Equipment for Fluidization and Delivery of Powders

Abstract

To provide a method and a tool for controlling hemostatic agents and achieving proper tissue contact with the agent at an appropriate pressure and flow rate.SOLUTION: A medical device comprises: a delivery device having a first fluid passageway; and a container movably attached to the delivery device. The container and the delivery device have a second fluid passageway extending therethrough, the container including an interior chamber at intermediate proximal and distal portions of the second fluid passageway. The internal chamber is fluidly isolated from the proximal portion of the second fluid passageway at a first position of the container and fluidly connected to the proximal portion and distal portion of the second fluid passageway at a second position of the container. The first fluid passageway bypasses the container, and passage of fluid through the first fluid passageway is separately controllable from passage of fluid through the second fluid passageway.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates generally to medical systems and devices for delivering pressurized fluids, and more particularly to methods and tools for controlling hemostatic agents to achieve appropriate tissue contact with the agent at appropriate pressures and flow rates.

Background Art

[0002] During medical procedures, delivery systems and devices are used to supply various substances, such as powders. These procedures may include using a fluid, such as an injection fluid within an appropriate pressure and flow rate or an appropriate pressure or flow rate range, to supply the powder. These powders may include hemostatic agents that are optimally delivered to tissue at appropriate pressures and flow rates or an appropriate pressure or flow rate for a particular administration.

[0003] Conventional endoscopic devices for dispensing fluids, powders, and / or reagents to a patient involve advancing a catheter into a target site within the patient and then dispensing the fluid. Disadvantages of conventional devices include, for example, catheter clogging by fluids or powders, catheter kinking, large variations in fluid flow rate and pressure during dispensing, and non-uniformity of the substance dispensed to the target site. Further, medical fluid delivery systems often need to deliver fluid from a high-pressure storage tank to tissue at a lower pressure more suitable for administration. The fluid should be administered at a constant flow rate and a constant pressure. Further, medical fluid delivery systems often require multiple regulators to appropriately convert high-pressure fluid to a pressure suitable for administration to tissue. The multiple regulators prevent the function of incorporating a fluid cylinder into the regulator, often increase costs, and make it difficult to incorporate the regulator into a handheld device for ease of operation. Further, conventional regulators include washers or O-rings that create frictional forces with the regulator, making it difficult to dispense fluid at a constant flow rate and a constant pressure. These disadvantages can prevent the appropriate amount of fluid and substance or fluid or substance from being discharged to the target location, thereby reducing the accuracy of procedures using these conventional devices and increasing time and cost. Thus, it is desirable to ensure that fluids, powders, and / or reagents are dispensed appropriately and consistently to the target location. The present disclosure makes it possible to solve one or more of these problems or other problems in the art. However, the scope of the present disclosure is defined by the appended claims and is not the ability to solve specific problems. SUMMARY OF THE INVENTION

[0004] According to one example, a medical device includes a dosing device having a first fluid passageway, and a container movably attached to the dosing device. The container and the dosing device have a second fluid passageway that passes through the container and the dosing device. The container includes internal chambers at a proximal portion and a distal portion intermediate the second fluid passageway. The internal chambers are fluidly isolated from the proximal portion of the second fluid passageway at a first position of the container, and the internal chambers are fluidly connected to the proximal and distal portions of the second fluid passageway at a second position of the container. The first fluid passageway bypasses the container, and the passage of fluid through the first fluid passageway is controllable separately from the passage of fluid through the second fluid passageway.

[0005] The medical device may further include a second container having an injection fluid and may be configured to be attached to an inlet of the dosing device. The dosing device may further include a locking mechanism for fixing the second container to the dosing device.

[0006] The locking mechanism may include a lever rotatably coupled to the dosing device such that at a first position of the lever, the second container may be fluidly separated from the dosing device, and at a second position of the lever, the second container may be fluidly connected to the dosing device, and a piston coupled to the lever and in contact with the second container.

[0007] The protrusion may extend from the surface of the piston with respect to the inlet, and the gap may extend into the container from the surface facing the piston. The protrusion may extend into the gap to maintain the fixed position of the container with respect to the piston.

[0008] The container may include a chamber inlet and a chamber filter between the internal chamber and the proximal portion of the second fluid passageway. The filter may be configured to allow fluid to enter the internal chamber from the proximal portion of the second fluid passageway, and the filter may also be configured to prevent substances disposed within the container from entering the proximal portion of the second fluid passageway.

[0009] The internal chamber may include one or more protrusions extending into the internal chamber from the bottom surface of the internal chamber, and the one or more protrusions may be configured to change the fluid passageway within the internal chamber.

[0010] The internal chamber may include a tube having an outlet port and a sheath disposed around the tube such that when the container is in the first position, the outlet port may be covered by the sheath, and when the container is in the second position, the outlet port may be exposed from the sheath.

[0011] The internal chamber may include an attachment member fixedly attached to the sheath and the outer surface of the container such that rotation of the outer surface causes the sheath to move longitudinally on the tube. The dosing device may include a groove having a first end and a second end, and the container may include a cam extending from the outer surface of the container, the cam being movable within the groove and being disposed at the first end of the groove when the container is in the first position and at the second end of the groove when the container is in the second position.

[0012] The dosing device may include a first drive device and a second drive device, the first drive device being configured to control the injected fluid in the first fluid passageway and the second drive device being configured to control the injected fluid in the second fluid passageway.

[0013] The second fluid passageway may include a pressure relief mechanism configured to release fluid when the pressure of the fluid in the second fluid passageway exceeds a threshold value, the threshold value being greater than the desired pressure of the fluid at the outlet of the second fluid passageway.

[0014] The pressure relief mechanism may include a rupture disk and may be disposed within the internal chamber of the container. The inlet of the dosing device includes a second pressure relief mechanism, and actuation of the second pressure relief mechanism may cause the injection of fluid from a second container.

[0015] The catheter may be attached to the outlet of the distal portion of the second fluid passage via a luer connection. According to another example, a medical device includes an administration device having a first fluid passage therethrough, and a container movably attached to the administration device. The container and the administration device have a second fluid passage therethrough. The container has an internal chamber having an inlet configured to be fluidly connected to the proximal portion of the second fluid passage and an outlet configured to be fluidly connected to the distal portion of the second fluid passage. The container includes a filter configured to prevent the substance supplied into the container from entering the proximal portion of the first fluid passage. When the container is in the first position, the internal chamber is fluidly separated from the proximal portion of the second fluid passage. When the container is in the second position, the internal chamber is fluidly connected to the proximal and distal portions of the second fluid passage.

[0016] The internal chamber may include a tube having an outlet port and a sheath disposed around the tube. When the container is in the first position, the outlet port may be covered by the sheath. When the container is in the second position, the outlet port may be exposed from the sheath.

[0017] The administration device may include a groove having a first end and a second end. The container may include a cam extending from the outer surface of the container. The cam may be in the groove. When the container is in the first position, the cam may be disposed at the first end of the groove. When the container is in the second position, the cam may be disposed at the second end of the groove.

[0018] According to yet another example, a medical device includes a first fluid passageway, a dosing device having an inlet and an outlet, and a container attached to the dosing device. The container and the dosing device have a second fluid passageway passing through the container and the dosing device. The container includes an internal chamber between a distal portion and a proximal portion of the second fluid passageway. The internal chamber includes an inflow configured to be fluidly connected to the proximal portion of the second fluid passageway and an outflow configured to be fluidly connected to the distal portion of the second fluid passageway. The internal chamber includes at least one protrusion extending into the internal chamber. Fluid in the first fluid passageway moves from the inlet to the outlet bypassing the container. The second fluid passageway includes a relief valve configured to release fluid from the second fluid passageway when the pressure in the second fluid passageway exceeds a threshold.

[0019] The medical device may further include a second container containing an injection fluid and a locking mechanism. The locking mechanism may include a lever rotatably coupled to the dosing device and a piston connected to the lever and in contact with the second container. In a first position of the lever, the second container may be fluidly separated from the dosing device. In a second position of the lever, the second container may be fluidly connected to the dosing device.

[0020] In yet another aspect, a device for controlling the pressure of a fluid includes a body having an inlet for receiving the fluid, an outlet for delivering the fluid, and a chamber between the inlet and the outlet that is in fluid communication with the inlet and the outlet. The chamber defines a flexible membrane having a chamber opening and a first surface in contact with the body and sealingly covering the chamber opening, and a piston adjacent to a second surface of the membrane on the opposite side of the first surface for controlling the position of the membrane to control the pressure of the fluid.

[0021] The device may include a pierce pin within the chamber configured to puncture a seal of a storage device adjacent to the inlet and configured to store the fluid. The body extends into the chamber and may include a protrusion that divides the chamber into a first chamber adjacent to the inlet and an annular chamber adjacent to the outlet. The device may include an actuator that surrounds at least a portion of the protrusion and is in contact with the first surface of the membrane.

[0022] The protrusion may include a first hole that fluidly connects the first chamber and the annular chamber, and the plunger of the actuator may extend into the first hole. The device may include a first spring that is disposed in the first chamber and configured to push a ball bearing toward the first hole.

[0023] The device may include an O-ring provided between the ball bearing and the first hole. The wall of the actuator may include a second hole that is between the annular chamber and the first chamber and fluidly communicates the annular chamber and the first chamber.

[0024] The device may include a capture member having a first end attached to the body and a second end that defines a capture member chamber in which the piston is movably received. A cap may be attached to the capture member adjacent to the second end to cover the opening of the capture member.

[0025] The membrane may be fixed between the body and the capture member. The device may include a second spring that is disposed between the piston and the cap and configured to push the piston toward the membrane.

[0026] The annular chamber may not include an O-ring. The fluid passageway may extend from the inlet, through the first chamber, through the first hole, through the annular chamber, and out of the outlet.

[0027] The device may include an O-ring disposed within a first chamber adjacent to a first hole, the ball bearing may be disposed within the first chamber adjacent to the O-ring on the side opposite the first hole, and the spring may be provided within the first chamber configured to contact the ball bearing and the pierce pin and bias the ball bearing toward the O-ring.

[0028] The device may include a first hole within a protrusion fluidly connecting the first chamber and the annular chamber, the O-ring may be disposed within the first chamber adjacent to the first hole, the poppet may have an annular ring surrounding the body and include a body portion disposed within the first chamber adjacent to the O-ring on the side opposite the first hole, the poppet may extend from the body portion, perpendicular to the annular ring, through the O-ring and the hole, and may include an elongate member contacting the body.

[0029] According to another aspect, a delivery system for dispensing fluid includes a storage device configured to store fluid, a dosing device coupled to the storage device and configured to dispense fluid, the dosing device including an inlet configured to be coupled to the storage device to receive fluid from the storage device, and a regulator in fluid communication with the inlet and configured to control the release of fluid. The regulator includes a body having an inlet for receiving fluid, an outlet for delivering fluid, and a chamber in fluid communication with the inlet and the outlet, the chamber defining a chamber opening, a flexible membrane having a first surface contacting the body and sealingly covering the chamber opening, and a piston adjacent to a second surface of the membrane on the side opposite the first surface and configured to control the position of the membrane to control the pressure of the fluid.

[0030] The system may include a piston chamber defined between or within the annular walls of the piston, and a spring may be disposed within the piston chamber and configured to bias the piston against the membrane.

[0031] The system may include a drive device and a fluid configured to be dispensed from a dispensing device by driving the drive device. In yet another aspect, a method for controlling fluid delivery to a patient's body includes moving a piston and a flexible membrane of a regulator relative to an inlet of the regulator, the inlet receiving fluid from a storage device, contacting an actuator of the regulator with the membrane to open a fluid passage from the inlet to an outlet of the regulator, and discharging the fluid.

[0032] The method may include compressing a spring adjacent to the inlet and breaking a fluid seal between the inlet and the outlet to open a fluid passage between the inlet and the outlet of the regulator. According to another aspect, a device configured to control the pressure of a fluid includes a first body having an inlet for receiving the fluid and an outlet for delivering the fluid, the first body including a protrusion extending into a chamber and dividing the chamber into a first chamber adjacent to the inlet and a second chamber adjacent to the outlet, the protrusion including a hole fluidly connecting the first chamber and the second chamber, an X-ring disposed in the first chamber adjacent to the hole, and a second body disposed in the first chamber and adjacent to the X-ring opposite the hole.

[0033] The protrusion may have a first surface and a second surface substantially perpendicular to the first surface, and each of the first surface and the second surface may face the first chamber. The X-ring may contact at least one of the first surface and the second surface at two split portions.

[0034] The X-ring may contact two split portions of each of the first surface and the second surface. The X-ring may include four protrusions, and the second body may be configured to contact one of the four protrusions in at least one state of the device.

[0035] The X-ring and the second body may be configured to prevent fluid from passing through the hole in at least one state of the device. The device may further include a first spring disposed within the first chamber and configured to push the second body toward the hole.

[0036] The fluid passageway may extend from the inlet, through the first chamber, through the hole, through the second chamber, and out of the outlet. The second chamber may define a chamber opening, and the device may further include a flexible membrane having a first surface that contacts the body and hermetically covers the chamber opening.

[0037] The device may further include an actuator that surrounds at least a portion of the protrusion and contacts the first surface of the membrane. The device may further include a piston that is adjacent to the second surface of the membrane on the opposite side of the first surface and is configured to control the position of the membrane.

[0038] The device may further include a second spring disposed between the piston and the cap and configured to push the piston toward the membrane. The second body may include rubber.

[0039] The X-ring may include silicone. The characteristics of the second body and the X-ring may be such that the second body and the X-ring are compatible with a temperature of -50°C.

[0040] According to another aspect, the device is configured to control the pressure of a fluid and includes an inlet for receiving the fluid, an outlet for delivering the fluid, and a first body having a chamber between the inlet and the outlet. The chamber defines a chamber opening, a flexible membrane having a first surface that contacts the first body and hermetically covers the chamber opening, an X-ring disposed within the chamber, a second body disposed within the chamber adjacent to the X-ring, and a spring provided within the chamber that contacts the second body and is configured to bias the second body toward the X-ring.

[0041] The chamber may be at least partially defined by the first surface and a second surface, and the X-ring may contact at least one of the first surface and the second surface at two break portions.

[0042] The X-ring may include four protrusions, and the second body may be configured to contact one of the four protrusions in at least one state of the device. According to one aspect, the device may be configured to control the pressure of a fluid and includes an inlet for receiving the fluid, an outlet for delivering the fluid, a first body having a chamber therebetween that is in fluid communication with the inlet and the outlet, an X-ring disposed within the chamber, a second body disposed within the chamber adjacent to the X-ring, a first spring provided within the chamber that contacts the second body and is configured to bias the second body in a first direction toward the X-ring, a piston, and a second spring configured to push the piston in a second direction opposite the first direction toward the X-ring.

[0043] The chamber may be at least partially defined by the first surface and a second surface, and the X-ring may contact two break portions of at least one of the first surface and the second surface.

[0044] According to another aspect, the device for fluidizing and delivering a powder agent extends longitudinally from a first end to a second end and includes a cannister defining an internal space for receiving the powder agent, an inlet connectable to a gas source for supplying gas to the internal space to fluidize the powder agent received therein to create a fluid mixture, an outlet through which the gas mixture is delivered to a target region of treatment, and a tube extending from the first end in communication with the outlet to the second end extending into the internal space, the tube including slots extending through its wall such that the gas mixture can pass from the internal space, through the second end and the slots, and through the outlet. The device further includes a door movably coupled to the tube such that the door is movable over the slots to control the dimensions of the slots opening into the internal space of the cannister.

[0045] In one aspect, the door may be configured as an overtube movably mounted over the tube. In one aspect, the device may further include a stabilization ring extending radially outward from the overtube to the inner surface of the cannister to fix the tube to the cannister.

[0046] In one aspect, the cannister may be rotatable relative to the tube to move the overtube longitudinally relative to the tube and control the dimensions of the slots opening into the internal space.

[0047] In one aspect, the device may further include a lid connectable to the cannister to seal the internal space and the inlet and outlet configured as openings extending through the lid. In one aspect, the device may further include a delivery catheter connectable to the outlet and sized and shaped to be inserted through an endoscope working channel into the target region.

[0048] This aspect relates to an apparatus for fluidizing and delivering a powder agent, comprising a cannister extending longitudinally from a first end to a second end and including a first internal space for receiving the powder agent, a first inlet connectable to a gas source for supplying gas to the internal space to fluidize the received powder agent and create a fluid mixture, an outlet through which the gas mixture is delivered from the first internal space to a target region for treatment, and a filler chamber communicating with the first internal space via a filler inlet, the filler chamber containing a filler substance that is passable from the filler chamber to the first internal space to maintain a substantially constant amount of the substance therein, the filler chamber containing a substance that includes at least one of the powder agent and the filler substance.

[0049] In one aspect, the filler substance may include one of simulated particles, beads, bounce balls, and foams. In one aspect, the filler substance may be sized and shaped such that, or configured such that, the filler substance cannot pass through the outlet.

[0050] In one aspect, the filler chamber may be supplied with gas to move the filler substance from the filler chamber into the first internal space. In one aspect, the filler chamber may be configured as a second internal space defined by the cannister.

[0051] In one aspect, the second internal space may include an inclined surface guiding the filler substance to the filler inlet. In one aspect, the filler substance may be an additional powder agent.

[0052] In one aspect, the apparatus may further include a door movable relative to the filler inlet between a first configuration in which the door covers the filler inlet and a second position in which the door opens the filler inlet to allow the filler substance to pass from the filler chamber to the first internal space by gravity.

[0053] In one aspect, the device is a turbine connected to a paddle housed within a filler inlet, where the turbine rotates when receiving a gas flow within a flow path housing the turbine, and accordingly rotates the paddle, and the filler material within the filler chamber may further include a turbine driven by the gas flow so as to be actively moved from there into the first internal space.

[0054] This aspect also relates to a method comprising supplying gas to an internal space within a cannister in which a powder agent is received to fluidize the powder agent, and delivering a fluid mixture to a target region within a patient's body by a delivery catheter inserted through a working channel of an endoscope to create the fluid mixture, wherein during delivery of the fluid mixture, a door movably mounted over a tube moves with respect to a slot extending through a wall of the tube extending into the internal space of the cannister in communication with the delivery catheter to control the dimension or a part thereof of the slot exposed to the internal space.

