Devices, Assemblies, and Methods for Delivering Agents

Abstract

A valve assembly for a medical device, comprising a body having an inlet in fluid communication with a fluid source and an outlet in fluid communication with a delivery conduit of the medical device. The valve assembly includes a shuttle configured to move between a first position and a second position within the body to control the delivery of fluid from the inlet to the outlet. In the first position, the shuttle is configured to maintain the fluid at a first pressure within the body and seal the outlet from the inlet, such that the delivery conduit is isolated from the fluid at the first pressure. In the second position, the shuttle is configured to maintain the fluid at a second pressure within the body and fluidly couple the outlet to the inlet, such that the delivery conduit receives the fluid at the second pressure.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to devices and methods for delivering agents. More particularly, in embodiments, the present disclosure relates to devices for delivering powdered agents such as hemostatic agents.

Background Art

[0002] In certain medical procedures, it may be necessary to minimize or stop bleeding within the body. For example, in endoscopic medical procedures, hemostasis of bleeding tissue within the gastrointestinal tract, such as within the esophagus, stomach, or intestine, may be required. During an endoscopic procedure, a user inserts the sheath of an endoscope into the body lumen of a patient. The user controls the endoscope using the handle of the endoscope during the procedure. Instruments can be passed through the working channel of the endoscope, for example, via a port within the handle, to deliver treatment at a treatment site near the distal end of the endoscope. The treatment site is located away from the user.

[0003] To achieve hemostasis at a remote site, a hemostatic agent can be delivered by a device inserted into the working channel of the endoscope. Agent delivery can be achieved, for example, via a mechanical system. However, such systems may require a number of steps or actuations to achieve delivery, may not achieve the desired rate of delivery or the desired dosage of the agent, may clog a portion of the delivery device, resulting in a non-uniform dosage of the agent, and / or may result in the agent not reaching a deep treatment site within the gastrointestinal tract. The present disclosure may address one or more of these or other problems in the art.

Summary of the Invention

[0004] Each of the aspects disclosed herein may include one or more of the features described in relation to any of the other disclosed aspects. According to one example, a valve assembly for a medical device includes a body having an inlet in fluid communication with a fluid source and an outlet in fluid communication with a delivery conduit of the medical device, and a shuttle configured to move between a first position and a second position within the body to control the delivery of fluid from the inlet to the outlet. In the first position, the shuttle is configured to maintain the fluid at a first pressure within the body and seal the outlet from the inlet, such that the delivery conduit is isolated from the fluid received from the source at the first pressure. In the second position, the shuttle is configured to maintain the fluid at a second pressure within the body and fluidly couple the outlet to the inlet, such that the delivery conduit receives fluid from the source at the second pressure, and the second pressure is less than the first pressure.

[0005] Any of the valve assemblies described herein may include any of the following features. The valve assembly includes a piercing element configured to move between a retracted position and an extended position within a shuttle to fluidly couple an inlet to a fluid source. The piercing element includes a needle or lance having a sharp tip. The valve assembly is configured to receive fluid from the source through the inlet when the shuttle is moved from a first position to a second position and the piercing element is disposed in the retracted position, and the valve assembly is configured to prevent delivery of fluid from the inlet to the outlet when the shuttle is moved from the second position to the first position and the piercing element is disposed in the extended position. In a first configuration of the valve assembly, the shuttle is disposed in the first position, the piercing element is in the retracted position and separated from the fluid source, and the inlet is not in fluid communication with the outlet such that fluid is maintained at a first pressure at the fluid source. In a second configuration of the valve assembly, the shuttle is disposed in the second position, the piercing element is in the retracted position and in contact with the fluid source, and the inlet is in fluid communication with the outlet such that fluid is directed to the outlet at a second pressure. In a third configuration of the valve assembly, the shuttle is disposed in the first position, the piercing element is in the extended position and in contact with the fluid source, and the inlet is not in fluid communication with the outlet such that fluid is maintained at a first pressure and a second pressure within the body. The body is in fluid communication with a regulator assembly configured to convert fluid from the first pressure to the second pressure. The shuttle includes a gasket disposed around the outer surface of the shuttle. In a first configuration of the valve assembly, the shuttle is disposed in the first position and the gasket is disposed between the inlet and the outlet to fluidly isolate the delivery conduit from the fluid source. In a second configuration of the valve assembly, the shuttle is disposed in the second position and the gasket is not disposed between the inlet and the outlet to fluidly couple the delivery conduit to the fluid source. The body includes a channel configured to receive the shuttle and a ledge extending radially inwardly within the channel, and the shuttle includes a flange extending radially outwardly from the outer surface of the shuttle.The flange is configured to engage the ledge when the shuttle is in a first position relative to the channel, dispose the gasket between the inlet and the outlet, thereby fluidly isolating the delivery conduit from the fluid source. The flange is configured to disengage the ledge when the shuttle is in a second position relative to the channel, dispose the gasket outside the inlet and the outlet, thereby fluidly coupling the delivery conduit to the fluid source. The valve assembly includes a biasing mechanism coupled to the shuttle, and the biasing mechanism is configured to move the shuttle from the second position to the first position.

[0006] According to another example, a device for delivering a drug includes a housing configured to store the drug, a pressurized fluid source configured to store a pressurized fluid, and a valve assembly. The valve assembly includes a body having a first channel and a shuttle configured to move between a first position and a second position within the first channel to fluidly couple the pressurized fluid source to the housing, the shuttle having a second channel, and a piercing element configured to move between a retracted position and an extended position within the second channel to fluidly couple the pressurized fluid source to the body. The valve assembly is configured to selectively discharge the pressurized fluid from the pressurized fluid source when moving the shuttle to the second position and the piercing element to the retracted position, or when moving the shuttle to the first position and the piercing element to the extended position. The valve assembly includes a biasing mechanism configured to bias the shuttle toward the first position when in the second position.

[0007] Any of the valve assemblies described herein may include any of the following features. The pressurized fluid from the pressurized fluid source is configured to bias the shuttle toward the first position when in the second position. The valve assembly is configured to selectively prevent delivery of the pressurized fluid from the pressurized fluid source to the housing when moving the shuttle from the second position to the first position and the piercing element to the extended position.

[0008] According to a further example, a method for delivering fluid from a medical device includes moving a shuttle relative to a valve body from a first position offset from a fluid source coupled to the valve body to a second position in contact with the fluid source, thereby discharging fluid into the valve body; directing fluid from the source to an inlet of the valve body based on the second position of the shuttle, wherein the pressure of the fluid is adjusted from a first pressure to a second pressure lower than the first pressure as it is directed through the inlet; directing fluid from the inlet to an outlet of the valve body based on the second position of the shuttle, wherein the outlet is in fluid communication with a delivery conduit of the medical device such that fluid at the second pressure is received in the delivery conduit; moving the shuttle relative to the valve body from the second position to the first position, wherein the shuttle is configured to continue discharging fluid into the valve body when in the first position; and preventing fluid from flowing into the outlet of the valve body based on the first position of the shuttle, such that fluid at the first pressure and the second pressure is maintained within the valve body.

[0009] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention described in the claims. As used herein, the term "comprises," "comprising," or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "diameter" may refer to the width in cases where the element is not circular. The term "upper" refers to the direction or side of the device with respect to the orientation during use, and the term "bottom" refers to the opposite of "upper," the direction or side of the device with respect to the orientation during use. The term "exemplary" is used in the sense of "example" rather than "ideal." The term "about" or similar terms (e.g., "substantially") includes values within + / - 10% of the stated value.

