Medical devices for drug delivery and related methods of use

Abstract

An apparatus can be configured to deliver a medicament to a target tissue using a pressurized fluid, and the apparatus can include a catheter including a lumen, a cartridge configured to store the medicament, receive the pressurized fluid, and release a mixture of the pressurized fluid and the medicament, and a valve at a location downstream of the cartridge to receive the mixture of the pressurized fluid and the medicament from the cartridge. The valve can have a first configuration that blocks flow of the mixture through the lumen and a second configuration that allows flow of the mixture through the lumen.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 943,060, filed November 3, 2019, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present disclosure relates generally to medical systems and devices for delivering pressurized fluids / drugs, and more particularly to methods and tools for controlling delivery of fluids / drugs at suitable pressures and flow rates. BACKGROUND

[0004] In certain medical procedures, it is necessary to stop or minimize bleeding inside the body. For example, endoscopic medical procedures can require hemostasis of bleeding tissue inside the gastrointestinal tract, such as in the esophagus, stomach, or intestines.

[0005] During an endoscopy, a user inserts a sheath of an endoscope into a patient's body cavity. The user controls the endoscope during the procedure using a handle of the endoscope. A tool is passed through a working channel of the endoscope, such as through a port in the handle, to deliver a therapeutic drug at a treatment site proximate a distal end of the endoscope. The treatment site is remote from the operator.

[0006] To achieve hemostasis at the remote site, a device inserted into the working channel of the endoscope can be used to deliver a hemostatic drug. For example, drug delivery can be accomplished through a mechanical system. However, such systems can require many steps or actuations to achieve delivery, can not achieve a desired rate of drug delivery or a desired dose of drug, can cause clogging of portions of the delivery device with the drug, can cause inconsistent dosing of the drug, or can not cause the drug to reach treatment sites at a depth inside the gastrointestinal tract. The present disclosure can address one or more of these problems or other problems in the art. SUMMARY

[0007] In addition, examples of the present disclosure relate to drug delivery devices. Each of the examples disclosed herein can include one or more features described in the disclosure of the examples.

[0008] A device can be configured to deliver a drug to a target tissue with a pressurized fluid, and the device can include a catheter including a lumen, a cartridge configured to store the drug, receive the pressurized fluid, and release a mixture of the pressurized fluid and the drug, and a valve at a location downstream of the cartridge to receive the mixture of the pressurized fluid and the drug from the cartridge. The valve can have a first configuration that blocks flow of the mixture through the lumen and a second configuration that allows flow of the mixture through the lumen.

[0009] Any of the systems and devices disclosed herein can have any of the following features. A first fluid input can be configured to release pressurized fluid from a pressurized fluid container into the interior cavity when a container is coupled to the first fluid input. A valve can be inside the housing, and the housing can include a handle. The medicament can be a powdered medicament. The valve can include a chamber, and the chamber can be fluidly connected to the interior cavity via an output channel. The valve can also include a stem including a plunger at a distal end of the stem, and the stem can extend through the chamber and can be configured to prevent fluid flow to the output channel in a first configuration and allow fluid flow to the output channel in a second configuration. The valve can further include a slider slidably coupled to the chamber and including a slot, and the stem can extend through the slot, and the slider can be configured to transition the valve from the first configuration to the second configuration by movement of the slider. The valve can also include a biasing member coupled to the stem, and the biasing member can be configured to bias the stem toward the first configuration of the valve. The slider can include a slider on which the stem is supported, the slider having a first portion including a curved surface and a second portion including a flat surface. The stem can include an end portion extending radially outward relative to an adjacent portion of the stem, and wherein the end portion of the stem stops the stem from moving through the slot when the end portion of the stem contacts the slider. The end portion of the stem can slidably engage the slider.

[0010] The valve can include a chamber, and the chamber can be fluidly connected to the interior cavity via an output channel. The valve can also include a stem including a plunger at a first end of the stem and a cam engagement surface at a second end of the stem, wherein the stem extends through the chamber and is configured to prevent fluid flow to the output channel in a first configuration and allow fluid flow to the output channel in a second configuration. The valve can further include a cam engaged with the cam engagement surface; a pinion fixedly coupled to the cam and including a first plurality of gears; a rack including a second plurality of gears, wherein the second plurality of gears is configured to mate with the first plurality of gears; and a biasing member coupled to the stem, wherein the biasing member is configured to bias the stem toward the first configuration of the valve. The cam can be pear-shaped, the stem can be U-shaped, and the cam engagement surface can include a wheel. A trigger can be coupled to the rack, wherein actuation of the trigger moves the stem to transition the valve from the first configuration to the second configuration. Movement of the rack in a first direction can be used to move the pinion and the cam to transition the cam from a first position in which a longitudinal center axis of the cam is substantially parallel to a longitudinal center axis of the rack to a second position in which the longitudinal center axis of the cam is transverse to the longitudinal center axis of the rack; and movement of the rack in a second direction can be used to move the pinion and the cam from the second position to the first position. The valve can include a chamber, wherein the chamber includes a distal opening fluidly connecting an interior of the chamber to the output channel; and a butterfly valve inside the distal opening. The butterfly valve can be configured to prevent fluid flow to the output channel in a first configuration of the valve and allow fluid flow to the output channel in a second configuration of the valve, and rotation of the butterfly valve moves the butterfly valve to transition the valve from the first configuration to the second configuration.