[0055] This aspect also relates to a device for fluidizing and delivering a powder agent, comprising a cannister extending longitudinally from a first end to a second end and defining an internal space in which the powder agent is received, an inlet connectable to a gas source for supplying gas to the internal space to fluidize the received powder agent to create a fluid mixture, an outlet through which the gas mixture is delivered to a target region of treatment, and a piston movably coupled to the cannister, wherein the piston moves from an initial configuration coupled to the first end of the cannister to a piston movable with respect to the second end of the cannister so as to reduce the volume of the internal space as the amount of the powder agent decreases during delivery of the fluid mixture to the target region.

[0056] In one aspect, each of the inlet and the outlet may extend through a part of the piston. In one aspect, the outlet may be connectable to a delivery catheter sized and shaped to be inserted through a working channel of an endoscope to a target region.

[0057] In one aspect, the piston may be movable by one of a pneumatic cylinder and a motor. In one aspect, the device further comprises a chamber connected to a first end on the canister on the side of the piston facing the internal space of the canister, the chamber housing an expandable member configured to receive gas during delivery of the fluid mixture such that the expandable mixture expands and moves the piston towards the second end of the canister.

[0058] In one aspect, the expandable member may be configured to be connected to a gas source by a connecting member including a one-way valve that allows flow of gas to the expandable member while impeding flow of gas from the expandable member.

[0059] In one aspect, the device further comprises a bypass connected to the first end of the canister and connected to the piston by a threaded rod, the bypass housing a turbine connected to the threaded rod, the bypass configured to receive flow of gas therethrough such that when gas flows through the bypass during delivery of the fluid mixture, the turbine and the threaded rod rotate to move the piston towards the second end of the canister.

[0060] This aspect relates to a device for fluidizing and delivering a powder agent, comprising: a canister extending longitudinally from a first end to a second end and including a first internal space in which the powder agent is received; an inlet connectable to a gas source for supplying gas to the internal space to fluidize the received powder agent to create a fluid mixture; an outlet through which the gas mixture is delivered to a target region of treatment; a first biasing configuration; and an expandable member movable between the first biasing configuration and an expanded configuration in which a portion of the expandable member extends into the first internal space such that as the amount of powder agent therein decreases during delivery of the fluid mixture to the target region, the expandable member deforms to reduce that amount.

[0061] In one aspect, the cannister may further include a second internal space configured to receive gas therein during delivery of the fluid mixture to the target region. In one aspect, the first internal space and the second internal space may be separated from each other by an expandable member, and the expandable member may be deformed into the first internal space by a pressure difference between the first internal space and the second internal space.

[0062] In one aspect, the expandable member may be a diaphragm. In one aspect, the first internal space may be defined by the inner wall of the expandable member, and the second internal space may be defined by the outer wall of the expandable member and the inner surface of the cannister.

[0063] In one aspect, the expandable member may be substantially cylindrical. In one aspect, the expandable member may extend from a first end of the cannister to a second end of the cannister.

[0064] In one aspect, the expandable member may be a balloon housed within the cannister and configured to receive gas therein such that as the balloon expands, the balloon occupies the first internal space.

[0065] This aspect also relates to a method comprising supplying gas to an internal space within a cannister in which a powder agent is received to fluidize the powder agent, creating a fluid mixture and delivering the fluid mixture to a target region within a patient's body by a delivery catheter inserted through a working channel of an endoscope and into the target region, wherein during delivery of the fluid mixture, the volume of the internal space of the cannister is decreased in correspondence with a decrease in the amount of the powder agent so that the delivery rate of the fluid mixture is maintained substantially constant.

[0066] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0068] Next, the present disclosure will be described with reference to exemplary medical devices that may be used for dispensing substances. However, it should be noted that the reference to a particular method is provided for convenience only and is not intended to limit the present disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed devices and administration methods may be used in medical or any other appropriate method. The present disclosure may be understood by referring to the following description and the accompanying drawings in which the same elements are assigned the same reference numerals.

[0069] For simplicity of explanation, a device and its components, or parts / regions / ends of a device or its components, are referred to as proximal and distal ends / regions. In the case of an administration device, the term "proximal" refers to the end / region closer to the inlet of the injection gas of the administration device (e.g., the position of the administration device where the injection gas is released from the storage device to the administration device), and in the case of an administration device, the term "distal" is used herein to refer to the end / region where at least one of the injection gas and any substance is released from the administration device to the target region, or, if a catheter is attached to the administration device, the end / region where it is released from the catheter to the target region. Similarly, "extending distally" indicates that a component extends in the distal direction, and "extending proximally" indicates that a component extends in the proximal direction. Both the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the claimed features. As used herein, the terms "comprises," "comprising," "having," "including," or other variations of those terms include non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. In the present disclosure, relative terms such as "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% in the stated value or characteristic.

[0070] Referring to FIG. 1, a medical system according to one embodiment, such as delivery system 10, is shown. Delivery system 10 includes a storage device 20 and an administration device 30 (such as a handheld device connected thereto by conduit 22). As described herein, administration device 30 may be directly attached to storage device 20 without conduit 22 therebetween or otherwise incorporated therein (see, e.g., FIG. 2). As further shown in FIGS. 1-3, administration device 30 includes an inlet 32, an outlet 34, drive devices 36a, 36b. According to one example, outlet 34 may be a male or female luer fitting, but is not limited to this configuration. As described herein, at least one of the injection fluid and any additional substances is discharged to catheter 190 via outlet 34, enabling the user to discharge the injection fluid at a desired location. An example of an apparatus for delivering a powder agent can be found in U.S. Patent Application No. 16 / 259,024, filed Jan. 28, 2019, entitled "Apparatus and Method for Delivering a Powder Agent", the complete disclosure of which is incorporated herein by reference.

[0071] Referring to FIG. 1, the storage device 20 is configured to store a fluid such as a gas (e.g., carbon dioxide or any other gas known in the art). Although shown as a box, the storage device 20 may be of any shape, such as a torpedo shape (see, e.g., FIG. 2), a sphere, or any other shape known in the art for storing a gas. For example, the storage device 20 could typically be a carbon dioxide tank or cylinder provided at a medical site such as a hospital. The storage device 20 includes one or more internal chambers (not shown) and one or more outer walls that define an internal chamber configured to store a fluid. The walls of the storage device 20 may be composed of any material suitable for storing a fluid, such as, but not limited to, a metal alloy, a ceramic, or any other material known in the art. The fluid stored within the internal chamber of the storage device 20 may be under pressure. Thus, the walls are formed of, or with, a material and thickness appropriate for storing the fluid at a pressure of, for example, at least approximately 6.89 MPa (1,000 pounds per square inch (PSI)), or approximately 5.86 MPa (850 PSI). For example, the gas that may be stored in the storage device 20 may include carbon dioxide (CO 2 ) having a vapor pressure of approximately 2,000 to 8,000 kPa at typical equipment temperatures or nitrogen (N2) having a vapor pressure of less than 40 MPa at typical equipment temperatures. Of course, these gases are examples and do not limit the types of gases that may be stored in the storage device 20.

[0072] Continuing to refer to FIG. 1, the dosing device 30 is attached to the storage device 20 by a conduit 22. The conduit 22 may supply fluid from the storage device 20 to the dosing device 30 under pressure. As will be described in more detail herein, the driving of the drive device 36a and the drive device 36b enables the user to move the fluid from the storage device 20 through the conduit 22 to the dosing device 30 and discharge the fluid to a desired position via the catheter 190. The conduit 22 may be made of any material, such as reinforced rubber or a suitable plastic, that allows free movement of the conduit 22 while enabling the conduit 22 to withstand the pressure of the fluid. The conduit 22 may be attached to the storage device 20 and the dosing device 30 by any attachment device including, but not limited to, a threaded connector, a high-pressure cleaning adapter, or any other device known in the art.

[0073] According to other embodiments, as shown in FIG. 2, the dosing device 30 may be directly connected to the storage device 20' without an intervening structure. For example, the inlet 32 may be directly connected to an outlet, such as a protrusion, of the storage device 20' using a threaded connection, a high-pressure cleaning adapter, etc. The protrusion of the storage device 20' may extend into the inlet 32 of the dosing device 30 and may be connected directly or via an intervening structure (e.g., a lumen) to the regulator 40. To enable better portability of the delivery system 10, for example, for a small-volume storage device 20' that stores compressed gas in the range of approximately 5 g to 75 g, or preferably approximately 12 g to 40 g, it may be suitable to directly connect the dosing device 30 to the storage device 20'.

[0074] Referring to FIG. 1, fluid is exiting the delivery system 10 through the outlet 34 of the dosing device 30 by driving the drive devices 36a and 36b of the dosing device 30. Of course, in some embodiments, only one of the drive devices 36a and 36b may be driven. Instead of, or in addition to, this, for example, as a safety measure to release fluid, a plurality of drive devices 36a and 36b may be driven simultaneously. As described herein, driving the drive devices 36a and 36b causes the regulator 40 to release fluid from the storage device 20' at a predetermined pressure, relieving the pressure increase within the delivery system 10. The dosing device 30 may be a handle, for example (such as a garden hose handle or other pistol-like configuration). The drive devices 36a and 36b may be any push button, trigger mechanism, or other device that, when driven, opens a valve to release fluid, as described in more detail herein.

[0075] Referring to FIG. 2, the dosing device 30 is directly attached to the torpedo-shaped storage device 20' without an intervening structure. The storage device 20' may be attached to the inlet 32 of the dosing device 30 by any attachment device 38, including but not limited to screw connectors, high-pressure cleaning adapters, pierce pins, and sealing devices, or any other device known in the art. The attachment device 38 or any other device for attaching the storage device 20' to the dosing device 30 may also include an actuator 39 (such as a tab, button, etc.) for opening or breaking a rupture disk or pressure relief valve attached to at least one of the storage device 20' and the dosing device 30. The actuator 39 may be driven at the end of the procedure to drain all remaining injection fluid from the storage device 30. An alert, such as a tactile alert or warning sound, may be generated when the storage device 20' is attached to the dosing device 30. Alternatively, as described in more detail below, the storage device 20' may be attached to the dosing device 30 by a locking mechanism 50. Further, a cap 150 may be attached to the handle 31 of the dosing device 30 by a screw fit, snap fit, or any other attachment mechanism. For example, the cap 150 may be attached to the end of the handle 31 on the opposite side of the attachment device 38. The cap 150 may provide additional support for securing the storage device 20' to the dosing device 30.

[0076] As will be described in more detail with reference to FIGS. 5 to 11B, as described above, one or more regulators 40 may assist in controlling the amount of injection fluid discharged from the storage device 20' at a specific pressure. For example, the regulator 40 may be a two-stage regulator, or the regulator 40 may be two single-stage regulators, such as two piston regulators arranged in series. As will be described in more detail below, the regulator 40 may include a pierce pin 670 (see FIG. 6A) for piercing a hole in the seal of the storage device 20' when the storage device 20' is attached to the dosing device 30. Alternatively, another device, such as a pierce pin or other mechanism for breaking the seal of the storage device 20', may be provided at the inlet 32 of the dosing device 30. Further, the inlet 32 may use, for example, a gasket or washer (not shown) to provide an all-or-nothing scenario where the storage device 20' is either fully attached to or fully detached from the dosing device 30 to prevent leakage at the inlet 32. The injection fluid pressure may be further adjusted by a diaphragm regulator 44 provided in series after the regulator 40. The combination of the regulator 40 and the diaphragm regulator 44 may reduce the pressure of the gas from the storage device 20' to an acceptable outlet pressure (i.e., the pressure of the gas and any substance at the outlet 34). The pressures of the gas after the regulator 40, after the regulator 44, and within the delivery system 10 at the target area of the patient may be predetermined based on the tissue into which the gas and substance are dispensed. The acceptable pressure at the outlet 34 may be a deviation of approximately ±40% from the target pressure, and more preferably, a deviation of approximately ±25% from the target pressure. For example, the regulator 40 may reduce the inlet pressure of the injection fluid to approximately 0.34 to 1.03 MPa (50 to 150 PSI), and subsequently, the diaphragm regulator 44 may reduce the injection fluid to approximately 0.13 to 0.34 MPa (20 to 50 PSI). According to one example, the regulator 40 and the diaphragm regulator 44 reduce the injection fluid to the desired discharge pressure of the injection fluid based on a predetermined setting during manufacturing.Alternatively, or in addition thereto, one or both of the regulator 40 and the membrane regulator 44 may include a mechanism (not shown) for adjusting the pressure of the injected fluid discharged from each regulator. Further, the pressure of the injected fluid at the outlet of the membrane regulator 44 may be approximately equal to the pressure of the injected fluid at the outlet 34. Alternatively, the pressure of the injected fluid at the outlet 34 may be different from the pressure of the injected fluid at the outlet of the membrane regulator 44.

[0077] Referring to FIGS. 2 and 3, the two fluid passages branch at a Y-connector 45 that is just at the end of the outlet of the membrane regulator 44. The first fluid passage 46, which may be a purge passage and may bypass the substance storage container, may be controlled by the drive device 36b. For example, the first fluid passage 46 may bypass the container 100 to directly discharge the injected fluid from the membrane regulator 44 to the outlet 34. The first fluid passage 46 enables the injected fluid from the storage device 20' to purge the catheter 190 to remove any debris brought into the catheter 190. The second fluid passage 48 may be controlled by the drive device 36a to direct the injected fluid from the membrane regulator 44 through the container 100 to the outlet 34. As will be described in more detail below, the second fluid passage 48 allows the injected fluid to enter the container 100 containing the dispensed powder or other substance, mix the powder or substance stored therein, and send the mixture through the catheter 190 to the target site through the outlet 34. According to one example, the injected fluid moves through the first fluid passage 46 at approximately 8 to 12 standard liters per minute (SLPM), or preferably at approximately 10 SLPM. Alternatively, the injected fluid may move through the first fluid passage 46 at approximately 4 to 6 SLPM, or preferably at approximately 5 SLPM. The injected fluid moves through the second fluid passage 48 at approximately 0.5 to 4.5 SLPM, or preferably at approximately 2 SLPM.

[0078] The flow path of the injection fluid including the fluid passage 46 and the fluid passage 48 is shown in FIG. 3. The injection fluid flows from the regulator 40, through the diaphragm regulator 44, along the first passage J, to the junction of the first fluid passage 46 and the second fluid passage 48. At the junction of the first fluid passage 46 and the second fluid passage 48, the passage J branches into a second passage K and a third passage M. The second passage K runs along the first fluid passage 46 to the second drive device 36b. When driven, the second drive device 36b dispenses the dispensing fluid along a fourth passage L (distal to the second drive device 36b) that terminates at the outlet 34. The first passage J, the second passage K, and the fourth passage L form the first fluid passage 46. Alternatively, the injection fluid from the first passage J may proceed through the third passage M to the first drive device 36a. When driven, the first drive device 36a dispenses the injection fluid along the fifth passage N (distal to the first drive device 36a) and each of a plurality of sixth passages O that provide the injection fluid to the container 100 through the filter hole 104a (see FIG. 12). As described herein, the injection fluid mixes with the substance provided within the container 100 (for ease of understanding, the housing 107 of the container 100 is not shown in FIG. 3), and this mixture moves from the container 100 along a seventh passage O' that leads from the outlet of the container 100 (described below) to the chamber outlet 114 (see FIGS. 14A and 14B) and an eighth passage P that leads from the chamber outlet 114 to the outlet 34. The first, third, fifth, sixth, seventh, and eighth passages J, M, N, O, O', P each form the second fluid passage 48. Further, the first, third, and fifth passages J, M, and N form the proximal portion of the second fluid passage 48, the eighth passage P forms the distal portion of the second fluid passage 48, and the sixth and seventh passages O, O' form the intermediate portion of the second fluid passage 48. As shown in FIG. 3, the first through eighth passages J through P are tubes or lumens that extend through and interconnect elements of the medical device 10 or extend through and interconnect elements of the medical device 10. At least one of these tubes and lumens may be formed of a medical grade plastic, metal, ceramic, or any other suitable material for moving at least one of the injection fluid and the substance throughout the medical device 10.

[0079] Referring to FIG. 4, a lock mechanism 50 for fixing the storage device 20' will be described. The lock mechanism 50 may be replaced with the cap 150 in FIG. 2. The lock mechanism 50 includes a lever 52 rotatably connected to the handle 31 of the dispensing device 30 at the pivot axis R. The lever 52 includes a cam passage 54 that defines a curved passage and a lock notch 56 at one end of the cam passage 54. A pin 57 extends generally perpendicular from the shaft 60, and the pin 57 moves along the cam passage 54 between the lock notch 56 and the opposite end of the cam passage 54. The shaft 60 extends along the longitudinal axis of the handle 31 and includes a piston head 58 attached to the end of the shaft 60 opposite the pin 57. As shown in FIG. 4, the bottom surface of the storage device 20' is placed on the top surface of the piston 58. The lever 52 is angled with respect to the handle 31 when the lock mechanism 50 is unlocked (e.g., when attaching or removing the storage device 20' to or from the handle 31). The lever 52 rotates about the pivot axis R, and the pin 57 rides along the cam passage 54 from the first end to the lock notch 56. The pin 57 fits into the lock notch 56 when the lever 52 is substantially parallel to the handle 31. The curvature of the cam passage 56 pushes the shaft 60 and the piston 58 against the bottom surface of the storage device 20', moves the storage device 20' towards the piercing pin (not shown, see, e.g., the piercing pin 670 in FIG. 6A), breaks a seal (not shown) of the storage device 20' by the piercing pin, and fluidly connects the storage device 20' to the dispensing device 30. In one example, the void 20a extends on the bottom surface of the storage device 20' and receives a protrusion 58a extending from the outermost surface of the piston 58, thereby detachably connecting the storage device 20' and the piston 58 and preventing the storage device 20' from sliding relative to the piston 58. Alternatively, or in addition to this, at least one of the outermost surface of the piston 58 and the bottommost surface of the storage device 20 may include a textured surface such as wear, knurl, voids, slots, or any other friction-enhancing coating to enhance the friction between the storage device 20' and the piston 58 and maintain the relative position between the storage device 20' and the piston 58.This configuration may help properly bias the storage device 20' toward the piercing pin and properly seal the storage device 20' to the dosing device 30.

[0080] Referring to FIG. 5, many elements of the dosing device 30 have been removed to show the position of the regulator 40. Of course, the position of the regulator 40 within the dosing device 30 is merely an example and is not limited to that shown in FIG. 5.

[0081] Referring to FIGS. 6A and 8, a regulator 40 according to one embodiment is described. The regulator 40 includes a body 650 (including an inlet 652 and an outlet 654 for communication with the external environment), a cap 700, and a capture cylinder 710 (such as a capture member). A membrane 730 is provided between the piston 690 and the actuator 680. As further shown in FIG. 6A, the regulator 40 includes a piercing pin 670, first and second springs 740, 742, a ball bearing 750 (or other type of body), and an O-ring 760.

