System for delivering pressurized fluid to a target site alone or in combination with a therapeutic agent

Abstract

A system suitable for delivering a therapeutic agent to a target site may include a container for housing the therapeutic agent, a pressure source having a pressurized fluid, the pressure source in selective fluid communication with at least a portion of the container, a catheter in selective fluid communication with the container and configured to deliver the therapeutic agent or the pressurized fluid to the target site, and a housing configured to securely hold the container and movably support a switch, the switch being movable between a first position and a second position, where when the switch is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and where when the switch is in the second position, delivery of the therapeutic agent is permitted.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority from U.S. Provisional Patent Application No. 63 / 271,556, filed October 25, 2021, the entire contents of which are hereby fully incorporated by reference.

[0002] The present embodiments relate generally to medical devices, and more particularly to medical devices for delivering therapeutic agents to a target site. [Background technology]

[0003] There are several instances in which it may be desirable to introduce a therapeutic agent into the human or animal body. For example, a therapeutic agent or bioactive substance may be introduced to achieve a biological effect. The biological effect may include any number of targeted outcomes, such as inducing hemostasis, sealing a perforation, reducing the likelihood of restenosis, or treating a cancerous tumor or other disease.

[0004] Many such therapeutic agents are injected using intravenous (IV) techniques or via oral administration. While such techniques allow for the systemic introduction of pharmaceutical agents, it may often be desirable to provide localized or targeted delivery of the therapeutic agent, which may allow for directed and precise delivery of the therapeutic agent to a selected target site. For example, localized delivery of a therapeutic agent to a tumor may reduce exposure of the therapeutic agent to normal, healthy tissue, thereby reducing potentially harmful side effects.

[0005] Localized delivery of therapeutic agents has been achieved using catheters and similar introduction devices. For example, a catheter can be advanced to a target site within a patient, and the therapeutic agent can be injected through a lumen of the catheter into the target site. Typically, a syringe or similar device can be used to inject the therapeutic agent into the lumen of the catheter. However, such delivery techniques can result in a relatively weak flow of injected therapeutic agent.

[0006] Additionally, it may be difficult or impossible to deliver a therapeutic agent in certain forms, such as powder form, to a desired site in a targeted manner. For example, if a therapeutic powder is contained within a syringe or other container, it may not be easily delivered through a catheter to a target site in a localized manner that may also reduce potentially harmful side effects. Summary of the Invention [Means for solving the problem]

[0007] One general aspect of the present disclosure includes a system suitable for delivering a therapeutic agent to a target site, the system including: a container for containing the therapeutic agent; a pressure source having a pressurized fluid, the pressure source in selective fluid communication with at least a portion of the container; a catheter in selective fluid communication with the container and configured to deliver the therapeutic agent or the pressurized fluid to the target site; and a housing configured to securely hold the container and movably support a switch, the switch being movable between a first position and a second position, wherein when the switch is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and when the switch is in the second position, delivery of the therapeutic agent is permitted.

[0008] Another general aspect of the present disclosure includes a method suitable for delivering a therapeutic agent to a target site, the method including: actuating a pressure source having pressurized fluid, the pressure source in selective fluid communication with at least a portion of a container containing the therapeutic agent; depressing a button to actuate a first valve such that pressurized fluid flows through the first valve and into a catheter without delivery of the therapeutic agent, the first valve being connected between the pressure source and the container, and the catheter being in selective fluid communication with the container and configured to deliver pressurized fluid or the therapeutic agent to the target site; and moving a switch from a first position to a second position such that the button can be further depressed to actuate the first valve to allow pressurized fluid to flow through the first valve and into the container, the switch being movably supported by a housing that securely holds the container.

[0009] Another general aspect of the present disclosure includes a system suitable for delivering a therapeutic agent to a target site, the system including: a container for containing the therapeutic agent; a pressure source having a pressurized fluid, the pressure source in selective fluid communication with at least a portion of the container; a catheter in selective fluid communication with the container and configured to deliver the therapeutic agent or the pressurized fluid to the target site; and a housing configured to securely hold the container and movably support a switch, the switch including a splittable portion and movable between a first position and a second position after the splittable portion is split, wherein when the switch is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and when the switch is moved to the second position, the splittable portion splits such that delivery of the therapeutic agent is permitted when the switch is in the second position.

[0010] Another general aspect of the present disclosure includes a valve including a body including a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the body including an inlet port, a first outlet port, and a second outlet port, and a piston slidably movable along the length of the body lumen, the piston including first and second spaced apart openings disposed on an outer surface of the piston, the first and second openings being connected by a bridge extending through the piston at an angle relative to the length of the piston.

[0011] Another general aspect of the present disclosure includes a valve including a body including a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the body including an inlet port, a first outlet port, and a second outlet port, and a piston slidably movable along the length of the body lumen, the piston including first and second spaced apart grooves connected by a bridge extending along the length of the piston, the first groove extending radially through the piston along a diameter of a first cross-section of the piston and the second groove extending radially through the piston along a diameter of a second cross-section of the piston.

[0012] Another general aspect of the present disclosure includes a method of operating a valve, the valve including a body including a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the body including an inlet port, a first outlet port, and a second outlet port; and a piston slidably movable along the length of the body lumen, the piston including a bridge extending through at least a portion of the piston, the method including: moving the piston such that a first fluid communication is established between the inlet port and the first outlet port through the bridge; and moving the piston such that a second fluid communication is established between the inlet port and the second outlet port through the bridge.

[0013] Systems suitable for delivering therapeutic agents to a target site or valve according to the present disclosure may include any combination of the features described above and / or as recited in the claims as originally submitted.

[0014] Other systems, methods, features, and advantages of the present invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description, and it is intended that all such additional systems, methods, features, and advantages be within the scope of the present invention.

