Devices, assemblies, and methods for delivering pharmaceutical agents

Abstract

A valve assembly for a medical device includes a container including a first region and a second region, a first fluid inlet fluidly coupled to the first region, a second fluid inlet fluidly coupled to the second region, and a piston assembly disposed within the container. The container is configured to contain a medicament in the second region, the first fluid inlet configured to deliver a first portion of pressurized fluid to the first region at a first pressure level, and the second fluid inlet configured to deliver a second portion of pressurized fluid to the second region at a second pressure level lower than the first pressure level. The piston assembly includes a valve configured to move from a first position to a second position in response to movement of the piston assembly relative to the container.

Description

[Technical Field]

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

[0002] Certain medical procedures may require minimizing or stopping bleeding within the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the digestive tract, e.g., the esophagus, stomach, or intestines. During an endoscopic procedure, a user inserts an endoscope sheath into a patient's body lumen. The user utilizes the endoscope's handle to control the endoscope during the procedure. Instruments may be passed through the endoscope's working channel, for example, via ports in the handle, to deliver therapy at a treatment site near the distal end of the endoscope. The treatment site is remote from the user.

[0003] To achieve hemostasis at a remote site, a hemostatic agent may be delivered by a device inserted into the working channel of an endoscope. Drug delivery may be achieved, for example, by a mechanical system designed to allow the agent to flow continuously from the device to the remote site. However, such systems may require multiple steps or actuations to achieve delivery or may not achieve the desired rate of drug delivery or the desired dosage of drug. Thus, these systems may be inefficient, may not achieve the desired rate of drug delivery, may result in the drug clogging portions of the delivery device, and / or may result in inconsistent drug dosage. The present disclosure may solve one or more of these or other problems in the art. Summary of the Invention

[0004] Each of the embodiments disclosed herein may include one or more of the features described in connection with any of the other disclosed embodiments. Aspects of the present disclosure relate, among other things, to systems, devices, and methods for delivering a medicament to a target treatment site using a medical device including a valve assembly. According to one example, a valve assembly for a medical device includes: a container including a first region and a second region and configured to contain a medicament in the second region; a first fluid inlet fluidly coupled to the first region, the first fluid inlet configured to deliver a first portion of pressurized fluid to the first region, the first portion of pressurized fluid having a first pressure level; a second fluid inlet fluidly coupled to the second region, the second fluid inlet configured to deliver a second portion of pressurized fluid to the second region, the second portion of pressurized fluid having a second pressure level that is lower than the first pressure level; and and a piston assembly disposed within the container, the piston assembly configured to move relative to the container in response to a first region receiving the first portion of pressurized fluid and a second region receiving a second portion of pressurized fluid, the piston assembly including a valve configured to move from a first position to a second position in response to the piston assembly moving relative to the container, wherein in the first position the valve is configured to prevent the medicament from exiting the second region of the container and in the second position the valve is configured to direct the medicament out of the second region of the container for delivery from the medical device.

[0005] Any of the valve assemblies described herein may include any of the following features: a first funnel is disposed within the second region, the first funnel configured to receive the medicament when the valve is in the first position; a second funnel is disposed within the second region relatively below the first funnel, the second funnel configured to receive the medicament from the first funnel when the valve is in the second position; the second funnel is in fluid communication with a source of pressurized fluid via a second fluid inlet, the second funnel including a porous portion along a wall of the second funnel; the second funnel is configured to mix the medicament received from the first funnel with a second portion of the pressurized fluid received from the second fluid inlet through the porous portion; and the second funnel is configured to direct the mixture of the medicament and the second portion of the pressurized fluid to a delivery conduit of a medical device in fluid communication with the second region of the container. The container is configured to generate a first pressure level of a first portion of the pressurized fluid in a first region and a second pressure level of a second portion of the pressurized fluid in a second region, thereby creating a pressure differential between the first and second regions. The piston assembly includes a piston at least partially disposed in the first region and a piston rod at least partially disposed in the second region, the piston rod having a first end coupled to the valve and a second end coupled to the piston, and the piston assembly includes a biasing mechanism configured to bias the piston toward a first direction, thereby moving the piston rod and the valve to a first position. In response to creating a pressure differential between the first and second regions, the valve assembly is configured to move the piston rod and the valve from the first position to a second position against a bias generated by the biasing mechanism on the piston. The tube is coupled to the second fluid inlet, the tube is configured to deliver a second portion of the pressurized fluid to the second fluid inlet, and the tube includes at least one orifice configured to restrict flow of the second portion of the pressurized fluid through the second fluid inlet. The orifice is configured to regulate the second portion of the pressurized fluid to a second pressure level, thereby creating a pressure differential between the first region and the second region.The orifice is configured to discharge at least a second portion of the pressurized fluid to an ambient atmosphere of the medical device. The valve includes a plurality of channels configured to regulate a flow rate of the agent moving through the second region when the valve is in the second position. Each of the plurality of channels is separated from an adjacent channel by at least one of a plurality of ribs. Each of the plurality of ribs is configured to impede lateral movement of the piston rod relative to the second region of the container.

[0006] According to another example, a valve assembly for delivering a medicament may include an actuator, a container configured to store the medicament, a fluid inlet fluidly coupled to the container, a piston assembly disposed within the container and movable relative to the container, the piston assembly including a valve configured to release the medicament from the container upon movement from a first position to a second position, and an actuation assembly coupled to the actuator, the piston assembly, and a source of pressurized fluid, wherein in response to actuating the actuator, the actuation assembly is configured to interact with the source of pressurized fluid, thereby releasing pressurized fluid from the source through the fluid inlet into the container and move the piston assembly within the container, thereby moving the valve from the first position to the second position and releasing the medicament from the container, and the pressurized fluid is configured to mix with the medicament in the container and direct the mixture of the medicament and pressurized fluid toward an outlet in fluid communication with the container.

[0007] Any of the valve assemblies disclosed herein may include any of the following features: the actuation assembly includes a cam coupled to the source of pressurized fluid and at least one movable rod coupled to the piston assembly, the cam configured to engage a seal on the source of pressurized fluid to release the pressurized fluid, and the at least one movable rod configured to urge the valve toward the second position; the valve includes a plurality of channels and a plurality of ribs disposed around the periphery of the valve, at least one of the plurality of ribs being disposed between adjacent pairs of the plurality of channels; and the plurality of channels configured to control a flow rate of the medicament moving through the valve when in the second position.