Brief Description of the Drawings

[0010] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

Figure 5C

Figure 6A

Figure 6B

Figure 6C

Figure 7

Figure 8

[0011] Embodiments of the present disclosure relate to a dispensing device having a valve assembly for selectively discharging a pressurized fluid for delivering a drug (e.g., a powder drug) to a site of a medical treatment. The valve assembly may include a movable piercing element for actuating a source of pressurized medium (e.g., a gas canister) from which the pressurized fluid (e.g., a gas) can be discharged before encountering the drug. The drug is housed within the housing of the dispensing device and may be in fluid communication with the pressurized fluid via an outlet of the valve assembly. Thus, when the pressurized fluid is selectively discharged from the pressurized fluid source by the valve assembly, the pressurized fluid moves toward the outlet, enters the housing, and can agitate the drug before being delivered to the target site of the medical treatment. Aspects of the dispensing device and the valve assembly, such as the movable piercing element and the outlet, can promote fluidization of the drug by the flow of the pressurized fluid prior to delivery of the drug, thereby assisting in selectively controlling the flow of the pressurized fluid to prevent or minimize clogging during delivery.

[0012] Figure 1 shows a delivery system 10, which may be a powder delivery system. The delivery system 10 may include a handle body 12. The handle body 12 may include (or be configured to receive) a housing 14 (or other source or container) that stores a material (e.g., a powdered medicament). The housing 14 may be coupled to the handle body 12 to provide the medicament to the handle body 12, or the lid / housing of the medicament may be screwed onto or coupled to the housing 14 to supply the medicament to the housing 14. The medicament may be a powdered medicament such as a hemostatic agent, for example. The medicament may alternatively be another type of medicament or material, or a form of medicament (e.g., a liquid or gel medicament), and may have any desired function. The housing 14 may be removably attached to other components of the delivery system 10, including components of the handle body 12.

[0013] The body 12 can have various features described in further detail herein. U.S. Patent Application No. 16 / 589,633, filed on October 1, 2019 and published as U.S. Patent Application Publication No. 2020 / 0100986 on April 2, 2022, discloses exemplary features of delivery devices and systems, the disclosure of which is incorporated herein by reference in its entirety. The features of the present disclosure can be combined with any of the features described in the application referenced above. The features described herein may be used alone or in combination and are not mutually exclusive. Similar reference numbers and / or terms are used, where possible, to indicate similar structures.

[0014] Continuing to refer to FIG. 1, the delivery system 10 may include an actuating mechanism 30 used to actuate a flow of pressurized fluid (e.g., gas) from a source of pressurized medium in fluid communication with the delivery system 10. The actuating mechanism 30 can be selectively actuated (e.g., manually depressible), moved, or actuated in other ways to control the delivery of material (e.g., powdered drug) and pressurized fluid. Only the pressurized fluid, or a combination of the powdered drug and the fluid, can be delivered from the outlet 34 of the handle body 12. The outlet 34 can be in fluid communication with a catheter 36 or another component to deliver the combination of drug and fluid to a desired location within the body lumen of a patient.

[0015] FIG. 2 shows an exemplary valve assembly 100. The valve assembly 100 is housed within the handle body 12 of the delivery system 10 and can be selectively actuated by the actuating mechanism 30. In this example, the actuating mechanism 30 may include a trigger 32 that can be actuated by a user of the delivery system 10, such as by manually operating the trigger 32. Although not shown, the actuating mechanism 30 may include one or more other actuating elements, such as buttons, sliders, levers, knobs, dials, and various other suitable actuators. The delivery system 10 may include a cam 40 pivotally coupled to the trigger 32 of the actuating mechanism 30 and the valve assembly 100. As described herein, actuation of the trigger 32 provides a corresponding movement of the cam 40 relative to at least a portion of the valve assembly 100, thereby controlling the delivery of pressurized fluid through the valve assembly 100.

[0016] The valve assembly 100 can include a valve body 102 having a first end 104, a second end 106, and an intermediate portion 108 positioned between the first end 104 and the second end 106. The first end 104 can include a first opening 105 (see FIG. 4) configured to interface with a pressurized media source, such as a storage device 50 (e.g., a canister). That is, the first opening 105 can define an inlet for receiving pressurized fluid from the storage device 50. The second end 106 can include a second opening 107. The valve assembly 100 can further include a movable shuttle 120 (see FIG. 4) disposed within the valve body 102, the movable shuttle 120 having a first end 124 and a second end 126 opposite the first end 124. In this example, at least a portion of the movable shuttle 120, such as the second end 126, can extend outwardly from the second end 106 through the opening 107 and interface with a cam 40. As described below, actuation of the actuation mechanism 30 (e.g., via a trigger 32) can provide for the release of at least a portion of the pressurized fluid from the storage device 50 via a corresponding movement of the movable shuttle 120 relative to the valve body 102.

[0017] Continuing to refer to FIG. 2, the valve assembly 100 may include an adapter 140, and the intermediate portion 108 may be configured to couple the valve body 102 to the adapter 140. The adapter 140 may be configured to fluidly couple the regulator 60 to the valve body 102. In other embodiments, the adapter 140 may be completely omitted such that the regulator 60 can be directly coupled to the valve body 102, such as along the intermediate portion 108. The regulator 60 may be configured to adjust the amount of pressurized fluid released from the storage device 50 at a particular pressure. For example, the regulator 60 may be a two-stage regulator, or the regulator 60 may include two single-stage regulators, such as two piston regulators arranged in series. The valve assembly 100 can fluidly couple the storage device 50 to the regulator 60 when the storage device 50 is attached to the adapter 140. The regulator 60 can reduce the pressure of the pressurized fluid (e.g., gas) from the storage device 50 to an acceptable outlet pressure, i.e., the pressure of the gas and any material (e.g., powder agent) delivered from the outlet 34.

[0018] In some embodiments, the pressure of the gas within the delivery system 10 after being received within the regulator 60 may be pre-determined based on the target site (e.g., tissue) within the patient to which the gas and agent are to be administered. Alternatively or additionally, the pressure of the gas controlled by the regulator 60 may be determined based at least in part on the pressure necessary to mix and / or agitate the powdered agent stored within the housing 14. For example, the regulator 60 may be able to reduce the pressure of the pressurized fluid to about 50 - 150 pounds per square inch ("PSI") (about 344.7 - 1034 kPa), more specifically to about 20 - 30 PSI (about 137.9 - 206.8 kPa). The pressure of the fluid exiting the regulator 60 may be approximately equal to the pressure of the fluid exiting the body 12 at the outlet 34 (FIG. 1). Alternatively, the pressure of the fluid at the outlet 34 may be different from the pressure of the fluid exiting the regulator 60. In some embodiments, the dispensing system 10 may include a rupture valve or a safety valve along the fluid path downstream of the regulator 60 and upstream of the outlet 34, which can rupture or release if the pressure of the fluid from the regulator 60 exceeds a predetermined threshold.

[0019] Continuing to refer to FIG. 2, the regulator 60 may include an opening 62 configured to discharge the pressurized fluid received therein from the valve assembly 100. Stated another way, the opening 62 can communicate with the atmospheric pressure within the body 12 to facilitate pressure control of the fluid released from the storage device 50. In some embodiments, the fluid may be released to atmospheric pressure within the handle body 12. In other embodiments, the handle body 12 may include a fluid connection and / or an opening extending outside of the handle body 12 for discharging the pressurized fluid.

[0020] The valve assembly 100 may include an outlet port 110 on the valve body 102, such as along the intermediate portion 108. Although not shown, it should be understood that a tube and / or other suitable device may be coupled to the outlet port 110 to connect the outlet port 110 to one or more components of the delivery system 10 that are in fluid communication with the outlet 34. Thus, the outlet port 110 can be in fluid communication with the outlet 34 to facilitate delivering the pressurized fluid received from the regulator 60 to the catheter 36 via the tube.