[0082] Referring to FIGS. 6A and 9, the body 650 of the regulator 40 is generally cylindrical and has a central axis A. The body 650 includes a regulator wall 656, and a first chamber 658 (adjacent to the inlet 652) and a second chamber 660 defined within the regulator wall 656, respectively. As described herein, the regulator wall 656 may include threads on the radially outer surface of the wall 656 for attachment to a further structure. The inner diameter of the regulator wall 656 within the first chamber 658 is smaller than the inner diameter of the regulator wall 656 within the second chamber 660. A cylindrical protrusion 662 extends into the second chamber 660, and the cylindrical protrusion 662 has a hole 664 at its upper end that is transverse to and coaxial with the central axis A. The hole 664 is in fluid communication with a third chamber 666 defined by the inner wall 662a of the cylindrical protrusion 662. The third chamber 666 is between the first chamber 658 and the second chamber 660 and is in fluid communication with the first chamber 658 and the second chamber 660. According to one embodiment, no O-ring or other sealing member is provided within the second chamber 660 to thereby remove frictional forces between the regulator wall 656 and the actuator 680 upon movement of the actuator 680. Further, the body 650 may be any material known in the art, including but not limited to metal alloys, ceramics, and / or resins.

[0083] As shown in FIG. 6A, the O-ring 760 is disposed within the third chamber 666 adjacent to the inner wall 662a and positioned adjacent to the hole 664. The ball bearing 750 is adjacent to the O-ring 760 on the side opposite the hole 664. As described herein, the ball bearing 750 and the O-ring 760 can seal the hole 664 from communication with the third chamber 666. The second spring 742 is disposed within the third chamber 666 in contact with both the pierce pin 670 and the ball bearing 750 therebetween. The second spring 742 is dimensioned to have an outer diameter smaller than the diameter of the inner wall 662a so that it can expand and contract without generating frictional force between the second spring 742 and the inner wall 662a. The O-ring 760 and the ball bearing 750 are dimensioned such that their respective outer diameters are smaller than the inner diameter of the inner wall 662a. In such a manner, when at least one of the O-ring 760 and the ball bearing 750 does not seal the hole 664, fluid flows within the chamber 666, between the inner wall 662a and the ball bearing 750, within and around the O-ring 760 or within or around the O-ring 760, and through the hole 664 into the chamber 660. According to one example, the sealing effective diameter when the ball bearing 750 seals against the O-ring 760 is approximately 1.27 mm to 3.55 mm (0.05 inch to 0.14 inch), preferably approximately 2.03 mm to 2.79 mm (0.08 inch to 0.11 inch).

[0084] Continuing to refer to FIG. 6A, the first chamber 658 is in fluid communication with the third chamber 666 by a pierce spin chamber 676 within the pierce spin 670. The first chamber 658 includes a region having a first diameter (defined by the wall surface 656a) and a smaller second diameter (defined by the wall surface 656b). The surface of the first chamber 658 may include threads (not shown) for accommodating components that may be used to drill holes in the storage device 20'. Alternatively, the threads on the surface of the first chamber 658 may accommodate a threaded storage device 20'. For example, when threading the storage device 20' into the first chamber 658 (e.g., using threads), the pierce spin 670 may drill a hole in the storage device 20'. The third chamber 666 is adjacent to the second diameter portion of the chamber 658 and has a diameter smaller than that of the second diameter portion of the chamber 658. The confluence point of the second diameter portion of the chamber 658 and the third chamber 666 is outside the third chamber 666 and defines a notch 668 along the boundary of the third chamber 666. The notch 668 defines an annular flange surface 668a at its upper portion.

[0085] Figure 6A shows a pierce pin 670. According to one embodiment, the pierce pin 670 may be disposed within the notch 668 and adjacent to the flange surface 668a. According to one embodiment, the pierce pin 670 may have an outer diameter equal to the inner diameter of the second diameter portion of the chamber 658. The pierce pin 670 includes a body portion 672 and a protrusion 674 extending from the body portion 672 into the chamber 658. The pierce pin 670 is open at both ends and defines a pierce pin chamber 676 extending through the body 672 and the protrusion 674. The first chamber 658 may be in fluid communication with the pierce pin chamber 676 via an opening 675. The first portion of the chamber 676 adjacent to the chamber 666 has a larger diameter than the second portion of the chamber 676 adjacent to the chamber 658. According to one embodiment, the protrusion 674 includes an end wall 674a angled with respect to the central axis A, preferably not perpendicular to the central axis A. The pierce pin 670 may be fixed to the body 650, for example, by an adhesive, friction between the body 650 and the pierce pin 670, welding, threads, etc. In addition to, or alternatively to, this, the pierce pin 670 may be formed as a single structure with the body 650, for example, by additive manufacturing techniques. The pierce pin 670 may have any suitable geometric shape, including, for example, an arrow shape (not shown). In such a configuration, instead of having a protrusion 674, the surface of the pierce pin 670 may slope radially outward from a constriction adjacent to the opening 675. The inclined surface may terminate at a shoulder and may include a stem extending from the shoulder into the third chamber 666. The arrow-shaped pierce pin 670 may facilitate creating a relatively large hole within the storage device 20'. Air may flow into the third chamber 666 through the opening 675 and the stem portion.

[0086] According to one embodiment, the protrusion 674 of the pierce pin 670 pierces a gasket of the storage device 620 or the conduit 622. Alternatively or in addition, the protrusion 674 interacts with a device (not shown) related to the storage device 20' or the conduit 22, such as locking the device or providing a fluid connection between the regulator 40 and the storage device 20' or the conduit 22. According to one embodiment, the pierce pin 670 may be made of any material known in the art, including but not limited to metal alloys, ceramics, and / or resins.

[0087] FIG. 6A further shows an actuator 680, which is a cylindrical member having an external actuator wall 682 and a top wall 683 that define an actuator chamber 684. The actuator chamber 684 is open at one end of the actuator 680, and the end faces the lower part of FIG. 6A on the opposite side of the top wall 683. According to one embodiment and as shown in FIG. 6A, the actuator 680 may include a through-hole 686 in the actuator wall 682 near the top wall 683, as described in more detail herein. According to one embodiment, the central axis of the through-hole 686 is perpendicular to the plunger 688. Further, as shown in FIG. 6A, the plunger 688 may extend into the chamber 684 from the top wall 683. The plunger 688 is perpendicular to the top wall 683 and may extend into the chamber 666 through the hole 664 along the central axis A. When assembled, the actuator 680 is provided in the second chamber 660 and at least partially surrounds the cylindrical protrusion 662 in a ring shape. The actuator 680 and the cylindrical protrusion 662 are dimensioned such that the outer wall 662b of the cylindrical protrusion 662 has a diameter smaller than the diameter of the inner wall 680a of the actuator 680, thereby forming an annular space 665 between the actuator 680 and the cylindrical protrusion 662. Thereby, the actuator 680 can slide (move) along the central axis A, and the fluid can flow between the actuator 680 and the cylindrical protrusion 662 in the space 665. According to one embodiment, the actuator 680 may be made of any material known in the art, including but not limited to metal alloys, ceramics, and / or resins.

[0088] Continuing to refer to FIG. 6A, piston 690 is generally cylindrical in shape and includes an outer piston wall 692 and a bottom wall 693. The inner surface of piston wall 692 and the upper surface of wall 693 define piston chamber 694, and piston chamber 694 is open at the upper end on the opposite side of wall 693. According to one embodiment, piston 690 may be any material known in the art, including but not limited to metal alloys, ceramics, and / or resins.

[0089] Cap 700 is also generally cylindrical in shape and has a cap outer wall 702 and an upper cap wall 703, which together define cap chamber 704, and cap chamber 704 is open at one end. Projection 706 extends from upper cap wall 703 and is generally perpendicular to upper cap wall 703. As shown in FIG. 6A, spring 740 is provided within piston chamber 694. The first end of spring 740 contacts the inner upper surface of piston wall 693. Spring 740 extends at least partially around and surrounds projection 706 such that the end of spring 740 opposite the first end contacts the inner lower surface of upper cap wall 703. A hole (not shown) may be formed in upper cap 703 above projection chamber 707 formed by the wall of projection 706 such that chamber 707 and piston chamber 694 may be in fluid communication with air. Such a hole may relieve the increased vacuum or pressure within piston chamber 694 when membrane 732 moves as described below.

[0090] Figures 6 and 10 schematically show a capture cylinder 710 of generally cylindrical shape. A first wall 712 defines a first chamber 716, and a second wall 714 connected to the first wall 712 by a step 720 defines a second chamber 718. The first chamber 716 and the second chamber 718 are fluidly connected, and the capture cylinder 710 is open at the ends of the first chamber 716 and the second chamber 718. According to one embodiment, the diameter of the first chamber 716 is larger than the diameter of the second chamber 718. However, the capture cylinder 710 is not limited to this configuration. As shown in FIG. 6A, the piston 690 occupies a position within the second chamber 718 such that the open end of the piston chamber 694 and the open end of the second chamber 718 face in the same direction (upper part of FIG. 6A). As will be described in more detail herein, the piston 690 is dimensioned and shaped to slide within the second chamber 718. For example, the outer diameter of the wall 692a of the piston 690 is smaller than the diameter of the inner wall 714a of the capture cylinder 710, whereby the frictional force between the piston 690 and the capture cylinder 710 is reduced and removed, or such frictional force is reduced or removed. This reduction in friction provides more freedom of movement between the elements, thereby improving the consistency of the fluid discharge pressure and flow rate.

[0091] As shown in FIGS. 6 and 10, the outer portion of the second wall 714 includes a thick annular region 724. The region 724 includes a wall 722 that tapers into a thinner region of the second wall 714. According to one embodiment, the first wall 712 and the second wall 714 are generally parallel to the central axis A and perpendicular to the wall 720, but are not limited to this configuration. As shown in FIG. 6A, the region 724 allows the cap 700 to be fixedly attached to the capture cylinder 710 to seal the capture cylinder 710. For example, the cap 700 may be snap-fitted, welded, adhered, screwed, or attached to the capture cylinder 710 by any method known in the art. The attachment of the cap 700 to the capture cylinder 710 may allow the cap 700 to be removed, for example, using threads. Alternatively, the cap 700 may be fixedly secured to the cylinder 710, for example, by welding the cap 700 to the capture cylinder 710, and may not be removable without destroying the regulator 40. When pressurized fluid does not flow into the regulator 40 / when pressurized fluid does not flow through the regulator 40, the cap 700 may be configured to compress the spring 740 by a predetermined amount in the relaxed state of the regulator 40. The predetermined compression of the spring 740 may determine the pressure discharged through the outlet 654 when high-pressure fluid flows through the inlet 652. The compression of the spring 740 by the cap 700 may be adjustable after the regulator 40 is assembled (for example, to allow for changes in the discharge pressure), or may be fixed during the assembly of the regulator 40.

[0092] Continuing to refer to FIG. 6A, the membrane 730 is provided within the first chamber 716 of the capture cylinder 710. The membrane 730 includes a base 732, and the wall 734 extends along the outer periphery of the base 732 and is generally perpendicular to the base 732. According to one embodiment, the membrane 730 is formed of a silicone material, but is not limited thereto. For example. The membrane 730 may be any material that is flexible and reduces the coefficient of friction between the membrane 730 and other structures of the regulator 40.

[0093] As shown in FIG. 6A, the membrane 730 covers the top wall 683 and the upper opening of the second chamber 660 of the body 650. The inner diameter of the wall 734 is approximately equal to the outer diameter of the upper portion of the regulator wall 656 of the body 650, enabling the membrane 730 to seal the upper opening of the second chamber 660. As described herein, this prevents fluid from escaping from the body 650 (other than through the outlet 654) during operation of the regulator 40. When assembled, the lower surface of the step 720 of the capture cylinder 710 contacts the top surface of the base 732, securing the membrane 730 to the base 650. In this way, the membrane 730 is pressed between the cylinder 710 and the base 650. For example, as shown in FIG. 6A, the capture cylinder 710 is screwed into the body 650, but it may be snap-fitted, welded, glued, or attached in any manner known in the art. Alternatively, or in addition to this, the membrane 730 may be fixed to the base 650 independently of the capture cylinder 710, for example using an adhesive. According to one example, in order to reduce the sensitivity to changing pressures at the inlet 632, the effective diameter of the membrane, which is the outer diameter of the second chamber 660 in contact with the membrane 730, is approximately 15.24 mm to 31.75 mm (0.6 inches to 1.25 inches), preferably 17.78 mm to 25.4 mm (0.7 inches to 1.0 inches).

[0094] Next, the operation of the regulator 40 will be described. FIG. 6A shows the regulator 40 in a configuration where the third chamber 666 is sealed, which means that fluid may not pass through the hole 664, and also means that the third chamber 666 is not in fluid communication with the second chamber 660 and the discharge port 654. FIG. 6B shows the regulator 40 in a configuration where the third chamber 666 is not sealed (fluid may pass through the hole 664 such that the third chamber 666 is in fluid communication with the second chamber 660 and the discharge port 654), but the regulator 40 is not receiving high pressure from a fluid supply source such as the storage device 20, the storage device 20'. FIG. 6C shows the regulator 40 in a configuration where the third chamber 666 is not sealed (fluid may pass through the hole 664 such that the third chamber 666 is in fluid communication with the second chamber 660 and the discharge port 654), and the regulator 40 is receiving high pressure from a fluid supply source such as the storage device 20, the storage device 20'.

[0095] Referring to FIG. 6B, when the regulator 40 is not exposed to any high pressure (for example, when the storage device 20, the storage device 20' (not shown in FIGS. 6A - 6C) is not installed, or when the pierce pin 670 has not yet pierced the storage device 20, the storage device 20'), as shown in FIG. 6B, the regulator 40 is in a static equilibrium. In the static state, the spring 740 may exert a force in a first direction along the central axis A towards the pierce pin 670. The force in the first direction from the spring 740 may be transmitted to the piston 690 and the diaphragm 730, which may transmit the force in the first direction to the actuator 680 (including the plunger 688). When the plunger 688 is in contact with the ball bearing 750, the plunger 688 may transmit the force in the first direction to the ball bearing 750 and thus to the spring 742.

[0096] On the one hand, the spring 742 may exert a force in the second direction opposite to the central axis A (in the direction opposite to the force exerted by the spring 740) toward the upper cap wall 703. The force from the spring 742 may be transmitted to the ball bearing 750, which may exert a force in the second direction on the actuator 780, the membrane 730, the piston 690, and the spring 740 through contact with the prong 788. The spring 742 may be configured to bias the ball bearing 750 in the second direction toward the O-ring 760.

[0097] The spring constant of the spring 740 may be greater than that of the spring 742 (i.e., the spring 740 may be stiffer than the spring 742). Due to the greater spring constant of the spring 740, the spring 740 may be dominant over the spring 742. In the stationary state of FIG. 6B, the membrane 730 may be deformed so that the membrane 730 protrudes in the first direction toward the pierce pin 670. The prong 688 may press against the ball bearing 750 in the first direction such that there is a gap between the ball bearing 150 and the O-ring 160, and the third chamber 666 may be unsealed / open so that fluid passes through the hole 664 and the third chamber 666 is in fluid communication with the second chamber 660 and the discharge port 654.

[0098] After high pressure is introduced into the regulator 40, as shown in FIG. 6C, the high-pressure fluid may pass through the inlet 652, through the pierce pin chamber 676, and into the third chamber 666. Then, the fluid may pass through the gap between the ball bearing 750 and the hole 664 and into the actuator chamber 684. Then, the fluid may flow between the actuator 680 and the protrusion 662 and flow into the second chamber 660. As shown in FIG. 6C, the fluid may also pass through the through hole 686 and into the second chamber 660. Subsequently, the fluid passes through the discharge port 654 (indicated by the arrow E) as fluid.

[0099] When the drive device 634 is not driven, the valve (not shown) is closed and fluid does not flow through the delivery system 10. The fluid may be prevented from passing downstream (with respect to outlet 34) of a part of the delivery system 10 (such as a valve) controlled by the drive devices 36a, 36b. Thus, the pressure may increase in the part of the system 10 upstream (away from outlet 34) of that part (such as a valve) of the delivery system 10. The regulator 40 may be upstream of that part (such as a valve), and thus the pressure may increase in the regulator 40.

[0100] The pressure increase within the regulator 40 may affect various components of the regulator 40 and may cause the regulator 40 to transition from the configuration shown in FIG. 6C (open / sealed) to the configuration shown in FIG. 6A (closed / sealed). For example, the pressurized fluid accumulated within the second chamber 660 may, as a result, exert a force on the diaphragm 730 in the second direction. This force may be transmitted to the piston 690 and the spring 740. The pressurized fluid within the third chamber 666 may also exert a force on the ball bearing 750 in the second direction. This force on the ball bearing 750 may be transmitted to the actuator 680, the diaphragm 730, the piston 690, and the spring 740.

[0101] These additional forces in the first direction may overcome the force of the spring 740 in the first direction such that the ball bearing 750, the actuator 680, the diaphragm 730, and the piston 690 move in a second direction towards the upper cap wall 703. As shown, the diaphragm 730 may be flat or approximately flat in the configuration shown in FIG. 6A. The diaphragm 730 may also be further deformable in the second direction such that the diaphragm 730 protrudes in the second direction. For example, the diaphragm 730 may protrude or curve in the second direction when sufficient force is exerted on the ball bearing 750, as in a sufficiently pressurized configuration. Of course, FIGS. 6A-6C are merely illustrative, and various positions of the components of the regulator 40 are possible. For example, in a static equilibrium (when the regulator 40 is not exposed to pressurized fluid), the diaphragm 730 may be straight, and when the regulator 40 is pressurized, it may protrude in the second direction.

[0102] In the configuration of FIG. 7A, the ball bearing 750 may be pressed against the O-ring 760 to form a seal between the ball bearing 750 and the O-ring 760. When the ball bearing 750 and the O-ring 760 are sealed, the third chamber 666 may be sealed so that fluid does not move into the actuator chamber 684 through the hole 664. The arrows in FIG. 6A indicate a fluid flow path in which fluid flows into the inlet 652 but cannot exit through the hole 664. Thereby, the pressure of the fluid in the second chamber 660 (and the region downstream of the discharge port 654) may be limited to a constant value (for example, a pressure controlled to 0.17 to 0.68 MPa (25 to 100 PSI) as described below). As will be described in more detail below, this control of the pressure in the second chamber 660 is performed both when the drive device 634 is being driven and when the drive device 634 is not being driven. This pressure control not only protects the components of the delivery system 10 but also the subjects of the procedures using the delivery system 10. Ultimately, when separate storage devices 20, 20' are used, the pressure in the third chamber 666 may be made equal to the pressure of the storage devices 20, 20' so that fluid does not flow from the storage devices 20, 20' through the inlet 652.