[0008] According to another example, a method for delivering a medicament from a medical device may include releasing pressurized fluid to a first region of a valve assembly of the medical device to pressurize the first region to a first pressure level and releasing pressurized fluid to a second region of the valve assembly to pressurize the second region to a second pressure level lower than the first pressure level, the second region containing the medicament, the method including creating a pressure differential between the first region and the second region in response to the first region receiving the pressurized fluid at the first pressure level and the second region receiving the pressurized fluid at the second pressure level, and moving a piston assembly relative to the first region and the second region in response to the valve assembly creating the pressure differential between the first region and the second region, the piston assembly including a valve configured to move from a first position to a second position when the pressure differential is created in the valve assembly, and the method may include releasing the medicament from the second region when the valve is moved to the second position, thereby allowing the pressurized fluid and the medicament to mix prior to delivery from the medical device.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the invention as claimed. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may include other elements not expressly listed or elements inherent to such process, method, article, or apparatus. The term "diameter" may refer to the width when an element is not circular. The terms "top" and "upper" refer to the direction or side of the device relative to its orientation in use, and the terms "bottom" and "lower" refer to the direction or side of the device relative to its orientation in use, which is opposite to "top" and "bottom." The term "exemplary" is used in the sense of "example" rather than "ideal." The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value. [Brief explanation of the drawings]

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] FIG. 1 illustrates an exemplary delivery device according to some embodiments. [Figure 2] 2 is a cross-sectional view of an exemplary valve assembly of the delivery device of FIG. 1, according to some embodiments. [Figure 3A] FIG. 3A is a top view of a valve of the valve assembly of FIG. 2 according to some embodiments. [Figure 3B] 3B is a cross-sectional view of the valve of FIG. 3A taken along line 3B-3B of FIG. 3A, according to some embodiments. [Figure 4A] FIG. 4A illustrates a first actuation position of the valve assembly of FIG. 2, according to some embodiments. [Figure 4B]FIG. 4B illustrates a second actuation position of the valve assembly of FIG. 2, according to some embodiments. [Figure 5A] FIG. 5A illustrates an exemplary actuation assembly of the delivery device of FIG. 1, according to some embodiments. [Figure 5B] FIG. 5B is a partial side view of a portion of the actuation assembly of FIG. 5A, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0011] Embodiments of the present disclosure relate to a dispensing (delivery) device having a valve assembly for selectively releasing a medicament (e.g., a powdered medicament) at a site of a medical procedure. The valve assembly may include a piston assembly and a valve, which may be collectively configured to release a medicament stored in the delivery device when the valve assembly moves between a first position and a second position in response to receiving pressurized fluid (e.g., gas) from a pressurized medium source (e.g., a gas canister). The medicament may be contained within a housing of the dispensing device and in fluid communication with the pressurized fluid through one or more inlets of the valve assembly.

[0012] Thus, when the valve is selectively moved by the piston assembly from a first position to a second position in fluid communication with a source of pressurized fluid, the agent can be released from the housing and exposed to the pressurized fluid. The agent may interact with the pressurized fluid and be agitated prior to delivery to a target site for medical treatment. Aspects of the dispensing device and valve assembly, such as the piston assembly and valve, can facilitate controlled fluidization (e.g., agitation) of the agent with the flow of pressurized fluid before the agent is delivered, which can help selectively control the flow of agent out of the dispensing device to prevent or minimize clogging during delivery.

[0013] FIG. 1 illustrates 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 accommodate a housing 14 (or other source or container) that stores a material (e.g., a powdered medication). The housing 14 may be coupled to the handle body 12 to provide the medication to the handle body 12, or a medication cap / housing may be threaded onto or coupled to the housing 14 to supply the medication to the housing 14. The medication may be, for example, a powdered medication, such as a hemostatic agent. The medication may alternatively be another type of medication or material, or a medication form (e.g., a liquid or gel medication), and may have any desired functionality. The housing 14 may be removably attached to other components of the delivery system 10, including components of the handle body 12.

[0014] The handle body 12 can have various features, which are described in further detail herein. U.S. Patent Application No. 16 / 589,633, filed October 1, 2019, and published April 2, 2022, as U.S. Patent Application Publication No. 2020 / 0100986, discloses exemplary delivery device and system features, the disclosure of which is incorporated herein by reference in its entirety. Features of the present disclosure can be combined with any of the features described in the above-referenced applications. Features described herein may be used alone or in combination and are not mutually exclusive. Like reference numbers and / or terminology are used where possible to indicate like structures.

[0015] 1 , delivery system 10 may include an actuation mechanism 30 used to actuate the flow of pressurized fluid (e.g., gas) from a pressurized medium source in fluid communication with delivery system 10. Actuation mechanism 30 can be selectively actuated (e.g., manually depressible) or otherwise moved or activated to control the delivery of the material (e.g., powdered medicament) and pressurized fluid. The pressurized fluid alone, or a combination of powdered medicament and fluid, can be delivered from an outlet 34 in handle body 12. Outlet 34 can be in fluid communication with a delivery conduit, e.g., a catheter 36 or another component, to deliver the medicament and fluid combination to a desired location within a patient's body lumen.

[0016] FIG. 2 illustrates an exemplary embodiment of a valve assembly 100. The valve assembly 100 may be housed within the handle body 12 of the delivery system 10, specifically within the housing 14. In some embodiments, the valve assembly may be coupled to the handle body 12 instead of the housing 14. The valve assembly 100 may be selectively actuated when a pressure differential is created within the valve assembly 100. The pressure differential may be created by introducing pressurized fluid into the valve assembly 100, which may be selectively introduced to the valve assembly 100 via an actuation mechanism 30 (see FIG. 1 ). While not shown, the actuation mechanism 30 may include one or more other actuation elements, such as, for example, a trigger, a button, a slider, a lever, a knob, a dial, and various other suitable actuators. As described herein, actuation of the actuation mechanism 30 provides a corresponding release of pressurized fluid toward the valve assembly 100 and / or movement of the valve assembly 100, thereby controlling the delivery of a drug through the valve assembly 100 toward a target treatment site in a patient.

[0017] Alternatively, as described in detail below, actuation mechanism 30 may be coupled to valve assembly 100 by a mechanical actuation assembly configured to selectively actuate valve assembly 100 (see FIGS. 5A-5B). As described herein, the mechanical actuation assembly may include one or more cables, wires, rods, and / or various other suitable mechanisms for ejecting pressurized fluid toward valve assembly 100 and / or moving one or more internal components of valve assembly 100.

[0018] 2, the valve assembly 100 may include a first (upper) container 103 and a second (lower) container 110 coupled to one another. The first container 103 may define a first region of the valve assembly 100, and the second container 110 may define a second region of the valve assembly 100. The first container 103 and the second container 110 may collectively form a canister housing that defines an enclosure for storing the medicament 180. Thus, although described herein as separate containers, it should be understood that the first container 103 and the second container 110 may define subcomponents of a single canister housing.

[0019] The second container 110 may include a bottom 109, a top 112 opposite the bottom 109, and a middle section 114 disposed between the bottom 109 and the top 112. In this example, at least one or more of the middle section 114 and / or the bottom 109 of the second container 110 may define a second region of the valve assembly 100. The first container 103 may include a cavity 101, and the second container 110 may include a first (upper) cavity 105 along the top 112, a second (middle) cavity 108 along the middle section 114, and a third (lower) cavity 134 in the bottom 109. It should be understood that the first cavity 105, the second cavity 108, and the third cavity 134 of the second container 110 may be in fluid communication with one another. As described herein, the cavity 101 of the first container 103 may be fluidly isolated from the cavity of the second container 110 by a gasket or the like disposed between the cavity 101 and the first cavity 105.

