Tamper evident syringes and caps

Abstract

A syringe includes an adapter section and a barrel having a chamber holding a fluid. The adapter section includes an outer wall and an inner wall forming a first recess. The inner wall includes a cartridge thread and the outer wall includes a first protrusion. A cap having a cap thread is threadingly engaged with the cartridge to removably attach the cap to the adapter section. A locking element having a sidewall including a second protrusion is received in the first groove and removably attached to the cap by an interference fit. Rotation of the cap causes upward movement of the cap, which overcomes the interference fit, thereby removing the cap. The locking element is prevented from being removed from the first groove due to contact between the first protrusion and the second protrusion. After removal of the cap, the presence of the locking element in the first groove provides evidence of tamper.

Description

Technical Field

[0001] The present disclosure generally relates to a tamper-evident syringe and, more particularly, to a syringe comprising an adapter section having an outer wall and an inner wall forming a first recess, wherein the inner wall is threadably engageable with a cap and the outer wall comprises a first protrusion that contacts a second protrusion of a locking element located in the first recess, wherein the locking element and the cap form an interference fit and removal of the cap causes the cap to move upwardly overcoming the interference fit, thereby removing the cap, and wherein the locking element is prevented from being removed from the first recess due to contact between the first protrusion and the second protrusion, and wherein the presence of the locking element in the first recess after removal of the cap provides tamper evidence. Background Art

[0002] Conventional hypodermic syringes are used in conjunction with vials of medication or fluid, wherein the user draws the fluid from the vial into the syringe before injecting and delivering the fluid to the patient. For example, the fluid can be a medication, saline solution, or a component of a medical treatment that is designed to be mixed with another component before administration to the patient.

[0003] Syringe also can be packaged as pre-filled device, and wherein syringe is pre-filled with fluid before being packaged and shipped to end user such as clinician, nurse or other health care provider.Importantly, the content of syringe is retained in syringe before using, and content keeps sterile and unadulterated before its expected using.Equally important, health care provider and patient can determine whether any tampering to syringe or its contained material has occurred.Yet, the prior art that is used to detect tampering is loaded down with trivial details and is difficult to use, and aspect the sterility of maintenance syringe content and syringe itself, may be invalid. 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 section formed on the syringe barrel, wherein the adapter section includes an outer wall and an inner wall forming a first groove. The inner wall includes barrel threads, and the outer wall includes a first protrusion, wherein the adapter section further includes a fluid passage capable of fluid communication with the chamber. The syringe further includes a movable plunger having a plunger flange, the plunger moving forward within the chamber to reduce the volume of the chamber to force the fluid out of the fluid passage. Additionally, a cap having cap threads threadably engages with the barrel threads to removably attach the cap to the adapter section, wherein the cap seals the fluid passage, and wherein the cap further includes a second groove. The syringe also includes a locking element having a sidewall including a second protrusion, wherein the locking element is received by the first groove, and wherein the locking element is removably attached to the cap by an interference fit between the sidewall and the second groove. Furthermore, rotation of the cap causes the cap to move upwardly, overcoming the interference fit between the cap and the locking element, thereby removing the cap from the adapter section, wherein the locking element is prevented from being removed from the first recess due to contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first recess after the cap is removed provides tamper evidence.

[0005] A method for detecting tampering of a syringe is also disclosed. The method includes providing a syringe barrel having a chamber for holding a fluid and providing an adapter section on the syringe barrel, the adapter section including an outer wall and an inner wall forming a first groove, wherein the inner wall includes barrel threads and the outer wall includes a first protrusion, and the adapter section further includes a fluid passage capable of being in fluid communication with the chamber. The method also includes providing a movable plunger having a plunger flange, the plunger moving forward within the chamber to reduce the volume of the chamber so that the fluid is forced out of the fluid passage, and providing a cap having cap threads that are threadably engaged with the barrel threads to removably attach the cap to the adapter section, wherein the cap closes the fluid passage, and wherein the cap further includes a second groove. In addition, the method includes providing a locking element having a sidewall, the sidewall including a second protrusion, wherein the locking element is received by the first groove and forms an interference fit between the sidewall and the second groove to removably attach the cap. The method further includes providing upward movement of the cap to overcome the interference fit between the cap and the locking element to remove the cap from the adapter section, providing contact between the first protrusion and the second protrusion during the upward movement of the cap, and preventing the locking element from being removed 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 tamper evidence.