[0015] The present invention can be better understood with reference to the following drawings and description. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the drawings, like reference numerals indicate corresponding parts throughout the different views. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of a system for delivering a therapeutic agent according to one embodiment, showing the housing, forward valve (second valve), switch, and button. [Figure 2A] 2 is another perspective view of the system of FIG. 1 showing the forward valve in a first state, the switch in a first position, and the button in a default state. [Figure 2B] 2 is another perspective view of the system of FIG. 1 showing the forward valve in a second state, the switch in a second position, and the button in a default state. [Figure 3] FIG. 2 is an exploded view of the system of FIG. 1 showing the rear valve (first valve). [Figure 4] 2 is another perspective view of the system of FIG. 1 with a portion of the housing removed, showing the forward valve in a first state, the switch in a first position, and the button depressed. [Figure 4A] 5 is a partial enlarged perspective view of a portion of the system of FIG. 4 showing the switch in a first position and the button depressed. [Figure 4B] FIG. 5 is an enlarged detail view of a portion of the system of FIG. 4. [Figure 5] 5 is another perspective view of the system of FIG. 4 showing the forward valve in a second state, the switch in a second position, and the button depressed. [Figure 5A]6 is a partial enlarged perspective view of a portion of the system of FIG. 5 showing the switch in a second position and the button depressed. [Figure 5B] FIG. 6 is an enlarged detail view of a portion of the system of FIG. 5. [Figure 6] FIG. 2 is a perspective view of a first portion of the housing of the system of FIG. 1. [Figure 6A] FIG. 7 is an enlarged detail view of a portion of the first portion of the housing of FIG. 6. [Figure 7] FIG. 2 is a perspective view of a second portion of the housing of the system of FIG. 1. [Figure 8A-8B] FIG. 2 is a perspective view of a switch of the system of FIG. 1. [Figure 8C-8D] FIG. 2 is a side view of a switch of the system of FIG. 1. [Figure 9] 2 is an enlarged exploded view of a portion of the system of FIG. 1 showing the rear valve and button, the rear valve including a body and a piston. [Figure 10] FIG. 10 is a perspective view of the body of the rear valve of FIG. [Figure 11] FIG. 10 is a perspective assembly view of the system of FIG. 9, showing the rear valve and button coupled together. [Figure 12] FIG. 10 is a perspective view of the piston of the rear valve of FIG. [Figures 12A-12D] FIG. 13 is a cross-sectional view of the piston of FIG. 12. [Figure 13A] 2 is an enlarged perspective view of the front valve of FIG. 1 showing the top of the front valve and the bottom of the front valve. [Figure 13B] FIG. 13B is an enlarged perspective view of the top of the anterior valve of FIG. 13A. [Figures 14A-14B] FIG. 13B is a perspective view of the front valve of FIG. 13A showing the top and bottom portions of the front valve joined together. [Figure 15] 2 is a cross-sectional view of the system of FIG. 1 showing the forward valve in a first state, the switch in a first position, and the button in a default state. [Figure 15A] FIG. 16 is a detailed view of the switch of FIG. 15. [Figure 15B] FIG. 16 is an enlarged detail view of a portion of the system of FIG. 15. [Figure 16]2 is another cross-sectional view of the system of FIG. 1 showing the forward valve in a first state, the switch in a first position, and the button depressed. [Figure 16A] FIG. 17 is a detailed view of the switch of FIG. 16. [Figure 16B] FIG. 17 is a cross-sectional view of a portion of the system of FIG. 16 showing the switch in a first position. [Figure 16C] FIG. 17 is an enlarged detail view of a portion of the system of FIG. 16. [Figure 17] 2 is another cross-sectional view of the system of FIG. 1 showing the forward valve in a second state, the switch in a second position, and the button in a default state. [Figure 17A] FIG. 18 is a detailed view of the switch of FIG. 17. [Figure 17B] 18 is a cross-sectional view of a portion of the system of FIG. 17 showing the switch moved from a first position to a second position. [Figure 17C] FIG. 18 is an enlarged detail view of a portion of the system of FIG. 17. [Figure 18] 2 is another cross-sectional view of the system of FIG. 1 showing the forward valve in a second state, the switch in a second position, and the button depressed. [Figure 18A] FIG. 19 is a detailed view of the switch of FIG. 18. [Figure 18B] FIG. 19 is an enlarged detail view of a portion of the system of FIG. 18. [Figure 19] FIG. 1 is a perspective view of a system for delivering a therapeutic agent according to another embodiment, showing the housing, forward valve (second valve), switch, and button. [Figure 20] FIG. 20 is a partial exploded view of the system of FIG. 19 showing a first portion of the housing and a second portion of the housing. [Figure 21] FIG. 20 is a perspective view of a first portion of the housing of the system of FIG. 19. [Figure 21A] FIG. 22 is an enlarged detail view of a portion of the first portion of the housing of FIG. 21. [Figure 21B] 22 is another perspective view of the first portion of the housing of FIG. 21. [Figure 22] FIG. 20 is a perspective view of a second portion of the housing of the system of FIG. 19. [Figure 22A] FIG. 23 is an enlarged detail view of a portion of the second portion of the housing of FIG. 22. [Figure 23A] FIG. 20 is a perspective view of a portion of the switch of the system of FIG. 19. [Figure 23B] FIG. 23B is a side view of the switch portion of FIG. 23A. [Figure 23C] FIG. 23B is a cross-sectional view of a portion of the switch of FIG. 23A. [Figure 24A] FIG. 20 is a perspective view of the top of the switch of the system of FIG. 19. [Figure 24B] FIG. 24B is a side view of the top of the switch of FIG. 24A. [Figure 25] 20 is an enlarged perspective view of another embodiment of a guide member of the first portion of the housing of the system of FIG. 19. [Figure 26] 20 is a perspective view of another embodiment of a portion of the switch of the system of FIG. 19. [Figure 27] FIG. 10 is a schematic cross-sectional view of another embodiment of a rear valve. [Figure 28] 10 is a perspective view of another embodiment of the piston of the rear valve of FIG. 9. FIG. [Figure 29] FIG. 29 is another perspective view of the piston of FIG. 28. [Figure 30] FIG. 29 is another perspective view of the piston of FIG. 28. [Figure 31] FIG. 29 is a cross-sectional view of the piston of FIG. 28. [Figure 32] FIG. 29 is a cross-sectional view of the rear valve including the piston of FIG. 28 in a default state. [Figure 33] FIG. 33 is a cross-sectional view of the rear valve of FIG. 32 in a positive pressure position. [Figure 34] FIG. 33 is a cross-sectional view of the rear valve of FIG. 32 in a therapeutic agent delivery position. [Figure 35] FIG. 10 is an expanded view of a switch of a therapeutic agent delivery system according to another embodiment. [Figure 36-37] FIG. 10 is an enlarged partial view of a switch of a therapeutic agent delivery system according to another embodiment. [Figure 38] 10 is an illustration of a therapeutic agent delivery system showing another embodiment of a switch in an extended position. [Figure 39] FIG. 39 is an illustration of the system of FIG. 38 showing the switch of FIG. 38 in the retracted position. [Figure 40] FIG. 39 is an illustration of the switch of FIG. 38, showing the switch in an extended position. [Figure 41] FIG. 39 is an illustration of the switch of FIG. 38, showing the switch in the retracted position. DETAILED DESCRIPTION OF THE INVENTION

[0017] Various aspects are described below with reference to the drawings, in which like elements are generally identified with like numerals. The relationships and functions of the various elements of these aspects may be better understood by reference to the detailed description that follows. However, these aspects are not limited to what is shown in the drawings or explicitly described below. It should also be understood that the drawings are not necessarily to scale (although certain drawings may be drawn to scale and may be relied upon as such), and that in certain instances, details not necessary to an understanding of the aspects disclosed herein, such as conventional materials, structures, and assemblies, may be omitted.

[0018] For the purposes of promoting an understanding of the presently disclosed embodiments, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It is nevertheless to be understood that no limitation of the scope of the invention is thereby intended, and that changes and further modifications in the illustrated devices and further applications of the principles of the invention as set forth herein are contemplated as would normally occur to one skilled in the art to which the invention pertains.

[0019] In this application, the term "proximal" refers generally to a direction toward a physician during a medical procedure, and the term "distal" refers generally to a direction toward a target site within a patient's anatomy during a medical procedure. The term "configured to" is used to describe structural limitations in particular embodiments that require a particular structure to achieve a described function and / or interface or interact with other components, and is not used to describe merely intended or theoretical applications. Relative terms such as "generally," "about," "substantially," and the like, as well as broader terms, will be understood by those skilled in the art to provide a clear and distinct scope of the disclosure and / or claims. For example, the term "approximately 4-6 N" will not require exactly 4-6 N, but rather will be understood to include it and functional equivalents.

[0020] 1-18, an embodiment of a system 20 suitable for delivering one or more therapeutic agents to a target site is shown. In this embodiment, the system 20 includes a container 30 configured to contain a therapeutic agent 38, at least one pressure source 68 having a pressurized fluid configured to be placed in selective fluid communication with at least a portion of the container 30, and a catheter 90 positioned in selective fluid communication with the container 30 and configured to deliver the therapeutic agent 38 or the pressurized fluid through the catheter 90 to a target site within a patient, as described more fully below.

[0021] System 20 further includes a housing 22 suitable for securely holding, containing, engaging, and / or covering container 30, pressure source 68, catheter 90, and other components described below. Preferably, housing 22 includes an upright section 24 that can be grasped by a user and a section 25 that serves as a housing for container 30. Housing 22 is also configured to movably support switch 100, which is movable between a first position 102 (e.g., as shown in FIG. 2A ) and a second position 104 (e.g., as shown in FIG. 2B ). System 20 is configured such that, when switch 100 is in first position 102, delivery of pressurized fluid is permitted while delivery of therapeutic agent 38 is prevented, and when switch 100 is in second position 104, delivery of therapeutic agent 38 is permitted, as described in further detail below. Actuator 26 can be engaged by a user prior to delivering pressurized fluid without therapeutic agent or prior to delivering therapeutic agent.

[0022] The system 20 includes a first valve 80 (e.g., as shown in Figures 4 and 5) configured to be connected between the pressure source 68 and the container 30, a second valve 43 configured to be connected between the container 30 and the catheter 90, and a button 88 configured to selectively actuate the first valve 80 to deliver pressurized fluid without the therapeutic agent 38 or to deliver the therapeutic agent 38, as described in further detail below.

[0023] Container 30 may include any suitable size and shape for containing therapeutic agent 38. As shown in Figures 1 and 3, container 30 includes a generally tubular configuration having a first region 31, a second region 32, and a reservoir 33 defined by the interior of container 30.

[0024] 3, the container 30 may further include an inlet tube 40, an outlet tube 50, and a cap 60, where the cap 60 is configured to be secured to the first region 31 of the container 30. The inlet tube 40 has first and second ends 41 and 42 with a lumen extending therebetween, and the outlet tube 50 has first and second ends 51 and 52 with a lumen extending therebetween. The first end 41 of the inlet tube 40 is disposed in fluid communication with an inlet port 62 formed in the cap 60, and the first end 51 of the outlet tube 50 is disposed in fluid communication with an outlet port 63 formed in the cap 60. A cap 67 may be secured to the inlet port 62, thereby enabling connection between the inlet port 62 and the tube 61 (see FIGS. 3 and 4). In some embodiments, an O-ring may be placed around the inlet port 62 or around the first end 41 of the inlet tube 40 (e.g., as the first end 41 extends from the inlet port 62) so that when the cap 67 is secured onto the inlet port 62, the cap 67 provides a good seal, thereby allowing fluid to properly enter the container 30 without leaking during operation.

[0025] The outlet port 63 of the cap 60 can be disposed in fluid communication with a tube 64, which extends distally and connects to a catheter 90, with a second valve 43 disposed therebetween. By manipulating the second valve 43, a user has the option of selectively delivering the therapeutic agent 38 flowing from the tube 64 through the catheter 90. For example, the second valve 43 can be configured to have a first state 45 (e.g., a closed state as shown in FIG. 2A ) and a second state 47 (e.g., an open state as shown in FIG. 2B ). When the second valve 43 is in the first state 45 (e.g., as shown in FIGS. 4 , 15 , and 16 ), the catheter 90 is not in fluid communication with the tube 64 and the container 30. When the second valve 43 is in the second state 47 (e.g., as shown in FIGS. 5 , 17 , and 18 ), the catheter 90 is in fluid communication with the tube 64 and the container 30.

