Abstract:
A syringe having an integral ampule is disclosed. The syringe includes a barrel defining a reservoir configured to store a fluid and a plunger defining an inner cavity. The plunger includes an ampule within the inner cavity, where the ampule seals the fluid. The plunger also includes a cap at a proximal end of the plunger that is configured to move distally relative to the plunger, and a first one-way valve at the distal end of the plunger. The distal movement of the cap relative to the plunger causes an opening within the ampule. A method of injecting a fluid within a patient using a syringe having an integral ampule is also disclosed.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/872,027, filed on Aug. 30, 2013, the disclosure of which is hereby incorporated by reference, in its entireties. 
     
    
     TECHNICAL FIELD 
       [0002]    This disclosure generally relates to medical devices for administering a fluid, such as a liquid medicament, in a patient. More particularly, this disclosure relates to a syringe having an integral ampule storing a fluid to be administered to a patient, resulting in increased procedural efficiency and safety, as well as decreased risk of contamination, relative to known syringes. 
       BACKGROUND 
       [0003]    Liquid medicaments, such as saline, drugs, and anesthetics, are typically stored in sealed ampules before administration to prevent contamination of the liquid medicaments. To administer a liquid medicament, a clinician first cracks the top of the sealed ampule, withdraws the liquid medicament from the ampule into the barrel of a syringe, inserts the needle of the syringe into a patient, and depresses the plunger of the syringe to inject the liquid medicament into the patient. Such a procedure is time consuming and poses several risks to the clinician and the patient. 
         [0004]    In particular, with regard to clinician and patient safety, because many liquid medicaments are reactive, the ampules are typically made of an inert material, such as glass, to increase the shelf life of the liquid medicaments. By cracking a glass ampule, however, small glass shards from the broken ampule can contaminate the liquid medicament, which can be harmful to the patient. In addition, the cracked region of the glass ampule presents risks of sharps injuries to the clinician before disposal of the broken ampule. Moreover, once the ampules are cracked, bacteria can contaminate the liquid medicament through the opening formed in the ampule, which is especially risky in healthcare settings where the atmospheric air is contaminated with harmful bacteria and viruses. In addition, injection kits include several different parts, such as an ampule cracker and a filter straw, in addition to the syringe and ampule. The multiple separate parts increase the risk of contamination. 
         [0005]    Further, with regard to procedural efficiency, in addition to the time required to crack the ampule, the clinician must also remove air and/or air bubbles within the barrel of the syringe prior to injection, which increases the amount of clinician time required per injection. The clinician must also dispose of the different parts of the injection kit in different containers. For example the cracked ampule and syringe needle must be disposed in sharps disposal containers. 
         [0006]    Therefore, a need exists for a syringe having an integral ampule that reduces the risk of contamination and injury to the clinician and patient, while increasing the procedural efficiency of injection. 
       SUMMARY 
       [0007]    The foregoing needs are met, to a great extent, by implementations of the syringe having an integral ampule according to this disclosure. In accordance with one implementation, a syringe includes a barrel defining a reservoir configured to store a fluid and a plunger defining an inner cavity. The plunger includes an ampule within the inner cavity, where the ampule seals the fluid. The plunger also includes a cap at a proximal end of the plunger that is configured to move distally relative to the plunger, and a first one-way valve at the distal end of the plunger. The distal movement of the cap relative to the plunger causes an opening within the ampule. 
         [0008]    In some implementations, the distal end of the plunger can include a filter that is proximal of the first one way valve. Rotation of the cap can cause the distal movement of the cap relative to the plunger. The distal end of the cap can include external threads that are received within internal threads at the proximal end of the plunger. 
         [0009]    In some implementations, the syringe can further include a needle hub configured to be connected to a distal end of the barrel of the syringe, and a needle extending distally from the needle hub. The needle hub can also further include a second one-way filter configured to permit fluid flow only in the distal direction and a needle safety housing that is configured to move distally relative to the needle to cover a sharp distal tip of the needle. 
