Devices, assemblies and methods for delivering medicaments

Abstract

A valve assembly for a medical device includes a container having a first region and a second region, a first fluid inlet in fluid communication with the first region, a second fluid inlet in fluid communication with the second region, and a piston assembly disposed within the container. The container is configured to store a medicament within the second region, the first fluid inlet is configured to deliver a first portion of the pressurized fluid to the first region at a first pressure level, and the second fluid inlet is configured to deliver a second portion of the 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

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 377,456, filed on September 28, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of the present disclosure generally relate to devices and methods for delivering medicaments. More specifically, in some embodiments, the present disclosure relates to devices for delivering powdered medicaments (eg, hemostatic agents). Background Art

[0003] During certain medical procedures, it may be necessary to reduce or stop bleeding in the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the gastrointestinal tract (e.g., the esophagus, stomach, or intestines). During an endoscopic procedure, a user inserts a sheath of an endoscope into a body cavity of a patient. The user controls the endoscope during the procedure using the handle of the endoscope. Tools may be passed through the working channel of the endoscope, such as through ports on the handle, to provide treatment at a surgical site near the distal end of the endoscope. The surgical site is distal to the user.

[0004] To achieve hemostasis at a distal site, a hemostatic agent may be delivered via a device inserted into a working channel of an endoscope. Agent delivery may be achieved, for example, by a mechanical system designed to allow a continuous flow of agent from the device to the distal site. However, such systems may require multiple steps or operations to achieve delivery, or may not achieve a desired agent delivery rate or a desired agent dosage. As a result, these systems may be inefficient, may not achieve a desired agent delivery rate, may cause the agent to clog portions of the delivery device, and / or may cause inconsistent agent dosages. The present disclosure may address one or more of these problems, or other problems in the art. Summary of the invention

[0005] Each aspect disclosed herein may include one or more features described in relation to any other disclosed aspect.Aspects of the present disclosure relate particularly 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 may include: a container comprising a first region and a second region, the container being configured to contain a medicine in the second region; a first fluid inlet being fluidly connected to the first region, the first fluid inlet being 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 being fluidly connected to the second region, the second fluid inlet being configured to deliver a second portion of pressurized fluid to the second region, the second portion of pressurized fluid having a second pressure level lower than the first pressure level; a piston assembly disposed in the container, the piston assembly being configured to move relative to the container in response to the first region receiving the first portion of pressurized fluid and the second region receiving the second portion of pressurized fluid, wherein the piston assembly includes a valve, the valve being configured to move from a first position to a second position in response to movement of the piston assembly relative to the container, wherein, in the first position, the valve is configured to prevent the medicine from leaving the second region of the container, and in the second position, the valve is configured to guide the medicine to leave the second region of the container for delivery from the medical device.

[0006] Any valve assembly described herein may include any of the following features. A first funnel, located within the second region, wherein the first funnel is configured to receive a medicament when the valve is in a first position. A second funnel, located within the second region and relatively below the first funnel, wherein the second funnel is configured to receive a medicament from the first funnel when the valve is in a second position. The second funnel is in fluid communication with a source of pressurized fluid through a second fluid inlet, and the second funnel includes a porous portion along its wall. 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. 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 the first portion of the pressurized fluid within the first region and a second pressure level of the second portion of the pressurized fluid within the second region, thereby forming a pressure differential between the first region and the second region. The piston assembly includes a piston at least partially disposed in a first region and a piston rod at least partially disposed in a second region, wherein a first end of the piston rod is connected to a valve, a second end is connected to the piston, and wherein the piston assembly includes a biasing mechanism configured to bias the piston in a first direction, thereby moving the piston rod and the valve to a first position. In response to a pressure difference between the first region and the second region, the valve assembly is configured to offset the biasing force generated by the biasing mechanism on the piston to move the piston rod and the valve from the first position to the second position. A pipeline connected to a second fluid inlet, the pipeline is configured to deliver a second portion of pressurized fluid to the second fluid inlet, wherein the pipeline includes at least one orifice, the orifice is configured to limit the flow rate of the second portion of pressurized fluid through the second fluid inlet. The orifice is configured to adjust the second portion of the pressurized fluid to a second pressure level, thereby generating a pressure difference between the first region and the second region. The orifice is configured to discharge at least the second portion of the pressurized fluid into the surrounding environment of the medical device. The valve includes a plurality of channels, the plurality of channels being configured to adjust the flow rate of the medicament passing 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 the plurality of ribs. Each of the plurality of ribs is configured to inhibit lateral movement of the piston rod relative to the second region of the container.

[0007] 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 connected to the container fluid; a piston assembly disposed in the container and movable relative to the container, the piston assembly including a valve configured to release the medicament from the container when moving from a first position to a second position; and an actuation assembly connected to the actuator, the piston assembly and a pressurized fluid source, wherein, in response to actuating the actuator, the actuation assembly is configured to: interact with the pressurized fluid source to release the pressurized fluid from the source into the container through the fluid inlet; and move the piston assembly within the container to reposition the valve from the first position to the second position and release the medicament from the container, wherein the pressurized fluid is configured to mix with the medicament within the container and direct the mixture of the medicament and the pressurized fluid to an outlet connected to the container fluid.

[0008] Any valve assembly disclosed herein may include any of the following features. The actuating assembly includes a cam connected to a pressurized fluid source and at least one movable rod connected to a piston assembly, wherein the cam is configured to engage a seal of the pressurized fluid source to release the pressurized fluid, and at least one movable rod is configured to push the valve to a second position. The valve includes a plurality of channels (grooves) and a plurality of ribs arranged around the periphery of the valve, wherein at least one of the plurality of ribs is located between a pair of adjacent channels in the plurality of channels. The plurality of channels are configured to control the flow rate of the medicament passing through the valve when the valve is in the second position.

[0009] According to another example, a method for delivering a medicament from a medical device may include: releasing a pressurized fluid into a first region of a valve assembly of the medical device to pressurize the first region to a first pressure level and pressurize a second region of the valve assembly to a second pressure level lower than the first pressure level, wherein the second region contains the medicament; generating 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; moving a piston assembly relative to the first region and the second region in response to the valve assembly generating a pressure differential between the first region and the second region, wherein the piston assembly includes a valve configured to move from a first position to a second position when a pressure differential is generated within the valve assembly; and releasing the medicament from the second region when the valve moves to the second position, thereby mixing the pressurized fluid and the medicament before delivery from the medical device.