[0006] In one embodiment, the locking element is annular.

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

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

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

[0010] In one or more embodiments, the cap includes a shoulder section between the upwardly extending grip section and the downwardly extending attachment section, wherein the shoulder section includes the second groove and the attachment section includes the cap threads.

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

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

[0013] In one embodiment, the cap includes an inner wall defining a cavity that encloses the fluid passageway.

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

[0015] In one or more embodiments, the depth of the first groove is greater than the height of the locking element such that the locking element does not extend beyond the first groove to prevent the locking element from being reinserted back into the first groove after the cap is removed. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A tamper-evident syringe is illustrated according to one embodiment of the present disclosure.

[0017] Figure 2 is a side view of a tamper-evident cap assembly according to one embodiment of the present disclosure.

[0018] Figure 3 is a cross-sectional view of the cap.

[0019] Figure 4 is a side view of the annular locking element.

[0020] Figure 5 is a cross-sectional view of an adapter section for a syringe.

[0021] Figure 6 is a cross-sectional view of the cap assembled to the adapter section.

[0022] Figure 7 yes Figure 6FIG1 is an enlarged view of the balloon-shaped section 7 of FIG1 and depicts the shoulder section, the locking element, the first groove, the first and second protrusions and the adapter section of the cap.

[0023] Figure 8 It is a cross-sectional view after the cap is separated from the locking element.

[0024] Figure 9 yes Figure 8 An inverted view of the separated cap and locking element is shown in FIG.

[0025] Figure 10 is a side view of an alternative embodiment of a cap.

[0026] Figure 11 is a side view of an alternative embodiment of an adapter segment.

[0027] Figure 12 is a cross-sectional view of an alternative embodiment of a tamper-evident cap assembly.

[0028] Figure 13 is a side view of an alternative embodiment of a tamper-evident cap assembly.

[0029] Figure 14 yes Figure 13 1 is an enlarged view of the balloon section 14 of FIG. 1 , depicting selected tab and rod elements of an alternative embodiment.

[0030] Figure 15 The ring element of the alternative embodiment is illustrated after being severed from the rod element.

[0031] Figure 16 Shown is a replacement cap after removal from the adapter section and a severed ring element located on the syringe barrel. DETAILED DESCRIPTION

[0032] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description, and the present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0033] Embodiments of the present disclosure relate to a multi-layer disinfection device for disinfecting female medical connectors. The device includes an inner shell and an outer shell that are threadably engaged. In particular, the inner shell includes a flange and a first inner thread that engages the first outer thread of the medical connector. The device also includes an outer shell having a second inner thread formed on an outer surface of the shell, the second inner thread engaging the second outer thread of the inner shell. The outer shell also includes an absorbent material having a disinfectant or antimicrobial agent. Rotation of the outer shell provides frictional engagement between the absorbent material and the medical connector and moves the outer shell toward the inner shell. The second inner thread and the second outer thread are configured to provide sufficient scrubbing time and scrubbing rotation through the absorbent material to disinfect the medical connector. In one or more embodiments, the outer shell also includes at least one resilient snap element that moves to an extended position after contacting the flange to indicate that disinfection of the medical connector is complete.

[0034] With respect to terms used in this disclosure, the following definitions are provided.

[0035] As used herein, the use of “a,” “an,” and “the” includes both the singular and the plural.

[0036] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method of attaching syringes, catheters, necked needles, IV tubing, etc. to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered so that they can be better held together even with just a simple press / twist fit. The Luer connector may optionally include an additional threaded outer rim to make it more secure. The male end of the Luer connector is generally associated with a flush syringe and can interlock and connect to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a molded central passageway for fluid communication from the chamber of the barrel of the syringe to the hub of the VAD. The Luer connector also has a distal end channel and a proximal end channel, the distal end channel releasably attaching the Luer connector to the hub of the VAD, and the proximal end channel releasably attaching the Luer connector to the barrel of the syringe.