[0011] The lumen can be a first lumen and the valve can include a chamber, where the chamber includes a distal opening fluidly connecting an interior of the chamber to the output channel, and a ball valve located inside the distal opening and including a second lumen extending through the ball valve. The ball valve can be configured to block fluid flow to the output channel in a first configuration of the valve and to allow fluid flow to the output channel through the second lumen in a second configuration of the valve, and rotation of the ball valve can transition the ball valve from the first configuration to the second configuration. The housing can include a handle, where the handle includes an interior configured to receive a fluid container.

[0012] A delivery device can be configured to deliver a drug to a target tissue using pressurized fluid. The delivery device can include a catheter including a lumen, a proximal end, and a distal end, a cartridge configured to store a drug, receive pressurized fluid, and release a mixture of pressurized fluid and drug, and a first fluid input at a location upstream of the cartridge. The first fluid input can be configured to release pressurized fluid from a pressurized fluid container toward the cartridge when the container is coupled to the first fluid input. In some examples, pressurized fluid and drug can flow from the cartridge to the distal end of the catheter when the container is coupled to the first fluid input. The entire volume of pressurized fluid inside the container can be used to deploy a first amount of drug through the distal end of the catheter.

[0013] In other examples, a method for controlling fluid delivery to a patient's body is disclosed. The method can include fluidly connecting a cartridge to a catheter, where the cartridge includes a drug in an interior of the cartridge and is configured to flow the drug into a lumen of the catheter, moving a distal end of the catheter to a target tissue site, the catheter including a lumen extending longitudinally through the catheter, and where the lumen is configured to receive pressurized fluid from a container through a first input at a location proximal of the cartridge, coupling the container to the first input, where the container releases pressurized fluid stored inside the container into the first input when the container is coupled to the first input, and contacting an actuator of a valve to open a fluid path from the first input to a distal opening of the lumen, causing the fluid and the drug to be released from the distal end of the catheter. In some examples, the method can also include compressing a spring inside a valve assembly, and breaking a fluid seal between an input channel and an output channel of the valve, where breaking the fluid seal fluidly connects the first input to the distal opening of the lumen.

[0014] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application, as claimed. As used herein, the terms "comprise", "comprising", or other variations such as "comprises", "comprising", or "comprise", are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. In all the drawings, the word "exemplary" is used to mean "example" not "ideal." The term "distal" refers to the direction away from the operator, and the term "proximal" refers to the direction toward the operator. The word "about" and like terms (e.g., "approximately") include + / - 10% of the stated value. The term "distal" refers to the portion of the device that is farthest from the user when introducing the device into the patient. Conversely, the term "proximal" refers to the portion of the device that is closest to the user when placing the device into the patient. In all the drawings, the proximal and distal directions are marked with arrows labeled "P" and "D," respectively. BRIEF DESCRIPTION OF DRAWINGS

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various example embodiments and together with the description, serve to explain the principles of the disclosed embodiments.

[0016] Figure 1 is a side view of a delivery system according to one example embodiment.

[0017] Figure 2 is a side view of a delivery system according to one example embodiment.

[0018] Figure 3A and Figure 3B are cross-sectional views of a valve assembly in a first configuration and a second configuration, respectively, according to one example embodiment.

[0019] Figure 4A and Figure 4B are top views of a valve assembly in a first configuration and a second configuration, respectively, according to one example embodiment.

[0020] Figure 5A and Figure 5B are cross-sectional views of a valve assembly in a first configuration and a second configuration, respectively, according to one example embodiment.

[0021] Figure 6A and Figure 6B are cross-sectional views of a valve assembly in a first configuration and a second configuration, respectively, according to one example embodiment.

[0022] Figure 7A andFigure 7B is a cross-sectional view of a valve assembly in a first configuration and a second configuration, respectively, according to one example embodiment.

[0023] Figure 8 is a cross-sectional side view of a handle assembly including a valve assembly, according to one example embodiment. DETAILED DESCRIPTION

[0024] A drug delivery device can be configured to contain a drug at the distal end of the delivery device and can be configured to control the rate at which the drug and fluid exit the delivery device at a single location. The delivery device can be configured to contain a single component drug or a multi-component drug. In the case of a multi-component drug, the delivery device can be configured to allow mixing of the components prior to delivery from the device. Various mechanisms can be applied to pre-pressurize the chamber of the drug and actuate the delivery device to deliver the drug while limiting the number of valves required in the device. These mechanisms can include pneumatic devices, wires, tubes, valves, or any suitable combination thereof.

[0025] Referring to Figure 1 , a delivery system 100 according to one embodiment is shown. The delivery system 100 can include a catheter 102, a cartridge 104 containing a drug 112, a cartridge connector 105, a fluid container 106, a regulator 107 including a fluid source input port 109, and a filter 110. In some instances, the fluid container 106 can release pressurized fluid into the regulator 107 when coupled to the regulator 107. For example, the input port 109 can be configured to pierce the fluid container 106 when the fluid container 106 is coupled to the regulator 107, thereby releasing pressurized fluid into the regulator 107.