[0010] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the claimed invention. As used herein, the terms "comprises," "comprising," or any other variations are intended to cover non-exclusive inclusions such that a process, method, article, or device that includes a series of elements includes not only those elements, but may also include other elements not expressly listed, or elements inherent to such processes, methods, articles, or devices. The term "diameter" may refer to the width of an element when it is non-circular. The terms "top" and "upper" refer to the direction or side of the device relative to its orientation during use, and the terms "bottom" and "lower" refer to the direction or side of the device relative to its orientation during use that is opposite to the "top" and "bottom." The term "exemplary" is used in the sense of "example," not in the sense of "ideal." The term "about" or similar terms (e.g., "substantially") include a range of + / -10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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 present disclosure.

[0012] Figure 1 An exemplary delivery device according to some embodiments is shown.

[0013] Figure 2 According to some embodiments Figure 1 A cross-sectional view of an exemplary valve assembly of a delivery device.

[0014] Figure 3A According to some embodiments Figure 2 Top view of the valve in the valve assembly.

[0015] Figure 3B According to some embodiments Figure 3A Sectional view of the middle valve, along Figure 3A Intercepted from line 3B-3B in .

[0016] Figure 4A According to some embodiments Figure 2 The first actuated position of the valve assembly.

[0017] Figure 4B According to some embodiments Figure 2 The second actuated position of the valve assembly.

[0018] Figure 5A According to some embodiments Figure 1 An exemplary actuation assembly for a delivery device in the embodiment of the present invention.

[0019] Figure 5BAccording to some embodiments Figure 5A A partial side view of a portion of the actuation assembly. DETAILED DESCRIPTION

[0020] 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) to a medical surgical site. The valve assembly may include a piston assembly and a valve, which are configured to release a medicament stored in the delivery device when moving between a first position and a second position in response to the valve assembly receiving a pressurized fluid (e.g., a gas) from a pressurized medium source (e.g., a gas tank). The medicament may be contained within a housing of the dispensing device and communicated with the pressurized fluid fluid through one or more inlets of the valve assembly.

[0021] 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 medicament can be released from the housing and exposed to the pressurized fluid. The medicament may be agitated when interacting with the pressurized fluid prior to delivery to a target site of a medical procedure. Various aspects of the dispensing device and valve assembly, such as the piston assembly and the valve, can facilitate controllable fluidization (e.g., agitation) of the medicament as the pressurized fluid flows prior to delivery of the medicament, which can help selectively control the flow rate of the medicament out of the dispensing device, helping to prevent or minimize blockages during delivery.

[0022] Figure 1 A delivery system 10 is shown, which can be a powder delivery system. The delivery system 10 can include a handle body 12. The handle body 12 can include or be configured to accommodate a housing 14 (or other source or container) for storing a material (e.g., a powdered medicament). The housing 14 can be connected to the handle body 12 for providing the medicament to the handle body 12, or a cover / housing for the medicament can be screwed to or otherwise connected to the housing 14 for supplying the medicament to the housing 14. The medicament can be, for example, a powdered medicament, such as a hemostatic agent. The medicament can also be another type of medicament or material, or a medicament form (e.g., a liquid or gel-like medicament), and can have any desired function. The housing 14 can be removably connected to other components of the delivery system 10, including components of the handle body 12.

[0023] The handle body 12 can have a variety of features, which will be discussed in further detail herein. U.S. Patent Application No. 16 / 589,633, filed on October 1, 2019, was published as U.S. Patent Application Publication No. 2020 / 0100986A1 on April 2, 2022, the disclosure of which is incorporated herein by reference in its entirety, and the application discloses features of exemplary delivery devices and systems. The features of the present disclosure may be combined with any features described in the above-referenced applications. The features described herein may be used alone or in combination and are not mutually exclusive. Where possible, the same reference numerals and / or terms are used to represent similar structures.

[0024] Still reference Figure 1 , the delivery system 10 may include an actuation mechanism 30 for activating the flow of a pressurized fluid (e.g., gas) from a pressurized medium source in fluid communication with the delivery system 10. The actuation mechanism 30 may be selectively actuated (e.g., manually depressed) or otherwise moved or actuated to control the delivery of a material (e.g., a powdered medicament) and a pressurized fluid. The pressurized fluid alone, or a combination of the powdered medicament and the fluid, may be delivered from an outlet 34 of the handle body 12. The outlet 34 may be in fluid communication with a delivery conduit (e.g., conduit 36) or other component for delivering the combination of the medicament and the fluid to a desired location within a patient's body cavity.

[0025] Figure 2 Various aspects of an exemplary valve assembly 100 are shown. The valve assembly 100 can be housed within the handle body 12 of the delivery system 10, and in particular within the housing 14. In some embodiments, the valve assembly can be connected to the handle body 12 in place of the housing 14. The valve assembly 100 can be selectively actuated when a pressure differential is created within the valve assembly 100. The pressure differential can be created by introducing a pressurized fluid into the valve assembly 100, which can be moved by the actuation mechanism 30 (see Figure 1 ) is selectively introduced into the valve assembly 100. Although not shown, the actuation mechanism 30 may include one or more other actuation elements, such as triggers, buttons, sliders, levers, knobs, dials, and various other suitable actuators. As described herein, actuation of the actuation mechanism 30 may release pressurized fluid to the valve assembly 100 and / or move the valve assembly 100, thereby controlling the delivery of the medicament through the valve assembly 100 to the target treatment site in the patient's body.

[0026] Alternatively, as described in detail below, the actuation mechanism 30 may be connected to the valve assembly 100 via a mechanical actuation assembly configured to selectively actuate the valve assembly 100 (see Figure 5A-5BAs described herein, the mechanical actuation assembly may include one or more cables, wires, rods, and / or various other suitable mechanisms for releasing pressurized fluid to the valve assembly 100 and / or moving one or more internal components of the valve assembly 100.

[0027] Still reference Figure 2 , the valve assembly 100 may include a first (top) container 103 and a second (bottom) container 110 connected to each other. 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 together form a canister, defining a housing for storing the medicament 180. Therefore, 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.

[0028] The second container 110 may include a bottom portion 109, a top portion 112 opposite the bottom portion 109, and an intermediate portion 114 disposed between the bottom portion 109 and the top portion 112. In this example, at least one or more of the intermediate portion 114 and / or the bottom portion 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 portion 112, a second (middle) cavity 108 along the intermediate portion 114, and a third (lower) cavity 134 within the bottom portion 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 each other. As described herein, the cavity 101 of the first container 103 may be isolated from the cavity fluid of the second container 110 by a gasket located between the cavity 101 and the first cavity 105.