[0020] In some embodiments, at least a portion of cavity 101 can define a high-pressure zone of valve assembly 100, and one or more of first cavity 105, second cavity 108, and / or third cavity 134 can define a low-pressure zone of valve assembly 100. In one example, first cavity 105 can define a portion of the low-pressure zone. Alternatively, in other embodiments, cavity 101 and at least a portion of first cavity 105 can collectively define a high-pressure zone of valve assembly 100.

[0021] Still referring to FIG. 2 , the second container 110 may be configured to store a medicament, such as a medicament 180 (e.g., a powder), within the second cavity 108. In some embodiments, the first container 103 and the second container 110 may each include a complementary connection interface that allows the bottom of the first container 103 to be selectively coupled onto the top 112 of the second container 110. For example, the outer surface of the second container 110 may include threads 111 along the top 112, and the inner surface of the first container 103 may include corresponding threads 115 for engaging with the threads 111 of the second container 110. However, various suitable connection mechanisms and / or interfaces for joining the first container 103 to the second container 110 may be utilized without departing from the scope of the present disclosure.

[0022] The first vessel 103 may be fluidly coupled to a first fluid inlet 102 in fluid communication with a pressurized medium source (not shown), such that the valve assembly 100 may be configured to receive pressurized fluid at the first vessel 103 via the first fluid inlet 102. As described herein, the first fluid inlet 102 may define a high-pressure fluid inlet of the valve assembly 100. The second vessel 110 may be fluidly coupled to a second fluid inlet 104 in fluid communication with the pressurized medium source, such that the valve assembly 100 may be configured to receive pressurized fluid at the second vessel 110, particularly the chamber 129 of the bottom 109, via the second fluid inlet 104. As described herein, the second fluid inlet 104 may define a low-pressure fluid inlet of the valve assembly 100.

[0023] In some embodiments, the valve assembly 100 may be configured to simultaneously receive pressurized fluid in the cavity 101 of the first container 103 and the third cavity 134 of the second container 110. In other embodiments, the valve assembly 100 may be configured to selectively receive pressurized fluid through each of the first container 103 and the second container 110. In some embodiments, the second cavity 108 may be configured to receive pressurized fluid from the second fluid inlet 104, with the bottom portion 109 in fluid communication with the middle portion 114.

[0024] Although the fluid inlets 102, 104 are shown along the respective sidewalls of the first container 103 and the second container 110, it should be understood that the fluid inlets 102, 104 may be disposed in various alternative locations relative to the valve assembly 100 without departing from the scope of the present disclosure. In some embodiments, the inner and / or outer walls of the first fluid inlet 102 may include an interface (e.g., a lip, protrusion, tab, recess, etc.) configured to facilitate connection between the first fluid inlet 102 and a tube (not shown) in fluid communication with a pressurized medium source. Thus, the tube can fluidly couple the first container 103 with the pressurized medium source to deliver pressurized fluid into the cavity 101. The inner and / or outer walls of the second fluid inlet 104 may include an interface (e.g., a lip, protrusion, tab, recess, etc.) configured to facilitate connection between the second fluid inlet 104 and a tube 130 in fluid communication with the pressurized medium source. Thus, the tube 130 can fluidly couple the second container 110 with a source of pressurized medium for delivering pressurized fluid into the third cavity 134 .

[0025] The tube 130 may include an opening and / or orifice 132 extending through a sidewall 131 of the tube 130. The orifice 132 may establish fluid communication between the tube 130, specifically the lumen of the tube 130, and an exterior region of the tube 130 that is exposed to atmospheric pressure. As described herein, the valve assembly 100 may be configured to generate a ratio and / or difference between high-pressure and low-pressure fluid between the first vessel 103 and the second vessel 110 based on the pressure levels of fluid received at the first fluid inlet 102 and the second fluid inlet 104, respectively.

[0026] Specifically, orifice 132 may be configured to restrict and / or regulate the flow of pressurized fluid entering second container 110 through second fluid inlet 104, while the flow of pressurized fluid entering first container 103 may remain relatively unrestricted and / or unregulated. Thus, by restricting the flow of pressurized fluid received by second container 110 (particularly chamber 129, third cavity 134, second cavity 108, and first cavity 105), valve assembly 100 may be configured to create low-pressure zones in one or more of first cavity 105, second cavity 108, third cavity 134, and / or chamber 129. By not restricting the flow of pressurized fluid received by first container 103, valve assembly 100 may be configured to create high-pressure zones within cavity 101. In other words, valve assembly 100 allows for a higher pressure level of fluid to be formed within cavity 101, at least relative to cavity 134, thereby forming high pressure and low pressure zones, respectively.

[0027] It should be understood that the pressure level within the low-pressure zone may vary for one or more of the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129. For example, the first cavity 105 may have a lower relative pressure level than one or more of the second cavity 108, the third cavity 134, and / or the chamber 129. As a further example, the third cavity 134 and / or the chamber 129 may have a higher relative pressure level than one or more of the first cavity 105 and / or the second cavity 108.

[0028] Thus, the orifice 132 may be configured to restrict the flow of pressurized fluid received into the valve assembly 100 through the second fluid inlet 104, such that the pressure level of the fluid received in the tube 130 may be controlled (e.g., reduced) by venting a portion of the fluid through the orifice 132, such as to the atmosphere surrounding the delivery system 10. If the tube (not shown) coupled to the first fluid inlet 102 does not include an orifice, the pressure level of the pressurized fluid received in the first container 103 (and specifically cavity 101) may be greater than the pressure level of the pressurized fluid received in the second container 110 (and specifically first cavity 105, second cavity 108, third cavity 134, and / or chamber 129). The difference in pressure levels can create a high pressure zone in cavity 101 within valve assembly 100 and low pressure zones in first cavity 105, second cavity 108, third cavity 134, and / or chamber 129. As described herein, the high pressure zone and low pressure zone may be separated from one another by one or more devices of valve assembly 100 (e.g., piston 122 and gasket 127).

[0029] In some embodiments, the size and / or shape of the orifice 132 may be determined based on the desired pressure differential to be generated within the valve assembly 100 between the high pressure zone and the low pressure zone. For example, the orifice 132 may be sized and / or shaped such that the orifice 132 is configured to limit the flow rate and / or pressure level of the pressurized fluid received by the second container 110 to a range of about 800 liquid ohms to about 1200 liquid ohms, e.g., 1000 liquid ohms. The nominal pressure level within the valve assembly 100 may be in the range of about 5 psi (about 34.4738 kPa) to about 75 psi (about 517.107 kPa).