[0026] Referring to Figure 1The fluid container 106 is configured to contain a fluid, such as a gas (e.g., carbon dioxide or any other gas known in the art or other fluid). Although illustrated as a cylinder, the fluid container 106 can be any shape, such as a torpedo shape, a sphere, or any other shape known in the art and used to store a fluid. For example, the fluid container 106 can be a carbon dioxide tank or cylinder commonly found in a medical setting, such as a hospital, or a smaller, portable cartridge. In some examples, the fluid container 106 can be fluidly connected to a fluid source that is separate from the delivery system 100, such as via a fluid conduit that can be fluidly connected to a stationary fluid source in an operating room. The fluid container 106 can include one or more outer walls that define one or more interior chambers (not shown), the interior chambers configured to contain a fluid. The walls of the fluid container 106 can be constructed of any material suitable for containing a fluid, such as, but not limited to, a metal alloy, ceramic, or other material known in the art. The fluid contained in the interior chambers of the fluid container 106 can be under pressure. Accordingly, the walls are constructed of a material and / or thickness suitable for containing a fluid at a pressure of, for example, at least about 1,000 pounds per square inch (PSI), or about 850 PSI. For example, the gas that can be contained in the fluid container 106 can include carbon dioxide (C02) having a vapor pressure of about 2,000-8,000 kPa at typical device temperatures, or nitrogen (N2) having a vapor pressure of less than 40 MPa at typical device temperatures. It should be understood that these gases are examples and are not limiting to the type of gas contained in the fluid container 106.

[0027] With continued reference to Figure 1The fluid container 106 is attached to the regulator 107 at a regulator input port 109. The regulator 107 includes a body 108 (which includes an input port 109 and an output port 111, each being for communication with an external environment). The input port 109 of the regulator 107 can be configured to pierce the fluid container 106. The output port 111 can be configured to fluidly couple to the proximal end of the conduit 102. The body 108 of the regulator 107 can be any material known in the art, including but not limited to a metal alloy, ceramic, and / or resin. The regulator 107 can be configured to change the flow rate of the fluid exiting the fluid container 106 such that the fluid enters the distal end of the conduit 102 at a selected flow rate. In some examples, the fluid can enter the distal end of the conduit 102 at a flow rate in the range of about 4 standard liters per minute to 12 standard liters per minute. In some examples, the delivery system 100 can be configured to flow the fluid through the distal end of the conduit 102 at a flow rate in the range of between about 5 standard liters per minute to 10 standard liters per minute. The fluid container 106 can be coupled to the regulator 107 via a pull cord coupling mechanism or a pump mechanism. In some examples, a pull cord coupling mechanism can be included in the system 100 and can include an actuator including a cord and a pin, and the pin can engage with a carbon dioxide cartridge (or other fluid cartridge) to release fluid from the cartridge when the cord is pulled by a user. For example, the pin can pierce the cartridge and cause pressurized fluid to flow in the system 100. In other examples, a pump mechanism can be included in the system 100 and can be configured to provide pressurized fluid to the system 100, such as by providing pressurized gas in the system 100. In some examples, the system 100 can not include the regulator 107 and the container 106 can be coupled to the conduit 102 via an input port similar to the input port 109.

[0028] The distal end of the conduit 102 (the portion distal of the regulator 107) can provide fluid from the fluid container 106 and the regulator 107 to the barrel 104 and the barrel connector 105 under pressure. The barrel 104 can be cylindrical and can include an inner chamber 118 and a funnel 119 at an end of the barrel 104. The barrel 104 can be configured to store a medicament 112 (such as a powder or liquid drug agent) inside the inner chamber 118, which can be fluidly connected to the connector 105. The funnel 119 can include tapered surfaces that form a portion of the inner chamber 118 at the end of the barrel 104 to an opening 123. The funnel 119 can be configured to direct the medicament 112 through the opening 123 into the connector 105. In some examples, the barrel 104 can be configured to use gravity to flow the medicament 112 into the connector 105. The barrel 103 can be any suitable material known in the art. In some examples, the barrel 103 can be made of a transparent material.

[0029] The opening 123 can be configured to be coupled to the connector 105. The connector 105 can include an internal lumen (not shown) that fluidly connects the three separate openings. Two of the three separate openings can be configured to be coupled to the conduit 102 portion, and one of the three separate openings can be configured to be coupled to the opening 123 of the barrel 104. The openings of the connector 105 can be configured to be removably coupled to the barrel 104. The connector 105 can be made of metal, polymer, or any other suitable material known in the art.

[0030] The conduit 102 can be cylindrical and can include an internal lumen extending along its longitudinal center axis. In some examples, the conduit 102 can include a proximal portion 122 and a distal portion 121. The proximal portion 122 of the conduit 102 can be coupled to the connector 105 and can fluidly connect the regulator 107 to the connector 105. The distal portion 121 of the conduit 102 can be coupled to the connector 105 at a proximal end of the distal portion 121, and the distal portion 121 can extend to the distal opening 115. The conduit 102 can be made of any material (e.g., reinforced rubber or a suitable plastic) that allows the conduit 102 to withstand pressure of the fluid while allowing unrestricted movement of the conduit 102. The distal portion 121 can be flexible and can be configured to bend to facilitate movement through a patient's body lumen (e.g., the gastrointestinal tract). The proximal portion 122 of the conduit 102 can include a filter 110 inside the internal lumen of the conduit 102. The filter 110 can be configured to allow fluid to flow distally from the regulator 107 through the internal lumen of the conduit 102, and can also be configured to prevent the drug 112 from moving proximally through the conduit 102. In some examples, the filter 110 can be configured to restrict fluid flow through the conduit 102 by narrowing the internal lumen diameter of the conduit 102. The system 100 can provide a means of delivering the drug 112 to the target tissue without the need for any valves inside the conduit 102, which can reduce the procedure time and can simplify the process of delivering the drug 112 to the tissue.