[0029] In some embodiments, at least a portion of the cavity 101 can define a high pressure region of the valve assembly 100, and one or more of the first cavity 105, the second cavity 108, and / or the third cavity 134 can define a low pressure region of the valve assembly 100. In one example, the first cavity 105 can define a portion of the low pressure region. Alternatively, in other embodiments, the cavity 101 and at least a portion of the first cavity 105 can jointly define a high pressure region of the valve assembly 100.

[0030] Still reference Figure 2, the second container 110 can be configured to contain a medicament, such as a medicament 180 (e.g., a powder) in the second cavity 108. In some embodiments, each of the first container 103 and the second container 110 can include a complementary connection interface so that the bottom portion of the first container 103 can be selectively connected to the top portion 112 of the second container 110. For example, the outer surface of the second container 110 can include a threaded portion 111 along the top portion 112, and the inner surface of the first container 103 can include a corresponding threaded portion 115 for engaging with the threaded portion 111 of the second container 110. However, various suitable connection mechanisms and / or interfaces can be used to connect the first container 103 to the second container 110 without departing from the scope of the present disclosure.

[0031] The first container 103 can be in fluid communication with a first fluid inlet 102, which is in fluid communication with a source of pressurized medium (not shown), such that the valve assembly 100 can be configured to receive a pressurized fluid at the first container 103 through the first fluid inlet 102. As described herein, the first fluid inlet 102 can define a high-pressure fluid inlet of the valve assembly 100. The second container 110 can be in fluid communication with a second fluid inlet 104, which is in fluid communication with a source of pressurized medium, such that the valve assembly 100 can be configured to receive a pressurized fluid at the second container 110, particularly at the chamber 129 of the bottom portion 109, through the second fluid inlet 104. As described herein, the second fluid inlet 104 can define a low-pressure fluid inlet of the valve assembly 100.

[0032] In some embodiments, the valve assembly 100 can be configured to simultaneously receive pressurized fluid at 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 can 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 can be configured to receive pressurized fluid from the second fluid inlet 104 because the bottom portion 109 is in fluid communication with the middle portion 114.

[0033] Although the fluid inlets 102, 104 are shown on the respective sidewalls of the first container 103 and the second container 110, respectively, it should be understood that the fluid inlets 102, 104 can be located in various alternative positions relative to the valve assembly 100 without departing from the scope of the present disclosure. In some embodiments, the inner wall and / or outer wall of the first fluid inlet 102 can include an interface (e.g., a lip, a protrusion, a tab, a groove, etc.) configured to facilitate the connection between the first fluid inlet 102 and a conduit (not shown) in fluid communication with a pressurized medium source. Thus, the conduit can fluidly connect the first container 103 with the pressurized medium source for delivering the pressurized fluid into the cavity 101. The inner wall and / or outer wall of the second fluid inlet 104 can include an interface (e.g., a lip, a protrusion, a tab, a groove, etc.) configured to facilitate the connection between the second fluid inlet 104 and a conduit 130 in fluid communication with the pressurized medium source. Thus, the conduit 130 can fluidly connect the second container 110 with the pressurized medium source for delivering the pressurized fluid into the third cavity 134.

[0034] The conduit 130 may include an opening and / or orifice 132 extending through a sidewall 131 of the conduit 130. The orifice 132 may establish fluid communication between the conduit 130 (specifically, the inner cavity of the conduit 130) and an area outside the conduit 130 that is exposed to atmospheric pressure. As described herein, the valve assembly 100 may be configured to generate a ratio and / or pressure differential of high-pressure fluid and low-pressure fluid between the first container 103 and the second container 110 based on the pressure levels of the fluids received at the first fluid inlet 102 and the second fluid inlet 104, respectively.

[0035] Specifically, the orifice 132 can be configured to restrict and / or regulate the flow of pressurized fluid entering the second container 110 through the second fluid inlet 104, while the flow of pressurized fluid entering the first container 103 can remain relatively unrestricted and / or unregulated. Therefore, due to the restricted flow of pressurized fluid entering the second container 110 (particularly the chamber 129, the third cavity 134, the second cavity 108, and the first cavity 105), the valve assembly 100 can be configured to form a low pressure region within one or more of the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129. Due to the unrestricted flow of pressurized fluid entering the first container 103, the valve assembly 100 can be configured to form a high pressure region within the cavity 101. In other words, the valve assembly 100 can make the fluid pressure level within the cavity 101 higher relative to at least the cavity 134, thereby forming a high pressure region and a low pressure region, respectively.

[0036] It should be understood that the pressure level within the low pressure region may vary relative to one or more of the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129. For example, the relative pressure level of the first cavity 105 may be lower than one or more of the second cavity 108, the third cavity 134, and / or the chamber 129. For another example, the relative pressure level of the third cavity 134 and / or the chamber 129 may be higher than one or more of the first cavity 105 and / or the second cavity 108.

[0037] Thus, the orifice 132 can be configured to restrict the flow of pressurized fluid entering the valve assembly 100 through the second fluid inlet 104, so that releasing a portion of the fluid through the orifice 132 (e.g., releasing into the surrounding atmosphere of the delivery system 10) can control (e.g., reduce) the pressure level of the fluid received in the conduit 130. Since the conduit (not shown) connected to the first fluid inlet 102 does not include an orifice, the pressure level of the pressurized fluid received in the first container 103 (specifically, the cavity 101) may be higher than the pressure level of the pressurized fluid received in the second container 110 (specifically, the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129). The difference in pressure levels can form a high pressure area at the cavity 101 within the valve assembly 100, and a low pressure area at the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129. As described herein, the high pressure region and the low pressure region may be separated from one another by one or more devices of the valve assembly 100 , such as the piston 122 and the gasket 127 .

[0038] In some embodiments, the size and / or shape of the orifice 132 can be determined based on a desired pressure differential to be generated between high pressure and low pressure regions within the valve assembly 100. For example, the size and / or shape of the orifice 132 can be set such that the orifice 132 is configured to limit the flow rate and / or pressure level of the pressurized fluid entering the second container 110 to within a range of about 800 liquid ohms to about 1200 liquid ohms, such as 1000 liquid ohms. The nominal pressure level within the valve assembly 100 can be within a range of about 5 psi to about 75 psi.