[0103] When the drive devices 36a and 36b are open, the downstream valve is open, so the fluid may move freely from the outlet 34. Thus, the fluid may flow from the second chamber 660 and out through the discharge port 654, thereby equalizing the pressure between the second chamber 660 and the air surrounding the dosing device 30. Since the second chamber 660 is no longer at high pressure, the fluid within the second chamber 660 may no longer exert a force on the membrane 730 in the second direction. As a result, the resultant force along the second direction may decrease (although the high-pressure fluid continues to exert a force on the ball bearing 750 in the second direction), and the regulator 40 may transition to the configuration as shown in FIG. 6C. The force of the spring 740 pushing in the first direction on the piston 690 and the membrane 730 may move the actuator 680 along the central axis A towards the pier spin 670. The movement of the actuator 680 towards the pier spin 670 causes the plunger 688 to push the ball bearing 750 towards the spring 742, thereby providing an opening through the hole 664 of the protrusion 662. Of course, depending on the balance between the force in the first direction (exerted by the spring 740) and the force in the second direction (exerted by the spring 742 and the high-pressure fluid on the membrane 730 and the ball bearing 750), the amount by which the hole 664 is opened may vary. FIG. 6C shows an exemplary open configuration. However, parts such as the membrane 730, the actuator 680, and / or the ball bearing 750 may be in different positions depending on the balance of the forces acting at that time, allowing more or less fluid to pass through the hole 664. The various amounts of fluid passing through the hole 664 may facilitate maintaining the second chamber 660 at a desired controlled pressure (described in more detail below).

[0104] While the third chamber 666 is unsealed (FIG. 6C), pressurized fluid may flow from the storage devices 20, 20' through the inlet 652 and the hole 664. For example, as shown in FIG. 6C, the flow path (arrow in FIG. 6C) indicates a fluid input I through the inlet 652. The fluid flows into the third chamber 666 through the pierce pinch chamber 676 in the direction of the arrow. The fluid flows into the actuator chamber 684 through the hole 664 and flows between the actuator 680 and the protrusion 662 up to the second chamber 660. As shown in FIG. 6C, the fluid may also pass through to the second chamber 660 via the through hole 686. The fluid then passes as fluid through the outlet 654 (indicated by arrow E). Fluid discharge is controlled by the regulator 40 as described herein. Although not shown, one or more devices such as a tube, catheter, or administration tip may be attached to the outlet 34 to assist in supplying the fluid to a desired location, as will be described in detail herein.

[0105] When high-pressure fluid accumulates in the second chamber 660, as described above, the pressure may exert a force on the membrane 730 in the second direction, potentially moving the membrane 730 in the second direction. This force may be transmitted to the piston 690. The pressurized fluid in the third chamber 666 may also be a force in the second direction on the ball bearing 750, as described above. These forces, together or separately, may shift the regulator 40 to a configuration in which the third chamber 666 is sealed via the ball bearing 750 and the O-ring 760 (as shown in FIG. 6A). The aforementioned interaction causes the regulator 40 to perform an iterative shift between a configuration in which the third chamber 666 is sealed and a configuration in which the third chamber 666 is unsealed.

[0106] Using the mechanism described herein, the regulator 40 controls the fluid pressure supplied through the outlet 654. For example, the pressure is controlled by controlling the opposing forces of the spring 740 on one side and the spring 742 and fluid pushing against the ball bearing 750 and the membrane 730 on the opposite side.

[0107] The spring forces of spring 740 and spring 742 are predetermined based on the desired pressure of the fluid to be dispensed and the desired velocity at which the fluid is to be dispensed. For example, a spring having a lower rate (i.e., the minimum amount of weight to compress the spring 25.4 mm (1 inch)) and a higher compression / compression rate may provide better control over the pressure of the fluid through outlet 654. For example, according to one embodiment, regulator 40 may be designed to supply a hemostatic agent to tissue at a pressure of approximately 0.17 - 0.68 MPa (25 - 100 PSI), more specifically at a pressure of approximately 0.27 - 0.41 Mpa (40 - 60 PSI), and at a rate of approximately 5 - 15 liters per minute (LPM), more specifically at a rate of 7 - 10 LPM. Regulator 40 provides a constant pressure and a constant fluid flow from storage device 20, storage device 20'.

[0108] When fluid is released from storage device 20, storage device 20', the pressure released from storage device 20, storage device 20' varies, for example, from a high pressure (approximately 5.86 MPa (850 PSI)) to zero MPa (zero PSI) when storage device 20, storage device 20' is empty. As the pressure in storage device 20, storage device 20' decreases, the pressure of the fluid against ball bearing 750 and membrane 730 changes (e.g., decreases), and the force exerted on spring 740 in the second direction decreases. Thus, as the pressure in storage device 20, storage device 20' decreases, the force of spring 740 opens most of aperture 664, thereby providing a constant flow rate and pressure of fluid supply at outlet 654. However, the pressure of the fluid from storage device 20, storage device 20' may be large enough to continue to exert a force on ball bearing 750 to provide a seal for chamber 666 through the contact between ball bearing 750 and O-ring 760 if pressure control is required.

[0109] The configuration shown in FIG. 6A improves the consistency of the fluid flow rate and discharge pressure. For example, the membrane 730 is silicone or other friction-reducing material. The silicone may maintain flexibility at the low temperatures present in the regulator 40 due to the high flow rate of the fluid from the storage device 20, storage device 20'. That is, when the actuator 680 moves along the central axis A, there is no structure (such as an O-ring) in the second chamber 660 that contacts between the actuator 680 and the inner surface of the regulator wall 656 of the body 650. Such a structure would cause frictional forces, making it difficult for the actuator 680 to move, thereby reducing the consistency with which the fluid flow rate and discharge pressure are maintained. Thus, the regulator 40 of FIG. 6A minimizes frictional forces and provides improved consistency in the fluid flow rate and discharge pressure when the actuator 680 and the piston 690 move along the central axis A.

[0110] FIG. 7 shows another embodiment of the regulator 40'. Similar elements in FIG. 7 have the same reference characters as those in FIG. 6A. As shown in FIG. 7, the regulator 40' has several different structures for controlling the fluid flow and pressure. Further, the regulator 40' shows a snap-fit connection between the capture cylinder 710' and the body 650'. For example, in the embodiment shown in FIG. 7, the regulator wall 656' is snap-fitted with the first wall 712' of the capture cylinder 710'. Additionally and / or alternatively, the capture cylinder 710' and the body 650' may be attached by an adhesive, welding, or any other attachment mechanism known in the art.

[0111] As shown in FIG. 7, the actuator 680' interacts with the poppet 770. The poppet 770 includes a body 772, a tab 774, and a protrusion 776. One end of the protrusion 776 is configured to contact the actuator 680'. The protrusion 776 may be fixed to the actuator 680', for example, by adhesion or welding, to enable the protrusion 776 and the actuator 680' to move together, as described in more detail herein. The protrusion 776 extends through the hole 664 at the base 650', and the O-ring 760' seals the space between the hole 664 and the tab 774. The O-ring 760' may be a resin or any other material known in the art (such as silicone) for fluidly sealing the opening. According to an example, when the O-ring 760' seals the space between the hole 674 and the tab 774, the effective sealing diameter is approximately 1.27 mm to 3.55 mm (0.05 inches to 0.14 inches), preferably approximately 2.03 mm to 2.79 mm (0.08 inches to 0.11 inches). As further shown in FIG. 7, the body 772 extends into the chamber 676 of the pierce pin 670 such that the poppet 770 moves axially with respect to the pierce pin 670. For example, the outer wall 770a of the poppet 770 has a diameter smaller than the diameter of the inner wall 676a of the chamber 676. Thereby, fluid may flow from the inlet 652 to the third chamber 666. In the embodiment of FIG. 7, a spring 744 is provided in the second chamber 660 and is annularly arranged around the cylindrical protrusion 662 to move the actuator 680' along the central axis A, as described herein.

[0112] Similar to FIG. 6A, the O-ring 760' in FIG. 7 is disposed adjacent to the inner wall 662a in the third chamber 666 and is positioned adjacent to the hole 664. The tab 774 is adjacent to the O-ring 760' on the opposite side of the hole 664. The O-ring 760' may be fixed to the tab 774. For example, the tab 774 may include a groove or alternative structure for receiving the O-ring 760'. As described herein, the tab 774 and the O-ring 760 can seal the hole 664 from communication with the third chamber 666 when the O-ring 760' is pressed against the inner wall 662a. The third spring 744 is disposed between the actuator 680' and the base 650, in contact with both, within the second chamber 660. The third spring 744 is sized to have an outer diameter smaller than the outer diameter of the second chamber 660 such that the third spring 744 can expand and contract without creating a frictional force between the third spring 744 and the outer wall of the second chamber 660. The O-ring 760' and the tab 774 are sized such that their respective outer diameters are smaller than the diameter of the inner wall 662a. In that way, when at least one of the O-ring 760' and the tab 774 is not sealing the hole 664, fluid flows between the inner wall 662a and the tab 774 and / or the O-ring 760' and through the hole 664 into the chamber 660.

[0113] Next, the operation of the regulator 40' will be described. The regulator 40' in FIG. 7 operates in the same manner as described with reference to FIG. 6A. The regulator 40' may have a sealed first configuration (shown in FIG. 7) in which the O-ring 760' is pressed against the inner wall 662a to form a seal such that fluid does not pass between the O-ring 760 and the inner wall 662a or between the O-ring 760' and the tab 774. Thereby, the fluid may not be able to pass through the hole 664, and the regulator 40' may have an unsealed second configuration (not shown) in which the O-ring 760' does not form a seal with at least one of the inner wall 662a and the tab 774 such that fluid flows through the hole 664.

[0114] Spring 744 provides an opposing force to spring 740. When one or more of the drive devices 36a, 36b of the dosing device 30 are operated, the pressure between the second chamber 660 and the air surrounding the dosing device 630 is equalized, thereby causing the regulator 40' to transition from the sealed configuration of FIG. 7 (where the O-ring 760' prevents the passage of fluid through the hole 664) to an unsealed configuration (where the O-ring 760' does not prevent the passage of fluid through the hole 664), thereby releasing the fluid. As described herein, upon release of the fluid, spring 740 presses piston 690 against diaphragm 730, thereby pushing actuator 680' towards pierce spin 670. The movement of actuator 680' towards pierce spin 670 moves poppet 770, which includes O-ring 760', in a first direction towards pierce spin 670. When poppet 770 moves in the first direction, a space is created between O-ring 760' and the inner wall 662a. Fluid from storage devices 20, 20' may flow through the space between O-ring 760 and inner wall 662a and through hole 664. Alternatively, tab 774 of poppet 770 is loosened around O-ring 760, thereby creating an opening between the third chamber 666 and the hole 664. Fluid may move from storage devices 20, 20' through chamber 676 of pierce spin 670 and into the second chamber 660 and out through the discharge port 654, as shown by the flow path in FIG. 7. Regulator 40' is shown in a configuration where fluid does not pass through the discharge port 654 due to the seal between tab 774 and O-ring 760', but the flow path in FIG. 7 shows how fluid flows when tab 774 is loosened around O-ring 760'. The configuration shown in FIG. 7 similarly improves the consistency of the fluid flow rate and discharge pressure. With the configuration of FIG. 7, in particular, the seal diameter between O-ring 760', tab 774, and inner wall 662a may be reduced. This reduced diameter may allow for an additional seal to prevent the passage of fluid from hole 664 if the passage of fluid results in a deviation from the desired controlled pressure. As described with reference to FIGS. 6A-6C, the movement of diaphragm 730 and actuator 680' may allow for dynamic adjustment of a fixed amount of fluid passing through hole 664 and out through discharge port 654.

[0115] As described herein, the membrane 730 reduces the friction between the actuator 680 and the body 650. This reduction in friction provides more freedom of movement between the elements, thereby improving the consistency of the fluid discharge pressure and flow rate. Also, as described herein, the through-hole 686 may be provided within the actuator 680. The through-hole 686 may help to provide a constant pressure and a constant velocity of the fluid flow from the outlet 654.

[0116] Figures 11A and 11B illustrate a further exemplary regulator 40'' that may have any of the characteristics of the aforementioned regulator 40 or regulator 40' and may be used in combination with the delivery system 10. Not all of the characteristics of the regulator 40'' corresponding to the characteristics of the regulator 40 are described in the following description, but, unless otherwise explicitly stated, it is understood that those characteristics may be present in the regulator 40''. Like reference numerals mean corresponding structures. Figure 11A shows a regulator 40'' having a sealed third chamber 666, and Figure 11B shows a regulator 40'' having an unsealed third chamber 666.

[0117] The regulator 40'' may include an X-ring seal 760'' (e.g., a square ring seal). The X-ring seal 760'' may have rounded corners and a cross-section that is similar to an X-shape. The X-ring seal 760'' may have a central outer circumference and four protrusions 762, 764, 766, 768 that extend radially outward from the central outer circumference. Alternatively, the X-ring seal 760'' may have any other suitable number of protrusions. The X-ring seal 760 may have a cross-section that resembles an asterisk where the X-ring seal 760'' has five or more protrusions.

[0118] The X-ring seal 760’’ may be attached to the inner wall 662a of the cylindrical protrusion 662. For example, the inner wall 662a may have one or more grooves into which the X-ring seal 760’’ may be received. The protrusions 764, 766, and 768 may each contact one or more surfaces of the inner wall 662a. For example, as described below, the surfaces 662aa, 662ab of the inner wall 662a may form corners into which the X-ring seal 760’’ may be received. Each of the surfaces 662aa and 662ab may face the third chamber 666.

[0119] Compared to an O-ring, the X-ring seal 760’’ provides additional contact points with the inner wall 662a. Of course, when contact points are referred to herein, the contact between the X-ring seal 760’’ and the inner wall 662a may extend over more than just one or more points and may include a larger (and perhaps continuous) area.

[0120] The X-ring seal 760’’ may provide four contact points to the inner wall 662a. The first surface 662aa of the inner wall 662a may be perpendicular or substantially perpendicular to the axis A. The second surface 662ab of the inner wall 662a may be parallel or substantially parallel to the axis A. The first surface 662aa and the second surface 662ab may intersect at a corner. The protrusion 768 may contact the first surface 662aa at point W (shown in the inserted image of FIG. 11A). The protrusion 764 may contact the second surface 662ab at point X. The protrusion 766 may have contact points to both the second surface 662ab (at point Y) and the first surface 662aa (at point Z). In contrast, the O-ring only provides one contact point to the first surface 662aa and one contact point to the second surface 662ab. Therefore, the X-ring seal 760’’ provides a more redundant seal than the O-ring by providing additional individual contact points. The points W, X, Y, and Z may be separated from each other by gaps or spaces. Even if one or more contact points are broken, the other contact points provide the seal. The X-ring seal 760’’ would be able to maintain the seal even if two (or three) contact points are broken, while an O-ring with two broken contact points would not be able to provide a seal. Further, by having the separated contact points W, X, Y, Z, a suction effect may be provided that strengthens the seal.

[0121] The respective surface areas of the contacts W, X, Y, Z between the X-ring seal 760’’ and the inner wall 662a may be smaller than the respective surface areas that contact between the O-ring and the inner wall 662a. Compared to the O-ring 760, the protrusions 762, 764, 766, 768 of the X-ring seal 760’’ may provide narrower and more concentrated contact points between the X-ring seal 760’’ and the inner wall 662a. The respective radii of curvature of the protrusions 762, 764, 766, and 768 may be smaller than the radius of curvature of the O-ring, resulting in more defined contact points.

[0122] Pressing the ball bearing 750’’ (or another type of body) against the X-ring seal 760’’ (at least at one point), when contacting the X-ring seal 760’’ (at least at one point), these more concentrated contacts may provide additional sealing compared to an O-ring. Since the same (or similar) force is exerted by the ball bearing 750’’ on a smaller area compared to an O-ring, a greater pressure may be exerted on the protrusions 762, 764, 766, 768 of the X-ring seal 760’’, thereby providing additional sealing. Due to the shape of the protrusions 762, 764, 766, 768, the pressure exerted at each contact point between the X-ring seal 760’’ and the ball bearing 750’’ or the inner wall 662a may be greater than the corresponding pressure of an O-ring. As will be described in more detail below, even when the ball bearing 750’’ exerts a relatively small force (for example, when the pressure drops within the storage devices 20, 20’), the X-ring seal 760’’ may provide a more reliable seal against the ball bearing 750’’ compared to an O-ring.

[0123] The X-ring seal 760’’ may have a durometer dimension selected to provide the desired seal characteristics described below. For example, the durometer dimension may be 70 or approximately 70. The durometer dimension of the seal 760’’ may be in the range of approximately 55 to approximately 90, and more specifically, may be in the range of approximately 70 to approximately 80. The X-ring seal 760’’ may be formed of a material that enables the X-ring seal 760’’ to maintain elastomeric properties under conditions (such as at a low temperature like approximately -50 °C (for example, in the range of approximately -40 °C to approximately -60 °C)) that may exist in the regulator 40’’ during operation of the delivery system 10. For example, the X-ring seal 760’’ may be formed of, or include, all silicone, rubber (such as nitrile rubber), and / or polyurethane. An X-ring seal having the quality of the X-ring seal 760’’ may be used in place of the O-ring 760 or O-ring 760’ in the regulators 40, 40’ described above. The O-ring 760 or O-ring 760’ may have at least one of the durometer and material characteristics of the aforementioned X-ring seal 760’’.

[0124] The regulator 40'' may also include a ball bearing 750''. The material forming the ball bearing 750'' (or a portion thereof) may have a durometer dimension selected to achieve a desired seal between the ball bearing 750'' and the X-ring seal 760'' as described below. For example, the durometer dimension of the ball bearing 750'' may be 90 or approximately 90. The durometer dimension of the ball bearing 750'' may be in the range of approximately 80 to approximately 90. The composition of the ball bearing 750'' may be such that the ball bearing 750'' does not freeze to other components of the regulator 40'' when exposed to solid, liquid and / or frozen gas carbon dioxide. For example, the ball bearing 750'' may be formed of or include all rubber, silicone, nitrile, polyurethane, steel and / or ceramics. A ball bearing having the characteristics of the ball bearing 750'' may be used in place of the ball bearing 750 in the regulator 40 above, either in combination with or separately from the X-ring seal 760'' (i.e., the regulator 40 may use a structure having the quality of one or both of the X-ring seal 760'' and the ball bearing 750'').

