Tamper-evident syringes and caps

Abstract

The syringe includes an adapter portion and a barrel having a chamber for holding a fluid. The adapter portion includes an outer wall and an inner wall forming a first groove. The inner wall includes a barrel thread, and the outer wall includes a first protrusion. The cap has cap threads that engage with the barrel threads to removably attach the cap to the adapter portion. A locking element having a sidewall including a second protrusion is received by the first groove and removably attached to the cap by an interference fit. Rotation of the cap causes upward movement of the cap, overcoming the interference fit and thereby removing the cap. The locking element is prevented from being removed from the first groove by contact between the first protrusion and the second protrusion. After the cap is removed, the presence of the locking element in the first groove provides evidence of tampering.

Description

[Technical Field]

[0001] The present invention relates generally to a tamper-evident syringe, and more particularly to a syringe including an adapter portion having an outer wall and an inner wall forming a first groove, the inner wall threadably engaging a cap, the outer wall including a first protrusion that contacts a second protrusion of a locking element residing in the first groove, the locking element and the cap forming an interference fit, removal of the cap causes upward movement of the cap, overcoming the interference fit and thereby removing the cap, the locking element being prevented from being removed from the first groove by contact of the first and second protrusions, and the presence of the locking element in the first groove after the cap is removed provides tamper evidence. [Background technology]

[0002] A conventional hypodermic syringe is used in conjunction with a vial of medication or fluid, and the user draws the fluid from the vial into the syringe before injecting and delivering the fluid to a patient. For example, the fluid may be medication, saline, or a component of a medical treatment designed to be mixed with another component before administration to a patient.

[0003] Syringes may also be packaged as pre-filled devices, in which case the syringe is pre-filled with a fluid before being packaged and shipped to an end user, such as a clinician, nurse, or other healthcare professional. It is important that the contents of the syringe remain within the syringe prior to administration, and that the contents are sterile and free of impurities prior to the desired administration. It is also important that healthcare professionals and patients can determine if there has been tampering with the syringe or the material contained therein. However, existing technologies for detecting tampering are cumbersome, difficult to use, and may not be effective in maintaining the sterility of the syringe contents and the syringe itself. Summary of the Invention

[0004] In one or more embodiments, a tamper-evident syringe is disclosed. The syringe includes a syringe barrel having a chamber for holding a fluid. The syringe also includes an adapter portion formed on the syringe barrel, the adapter portion including an outer wall and an inner wall forming a first groove. The inner wall includes a barrel thread, and the outer wall includes a first protrusion, and the adapter portion further includes a fluid passageway allowing fluid communication with the chamber. The syringe further includes a movable plunger having a plunger flange that moves forward within the chamber to reduce the volume of the chamber and force the fluid out of the fluid passageway. The syringe further includes a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap enclosing the fluid passageway, and the cap further including a second groove. The syringe also includes a locking element having a sidewall including a second protrusion, the locking element received by the first groove, the locking element removably attached to the cap by an interference fit between the sidewall and the second groove. Further, rotation of the cap causes upward movement of the cap, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter portion, and the locking element is prevented from being removed from the first groove by contact between the first protrusion and the second protrusion, and the presence of the locking element in the first groove after the cap is removed provides evidence of tampering.

[0005] A method for detecting syringe tampering is also disclosed. The method includes providing a syringe barrel having a chamber for holding a fluid, and an adapter portion formed on the syringe barrel, the adapter portion including outer and inner walls forming a first groove, the inner wall including a barrel thread, the outer wall including a first protrusion, and the adapter portion further including a fluid passageway allowing fluid communication with the chamber. The method also includes providing a movable plunger having a plunger flange that moves forward within the chamber to reduce the volume of the chamber and force the fluid out of the fluid passageway, and providing a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap surrounding the fluid passageway, and the cap further including a second groove. The method further includes providing a locking element having a sidewall including a second protrusion, the locking element received by the first groove, and forming an interference fit between the sidewall and the second groove to removably attach the cap. The method further includes providing an upward movement of the cap to overcome the interference fit between the cap and the locking element, thereby removing the cap from the adapter portion, providing contact between the first protrusion and the second protrusion during upward movement of the cap, and preventing removal of the locking element from the first groove due to the contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first groove after the cap is removed provides evidence of tampering.