[0021] Referring now to FIG. 3, the intermediate portion 108 can include an inlet connector 112 and an outlet connector 114. In some embodiments, one or more of the connectors 112, 114 may be coupled to respective portions of the valve body 102, such as the intermediate portion 108, while in other embodiments, the connectors 112, 114 may be integrated with the valve body 102 and, for example, the intermediate portion 108. Each of the inlet connector 112 and the outlet connector 114 can be in fluid communication with respective internal conduits of the valve body 102 (see FIG. 4). Further, each of the inlet connector 112 and the outlet connector 114 may be configured to fluidly couple the respective internal conduits of the valve body 102 to corresponding channels of the adapter 140 such that the valve body 102 can be in fluid communication with the regulator 60 via the inlet connector 112 and the outlet connector 114 when the regulator 60 is coupled to the adapter 140.

[0022] As best shown in FIG. 4, each of the inlet connector 112 and the outlet connector 114 may include one or more gaskets 115 (e.g., seals, O-rings, etc.) to form a fluid-tight seal between the adapter 140 and the valve body 102. The valve body 102 may include an inner channel 101 that extends between a first end 104 and a second end 106. In this example, the inner channel 101 can have a longitudinal length that extends between a first opening 105 at the first end 104 and a second opening 107 at the second end 106. The valve body 102 may further include a first (outlet) conduit 111 and a second (inlet) conduit 113 that extend from the inner channel 101 through an intermediate portion 108. In other words, the first (outlet) conduit 111 and the second (inlet) conduit 113 may be in fluid communication with the inner channel 101.

[0023] The first (outlet) conduit 111 can provide an outlet from the inner channel 101 and may be fluidly coupled to the inlet channel 142 of the adapter 140 via the inlet connector 112. The second (inlet) conduit 113 can provide an inlet to the inner channel 101 and may be fluidly coupled to the outlet channel 144 of the adapter 140 via the outlet connector 114. Each of the first (outlet) conduit 111 and the second (inlet) conduit 113 may be angled (e.g., laterally) with respect to the central longitudinal axis of the inner channel 101 which may be parallel to the longitudinal length of the valve body 102. As detailed below and shown in FIG. 5B, high-pressure fluid A received by the valve assembly 100 (e.g., from the storage device 50) can be directed into the regulator 60 via a first fluid path at least partially defined by the inner channel 101, the first (outlet) conduit 111, the inlet connector 112, and the inlet channel 142. Further, as shown in FIGS. 5B and 5C, low-pressure fluid B exiting the regulator 60 (from and converted / regulated with respect to high-pressure fluid A) can be directed into the valve assembly 100 via a second fluid path at least partially defined by the outlet channel 144, the outlet connector 114, the second (inlet) conduit 113, and the inner channel 101.

[0024] Continuing to refer to FIG. 4, the inner channel 101 can be at least partially defined by a ledge 103 that extends radially inwardly toward the central longitudinal axis of the inner channel 101 (extending parallel to the longitudinal length of the valve body 102). As described herein, the ledge 103 may be sized, shaped, and / or configured to engage at least a portion of the movable shuttle 120 within the inner channel 101, such as a lateral protrusion or flange 123. In this example, the ledge 103 may be disposed relatively closer to the first end 104 than to the second end 106, and the inner channel 101 can have a diameter that varies along the longitudinal length of the valve body 102. For example, the inner channel 101 may have a first diameter along a portion extending between the ledge 103 and the first end 104, and the first diameter may be larger than a second diameter along another portion extending between the ledge 103 and the second end 106. Thus, the ledge 103 can define an interface surface within the valve body 102 where the first diameter of the inner channel 101 transitions to the second diameter.

[0025] As detailed herein, the inner channel 101 may be sized, shaped, and / or configured to receive the biasing mechanism 136 of the valve assembly 100. For example, the inner channel 101 can receive the biasing mechanism 136 within a portion of the inner channel 101 having a larger first diameter between the ledge 103 and the first end 104. As shown in FIG. 4, the biasing mechanism 136 can be a helical spring. The first opening 105 can include a threaded portion along an inner surface that defines the first opening 105. The threaded portion can be configured to engage or mate with a corresponding threaded portion along the outer surface of the neck 52 of the storage device 50, which can help facilitate the connection between the valve body 102 and the storage device 50. Thus, the storage device 50 can be rotatably coupled to the valve assembly 100 at the first end 104.

[0026] Continuing to refer to FIG. 4, the movable shuttle 120 can be slidably received within the inner channel 101 of the valve body 102. The movable shuttle 120 can include a shuttle body 122 having a longitudinal length defined between a first end 124 and a second end 126 opposite the first end 124. The movable shuttle 120 may have a size and shape corresponding to the cross-sectional dimensions of the inner channel 101. In this example, the shuttle body 122 may have a generally cylindrical shape having a diameter smaller than the diameter of the inner channel 101. Accordingly, the outer surface of the shuttle body 122 can be offset from and / or separated from contact with the inner surface of the valve body 102 that defines the inner channel 101. Thus, the movable shuttle 120 may be configured to move (e.g., translate, rotate) relative to the valve body 102 within the inner channel 101. As described herein, the movable shuttle 120 may be operable to move between a plurality of positions relative to the valve body 102 to transition the valve assembly 100 between corresponding plural configurations.

[0027] The movable shuttle 120 may include one or more recesses and / or cavities formed along the longitudinal length of the shuttle body 122 to receive at least one gasket (e.g., a seal, an O-ring, etc.). In this example, the movable shuttle 120 may include three recesses along the shuttle body 122 between a first end 124 and a second end 126, and corresponding first gasket 128A, second gasket 128B, and third gasket 128C are received within each recess. The first gasket 128A may be disposed in a first recess 127A along the shuttle body 122 proximate the first end 124 relative to the second gasket 128B and the third gasket 128C. The second gasket 128B may be disposed in a second recess 127B along the shuttle body 122 between the first gasket 128A and the third gasket 128C. The third gasket 128C may be disposed in a third recess 127C along the shuttle body 122 proximate the second end 126 relative to the first gasket 128A and the second gasket 128B. It should be understood that the valve assembly 100 may include additional and / or fewer gaskets and corresponding recesses without departing from the scope of the present disclosure.

[0028] As shown in FIG. 4, each of the first gasket 128A, the second gasket 128B, and the third gasket 128C may have a size and / or shape such that it has a cross-sectional dimension extending radially outward from the corresponding recesses 127A, 127B, 127C on the shuttle body 122. As a result, the gaskets 128A, 128B, 128C may be configured to interface with the inner surface of the valve body 102 that defines the inner channel 101. In other words, the gaskets 128A, 128B, 128C are sized to fit within the corresponding recesses 127A, 127B, 127C such that at least a portion of each gasket 128A, 128B, 128C can extend out of the respective recesses 127A, 127B, 127C and are at least partially larger than the corresponding recesses 127A, 127B, 127C. As described herein, the gaskets 128A, 128B, 128C may be configured to abut against the inner surface of the valve body 102, such as the inner wall of the inner channel 101, to form a fluid seal at three respective locations within the inner channel 101. The valve assembly 100 may be configured to control the fluid flow path of the pressurized fluid released from the storage device 50 and received within the valve body 102 in response to the corresponding positions of the movable shuttle 120 relative to the inner channel 101, particularly the corresponding positions of the gaskets 128A, 128B, 128C.

[0029] The movable shuttle 120 may include a flange 123 proximate to the first end 124 relative to the second end 126. The flange 123 may have a size and shape with a diameter smaller than the first diameter of the inner channel 101 between the ledge 103 and the first end 104. Thus, the flange 123 may be offset and / or separated from contact with the inner surface of the valve body 102 that defines the inner channel 101. Further, the diameter of the flange 123 may be larger than the second diameter of the inner channel 101 between the ledge 103 and the second end 106. Thus, when the movable shuttle 120 moves upward in FIG. 4 toward the second end 106, the flange 123 can abut against and contact the ledge 103 within the inner channel 101.

