Abstract:
The device includes a manipulation mechanism for maneuvering a base into position proximate a subcutaneous port. Arms extending from the base enable the device to receive the port and substantially immobilize the port relative to the device. The manipulation mechanism also enables a user to substantially immobilize the device relative to a patient. With the subcutaneous port substantially immobilized by the device, the user has greater confidence and accuracy when inserting a needle into the port. Further, embodiments of the device provide protection to the user to prevent inadvertent sticking of the user as the needle is introduced.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/270,198, filed Dec. 21, 2015, which is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    In the medicine and nursing arts, it is vital that each task be performed with the highest possible standards of safety and sterility in mind. One challenge faced in these fields is how to protect the users (the doctors, nurse, and the like) of medical equipment and compounds from inadvertently receiving the effects of this equipment while utilizing them to treat another individual, such as a patient. The tip of a needle does not discriminate and it is not uncommon for medical practitioners to inadvertently “stick” themselves when attempting to inject another individual. 
         [0003]    This concern is particularly applicable when a patient or other individual has had a subcutaneous port installed. Located under the skin, the port has a septum through which drugs can be injected and blood samples can be drawn many times, usually with less discomfort for the patient than a more typical stick with a needle. A catheter then connects the port to a vein. 
         [0004]      FIG. 1  shows a standard catheter and port being accessed by a standard injection device using the method currently approved in the field. The port is in near constant motion due to its movement under the skin or movement of the individual in which the port is installed. Thus, the doctor or nurse&#39;s target injection site is in constant motion, leaving them even more susceptible to the dangers identified above. 
         [0005]    To date, there are no assistive devices for accessing ports. What is desired, therefore, is the development of a device that will allow users to easily access ports while avoiding accidental needle sticks caused by patient movements, immobilize a clumsy port catheter that slides around under the skin, and ensure that the user has a clear visual field of the port&#39;s center. 
       SUMMARY 
       [0006]    In some embodiments, the present disclosure is directed to a device comprising a base, a first arm, a second arm, and at least one manipulation mechanism for manipulating/maneuvering the device into position adjacent or proximate to a port in an individual receiving an injection. 
         [0007]    The device of the present disclosure assists users in easily accessing a port without contaminating the insertion site while keeping the user (such as a nurse or doctor) and patient safe from accidental needle punctures. The device also allows the user to visualize the insertion site without having to crowd the area with fingers. The device safely secures the port while minimizing movement and allowing for correct accessing to occur the first time. 
         [0008]    In some embodiments, the present disclosure is directed to a device for stabilizing a subcutaneous port including a base, a first arm, a second arm, and at least one manipulation mechanism. In some embodiments, the second arm opposes the first arm. In some embodiments, the first arm and the second arm extend from the base. In some embodiments, at least one of the base, the first arm, and the second arm are configured to substantially immobilize movement of a subcutaneous port with respect to the device. In some embodiments, the first arm has a first end and the second arm has a second end, wherein an opening separates the first end from the second end. 
         [0009]    In some embodiments, the at least one manipulation mechanism is adjacent the base, the first arm, and the second arm. In some embodiments, the at least one manipulation mechanism is apart from the base, the first arm, and the second arm. In some embodiments, the at least one manipulation mechanism extends from at least one of the base, the first arm, and the second arm. 
         [0010]    In some embodiments, the at least one manipulation mechanism is selected from the group consisting of: a handle, at least one platform, at least one tube, and combinations thereof. In some embodiments, the at least one platform is covered. In some embodiments, the at least one platform is oriented vertically. In some embodiments, the at least one platform is curved. 
         [0011]    In some embodiments, the at least one of the base, first arm, and second arm further comprise a stabilizing mechanism. In some embodiments, the stabilizing mechanism is a sidewall. In some embodiments, the sidewall is provided at an angle. 
         [0012]    In some embodiments, at least one of the base, the first arm, the second arm, the at least one manipulation mechanism, and the stabilizing mechanism is adjustable. In some embodiments, at least one of the base, the first arm, the second arm, the at least one manipulation mechanism, and the stabilizing mechanism is flexible. 
         [0013]    In some embodiments, the at least one of the base, the first arm, the second arm, the at least one manipulation mechanism, and the stabilizing mechanism is configured to interface with a patient&#39;s skin and stabilize the device against the patient&#39;s skin. In some embodiments, at least one of the base, the first arm, the second arm, and the stabilizing mechanism is curved. 
