Devices, assemblies and methods for delivering pharmaceutical agents - Patents.com

Abstract

A valve assembly including a body having an inlet in fluid communication with an enclosure of a medical device, an outlet in fluid communication with a delivery conduit of the medical device, and a channel in fluid communication with a source of fluid. The body is configured to move relative to the inlet and outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit. In a first position of the body, the channel is not aligned with at least one of the inlet or outlet, such that the delivery conduit is not in fluid communication with at least one of the enclosure or the source of fluid. In a second position of the body, the channel is aligned with the inlet and outlet, such that the delivery conduit is in fluid communication with the enclosure and the source of fluid.

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to devices and methods for delivering medicaments. More specifically, 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, endoscopic medical procedures may require hemostasis of bleeding tissue within the digestive tract, such as the esophagus, stomach, or intestines.

[0003] During an endoscopic procedure, a user inserts the sheath of the endoscope into a body lumen of a patient. The user utilizes the handle of the endoscope to control the endoscope during the procedure. Tools are passed through the working channel of the endoscope, for example through ports in the handle, to deliver therapy at a treatment site near the distal end of the endoscope, the treatment site being remote from the operator.

[0004] 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, through a system that may be manually operated. However, such systems may require multiple steps or actuations to achieve delivery, may not achieve a desired rate of drug delivery or a desired dosage of drug, may result in the drug clogging a portion of the delivery device, may result in inconsistent dosing of the drug, or may result in the drug not reaching a treatment site deep within the GI tract. The present disclosure may solve one or more of these or other problems in the art. Summary of the Invention

[0005] Each of the embodiments disclosed herein may include one or more of the features described in association with any of the other disclosed embodiments. According to one example, a valve assembly for a medical device includes an inlet in fluid communication with an enclosure of the medical device, the enclosure storing a medicinal agent, an outlet in fluid communication with a delivery conduit of the medical device, and a body having a channel in fluid communication with a source of fluid, the body configured to move relative to the inlet and outlet to selectively fluidly couple the channel with the enclosure and the delivery conduit, wherein in a first position of the body, the channel is not aligned with at least one of the inlet or the outlet, such that the delivery conduit is not in fluid communication with the enclosure or at least one of the source of fluid, and in a second position of the body, the channel is aligned with the inlet and the outlet, such that the delivery conduit is in fluid communication with the enclosure and the source of fluid.

[0006] Any of the valve assemblies described herein may include any of the following features: In the first position, the channel is aligned transversely to an axis extending between the inlet and the outlet; In the second position, the channel is aligned parallel to an axis extending between the inlet and the outlet; The channel is in fluid communication with a source of the fluid when the body is in the first position and the second position; The body is configured to direct the fluid through the channel and into the enclosure via the inlet to agitate the agent in the enclosure when in the first position; The body is configured to direct a mixture of the fluid and the agent from the enclosure through the inlet and into the channel, the channel configured to direct the mixture into the delivery conduit via the outlet; The body includes an insert positioned in the channel, the insert including a porous mesh; The insert is configured to prevent the agent from migrating through the insert toward a source of the fluid and to allow the fluid to pass through the insert. The channel is a first channel, and the body includes a second channel in fluid communication with the first channel, the second channel having a length less than a length of the first channel. In the first and second positions of the body, the second channel is not aligned with the outlet, is in fluid communication with a source of fluid, and is not in fluid communication with the inlet. In a third position of the body, the second channel is aligned with the outlet, such that the delivery conduit is in fluid communication with a source of fluid via the second channel. In the third position of the body, the channel is not aligned with the inlet and the outlet, such that the delivery conduit is not in fluid communication with the enclosure via the first channel. The body includes an insert positioned within the second channel, the insert configured to block the agent from moving through the second channel while allowing the fluid to pass through the second channel.The method further includes a housing defining the inlet and the outlet, the housing configured to receive the body, a gap being formed between the housing and the body, the gap being positioned between the inlet and the outlet such that when the body is in the first position, the delivery conduit is in fluid communication with a source of the fluid through the gap, the gap being sized such that the agent cannot pass through the gap.

[0007] According to another example, a device for delivering a drug includes an enclosure configured to store the drug and having an inlet, a pressurized fluid source configured to store a pressurized fluid, and a valve assembly including a body having a channel, the body configured to move between a first position and a second position to selectively fluidly couple the pressurized fluid source to the enclosure via the channel, wherein in the first position, the valve assembly is configured to misalign the channel with the inlet to prevent the pressurized fluid from moving through the channel and delivering the drug out of the device, and in the second position, the valve assembly is configured to align the channel with the inlet to allow the pressurized fluid to move through the channel and deliver the drug out of the device.

[0008] Any of the devices described herein may include any of the following features: The body includes an insert positioned within the channel, the insert configured to prevent the agent from moving through the insert while allowing the pressurized fluid to pass through the insert. The channel is a first channel, and the body includes a second channel in fluid communication with the first channel. In the first and second positions of the body, the valve assembly is configured to prevent the pressurized fluid from moving out of the device through the second channel, and in a third position of the body, the valve assembly is configured to allow the pressurized fluid to move out of the device through the second channel. The valve assembly includes a housing configured to receive the body, a gap being formed between the housing and the body. When in the first position, the valve assembly is configured to allow the pressurized fluid to move out of the device through the gap while preventing delivery of the agent out of the device.

[0009] According to a further example, a method for delivering a fluid from a medical device including an enclosure for storing a medication includes moving a channel of a valve body to a first position aligned with an inlet and an outlet of the enclosure, thereby allowing fluid to be delivered through the channel and into the enclosure via the inlet to agitate the medication in the enclosure and allowing the fluid and agitated medication to be delivered through the channel toward a delivery conduit of the medical device via the outlet, and moving the channel to a second position not aligned with the inlet and outlet, thereby preventing the fluid from being delivered through the channel into the enclosure via the inlet and preventing the fluid from being delivered toward the delivery conduit via the outlet.