[0006] In one embodiment, the locking element is ring-shaped.

[0007] In one or more embodiments, the first protrusion and the second protrusion are wedge-shaped.

[0008] In one embodiment, the adapter portion is transparent to enhance visibility of the locking element.

[0009] In one or more embodiments, the outer wall of the adapter portion is made from a resilient material.

[0010] In one or more embodiments, the cap includes a shoulder located between an upwardly extending gripping portion and a downwardly extending mounting portion, the shoulder including the second groove, and the mounting portion including the cap threads.

[0011] In one or more embodiments, the cap threads are configured as external threads formed on the mounting portion.

[0012] In one or more embodiments, the barrel threads are configured as internal threads formed on an inner wall of the adapter portion.

[0013] In one embodiment, the cap includes an interior wall that defines a cavity that surrounds the fluid passageway.

[0014] In one or more embodiments, the fluid is a medication, saline, or component of a medical procedure designed to be mixed with another component before administration to the patient.

[0015] In one or more embodiments, the depth of the first groove is greater than the height of the locking element, thereby preventing the locking element from extending beyond the first groove and preventing reinsertion of the locking element into the first groove after the cap is removed. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 illustrates a tamper-evident syringe according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a side view of a tamper-evident cap assembly according to one embodiment of the present disclosure. [Figure 3] FIG. 3 is a cross-sectional view of the cap. [Figure 4] FIG. 4 is a side view of a ring-shaped locking element. [Figure 5] FIG. 5 is a cross-sectional view of the adapter portion of the syringe. [Figure 6] FIG. 6 is a cross-sectional view of the cap assembled to the adapter portion. [Figure 7] FIG. 7 is an enlarged view of the balloon portion 7 of FIG. 6, showing the shoulder portion of the cap, the locking element, the first groove, the first protrusion, the second protrusion, and the adapter portion. [Figure 8] FIG. 8 is a cross-sectional view of the cap after it has been separated from the locking element. [Figure 9] FIG. 9 is an inverted view of the separated cap and locking element shown in FIG. [Figure 10] FIG. 10 is a side view of an alternative embodiment of the cap. [Figure 11] FIG. 11 is a side view of an alternative embodiment of the adapter portion. [Figure 12] FIG. 12 is a cross-sectional view of an alternative embodiment of a tamper-evident cap assembly. [Figure 13] FIG. 13 is a side view of an alternative embodiment of a tamper-evident cap assembly. [Figure 14] FIG. 14 is an enlarged view of the balloon portion 14 of FIG. 13 showing selected tab and rod elements of an alternative embodiment. [Figure 15] FIG. 15 shows the ring element of the alternative embodiment after it has been separated from the rod element. [Figure 16] FIG. 16 shows the alternative cap after it has been removed from the adapter portion and the cut ring element located on the syringe barrel. DETAILED DESCRIPTION OF THE INVENTION

[0017] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0018] An embodiment of the present disclosure relates to a multi-layer disinfection device for disinfecting female medical connectors. The device includes an inner housing and an outer housing that thread together. In particular, the inner housing includes a flange and a first female thread that engages with the first male thread of the medical connector. The device also includes an outer housing having a second female thread formed on its exterior surface that engages with the second male thread of the inner housing. The outer housing also includes an absorbent material containing a disinfectant or antibacterial agent. Rotation of the outer housing creates frictional engagement between the absorbent material and the medical connector, moving the outer housing toward the inner housing. The second female thread and the second male thread are configured to provide sufficient cleaning time and rotation for the absorbent material to disinfect the medical connector. In one or more embodiments, the outer housing further includes at least one resilient snap element that moves to an extended position after contact with the flange, indicating that disinfection of the medical connector is complete.