         [0014]    In some embodiments, the present disclosure is directed to a method for stabilizing a subcutaneous port including engaging via at least one manipulation mechanism a device that comprises a base, a first arm, and a second arm opposing the first arm, contacting the base with a patient proximate the subcutaneous port, thus limiting movement of the device with respect to the subcutaneous port, stabilizing the device against the patient, thus limiting movement of the device with respect to the patient&#39;s skin, and maintaining the device in a stabilized position with the base proximate the subcutaneous port until a needle is inserted into the subcutaneous port. In some embodiments, the step of maintaining the device in a stabilized position includes maintaining contact via a stabilizing mechanism between the subcutaneous port and at least one of the base, a first arm extending from the base, and a second arm extending from the base. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The drawings show embodiments of the present disclosure for the purpose of illustrating the invention. However, it should be understood that the present application is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein: 
           [0016]      FIG. 1  portrays a prior art diagram of a technique for inserting a needle into a subcutaneous port; 
           [0017]      FIG. 2  portrays a device for assisting access to a subcutaneous port consistent with some embodiments of the present disclosure; 
           [0018]      FIG. 3  portrays a further embodiment of the device shown in  FIG. 2 ; 
           [0019]      FIG. 4  portrays a further embodiment of the device shown in  FIG. 2 ; 
           [0020]      FIG. 5  portrays a further embodiment of the device shown in  FIG. 2 ; 
           [0021]      FIG. 6  portrays a further embodiment of the device shown in  FIG. 2 ; 
           [0022]      FIG. 7  portrays a method for stabilizing a subcutaneous port utilizing the device shown in  FIG. 2 ; and 
           [0023]      FIG. 8  portrays a further embodiment of the method shown in  FIG. 7 . 
       
    
    
     DESCRIPTION 
       [0024]    Referring to  FIGS. 2, 4, and 5 , in some embodiments, the present disclosure is directed to a device  1  for assisting a user at an insertion site  10  for an individual. In some embodiments, device  1  comprises a base  100 , a first arm  101 , and a second arm  102 . In some embodiments, second arm  102  opposes first arm  101 . In some embodiments, device  1  comprises at least one manipulation mechanism  103 . In some embodiments, at least one of base  100 , first arm  101 , and second arm  102  are configured to substantially immobilize movement of a subcutaneous port with respect to device  1 . 
         [0025]    In some embodiments, first arm  101  has a first end  101 A and second arm  102  has a second end  102 A. In some embodiments, first end  101 A and second end  102 A are connected. In some embodiments, first end  101 A and second end  102 A are not connected, leaving an opening in between them through which a port may be inserted and removed from the device (as will be discussed below). 
         [0026]    In some embodiments, first arm  101  and second arm  102  extend from base  100 . In some embodiments, first and second arms are attached to the device independent of the base  100 . In these embodiments, base  100  is itself attached to a single base along with separately attached first arm  101  and second arm  102 . In some embodiments, base  100  is designed to brace the device against a port within an individual. When base  100  interfaces with the port, frictional forces prevent device  1  from sliding past the port. The first arm  101  and the second arm  102  then provide additional structures upon which device  1  can interface with the subcutaneous port. With base  100  substantially preventing forward movement of device  1  with respect to the port and the user, first and second arms substantially prevent side-to-side movement of device  1 . In some embodiments, additional frictional forces are provided between device  1  and the patient&#39;s skin to limit movement of device  1  relative to the skin, such as through contact between manipulation mechanism platforms (discussed in greater detail below) and the skin&#39;s surface. In some embodiments, the shapes of base  100 , first arm  101 , and/or second arm  102  are substantially crescent-shaped. In other embodiments, the shapes of base  100 , first arm  101 , and/or second arm  102  are triangular, rectangular, and the like. 
         [0027]    In some embodiments, the user engages with device  1  using their hands. In some embodiments, the user engages with device  1  using their fingers. Specific engagement schemes depend on the specific configuration of device  1  and vary based on user preference.  FIG. 2  shows exemplary embodiments of the device designed to be maneuvered by a user&#39;s index and middle finger.  FIG. 3  shows an exemplary embodiment of the device designed to be maneuvered by a user&#39;s index finger and thumb. One of skill in the art would understand that various combinations of a user&#39;s fingers may be used to manipulate the devices and could design platforms optimized for use with those specific finger combinations. Referring to  FIG. 5 , the user engages with an embodiment of device  1  at a handle via any suitable manner, such as with their palm or finger tips. 