[0010] It can be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the claimed invention. As used herein, the terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "diameter" may refer to width if the element is not circular. The term "top" refers to the direction or side of the device relative to its orientation in use, and the term "bottom" refers to the direction or side of the device relative to its orientation in use that is opposite to "top". The term "exemplary" is used in the sense of "example" rather than "ideal". The term "about" or similar terms (e.g., "substantially") include values ​​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 disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] 1 illustrates an exemplary delivery device. [Diagram 2] 2 shows a perspective view of an exemplary valve assembly of the delivery device of FIG. 1. [Figure 3A] FIG. 3 shows a partial side view of the valve assembly of FIG. 2 in a first position. [Figure 3B] 3 shows a partial side view of the valve assembly of FIG. 2 in a second position. [Figure 4] 2 shows a perspective view of another exemplary valve assembly of the delivery device of FIG. 1. [Figure 5A] 5 shows a partial side view of the valve assembly of FIG. 4 in a first position. [Figure 5B] 5 shows a partial side view of the valve assembly of FIG. 4 in a second position. [Figure 5C] 5 shows a partial side view of the valve assembly of FIG. 4 in a third position. [Figure 6] 2 shows a perspective view of another exemplary valve assembly of the delivery device of FIG. 1. [Figure 7] FIG. 7 shows a perspective view of a movable body of the valve assembly of FIG. [Figure 8A] FIG. 7 shows a partial side view of the valve assembly of FIG. 6 in a first position. [Figure 8B] 7 shows a partial side view of the valve assembly of FIG. 6 in a second position. [Figure 9A] 8 shows a partial side view of the moveable body of FIG. 7 in a first position. [Figure 9B] 8 shows a partial side view of the moveable body of FIG. 7 in a second position. [Figure 10A] 11 illustrates a partial side view of another exemplary valve assembly of the delivery device of FIG. 1 in a first position. [Figure 10B] FIG. 10B shows a partial side view of the valve assembly of FIG. 10A in a second position. [Figure 10C] FIG. 10B shows a partial side view of the valve assembly of FIG. 10A in a third position. [Figure 11] 2 shows a partial side view of another exemplary valve assembly of the delivery device of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] An embodiment of the present disclosure relates to a dispensing device having a valve assembly for selectively releasing a pressurized fluid for delivery of a medicament (e.g., a powdered medicament) to a site of a medical procedure. The valve assembly may include a movable body for fluidly coupling a pressurized medium source (e.g., a gas cylinder) from which the pressurized fluid (e.g., gas) can be released with an enclosure that stores the medicament. The medicament may be received within the enclosure of the dispensing device and selectively in fluid communication with the pressurized fluid through a channel of the movable body. Thus, when the channel is selectively moved by the valve assembly to align with the enclosure, the pressurized fluid received within the channel from the pressurized fluid source can move toward and enter the enclosure to agitate the medicament before it is delivered to a target site of the medical procedure. Aspects of the dispensing device and valve assembly, such as the movable body and the channel, can facilitate fluidization of the medicament with a flow of pressurized fluid before the medicament is delivered, which can help selectively control the flow of pressurized fluid to help prevent or minimize clogging during delivery.

[0013] FIG. 1 illustrates a delivery system 10, which may be a drug (e.g., powder) delivery system. The delivery system 10 may include a handle body 12. The handle body 12 may include or be configured to receive an enclosure 14 (or other source or container) that stores a material (e.g., drug). The enclosure 14 may be coupled to the handle body 12 to supply the drug to the handle body 12, or a drug cap / enclosure may be threaded or otherwise coupled to the enclosure 14 to supply the drug to the enclosure 14. The drug may be, for example, a powdered drug, such as a hemostatic agent. The drug may alternatively be another type of drug or material, or drug form (e.g., liquid or gel drug), and may have any desired functionality. The enclosure 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 may have various features that 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 / 0100986A1, discloses exemplary features of delivery devices and systems, the disclosure of which is incorporated herein by reference in its entirety. Features of the present disclosure may 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. Similar reference numbers and / or terms are used where possible to indicate similar structures.

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

[0016] 2 illustrates aspects of an exemplary valve assembly 100. The valve assembly 100 may be at least partially housed within the handle body 12 of the delivery system 10. In some embodiments, the valve assembly 100 may be selectively actuated (e.g., moved) by an actuation mechanism 30. In other embodiments, the valve assembly 100 may be actuated by a separate actuator, such as a control knob 106 (described in further detail below). In this case, the actuation mechanism 30 may be configured to deliver pressurized fluid from a pressurized fluid source to the valve assembly 100, and the control knob 106 may be configured to actuate (e.g., move) one or more components of the valve assembly 100 to selectively direct the pressurized fluid through the valve assembly 100.

[0017] In further embodiments, the actuation mechanism 30 may be configured to establish fluid communication between a source of pressurized fluid and the valve assembly 100 while simultaneously actuating the control knob 106 to control movement of one or more components of the valve assembly 100. In other words, an operator may only interact with the actuation mechanism 30, which in turn may actuate the control knob 106. Although not shown, the actuation mechanism 30 and / or the control knob 106 may include one or more other actuating elements, such as, for example, buttons, sliders, levers, triggers, dials, and various other suitable actuators. As described herein, actuation of the control knob 106 may control delivery of pressurized fluid and medication through the valve assembly 100.

[0018] The valve assembly 100 may include a housing 102, a fixed body 103 at least partially disposed within the housing 102, a movable body 104 disposed within the fixed body 103, and a control knob 106 coupled to the movable body 104 (e.g., at one end of the movable body 104). The control knob 106 may extend outwardly from an opening in the housing 102 to allow an operator to access and actuate the control knob 106. The housing 102 may be attached to the enclosure 14 (e.g., by any of the mechanisms described above with respect to the enclosure 14 and the handle body 12), and specifically, to a funnel 16 extending from the enclosure 14. The funnel 16 may extend at least partially within the housing 102 and may be configured to receive a drug stored within the enclosure 14 and direct the drug into the valve assembly 100, e.g., by gravity. The funnel 16 may have a conical profile with tapered sidewalls that extend radially inward toward a central opening (eg, inlet 114) of the valve assembly 100.

[0019] The fixed body 103 may be coupled to the housing 102, and specifically may be pressed through an opening in the housing 102 downstream of the enclosure 14 and the funnel 16. The fixed body 103 may be fixed relative to the housing 102 such that the fixed body 103 cannot move relative to the housing 102, the enclosure 14, and the funnel 16. As described in detail herein, the fixed body 103 may include an inlet 114 in fluid communication with the enclosure 14 and the funnel 16, and an outlet 116 in fluid communication with the tube 32 of the delivery device 10. The movable body 104 may be coupled to the fixed body 103, and specifically may be pressed through an opening in the fixed body 103. The movable body 104 may be configured to move (e.g., rotate) relative to the fixed body 103, the housing 102, the enclosure 14, and the funnel 16 within the opening. In some embodiments, the fixed body 103 may be omitted entirely such that the movable body 104 may be coupled to the housing 102, which may include the inlet 114 and the outlet 116.

[0020] 2, the valve assembly 100 may include one or more internal channels within the movable body 104. For example, the valve assembly 100 may include a channel 108 extending through the movable body 104, the channel 108 having a longitudinal length defined between a first open end 110 and a second open end 112. In other embodiments, the valve assembly may include additional channels within the movable body (see FIG. 4). The valve assembly 100 may include an inlet 114 along a first end of the housing 102 and an outlet 116 along a second end of the fixed body 103. The inlet 114 may be in fluid communication with the funnel 16 and may further be in fluid communication with the channel 108 in configurations in which at least one of the first open end 110 and / or the second open end 112 is aligned with the inlet 114. The inlet 114 may be configured to direct pressurized fluid from the channel 108 into the enclosure 14 to agitate the drug stored in the enclosure 14, and to direct the agitated drug out of the enclosure 14 (e.g., through the funnel 16) into the channel 108.