[0031] In operation, a user can first insert the medicament 112 into the barrel 104 of the delivery system 100. The user can then position the distal opening 115 of the catheter 102 proximal to a target tissue of a patient, such as a target tissue inside a body cavity of the patient. Once the distal opening 115 is positioned proximate to or at the target tissue, the user can couple the fluid container 106 to the regulator 107. By coupling the fluid container 106 to the regulator 107, the input port 109 can puncture or initiate the flow of fluid from the fluid container 106 through the regulator 107 into the catheter 102. The fluid can then flow from the regulator 107 through the proximal portion 122 of the catheter 102 into the connector 105 and barrel 104. As the fluid flows into the connector 105 and barrel 104, the medicament 112 can move in the direction of the fluid flow and be transported through the catheter 102 to the distal opening 115. With the flow of fluid, the medicament 112 can then be deployed through the distal opening 115 and pushed toward the target tissue. Because the flow of fluid is initiated when the fluid container 106 is coupled to the regulator 108, the user need not actuate a valve or adjust the deployment of the medicament with the flow of fluid from the fluid container 106. Actuation of the system 100 by coupling the fluid container 106 to the regulator 107, such as by coupling it to the regulator 107 to puncture the carbon dioxide container, provides a means to deliver the medicament 112 to the target tissue and form a single injection of the medicament 112 toward the target tissue without the need for valve regulation. For example, the system 100 can be configured to receive a single delivery of pressurized fluid provided by the fluid container 106, such as the release of a specific amount of carbon dioxide from the fluid container 106, to deliver a specific amount of the medicament 112 to the distal opening 115. By providing the user with a device that can deliver a measured amount of medicament by coupling the fluid container 106 with a specific amount of fluid, an additional step of actuating a valve assembly or selectively releasing liquid into the device with an actuator can be eliminated and the user's time during operation can be saved. In some examples, the system 100 can not include a regulator 107. In some examples, when the fluid container 106 is coupled to the regulator 108, all or most of the medicament 112 can be expelled from the barrel 104, such as each barrel 104 can be a single dose of therapeutic medicament. The volume of the fluid barrel 106 can be used to deploy a selected amount of the medicament 112 with the system 100.

[0032] Figure 2An alternative embodiment of a delivery system 200, generally similar to delivery system 100, is shown. Delivery system 200 may include: a catheter 202 (which includes a distal portion 222, a proximal portion 223, and a distal opening 215); a connector 205; a fluid container 206; a regulator 207 (which includes a regulator body 208, a regulator inlet 209, and an outlet 211); a cylinder 204; a drug 212; and a filter 210. Any features described above with respect to delivery system 100 may be included in delivery system 200. Delivery system 200 may also include a valve 220 at the distal portion of catheter 202 (e.g., any portion of catheter 202 distal to connector 205). Valve 220 may be fluidly connected to the lumen of catheter 202. In some instances, valve 220 may be coupled to the distal portion 222 and the distal end 221 of catheter 202. In other instances, valve 220 may be located just off the connector 205.

[0033] In operation, the user first connects the fluid container 206 to the regulator 207 to pressurize the delivery system 200 with a pressurized fluid (such as pressurized carbon dioxide). The delivery system 200 may be configured to withstand column pressure, wherein the valve 220 maintains the fluid pressure and the drug 212 contained within the delivery system 200. Once the delivery system 200 has been pressurized with fluid by connecting the fluid container 206 to the regulator 207, the user can selectively release the pressurized fluid and drug 212 from the delivery system 200 by actuating the valve 220. In some instances, actuation of the valve 220 may result in the release of fluid and / or drug 212 through the distal end 221 of the catheter 202 and from the distal opening 215. By placing the valve 220 at the distal end of the catheter 202, the user can selectively deliver the drug 212 to the target tissue and can allow the user to deliver the drug 212 multiple times to the same target area or different target areas. Valve 220 may have any number of mechanisms for regulating the release of fluid from the delivery system 200 discussed below herein.

[0034] Figure 3A and Figure 3B A cross-sectional view of an exemplary valve assembly 300 is shown. The valve assembly 300 can be used as... Figure 2 Valve 220 is included. Valve assembly 300 can be configured to operate under a constant fluid pressure flowing into inlet passage 351. Valve assembly 300 may include: valve chamber 323, inlet passage 351 including inlet chamber 350, outlet passage 353 including outlet chamber 352, rod 325 (which includes plunger 327 at the distal end of rod 325), biasing member 331, and slider 321. Valve assembly 300 can be housed within a retaining device (not shown) that can be of any suitable shape. For example, valve assembly 300 may be incorporated into a handle for a user to hold during surgery (shown in...). Figure 8).

[0035] Chamber 323 can be cylindrical and can include a cap portion 333 at a proximal end of chamber 323 and a distal opening 390 fluidly connecting chamber 323 with output channel 353. Chamber 323 can include a tapered distal end 358, with a conical inner surface 359 tapering toward a longitudinal center axis of chamber 323 and toward distal opening 390. Input channel 351 can be cylindrical and can fluidly connect to chamber 323 at an opening 354 located at a proximal portion of chamber 323. In some examples, a distal portion 222 (shown in Figure 2 ) of catheter 202 can be fluidly coupled to input channel 351, and a most distal portion 221 (shown in Figure 2 ) of catheter 202 can be fluidly coupled to output channel 353. Input channel 351 can be located superior to output channel 353 to facilitate fluid flow from input channel 351 through chamber 323 to output channel 353 (e.g., by allowing gravity to exert a force on the fluid to push the fluid toward output channel 353).

