Pressure relief assembly for fluid injector tubing suite

Abstract

A pressure relief assembly for a tubing kit may include: an engagement sleeve including an inner surface defining a cavity, the inner surface including a connection device configured to connect the engagement sleeve to the tubing kit; and a pin member configured to be received in the cavity of the engagement sleeve. The pin member is movable between a first position in which the pin member is removed from the seal of the tubing kit and a second position in which the pin member is inserted into the seal of the tubing kit to allow air to be purged from the tubing kit.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 417,097, filed on October 18, 2022, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure is generally directed to features associated with fluid path elements of powered medical fluid injection systems. The described features provide a pressure relief assembly for a fluid path element of a fluid injector tubing set that allows for pressure relief through a wipeable valve of the tubing set during a priming operation. Background Art

[0004] Syringe injection systems are one of the medical devices that have been used in medical imaging procedures for many years. Many such syringes are manually operated by advancing a piston operably connected to an internal plunger to pressurize the fluid in the syringe. In order to reduce the number of disposable components during a series of fluid injections, the system can include a multi-patient portion, such as a multi-patient pump system and a multi-patient fluid path element, which can be used in a series of fluid injection procedures; and a single-patient fluid path element, including an associated check valve, which is only used for a single injection procedure and then discarded and replaced by a new sterile single-patient fluid path element for a subsequent fluid injection procedure.

[0005] A variety of syringe-based or peristaltic pump-based powered injectors have been developed for administering fluids, such as contrast media or saline, in medical imaging procedures such as cardiovascular imaging (CV), computed tomography (CT), positron emission tomography (PET), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). Some of these powered injectors may include the option of being used in a multi-patient configuration utilizing both multiple-use components and single-use components. An example of such a system is the Bayer MEDRAD ® The Centargo CT fluid injection system, including multi-patient and single-patient components, is described in U.S. Patent Nos. 10,507,319 and 10,549,084, the disclosures of which are incorporated herein by reference.

[0006] Because various multi-patient components are used during multiple fluid infusion procedures, steps must be taken to ensure that these components are sterile and not exposed to microbial contaminants from previous patients or environments that could be harmful to subsequent patients. For example, many systems can include wipeable valves that can be disinfected by a technician wiping the valve with an alcohol-soaked wipe between infusion procedures.

[0007] Conventional systems with wipeable valves include standard Luer-type connectors between multi-patient and single-patient components, which are equipped with readily available wipeable valves on female Luer components and may include threaded connection mechanisms. An example of a threaded connector for multi-patient configuration is described in U.S. Patent No. 8,540,698, the disclosure of which is incorporated herein by reference. Various embodiments of the wipeable valve may include an elastic cover portion with a slit that may engage a male Luer to provide fluid communication between a fluid path component with a wipeable valve and a fluid path component with a male Luer connector. When disconnected from the male Luer component, the elastic cover portion with a slit prevents fluid from flowing through the wipeable valve because the slit in the elastic material is effectively sealed to create a liquid-tight barrier. Before connection, the outer surface of the wipeable valve may be wiped or wiped with a disinfectant cloth such as an alcohol wipe to remove any microbial contaminants from the outer surface and prevent contamination inside the fluid path.

[0008] In some multi-patient injection procedures, the tubing path sealed with a wipeable valve may need to be purged of air before connection. The purging of air can be performed by flowing a pressurized fluid through the tubing path to exhaust air from the tubing path. However, conventional wipeable valves remain sealed at pressures up to 100 psi or higher before the seal flips and allows air and fluid to flow through. In some cases, this may result in a certain volume of fluid being released in addition to air during the purging operation, resulting in fluid contamination of medical surfaces and injector components and waste of medical fluid. A new fluid path component configuration is needed that allows air to be easily purged at low fluid pressures, such as without the escape of medical fluids, and that can allow wiping disinfection of fluid path valves. Summary of the invention

[0009] The present disclosure provides a fluid path element, a fluid injector system, and a method for using a wipeable valve assembly, which includes a pressure release assembly for a fluid path element of a fluid injector tubing set, which allows a large amount of air to be released through the wipeable valve of the tubing set during an infusion operation. The pressure release assembly allows air to be released through the outlet of the wipeable valve attached to the tubing set during an infusion or purge operation without significantly releasing the fluid when the fluid is pressurized to infuse / purge the tubing set. The pressure release assembly may include a cover detachably attached to the wipeable valve assembly, which is connected to the distal end of the tubing set. The cover may be threadedly attached to the wipeable valve assembly, or attached by other conventional means. After the infusion or purge operation, the cover may be removed from the wipeable valve assembly so that the wipeable valve can be sterilized and / or connected to another fluid path component, such as a spike for connecting the tubing set fluid to a bulk fluid container. The cover may include a distal opening for the pressure release assembly to be inserted through the opening. In some embodiments, the pressure relief assembly may include a through hole extending from the proximal end to the distal opening to allow pressurized air to flow out of the tubing set. The proximal end may be configured to be inserted into or through a wipeable valve, such as through a slit in the elastic cover portion, to provide fluid communication between the interior of the tubing set and the exterior of the pressure relief assembly through the distal opening of the pressure relief assembly when inserted through the wipeable valve. The pressure relief assembly may be movable between a first non-inserted position and a second inserted position, in which the proximal end of the pressure relief assembly is not inserted through the wipeable valve and there is no fluid communication between the interior of the tubing set and the distal opening of the pressure relief assembly, and in the second inserted position, the proximal end of the pressure relief assembly is inserted through the wipeable valve. In the second inserted position, the pressure relief assembly may allow air to be purged or infused from the tubing set through the wipeable valve. In some embodiments, the pressure relief assembly may be manually moved between the first and second positions. In some embodiments, the pressure relief assembly may be moved between the first and second positions by a fluid injector. In some embodiments, the pressure relief assembly may be reversibly movable between the first and second positions. In other embodiments, once moved to the second position, the pressure relief assembly may be locked in the second position.

[0010] In some embodiments, at least a portion of a tubing element, including a portion of a tubing set, a wipeable valve, and a pressure relief assembly, may be configured to insert a sensor, such as an air and / or fluid sensor associated with a fluid injector and in communication with a controller of the fluid injector system. In some embodiments, the sensor may detect, for example, an interface between air and liquid in the tubing set and control a purge or priming procedure so that substantially all of the air is removed from the tubing set. In some embodiments, when the sensor detects an interface between air and liquid at a location near the elastic cover portion of the wipeable valve, the sensor may send a signal to the controller to stop the purge or priming procedure. In this way, during a purge or priming procedure, substantially all of the air within the tubing set may be removed from the tubing set without any liquid spilling or spraying out through the wipeable valve and the pressure relief assembly, thereby preventing any spillage of medical liquid, or contamination of the fluid injector components or components in the injection set. In other embodiments, for example, where the pressure relief assembly is configured to accommodate a small amount of liquid, the sensor may detect when the interface between air and liquid enters the pressure relief assembly through the wipeable valve.

[0011] In various embodiments, once the tubing set is purged or exhausted of most or all of the air, the pressure relief assembly can be removed from the wipeable valve, and the wipeable valve and tubing set can be connected to another fluid path component, such as a spike for piercing a source of body fluid, for example, when it is necessary to load additional fluid into the syringe for one or more additional injection procedures. According to this embodiment, any remaining small amount of air can be purged into the body fluid source after the spike is attached, such as by pressurizing the syringe or activating a peristaltic pump and associated fluid path components.

[0012] According to one non-limiting embodiment or aspect of the present disclosure, a pressure relief assembly may include: an engagement sleeve including an inner surface defining a cavity, the inner surface including a connection device, the connection device being configured to connect the engagement sleeve to the tubing kit and / or an associated wipeable valve; and a pin member, the pin member being configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position and a second position, in the first position, the pin member is removed from the tubing kit and / or the seal of the wipeable valve, and in the second position, the pin member is inserted into the tubing kit and / or the seal of the wipeable valve to allow a certain volume of air to be purged from the tubing kit through the pressure relief assembly.

[0013] According to one non-limiting embodiment or aspect of the present disclosure, the connection device of the engagement sleeve includes a threaded surface for threading the engagement sleeve to the tubing set, for example, to a corresponding threaded surface on the wipeable valve. The pin member may include a flange disposed on the distal end of the pin member. The pin member defines a through hole extending through the pin member; and wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the interior of the tubing set to allow air to be purged from the tubing set. The pin member may define at least one pawl; and wherein, when the pin member is maintained in the first position, a portion of the engagement sleeve engages with the at least one pawl to maintain the pin member in the first position. The portion of the engagement sleeve that engages with the at least one pawl includes at least one flexible engagement member for flexibly engaging with the at least one pawl. In some embodiments, the pin member may define a first pawl and a second pawl, the second pawl being defined at a distance from the first pawl; and wherein, when the pin member is held in the first position, a portion of the engagement sleeve engages with the first pawl to hold the pin member in the first position; and wherein, when the pin member is held in the second position, a portion of the engagement sleeve engages with the second pawl to hold the pin member in the second position. In some embodiments, the pin member may define a through hole extending through at least a portion of the pin member; for example, along at least a portion of the longitudinal axis of the pin member, and wherein a filter is disposed in the through hole to allow air to move through the through hole while preventing fluid from moving through the filter through the through hole. In some embodiments, the outer surface of the engagement sleeve may include at least one gripping element. In some embodiments, the outer surface of the pin member may include a corresponding connection device, the corresponding connection device being configured to engage with the connection device of the engagement sleeve to move the pin member between the first position and the second position. In some embodiments, the engagement sleeve includes a flexible arm member, the flexible arm member being configured to engage with at least one pawl defined on the pin member. In some embodiments, the pin member includes a ring slidably received on an outer surface of the pin member, and wherein when the pin member moves from the first position to the second position, the ring is pushed by a portion of the engagement sleeve from a first indication position to a second indication position to indicate that the pin member has broken a seal of the tubing set. In some embodiments, the engagement sleeve defines a vent configured to allow air to pass therethrough after the pin member moves to the second position.

[0014] In other embodiments, the outer surface of the pin member may include at least one longitudinal groove. The at least one longitudinal groove may provide fluid communication with the interior of the tubing set, such as through a wipeable valve member of the pressure relief assembly, wherein in the second position, the at least one longitudinal groove prevents a fluid-tight seal with the wipeable valve member.

[0015] According to one non-limiting embodiment or aspect of the present disclosure, a fluid injector comprises: a housing; at least one syringe detachably engaged with the housing; a tubing kit, the tubing kit being configured to fluidically connect the at least one syringe at a proximal end and having a wipeable valve at a distal end; and at least one fluid reservoir, the at least one fluid reservoir containing a fluid for filling the at least one syringe; and a pressure relief assembly, the pressure relief assembly being configured to be connected to the distal end of the tubing kit to purge air from the tubing kit, the pressure relief assembly comprising: an engagement sleeve, the engagement sleeve comprising an inner surface defining a cavity, the inner surface comprising a connecting device, the connecting device being configured to detachably connect the engagement sleeve to the tubing kit; and a pin member, the pin member being configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position and a second position, in the first position, the pin member is removed from a seal of the wipeable valve at the distal end of the tubing kit, and in the second position, the pin member is inserted into the seal of the wipeable valve at the distal end of the tubing kit to allow air to be purged from the tubing kit.