[0021] The outlet 116 may be in fluid communication with the tube 32 of the delivery device 10 and, in a configuration in which at least one of the first open end 110 and / or the second open end 112 is aligned with the outlet 116, may further be in fluid communication with the channel 108. The outlet 116 may be configured to direct the agitated drug received in the channel 108 (e.g., from the enclosure 14) to the tube 32. In some embodiments, the tube 32 may include a hypotube fluidly coupled to the catheter 36 (see FIG. 1 ). The tube 32 may be configured to direct a mixture of the agitated drug and pressurized fluid received from the valve assembly 100 to the catheter 36 for delivery to the patient.

[0022] 2, the valve assembly 100 may include a fluid channel 120 extending through the moveable body 104 in a transverse (e.g., generally perpendicular) orientation to the channel 108. The fluid channel 120 may be in fluid communication with the channel 108 at a junction 118 located along an intermediate portion of the channel 108 between the first open end 110 and the second open end 112. The fluid channel 120 may further be in fluid communication with a source of pressurized fluid such that the valve assembly 100 may be configured to receive pressurized fluid via the fluid channel 120.

[0023] In this example, the valve assembly 100 may include an insert 122 positioned within the fluid channel 120, such as adjacent the coupling 118. The insert 122 may include a porous mesh configured to allow pressurized fluid received from a pressurized fluid source to pass through the fluid channel 120 and enter the channel 108 at the coupling 118, while preventing a drug received in the channel 108 from entering the fluid channel 108.

[0024] The valve assembly 100 may be configured to transition between multiple configurations, such as, for example, a non-delivery configuration (FIG. 3A) and a delivery configuration (FIG. 3B). As described herein, the movable body 104 may be configured to move (e.g., rotate) relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 in response to actuation of the control knob 106 between multiple positions corresponding to the configurations of the valve assembly 100. In some embodiments, the valve assembly 100 may include one or more visual indicators (e.g., markers, indicia, colors, etc.) and / or physical stops (e.g., protrusions, tabs, recesses, etc.) that define multiple positions of the control knob 106 corresponding to respective configurations of the valve assembly 100 to facilitate actuation of the control knob 106 by a user.

[0025] For example, the movable body 104 may be configured to rotate about an axis that is generally coaxial with the fluid channel 120. It should be appreciated that the channel 108 and / or the fluid channel 120 may be configured to move (e.g., rotate) simultaneously with the movable body 104, thereby adjusting the alignment and / or orientation of the respective channels relative to the enclosure 14, the funnel 16, and / or the tube 32.

[0026] In an exemplary use, as seen in FIG. 3A , when the control knob 106 is actuated to position the movable body 104 in a first position in which the channel 108 is not aligned with the inlet 114 and the outlet 116, the valve assembly 100 may be in a non-delivery configuration. Stated differently, the movable body 104 may be moved (e.g., rotated) relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 such that the first open end 110 and the second open end 112 are fluidly isolated from the inlet 114 and the outlet 116. In this case, while the movable body 104 is in the first position, pressurized fluid received in the channel 108 from the fluid channel 120 may be prevented from entering the enclosure 14 and the funnel 16 via the inlet 114 and / or the tube 32 via the outlet 116. With first open end 110 and second open end 112 forming a terminated / closed pathway, pressurized fluid may be maintained within channel 108 and / or fluid channel 120 when movable body 104 is in the first position. In other embodiments, pressurized fluid may be prevented from being delivered to valve assembly 100 while movable body 104 is in the first position.

[0027] It should be understood that the channel 108 may be oriented in a variety of suitable orientations and / or alignments relative to the inlet 114 and outlet 116 when the movable body 104 is in the first position, such that the corresponding position of the channel 108 may include a plurality of positions in which the first open end 110 and the second open end 112 are not aligned with each of the inlet 114 and outlet 116. Although the channel 108 is shown in a particular alignment relative to the inlet 114 and outlet 116 in FIG. 3A (e.g., an alignment in which the longitudinal axis of the channel 108 is offset approximately 90 degrees from the longitudinal axes of the inlet 114 and outlet 116, such that the longitudinal axis of the channel 108 extends into / out of the page in FIG. 3A), it should be understood that the first position of the movable body 104 may include other possible orientations and / or alignments of the channel 108 without departing from the scope of the present disclosure.

[0028] 3B, the valve assembly 100 may be transitioned to the delivery configuration when the control knob 106 is actuated to move (e.g., rotate) the movable body 104 to a second position in which the channel 108 is aligned with the inlet 114 and the outlet 116. Stated differently, the movable body 104 may rotate relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 to fluidly couple the first open end 110 and the second open end 112 with the inlet 114 and the outlet 116, or vice versa. In this case, when the movable body 104 is in the second position, pressurized fluid received within the channel 108 from the fluid channel 120 may enter the enclosure 14 and the funnel 16 via the inlet 114 and / or the tube 32 via the outlet 116.

[0029] When the movable body 104 is in the second position, with the first open end 110 forming an open path toward the inlet 114, at least a first portion of the pressurized fluid received from the fluid channel 120 may be directed through the channel 108 and into the enclosure 14 and the funnel 16 via the inlet 114. The first portion of the pressurized fluid may travel through the funnel 16 and agitate the drug stored in the funnel 16 and / or the enclosure 14. Upon agitating and / or fluidizing the drug, the mixture of the drug and the pressurized fluid may exit the channel 108 via the outlet 116 after being directed through the channel 108 via the inlet 114 and into the tube 32. With the tube 32 in fluid communication with the catheter 36, the mixture may be delivered to the patient via the catheter 36.

[0030] 3B , with the second open end 112 forming an open path toward the outlet 116 when the movable body 104 is in the second position, at least a second portion of the pressurized fluid received from the fluid channel 120 may be directed through the channel 108 and into the tube 32 via the outlet 116. It should be appreciated that at the same time that a first portion of the pressurized fluid is directed through the channel 108 toward the inlet 114, a second portion of the pressurized fluid may be directed through the channel 108 toward the outlet 116. The insert 122 may be configured to block any material and / or agent maintained within the enclosure 14, the funnel 16, the tube 32, and / or the catheter 36 from flowing from the channel 108 into the fluid channel 120.

[0031] In some embodiments, the fluid channel 120 may be configured to maintain fluid communication with the pressurized fluid source when the movable body 104 is in the first and second positions. Stated another way, the fluid channel 120 may continue to receive the pressurized fluid source regardless of the relative position of the movable body 104. In other embodiments, the fluid channel 120 may remain in fluid communication with the pressurized fluid source as the movable body 104 moves from the first position (FIG. 3A) to the second position (FIG. 3B). In this example, the fluid channel 120 may be configured to maintain a fixed orientation relative to the enclosure 14, the funnel 14, the tube 32, and / or the housing 102 as the movable body 104 moves between the first and second positions.

[0032] Referring now to FIG. 4, another exemplary aspect of the valve assembly 200 is shown. The valve assembly 200 may be configured similarly to the valve assembly 100, except for the differences explicitly described herein, and therefore similar reference numbers are used to identify similar components. The valve assembly 200 may be housed within the handle body 12. The valve assembly 200 may include a movable body 204 that is at least partially housed within the fixed body 103 and coupled to the control knob 106. As described above with respect to the movable body 104 of the valve assembly 100, the movable body 204 may be selectively actuated by the actuation mechanism 30 that may interact with the control knob 106 (see FIG. 1) or separately by the control knob 106. In this embodiment, the valve assembly 200 may include two or more internal channels within the movable body 204.