[0030] 2, the valve assembly 100 may include a first (upper) funnel 106 and a second (lower) funnel 107. For example, the first funnel 106 may be disposed within the second cavity 108, and the second funnel 107 may be disposed within the third cavity 134. The first funnel 106 may be in fluid communication with the second cavity 108, such that the drug 180 may flow (e.g., by gravity) from the second cavity 108 onto the first funnel 106. As described herein, the first funnel 106 may include a central opening 137 defining a valve seat for receiving one or more components of the valve assembly 100 (e.g., valve 140) thereon. In some embodiments, the second funnel 107 may be in fluid communication with a tube 118, which may be fluidly coupled to the lower end 136 of the second funnel 107. The tube 118 may include a connector 113 operable and configured to attach the tube 118 to the valve assembly 100. The connector 113 may have a bulbous shape defining one or more flanges to facilitate gripping and / or manipulating the tube 118 during connection to the valve assembly 100, particularly the bottom portion 109. It should be understood that the connector 113 may have a variety of other shapes and / or sizes that may be suitable for gripping the tube 118 and providing a surface to facilitate connection of the tube 118 to the valve assembly 100.

[0031] In some embodiments, the first funnel 106 may include a wall 116 having a generally conical or funnel shape, although in other embodiments, the wall 116 may have various other suitable shapes and / or configurations without departing from the scope of the present disclosure. The wall 116 may be sized and / or shaped to form a varying cross-sectional profile between the upper and lower ends of the first funnel 106. In other words, the wall 116 may taper radially inward toward the central opening 137. Thus, as the medicament 180 travels downward through the first funnel 106, the medicament 180 encounters portions of the first funnel 106 that vary in size, which may help reduce clogging of the medicament 180 within the second container 110. The medicament 180 may be prone to bridging, which could cause clogging without the change in size of the first funnel 106. In other words, the first funnel 106 may be configured to prevent the drug 180 in the second container 110 from filling up and / or clogging by directing the drug 180 along the wall 116 toward the central opening 137.

[0032] Still referring to FIG. 2 , the second funnel 107 may include a wall 119 having a generally conical or funnel shape. The wall 119 may be sized and / or shaped to form a varying cross-sectional profile between the upper and lower ends 136 of the second funnel 107. In other words, the wall 119 may taper radially inward toward the central opening 135 of the second funnel 107. Thus, the third cavity 134 may have a larger diameter at the upper end of the second funnel 107 relative to the lower end 136. The inner surface 133 of the wall 119 may at least partially define the third cavity 134 for receiving the medicament 180 from the first funnel 106 (e.g., by gravity), and the third cavity 134 may terminate at the central opening 135. As the drug 180 moves downward through the second funnel 107, the drug 180 encounters portions of the third cavity 134 that vary in size, which may help to reduce clogging of the drug 180 within the third cavity 134.

[0033] As mentioned above, the agent 180 may be prone to bridging, which may result in clogging without a change in the diameter of the third cavity 134. As described herein, the agent 180 may be at least partially received within the third cavity 134 from the second cavity 108 in response to corresponding movement of one or more components of the valve assembly 100 (e.g., the valve 140). Although the first funnel 106 and the second funnel 107 are shown and described herein as having substantially similar shapes and / or cross-sectional profiles, it should be understood that each funnel may have a different shape and / or size relative to one another without departing from the scope of the present disclosure.

[0034] Still referring to FIG. 2 , the wall 119 may have a constant thickness between the upper end and the lower end 136 of the second funnel 107. In other embodiments, the wall 119 may have a varying thickness. Additionally, the tube 118 may be coupled to the second funnel 107 at the lower end 136 such that the tube 118 can be in fluid communication with the third cavity 134 via the central opening 135. The tube 118 may be coupled to the second funnel 107 via a variety of suitable mechanisms, including, but not limited to, adhesive, a friction fit, one or more complementary interfaces (e.g., ridges, tabs, protrusions, grooves), etc. The tube 118 may include an outlet 190 in fluid communication with the catheter 36 (see FIG. 1 ). Thus, as described herein, the medication 180 and pressurized fluid received within the second funnel 107 can be directed through the tube 118 (via the central opening 135) and delivered to the patient via the catheter 36.

[0035] In some embodiments, the wall 119 may include a sintered and / or porous portion 121. For example, the porous portion 121 may include a plurality of pores and / or passages formed between the outer surface and the inner surface 133 of the wall 119. The porous portion 121 may be configured to receive a pressurized fluid therethrough, while the remainder of the wall 119 may not include pores and / or passages. That is, the plurality of pores and / or passages may be disposed only along the porous portion 121. In this example, the porous portion 121 may be disposed relatively adjacent to (e.g., facing) the second fluid inlet 104. In other embodiments, two or more portions of the wall 119 may be sintered and / or porous. In further embodiments, a substantial portion of the wall 119 may be sintered and / or porous, such that a plurality of pores and / or passages may be formed along the entirety of the wall 119. Each of the multiple passages may be sized, shaped, and configured to allow pressurized fluid from the second fluid inlet 104 to be received through the wall 119 and to prevent the drug 180 from exiting the third cavity 134 through the wall 119.

[0036] Still referring to FIG. 2 , the upper end of the second funnel 107 may be at least partially disposed in the bottom 109 and positioned relatively below the first funnel 106. Furthermore, the second funnel 107 may be fluidly coupled to the middle portion 114 via the first funnel 106. In this example, the upper end of the second funnel 107 may be configured to couple to and form a seal with one or more surfaces defining the middle portion 114 of the first funnel 106 and / or second container 110. In some examples, the valve assembly 100 may include one or more sealing mechanisms (e.g., O-rings) positioned between the interface of the first funnel 106 and the second funnel 107 to fluidly couple the second funnel 107 to the second cavity 108, specifically the first funnel 106 positioned therein. With the second funnel 107 coupled to the second cavity 108, the medicament 180 can travel from the second cavity 108 to the second funnel 107 via the first funnel 106. As described herein, the valve assembly 100 can be configured to deliver a mixture of the medicament 180 (stored in the second cavity 108) and the pressurized fluid (received in the third cavity 134) through the second funnel 107 to the patient.

[0037] Still referring to FIG. 2 , the valve assembly 100 may include a piston assembly 120. The piston assembly 120 may include a piston 122, a piston rod 128, and a valve 140. The piston 122 may be disposed within one or both of the first container 103 and the second container 110. The piston 122 may include an upper body 123 at least partially received in each of the cavity 101 and the first cavity 105, and a lower body 126 received in the second cavity 108. The upper body 123 may have a cross-sectional dimension relatively larger than the cross-sectional dimension of the lower body 126. In some embodiments, a first (top) end of the piston rod 128 may be coupled to the lower body 126 of the piston 122 in the second cavity 108, and a second (bottom) end of the piston rod 128 may be coupled to an upper end of the valve 140 in the second cavity 108. In some embodiments, piston 122 may include an internally threaded portion along lower body 126, and piston rod 128 may include an externally threaded portion on a first (top) end for threadably coupling with the internally threaded portion of lower body 126. Piston rod 128 may further include an externally threaded portion on a second (bottom) end for threadably coupling with the internally threaded portion of valve 140.