[0019] The following definitions are provided for terms used in this disclosure.

[0020] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0021] As used herein, the term "Luer connector" refers to a connection collar, a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing, slightly tapered for a secure hold with a simple pressure / torsion fit. Luer connectors can optionally include an additional outer thread, which provides additional safety. The male end of a Luer connector is typically associated with a flush syringe and can interlock with a female end found on a vascular access device (VAD). Luer connectors include a distal end, a proximal end, an irregularly shaped outer wall, and a profiled central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Luer connectors also have a distal end channel that releasably attaches the Luer connector to the hub of the VAD and a proximal end channel that releasably connects the Luer connector to the syringe barrel.

[0022] FIG. 1 illustrates a syringe 100 having a barrel 102 located on a central axis 142 and including an inner surface 104 defining an internal chamber 106 for receiving a fluid. For example, the fluid may be a medication, saline, or a component of a medical treatment designed to be mixed with another component before administration to a patient. The barrel 102 includes an open end 108 and a barrel flange 110 located at a first end 112 of the barrel 102. A second end 114 of the barrel 102, opposite the first end 112, includes a barrel adapter portion 140 having an extended barrel tip 116. The barrel tip 116 includes a fluid passageway 118 that allows fluid communication between the chamber 106 and a needle or other dispensing device removably attached to the adapter portion 140. The adapter portion 140 includes an outer wall 120 and may include a luer connector so that a medical instrument or device can be removably attached to the adapter portion 140. In one embodiment, the barrel 102 is substantially transparent.

[0023] Syringe 100 further includes a movable plunger 124 having a first portion 126 that extends into chamber 106 and a second portion 128 that extends from chamber 106 through open end 108 of barrel 102. Plunger 124 includes a first sealing flange 130 that seals against interior surface 104 of barrel 102. Plunger 124 may also include a second sealing flange 131 near open end 108 to enhance the seal against interior surface 104.

[0024] The second portion 128 includes a plunger flange 132 that facilitates a user's grip of the plunger 124 and allows the plunger 124 to move in and out of the barrel 102. In one or more embodiments, the plunger flange 132 is provided. In one or more embodiments, the chamber 106 may be pre-filled with fluid before being packaged and shipped to an end user, such as a clinician, nurse, or other healthcare professional. Additionally, the barrel 102 may include markings, such as graduations 135, that indicate the level or amount of fluid contained within the barrel 102. In operation, fluid is dispensed from the chamber 106 by applying a force to the plunger flange 132 to move the plunger 124 forward within the chamber 106, thereby decreasing the volume of the chamber 106 and forcing fluid into and out of the barrel tip 116.

[0025] Referring to FIG. 2, a side view of a tamper-evident cap assembly 134 of a syringe 100 is shown, according to one embodiment of the present disclosure. The cap assembly 134 includes a cap 136 disposed on a central shaft 142, a locking element 138, and an adapter portion 140 (including the fluid passageway 118). The cap 136 includes a shoulder 144 located between an upwardly extending gripping portion 146 and a downwardly extending mounting portion 148. The locking element 138 is located between the shoulder 144 and the adapter portion 140 (see also FIG. 6). According to the present disclosure, the locking element 138 is used to indicate that the cap 136 has been previously removed, as described below. The gripping portion 146 includes a plurality of raised ribs 150 to facilitate a user's grip of the cap 136 when rotating the cap 136.

[0026] Referring to FIG. 3, a cross-sectional view of the cap 136 is shown. The shoulder 144 includes a first circumferential groove 152 that receives the locking element 138. The mounting portion 148 includes an inner wall 154 that defines a cavity 156 that receives a portion of the barrel tip 116. The mounting portion 148 also includes an outer surface 158 having external threads 160 that threadably mate with the internal threads 122 (see FIG. 5) of the adapter portion 140. The inner wall 154 of the cap 136 surrounds the barrel tip 116 and isolates or blocks the barrel tip 116 and a portion of the fluid passageway 118 from the environment to maintain a sterile, impurity-free state prior to a desired administration. This allows the syringe 100 to be pre-filled, stored, and / or transported with a predetermined amount of fluid disposed within the chamber 106.

