Patent Grant
9480801
1. Field of the Invention
The present invention is directed to a pre-filled syringe assembly adapted for dispensing and delivery of a fluid. More particularly, the present invention is directed to a pre-filled syringe assembly having a tamper evident tip cap providing an indication if the contents of the syringe assembly have been compromised.
2. Description of Related Art
Conventional syringes are well known to be used in connection with a vial of a medication, where the user draws the fluid into the syringe immediately prior to injection and delivery of the fluid to the patient. Oftentimes, hypodermic syringes may be packaged as “pre-filled” devices, wherein the syringe is pre-filled with medication prior to being packaged and delivered to the end user. In this manner, there is no need for the user to fill the device prior to injection, thereby saving time for the end user and maintaining consistent volumes for delivery.
Pre-filled syringes and pre-filled metered dose syringes are often filled with narcotics or other drugs at a production facility, packaged, and then shipped to a medical facility. Once at the facility, these syringes are often placed in controlled storage and/or locked cabinets to reduce theft of the syringes themselves and/or theft of the contents of these syringes. Even though measures, such as controlled storage, are taken to ensure that the contents of these syringes remain intact, the risk still remains that the syringe contents can be tampered with and/or stolen and replaced with a saline solution. One technique for preventing tampering is the use of a snap cap for the tip cap that makes a snapping noise when removed from the syringe assembly. U.S. Pat. No. 4,667,837 to Vitello et al. discloses a tamper proof cap for a pre-filled syringe comprising a top member concentrically disposed in a generally cylindrical sleeve member and connected by frangible elements to the sleeve member. U.S. Pat. No. 7,041,087 to Henderson et al. discloses an outer cap for a pre-filled syringe that is covered with a cylindrical cover cap which connects with the top wall of a holding member through a frangible portion. The cylindrical cover cap may be broken from the top wall of the holding member for tampering prevention/tamper-proof evidence. One drawback to this type of system is that the contents of the syringe can be heated and the cap reapplied to “reset” it to its previously deformed state, or the user tampering with the device can use an additional syringe to create a vacuum inside the “tampered” syringe and reset the snap cap. Then, it appears as if the syringe has not been tampered with. In these tamper resistant systems, a shrink wrap band is required to show that the cap has not been altered. It is desirable to produce pre-filled syringes having a readily viewable, non-reversible tamper indicator that ensures the integrity of the syringe contents.
According to one aspect, the invention is directed to a tamper evident pre-filled syringe assembly comprising a syringe barrel defining an interior chamber, a proximal end, and a distal end terminating in a tip having an opening extending therethrough, the syringe barrel defining a pressure contained within the interior chamber and an indicator associated with the syringe assembly. The indicator is configured for changing state upon a change in the pressure within the interior chamber to indicate tampering of contents within the syringe assembly. The syringe assembly can further include a first seal for sealing the interior chamber and a second seal for sealing the opening extending through the tip of the distal end of the syringe barrel. According to one embodiment, the plunger assembly can include a plunger head wherein the plunger head extends within the syringe barrel and comprises the first seal. The second seal can be positioned about the distal end of the syringe barrel and is formed from a deformable material. Tampering of contents within the syringe barrel causes a change in the pressure within the interior chamber resulting in a deformation of the second seal. The indicator can be associated with the second seal such that deformation of the second seal results in movement of the indicator.
According to one embodiment, the pressure defined by the interior chamber can be a positive pressure, wherein tampering with the syringe contents reduces the pressure within the interior chamber resulting in deformation of the second seal and movement of the indicator toward a proximal end of the syringe assembly.
According to another embodiment, the pressure defined by the interior chamber can be a negative pressure, wherein tampering with the syringe contents results in an increase of pressure within the syringe barrel resulting in deformation of the second seal and movement of the indicator toward a distal end of the syringe assembly.
The change in state of the indicator can comprise a visual change. For example, this visual change can be a color change, an indicia change, or any other visually distinguishable contrast.
The syringe assembly can further include a tip cap located about the distal end of the syringe barrel. The tip cap can contain at least a portion of the indicator therein and at least one viewing portion for viewing the change of state of the indicator. The viewing portion can comprise a cut-out portion in a wall of the tip cap. Alternatively, the viewing portion can comprise a transparent portion in the tip cap. The tip cap can be threadedly engaged with the distal end of the syringe barrel. A holding member can be provided for cooperating with the indicator and for preventing the indicator from returning to an original pre-tampered state. For example, this holding member can comprise flexible fingers or a washer.