[0039] Still reference Figure 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 medicament 180 may flow (e.g., under gravity) from the second cavity 108 to 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., the valve 140) thereon. In some embodiments, the second funnel 107 may be in fluid communication with a conduit 118, which may be fluidly connected to the bottom end 136 of the second funnel 107. The conduit 118 may include a connector 113 operable and configured to connect the conduit 118 to the valve assembly 100. The connector 113 can have a spherical shape defining one or more flanges to facilitate gripping and / or handling of the conduit 118 during connection to the valve assembly 10 (particularly the bottom portion 109). It should be understood that the connector 113 can have a variety of other shapes and / or sizes that can be suitable for providing a surface for gripping and facilitating connection of the conduit 118 to the valve assembly 100.

[0040] In some embodiments, the first funnel 106 may include a wall 116, which may have a generally conical or funnel shape; however, 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 size and / or shape of the wall 116 may be set to form a variable cross-sectional profile between the top and bottom ends of the first funnel 106. In other words, the wall 116 may taper radially inward toward the central opening 137. Therefore, when the agent 180 moves downward through the first funnel 106, the agent 180 may encounter portions of the first funnel 106 that are different in size, which may help reduce the blockage of the agent 180 in the second container 110. If there is no change in the size of the first funnel 106, the agent 180 may easily form a bridge, thereby causing a blockage. In other words, the first funnel 106 can be configured to suppress the accumulation and / or blockage of the agent 180 in the second container 110 by guiding the agent 180 to move along the wall 116 toward the central opening 137.

[0041] Still reference Figure 2, the second funnel 107 may include a wall 119 having a generally conical or funnel shape. The size and / or shape of the wall 119 may be set to form a varying cross-sectional profile between the top end and the bottom end 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. Therefore, the diameter of the third cavity 134 at the top end of the second funnel 107 may be larger relative to the bottom end 136. The inner surface 133 of the wall 119 may at least partially define the third cavity 134 for receiving the agent 180 from the first funnel 106 (e.g., under the action of gravity), and the third cavity 134 may terminate at the central opening 135. When the agent 180 moves downward through the second funnel 107, the agent 180 may encounter portions of the third cavity 134 of different sizes, which may help reduce the blockage of the agent 180 in the third cavity 134.

[0042] As described above, without the change in diameter of the third cavity 134, the medicament 180 may easily form a bridge, thereby causing a blockage. As described herein, in response to corresponding movement of one or more components of the valve assembly 100 (e.g., the valve 140), the medicament 180 can at least partially enter the third cavity 134 from the second cavity 108. Although the first funnel 106 and the second funnel 107 shown and described herein have substantially similar shapes and / or cross-sectional profiles, it should be understood that each funnel can have a varying shape and / or size relative to the other funnel without departing from the scope of the present disclosure.

[0043] Still reference Figure 2 , the wall 119 can have a constant thickness between the top end and the bottom end 136 of the second funnel 107. In other embodiments, the wall 119 can have a varying thickness. In addition, the conduit 118 can be connected to the second funnel 107 at the bottom end 136 so that the conduit 118 is in fluid communication with the third cavity 134 through the central opening 135. The conduit 118 can be connected to the second funnel 107 by various suitable mechanisms, including but not limited to adhesives, friction fit, one or more complementary interfaces (e.g., ridges, tabs, protrusions, grooves), etc. The conduit 118 can include an outlet 190 that is connected to the conduit 36 ​​(see Figure 1 ) fluid communication. Thus, as described herein, the medicament 180 and pressurized fluid received in the second funnel 107 can be directed through the conduit 118 (through the central opening 135) and delivered to the patient through the catheter 36.

[0044] 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 channels 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 be free of pores and / or channels. In other words, a plurality of pores and / or channels may be positioned only along the porous portion 121. In this example, the porous portion 121 may be positioned relatively close 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 majority of the wall 119 may be sintered and / or porous, such that a plurality of pores and / or channels may be formed along the entire portion of the wall 119. The size, shape, and other configurations of each of the plurality of channels may be set to allow the pressurized fluid from the second fluid inlet 104 to be received through the wall 119, and to inhibit the agent 180 from leaving the third cavity 134 through the wall 119.

[0045] Still reference Figure 2 , the upper end of the second funnel 107 can be at least partially disposed within the bottom portion 109 and relatively located below the first funnel 106. In addition, the second funnel 107 can be fluidly connected to the middle portion 114 through the first funnel 106. In this example, the upper end of the second funnel 107 can be connected to the first funnel 106 and / or one or more surfaces defining the middle portion 114 of the second container 110, and configured to form a seal with them. In some examples, the valve assembly 100 may include one or more sealing mechanisms (e.g., O-rings) located between the interface of the second funnel 107 and the first funnel 106, for connecting the second funnel 107 fluidly to the second cavity 108, particularly the first funnel 106 disposed therein. Since the second funnel 107 is connected to the second cavity 108, the medicament 180 can be moved from the second cavity 108 to the second funnel 107 through the first funnel 106. As described herein, valve assembly 100 may be configured to deliver a mixture of medicament 180 (stored in second cavity 108 ) and pressurized fluid (received at third cavity 134 ) to a patient via second funnel 107 .

[0046] Still reference Figure 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 in one or more of the first container 103 and the second container 110. The piston 122 may include an upper body 123 at least partially accommodated in the cavity 101 and the first cavity 105, and a lower body 126 accommodated in the second cavity 108. The cross-sectional dimension of the upper body 123 may be relatively larger than the cross-sectional dimension of the lower body 126. In some embodiments, the first (top) end of the piston rod 128 may be connected to the lower body 126 of the piston 122 in the second cavity 108, and the second (bottom) end of the piston rod 128 may be connected to the top end of the valve 140 in the second cavity 108. In some embodiments, the piston 122 may include an internal threaded portion on the lower body 126, and the piston rod 128 may include an external threaded portion on the first (top) end for threaded connection with the internal threaded portion of the lower body 126. The piston rod 128 may also include an externally threaded portion on the second (bottom) end for threaded connection with an internally threaded portion of the valve 140 .