[0027] Referring to FIG. 4, a side view of locking element 138 is shown. In one or more embodiments, locking element 138 has an annular or ring-shaped portion 164 and includes a sidewall 166. A thickness 168 of sidewall 166 and a width 170 of first groove 152 (see FIG. 3) are sized so that when sidewall 166 is inserted into first groove 152 and frictionally attaches locking element 138 to first groove 152, an interference fit is formed between first groove 152 and sidewall 166. A bottom of sidewall 166 includes at least one first protrusion 172 extending outward from outer surface 162 of sidewall 166. In one or more embodiments, first protrusion 172 includes a first side 174 and a first tapered portion 176 that substantially forms a first wedge shape (see FIG. 7) at the bottom of sidewall 166.

[0028] Referring to FIG. 5, a cross-sectional view of the adapter portion 140 is shown. The adapter portion 140 includes an inner wall 180 spaced apart from the outer wall 120 to form a second circumferential groove 178. The inner wall 180 includes internal threads 122 that mate with the external threads 160. An inner surface 185 of the outer wall 120 includes at least one second protrusion 184 (see also FIG. 7) that extends outward from the outer wall 120 toward the locking element 138. In one or more embodiments, the second protrusion 184 includes a second side portion 186 at an upper portion of the outer wall 120 and a second tapered portion 188 that substantially forms a second wedge shape. Additionally, the outer wall 120 and the second protrusion 184 are fabricated from a resilient material. Alternatively, the first protrusion 172 of the locking element 138 is positioned on the inner surface of the side wall 166 and the second protrusion 184 is positioned on the outer surface of the inner wall 180 .

[0029] Figure 6 is a cross-sectional view of the cap 136 assembled to the adapter portion 140. Figure 7 is an enlarged view of the balloon portion 7 of Figure 6, showing the cap's shoulder 144, locking element 138, first groove 152, first protrusion 172, second protrusion 184, and the adapter portion 140. To removably attach the cap 136 to the locking element 138, the side wall 166 of the locking element 138 is inserted into the first groove 152 to form an interference fit configured to allow for removably attaching the cap 136 to the locking element 138. Furthermore, the interference fit provides sufficient strength to withstand vibrations during shipping of the syringe 100, and therefore does not affect the performance of the locking element 138.

[0030] The cap 136 is then removably attached to the adapter portion 140 by rotating or twisting the cap 136 in a first direction, mating the male threads 160 and the female threads 122. This causes downward movement of the cap 136, moving the first protrusion 172 downward toward the second protrusion 184. According to aspects of the present disclosure, the first protrusion 172 is configured to contact or interfere with the second protrusion 184. Prior to contact between the first protrusion 172 and the second protrusion 184, the second protrusion 184 is in a non-deflected position (i.e., the first position). Continued downward movement of the cap 136 while rotating the cap 136 results in engagement of the first protrusion 172 and the second protrusion 184. This causes the outer wall 120 and second protrusion 184 to move outward relative to the central axis 142, deflecting to a position that creates a gap between the first protrusion 172 and the second protrusion 184. As the cap 136 moves further downward, the first protrusion 172 moves downward past the second protrusion 184 until the first protrusion 172 and the second protrusion 184 are no longer engaged. When this occurs, the second protrusion 184 and the outer wall 120 return to, or snap back into, the first position. In the first position, the first protrusion 172 is configured to again interfere with the second protrusion 184 such that the first protrusion 172 abuts the second protrusion 184 to stop or prevent upward movement of the locking element 138 due to contact between the first protrusion 172 and the second protrusion 184.