[0036] Rod 325 can be cylindrical and can extend through chamber 323. In some examples, rod 325 can extend along a longitudinal center axis of chamber 323. Plunger 327 can be coupled to a distal end of rod 325. Plunger 327 can be conical and can extend radially outward from the longitudinal center axis of rod 325. In some examples, plunger 327 tapers such that the distance between the longitudinal center axis of rod 325 and the radially outer surface of the plunger decreases as plunger 327 extends distally. Plunger 327 can be rubber, hard plastic, or any other suitable material known in the art. Plunger 327 can be configured to form a fluid-tight seal with chamber 323 at distal opening 390. In some examples, rod 325 can be configured to translate distally inside chamber 323 until plunger 327 contacts the inner surface of chamber 323 and forms a fluid-tight seal, thereby preventing fluid flow through distal opening 390. Proximal end 329 of rod 325 can be tapered and can extend radially outward from the longitudinal center axis of rod 325 as proximal end 329 extends proximally. Rod 325 can extend through an opening 371 (shown in Figure 4A and Figure 4B ) in slide 321 and also through an opening in cap 333. Proximal end 329 of rod 325 can be tapered to prevent movement through opening 371. Rod 325 can move proximally (upward in the figures) through opening 371, for example, when proximal end 329 is translated along proximally-facing surfaces 355, 357 of slide 321.

[0037] The biasing member 331 can extend circumferentially around the stem 325 and can be coupled to the cap 333 via a coupling 337. The coupling 337 can fixedly couple a proximal end of the biasing member 331 to the cap 333. A distal end of the biasing member 331 can be fixedly coupled to the plunger 327 and can contact a proximal-facing surface 361 of the plunger 327. In some examples, the biasing member 331 can be a spring. The stem 325 can extend through a longitudinal center axis of the biasing member 331. The biasing member 331 can exert a force on the stem 325, pushing the stem 325 toward the distal opening 390. In an extended state (shown in Figure 3A ), the biasing member 331 can exert a force on the stem 325 such that the plunger 327 forms a fluid-tight seal with the inner surface of the chamber 323, preventing fluid flow through the distal opening 390. In a retracted state (shown in Figure 3B ), the biasing member 331 can exert a force on the stem 325, pushing the stem distally toward the distal opening 390. The proximal end 329 of the stem 325 can contact the slide 321 and counteract the force exerted on the stem 325 from the biasing member 331. In some examples, when a user transitions the proximal end 329 from a position contacting the first portion 355 of the slide 321 to a position contacting the second portion 357 of the slide 321, the proximal end 329 can slide at the second portion 357 and the stem 325 can move distally toward the distal opening 390 with the force exerted on the stem 325 from the biasing member 331.

[0038] The slide 321 can extend across the cap 333 and across a proximal portion of the chamber 323 (above the cap 333 and the chamber 323). The slide 321 can be rectangular or any other suitable geometric shape. The proximal-facing surface of the slide 321 can include a first portion 355 and a second portion 357. In some examples, the first portion 355 can be planar and the second portion 357 can be curved. The slide 321 can have a varying thickness, with portions of the slide 321 including the first portion 355 having a greater thickness and portions of the slide 321 including the second portion 357 having a lesser thickness. For example, the slide 321 can extend outward from a longitudinal center axis of the slide 321 as the slide 321 extends from the second portion 357 to the first portion 355. The distal-facing surface 376 of the slide 321 can be planar and can be configured to slide on the cap 333 and / or the chamber 323. Figure 4A and Figure 4B are top views of the valve assembly 300, showing the chamber 323, the cap 333, the proximal end 329 of the stem 325, and the slide 321 including the opening 371. Figure 4A corresponds to the position of the valve assembly 300 shown in Figure 3A , and Figure 4B corresponds to the position of the valve assembly 300 shown in Figure 3BThe position of the valve assembly 300 is shown. The slider 321 may be designed with a beveled second portion 357 such that when the slider 321 is moved from a position where its proximal end 329 contacts the first portion 355 to a position where it contacts the second portion 357, the biasing member 331 returns the rod 325 to the closed position, which facilitates the administration of the drug 339.

[0039] The slider 321 is configured to translate transversely to the longitudinal central axis of the rod 325 and to move the rod 325 in a proximal or distal direction (upward or downward in the figures). As the slider 321 moves transversely to the longitudinal axis of the rod 325, the proximal end 329 slidably engages with the proximal surfaces 355, 357 of the slider 321. For example, a user can move the valve assembly 300 from the proximal end 329 past the second part 357 to the first part 355 by translating the slider across the cover 333. Figure 3A and Figure 4A The first state shown in the diagram transitions to Figure 3B and Figure 4B The second state shown in the diagram, and thus the interaction between the proximal end 329 of the slider 321 and the proximal surfaces 355, 357, forces the rod 325 to move proximally. In some instances, the slider 321 may include a flange 373 extending radially outward from the longitudinal axis of the slider 321. The flange 373 may be configured to prevent movement of the slider 321 on the cover 333 once the flange 373 engages with the outer surface of the chamber 323. Figure 3B An example of the position of a valve assembly 300 in which flange 373 engages with the outer surface of chamber 323 is shown. Slide 321 may be configured to be coupled to an actuator so that movement of slide 321 actuates valve assembly 300. For example, slide 321 may be coupled to a trigger assembly (such as a similar...). Figure 5A , Figure 5B ,and Figure 8 The trigger 574 shown in the figure.

