Patent Publication Number: US-2023158239-A1

Title: Pre-Filled Syringe System and Method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 63/010,232 filed on Apr. 15, 2020, the disclosure of which are hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     The pharmaceutical industry uses various devices and methods for delivering drugs. Pre-filled syringes are a way to quickly and easily deliver a drug directly to the blood stream with maximum efficacy. However, subcutaneous injection using a pre-filled syringe does have its challenges with both devices and methods of injection. For instance, self-injection using a pre-filed syringe requires a user to find and maintain a forty-five-degree angle while inserting the needle through their own skin. In addition, in many instances it also requires the user to maintain a skin fold while they inject themselves. This can be difficult to do correctly and if a wrong angle is obtained the needle could penetrate too deeply. Further, in many pre-filled syringe embodiments there is no possible way for controlling the depth in which the needle is inserted. This can allow the needle to penetrate too deep causing, pain, damage, and exposure to skin or blood complications. Additionally, many pre-filled syringe devices in the art do not provide a needle protection to help eliminate needle sticks after the needle injection is complete. Needle stick injuries post injection are a problem for the pharmaceutical industry. 
     The pre-filled syringes that exist in the art also have challenges for their uses. For instance, in almost all known devices the user must first insert the needle with their thumb and index finger against the barrel of the syringe while also squeezing the barrel while they insert the needle. Next, to perform the injection, the hand must be repositioned and re-oriented while the needle is inside the patient to do the final injection. In some instances, incorrect injections necessitate repeat attempts in order to make the final injection. The device and methods, therefore, provide many challenges to make a correct and effective injection. 
     Therefore, with these and other challenges in the industry, there is an ongoing need for a pre-filled syringe and method which do not require an injection by the patient at a forty-five-degree angle. 
     There is still a further need for a pre-filled syringe, system and method which controls the depth of the needle insertion and injection. 
     Further, there is a need for a pre-filled syringe and system that doesn&#39;t require the patient to reposition the needle while the needle is stuck in them. 
     Still further, there is a need for a pre-filled syringe and system where the syringe provides needle protection after the injection has been completed. 
     These and other problems experienced in the art have been addressed and obviated by the present embodiments. 
     SUMMARY 
     The embodiments comprise pre-filled syringe devices and their methods of use. 
     The embodiments provide a pre-filled syringe system for controlled depth of injection in a subject, comprising a pre-filled syringe having a needle tip and a plunger for injecting the contents of the pre-filled syringe; a housing for holding the pre-filled syringe and needle tip in a defined position for a controlled depth of injection; and a needle shield mounted on the housing for movement from a locked injection position to a shield position, wherein after the needle shield is moved into the locked injection position with the needle tip extended out of the needle shield and pre-filled syringe system, the needle can be inserted into the subject at a controlled depth of injection. 
     The embodiments further provide methods of using and injecting a subject using a pre-filled syringe and system, comprising, providing a pre-filled syringe system having a housing, a needle shield mounted on the housing, and a pre-filled syringe with a needle tip; moving the needle shield mounted on the housing into a locked injection position to extend the needle tip of the pre-filled syringe and system at a defined length out of the needle shield and pre-filled syringe system; inserting the needle tip of the pre-filled syringe and system into a subject at a controlled injection depth, and injecting the contents of the pre-filled syringe and system into the subject. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The skilled artisan will understand that the drawings, described below, are for illustration purposes only. The drawings are not intended to limit the scope of the present teachings or claims in any way. 
         FIG.  1   —This figure shows a general pre-filled syringe system. 
         FIG.  2   —This figure shows an exploded view of the pre-filled syringe system and how the components are assembled. 
         FIG.  3   —This figure shows a side elevation view of the needle shield. 
         FIG.  4 A —This figure shows a view of a first end of the needle shield. 
         FIG.  4 B —This figure shows a view of a second end of the needle shield. 
         FIG.  5   —This figure shows a side elevation view of the housing. 
         FIG.  6 A —This figure shows the housing and needle shield in a partial assembled releasable locked injection position without the pre-filled syringe. 
         FIG.  6 B —This figure shows the housing and needle shield in a partial assembled and extended shield position without the pre-filled syringe. 
         FIG.  7 A —This figure shows a cross-sectional view of the pre-filled syringe system and needle tip in a locked injection position. 