[0033] For example, the valve assembly 200 may include a first channel 108 (described above with respect to FIGS. 2-3B) and a second channel 208 extending through the movable body 204. The second channel 208 may have a transverse orientation with respect to the first channel 108. For example, the second channel 208 may be at an angle ranging from about 50 degrees to about 70 degrees, such as 60 degrees, with respect to the first channel 108. In this example, the second channel 208 may be in fluid communication with the first channel 108 and the fluid channel 120 at the junction 118. The second channel 208 may have a longitudinal length defined between the junction 118 and the open end 210. In this example, the second channel 208 may have a longitudinal length that is shorter than the longitudinal length of the first channel 108. In other embodiments, the first channel 108 and the second channel 208 may have substantially similar longitudinal lengths.

[0034] 4, the valve assembly 200 may include an insert 212 positioned within the second channel 208, such as adjacent the coupling 118. The insert 212 may be substantially similar to the insert 122 described above, and thus the insert 212 may be configured to allow pressurized fluid received from a pressurized fluid source (via the fluid channel 120) to enter the second channel 208, while preventing a drug received in the first channel 108 from entering the second channel 208. As described herein, the second channel 208 may be configured to deliver pressurized fluid to the patient in isolation from the drug when the moveable body 204 is moved to a second position (FIG. 5B) in which the second channel 208 is aligned with the outlet 116.

[0035] In some embodiments, one or more of the open ends of the first channel 108 may have a widened and / or expanded configuration to facilitate the flow of pressurized fluid through the first channel 108. For example, the second open end 112 may have a widened configuration to enhance the flow of pressurized fluid exiting the first channel 108 through the second open end 112. In this case, the widened configuration of the second open end 112 may allow more flow of fluid and / or agent entering the outlet 116 for delivery through the tube 32. In another example, the first open end 110 may have a widened configuration to allow more flow of fluid entering the inlet 114 to agitate the agent stored within the enclosure 14 and the funnel 16. Although described with respect to the valve assembly 200, the valve assembly 100 may also include a widened configuration of the second open end 112 and / or the first open end 110.

[0036] Valve assembly 200 may be configured to transition between a number of configurations, such as, for example, a non-delivery configuration (FIG. 5A), a fluid delivery configuration (FIG. 5B), and a drug delivery configuration (FIG. 5C). Movable body 204 may be configured to move (e.g., rotate) relative to housing 102, stationary body 103, enclosure 14, funnel 16, and / or tube 32 in response to actuation of control knob 106 between a number of positions corresponding to the configurations of valve assembly 200. For example, movable body 204 may be configured to rotate about an axis that is coaxial with a central longitudinal axis of fluid channel 120.

[0037] It should be understood that the first channel 108, the second channel 208, and the fluid channel 120 may be configured to move (e.g., rotate) simultaneously with the movable body 204, thereby adjusting the alignment and / or orientation of the respective channels relative to the enclosure 14, the funnel 16, and / or the tube 32. Although the valve assembly 200 is described below with respect to first, second, and third positions of the movable body 204, it should be understood that such terminology is merely exemplary, as the valve assembly 200 may be shifted among a plurality of configurations in any respective sequence. As illustrative examples only, the valve assembly 200 may transition from a non-delivery configuration to a drug delivery configuration, from a drug delivery configuration to a fluid delivery configuration, from a fluid delivery configuration to a non-delivery configuration, or in various other suitable sequences.

[0038] In an exemplary use, as seen in FIG. 5A, the valve assembly 200 may be in a non-delivery configuration when the control knob 106 is actuated to move the movable body 204 to a first position in which the first channel 108 and the second channel 208 are not aligned with the inlet 114 and the outlet 116, respectively. Stated differently, the movable body 204 may be moved (e.g., rotated) relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 such that the first open end 110, the second open end 210, and the open end 210 are fluidly isolated from the inlet 114 and the outlet 116. In this case, when the movable body 204 is in the first position, pressurized fluid received in the first channel 108 and the second channel 208 from the fluid channel 120 may be prevented from entering the enclosure 14 via the inlet 114 and / or the tube 32 via the outlet 116. Pressurized fluid can be maintained within first channel 108, second channel 208, and / or fluid channel 120 when movable body 204 is in the first position, with first open end 110, second open end 112, and open end 210 forming a terminated / closed pathway.

[0039] It should be understood that each channel 108, 208 may be oriented in a variety of suitable orientations and / or alignments relative to the inlet 114 and outlet 116 when the moveable body 204 is in the first position, such that the corresponding positions of the channels 108, 208 may include a plurality of positions in which the first open end 110, the second open end 112, and the open end 210 are not aligned with the inlet 114 and outlet 116. Thus, while the channels 108, 208 are shown in a particular alignment relative to the inlet 114 and outlet 116 in FIG. 5A, it should be understood that the first position of the moveable body 204 may include other possible orientations and / or alignments of the channels 108, 208.

[0040] 5B, the valve assembly 200 may be transitioned to a fluid delivery configuration when the control knob 106 is actuated to move (e.g., rotate) the movable body 204 to a second position in which the second channel 208 is aligned with the outlet 116 and the first channel 108 remains misaligned with each of the inlet 114 and outlet 116. Stated another way, the movable body 204 may rotate relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 to fluidly couple the open end 210 with the outlet 116 and keep the first open end 110 and the second open end 112 fluidly isolated from the inlet 114 and outlet 116. Pressurized fluid from a pressurized fluid source may flow into the fluid channel 120, through the insert 122 and the coupling 118, and into the second channel 208. In this case, pressurized fluid received in the second channel 208 from the fluid channel 120 can enter the tube 32 via the outlet 116 when the movable body 204 is in the second position.

[0041] In this case, the valve assembly 200 may be configured to deliver pressurized fluid through the tube 32 and into the catheter 36 without the agent. When in the fluid delivery configuration of FIG. 5B, the valve assembly 200 may remove any pre-existing material and / or agent maintained within the tube 32 and / or catheter 36 by dispensing pressurized fluid through the tube 32 and / or catheter 36 via the second channel 208 without introducing any additional material (e.g., agent). The insert 212 may be configured to block any of the pre-existing material and / or agent maintained within the tube 32 and / or catheter 36 from flowing through the second channel 208 into the first channel 108 and / or fluid channel 120.

[0042] 5C, the valve assembly 200 may be transitioned to a drug delivery configuration when the control knob 106 is actuated to move (e.g., rotate) the movable body 204 to a third position in which the first channel 108 is aligned with the inlet 114 and the outlet 116 and the second channel 208 is not aligned with the inlet 114 and the outlet 116. Stated differently, the movable body 204 may be rotated relative to the housing 102, the fixed body 103, the enclosure 14, the funnel 16, and / or the tube 32 to fluidly couple the first open end 110 and the second open end 112 with the inlet 114 and the outlet 116, or vice versa. Thus, the open end 210 may be fluidly isolated from the outlet 116. In this case, when the movable body 204 is in the third position, pressurized fluid received in the first channel 108 from the fluid channel 120 can enter the enclosure 14 via the inlet 114 and / or the tube 32 via the outlet 116.