[0026] In operation, fluid passing through the inlet port 62 of the cap 60 is directed through the inlet tube 40 into the reservoir 33. Notably, the U-shaped bend near the second region 32 of the container 30 effectively changes the direction of fluid flow by approximately 180 degrees, such that the fluid originally flows from the first region 31 of the container 30 toward the second region 32, and then flows from the second region 32 back to the first region 31. As shown in FIGS. 1 and 3 , the first region 31 of the container 30 is positioned vertically above the second region 32 of the container 30 during use, although the first region 31 and the second region 32 can be positioned differently relative to one another, such that the first region 31 and the second region 32 are positioned at least partially horizontally adjacent to one another.

[0027] The second end 52 of the outlet tube 50 may terminate a predetermined distance above the second region 32 of the container 30, as shown in FIG. 3 . Thus, when fluid from the pressure source 68 is diverted from the second region 32 toward the first region 31, the fluid and therapeutic agent 38 in the reservoir 33 may be directed through the outlet tube 50, through the outlet port 63, and toward the target site. Alternatively, the outlet tube 50 may be omitted, and the therapeutic agent 38 may flow directly from the reservoir 33 into the outlet port 63. Other variations regarding the container 30 and outlet port 63 may be found in U.S. Pat. No. 8,118,777, which is incorporated herein by reference in its entirety.

[0028] The cap 60 may include any suitable configuration for sealably engaging the first region 31 of the container 30. In one example, an O-ring is held in place around the periphery of the cap 60 to contain the therapeutic agent 38 within the reservoir 33. The inlet tube 40 and the outlet tube 50 may be held in place within the container 30 by one or more support members, such as those further described in U.S. Pat. No. 8,118,777.

[0029] Additionally, cap 60 may include one or more flanges that allow for secure, removable engagement with a complementary interior region of section 25 of housing 22. For example, by rotating container 30, flanges of cap 60 may be locked into place within section 25.

[0030] Advantageously, in this aspect, a first container containing a first therapeutic agent may be coupled to the housing 22 for use with the system 20, followed by a second container containing a second composition or agent. By way of example, and not limitation, in one embodiment, the system 20 may be "pre-loaded" with a first container 30 containing a therapeutic agent in the form of a hemostatic agent. It may be deemed beneficial to deliver a mucoadhesive composition at a later time, in which case the first container 30 may be rotated to disengage its flange from the section 25 of the housing 22, and then a second container 30 may be inserted into the section 25 of the housing 22 to deliver the mucoadhesive composition. For simplicity, the formulation within the container 30 will be referred to as a "therapeutic agent 38," although, as described herein, the particular formulation within the container 30 coupled to the housing 22 may be replaced or changed and may or may not achieve a therapeutic effect itself.

[0031] Pressure source 68 may include one or more components capable of generating or supplying a fluid having a desired pressure. In one embodiment, pressure source 68 may include a pressurized fluid, such as a liquid or gas. For example, as shown in FIG. 3 , pressure source 68 may include a pressurized fluid cartridge of a selected gas or liquid, such as carbon dioxide, nitrogen, or any other suitable gas or liquid compatible with the human body. The pressurized fluid cartridge may contain a gas or liquid at a relatively high first predetermined pressure, e.g., about 1,800 psi, within the cartridge. Pressure source 68 may optionally include one or more commercially available components.

[0032] Fluid may flow from pressure source 68 through a pressure regulator, such as a regulator valve 70 having a pressure outlet 72, which may reduce the pressure to a second, lower, predetermined pressure. In some embodiments, as shown in FIG. 3, a spacer 71 may be placed between regulator valve 70 and pressure source 68, which facilitates securing pressure source 68 in place during transport.

[0033] The actuator 26 can be actuated to release fluid from the pressure source 68. For example, a user can rotate the actuator 26, which is converted to linear motion via the threaded engagement between the actuator 26 and the housing 22. When a linear advance is applied to the pressure source 68, the regulator valve 70 can release high-pressure fluid through the seal of the pressure cartridge (and spacer 71). After the regulator valve 70 reduces the pressure, fluid can flow from the pressure outlet 72 through the tube 75 toward the first valve 80.

[0034] 3 and 13A-14B, second valve 43 may be a stopcock including an upper portion 120 and a lower portion 122. Lower portion 122 includes a first inlet port 124, a second inlet port 126, an outlet port 128, and a middle section 125, with first inlet port 124 and outlet port 128 disposed distally of middle section 125 and second inlet port 126 disposed proximally of middle section 125. Lower section 123 of upper portion 120 includes through-hole 121 and is configured to be received in middle section 125. Second inlet port 126 is configured to be connected to tube 64, and outlet port 128 is configured to be connected to catheter 90.

[0035] The second valve 43 can be transitioned between a first state 45 (e.g., a closed state as shown in FIG. 2A ) and a second state 47 (e.g., an open state as shown in FIG. 2B ) via rotation of a top portion 120 of the second valve 43. For example, as shown in FIGS. 2A and 2B , rotating the top portion 120 of the second valve 43 in a first direction 110 (e.g., clockwise) can transition the second valve 43 from the first state 45 (e.g., a closed state) to the second state 47 (e.g., an open state), and rotating the second valve 43 in an opposite second direction (e.g., counterclockwise; not shown) can transition the second valve 43 from the second state 47 (e.g., an open state) back to the first state 45 (e.g., a closed state). When the second valve 43 is in the first state 45, the passage between the second inlet port 126 and the outlet port 128 is blocked by the lower portion 123 of the upper portion 120 so that the catheter 90 is not in fluid communication with the container 30. When the second valve 43 is in the second state 47, a passage is established between the second inlet port 126 and the outlet port 128 through the through-hole 121, and the catheter 90 is in fluid communication with the container 30.

[0036] 3 and 9-12, first valve 80 includes a body 81 having a proximal end 81a, a distal end 81b, and a lumen 81c extending between proximal end 81a and distal end 81b. A piston 82 having a proximal end 82a and a distal end 82b is at least partially disposed within body 81 and is slidably movable along the length of lumen 81c of body 81. A button 88 is configured to be connected to proximal end portion 82a of piston 82 such that depression of button 88 moves piston 82 distally along the length of lumen 81c of body 81. This proximal end portion 82a of piston 82 may extend a distance outside of body 81 (e.g., as shown in FIG. 15) to facilitate coupling to button 88. Distal end portion 82b of piston 82 may be positioned adjacent proximal end 95a of compression spring 95 (e.g., as shown in FIGS. 9 and 15B). In this embodiment, piston 82 may be provided with a default state (e.g., when no force is applied to button 88) in which piston 82 is tilted to be positioned further proximally, but when a user applies sufficient force to button 88, piston 82 may be moved distally against the force of compression spring 95 for purposes described below. When button 88 is released (e.g., undepressed), piston 82 returns to the default state.

[0037] Various inlet and outlet ports may be associated with the first valve 80. In the embodiment shown in FIGS. 1-18 , the body 81 includes an inlet port 92, a first outlet port 93, and a second outlet port 94. The inlet port 92 of the first valve 80 may be coupled to a tube 75 extending from the pressure outlet 72 of the regulator valve 70 (e.g., as shown in FIG. 4 ), thus providing pressurized fluid at a predetermined pressure to the first valve 80. The first outlet port 93 may be coupled to a tube 65 extending from a first inlet port 124 of the second valve 43 (e.g., as shown in FIG. 4 ). The second outlet port 94 may be coupled to a tube 61 extending from the inlet port 62 of the cap 60.

[0038] As shown in FIG. 12 , the piston 82 of the first valve 80 can include a generally tubular body 83 having a first groove 130 and a second groove 132 spaced apart and connected by a bridge 134 extending along the length of the piston 82. The bridge 134 can extend through at least a portion of the piston 82. In some embodiments, as shown in FIG. 27 , the bridge 134 can extend to the distal end portion 82 b of the piston 82, which can facilitate manufacturing of the piston 82. The first groove 130 extends radially through the piston 82 along the diameter of a first cross-section 136 of the piston 82, and the second groove 132 extends radially through the piston 82 along the diameter of a second cross-section 138 of the piston 82. With this configuration, a fluid communication path can be aligned to allow flow between the first and second grooves 130 and 132 through the bridge 134 in the piston 82.

[0039] 9 and 12, the piston 82 of the first valve 80 may further include spaced apart first and second valleys 140, 142 disposed on an outer surface of the piston 82. The first and second valleys 140, 142 are configured to receive first and second seal members 144, 146, respectively, configured to selectively close the inlet port 92, the first outlet port 93, or the second outlet port 94, as discussed in more detail below.

[0040] 12-12D , first valley 140 can extend at a constant depth around the circumference of third cross section 137 of piston 82, and second valley 142 can extend at a constant depth around the circumference of fourth cross section 139 of piston 82. First, second, third, and fourth cross sections 136, 138, 137, and 139 of piston 82 can be spaced apart and parallel to one another. As shown in FIG. 12 , first valley 140 is disposed proximal to second valley 142, first groove 130 is disposed proximal to first valley 140, and second groove 132 is disposed between first and second valleys 140 and 142.

