Devices for delivering powdered agents

Abstract

To provide improved devices for delivering powdered agents.SOLUTION: A device for delivering an agent may comprise: a housing defining an enclosure. The housing may be configured to store an agent. The device may further comprise an inlet, in fluid communication with the enclosure, for receiving a flow of pressurized fluid; an outlet in fluid communication with the enclosure; and a filter disposed within the enclosure. Pores of a wall of the filter may be configured such that the fluid is permitted to pass through the pores into a channel defined by an inner surface of the wall. An actuation member may be configured to transition between a first configuration, in which portions of the agent disposed proximally to the actuation member are prevented from passing distally of the actuation member, and a second configuration, in which portions of the agent disposed proximally to the actuation member are capable of passing distally of the actuation member.SELECTED DRAWING: Figure 2C

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to devices and methods for delivering medicaments. More particularly, in embodiments, the present disclosure relates to a device for the delivery of powdered agents, such as hemostatic agents. [Background technology]

[0002] In some medical procedures, it may be necessary to minimize or stop bleeding within the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the digestive tract, such as the esophagus, stomach, or intestines.

[0003] During an endoscopic procedure, a user inserts the endoscope's sheath into a patient's body lumen. The user utilizes the endoscope's handle to control the endoscope during the procedure. Tools are passed through the endoscope's working channel, for example through a port in the handle, to deliver therapy at a procedure site near the distal end of the endoscope, which is remote from the operator. Summary of the Invention [Problem to be solved by the invention]

[0004] To achieve hemostasis at a remote site, a hemostatic agent may be delivered by a device inserted into the working channel of an endoscope. Drug delivery may be achieved, for example, through a mechanical system. Such systems, however, may require multiple steps or actuations to achieve delivery, may not achieve a desired rate of drug delivery or a desired dosage of drug, may result in drug-clogging portions of the delivery device, may result in inconsistent administration of drug, or may not reach treatment sites deep within the gastrointestinal tract. The current disclosure may solve one or more of these problems or other problems in the art. [Means for solving the problem]

[0005] Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects. The device for delivering a medicament may include a housing defining an enclosure. The housing may be configured to store the medicament. The device may further include an inlet in fluid communication with the enclosure for receiving a flow of pressurized fluid, an outlet in fluid communication with the enclosure, and a filter disposed within the enclosure. A wall of the filter may include a plurality of pores. The pores may be configured such that fluid is permitted to pass through the pores and into a channel defined by an inner surface of the wall. The device may further include an actuating member disposed within the enclosure. The actuating member may be configured to transition between a first configuration in which a portion of the medicament disposed proximal to the actuating member is prevented from passing distal to the actuating member and a second configuration in which a portion of the medicament disposed proximal to the actuating member is permitted to pass distal to the actuating member.

[0006] Any of the devices disclosed herein may have any of the following features: The actuation member may include a rotatable shaft. The rotatable shaft may include an aperture extending substantially perpendicular to a longitudinal axis of the rotatable shaft. In the second configuration, the agent may be able to pass through the aperture. The aperture may include a first portion where the aperture diameter tapers radially inwardly, distal to the longitudinal axis of the aperture, and a second portion where the aperture diameter is constant. The aperture may include a third portion distal to the second portion where the aperture diameter tapers radially outwardly, distal to the longitudinal axis of the aperture. The channel may include a first portion where the channel diameter tapers radially inwardly, distal to the longitudinal axis of the channel. The first portion may terminate distally within the distal end. The channel may include a second portion adjacent the distal end where the diameter is constant. The second portion of the channel may be proximal to the first portion of the aperture. The channel may include a third portion, distal to the opening. Within the third portion of the channel, the diameter of the channel may taper radially inwardly, distally relative to the longitudinal axis of the channel. The filter may be sintered. The pores may extend along a tortuous path. The pores may be configured such that the agent is not permitted to pass through the pores. The agent may be a powder having a particle diameter between 50 microns and 600 microns. The pores may have a diameter between 2 microns and 100 microns. The fluid may be permitted to pass through the outlet in both the first and second configurations. The actuating member may be a slider configured to move in a plane substantially perpendicular to the longitudinal axis of the housing. The fluid may exit the filter in a turbulent flow pattern.

[0007] In another example, a device for delivering a medicament may include a housing defining an enclosure. The housing may be configured to store the medicament. The inlet may be in fluid communication with the enclosure to receive a flow of pressurized fluid. The filter may be disposed within the enclosure. A wall of the filter may include a plurality of holes. The holes may be configured such that a flow of fluid is permitted to pass through the holes and into a channel defined by an inner surface of the wall. The holes may be configured such that the medicament is not permitted to pass through the holes. The outlet may be in fluid communication with the channel. An actuating member may be disposed within the enclosure. The actuating member may be configured to transition between a first configuration in which the medicament is not permitted to pass through the outlet and a second configuration in which the medicament is permitted to pass through the outlet. Fluid may be permitted to pass through the outlet in both the first and second configurations.

[0008] Any of the devices disclosed herein may have any of the following features: Fluid from the fluid inlet may only be allowed to pass through the outlet after passing through the aperture; The actuation member may include a rotatable shaft having an opening extending substantially perpendicular to a longitudinal axis of the rotatable shaft, and in the second configuration, the agent is allowed to pass through the opening.

[0009] In another example, a device for delivering a medicament may include a housing defining an enclosure and configured to hold a powder. The powder may have a particle size between 50 microns and 600 microns. The inlet may be in fluid communication with the enclosure for receiving a flow of pressurized gas. A sintered filter may be disposed within the enclosure. A wall of the filter may include a plurality of serpentine extending holes. The holes may be configured such that gas is permitted to pass through the holes and into a channel defined by a surface of the wall. The holes may be configured such that powder is not permitted to pass through the holes. The holes may have a diameter between 2 microns and 100 microns. The outlet may be in fluid communication with the channel. An actuating member may be disposed within the enclosure. The actuating member may be configured to transition between a first configuration in which a combination of gas and powder is permitted to pass through the outlet and a second configuration in which only gas is permitted to pass through the outlet.

[0010] Any of the devices described herein may have any of the following features: The actuation member may include a rotatable shaft having an opening extending substantially perpendicular to a longitudinal axis of the rotatable shaft. In a second configuration, the agent may be allowed to pass through the opening.

[0011] It can be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the invention as claimed. As used herein, the terms "comprises", "comprising" or any other variations thereof are intended to encompass a non-exclusive inclusive form such that a process, method, article, or device comprising a list of elements does not include only those elements, but may include other elements not expressly listed or that are inherent to such process, method, article, or device. The term "diameter" may refer to the width of an element that is not circular. The term "distal" refers to a direction away from the operator and the term "proximal" refers to a direction toward the operator. The term "exemplary" is used in the sense of "example" rather than "ideal". The term "approximately" or similar terms (e.g., "substantially") include ±10% of the value of a condition value.