[0037] Figure 1The diagram shows a syringe 100 positioned on a central axis 142 and having a barrel 102, which includes an interior surface 104 defining an inner 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 section 140 having an extended barrel tip 116. The barrel tip 116 includes a fluid passage 118 that enables fluid communication between the chamber 106 and a needle or other dispensing device that is removably attached to the adapter section 140. The adapter section 140 includes an outer wall 120 and may include a Luer connector to enable removable attachment of a medical device or apparatus to the adapter section 140. In one embodiment, the barrel 102 is substantially transparent.

[0038] The syringe 100 further includes a movable plunger 124 having a first portion 126 extending into the chamber 106 and a second portion 128 extending from the chamber 106 via the open end 108 of the barrel 102. The plunger 124 includes a first sealing lip 130 that seals against the interior surface 104 of the barrel 102. The plunger 124 may also include a second sealing lip 131 proximate the open end 108 to enhance the seal against the interior surface 104.

[0039] Second portion 128 comprises plunger flange 132, and plunger flange 132 is convenient for user to grip plunger 124 so that plunger 124 can be inwardly and outwardly moved relative to tube 102.In one or more embodiments, chamber 106 can be pre-filled with fluid before being packaged and shipped to end user such as clinician, nurse or other health care providers.In addition, tube 102 can comprise mark, such as scale 135, and it provides the indication about the level of the fluid being included in tube 102 or amount.In operation, by plunger flange 132 applying force so that plunger 124 moves forward in chamber 106 and distributes fluid from chamber 106, thereby impel the volume of chamber 106 to reduce, and impel fluid to be forced into and out of tube end 116.

[0040] refer to Figure 2 , Figure 2A side view of a tamper evident cap assembly 134 of a syringe 100 according to one embodiment of the present disclosure is shown. The cap assembly 134 includes a cap 136 disposed on a central axis 142, a locking element 138, and an adapter section 140 (including a fluid passageway 118). The cap 136 includes a shoulder section 144 located between an upwardly extending gripping section 146 and a downwardly extending attachment section 148. The locking element 138 is located between the shoulder section 144 and the adapter section 140 (see also FIG. Figure 6 ). According to the present disclosure, the locking element 138 is used to indicate that the cap 136 has been previously removed, as will be described. The gripping section 146 includes a plurality of raised ribs 150 to facilitate a user gripping the cap 136 when rotating it.

[0041] refer to Figure 3 , a cross-sectional view of the cap 136 is shown. The shoulder section 144 includes a first circumferential groove 152 that receives the locking element 138. The attachment section 148 includes an inner wall 154 that defines a cavity 156 that receives a portion of the barrel end 116. The attachment section 148 also includes an outer surface 158 having an outer thread 160 that aligns with the inner thread 122 of the adapter section 140 (see FIG. Figure 5 ) can be threadably engaged. The inner wall 154 of the cap 136 closes the barrel end 116 and, thereby, isolates or seals the barrel end 116 and a portion of the fluid passage 118 from the environment, keeping them sterile and unadulterated until the desired administration. This allows the syringe 100 to be pre-filled, stored, and / or shipped with a predetermined amount of fluid disposed within the chamber 106.

[0042] refer to Figure 4 , Figure 4 FIG shows a side view of the locking element 138. In one or more embodiments, the locking element 138 has an annular or ring-shaped section 164 and includes a sidewall 166. The thickness 168 of the sidewall 166 and the width 170 of the first groove 152 (see FIG. Figure 3 ) is sized so that when the side wall 166 is inserted into the first groove 152 to removably attach the locking element 138 in the first groove 152 by friction, an interference fit is formed between the first groove 152 and the side wall 166. The lower portion of the side wall 166 includes at least one first protrusion 172 that extends outwardly from the outer surface 162 of the side wall 166. In one or more embodiments, the first protrusion 172 includes a first wide section 174 and a first tapered section 176 located at the lower portion of the side wall 166 to form a substantially first wedge shape (see Figure 7 ).