         [0010]    In some implementations, the first one-way valve can be configured to permit fluid flow only in the distal direction. A predetermined region at a distal end of the ampule can be configured to open in response to the distal movement of the cap relative to the plunger. The wall thickness of a distal end of the ampule can be less than the wall thickness of a proximal end of the ampule. The inner cavity of the plunger can include a pointed structure configured to break the ampule in response to the distal movement of the cap relative to the plunger. 
         [0011]    In some implementations, the ampule can be made of a flexible material, and the flexible ampule can be configured to sever in response to the distal movement of the cap relative to the plunger. The flexible ampule can be configured to sever in response to the distal movement of the cap relative to the plunger by contacting a sharp structure within the inner cavity of the plunger in response to the distal movement of the cap relative to the plunger. 
         [0012]    In some implementations, at least a portion of the walls of the ampule can be scored. The cap can further define an air vent. The air vent can be a longitudinal bore running along the entire longitudinal length of the cap. The cap can be configured to be removably connected to the plunger. 
         [0013]    According to another implementation, a method of using a syringe having an integral ampule is disclosed. Initially, a clinician receives the syringe having an integral ampule. The syringe includes a barrel and a plunger. The barrel defines a reservoir, and the plunger includes an ampule sealing a fluid and a cap. Distal movement of the cap relative to the plunger is caused, where the distal movement of the cap causing an opening within the ampule. Next, the plunger is caused to move in a proximal direction to cause the fluid to pass through the plunger into the reservoir defined by the barrel. Finally, the plunger is caused to move in a distal direction to cause the fluid in the reservoir to pass through the syringe. 
         [0014]    In some implementations, the received syringe can be a prefilled syringe including the ampule sealing the fluid within the plunger. In other implementations, the received syringe does not include the ampule and the clinician initially can remove the cap from the plunger, can insert the ampule storing the fluid within the plunger, and can apply the cap to the plunger. 
         [0015]    In some implementations, the distal movement of the cap relative to the plunger can be caused by rotating the cap of the plunger. The plunger can be caused to move in the proximal direction by pulling the plunger in the proximal direction. The plunger can be caused to move in the distal direction by pushing the plunger in the distal direction. 
         [0016]    Certain implementations of the syringe having the integral ampule have been outlined so that the detailed description below may be better understood. There are, of course, additional implementations that will be described below and which will form the subject matter of the claims. 
         [0017]    In this respect, before explaining at least one implementation in detail, it is to be understood that the syringe having the integral ampule is not limited in its application to the details of construction and to the arrangements of the components set forth in the following disclosure or illustrated in the drawings. Also, it is to be understood that the phraseology and terminology employed herein, as well as in the Abstract, are for the purpose of description and should not be regarded as limiting. 
         [0018]    As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the syringe having the integral ampule. It is understood, therefore, that the claims include such equivalent constructions insofar as they do not depart from the spirit and scope of the present disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1   a  illustrates a cross-sectional view of an implementation of a syringe having an integral ampule taken along its longitudinal axis. 
           [0020]      FIG. 1   b  illustrates a cross-sectional view of an implementation of a needle hub connected to the syringe having the integral ampule taken along the longitudinal axis of the syringe. 
       
    
    
       [0021]    Implementations of the syringe having the integral ampule are described with reference to the drawings, in which like reference numerals refer to like parts throughout. 
       DETAILED DESCRIPTION 
       [0022]    Referring to  FIG. 1   a,  a cross-sectional view of an implementation of a syringe  100  having an integral ampule taken along its longitudinal axis is illustrated. The syringe  100  includes a barrel  102  and a plunger  104  that is received within the barrel  102 . The barrel  102  and plunger  104  of the syringe  100  can be made of plastic, such as a polymer, or glass. The plunger  104  includes a distal seal  105  that is in contact with the inner surface of the barrel  102  to seal the reservoir defined by the barrel  102  and the distal seal  105 . The plunger  104  defines an inner cavity  106  that receives an ampule  108  storing a fluid. The fluid can be a liquid, a gas, a gel, a slurry, an emulsion, or a suspension and is, preferably, a liquid medicament. The ampule  108  can be made of any material that can be broken or severed and, preferably, can be made of glass. The proximal end  110  of the plunger  104  includes a cap  112  that can be twisted by the clinician to break or sever the ampule  108 . 