[0041] The first valley 140 may include a first sub-valley 140a and a second sub-valley 140b separated by a portion of the outer surface of the piston 82. The second valley 142 may include a third sub-valley 142a and a fourth sub-valley 142b separated by a portion of the outer surface of the piston 82. The first seal member 144 and the second seal member 146 may each include at least one O-ring configured to be received in the respective first valley 140 and second valley 142. As shown in FIG. 9 , the first seal member 144 includes a first O-ring 144a configured to be disposed in the first sub-valley 140a and a second O-ring 144b configured to be disposed in the second sub-valley 140b. The second seal member 146 includes a third O-ring 146a configured to be disposed in the third sub-valley portion 142a and a fourth O-ring 146b configured to be disposed in the fourth sub-valley portion 142b.

[0042] In use, the piston 82 is at least partially disposed within the body 81 and is slidably movable along the length of the bore 81c of the body 81. The inlet port 92, the first and second outlet ports 93, 94 of the body 81 of the first valve 80, the first and second valleys 140 and 142 of the piston 82, and the first and second sealing members 144 and 146 are configured and spaced (e.g., as shown in FIG. 16 ) such that when the second sealing member 146 is axially aligned with the second outlet port 94, the first sealing member 144 is axially offset from the inlet port 92 and the first outlet port 93, whereby fluid communication (e.g., first fluid communication) is established between the inlet port 92 and the first outlet port 93 via the first and second grooves 130 and 132 and the bridge 134. On the other hand, when the first seal member 144 is axially aligned with the first outlet port 93, the first seal member 144 is axially offset from the inlet port 92, and the second seal member 146 is axially offset from the second outlet port 94, thereby establishing fluid communication (e.g., second fluid communication) between the inlet port 92 and the second outlet port 94 via the first and second grooves 130 and 132 and the bridge 134 (e.g., as shown in FIG. 18).

[0043] As mentioned above, system 20 also includes switch 100, which is configured to selectively permit actuation of first valve 80 to deliver pressurized fluid without or with therapeutic agent 38. In some embodiments, as shown in FIGS. 2A, 2B, and 4-5A, switch 100 can be a slider 100, and housing 22 is configured to slidably support slider 100, such that when slider 100 is in first position 102 (e.g., as shown in FIGS. 2A and 4A), slider 100 enables button 88 to be depressed to first state 87 (e.g., as shown in FIG. 4A), which allows pressurized fluid in pressure source 68 to be released through first valve 80. When slider 100 is in second position 104 (e.g., as shown in Figures 2B and 5A), slider 100 allows button 88 to be depressed to second state 91 (e.g., as shown in Figure 5A), which allows pressurized fluid in pressure source 68 to flow through first valve 80 into container 30 and force therapeutic agent 38 in container 30 through catheter 90, as discussed in more detail below.

[0044] 4-5B, when slider 100 is in first position 102 (e.g., as shown in FIGS. 4 and 4A), slider 100 blocks button 88, thereby allowing button 88 to be moved distally up to a first distance (e.g., until distal end 88b of button 88 contacts slider 100; as shown in FIG. 4A, where button 88 is in first state 87) from a default state (e.g., when no force is applied to button 88; as shown in FIG. 15). When slider 100 is in second position 104 (e.g., as shown in FIGS. 5 and 5A), slider 100 allows button 88 to be moved distally up to a second distance (e.g., until distal end 88b of button 88 contacts proximal end 81a of body 81 of first valve 80; as shown in FIG. 5A, where button 88 is in second state 91). The first distance is less than the second distance. As shown in Figure 4A, when slider 100 is in first position 102, slider 100 occupies space 89 which, when unoccupied, allows button 88 to move from first state 87 to second state 91. As shown in Figure 5A, when slider 100 is in second position 104, slider 100 is clear of space 89, allowing button 88 to be depressed to second state 91.

[0045] 15-18, when button 88 is in a default state (e.g., where it is not engaged by a user, as shown in FIG. 15), the force provided by compression spring 95 biases piston 82 to its default state, in which first seal member 144 disposed in first valley 140 of piston 82 is axially aligned with inlet port 92 of body 81, thereby preventing pressurized fluid from pressure source 68 (regulated by regulator valve 70) from entering first valve 80.

[0046] As shown in Figures 16-16C, when slider 100 is in first position 102 and button 88 is depressed by a user to overcome the force provided by compression spring 95, button 88 is advanced distally to first state 87 (e.g., where button 88 is fully depressed and blocked by slider 100), first seal member 144 is axially offset from inlet port 92 and first outlet port 93, and second seal member 146 is axially aligned with second outlet port 94, thereby allowing pressurized fluid from pressure source 68 to flow into first valve 80 via inlet port 92, into first groove 130, through bridge 134 into second groove 132, and out of first valve 80 via first outlet port 93. In this manner, pressurized fluid from pressure source 68 (regulated by regulator valve 70) is directed to first outlet port 93, enters tubing 65, and is then directed to catheter 90 via first inlet port 124 of second valve 43.

[0047] 17-18B, when the slider 100 is moved from the first position 102 to the second position 104 (e.g., as shown in FIG. 17B), the slider 100 is moved out of the path of the button 88, thereby allowing the button 88 to be moved distally until the distal end 88b of the button 88 contacts the proximal end 81a of the body 81 of the first valve 80 (e.g., as shown in FIG. 18B, where the button 88 is in the second state 91). When the button 88 is depressed to the second state 91, the first seal member 144 is axially offset from the inlet port 92 of the body 81 but axially aligned with the first outlet port 93, and the second seal member 146 is axially offset from the second outlet port 94 of the body 81, thereby allowing pressurized fluid from the pressure source 68 to enter the first valve 80 through the inlet port 92, into the first groove 130, through the bridge 134 into the second groove 132, and exit the first valve 80 through the second outlet port 94.

[0048] In this manner, pressurized fluid from pressure source 68 (regulated by regulator valve 70) is directed to second outlet port 94, to tubing 61, thence to inlet port 62 of cap 60, to container 30 containing therapeutic agent 38, thence to outlet tubing 50, to outlet port 63 of cap 60, and to tubing 64, at which point delivery of therapeutic agent 38 can be controlled by second valve 43, as described above. When second valve 43 is in second state 47 (e.g., as shown in FIG. 18 ), a passage is established between second inlet port 126 and outlet port 128, whereby therapeutic agent 38 flowing from tubing 64 can be delivered through catheter 90 coupled to outlet port 128.

[0049] As described above, the configuration of slider 100, first valve 80, and button 88 enables system 20 to deliver positive pressure prior to delivery of therapeutic agent 38 (e.g., powder), which is advantageous for preventing fluid ingress in various situations, including, but not limited to, when catheter 90 is fed through the scope channel, during powder spraying, when the scope is moved to a new target, and when the scope is irrigated or accidentally immersed in a pool of blood / fluid, thereby improving system performance in fluid and water-saturated media. Furthermore, system 20's ability to deliver therapeutic agent 38 (e.g., sprayed powder) in a water-saturated media, eliminating the risk of the system clogging, advantageously improves overall procedure time and customer experience, and also leads to a reduction in the number of catheters packaged per system, thereby reducing the environmental impact.

[0050] It will be understood that the number, configuration, and location of the grooves, bridges, valleys, sub-valleys, and sealing members included in piston 82 and the inlet and outlet ports associated with first valve 80 can be varied as desired and / or needed without departing from the scope of the present invention, so long as the fluid communication paths can be selectively aligned such that, in one state of first valve 80, flow is permitted between the inlet port and an outlet port connected to tubing 65 coupled to inlet port 124 of second valve 43, and, in another state of first valve 80, flow is permitted between the inlet port and an outlet port connected to tubing 61 coupled to inlet port 62 of cap 60, such that pressurized fluid (without therapeutic agent 38) or therapeutic agent 38 can be selectively delivered using first valve 80 and a button coupled to first valve 80.

[0051] 6-8D, a first embodiment of a housing 22 and a switch 100 is shown, where the switch 100 is a slider 100 slidably supported by the housing 22. The housing 22 includes a first portion 150 and a second portion 152 that, when coupled together, form a cavity therebetween configured to at least partially hold, receive, engage, and / or cover other components of the system 20 (e.g., the container 30) and slidably support the slider 100. As shown in FIGS. 6-7, the first portion 150 of the housing 22 includes a first upper portion 151 and a first inner surface 154, and the second portion 152 of the housing 22 includes a second upper portion 153 and a second inner surface 156.

[0052] First upper portion 151 includes a first concave portion 171 extending downward from a first upper surface 155 of first upper portion 151, first concave portion 171 including a first portion 166 and a second portion 168 disposed below first upper surface 155 and including a first notch 170 disposed therebetween. Second upper portion 153 includes a second concave portion 173 extending downward from a second upper surface 157 of second upper portion 153, second concave portion 173 including a third portion 172 and a fourth portion 174 disposed below second upper surface 157 and including a second notch 176 disposed therebetween. First and second concave portions 171 and 173 are configured to slidably support at least a portion of slider 100, as discussed in further detail below.