[0038] The valve 140 may include a top or upper end 141 sized, shaped, and / or configured to interface with the first funnel 106, particularly the central opening 137 (e.g., the valve seat of the first funnel 106). In this example, the top end 141 may be angled relative to the longitudinal axis of the piston rod 128. As described herein, the valve 140 may be configured to move between a first (closed) position in which the valve 140 is engaged with at least a portion of the first funnel 106 (e.g., the valve seat) and a second (open) position in which the valve 140 is disengaged from the first funnel 106 and extends into the third cavity 134. Alternatively, the valve 140 may disengage from the first funnel 106 upon moving upward (e.g., retracting) into the second cavity 108. The valve 140 may be configured to allow the drug 180 received on the first funnel 106 to move toward the second funnel 107 (e.g., by gravity) when moved from the first (closed) position to the second (open) position.

[0039] Piston assembly 120 may be configured to transition piston 122, piston rod 128, and valve 140 between one or more configurations in response to valve assembly 100 receiving pressurized fluid from a pressurized medium source (see FIGS. 4A-4B ). For example, piston assembly 120 may be actuated to move piston 122, piston rod 128, and valve 140 between one or more positions relative to first container 103, second container 110, and / or funnels 106, 107. As described herein, piston assembly 120 may be actuated in response to valve assembly 100 receiving pressurized fluid from a pressurized medium source of delivery system 10 through each of first fluid inlet 102 and second fluid inlet 104.

[0040] 2 , piston assembly 120 may further include at least one biasing mechanism 124 disposed within first cavity 105 of upper portion 112. Biasing mechanism 124 may be coupled to piston 122, particularly a lower end of piston 122, such that biasing mechanism 124 may be disposed between the lower end of piston 122 and an inner (bottom) surface of upper portion 112 that defines first cavity 105. Biasing mechanism 124 is configured to bias piston 122 in a first (upward) direction relative to first cavity 105, thereby pushing piston 122 away from the inner (bottom) surface that defines first cavity 105. Valve assembly 100 may include at least one gasket 127 coupled to piston 122 adjacent to upper surface 125 of piston 122. A gasket 127 may be disposed around the exterior of the piston 122 and may be configured to prevent fluid (e.g., gas) from moving between opposing ends of the piston 122. Thus, the gasket 127 may prevent fluid communication between the cavity 101 and the first cavity 105. The biasing mechanism 124 may be configured to bias the piston 122, thereby biasing a valve 140 coupled thereto, via the piston rod 128, to a first position (see FIG. 4A ). As shown and described below, the valve 140 may be configured to engage a portion of the first funnel 106 (e.g., a valve seat at the central opening 137) when the piston 122 is in the first position.

[0041] Alternatively, in embodiments in which valve 140 can disengage first funnel 106 by retracting upward into second cavity 108, biasing mechanism 124 can be positioned relatively above piston 122, such as within cavity 101. In this example, biasing mechanism 124 is configured to bias piston 122 downwardly relative to first cavity 105, thereby pushing piston 122 toward the interior (bottom) surface that defines first cavity 105.

[0042] The piston assembly 120 may be configured to compress the biasing mechanism 124 in response to actuation of the actuation mechanism 30 and receipt of pressurized fluid into the cavity 101 (via the first fluid inlet 102) and into the third cavity 134 (via the second fluid inlet 104). The pressurized fluid received within the valve assembly 100 at the first container 103 and the second container 110 may create a resultant pressure differential between the first container 103 (e.g., a first region) and the second container 110 (e.g., a second region). In this example, the created pressure differential may move the piston 122, piston rod 128, and valve 140 downward relative to the first cavity 105, the second cavity 108, and the third cavity 134, e.g., to a second position (see FIG. 4B). As shown and described below, the valve 140 may be configured to disengage a portion of the first funnel 106 (e.g., the valve seat) when the piston 122 is moved to the second position.

[0043] 3A and 3B, the valve 140 may be sized, shaped, and / or configured to meter (e.g., control) the flow rate of the medicament 180 released from the second cavity 108 to the third cavity 134. For example, the valve 140 may include one or more features and / or surfaces for controlling the flow rate of the medicament 180 via gravity feed to enhance a continuous, stable pressure, volume, and / or dosage rate of the medicament 180 from the valve assembly 100.

[0044] 3A , the valve 140 may include a body having a plurality of ribs 146 disposed adjacent to a plurality of channels 144, the body of the valve 140 being sized, shaped, and / or configured to be received within the central opening 137 of the first funnel 106. The plurality of channels 144 and the plurality of ribs 146 may collectively be sized, shaped, and / or configured to accommodate a metered flow of the medicament 180 through the valve 140. The plurality of channels 144 may extend through the valve 140 such that when the valve 140 is moved (repositioned) from the second cavity 108 into the third cavity 134, the medicament 180 can flow through the plurality of channels 144 and through the central opening 137.

[0045] The plurality of ribs 146 may be configured to at least partially obstruct the flow of the medicament 180 through the central opening 137, thereby controlling the flow rate of the medicament 180 from the first funnel 106 to the second funnel 107. In this example, the valve 140 may include at least three channels 144 and at least three ribs 146. It should be understood that the valve 140 may include additional and / or fewer channels 144 and / or ribs 146 than those shown and described herein without departing from the scope of the present disclosure.

[0046] 3B, the plurality of channels 144 and the plurality of ribs 146 may be configured to increase the flow rate of the agent 180 moving through the central opening 137 when the valve 140 is moved to the second position. The increased flow rate may be due to a smaller volume of the agent 180 moving through each of the plurality of channels 144, as opposed to a single opening in the central opening 137 through which the entire volume of the agent 180 may move.

[0047] For example, valve 140 may be configured to deliver medicament 180 at a flow rate of greater than about 0.08 g / s due to the presence of multiple channels 144 and multiple ribs 146 within central opening 137. Alternatively, as an illustrative example, valve 140 may be configured to deliver medicament 180 at a flow rate of about 0.055 g / s when channels 144 and ribs 146 are omitted. medicament 180 may have a particle size ranging from about 320 μm to about 740 μm, and valve assembly 100 may be configured to deliver medicament 180 at a flow rate of about 5 liters / minute.

[0048] In some embodiments, the size and / or diameter of the plurality of channels 144 may at least partially determine the flow rate of the powdered medicament (e.g., medicament 180) through the system. For example, in embodiments in which the plurality of channels 144 may have a relatively large size, the valve assembly 100 may be configured to allow the powdered medicament (e.g., medicament 180) to achieve a higher flow rate compared to other embodiments in which the plurality of channels 144 may have a relatively small size. In other embodiments, the size and / or shape of the plurality of ribs 146 may at least partially determine the flow rate of the powdered medicament (e.g., medicament 180) through the system.