[0043] For example, when the movable body 204 is in the third position, with the first open end 110 forming an open path toward the inlet 114, at least a first portion of the pressurized fluid received from the fluid channel 120 may be directed through the first channel 108 and into the enclosure 14 via the inlet 114. The first portion of the pressurized fluid may travel through the funnel 16 and agitate the agent within the funnel 16 and / or the enclosure 14. As the agent is agitated, a mixture of the agent and the pressurized fluid may be directed through the inlet 114, the first channel 108, and the outlet 116 before entering the tube 32.

[0044] 5C , with the second open end 112 forming an open path toward the outlet 116 when the movable body 204 is in the third position, at least a second portion of the pressurized fluid received from the fluid channel 120 may be directed through the first channel 108 and into the tube 32 via the outlet 116. It should be appreciated that at the same time that the first portion of the pressurized fluid is directed through the first channel 108 toward the inlet 114, a second portion of the pressurized fluid may be directed through the first channel 108 toward the outlet 116.

[0045] Although not shown, it should be understood that the valve assembly 200 may be further transitioned to an agitation configuration in which the movable body 204 may be moved (e.g., rotated) to a fourth position in which the open end 210 is aligned with the inlet 114. In this case, the second channel 208 may be fluidly coupled to the enclosure 14 and the funnel 16 such that pressurized fluid received from the fluid channel 120 may be directed toward the medicament stored therein. In this case, the valve assembly 200 may be configured to agitate the medicament within the enclosure 14 and / or funnel 16 without delivering any portion of the medicament to the tube 32.

[0046] Although valve assembly 100 and valve assembly 200 are each shown and described herein as having a body 104, 204 that is movable relative to the respective housing 102, it should be understood that in other embodiments, the body 104, 204 (and particularly one or more channels) may remain relatively fixed. In this case, enclosure 14 and / or funnel 16 may be selectively moved to align inlet 114 with the channel.

[0047] 6, another exemplary embodiment of a valve assembly 300 is shown. The valve assembly 300 may be configured similarly to the valve assembly 100, except for differences explicitly described herein, and therefore like reference numbers are used to identify like components. The valve assembly 300 may be housed within the handle body 12. The valve assembly 300 may include a housing 302, an outlet port 318, and a fluid channel 120. The housing 302 may be coupled to the enclosure 14, and in particular the funnel 16.

[0048] The valve assembly 300 may further include a movable body 304 at least partially housed within the housing 302. At least a portion of the movable body 304 may include an opening 305 to facilitate connection to an actuator (not shown). For example, a linkage (e.g., a rod, wire, cable, etc.) may be coupled to the actuator and the movable body 304 at the opening 305. The movable body 304 may thus be configured to move (e.g., pivot, rotate, translate, etc.) relative to the housing 302 in response to actuation of the actuator. It should be understood that the actuator may be separate from the actuation mechanism 30 (FIG. 1), and thus the valve assembly 300 may be configured to actuate the movable body 304 (via the actuator) and deliver pressurized fluid (via the actuation mechanism 30) independently of one another. In other embodiments, the valve assembly 300 may be selectively actuated by the actuation mechanism 30 (see FIG. 1). As described herein, the movable body 304 may include one or more internal channels.

[0049] 7, the movable body 304 may include a proximal portion 306A, a distal portion 306B, and a distal end 306C. The movable body 304 may further include an intermediate body 310 positioned between the proximal portion 306A and the distal portion 306B. The intermediate body 310 may have a channel 308 formed along a sidewall of the intermediate body 310, and the channel 308 may open along an outer surface of the intermediate body 310. A longitudinal length of the channel 308 may be defined between a first open end 312 and a second open end 314. As described herein, the channel 308 may be configured to receive a medicament and / or a pressurized fluid when the movable body 304 is moved to one or more positions within the housing 302.

[0050] The proximal portion 306A may be separated from the intermediate body 310 by a first slot 307A, the intermediate body 310 may be separated from the distal portion 306B by a second slot 307B, and the distal portion 306B may be separated from the distal end 306C by a third slot 307C. Each of the slots 307A, 307B, 307C may be sized and shaped to receive a corresponding feature therein. For example, each of the first slot 307A and the second slot 307B may be configured to receive a sealing feature, such as, for example, an O-ring. The sealing feature (not shown) may be disposed about the intermediate body 310 to fluidly seal the channel 308 within the housing 302. The third slot 307C may be configured to receive a fastening mechanism, such as, for example, a retaining clip. A fastening mechanism (not shown) may be configured to maintain the moveable body 304 fixed within the housing 302 during movement (eg, rotation) of the moveable body 304 relative to the housing 302 .

[0051] The valve assembly 300 may be configured to transition between a plurality of configurations, such as, for example, a non-delivery configuration (FIG. 8A), a fluid delivery configuration (also shown in FIG. 8A), and a drug delivery configuration (FIG. 8B). As described herein, the movable body 304 may be configured to move (e.g., rotate) relative to the housing 302, the enclosure 14, the funnel 16, and / or the outlet port 318 in response to actuation of an actuator (not shown) between a plurality of positions corresponding to the configurations of the valve assembly 300. It should be appreciated that the intermediate body 310 and the channel 308 may be configured to move (e.g., rotate) simultaneously with the movable body 304, thereby adjusting the alignment and / or orientation of the channel 308 relative to the housing 302, the enclosure 14, and / or the funnel 16. Additionally, the valve assembly 300 may be configured to receive pressurized fluid from a pressurized fluid source in response to actuation of the actuation mechanism 30.

[0052] 8A, the movable body 304 may be disposed within the housing 302 with the intermediate body 310 positioned adjacent the coupling 118. Thus, any pressurized fluid received within the housing 302 via the fluid channel 120 may encounter the intermediate body 310 upon passing through the insert 122 and the coupling 118. In an exemplary use, the valve assembly 300 may be in a non-delivery configuration when the movable body 304 is in a first position, in which case the channel 308 is not aligned with the inlet 114 and the outlet 116, and pressurized fluid is not actively delivered (from a pressurized fluid source in response to actuation of the actuation mechanism 30) to the fluid channel 120. In this configuration, as described in more detail below, a drug stored within the enclosure 14 and funnel 16 may be prevented from moving (e.g., via gravity) between the inlet 114 and the outlet 116 by the intermediate body 310 disposed between the inlet 114 and the outlet 116 to block the path of the drug.

[0053] The valve assembly 300 may be transitioned from the non-delivery configuration to the fluid delivery configuration upon maintaining the movable body 304 in a first position and actuating the actuation mechanism 30 to deliver pressurized fluid from a pressurized fluid source to the fluid channel 120, as shown in FIG. 8A. In this case, the channel 308 may remain misaligned with the inlet 114 and outlet 116, thereby preventing the medication from exiting the funnel 16. In this example, the intermediate body 310 may be sized and / or shaped such that a gap 316 is formed between the inner surface of the housing 302 and the outer surface of the intermediate body 310.