         [0023]    In some implementations, the ampule  108  can be placed within the inner cavity  106  of the plunger  104  before the cap  112  is applied to seal the inner cavity  106 , i.e., before packaging of the syringe  100 . Such a syringe is commonly referred to as a prefilled syringe. In other implementations, the syringe  100  can be packaged without the ampule  108 . A clinician can then remove the syringe  100  from its packaging, then unscrew the cap  112 , insert the ampule  108  with the fluid of choice, and then screw the cap  112  back on the proximal end  120  of the plunger  104 . 
         [0024]    The cap  112  includes a flat proximal surface  114  to which a clinician can apply a distal force to move the plunger  104  in the distal direction. A distal force applied to the flat proximal surface  114  by the clinician will cause distal movement of the plunger  104 , but not distal movement of the cap  112  relative to the plunger  104  due to the threaded attached attachment of the cap  112  to the plunger  104 . In some implementations, as shown in  FIG. 1 , the cap  112  can have a circular cross-section in a plane perpendicular to its longitudinal axis. In other implementations, the cross-section of the cap  112  can have an oval, a square, or other geometric shape in the plane perpendicular to its longitudinal axis. 
         [0025]    In some implementations, the outer wall of the proximal portion  116  of the cap  112  can include gripping features to improve grip of the cap  112  while the clinician is twisting the cap  112 . The gripping features can be, for example, depressions, projections, a textured surface, and/or a different material, such as rubber, that covers the outer wall of the proximal portion  116  of the cap  112 . The distal region  118  of the cap  112  includes external threads along its outer wall that are received within corresponding internal threads along the proximal end  120  of the plunger  104 . The cap  112  also includes an air vent  122  that allows air to pass through the cap  112  into the inner cavity  106  defined by the plunger  104 . In some implementations, as illustrated in  FIG. 1 , the air vent  122  can be a central longitudinal bore running along the entire longitudinal length of the cap  112 . In other implementations, the cap  112  can include multiple longitudinal bores located adjacent the circumference of the cap  112 . In some implementations, the air vent  122  can include a one-way valve (not shown) to only allow atmospheric air to enter the inner cavity  106  while not allowing fluid to exit the inner cavity  106 . The one-way valve of the air vent  122  can be any type of one-way valve, including a flap valve, a ball valve, a duck-bill valve, a slit valve, an umbrella valve, etc. 
         [0026]    In some implementations, the distal surface  124  of the cap  112  can be shaped to complement the proximal surface  126  of the ampule  108 . For example, as shown in  FIG. 1 , the distal surface  124  of the cap  112  is curved to maximize the area of the distal surface  124  contacting the curved proximal surface  126  of the ampule  108 . In other implementations where the proximal surface  126  of the ampule  108  is flat, the distal surface  124  of the cap  112  can also be flat. As a result of the complementary shape of the distal surface  124 , the longitudinal force applied by the cap  112  can be evenly spread to the ampule  108  over the contact area between the cap  112  and the ampule  108 . 
         [0027]    Similarly, as shown in  FIG. 1 , the distal end  128  of the ampule  108  is shown to be curved, but can, in some implementations, be flat. In addition, is some implementations, the ampule  108  can have a neck at its proximal end and be placed upside-down in the plunger  104 , so that the neck is distal of the base of the ampule  108 . In such implementations, the ampule  108  can be configured to break at its neck by an angled platform located at the distal end of the inner cavity  106 . As such, the distal force applied by the cap  112  will force the neck of the ampule  108  against the angled platform, causing the neck to break. 
         [0028]    The cap  112  is configured to be rotated by the clinician to impart distal movement of the cap  112  relative to the plunger  104 . The distal movement of the cap  112  applies a longitudinal force to the ampule  108 , causing the ampule  108  to break or sever when the longitudinal force applied by the cap  112  is greater than the force required to break a predetermined region of the ampule  108 . The opening created within the ampule  108  in turn releases the fluid stored in the ampule  108  so that it can be received within the reservoir defined by the barrel  102 . 