[0016] According to one non-limiting embodiment or aspect of the fluid injector of the present disclosure, the fluid injector may further include a box for accommodating a tubing set, wherein the box includes a body defining at least one feature for accommodating at least a portion of the tubing set, at least a portion of the tubing set having a pressure relief assembly as described herein; and a connecting member for removably connecting the body of the box to the fluid injector, the connecting member being operably connected to the body. In certain embodiments, the pressure relief assembly is configured to operably engage the release assembly box to move the pressure relief assembly from a first position to a second position. The connection device of the engagement sleeve includes a threaded surface to thread the engagement sleeve to the tubing set. The pin member includes a flange disposed on an end of the pin member. The pin member defines a through hole extending longitudinally through the pin member from a proximal end to a distal end; and wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the tubing set through an opening at the distal end of the through hole to allow air to be purged from the tubing set. The pin member defines at least one pawl; and wherein, when the pin member is held in at least one of the first position and the second position, a portion of the engagement sleeve engages with the at least one pawl to hold the pin member in at least one of the first position and the second position. The portion of the engagement sleeve that engages with the at least one pawl may include at least one flexible engagement member. In some embodiments, the pin member may define a first pawl and a second pawl, the second pawl being defined at a distance from the first pawl; and wherein, when the pin member is held in the first position, a portion of the engagement sleeve engages with the first pawl to hold the pin member in the first position; and wherein, when the pin member is held in the second position, a portion of the engagement sleeve engages with the second pawl to hold the pin member in the second position. In some embodiments, the pin member may also include a filter located in the through hole to allow air to move through the through hole while preventing fluid from moving through the filter through the through hole. The outer surface of the engagement sleeve includes at least one gripping element. The outer surface of the tubing set and / or the pressure relief assembly is configured to releasably engage with the box to keep the tubing set and / or the pressure relief assembly operably connected to the box. The outer surface of the pin member includes a corresponding connection device, which is configured to engage with the connection device of the cartridge to move the pin member between the first position and the second position. The pin member includes a ring slidably received on the outer surface of the pin member, and wherein, when the pin member moves from the first position to the second position, the ring is pushed from the first indication position to the second indication position by a portion of the engagement sleeve to indicate that the pin member has broken the seal of the tubing set. The engagement sleeve defines a vent, which is configured to allow air to pass therethrough after the pin member moves to the second position. An activation member is provided on the cartridge, the activation member being used to engage the pin member of the pressure relief assembly to move the pin member from the first position to the second position.In some embodiments, the activation member can engage the pin member when the tubing kit and / or the pressure relief assembly is manually inserted into the cassette to move the pressure relief assembly and the associated pin from the first position to the second position. In other embodiments, the activation member can communicate with a controller associated with the fluid injector, wherein the activation member activates the pressure relief assembly and moves the pin from the first position to the second position in response to a signal from the controller. The activation member can include a solenoid valve or other electromechanical component configured to move the pin of the pressure relief assembly.

[0017] According to one non-limiting embodiment or aspect of the present disclosure, a method for purging air from a tubing set may include: connecting a pressure relief assembly to a distal end of a tubing set, such as a wipeable valve at the distal end of the tubing set, the pressure relief assembly including an engagement sleeve, the engagement sleeve including an inner surface defining a cavity, the inner surface including a connection device configured to connect the engagement sleeve to the tubing set, and a pin member configured to be received in the cavity of the engagement sleeve; moving the pin member from a first position to a second position to break the seal at the distal end of the tubing set, and inserting the proximal end of the pin member into the tubing set; and purging air from the tubing set through the pressure relief assembly. In some embodiments, air can be purged through one or more grooves on the outer surface of the pin member and through a vent defined in the engagement sleeve of the pressure relief assembly. In other embodiments, the pin member defines a through hole extending from the proximal end of the pin to the distal end of the pin, or extending to a vent extending through the outer surface of the pin between the proximal end and the distal end of the pin, and when the pin member is in the second position, the vent establishes fluid communication with the tubing set so that air is purged through the through hole of the pin member.

[0018] Various features of the present disclosure are further defined by the following clauses:

[0019] Item 1. A pressure relief assembly for a tubing kit, the pressure relief assembly comprising: an engagement sleeve, the engagement sleeve comprising an inner surface defining a cavity, the inner surface comprising a connection device, the connection device being configured to connect the engagement sleeve to the tubing kit and / or an associated wipeable valve; and a pin member, the pin member being configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position and a second position, in the first position, the pin member is removed from a seal of the tubing kit and / or the associated wipeable valve, and in the second position, the pin member is inserted into a seal of the tubing kit and / or the associated wipeable valve to allow a certain volume of air to be purged from the tubing kit through the pressure relief assembly.

[0020] Clause 2. The pressure relief assembly of clause 1, wherein the connection device of the engagement sleeve includes a threaded surface for threading the engagement sleeve to the tubing set.

[0021] Clause 3. The pressure relief assembly of clause 1 or clause 2, wherein the pin member includes a flange disposed on a distal end of the pin member.

[0022] Clause 4. A pressure relief assembly according to any one of clauses 1 to 3, wherein the pin member defines a through hole extending through the pin member; and wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the interior of the tubing kit to allow the air to be purged from the tubing kit.

[0023] Clause 5. A pressure relief assembly according to any one of clauses 1 to 4, wherein the pin member defines at least one pawl; and wherein, when the pin member is maintained in the first position, a portion of the engagement sleeve engages with the at least one pawl to maintain the pin member in the first position.

[0024] Clause 6. The pressure relief assembly of Clause 5, wherein the portion of the engagement sleeve that engages the at least one pawl comprises at least one flexible engagement member for flexibly engaging the at least one pawl.

[0025] Clause 7. A pressure release assembly according to any one of clauses 1 to 7, wherein the pin member defines a first pawl and a second pawl, the second pawl being defined at a certain distance from the first pawl; and wherein, when the pin member is maintained in the first position, a portion of the engagement sleeve engages with the first pawl to maintain the pin member in the first position; and wherein, when the pin member is maintained in the second position, the portion of the engagement sleeve engages with the second pawl to maintain the pin member in the second position.

[0026] Clause 8. A pressure relief assembly according to any one of clauses 1 to 7, wherein the pin member defines a through hole extending through at least a portion of the pin member, and wherein a filter is disposed in the through hole to allow air to move through the through hole while preventing fluid from moving through the filter through the through hole.

[0027] Clause 9. The pressure relief assembly of any one of clauses 1 to 8, wherein an outer surface of the engagement sleeve comprises at least one gripping element.

[0028] Clause 10. A pressure relief assembly according to any one of clauses 1 to 9, wherein an outer surface of the pin member includes a corresponding connection device, and the corresponding connection device is configured to engage with the connection device of the engagement sleeve to move the pin member between the first position and the second position.

[0029] Clause 11. The pressure relief assembly of any one of clauses 1 to 10, wherein the engagement sleeve comprises a flexible arm member configured to engage at least one detent defined on the pin member.

[0030] Clause 12. A pressure relief assembly according to any one of clauses 1 to 11, wherein the pin member includes a ring slidably received on an outer surface of the pin member, and wherein, when the pin member moves from the first position to the second position, the ring is pushed from a first indication position to a second indication position by a portion of the engagement sleeve to indicate that the pin member has broken a seal of the tubing kit.

[0031] Clause 13. The pressure relief assembly of any one of clauses 1 to 12, wherein the engagement sleeve defines a vent configured to allow air to pass therethrough after the pin member is moved to the second position.

[0032] Article 14. A fluid injector, comprising: a housing; at least one syringe detachably engaged with the housing; a tubing set, the tubing set being configured to fluidically connect the at least one syringe at a proximal end and having a wipeable valve at a distal end; and at least one fluid reservoir, the at least one fluid reservoir containing a fluid for filling the at least one syringe; and a pressure relief assembly, the pressure relief assembly being configured to be connected to the distal end of the tubing set to purge air from the tubing set, the pressure relief assembly comprising: an engagement sleeve, the engagement sleeve comprising an inner surface defining a cavity, the inner surface comprising a connection device, the connection device being configured to detachably connect the engagement sleeve to the tubing set; and a pin member, the pin member being configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position and a second position, in which the pin member is removed from a seal of the wipeable valve at the distal end of the tubing set, and in which the pin member is inserted into the seal of the wipeable valve at the distal end of the tubing set to allow air to be purged from the tubing set.

[0033] Item 15. The fluid injector according to Item 14, further comprising a box for accommodating the tubing kit, the box comprising: a main body, the main body defining at least one feature portion for accommodating at least a portion of the tubing kit; and a connecting member for detachably connecting the main body of the box to the fluid injector, the connecting member being operably connected to the main body.

[0034] Clause 16. The fluid injector of clause 14 or clause 15, wherein the connection means of the engagement sleeve comprises a threaded surface to threadably connect the engagement sleeve to the tubing set.

[0035] Clause 17. The fluid injector of any one of clauses 14 to 16, wherein the pin member comprises a flange disposed on an end of the pin member.

[0036] Clause 18. A fluid injector according to any one of clauses 14 to 17, wherein the pin member defines a through hole extending longitudinally through the pin member from a proximal end to a distal end; and wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the tubing kit through an opening located at the distal end of the through hole to allow the air to be cleared from the tubing kit.

[0037] Clause 19. A fluid injector according to any one of clauses 14 to 18, wherein the pin member defines at least one pawl; and wherein, when the pin member is maintained in at least one of the first position and the second position, a portion of the engagement sleeve engages with the at least one pawl to maintain the pin member in at least one of the first position and the second position.

[0038] Clause 20. The fluid injector of Clause 19, wherein the portion of the engagement sleeve that engages the at least one detent comprises at least one flexible engagement member.

[0039] Clause 21. A fluid injector according to any one of clauses 14 to 20, wherein the pin member defines a first pawl and a second pawl, the second pawl being defined at a certain distance from the first pawl; and wherein, when the pin member is maintained in the first position, a portion of the engagement sleeve engages with the first pawl to maintain the pin member in the first position; and wherein, when the pin member is maintained in the second position, the portion of the engagement sleeve engages with the second pawl to maintain the pin member in the second position.

[0040] Clause 22. A fluid injector according to any one of clauses 14 to 21, wherein the pin member defines a through hole extending through the pin member; and wherein a filter is disposed in the through hole to allow air to move through the through hole while preventing fluid from moving through the filter through the through hole.

[0041] Clause 23. The fluid injector of any one of clauses 14 to 22, wherein an outer surface of the engagement sleeve comprises at least one gripping element.

[0042] Clause 24. A fluid injector according to any one of clauses 14 to 23, wherein an outer surface of the pin member includes a corresponding connection device, and the corresponding connection device is configured to engage with the connection device of the box to move the pin member between the first position and the second position.

[0043] Clause 25. A fluid injector according to any one of clauses 14 to 24, wherein the pin member includes a ring slidably received on an outer surface of the pin member, and wherein, when the pin member moves from the first position to the second position, the ring is pushed from a first indication position to a second indication position by a portion of the engagement sleeve to indicate that the pin member has broken a seal of the tubing kit.

[0044] Clause 26. The fluid injector of any of Clauses 14 to 25, wherein the engagement sleeve defines a vent configured to allow air to pass therethrough after the pin member is moved to the second position.

[0045] Clause 27. The fluid injector of any one of clauses 14 to 26, further comprising an activation member disposed on the cartridge, the activation member for engaging a pin member of the pressure relief assembly to move the pin member from the first position to the second position.

[0046] Clause 28. The fluid injector of Clause 27, wherein the activation member comprises a solenoid valve or other electromechanical component configured to move a pin member of the pressure relief assembly.