[0040] During operation, the user can operate the valve assembly 300 while operating the conveying system 200, wherein the valve assembly 300 starts... Figure 2 The function of valve 220 is illustrated. Once fluid container 206 is connected to input port 209 and provides pressurized fluid to delivery system 200, the user can actuate valve assembly 300 to selectively release drug 339 through valve assembly 300. For example, the user can translate slider 321 in a first direction to move valve assembly from a closed state (shown in...). Figure 3A ) becomes open (shown in Figure 3B), to release the drug 339 and be delivered to the target tissue of the patient through the output passage 353. The drug 339 can be expelled from the container 204, through the conduit 202, into the valve assembly 300, and out through the output passage 353 for delivery to the distal opening 215. The drug 339 can be expelled using the force applied to the drug 339 by the pressurized fluid provided by the fluid container 206. To prevent the release of the drug 339 through the output passage 353, the user can translate the slide 321 in a second direction opposite the first direction to move the proximal end 329 from being in contact with the first portion 355 of the proximal-facing surface of the slide 321 to being in contact with the second portion 357 of the proximal-facing surface of the slide 321, thereby allowing the member 331 to be biased to move the stem 325 distally and the plunger 327 into a position that fluidly seals the distal opening 390. Once the plunger 327 is in the position that fluidly seals the distal opening 390, fluid flow (illustrated as arrows 341, 343, and 345 in Figure 3A and 3B ) to the output passage 353 is prevented. In some examples, the user can transition the slide 321 from the position shown in Figure 4B to the position shown in Figure 4A to prevent the release of the drug 339 from the output passage 353.

[0041] Figure 5A and Figure 5B shows an alternative embodiment of a valve assembly 500 that applies a cam and follower mechanism to actuate the valve assembly 500. The valve assembly 500 can be used as the valve 220 in Figure 2 . In some examples, the valve assembly 500 can be configured to operate under a constant fluid pressure into the input passage 551. The valve assembly 500 can include a valve chamber 523, an input passage 551 including an input cavity 550, an output passage 553 including an output cavity 552, a stem 525 including a plunger 527 at a distal end of the stem 525, a biasing member 531, a cap 533, and a coupling 537. Any of the components of the valve assembly 500 can have any of the properties and / or features of the components of the valve assembly 300. The valve assembly 500 can be housed inside a holding device (not shown), which can be in any suitable shape. For example, the valve assembly 500 can be incorporated into a handle that is for the user to hold during operation (shown in Figure 8 ).

[0042] The stem 525 can include a first portion 526, a second portion 528, a third portion 530, and a wheel 560 distal to the third portion 530. The first portion 526, the second portion 528, and the third portion 530 can each be rigid and cylindrical or any other suitable shape. In some examples, the wheel 560 can be rotatable relative to the third portion 530. In other examples, the wheel 560 can be fixedly coupled to the third portion 530, can be configured to slidably engage with a cam 571, and can not rotate. Although both the third portion 530 and the input channel 551 are shown in cross-section, the third portion 530 is in a different plane than the input channel 551 such that the third portion 530 does not intersect the input channel 551, but extends laterally to one another. The first portion 526 can extend from the plunger 527 through an opening in the cap 533 to a location proximal to the cap 533. The first portion 526 can be fixedly coupled to the second portion 528, and in some examples, the second portion can extend laterally to the first portion 526. In some examples, the second portion 528 can have a longitudinal central axis that is perpendicular to a longitudinal central axis of the first portion 526 and / or a longitudinal central axis of the third portion 530. The second portion 528 can be fixedly coupled to the third portion 530 at a first end and can be fixedly coupled to the first portion 526 at a second end opposite the first end. The third portion 530 can extend distally from the first end to the second end, with the second end of the third portion 530 coupled to the wheel 560. In some examples, the longitudinal central axis of the third portion 530 can be parallel to the longitudinal central axis of the first portion 526. In some examples, the first portion 526, the second portion 528, and the third portion 530 can form a U-shape. The third portion 530 can be held by a cradle 559 of a housing (not shown) that houses the valve assembly 500. The cradle 559 can allow proximal and distal movement of the third portion 530 and can prevent lateral movement that is transverse to the proximal and distal directions. In some examples, the cradle 559 can be integrally formed with and / or fixedly coupled to the housing 840 (shown in FIG. 8). Figure 8 ).

[0043] The cam 571 can be fixedly coupled to a pinion 572. The cam 571 can be pear-shaped (shown in Figure 5A and Figure 5B ), snail-shaped, form a loop with the pinion coupled at an eccentric position, or any other suitable shape, and can be made of any suitable material known in the art. The pinion 572 can be cylindrical and rotatably coupled to a housing (not shown) that houses the valve assembly 500. The pinion 572 can include teeth 579, and rotation of the pinion 572 can cause rotation of the cam 571. The teeth 579 can be configured to mate with teeth 573 of a rack 570. The rack 570 can be coupled to an actuator that is used to translate the rack 570 to move the teeth 573, as in Figure 5Aand Figure 5B Alternatively, the rack 570 can be actuated with a button, lever, electrically controlled motor, or any other means known in the art. In some examples, actuation with the trigger 574 causes the rack 570 to move, which can cause the teeth 573 to engage the teeth 579, and thus can cause rotation of the pinion 572 and the cam 571. The longitudinal center axis of the rack 570 can extend transverse to the axis of rotation of the pinion 572. In some examples, rotation of the pinion 572 with the rack 570 can transition the cam 571 from a position in which the longitudinal center axis of the cam 571 is transverse to the longitudinal center axis of the third portion 530 (as shown in Figure 5A ) to a position in which the longitudinal center axis of the cam 571 is aligned with the longitudinal center axis of the third portion 530 (as shown in Figure 5B ).