[0047] The valve 140 may include a top portion or tip 141 that is sized, shaped, and / or otherwise configured to engage the first funnel 106, particularly the central opening 137 (e.g., a valve seat of the first funnel 106). In this example, the tip 141 may be at an angle 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 engages at least a portion of the first funnel 106 (e.g., a 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 be disengaged from the first funnel 106 when moved upward (e.g., retracted) into the second cavity 108. The valve 140 may be configured to allow the medicament 180 received on the first funnel 106 to move toward the second funnel 107 (e.g., under the action of gravity) when moving from the first (closed) position to the second (open) position.

[0048] The piston assembly 120 can be configured to respond to the valve assembly 100 receiving a pressurized fluid from a pressurized medium source (see Figure 4A-4B ), converting (moving) the piston 122, the piston rod 128, and the valve 140 between one or more configurations. For example, the piston assembly 120 can be actuated to move the piston 122, the piston rod 128, and the valve 140 between one or more positions relative to the first container 103, the second container 110, and / or the funnels 106, 107. As described herein, the piston assembly 120 can be actuated in response to the valve assembly 100 receiving a pressurized fluid from a pressurized medium source of the delivery system 10 through the first fluid inlet 102 and the second fluid inlet 104.

[0049] Still reference Figure 2 , the piston assembly 120 may also include at least one biasing mechanism 124 disposed within the first cavity 105 of the top portion 112. The biasing mechanism 124 may be connected to the piston 122, particularly to the lower end of the piston 122, such that the biasing mechanism 124 may be disposed between the lower end of the piston 122 and the inner (bottom) surface of the top portion 112 defining the first cavity 105. The biasing mechanism 124 may be configured to push the piston 122 in a first (upward) direction relative to the first cavity 105, thereby pushing the piston 122 away from the inner (bottom) surface defining the first cavity 105. The valve assembly 100 may include at least one gasket 127 connected to the piston 122 and adjacent to the top surface 125 of the piston 122. The gasket 127 may be disposed around the exterior of the piston 122 and may be configured to inhibit the movement of a fluid (e.g., a gas) between the opposite ends of the piston 122. Thus, the gasket 127 may inhibit fluid communication between the cavity 101 and the first cavity 105. The biasing mechanism 124 can be configured to bias the piston 122 and the valve 140 connected thereto via the piston rod 128 to a first position (see Figure 4A As shown and described below, when the piston 122 is in the first position, the valve 140 can be configured to engage with a portion of the first funnel 106 (eg, a valve seat at the central opening 137).

[0050] Alternatively, in an embodiment where the valve 140 can be disengaged from the first funnel 106 by retracting upward into the second cavity 108, the biasing mechanism 124 can be relatively disposed above the piston 122, such as within the cavity 101. In this case, the biasing mechanism 124 can be configured to push the piston 122 in a downward direction relative to the first cavity 105, thereby pushing the piston 122 toward the interior (bottom) surface defining the first cavity 105.

[0051] The piston assembly 120 can be configured to compress the biasing mechanism 124 in response to actuation of the actuation mechanism 30 and receiving pressurized fluid in the chamber 101 (through the first fluid inlet 102) and the third chamber 134 (through the second fluid inlet 104). The pressurized fluid received in the first container 103 and the second container 110 of the valve assembly 100 can generate a pressure differential between the first container 103 (e.g., the first region) and the second container 110 (e.g., the second region). In this case, the generated pressure differential can cause the piston 122, the piston rod 128, and the valve 140 to move downward relative to the first chamber 105, the second chamber 108, and the third chamber 134, for example, to move to the second position (see Figure 4B As shown and described below, when the piston 122 moves to the second position, the valve 140 can be configured to disengage from a portion of the first funnel 106 (eg, a valve seat).

[0052] refer to Figure 3A and Figure 3B The size, shape, and / or other configuration of the valve 140 can be configured to regulate (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 can include one or more features and / or surfaces for controlling the flow rate of the medicament 180 fed by gravity to enhance a continuous and stable pressure, volume, and / or dosage rate of the medicament 180 output from the valve assembly 100.

[0053] Specific reference Figure 3A , the valve 140 may include a body having a plurality of ribs 146 adjacent to the plurality of channels 144 (recesses 144), the body of the valve 140 being sized, shaped, and / or otherwise 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 are collectively sized, shaped, and / or otherwise configured to accommodate metered flow of the medicament 180 through the valve 140. The plurality of channels 144 may extend through the valve 140 such that the medicament 180 may flow through the central opening 137 through the plurality of channels 144 when the valve 140 is moved (repositioned) from the second cavity 108 to the third cavity 134.

[0054] The plurality of ribs 146 can be configured to at least partially restrict 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 can include at least three channels (grooves) 144 and at least three ribs 146. It should be understood that the valve 140 can include more or fewer channels 144 and / or ribs 146 than shown and described herein without departing from the scope of the present disclosure.

[0055] refer to Figure 3B , the plurality of channels 144 and the plurality of ribs 146 can be configured to increase the flow rate of the medicament 180 through the central opening 137 when the valve 140 is moved (repositioned) to the second position. The increase in flow rate may be because the medicament 180 passes through the plurality of channels 144 in smaller amounts, rather than passing through a single orifice at the central opening 137 in its entirety.

[0056] For example, due to the presence of the plurality of channels 144 and the plurality of ribs 146 within the central opening 137, the valve 140 can be configured to deliver the medicament 180 at a flow rate greater than about 0.08 g / s. Alternatively, as an illustrative example, in the case where the channels 144 and the ribs 146 are omitted, the valve 140 can be configured to deliver the medicament 180 at a flow rate of about 0.055 g / s. The particle size of the medicament 180 can range from about 320 μm to about 740 μm, and the valve assembly 100 can be configured to deliver the medicament 180 at a flow rate of about 5 liters / minute.

[0057] In some embodiments, the size and / or diameter of the plurality of channels 144 can at least partially determine the flow rate of the powdered medicament (e.g., medicament 180) through the system. For example, in embodiments where the plurality of channels 144 are relatively large in size, the valve assembly 100 can be configured to allow a higher flow rate of the powdered medicament (e.g., medicament 180) relative to other embodiments where the plurality of channels 144 are relatively small in size. In other embodiments, the size and / or shape of the plurality of ribs 146 can at least partially determine the flow rate of the powdered medicament (e.g., medicament 180) through the system.

[0058] Still reference Figure 3B , the plurality of ribs 146 can be configured to enhance the stability of the piston rod 128 relative to the second cavity 108. For example, the plurality of ribs 146 can be disposed around the outer periphery of the valve 140, which surrounds and surrounds the periphery of the piston rod 128. The enhanced stability provided by the plurality of ribs 146 around the outer periphery of the piston rod 128 can be used to inhibit the piston rod 128 from tilting or otherwise moving laterally within the second container 110, thereby maintaining a concentric position of the piston rod 128 relative to the second cavity 108 and / or the central opening 137.