[0053] First portion 150 includes a first guide member 158 and a second guide member 160 extending outward from first inner surface 154. First guide member 158 and second guide member 160 are spaced apart and at least partially disposed beneath first recessed portion 171. Second portion 152 includes a third guide member 162 and a fourth guide member 164 extending outward from second inner surface 156. Third guide member 162 and fourth guide member 164 are spaced apart and at least partially disposed beneath second recessed portion 173. The first, second, third, and fourth guide members are configured to slidably support at least a portion of slider 100, as discussed in further detail below.

[0054] 8A-8D, slider 100 includes an upper portion 180 and a lower portion 181. Upper portion 180 includes a top portion 186 and a neck portion 187 extending downward from top portion 186. Lower portion 181 includes a main portion 188, which includes an upper section 189, a lower section 190, and a middle section 191 extending between and connecting upper section 189 and lower section 190. First groove 192 and second groove 194 are formed between upper section 189 and lower section 190 and are disposed on either side of middle section 191. Neck portion 187 extends upward from upper section 189 of lower portion 181. Lower portion 181 also includes arm portions 182 extending outward and downward from side surfaces 183 of upper section 189. Arm portion 182 also includes a notch 184 configured to receive at least a portion of proximal end portion 82a of piston 82, as will be discussed in more detail below.

[0055] 3-5B, first portion 150 of housing 22 and slider 100 are configured such that first and second guide members 158 and 160 are slidably received within first and second grooves 192 and 194, respectively, while top portion 186 is slidably received within first recessed portion 171 and is slidably supported by first and second portions 166 and 168, and neck portion 187 is slidably movable within first notch 170 (e.g., as shown in FIG. 5B). The second portion 152 of the housing 22 and the slider 100 are configured such that the third and fourth guide members 162 and 164 are slidably received within the first and second grooves 192 and 194, respectively, while the top portion 186 is slidably received within the second recessed portion 173 and is slidably supported by the third and fourth portions 172 and 174, and the neck portion 187 is slidably movable within the second notch 176.

[0056] 1-5B, when slider 100 is in the first position (e.g., as shown in FIGS. 2A and 4B), top 186 of slider 100 is slidably received in second recessed portion 173 of second part 152 of housing 22 and is slidably supported by third and fourth portions 172 and 174, neck portion 187 is slidably movable within second notch 176, and third and fourth guide members 162 and 164 are slidably received in first and second grooves 192 and 194 of the slider, respectively. When the slider 100 is in the second position 104 (e.g., as shown in Figures 2B and 5B), the top 186 is slidably received in the first recessed portion 171 of the first part 150 of the housing 22 and is slidably supported by the first and second parts 166 and 168, the neck portion 187 is slidably movable within the first notch 170, and the first and second guide members 158 and 160 are slidably received in the first and second grooves 192 and 194 of the slider 100, respectively.

[0057] The first and second parts 150, 152 of the housing 22 are configured such that, when coupled together, the first and second concave portions 171, 173 form a continuous concave portion that slidably supports the top 186 as it moves between the first and second concave portions 171, 173; the first and second notches 170, 176 form a continuous notch that allows the neck 187 to move between the first and second notches 170, 176; the first and third guide members 158, 162 form a continuous guide member; and the second and fourth guide members 160, 164 form a continuous guide member, thereby allowing the slider 100 to move along the continuous guide members between the first position 102 and the second position 104. The arm portion 182 of the slider 100 is configured such that when the slider 100 is in the first position 102, at least a portion of the proximal end portion 82a of the piston 82 is received in the notch 184 (e.g., as shown in FIG. 4A) so that distal movement of the button 88 is blocked by the arm portion 182, and when the slider 100 is in the second position 104, the arm portion 182 is out of the path of distal movement of the button 88 (e.g., as shown in FIG. 5A).

[0058] The configurations and positions of the first concave portion 171, the second concave portion 173, the switch 100 (e.g., the slider 100), the first to fourth guide members 158 to 164, the piston 82 of the first valve 80, and the button 88 may be changed as desired and / or needed without departing from the scope of the present invention, as long as the intended functions / purposes / uses described above can be achieved.

[0059] For example, the shape of the notch 184 can vary depending on the shape of the proximal end portion 82a of the first valve 80. As shown in Figures 4A and 8D, the proximal end portion 82a of the first valve 80 has a generally tubular shape, and the notch 184 has a corresponding generally semicircular shape configured to receive at least a portion of the proximal end portion 82a of the first valve 80. As another example, the width 185 of the arm portion 182 (e.g., as shown in FIG. 8C ) is configured such that when the button 88 is in the first state 87 (e.g., as shown in FIG. 4A ; the button is blocked by the width 185 of the arm portion 182), the first valve 80 is in a state in which pressurized fluid is delivered without the therapeutic agent 38, as discussed in further detail above, and when the arm portion 182 is removed and the distal end 88 b of the button 88 contacts the proximal end 81 a of the body 81 of the first valve 80 (e.g., as shown in FIG. 5A ), the first valve 80 is in a state in which the therapeutic agent 38 is delivered.

[0060] 36 and 37, the slider 300 can include a shaft 107 and a ring 109, where the ring 109 includes a splittable portion 111 and a remaining portion 113. Features discussed below with respect to this embodiment of the slider 300 can be incorporated into other embodiments of the switch, and features and / or functions discussed herein with respect to other embodiments of the switch can be applied to this embodiment of the switch 300; therefore, for the sake of brevity, similar features / functions will not be discussed in detail in this embodiment of the switch 300. The slider 300 is movable between a first position 302 and a second position 304 after the splittable portion 111 is split. In some embodiments, for example, before the splitting operation, slider 300 may look like slider 100 of FIG. 4A (or slider 100' of FIG. 26), but with a full 360-degree ring, and after the splitting operation, slider 300 may look like slider 100 of FIG. 4A (or slider 100' of FIG. 26).

[0061] 36 and 37, portions of slider 300 have been omitted for purposes of illustration, but may otherwise appear similar to slider 100 of FIG. 4A (or slider 100' of FIG. 26). Similar to the other switch embodiments discussed herein, when slider 300 is in first position 302 (as shown in FIG. 2A), slider 300 enables the button to be depressed to a first state, allowing pressurized fluid in the pressure source to flow through the first valve and into the catheter without delivery of therapeutic agent, and when slider 300 is in second position 304 (as shown in FIG. 2B), slider 300 enables the button to be depressed to a second state, allowing pressurized fluid in the pressure source to flow through the first valve and into the reservoir, forcing the therapeutic agent in the reservoir through the catheter.

[0062] 36 and 37, when the slider 300 is in the first position 302, the proximal end portion 82a of the piston 82 of the first valve extends through the ring 109 of the slider 300, and as discussed in other switch embodiments, the ring 109 occupies a space that, when unoccupied, allows movement of the button from the first state to the second state. As discussed in other switch embodiments, when the slider 300 is in the first position 302, the ring 109 blocks the button such that the button can be moved distally a maximum of a first distance.

[0063] Moving the slider 300 from the first position 302 toward the second position 304 splits the splittable portion 111 (e.g., by force applied to the shaft 107 and by the proximal end portion 82a of the piston 82 extending through the ring 109), and after the splittable portion 111 is split, the slider 300 can be moved to the second position 304. When the slider 300 is in the second position 304, the splittable portion 111 has already split from the remaining portion 113 of the ring 109, which is away from the space (e.g., the remaining portion 113 no longer blocks the button), and the button can be depressed to a second state (e.g., the button can be moved distally up to a second distance, and the first distance is less than the second distance, as discussed in other switch embodiments).

[0064] This embodiment of switch 300 is advantageous in that the slider is securely locked in place during shipping and device setup, reducing the risk of accidental deployment of the therapeutic agent. When initially depressing the slider to activate spray of the therapeutic agent, the user must apply force to separate separable portion 111. By way of non-limiting example, the force required to separate the slider may be approximately 4-6 N to ensure that the slider can withstand the dispensing force, but not so great that the user cannot activate the slider. The configuration of shaft 107, ring 109, separable portion 111, and remaining portion 113 may be varied as desired and / or needed without departing from the scope of the present invention, so long as a portion of the switch is required to separate to allow initial deployment of the therapeutic agent.

[0065] Additionally, in some embodiments, the switch need not be a slider without departing from the scope of the present invention, so long as, without limitation, rotating, pivoting, twisting, and / or depressing the switch 100 is configured to selectively block a button for selectively delivering pressurized fluid (without therapeutic agent 38) or therapeutic agent 38, as described above. By way of non-limiting example, in some embodiments, the switch 400 is movable between an upper / retracted position 402 and a lower / extended position 404 (discussed in more detail below but not specifically shown), as shown in FIG. 35 . Features discussed below with respect to this embodiment of the switch 400 may be incorporated into other embodiments of the switch, and features and / or functionality discussed herein with respect to other embodiments of the switch may be applicable to this embodiment of the switch 400; therefore, for the sake of brevity, similar features / functionality will not be discussed in detail in this embodiment of the switch 400.