[0044] In operation, a user can actuate the rack 570 in order to open the valve assembly 500 and release the medicament 539 to the distal opening 215 of the conduit 202 (shown in Figure 2 ). After coupling the fluid container 206 to the regulator 207, pressurized fluid can flow into the input channel 551 and the chamber 523. In the closed configuration (shown in Figure 5B ), the plunger 527 blocks fluid flow through the distal opening 590. To open the valve assembly 500, a user can actuate the rack 570, for example by pushing on the trigger 574. By pushing on the trigger 574, the gears 573 of the rack 570 can engage the gears 590 of the pinion 572, causing the pinion 572 and the cam 571 to rotate. As the cam 571 rotates, the wheel 560 engages the outer surface of the cam 571, and the cam 571 pushes the rod 525 proximally. By pushing the rod 525 proximally, the plunger 527 disengages from the inner surface of the chamber 523 and allows fluid flow through the distal opening 590. When the user releases the trigger 574, the biasing member 531 can move the rod 525 distally and return the valve assembly 500 to the closed position (shown in Figure 5B ).

[0045] Figure 6A and Figure 6B An alternative embodiment of a valve assembly 600 is shown. The valve assembly 600 can be used as the valve 220 in Figure 2 . The valve assembly 600 can include a valve chamber 623 (which includes an interior 635), an input channel 651 (which includes an input cavity 650), an output channel 653 (which includes an output cavity 652), a cap 633, and a flap valve 601. Any of the components of the valve assembly 600 can have any of the properties and / or features of the components of the valve assemblies 300 and 500. The valve assembly 600 can be housed within a holding device (not shown) which can be of any suitable shape. For example, the valve assembly 600 can be incorporated into a handle (shown inFigure 8 ). In some examples, the valve assembly 600 can be configured to operate at a constant fluid pressure in the inflow input channel 651.

[0046] The input channel 651 can extend through an opening in the cap 633 and inside the chamber 623. For example, in some examples, the distal portion 624 of the input channel 651 can extend along the longitudinal center axis of the chamber 623, and the distal end 692 of the input channel 651 can be located directly above (proximally) the distal opening 690. The butterfly valve 601 can be oval, or can be any other suitable shape. The butterfly valve 601 can be configured to extend toward the distal opening 690 so as to block fluid flow (shown as arrows 641, 642 in Figure 6A the distal opening 690 into the lumen 652 of the output channel 653. The butterfly valve 601 can include a pivot rod 602, and the butterfly valve 601 can pivot about the pivot rod 602. In some examples, the pivot rod 602 can be configured to be actuated by a user by rotating the pivot rod 602 to move the butterfly valve 601. In other examples, the valve assembly 600, and in some embodiments the butterfly valve 601, can be actuated by a trigger rack and pinion, by air flow, by a manual twist action, or by a pneumatic liquid / gas system. In some examples, actuating the valve assembly 600 to transition the valve assembly 600 from the closed configuration to the open configuration can require the butterfly valve 601 to rotate 90 degrees. Figure 6A The valve assembly 600 is shown in a closed configuration in which fluid flow (shown by arrows 641, 642) into the chamber 623 is blocked from flowing into the lumen 652 of the output channel 653. When the valve assembly 600 is in the closed configuration as shown in Figure 6A the distal opening 690 and seals the distal opening 690, thereby blocking fluid flow into the output channel 653. In the closed configuration, the longitudinal axis of the butterfly valve 601 can extend toward the distal opening 690. When the valve assembly 600 is in an open configuration (as shown in Figure 6B the butterfly valve 601 is positioned to allow fluid flow through the distal opening 690, and thus to allow the medicament 639 to flow through the output channel 653, as shown by arrows 643, 644, 695. For example, in the open configuration, the longitudinal axis of the butterfly valve 601 can be aligned with the longitudinal axis or distal end 624 or the longitudinal axis of the chamber 623. A user can rotate the pivot rod 602 to transition the valve assembly 600 from the closed configuration to the open configuration, and vice versa.

[0047] Figure 7A and Figure 7B Another alternative embodiment of a valve assembly 700 is shown. The valve assembly 700 can be used as Figure 2Valve 220 is included. Valve assembly 700 may include: valve chamber 723, input channel 751 including input cavity 750 and distal end 792, output channel 753 including output cavity 752, cover 733, and ball valve 711. Any component of valve assembly 700 may have any characteristics and / or features of components of valve assemblies 300, 500, and 600. Valve assembly 700 may be housed within a retaining device (not shown) that may have any suitable shape. For example, valve assembly 700 may be incorporated into a handle for a user to hold during operation (shown in...). Figure 8 In some instances, valve assembly 700 may be configured to operate under a constant fluid pressure flowing into input passage 751.

[0048] Ball valve 711 may be configured to extend distally into opening 712 in order to stop fluid (in) Figure 7A The flow (illustrated as arrows 741, 742) enters the cavity 752 of the output passage 753 through the distal opening 712. The ball valve 711 may be spherical and may include a cavity 713 extending through it. In some embodiments, the ball valve 711 may include a pivot (not shown), and the ball valve 711 may pivot about the pivot. In some embodiments, actuation of the pivot may rotate the ball valve 711. Figure 7A A valve assembly 700 in a closed configuration is shown, wherein fluid (indicated by arrows 741, 742) flows into chamber 723 but is prevented from flowing into the inner cavity 752 of the output channel 753. When the valve assembly 700 is in such a closed configuration... Figure 7A In the closed configuration shown, the ball valve 711 spans and seals the distal opening 712, thereby preventing fluid flow into the output passage 753. In the closed configuration, the longitudinal axis of the cavity 713 may extend toward the distal opening 712, and the inner surface of the chamber 723 may cover each end of the cavity 713. When the valve assembly 700 is in such a position... Figure 7B In the open configuration shown, ball valve 711 is positioned to allow fluid flow (indicated by arrows 743, 744, 745) through the cavity 713 and the distal opening 712, and thus allow drug 739 to flow through the output channel 753. For example, in the open configuration, the longitudinal axis of the cavity 713 may be aligned with the longitudinal axis of the distal portion 724 of the input channel 751 or the longitudinal axis of the chamber 723. The user can rotate ball valve 711 to change valve assembly 700 from a closed configuration to an open configuration, and vice versa. In some instances, actuating valve assembly 700 to change valve assembly 700 from a closed configuration to an open configuration requires ball valve 711 to rotate 90 degrees. Valve assembly 700, and in some embodiments ball valve 711, may be actuated by gas flow, by manual torsion, by a pneumatic liquid / gas system, or by any other method known in the art, using a trigger rack and pinion.