[0054] As best seen in Figure 9A, gap 316 may be sized such that only pressurized fluid may be received therein, thereby preventing any material (e.g., drug) from passing therethrough. In other words, Figure 9A shows a partial perspective view from within funnel 16, where movable body 304 may be positioned in a first position with intermediate body 310 covering an opening of funnel 16. Gap 316 may be formed between intermediate body 310 and an inner surface of housing 302, thereby allowing pressurized fluid to pass through gap 316 and enter funnel 16.

[0055] Thus, with the movable body 304 in the first position, the valve assembly 300 may be configured to allow pressurized fluid to at least partially bypass the movable body 304 via the gap 316. In other words, when the valve assembly 300 is in the fluid delivery configuration, pressurized fluid received at the coupling 118 from the fluid channel 120 may pass around the intermediate body 310. In this case, at least a first portion of the pressurized fluid may be directed towards the inlet 114 and at least a second portion of the pressurized fluid may be directed towards the outlet 116 via the gap 316 formed between the intermediate body 310 and the housing 302.

[0056] The first portion of the pressurized fluid may travel through the funnel 16 and agitate the medicament stored within the funnel 16 and / or enclosure 14. Due to the size of the gap 316 relative to the particle size of the medicament, the movable body 304 may be configured to prevent the agitated medicament within the enclosure 14 and funnel 16 from exiting while the movable body 304 remains in the first position. Thus, a mixture of the medicament and the pressurized fluid may be prevented from traveling toward the outlet 116 and the outlet port 318. By allowing the first portion of the pressurized fluid to travel through the housing 302 while in the fluid delivery configuration, the valve assembly 300 may be operable to prevent long-term pressurization of the enclosure 14.

[0057] 8A , the valve assembly 300 may further allow delivery of at least a second portion of the pressurized fluid via the outlet 116 toward the outlet port 318 without delivering any portion of the agent stored within the enclosure 14. With the outlet port 318 in fluid communication with the catheter 36, the valve assembly 300 may also be configured to remove any existing material and / or agent maintained within the outlet port 318 and / or catheter 36, such as from a previous delivery, by only allowing delivery of pressurized fluid while in the fluid delivery configuration.

[0058] It should be understood that the channel 308 may be oriented in a variety of suitable orientations and / or alignments relative to the inlet 114 and the outlet 116 when the movable body 304 is in the first position. Although the channel 308 is shown in a particular alignment relative to the inlet 114 and the outlet 116 in FIG. 8A, it should be understood that the first position of the movable body 304 may include other possible orientations and / or alignments of the channel 308.

[0059] 8B, the valve assembly 300 can be transitioned to a drug delivery configuration when the actuator is actuated to move (e.g., rotate) the movable body 304 to a second position in which the channel 308 is aligned with the inlet 114 and the outlet 116. Stated differently, the movable body 304 can rotate relative to the housing 302, the enclosure 14, the funnel 16, and / or the outlet port 318 to fluidly couple the first open end 312 and the second open end 314 with the inlet 114 and the outlet 116, or vice versa. In this case, as seen in FIG. 9B, pressurized fluid received within the enclosure 14 and / or the funnel 16 via the inlet 114 can induce the agitated drug into the channel 308 at the first open end 312. 9B shows a partial perspective view from within funnel 16, where moveable body 304 may be positioned in a second position with first open end 312 aligned with the opening of funnel 16. Channel 308 may be in fluid communication with funnel 16, thereby allowing pressurized fluid to pass into funnel 16 and subsequently allowing the agitated drug-fluid mixture to enter channel 308 from funnel 16 via first open end 312.

[0060] With the channel 308 forming an open pathway between the inlet 114 and the outlet 116 when the movable body 304 is in the second position, the agitated drug and pressurized fluid received within the enclosure 14 can travel through the funnel 16 and into the channel 308 before exiting the intermediate body 310 at the outlet 116. As noted above, the outlet port 318 can be in fluid communication with the catheter 36 such that a mixture of drug and pressurized fluid received in the outlet port 318 can be delivered to a patient via the catheter 36 (FIG. 1). The insert 122 can be configured to block drug traveling through the channel 308 from entering the fluid channel 120.

[0061] 10A-10C, aspects of another exemplary valve assembly 400 are shown. The valve assembly 400 may be configured similarly to the valve assembly 100, except for differences explicitly described herein, and therefore similar reference numbers are used to identify similar components. The valve assembly 400 may include a housing 402 that may be housed within the handle body 12 (FIG. 1) and coupled to the enclosure 14 via the funnel 16. In some embodiments, the housing 402 may be integral with the funnel 16 and the enclosure 14, while in other embodiments, the housing 402 may be selectively attached to the funnel 16 and the enclosure 14. In this embodiment, the valve assembly 400 may include one or more internal channels.

[0062] 10A , the valve assembly 400 may include a channel 404 extending through a housing 402. The channel 404 may have a longitudinal length defined between an inlet 406 and an outlet 408. In this example, the inlet 406 may be fluidly coupled to the fluid channel 120 for receiving pressurized fluid within the channel 404, and the outlet 408 may be fluidly coupled to the catheter 36 (see FIG. 1 ) for delivering an agent received within the channel 404 (from the enclosure 14) to a patient. The valve assembly 400 may include one or more moveable bodies for selectively controlling the delivery of the pressurized fluid and agent to the patient.

[0063] For example, the valve assembly 400 may include at least a first movable body 410 and a second movable body 420, each of which may be at least partially received within the channel 404. The first movable body 410 may include a first end 412 and a second end 414, and in at least some forms, the first end 412 is positioned within the channel 404 and adjacent to a central opening of the funnel 16. In some embodiments, the central opening of the funnel 16 may be at least partially defined by one or more surfaces 18. The surfaces 18 may at least partially define a junction between the funnel 16 and the channel 404. In this example, the surfaces 18 may be at least partially angled to taper outwardly from the central opening of the funnel 16.

[0064] 10A , when the first movable body 410 is in a first position where the first end 412 abuts against the surface 18, the first end 412 may be sized, shaped, and otherwise configured to contact the surface 18, thereby sealing the central opening of the funnel 16. At least some surfaces of the first end 412 may have a shape complementary to the shape of the surface 18. For example, the first end 412 may include a surface and / or edge that tapers inwardly to mate with the surface 18. The second end 414 may be positioned outside the channel 404, and the first movable body 410 may be coupled to a biasing mechanism 440 (e.g., a spring) at the second end 414. The biasing mechanism 440 may be configured to bias the first movable body 410 to the first position, such that the first end 412 may be biased toward the surface 18 of the funnel 16. As described herein, the valve assembly 400 may include an actuator 430 (e.g., a lever assembly) configured to move the first movable body 410 between one or more positions relative to the funnel 16.