[0125] The X-ring seal 760’’ may have a cross-section of 1.58 mm (1 / 16 inch) (measured along line B and shown in the inset of Figure 11A), an inner diameter of 1.98 mm to 2.77 mm (5 / 64 to 7 / 64 inch) (measured along line C and shown in Figure 11A), and an outer diameter of 5.15 mm to 5.95 mm (13 / 64 to 15 / 64 inch) (measured along line D and shown in Figure 11A). The X-ring seal 760’’ may have a cross-section between approximately 0.79 mm (1 / 32 inch) and approximately 2.38 (3 / 32 inch), an inner diameter between approximately 1.58 mm (1 / 16 inch) and approximately 3.17 mm (1 / 8 inch), and an outer diameter between approximately 4.76 mm (6 / 32 inch) and approximately 3.17 mm (1 / 8 inch). The ball bearing 750’’ may have a diameter of approximately 4.77 mm (0.188 inch). In either the regulator 40’’ for use in the system 10 or the regulator 40’’ for use in an alternative system, similar or alternative dimensions may be used. The dimensions of the ball bearing 750’’ may not exceed the diameter of the third chamber 666 and may exceed the inner diameter of the X-ring seal 760’. For example, the ball bearing 750’’ may have a diameter between 3.17 mm (0.125 inch) and 6.35 mm (0.25 inch). For example, the regulator 40’’ used in an alternative system may have dimensions different from those of the regulator 40’’ used in the system 10.

[0126] Next, the operation of the regulator 40’’ will be described. The regulator 40’’ in Figures 11A - 11B operates in the same manner as described with reference to Figures 6A - 6C. Therefore, the operation of the regulator 40’’ will not be described in detail separately. The differences in operation between the regulator 40 and the regulator 40’’ are described below.

[0127] Similar to ball bearing 750 and O-ring 760, ball bearing 750'' and X-ring seal 760'' may seal hole 664 from communication with the third chamber 666. FIG. 11A shows regulator 40'' with the third chamber 666 sealed so that fluid cannot pass through hole 664. In a particular configuration of regulator 40'' (as shown in FIG. 11A), ball bearing 750'' may exert a force on protrusion 762 of X-ring seal 760''. Such a configuration has been described above for regulator 40.

[0128] As described above, the seal between ball bearing 750'' and X-ring seal 760'' may be stronger than the seal between a ball bearing (such as ball bearing 750) and an O-ring seal (such as O-ring 760). As described above, protrusion 762 has a smaller radius of curvature than O-ring 760. Thus, for a given force, ball bearing 750'' exerts a greater pressure on protrusion 762, which provides a stronger seal between X-ring seal 760'' and ball bearing 750''.

[0129] When pressing ball bearing 750'' against protrusion 762, the second, third, and fourth protrusions 764, 766, 768 may press against surfaces 662aa and 662ab at points W, X, Y, and Z, respectively. As described above, protrusions 664, 666, and 668 may provide an overlapping seal by increasing the number of contact points.

[0130] Additional sealing provided by ball bearing 650’’ and X-ring seal 660’’ may improve the performance of regulator 40’’. For example, if pressure needs to be controlled and third chamber 666 needs to be sealed, additional sealing may prevent fluid from leaking through hole 664. Further, as previously described for regulator 40, the pressure of the fluid discharged from storage device 20, storage device 20’ may change over time. In particular, the pressure from storage device 20, storage device 20’ may decrease over time. As the pressure from storage device 20, storage device 20’ decreases, the force exerted on ball bearing 750’’ in the second direction by the pressurized fluid may decrease. However, a seal for chamber 666 may be required to achieve the desired controlled pressure. When an O-ring is used, as the force exerted by ball bearing 750’’ decreases, the pressure applied to seal chamber 666 may become insufficient. Since the area / volume of protrusion 762 is smaller, a smaller force may be required to apply a sealing pressure to X-ring seal 760’’. Thus, when the pressure from storage device 20, storage device 20’ decreases, X-ring seal 760’’ may maintain the seal of chamber 666 as needed, while an O-ring may not maintain as consistent a seal under similar circumstances. Additional sealing achieved by X-ring seal 760’’ may improve the performance of regulator 40’’.

[0131] Although many of the features of regulators 40, 40', 40'' are described as cylindrical, the shape of the elements is not limited thereto. Rather, the features may be of any shape suitable for regulators 40, 40', 40'' in order to appropriately control the fluid dispersion from storage devices 20, 20'. Further, unless otherwise specified, at least one structural element of the dosing device 30 and regulators 40, 40', 40'' may be any material known in the art including, but not limited to, metal alloys, ceramics and / or resins.

[0132] Referring to FIG. 12, a relief valve 62 according to one embodiment is shown. The relief valve 62 is arranged along the second fluid passage 48 between the diaphragm regulator 44 and the container 100 (for clarity, the housing 107 of the container 100 is not shown in FIG. 12) to discharge the injection fluid from the storage device 20, the storage device 20' when, for example, one or more of the diaphragm regulator 44 or the regulator 40 fails to operate. For example, the relief valve 62 may include a rupture disk 62a that may rupture when the pressure at the relief valve 62 exceeds a final predetermined controlled pressure (for example, the pressure of the injection fluid after passing through the properly functioning and properly adjusted regulator 40 and diaphragm regulator 44). The pressure at which the rupture disk 62a ruptures may be approximately 0.13 MPa to 1.03 MPa (20 PSI to 150 PSI), more preferably approximately 0.34 MPa to 0.48 Mpa (50 PSI to 70 PSI), and even more preferably approximately 0.41 Mpa (60 PSI). Of course, the rupture pressure of the rupture disk 62a may be changed, or rupture disks 62a having different rupture pressures may be used based on the desired discharge pressure from the diaphragm regulator 44. It will also be understood that the relief valve 62 is not limited to the rupture disk 62a and may be any relief valve suitable for exhausting the injection fluid at a pressure exceeding the desired discharge pressure, such as a pilot valve. The relief valve 62 is not limited to being arranged as shown in FIG. 12, and it will further be understood that it may be arranged at any position between the storage device 20, the storage device 20' and the outlet 34 to prevent the injection fluid and the mixture of the injection fluid and the substance or the injection fluid or the mixture of the injection fluid and the substance from being released from the dosing device 30 at a pressure exceeding the desired pressure. In addition to this, or instead of this, the relief valve 62 may be installed at any position along the fluid passage to release the fluid pressure.

[0133] A container 100 according to an embodiment is shown in FIG. 13. As described above, the container 100 may store a powder, a fluid, or other substances that are mixed with the injection fluid from the storage device 20, 20' and dispensed into the catheter 190 through the outlet 34. The container 100 stores an internal chamber 106 defined by a housing 107 of the container 100 and a surface 109 of the dosing device 30 that defines the bottommost surface of the internal chamber 106. The internal chamber 106 contains a powder, a fluid, or other substances. According to an example, the housing 107 is a transparent material for visualizing the internal chamber 106, but the present invention is not limited thereto. The injection fluid enters the container 100 from the second fluid passage 48 through the chamber inlet 102 (see FIGS. 14A and 14B). The injection fluid passes through a filter 104 provided in the filter holes 104a at the bottommost surface 109 of the internal chamber 106 of the container 100 (as described above, the injection fluid enters the container 100 through a plurality of sixth passages O through the filter holes 104a) that stores the powder or fluid. Although two filter holes 104a are shown in FIG. 13, the container 100 may include any number of filter holes 104a, for example, 1 to 4 filter holes 104a. The filter 104 has holes approximately 25 to 50 microns in diameter to prevent powder or fluid from the internal chamber 106, which may clog or contaminate the dosing device 30, from passing back from the internal chamber 106 to the second fluid passage 48.

[0134] Continuing to refer to FIG. 13, the internal chamber 106 includes a chamber relief valve 108. The chamber relief valve 108 may be similar to the relief valve 62 and may be, for example, a rupture disk or any other pressure relief valve known in the art. Similar to the relief valve 62, the chamber relief valve 108 relieves pressure when the pressure within the dosing device 30 (particularly within the chamber 106) exceeds the final controlled pressure. For example, the burst pressure of the relief valve 108 may be approximately 0.13 MPa to 1.03 MPa (20 PSI to 150 PSI), more preferably approximately 0.34 MPa to 0.48 Mpa (50 PSI to 70 PSI), and even more preferably approximately 0.41 Mpa (60 PSI). The chamber relief valve 108 is provided within the lowermost surface of the internal chamber 106, although the position of the relief valve 108 is not so limited. Although not shown, the relief valve 108 may discharge the injection gas through a lumen provided within the lowermost surface 109 of the internal chamber 106.

[0135] The tube 110, for example a hypodermic tube, extends from the bottommost surface 109 of the internal chamber 106, generally at a right angle thereto, towards the topmost surface of the internal chamber 106, but is not limited to this configuration. As shown in FIGS. 12 and 13, slots 112 are provided in the tube 110 near the bottommost surface of the internal chamber 106 and within the wall of the tube 110. The slots 112 are fluidly connected to a chamber outlet 114 (see FIGS. 14A and 14B) that connects to the outlet 34, enabling the dispensing of the injection fluid and the fluid from the internal chamber 106, or a mixture of fluid and powder, from the internal chamber 106 to the outlet 34. Alternatively or in addition to this, additional dispensing outlets from the internal chamber 106 may be provided, and there may be a plurality of slots 112 circumferentially arranged around the longitudinal axis A of the tube 110. According to another example, the slots 112 may be one or more circular (or other shaped) holes provided within the tube 110. The shape, number and arrangement of the slots 112 may assist in the proper dispensing of an appropriate amount of the mixture of injection fluid and powder from the internal chamber 106 to the chamber outlet 114, and the number of slots 112 may be varied according to the desired discharge. According to one example, the area of the slots 112 (either the area of one slot 112 or the sum of the areas of all the slots 112) may be approximately 1.61 mm 2 to 19.35 mm 2 (0.0025 square inches to 0.030 square inches), more preferably 2.96 mm 2 to 16.12 mm 2 (0.0046 square inches to 0.025 square inches). Further, the slots 112 may be approximately 1.27 mm to 5.08 mm (0.05 to 0.2 inches) from the filter holes 104a.

[0136] The container 100 may include one or more spacers 216 (see FIG. 12) extending from the bottommost surface of the internal chamber 106. As will be described in more detail below, the spacers 216 may alter the movement of the substance and the injection fluid or substance or injection fluid through the container 100. Of course, the container 100 may be configured without the spacers 216.

[0137] As shown in FIGS. 13, 14A, and 14B, the ring or wheel-shaped attachment member 116 includes spokes 116a, is attached to a sheath 118 (described in detail below) and extends from the sheath 118, and is attached to the inner surface of the housing 107. The attachment member 116 may connect the sheath 118 to the housing 107 such that movement of the housing 107 results in simultaneous movement of the sheath 118. The attachment member 116 (and the spacer 216 in embodiments including the spacer 216) may fill one or more voids in the internal chamber 106 to change the movement of the substances therein. For example, the attachment member 116 and the spacer 216 may fill voids that would prevent either or both of proper mixing of the substance with the substance disposed in the internal chamber 106 and proper dispensing of the mixture through the slots 112. The attachment member 116 and the spacer 216 may further create at least one of a new passage and an additional passage for the combination of the injected fluid and the substance to pass through the internal chamber 106. For example, as shown in FIGS. 14A and 14B, there is a space between the spokes 116a of the attachment member 116 that allows the injected fluid and the substance to flow therethrough while changing the flow pattern of the fluid and the substance in the container 100. These additional passages may improve the mixing of the injected fluid and the substance and may also ensure that a more consistent amount of the substance is discharged from the internal chamber 106.

[0138] Continuing to refer to FIG. 13, the sheath 118 is provided coaxially with the tube 110 on the outer surface of the tube 110. Further, the conical member 120 may be adjacent to the outermost surface of the inner chamber 106 and formed integrally with the housing 107 or alternatively fixed to the housing 107. In the closed configuration, for example, as shown in FIG. 14A, when the inner chamber 106 is not fluidly connected to the dispensing device 30, the sheath 118 seals over the slot 112 and the conical member 120 extends into the most distal end portion 110a of the tube 110 to seal the most distal end portion 110a. This closed configuration prevents the substance provided in the inner chamber 106 from being contaminated and prevents the substance from being dispensed before the physician is ready to dispense the substance. In contrast, as shown in FIG. 14B, when the inner chamber 106 is in the open configuration and the inner chamber 106 is fluidly connected to the dispensing device 30, the slot 112 is exposed and the most distal end portion 110a of the tube 110 is open to the inner chamber 106. The open configuration allows the mixture of the injection fluid and the substance in the inner chamber 106 to be dispensed through the slot 112 to the outlet 34.

[0139] As further shown in FIG. 14A, one or more cams 122 are attached to the inner or outer surface of the housing 107, disposed within the camshaft 124, and are movable along the camshaft 124. The camshaft 124 is in an inclined path shape and is inclined downward from the internal chamber 106 toward the chamber inlet 102. In the closed configuration achieved by screwing the container 100 in the direction of arrow Y in FIG. 14A, the cam 122 is disposed at the first end 124b of the camshaft 124 disposed near the internal chamber 106. In FIG. 14B, in the open configuration achieved by screwing the container 100 in the direction of arrow X, as shown in FIG. 14B, the cam 122 is disposed at the second end 124a of the camshaft 124, which is on the opposite side of the first end 124b. When the container 100 is screwed in the direction of arrow X, as shown in FIG. 14B, the housing 107 moves upward. Since the attachment member 116 is attached inside the housing 107 and the attachment member 116 is also attached to the sheath 118, by screwing the container 100 in the direction of arrow X, the sheath 118 also moves upward to expose the slot 112. Further, since the conical member 120 is also attached inside the housing 107, by moving the container 100 upward, the most distal end 110a of the tube 110 is exposed.

[0140] To attach the dosing device 30 to the housing 107, the cam 122 is disposed in the U-shaped groove 124c of the camshaft 124. Next, the housing 107 may be screwed in the direction of arrow Y to close the container 100 as described above, or may be screwed in the direction of arrow X (from the closed position) to open the container 100. According to an example, one or more O-rings and seal members or one or more O-rings or seal members may be provided between the housing 107 and the dosing device 30 to assist in fluidly sealing the seal housing 107 to the dosing device 30.

[0141] Next, a method of operating the medical device 10 will be described. At least one of the dosing device 30 and the storage device 20' may be packaged together with the container 100 to which it is attached, or it is also possible to have a container 100 separately attached to the dosing device. After the container 100 is attached to the dosing device 30, the storage device 20' may be attached to the inlet 42. For example, the storage device 20' may be attached to the dosing device 30 using a locking mechanism 50. According to one example, the storage device 20' may be disposed on the surface of the piston 58 when the lever 52 is in the first position, as shown in FIG. 4. Subsequently, the lever 52 is pushed towards the handle 31 around the pivot axis R, and the storage device 20' is biased towards the inlet 42 via the mounting device 38. A pierce pin (not shown) on the dosing device 30 breaks a seal (not shown) of the storage device 20', putting the storage device 20' and the dosing device 30 in fluid communication. The lever 52 is held in a locked position to maintain the position of the lever 52 adjacent to the handle 31 and to maintain the storage device 20' towards the inlet 42 when the cam 57 fits into the lock notch 56.

[0142] Referring to FIG. 2, the driving of the first actuator 36a and the second actuator 36b may independently control the release of the injection fluid through the dosing device 30. For example, the driving of the second actuator 36b moves the injection fluid along the first fluid passage 46, i.e., as shown in FIG. 3, through the first passage J, the second passage K, and the fourth passage L to the outlet 34. When a catheter 190 is attached to the dosing device 30 (see FIG. 2), the use of this first fluid passage 46 enables the user to purge a substance from at least one of the outlet 34 and the catheter 190. The pressure of the injection fluid released into the dosing device 30 may be controlled as described herein with reference to the regulator 40.

[0143] Referring to FIGS. 14A and 14B, the user moves the container 100 from the first position (FIG. 14A) to the second position (FIG. 14B) by rotating the container 100 in the X direction. As shown in FIG. 14B, the slot 112 is exposed to the internal chamber 106. Further, at the second position, the intermediate portion including the sixth passage O and the seventh passage O' is fluidly connected to the distal portion including the eighth passage P and the proximal portion including the first, third, and fifth passages J, M, and N of the second fluid passage 48. Subsequently, the user drives the second drive device 36a to move the injection fluid into the internal chamber 106 through the proximal portion of the second fluid passage 48. The injection fluid mixes with a substance such as powder in the container 100, and the mixture of the substance and the propellant is discharged into the distal portion of the second fluid passage 48 through the slot 112. The mixture of the injection fluid and the substance exits the delivery device at the outlet 34, travels down the catheter 190, and moves to the distal end 193 (see FIG. 35). The user can direct the mixture to the target location by moving the distal end 193 to different locations.

[0144] Referring to FIGS. 15 and 16, an apparatus 100' for fluidizing and delivering a powder agent (e.g., a powder therapeutic agent) to a site in a living body (e.g., a target site) according to another embodiment. An apparatus (e.g., a container) 100' according to an example further includes an overtube (e.g., a sheath) 118' movably attached to a portion of the tube 110 to move along the length of the tube 110 and extend over the slot 112 to control the dimensions of the opening of the slot 112. Tests have shown that increasing the slot dimensions increases the powder delivery rate, while decreasing the slot dimensions decreases the powder delivery rate. The overtube 118' is movable relative to the tube 110 from an initial configuration, in which the overtube 118' covers at least a portion of the slot 112 towards an open configuration, and in which the overtube 118' is moved along the length of the tube 110 to gradually increase the dimensions of the slot 112 during the course of a treatment procedure such that the delivery rate of the fluidized powder delivery remains above a threshold level (e.g., remains substantially constant over time) even when the amount of powder agent in the cannister 107' decreases as the powder is dispensed. Of course, the fluidized powder / substance includes, but is not limited to, a powder / substance that acquires fluid characteristics by passing an injection fluid (e.g., a gas) through or into it, and further, a stirred powder / substance that is a substance going with the injection fluid or a substance propelled by the injection fluid.