[0031] To access the adapter portion 140, the medical professional unscrews the cap 136 by rotating it in a second direction opposite the first direction and moves the cap 136 upward. The contact between the first protrusion 172 and the second protrusion 184 prevents the locking element 138 from moving upward. Therefore, as the cap 136 moves upward, the locking element 138 remains within the second groove 178. The upward movement of the cap 136 also creates an upward force that overcomes the frictional force due to the interference fit between the first groove 152 and the side wall 166, and thus the cap 136 is removed or separated from the locking element 138 while the locking element 138 remains within the second groove 178 of the adapter portion 140 due to the contact between the first protrusion 172 and the second protrusion 184.

[0032] According to the present disclosure, a syringe 100 including a locking element 138 on the adapter portion 140 but without a cap 136 indicates previous tampering with the syringe 100 or cap 136. Thus, the sterility of the syringe 100 and its contents cannot be verified. For example, a syringe 100 including a locking element 138 but without a cap 136 may indicate that the cap 136 has been removed by a previous user and that the syringe 100 has been used. In one or more embodiments, the adapter portion 140 is substantially transparent to enhance the visibility of the locking element 138. Additionally, the locking element 138 may be brightly colored or marked to enhance visibility when positioned on the adapter portion 140.

[0033] Referring to FIG. 8 , a cross-sectional view of the cap 136 after it has been separated from the locking element 138 is shown. When this occurs, the locking element 138 falls to the bottom of the second groove 178 due to gravity. In accordance with the present disclosure, the depth 190 of the second groove 178 is sized greater than the height 182 of the locking element 138, so that the locking element 138 fits within, but does not extend beyond, the second groove 178. Because the locking element 138 is within the second groove 178, the locking element 138 cannot access or contact the cap 136. This prevents the locking element 138 from being reinserted into the first groove 152 of the cap 136 if a user were to reassemble the cap assembly 134. FIG. 9 is an inverted view of the separated cap 136 and locking element 138 shown in FIG. 8 . If a user turns cap 136 and locking element 138 upside down and attempts to reinsert locking element 138 into first groove 152, they will be unsuccessful. In particular, the depth of the groove causes locking element 138 to be forced up into second groove 178 and, therefore, unable to generate the force required for an interference fit. Furthermore, the weight of the locking element alone is not sufficient to generate the force required for an interference fit.

[0034] Referring to FIG. 10 , a side view of an alternative embodiment of a cap 200 according to the present disclosure is shown. In this embodiment, the cap 200 includes a plurality of spaced-apart rod elements 202 positioned between a shoulder 144 and a ring element 204. A first end 206 of each rod element 202 is attached to the periphery of the shoulder 144. The ring element 204 is attached to a second end 208 of each rod element 202 opposite the first end 206. Referring to FIG. 11 , a side view of an alternative embodiment of an adapter portion 210 is shown. The outer wall 120 (see FIG. 1 ) includes a plurality of spaced-apart protrusions or tab elements 212 positioned on the upper periphery of the outer wall 120. Each tab element 212 is configured to contact an associated rod element 202. According to the present disclosure, the ring element 204 is used to indicate that the cap 200 has previously been removed. In this embodiment, the inner surface 205 of the outer wall 120 includes internal threads 122 (see FIG. 12 ).

[0035] 12 and 13, cross-sectional and side views, respectively, of an alternative embodiment of a tamper-evident cap assembly 214 are shown. The external threads 160 of the fitting 148 are threadedly engaged with the internal threads 122 of the outer wall 120. The inner wall 154 of the cap 200 surrounds the barrel tip 116 and isolates or blocks the barrel tip 116 and a portion of the fluid passageway 118 from the environment to maintain a sterile, impurity-free state prior to a desired administration. This allows the syringe 100 to be pre-filled, stored, and / or transported with a predetermined amount of fluid disposed within the chamber 106.