[0065] The second movable body 420 may include a first end 422 and a second end 424, with the first end 422 positioned within the channel 404 adjacent the inlet 406. In this example, the first end 422 may be sized, shaped, and otherwise configured to contact the inlet 406 when the second movable body 420 is in a first position where the first end 422 abuts against one or more surfaces defining the inlet 406, thereby sealing the channel 404 from the fluid channel 120.

[0066] 10A , the second end 424 may be positioned outside the channel 404, and the second movable body 420 may be coupled to a biasing mechanism 442 (e.g., a spring) at the second end 424. The biasing mechanism 442 may be configured to bias the second movable body 420 to the first position such that the first end 422 is biased toward a surface defining the inlet 406. As described herein, the actuator 430 may be configured to move the second movable body 420 between one or more positions relative to the inlet 406.

[0067] The actuator 430 may be a lever assembly including a rod / shaft 432 having a handle 434 at one end and a pivot joint 436 at an opposite end. The handle 434 may be configured to move (e.g., pivot) the shaft 432 between one or more positions about the pivot joint 436. In some embodiments, the actuator 430 may be manually operated via the handle 434. In other embodiments, the actuator 430 may be automatically actuated in response to actuation of the actuation mechanism 30 (FIG. 1). In further embodiments, the actuation mechanism 30 may be omitted entirely, such that the actuator 430 may be configured to release pressurized fluid from a pressurized fluid source and simultaneously move the moveable bodies 410, 420.

[0068] 10A , the actuator 430 may be coupled to each of the first movable body 410 and the second movable body 420 via at least one engagement mechanism. For example, the first movable body 410 may be coupled to the actuator 430, and in particular the shaft 432, via a pin 438 received in a slot 416 formed in the first movable body 410. The second movable body 420 may be coupled to the shaft 432 via a pin 439 received in an opening formed in the second end 424. Thus, movement of the shaft 432 (via actuation of the handle 434) may provide corresponding movement of the first movable body 410 and the second movable body 420 between one or more positions.

[0069] Valve assembly 400 may be configured to transition between multiple configurations, such as, for example, a non-delivery configuration ( FIG. 10A ), a fluid delivery configuration ( FIG. 10B ), and a drug delivery configuration ( FIG. 10C ). As described herein, moveable bodies 410, 420 may be configured to move (e.g., translate) relative to housing 402, enclosure 14, funnel 14, and / or channel 404 in response to actuation of actuator 430 between multiple positions corresponding to configurations of valve assembly 400.

[0070] In an exemplary use, as seen in FIG. 10A , the valve assembly 400 may be biased to a non-delivery configuration in which the movable bodies 410, 420 are biased to a first position. In the first position, the first movable body 410 may be engaged against the surface 18 of the funnel 16 and the second movable body 420 may be engaged against the inlet 406. Thus, the valve assembly 400 may be configured to prevent the release of a drug from the enclosure 14 and / or the funnel 16 into the channel 404 with the first movable body 410 forming a fluid-tight seal against the surface 18. The valve assembly 400 may further be configured to prevent the release of pressurized fluid from the fluid channel 120 into the channel 404 with the second movable body 420 forming a fluid-tight seal at the inlet 406.

[0071] The valve assembly 400 may be maintained in the non-delivery configuration without applying an opposing (downward) force to the biasing mechanisms 440, 442 (e.g., in response to actuation of the actuator 430). As seen in FIG. 10B, the valve assembly 400 may be transitioned from the non-delivery configuration (FIG. 10A) to the fluid delivery configuration upon actuation of the handle 434 to at least partially compress the biasing mechanisms 440, 442 to a first extent. The first movable body 410 may remain in a first position relative to the channel 404, in which the first end 412 is positioned against the surface 18 such that the first movable body 410 remains coupled to the funnel 16. Thus, the agent stored within the enclosure 14 and the channel 16 may remain sealed therein by the first movable body 410.

[0072] In response to moving the handle 434, the biasing mechanism 440 may be at least partially compressed, thereby moving the pin 438 within the slot 416, such as from a first position (seen in FIG. 10A) to a second position (seen in FIG. 10B). The second movable body 420 may be moved to a second position relative to the channel 404, where the first end 422 moves away from the inlet 406 in response to the compression of the biasing mechanism 442. In this case, the first end 422 may disengage from a surface defining the inlet 406, thereby separating the second movable body 420 from the inlet 406. Thus, the pressurized fluid within the fluid channel 120 may be received within the channel 404. With the second movable body 420 in the second position, the pressurized fluid may be received within the channel 404 via the inlet 406, thereby delivering the pressurized fluid towards the outlet 408.

[0073] In some embodiments, pressurized fluid may travel through the channel 404 and exit from the outlet 408 when the valve assembly 400 is in the fluid delivery configuration. For example, the pressurized fluid may travel around the first movable body 410 toward the outlet 408. In other embodiments, the pressurized fluid may be received in the channel 404 and prevented from exiting from the outlet 408 by the first movable body 410. In this case, the pressurized fluid may be maintained in the channel 404 and directed toward the outlet 408 only when the valve assembly 400 transitions to the drug delivery configuration (see FIG. 10C). By directing the pressurized fluid into the channel 404 prior to releasing the drug from the enclosure 14 and funnel 16 into the channel 404, the valve assembly 400 may be configured to prevent clogging of the channel 404, such as when a drug is received in the channel 404 prior to the pressurized fluid.

[0074] As seen in FIG. 10C, the valve assembly 400 may be transitioned from the fluid delivery configuration (FIG. 10B) to the drug delivery configuration upon actuation of the handle 434 to further compress the biasing mechanism 440, 442 to a second degree greater than the first degree (FIG. 10B). The first movable body 410 may move to a second position relative to the channel 404, where the first end 412 moves away from the funnel 16 in response to compression of the biasing mechanism 440 and movement of the pin 438 within the slot 416, such as from the second position (seen in FIG. 10B) to a third position (seen in FIG. 10C). In this case, the first end 412 may disengage from the surface 18 that defines the central opening of the funnel 16, thereby separating the first movable body 410 from the funnel 16. Thus, the drug stored within the enclosure 14 and the funnel 16 may be received within the channel 404.

[0075] The second movable body 420 may move to a third position relative to the channel 404, in which the first end 422 moves further away from the inlet 406 (relative to the second position of FIG. 10B) in response to a greater compression of the biasing mechanism 442. In this case, the first end 422 may remain disengaged from the surface defining the inlet 406, thereby maintaining the second movable body 420 separated from the inlet 406. Thus, the pressurized fluid in the fluid channel 120 may continue to be received in the channel 404. In some embodiments, the second position of the second movable body 404 may be substantially the same as the third position. With the first movable body 410 in the second position and the second movable body 420 in the third position, the pressurized fluid may be received in the channel 404 via the inlet 406, and the drug stored in the enclosure 14 and / or the funnel 16 may be received in the channel 404 via the central opening of the funnel 16. In this case, the pressurized fluid may agitate the agent within the channel 404. It should be appreciated that the pressurized fluid may be received within the channel 404 prior to the release of the agent from the enclosure 14 and / or funnel 16 into the channel 404.