According to another aspect, the invention is directed to a tamper evident pre-filled syringe assembly comprising a syringe barrel defining an interior chamber, a proximal end, and a distal end having an opening extending therethrough. A first seal is provided within the interior chamber of the syringe barrel and a second seal is provided for sealing the opening of the distal end of the syringe barrel. The second seal is deformable upon a change in pressure within the interior chamber. An indicator is associated with the second seal and has a first distinguishing feature indicating an untampered state and a second distinguishing feature indicating a tampered state. The indicator is adapted for movement upon a change of pressure within the syringe barrel such that the second distinguishing feature is located in a viewable location. The syringe assembly can include a plunger assembly comprising a plunger head extending within the syringe barrel, wherein this plunger head forms the first seal within the interior chamber of the syringe barrel. Tampering of contents within the syringe barrel causes a change in pressure within the syringe barrel resulting in a deformation of the second seal and movement of the indicator to position the second distinguishing feature in the viewable location. A tip cap can be located about the second seal and the distal end of the syringe barrel. The tip cap can include a hollow portion and at least one viewing portion extending therethrough. The indicator is positioned within the hollow portion of the tip cap so that the first distinguishing feature is viewable through the viewing portion when the syringe assembly is in an untampered state, and the second distinguishing feature is viewable through the viewing portion when the syringe assembly is in a tampered state. The tip cap can include biased flexible fingers located in a sidewall thereof so that upon movement of the indicator showing a tampered state, the flexible fingers bias into the hollow portion of the tip cap to contact the indicator and prevent a return of the indicator to a pre-tampered position. The first distinguishing feature and the second distinguishing feature of the indicator can comprise a color change, an indicia change, or any other type of visually distinguishable contrast.
According to one embodiment, the interior chamber of the syringe can be pressurized to have a positive (above atmospheric) pressure such that tampering results in a reduction of the pressure within the syringe barrel which results in movement of the second seal toward the proximal end of the barrel. According to an alternative embodiment, the interior chamber of the syringe can be pressurized to have a negative (below atmospheric) pressure such that tampering results in an increase of pressure within the syringe barrel and a movement of the second seal in a forward or distal direction with respect to the syringe barrel and a bottom face of the tip cap.
According to yet another aspect, the invention is directed to a tamper evident pre-filled syringe assembly comprising a syringe barrel extending between a proximal end and a distal end, the distal end having an opening extending therethrough. The assembly further includes a plunger assembly comprising a plunger head extending within the syringe barrel at a position between the proximal end of the syringe barrel and the opening of the distal end forming an interior chamber therebetween, with the plunger head forming a first seal within the interior chamber. A second seal seals the interior chamber adjacent the opening of the distal end of the syringe barrel. The second seal is deformable upon a change in pressure within the interior chamber. An indicator is associated with the second seal, with the indicator adapted for movement upon deformation of the second seal. Tampering of the contents within the interior chamber causes a change in pressure within the interior chamber, resulting in a deformation of the second seal and movement of the indicator to provide a visual indication of tampering.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
Reference is now made to
The syringe assembly 10 includes a syringe barrel 12 defined by barrel wall 14 extending between a distal or forward end 16 and a proximal or rearward end 18, thereby defining an interior chamber 20 of the syringe barrel 12. The syringe barrel 12 may be in the general form of an elongated cylindrical barrel as is known in the art for the general shape of a hypodermic syringe, although other forms for containing a fluid for delivery are also contemplated by the present invention. Additionally, the syringe barrel 12 may be formed of glass, or may be injection molded from thermoplastic material such as polypropylene and polyethylene according to techniques known to those of ordinary skill in the art, though it is to be appreciated that the syringe barrel 12 may be made from other suitable materials and according to other applicable techniques.
As illustrated in
The syringe barrel 12 may include markings, such as graduations 26 on the wall 14 thereof, for providing an indication as to the level or amount of fluid contained within the syringe barrel 12. Such markings may be provided on the external wall, the internal wall, or integrally formed or otherwise within the wall of syringe barrel 12. Alternatively, or in addition thereto, the markings may provide a description of the contents of the syringe, or other identifying information, as may be known in the art.