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 illustrates an exemplary delivery device. [Figure 2A] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 2B] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 2C] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 2D] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 2E] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 3A] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 3B] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 4A] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 4B] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Diagram 5] 2 illustrates one embodiment of an exemplary enclosure for the delivery device of FIG. 1. [Figure 6A] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 6B] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 6C] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 6D] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 6E] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 7A] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 7B] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 8A] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 8B] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 8C] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. [Figure 8D] FIG. 6 illustrates an exemplary filter for use with the enclosure of FIGS. 2A-5. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Embodiments of the present disclosure relate to an enclosure for storing a medication (e.g., a powdered medication) and a metering / actuation mechanism for delivering the medication to a site of a medical procedure. The enclosure may include a sintered filter through which pressurized fluid may pass. The medication may be received within a channel of the sintered filter. As the pressurized fluid passes through the sintered filter, it may enter a chamber having medication in a variety of different vectors at the same time and may fluidize the medication. Aspects of the sintered filter and / or the metering / actuation mechanism may facilitate flow of the pressurized fluid even when medication is not being delivered, which may help prevent or minimize clogging during depressurization of the device.

[0015] FIG. 1A illustrates a delivery system 10, which may be a powder delivery system. The delivery system 10 may include a body 12. The body 12 may include or be configured to receive an enclosure 14 (or other source) that stores a drug. The enclosure 14 may be coupled to the body 12 to provide the drug to the body 12, or a drug cap / enclosure may be screwed onto or coupled to the enclosure 14 to provide the drug to the enclosure 14. The drug may be, for example, a powder drug, such as a hemostatic drug. The drug may alternatively be another type of drug or material or another form of drug (e.g., liquid or gel) and may have any desired functionality. The enclosure 14 may be removably attached to other components of the delivery system 10, including components of the body 12. The body 12 may have various features that are discussed in more detail herein. U.S. Patent Application No. 16 / 589,633, filed October 1, 2019, which is incorporated herein by reference in its entirety, discloses exemplary features of delivery devices and systems. Features of the present disclosure may be combined with any of the features described in the above-referenced applications. Features described herein may be used alone or in combination and are not mutually exclusive. Similar reference numbers and / or terminology are used to denote similar structures when possible.

[0016] The actuation mechanism 30 may be used to initiate the flow of pressurized fluid and / or agent. The fluid alone or a combination of agent and fluid may be delivered from an outlet 34 of the body 12. As used herein, the terms "distal" / "first direction" may refer to a direction toward the outlet 34 and away from the enclosure 14, and the terms "proximal" / "second direction" may refer to the opposite direction. The outlet 34 may be in fluid communication with a catheter 36 or other component for delivering the agent and fluid combination to a desired location within a patient's body lumen.

[0017] 2A-2E illustrate an embodiment of an example dispensing portion 100. The dispensing portion 100 may be used in place of the enclosure 14 of the delivery device 10. FIGS. 2A-2D illustrate cross-sectional views and FIG. 2E illustrates a perspective view. The views in FIGS. 2C and 2D are rotated 90 degrees relative to the views in FIGS. 2A and 2B, respectively.

[0018] Dispensing portion 100 may include an enclosure 104 (which may have any of the properties of enclosure 14) that contains medicament 102. As shown in Figures 2A and 2B, enclosure 104 may be defined by the inner surfaces of housing 106 and lid 108. Housing 106 and / or lid 108 may include threads 110 that allow a distal end of lid 108 (the bottom end as shown in the figures) to be screwed onto a proximal end of housing 106 (the top end as shown in the figures). For example, the outer surface of housing 106 may include threads and the inner surface of lid 108 may also include threads.

[0019] The housing 106 may have a fluid inlet 112 (see FIGS. 2C and 2D). The wall of the housing 106 may form a protrusion 111, which may define the fluid inlet 112. The protrusion 111 may include a lip or other structure that may assist in mating with tubing or other structure used to deliver the fluid. The fluid inlet 112 is illustrated in a side portion of the housing 106, but it will be understood that the fluid inlet 112 may be in alternative locations. For example, the fluid inlet 112 may be in a distal surface of the housing 106 (the bottom of the housing 106 in the figures) or in the lid 108. The housing 106 may also have an outlet 114. The catheter or other type of tubing 116 may define the outlet 114, as described in more detail below. The outlet 114 may be in fluid communication with the outlet 34 of the delivery system 10.

[0020] Filter 120 may be disposed within a proximal portion of enclosure 104. Filter 120 may have a wall 121. In a cross-section of filter 120 along a longitudinal axis of filter 120, wall 121 may have a generally annular shape. An inner surface of wall 121 may define a channel 122. Medication 102 may be received at least partially within channel 122. A surface of wall 121 and a surface of housing 106 may help form a boundary for medication 102.

[0021] Filter 120 and channel 122 may be substantially conical or funnel-shaped. At the proximal end of filter 120 (top of filter 120 in the figures), channel 122 may have its largest diameter (perpendicular to the longitudinal axis of channel 122). Wall 121 may be angled such that moving distally (towards the bottom of the figures), channel 122 tapers to a smallest diameter. Further details regarding the shape of channel 122 are described below.

[0022] The proximal end of filter 120 may be sealed to housing 106. For example, the outer surface of wall 121 may be sealed to the inner surface of housing 106. Sealing may be accomplished, for example, via a structure integrally formed with the remainder of filter 120, a seal (e.g., an O-ring seal) fitted over the remainder of filter 120, and / or a substance such as an adhesive that secures filter 120 to housing 106. Because filter 120 is sealed to housing 106, medication and / or fluid may not pass between the outer surface of wall 121 and the inner surface of housing 106 at the proximal end of filter 120. The distal end of filter 120 may also be sealed to housing 106. For example, the distal end of filter 120 may be sealed to the inner surface of the distal wall (the bottom wall in the figure) of housing 106.

[0023] The wall 121 may have a constant thickness or may have a variable thickness. The wall 121 may be sintered such that a tortuous passage is formed between the outer surface of the wall 121 and the inner surface of the wall 121. The tortuous passage may be sized such that the drug 102 does not pass through a passage between the inner and outer surfaces of the wall 121. Fluid from the fluid inlet 112 may be allowed to flow through openings in the wall 121, as described in more detail below. The openings may have a size between about 40 microns and 150 microns (e.g., 100 microns). The particle size of the drug 102 may range from about 200 microns to 600 microns (e.g., 320 microns to 400 microns). The filter 120 may be formed, for example, via additive manufacturing techniques (e.g., three-dimensional printing). For example, a pattern or model created to form the filter 120 may incorporate sintered openings. Such openings may be formed by an algorithm that divides the model filter 120 into triangles or other shapes. 6A and 6B illustrate a portion of a filter 120′ made according to such an algorithm. FIG. 6A illustrates a zoomed-in portion of such a filter 120′, and FIG. 6B illustrates a wider view of such a filter 120′. Other methods, such as Triply Periodic Minimal Surfaces (“TPMS”), may alternatively be used to form gyroids, diamonds, or other shapes. The parts may be printed (e.g., via an electron beam or laser beam) using, for example, a powder bed fusion method. Alternatively, a solid model of the filter 120 may be made, and energy may be applied to form holes (passages) in the wall 121. For example, a laser may be applied to a combination of a metal powder and a foaming agent, which results in the generation of holes / passages. Alternatively, a laser may be applied with an energy calibrated to form holes when the metal powder is melted. FIGS. 6C-6E illustrate an example of such a filter 120″ made according to such a laser-based method. FIG. 6D illustrates an enlarged version of FIG. 6C illustrating details of the pores of filter 120''. FIG. 6E illustrates a cross-sectional view of filter 120''.