[0059] In an exemplary use, Figure 4A As shown, in the actuating mechanism 30 (see Figure 1 ) before actuation, the medicament 180 can be stored in the second container 110, in particular in the second cavity 108. When the valve assembly 100 does not receive a pressurized fluid, the valve assembly 100 can be in a first actuation position, and the piston assembly 120 is in a first position relative to the first container 103 and / or the second container 110. When in the first actuation position, the corresponding cavities of the first container 103 and / or the second container 110 can be at an atmospheric pressure level. Since the valve 140 is connected to the second (bottom) end of the piston rod 128, the valve 140 can be positioned to engage with the first funnel 106, in particular against one or more surfaces (e.g., a valve seat) defining the central opening 137. Therefore, when the valve assembly 10 is in the first actuation position, the valve 140 can be configured to close and / or seal the central opening 137, thereby preventing the medicament 180 from leaving the second cavity 108 and entering the third cavity 134.

[0060] In some embodiments, the size, shape, and other configurations of the valve 140 can be set to fit tightly between the first funnel 106 and the second funnel 107. In some embodiments, the cross-sectional profile of the valve 140 can be substantially similar to the diameter of the central opening 137, so that when the valve 140 is received therein, the medicament 180 is blocked from flowing through the central opening 137. In other words, the size, shape, and / or other configurations of the tip 141 can be set to form a fluid seal with the first funnel 106 when the valve 140 is in the first position, thereby blocking the medicament 180 from flowing through the central opening 137 before the piston assembly 120 moves to the second position. By preventing the medicament 180 from being accidentally delivered and / or leaking into the third cavity 134 through the central opening 137, the valve assembly 100 can be configured to prevent the delivery system 10 from being blocked, thereby improving the efficiency of the procedure.

[0061] Still reference Figure 4A When the piston assembly 120 is in the first position, the valve 140 can 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 flowing into the second funnel 107 through the central opening 137. In response to actuating the actuation mechanism 30, a pressurized fluid from a pressurized medium source (not shown) can be received by the valve assembly 100. At least a first portion of the pressurized fluid can be received at the first container 103 through the first fluid inlet 102, and at least a second portion of the pressurized fluid can be received at the bottom portion 109 of the second container 110 through the second fluid inlet 104, for example, from the conduit 130.

[0062] Since the conduit 130 includes the orifice 132, the valve assembly 100 can be configured to generate a pressure difference between the first (unrestricted) portion of the pressurized fluid received in the cavity 101 and the second (restricted) portion of the pressurized fluid received in the third cavity 134. Therefore, a high pressure area is formed in the first container 103 (e.g., the cavity 101 above the piston 122), and a low pressure area is formed in the top portion 112 below the piston 122 (e.g., the first cavity 105) and / or the second container 110 (e.g., the second cavity 108, the third cavity 134 and / or the chamber 129), and the pressure level of the high pressure area is higher than that of the low pressure area. In other words, the pressurized fluid received from the first fluid inlet 102 into the valve assembly 100 can have a first pressure level, and the pressurized fluid received from the second fluid inlet 104 into the valve assembly 100 can have a second pressure level lower than the first pressure level.

[0063] When the pressure level in the high pressure region (e.g., defined by cavity 101) exceeds a predetermined threshold, the pressurized fluid in the high pressure region may be greater than the opposing (upward) biasing force exerted by the biasing mechanism 124 (e.g., a spring) on ​​the piston 122. In other words, the predetermined threshold may correspond to a downward force that is greater than the opposing (upward) biasing force of the biasing mechanism 124. In some embodiments, when the valve assembly 100 receives pressurized fluid through the fluid inlets 102, 104, the pressure level in the high pressure region may be in the range of about 20PSI to about 30PSI, while the pressure level in the low pressure region (e.g., defined by the first cavity 105, the second cavity 108, the third cavity 134, and / or the chamber 129) may be in the range of about 14PSI to about 25PSI. For example, the pressure level in the high pressure region may be about 21psi, while the pressure level in the low pressure region may be about 16psi. In some embodiments, the biasing force of the biasing mechanism 124 may be about 20lb / inch.

[0064] Thus, the first portion of the pressurized fluid can cause the piston assembly 120 to move from a first position ( Figure 4A ) moves to the second position ( Figure 4B ). For example, the first portion of the pressurized fluid can push the piston 122 in a downward direction relative to the first container 103 (e.g., toward the second cavity 108), thereby counteracting the biasing force generated by the biasing mechanism 124 and compressing the biasing mechanism 124. As the piston 122 is pushed downward relative to the first cavity 105, the piston rod 128 and the valve 140 can move downward relative to the second cavity 108 (e.g., toward the third cavity 134). In other words, the piston rod 128 and the valve 140 can be repositioned from the first position to the second position.

[0065] like Figure 4B As shown, 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, when the piston assembly 120 moves to the second position, the top end 141 of the valve 140 can be disengaged from one or more surfaces (e.g., a valve seat) of the first funnel 106, thereby opening the central opening 137. The size, shape, and / or other configuration of the top end 141 can be set to guide the medicament 180 into the third cavity 134 when the valve 140 moves to the second position. For example, the top end 141 can include an inclined configuration that guides the medicament 180 toward the inner surface 133 of the second funnel 107 when the valve 140 moves to the second position, thereby promoting the continuous flow of the medicament 180 into the third cavity 134.

[0066] When the agent 180 flows into the second funnel 107 (through the porous portion 121), the pressurized fluid received in the third cavity 134 can mix with the agent 180, thereby agitating (e.g., mixing with) the agent 180 in the second funnel 107. After the pressurized fluid agitates the agent 180 in the third cavity 134, the second funnel 107 can be configured to guide the agitated mixture of the agent 180 and the pressurized fluid into the conduit 118 through the central opening 135 and through the conduit 36 ​​( Figure 1 ). In other words, the pressurized fluid can mix with the medicament 180 in the third cavity 134, and the mixture of the pressurized fluid and the medicament 180 can simultaneously exit the valve assembly 100 through the conduit 118. In other embodiments, when the valve 140 is disengaged from the valve seat of the first funnel 106, at least a portion of the pressurized fluid can be directed (upward) through the central opening 137 to mix with the medicament 180 in the second cavity 108.