[0049] Figure 8 A cross-sectional side view of an example housing 840 containing a valve assembly 500 is shown. The housing 840 can include a handle portion 850 configured for a user to hold the housing 840. In some examples, the handle portion 850 can be configured to enclose a regulator 851 and / or a fluid container 852. A user can access (into and out of) the interior of the handle portion 850 via a cover 853 removably coupled to a portion of the handle portion 850. The trigger 574 can extend outwardly from the housing 840 to allow a user to actuate the trigger 574. Pressurized fluid can flow (illustrated as arrows 860, 861) from the fluid container 852 through the regulator 851 into the valve assembly 500. Any of the valve assemblies 300, 500, 600, 700 disclosed herein can be incorporated into the housing 840. By providing the handle portion 850, the housing 840 can facilitate use of the valve assemblies 300, 500, 600, 700 and provide a more ergonomic approach for a user to hold and actuate the valve assemblies 300, 500, 600, 700.

[0050] Unless otherwise described, the structural elements of the valve assemblies 300, 500, 600, 700 can be any material known in the art, including but not limited to metal alloys, ceramics, and / or resins.

[0051] Those skilled in the art will appreciate that various modifications and variations can be made to the disclosed devices without departing from the scope of the present disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed devices. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosure being indicated by the following claims.

Claims

1. A device configured to deliver a medicament to a target tissue using pressurized fluid, the device comprising: a catheter having an internal lumen; a barrel configured to store a medicament, receive pressurized fluid, and release a mixture of the pressurized fluid and the medicament into a valve; and a rod disposed inside the valve, the rod including a plunger at a first end of the rod and having a spring extending around an exterior of the rod, wherein the valve is positioned downstream of the barrel and upstream of the internal lumen such that the barrel is fluidly connected to the internal lumen through the valve, the valve is configured to receive the mixture of pressurized fluid and medicament from the barrel, the valve has a first configuration that prevents the mixture from flowing into the internal lumen and a second configuration that allows the mixture to flow into the internal lumen; wherein the spring is configured to move the rod toward the internal lumen and place the valve in the first configuration such that the plunger prevents the mixture from flowing into the internal lumen.

2. The device of claim 1, further comprising a first fluid input port configured to release pressurized fluid from a pressurized fluid container into the internal lumen when the pressurized fluid container is coupled to the first fluid input port.

3. The device of any of the preceding claims 1-2, wherein the valve is inside a housing, and wherein the housing includes a handle.

4. The device of any of the preceding claims 1-2, wherein the medicament is a powdered medicament.

5. The device of claim 1, wherein the valve includes: a chamber, wherein the chamber is fluidly connected to the internal lumen via an output passage, the rod extends through the chamber and is configured to prevent fluid flow to the output passage by closing the output passage when in the first configuration and allow fluid flow to the output passage by opening the output passage when in the second configuration; and a slider slidably coupled to the chamber and including a slot, wherein the rod extends through the slot, and wherein the slider is configured to transition the valve from the first configuration to the second configuration by movement of the slider.

6. The device of claim 5, wherein the slider includes a slide portion on which the rod rests, the slide portion having a first portion including a curved surface and a second portion including a flat surface.

7. The device of any of claims 5 and 6, wherein the rod includes an end portion that extends radially outward relative to an adjacent portion of the rod, and wherein the end portion of the rod prevents the rod from moving through the slot when the end portion of the rod contacts the slider.

8. The device of claim 7, wherein the end portion of the rod slidingly engages the slider.

9. The device of claim 1, wherein the valve includes: a chamber, wherein the chamber is fluidly connected to the internal lumen via an output passage; ​ a camming surface at a second end of the stem opposite the first end, wherein the stem extends through the chamber and is configured to prevent fluid flow to the output passage by closing the output passage in the first configuration and to allow fluid flow to the output passage by opening the output passage in the second configuration; a cam engaged with the camming surface; a pinion fixedly coupled to the cam and including a first set of teeth; and a rack including a second set of teeth, wherein the second set of teeth is configured to mate with the first set of teeth.

10. The device of claim 9, wherein the cam is pear-shaped, the stem is U-shaped, and the camming surface includes a wheel.

11. The device of any one of claims 9 and 10, further comprising a trigger coupled to the rack, wherein actuation of the trigger causes the stem to move to transition the valve from the first configuration to the second configuration.

12. The device of any one of claims 9 and 10, wherein movement of the rack in a first direction is configured to cause the pinion and the cam to move to transition the cam from a first position, in which a longitudinal center axis of the cam is substantially parallel to a longitudinal center axis of the rack, to a second position, in which the longitudinal center axis of the cam is perpendicular to the longitudinal center axis of the rack; and wherein movement of the rack in a second direction is configured to cause the pinion and the cam to move from the second position to the first position.

13. The device of any one of the preceding claims 1-2, further comprising a housing having a handle, wherein the handle includes an interior configured to receive a fluid container.

Images