[0043] refer to Figure 5, shows a cross-sectional view of the adapter segment 140. The adapter segment 140 includes an inner wall 180 that is spaced apart from the outer wall 120 to form a second circumferential groove 178. The inner wall 180 includes an inner thread 122 that is threadably engaged with the outer thread 160. An inner surface 185 of the outer wall 120 includes at least one second protrusion 184 (see also Figure 7 ), which extends outward from the outer wall 120 toward the locking element 138. In one or more embodiments, the second protrusion 184 includes a second tapered section 188 and a second wide section 186 at the upper portion of the outer wall 120 to form a substantially second wedge shape. In addition, the outer wall 120 and the second protrusion 184 are made of a resilient material. Alternatively, the first protrusion 172 of the locking element 138 is located on the inner surface of the side wall 166, while the second protrusion 184 is located on the outer surface of the inner wall 180.

[0044] Figure 6 is a cross-sectional view of the cap 136 assembled to the adapter segment 140 . Figure 7 yes Figure 6 152, first protrusion 172, second protrusion 184, and adapter section 140 of cap 136. To removably attach cap 136 to locking element 138, sidewall 166 of locking element 138 is inserted into first protrusion 152 to form an interference fit configured to enable removable attachment of cap 136 to locking element 138. Furthermore, the interference fit provides sufficient strength to withstand vibrations during shipping of syringe 100, thereby not affecting the performance of locking element 138.

[0045] The cap 136 is then removably attached to the adapter segment 140 by rotating or twisting the cap 136 in a first direction so that the external threads 160 and the internal threads 122 can be threadedly engaged. This causes the cap 136 to move downward and causes the first protrusion 172 to move downward toward the second protrusion 184. According to one aspect 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., a first position). The continued downward movement of the cap 136 as it is rotated causes the first protrusion 172 to engage with the second protrusion 184. This, in turn, causes the outer wall 120 and the second protrusion 184 to move outward relative to the central axis 142 to a deflected position that provides clearance for the first protrusion 172 relative to 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 or snap back to the first position. In the first position, the first protrusion 172 is again configured to interfere with the second protrusion 184, so that the first protrusion 172 abuts the second protrusion 184 to stop or prevent the locking element 138 from moving upward due to the contact between the first protrusion 172 and the second protrusion 184.

[0046] To access the adapter segment 140, the healthcare provider loosens the cap 136 by rotating the cap 136 in a second direction opposite to the first direction, thereby moving the cap 136 upward. Due to the contact between the first protrusion 172 and the second protrusion 184, upward movement of the locking element 138 is prevented. Therefore, when the cap 136 moves upward, the locking element 138 is retained in the second groove 178. The upward movement of the cap 136 also generates an upward force that overcomes the friction force generated by the interference fit between the first groove 152 and the sidewall 166, thereby removing or separating the cap 136 from the locking element 138 while retaining the locking element 138 in the second groove 178 of the adapter segment 140 due to the contact between the first protrusion 172 and the second protrusion 184.

[0047] According to the present disclosure, a syringe 100 including a locking element 138 in the adapter section 140 but without a cap 136 indicates that tampering with the syringe 100 or the cap 136 has previously occurred. Therefore, 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 can indicate that the cap 136 was previously removed by a previous user and that the syringe 100 has been used. In one or more embodiments, the adapter section 140 is substantially transparent to facilitate visibility of the locking element 138. Additionally, the locking element 138 can be a bright color or have markings to provide additional visibility when located in the adapter section 140.

[0048] refer to Figure 8 , shows a cross-sectional view of the cap 136 after it has been separated from the locking element 138. When this occurs, the locking element 138 drops 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 to be greater than the height 192 of the locking element 138 so that the locking element 138 is within the second groove 178 and does not extend beyond the second groove 178. Because the locking element 138 is within the second groove 178, the locking element 138 cannot approach or contact the cap 136. This prevents the locking element 138 from being reinserted into the first groove 152 of the cap 136 if the user attempts to reassemble the cap assembly 134. Figure 9 yes Figure 8 . An inverted view of the separated cap 136 and locking element 138 is shown in FIG. A user's attempt to invert the cap 136 and locking element 138 to reinsert the locking element 138 into the first groove 152 was also unsuccessful. Specifically, due to the size of the groove depth, the locking element 138 was pushed upward in the second groove 178 and thus could not generate the force required for the interference fit. Furthermore, the weight of the locking element alone was insufficient to generate the force required for the interference fit.