[0145] According to one embodiment, the target delivery rate may exceed, for example, 1 gram of delivery every 5 seconds. Device 100' may provide the best delivery results when canister 107' is approximately 45% - 80% filled with the powder agent. For example, at 80% fill, the target rate may be maintained for 30 delivery seconds. This delivery rate is also determined by the amount of gas that device 100' may use for delivery. The delivery rate may be maintained (e.g., exceeding 30 delivery seconds) even when the amount of powder agent in canister 107' decreases by gradually increasing the dimensions of slot 112 through which the fluidized powder mixture exits canister 107'.

[0146] The canister 107' in this embodiment extends longitudinally from an open first end 119 to a closed second end 121 to define an internal chamber 106' configured to receive a powder agent therein. A lid (e.g., surface) 109' is connected to the first end 119 to seal the internal chamber 106' and prevent at least one of the powder agent and the gas from leaking out of the internal chamber 106'. In one embodiment, the lid 109' is received within the first end 119 and connected to the first end 119. At least one of the inlet (e.g., filter hole) 104' and the outlet (via slot 112) in this embodiment is configured as an opening extending through the lid 109'. However, it will be apparent to those skilled in the art that the inlet 104' and the outlet may have any of various configurations as long as the inlet 104' and the outlet are connectable to a gas source and a delivery member, respectively, to supply a high-flow gas to the powder agent to fluidize the powder agent and deliver the fluidized powder mixture to a target site. For example, the inlet 104' may be connected to a connecting member (e.g., a second fluid passage) 48' that connects a gas source to the inlet 104'. In one embodiment, the gas may be supplied to the canister 107' at least at a pressure in the range of 0.03 - 0.13 MPa (5 - 20 psi) and a flow rate of 8 - 15 standard liters per minute. The outlet in this embodiment is connected to a catheter 190' (dimensioned, shaped, and configured to be inserted through a working channel of a flexible endoscope to a target site in vivo). In one example, the catheter 190' may have an inner diameter of 1.65 mm - 2.79 mm (0.065 inch - 0.11 inch). In other embodiments, the inlet 104' and the outlet may extend through a portion of the canister 107'.

[0147] The tube 110 extends from a first end 128 that is connected to an outlet to a second end (e.g., the distal end) 110a' that extends into the internal space 106'. As described above, the tube 110 in FIGS. 15 and 16 also includes slots 112 that extend through the wall of the tube 110. The slot 112 in this embodiment is disposed proximal to the first end 128 such that the fluidized powder mixture may exit the internal space 106' of the canister 107' through one of the second end 110a' of the tube 110 and the slot 112 proximal to the first end 128.

[0148] The overtube 118' is movably attached over a portion of the length of the tube 110. The overtube 118' is movable relative to the tube 110 and varies the area of the slot 112 covered by the overtube 118' as the overtube 118' moves over the tube 110 to control the dimensions of the portion of the slot 112 that is exposed to the internal space 106' such that the fluidized powder mixture may exit the internal space 106' of the canister 107' through the slot 112. For example, in an initial configuration, the overtube 118' extends over the entire slot 112 such that the slot 112 is completely covered and prevents any fluidized powder mixture from exiting through the slot 112. However, during treatment of the target site, the overtube 118' may be moved relative to the tube 110 to increase the dimensions of the exposed portion of the slot 112 through which the fluidized powder exits to maintain a desired level (e.g., above a threshold delivery rate) of the delivery rate of the fluidized powder mixture. For example, FIG. 16 shows the slot 112 partially covered by a portion of the overtube 118', and FIG. 15 shows the slot 112 fully exposed. This embodiment describes an initial configuration in which the entire slot 112 is covered, but it will be apparent to those skilled in the art that the overtube 118' may have any of various positions relative to the slot 112 as long as the dimensions of the slot 112 through which the fluidized powder may exit increase during the course of treatment as the powder in the canister 107' is dispensed.

[0149] It will also be apparent to those skilled in the art that the overtube 118' may be moved relative to the tube 110 by any of a variety of mechanisms. In one embodiment, the overtube 118' may be connected, for example, to a stabilization ring 116' that extends radially outward from the overtube to the inner surface of the canister 107' to fix the position of the overtube 118' to the canister 107'. The canister 107' and the tube 110 in this example are rotatably connected to each other such that when the canister 107' is rotated relative to the tube 110, the overtube 118' rotates around the tube 110 while moving longitudinally relative to the tube 110 to increase (or decrease, depending on the direction of rotation) the dimensions of the slot 112 through which the fluidized powder mixture may exit. In one example, the lid 109' from which the tube 110 extends includes a cam passage 124 that extends along a partially helical passage in which an engagement feature (e.g., the protrusion 122 in FIGS. 14A and 14B) of the canister 107' rides such that when the canister 102 and thus the tube 110 are rotated relative to the lid 109' and the tube 110, the overtube 118' moves longitudinally relative to the tube 110. As will be apparent to those skilled in the art, the cam passage 124 and the corresponding engagement feature of the canister 107' function in a manner similar to the screw engagement between the canister 107' and the lid 109' to achieve the desired relative movement between the overtube 118' and the tube 110.

[0150] This embodiment describes the dimensions of the portion of slot 112 available to the fluidized powder mixture such that the fluidized powder mixture exits as controlled by overtube 118’, but the dimensions of slot 112 may be controlled by any “door” having any of a variety of structures and geometries, so long as it is possible to gradually open the “door” during the course of the treatment procedure to maintain the desired flow rate of the therapeutic agent from cannister 107’. The movement of overtube 118’ or any other “door” may be driven mechanically (e.g., by physically turning overtube 118’) or pneumatically by a gas flow. Further, although this embodiment shows and describes a single slot 112, tube 110 may, if desired, include two or more slots 112 that may be covered and / or exposed through any of several door mechanisms, as described above.

[0151] According to an example of a method of using the apparatus 100', before assembling the apparatus 100', the cannister 107' is filled with a powder, for example, a hemostatic agent. After a desired amount of the powdered therapeutic agent is filled in the cannister 107', a lid 109' is attached to the cannister 107' to seal the powder therein. Next, the inlet 104' is connected to a gas source, for example, via a connecting member 48', and the outlet is connected to a catheter 190'. Next, the catheter 190' is inserted into a target site in the body (for example, through the working channel of a delivery device (such as an endoscope)). A high-flow gas is introduced into the internal space 106' of the cannister 107' to form a fluidized powder mixture. The user may press a trigger or other controller to spray the fluid mixture and deliver the fluid mixture to the target area (for example, a bleeding site) to provide treatment there. When delivering the fluidized powder mixture to the target site, the user may physically rotate the cannister 107' relative to the tube 110 to increase the dimension of the slot 112 through which the fluid mixture exists in the internal space 106' to maintain a desired flow rate level. Alternatively, when using a trigger to control the delivery of the fluidized powder mixture, when the trigger is pressed, more cross-sectional area of the slot 112 (through which the fluid mixture may exit the internal space) is exposed, and a pneumatic cylinder or motor may be operated to rotate and move the lid 109' relative to the cannister 107' to increase the dimension of the slot 112. Thus, as the amount of the powder agent in the cannister 107' decreases, the cross-sectional area of the exposed slot 112 is increased to maintain a substantially constant delivery rate of the fluidized powder mixture. Alternatively, a sensor may detect the flow rate and automatically control the opening of the slot 112 to ensure maintaining a desired flow rate.

[0152] Device 200 according to another embodiment of the present disclosure, as shown in FIG. 17, is substantially the same as the aforementioned device 100' unless otherwise specified. Device 200 includes a cannister 202 that defines an internal space 204 into which a powder agent is received. Similar to device 100 and device 100', the internal space 204 is sealed by a lid 222 connected to the internal space 204 such that when a high-flow gas is supplied to the internal space 204 through an inlet 206, the powder agent stored in the internal space 204 forms a fluidized powder mixture. The fluidized powder mixture exits the internal space 204 through an outlet 208 and is delivered to a target site within a patient during treatment. As the amount of powder agent in the internal space 204 decreases during the course of treatment, the lid 222 includes a turbulator plate 230 to maintain a desired delivery rate. When gas passes through the turbulator plate 230, the turbulator plate 230 vibrates and rattles or vibrates or rattles to prevent or at least reduce the settling of the powder agent stored in the cannister 202. In the absence of the turbulator plate 230, during the course of treatment, some of the powder agent becomes otherwise balanced and resists fluidization, making it difficult to maintain the desired delivery rate of the therapeutic agent.

[0153] Similar to cannister 107', cannister 202 extends longitudinally from an open first end 218 to a closed second end 220 and defines the internal space 204. The lid 222 is connected to the first end 218 to seal the internal space 204 and store the powder agent therein. The inlet 206 and the outlet 208 are configured as openings that extend through the lid 222 in communication with the internal space 204. Although not shown, similar to device 100', the outlet 208 includes a tube that extends from there into the internal space 204 and allows the fluidized powder mixture to exit the outlet 208 through the tube.

[0154] In this embodiment, the turbulator plate 230 extends along a part of the lid 222 facing away from the internal space 204. In this embodiment, the turbulator plate 230 includes an opening 232 that extends through its wall 234 and is configured to be connected to a gas source, for example, via a connecting element 224. The turbulator plate 230 extends along the lid 222 such that the opening 232 communicates with the inlet 206. Thereby, the gas passes through the turbulator plate 230 and enters the internal space 204 through the inlet 206. The interior 236 of the turbulator plate 230 includes a plurality of structures 238 (such as ribs, bumps, or protrusions, etc.) that disrupt the flow of gas passing through it and cause a vibration response in the turbulator plate 230. And in turn, this vibration prevents the powder from settling on the lid 222. Thus, the gas flow into the internal space 204 through the turbulator plate 230 results in both the vibration of the turbulator plate 230 and the fluidization of the propellant within the canister 202. The magnitude of the vibration may be controlled by controlling the velocity of the gas passing through the turbulator plate 230, as will be apparent to those skilled in the art. In this embodiment, the magnitude of the vibration of the turbulator plate 230 is held constant over time while the user presses the trigger for supplying gas to the canister 202. The fluidized powder exits the canister 202 through an outlet 208 that does not communicate with the interior 236 of the turbulator plate 230. The outlet 208 in this embodiment is connected to a delivery catheter 226 for delivering the fluidized powder mixture to a target site.

[0155] In another embodiment, as shown in FIG. 18, unless otherwise specified, the device 200' is substantially the same as the aforementioned device 200. In this embodiment, the turbulator plate 230' extends along a part of the lid 222' that seals the internal space 204' defined by the canister 202', and includes a first opening 232' and a second opening 240' that extend through its wall 234'. Neither the first opening 232' nor the second opening 240' communicates with the inlet 206' and the outlet 208' of the device 200'. The inlet 206' and the first opening 232' are each configured to be connected to a gas source and the turbulator plate 230' for supplying gas to the internal space 204'. The inlet 206' and the first opening 232' are each connected to the same or different gas sources.

[0156] The gas supplied to the turbulator plate 230' through the first opening 232' passes through the turbulator plate 230' and exits the turbulator plate 230' through the second opening 240'. For example, the gas may be supplied to the turbulator plate 230' at a constant rate while the powder is fluidized and delivered to the target site to maintain vibrations of a certain magnitude. Alternatively, the gas flow supplied to the turbulator plate 230' may be changed over time or intermittently as needed to optimize the delivery rate of the fluidized powder mixture, thereby changing the magnitude of the vibrations. However, the function of the turbulator plate 230' is otherwise the same as that of the device 200, and it will be apparent to those skilled in the art that it prevents the powder from settling on the lid 222'.

[0157] As shown in FIGS. 19 and 20, the device 300 according to another embodiment of the present disclosure is substantially the same as the device 100' and the device 200, unless otherwise specified. The device 300 includes a cannister 302 that defines an internal space 304 therein where a powder agent (e.g., a hemostatic agent) is received and fluidized via a high-flow gas for delivery to a target site (e.g., a bleeding site) for treatment. The internal space 304 is sealed via a lid 322 attached to the open end of the cannister 302, and gas is supplied to the internal space 304 via an inlet 306 that extends through the lid 322. The resulting fluidized powder mixture exits the internal space 304 via an outlet 308 that extends through the lid 322 and is delivered to the target site. The device 300 also includes a tube 310 that extends from a first end 328 connected to the outlet 308 to a second end 314 that extends into the internal space 304. However, rather than a single slot extending through the wall of the tube 310, the tube 310 includes a plurality of slots 312 disposed around the tube 310 to prevent uneven distribution of the powder agent within the cannister 302 and prevent buildup of the powder agent on either side of the tube 310 that could potentially reduce the delivery rate of the fluidized powder mixture.

[0158] In one embodiment, as shown in FIG. 20, the tube 310 includes four slots 312 disposed around the tube 310 and equally spaced from each other. The slots 312 in this embodiment are disposed proximal to the first end 328. However, it will be apparent to those skilled in the art that the number, location, and configuration of the slots 312 may vary.

[0159] As shown in FIG. 21, device 400 according to another embodiment of the present disclosure is substantially similar to the aforementioned devices 100', 200, and 300 unless otherwise specified. Device 400 includes a cannister 402 that defines an internal space 404 into which a powder agent 405 is received and fluidized to form a fluidized powder mixture for delivery to a target site in vivo. Similarly, device 400 may include a lid 422 that seals the internal space 404 with an inlet 406 through which gas is supplied to the internal space 404 to fluidize the powder agent 405 and an outlet 408 through which the fluidized powder agent exits the cannister 402 and is delivered to the target site. Device 400 may include a tube 410 that extends into the internal space 404 in communication with the outlet 408. Device 400 further includes a filler chamber 450 connected to the cannister 402 and in communication with the internal space 404 of the cannister 402. The filler chamber 450 houses a filler substance 452 (e.g., simulated particles, beads, small "bounce balls", or foams, etc.) that is injected into the cannister 402 as the fluidized powder mixture exits the cannister 402 to compensate for a decrease in the amount of the powder agent when the fluidized powder mixture is delivered to the target site. The filler substance 452 is injected into the cannister 402 to maintain a constant ratio of the amount of the substances (e.g., the powder agent and the filler) and the amount of the gas in the cannister 402 to maintain a desired delivery rate of the fluidized powder mixture to the target site.

[0160] The filler chamber 450 may be connected to the cannister 402 such that the filling substance 452 passes from the filler chamber 450 through the filler inlet 454 to the cannister 402. In one embodiment, the filler chamber 450 may also include a gas inlet 456 such that when the user drives the delivery of the fluidized powder mixture to the target site, for example by pressing a trigger, gas is supplied to both the cannister 402 and the filler chamber 450. The gas supplied into the filler chamber 450 moves the filling substance 452 from the filler chamber 450 to the cannister 402. The filler chamber 450 may include a pressure regulator that controls the gas inlet pressure as needed to control the amount of the filling substance 452 supplied to the cannister 402 to correspond to the amount of the powder agent 405 exiting the cannister 402. In one embodiment, the filler inlet 454 may be sized and shaped, and / or otherwise configured, to facilitate the passage of the filling substance 452 (e.g., beads) into the cannister 402 in a single flow through the cannister 402.

[0161] The filling substance 452 may be configured to be able to enter the internal space 404 of the cannister 402, but is prevented from exiting the cannister 402 during the delivery of the fluidized powder mixture. In one embodiment, this is achieved by sizing the individual particles of the filling substance 452. For example, the filling substance 452 may be sized and shaped, or dimensioned or shaped, such that it prevents it from entering at least one of the tube 410 and the outlet 408. In other words, each bead or particle of the filling substance 452 is selected to be larger than at least one of the openings of the tube 410 and the outlet 408. The filling substance 452 is configured such that the powder agent bounces off the wall 403 of the cannister 402 to prevent clogging of the device 400 as the powder agent moves and is fluidized within the internal space 404, while being large enough in size and shape to prevent the filling substance from exiting the cannister 402.

[0162] In this way, during use, the cannister 402 of the device 400 loses powder during the delivery of the fluidized powder agent, but at the same time, the decrease is compensated by supplying a corresponding amount of the filling substance 452 to the cannister 402. The delivery rate of the filling substance 452 to the cannister 402 may be determined by calculating the amount of the lost powder agent in consideration of the delivery rate of the fluidized powder mixture and adjusting it based on the difference in the amount and flow rate between the filling substance 452 and the powder agent 405. The delivery rate of the filling substance 452 into the cannister 402 is selected to compensate for the decrease in the amount of the powder agent 405 and maintain a substantially constant delivery rate of the fluidized powder mixture. Although the inlet 406 of the cannister 402 and the gas inlet 456 of the filler chamber 450 are shown and described as being connected to a single gas source, the inlet 406 and the gas inlet 456 may each be connected to an individual gas source, and when the delivery of the fluidized powder mixture to the target site is driven or triggered, or when the delivery of the fluidized powder mixture to the target site may be driven or triggered, it will be apparent to those skilled in the art that supplying gas to the inlet 406 and the gas inlet 456.

[0163] As shown in FIGS. 22 and 23, device 500 may be substantially the same as device 400 unless otherwise specified. Device 500 includes a cannister 502 that defines a first internal space 504 therein for receiving a powder agent, fluidizing it, and delivering a fluidized powder mixture to a target site of a patient for treatment. However, cannister 502 defines not an individual filler chamber but rather both a first internal space 504 and a second internal space 550 that extends above the first internal space 504 when device 500 is in an operating position. Further, rather than the first internal space 504 being occupied by a filling substance to maintain a certain amount of substance (at least one of a powder agent and a filler) therein, the second internal space 550 stores additional powder agent that may be supplied to the first internal space 504 by gravity when the fluidized powder mixture exits the first internal space 504 and is delivered to the target site. Only the powder agent stored within the first internal space 504 is fluidized to form a fluidized powder mixture, and only the powder agent within the first internal space 504 is permitted to exit device 500 to the target site, so the inlet and outlet (not shown) communicate with the first internal space 504.

[0164] The second internal space 550 may communicate with the first internal space 504 via an opening 554 that extends therebetween. Device 500 further includes a movable door 558 between a first configuration as shown in FIG. 22 before the start of a treatment procedure and a second configuration as shown in FIG. 23 during the course of treatment. In the first configuration, door 558 may extend over opening 554 to prevent passage of any powder agent from the second internal space 550 to the first internal space 504 when the fluidized powder mixture is not being delivered. As indicated by the dashed line in FIG. 22, the first internal space 504 contains a given amount of powder agent therein.