         [0029]    In some implementations, predetermined regions of the walls of the ampule  108  can be thinner than other regions of the walls of the ampule  108  to control breakage of the ampule  108  in the predetermined regions. For example, preferably, the walls of the distal end  128  of the ampule  108  can be thinner than the side and proximal walls of the ampule  108 , such that the distal end  128  of the ampule  108  breaks before the other regions of the ampule  108  under the longitudinal force applied by the cap  112 . In some implementations, all or part of the circumference at a longitudinal region of the ampule  108  can be scored to create a weakened or frangible region of the ampule  108  configured to break more quickly upon force exerted from the cap  112 . For example, a circumferential score line can be formed at the distal end  128  of the ampule  108 . 
         [0030]    In other implementations, the walls of the ampule  108  can have a consistent thickness and a pointed or sharp structure (not shown) can be included in the inner cavity  106 . Therefore, under the longitudinal force from the cap  112 , the force concentrated against the pointed or sharp structure will cause breakage of the ampule at the region aligned with the pointed or sharp structure. 
         [0031]    Following breakage of the ampule  108  and release of the fluid within the ampule  108 , the clinician can pull proximally on the plunger  104  or cap  112  to permit the fluid to flow from the inner cavity  106  into the reservoir defined by the barrel. In particular, a vacuum is created within the distal end of the barrel  102  as the clinician pulls proximally on the plunger  104 . The vacuum draws the fluid through the filter  130  and the first one-way valve  132  into the barrel  102 . As the fluid is drained, air is sucked from the atmosphere through the air vent  122  to replace the volume of the fluid exiting the inner cavity  106 . 
         [0032]    The filter  130  prevents fragments of the broken ampule  108  to pass from the inner cavity  106  into the barrel  102 . The filter  130  can also filter other impurities that may be present in the fluid, depending on the pore size of the filter  130 . In some implementations, the filter  130  can be a single layer filter, while in other implementations, the filter  130  can include multiple stacked layers. 
         [0033]    The first one-way valve  132  can be any type of one-way valve, including a flap valve, a ball valve, a duck-bill valve, a slit valve, an umbrella valve, etc. The first one-way valve  132  can be configured to be biased closed when a vacuum is not formed within the reservoir of the barrel  102  and to open when the vacuum is formed. 
         [0034]    The distal end of the barrel  102  may include a Luer-lock nozzle  134  that is sealed by a protective cap  136 . In some implementations, the syringe  100  can be packaged with the protective cap  136  and the clinician can remove the protective cap  136  and attach needle hub  138  to the Luer-lock nozzle  134  to prepare the syringe  100  for injection. In other implementations, the syringe  100  may not include the protective cap  136  and the needle hub  138  may be connected to the Luer-lock nozzle  134  at the factory. In such implementations, the needle  140  extending distally from the needle hub  138  can be covered by a needle guard (not shown). In some implementations, the syringe  100  may not include the Luer-lock nozzle  134  and the needle hub  138  may be integral with the barrel  102 . 
         [0035]    In particular,  FIG. 1   b  illustrates a cross-sectional view of an implementation of the needle hub  138  connected to the Luer-lock nozzle  134  taken along the longitudinal axis of the syringe  100 . The needle hub  138  includes a second one-way valve  142  that allows the fluid in the barrel  102  to pass through the needle hub  138  to the needle  140  for injection in the patient when the clinician presses down on the plunger  104  or the cap  112 . The second one-way valve  142  prevents fluids from the patient, such as blood, to enter the barrel  102  of the syringe  100  and contaminate the fluid. The second one-way valve  142  can be any type of one-way valve, including a flap valve, ball valve, a duck-bill valve, a slit valve, an umbrella valve, etc. In some implementations, the second one-way valve  142  can be the same type as the first one-way valve  132 , while in other implementations, the second one-way valve  142  can be a different type. The second one-way valve  142  can be configured to be biased closed when a positive pressure is not applied to the fluid within the barrel  102  and to open when positive pressure is applied to the fluid within the barrel  102  by the clinician. 