[0036] Referring to FIG. 14 , an enlarged view of the balloon portion 14 of FIG. 13 is shown, illustrating selected tabs 212 and rod elements 202. Each tab element 212 is positioned between a pair of rod elements 202. Each rod element 202 is frangible and configured to break upon contact with the tab element 212. To access the adapter portion 210, a medical professional unscrews or rotates the cap 200. Rotation of the cap 200 causes a responsive rotation of the rod elements 202, with each rod element 202 contacting its associated fixed tab element 212. Further rotation of the cap 200 causes each tab element 212 to break its associated fixed rod element 202, separating the ring element 204 from each rod element 202. In one or more embodiments, each tab element 212 includes an angled surface 220 that contacts the associated rod element 202 to facilitate separation of the rod element 202. Referring to FIG. 15, the ring element 204 is shown separated from the rod element 202 after the tab element 212 contacts and breaks the rod element 202 (see arrow 216).

[0037] 16 shows the cap 200 removed from the adapter portion 210 and the severed ring element 204 on the barrel 102 of the syringe 100. When the rod element 202 breaks, the ring element 204 falls by gravity (see arrow 218) onto the barrel 102. According to an alternative embodiment of the present disclosure, the presence of the ring element 204 on the barrel 102 of the syringe 100 indicates prior tampering with the syringe 100 or cap 200. Therefore, the sterility of the syringe 100 and its contents cannot be verified.

[0038] Embodiment Embodiment (a): A tamper-evident syringe comprising: a syringe barrel having a chamber for holding a fluid; an adapter portion formed on the syringe barrel, the adapter portion including outer and inner walls forming a first groove, the inner wall including a barrel thread, and the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; a movable plunger having a plunger flange that moves forward within the chamber to reduce a volume of the chamber and force the fluid out of the fluid passageway; and a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap enclosing the fluid passageway; a cap further including a second groove; and a locking element having a sidewall including a second protrusion, the locking element received by the first groove, the locking element removably attached to the cap by an interference fit between the sidewall and the second groove, wherein rotation of the cap causes upward movement of the cap, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter portion, the locking element being prevented from being removed from the first groove by contact between the first protrusion and the second protrusion, and wherein presence of the locking element in the first groove after the cap is removed provides evidence of tampering.

[0039] Embodiment (b): A syringe according to embodiment (a), wherein the locking element is ring-shaped.

[0040] Embodiment (c): A syringe according to embodiment (a), wherein the first protrusion and the second protrusion are wedge-shaped.

[0041] Embodiment (d): A syringe according to embodiment (a), wherein the adapter portion is transparent to enhance visibility of the locking element.

[0042] Embodiment (e): A syringe according to embodiment (a), wherein the outer wall of the adapter portion is made of an elastic material.

[0043] Embodiment (f): A syringe according to embodiment (a), wherein the cap includes a shoulder portion located between an upwardly extending gripping portion and a downwardly extending mounting portion, the shoulder portion including the second groove, and the mounting portion including the cap threads.

[0044] Embodiment (g): A syringe according to embodiment (f), wherein the cap threads are configured as external threads formed on the mounting portion.

[0045] Embodiment (h): A syringe according to embodiment (a), wherein the barrel thread is configured as an internal thread formed on the inner wall of the adapter portion.

[0046] Embodiment (i): A syringe according to embodiment (a), wherein the cap includes an interior wall defining a cavity surrounding the fluid passage.

[0047] Embodiment (j): A syringe according to embodiment (a), wherein the fluid is a medication, saline, or a component of a medical treatment designed to be mixed with another component before administration to the patient.