[0049] refer to Figure 10 , Figure 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 the shoulder section 144 and the ring element 204. A first end 206 of each rod element 202 is attached to the periphery of the shoulder section 144. The ring element 204 is attached to a second end 208 of each rod element 202 opposite the first end 206. Figure 11 , Figure 11 A side view of an alternative embodiment of the adapter section 210 is shown. The outer wall 120 (see Figure 1) includes a plurality of spaced apart protrusions or tab elements 212 located 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 been previously removed. In this embodiment, the interior surface 205 of the outer wall 120 includes internal threads 122 (see Figure 12 ).

[0050] refer to Figure 12 and Figure 13 , respectively, show a cross-sectional view and a side view of an alternative embodiment of a tamper-evident cap assembly 214. The external threads 160 of the attachment section 148 are threadably engaged with the internal threads 122 of the outer wall 120. The inner wall 154 of the cap 200 encloses the barrel end 116 and, thereby, isolates or seals the barrel end 116 and a portion of the fluid passage 118 from the environment, keeping them sterile and unadulterated until the 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.

[0051] refer to Figure 14 , Figure 14 Shown Figure 13 , which depicts selected tabs 212 and rod elements 202. Each tab element 212 is located between a pair of rod elements 202. Each rod element 202 is frangible and is configured to break upon contact with the tab element 212. To access the adapter segment 210, the healthcare provider unscrews or rotates the cap 200. Rotation of the cap 200 causes a corresponding rotation of the rod elements 202 such that each rod element 202 contacts an associated stationary tab element 212. Further rotation of the cap 200 causes each tab element 212 to break the associated rod element 202, thereby severing the ring element 204 from each rod element 202. In one or more embodiments, each tab element 212 includes an inclined surface 220 that strikes the associated rod element 202 to facilitate severing the rod element 202. Reference Figure 15 , the ring member 204 is shown severed from the rod member 202 (see arrow 216 ) after the tab member 212 contacts and breaks the rod member 202 .

[0052] Figure 16 The cap 200 is removed from the adapter section 210 and the severed ring element 204 is shown on the barrel 102 of the syringe 100. When the stem element 202 breaks, the ring element 204 falls onto the barrel by gravity (see arrow 218). 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 that tampering with the syringe 100 or the cap 200 has previously occurred. Therefore, the sterility of the syringe 100 and its contents cannot be verified.

[0053] Example

[0054] Example (a):

[0055] A tamper-evident syringe comprising:

[0056] A syringe barrel having a chamber for holding a fluid; an adapter section formed on the syringe barrel, the adapter section comprising an outer wall and an inner wall forming a first groove, wherein the inner wall comprises a barrel thread and the outer wall comprises a first protrusion, the adapter section further comprising a fluid passage capable of being in fluid communication with the chamber; a movable plunger having a plunger flange, the plunger moving forward in the chamber to reduce the volume of the chamber so that the fluid is forced out of the fluid passage; a cap having a cap thread, the cap thread being threadably engaged with the barrel thread to removably attach the cap to the adapter section, wherein the cap closes the fluid passage, and wherein the The cap further includes a second groove; and a locking element having a sidewall, the sidewall including a second protrusion, wherein the locking element is received by the first groove, and wherein the locking element is removably attached to the cap by an interference fit between the sidewall and the second groove, wherein rotation of the cap causes the cap to move upwardly to overcome the interference fit between the cap and the locking element, thereby removing the cap from the adapter section, and wherein the locking element is prevented from being removed from the first groove due to 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 tamper evidence.

[0057] Embodiment (b): The syringe of embodiment (a), wherein the locking element is annular.

[0058] Embodiment (c): The syringe of embodiment (a), wherein the first protrusion and the second protrusion are wedge-shaped.

[0059] Embodiment (d): The syringe of embodiment (a), wherein the adapter section is transparent to enhance visibility of the locking element.

[0060] Embodiment (e): The syringe of embodiment (a), wherein the outer wall of the adapter section is made of a resilient material.

[0061] Embodiment (f): The syringe of embodiment (a), wherein the cap includes a shoulder section between an upwardly extending grip section and a downwardly extending attachment section, wherein the shoulder section includes the second groove and the attachment section includes the cap threads.

[0062] Embodiment (g): The syringe of embodiment (f), wherein the cap threads are configured as external threads formed on the attachment section.