         [0028]    Referring again to  FIGS. 2, 3, and 5 , these drawings show exemplary embodiments of the above-identified manipulating mechanism  103 . In some embodiments, manipulation mechanism  103  is apart from at least one of base  100 , first arm  101 , and second arm  102 . In some embodiments, manipulation mechanism  103  is adjacent to at least one of base  100 , first arm  101 , and second arm  102 . In some embodiments, manipulation mechanism  103  extends from base  100 , first arm  101 , and second arm  102 . In some embodiments, manipulation mechanism  103  is at least one of a handle, at least one platform, at least one tube, and combinations thereof. In some embodiments, manipulation mechanism  103  has a covering (as will be discussed in greater detail below). 
         [0029]    The purpose of manipulating mechanism  103  is two-fold. Firstly, manipulating mechanism  103  allows a user to position the base  100 , first arm  101 , and second arm  102  relative to the port. Secondly, manipulating mechanism  103  allows this positioning to occur while the user remains protected from injection devices that may be around injection site  10 . One embodiment wherein manipulating mechanism  103  is shown to be a handle is shown in  FIG. 5 . A user grasping one end of the handle (for example, such as in the manner of a magnifying glass) is able to maneuver base  100 , first arm  101 , and second arm  102  at the other end of the handle. Once the port has been essentially immobilized by the user&#39;s placement of base  100 , first arm  101 , and second arm  102  adjacent to the port, the user can continue to hold the port in place relative to device  1  from a distance while performing other tasks, such as obtaining the relevant injection device, moving the relevant injection device into place to inject the target individual, and physically injecting the target individual using the injection device. Throughout those process steps, the user&#39;s hands and other parts of their body are protected from accidental self-injection by the distance afforded to them by the handle of device  1 , thus limiting the possibility of an accident. 
         [0030]    One embodiment wherein manipulating mechanism  103  is a plurality of platforms is shown in  FIGS. 2 and 3 . Referring specifically to  FIG. 2 , the platforms are attached to the device to provide stable regions from which a user may interact with device  1 . In some embodiments, the platforms are attached to base  100 . In some embodiments, the platforms are attached to at least one of first arm  101  and second arm  102 . In some embodiments, interaction by objects with these platforms allows for device  1  to be maneuvered with respect to a subcutaneous port and then held in place once device  1  is moved into the proper position. Once at least one of base  100 , first arm  101 , and second arm  102  are moved into position adjacent to a port, the user presses on the platforms, thus pressing the device onto the skin of the individual to receive the injection. Frictional forces prevent significant movement of the device relative to the skin, and the dual platforms provide additional control to the user to prevent rotation or translation of device  1 . 
         [0031]    In some embodiments, the platforms have raised sidewalls to help position objects, such as a user&#39;s fingers, in the proper position upon the platforms. In some embodiments, the platforms are curved. In some embodiments, the platforms are oriented vertically. 
         [0032]    Referring now to  FIG. 4 , in some embodiments, the platforms include at least one upper portion  104 . In some embodiments, upper portion  104  covers the platform and defines a cavity  105  between it and the platform below it. In some embodiments, manipulation mechanism  103  is a tube (such as a cylindrical tube, square tube, and the like). In this embodiment, upper portion  104  acts as a shield to prevent injection devices from entering cavity  105 . Upper portion  104  also provides increased surface area for enabling increased control over device  1  by a user (e.g. the covering makes it more difficult for device  1  to accidentally disengage from a user). In embodiments where device  1  is manipulated via a user&#39;s fingers inserted into these cavities  105 , those fingers are shielded from the environment while the user performs other tasks such as obtaining the relevant injection device, moving the relevant injection device into place to inject the target individual, and physically injecting the target individual using the injection device. While conventional methods of injection into a subcutaneous port required the fingers of the person injecting to be close to the injection site, and thus vulnerable to errant needle sticks, upper portion  104  according to some embodiments of the instant disclosure provides protection against these sticks, as upper portion  104  would absorb the impact of the needle before it could make contact with the user&#39;s fingers. 
         [0033]    Manipulating mechanisms  103  as described herein may be combined or multiplied as a matter of design choice that is well within the abilities of one having skill in the art. 