[0030] Thus, the valve body 102 may be configured to limit the movement of the movable shuttle 120 relative to the valve body 102 within the inner channel 101 when the flange 123 engages the ledge 103. The biasing mechanism 136 may be received within a portion of the inner channel 101 between the ledge 103 and the first end 104. The biasing mechanism 136 may be disposed around a portion of the shuttle body 122, such as along the first end 124, and one end of the biasing mechanism 136 is disposed relative to the flange 123. The biasing mechanism 136 may be configured to bias the movable shuttle 120 upwardly relative to the valve body 102 in the direction of FIG. 4. For example, the biasing mechanism 136 may be configured to apply an upward force to the flange 123, thereby biasing the movable shuttle 120 upwardly.

[0031] Continuing to refer to FIG. 4, the movable shuttle 120 may include a closed channel 125 within the shuttle body 122. In this example, the closed channel 125 may extend from the opening 121 at the first end 124 toward the second end 126. The closed channel 125 may terminate within the shuttle body 122, for example, at a location proximate the location of the first recess 127A. The size, shape, and longitudinal length of the closed channel 125 may correspond to the size, shape, and length of the piercing element 130 of the valve assembly 100 received therein.

[0032] The piercing element 130 can have a longitudinal length defined between a front end 132 and a rear end 134. The piercing element 130 can be configured to move relative to the shuttle body 122 of the movable shuttle 120 within the closed channel 125, for example, between one or more of a plurality of positions. The piercing element 130 can be configured to move relative to the valve body 102 within the inner channel 101, together with the movable shuttle 120 and the like. As described herein, in at least a first position relative to the shuttle body 122, the piercing element 130 can move simultaneously with the movable shuttle 120, while in at least a second position relative to the shuttle body 122, the piercing element 130 can move independently of the movable shuttle 120.

[0033] In some examples, the piercing element 130, for example, a portion of the front end 132, can include a lance and / or a needle. The front end 132 of the piercing element 130 can define a sharp tip configured to pierce one or more components of the delivery system 10 (FIG. 1), such as the seal 54 of the storage device 50. The rear end 134 of the piercing element 130 can define a bulbous tip configured to interface with the inner surface of the shuttle body 122 that defines the closed channel 125, such that the rear end 134 interfaces with the closed channel 125 to form a frictional resistance within the shuttle body 122 and maintain the piercing element 130 within the movable shuttle 120.

[0034] Continuing to refer to FIG. 4, the biasing mechanism 136 may abut against the bottom surface of the flange 123 and the upper surface of the neck 52 of the storage device 50 when the storage device 50 is coupled to the valve body 102. When the actuating mechanism 30 is not actuated, the biasing mechanism 136 can bias (e.g., apply a force to) the movable shuttle 120 to a position relatively upward through the inner channel 101, away from the first end 104 and toward the second end 106. As will be described below, the biasing mechanism 136 transitions from a first (extended) configuration to a second (compressed) configuration in response to actuation of the actuating mechanism 30 and can return from the second configuration to the first configuration when the actuating mechanism 30 is released.

[0035] FIGS. 5A-5C illustrate an exemplary use of the delivery system 10. As shown in FIG. 5A, the valve assembly 100 is in a first configuration, the movable shuttle 120 is in a first position relative to the valve body 102, and the piercing element 130 is in a first position relative to the shuttle body 122. For example, when a downward (longitudinal) force is not applied to the movable shuttle 120 (e.g., by the cam 40 (FIG. 2) from actuation of the actuating mechanism 30) against the second end 126, the upward (longitudinal) force applied by the biasing mechanism 136 against the first end 124 can bias the movable shuttle 120 upward to the first position relative to the valve body 102. In this case, the biasing mechanism 136 may be in a first (extended) configuration and can maintain the shuttle body 122 in the first position until an opposing downward force greater than the upward force of the biasing mechanism 136 is applied to the movable shuttle 120 (e.g., by the cam 40).

[0036] In the first position of the movable shuttle 120, the shuttle body 122 can be positioned at its upward-most extent relative to the valve body 102 such that the flange 123 engages the ledge 103 within the inner channel 101. In this position, the second end 126 of the movable shuttle 120 may extend outwardly from the second end 106 of the valve body 102 (through the second opening 107) to its upward-most extent. In the first configuration of the valve assembly 100, the first gasket 128A may be positioned between the first (outlet) conduit 111 and the second (inlet) conduit 113, the second gasket 128B may be positioned between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may be positioned between the outlet port 110 and the second opening 107. Thus, the second gasket 128B may be arranged to prevent fluid communication between the second (inlet) conduit 113 and the outlet port 110. Although not shown, the cam 40 (FIG. 2) may abut the second end 126 when the movable shuttle 120 is in the first position.

[0037] In the first position of the piercing element 130, the piercing element 130 may be positioned at its upward-most extent relative to the shuttle body 122 such that the rear end 134 abuts the end of the closed channel 125. In this position, the piercing element 130 may be received within the shuttle body 122 and the front end 132 may extend at least partially outwardly from the closed channel 125 through the opening 121. In other words, when the piercing element 130 is in the first position, the front end 132 may be exposed from the shuttle body 122. The front end 132 may be spaced from the seal 54 when the movable shuttle 120 is in the first position and the piercing element 130 is in the first position. The movement of the movable shuttle 120 within the inner channel 101 can bring the front end 132 into contact with the seal 54 of the storage device 50. In the first configuration of the valve assembly 100, the seal 54 of the storage device 50 may remain intact such that the pressurized fluid stored therein can be maintained within the storage device 50.

[0038] Referring now to FIG. 5B, the valve assembly 100 can transition to a second configuration when the actuating mechanism 30 is actuated and the cam 40 moves. In this case, the movable shuttle 120 can move to a second position relative to the valve body 102, and the piercing element 130 can remain in a first position relative to the shuttle body 122. For example, actuation of the actuating mechanism 30 moves the cam 40 (FIG. 2) to engage the second end 126, thereby applying a downward (longitudinal) force to the movable shuttle 120 that is greater than the opposing upward force applied to the first end 124 by the biasing mechanism 136. In this case, the biasing mechanism 136 can transition to a second (compressed) configuration when the movable shuttle 120 moves downward to the second position relative to the valve body 102.

[0039] In the second position of the movable shuttle 120, the shuttle body 122 can be positioned at the downward-most extent relative to the valve body 102 such that the flange 123 is disengaged from the ledge 103. In this position, the second end 126 of the movable shuttle 120 may extend through the second end 106 of the valve body 102 (through the second opening 107) to its downward-most extent. When the valve assembly 100 is in the second configuration, the first gasket 128A and the second gasket 128B may be positioned between the first (outlet) conduit 111 and the second (inlet) conduit 113, and the third gasket 128C may be positioned between the outlet port 110 and the second opening 107. Thus, the second gasket 128B may be arranged to permit fluid communication between the second (inlet) conduit 113 and the outlet port 110.

[0040] Continuing to refer to FIG. 5B, at the first position of the piercing element 130, the piercing element 130 may remain in the uppermost range relative to the shuttle body 122 such that the rear end 134 continues to abut against the end of the closed channel 125. In this position, the piercing element 130 is maintained within the shuttle body 122, and the front end 132 extends at least partially outwardly from the closed channel 125 through the opening 121. With the front end 132 exposed from the shuttle body 122, the movement of the movable shuttle 120 within the inner channel 101 can bring the front end 132 into contact with the seal 54 of the storage device 50, thereby piercing the seal 54. Thus, in the second configuration of the valve assembly 100, the seal 54 of the storage device 50 can be permanently deformed such that the high-pressure fluid A stored therein is released into the valve body 102 and received within the inner channel 101. At the second position, the first end 124 is spaced from the seal 54, allowing the high-pressure fluid A to exit the storage device 50 and enter the inner channel 101. The seal 54 may include a deformable barrier disposed to cover the opening of the storage device 50 at the end of the neck 52. The seal 54 may be at least partially flexible and may be configured to be perforated and / or pierced when encountering a sharp object such as the front end 132 of the piercing element 130.