[0063] Embodiment (h): The syringe of embodiment (a), wherein the barrel threads are configured as internal threads formed on the interior wall of the adapter section.

[0064] Embodiment (i): The syringe of embodiment (a), wherein the cap comprises an inner wall defining a cavity, the cavity enclosing the fluid passage.

[0065] Embodiment (j): The syringe of embodiment (a), wherein the fluid is a medication, saline, or a component of a medical treatment designed to be mixed with another component prior to administration to a patient.

[0066] 18. The syringe of claim 17, wherein the syringe comprises a first end for injecting fluid into the syringe and a second end for injecting fluid therein. The syringe comprises a first end for injecting fluid into the syringe. The first end for injecting fluid into the syringe is injected into the syringe. The second end for injecting fluid into the syringe is injected into the syringe. The second end for injecting fluid into the syringe is injected into the syringe. and a second protrusion that is adapted to engage said first and second locking members when said cap is engaged.

[0067] Embodiment (1): The syringe according to embodiment (k), wherein the locking element is annular.

[0068] Embodiment (m): The syringe of embodiment (k), wherein the first protrusion and the second protrusion are wedge-shaped.

[0069] Embodiment (n): The syringe of embodiment (k), wherein the adapter section is transparent to enhance visibility of the locking element.

[0070] Embodiment (o): The syringe of embodiment (k), wherein the outer wall of the adapter section is made of a resilient material.

[0071] Embodiment (p): The syringe of embodiment (k), wherein the cap comprises a shoulder section between an upwardly extending grip section and a downwardly extending attachment section, wherein the shoulder section comprises the second groove and the attachment section comprises the cap threads.

[0072] Embodiment (q): The syringe of embodiment (p), wherein the cap thread is configured as an external thread formed on the attachment section.

[0073] Embodiment (r): The syringe of embodiment (k), wherein the barrel threads are configured as internal threads formed on the interior wall of the adapter section.

[0074] Embodiment(s): The syringe of embodiment (k), wherein the fluid is a medication, saline, or a component of a medical treatment designed to be mixed with another component prior to administration to a patient.

[0075] Embodiment (t): A method for detecting tampering of a syringe, the method comprising: providing a syringe barrel, the syringe barrel having a chamber for holding a fluid; providing an adapter section on the syringe barrel, the adapter section comprising an outer wall and an inner wall forming a first groove, wherein the inner wall comprises barrel threads and the outer wall comprises a first protrusion, the adapter section further comprising a fluid passage capable of being in fluid communication with the chamber; providing a movable plunger having a plunger flange, the plunger moving forward within the chamber to reduce the volume of the chamber to force the fluid out of the fluid passage; providing a cap having cap threads threadably engageable with the barrel threads to removably attach the cap to the adapter section, wherein the cap closes the fluid passage, and wherein the cap further comprises a second groove; and providing a locking element having a sidewall, the sidewall comprising a second protrusion, wherein the locking element is received by the first groove and forms an interference fit between the sidewall and the second groove to removably attach the cap; providing upward movement of the cap to overcome the interference fit between the cap and the locking element, thereby removing the cap from the adapter section; providing contact between the first protrusion and the second protrusion during the upward movement of the cap; and preventing removal of the locking element from the first recess due to the contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first recess after the cap is removed provides evidence of tampering.

[0076] Throughout this specification, reference to "one embodiment," "some embodiments," "one or more embodiments," or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearance of phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily referring 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.

[0077] Although the disclosure herein has provided a description with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A syringe providing tamper evidence, comprising: a syringe barrel having a chamber for holding a fluid; an adapter section formed on the syringe barrel, the adapter section comprising an outer wall and an inner wall defining a first recess, wherein the inner wall comprises barrel threads and the outer wall comprises a first protrusion, the adapter section further comprising a fluid passageway capable of fluid communication with the chamber; a movable plunger having a plunger flange, the plunger moving forward within the chamber to reduce the volume of the chamber so that the fluid is forced out of the fluid passage; a cap having cap threads threadably engageable with the barrel threads to removably attach the cap to the adapter section, wherein the cap closes the fluid passageway, and wherein the cap further comprises a second groove; and a locking element having a sidewall including a second protrusion, wherein the locking element is received by the first groove, and wherein the locking element is removably attached to the cap by an interference fit between the sidewall and the second groove, wherein rotation of the cap causes the cap to move upwardly, overcoming an interference fit between the cap and the locking element, thereby removing the cap from the adapter section, and wherein the locking element is prevented from being removed from the first recess due to contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first recess after the cap is removed provides tamper evidence.