[0047] Item 29. A method for clearing air from a tubing kit, the method comprising: connecting a pressure relief assembly to a distal end of the tubing kit, the pressure relief assembly comprising an engagement sleeve, the engagement sleeve comprising an inner surface defining a cavity, the inner surface comprising a connection device configured to connect the engagement sleeve to the tubing kit, and a pin member configured to be received in the cavity of the engagement sleeve; moving the pin member from a first position to a second position to break a seal at the distal end of the tubing kit, and inserting a proximal end of the pin member into the tubing kit; and clearing air from the tubing kit through the pressure relief assembly.

[0048] Clause 30. The method of Clause 29, wherein the air is purged through one or more grooves on an outer surface of the pin member and through a vent defined in an engagement sleeve of the pressure relief assembly.

[0049] Clause 31. A method according to clause 29, wherein the pin member defines a through hole extending from the proximal end of the pin member to the distal end of the pin member, or a vent extending through the outer surface of the pin member between the proximal end and the distal end of the pin member, and when the pin member is in the second position, the vent establishes fluid communication with the tubing kit so that the air is cleared through the through hole of the pin member. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The novel features herein are set forth with particularity in the appended claims. However, these features, both as to their organization and method of operation, may be better understood by reference to the following description taken in conjunction with the accompanying drawings.

[0051] Figure 1 is a perspective view of a pressure relief assembly and a wipeable valve in a first non-inserted position according to a non-limiting embodiment of the present application;

[0052] Figure 2 for Figure 1 a cross-sectional view of a pressure relief assembly and a wipeable valve;

[0053] Figure 3 for Figure 1 A perspective view of the pressure relief assembly and the wipeable valve disposed in a second insertion position;

[0054] Figure 4 for Figure 3 a cross-sectional view of a pressure relief assembly and a wipeable valve;

[0055] Figure 5 are perspective and front views of a pin member according to one non-limiting embodiment of the present disclosure;

[0056] Figure 6 are perspective and front views of a pin member according to another non-limiting embodiment of the present disclosure;

[0057] Figure 7 is a cross-sectional view of a pressure relief assembly, wherein Figure 5 The pin member is shown in a first non-insertion position;

[0058] Figure 8 is a cross-sectional view of a pressure relief assembly, wherein Figure 6 The pin member is shown in a first non-insertion position;

[0059] Fig. 9 is a cross-sectional view of a pressure relief assembly, wherein Figure 5 The pin member is shown in a second insertion position;

[0060] Fig.10is a cross-sectional view of a pressure relief assembly, wherein Figure 6 The pin member is shown in a second insertion position;

[0061] Fig.11 is a cross-sectional view of a pressure relief assembly according to another non-limiting embodiment of the present disclosure, the pressure relief assembly having a pin member in a first non-inserted position, the pin member having a side vent;

[0062] Fig.12 for Fig.11 The pressure relief assembly is shown in a cross-sectional view in a second insertion position;

[0063] Fig.13 is a perspective view of a pressure relief assembly and a wipeable valve disposed in a first non-inserted position according to one non-limiting embodiment;

[0064] Fig.14 for Fig.13 a cross-sectional view of a pressure relief assembly and a wipeable valve;

[0065] Fig.15 for Fig.13 A perspective view of the pressure relief assembly and the wipeable valve disposed in a second insertion position;

[0066] Fig.16 for Fig.15 a cross-sectional view of a pressure relief assembly and a wipeable valve;

[0067] Fig.17 is a perspective view of a pressure relief assembly and a wipeable valve disposed in a first non-inserted position according to one non-limiting embodiment;

[0068] Fig.18 for Fig.17 a cross-sectional view of a pressure relief assembly and a wipeable valve;

[0069] Fig.19 for Fig.17 A cross-sectional view of the pressure relief assembly and the wipeable valve disposed in a second insertion position;

[0070] Fig. 20 According to a non-limiting embodiment of the present application Fig.17 a side view of a pressure relief assembly and a wipeable valve disposed in a first non-inserted position, disengaged from a cartridge of a fluid injector;

[0071] Fig.21 is a side view of a fluid injector box, the fluid injector box and the Fig. 20 a pressure relief assembly engaged with the wipeable valve and disposed in a second insertion position in the injector module;

[0072] Fig. 22 is a cross-sectional view of a pressure relief assembly and a wipeable valve disposed in a first non-inserted position according to one non-limiting embodiment;

[0073] Fig.23 for Fig. 22 A cross-sectional view of the pressure relief assembly and the wipeable valve disposed in a second insertion position;

[0074] Fig.24 is a cross-sectional view of a pressure relief assembly and a wipeable valve disposed in a first non-inserted position according to one non-limiting embodiment;

[0075] Fig.25 for Fig.24 A cross-sectional view of the pressure relief assembly and the wipeable valve disposed in a second insertion position;

[0076] Fig.26 for Fig.24 a cross-sectional view of the pressure assembly and wipeable valve shown with the irrigation tube attached; and

[0077] Fig. 27 is a side view of a pressure relief assembly and a wipeable valve disposed in a second insertion position and engaged with a cartridge of a fluid injector according to one non-limiting embodiment of the present application. DETAILED DESCRIPTION

[0078] In the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. The illustrative features shown and described in the detailed description, drawings, and claims are not meant to be limiting. Other features may be utilized and other changes may be made without departing from the scope of the subject matter presented herein.

[0079] Before explaining in detail the various aspects of the pressure relief assembly and its various features, it should be noted that the various aspects disclosed herein are not limited in their application or use to the details of the construction and arrangement of the components shown in the drawings and description. Instead, the disclosed apparatus may be positioned or incorporated into other apparatus, variations and modifications thereof, and may be practiced or implemented in various ways. Therefore, the aspects of the pressure relief assembly and fluid injector features disclosed herein are illustrative in nature and are not meant to limit their scope or application. Furthermore, unless otherwise stated, the terms and expressions used herein are selected for the convenience of the reader in describing the various aspects of the pressure relief assembly and fluid injector features and are not intended to limit their scope. Furthermore, it should be understood that any one or more of the components of the pressure relief assembly and fluid injector features, their manifestations and / or examples thereof may be combined with any one or more of the other components, their manifestations and / or examples thereof without limitation.

[0080] In addition, in the following description, it should be understood that terms such as front, rear, inside, outside, top, bottom, etc. are used for convenience and should not be interpreted as limiting terms. The terms used herein are not meant to be limiting, as the devices described herein or portions thereof may be attached or used in other orientations. Various aspects of the pressure relief assembly and fluid injector features will be described in more detail with reference to the accompanying drawings. As used herein, the term "proximal end" refers to the end of a component positioned close to the fluid injector, and the term "distal end" refers to the end of a component positioned away from the end of the tubing kit facing the fluid injector.

[0081] The present disclosure relates to the design of a pressure relief assembly for use with a sealing element, such as a wipeable valve, associated with a distal end of a tubing kit and other fluid path elements associated with a powered fluid injector, such as a fluid injector used to inject one or more medical fluids during a medical imaging procedure. According to various embodiments, certain medical imaging procedures may include the injection of a contrast medium or agent that highlights certain features in a medical image. This procedure is known as contrast enhanced medical imaging and typically involves the injection of a contrast agent, such as saline, with a suitable flushing agent prior to the imaging procedure. Powered fluid injectors have been used to control the injection of fluids and are typically designed with one or more, typically two, syringes for containing and dispensing contrast agents, flushing fluids, and other medical fluids administered prior to or during an imaging procedure. For example, U.S. Application Publication Nos. 2023 / 0149263; 2023 / 0310750; and 2023 / 0285733; U.S. Patent Nos. 5,383,858; 7,549,977; 9,173,995; 10,507,319, 10,583,256; and 11,712,552 and PCT Publication Nos. WO 2022 / 119837; and WO 2022 / 182235 describe front-loading syringes, tubing kits, and power injectors in pressure sheath and sheathless examples, the disclosures of which are incorporated herein by this reference. Common contrast-enhanced medical imaging procedures include computed tomography (CT), magnetic resonance imaging (MR), positron emission tomography (PET, SPECT), and angiography (CV). Due to viscosity and the need to deliver large amounts of contrast media in a short period of time, certain injection procedures may be performed at high injection pressures, such as up to 300 psi for CT and MR, and up to 1200 psi for CV procedures, in order to provide a "tight bolus". The injector may be configured to inject or dispense the fluid medium contained in the first, second, and / or additional syringes in a controlled manner, such as may be used in medical procedures such as angiography, CT, PET, and NMR / MRI.

[0082] The fluid injection system may include a configuration for multi-patient injection, wherein a portion of the disposable components of the fluid path kit, such as the pumping mechanism (syringe, components of the peristaltic pump system, etc.) and the upstream components of the fluid path kit are used in a series of injection procedures before being discarded (multi-patient components); and another portion of the disposable components of the fluid path kit (single-patient components) is used once for a single patient and then discarded. Thus, upon completion of the fluid injection procedure, the single-patient component is disconnected from the multi-patient component of the fluid path and discarded; and a new, sterile single-patient component is attached to the multi-patient component for the next injection procedure. Such a device can reduce the cost of each fluid injection procedure and reduce the amount of medical waste generated by the injection site. Between injection procedures, care must be taken to ensure that the (multiple) distal connections of the multi-patient component are not contaminated by microorganisms and are sterile when a new single-patient component is attached. The sterility of the single-patient component is ensured by storing and removing it from the associated sterile packaging immediately before connecting it to the multi-patient component. Optionally, the fluid spike can be used to access a body fluid container, such as a contrast medium container or a saline bag, when filling an associated syringe with a medical fluid. In such an embodiment, for example, when a new body fluid container is used, the spike may need to be engaged with the distal end of the tubing set before filling or replacing. During such a procedure, the tubing set used to fill the syringe may need to be cleared of any bubbles to prevent the bubbles from being sucked into the syringe. Although it is conceivable that air can be cleared directly from the tubing set into the body fluid container, after attaching the spike and piercing the body fluid container, the volume of air in the tubing set may be too large for the body fluid container. Removing air through the spike into a non-sterile container may cause the spike and the tubing set to be contaminated by microorganisms and / or the surface to be soiled by medical fluids (e.g., viscous contrast fluids). Therefore, the present pressure relief assembly can be used to remove all or substantially all of the air from the tubing set before piercing the body fluid container. As described herein, if substantially all of the volume of air is removed using the pressure relief assembly, any remaining small amount of air can be removed into the body fluid container. The present disclosure provides components that can be used with a multi-patient element to ensure that the connection features of the multi-patient element are sterile when connected to a single-patient element in preparation for a subsequent injection procedure, while also allowing any air bubbles that may be trapped in the tubing set of the multi-patient element to be substantially cleared from the multi-patient tubing set during disconnection of a used single-patient tubing element or fluid spike and attachment of a new single-patient tubing element or fluid spike so that they are not accidentally injected into the patient during the next fluid injection procedure.

[0083] According to various embodiments, the distal end of a multi-patient fluid path kit with a sealing element (such as a wipeable valve) attached can be pre-assembled with a pressure relief assembly according to various embodiments of the present disclosure, wherein the cover is in a first, non-inserted position. According to these embodiments, the pressure relief assembly can be used as a dust cover to prevent microbial contamination, inadvertent contact with, or soiling of the wipeable valve during unpacking and installation of the fluid path kit onto a fluid injector element. Alternatively, the pressure relief assembly in the first, non-inserted position can be a separate sterile component that can be attached to the distal end of the multi-patient tubing kit after a previously used single-patient tubing component or spike is detached, and any air trapped in the tubing kit can be purged as described herein.