As noted, distal end 16 of syringe barrel 12 includes an outlet opening 22. The profile of outlet opening 22 may be adapted for engagement with a separate dispensing device, such as a needle assembly or IV connection assembly, and therefore may include a mechanism for such engagement, for example, a generally tapered luer tip, for engagement with a separate tapered luer mating surface (not shown) of such a separate device for attachment therewith. In addition, a mechanism for locking engagement therebetween may also be provided, such as a luer collar or luer lock including interior threads. Such luer connections and luer locking mechanisms are well known in the art.
Referring back to
All of the components of syringe assembly 10 may be constructed of any known material, and are desirably constructed of medical grade polymers.
As stated above, the syringe assembly 10 is particularly useful as a pre-filled syringe, and therefore may be provided for end use with a fluid, such as a medication, contained within interior chamber 20 of syringe barrel 12, pre-filled by the manufacturer. In this manner, syringe assembly 10 can be manufactured, pre-filled with a medication, sterilized, and packaged in appropriate packaging for delivery, storage, and use by the end user, without the need for the end user to fill the syringe with medication from a separate vial prior to use.
As previously discussed, steps have been taken to ensure the integrity of the contents of the syringe assembly 10, such as through the use of snap caps and shrink wrap bands, however, tampering with and/or theft of the contents can still occur. Reference is made to
With continuing reference to
A second seal 65 as shown in
The tip cap 60 is located about the second seal 65 and the distal end 16 of the syringe barrel 12. This tip cap 60 includes a hollow portion 62 and at least one viewing portion or window 64 extending therethrough. This viewing portion 64 can be a cut-out portion in the wall 66 of the tip cap 60 or a transparent portion of the tip cap 60. The tip cap 60 can be secured to the distal end 16 of the syringe barrel 12 by a threaded engagement 68 or any other well known means.
An indicator 70 capable of visually changing state upon a change in pressure within the syringe barrel 12 is located within the hollow portion 62. According to one embodiment, the indicator 70 can have at least a first distinguishing feature 72 and a second distinguishing feature 74. The first distinguishing feature 72 can represent the syringe assembly as being in an untampered state. The second distinguishing feature 74 can represent the syringe assembly as being in a tampered state. The indicator 70 has a portion 76 positioned in contact with the second seal 65 such that at least a portion of the first distinguishing feature 72 is viewable through the viewing portion 64 of the tip cap 60. Any tampering of the contents within the syringe barrel 12 will cause a change in pressure within the syringe barrel 12 resulting in a deformation of the second seal 65. As particularly shown in
According to a second embodiment, as shown in
Since the interior chamber 20 of the syringe barrel 12 is sealed via first seal 45 and second seal 65, any tampering with the syringe contents would result in a change in pressure within the chamber, which would cause deformation of the second seal 65 and movement of the indicator 70. Accordingly, although embodiments showing a positively pressurized or a negatively pressurized chamber within the syringe barrel are specifically described and shown in the drawings, it can be appreciated that the syringe barrel of the pre-filled syringe assembly can define any pressure within the interior chamber 20, such as atmospheric or ambient pressure, so long as the deformation of seal 65 is achieved through a change in pressure across seal 65 as a pressure gradient, based on a change in pressure within interior chamber 20.
A holding member can be provided for preventing the indicator from returning to an original pre-tampered state. One example of a holding member can be flexible fingers 90, as shown in
While the above description is directed to the prevention of tampering and/or theft of the syringe contents, it can be appreciated that the present invention can also be used to detect leakage of the contents in positively pressurized syringe assemblies and to detect the entrance of unwanted contaminants within negatively pressurized syringe assemblies.
In accordance with an embodiment of the present invention, if the syringe is pressurized, then the plunger rod assembly may be biased to move proximally. The clinician may, upon removing the syringe assembly from the packaging, apply a twist to the plunger rod, disengaging the retaining features between the plunger rod and the barrel that maintain the pressure. The assembly will then be displaced proximally by the pressure inside the syringe and a color change, molded or affixed to the plunger rod, could appear to indicate that the internal pressure has been held up to the point of disengagement by the clinician. In certain embodiments, this color change may be evident as the device is held within the clinician's hand.
While specific embodiments of the invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives to those details could be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are meant to be illustrative only and not limiting as to the scope of invention which is to be given the full breadth of the claims appended and any and all equivalents thereof.
This application claims benefit of U.S. Provisional Patent Application No. 61/235,822 entitled “Tamper Evident Tip Cap and Syringe” filed Aug. 21, 2009, which is hereby incorporated by reference in its entirety.
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