clearly on a single face of the perimeter fill syringe  100 , thus eliminating the need to roll or rotate the syringe in a user&#39;s hand while drawing up a dosage of medication. 
         [0032]    As described above, the perimeter fill syringes  100  can take on a plurality of shapes and geometries. For instance, the perimeter fill syringe  100  can be of a cylindrical shape. Alternatively, a rectangular prism-like shape can be used. Yet another embodiment features a triangular prism-like shape for the perimeter fill syringe  100 . 
         [0033]    Table 1 shows an example of the calculations for a 500 unit syringe and various inner width dimensions, specifically for estimating a desired fluid space  205  for a perimeter fill syringe  100  that is rectangular in shape and the core  201  and outer shell  203  each have widths that are the same (i.e., their top and bottom ends are squares), given the dimensions of the outer shell  203  and the core  201 , for a desired height of the perimeter fill syringe, and an inner width core  201  diameter. Such calculations are conducted using volume dimensions and the exact calculations can vary depending on the geometry of the perimeter fill syringe  100  (e.g., volumetric calculations for a cylinder can be used if the perimeter fill syringe  100  is cylindrical; volumetric calculations for a triangle will be used if the perimeter fill syringe  100  is triangular). The fluid space  205  needs to be calculated such that the plunger will not cripple with the force of drawing the fluid in and out of the perimeter fill syringe  100 . 
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Sample Fluid Space and Dimension Calculations for a 500 unit syringe 
               
             
          
           
               
                   
                   
                 Outer Width (i.e., the 
                   
               
               
                   
                 Inner Width 
                 radius square that is 
               
               
                 Height of 
                 (i.e., radius of the square 
                 the outer perimeter of 
               
               
                 intermediate space 
                 that forms the inner 
                 the fluid space (i.e., 
               
               
                 between the top and 
                 perimeter of the fluid 
                 the inner cutout 
               
               
                 bottom of the outer 
                 space) (i.e., the width 
                 portion of the outer 
               
               
                 shell 
                 of the core) 
                 shell)) 
                 Fluid Space 
               
               
                   
               
             
          
           
               
                 4 
                 0.1 
                 0.367423 
                 2.67435 
               
               
                 4 
                 0.15 
                 0.384057 
                 2.340573 
               
               
                 4 
                 0.2 
                 0.40620192 
                 2.062019 
               
               
                 4 
                 0.25 
                 0.433013 
                 1.830127 
               
               
                 4 
                 0.3 
                 0.463681 
                 1.636809 
               
               
                 4 
                 0.35 
                 0.497494 
                 1.474937 
               
               
                 4 
                 0.4 
                 0.533854 
                 1.338539 
               
               
                 4 
                 0.45 
                 0.572276 
                 1.222762 
               
               
                 4 
                 0.5 
                 0.612372 
                 1.123724 
               
               
                   
               
             
          
         
       
     
         [0034]    The exact dimensions can vary depending on a variety of factors, including the desired ease of flow of the particular medication to be administered and the age and physical abilities of individual administering the medication. For example, a patient with weak hands and poor dexterity may need a perimeter fill syringe  100  that is capable of having a sliding motion that has less resistance than what is considered normal in the field. Similarly, if the user of the perimeter fill syringe  100  is a child, the sliding motion may have to be altered accordingly to ensure ease of use for the patient. Alternate colors and shapes can also be used to help identify and alert the user as to which medication and dosage is being administered. 
         [0035]    Such configurations can revolutionize the way in which medications are administered by patient and health care providers. Such designs address the issue of drawing up different concentrations of insulin into a single type of syringe. In the example given above where a health care provider walks away from two identical volumes of different concentrations of insulin, it was previously impossible to discern between the two. Now, with this disclosure, the rectangular shape of the U500 insulin syringe acts as a physical alert and a forcing function to warn both patients and nurses alike that this syringe contains highly concentrated insulin. Using this new invention, a new standard will be set for administration of insulin. The cylindrical shape will be retained for U100 insulin while the rectangular shape will become the new standard by which all 500 unit/mL insulin will be dispensed and administered. Changing the shape of the syringe is a human factors strategy that will reduce the cognitive load on nurses and patients when they need to be focused on other matters. Now, rather than having to be extremely diligent to avoid mixing concentrations, they can consistently rely upon syringe geometry as a forcing function to prompt safe dispensing and administration techniques. 
         [0036]    In addition to the differing syringe geometries, each syringe can have markings on the barrel or outer shell  203  that precisely correlate to the concentration of the corresponding insulin being administered. Therefore, in a U100 syringe, 0.2 mL will be 20 units every time and no dose of U500 should ever be drawn up in these syringes ever again. A U500 syringe will have 100 units marked at the corresponding 0.2 mL line on the barrel because only 500 unit/mL insulin shall ever be used in this shape of syringe. Keeping the markings distinct eliminates the need for additional math and calculations or incorrect labeling on the barrel after drawing up insulin. 
         [0037]    Those skilled in the art will recognize that numerous modifications can be made to the specific implementations described above. The implementations should not be limited to the particular limitations described. Other implementations may be possible.