[0084] The present disclosure provides embodiments of fluid path elements, fluid injector systems, and methods of using sealing elements, such as a wipeable valve assembly including a pressure release assembly for a fluid path element of a fluid injector tubing set that allows pressure and any volume of air to be released through a wipeable valve at the distal end of the tubing set during a priming operation. The pressure release assembly allows air to be released through an outlet of a wipeable valve attached to the tubing set during a priming or purging operation without releasing a large amount of fluid when the fluid is pressurized to priming / purging the tubing set. The pressure release assembly may include a cap removably attached to the wipeable valve assembly, which is connected to the distal end of the tubing set.

[0085] The wipeable valve typically includes a proximal attachment portion for attaching the wipeable valve to a tubing kit, such as the distal end of a tubing. The distal end of the wipeable valve may include an elastic diaphragm, such as a silicone end with a slit therein, the slit fluid sealing the diaphragm. The silicone end and the slit are configured to engage a male Luer connector, which can pierce the slit and provide fluid communication between the interior of the tubing and the inner cavity of the male Luer connector. The slit is configured to seal around the outer circumference of the male Luer connector. Optionally, the elastic diaphragm can be compressible, such as by inserting a male Luer, so that the seal between the side wall of the diaphragm and the side wall of the valve is destroyed, and the fluid can bypass the diaphragm and flow into the inner cavity of the male Luer. The wipeable valve may include a female Luer configuration compatible with a male Luer connector. For example, the female Luer lock connector of the wipeable valve may include an external thread that is configured to interact with the internal thread on the skirt around the male Luer lock connector, so that, for example, when the male Luer member punctures or has punctured the slit of the wipeable valve, the male connector is releasably attached to the female connector. In certain embodiments, the pressure relief assembly can be attached to the wipeable valve by a friction fit or other attachment mechanism between the engagement sleeve of the pressure relief assembly and the outer circumference of the wipeable valve. The wipeable valve can be used to replace the needle-based connector system. In the connection procedure, the wipeable valve including the silicone diaphragm can be wiped or "wiped" with an alcohol cloth or other cloth or swab soaked with a disinfectant to remove any microbial contaminants and provide a sterile connection surface punctured by a sterile male Luer connector connector. Therefore, the wipeable valve provides a method that can ensure sterility when attaching a sterile single-patient tubing component (e.g., a spike) with a male Luer to a multi-patient tubing component with a wipeable valve that has been disinfected before connection. Suitable wipeable valves are available from Halkey-Roberts, St. Petersburg, Florida, USA. ® The company purchased.

[0086] For disposable systems in many fluid injection procedures, such as CT, CV, MR or other imaging procedures that can inject contrast agents and saline flushing fluids into patients, it is necessary to provide a sterile appearance of a wipeable valve and destroy the silicone seal before the perfusion system. However, if the seal is destroyed by the male Luer connector and the Luer remains in the seal for too long, such as more than 8 hours, the silicone will be permanently cured and will not work as expected, such as it will not be able to effectively seal and prevent fluids from leaking from the tubing kit. Conventional wipeable valves can use standard Luers to destroy the seal, but in some applications, it may be desirable to open the silicone slit to allow air to be purged from the system during a purge or perfusion operation without the need to attach a male Luer connector. As described herein, if the air pressure is not purged, the pressure in the system may accumulate to more than 100 psi before the seal flips and releases itself. In such a situation, not only air, but possibly also a volume of medical fluid may be released through the wipeable valve, potentially causing spillage of medical fluid requiring cleaning and / or soiling of various injector components with viscous and / or hazardous medical fluid.

[0087] According to various embodiments of the present disclosure, a male Luer component with an open lumen and / or through hole or irregular shape in the center (e.g., a Luer-shaped pin with at least one groove on the outer surface of the pin or a pin with a cross-shaped cross-section) can be used to interrupt the seal and allow air to escape from the tubing during a purge or priming operation. In certain embodiments, the fluid path can be associated with a sensor, such as a fluid or air sensor, which can detect when substantially all of the air has been purged from the fluid path and stop the purge / priming operation before the fluid passes through a wipeable valve or is ejected from a pressure release assembly. For some single-patient systems, the syringe will typically be filled before the disposable is attached. Once attached, all fluid lines must be purged of air, including tubing configured for attachment to a body fluid container, the tubing including a wipeable valve connector on the end of the tubing, and can be configured with a spiked component having a male Luer connector. However, in some cases, the syringe may be initially filled with medical fluid, and the body fluid fill line may not be used until after the initial filling, for example, if additional fluid from the body fluid container is not needed before one or several additional patients. In this case, the body fluid fill line cannot be properly primed unless air is allowed to escape through the wipeable valve. Alternatively, if the operator wishes to refill the syringe after all lines are primed, they need to remove the dust cap (and septum interrupter), wipe the wipeable valve with a sterile wipe, and attach the required fluid path component (i.e., spike) to the wipeable valve and fluidly connect the body fluid source. During this process, any air that may be trapped in the line needs to be cleared before attaching a new spike.

[0088] According to various embodiments herein, a dust cover that can keep the system sterile can be provided in a "shipping" state, the dust cover including a pressure release assembly, wherein the wipeable valve is in an initial sealing configuration or "first position". Before use, when the fluid path is purged of any air, the operator will "break" the wipeable valve by advancing the pressure release assembly including the pressure release assembly to open the diaphragm of the wipeable valve without compromising the sterility of the system. According to various embodiments described herein, the "break" of the wipeable valve can be achieved in various different ways. According to certain embodiments, the rupture and infusion can be at least partially initiated by the operator. According to other embodiments, the rupture and the purge / infusion can be initiated by a component connected to the fluid injector (fluid control module or other controller), and the fluid injector can activate the purge / infusion sequence as part of the syringe setting sequence-the initial setting sequence or the new patient setting sequence after the previous patient injection procedure. In some embodiments, the pressure release assembly and the wipeable valve assembly can be configured so that it is only suitable for the fluid control module after being activated. In other embodiments, the pressure release assembly and the wipeable valve assembly can be manually activated by the user. In other embodiments, the pressure relief assembly and the wipeable valve assembly can be inserted into a box associated with a fluid injector, where insertion into the box activates the assembly or allows the assembly to be activated by a controller associated with the fluid injector, such as using one or more sensors to determine the status of the pressure relief assembly and the wipeable valve assembly and move the pressure relief assembly from a first, non-inserted position to a second, inserted position.

[0089] According to various embodiments, the release assembly can be screwed onto a standard female Luer thread of a wipeable valve, and the pressure relief assembly can be advanced by pushing the center pin from a first non-inserted position to a second inserted position, in which the center pin has pierced or opened the seal of the wipeable valve. In other embodiments, the pressure relief assembly can be a threaded pin that interfaces with a standard female Luer thread (or has a unique thread), and the pressure relief assembly can be advanced by turning the threaded pin and pushing the pin through the seal of the wipeable valve. In some embodiments, there can be lines or markings to indicate that the pressure relief assembly has been advanced to the correct position.

[0090] According to a non-limiting embodiment or aspect of the present disclosure, Figure 1-4As shown, the pressure relief assembly 2 is shown and described in detail. The pressure relief assembly 2 can be reversibly threadedly attached to the wipeable valve 4. In one example of the present disclosure, the pressure relief assembly 2 may include a connection device 6, which provides an inner surface of an engagement sleeve 8 disposed on the pressure relief assembly 2. In one example, the engagement sleeve 8 may have a generally cylindrical shape. The cavity 10 may be defined by the engagement sleeve 8. In a non-limiting embodiment or aspect of the present disclosure, the connection device 6 may include a thread on the inner surface of the engagement sleeve 8, which is configured to engage a corresponding thread 12 on the wipeable valve 4 to fix the pressure relief assembly 2 to the wipeable valve 4. It should be understood that the thread of the engagement sleeve 8 and the thread 12 of the wipeable valve 4 may be corresponding external threads and internal threads. In one example, the distal portion of the wipeable valve 4 may be received in the proximal end of the engagement sleeve 8. In this example, the thread 12 of the wipeable valve 4 is an external thread, which is received in the internal thread of the connection device 6 of the engagement sleeve 8.

[0091] In one non-limiting embodiment or aspect of the present disclosure, the connection device 6 of the engagement sleeve 8 can also engage the threads 14 disposed on the pin member 16 retained in the cavity 10 of the engagement sleeve 8. It should be understood that alternative connection devices or methods other than threads can also be used to operably connect the pin member 16 to the engagement sleeve 8. In one example, the pin member 16 can be rotated in a first direction to advance the pin member 16 in a proximal direction (toward the wipeable valve 4) relative to the engagement sleeve 8, and can be rotated in a second direction (opposite to the first direction) to advance the pin member 16 in a distal direction (away from the wipeable valve 4) relative to the engagement sleeve 8. In another embodiment, once the pin member 16 is moved to the second inserted position, the pin member 16 cannot be moved back to the first non-inserted position. In this embodiment, the engagement sleeve 8 must be removed from the wipeable valve 4 by rotating the engagement sleeve 8 relative to the wipeable valve 4 to separate the pressure relief assembly 2 from the wipeable valve 4.

[0092] In one example, the pin member 16 may define at least a portion of the through hole 18. According to a first embodiment, at least a portion of the through hole 18 may be a complete through hole extending from the proximal end 27a of the pin member 16 to the distal end 27b along the longitudinal axis of the pin member 16. In a second embodiment, at least a portion of the through hole 18 may be a partial through hole extending from the proximal end 27a of the pin member 16. In one non-limiting embodiment or aspect of the present disclosure, a plurality of gripping members 19 may be disposed on the outer surface of the distal end 27b of the pin member 16. A user may grasp the plurality of gripping members 19 to help the pin member 16 rotate or advance relative to the engagement sleeve 8. In one example, the plurality of gripping members 19 may be fins or protrusions distributed parallel to the longitudinal axis around the circumference of the distal end 27b of the pin member 16. In one non-limiting embodiment or aspect of the present disclosure, a plurality of gripping members 23 may be disposed on the outer surface of the engagement sleeve 8. A user may grasp the plurality of gripping members 23 to help the engagement sleeve 8 rotate or advance relative to the wipeable valve 4.

[0093] Continue to refer Figure 1-4 According to a non-limiting embodiment of the present disclosure, the engagement sleeve 8 may include a flexible retaining arm 20 protruding from the distal end (as shown) or the proximal end (not shown) thereof, and is configured to engage with the outer surface of the pin member 16 when the pin member 16 is in one of a first non-inserted position and a second inserted position, in which the wipeable valve 4 can be transported with the seal 21 in a sealed state, and in which the pin member 16 opens the seal 21 of the wipeable valve 4 in the second inserted position. According to certain embodiments, when the flexible retaining arm 20 engages the outer surface of the pin member 16 in the second position, the pin member 16 can be locked in the second inserted position, that is, the seal 21 of the wipeable valve 4 can be locked in the open position, in which the pin member 16 is inserted through the seal. In order to fluid-tighten the seal 21 of the wipeable valve 4, the pressure relief assembly 2 must be disengaged from the wipeable valve 4.

[0094] In use, the pressure relief assembly 2 can be shipped in a sterile package in a first non-insertion position with the pin member 16 in a distal position. In this example of the pressure relief assembly 2, the retaining arm 20 can be snapped into the first pawl 22 on the thread 14 of the pin member 16 in the first non-insertion position. In some embodiments, the pressure relief assembly 2 can be shipped with an associated wipeable valve 4, and the entire pressure relief assembly 2 and wipeable valve 4 can be attached to the tubing and attached to the fluid injector fluid path. In other embodiments, the wipeable valve 4 can be pre-attached to the fluid injector fluid path, the wipeable valve 4 can be sterilized, for example by wiping with a sterile cloth, as described herein, and the pressure relief assembly 2 can be removed from the sterile package and threaded onto the wipeable valve 4.