         [0034]    Referring again to  FIG. 4 , in some embodiments, at least one of base  100 , first arm  101 , and second arm  102  further comprise a stabilizing mechanism  106 . In some embodiments, stabilizing mechanism  106  is a sidewall. In some embodiments, stabilizing mechanism  106  is angled. In these embodiments, at least one of base  100 , first arm  101 , and second arm  102  have a sidewall that while normally vertical (i.e. substantially perpendicular to the skin of the individual requiring an injection) is instead angled to facilitate acceptance of the port into base  100 , first arm  101 , and/or second arm  102 . 
         [0035]    Referring now to  FIG. 6 , the embodiment shown is consistent with the embodiments described above, but further including an adjustable region  107  in base  100 . In some embodiments, at least one of base  100 , first arm  101 , and second arm  102  are adjustable. In some embodiments, the adjustment at least one of base  100 , first arm  101 , and second arm  102  performed via a hinge, a ratchet, a piston, a track, and the like. By allowing the stabilizing base, the first arm, and/or the second arm to be adjustable, device  1  is more compatible with different sized ports and allows a user to have greater control over the device while in use. In the embodiment shown in  FIG. 6 , adjustable region  107  is a hinge placed in base  100 , allowing flex at three places. With the user&#39;s fingers inserted into manipulating mechanism  103  (platforms in this case), the user can spread his or her fingers wide to open the first and second arms to the greatest possible extent (region  107  lies flat) while maneuvering device  1  towards a port. Once device  1  has been positioned, the user moves their fingers closer together, bending the hinge, and bringing first arm  101  and second arm  102  closer together. The result is a pincer movement that allows the user to more easily secure the port within device  1 . The adjustability of device  1  described in this embodiment means that the above-identified method may be performed on ports of different sizes. 
         [0036]      FIGS. 7 and 8  are directed to a method of stabilizing a subcutaneous port consistent with some embodiments of the present disclosure. In some embodiments, the method comprises the step of a user engaging  700  a device (such as device  1  described above) via at least one manipulation mechanism. The device is then contacted  710  with the patient and/or the port proximate the port and stabilized  720  there, thus limiting movement of the device relative to the port and the patient. The device contact is maintained  730  proximate the port until a needle is inserted into the port. In some embodiments, contact is maintained  830  via a stabilizing mechanism between the port and at least one of the base, firm arm, and second arm. As used herein, “contact” between a component of the device and the subcutaneous port includes “indirect” contact, i.e. where layers such as bandages, protective films, or a patient&#39;s own skin, fat, or other tissue, and combinations thereof and the like are disposed between the device and the port. 
         [0037]    In one embodiment showing an exemplary method including a device consistent with the instant disclosure, a user identifies a subcutaneous port in an individual that is to receive an injection. The user then maneuvers the device towards the port using the manipulation mechanism. The device is then pressed onto the skin of the individual and held adjacent to the port using at least one of the stabilizing base, the first arm, and the second arm. In some embodiments, the device is held adjacent to the port with the port substantially encircled by the stabilizing base, the first arm, and the second arm. One further advantage of this embodiment is that the device itself highlights the injection site for the user, creating a clearly defined and substantially immobile target at which the user can aim the injection device. Contact between at least one of the stabilizing base, the first arm, and the second arm holds the port substantially immobile with respect to the subcutaneous port. Thus immobilized, the user injects the individual through the port. The user then removes the injection device and the device itself. 
         [0038]    In some embodiments, while the manipulation mechanism may be directly or indirectly connected to the one or more of the stabilizing base, first arm, and second arm, the manipulation mechanism is configured such that the user interacts with the manipulation mechanism at a location remote or apart from the stabilizing base, first arm, or second arm. Configured thusly, the user manipulates the base, first arm, or second arm without the need to interact directly with any of those features using their hands or other part of their body. 
         [0039]    The method steps discussed above may be performed in any suitable order. 
         [0040]    In some embodiments, the device is fashioned from plastic, metal, wood, or any other suitable material and combinations thereof. In some embodiments, the device is provided as a kit having different sized devices to accommodate differently sized individuals and ports. 
         [0041]    Although the invention has been described and illustrated with respect to exemplary embodiments thereof, it should be understood by those skilled in the art that the foregoing and various other changes, omissions and additions may be made therein and thereto, without parting from the spirit and scope of the present invention.