         FIG.  7 B —This figure shows a similar cross-sectional view to  7 A, but the pre-filled syringe system and needle tip are in a shield position. 
         FIG.  8 A —This figure shows the locking mechanism of the pre-filled syringe system with seated syringe barrel flange prior to rotation into the locked position. 
         FIG.  8 B —This figure shows the locking mechanism of the pre-filled syringe system with seated syringe barrel flange after it is rotated into the locked position. 
         FIG.  8 C —This figure shows a cross-sectional view of the locking mechanism of the pre-filled syringe system. 
         FIG.  9   —This figure shows the method of injection of the pre-filled syringe system including system preparation  9 A, injection of subject  9 B, system and needle removal  9 C, and system and needle tip placed in shield position  9 D. 
     
    
    
     DETAILED DESCRIPTION 
     This disclosure describes embodiments related to a pre-filled syringes and methods of using them. 
     Definitions 
     For the purpose of interpreting this specification, the following definitions will apply. In the event that any definition set forth below conflicts with the usage of that word in any other document, including any document incorporated herein by reference, the definition set forth below shall always control for purposes of interpreting this specification and its associated claims unless a contrary meaning is clearly intended (for example in the document where the term is originally used). 
     Whenever appropriate, terms used in the singular will also include the plural and vice versa. The use of “a” herein means “one or more” unless stated otherwise or where the use of “one or more” is clearly inappropriate. 
     The use of “or” means “and/or” unless stated otherwise. The use of “comprise,” “comprises,” “comprising,” “include,” “includes,” and “including” are interchangeable and are not limiting. The terms “such as,” “for example,” and “e.g.” also are not intended to be limiting. For example, the term “including” shall mean “including, but not limited to.” 
     As used herein, the term “about” refers to +/−10% of the unit value provided. 
     As used herein, the term “substantially” refers to the qualitative condition of exhibiting a total or approximate degree of a characteristic or property of interest. One of ordinary skill in the biological arts will understand that biological and chemical phenomena rarely, if ever, achieve or avoid an absolute result because of the many variables that affect testing, production, and storage of biological and chemical compositions and materials, and because of the inherent error in the instruments and equipment used in the testing, production, and storage of biological and chemical compositions and materials. The term “substantially” is, therefore, used herein to capture the potential lack of completeness inherent in many biological and chemical phenomena. 
     Referring now to the figures,  FIG.  1    shows a general perspective view of the pre-filled syringe system  1 . The pre-filled syringe system  1 , comprises a housing  9 , a needle shield  3 , and a pre-filled syringe  17 . Although the presently described embodiments describe certain components or parts, it is also possible to design the pre-filled syringe system  1  with various other components, orientations, or combinations of elements or parts. Further, each of the components can be further designed to fit in and around each other in various orientations and designs. 
       FIG.  2    shows an exploded view of one embodiment of the present invention and how the parts fit together to define the pre-filled syringe system  1 . Other embodiments, orientations, and ordering of the parts and assembly can also be possible. As can be seen from  FIG.  2    the housing  9  holds the pre-filled syringe  17 , and needle shield  3  is then mounted on the housing  9  over the pre-filled syringe  17 . The pre-filled syringe  17  can be obtained over the counter or designed for the pre-filled syringe system  1 . Various disposable or non-disposable types can be employed with the present embodiments. Pre-filled syringe  17  can comprise a syringe barrel  18  with syringe barrel flange  21 , needle  19 , needle tip  20 , plunger  22  with plunger finger flange  23 , and optional needle cap  31 . Plunger  22  is designed to fit into syringe barrel  18 . Syringe barrel  18  is designed to hold a drug formulation or similar type solution. 
       FIG.  3    shows a perspective view of the needle shield  3  of the present embodiments. The needle shield  3  of the present embodiments can be designed to comprise a first needle shield window  4   a  and a second needle shield window  4   b  ( 4   b  not shown in  FIG.  3   ). The needle shield windows  4   a  and  4   b  can be designed so that they are positioned opposite each other. Other orientations and designs are possible. Needle shield  3  can also be designed to comprise a first needle shield finger grip  6   a  and a second needle shield finger grip  6   b  as shown in the figures. The first needle shield finger grip  6   a  and second needle shield finger grip  6   b  can be designed and positioned opposite each other and orthogonal to the first needle shield window  4   a  and the second needle shield window  4   b . Various types and numbers of finger grips may be employed. Finger grips  6   a  and  6   b  are shown in ridge format with two pairs on each side (four on each side or total of 8 ridges). However, other designs are possible. For instance, instead of ridges a series of dimples, notches, or other projection types can be employed for ease of gripping the component. 