[0095] In one example of the present disclosure, when the pin member 16 is moved to the second insertion position, the through hole 18 of the pin member 16 can allow air in the inner cavity of the tubing connected to the wipeable valve 4 to be released through the through hole 18 of the wipeable valve 4 and the pin member 16, and instruct the fluid injector to perform a purge or priming operation, wherein the fluid and / or air in the tubing is pressurized, for example by moving the piston and plunger of the syringe in the distal direction. In certain embodiments, the through hole 18 of the pin member 16 may also include an adsorbent material or a filter material that is configured to absorb or block any medical fluid passage that may be discharged during the purge / priming sequence while allowing air to pass therethrough. Non-limiting examples of such filter materials include filter materials, membranes, filters, and fibers based on Porex (porous sintered polytetrafluoroethylene (PTFE)); and other materials that are permeable to air or other gases but substantially impermeable to the passage of liquids such as contrast media or saline.

[0096] In certain embodiments, such as Figure 1 and Figure 3 As shown, the engagement sleeve 8 of the pressure relief assembly 2 may further define one or more outlet vents 24 on the sidewall of the engagement sleeve 8. The one or more outlet vents 24 may allow any air from the line that exits through the seal 21 of the wipeable valve 4 outside the pin member 16 to escape from the engagement sleeve 8, and may be further aided by allowing the retaining arm 20 to flex circumferentially around the outer surface of the pin member 16. It should be understood that the flexing movement of the retaining arm 20 may be minimal, but the flexing movement will occur when the pin member 16 is inserted into the engagement sleeve 8.

[0097] During a purge or priming sequence of the tubing connected to the wipeable valve 4, the injector syringe and tubing can be pressurized. Before or during the purge or priming sequence, the pressure relief assembly 2 can be moved from the first non-insertion position to the second insertion position. Moving from the first position to the second position can be manually accomplished by a user grasping one or more of the plurality of gripping members 19 at the distal end of the pin member 16 and rotating the pin member 16 clockwise or counterclockwise. Depending on the directionality of the thread, in some embodiments, moving the pin member 16 from the first position to the second position can be achieved by rotating the pin member 16 in a counterclockwise direction. As the pin member 16 rotates, the thread 14 moves the pin member 16 in the proximal direction until the proximal end 27a of the pin member 16 engages and destroys the seal 21 associated with the wipeable valve 4 (e.g., by puncturing a slit in the elastic sealing material) and is in the second insertion position. Once the seal 21 of the wipeable valve 4 is destroyed, the through hole 18 of the pin member 16 is in fluid communication with the internal volume of the tubing. As the purge and prime sequence continues, air from the interior volume of the tubing is purged out of the tubing and through the through hole 18 of the pin member 16. At the end of the purge and prime sequence, the pin member 16 can be moved from the second inserted position back to the first non-inserted position and the wipeable valve 4 returns to the sealing configuration. The pin member 16 can be moved from the second position to the first position by rotating the plurality of gripping elements 19 and the pin member 16 in a direction opposite to the direction of rotation from the first position to the second position, i.e., counterclockwise if the pin member 16 was initially rotated clockwise to move from the first position to the second position; or clockwise if the pin member 16 was initially rotated counterclockwise to move from the first position to the second position. As the pressure relief assembly 2 moves from the first position to the second position, the retaining arm 20 can move from the first pawl 22 that retains the pin member 16 in the first position to the second pawl 26 that retains the pin member 16 in the second inserted position. When the retaining arm 20 moves into the second detent 26, the user may hear an audible click or the user may feel a tactile click to indicate that the pressure relief assembly 2 is now in the second insertion position and a purge / prime operation may be performed to remove air from the tubing. According to another embodiment, the retaining arm 20 may engage the second detent 26 in a non-removable engagement when the pin member 16 moves to the second insertion position. In this embodiment, once the tubing has been substantially purged of air and the single-patient component or spike is ready to be installed, the user may simply disengage the entire pressure relief assembly 2 from the wipeable valve 4 so that the seal of the wipeable valve 4 is sealably reformed and ready to be wiped, and the single-patient component or spike is installed.

[0098] like Figure 5-10 As shown, according to a non-limiting embodiment of the present disclosure, at least a portion of the pin member 16 may have a Figure 1-4 Cross-sectional shapes other than the cylindrical shape shown. For example, Figure 5 As shown, the proximal end 27a of the pin member 16 may include a cross-shaped cross-section 30. Figure 6-10 As shown, the proximal end 27a of the pin member 16 may include a moon-shaped cross-section 32 defined by at least one longitudinal groove 25, which is defined on one side of the pin member 16. These different shapes of the pin member 16 can be provided to help release air from the wipeable valve 4 and through the release assembly 2. In these examples, the pin member 16 may not define a through hole for releasing air from the wipeable valve 4. Instead, as shown Fig. 9 and 10 As shown, after the pin member 16 has been inserted into the wipeable valve 4 and the seal 21 of the wipeable valve 4 is broken, the proximal end 27a of the pin member 16 can hold open the seal 21 of the wipeable valve 4. Air from the wipeable valve 4 can be released through the groove defined on the side of the pin member 16 by the cross-sectional shape of the proximal end 27a of the pin member 16. The air can then be released from the release assembly 2, for example, through the threads of the engagement sleeve 8 and / or the vent 24 defined in the engagement sleeve 8. In one example, it is also contemplated that a partial through hole can be defined in the distal end 27b of the pin member 16, which will help reduce the material cost associated with forming the pin member 16 (i.e., less plastic).

[0099] According to a non-limiting embodiment or aspect of the present disclosure, Fig.11 and Fig.12 As shown, the pin member 16 may define a portion of the through hole 18 at the proximal end 27a of the pin member 16. In addition, at least one vent 29 may be defined in the side surface of the proximal end 27a of the pin member 16 connecting the portion of the through hole 18 to the cavity 10 of the engagement sleeve 8. It should also be understood that additional vents may be defined in the proximal end 27a of the pin member 16. The vent 29 may include an inlet defined in the inner surface of the pin member 16 and an outlet defined in the outer surface of the pin member 16. As shown in FIG. Fig.11 As shown, when the pin member 16 is positioned in the first non-inserted position, the vent 29 is positioned distal to the seal 21 of the wipeable valve 4. In this configuration, when the vent 29 is positioned within the cavity 10 of the engagement sleeve, the vent 29 is protected from particulate or microbial contamination. Fig.12 As shown, when the pin member 16 is positioned at the second insertion position, the inlet at the proximal end 27a of the partial through hole 18 is positioned close to the seal 21 of the wipeable valve 4, and the vent 29 remains positioned away from the seal 21 of the wipeable valve 4. Therefore, when the pin member 16 is positioned at the second insertion position, air can be released from the wipeable valve 4 through the inlet at the proximal end 27a of the partial through hole 18, and out of the vent 29 to be released from the engagement sleeve 8 to the atmosphere.

[0100] According to a non-limiting embodiment or aspect of the present disclosure, Figure 13-16 As shown, the pressure relief assembly 102 is shown and described in detail. Figure 1-4 As described above, the pressure relief assembly 102 can be reversibly threadedly attached to the wipeable valve 104. It should be understood that the details of the pressure relief assembly 102 will not be discussed in detail herein. Figure 1-4 Any feature corresponding to the feature in .

[0101] In one example, the pin member 116 can define a through hole 118. The through hole 118 can extend along the longitudinal axis of the pin member 116 from a proximal end of the pin member 116 to a distal end of the pin member 116.

[0102] In one example of the present disclosure, when the pin member 116 moves from the first non-inserted position to the second non-inserted position, the through hole 118 of the pin member 116 can allow air from the lumen of the tubing connected to the wipeable valve 104 to be released through the wipeable valve 104 and the through hole 118 of the pin member 116, and instruct the fluid injector to perform a purge or priming operation, wherein the fluid in the tubing is pressurized, for example, by moving the piston and plunger of the syringe in the distal direction. In this embodiment or aspect, the pin member 116 may include a bell-shaped element 124 located at the distal end of the pin member 116, wherein the bell-shaped element 124 defines an internal volume 126. According to these embodiments, the bell-shaped element 124 can be configured to capture or fix a small amount of fluid that can be discharged through the pressure relief assembly 102 during the purge or priming sequence. This can prevent fluid contamination or staining by retaining any medical fluid with the pressure relief assembly 102. In some embodiments, the bell-shaped element 124 may include an adsorbent material or a filter material 125 to absorb or prevent the escape of the medical fluid while allowing any air to pass through. For example, the adsorbent material may be an air-permeable but substantially liquid-impermeable material, such as the Porex-based material described herein, such that air can pass through the filter material 125 while contrast media or saline liquid cannot pass through the filter material 125. In other embodiments, the bell-shaped element 124 may include one or more gripping elements 119 protruding from an outer surface of the bell-shaped element 124 to allow a user to rotate the pin member 116 to move the pin member 116 from a first position to a second position, and in some embodiments, from the second position back to the first position.

[0103] Certain embodiments of the various pressure relief assemblies 102 described herein may also include one or more indicators, such as a visual band 128, for example, on one or both of the pin member 116 and the engagement sleeve 108, which may indicate to the user that the pin member 116 has not yet been fully moved to the second insertion position. As the pin member 116 is rotated, the retaining arm 120 of the engagement sleeve 108 may engage the visual band 128 and move the visual band 128 distally and rotate the pin member 116. In the second insertion position, the visual band 128 may move completely around the proximal wall of the bell element 124, indicating to the user that the pressure relief assembly 102 is ready to begin a purge / prime sequence. Optionally, the visual band 128 can be at least a portion of at least one colored ring or a bar code surrounding the circumference of the pin member 116, wherein the visual band 128 can be positioned so that when the pin member 116 is in the second insertion position, the colored ring is in a specific position, such as completely within the engagement sleeve 108 and not visible to the user, or a sensor on the fluid injector can sense the position of at least a portion of the at least one colored ring or bar code and send a signal to a controller of the fluid injector indicating that the pin member is in the second position.

[0104] During a purge or priming sequence of the tubing connected to the wipeable valve 104, the injector syringe and other tubing portions may be pressurized. Before or during a purge or priming sequence, the pressure relief assembly 102 may be moved from a first non-inserted position to a second inserted position. Moving from the first position to the second position may be accomplished manually by a user grasping one or more gripping members 119 at the bell-shaped feature 124 of the pin member 116 and rotating the one or more gripping members 119 and the pin member 116 in a clockwise direction. Depending on the directionality of the threads, in some embodiments, moving the pin member 116 from the first position to the second position may be accomplished by rotating the one or more gripping members 119 and the pin member 116 in one of a clockwise or counterclockwise direction depending on the direction of the threads. As the pin member 116 rotates, the threads 114 move the pin member 116 in a proximal direction until the proximal end of the pin member 116 engages and breaks the seal 121 associated with the wipeable valve 104 and is in the second inserted position. Once the seal 121 of the wipeable valve 104 is broken, the lumen or through-hole 118 of the pin member 116 is in fluid communication with the interior volume of the tubing. As the purge and prime sequence continues, air from the interior volume of the tubing is purged out of the tubing and through the through-hole 118 of the pin member 116 and into the bell element 124; if a filter material 125 is present, the air exits through the filter material 125. Any liquid may also be purged or primed through the through-hole 118 and collected in the bell element 124. In embodiments where the filter material 125 is present, the filter material 125 may prevent any liquid from escaping the bell element 124. At the end of the purge and prime sequence, the pin member 116 may be moved from the second inserted position back to the first non-inserted position, and the wipeable valve 104 returns to the sealed configuration. The pin member 116 can be moved from the second position to the first position by rotating the one or more gripping elements 119 and the pin member 116 in a direction opposite to the direction of rotation from the first position to the second position, i.e., counterclockwise if the pin member 116 was initially rotated clockwise to move from the first position to the second position, or clockwise if the pin member 116 was initially rotated counterclockwise to move from the first position to the second position. As the pressure relief assembly 102 moves from the first position to the second position, the retaining arm 120 can move from the first detent 122 that retains the pin member 116 in the first position to the second detent 132 that retains the pin member 116 in the second insertion position. When the retaining arm 120 moves into the second detent 132, an audible click can be heard by the user or a tactile click can be felt by the user to indicate that the pressure relief assembly 102 is now in the second insertion position and a purge / prime operation can proceed to remove air from the tubing. Alternatively, in embodiments where the pin member 116 is locked in the second position, the pin member 116 may be removed from the ruptured seal 121 by removing the pressure balancing cap 102 from the wipeable valve 104 .