[0041] The high-pressure fluid A discharged from the storage device 50 can move along the first fluid path through the inner channel 101 until it encounters the first gasket 128A disposed relatively downstream (i.e., above in FIG. 5B) of the first (outlet) conduit 111. The first gasket 128A may be configured to prevent the high-pressure fluid A from flowing beyond the location of the first gasket 128A with respect to the inner channel 101 (upward in FIG. 5B). Thus, the first gasket 128A can redirect the high-pressure fluid A to the regulator 60 via the first (outlet) conduit 111 and the inlet channel 142 of the adapter 140. After passing through the regulator 60, the low-pressure fluid B can move along the second fluid path through the outlet channel 144 of the adapter 140 and the second (inlet) conduit 113 until it exits the regulator 60 (coupled to the adapter 140) and enters the inner channel 101.

[0042] Continuing to refer to FIG. 5B, with the movable shuttle 120 in the second position and the second gasket 128B and the third gasket 128C disposed on the opposite side of the second (inlet) conduit 113, the low-pressure fluid B can enter the inner channel 101 between the second gasket 128B and the third gasket 128C. Thus, the second gasket 128B may be configured to prevent the low-pressure fluid B from flowing beyond the location of the second gasket 128B with respect to the inner channel 101 (downward), and the third gasket 128C may be configured to prevent the low-pressure fluid B from flowing beyond the location of the third gasket 128B with respect to the inner channel 101 (above in FIG. 5B). With the outlet port 110 positioned between the second gasket 128B and the third gasket 128B, the pair of gaskets 128B, 128C can cooperate to redirect the low-pressure fluid B to the outlet port 110 for delivery toward the catheter 36 (FIG. 1).

[0043] Referring now to FIG. 5C, the valve assembly 100 can transition to a third configuration when the actuating mechanism 30 is released. In this case, the movable shuttle 120 can move to a third position relative to the valve body 102, and the piercing element 130 can move to a second position relative to the shuttle body 122. In some examples, the third position of the movable shuttle 120 may be substantially similar to the first position (FIG. 5A), and by releasing the actuating mechanism 30, the movable shuttle 120 can be returned to the first position. For example, by stopping the actuation of the actuating mechanism 30, the cam 40 can be moved away from the movable shuttle 120, thereby releasing the engagement of the second end 126. In this case, the biasing mechanism 136 can return to a first (extended) configuration in which an upward (longitudinal) force applied by the biasing mechanism 136 against the first end 124 can move the movable shuttle 120 upward (through the inner channel 101) relative to the valve body 102.

[0044] In the third position of the movable shuttle 120, the shuttle body 122 can be repositioned to the uppermost extent relative to the valve body 102 such that the flange 123 engages the ledge 103. In this position, the second end 126 of the movable shuttle 120 may extend through the second end 106 of the valve body 102 (through the second opening 107) to its uppermost extent. When the valve assembly 100 is in the third configuration, the first gasket 128A may remain between the first (outlet) conduit 111 and the second (inlet) conduit 113, the second gasket 128B may be repositioned between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may remain between the outlet port 110 and the second opening 107. Thus, the second gasket 128B may be positioned to prevent fluid communication between the second (inlet) conduit 113 and the outlet port 110.

[0045] Continuing to refer to FIG. 5C, at the second position of the piercing element 130, the piercing element 130 may be positioned in the lowermost range relative to the shuttle body 122 such that the rear end 134 is offset from and / or separated from the end of the closed channel 125. In this position, the piercing element 130 is at least partially maintained within the shuttle body 122, and the front end 132 extends outwardly from the closed channel 125 at the first end 124. With the piercing element 130 being able to move independently of the movable shuttle 120, when the movable shuttle 120 moves from the second position to the third position within the inner channel 101, the front end 132 may remain in contact with the seal 54. Thus, the piercing element 130 may be configured to keep the seal 54 in an open state.

[0046] It should be understood that malfunctions of the dispensing system 10, such as those caused by the movable shuttle 120 becoming immovable at the second (lowermost) position due to the engagement between the front end 132 and the seal 54, can be minimized by the independent movement of the movable shuttle 120 and the piercing element 130. Thus, the valve assembly 100 can help prevent the unintentional release of the low-pressure fluid B from the dispensing system 10, such as that caused by the movable shuttle 120 becoming immovable at the second position when the actuating mechanism 30 is in a non-operating state.

[0047] Thus, in the third configuration of the valve assembly 100, the front end 132 may remain extending through the seal 54 such that the high-pressure fluid A stored in the storage device 50 can continue to be released into and received within the valve body 102 and then within the inner channel 101. In other words, the valve body 102 may remain in fluid communication with the storage device 50 when the actuating mechanism 30 is released. In an example where the piercing element 130 moves away from (upward in FIGS. 5A - 5C) the storage device 50 in response to the movable shuttle 120 moving upward, it should be understood that the seal 54 may remain permanently deformed such that the high-pressure fluid A continues to be released despite the retraction of the front end 132 from the seal 54.

[0048] The high-pressure fluid A discharged from the storage device 50 can move along the first fluid path through the inner channel 101 until it encounters the first gasket 128A located relatively above the first (outlet) conduit 111. The first gasket 128A may be configured to prevent the high-pressure fluid A from flowing beyond the location of the first gasket 128A with respect to the inner channel 101 (upward in FIGS. 5A-5C). Thus, the first gasket 128A can redirect the high-pressure fluid A through the first (outlet) conduit 111 and the inlet channel 142 of the adapter 140 to the regulator 60. When the pressure of the high-pressure fluid A is reduced, the low-pressure fluid B can move along the second fluid path through the outlet channel 144 of the adapter 140 and the second (inlet) conduit 113 until it exits the regulator 60 and enters the inner channel 101.

[0049] Continuing to refer to FIG. 5C, with the movable shuttle 120 in the third position, the second gasket 128B may be located between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may remain between the outlet port 110 and the second opening 107. Thus, the second gasket 128B may be arranged to prevent fluid communication between the second (inlet) conduit 113 and the outlet port 110. Thus, the low-pressure fluid B can enter the inner channel 101 between the first gasket 128A and the second gasket 128B. The first gasket 128A may be configured to prevent the low-pressure fluid B from flowing beyond the location of the second gasket 128B with respect to the inner channel 101 (downward in FIG. 5C), and the second gasket 128B may be configured to prevent the low-pressure fluid B from flowing beyond the location of the second gasket 128B with respect to the inner channel 101 (upward). With the outlet port 110 located above the second gasket 128B, the second gasket 128B can help fluid-tightly seal the outlet port 110 and prevent the delivery of the low-pressure fluid B toward the catheter 36.

[0050] It should be understood that the valve assembly 100 may be operable to provide consistent control and operation of the dispensing system 10 by requiring substantially the same force to operate the actuating mechanism 30 regardless of the current configuration of the valve assembly 100 (e.g., the first configuration of FIG. 5A, the second configuration of FIG. 5B, and the third configuration of FIG. 5C). Whether high-pressure fluid A and / or low-pressure fluid B is stored in one or more portions of the valve body 102 such as the inner channel 101, the valve assembly 100 moves the movable shuttle 120 (e.g., downwardly toward the storage device 50), and the force required to distribute the pressurized fluid to the outlet port 110 is substantially constant. The opposing force applied to the movable shuttle 120 (e.g., upwardly away from the storage device 50, by the high-pressure fluid A and / or the low-pressure fluid B) can be reduced and / or minimized.

[0051] Referring now to FIGS. 6A-6C, another exemplary embodiment of the valve assembly 200 is shown. The valve assembly 200 may be configured similarly to the valve assembly 100, except for the differences explicitly described herein, and thus, similar reference numerals are used to identify similar components. The valve assembly 200 is housed within the body 12 of the delivery system 10 and can be selectively actuated by an actuating mechanism 30 (see FIG. 1).