     The needle shield  3  can be configured to further comprise a needle shield elongated bore  5  which passes through the entire component. The needle shield elongated bore  5  can be designed to receive the housing  9  with or without the inserted pre-filled syringe  17 . The needle shield  3  can comprise a single part or various different components that fit together. 
     Referring to  FIG.  3   , the needle shield  3  of the shown embodiment comprises a first locking tab  7   a  and a second locking tab  7   b . The locking tabs  7   a  and  7   b  can be designed to be inwardly facing. The function of the locking tabs  7   a  and  7   b  will be further discussed below in conjunction with how they interact with the complementary locking features of the housing  9 . 
     The needle shield  3  can also be designed with various other designs numbers and locking tabs.  FIG.  4 A  shows a plan view of the needle shield  3  from a first end  8   a .  FIG.  4 B  shows a plan view of the needle shield  3  from the opposite or second end  8   b.    
       FIG.  5    shows the housing  9  of the present embodiments. The housing  9  can be designed as a single part or a series of components that fit together. The embodiment of housing  9  shown in  FIG.  5    comprises a universal finger flange  10 . The universal finger flange  10  can be designed in various embodiment sizes and shapes. For purpose of the present embodiments the diameter of the universal finger flange  10  can range from about 5 to about 100 millimeters. The circular and narrow tapering design allows a user to easily grip, hold, and orient the pre-filled syringe system  1  when it is assembled and employed in an injection as will be further discussed below. The universal finger flange  10  as shown in  FIG.  5    is designed as part of housing  9 . However, it can be imagined in certain embodiments that the universal finger flange  10  can be designed as a separate component with or without a tapered neck and mounted on the housing  9  in various designs and orientations. 
     Referring again to  FIG.  5   , the housing  9  can further comprise a housing elongated bore  11 . The housing elongated bore  11  is adapted to receive a pre-filled syringe  17  (See  FIG.  2    for further details regarding how the parts fit together) when it is assembled and ready for injection of a pharmaceutical drug. The housing elongated bore  11  runs through the entire housing  9  including the finger flange  10 . The housing elongated bore  11  receives the pre-filled syringe  17  via the first end  12   a  near the finger flange  10 . 
     The housing  9  can further comprise a first ramp  13   a  and second ramp  13   b  at the second end  12   b . The ramps  13   a  and  13   b  can be designed to engage the locking tabs  7   a  and  7   b  of the needle shield  3  when the components are assembled together. The first ramp  13   a  and second ramp  13   b  can be designed to taper inwardly toward the central axis of the housing bore  11 . Adjacent to the first ramp  13   a  and second ramp  13   b  are first locking notch  14   a  and second locking notch  14   b . Locking notches  14   a  and  14   b  are designed to receive and engage the locking tabs  7   a  and  7   b  of the needle shield  3 . In order for the locking tabs  7   a  and  7   b  to engage the locking notches  14   a  and  14   b , the needle shield  3  must first be mounted on the housing  9 .  FIG.  6 A  shows the housing  9  and the needle shield  3  in a partial assembled releasable locked injection position without the pre-filled syringe  17 . It should be noted that both locking notches  14   a  and  14   b  are designed to be releasable. This allows the needle shield  3  to then be later adjusted to slide forward and engage locking notches  16   a  and  16   b  as will be further discussed below.  FIG.  6 B  shows the housing  9  and the needle shield  3  in a partial assembled shield position without the pre-filled syringe  17 . Locking notches  16   a  and  16   b  can preferably be designed to be non-releasable. However, it can be imagined in certain embodiments that they can be designed to be releasable if desired. 
     Adjacent and spaced near the locking notches  14   a  and  14   b  are first locking notch  16   a  and second locking notch  16   b . After the needle shield  3  is mounted on the housing  9  it must be rotated into position so that the locking tabs  7   a  and  7   b  drop into position and engage locking notches  14   a  and  14   b . This click-feel engagement allows the user to know when the system is engaged and locked. The pre-filled syringe system  1  is then in position to make an injection while maintaining the needle  19  and pre-filled syringe  17  in a defined locked position and orientation. After the injection is complete, the needle shield  3  can then be released and moved away from the housing  9  to only cover a portion of the housing  9  while shielding the needle  19  and engaging first locking notch  16   a  and second locking notch  16   b.    