[0024] The tortuous path of the wall 121 may cause the fluid flowing through the filter 120 to enter the channel 122 at a variety of vectors, including angles, velocities, and / or pressures, at the same time. The fluid exiting the wall 121 may have a turbulent flow pattern (e.g., a radial pattern). As also described below, the various vectors with which the fluid enters the channel 122 may cause the drug 102 in the channel 122 to become fluidized. The turbulent flow of the fluid (which may result in fluidization of the drug 102, such as a liquid sand effect) may aid in the flow of the drug 102 through the outlet 114 and may prevent or minimize clogging of the drug 102. The fluidization may break up agglomerates of the drug 102. The drug 102 may include a semi-cohesive material, such as chitosan acetate, for example.

[0025] The catheter 116 or another component (e.g., tubing) may be received within a distal end of the channel 122. For example, an outer surface of the catheter 116 may conform against an inner surface of the wall 121. The catheter 116 may be secured to the filter 120 via adhesive, friction fit, ridges / grooves, or other suitable means. The catheter 116 may define an outlet 114, which may be in fluid communication with the outlet 34.

[0026] The rotatable shaft 130 may extend through the enclosure 104 such that the longitudinal axis of the shaft 130 is in transverse relationship to (e.g., substantially perpendicular to) the longitudinal axis of the enclosure 104 and / or the proximal portion of the catheter 116. In Figures 2C and 2D, the shaft 130 is shown extending longitudinally into and out of the page.

[0027] The opening 132 may be formed in the shaft 130. The opening 132 may extend substantially perpendicular (or at least offset) to the longitudinal axis of the shaft 130 and through the entirety of the shaft 130. The opening 132 may be substantially parallel to the longitudinal axis of the enclosure 104 in some configurations (such as the configuration illustrated in FIG. 2C). As described in more detail below, in a first configuration of the shaft 130 (FIGS. 2A, 2C), the longitudinal axes of the opening 132 and the channel 122 may be aligned, such that the fluid and / or agent 102 passes from a portion of the channel 122 that is proximal to the shaft 130, through the opening 132, and into a portion of the channel 122 that is distal to the shaft 130. In a second configuration of the shaft 130 (FIGS. 2B, 2D), in which the shaft 130 is rotated relative to the first configuration, the longitudinal axis of the opening 132 may be misaligned with respect to the longitudinal axis of the channel 122 such that the fluid and / or agent 102 does not pass through the opening 132 between a portion of the channel 122 that is proximal to the shaft 130 and to a portion of the channel 122 that is distal to the shaft 130. As the shaft 130 is rotated, the longitudinal axes of the channel 122 and the opening 132 may be aligned or misaligned. For example, the longitudinal axes of the channel 122 and the opening 132 may be aligned with each 180 degree rotation of the shaft 130.

[0028] The filter 120 may be configured to accommodate the shaft 130. For example, the cylindrical conduits 152, 154 of the filter 120 may extend radially outward from the longitudinal axis of the channel 122. The cylindrical conduits 152, 154 may have a longitudinal axis that is parallel to the longitudinal axis of the shaft 130. The shaft 130 may be received within the cylindrical conduits 152, 154. In some examples, the cylindrical conduits 152, 154 may together form a cylindrical conduit with an opening that forms the channel 122 extending through the cylindrical conduit transversely to the longitudinal axis of the cylindrical conduit. The cylindrical conduits 152, 154 and other surfaces of the filter 120 may be configured to form a sleeve around the shaft 130. The surface of shaft 130 may form a seal with the inner surface of wall 121 such that when shaft 130 is in the second configuration, agent 102 may not migrate distally beyond shaft 130 and opening 132 is not in fluid communication with channel 122. The seal may be formed, for example, by the material forming filter 120 and / or shaft 130. Shaft 130 may have the effect of dividing channel 122 into a proximal portion 142, proximal to shaft 130, and a distal portion 144, distal to shaft 130.

[0029] The shaft 130 may extend through an opening 156 in the side of the housing 106. The longitudinal axis of the opening 156 may be substantially parallel to the longitudinal axis of the shaft 130, and the longitudinal axes of the openings 156 may be collinear with each other and / or with the shaft 130. The protrusion 158 may extend around and define the opening 156. The shape of the protrusion 158 may be complementary to the shape of the shaft 130. For example, the protrusion 158 may have an annular or cylindrical shape. A seal 159 (e.g., an O-ring seal) may be disposed around the shaft 130 to create a seal between the shaft 130 and an inner surface of the protrusion 158. The seal 159 may be disposed in a circumferential groove of the shaft 130, as illustrated in the figures, or may be disposed around a flush surface of the shaft 130. Alternatively, the seal 159 may be integrally formed with the shaft 130. The seal 159 may prevent the flow of fluids and / or agents between the shaft 130 and the inner surface of the projection 158.

[0030] The shaft 130 may have a first configuration, illustrated in Figures 2A and 2C, and a second configuration, illustrated in Figures 2B and 2D. In the first configuration (Figures 2A and 2C), the agent 102 may flow through the outlet 114. In the second configuration (Figures 2B and 2D), the agent 102 does not flow through the outlet 114 (i.e., the agent 102 is prevented and / or obstructed from flowing through the outlet 114).

[0031] Prior to use of the delivery system 10, the shaft 130 may assume the second configuration of Figures 2B and 2D. In the second configuration, the longitudinal axis of the opening 132 may be misaligned or offset from the channel 122 such that the opening 132 is not in fluid communication with the channel 122. Because the opening 132 is not in fluid communication with the channel 122, the agent 102 cannot flow distally beyond the shaft 130 through the outlet 114. The agent 102 may be retained within the proximal portion 142 of the channel 122 and other portions of the enclosure 104.

[0032] Upon activation of the actuation mechanism 30 or another actuation mechanism (transforming the shaft 130 to the first configuration), fluid may be permitted to flow through the fluid inlet 112 (see FIGS. 2C-2E). Fluid from the fluid inlet 112 may pass through the sintered portion of the wall 121 of the distal portion 144 of the filter 120. The fluid may flow into the channel 122, into the catheter 116, and out of the outlet 114. Fluid from the inlet 112 may also flow through the sintered portion of the wall 121 into the proximal portion 142 of the channel 122. However, when the shaft 130 remains in the second configuration, the agent 102 may not flow into the opening 132 and into the portion of the channel 122 in the distal portion 144 of the filter 120. The arrows in FIGS. 2A and 2C illustrate the flow of fluid in the first configuration while fluid flows through the fluid inlet 112.

[0033] When shaft 130 is rotated to the first configuration (FIGS. 2A and 2C), via actuation mechanism 30 or via a separate actuator, agent 102 may be allowed to flow through channel 122 to distal portion 144. Fluid may continue to flow through wall 121 of filter 120 to proximal portion 142 and distal portion 144, as described above. Fluid flowing into channel 122 (e.g., into proximal portion 142) may fluidize agent 102.

[0034] The inner surface of the wall 121 and the surfaces defining the opening 132 may be shaped such that the channel 122 and the opening 132 have a varying diameter between the proximal end of the channel 122 and the distal end of the channel 122. As the agent 102 travels distally, it encounters a portion of the channel 122 that changes diameter, which reduces clogging of the agent 102 within the channel 122. The agent 102 may be prone to bridging, which may result in clogging without a variation in the diameter of the channel 122.