[0066] When switch 400 is in the up / retracted position 402, delivery of pressurized fluid is permitted while delivery of therapeutic agent is prevented, and when switch 400 is in the down / extended position 404, delivery of therapeutic agent is permitted. As discussed with other switch embodiments, when switch 400 is in the up / retracted position 402, switch 400 allows a button to be depressed to a first state, allowing pressurized fluid in the pressure source to flow through the first valve and into the catheter without delivery of therapeutic agent, and when switch 400 is in the down / extended position 404, switch allows a button to be depressed to a second state, allowing pressurized fluid in the pressure source to flow through the first valve and into the reservoir, forcing the therapeutic agent in the reservoir through the catheter.

[0067] As shown in FIG. 35 , the switch 400 includes a middle portion 103 pivotally connected to the inner surface 23 of the housing, a hook 105 extending downward from the middle portion 103, and a protrusion 101 extending upward from the middle portion 103, the protrusion 101 extending upward above the housing. The switch 400 is configured such that pressing the protrusion 101 downward moves the hook 105 downward, thereby moving the switch 400 from an upper / retracted position 402 toward a lower / extended position 404. In some embodiments, the middle portion 103 can be a spring plate extending between a first end portion 103 a and a second end portion 103 b, where the first end portion 103 a is connected to the inner surface 23 of the housing and the second end portion 103 b is cantilevered. The protrusion 101 and the hook 105 can both extend from the second end portion 103 b of the middle portion 103.

[0068] When protrusion 101 is not depressed, hook 105 occupies a space which, when unoccupied, allows movement of the button from a first state to a second state, as discussed in other switch embodiments, and hook 105 blocks the button so that the button can be moved distally a maximum first distance. When protrusion 101 is depressed, hook 105 moves downward (e.g., hook 105 moves away from the space), which allows the button to move distally a maximum second distance (e.g., allows the button to be depressed to the second state), as discussed in other switch embodiments, and the first distance is less than the second distance.

[0069] 35 , the hook 105 may be a J-hook such that when the protrusion 101 is not depressed, the hook 105 engages the proximal end portion 82a of the first valve piston, and when the protrusion 101 is depressed, the hook 105 moves downward and disengages the first valve piston. Holding the protrusion 101 down allows the switch 400 to remain in the downward / extended position 404, and releasing the protrusion 101 moves the hook 105 upward, moving the switch 400 from the downward / extended position 404 to the upward / retracted position 402. This embodiment of the switch 400 is advantageous in that the user must hold down the protrusion to deploy the therapeutic agent, thereby reducing the risk of accidental deployment of the therapeutic agent. The configuration of the intermediate portion 103, the protrusion 101, and the hook 105 can be varied as desired and / or needed without departing from the scope of the present invention, so long as the switch must be held down to allow deployment of the therapeutic agent.

[0070] As another non-limiting example, in some embodiments, as shown in FIGS. 38-41 , switch 500 is movable between an extended position 502 (e.g., as shown in FIGS. 38 and 40 ) and a retracted position 504 (e.g., as shown in FIGS. 39 and 41 ). When switch 500 is in extended position 502, delivery of pressurized fluid is permitted while delivery of therapeutic agent is prevented, and when switch 500 is in retracted position 504, delivery of therapeutic agent is permitted. This embodiment of switch 500 is advantageous for reducing the force required to actuate switch 500. Features discussed below with respect to this embodiment of switch 500 may be incorporated into other embodiments of the switch, and features and / or functionality discussed herein with respect to other embodiments of the switch may be applicable to this embodiment of switch 500; therefore, for the sake of brevity, similar features / functionality will not be discussed in detail in this embodiment of switch 500.

[0071] Switch 500 includes a clickable button 501 and a hook 503 extending downwardly from clickable button 501, and switch 500 is configured to move between an extended position 502 and a retracted position 504 by pressing and releasing clickable button 501. As shown in FIGS. 40 and 41 , clickable button 501 includes a cam body 506 having a notch 510, a ball 508, and a spring 512. The functionality and operating mechanism of clickable button 501 is well known in the writing art, and other embodiments of clickable buttons in the writing art can be incorporated into switch 500 without departing from the scope of the present invention, including, for example, the clickable button of a Parker Jotter pen.

[0072] When switch 500 is in extended position 502, switch 500 allows button 88 to be depressed to a first state, allowing pressurized fluid in the pressure source to flow through the first valve and into the catheter without delivering a therapeutic agent, and when switch 500 is in retracted position 504, switch 500 allows button 88 to be depressed to a second state, allowing pressurized fluid in the pressure source to flow through the first valve and into the container, forcing the therapeutic agent in the container through the catheter.

[0073] 38 , when switch 500 is in extended position 502, hook 503 engages proximal end portion 82 a of first valve piston 82 and blocks button 88 so that button 88 can be moved distally a maximum of a first distance. As shown in FIG. 39 , when switch 500 is in retracted position 504, hook 503 moves upward and does not engage first valve piston 82, so that button 88 can be moved distally a maximum of a second distance, where the first distance is less than the second distance.

[0074] 38 and 39, when the switch 500 is in the extended position 502, the hook 503 occupies a space that, when unoccupied, allows the button 88 to move from a first state to a second state. When the switch is in the retracted position 504, the hook 503 is moved away from the space, allowing the button 88 to be depressed to the second state.

[0075] In use, with the catheter 90 connected to the outlet port 128 of the second valve 43, the user ensures that the switch 100 is in the first position 102 and the second valve is in the first state 45 (e.g., as shown in FIG. 2A ) and can then activate the pressure source 68 (e.g., by operating the actuator 26). To deliver pressurized fluid without the therapeutic agent 38, the user can activate the first valve 80 by fully depressing the button 88 until it is blocked by the switch 100 (e.g., as shown in FIGS. 4A and 16 ). This allows pressurized fluid to flow through the first valve 80 and into the catheter 90 without delivering the therapeutic agent 38. With the button 88 still fully depressed, the user can insert the catheter 90 into the patient's cavity (e.g., into a scope extending into the patient's cavity) until the target site is reached (e.g., until the distal end of the catheter 90 exits the scope).

[0076] Next, to deliver the therapeutic agent 38, the user releases the button 88, moves the switch 100 from the first position 102 to the second position 104 (e.g., as shown in FIG. 17B ; such that the button 88 can be further depressed to activate the first valve 80), transitions the second valve 43 from the first state 45 to the second state 47 (e.g., as shown in FIG. 2B ; such that pressurized fluid can force the therapeutic agent 38 in the container 30 through the catheter 90), and can fully depress the button 88 until it is blocked by the proximal end 81 a of the body 81 of the first valve 80. This allows pressurized fluid to flow through the first valve 80 and into the container 30. The desired number of shots (e.g., three shots) of the therapeutic agent 38 can be delivered by depressing and holding the button 88 a desired number of times (e.g., three times). After the desired amount of therapeutic agent 38 has been delivered, the user can release button 88 , returning second valve 43 to first state 45 and returning switch 100 to first position 102 .

[0077] 19-24B, another embodiment of a system 20' for delivering a therapeutic agent is disclosed. As shown in FIGS. 19 and 20, the system 20' includes a housing 22', a first valve 80', a second valve 43', a switch 100', and a button 88'. The features described above with respect to the embodiment of the system 20' as shown in FIGS. 1-18 may be included, alone or in combination, in the embodiment of the system 20' as shown in FIGS. 19-24B, including, but not limited to, the basic components forming the system 20', the configuration, positioning, and function of those basic components, and the method of operating the button 88' to selectively deliver pressurized fluid without or with the therapeutic agent 38. For the sake of brevity, the features described above will not be repeated with respect to this embodiment of the system 20' as shown in FIGS. 19-24B.

[0078] 20-22A, housing 22' includes a first portion 150' and a second portion 152' that, when coupled together, form a cavity configured to at least partially retain, accommodate, engage, and / or cover other components of system 20' (e.g., first valve 80') and slidably support slider 100'. As shown in FIGS. 21-21B, first portion 150' of housing 22' includes a first upper portion 151' and a first inner surface 154'. As shown in FIGS. 22 and 22A, second portion 152' of housing 22' includes a second upper portion 153' and a second inner surface 156'.

[0079] The first top 151′ includes a cantilevered portion 171′ extending at least partially outward from a side surface 159 of the first top 151′. The cantilevered portion 171′ includes a platform 167 surrounded by a flange 169 extending upwardly from the platform 167, with a first notch 170′ extending along at least a portion of the platform 167. The second top 153′ of the second portion 152′ includes a second notch 176′ configured to receive at least a portion of the cantilevered portion 171′ extending outward from the side surface 159 of the first top 151′, such that the first and second portions 150′ and 152′ can be coupled together to form the housing 22′ with the cantilevered portion 171′ at least partially received within the second notch 176′. The cantilevered portion 171′ is configured to slidably support at least a portion of the slider 100′, as discussed in more detail below.