[0105] According to a non-limiting embodiment of the present disclosure, Figure 17-19 , the pressure relief assembly 202 is shown and described in detail. The pressure relief assembly 202 can be reversibly threadedly attached to the wipeable valve 204. In one example of the present disclosure, the pressure relief assembly 202 may include a connection device 206 disposed on an inner surface of an engagement sleeve 208 of the pressure relief assembly 202. In one example, the engagement sleeve 208 may have a generally cylindrical shape. A plurality of gripping elements 209 may be positioned on an outer circumferential surface of the engagement sleeve 208 to assist a user in grasping the engagement sleeve 208 for rotating the engagement sleeve 208 relative to the wipeable valve 204. A cavity 210 may be defined by the engagement sleeve 208. In one non-limiting embodiment or aspect of the present disclosure, the connection device 206 may include threads on an inner surface of the engagement sleeve 208, the threads being configured to engage threads 212 on the wipeable valve 204 to secure the pressure relief assembly 202 to the wipeable valve 204. It should be understood that the threads of the engagement sleeve 208 and the threads 212 of the wipeable valve 204 can be corresponding external threads and internal threads. In one example, the distal portion of the wipeable valve 204 can be received in the proximal end of the engagement sleeve 208. In this example, the threads 212 of the wipeable valve 204 are external threads that are received in the internal threads of the connection device 206 of the engagement sleeve 208. In certain embodiments, the pressure relief assembly 202 can be attached to the wipeable valve 204 by a friction fit between the inner surface of the engagement sleeve 208 and the outer circumference of the wipeable valve 204 or by some other suitable attachment mechanism known in the art. These alternative attachment means can be incorporated into any of the various embodiments of the pressure relief assembly described herein.

[0106] In one non-limiting embodiment or aspect of the present disclosure, the pressure relief assembly 202 may include a pin member 214 that can slide from a first non-inserted position to a second inserted position relative to the engagement sleeve 208. The engagement sleeve 208 may define an opening 216 on its distal surface. The pin member 214 may be received in the opening 216 to slide relative to the engagement sleeve 208. One or more flexible engagement elements 218 may extend radially inward from the opening 216 to flexibly engage one or more pawls 220, 222 defined on the slidable pin member 214. The pin member 214 may include at least a portion of a through hole or lumen 224 to provide fluid communication between the proximal end and the exterior of the pin member 214. In one embodiment, where the pin member 214 includes a portion of the through hole 224, fluid communication is provided between the proximal end of the pin member 214 and at least one side vent 221a, 221b positioned at the distal end of the portion of the through hole 224. At least one side vent 221a, 221b can be located at a position on the pin member 214 surrounded by the engagement sleeve 208. According to this embodiment, the position of at least one side vent 221a, 221b can be selected to prevent microbial contamination of the portion of the through hole 224, such as by accidentally touching at least one side vent 221a, 221b with a finger on a contaminated surface. In other embodiments, the pin member 214 may include a full through hole extending from the proximal end of the pin member 214 to the distal end along the longitudinal axis. The distal end of the pin member 214 may include a flange 226, which is configured for press engagement, such as by manually pressing the pin member 214 to move from a first non-insertion position to a second insertion position, or by pressing the electromechanical components of the box element to move the pin member 214 from the first non-insertion position to the second insertion position.

[0107] The pin member 214 may also include a first circumferential detent 220 and, in certain embodiments, a second circumferential detent 222 configured to interact with the one or more flexible engagement elements 218 to retain the pin member 214 in the first position and the second position, respectively. The first circumferential detent 220 may be located around a substantially central portion of the pin member 214 to releasably retain the pin member 214 in the first position, and the second circumferential detent 222 may be located near a proximal surface of the flange 226 to releasably or non-releasably retain the pin member 214 in the second position. In one example, the pin member 214 can be pushed in a first direction to advance the pin member 214 in a proximal direction (toward the wipeable valve 204) relative to the engagement sleeve 208, and in an embodiment where the pin member 214 is releasably retained in the second position, can be pulled in a second direction (opposite to the first direction) to advance the pin member 214 in a distal direction (away from the wipeable valve 204) relative to the engagement sleeve 208 to disengage the pin member 214 from the seal 228 of the wipeable valve 204. The first non-insertion position can be understood as a position where the pin member 214 does not break or open the seal 228 of the wipeable valve 204, and the second insertion position can be understood as a position where the pin member 214 has broken and inserted into the wipeable valve 204 through the seal 228. In another embodiment, once the pin member 214 is advanced to the second insertion position, the pin member 214 is non-releasably retained in the second insertion position and cannot be moved back to the first non-insertion position. In this embodiment, the engagement sleeve 208 must be removed from the wipeable valve 204 by rotating the engagement sleeve 208 relative to the wipeable valve 204 to decouple the pressure relief assembly 202 and the pin member 214 from the wipeable valve 204 .

[0108] According to other embodiments, Fig.18 and 19 As shown, the pressure relief assembly 202 of the present disclosure may optionally include an adsorbent or filter material 230, as described herein, held near the distal end of the pin member 214, within a longitudinal through hole or lumen 224 extending from the proximal end to the distal end of the pin member 214. In the second insertion position, during a purge / prime operation of the tubing operably connected to the wipeable valve 204, air may pass through the through hole or lumen 224. However, any small amount of medical fluid that may inadvertently flow through the wipeable valve 204 may be retained by the adsorbent or filter material 230.

[0109] In use, the pressure relief assembly 202 can be shipped in a sterile package in a first non-insertion position, wherein the pin member 214 is located in a distal position, separated from the wipeable valve 204, and not inserted through the wipeable valve 204. In this example of the pressure relief assembly 202, one or more flexible engagement elements 218 can be snapped into or positioned in a first detent 220 on the pin member 214 at the first non-insertion position. In some embodiments, the pressure relief assembly 202 can be shipped with an associated wipeable valve 204; and the entire pressure relief assembly 202 and wipeable valve 204 can be pre-attached to the tubing. In other embodiments, the wipeable valve 204 can be pre-attached to the associated tubing of the fluid path, the wipeable valve 204 can be sterilized, such as by wiping with a sterile cloth, as described herein, and the pressure relief assembly 202 can be removed from the sterile package and threaded onto the wipeable valve assembly 204. In certain embodiments, a previously used pressure relief assembly 202 may be removed from the wipeable valve 204 and a new sterile pressure relief assembly 202 may be installed on the wipeable valve, such as after the wipeable valve 204 has been wipe sterilized.

[0110] In one example of the present disclosure, when the pin member 214 moves from the first non-inserted position to the second non-inserted position, the through hole 224 of the pin member 214 can allow almost all of the air in the lumen of the tubing connected to the wipeable valve 204 to be released through the wipeable valve 204 and at least a portion of the through hole 224 of the pin member 214, and instruct the fluid injector to perform a purge or priming operation, in which the fluid in the tubing is pressurized, such as by moving the piston and plunger of the syringe in the distal direction. To activate the pressure release assembly 202, before or during a purge or priming operation of the fluid injector, the user can press the distal surface of the flange 226 to slide the pin member 214 in the proximal direction relative to the engagement sleeve 208. Upon application of pressure, the flexible engagement elements 218 of the engagement sleeve 208 are released from the first circumferential detents 220 on the pin member 214, and the pin member 214 slides proximally relative to the engagement sleeve 208, piercing the seal 228 of the wipeable valve 204 and providing fluid communication between at least a portion of the through-hole or lumen 224 of the pin member 214 and the lumen (i.e., tubing) of the fluid path attached to the wipeable valve 204. In certain embodiments, the pin member 214 continues to slide proximally relative to the engagement sleeve 208 until one or more flexible engagement elements 218 of the engagement sleeve 208 engage the second circumferential detents 222, retaining the pressure relief assembly 202 in the second insertion position. Alternatively, in other embodiments, the pin member 214 slides until the proximal surface of the flange 226 of the pin member 214 abuts the distal surface of the engagement sleeve 208. In certain embodiments, the pressure relief assembly 202 can be returned to the first position by pulling the flange 226 in the distal direction relative to the engagement sleeve 208. Alternatively, in embodiments where the pin is non-releasably retained in the second insertion position, rotationally removing the engagement sleeve 208 from the wipeable valve 204 removes the pin member 214 from the seal 228 of the wipeable valve 204, thereby resealing the wipeable valve 204. After the pressure relief assembly 202 is removed from the wipeable valve 204, a tubing element (e.g., a spike) having a male luer connector can be engaged with the wipeable valve 204 after the wipeable valve 204 is appropriately sterilized (e.g., wiping the wipeable valve with a sterile wipe).

[0111] Other embodiments of the pressure relief assembly may be substantially similar, with a sliding activation mechanism from a first non-inserted position to a second inserted position. However, according to these embodiments, the flange 226 on the pin member 214 may be a bell-shaped element (see, with Figure 13-16The bell-shaped element is replaced with an associated bell-shaped element 124) that is configured to capture and retain any medical fluid that may inadvertently pass through the wipeable valve during the purge / prime sequence, as described herein. In certain embodiments, the interior volume of the bell-shaped element may include an adsorbent material to adsorb any medical fluid; alternatively, the distal end of the bell-shaped element may include an air-permeable but substantially liquid-impermeable filter material, as described herein, that is configured to allow air to pass through but retain any medical fluid that contacts the material.