[0035] As explained above, in the first, proximal portion 162 of the channel 122, the inner surface of the wall 121 may taper inward moving in a distal direction. The angle of the first portion 162 may be greater (i.e., steeper) than the angle of repose of the drug 102. The angle of repose of the drug 102 may be the angle formed by a cone-like deposit of the drug 102 as the drug 102 flows through an orifice and collects on a surface in the cone-like deposit. The angle of repose may be the angle between the surface over which the drug 102 flows and the surface of the cone-like deposit. The angle of repose may relate to friction or resistance to movement between particles of the drug 102. The wall 121 may have an angle greater than the angle of repose of the drug 102, so that the drug 102 may flow freely through the funnel channel 122 due to gravity.

[0036] Just proximal to shaft 130, at second portion 164 of channel 122, the inner surface of wall 121 may have a constant diameter. The proximal end of opening 132 may be narrower (e.g., slightly narrower) than the portion of the channel adjacent to the proximal end of opening 132. Alternatively, the proximal end of opening 132 may have substantially the same width as or a greater width than the portion of channel 122 adjacent and proximate to opening 132.

[0037] The aperture 132 may have a first portion 166, a second portion 168, and a third portion 170. At the first portion 166, the inner surface of the shaft 130 may taper radially inward moving in a distal direction such that the size of the aperture 132 decreases. At the second portion 168, the aperture 132 may have a constant or substantially constant diameter. At the third portion 170, the inner surface of the shaft 130 may taper radially outward moving in a distal direction such that the size of the aperture 132 increases. The distal end of the aperture 132 may have a size that is the same or substantially the same as the size of the channel 122 adjacent the distal end of the aperture 132.

[0038] Distal to the distal end of opening 132, a third portion 172 of channel 122 may be defined by an inner surface of wall 121 that tapers inwardly moving distally to a fourth portion 174 of channel 122, which may have a constant diameter. The diameter of fourth portion 174 may be substantially the same as the inner diameter of catheter 116.

[0039] In passing through the channel 122, the agent 102 first passes through a narrowed portion (first portion 162), through a constant diameter portion (second portion 164), through a wider portion (proximal end of the opening 132), into a narrowed portion (first portion 166), through a constant diameter portion (second portion 168), through a widened portion (third portion 170), through a narrowed portion (third portion 172), and then through a constant diameter portion 174 to the catheter 116. These alternating widened and narrowed segments of the passageway 122 and opening 132 may result in reduced clogging of the agent 102, in some embodiments, due to, for example, reduced cross-linking of the agent 102. The tapered and / or angled portion of the channel 122 may have an angle of about 45 degrees.

[0040] Following a desired flow of the agent 102, the shaft 130 may be transitioned from the first configuration to the second configuration such that the agent 102 is no longer able to flow through the outlet 114. Fluid may continue to flow from the inlet 112 through the outlet 114 as described above. Such continued fluid flow may aid in purging the agent delivery device 10.

[0041] During fluid flow, the enclosure 104 may become pressurized. Aspects of the dispensing portion 100 may facilitate depressurization of the enclosure 104, particularly while the shaft 130 assumes the second configuration. If the medicament 102 were allowed to flow from the outlet 114 during depressurization, the medicament 102 may exit the outlet 114, which may lead to clogging of the medicament delivery device 10. The filter 120 and shaft 130 allow the enclosure 104 to depressurize without risk of the medicament 102 being drawn out of the exit port 114 when the shaft 130 assumes the second configuration. Because the shaft 130 does not allow passage of the medicament 102 through the outlet 114, fluid may flow from the outlet 114 without flow of the medicament 102.

[0042] Dispensing portion 100 may also include a release valve 180 (FIG. 2E). Release valve 180 may provide a mechanism for depressurizing chamber 104. For example, release valve 180 may be particularly useful in circumstances where pressure requires emergency relief (e.g., during a procedure). Release valve 180 may also provide a mechanism for depressurizing enclosure 104 during the normal course of a procedure. Release valve 180 may be used in addition to or as an alternative to the depressurization mechanisms described above. The relief pressure may be approximately 60 pounds per square inch gauge (PSIG) (approximately 413 kPa).

[0043] The dispensing portion 100 may provide a number of benefits in some embodiments. For example, the filter 120 may provide turbulent flow of the fluid as it mixes with the medicament 102. The turbulent flow of the fluid may provide an improvement to the flow of the medicament 102 through the outlet 34 compared to devices without the filter 120 and / or devices that do not allow for turbulent flow. The dispensing portion 100 may also allow for depressurization of the enclosure 104 without flow of the medicament 102 to a distal portion of the delivery device 10. The configuration of the channels 122 and openings 132 may facilitate unclogging (or significantly unclogging) delivery of the medicament 102, for example, due to bridging of the medicament 102.

[0044] 3A illustrates an alternative dispensing portion 200. Dispensing portion 200 may have any of the characteristics of dispensing portion 100, except as specifically noted herein. Where possible, similar reference numbers are used. Embodiments of dispensing portion 200 may be combined with embodiments of dispensing portion 100 and are not mutually exclusive.

[0045] Enclosure 104 may include filter 220 disposed therein. Filter 220 may be manufactured according to the same techniques and may include the same types of materials and tortuous paths as filter 120. The shape of filter 220 may differ from the shape of filter 120. The distal end (top end in FIG. 3A ) of filter 220 may extend further proximally within enclosure 104 compared to filter 120.

[0046] The rotatable shaft 230 may extend through the enclosure 104 such that the longitudinal axis of the shaft 230 is in transverse relationship to (e.g., substantially perpendicular to) the longitudinal axis of the enclosure 104 and / or the proximal portion of the catheter 116. The rotatable shaft 230 may have any of the properties of the rotatable shaft 130. The shape of the opening 232 that extends through the shaft 230 substantially perpendicular to the longitudinal axis of the shaft 230 may be different than the shape of the opening 132 of the shaft 130.

[0047] An inner surface of the wall 221 of the filter 220 may define a channel 222. At a first, proximal portion 262 of the channel 222, the inner surface of the wall 221 may taper inward in a distal direction (lower portion in FIG. 3A ). An angle with the surface defining the first portion 262 may be greater than the angle of repose of the agent 102 (e.g., the angle may be steeper than the angle of repose). The agent 102 may flow freely through portion 262 due to gravity.

[0048] Proximal to the shaft 230, in a second portion 264 of the channel 222, an inner surface of the wall 221 may extend in a direction substantially parallel to a longitudinal axis of the channel 222. The second portion 264 may have a tubular shape and a substantially constant diameter.

[0049] The opening 232 may have a tubular shape and a substantially constant diameter. The opening 232 may have substantially the same diameter as the second portion 264. Alternatively, the proximal end of the opening 232 may have a greater or lesser width than the second portion 264. The distal end of the opening 232 may have a smaller size than the size of the channel 222 adjacent the distal end of the opening 232.

[0050] Distal to shaft 230, channel 222 may have the same shape as channel 122, described above. As mentioned above, the features of dispensing portions 100 and 200 are not mutually exclusive. For example, filter 120 may be utilized with shaft 230 and filter 220 may be utilized with shaft 130.

[0051] When the shaft 230 is in a configuration that allows the flow of the medicament 102 through the opening 232 (as shown in FIG. 3A ), as the medicament 102 travels distally within portion 262, it may travel through a gradually smaller channel 222 until it reaches portion 264 where the diameter of the channel 222 is constant. The medicament 102 may continue to pass through a constant diameter region through the opening 232. Distal to the opening 232, the medicament 102 may encounter a larger diameter portion of the passageway 222 at the proximal end of portion 172. The diameter of the passageway 222 may taper distally at portion 172 until the powder 102 encounters the constant diameter segment of the passageway 222 at portion 174.