     The housing  9  can further comprise a first window housing  15   a  and second window housing  15   b . The first and second window housings  15   a  and  15   b  preferably align with the first and second needle window shields  4   a  and  4   b  when the pre-filled syringe system  1  is assembled. This alignment is preferable since it allows the subject  30  to view the level and amount of the formulation in the pre-filled syringe  17  at various desired times. For instance, to determine if the pre-filled syringe is filled prior to injection, is injecting the solution or formulation during an injection, or is empty after an injection. 
     Referring to  FIG.  2   , the pre-filled syringe  17  comprises a syringe barrel  18  with syringe barrel flange  21 , a needle  19  with a needle tip  20  (with optional cap  31 ), and a plunger  22  having a plunger finger flange  23 . The pre-filled syringe  17  can be designed to hold a pharmaceutical product. Pharmaceutical products can comprise both small molecules and biologics in various formulations. For instance, certain biologics which can be used with the present device can comprise biologics for treatment of hemophilia disease such as Factor VII, Factor VIII, Factor IX, Factor X, Factor XI, insulin, Betaseron®, and other similar small molecules, biologics and their combinations which are known and used in the art. Typically syringe barrel  18  can hold from about 0.25 milliliters of formulation to about 2.0 milliliters of formulation. However, it is within the scope of the present embodiments that various volumes can be employed. 
     The pre-filled syringe system  1 , can further comprise a locking mechanism  33  for attaching the pre-filled syringe  17  to the housing  9  and pre-filled syringe system  1 . The locking mechanism  33  can comprise syringe barrel flange  21 , mounting surface  32 , first locking surface  32   a , and second locking surface  32   b  (See  FIG.  8    for details and assembly). It can be imagined that locking mechanism  33  can comprise various parts, organizations, and designs for attaching the pre-filled syringe  17  to the housing  9  and pre-filled syringe system  1 . Further, it could be imagined that the locking mechanism  33  could comprise a portion of the pre-filled syringe system  1  (as shown in the present embodiments) or comprise one or more separate parts for attaching the pre-filled syringe  17  onto the housing  9  and pre-filled syringe system  1 . Further, barrel flange  21  could be designed in different shapes or sizes for mounting and seating on the first and second locking surfaces  32   a  and  32   b  respectively. The first locking surface  32   a  and the second locking surface  32   b  could also be designed as a tab or similar type structure. 
     The assembly of the embodiments can begin by placing a pharmaceutical formulation into the syringe barrel  18  of the pre-filled syringe  17 . The plunger  22  then is inserted into the syringe barrel  18  behind the pharmaceutical formulation so it contacts or nearly contacts the formulation and any air bubbles are removed from the needle tip  20 . Optional cap  31  can be included in the assembly and remain mounted on needle tip  19  to prevent accidental needle sticks. However, optional cap  31  must be removed prior to the injection of the subject  30 . The plunger  22  then remains in the loaded, pre-injection position. The pre-filled syringe  17  with formulation is then inserted into the housing bore  11  via the end with the universal finger flange  10  (second end  12   a ). The pre-filled syringe  17  slides all the way into the housing bore  11  until the syringe barrel  18  and syringe barrel flange  21  are seated against mounting surface  32  of the universal finger flange  10  (See  FIGS.  7  and  8   ). The mounting surface  32  can be designed to be grooved, indented, tapered, dimpled or in other similar type designs or shapes to engage syringe barrel  18  and syringe barrel flange  21  of the pre-filled syringe  17 . 
     The pre-filled syringe  17  should preferably fit tight enough via friction that it does not disengage or fall out of the housing  9 . In certain embodiments (as show in the  FIGS.  7  and  8   ) locking mechanism  33  may be employed for attaching the pre-filled syringe  17  to the housing  9  and pre-filled syringe system  1 . For instance, after the pre-filled syringe  17  is assembled, mounted in housing  9 , and pre-filled syringe flange  21  is seated on mountain surface  32  of the universal finger flange, the locking mechanism  33  can be locked. For instance, the syringe barrel flange  21  can be rotated to engage the first locking surface  32   a  and the second locking surface  32   b  to securely lock and attach the pre-filled syringe  17  to the housing  9  and pre-filled syringe system  1  (See  FIGS.  8 B and  8 C ). It can be imagined that locking mechanism  33  can be designed in various releasable and non-releasable locking designs and formats. 