2. The syringe according to claim 1, wherein The locking element is annular.

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

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

5. The syringe according to claim 1, wherein The outer wall of the adapter section is made of a resilient material.

6. The syringe according to claim 1, wherein The cap includes a shoulder section between an upwardly extending grip section and a downwardly extending attachment section, wherein the shoulder section includes the second groove and the attachment section includes the cap threads.

7. The syringe according to claim 6, wherein The cap thread is configured as an external thread formed on the attachment section.

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

9. The syringe according to claim 1, wherein The cap includes an inner wall defining a cavity that encloses the fluid passageway.

10. The syringe according to claim 1, wherein The fluid is a medication, saline solution, or a component of a medical treatment designed to be mixed with another component prior to administration to a patient.

11. A tamper-evident syringe comprising: a syringe barrel having a chamber for holding a fluid; an adapter section formed on the syringe barrel, the adapter section comprising an outer wall and an inner wall defining a first recess, wherein the inner wall comprises barrel threads and the outer wall comprises a first protrusion, the adapter section further comprising a fluid passageway capable of fluid communication with the chamber; a movable plunger having a plunger flange, the plunger moving forward within the chamber to reduce the volume of the chamber so that the fluid is forced out of the fluid passage; a cap having cap threads threadably engageable with the barrel threads to removably attach the cap to the adapter section, wherein the cap closes the fluid passageway, and wherein the cap further comprises a second groove; and a locking element having a sidewall including a second protrusion, wherein the locking element is received by the first groove, and wherein the locking element is removably attached to the cap by an interference fit between the sidewall and the second groove, wherein rotation of the cap causes the cap to move upwardly overcoming an interference fit between the cap and the locking element, thereby removing the cap from the adapter section, and wherein the locking element is prevented from being removed from the first recess due to contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first recess after the cap is removed provides tamper evidence; and The depth of the first groove is greater than the height of the locking element, so that the locking element does not extend beyond the first groove to prevent the locking element from being reinserted back into the first groove after the cap is removed.

12. The syringe according to claim 11, wherein The locking element is annular.

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

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

15. The syringe according to claim 11, wherein The outer wall of the adapter section is made of a resilient material.

16. The syringe according to claim 11, wherein The cap includes a shoulder section between an upwardly extending grip section and a downwardly extending attachment section, wherein the shoulder section includes the second groove and the attachment section includes the cap threads.

17. The syringe according to claim 16, wherein The cap thread is configured as an external thread formed on the attachment section.

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

19. The syringe according to claim 11, wherein The fluid is a medication, saline solution, or a component of a medical treatment designed to be mixed with another component prior to administration to a patient.

20. A method for detecting tampering of a syringe, the method comprising: providing a syringe barrel having a chamber for holding a fluid; An adapter section is provided on the syringe barrel, the adapter section comprising an outer wall and an inner wall forming a first groove, wherein The inner wall includes barrel threads, and the outer wall includes a first protrusion, the adapter segment further including a fluid passageway capable of fluid communication with the chamber; providing a movable plunger having a plunger flange, the plunger being moved forward within the chamber to reduce the volume of the chamber so that the fluid is forced out of the fluid passage; providing a cap having cap threads threadably engageable with the barrel threads to removably attach the cap to the adapter section, wherein the cap closes the fluid passageway, and wherein the cap further includes a second groove; and providing a locking element having a sidewall, the sidewall including a second protrusion, wherein the locking element is received by the first recess; forming an interference fit between the sidewall and the second recess to removably attach the cap; providing upward movement of the cap to overcome an interference fit between the cap and a locking element, thereby removing the cap from the adapter segment; providing contact between the first protrusion and the second protrusion during upward movement of the cap; and Removal of the locking element from the first recess is prevented due to contact between the first protrusion and the second protrusion, wherein the presence of the locking element in the first recess after the cap is removed provides tamper evidence.

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