[0076] In some embodiments, at least a portion of the pressurized fluid may be directed into the funnel 16 and / or enclosure 14, thereby agitating the drug therein. With the first movable body 410 positioned at least partially within the channel 404 between the inlet 406 and the outlet 408, the pressurized fluid may be directed around the first movable body 410 by a surface of the first movable body 410, such that at least a portion of the pressurized fluid may be received within the funnel 16 and / or enclosure 14.

[0077] 10C, the pressurized fluid may agitate the agent in either the channel 404 and / or the funnel 16 and the enclosure 14 before directing the agitated agent toward the outlet 408 for delivery to the catheter 36 (FIG. 1). Although a single actuator 430 is shown and described herein, it should be understood that the valve assembly 400 may include a respective actuator for selectively controlling the movement of each movable body 410, 420. Alternatively, the actuator 430 may be configured to selectively move each of the first movable body 410 and the second movable body 420 independently of one another. As mentioned above, in some embodiments, the actuator 430 may be coupled to the actuation mechanism 30 such that the actuator 430 may be configured to move in response to actuation of the actuation mechanism 30, or vice versa. Thus, the movable bodies 410, 420 may move between one or more positions upon release of pressurized fluid from a pressurized fluid source by the actuator 30.

[0078] In some embodiments, the fluid channel 120 may be configured to maintain fluid communication with the pressurized fluid source when the movable bodies 410, 420 are in their respective positions. Stated another way, the fluid channel 120 may continue to receive the pressurized fluid source regardless of the relative positions of the movable bodies 410, 420. In other embodiments, the fluid channel 120 may be in fluid communication with the pressurized fluid source in response to the second movable body 420 moving from the first position (FIG. 10A) to the second position (FIG. 10B). In this case, actuation of the actuator 430 may provide a corresponding release of pressurized fluid from the pressurized fluid source.

[0079] 11, an embodiment of another exemplary valve assembly 500 is shown. The valve assembly 500 may be configured similarly to the valve assembly 400, except for the differences explicitly described herein, and therefore similar reference numbers are used to identify similar components. The valve assembly 500 may include a housing 502 that may be housed within the handle body 12 (FIG. 1) and coupled to the enclosure 14 via the funnel 16. In some embodiments, the housing 502 may be integral with the funnel 16 and the enclosure 14, while in other embodiments, the housing 502 may be selectively attached to the funnel 16 and the enclosure 14. In this embodiment, the valve assembly 500 may include one or more internal channels.

[0080] For example, the valve assembly 500 may include a channel 504 having a larger cross-sectional profile than the channel 404 and / or the fluid channel 120 of the valve assembly 400 (FIGS. 10A-10B). In this case, the valve assembly 500 may be configured to generate a vortex within the channel 504 when transitioning from a non-delivery configuration to a delivery configuration (FIG. 11). Stated differently, when the movable bodies 410, 420 are moved to their respective second positions shown in FIG. 11, the agent stored in the enclosure 14 and / or the funnel 16 may enter the channel 504 as pressurized fluid from the fluid channel 120 is received at the inlet 406. In this case, the pressurized fluid may form a swirling vortex within the channel 504 and around the first movable body 410, as shown by the arrows in FIG. 11, to agitate the agent before being delivered toward the outlet 408.

[0081] In some embodiments, one or more surface features may be positioned within the channel 504 to create turbulence and improve mixing and fluidization of the agent prior to delivery towards the outlet 408. For example, the valve assembly 500 may include one or more baffles, protrusions, dimples, recesses, cavities, and / or other suitable structures to form physical obstructions within the channel 504. Such surface features may similarly be positioned within each of the channels of the valve assemblies 100, 200, 300, 400 shown and described above. It should be understood that apart from the differences noted above, an exemplary use of the valve assembly 500 may be substantially similar to the valve assembly 400 shown and described above.

[0082] Although the principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art and who have access to the teachings provided herein will recognize that additional modifications, applications, and equivalent substitutions are all within the scope of the examples described herein. Thus, the present invention should not be considered as limited by the foregoing description.

Claims

1. A valve assembly for a medical device, An inlet that communicates fluidly with the enclosure of the medical device, the enclosure containing the drug, The delivery conduit of the medical device and the outlet that communicates with fluid, A body having a channel that is in fluid communication with a fluid supply source, the body being configured to move relative to the inlet and outlet so as to selectively and fluidly couple the channel with the enclosure and the delivery conduit, In the first position of the main body, the channel is not aligned with at least one of the inlet or outlet, and as a result, the delivery conduit does not have fluid communication with at least one of the enclosure or the fluid supply source. A valve assembly in which, at a second position of the main body, the channel is aligned with the inlet and outlet, and as a result, the delivery conduit is in fluid communication with the enclosure and the fluid source.

2. The valve assembly according to claim 1, wherein, in the first position, the channel is positioned transversely with respect to an axis extending between the inlet and the outlet.

3. The valve assembly according to claim 1, wherein, in the second position, the channel is positioned parallel to an axis extending between the inlet and the outlet.

4. The valve assembly according to claim 1, wherein the channel is in fluid communication with the fluid source when the body is in the first position and the second position.

5. The valve assembly according to claim 1, wherein the body is configured to guide the fluid into the enclosure through the channel and the inlet in order to agitate the agent in the enclosure when it is in the first position.

6. The valve assembly according to claim 5, wherein the body is configured to guide a mixture of the fluid and the agent from the enclosure through the inlet into the channel, and the channel is configured to guide the mixture through the outlet into the delivery conduit.

7. The valve assembly according to claim 1, wherein the body includes an insert positioned within the channel, and the insert includes a porous mesh.

8. The valve assembly according to claim 7, wherein the insert is configured to prevent the agent from moving through the insert toward the fluid source and to allow the fluid to pass through the insert.

9. The valve assembly according to claim 1, wherein the channel is a first channel, the body includes a second channel that is in fluid communication with the first channel, and the second channel has a length shorter than the length of the first channel.

10. The valve assembly according to claim 9, wherein in the first and second positions of the main body, the second channel is not aligned with the outlet, is in fluid communication with the fluid supply source, and is not in fluid communication with the inlet.

11. The valve assembly according to claim 10, wherein at the third position of the body, the second channel is aligned with the outlet, and as a result, the delivery conduit is in fluid communication with the fluid source through the second channel.

12. The valve assembly according to claim 11, wherein at the third position of the main body, the channel is not aligned with the inlet and outlet, and as a result, the delivery conduit does not have fluid communication with the enclosure through the first channel.

13. The valve assembly according to claim 9, wherein the body includes an insert positioned within the second channel, the insert being configured to prevent the agent from moving through the second channel and to allow the fluid to pass through the second channel.

14. The valve assembly according to any one of claims 1 to 13, further comprising a housing defining the inlet and the outlet, wherein the housing is configured to receive the body, and a gap is formed between the housing and the body, the gap being positioned between the inlet and the outlet such that when the body is in a first position, the delivery conduit is in fluid communication with the fluid source through the gap.

15. The valve assembly according to claim 14, wherein the gap is sized such that the drug cannot pass through the gap.

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