[0080] First portion 150' includes first guide member 158' and second guide member 160' extending outward from first inner surface 154'. First and second guide members 158' and 160' are spaced apart. Second portion 152' includes a guide support 165' extending outward from second inner surface 156'. First and second guide members 158' and 160' and guide support 165' are configured such that, when first portion 150' and second portion 152' of housing 22' are coupled together to form housing 22', proximal ends 158'a and 160'a of first and second guide members 158' and 160' engage guide support 165', thereby supporting and securing first and second guide members 158' and 160' by guide support 165'. The first and second guide members 158' and 160' are configured to slidably support at least a portion of the slider 100', as will be discussed in more detail below.

[0081] 19, 20, and 23A-24B, a switch 100' (e.g., a slider 100') includes an upper portion 180' and a lower portion 181'. The upper portion 180' includes a top portion 186' and a neck portion 187'. The lower portion 181' includes a main portion 188', which includes an upper section 189', a lower section 190', and a middle section 191' extending between and connecting the upper section 189' and the lower section 190'. A first groove 192' and a second groove 194' are formed between the upper section 189' and the lower section 190' and disposed on opposite sides of the middle section 191'. The lower section 181' also includes an arm portion 182' extending outward and downward from a side surface 183' of the upper section 189'. Arm portion 182' also includes a notch 184' configured to receive at least a portion of a proximal end portion of a piston of first valve 80', as discussed in more detail above with respect to embodiments of system 20.

[0082] Top portion 186' includes an upper portion 193 and a lower portion 195. Neck portion 187' includes a groove 197 configured to receive at least a portion of lower portion 195 of top portion 186' such that top portion 186' and neck portion 187' are coupled together such that movement of slider 100' can be achieved by manipulating upper portion 193 of top portion 186'. This configuration is advantageous in that it allows for ease of assembly, as top portion 186' can be easily assembled by inserting lower portion 195 into groove 197 of neck portion 187' after all other components of system 20' have been assembled. As discussed in more detail above with respect to embodiments of system 20, housing 22' and first portion 150' of slider 100' are configured such that first and second guide members 158' and 160' are slidably received within first and second grooves 192' and 194', respectively, while upper portion 193 of top portion 186' of slider 100' is slidably received within cantilever portion 171' and slidably supported by platform 167' with neck portion 187' slidably movable within first notch 170'.

[0083] When the upper portion 193 of the slider 100' is disposed at the first end 196 of the flange 169, the slider 100' is in a first position 102' and at least a portion of the proximal end portion of the piston of the first valve 80' is received within the notch 184' of the arm portion 182', thereby blocking distal movement of the button 88' by the arm portion 182'. When the upper portion 193 of the slider 100' is disposed at the second end 198 of the flange 169, the slider 100' is in a second position 104' in which the arm portion 182' is out of the path of distal movement of the button 88'. The ability to move the upper portion 193 of the slider 100' along the platform 167' and along the first and second guide members 158' and 160' between the first position 102' and the second position 104' is advantageous for providing smooth movement / operation of the slider 100'.

[0084] In some embodiments, guide members 158' and 160' and switch 100' (e.g., slider 100') can be configured to prevent unintended relative movement between slider 100' and guide members 158' and 160'. For example, as shown in FIG. 25 , guide members 158' and 160' can include multiple notches 208 and 210, respectively. In some embodiments, multiple notches 208 and 210 can be continuous along the length of respective guide members 158' and 160', respectively. For example, as shown in FIG. 25 , multiple notches 208 and 210 can each include five notches arranged consecutively, each notch having the same / similar configuration (e.g., shape, size). As shown in FIG. 25 , each notch has a curved configuration.

[0085] 26 , a pair of arms 200 and 202 can extend outward from opposite sides of the mid-section 191′ of the slider 100′ along the respective directions of the first and second grooves 192′ and 194′, and the distal ends of the pair of arms 200 and 202 include protrusions 204 and 206, respectively, extending outward from the respective arms 200 and 202. The protrusions 204 and 206 can be configured to be received in the respective notches 210 and 208. 19, 20, 25 and 26, the arms 200 and 202 and the protrusions 204 and 206 are configured such that when the top 193 of the slider 100' is positioned on the first end 196 of the flange 169, the slider 100' is in the first position 102', and the protrusions 204 and 206 engage / are at least partially received in corresponding notches 210 and 208 of the respective guide members 160' and 158', thereby preventing unintentional movement of the slider 100' relative to the guide members 158' and 160' (e.g., during transport), which is advantageous in preventing accidental movement of the slider 100' between the first position 102' and the second position 104'.

[0086] A user can manually move the slider 100′ between the first position 102′ and the second position 104′ by pushing the slider 100′ in the corresponding direction. During movement of the slider 100′, the plurality of notches 208 and 210 provide tactile feedback to the user as the protrusions 204 and 206 move in and out of the corresponding notches 210 and 208 in the guide members 160′ and 158′, respectively. The configuration (e.g., shape, size), number, and location of the notches 208 and 210 in each guide member 158' and 160' and the configuration (e.g., shape, size, length) of each arm 202 and 200 and protrusion 206 and 204 can be varied as desired and / or needed without departing from the scope of the present invention, so long as the tactile feedback described above can be provided and / or the function of preventing accidental movement between the slider 100' and the guide members 158' and 160' can be achieved as the slider 100' moves between the first position 102' and the second position 104'.

[0087] 28-34, another embodiment of piston 382 of first valve 380 is shown, which may be incorporated into any of the embodiments of system 20 described above, along with any of the other components (e.g., housing, slider) described above, as desired and / or required, without departing from the scope of the present invention. First valve 380 includes body 381 having proximal end 381a, distal end 381b, and lumen 381c extending between proximal end 381a and distal end 381b. Piston 382, ​​having proximal end portion 382a and distal end portion 382b, is at least partially disposed within body 381 and slidably movable along the length of lumen 381c of body 381. Button 388 is configured to be connected to proximal end portion 382a of piston 382, ​​such that depression of button 388 moves piston 382 distally along the length of lumen 381c of body 381. This proximal end portion 382a of piston 382 can extend a distance outside of body 381 (e.g., as shown in FIG. 32) to facilitate coupling to button 388. Distal end portion 382b of piston 382 can be positioned adjacent proximal end 395a of compression spring 395 (e.g., as shown in FIGS. 32-34). In this embodiment, piston 382 can be provided with a default state (e.g., when no force is applied to button 388, as shown in FIG. 32) in which piston 382 is tilted to be positioned further proximally, but when a user applies sufficient force to button 388, piston 382 can be moved distally against the force of compression spring 395 for purposes described below. When button 388 is released (e.g., undepressed), piston 382 returns to the default state.

[0088] Various inlet and outlet ports may be associated with the first valve 380. In the embodiment shown in FIGS. 32-34, the body 381 includes an inlet port 392, a first outlet port 393, and a second outlet port 394. The inlet port 392 of the first valve 380 may be coupled to a tube 75 extending from a pressure outlet 72 of the regulator valve 70 (e.g., as shown in FIG. 4 described above with respect to another embodiment of the first valve 80), thus providing pressurized fluid at a predetermined pressure to the first valve 380. The first outlet port 393 may be coupled to a tube 65 extending from a first inlet port 124 of the second valve 43 (e.g., as shown in FIG. 4 described above with respect to another embodiment of the first valve 80). The second outlet port 394 may be coupled to a tube 61 extending from an inlet port 62 of the cap 60 (e.g., as shown in FIG. 4 described above with respect to another embodiment of the first valve 80).

[0089] 28-31 , the piston 382 of the first valve 380 can include a generally tubular body 383 having spaced-apart first and second openings 330 and 332 disposed on the exterior surface of the piston 382. The first and second openings 330 and 332 are connected by a bridge 334 that extends through the piston 382 at an angle α relative to the length of the piston 382. The bridge 334 can extend through at least a portion of the piston 382. In some embodiments, as shown in FIG. 31 , the angle α is less than 90 degrees. With this configuration, a fluid communication path can be aligned to allow flow between the first and second openings 330 and 332 through the bridge 334 within the piston 382.

[0090] The piston 382 further includes first and second spaced recesses 331 and 333 disposed on the outer surface of the piston 382. The first opening 330 is disposed in the first recess 331, and the second opening 332 is disposed in the second recess 333. The presence of the first and second recesses 331 and 333 is advantageous in aiding in the delivery of air flow to the respective first and second outlet ports 393 and 394. As shown in FIG. 31 , the first recess 331 can extend around the circumference of a first cross-section 336 of the piston 382 at a constant depth, and the second recess 333 can extend around the circumference of a second cross-section 338 of the piston 382 at a constant depth.

[0091] 31 , the piston 382 of the first valve 380 can further include spaced-apart first and second valleys 340, 342 disposed on an outer surface of the piston 382. The first and second valleys 340, 342 are configured to receive first and second seal members 344, 346, respectively, configured to selectively close an inlet port 392, a first outlet port 393, or a second outlet port 394, as discussed in more detail below. The first valley 340 can extend around the circumference of a third cross-section 337 of the piston 382 at a constant depth, and the second valley 342 can extend around the circumference of a fourth cross-section 339 of the piston 382 at a constant depth. The first, second, third, and fourth cross-sections 336, 338, 337, and 339 of the piston 382 can be spaced apart and parallel to one another. As shown in FIG. 31 , the first valley portion 340 can be positioned proximal to the second valley portion 342, the first opening 330 can be positioned proximal to the first valley portion 340, and the second opening 332 can be positioned between the first and second valley portions 340, 342.