[0052] Referring specifically to FIG. 6A, the valve assembly 200 can include a valve body 202 having a first end 204 and a second end 206. The first end 204 may include a first opening 205 configured to interface with a pressurized media source such as the storage device 50. For example, the first opening 205 may include a threaded portion for engaging or coupling with the threaded portion of the neck 52 along the inner surface defining the first opening 205. Thus, the storage device 50 can be rotatably coupled to the valve assembly 200 at the first end 204. The second end 206 may include a second opening 207.

[0053] The valve body 202 may include an inner channel 201 extending between the first end 204 and the second end 206, an outlet port 110 extending from the inner channel 101, a first (outlet) conduit 111, and a second (inlet) conduit 113. Thus, the outlet port 110, the first (outlet) conduit 111, and the second (inlet) conduit 113 may be in fluid communication with the inner channel 201. The valve body 202 may further include a cavity 208 disposed adjacent to the inner channel 101, and the cavity 208 is sized, shaped, and / or configured to receive a locking mechanism 210. The locking mechanism 210 may include a protrusion movably coupled within the valve body 202, such as around a tab, claw, beam, and / or pin. The locking mechanism 210 may be configured to transition from a retracted position (FIG. 6A) to an extended configuration (FIG. 6C) within the cavity 208.

[0054] In some embodiments, the locking mechanism 210 may be biased toward the extended configuration, for example, by a biasing mechanism coupled thereto. In other embodiments, the locking mechanism 210 may be selectively movable between the retracted and extended configurations. As will be described in detail herein, the locking mechanism 210 may be configured to extend out of the cavity 208 and into the inner channel 201 to engage one or more components of the valve assembly 200.

[0055] Continuing to refer to FIG. 6A, the valve assembly 200 may further include a first movable shuttle 220 and a second movable shuttle 230 disposed within the valve body 202. In this example, the first movable shuttle 220 can have a longitudinal length defined between a first end 222 and a second end 224, and the second movable shuttle 230 can have a longitudinal length defined between a first (lower) end 232 and a second (upper) end 234. Each of the first movable shuttle 220 and the second movable shuttle 230 may be sized, shaped, and / or configured to be received within the inner channel 201. In this example, the first movable shuttle 220 may be disposed relatively above the second movable shuttle 230 within the inner channel 201, such that the first movable shuttle 220 is disposed proximate to the second end 206 (relative to the second movable shuttle 220), and the second movable shuttle 230 can be disposed proximate to the first end 204 (relative to the first movable shuttle 220).

[0056] The first end 222 of the first movable shuttle 220 may be configured to interface with the second end 234 of the second movable shuttle 230, and the second end 224 of the first movable shuttle 220 may extend outwardly from the second end 206 through the opening 207 and interface with a cam 40 (FIG. 2). The first end 232 of the second movable shuttle 230 may be coupled to the piercing element 130, and the second end 234 of the second movable shuttle 230 may be configured to interface with the first end 222 of the first movable shuttle 220. In this example, the piercing element 130 may be fixed relative to the second movable shuttle 230. The valve assembly 200 may further include a biasing mechanism 226 disposed around at least a portion of the first movable shuttle 220. In this example, the biasing mechanism 226 may be coupled to the first movable shuttle 220 proximate to the second end 224 and may be located outside the inner channel 201.

[0057] Continuing to refer to FIG. 6A, one end of the biasing mechanism 226 may be disposed relative to the second end 206 of the valve body 202, and the opposite end of the biasing mechanism 236 may be disposed relative to the second end 224. In this example, the second end 224 may have a larger cross-sectional dimension and / or may define a widened portion relative to the first movable shuttle 220. Thus, the biasing mechanism 226 may be configured to abut against the widened portion of the second end 224. The biasing mechanism 236 may be configured to bias the first movable shuttle 220 upward relative to the valve body 202 in response to applying an upward force to the second end 224. It should be understood that the first movable shuttle 220 and the second movable shuttle 230 may be coupled to each other along the interface between the first end 222 and the second end 234 when the valve assembly 200 is in the first configuration shown in FIG. 6A.

[0058] In some embodiments, the first movable shuttle 220 and the second movable shuttle 230 may be coupled to each other via frictional engagement with each other and / or frictional engagement with the inner surface defining the inner channel 201. In other embodiments, the first movable shuttle 220 and the second movable shuttle 230 may be coupled to each other by an adhesive disposed along the interface between the first end 222 and the second end 234. It should be understood that the first movable shuttle 220 and the second movable shuttle 230 may be coupled to each other by various other suitable means without departing from the scope of the present disclosure.

[0059] The first movable shuttle 220 and the second movable shuttle 230 may include one or more recesses and / or cavities formed along the respective longitudinal lengths of the first movable shuttle 220 and the second movable shuttle 230 to receive at least one gasket (e.g., a seal, an O-ring, etc.). In this example, the second movable shuttle 230 may include a first recess 127A between a first end 232 and a second end 234, and a corresponding first gasket 128A is received within the first recess 127A. The first movable shuttle 220 may include a second recess 127B and a third recess 127 between a first end 222 and a second end 224, and corresponding second gaskets 128B and third gaskets 128C are received within each respective recess.

[0060] In an exemplary use, the valve assembly 200 may be in a first configuration as shown in FIG. 6A, where the first movable shuttle 220 and the second movable shuttle 230 are each in a respective first position relative to the valve body 202. When a downward (longitudinal) force is not applied to the first movable shuttle 220 (e.g., by the cam 40 to the second end 224), the upward (longitudinal) force applied by the biasing mechanism 236 to the second end 224 can move the first movable shuttle 220 and the second movable shuttle 230 upward to the first position relative to the valve body 202. In this case, the biasing mechanism 236 may be in a first (extended) configuration and can maintain the first movable shuttle 220 and the second movable shuttle 230 in the first position until an opposing downward force greater than the upward force of the biasing mechanism 236 is applied thereto.

[0061] In the first position, each of the first movable shuttle 220 and the second movable shuttle 230 may be disposed in the uppermost range with respect to the valve body 202. In this position, the second end 224 may extend outwardly from the second end 206 of the valve body 202 (through the second opening 207) to its uppermost range. In the first configuration of the valve assembly 200, the first gasket 128A may be located between the first (outlet) conduit 111 and the second (inlet) conduit 113, the second gasket 128B may be located between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may be located between the outlet port 110 and the second opening 207. Thus, the second gasket 128B may be arranged to block fluid communication between the second (inlet) conduit 113 and the outlet port 110.

[0062] Continuing to refer to FIG. 6A, in the first position of the second movable shuttle 230, the piercing element 130 may be disposed in the uppermost range with respect to the valve body 202. In this position, the piercing element 130 may be offset from and / or separated from contact with the seal 54. In a state where the piercing element 130 is coupled to the first end 232 of the second movable shuttle 230, the movement of the movable shuttle, specifically, the second movable shuttle 230, can bring the piercing element 130 into contact with the seal 54. In the first configuration of the valve assembly 200, the seal 54 of the storage device 50 may remain intact so that the pressurized fluid stored therein can be maintained within the storage device 50.

[0063] When in the first configuration of the valve assembly 200, the second movable shuttle 230 may be in a first position where the locking mechanism 210 is prevented from extending radially outward from the cavity 208 by the second movable shuttle 230 and inside the inner channel 201. In other words, the second movable shuttle 230 may overlap the cavity 208 when in the first position such that the locking mechanism 210 is maintained in a retracted position within the cavity 208, thereby enabling the second movable shuttle 230 to move through the inner channel 201.

[0064] Referring now to FIG. 6B, the valve assembly 200 (e.g., the first movable shuttle 220 and the second movable shuttle 230) can transition to the second configuration when the actuating mechanism 30 is actuated. In this case, the first movable shuttle 220 and the second movable shuttle 230 can each move to their respective second positions relative to the valve body 202. For example, actuation of the actuating mechanism 30 moves the cam 40 to engage the second end 224, thereby applying a downward (longitudinal) force to the first movable shuttle 220 that is greater than the opposing upward force applied to the second end 224 by the biasing mechanism 236. In this case, the biasing mechanism 236 can transition to a second (compressed) configuration when the first movable shuttle 220 and the second movable shuttle 230 move downward to the second position relative to the valve body 202.