[0112] like Fig. 20 , 2127, according to other non-limiting embodiments or aspects of the present disclosure, pressure relief assemblies according to various embodiments described herein, such as pressure relief assembly 202 and associated wipeable valve 204, can be configured to interact and engage with one or more features of a fluid injector module or cartridge 300. Although described with respect to embodiments of pressure relief assembly 202 / wipeable valve 204, it should also be understood that embodiments of pressure relief assembly 2, 102, 400, 502 / wipeable valve 4, 104, 408, 504 can also be used in conjunction with the fluid injector module or cartridge 300 described herein. For example, tubing 302, wipeable valve 204, and pressure relief assembly 202 can be configured to be inserted into one or more fluid injector constraints 304. According to certain embodiments, the orientation and shape of one or more injector constraints 304 may require that the pressure relief assembly 202 be moved from a first, non-inserted position to a second, inserted position prior to installing the pressure relief assembly 202 into the one or more injector constraints 304. According to these embodiments, during assembly of the fluid path kit with the injector module 300, a user is required to activate the pressure relief assembly 202. This ensures that the pressure relief assembly 202 is in the second insertion position when installed and the fluid path is ready for an air purge operation. In another embodiment, the injector module 300 may include an activation surface (e.g., an inclined activation surface 313) that moves the pin element 214 from the first non-insertion position to the second insertion position when the pressure relief assembly 202 / wipeable valve 204 assembly is inserted into the injector module 300. In another embodiment, once the pressure relief assembly 202 / wipeable valve 204 assembly is inserted into the injector module 300 and the fluid injector controller activates a priming or purging operation, an electromechanical component 311 of the injector module 300, such as a solenoid valve, that communicates with the controller of the fluid injector can activate the pressure relief assembly 202. As described herein, the injector module 300 may further include one or more sensors 306, 308, 310. For example, the first sensor 306 can be a liquid or air sensor configured to detect when the tubing set 302 is substantially purged of air, such as by detecting a liquid or air / liquid interface proximate to the wipeable valve 204. The first sensor 306 can then send a signal to the injector module 300 indicating that the purge operation is complete and the fluid path is substantially purged of any air. In other embodiments, the fluid injector module 300 can include a second sensor 308 configured to sense when the pressure relief assembly 202 has been installed within the injector constraint 304. The second sensor 308 can then send a signal to the controller of the injector module 300 indicating that the seal 228 of the wipeable valve 204 has been broken and the fluid path 302 is ready to be purged of air therefrom.In certain embodiments, the injector module 300 may include a third sensor 310, such as a liquid or air sensor, configured to detect the pin element 214 or the optional bell element (see. Fig. 27 ) to determine that substantially all volume of air has been purged or primed from the tubing 302. Once the sensors 306, 310 have determined that substantially all volume of air has been purged from the fluid path 302, the pressure relief assembly 202 / wipeable valve 204 assembly can be removed from the injector module 300, the pressure relief assembly 202 can be removed from the wipeable valve 204, the wipeable valve 204 can be sterilized by wiping it with a sterile wipe, and the fluid path element can be installed on the wipeable valve 204. For example, a spike can be installed on the wipeable valve 204 and inserted into a bulk fluid container; and any remaining volume of air can be purged into the fluid container before fluid is drawn into a syringe (or peristaltic pump) through the spike and fluid path 302.

[0113] According to another non-limiting embodiment, Fig. 22 and 23As shown, the pressure relief assembly 400 according to the present disclosure can be formed into an integral configuration. According to this embodiment, the pressure relief assembly 400 can include a first threaded female side 402 having a male Luer element 403 and a second threaded female side 404 without a male Luer element, each female side having threads 405a and 405b, respectively, configured to threadably engage threads 406 of a wipeable valve 408. In certain embodiments, the non-insertion end of the male Luer element can include a filter element 409, which can be permeable to air but impermeable to liquids as described herein. The fluid path kit including the wipeable valve 408 and the integral pressure relief assembly 400 can be transported in a non-insertion position, in which the wipeable valve 408 is threadably engaged with the second threaded female side 404 of the pressure relief assembly 400. An inner cavity or through hole 410 can be formed through the pressure relief assembly 400, passing through the male Luer element 403 of the first threaded female side 402 to reach the second female side 404. In this manner, the pressure relief assembly 400 can act as a dust cover to prevent contamination of the wipeable valve 408. In certain embodiments (not shown), the proximal end of the male luer element 403 can be slightly recessed in the first internally threaded side 402 to prevent inadvertent contact and contamination with the proximal end of the male luer element 403. To prepare the system for a purge / prime operation, the second internally threaded side 404 of the integrated pressure relief assembly 400 is unthreaded from the wipeable valve 408, rotated 180 degrees, and rethreaded onto the wipeable valve 408 such that the male luer element of the first internally threaded side 402 of the pressure relief assembly 400 engages and pierces the seal 412 of the wipeable valve 408, allowing any air in the tubing set to be purged during the purge operation. After the cleaning operation, the integrated pressure relief assembly 400 can be removed, the wipeable valve 408 can be wiped with a sterile wipe, and a single-patient fluid path element or spike for a body fluid container can be attached as described herein, or the integrated pressure relief assembly 400 can be removed again, inverted, and reattached to the wipeable valve 408 via the second female side 404 so that the pressure relief assembly 400 again acts as a dust cap. The integrated pressure relief assembly 400 can be configured such that when the first internally threaded side 402 is threaded onto the wipeable valve 408, the tip of the male Luer element 403 pierces and opens the silicone seal 412 and allows fluid communication between the atmosphere and the lumen of the tubing set.

[0114] According to a non-limiting embodiment or aspect of the present disclosure, Fig.24 and 25, a pressure relief assembly 502 is shown and described in detail. The pressure relief assembly 502 can be substantially similar in operation to the pressure relief assembly 202, as described herein, with minor differences. The pressure relief assembly 502 can be reversibly threadedly attached to the wipeable valve 504. In one example of the present disclosure, the pressure relief assembly 502 can include a connection device 506 disposed on an inner surface of an engagement sleeve 508 of the pressure relief assembly 502. In one example, the engagement sleeve 508 can have a generally cylindrical shape. The engagement sleeve 508 can define a cavity 510. In one non-limiting embodiment or aspect of the present disclosure, the connection device 506 can include threads on an inner surface of the engagement sleeve 508, the threads being configured to engage threads 512 on the wipeable valve 504 to secure the pressure relief assembly 502 to the wipeable valve 504. It should be understood that the threads of the engagement sleeve 508 and the threads 512 of the wipeable valve 504 can be corresponding external threads and internal threads. In one example, the distal portion of the wipeable valve 504 can be received in the proximal end of the engagement sleeve 508. In this example, the threads 512 of the wipeable valve 504 are external threads that are received in the internal threads of the connection device 506 of the engagement sleeve 508.

[0115] In one non-limiting embodiment or aspect of the present disclosure, the pressure relief assembly 502 of the present disclosure may include a pin member 514 that can slide from a first non-inserted position to a second inserted position relative to the engagement sleeve 508. The engagement sleeve 508 may define an opening 516 on its distal surface. The pin member 514 can be received in the opening 516 to slide relative to the engagement sleeve 508. One or more flexible engagement elements 518 can extend radially inward from the opening 516 to flexibly engage the pawls 520, 522 defined on the slidable pin member 514. The pin member 514 may include a through hole or lumen 524 to provide fluid communication between the proximal and distal ends of the pin member 514. In one example, the pin member 514 may include at least one vent similar to the vents 221a and 221b shown in the pressure relief assembly 202. The distal end of the pin member 514 may include a flange 526 configured to be pressed into engagement, such as by manually pressing the pin member 514 to move from the first non-insertion position to the second insertion position. The engagement sleeve 508 may also include a flange 527 disposed on the distal end of the engagement sleeve 508, the flange 527 being configured to receive the flange 526 of the pin member 514 when the pin member 514 moves to the second insertion position.

[0116] The pin member 514 may also include a first circumferential pawl 520 and a second circumferential pawl 522 for interacting with the one or more flexible engagement elements 518 to hold the pin member 514 in the first position and the second position, respectively. The first circumferential pawl 520 may be located around a substantially central portion of the pin member 514, and the second circumferential pawl 522 may be located near a proximal surface of the flange 526. In one example, the pin member 514 may be pushed in a first direction to advance the pin member 514 in a proximal direction (towards the wipeable valve 504) relative to the engagement sleeve 508, and may be pulled in a second direction (opposite to the first direction) to advance the pin member 514 in a distal direction (away from the wipeable valve 504) relative to the engagement sleeve 508. The first non-inserted position may be understood as a position in which the pin member 514 does not break or open the seal 528 of the wipeable valve 504, and the second inserted position may be understood as a position in which the pin member 514 has broken and inserted through the seal 528 into the wipeable valve 504. In another embodiment, once the pin member 514 is pushed to the second insertion position, the pin member 514 cannot be moved back to the first non-insertion position. In this embodiment, the engagement sleeve 508 must be removed from the wipeable valve 504 by rotating the engagement sleeve 508 relative to the wipeable valve 504 to separate the pressure relief assembly 502 from the wipeable valve 504.

[0117] In use, the pressure relief assembly 502 can be shipped in a sterile package in a first non-insertion position, in which the pin member 514 is located at a distal position separated from the wipeable valve 504. In this example of the pressure relief assembly 502, one or more flexible engagement elements 518 can be snapped into or positioned in a first detent 520 on the pin member 514 at the first non-insertion position. In some embodiments, the pressure relief assembly 502 can be shipped with an associated wipeable valve 504, and the entire pressure relief assembly 502 and wipeable valve 504 can be attached to the tubing and attached to the fluid injector fluid path. In other embodiments, the wipeable valve 504 can be pre-attached to the fluid injector fluid path, the wipeable valve 504 can be sterilized, such as by wiping with a sterile cloth, as described herein, and the pressure relief assembly 502 can be removed from the sterile package and threaded onto the wipeable valve 504.

[0118] In one example of the present disclosure, when the pin member 514 moves from the first non-inserted position to the second non-inserted position, the through hole 524 of the pin member 514 can allow air from the lumen of the tubing connected to the wipeable valve 504 to be released through the wipeable valve 504 and the through hole 524 of the pin member 514, and instruct the fluid injector to perform a purge or priming operation, wherein the fluid in the tubing is pressurized, such as by moving the piston and plunger of the syringe in the distal direction. To activate the pressure relief assembly 502, the user can press the distal surface of the flange 526 to slide the pin member 514 in the proximal direction relative to the engagement sleeve 508. Upon application of pressure, the one or more flexible engagement elements 518 of the engagement sleeve 508 are released from the first circumferential detent 520, and the pin member 514 slides proximally relative to the engagement sleeve 508, piercing the seal 528 of the wipeable valve 504 and providing fluid communication between the through hole or lumen 524 of the pin member 514 and the lumen of the fluid path attached to the wipeable valve 504. The pin member 514 continues to slide proximally relative to the engagement sleeve 508 until the one or more flexible engagement elements 518 of the engagement sleeve 508 engage the second circumferential detent 522, retaining the pressure relief assembly 502 in the second insertion position. In certain embodiments, the pressure relief assembly 502 can be returned to the first position by pulling the flange 526 in the distal direction relative to the engagement sleeve 508. Optionally, rotationally removing the engagement sleeve 508 from the wipeable valve 504 removes the pin member 514 from the seal 528 of the wipeable valve 504, thereby resealing the wipeable valve 504. It is also conceivable that once the pressure relief assembly 502 has been pushed to the second insertion position, the flange 526 cannot be pulled back in the distal direction, but the flange 526 is locked in the flange 527 of the engagement sleeve 508, thereby preventing the pressure relief assembly 502 from being used again.

[0119] According to a non-limiting embodiment of the present disclosure, Fig.26 As shown, it is also contemplated that the irrigation tube 320 may be used in conjunction with any release assembly 502 that includes a full through hole 524 defined in the pin member 514. The irrigation tube 320 may be inserted into the distal end of the pin member 514 such that the irrigation tube 320 is retained within the through hole 524 with a friction fit. The irrigation tube 320 may include a filter material 330. Air exhausted from the wipeable valve 504 through the through hole 524 may be directed into the irrigation tube 320.

[0120] It is worth noting that any reference to "one embodiment" or "an embodiment" means that the particular features, structures, or characteristics described in conjunction with the embodiment are included in at least one embodiment. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in various places in the specification do not necessarily refer to the same embodiment. In addition, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner.