[0052] Similar to the passageway 122 and opening 132, the passageway 222 and opening 232 may be configured to avoid clogging of the medicament 102, for example, by bridging the medicament 102 across the passageway 222 / opening 232. Regardless of the shape of the passageway 232, the fluid and medicament 102 may flow as described above with respect to Figures 2A-2E. The configuration of Figure 3A may allow the medicament 102 to pass a consistent diameter through the second portion 264 and opening 232. The sintered, neck-like structure of the second portion 264 may help keep the medicament 102 moving and fluidized through the narrowest sections of the system.

[0053] 3B illustrates a portion of another dispensing portion 300. Dispensing portion 300 may have the properties of either dispensing portion 100 or 200, except as specifically noted herein. Where possible, like reference numerals are used. Aspects of dispensing portions 100, 200, and / or 300 may be combined in various combinations and are not mutually exclusive.

[0054] Dispensing portion 300 may include a housing 306, which may have any of the properties of housing 106, except as specified herein. Housing 306 may define an enclosure 304, which may have any of the properties of enclosure 104.

[0055] The enclosure 304 may include a filter 320 disposed therein. The filter 320 may be manufactured according to the same techniques and may include the same types of materials and the same types of tortuous paths as the filters 120, 220. The shape of the filter 320 may differ from the shape of the filters 120, 220. The filter 320 may include a wall 321. An inner surface of the wall 321 may define a channel 322, which may receive the medication 102. The filter 320 may be sealed to an inner surface of the housing 306, as described above with respect to the filter 120 and the housing 106.

[0056] The rotatable shaft 330 may extend through the enclosure 104 such that the longitudinal axis of the shaft 330 is in transverse relationship (e.g., substantially perpendicular thereto) to the longitudinal axis of the enclosure 304 and / or the proximal portion of the catheter 116. The rotatable shaft 330 may have any of the properties of the rotatable shafts 130, 230. The shape of the aperture 332 is illustrated as being the same as the shape of the aperture 132. The first portion 366 may have any of the properties of the first portion 166, the second portion 368 may have any of the properties of the second portion 168, and the third portion 370 may have any of the properties of the third portion 170. Alternatively, the aperture 332 may have a shape similar to that of the aperture 232 or may have an alternative shape. FIG. 3B illustrates the rotatable shaft 330 in a configuration in which the agent 102 is permitted to pass distally through the aperture 332 and the outlet 114.

[0057] The shaft 330 may extend through a collinear opening 356 in the housing 306. The housing 306 may not include structure corresponding to the protrusion 158, but instead may include an opening disposed through and flush with a surface of the housing 106. The shaft 330 may not include structure corresponding to the seal 159. Alternatively, the housing 306 may be configured similar to the housing 106 and may include the protrusion 158, and / or the shaft 330 may include the seal 159. Alternatively, other structure may be used in any of the dispensing portions 100, 200, and / or 300 to seal the shaft 130, 230, and / or 330 to the enclosure 104 and / or 304.

[0058] The channel 322 may include a tapered portion 362 (proximal and distal to the shaft 330) and a straight portion 374 (distal to the shaft 330). The angle of the surface defining the first portion 362 may be greater (i.e., steeper) than the angle of repose of the medicament 102. The medicament 102 may flow freely through the portion 362 due to gravity. The straight portion 374 may be, for example, tubular. The shaft 330 may extend through the tapered portion 362. The filter 320 is illustrated as a missing structure corresponding to the cylindrical conduits 152, 154. Alternatively, the filter 320 may include a structure similar to the protrusions 152.

[0059] As the agent 102 moves distally through the channel 322, the agent 102 may first pass through a tapered portion 362 until it reaches an opening 332. The proximal end of the opening 332 may be narrower than a portion of the channel 322 adjacent to the proximal end of the opening 332. Within the opening 332, the agent 102 may pass through a first portion 366 that tapers distally inwardly until it reaches a second portion 368, which may have a constant diameter. The agent 102 may then pass through a third portion 370, which may have a width that tapers distally outwardly.

[0060] The portion of the channel 322 adjacent the distal end of the opening 332 may have substantially the same width as the distal end of the opening 332. The agent 102 may continue through the tapered portion 362 until it reaches a straight portion 374. The width of the straight portion 374 may be the same as the inner diameter of the catheter 116. The agent 102 may enter the catheter 116 from the straight portion 374 and through the exit port 114.

[0061] Similar to the passages 122, 222 and openings 132, 232, the passages 322 and openings 332 may be configured to avoid clogging of the medicament 102, for example, by bridging of the medicament 102 across the passages 322 / openings 332. Regardless of the shape of the passages 322, the fluid and powder 102 may flow as described above with respect to Figures 2A-2E.

[0062] 4A and 4B illustrate an alternative dispensing portion 400. Dispensing portion 400 may have the properties of dispensing portions 100, 200, 300 described above, except as specified below. Embodiments of dispensing portion 400 may be combined with embodiments of dispensing portions 100, 200, 300 described above.

[0063] Dispensing portion 400 may include a first housing 406, which may have any of the properties of housings 106, 306, except as specified herein. A lid 408 may have any of the properties of lid 108 and may be retained on first housing 406 via screws 410.

[0064] The housing 406 may define a first enclosure 404, which may have any of the properties of the enclosures 104, 304. The medicament 102 may be stored within the first enclosure 404. The inner surface of the walls of the housing 406 may define a funnel 407. The angle of the funnel 407 may be greater (i.e., steeper) than the angle of repose of the medicament 102. The medicament 102 may flow freely through the funnel 407 due to gravity.

[0065] The housing 406 may be disposed proximate to a second housing 450. The second housing 450 may include a wall 452. The wall 452 may be partially received within a rim 453 of the first housing 406. An inner surface of the rim 453 and an outer surface of the wall 452 may each include threads that may be used to mate the rim 453 with the wall 452. The second housing 450 may define a second enclosure 454. The second housing 450 may have a fluid inlet 112.

[0066] Filter 420 may be received within a distal portion of enclosure 454. Filter 420 may have the nature of any of filters 120, 220, 320. Proximal and distal ends of filter 420 may be sealed to an inner surface of second housing 450, which defines enclosure 454, using any of the mechanisms described with respect to filter 120 above. Filter 420 may have a substantially funnel shape, which defines channel 422. Catheter 116 may be received within channel 422, which may define outlet 114.

[0067] The first housing 406 may define an opening 462 near a distal end of the housing 406. The opening 462 may extend in a plane substantially perpendicular to the longitudinal axis of the enclosure 104, 454. A slider 460 (e.g., a plate) may be received in the opening 462 and may be movable in the plane of the opening 462 (perpendicular to the longitudinal axis of the enclosure 404, 454). Actuation of the actuation mechanism 30 or another actuation mechanism may transition the slider 460 between the first configuration ( FIG. 4A ) and the second configuration ( FIG. 4B ).

[0068] In the first configuration (FIG. 4A), the slider 460 may block and / or cover the distal end of the enclosure 404 such that the first enclosure 404 is not in fluid communication with the enclosure 454. The slider 460 and / or the first enclosure 404 may include a seal that prevents passage of the agent 102 and / or fluid proximally or distally past the slider 460 when the slider 460 is in the first configuration. In the first configuration, when fluid flow is initiated (e.g., via the actuation mechanism 30), the fluid may pass through the inlet 112, through the sintered portion of the wall of the filter 420, and into the channel 422. The fluid may then enter the catheter 116 and pass through the outlet 114.