[0065] In the second position, each of the first movable shuttle 220 and the second movable shuttle 230 may be disposed in the lowermost range relative to the valve body 202. When the valve assembly 200 is in the second configuration, the first gasket 128A and the second gasket 128B may be positioned between the first (outlet) conduit 111 and the second (inlet) conduit 113, and the third gasket 128C may be positioned between the outlet port 110 and the second opening 207. Accordingly, the second gasket 128B may be arranged to allow fluid communication between the second (inlet) conduit 113 and the outlet port 110.

[0066] Continuing to refer to FIG. 6B, in the second position of the second movable shuttle 230, the piercing element 130 can move simultaneously to the lowest range relative to the valve body 202 such that the piercing element 130 contacts and pierces the seal 54. Thus, in the second configuration of the valve assembly 200, the seal 54 of the storage device 50 can be permanently deformed so that the high-pressure fluid A stored therein is released into the valve body 202 and received within the inner channel 201. It should be understood that the high-pressure fluid A can push the movable shuttle when released from the storage device 50. As an exemplary example, the high-pressure fluid A ranges from about 800 PSI (about 5516 kPa) to 1000 PSI (about 6895 kPa), and a corresponding force of about 75 pounds (lbs.) (about 34.02 kg) to 90 lbs. (about 40.37 kg) can act on the second movable shuttle 230 and the first movable shuttle 220.

[0067] The high-pressure fluid A released from the storage device 50 can move along the first fluid path through the inner channel 201 until it encounters the first gasket 128A located relatively above the first (outlet) conduit 111. The first gasket 128A may be configured to help prevent the high-pressure fluid A from flowing (upward) beyond the location of the first gasket 128A relative to the inner channel 201. Thus, the first gasket 128A can redirect the high-pressure fluid A to the first (outlet) conduit 111 and the regulator 60. When the pressure of the high-pressure fluid A is reduced, the low-pressure fluid B can move along the second fluid path through the second (inlet) conduit 113 until it exits the regulator 60 and enters the inner channel 201.

[0068] Continuing to refer to FIG. 6B, with the first movable shuttle 220 and the second movable shuttle 230 in the second position and the second gasket 128B and the third gasket 128C disposed on the opposite side of the second (inlet) conduit 113, low-pressure fluid B can enter the inner channel 201 between the second gasket 128B and the third gasket 128C. Thus, the second gasket 128B may be configured to prevent low-pressure fluid B from flowing beyond (downward) the location of the second gasket 128B with respect to the inner channel 201, and the third gasket 128C may be configured to prevent low-pressure fluid B from flowing beyond (upward) the location of the third gasket 128B with respect to the inner channel 201. With the outlet port 110 located between the second gasket 128B and the third gasket 128B, the pair of gaskets 128B, 128C can cooperate to redirect low-pressure fluid B to the outlet port 110 for delivery toward the catheter 36.

[0069] When in the second configuration of the valve assembly 200, the second movable shuttle 230 may be in a second position where the locking mechanism 210 can freely extend radially outward from the cavity 208 and inside the inner channel 201 without encountering interference by the second movable shuttle 230. In other words, when the second movable shuttle 230 is in the second position such that the locking mechanism 210 is biased toward the extended position, the second end 234 may be located relatively lower in the cavity 208. In this case, the locking mechanism 210 may be configured to abut the second end 234 and at least partially prevent movement of the second movable shuttle 230 with respect to the inner channel 201, such as upward beyond the cavity 208. Thus, the locking mechanism 210 may be configured to maintain the second movable shuttle 230 in the second position.

[0070] Referring now to FIG. 6C, the valve assembly 300 can transition to a third configuration when the actuating mechanism 30 (FIG. 1) is released. In this case, the first movable shuttle 220 and the second movable shuttle 230 can move to a third position relative to the valve body 202. In the third position, the first movable shuttle 220 can move relative to the valve body 202, while the second movable shuttle 230 can remain stationary relative to the valve body 202. In some examples, the third position of the second movable shuttle 230 may be substantially similar to the second position of the second movable shuttle 230 (FIG. 6B), and the third position of the first movable shuttle 220 may be substantially similar to the first position of the first movable shuttle 220 (FIG. 6A), and by releasing the actuating mechanism 30, the first movable shuttle 220 can be returned to the first position.

[0071] For example, by stopping the actuation of the actuating mechanism 30, the cam 40 can be moved away from the second end 224, thereby releasing the engagement of the first movable shuttle 220. In this case, the biasing mechanism 226 can be returned to a first (extended) configuration in which the upward (longitudinal) force applied by the biasing mechanism 226 against the second end 224 can move the first movable shuttle 220 (upward) through the inner channel 201 relative to the valve body 202. As described in detail above, the locking mechanism 210 can help prevent the second movable shuttle 230 from returning to the first position.

[0072] In the third position of the movable shuttle, the first movable shuttle 220 may be repositioned to the uppermost range relative to the valve body 202, and the second movable shuttle 230 may remain in the lowermost range. In the third configuration of the valve assembly 200, the first gasket 128A may remain between the first (outlet) conduit 111 and the second (inlet) conduit 113, the second gasket 128B may be repositioned between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may remain between the outlet port 110 and the second opening 207. Accordingly, the second gasket 128B may be arranged to block fluid communication between the second (inlet) conduit 113 and the outlet port 110.

[0073] Continuing to refer to FIG. 6C, in the second position of the second movable shuttle 230, the piercing element 130 may remain in the lowermost range relative to the valve body 202 such that the piercing element 130 remains in contact with the seal 54 as the movable shuttle moves from the second position to the third position. Accordingly, in the third configuration of the valve assembly 200, the piercing element 130 may extend through the seal 54 such that the high-pressure fluid A stored in the storage device 50 can continue to be discharged into the valve body 202 and continue to be received within the inner channel 201.

[0074] The high-pressure fluid A discharged from the storage device 50 can move along the first fluid path through the inner channel 201 until it encounters the first gasket 128A located relatively above the first (outlet) conduit 111. The first gasket 128A may be configured to help prevent the high-pressure fluid A from flowing (upward) beyond the location of the first gasket 128A relative to the inner channel 201. Accordingly, the first gasket 128A can redirect the high-pressure fluid A to the first (outlet) conduit 111 and the regulator 60. The low-pressure fluid B can move along the second fluid path through the second (inlet) conduit 113 until it exits the regulator 60 and enters the inner channel 201 when the high pressure A decreases.

[0075] Continuing to refer to FIG. 6C, with the first movable shuttle 220 in the third position, the second gasket 128B may be positioned between the second (inlet) conduit 113 and the outlet port 110, and the third gasket 128C may remain between the outlet port 110 and the second opening 207. Accordingly, the second gasket 128B may be arranged to block fluid communication between the second (inlet) conduit 113 and the outlet port 110. Thus, the low-pressure fluid B can enter the inner channel 201 between the first gasket 128A and the second gasket 128B. The first gasket 128A may be configured to prevent the low-pressure fluid B from flowing (downward) beyond the location of the second gasket 128B with respect to the inner channel 201, and the second gasket 128B may be configured to prevent the low-pressure fluid B from flowing (upward) beyond the location of the second gasket 128B with respect to the inner channel 201. With the outlet port 110 positioned above the second gasket 128B, the second gasket 128B can fluidly seal the outlet port 110 and prevent the delivery of the low-pressure fluid B toward the catheter 36.

[0076] It should be understood that the second movable shuttle 230 can remain in the second position (FIG. 6C) during subsequent operation of the actuating mechanism 30. In other embodiments of the valve assembly 200, one or more of the first movable shuttle 220, the second movable shuttle 230, and / or the piercing element 130 may be stationary and / or fixed relative to the valve body 202, and the storage device 50 may be configured to move relative to the valve assembly 200 to provide a controlled release of pressurized fluid from the dispensing system 10.