[0048] Embodiment (k): A tamper-evident syringe comprising: a syringe barrel having a chamber for holding a fluid; an adapter portion formed on the syringe barrel, the adapter portion including outer and inner walls forming a first groove, the inner wall including a barrel thread, the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; a movable plunger having a plunger flange that moves forward within the chamber to reduce a volume of the chamber and force the fluid out of the fluid passageway; a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap enclosing the fluid passageway, the cap further including a second groove; and a locking element having a sidewall including a second protrusion; the locking element is received by the first groove, the locking element removably attached to the cap by an interference fit between the sidewall and the second groove, wherein rotation of the cap causes upward movement of the cap, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter portion; the locking element is prevented from being removed from the first groove by contact between the first protrusion and the second protrusion; presence of the locking element in the first groove after the cap is removed provides evidence of tampering; and a depth of the first groove is greater than a height of the locking element, whereby the locking element does not extend beyond the first groove and reinsertion of the locking element into the first groove is prevented after the cap is removed.

[0049] Embodiment (l): A syringe according to embodiment (k), wherein the locking element is ring-shaped.

[0050] Embodiment (m): The syringe according to embodiment (k), wherein the first protrusion and the second protrusion are wedge-shaped.

[0051] Embodiment (n): A syringe according to embodiment (k), wherein the adapter portion is transparent to enhance visibility of the locking element.

[0052] Embodiment (o): A syringe according to embodiment (k), wherein the outer wall of the adapter part is made of an elastic material.

[0053] Embodiment (p): A syringe according to embodiment (k), wherein the cap includes a shoulder portion located between an upwardly extending gripping portion and a downwardly extending mounting portion, the shoulder portion including the second groove, and the mounting portion including the cap threads.

[0054] Embodiment (q): A syringe according to embodiment (p), wherein the cap threads are configured as external threads formed on the mounting portion.

[0055] Embodiment (r): A syringe according to embodiment (k), wherein the barrel thread is configured as an internal thread formed on the inner wall of the adapter portion.

[0056] Embodiment(s): The syringe according to embodiment (k), wherein the fluid is a medication, saline, or a component of a medical treatment designed to be mixed with another component before administration to the patient.

[0057] Embodiment (t): A method of detecting tampering with a syringe, the method comprising: providing a syringe barrel having a chamber for holding a fluid; an adapter portion formed on the syringe barrel, the adapter portion including outer and inner walls forming a first groove, the inner wall including a barrel thread, and the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; providing a movable plunger having a plunger flange that moves forward within the chamber to reduce a volume of the chamber and force the fluid out of the fluid passageway; and a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap enclosing the fluid passageway, the cap further including a second groove. providing a cap; a locking element having a sidewall including a second protrusion, the locking element received by the first groove; forming an interference fit between the sidewall and the second groove to removably attach the cap; the cap moving upward to overcome the interference fit between the cap and the locking element, thereby removing the cap from the adapter part; providing contact between the first protrusion and the second protrusion during upward movement of the cap; and preventing removal of the locking element from the first groove due to the contact between the first protrusion and the second protrusion, wherein presence of the locking element in the first groove provides evidence of tampering after the cap is removed.

[0058] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "one embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases "in one or more embodiments," "a particular embodiment," "in one embodiment," or "in one embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0059] Although the disclosure herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed methods and devices without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. A tamper-evident syringe comprising: a syringe barrel having a chamber for holding a fluid; an adapter portion formed on the syringe barrel, the adapter portion including an outer wall and an inner wall forming a first groove, the inner wall including a barrel thread, and the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; a movable plunger having a plunger flange that moves forward within the chamber to decrease the volume of the chamber and force the fluid out of the fluid passage; a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap surrounding the fluid passageway, the cap further including a second groove; and a locking element having a sidewall including a second protrusion, the locking element being received by the first groove, the locking element being removably attached to the cap by an interference fit between the sidewall and the second groove; Equipped with rotation of the cap causes it to move upward, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter portion; the locking element is prevented from being removed from the first groove by contact between the first protrusion and the second protrusion; and the presence of the locking element in the first groove after the cap is removed provides evidence of tampering.

2. 2. The syringe of claim 1, wherein the locking element is ring-shaped.

3. 2. The syringe of claim 1, wherein the first protrusion and the second protrusion are wedge-shaped.