[0165] When the user drives and triggers or drives or triggers the delivery of the fluidized powder mixture, as shown in FIG. 23, the door 558 opens, the opening 554 is exposed, and the movement of the door 558 may be caused so that the powder can pass from the second internal space 550 to the first internal space 504. The driving of the door 558 may be caused in any of several different ways. For example, the door 558 may include a motor that is actuated after the device 500 is driven, a magnetic mechanism that uses magnetism to open the door 558 after actuation, and / or a pressure difference created by an increase in pressure after the device is driven. The second internal space 550 may include an inclined surface 560 that guides the powder toward the opening 554 so that when the door 558 is open, the powder in the second internal space 550 can fall into the first internal space 504. Thus, the first internal space 504 is passively supplied with additional powder by gravity. As shown by the dotted line in FIG. 23, since the fluidized powder mixture is supplied to the first internal space 504 through the second internal space 550 when delivered, the amount of powder in the first internal space 504 needs to be kept constant during the treatment process. The opening 554 may be sized to allow the powder to fall through the opening 554 at a controlled rate selected to keep the amount of powder substantially constant within the first internal space 504, and / or may be configured otherwise.

[0166] It has been described that additional powder within the second internal space 550 is passively fed into the first internal space 504 by gravity. However, in another embodiment, as shown in FIGS. 24 and 25, the powder within the second internal space 550' of the cannister 502' of the device 500' may be actively fed into the first internal space 504' of the cannister 502' via a turbine 562' that may be moved, for example, by a gas flow. In this embodiment, a rotatable paddle 564' is mounted within an opening 554' that extends between the first internal space 504' and the second internal space 550'. The rotatable paddle 564' is disposed along the outer side of the cannister 502' and is connected to a turbine 562' housed within a gas flow path 566'. The gas flow path 566' may be configured as a connection element 524' that connects a gas source to an inlet (not shown) that permits passage of gas therethrough into the first internal space 504. Thus, in this embodiment, the connection element 524' extends along the outer side of the cannister 502' to house the turbine 562'.

[0167] As shown in FIG. 24, in a first configuration of the device 500' where the delivery of the fluidized powder mixture is not driven and thus there is no gas flowing through the flow path 566', the turbine 562' does not rotate, and thus there is no powder agent that is allowed to pass from the second internal space 550' to the first internal space 504'. As shown in FIG. 25, in a second configuration, when the delivery of the fluidized powder mixture is driven, the turbine 562' is rotated by the flow of gas passing through the gas flow path 566'. The rotation of the turbine 562' correspondingly rotates the paddle 564', actively moving the powder agent in the second internal space 550' into the first internal space 504' through the opening 554'. Since the gas flow is initiated when the user drives and / or otherwise triggers the delivery of the fluidized powder mixture to the target site, the supply of the powder agent from the second internal space 550' to the first internal space 504' is performed simultaneously with the powder agent (e.g., the fluidized powder mixture) exiting the first internal space 504' in order to maintain a substantially constant amount of the powder agent in the first internal space 504'. Maintaining the amount of the powder agent in the first internal space 504' will correspondingly result in maintaining a substantially constant delivery rate of the fluidized powder mixture.

[0168] The above embodiments describe a single gas source / gas supply, but it will be apparent to those skilled in the art that the turbine 562' may be driven by a gas source separate from the gas source connected to the inlet of the device 500' as long as the amount of the powder agent supplied from the second internal space 550' to the first internal space 504' corresponds to the amount of the powder agent exiting the first internal space 504'. Further, although the above embodiments describe the active transport of the powder agent by a gas-powered turbine, the active transport from the second internal space 550' to the first internal space 504' may also be performed by other mechanisms.

[0169] As shown in FIG. 26, an apparatus 1200 for fluidizing and delivering a powder agent (e.g., a hemostatic agent) according to an embodiment of the present disclosure includes a canister 1202 and a piston 1204 movably coupled to the canister 1202. The canister 1202 is configured to receive the powder agent within its internal space 106. Subsequently, the canister 1202 is filled with gas through an inlet 1208 that may be connected to a gas source, for example, by a tubular member 1212. The powder agent is fluidized by the gas to form a two-phase mixture that may be sprayed through a catheter 1214 connected to an outlet 1210 to a target site (e.g., a bleeding site). The catheter 1214 is sized and shaped for endoscopic insertion into a target site within a patient's body (e.g., along a serpentine path traversed by a flexible endoscope through a body lumen accessed through a natural body opening), and has sufficient flexibility to accommodate such insertion. To maintain a substantially constant delivery rate of the mixture to the target site, the piston 1204 is movable relative to the canister 1202 to reduce the volume of the internal space 1206 during treatment of the target site. Thereby, as the amount of powder agent in the canister 1202 decreases, the volume of the internal space 1206 also decreases to maintain a substantially constant powder amount-to-canister volume ratio. The piston 1204 may be moved relative to the canister 1202 in any of several different ways. In this embodiment, the piston 1204 is moved by a pneumatic cylinder or motor 1216.

[0170] The cannister 1202 of this embodiment is formed of a rigid material for defining an internal space 1206 configured to receive a powder agent together with a gas and form a gaseous fluid mixture that is sprayed onto a target site to provide treatment thereto. The cannister 1202 extends longitudinally from an open first end 1216 to a closed second end 1218. The piston 1204 is movably coupled to the cannister 1202 at the first end 1216 and is movable toward the second end 1218 to reduce the volume of the internal space 1206. The piston 1204 seals the internal space 1206 such that powder, gas, and / or gas mixture do not leak from the cannister 1202, exit the cannister 1202 through the outlet 1210, and therefrom into the catheter 1214 and toward the target site. Thus, the piston 1204 of this embodiment is received within the open first end 1216 and has dimensions and a shape that substantially correspond to the dimensions and shape of the opening at the first end 1216. In one example, while the cannister 1202 is substantially cylindrical, the piston 1204 is substantially disc-shaped for being received within the open first end 1216 of the cannister 1202. The cannister 1202 has dimensions and a shape such that the piston 1204 is movable along at least a portion of its length toward the second end 1218 while preventing leakage of any fluid / substance received within the internal space 1206 while reducing the volume of the internal space 1206. In one example, the piston 1204 includes a sealing ring extending around its outer periphery to prevent any powder agent, gas, and / or fluid from leaking through the piston 1204.

[0171] As described above, the device 1200 also includes an inlet 1208 through which gas is introduced into the internal space 1206, and an outlet 1210 through which the fluidized powder is delivered to the catheter 1214 and reaches the target site. In one embodiment, the inlet 1208 and the outlet 1210 are each configured as openings that extend through a portion of the piston 1204 and are respectively connected to the tubular member 1212 and the catheter 1214. However, it will be apparent to those skilled in the art that the inlet 1208 and the outlet 1210 may be disposed on or along any portion of at least one of the cannister 1202 and the piston 1204, as long as the inlet 1208 is configured to receive high-pressure gas through or into the internal space 1206 and the outlet 1210 is connectable to a delivery element (such as a catheter 1214 that delivers a fluid mixture from the internal space 1206 to the target site). Although the inlet 1208 is described as being connected to a gas source via the tubular member 1212, it will also be apparent to those skilled in the art that the inlet 1208 may be connected to the gas source via any of several connections, as long as sufficient gas flow can be delivered through the tubular member 1212. Further, although the outlet 1210 is shown and described as an opening that extends through the piston 1204, it will be apparent to those skilled in the art that the outlet 1210 may be configured to include a hypo tube that extends into the internal space 1206 such that the fluid mixture formed within the internal space 1206 may be received within the hypo tube for delivery to the target site through the catheter 1214.

[0172] In this embodiment, the piston 1204 is movable relative to the canister 1202 by a pneumatic cylinder or motor 1220. The device 1200 may be programmed to include one or more inputs, such as time. When it is desired to deliver the fluid mixture to the target site, the user may initiate the delivery using a controller such as a trigger. For example, when the user depresses the trigger to deliver the fluid mixture, the piston 1204 moves toward the second end 1218 at a preset speed. When the user releases the trigger, the piston 1204 can stop and maintain its position relative to the canister 1202 until the user depresses the trigger again. Alternatively or in addition, the device 1200 may use other inputs, such as inputs based on flow sensors and pressure sensors or flow sensors or pressure sensors within the internal space 1206 of the canister 1202, the inlet 1208, and / or the outlet 1210.

[0173] Although the piston 1204 of the device 1200 is described and shown as being driven by a pneumatic cylinder or motor 1220, it will be apparent to those skilled in the art that the piston 1204 may be moved relative to the second end 1218 from its initial position proximal to the first end 1216 by any of a variety of different drive mechanisms, examples of which are described in further detail below. Further, although the piston 1204 is shown as forming the base (e.g., lower portion) of the canister 1202, it will be apparent to those skilled in the art that the piston 1204 may be coupled to the canister 1202 in any of several configurations. In particular, the piston 1204 may also be configured as the lid (e.g., upper portion) of the canister 1202. In a further embodiment, the device 1200 may include two or more pistons 1204 each of which is movable relative to the canister 1202 to reduce the volume of its internal space 1206.

[0174] According to an example method of using the apparatus 1200, the canister 1202 may be filled with a powder agent, such as a hemostatic agent, before the assembly of the apparatus 1200. After filling the canister 1202 with a desired amount of the powder agent, the canister 1202 and the piston 1204 are assembled, the inlet 1208 is connected to a gas source, for example, via a tubular member 1212, and the outlet 1210 is connected to a catheter 1214. Then, the catheter 1214 may be inserted into a target site in the body through a working channel of a delivery device, such as an endoscope. The user may depress a trigger or other controller to introduce a high-flow gas into the internal space 1206 of the canister 1202 to form a fluid mixture and deliver the fluid mixture to the target site (e.g., a bleeding site) to provide treatment thereto. When the trigger is depressed, the pneumatic cylinder or motor 1220 is operated to move the piston 1204 toward the second end 1218, and the volume of the internal space 1206 decreases by an amount corresponding to the decrease in the amount of the powder agent remaining in the internal space 1206. As it decreases, the powder agent exits the canister 1202 through the outlet 1210. When the user releases the trigger, both the delivery of the fluid mixture and the movement of the piston 1204 are stopped. Thereby, the piston 1204 moves only while the fluid mixture is being delivered, and thus, the decrease in the volume of the internal space 1206 corresponds to the decrease in the volume of the powder remaining in the internal space 1206. As described above, the speed of movement of the piston 1204 may be based on inputs such as time, flow, and / or pressure in the canister 1202, the inlet 1208, and the outlet 1210. In one embodiment, the piston 1204 is configured to move at a rate that maintains a substantially constant ratio of the volume of the available internal space 1206 in the canister 1202 to the remaining powder to maintain a substantially constant delivery rate of the fluid mixture.

[0175] As shown in FIG. 27, a device 1300 according to another embodiment is substantially similar to device 1200 and includes a cannister 1302 and a piston 1304 movably coupled thereto, and when the fluidized powder mixture is delivered to the target site, it moves from an initial position proximal to the first end 1316 of the cannister 1302 toward the second end 1318 to reduce the volume of the internal space 1306 of the cannister 1302. Similar to device 1200, a high flow gas is delivered to the internal space 1306 to fluidize the powder received within the cannister 1302 to form a fluid mixture for delivery to a target site within the body. The gas is received into the cannister 1302, for example, through an inlet 1308 coupled to a gas source via a tubular member 1312. The fluid mixture is delivered to the target site via a delivery catheter 1314 coupled to the outlet 1310 of the device 1300. However, in this embodiment, the piston 1304 is moved by a chamber 1320 that includes an expandable member 1322 that expands as it receives gas therein. In particular, when the user triggers (e.g., depresses a trigger) a controller to deliver the fluid mixture to the target site, a portion of the gas is diverted to the expandable member 1322 to move the piston 1304 toward the second end 1318 by expanding the expandable member 1322, as shown by the dashed line in FIG. 27.

[0176] In this embodiment, the chamber 1320 that houses the expandable member 1322 is connected to the first end 1316 of the cannister 1302 on the side of the piston 1304 opposite the internal space 1306 such that as the expandable member 1322 expands, the piston 1304 is moved toward the second end 1318 of the cannister 1302. The expandable member 1322 is also connected to a gas source via a connecting member 1324 that includes a one-way valve such that gas may pass in a first direction through the expandable chamber 1322 but is prevented from flowing in a second direction from the expandable chamber 1322. As described above, gas is directed to the chamber 1320 only while the fluid mixture is being delivered to the target site such that a decrease in the volume of the internal space 1306 corresponds to a decrease in the amount of powder in the cannister 1302. Similar to the device 1200, the device 1300 may receive inputs corresponding to flow, pressure, and / or time that control the rate at which the piston 1304 is moved toward the second end 1318. It will be apparent to those skilled in the art that the device 1300 may be used in a manner substantially similar to the device 1200.

[0177] As shown in FIGS. 28 and 29, an apparatus 1400 according to another embodiment includes a canister 1402 for receiving a powder agent within its internal space 1406 and a piston 1404 movably coupled to the canister 1402, and may be substantially similar to the aforementioned apparatuses 1200 and 1300. High-flow gas is delivered into the internal space 1406 via an inlet 1408 coupled to a gas source to form a fluidized powder mixture for delivery to a target treatment area via a delivery catheter 1414 coupled to an outlet 1410 of the apparatus 1400. The piston 1404 is movable from an initial position proximal to a first end 1416 of the canister 1402 toward a second end 1418 to reduce the volume of the internal space 1406 as the amount of powder agent within the internal space 1406 decreases. However, the apparatus 1400 further includes a turbine 1426 coupled to a threaded rod 1428 to which the piston 1404 is threadedly coupled. The turbine 1426 is housed within a bypass 1424 coupled to the first end 1416 of the canister 1402. When the user triggers the controller to deliver the fluid mixture, a portion of the gas is diverted through the bypass 1424. The flow of gas through the bypass 1424 rotates the turbine 1426, thereby rotating the threaded rod 1428 about its longitudinal axis. The piston 1424, to which the threaded rod 1428 is rotated, is moved longitudinally along and toward the second end 1418.

[0178] As shown in FIG. 29, bypass 1424 includes a first opening 1430 through which gas is received and a second opening 1432 through which gas exits, such that gas flows through bypass 1424 from the first opening 1430 to the second opening 1432 and rotates a turbine 1426 housed therein. A threaded rod 1428 is coupled to turbine 1426 such that rotation of turbine 1426 results in rotation of threaded rod 1428. Piston 1404 is threaded onto rod 1428, so rotation of threaded rod 1428 moves piston 1404 longitudinally along it. Piston 1404 is threaded onto rod 1428 such that rotation of threaded rod 1428 due to the flow of gas through bypass 1424 results in longitudinal movement of piston 1404 towards the second end 1418. Similar to apparatus 1300, a portion of the gas is diverted only through bypass 1424 during delivery of the fluid mixture such that a decrease in the volume of the internal space corresponds to the volume of powder remaining within internal space 1406. As described above, it will be apparent to those skilled in the art that apparatus 1400 may be used in a substantially similar manner as apparatus 1200 and apparatus 1300.

[0179] As shown in FIG. 30, apparatus 1600 according to another embodiment of the present disclosure includes a canister 1602 configured to receive a powder therein for fluidization by gas and may be substantially similar to the aforementioned apparatus 1200, apparatus 1300, and apparatus 1400. Similar to apparatus 1200, apparatus 1300, and apparatus 1400, the volume of the internal space 1606 of canister 1602 decreases as the fluid mixture is delivered to the target site for treatment. However, rather than decreasing the volume of the internal space 1606 via a movable piston, apparatus 1600 includes an expandable member 1604 that expands within the internal space 1606 of canister 1602, as shown by the dashed line in FIG. 30, to decrease its volume.

[0180] Similar to machines 1200, 1300, and 1400, gas is supplied into canister 1602 via inlet 1608 which may be connected to a gas source via connecting member 1612. The fluid mixture is delivered to the target site via delivery catheter 1614 connected to outlet 1610. Device 1600 further includes a second chamber 1620 connected to canister 1602. Similar to the aforementioned device 1300, a portion of the gas from the gas source may be diverted into the second chamber during delivery of the fluid mixture. The internal space 1634 of the second chamber 1620 is separated from the internal space 1606 of canister 1602 via expandable member 1604. In this embodiment, expandable member 1604 is configured as an expandable diaphragm extending between canister 1602 and second chamber 1620 such that when gas is received into the internal space 1634 of the second chamber 1620, the pressure difference between the internal space 1634 of the second chamber 1620 and the internal space 1606 of canister 1602 (as shown by the dashed line in FIG. 30) deflects the expandable member into canister 1602 to reduce the volume of the internal space 1606.

[0181] As described above with reference to devices 1300 and 1400, gas is diverted only into the second chamber 1620 during delivery of the fluid mixture. When delivery is triggered, gas is diverted into the second chamber 1620. When the user releases the trigger for delivery, the delivery of gas to the second chamber 1620 is stopped. As also described above, the flow rate diverted into the second chamber 1620 may be determined by the time, pressure, and / or flow rate detected within device 1600. As more gas flows into the second chamber 1620, its pressure increases and pushes the diaphragm further into the internal space 1606 of canister 1602. Thus, device 1600 may be used in a substantially similar manner as the aforementioned devices.

[0182] Device 1600 is shown with a single inflatable diaphragm and is described with respect thereto, but it will be apparent to those skilled in the art that device 1600 may include two or more inflatable diaphragms, and that the inflatable member may have any of a variety of shapes and configurations.

[0183] As shown in FIG. 31, a device 1700 according to another embodiment includes a cannister 1702 that includes an inflatable member 1704 that expands as the received powder is fluidized and delivered to a target site for treatment, thereby reducing the volume of the first internal space 1706 of the cannister 1702. The device 1700 may be substantially similar to the aforementioned device 1600. However, in this embodiment, the inflatable member 1704 may be housed within the cannister 1702 that defines both a first internal space 1706 in which the powder is fluidized and a second internal space 1708 that diverts a portion of the gas around the inflatable member 1704 into the first internal space 1706 to displace it and reduce its volume. The first end 1716 of the cannister 1702 may be substantially closed by a base 1740. An inlet 1708 for supplying gas into the first internal space 1706 and an outlet 1710 through which the fluid mixture is delivered to the target site may extend through the base 1740 that communicates with the first internal space 1706.