[0067] After delivering the drug 180 to the target treatment site in the patient's body, the user can stop actuating the actuation mechanism 30 (see Figure 1 ), thereby stopping further delivery of the pressurized fluid to the valve assembly 100. In this case, the pressure levels in the high-pressure region and the low-pressure region may balance each other (e.g., return to atmospheric pressure levels). In other words, the valve assembly 100 may be depressurized when delivery of the first and second portions of the pressurized fluid to the first container 103 and the second container 110, respectively, is terminated.

[0068] Therefore, the pressure level in the high pressure region may no longer be relatively higher than the pressure level in the low pressure region and / or greater than the (upward) biasing force of the biasing mechanism 124. Therefore, when the biasing mechanism 124 changes from the compressed state to the expanded state, the biasing force of the biasing mechanism 124 can push the piston 122 upward toward the cavity 101. As the biasing mechanism 124 expands, the piston assembly 120 can move from the second position ( Figure 4B ) moves to the first position ( Figure 4A ), thereby reengaging the valve 140 with the valve seat of the first funnel 106. Since the central opening 137 is closed by the valve 140, the piston assembly 120 can be configured to seal the medicament 180 fluid within the second cavity 108.

[0069] In some embodiments, upon cessation of further actuation of the actuation mechanism 30, a first portion of the pressurized fluid received in the first container 103 (from the first fluid inlet 102) and a second portion of the pressurized fluid received in the second container 110 (from the second fluid inlet 104) can be discharged from the valve assembly 100. The size and / or shape of the orifice 132 in the conduit 130 can control the rate of discharge of the pressurized fluid in the valve assembly 100. For example, at least a first portion of the pressurized fluid received in the first container 103 can be discharged from the valve assembly 100 through the first fluid inlet 102, and at least a second portion of the pressurized fluid received in the second container 110 can be discharged from the valve assembly 100 through the second fluid inlet 104 (e.g., at the orifice 132).

[0070] If further delivery of the medicament 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. Upon release of the actuation mechanism 30, the valve assembly 100 may be depressurized, thereby preventing delivery of the medicament 180. It should be appreciated that the valve assembly 100 may be configured to provide a pre-flow of pressurized fluid through the conduit 118 (and ultimately through the catheter 36) prior to delivering the mixture of pressurized fluid and medicament 180 to the target treatment site of the patient.

[0071] For example, when the actuation mechanism 30 is actuated for the first time, when the valve assembly 100 generates a pressure differential between the high pressure region and the low pressure region, at least a portion of the pressurized fluid received from the second fluid inlet 104 in the bottom portion 109 can be directed toward the conduit 118. Thus, the valve assembly 100 can be configured to deliver a pre-flow of pressurized fluid through the conduit 118 and the conduit 36, so that when the valve assembly 100 is moved from the first actuation position ( Figure 4A ) moves to the second actuation position ( Figure 4B ) before removing any residual material (e.g., agent 180, fluid, water or body fluid) from the second funnel 107, conduit 118 and / or catheter 36.

[0072] As the pressurized fluid pre-flows through the bottom portion 109 into the conduit 118, the valve assembly 100 may be further configured to move to the second actuated position ( Figure 4B), inhibiting stagnation of delivery of the agent 180. In this case, since the valve 140 is disengaged from the valve seat of the first funnel 106 and the pre-flow of the pressurized fluid has entered the conduit 118 through the bottom portion 109, the valve assembly 100 can be configured to minimize the delay and / or stagnation of the delivery of the agent 180 when the agent 180 begins to enter the third cavity 134. On the contrary, the agent 180 can interact with the pre-flow of the pressurized fluid entering the conduit 118 through the bottom portion 109, thereby enhancing the agitation and delivery of the agent 180 to the target treatment site with minimized and / or negligible delay. Therefore, during the surgical procedure, when the actuation mechanism 30 is actuated, the immediate delivery of the agent 180 by the delivery system 10 can be enhanced.

[0073] It should also be appreciated that the valve assembly 100 can be configured to provide a post-flow of pressurized fluid through the conduit 118 (and ultimately through the conduit 36) after the mixture of pressurized fluid and medicament 180 is delivered to the target treatment site of the patient. For example, upon deactivation of the actuation mechanism 30, when the pressure differential between the high pressure region and the low pressure region is balanced (e.g., during depressurization of the valve assembly 100), at least a portion of the pressurized fluid received from the second fluid inlet 104 within the bottom portion 109 can be continuously directed toward the conduit 118. Thus, the valve assembly 100 can be configured to deliver a post-flow of pressurized fluid without the medicament 180 through the conduit 118 and the conduit 36, thereby providing a post-flow of pressurized fluid after the valve assembly 100 is moved from the second actuated position ( Figure 4B ) moves to the first actuation position ( Figure 4A ), clear any residual material (e.g., agent 180) within the second funnel 107, pipe 118 and / or conduit 36.

[0074] Although the valve assembly 100 shown and described herein has a pneumatic system (e.g., a pressurized medium source), it should be understood that various other suitable systems and / or devices may be used to cause the piston assembly 120, particularly the piston 122, the biasing mechanism 124, the piston rod 128 and / or the valve 140 to move accordingly (e.g., hydraulic systems, mechanical linkages, actuators, electromechanical systems, etc.).

[0075] For example, Figure 5A and Figure 5BThe handle body 12 is omitted for illustration purposes only, and one or more internal components of the delivery system 10 are shown. In this example, the delivery system 10 can include a mechanical actuation assembly 500 that can be connected to the valve assembly 100 shown and described above. Therefore, the same reference numerals are used to identify the same components of the valve assembly 100. The mechanical actuation assembly 500 can be movably connected to the actuation mechanism 30 and the pressurized medium source 530 of the delivery system 10. As described herein, the mechanical actuation assembly 500 can be movably connected to the actuation mechanism 30 via one or more linkages (e.g., rods, bars, cables, etc.) and / or pivot joints (e.g., pins, gears, etc.).