[0069] In the second configuration (FIG. 4B), the slider 460 does not obstruct or surround (or at least partially does not obstruct or surround) the distal end of the first enclosure 404. Thus, the first enclosure 404 may be in fluid communication with the second enclosure 454, and the agent 102 may flow from the first enclosure 404 to the second enclosure 454 in the second configuration. The agent 102 may enter the channel 422 where the agent 102 may be mixed with the fluid from the inlet 112. The fluid may fluidize the agent 102. The agent 102 mixed with the fluid may pass through the catheter 116 and through the outlet 114.

[0070] In operation, a user may actuate the actuation mechanism 30, which may actuate only fluid flow through the inlet 112, or may actuate fluid flow through the inlet 112 and transition the slider 460 from the first configuration to the second configuration. Alternatively, separate actuation mechanisms may be used to actuate fluid flow through the inlet 112 and transition the slider 460 from the first configuration to the second configuration. After the slider 460 transitions to the second configuration, the medicament 102 may begin to flow through the outlet 114, as described above.

[0071] Following delivery of the desired amount of medicament 102, slider 460 may be transitioned from the second configuration to the first configuration to stop the flow of medicament 102 through outlet 114. After slider 460 is transitioned to the first configuration, the flow of fluid may or may not continue. As described above with respect to dispensing portion 100, dispensing portion 400 may facilitate depressurization of chamber 454. Because the second configuration of slider 460 prevents medicament 102 from entering chamber 454, chamber 454 may be depressurized (pressurized fluid may exit outlet 114) without medicament 102 being drawn through outlet 114. Being able to depressurize chamber 454 without drawing medicament 102 through outlet 114 may prevent or minimize clogging of medicament 102.

[0072] 5 illustrates portions of an alternative dispensing portion 500. Dispensing portion 500 may have the features of dispensing portions 100, 200, 300, 400 described above. Dispensing portion 500 may include a housing 506, which may have any of the features of housing 106. Housing 506 may receive a lid (not shown), such as lid 108. Housing 506 may define an enclosure 504. Fluid inlet 112 and outlet 514 may be in fluid communication with housing 506.

[0073] The filter 520 may be received within a distal portion of the housing 506. The filter 520 may have the properties of the filter 120, including the material properties of the filter 120 and the tortuous passage formed therein. The proximal end of the filter 520 may be sealed against the inner surface of 506, for example, by the mechanisms described with respect to the filter 120 above. The filter 520 may be cylindrical and / or cup-shaped. The filter 520 may have a flat distal wall 524 (bottom surface illustrated in FIG. 5) and a cylindrical wall 526. The filter 520 may define a channel 522. The drug 102 may be received within the channel 522 and other portions of the enclosure 504. An opening may be formed in the distal wall 524, which may be in fluid communication with the outlet 514. Although structure corresponding to catheter 116 is not shown in FIG. 5, it will be understood that a catheter such as catheter 116 may be received within outlet 514 and / or an opening in distal wall 524.

[0074] During operation, the flow of fluid through the inlet 112 may be initiated. The fluid may pass through the wall of the filter 520 (e.g., cylindrical wall 526). As discussed above, if the inlet 112 is disposed on the distal surface of the enclosure 504, the fluid from the inlet 112 may be piped through a cavity (not shown) at the bottom of the filter 520. The fluid may have exit filter 520 simultaneously along various vectors as described above (e.g., with respect to filter 520). The fluid may mix with the medication 102 and may fluidize the medication 102. The mixed fluid and medication 102 may pass through the outlet 514.

[0075] As discussed above, the filters 120, 220, 320, 420, 520 may have sintered walls through which openings / pores are formed. Alternatively, instead of a sintering process, the walls of the filters may be made porous through any other suitable process, including, for example, a three-dimensional (3D) printing process. The following description provides examples of pore sizes of the filters 120, 220, 320, 420, 520 and particle dimensions / sizes of the drug 102. The pores of the filters 120, 220, 320, 420, 520 may have sizes ranging from about 2 microns to about 100 microns (e.g., 40 microns or 100 microns). The size of the pores may be substantially uniform or may vary. As explained above, various simultaneous vectors of fluid passing through the walls of the filters 120, 220, 320, 420, 520 may cause the drug 102 to become fluid (e.g., may have a liquid sand effect). Fluidization of the drug 102 may have various advantages, including aerating the drug 102, reducing friction between particles of the drug 102, suspending the particles of the drug 102 in a fluid (e.g., air or carbon dioxide) to move the particles of the drug 102, faster delivery of the particles of the drug 102, and / or delivery of the drug 102 using less fluid. Fluidization may break up agglomerates of the drug 102. The drug 102 may include a semi-cohesive material, such as, for example, chitosan acetate.

[0076] In one embodiment, as seen in FIG. 7A, filter 620 may include an intermediate wall 622 disposed between a proximal portion 624 and a distal portion 626 of filter 620. The shape of filter 620 may be similar to the shapes of filters 120, 220, 320, 420 described above. Proximal portion 624 may have a larger cross-sectional dimension than distal portion 626. Intermediate wall 622 may taper inwardly in a distal direction relative to proximal portion 624 such that intermediate wall 622 may have a smaller cross-sectional dimension at an end adjacent distal portion 626 than an opposing end adjacent proximal portion 624. Stated differently, wall 622 may define a tapered surface and / or portion of filter 620 and may have a substantially funnel or cone-shaped shape similar to filters 120, 220, 320, 420 shown and described above.

[0077] The inner surface of the wall 622 may define a channel, which may receive the agent 102. The angle of the wall 622 with the inner surface may be greater than the angle of repose of the agent 102 (e.g., the angle may be steeper than the angle of repose). Thus, the agent 102 may flow freely along the wall 622 due to gravity. The inner surface of the distal portion 626 may extend along a plane that is substantially parallel to the longitudinal axis of the filter 620. The distal portion 626 may have a tubular shape and may have substantially constant inner and outer diameters. The distal portion 626 may further include an opening at a distal end of the distal portion 626, which has a diameter substantially similar to the diameter of the inner diameter of the distal portion 626. The opening is in fluid communication with the channel of the filter 620.

[0078] The filter 620 may be sintered (made via a sintering process) such that a plurality of holes 628 are formed through and within the wall 622, the proximal portion 624, and the distal portion 626. The plurality of holes 628 may be formed around the entire circumference of and within the wall 622, the proximal portion 624, and the distal portion 626. In one embodiment, the size, shape, and / or distribution of the plurality of holes 628 may be substantially uniform relative to one another. In other embodiments, the plurality of holes 628 may have various sizes, shapes, and / or spatial distributions relative to one another along and / or within one or more of the wall 622, the proximal portion 624, and / or the distal portion 626. In some embodiments, the filter 620 may be sintered, formed from a porous metal, formed from a lattice printed material, etc. It should be appreciated that by providing a sintered and / or porous filter, the fluidization consistency may be increased and potential clogging caused by the agent 102 may be reduced.