[0121] Those skilled in the art will recognize that, for the sake of conceptual clarity, the components (e.g., operations), devices, objects, and the accompanying discussions thereof described herein are intended to be examples only, and various configuration modifications are contemplated. Therefore, as used herein, the specific examples and accompanying discussions set forth are intended to be representative of their more general categories. In general, the use of any particular example is intended to be representative of its category, and the exclusion of a particular component (e.g., operation), device, and object should not be considered limiting.

[0122] Regarding the use of any plural and / or singular terms herein, those skilled in the art can translate from the plural to the singular and / or from the singular to the plural as appropriate according to the context and / or application. For clarity, various singular / plural arrangements are not explicitly set forth herein.

[0123] The subject matter described herein sometimes illustrates that different components are contained in other different components, or are connected to different other components. It should be understood that the architecture described in this way is merely exemplary, and in fact many other architectures can be implemented to achieve the same function. Conceptually, any device that implements the components of the same function is effectively "associated" to achieve the desired function. Therefore, any two components combined here to achieve a specific function can be regarded as "associated" with each other to achieve the desired function, regardless of the architecture or intermediate components. Similarly, any two components so associated can also be regarded as "operably connected" or "operably coupled" to each other to achieve the desired function, and any two components that can be so associated can also be regarded as "operably coupled" to each other to achieve the desired function. Specific examples of operable coupling include, but are not limited to, physically matchable and / or physically interacting components, and / or wirelessly interactable and / or wirelessly interacting components, logically interacting and / or logically interacting components.

[0124] "Coupled" and "connected" and their derivatives may be used to describe certain aspects. It should be understood that these terms are not intended to be synonymous with each other. For example, some aspects may be described using the term "connected" to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may be described using the term "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0125] In some cases, one or more components may be referred to herein as "configured," "operable," "adapted," etc. Those skilled in the art will recognize that "configured to" may generally encompass active state components and / or inactive state components and / or standby state components, unless the context requires otherwise.

[0126] Although particular aspects of the subject matter described herein have been shown and described, changes and modifications may be made by those skilled in the art based on the teachings herein without departing from the subject matter described herein and its broader aspects, and therefore, the appended claims are intended to cover within their scope all such changes and modifications within the scope of the subject matter described herein. Those skilled in the art will understand that, in general, the terms used herein, especially in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "at least having", the term "including" should be interpreted as "including but not limited to", etc.). Those skilled in the art will further understand that if a specific number of claim recitations is intended to be introduced, such intention will be explicitly stated in the claim, and if no such statement is made, such intention does not exist. For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be interpreted as implying that a claim recitation introduced by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations.

[0127] Furthermore, even if specific numbers of an introduced claim recitation are explicitly recited, those skilled in the art will recognize that such recitations should generally be interpreted to mean at least the number recited (e.g., a simple recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention similar to "at least one of A, B, and C, etc." is used, generally, such construction is intended to allow those skilled in the art to understand the convention (e.g., "a system having at least one of A, B, and C" would include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In instances where a convention similar to "at least one of A, B, or C, etc." is used, generally, such construction is intended to allow those skilled in the art to understand the convention (e.g., "a system having at least one of A, B, or C" would include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will further understand that disjunctive words and / or phrases that generally represent two or more optional terms, whether in the specification, claims or drawings, should be understood to include the possibility of one term, any one term or both terms, unless the context otherwise requires. For example, the phrase "A or B" is generally understood to include the possibility of "A" or "B" or "A and B".

[0128] In summary, numerous benefits resulting from the use of the concepts described herein have been described. The foregoing disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the precise forms disclosed. Modifications or variations are possible in light of the above teachings. The claims submitted herein are intended to define the overall scope of the present disclosure.

Claims

1. A pressure relief assembly for a tubing kit, the pressure relief assembly comprising: an engagement sleeve including an inner surface defining a cavity, the inner surface including a connection means configured to connect the engagement sleeve to the tubing set and / or an associated wipeable valve; as well as a pin member configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position in which the pin member is removed from the tubing set and / or a seal of the associated wipeable valve, and a second position in which the pin member is inserted into the tubing set and / or a seal of the associated wipeable valve to allow a volume of air to be purged from the tubing set through the pressure relief assembly.

2. The pressure relief assembly according to claim 1, wherein: The connection device of the engagement sleeve includes a threaded surface for threadably connecting the engagement sleeve to the tubing set.

3. A pressure relief assembly according to claim 1 or claim 2, wherein: The pin member includes a flange disposed on a distal end of the pin member.

4. A pressure relief assembly according to any one of claims 1 to 3, wherein: The pin member defines a through hole extending therethrough; and Wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the interior of the tubing set to allow the air to be purged from the tubing set.

5. The pressure relief assembly according to any one of claims 1 to 4, wherein: The pin member defines at least one detent; and Wherein, when the pin member is retained in the first position, a portion of the engagement sleeve engages with the at least one pawl to retain the pin member in the first position.

6. The pressure relief assembly of claim 5, wherein: The portion of the engagement sleeve that engages with the at least one pawl includes at least one flexible engagement member for flexibly engaging with the at least one pawl.

7. The pressure relief assembly according to any one of claims 1, wherein: the pin member defining a first pawl and a second pawl, the second pawl being defined a distance from the first pawl; and wherein, when the pin member is held in the first position, a portion of the engagement sleeve engages with the first pawl to hold the pin member in the first position; and Wherein, when the pin member is held in the second position, the portion of the engagement sleeve engages with the second pawl to hold the pin member in the second position.

8. A pressure relief assembly according to any one of claims 1 to 7, wherein: The pin member defines a through hole extending through at least a portion of the pin member, and Wherein, a filter is disposed in the through hole to allow air to move through the through hole while preventing fluid from moving past the filter and through the through hole.

9. A pressure relief assembly according to any one of claims 1 to 8, wherein: The outer surface of the engagement sleeve includes at least one gripping element.

10. A pressure relief assembly according to any one of claims 1 to 9, wherein: An outer surface of the pin member includes corresponding connection means configured to engage with the connection means of the engagement sleeve to move the pin member between the first position and the second position.

11. A pressure relief assembly according to any one of claims 1 to 10, wherein: The engagement sleeve includes a flexible arm member configured to engage at least one detent defined on the pin member.

12. A pressure relief assembly according to any one of claims 1 to 11, wherein: The pin member includes a ring slidably received on an outer surface of the pin member, and Wherein, when the pin member moves from the first position to the second position, the ring is pushed by the portion of the engagement sleeve from a first indication position to a second indication position to indicate that the pin member has broken a seal of the tubing set.

13. A pressure relief assembly according to any one of claims 1 to 12, wherein: The engagement sleeve defines a vent configured to allow air to pass therethrough after the pin member is moved to the second position.

14. A fluid injector, comprising: case; at least one syringe removably engaged with the housing; a tubing set configured to fluidly connect the at least one syringe at a proximal end and having a wipeable valve at a distal end; and at least one fluid reservoir containing a fluid for filling the at least one syringe; as well as a pressure relief assembly configured to be connected to a distal end of the tubing set to purge air from the tubing set, the pressure relief assembly comprising: an engagement sleeve including an inner surface defining a cavity, the inner surface including a connection device configured to removably connect the engagement sleeve to the tubing set; as well as a pin member configured to be received in the cavity of the engagement sleeve, wherein the pin member is movable between a first position in which the pin member is removed from a seal of the wipeable valve at the distal end of the tubing set and a second position in which the pin member is inserted into the seal of the wipeable valve at the distal end of the tubing set to allow air to be purged from the tubing set.

15. The fluid injector of claim 14, further comprising a box for accommodating the tubing set, the box comprising: a body defining at least one feature for receiving at least a portion of the tubing set; as well as A connecting member for removably connecting the body of the box to the fluid injector, the connecting member is operably connected to the body, wherein the box is configured to operably engage the pressure relief assembly to move the pressure relief assembly from the first position to the second position.

16. A fluid injector according to claim 14 or claim 15, wherein: The connection device of the engagement sleeve includes a threaded surface for threadably connecting the engagement sleeve to the tubing set.

17. The fluid injector according to any one of claims 14 to 16, wherein: The pin member includes a flange disposed on an end of the pin member.

18. The fluid injector according to any one of claims 14 to 17, wherein: The pin member defines a through hole extending longitudinally through the pin member from a proximal end to a distal end; and Wherein, when the pin member is maintained in the second position, the through hole establishes fluid communication with the tubing set through an opening located at a distal end of the through hole to allow the air to be purged from the tubing set.

19. The fluid injector according to any one of claims 14 to 18, wherein: The pin member defines at least one detent; and Wherein, when the pin member is held in at least one of the first position and the second position, a portion of the engagement sleeve engages with the at least one pawl to hold the pin member in at least one of the first position and the second position.

20. The fluid injector of claim 19, wherein: The portion of the engagement sleeve that engages the at least one pawl includes at least one flexible engagement member.

21. The fluid injector according to any one of claims 14 to 20, wherein: the pin member defining a first pawl and a second pawl, the second pawl being defined at a distance from the first pawl; and wherein, when the pin member is held in the first position, a portion of the engagement sleeve engages with the first pawl to hold the pin member in the first position; and Wherein, when the pin member is held in the second position, the portion of the engagement sleeve engages with the second pawl to hold the pin member in the second position.

22. The fluid injector according to any one of claims 14 to 21, wherein: The pin member defines a through hole extending longitudinally through at least a portion of the pin member; and Wherein, a filter is disposed in the through hole to allow air to move through the through hole while preventing fluid from moving past the filter and through the through hole.

23. The fluid injector according to any one of claims 14 to 22, wherein: The outer surface of the engagement sleeve includes at least one gripping element.

24. The fluid injector according to any one of claims 14 to 23, wherein: An outer surface of the pin member includes corresponding coupling means configured to engage with coupling means of the cassette to move the pin member between the first position and the second position.

25. The fluid injector according to any one of claims 14 to 24, wherein: The pin member includes a ring slidably received on an outer surface of the pin member, and Wherein, when the pin member moves from the first position to the second position, the ring is pushed by the portion of the engagement sleeve from a first indication position to a second indication position to indicate that the pin member has broken a seal of the tubing set.

26. The fluid injector according to any one of claims 14 to 25, wherein: The engagement sleeve defines a vent configured to allow air to pass therethrough after the pin member is moved to the second position.

27. The fluid injector of any one of claims 14 to 26, further comprising an activation member disposed on the cartridge, the activation member being adapted to engage a pin member of the pressure relief assembly to thereby move the pin member from the first position to the second position.

28. The fluid injector of claim 27, wherein: The activation member includes a solenoid valve or other electromechanical component configured to move a pin member of the pressure relief assembly.

29. A method of purging air from a tubing set, the method comprising: connecting a pressure relief assembly to the distal end of the tubing set, the pressure relief assembly comprising an engagement sleeve, the engagement sleeve comprising an inner surface defining a cavity, the inner surface comprising a connection device configured to connect the engagement sleeve to the tubing set, and a pin member configured to be received in the cavity of the engagement sleeve; moving the pin member from a first position to a second position to break a seal at a distal end of the tubing set and insert a proximal end of the pin member into the tubing set; as well as Air is purged from the tubing set through the pressure relief assembly.

30. The method of claim 29, wherein: The air is purged through one or more grooves on an outer surface of the pin member and through vents defined in an engagement sleeve of the pressure relief assembly.

31. The method of claim 29, wherein: The pin member defines a through hole extending from the proximal end of the pin member to the distal end of the pin member, or a vent extending through the outer surface of the pin member between the proximal and distal ends of the pin member, and when the pin member is in the second position, the vent establishes fluid communication with the tubing kit so that the air is cleared through the through hole of the pin member.

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