4. 2. The syringe of claim 1, wherein the adapter portion is transparent to enhance visibility of the locking element.

5. 2. The syringe of claim 1, wherein the outer wall of the adapter portion is made from a resilient material.

6. 2. The syringe of claim 1, wherein the cap includes a shoulder located between an upwardly extending gripping portion and a downwardly extending mounting portion, the shoulder including the second groove, and the mounting portion including the cap threads.

7. The syringe according to claim 6, wherein the cap thread is configured as a male thread formed on the mounting portion.

8. The syringe according to claim 1, wherein the barrel thread is configured as an internal thread formed on an inner wall of the adapter portion.

9. 2. The syringe of claim 1, wherein the cap includes an interior wall defining a cavity surrounding the fluid passage.

10. 10. The syringe of claim 1, wherein the fluid is a medication, saline, or a component of a medical procedure designed to be mixed with another component before administration to a patient.

11. 1. A tamper-evident syringe comprising: a syringe barrel having a chamber for holding a fluid; an adapter portion formed on the syringe barrel, the adapter portion including an outer wall and an inner wall forming a first groove, the inner wall including a barrel thread, and the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; a movable plunger having a plunger flange that moves forward within the chamber to decrease the volume of the chamber and force the fluid out of the fluid passage; a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap surrounding the fluid passageway, the cap further including a second groove; and a locking element having a sidewall including a second protrusion, the locking element being received by the first groove, the locking element being removably attached to the cap by an interference fit between the sidewall and the second groove; Equipped with rotation of the cap causes the cap to move upward, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter part, the locking element being prevented from being removed from the first groove by contact between the first protrusion and the second protrusion, and the presence of the locking element in the first groove after the cap is removed provides evidence of tampering; The depth of the first groove is greater than the height of the locking element, thereby preventing the locking element from extending beyond the first groove and preventing reinsertion of the locking element into the first groove after the cap is removed.

12. 12. The syringe of claim 11, wherein the locking element is ring-shaped.

13. 12. The syringe of claim 11, wherein the first protrusion and the second protrusion are wedge-shaped.

14. 12. The syringe of claim 11, wherein the adapter portion is transparent to enhance visibility of the locking element.

15. 12. The syringe of claim 11, wherein the outer wall of the adapter portion is made from a resilient material.

16. 12. The syringe of claim 11, wherein the cap includes a shoulder located between an upwardly extending gripping portion and a downwardly extending mounting portion, the shoulder including the second groove, and the mounting portion including the cap threads.

17. 17. The syringe of claim 16, wherein the cap threads are configured as external threads formed on the mounting portion.

18. The syringe according to claim 11, wherein the barrel thread is configured as an internal thread formed on an inner wall of the adapter portion.

19. 12. The syringe of claim 11, wherein the fluid is a medication, saline, or a component of a medical procedure designed to be mixed with another component before administration to a patient.

20. 1. A method for detecting syringe tampering, the method comprising: providing a syringe barrel having a chamber for holding a fluid; providing an adapter portion formed on the syringe barrel, the adapter portion including an outer wall and an inner wall forming a first groove, the inner wall including a barrel thread, and the outer wall including a first protrusion, the adapter portion further including a fluid passageway allowing fluid communication with the chamber; providing a movable plunger having a plunger flange that moves forward within the chamber to decrease the volume of the chamber and force the fluid out of the fluid passage; providing a cap having cap threads that threadably engage the barrel threads to removably attach the cap to the adapter portion, the cap surrounding the fluid passageway, the cap further including a second groove; providing a locking element having a sidewall including a second protrusion, said locking element being received by said first groove; forming an interference fit between the sidewall and the second groove to removably attach the cap; the cap moves upward to overcome the interference fit between the cap and the locking element, thereby removing the cap from the adapter part; providing contact between the first protrusion and the second protrusion during upward movement of the cap; preventing removal of the locking element from the first groove by contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first groove after the cap is removed provides evidence of tampering.

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