[0076] Specific reference Figure 5A , the mechanical actuation assembly 500 may also include a movable rod 507 connected to one or more components of the valve assembly 100 (e.g., the piston assembly 120). Therefore, the mechanical actuation assembly 500 can be configured to move the piston assembly 120 from the first position to the second position (as described in detail above) in response to the corresponding movement of the movable rod 507 when the actuation mechanism 30 is actuated. It should be understood that since the piston assembly 120 is connected to the actuation mechanism 30 through the mechanical actuation assembly 500, the valve assembly 100 can be configured to move from the first position to the second position (as described in detail above) through the movement of the movable rod 507. Figure 4A ) and the second actuation position ( Figure 4B )

[0077] In this example, one or more components of the piston assembly 120, such as the piston 122 disposed within the cavity 101 and / or the first cavity 105, can be connected to the movable rod 507, so that movement of the movable rod 507 can cause the piston 122 to move accordingly relative to the cavity 101 and / or the first cavity 105. For example, the movable rod 507 can extend into the first container 103 and / or the second container 110. Therefore, the movable rod 507 can be at least partially disposed within the cavity 101 and / or the first cavity 105 to interact with the piston assembly 120.

[0078] like Figure 5B As best shown in FIG. 5 , the mechanical actuation assembly 500 may include at least one first pivot joint 502 and a plurality of links 504. The plurality of links 504 may be movably connected 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 also be connected to a movable rod 507, such that the plurality of links 504 may be configured to move the movable rod 507 in response to movement of the actuation mechanism 30 about the first pivot joint 502.

[0079] In this example, the mechanical actuation assembly 500 (particularly the plurality of links 504) can be configured to convert 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 different from the first direction. In some embodiments, the plurality of links 504 can move the actuation mechanism 30 relative to the handle body 12 (see Figure 1 ) is converted into longitudinal movement of the movable rod 507 relative to the valve assembly 100. The plurality of linkages 504 may include a series of rods, bars, cables, pivot joints or pins, gears, racks and pinions, and / or various other suitable mechanisms for converting movement of the actuation mechanism 30 into corresponding movement of the movable rod 507.

[0080] Still reference Figure 5A and Figure 5B , the mechanical actuation assembly 500 may include a cam 506 movably connected 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 connect the pressurized medium source 530 to the fluid pressure regulator 540 of the delivery system 10 and / or the valve assembly 100 (e.g., via the conduit 130 and the second fluid inlet 104). For example, the cam 506 may be configured to engage and / or mesh with a portion of the pressurized medium source 530 (e.g., a fluid seal) to release pressurized fluid stored therein for delivery to the pressure regulator 540 and / or the valve assembly 100. In some examples, the cam 506 may include a rod and / or needle (not shown) connected thereto, such that movement of the cam 506 may cause the rod and / or needle to move accordingly toward the pressurized medium source 530 to interact with (e.g., pierce, puncture, break) the fluid seal.

[0081] The pressure regulator 540 can be operated to receive and regulate (e.g., reduce) the flow rate and / or pressure level of the pressurized fluid released from the pressure medium source 530 before directing the pressurized fluid to the valve assembly 100 (through the conduit 130 and the second fluid inlet 104). Therefore, actuation of the actuation mechanism 30 can simultaneously move the cam 506 (for releasing the pressurized fluid from the pressure medium source 530) and the movable rod 507 (for moving the piston assembly 120 to release the medicament 180) through the plurality of connecting rods 504. Since the mechanical actuation assembly 500 is configured and operable to cause the valve assembly 100 to be in the first actuation position ( Figure 4A ) and the second actuation position ( Figure 4B ) so that only a portion of the pressurized fluid is received into the valve assembly 100 for fluidizing (e.g., stirring, mixing) the agent 180.

[0082] Although the principles of the present disclosure are described herein with reference to the illustrative examples of specific applications, it should be understood that the present disclosure is not limited thereto. After exposure to the teachings provided herein, those of ordinary skill in the art will recognize that additional modifications, applications, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the above description.

Claims

1. A valve assembly for a medical device, comprising: a container comprising a first region and a second region, wherein the container is configured to contain a medicament within the second region; a first fluid inlet in fluid communication with 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 in fluid communication with the second region, the second fluid inlet 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; as well as a piston assembly disposed within the container, the piston assembly configured to move relative to the container in response to the first region receiving the first portion of the pressurized fluid and the second region receiving the second portion of the pressurized fluid, wherein 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; Wherein, 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 to leave the second area of ​​the container so as to be delivered from the medical device. 2 . The valve assembly of claim 1 , further comprising a first funnel located within the second region, wherein the first funnel is configured to receive a medicament when the valve is in the first position.

3. The valve assembly of claim 2, further comprising a second funnel located within the second region and relatively below the first funnel, wherein the second funnel is configured to receive the medicament from the first funnel when the valve is in the second position.

4. The valve assembly of claim 3, wherein the second funnel is in fluid communication with a source of pressurized fluid through the second fluid inlet, and the second funnel includes a porous portion along a wall thereof. 5 . The valve assembly of claim 4 , wherein the second funnel is configured to mix the medicament 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 of claim 5, wherein 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.

7. A valve assembly according to any of the preceding claims, wherein the container is configured to generate a first pressure level of the first portion of the pressurized fluid in the first region and a second pressure level of the second portion of the pressurized fluid in the second region, thereby forming a pressure differential between the first region and the second region.

8. The valve assembly of claim 7, wherein the piston assembly comprises a piston disposed at least partially within the first region and a piston rod disposed at least partially within the second region, wherein the piston rod has a first end connected to the valve and a second end connected to the piston; The piston assembly includes a biasing mechanism configured to bias the piston in a first direction, thereby moving the piston rod and the valve to the first position.

9. The valve assembly according to claim 8, wherein: In response to a pressure differential being established between the first region and the second region, the valve assembly is configured to counteract the biasing force of the biasing mechanism on the piston to move the piston rod and the valve from the first position to the second position.

10. The valve assembly according to any one of claims 7 to 9, further comprising a conduit connected to the second fluid inlet, the conduit being configured to deliver the second portion of pressurized fluid to the second fluid inlet; The conduit includes at least one orifice configured to restrict flow of the second portion of pressurized fluid through the second fluid inlet. 11 . The valve assembly of claim 10 , wherein the at least one orifice is configured to regulate the second portion of the pressurized fluid to the second pressure level, thereby creating a pressure differential between the first region and the second region.

12. The valve assembly of any one of claims 10 to 11, wherein the at least one orifice is configured to discharge at least the second portion of the pressurized fluid into an environment surrounding the medical device.

13. The valve assembly of any one of claims 8 to 12, wherein the valve comprises a plurality of channels configured to regulate a flow rate of the medicament through the second region when the valve is in the second position.

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

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

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