[0077] When the valve assembly 200 is in the third configuration, due to the position of the second movable shuttle 230 that seals the high-pressure fluid A below the first gasket 128A, it should be understood that when the high-pressure fluid A is isolated from interacting with the first movable shuttle 220, the high-pressure fluid A is prevented from affecting (e.g., increasing) the force required for the user to operate the actuating mechanism 30. In other words, the valve assembly 200 can be operable to prevent the high-pressure fluid A from interacting with the first movable shuttle 220 and to facilitate a constant force required to move the first movable shuttle 220 from the first position and / or the third position (FIGS. 5A and 5C) to the second position (FIG. 5B).

[0078] Referring now to FIGS. 7-8, an exemplary embodiment of another valve assembly 300 is shown. The valve assembly 300 may be configured similarly to the valve assemblies 100, 200, except for the differences explicitly described herein, and thus, similar reference numerals are used to identify similar components. The valve assembly 300 is housed within the body 12 of the delivery system 10 and can be selectively actuated by an actuating mechanism 30 (see FIG. 1). The valve assembly 300 can include a valve body 302 having a first end 304 and a second end 306. As shown in FIG. 8, the first end 304 can have a first opening 305, and the second end 306 can have a second opening 307. The valve assembly 300 can be fluidly coupled to the storage device 50 at the first end 304 via the first opening 305 and can be fluidly coupled to the regulator 60 (FIG. 1) via the adapter 140.

[0079] Continuing to refer to FIG. 8, the valve assembly 300 may include an inner channel 301 that extends through the valve body 302 between a first opening 305 at the first end 304 and a second opening 307 at the second end 306 for receiving the movable shuttle 120 and the piercing element 130. The inner channel 301 may be in fluid communication with the adapter 140 via the first (outlet) conduit 111 and the second (inlet) conduit 113. The inner channel 301 may further be in fluid communication with the outlet 34 (see FIG. 1) via the outlet port 110.

[0080] The valve assembly 300 may be configured and operable in a similar manner to the valve assembly 100 described in detail above. For example, each of the movable shuttle 120 and the piercing element 130 may move between respective plural positions (e.g., a first position, a second position, and a third position) to shift the valve assembly 300 between corresponding plural configurations (e.g., a first configuration, a second configuration, and a third configuration), similar to those illustrated and described in detail above with respect to the valve assembly 100 (see FIGS. 5A - 5C).

[0081] As shown in FIG. 8, the valve assembly 300 may be in the second configuration when each of the movable shuttle 120 and the piercing element 130 is moved to its respective lowest extent relative to the valve body 302, thereby establishing fluid communication between the inner channel 301 and the storage device 50. Considering the position of the first gasket 128A relative to the inner channel 301, the high - pressure fluid A stored within the storage device 50 may move along a first fluid path that passes through the inner channel 301, the first (outlet) conduit 111, and enters the regulator 60 via the adapter 140. The low - pressure fluid B discharged from the regulator 60 may move along a second fluid path that passes through the adapter 140, through the tube 310, into the second (inlet) conduit 113, and into the inner channel 301.

[0082] In a second configuration of the valve assembly 300, the second gasket 128B and the third gasket 128C may be cooperatively configured to direct low-pressure fluid B toward the outlet port 110 for delivery to the patient due to the respective positions of the gaskets 128B, 128C relative to the second (inlet) conduit 113 and the outlet port 110. It should be understood that the valve assembly 300 may include a first configuration and a third configuration that are substantially similar to the first configuration (FIG. 5A) and the third configuration (FIG. 5C) of the valve assembly 100.

[0083] It should be understood that the principles of the present disclosure are described herein with reference to exemplary examples for specific applications, but the present disclosure is not limited thereto. Those of ordinary skill in the art who access the teachings provided herein will recognize that all additional modifications, applications, and equivalent substitutions fall within the scope of the examples described herein. Accordingly, the present invention should not be regarded as limited by the foregoing description.

Claims

1. A valve assembly for a medical device, A main body having an inlet that communicates with a fluid supply source and an outlet that communicates with a delivery conduit of the medical device, A shuttle configured to move between a first position and a second position within the main body to control the delivery of the fluid from the inlet to the outlet, Equipped with, In the first position, the shuttle is configured to maintain the fluid at a first pressure within the body and to seal the outlet from the inlet, so that the delivery conduit is isolated from the fluid received from the supply source at the first pressure. In the second position, the shuttle is configured to maintain the fluid at a second pressure within the body and to fluidly couple the outlet to the inlet, so that the delivery conduit receives the fluid from the source at a second pressure, the second pressure being less than the first pressure, in the valve assembly.

2. The valve assembly according to claim 1, further comprising a puncture element configured to move between a retracted position and an extended position within the shuttle, thereby fluidly coupling the inlet with the fluid source.

3. The valve assembly according to claim 2, wherein the puncture element includes a needle or lance having a sharp tip.

4. The valve assembly is configured to receive the fluid from the supply source through the inlet when the shuttle is moved from the first position to the second position and the puncture element is positioned in the retracted position. The valve assembly according to claim 2 or 3, wherein the valve assembly is configured to prevent the delivery of the fluid from the inlet to the outlet when the shuttle is moved from the second position to the first position and the puncture element is positioned in the extended position.

5. In the first configuration of the valve assembly, The shuttle is positioned at the first position, The puncture element is in the retracted position and is separated from the fluid supply source. The valve assembly according to claim 4, wherein the inlet is not in fluid communication with the outlet so that the fluid is maintained at the first pressure in the fluid source.

6. In the second configuration of the valve assembly, The shuttle is positioned at the second location, The puncture element is in the retracted position and in contact with the fluid supply source. The valve assembly according to claim 5, wherein the inlet is in fluid communication with the outlet such that the fluid is guided to the outlet at the second pressure.

7. In the third configuration of the valve assembly, The shuttle is positioned at the first position, The puncture element is in the extended position and in contact with the fluid supply source. The valve assembly according to claim 6, wherein the inlet is not in fluid communication with the outlet so that the fluid is maintained in the body at the first pressure and the second pressure.

8. The valve assembly according to any one of claims 1 to 3, wherein the main body is in fluid communication with a regulator assembly configured to convert the fluid from a first pressure to a second pressure.

9. The valve assembly according to any one of claims 1 to 3, wherein the shuttle includes a gasket disposed around the outer surface of the shuttle.

10. In the first configuration of the valve assembly, The shuttle is positioned at the first position, The valve assembly according to claim 9, wherein the gasket is positioned between the inlet and the outlet to fluidly isolate the delivery conduit from the source of the fluid.

11. In the second configuration of the valve assembly, The shuttle is positioned at the second location, The valve assembly according to claim 10, wherein the gasket is not located between the inlet and the outlet in order to fluidly connect the delivery conduit to the source of the fluid.

12. The body includes a channel configured to receive the shuttle and a ledge extending radially inward within the channel. The valve assembly according to claim 9, wherein the shuttle includes a flange extending radially outward from the outer surface of the shuttle.

13. The valve assembly according to claim 12, wherein the flange is configured to engage with the ledge when the shuttle is in a first position relative to the channel, thereby positioning the gasket between the inlet and the outlet, and thereby fluidly isolating the delivery conduit from the source of the fluid.

14. The valve assembly according to claim 12, wherein the flange is configured to disengage the ledge when the shuttle is in the second position relative to the channel, thereby positioning the gasket outside the inlet and outlet, and thereby fluidly coupling the delivery conduit from the source of the fluid.

15. The valve assembly according to any one of claims 1 to 3, further comprising a biasing mechanism coupled to the shuttle, wherein the biasing mechanism is configured to move the shuttle from the second position to the first position.

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