[0079] In other embodiments, as seen in FIG. 7B, the filter 720 may include a wall 722 disposed between a proximal portion 724 and a distal portion 726 with a plurality of holes 728 formed along and within at least a portion of the wall 722 and the distal portion 726. In embodiments, the porous portion of the filter 720 defined by the plurality of holes 728 may be formed through the wall 722 along an edge adjacent the distal portion 726, such as along a side surface of the wall 722. It should be understood that the size, shape, and / or location of the porous portion and its plurality of holes 728 may determine the delivery rate of the agent 102 from the filter 720. In the embodiment of FIG. 7B, all portions of the filter 720 other than the porous portion of the holes 728 are non-porous and solid, and thus do not allow gas, fluid, or agent to pass through. As shown and described in further detail herein, the size, location, and / or shape of the porous portion may provide different fluidization performance capabilities for the filter, such as the average delivery rate of a drug from the filter.

[0080] As seen in Figures 8A-8D, the porous portion comprising a plurality of holes may be positioned along and / or within various sides and / or portions of the filter. Additionally, the porous portion may have various suitable sizes, shapes, heights, surface areas, and / or dimensions relative to one or more sides and / or other portions of the filter. It should be understood that the filter illustrated in Figures 8A-8D is substantially similar to filter 720, such that substantially similar reference numbers are used to identify similar components. The examples illustrated and described below were tested under simulated drug delivery conditions to compare the performance of various designs. Other than differences in size, shape, and location of the porous portion of the exemplary filters, environmental parameters that affect the operation and / or performance of the various exemplary filters were controlled when determining the average drug delivery rate, minimum drug delivery rate, and / or maximum drug delivery rate of each filter. For example, in determining the average delivery rate, maximum delivery rate, and minimum delivery rate described in detail below for each of the exemplary filters, one or more of the gas delivery rate (e.g., at 5 SLPM), filter geometry, powder particle size, and / or powder drug type were controlled across each of the exemplary filters.

[0081] For example, FIG. 8A illustrates a filter 720A having a porous portion defined by a plurality of holes 728A extending along and / or within a portion of the wall 722A and a distal portion 728A of the filter 720A. For example, the plurality of holes 728A may extend around half the circumference of the wall 722A and the distal portion 726A. Stated another way, the holes 728A may be formed around 180 degrees of the circumference of the wall 722A and the distal portion 726A. In an example, the plurality of holes 728A may be positioned along and / or within at least a portion of the wall 722A and the distal portion 726A, and the holes 728A may be located within a range of 0.00003081 m. 2 (0.04775in 2 (square inch), approximately 0.00003078m2 (0.04770in 2 ) to 0.00003084m 2 (0.04780in 2 ). The holes 728A may have a height (longitudinal length) defined from a distal end of the distal portion 726A ranging from about 0.30 in. to 0.35 in., such as 0.32 in. (0.8128 cm). The portions of the wall 722A including the holes 728A and the distal portion 726A may be sized and / or shaped to control an average delivery rate of the agent 102 at about 0.655 g / s with a minimum delivery rate of about 0.556 g / s, a maximum delivery rate of about 0.692 g / s, and a standard deviation of about 0.066. It should be understood that the remaining portions and / or sides of the filter 720A, excluding the porous portions, may be formed of a solid (e.g., impermeable) surface without holes. Thus, the medicament 102 and / or pressurized gas may be prevented from flowing through the remaining portions and / or sides of the filter 720A, which has a solid configuration.

[0082] 8B illustrates another filter 720B having a porous portion defined by a plurality of holes 728B that extend along and within only a portion of the intermediate wall 722B of the filter 720B (only within the conical portion of the filter 720). For example, the holes 728B may extend around one-eighth of the circumference of the wall 722B. Stated another way, the holes 728B may be formed around 45 degrees of the circumference of the wall 722B. In an example, the plurality of holes 728B may be positioned along and within at least one side of the wall 722B, and the holes 728B may be spaced apart from each other by 0.00001542 m. 2 (0.0239in 2 ), etc., approximately 0.0000151m 2 (0.0234in 2 ) to 0.00001577m 2 (0.02444in 2). The holes 728B may have a height (longitudinal length) defined from a distal (bottom) end of the porous portion ranging from about 0.135 in. to 0.145 in., such as 0.140 in. The portion of the wall 722B including the holes 728B may be sized and / or shaped to control a minimum delivery rate of 0.850 g / s, a maximum delivery rate of about 1.06 g / s, and an average delivery rate of the agent 102 at about 0.935 g / s with a standard deviation of about 0.065. It should be understood that the remaining portions and / or sides of the filter 720B, excluding the porous portion, may be formed of a solid (e.g., impermeable) surface without holes. Thus, the medicament 102 and / or pressurized gas may be prevented from flowing through the remaining portions and / or sides of the filter 720B, which has a solid configuration.

[0083] 8C illustrates another filter 720C having a porous portion defined by a plurality of holes 728C extending along and within a portion of the intermediate wall 722C and a distal portion 726C of the filter 720C. For example, the holes 728C may extend around one quarter of the circumference of the wall 722C and the distal portion 726C. Stated another way, the holes 728C may be formed around 90 degrees of the circumference of the wall 722C and the distal portion 726C. In an example, the plurality of holes 728C may be positioned along and within at least one side of the wall 722C and the distal portion 726C, and the holes 728C may be positioned at least 0.00001542 m. 2 (0.0239in 2 (square inch), approximately 0.0000151m 2 (0.0234in 2 ) to 0.00001577m 2 (0.02444in 2). The holes 728C may have a height (longitudinal length) defined from a distal end of the distal portion 726C ranging from about 0.30 in. to 0.35 in., such as 0.32 in. The portions of the wall 722C including the holes 728C and the distal portion 726C may be sized and / or shaped to control an average delivery rate of the agent 102 at about 0.374 g / s with a minimum delivery rate of 0.313 g / s, a maximum delivery rate of about 0.433 g / s, and a standard deviation of about 0.049.

[0084] In another example, the hole 728C may extend around one eighth of the circumference of the wall 722C and the distal portion 726C. Stated another way, the hole 728C may be formed around 45 degrees of the circumference of the wall 722C and the distal portion 726C. 2 (0.0239in 2 (square inch), approximately 0.0000151m 2 (0.0234in 2 ) to 0.00001577m 2 (0.02444in 2 ). The holes 728C may have a height (longitudinal length) defined from a distal end of the distal portion 726C ranging from about 0.386 in. to 0.396 in., such as 0.391 in. (0.9931 cm). The portions of the wall 722C including the holes 728C and the distal portion 726C may be sized and / or shaped to control an average delivery rate of the agent 102 at about 0.733 g / s with a minimum delivery rate of 0.708 g / s, a maximum delivery rate of about 0.764 g / s, and a standard deviation of about 0.023.

[0085] As a further example, hole 728C has a diameter of 0.000007678 m 2 (0.0119in 2 (square inch), approximately 0.000008m 2 (0.0124in 2 ) to 0.00000742m 2(0.0115in 2 ). The holes 728C may have a height (longitudinal length) defined from a distal end of the distal portion 726C ranging from about 0.315 in. to 0.325 in., such as 0.320 in. The portion of the wall 722C having the plurality of holes 728C and the distal portion 726C may be sized and / or shaped to control an average delivery rate of the agent 102 at about 0.452 g / s with a minimum delivery rate of 0.385 g / s, a maximum delivery rate of about 0.550 g / s, and a standard deviation of about 0.059.

[0086] It should be understood that the remaining portions and / or sides of the filter 720C, excluding the porous portions, may be formed from a solid (e.g., impermeable) surface without holes. Thus, the medicament 102 and / or pressurized gas may be prevented from flowing through the remaining portions and / or sides of the filter 720C having a solid configuration.