[0184] The expandable member 1704 may, in one example, have a substantially cylindrical configuration. The cylindrical expandable member 1704 is housed within the cannister 1702 such that the interior of the expandable member 1704 defines a first internal space 1706 in which the powder is fluidized by a high flow rate gas supplied from a gas source to the powder through the inlet 1708 after the powder is housed therein. A second internal space 1720 is defined by the outer surface 1736 of the expandable member 1704 and the inner surface 1738 of the cannister 1702 such that a fluid mixture is delivered to a target site by the first internal space 1706 via a delivery catheter 1714 connected to the outlet 1710 and a portion of the gas from the gas source gas is diverted into the second internal space 1738 via a connection element 1724. The pressure difference between the first internal space 1706 and the second internal space 1720 deflects the expandable member 1704 towards an expanded configuration as shown by the dashed line in FIG. 31, reducing the volume of the first internal space 1706 as the amount of powder in the first internal space 1706 is reduced. In one embodiment, in the expanded configuration, the expandable member 1704 may form a substantially hourglass shape. However, it will be apparent to those skilled in the art that the expandable member 1704 may have any of a variety of shapes and configurations as long as the expandable member 1704 reduces the volume of the first internal space 1706 when expanded. Similar to the aforementioned device, the gas may be diverted only into the second internal space 1720 during delivery of the fluid mixture and may be controlled by inputs including time, and / or flow rate and / or pressure within the device 1700.

[0185] Device 1700 is shown and described as including a substantially cylindrical expandable member 1704, however, as previously described, it will be apparent to those skilled in the art that the expandable member 1704 may have any of a variety of shapes as long as the expandable member defines the first internal space 1706 and the second internal space 1720.

[0186] As shown in FIG. 32, an apparatus 1800 according to another embodiment includes a cannister 1802 and an expandable member 1804 that define a first internal space 1806 in which a powder agent is fluidized by gas from a gas source to form a fluid mixture, and a second internal space 1820 that receives a portion of the gas diverted from the gas source during delivery of the fluid mixture to a target treatment area. The apparatus 1800 may be substantially similar to the aforementioned apparatus 1700. The first internal space 606 is defined by an inner wall 1805 of the expandable member 1804. The second external space 1820 is defined by an outer wall 1836 of the expandable member 1806 and an inner surface 1838 of the cannister 1802. However, in this embodiment, the expandable member 1804 extends from a first end 1816 of the cannister 1802 to a second end 1818 of the cannister 1802 such that in an initial biasing configuration, the expandable member 1804 may substantially correspond to the cannister 1802 in shape. However, when the second internal space 1820 is filled with the diverted gas, as shown by the dashed line in FIG. 32, the expandable member 1804 deflects into the first internal space 1806, increasing the volume of the second internal space 1820 and thereby reducing the volume of the second internal space 1820.

[0187] Similar to the apparatus 1700, the apparatus 1800 also includes a base 1840 at a first end 1816 of the cannister 1802 to seal the first internal space 1806 and the second internal space 1820. The inlet 1808 and the outlet 1810 extend through the base 1840 that communicates with the first internal space 1806 such that gas may be supplied thereto through the inlet 1808 to fluidize the powder agent therein and the fluid mixture may be delivered to the target site through the outlet 1810. A portion of the gas from the gas source may be diverted into the second internal space 1820 through a connection element 1824 that may be disposed along the base 1840 that communicates with the second internal space 1820.

[0188] As described above, during the delivery of the fluid mixture to the target site, as indicated by the dashed line in FIG. 32, a portion of the gas is diverted into the second internal space 1820 such that the pressure difference between the first internal space 1806 and the second internal space 1820 causes the expandable member to deflect radially inwardly and reduce the volume of the first internal space 1806. Thus, as the amount of powder in the first internal space 1806 is reduced, the volume of the first internal space 1806 is correspondingly reduced to maintain a substantially constant delivery rate of the fluid mixture. In the bypass configuration, the expandable member 1804 may be substantially conical in shape. However, as long as the expandable member 1804 is formed of a flexible and deflectable material that defines both the first internal space 1806 within its wall and the second internal space 1820 between the expandable member 1804 and the wall of the cannister 1802, it will be apparent to those skilled in the art that the expandable member 1804 may have any configuration, shape, and dimensions.

[0189] As shown in FIG. 33, an apparatus 1900 according to another embodiment includes a cannister 1902 and an expandable member 1904 that expands to reduce the volume of the internal space 1906 of the cannister 1902 when the powder is fluidized and delivered to a target site for treatment, and may be substantially similar to the apparatuses 1600, 1700, and 1800 described above. The volume of the internal space 1906 is reduced to accommodate the reduction in the amount of powder within the internal space 1906. However, the expandable member 1904 in this embodiment may be configured as an expandable balloon housed within the internal space 1906. Thus, as the volume of the balloon 1904 increases as it expands, the volume of the internal space 1906 decreases.

[0190] Similar to machines 1600, 1700, and 1800, machine 1900 includes an inlet 1908 for supplying gas to an internal space 1906 to fluidize the powder, and an outlet 1910 through which the fluid mixture is delivered to the target site. The inlet 1908 and the outlet 1910 may be connected to an end of the cannister 1902 and extend through a base 1940 of the machine 1900 that defines the internal space 1906. A portion of the gas supplied to the machine 1900 may be diverted to the expandable member 1904 via the connection element 1924 to inflate the balloon and fill the internal space 1906. As described above, the inlet 1908 may have any of various configurations and, in one embodiment, may include a hypo tube 1911 that extends into the internal space 1906. The hypo tube 1911 may include slots 1944 that extend through its wall along a portion thereof. The inflated expandable member 1904 may occupy the space around the hypo tube 1911 without restricting the flow of gas and powder through the slots 1944. Although the hypo tube 1911 is described as including slots 1944, it will be apparent to those skilled in the art that the term "slot" refers to any opening or hole that extends through its wall.

[0191] The connection element 1924 may be connected to the base 1940, as shown, to deliver gas to the expandable member 1904. In this embodiment, it will be apparent to those skilled in the art that the connection element 1920 may extend through the internal space 1906 and connect to the expandable member 1904. Alternatively, as shown in FIG. 34, the machine 1900' may have a separate supply line 1924' that extends through a portion of the cannister 1902' to supply gas to the expandable member 1904' housed therein. It will be apparent to those skilled in the art that the expandable members 1904, 1904' having a balloon configuration may receive a supply of gas to inflate the expandable member via any of various mechanisms.

[0192] The catheter 190 is shown in a coiled, wound configuration in FIG. 35. The catheter 190 includes a proximal end 191, a distal end 193, and an intermediate section 192 connecting the proximal end 191 and the distal end 193. The proximal end 191 may be connected to the outlet 34 by any mechanism such as a screw or snap-fit mechanism. Alternatively, the proximal end 191 may be a complementary luer to the luer provided at the outlet 34, such as a male or female luer. As shown in FIG. 35, the proximal end 191 may include a butterfly device to assist in screwing or otherwise attaching the catheter 190 to the delivery device 30. When a mixture of the injected fluid and the substance is dispensed from the delivery device 30, the mixture may move through the catheter 190 (preferably in an unwound configuration) and may also be dispensed from the distal end 193 to the target site. The catheter 190 may be of any dimension suitable for introducing the device into the patient while maintaining column strength so that the catheter 190 does not bend when the endoscope passes through. For example, the catheter 190 may be approximately 200 - 275 cm, preferably approximately 210 - 250 cm. Further, the diameter of the catheter 190 may be approximately 2.3 - 2.7 mm (7 - 8 French), the wall thickness of the catheter 190 may be approximately 1.27 mm - 3.81 mm (0.05 - 0.15 inches), or preferably approximately 2.54 mm (0.1 inches). Additionally, the catheter 190 may be made of nylon or any other suitable material. However, the dimensions and materials of the catheter are not limited thereto.

[0193] Although many features are described as cylindrical, the shape of the element is not limited thereto. Rather, the features may be of any shape suitable for the regulator 40 in order to appropriately control the fluid dispersion from the storage device 20, storage device 20'. Further, unless otherwise specified, at least one structural element of the dosing device 30 and the regulator 40, regulator 40' may be any material known in the art, including but not limited to metal alloys, ceramics and / or resins. Further, although the above embodiments are described as diverting a portion of the gas from the gas source / gas supply to drive the movement of the piston or the expansion of the expandable member, it will be apparent to those skilled in the art that the aforementioned devices may include one or more gas sources to provide gas to both internal spaces and to drive the piston to cause the expansion of the expandable member or to drive the piston or cause the expansion of the expandable member.

[0194] It will be apparent to those skilled in the art that various modifications and changes can be made to the disclosed devices without departing from the scope of the present disclosure. For example, any substance or fluid may be stored within the chamber and may also be mixed with the injection fluid and discharged from the dosing device to the target location. In addition to or instead of this, unless otherwise specified, the medical devices described herein may be formed of any metal, plastic or ceramic or any combination thereof suitable for use in medical applications. Other embodiments of the present disclosure will be apparent to the parties from the consideration of this specification and the practice of the invention disclosed herein. This specification and the examples are to be considered as illustrative only, and the true spirit and scope of the present invention are to be shown by the following claims. The technical idea included in the present disclosure is described below. (Appendix 1) An administration device having a first fluid passage penetrating the administration device, and a container movably attached to the administration device, wherein the container and the administration device have a second fluid passage penetrating the container and the administration device, the container includes inner chambers at a proximal portion and a distal portion intermediate the second fluid passage, the inner chambers are fluidly isolated from the proximal portion of the second fluid passage at a first position of the container, and the inner chambers are fluidly connected to the proximal portion and the distal portion of the second fluid passage at a second position of the container, the first fluid passage bypasses the container, and passage of fluid through the first fluid passage is controllable separately from passage of fluid through the second fluid passage, a medical device. (Appendix 2) The medical device according to Appendix 1, further comprising a second container that is a second container, includes injection fluid, and is attached to an inlet of the administration device. (Appendix 3) The medical device according to Appendix 2, wherein the administration device further includes a locking mechanism for fixing the second container to the administration device. (Appendix 4) The locking mechanism is a lever rotatably connected to the administration device, and a piston connected to the lever and in contact with the second container, wherein at a first position of the lever, the second container is fluidly separated from the administration device, and at a second position of the lever, the second container is fluidly connected to the administration device, the medical device according to Appendix 3. (Appendix 5) A protrusion extends from a surface of the piston toward the inlet, a gap extends into the container from a surface facing the piston, the protrusion extends into the gap, and a fixed position of the container with respect to the piston is maintained, the medical device according to Appendix 4. (Appendix 6) The container includes (a) a chamber inlet between the inner chamber and the proximal portion of the second fluid passage, and (b) a chamber filter. The filter is configured to allow fluid to enter the internal chamber from the proximal portion of the second fluid passage. The medical device according to any one of appendices 1 to 5, wherein the filter is configured to prevent a substance disposed in the container from entering the proximal portion of the second fluid passage. (Appendix 7) The internal chamber has one or more protrusions extending into the internal chamber from the bottom surface of the internal chamber. The medical device according to any one of appendices 2 to 6, wherein the one or more protrusions change the fluid passage of the injection fluid in the internal chamber. (Appendix 8) The internal chamber has (a) a tube having an outlet port and (b) a sheath disposed around the tube. When the container is in the first position, the outlet port is covered by the sheath. The medical device according to any one of appendices 1 to 7, wherein when the container is in the second position, the outlet port is exposed from the sheath. (Appendix 9) The internal chamber further includes a mounting member fixedly attached to the sheath and the outer surface of the container, and rotation of the outer surface causes longitudinal movement of the sheath on the tube. The medical device according to appendix 8. (Appendix 10) The dosing device has a groove having a first end and a second end. The container has a cam extending from the outer surface of the container. The cam is movable within the groove. When the container is in the first position, the cam is disposed at the first end of the groove. The medical device according to appendix 9, wherein when the container is in the second position, the cam is disposed at the second end of the groove. (Appendix 11) The dosing device further includes a first drive device and a second drive device. The first drive device controls the injection fluid in the first fluid passage. The medical device according to any one of appendices 2 to 10, wherein the second drive device controls the injection fluid in the second fluid passage. (Appendix 12) The second fluid passage includes a pressure relief mechanism configured to release fluid when the pressure of the fluid in the second fluid passage exceeds a threshold value, the threshold value being greater than the desired pressure of the fluid at the outlet of the second fluid passage. The medical device according to any one of appendices 1 to 11. (Appendix 13) The medical device according to appendix 12, wherein the pressure relief mechanism has a rupture disk and is disposed in the internal chamber of the container. (Appendix 14) The medical device according to any one of appendices 1 to 13, wherein the inlet of the administration device includes a second pressure relief mechanism, and driving of the second pressure relief mechanism discharges the injection fluid from the second container. (Appendix 15) The medical device according to any one of appendices 1 to 14, further comprising a catheter attached to an outlet of the distal portion of the second fluid passage via a luer connection portion.

Claims

1. The exit, a container configured to contain a medicament; a channel in fluid communication with the outlet and the reservoir; a mounting member coupled to an outer surface of the channel and an inner surface of the container and movable relative to the outer surface of the channel and the inner surface of the container while in contact with the outer surface of the channel and the inner surface of the container, the mounting member configured to transition the channel between a closed configuration and an open configuration in response to movement relative to the channel, In the closed configuration, the attachment member is positioned relative to the channel to close an opening of the channel such that the outlet is fluidly isolated from the container, thereby inhibiting the agent from exiting the container and entering the outlet for delivery out of the medical device; A medical device, wherein in the open configuration, the attachment member is positioned relative to the channel to open the opening of the channel such that the outlet is fluidly connected to the container, thereby allowing the agent to exit the container and enter the outlet for delivery outside the medical device.

2. The medical device of claim 1 , wherein the attachment member is configured to transition the channel between the closed configuration and the open configuration in response to rotation relative to the channel.

3. 2. The medical device of claim 1, an inlet in fluid communication with the vessel; a fluid source in fluid communication with the inlet; A medical device, wherein in the open configuration, the fluid source is configured to deliver pressurized fluid to the inlet, the inlet defining an opening configured to receive the pressurized fluid from the fluid source and direct the pressurized fluid to the container to displace the medication contained within the container.

4. 4. The medical device of claim 3, wherein in the open configuration, the attachment member is configured to generate a mixture of the pressurized fluid received in the container through the opening of the inlet and the drug.

5. 4. The medical device of claim 3, wherein in the open configuration, the attachment member is configured to direct a mixture of the drug and the pressurized fluid from the container toward the outlet through an opening of the channel exposed by the position of the attachment member relative to the channel.

6. 4. The medical device of claim 3, wherein in the closed configuration, the attachment member is configured to prevent a mixture of the drug and the pressurized fluid from exiting the container toward the outlet through an opening of the channel that is covered by the position of the attachment member relative to the channel.

7. 4. The medical device of claim 3, The medical device further comprising a porous filter disposed within the inlet, the porous filter configured to prevent the agent from exiting the container through the inlet.

8. 4. The medical device of claim 3, The medical device further comprising a puncture mechanism disposed adjacent to the fluid source, the puncture mechanism configured to move toward the fluid source to pierce a seal of the fluid source, thereby releasing the pressurized fluid from the fluid source.

9. 9. The medical device of claim 8, The medical device further comprising an actuator coupled to the lancing mechanism, the actuator configured to move the lancing mechanism relative to the fluid source.

10. 10. The medical device of claim 9, wherein in response to actuating the actuator, the actuator is configured to pierce a seal of the fluid source via the puncture mechanism, thereby releasing the pressurized fluid toward the outlet to purge residual material from the outlet when the mounting member is positioned such that the container is in the closed configuration.

11. 4. The medical device of claim 3, The medical device further comprising a regulator in fluid communication with the fluid source via the inlet, the regulator configured to control a pressure of the pressurized fluid received from the inlet.

12. 12. The medical device of claim 11, wherein the fluid source includes a gas cylinder or tank disposed within a body of the medical device, and the inlet is disposed between the gas cylinder or tank and the regulator.

13. 2. The medical device of claim 1, The medical device further comprising a catheter extending outwardly from a body of the medical device to a treatment site, the catheter fluidly connected to the outlet so as to deliver the mixture of the agent and pressurized fluid from the outlet to the treatment site.

14. The exit, a container configured to contain a medicament; a channel in fluid communication with the outlet and the reservoir, the channel including one or more openings; a mounting member coupled to an outer surface of the channel and an inner surface of the container and movable between a first position and a second position relative to the outer surface of the channel and the inner surface of the container while in contact with the outer surface of the channel and the inner surface of the container, In the first position, the attachment member is configured to block the one or more openings such that the outlet is not in fluid communication with the container through the one or more openings, thereby inhibiting the agent from leaving the container and entering the outlet through the one or more openings of the channel; A medical device wherein, in the second position, the attachment member is configured to unblock the one or more openings such that the outlet is in fluid communication with the container through the one or more openings, thereby allowing the agent to exit the container and enter the outlet through the one or more openings in the channel.

15. 15. The medical device of claim 14, wherein the attachment member is configured to transition between the first position and the second position in response to rotation relative to the channel.

16. 15. The medical device of claim 14, an inlet in fluid communication with the vessel; a fluid source in fluid communication with the inlet; A medical device, wherein the fluid source is configured to deliver pressurized fluid to the inlet, the inlet being configured to direct the pressurized fluid to the container.

17. 17. The medical device of claim 16, wherein in the first position, the mounting member is positioned and configured relative to the channel to prevent the mixture from entering the one or more openings of the channel and exiting the container towards the outlet, and in the second position, the mounting member is positioned and configured relative to the channel to allow the mixture to enter the one or more openings of the channel and exit the container towards the outlet.

18. The exit, A container for containing a medicine; an attachment member coupled to an outer surface of a channel and an inner surface of the container, the attachment member configured to transition the channel between a closed configuration and an open configuration in response to the attachment member contacting and moving relative to the outer surface of the channel, In the closed configuration, the attachment member is positioned relative to the channel to cover an opening of the channel and fluidly isolate the outlet from the container via the channel, thereby inhibiting the agent contained within the container from entering the outlet for delivery out of the medical device; A medical device, wherein in the open configuration, the attachment member is positioned relative to the channel to expose the opening of the channel and fluidly connect the outlet to the container via the channel, thereby allowing the agent contained within the container to enter the outlet for delivery outside the medical device.

19. 20. The medical device of claim 18, a fluid source containing a pressurized fluid; an inlet in fluid communication with the fluid source and the vessel; the medical device further comprising a porous filter disposed within the inlet to permit the pressurized fluid to enter the container via the inlet and to prevent the medication from exiting the container via the inlet.

20. 20. The medical device of claim 19, The medical device further comprises a puncture mechanism movable relative to the fluid source, the puncture mechanism configured to pierce a seal of the fluid source in response to movement toward the fluid source, thereby releasing the pressurized fluid from the fluid source.

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