         [0036]    The needle hub  138  also includes a needle safety housing  144 . The needle safety housing  144  can be moved distally relative to the needle  140  following injection by the clinician to prevent needle pricks. The needle safety housing  144  circumferentially covers the sharp distal tip  146  of the needle  140  when in its distal position. 
         [0037]    Following attachment of the needle hub  138 , the clinician presses down on the plunger  104  or cap  112  to force the fluid within the plunger  104  out of the sharp distal tip  146  of the needle  140 . Following injection of the desired amount of the fluid, the clinician can move the needle safety housing  144  over the sharp distal tip  146  of the needle  140  and dispose of the syringe  100 . 
         [0038]    The many features and advantages of the syringe  100  are apparent from the detailed specification, and thus, the claims cover all such features and advantages within the scope of this application. Further, numerous modifications and variations are possible. For example, although two one-way valves are illustrated in  FIGS. 1   a - b,  the syringe  100  can include only the first one-way valve  132  or three or more one-way valves. 
         [0039]    In another example, the cap  112  can be moved distally relative to the plunger  104  by longitudinal force applied by the clinician to the cap as opposed to rotation the cap  112 . In such an example, the cap  112  would not be connected to the plunger  104  by a threaded connection, but can be connected by a friction fit, for example. 
         [0040]    In yet another example, the syringe  100  may not include a cap  112  configured to apply a longitudinal force to crack the ampule  108 . Instead, the syringe  100  may include a contact member, such as a rod, extending from the side walls of the plunger  104  and configured to apply a perpendicular force to the side walls of the ampule  108  to break the ampule  108 . The contact member can be forced into the side walls of the ampule  108  by direct force from the clinician or by actuation of a lever, for example. 
         [0041]    In still another example, the plunger  104  can be made of a flexible material such that flexing of the plunger by the clinician can break the ampule  108 . In such an example, the plunger  104  can initially be separate from the barrel  102 . The clinician can then flex the plunger  104  to break the ampule and then insert the plunger  104  within the barrel  102 . In this example, the fluid with the inner cavity  106  would not escape from the plunger  104  due to the first one-way valve  132  at the proximal end of the plunger  104 . 
         [0042]    Although the ampule  108  has been described as being broken upon the excursion of force, in some implementations, the ampule  108  can be flexible. The ampule  108  can, for example, be made of a flexible plastic. In such examples, the plunger  104  and/or cap  112  can be configured to puncture the ampule  108  to release the fluid from the ampule  108  to the inner cavity  106 . For example, the distal portion of the inner cavity  106  can include a sharp object that can puncture the distal end  128  of the ampule  108 . In another example, the sharp object can be connected to the cap  112 , such that distal movement of the cap  112  will result in puncturing of the proximal surface  126  of the ampule  108 . 
         [0043]    Although a single ampule  108  has been described, two or more ampules can be held within the plunger  104 . For example, a first ampule can be filled with a granulated or powdered medicament and a second ampule can be filled with a liquid, such as saline. In such an example, both ampules can be broken simultaneously or sequentially to mix the contents of both ampules. In one example, the distal movement of the cap  112  can cause the first, more proximal ampule to break and then the second, more distal ampule to break. In another example, two ampules can be placed in parallel along their longitudinal axes. The distal movement of the cap  112  can then cause both ampules to break simultaneously. When the clinician pulls proximally on the plunger  104  or cap  112  to permit the fluid within the inner cavity  106  to flow into the reservoir defined by the barrel, the solid medicament is mixed with the liquid to form a reconstituted homogenous solution. 
         [0044]    In another example, the two or more ampules can contain separate liquids to be mixed prior to injection. When mixed, the combination of the liquids can have limited efficacy life and, therefore, they can be kept in separate ampules within the plunger  104 . Following breakage of the ampules, when the clinician pulls proximally on the plunger  104  or cap  112  to permit the fluid within the inner cavity  106  to flow into the reservoir defined by the barrel, the separate liquids are mixed. 
         [0045]    As such, it is not desired to limit the syringe  100  to the exact construction and operation described and illustrated and, accordingly, all suitable modifications and equivalents may fall within the scope of the claims.