[0049] 3B , the plurality of ribs 146 may be configured to improve stability of the piston rod 128 relative to the second cavity 108. For example, the plurality of ribs 146 may be disposed around the piston rod 128 and around the outer periphery of the valve 140, which surrounds the piston rod 128. The enhanced stability provided by the plurality of ribs 146 around the outer periphery of the piston rod 128 may serve to prevent the piston rod 128 from tilting or moving laterally within the second container 110, thereby maintaining the piston rod 128 in a concentric position relative to the second cavity 108 and / or the central opening 137.

[0050] In an exemplary use, as shown in FIG. 4A , the medicament 180 may be stored in the second container 110, particularly the second cavity 108, prior to actuation of the actuation mechanism 30 (see FIG. 1 ). When no pressurized fluid is received within the valve assembly 100, the valve assembly 100 may be in a first actuated position with the piston assembly 120 in a first position relative to the first container 103 and / or the second container 110. When in the first actuated position, the respective cavities of the first container 103 and / or the second container 110 may be at atmospheric pressure levels. With the valve 140 coupled to the second (bottom) end of the piston rod 128, the valve 140 may be engaged with the first funnel 106, particularly positioned against one or more surfaces (e.g., the valve seat) that define the central opening 137. Thus, the valve 140 may be configured to close and / or seal the central opening 137 when the valve assembly 100 is in the first actuated position, thereby preventing the drug 180 from exiting the second cavity 108 and entering the third cavity 134.

[0051] In some embodiments, valve 140 may be sized, shaped, and configured to fit snugly between first funnel 106 and second funnel 107. In some embodiments, valve 140 may have a cross-sectional profile substantially similar to the diameter of central opening 137 such that when valve 140 is received within central opening 137, medicament 180 is prevented from flowing through central opening 137. Stated another way, upper end 141 may be sized, shaped, and / or configured to form a fluid-tight seal with first funnel 106 when valve 140 is in the first position, thereby preventing medicament 180 from flowing through central opening 137 until piston assembly 120 is moved to the second position. By preventing the unintentional delivery and / or leakage of the agent 180 through the central opening 137 into the third cavity 134, the valve assembly 100 is configured to prevent the delivery system 10 from clogging, thereby improving the efficiency of the procedure.

[0052] 4A , when the piston assembly 120 is in the first position, the valve 140 may be positioned flush with the second (lower) end (e.g., valve seat) of the first funnel 106, thereby preventing the medicament 180 from passing through the first funnel 106 and into the second funnel 107 via the central opening 137. In response to actuation of the actuation mechanism 30, pressurized fluid from a pressurized medium source (not shown) may be received into the valve assembly 100. At least a first portion of the pressurized fluid may be received at the first container 103 via the first fluid inlet 102, and at least a second portion of the pressurized fluid may be received at the bottom 109 of the second container 110 via the second fluid inlet 104, such as from the tube 130.

[0053] With tube 130 including orifice 132, valve assembly 100 can be configured to create a pressure differential between a first (unrestricted) portion of pressurized fluid received in cavity 101 and a second (restricted) portion of pressurized fluid received in third cavity 134. Thus, a high pressure zone is formed in first vessel 103 (e.g., cavity 101 above piston 122) and a low pressure zone is formed in upper portion 112 below piston 122 (e.g., first cavity 105) and / or second vessel 110 (e.g., second cavity 108, third cavity 134, and / or chamber 129), with the high pressure zone having a greater pressure level relative to the low pressure zone. Stated another way, the pressurized fluid received into the valve assembly 100 from the first fluid inlet 102 can have a first pressure level, and the pressurized fluid received into the valve assembly 100 from the second fluid inlet 104 can have a second pressure level that is lower than the first pressure level.

[0054] When the pressure level within the high pressure zone (e.g., defined by cavity 101) exceeds a predetermined threshold, the pressurized fluid within the high pressure zone may be greater than the opposing (upward) biasing force generated by biasing mechanism 124 (e.g., spring) against piston 122. In other words, the predetermined threshold may correspond to a downward force that is greater than the opposing (upward) biasing force of biasing mechanism 124. In some embodiments, when valve assembly 100 receives pressurized fluid via fluid inlets 102, 104, the high-pressure zone may have a pressure level in a range of about 20 PSI (about 137.90 kPa) to about 30 PSI (about 206.84 kPa), while the low-pressure zone (e.g., defined by first cavity 105, second cavity 108, third cavity 134, and / or chamber 129) may have a pressure level in a range of about 14 PSI (about 96.527 kPa) to about 25 PSI (about 172.37 kPa). For example, the pressure level in the high-pressure zone may be about 21 psi (about 144.79 kPa), while the pressure level in the low-pressure zone may be about 16 psi (about 110.32 kPa). In some embodiments, the biasing force of the biasing mechanism 124 may be about 20 lb / inch (about 3502.54 N / m).

[0055] Thus, the first portion of the pressurized fluid can move the piston assembly 120 downward relative to the first container 103 and the second container 110 from a first position ( FIG. 4A ) to a second position ( FIG. 4B ). For example, the first portion of the pressurized fluid can bias the piston 122 downward relative to the first container 103 (e.g., toward the second cavity 108), thereby countering the bias generated by the biasing mechanism 124 and compressing the biasing mechanism 124. The piston rod 128 and the valve 140 can move downward relative to the second cavity 108 (e.g., toward the third cavity 134) when the piston 122 is biased downward relative to the first cavity 105. In other words, the piston rod 128 and the valve 140 can be moved from the first position to the second position.

[0056] 4B , when the piston assembly 120 is in the second position, the valve 140 can be pushed downward into the third cavity 134 (toward the second funnel 107), thereby opening the central opening 137. In this example, the upper end 141 of the valve 140 can disengage from one or more surfaces (e.g., the valve seat) of the first funnel 106 when the piston assembly 120 is moved to the second position, thereby opening the central opening 137. The upper end 141 can be sized, shaped, and / or configured to direct the medicament 180 into the third cavity 134 when the valve 140 is moved to the second position. For example, the upper end 141 may include an angled configuration that directs the drug 180 toward the inner surface 133 of the second funnel 107 when the valve 140 is moved to the second position, thereby facilitating the continuous flow of the drug 180 into the third cavity 134.

[0057] As the medicament 180 flows into the second funnel 107 (through the porous portion 121), the pressurized fluid received within the third cavity 134 can mix with the medicament 180, thereby agitating (e.g., mixing) the medicament 180 within the second funnel 107. As the pressurized fluid agitates the medicament 180 within the third cavity 134, the second funnel 107 can be configured to direct the agitated mixture of medicament 180 and pressurized fluid through the central opening 135 to the tube 118 and through the outlet 190 to the catheter 36 ( FIG. 1 ). In other words, the pressurized fluid can mix with the medicament 180 within the third cavity 134, and the mixture of the pressurized fluid and medicament 180 can simultaneously exit the valve assembly 100 through the tube 118. In other embodiments, at least a portion of the pressurized fluid may be directed (upward) through the central opening 137 when the valve 140 disengages from the valve seat of the first funnel 106 and mix with the drug 180 in the second cavity 108.