[0092] 31 , the first valley 340 can include a first sub-valley 340a and a second sub-valley 340b separated by a portion of the outer surface of the piston 382. The second valley 342 can include a third sub-valley 342a and a fourth sub-valley 342b separated by a portion of the outer surface of the piston 382. The first and second seal members 344 and 346 can each include at least one O-ring configured to be received in the respective first and second valleys 340 and 342. With reference to FIGS. 31 and 32 , the first seal member 344 includes a first O-ring 344a configured to be disposed in the first sub-valley 340a and a second O-ring 344b configured to be disposed in the second sub-valley 340b. The second seal member 346 includes a third O-ring 346a configured to be disposed in the third sub-valley portion 342a and a fourth O-ring 346b configured to be disposed in the fourth sub-valley portion 342b.

[0093] As shown in FIG. 32, the first valve 380 is configured such that when the button 388 is not depressed (e.g., no force is applied to the button 388), the first sealing member 344 is axially aligned with the inlet port 392, thereby blocking the inlet port 392 and preventing fluid communication between the inlet port 392 and any one of the first and second outlet ports 393 and 394.

[0094] In use (e.g., when first valve 380 having piston 382 is incorporated into system 20), piston 382 is at least partially disposed within body 381 and is slidably movable along the length of bore 381c of body 381. Inlet port 392, first outlet port 393, and second outlet port 394 of body 381 of first valve 380, first and second valleys 340 and 342 of piston 382, ​​and first and second seal members 344 and 346 are configured such that when second seal member 346 is axially aligned with second outlet port 394, first seal member 344 is axially offset from inlet port 392 and first outlet port 393, thereby providing fluid communication (e.g., a first fluid communication) between first and second openings 330 and 332 and and bridge 334 between inlet port 392 and first outlet port 393 (e.g., as shown in FIG. 33, where, as described above with respect to FIGS. 4A and 16C, slider 100 is in first position 102 (e.g., as shown in FIGS. 2A and 4A), allowing button 388 to be partially depressed to the extent shown in FIG. 33, allowing pressurized fluid in pressure source 68 to flow through first valve 380 and into catheter 90 without delivery of therapeutic agent).

[0095] Furthermore, when the first seal member 344 is axially aligned with the first outlet port 393, the first seal member 344 is axially offset from the inlet port 392 and the second seal member 346 is axially offset from the second outlet port 394, thereby establishing fluid communication (e.g., second fluid communication) between the inlet port 392 and the second outlet port 394 via the first and second openings 330 and 332 and the bridge 334 (e.g., as shown in FIG. 34 , where, as described above with respect to FIGS. 5A and 18B , the slider 100 is in the second position 104 (e.g., as shown in FIGS. 2B and 5A ), allowing the button 388 to be depressed to the extent shown in FIG. 34 ), allowing the pressurized fluid in the pressure source 68 to flow through the first valve 380 and into the container 30, forcing the therapeutic agent 38 in the container 30 through the catheter 90, as discussed in further detail above).

[0096] It will be understood that the number, configuration (e.g., shape / size), and location of the openings, bridges, valleys, sub-valleys, and sealing members included in piston 382 and the inlet and outlet ports associated with first valve 380 may be varied as desired and / or needed without departing from the scope of the present invention, so long as the fluid communication paths can be selectively aligned to allow flow between an inlet port and an outlet port connected to tubing 65 coupled to inlet port 124 of second valve 43 in one state of first valve 380, and to allow flow between the inlet port and an outlet port connected to tubing 61 coupled to inlet port 62 of cap 60 in another state of first valve 380, such that pressurized fluid (not including therapeutic agent 38) or therapeutic agent 38 can be selectively delivered using first valve 380 and button 388 coupled to first valve 380.

[0097] While various embodiments of the present invention have been described, the present invention is not limited except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the present invention, and it is not necessarily expected that all embodiments of the present invention will achieve all of the described advantages.

Claims

1. 1. A system suitable for delivering a therapeutic agent to a target site, comprising: a container for containing a therapeutic agent; a pressure source having a pressurized fluid in selective fluid communication with at least a portion of the vessel; a catheter in selective fluid communication with the reservoir and configured to deliver the therapeutic agent or the pressurized fluid to a target site; a housing configured to securely hold the container and to movably support a switch; a first valve connected between the pressure source and the container; a button configured to selectively actuate the first valve to deliver the pressurized fluid without the therapeutic agent or to deliver the therapeutic agent; Including, the switch is movable between a first position and a second position; when the switch is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, the switch allowing the button to be depressed to a first state, allowing the pressurized fluid in the pressure source to flow through the first valve and into the catheter without delivery of the therapeutic agent; When the switch is in the second position, delivery of the therapeutic agent is permitted, and the switch allows the button to be depressed to a second state, allowing the pressurized fluid in the pressure source to flow through the first valve into the container and force the therapeutic agent in the container through the catheter.

2. 10. The system of claim 1, further comprising a second valve connected between the container and the catheter, wherein when the second valve is in a first state, the catheter is not in fluid communication with the container, and when the second valve is in a second state, the catheter is in fluid communication with the container.

3. When the switch is in the first position, the switch blocks the button such that the button can be moved distally up to a first distance; when the switch is in the second position, the switch allows the button to be moved distally a maximum second distance; The system of claim 1 , wherein the first distance is less than the second distance.

4. 2. The system of claim 1, wherein the switch occupies a space when the switch is in the first position, and the space, when unoccupied, allows movement of the button from the first state to the second state.

5. 5. The system of claim 4, wherein when the switch is in the second position, the switch is moved away from the space, allowing the button to be depressed to the second state.

6. The system of claim 1 , wherein the switch includes a slider, and the housing is configured to slidably support the slider.

7. 2. The system of claim 1, wherein the switch is movable between a retracted position and an extended position, and when the switch is in the retracted position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and when the switch is in the extended position, delivery of the therapeutic agent is permitted.

8. The switch is an intermediate portion pivotally connected to an inner surface of the housing; a hook extending downward from the intermediate portion; a protrusion extending upward from the intermediate portion; Including, the protrusion extends above the housing; 8. The system of claim 7, wherein the switch is configured such that pressing the protrusion downwardly moves the hook downward, thereby moving the switch from the retracted position toward the extended position.

9. 2. The system of claim 1, wherein the switch is movable between an extended position and a retracted position, and when the switch is in the extended position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and when the switch is in the retracted position, delivery of the therapeutic agent is permitted.

10. The switch is Clickable buttons and a hook extending downward from the clickable button; 10. The system of claim 9, comprising: a switch configured to move between the extended position and the retracted position by pressing and then releasing the clickable button.

11. A system according to the limitations of claim 1 and any one or more of claims 2 to 10.

12. 1. A system suitable for delivering a therapeutic agent to a target site, comprising: a container for containing a therapeutic agent; a pressure source having a pressurized fluid in selective fluid communication with at least a portion of the vessel; a catheter in selective fluid communication with the reservoir and configured to deliver the therapeutic agent or the pressurized fluid to a target site; a housing configured to securely hold the container and to movably support a switch; Including, the switch includes a separable portion, and when the switch is moved from a first position toward a second position, the separable portion is separated to enable the switch to be moved between the first position and the second position; when the switch is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted; When the switch is in the second position, delivery of the therapeutic agent is permitted.

13. The switch includes a slider including a shaft and a ring; the ring includes the divisible portion and a remaining portion, The housing is configured to slidably support the slider, and the system includes: a first valve connected between the pressure source and the container; a button configured to selectively actuate the first valve to deliver the pressurized fluid without the therapeutic agent or to deliver the therapeutic agent; and further comprising when the slider is in the first position, the slider allows the button to be depressed to a first state, allowing the pressurized fluid in the pressure source to flow through the first valve and into the catheter without delivery of the therapeutic agent; 13. The system of claim 12, wherein when the slider is in the second position, the slider allows the button to be depressed to a second state, allowing the pressurized fluid in the pressure source to flow through the first valve into the container and force the therapeutic agent in the container through the catheter.

14. The system of claim 13 , wherein a piston of the first valve extends through the ring of the slider when the slider is in the first position.

15. 15. The system of claim 14, wherein moving the slider from the first position toward the second position causes the splittable portion to split, and after the splittable portion is split, the slider can be moved to the second position.

16. when the slider is in the first position, the ring blocks the button such that the button can be moved distally a maximum first distance; when the slider is moved to the second position, the remaining portion of the ring does not block the button, allowing the button to be moved distally up to a second distance; The system of claim 13 , wherein the first distance is less than the second distance.

17. 14. The system of claim 13, wherein the ring occupies a space when the slider is in the first position, and the space, when unoccupied, allows movement of the button from the first state to the second state.

18. 14. The system of claim 13, wherein when the slider is in the second position, the separable portion separates from the remaining portion of the ring and the remaining portion of the ring is moved out of space, allowing the button to be depressed to the second state.

19. A system according to the limitations of claim 12 and any one or more of claims 13 to 18.

Images