     The plunger  22  of the pre-filled syringe  17  remains in a loaded pre-injection position during this process. Next, the needle shield  3  is mounted on the housing  9  via sliding it over the housing using the needle shield bore  5 . The first and second locking tabs  7   a  and  7   b  of the needle shield  3  slide along first and second ramps  13   a  and  13   b  until they contact the housing  9 . The mounting orientation of the needle shield  3  is such that the end having the first and second finger grips  6   a  and  6   b  is mounted first on the housing  9 . Once the needle shield  3  has been mounted on the housing  9  it is then rotated so that the first and second tabs  7   a  and  7   b  drop into the first and second locking notches  14   a  and  14   b . In this orientation, the first and second needle shield windows  4   a  and  4   b  are aligned with the first and second housing windows  15   a  and  15   b  so that the syringe barrel  18  of the pre-filled syringe  17  with formulation can be viewed. The pre-filled syringe system  1  is now in locked injection mode and ready for use. The user at this point simply needs to remove the needle cap  31  from the pre-filled syringe needle tip  20  and perform the injection.  FIGS.  7 A and  7 B  show cross-sectional views of the pre-filled syringe system  1  and pre-filled syringe  17  in the locked and shielded positions and how the needle tip  20  can extend at a defined length from the needle shield  3  and pre-filled syringe system  1  (See  FIG.  7 A ) or be shielded by needle shield  3  (See  FIG.  7 B ). 
     Having now described the components and their assembly, a description of the method of using the pre-filled syringe system  1  is now in order. 
       FIG.  9    shows the method of injection of the present embodiments. As previously discussed, the pre-filled syringe system  1  is assembled with a pre-filled syringe  17  having a pharmaceutical formulation. The pre-filled syringe plunger  22  is also in an extended and loaded position once the drug has been loaded. Once the needle shield  3  has been positioned on the housing  9  and placed into the locked position with extended needle tip  20 , the device is ready for use. The extent of protrusion of the needle tip  20  can be dependent upon the length of the needle  19 , and the size of the needle shield  3 . The extension length can be anywhere from 2 to 30 millimeters (as measured from the edge of the needle shield  3 ) or preferably from about 4 millimeters to about 8 millimeters, depending up the desired depth of injection into the subject. 
     The subject takes the entire pre-filled syringe system  1  in one hand with fingers around the universal finger flange  10 , ( FIG.  9 A ). The needle tip  20  and a portion of the needle  19  is then inserted into the subject  30 . Once the needle  19  is inserted it continues until the needle shield  3  contacts the subject  30  and can&#39;t penetrate any deeper into the subject&#39;s skin ( FIG.  9 B ). Next, the plunger  22  of the pre-filled syringe  17  is depressed and the formulation contents is injected into the subject  30 . In the present context, the pharmaceutical drug is delivered into the subject  30  at the desired position and depth. After the injection has been completed the pre-filled syringe system  1  and pre-filled syringe  17  are then removed from the subject  30  (See  FIG.  9 C ). At this point the needle  19  and needle tip  20  are still extended from the needle shield  3  in locked position (as previously described with releasable first locking tab  7   a  and second locking tab  7   b  positioned in first locking notch  14   a  and second locking notch  14   b ). Pressure is then applied to the sides of needle shield  3  to release first locking tab  7   a  and second locking tab  7   b  from the first locking notch  14   a  and the second locking notch  14   b  so that needle shield  3  can be slid forward on housing  9  so the first locking tab  7   a  and second locking tab  7   b  of the needle shield  3  engage the first locking notch  16   a  and second locking notch  16   b  of the housing  9  (See  FIG.  9 D ). As previously discussed, the first and second locking notches  14   a  and  14   b  are preferably designed for releasable movement of the needle shield  3  while the first and second locking notches  16   a  and  16   b  are not. In this second position, the needle shield  3  now completely shields and encloses the needle  19  and needle tip  20  so they no longer extend outside the pre-filled syringe system  1  to possibly injure the subject  30 . The pre-filled syringe system  1  and pre-filled syringe  17  can then be safely disposed of without risk of injuring the subject  30  or others.