[0058] After delivery of the agent 180 to the target treatment site within the patient, the user can deactivate the actuation mechanism 30 (see FIG. 1), thereby stopping further delivery of pressurized fluid to the valve assembly 100. In this case, the pressure levels within each of the high and low pressure zones can equalize (e.g., return to atmospheric pressure levels). In other words, the valve assembly 100 can be depressurized upon completion of delivery of the first and second portions of pressurized fluid to the first container 103 and second container 110, respectively.

[0059] Thus, the pressure level in the high-pressure zone may no longer be relatively greater than the pressure level in the low-pressure zone and / or may no longer be greater than the (upward) biasing force of the biasing mechanism 124. Thus, the biasing force of the biasing mechanism 124 may urge the piston 122 upward toward the cavity 101 as the biasing mechanism 124 transitions from the compressed state to the expanded state. The piston assembly 120 may move from the second position ( FIG. 4B ) to the first position ( FIG. 4A ) as the biasing mechanism 124 expands, thereby re-engaging the valve 140 with the valve seat of the first funnel 106. With the central opening 137 closed by the valve 140, the piston assembly 120 may be configured to fluidly seal the medicament 180 within the second cavity 108.

[0060] In some embodiments, a first portion of the pressurized fluid received within the first container 103 (through the first fluid inlet 102) and a second portion of the pressurized fluid received within the second container 110 (through the second fluid inlet 104) may be vented from the valve assembly 100 upon cessation of further actuation of the actuation mechanism 30. The size and / or shape of the orifice 132 in the tube 130 may control the rate of venting of the pressurized fluid within the valve assembly 100. For example, at least a first portion of the pressurized fluid received within the first container 103 may be vented from the valve assembly 100 through the first fluid inlet 102, and at least a second portion of the pressurized fluid received within the second container 110 may be vented from the valve assembly 100 through the second fluid inlet 104, such as the orifice 132.

[0061] If further delivery of the agent 180 to the target treatment site is desired, the actuation mechanism 30 may be repeatedly actuated to deliver pressurized fluid to the valve assembly 100. Once the actuation mechanism 30 is released, the valve assembly 100 may be depressurized, thereby preventing delivery of the agent 180. It should be appreciated that the valve assembly 100 may be configured to provide a pre-flow of pressurized fluid through the tube 118 (and ultimately the catheter 36) prior to delivering the mixture of pressurized fluid and agent 180 to the target treatment site in the patient.

[0062] For example, upon initial actuation of actuation mechanism 30, at least a portion of the pressurized fluid received into bottom portion 109 from second fluid inlet 104 may be directed toward tube 118 as valve assembly 100 generates a pressure differential between the high pressure zone and the low pressure zone. Thus, valve assembly 100 may be configured to deliver a pre-flow of pressurized fluid through tube 118 and catheter 36, thereby removing any residual material (e.g., medication 180, fluid, water, or bodily fluids) within second funnel 107, tube 118, and / or catheter 36 before valve assembly 100 moves from the first actuation position ( FIG. 4A ) to the second actuation position ( FIG. 4B ).

[0063] With a prior flow of pressurized fluid moving through the bottom portion 109 and into the tube 118, the valve assembly 100 may be further configured to prevent stalling of the delivery of the medicament 180 when a pressure differential is created to move the valve assembly 100 to the second actuated position ( FIG. 4B ). In this example, with the valve 140 disengaged from the valve seat of the first funnel 106 and a prior flow of pressurized fluid already moving through the bottom portion 109 and into the tube 118, the valve assembly 100 may be configured to minimize delay and / or stalling of the delivery of the medicament 180 as the medicament 180 begins to move into the third cavity 134. Instead, the medicament 180 may interact with the prior flow of pressurized fluid being induced into the tube 118 through the bottom portion 109, thereby promoting agitation and delivery of the medicament 180 to the target treatment site with minimal and / or negligible delay. Thus, upon actuation of the actuation mechanism 30, instantaneous delivery of the medicament 180 from the delivery system 10 may be enhanced during a procedure.

[0064] It should be further appreciated that the valve assembly 100 may be configured to provide a subsequent flow of pressurized fluid through the tube 118 (and ultimately the catheter 36) after delivering the mixture of pressurized fluid and agent 180 to the target treatment site on the patient. For example, upon deactivation of the actuation mechanism 30, at least a portion of the pressurized fluid received into the base 109 from the second fluid inlet 104 may be continuously directed toward the tube 118 as the pressure differential between the high-pressure zone and the low-pressure zone equalizes (e.g., during depressurization of the valve assembly 100). Thus, the valve assembly 100 may be configured to deliver a subsequent flow of pressurized fluid through the tube 118 and the catheter 36 without the agent 180, thereby removing any residual material (e.g., agent 180) within the second funnel 107, the tube 118, and / or the catheter 36 when the valve assembly 100 is moved from the second actuation position ( FIG. 4B ) to the first actuation position ( FIG. 4A ).

[0065] Although valve assembly 100 is shown and described herein as having a pneumatic system (e.g., a source of pressurized media), it should be understood that various other suitable systems and / or devices may be utilized to provide corresponding movement of piston assembly 120, particularly piston 122, biasing mechanism 124, piston rod 128, and / or valve 140 (e.g., hydraulic systems, mechanical linkages, actuators, electromechanical systems, etc.).

[0066] 5A and 5B illustrate one or more internal components of delivery system 10, with handle body 12 omitted for ease of illustration. In this example, delivery system 10 may include a mechanical actuation assembly 500 that may be coupled to valve assembly 100 shown and described above. Accordingly, like reference numbers are used to identify like components of valve assembly 100. Mechanical actuation assembly 500 may be movably coupled to actuation mechanism 30 and pressurized medium source 530 of delivery system 10. As described herein, mechanical actuation assembly 500 may be movably coupled to actuation mechanism 30 via one or more links (e.g., bars, rods, cables, etc.) and / or pivot joints (e.g., pins, gears, etc.).

[0067] 5A , the mechanical actuation assembly 500 may further include a movable rod 507 coupled to one or more components of the valve assembly 100, such as the piston assembly 120. The mechanical actuation assembly 500 may thus be configured to move the piston assembly 120 from a first position to a second position (as described in detail above) in response to corresponding movement of the movable rod 507 upon actuation of the actuation mechanism 30. It should be appreciated that with the piston assembly 120 coupled to the actuation mechanism 30 via the mechanical actuation assembly 500, the valve assembly 100 may be configured to transition between the first actuation position ( FIG. 4A ) and the second actuation position ( FIG. 4B ) via movement of the movable rod 507.

[0068] In this example, one or more components of the piston assembly 120, such as the piston 122 disposed within the cavity 101 and / or first cavity 105, may be coupled to the movable rod 507 such that movement of the movable rod 507 can provide corresponding movement of the piston 122 relative to the cavity 101 and / or first cavity 105. For example, the movable rod 507 may extend into the first container 103 and / or the second container 110. Thus, the movable rod 507 may be at least partially disposed within the cavity 101 and / or first cavity 105 to interact with the piston assembly 120.