[0087] 8D illustrates another filter 720D having a porous portion defined by a plurality of holes 728D that extend along and within only a portion of the intermediate wall 722D of the filter 720D (only within the conical portion). For example, the holes 728D may extend around one quarter of the circumference of the wall 722D. Stated another way, the holes 728D may be formed around 90 degrees of the circumference of the wall 722D. In an example, the plurality of holes 728D may be positioned along and within at least one side of the wall 722D, and the holes 728D may be spaced apart from each other by 0.00001542 m. 2 (0.0239in 2 ), etc., approximately 0.0000151m 2 (0.0234in 2 ) to 0.00001577m 2 (0.02444in 2). The holes 728D may have a height (longitudinal length) defined from a distal end of the distal portion 726D ranging from about 0.080 in. to 0.090 in., such as 0.085 in. The portion of the wall 722D including the holes 728D may be sized and / or shaped to control a minimum delivery rate of 0.726 g / s, a maximum delivery rate of about 1.05 g / s, and an average delivery rate of the agent 102 at about 0.895 g / s with a standard deviation of about 0.131. It should be understood that the remaining portions and / or sides of the filter 720D, excluding the porous portion, may be formed of a solid (e.g., impermeable) surface without holes. Thus, the medicament 102 and / or pressurized gas may be prevented from flowing through the remaining portions and / or sides of the filter 720D, which has a solid configuration.

[0088] In some embodiments, a filter may include multiple separate porous portions, including any combination of the porous portions shown and described in Figures 7B-8D. For example, the annular array of porous portions may be evenly or unevenly spaced around the circumference of the filter wall.

[0089] As seen in FIGS. 8A-8D, the size (e.g., height, surface area, circumference, etc.), shape, and location of the porous portion of the filter may determine the delivery rate of the agent 102. It should be understood that the delivery rate of the agent through the filter may be proportional to or correlated with the size, shape, and / or location of the porous portion. Thus, the filter may be configured to deliver the agent 102 at a higher delivery rate, for example, when the porous portion has a larger size and / or shape. Furthermore, the delivery rate of the filter may be increased when the porous portion is positioned at least along and / or within the mid-wall (conical portion) as compared to the distal portion. All else being equal, having a greater amount of porous portion within the mid-wall increases the delivery rate of the agent.

[0090] The drug 102 may include particles having a variety of shapes, including flaky or substantially spherical (bead) shapes. Both flaky and bead (substantially spherical) shaped particles may be fluidized with a range of particle densities, as described below. The data described below may be generated from a fluid flow of 10 standard liters per minute (SLPM).

[0091] In one example, the semi-cohesive drug 102 may have a particle density of about 1.5 grams per cubic centimeter. If the semi-cohesive particles are scaly or substantially spherical and range in size from about 50 microns to about 425 microns, the delivery rate may be about 1.80 grams per second with an exit orifice size of about 0.080 inches. If the semi-cohesive particles are scaly or substantially spherical and range in size from about 355 microns to about 425 microns, the delivery rate may be about 0.3 grams per second to about 0.5 grams per second with an exit orifice size of about 0.050 inches. Alternatively, scaly particles having a size of about 500 microns to 600 microns may be used with an exit orifice size of about 0.080 inches.

[0092] In another example, a drug 102 having glass bead type particles may have a particle density of about 2.7 grams per cubic centimeter and a substantially spherical shape. If the particles have a size between about 500 microns and about 600 microns, and the exit orifice has a size of about 0.080 inches, the delivery rate may be about 0.60 grams per second. If the particles have a size between about 400 microns and about 450 microns, and the exit orifice has a size of about 0.050 inches, the delivery rate may be about 0.38 grams per second. If the particles have a size between about 400 microns and about 450 microns, and the exit orifice has a size of about 0.080 inches, the delivery rate may be about 0.4 grams per second. Combinations of the above particle sizes and delivery rates may be used. For example, an orifice size of about 0.080 inches may be used with a particle size of between about 500 and about 600 microns or between about 400 and about 450 microns to achieve a flow rate of about 0.38 grams per second, about 0.4 grams per second, or about 0.60 grams per second. In other examples, an orifice size of about 0.050 inches may be used with a particle size of between about 500 and about 600 microns or between about 400 and about 450 microns to achieve a flow rate of about 0.38 grams per second, about 0.4 grams per second, or about 0.60 grams per second.

[0093] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art with ordinary skill in the art and access to the teachings provided herein will recognize that additional modifications, applications, and equivalent substitutions all fall within the scope of the examples described herein. Thus, the present invention should not be considered limited by the foregoing description.

Claims

1. 1. A device for delivering a medicament, comprising: a housing defining an enclosure, the housing configured to store a medicament; an inlet in fluid communication with the enclosure for receiving a flow of pressurized fluid; an outlet in fluid communication with the enclosure; a filter disposed within the enclosure, the filter wall including a plurality of pores configured to allow the fluid to pass through the pores and into a channel defined by an inner surface of the wall; an actuation member disposed within the enclosure, the actuation member configured to transition between a first configuration in which a portion of the medicament disposed proximally of the actuation member is prevented from passing distally of the actuation member and a second configuration in which a portion of the medicament disposed proximally of the actuation member is permitted to pass distally of the actuation member; 1. A device comprising:

2. The device of claim 1 , wherein the actuation member comprises a rotatable shaft.

3. 3. The device of claim 2, wherein the rotatable shaft includes an opening extending substantially perpendicular to a longitudinal axis of the rotatable shaft, and wherein in the second configuration, the agent can pass through the opening.

4. 4. The device of claim 3, wherein the opening includes a first portion where the diameter of the opening tapers radially inward distally relative to the longitudinal axis of the opening, and a second portion where the diameter of the opening is constant.

5. The device of claim 4 , wherein the opening includes a third portion distal to the second portion, where the diameter of the opening tapers radially outward distally relative to the longitudinal axis of the opening.

6. The device of claim 5 , wherein the channel includes a first portion where the diameter of the channel tapers radially inward distally relative to the longitudinal axis of the channel.

7. 7. The device of claim 6, wherein the first portion terminates distally within a distal end, the channel includes a second portion adjacent the distal end where the diameter of the channel is constant, the second portion of the channel being proximal to the first portion of the opening.

8. 8. The device of claim 7, wherein the channel includes a third portion distal to the opening, wherein the diameter of the channel tapers radially inward in a distal direction relative to the longitudinal axis of the channel in the third portion of the channel.

9. 9. The device of claim 1, wherein the filter is sintered, comprises a porous metal, or comprises a grid-printed material.

10. 10. The device of claim 1, wherein the holes extend along a tortuous path.

11. 11. The device of claim 1, wherein the holes are configured such that the agent is not allowed to pass through the holes.

12. 12. The device of claim 11, wherein the agent is a powder having a particle diameter between 50 microns and 600 microns, and the pores have a diameter between 2 microns and 100 microns.

13. 13. The device of claim 1, wherein the fluid is allowed to pass through the outlet in both the first and second configurations.

14. 14. A device according to any one of claims 1 or 9 to 13, wherein the actuating member is a slider configured to move in a plane substantially perpendicular to the longitudinal axis of the housing.

15. 15. The device of claim 1, wherein the fluid exits the filter in a turbulent flow pattern.

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