[0069] 5B , the mechanical actuation assembly 500 may include at least a first pivot joint 502 and a plurality of links 504. The plurality of links 504 may be movably coupled to the actuation mechanism 30 via the first pivot joint 502, such that the plurality of links 504 may be configured to move in response to movement of the actuation mechanism 30 about the first pivot joint 502. The plurality of links 504 may further be coupled to a moveable rod 507, such that the plurality of links 504 may be configured to move the moveable rod 507 in response to movement of the actuation mechanism 30 about the first pivot joint 502.

[0070] In this example, the mechanical actuation assembly 500 (and the plurality of links 504 in particular) may be configured to translate movement of the actuation mechanism 30 in a first direction (e.g., about the first pivot joint 502) into corresponding movement of the movable rod 507 in a second direction, which may be different from the first direction. In some embodiments, the plurality of links 504 may translate lateral movement of the actuation mechanism 30 relative to the handle body 12 (see FIG. 1 ) into longitudinal movement of the movable rod 507 relative to the valve assembly 100. The plurality of links 504 may include a series of rods, bars, cables, pivot joints or pins, gears, rack and pinions, and / or various other suitable mechanisms for translating movement of the actuation mechanism 30 into corresponding movement of the movable rod 507.

[0071] 5A and 5B , the mechanical actuation assembly 500 may include a cam 506 movably coupled to the actuation mechanism 30. The cam 506 may be configured to move (e.g., translate, pivot, etc.) in response to actuation of the actuation mechanism 30. In some embodiments, the cam 506 may be configured to fluidly couple the pressurized medium source 530 to the fluid pressure regulator 540 and / or the valve assembly 100 of the delivery system 10 (e.g., via the tube 130 and the second fluid inlet 104). For example, the cam 506 may be configured to interface and / or engage with a portion (e.g., a fluid seal) of the pressurized medium source 530 to release pressurized fluid stored therein for delivery toward the pressure regulator 540 and / or the valve assembly 100. In some examples, the cam 506 can include a rod and / or needle (not shown) coupled thereto, such that movement of the cam 506 can provide corresponding movement of the rod and / or needle toward the pressurized medium source 530 to interact with (e.g., penetrate, puncture, breach) the fluid seal.

[0072] The pressure regulator 540 may be operable to receive and adjust (e.g., reduce) the flow rate and / or pressure level of the pressurized fluid released from the pressure medium source 530 prior to directing the pressurized fluid to the valve assembly 100 (via the tube 130 and the second fluid inlet 104). Thus, actuation of the actuation mechanism 30 may provide simultaneous movement of the cam 506 (to release the pressurized fluid from the pressurized medium source 530) and the movable rod 507 via the multiple links 504 (to move the piston assembly 120 and release the medicament 180). With the mechanical actuation assembly 500 configured and operable to transition the valve assembly 100 between the first actuation position ( FIG. 4A ) and the second actuation position ( FIG. 4B ), only a single portion of the pressurized fluid is received within the valve assembly 100 for purposes of fluidizing (e.g., agitating, mixing) the medicament 180.

[0073] While the principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art with access to the teachings provided herein will recognize additional modifications, adaptations, and equivalent substitutions that are all within the scope of the examples described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. A valve assembly for a medical device, A container comprising a first region and a second region, and configured to contain a drug within the second region, A first fluid inlet is fluidically coupled to the first region, the first fluid inlet is configured to deliver a first portion of pressurized fluid to the first region, the first portion of pressurized fluid having a first pressure level, and the first fluid inlet A second fluid inlet is fluidically coupled to the second region, the second fluid inlet is configured to deliver a second portion of the pressurized fluid to the second region, the second portion of the pressurized fluid having a second pressure level lower than the first pressure level, A piston assembly disposed within the container, wherein the piston assembly is configured to move relative to the container in response to a first region receiving a first portion of the pressurized fluid and a second region receiving a second portion of the pressurized fluid, and the piston assembly includes a valve configured to move from a first position to a second position in response to the movement of the piston assembly relative to the container. Equipped with, A valve assembly in which, in the first position, the valve is configured to prevent the drug from leaving the second area of ​​the container, and in the second position, the valve is configured to guide the drug out of the second area of ​​the container for delivery from the medical device.

2. The valve assembly according to claim 1, further comprising a first funnel positioned within the second region, wherein the first funnel is configured to receive the drug when the valve is in the first position.

3. The valve assembly according to claim 2, further comprising a second funnel positioned in the second region relatively below the first funnel, wherein the second funnel is configured to receive the drug from the first funnel when the valve is in the second position.

4. The valve assembly according to claim 3, wherein the second funnel is in fluid communication with the pressurized fluid source via the second fluid inlet, and the second funnel includes a porous portion along the wall of the second funnel.

5. The valve assembly according to claim 4, wherein the second funnel is configured to mix the agent received from the first funnel with the second portion of the pressurized fluid received from the second fluid inlet through the porous portion.

6. The valve assembly according to claim 5, wherein the second funnel is configured to guide a mixture of the drug and the second portion of the pressurized fluid into a delivery conduit of the medical device that is in fluid communication with the second region of the container.

7. The valve assembly according to any one of claims 1 to 6, wherein the container is configured to generate a first pressure level of a first portion of a pressurized fluid in a first region and a second pressure level of a second portion of a pressurized fluid in a second region, thereby forming a pressure difference between the first region and the second region.

8. The piston assembly includes a piston at least partially located within the first region and a piston rod at least partially located within the second region, the piston rod having a first end connected to the valve and a second end connected to the piston. The valve assembly according to claim 7, wherein the piston assembly includes a biasing mechanism configured to bias the piston toward a first direction, thereby moving the piston rod and the valve to a first position.

9. The valve assembly according to claim 8, wherein, in response to the formation of the pressure difference between the first region and the second region, the valve assembly is configured to move the piston rod and the valve from a first position to a second position in opposition to the biasing force generated on the piston by the biasing mechanism.

10. The system further comprises a tube connected to the second fluid inlet, the tube configured to deliver the second portion of the pressurized fluid to the second fluid inlet, The valve assembly according to claim 7, wherein the tube includes at least one orifice configured to restrict the flow of the second portion of the pressurized fluid through the second fluid inlet.

11. The valve assembly according to claim 10, wherein the at least one orifice is configured to adjust the second portion of the pressurized fluid to the second pressure level, thereby generating the pressure difference between the first region and the second region.

12. The valve assembly according to claim 10, wherein the at least one orifice is configured to discharge at least the second portion of the pressurized fluid into the ambient atmosphere surrounding the medical device.

13. The valve assembly according to claim 8, wherein the valve includes a plurality of channels configured to regulate the flow rate of the agent moving through the second region when the valve is in the second position.

14. The valve assembly according to claim 13, wherein each of the plurality of channels is separated from an adjacent channel by at least one of the plurality of ribs.

15. The valve assembly according to claim 14, wherein each of the plurality of ribs is configured to prevent lateral movement of the piston rod relative to the second region of the container.

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