Device for delivering a drug

Abstract

A device for delivering a medicament, the device including a housing configured to store the medicament and a cone-shaped assembly at least partially received within the housing. The cone-shaped assembly includes an inner wall configured to be adjacent to the medicament, an outlet channel extending from the inner wall, an inlet channel, and an intermediate channel between the outlet channel and the inlet channel. The inlet channel is in fluid communication with the outlet channel through the intermediate channel. The device includes a filter disposed within the inlet channel and positioned adjacent to the intermediate channel. The filter includes a plurality of pores configured to allow fluid received by the inlet channel to pass through the intermediate channel for mixing with the medicament adjacent the inner wall.

Description

[Technical field]

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

[0002] Certain medical procedures may require minimizing or stopping bleeding within the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the digestive tract, e.g., the esophagus, stomach, or intestines.

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

[0004] To achieve hemostasis at a remote site, a hemostatic agent may be delivered by a device inserted into the working channel of an endoscope. Drug delivery may be achieved, for example, via a mechanical system. However, such systems may require multiple steps or actuations to achieve delivery, may not achieve a desired drug delivery rate or desired drug dosage, the drug may clog portions of the delivery device, resulting in inconsistent drug dosing, or the drug may not reach a treatment site deep within the gastrointestinal tract. The present disclosure may solve one or more of these or other problems in the art. Summary of the Invention

[0005] Each embodiment disclosed herein can include one or more of the features described in connection with any of the other embodiments disclosed. According to one example, a device for delivering a drug may include a housing configured to store the drug; a conical assembly at least partially received within the housing, the conical assembly including an inner wall configured to be adjacent to the drug, an outlet channel extending from the inner wall, an inlet channel, and an intermediate channel between the outlet channel and the inlet channel, the intermediate channel such that the inlet channel is in fluid communication with the outlet channel via the intermediate channel; and a filter disposed within the inlet channel and positioned adjacent to the intermediate channel, the filter including a plurality of pores configured to allow fluid received by the inlet channel to pass through the intermediate channel to mix with the drug adjacent the inner wall.

[0006] Any of the devices described herein may include any of the following features: an outlet channel coupled to an outlet tube, the outlet tube adapted to be in fluid communication with the drug via the outlet channel, and an inlet channel coupled to an inlet tube, the inlet tube adapted to be in fluid communication with the drug via the inlet channel. The inlet tube is configured to supply fluid to the middle channel and through the filter for mixing with the drug. The outlet tube is configured to receive the drug from the inner wall via the outlet channel as the drug is displaced by the fluid supplied from the inlet tube. The outlet tube includes a first end disposed within the outlet channel and positioned below relative to the middle channel. The outlet tube includes a first end disposed within the outlet channel and positioned relative to the middle channel to overlap with the middle channel. The filter includes an insert received within the inlet channel. The filter includes a sintered, porous metal, or lattice printed material. The plurality of pores extend along a serpentine path between opposing ends of the filter. The conical assembly includes an opening at a first end of the conical assembly, and a diameter of a space defined by an outer surface of the inner wall decreases in a direction toward the opening at the first end. The intermediate channel is positioned below the opening and extends at least partially into the outlet channel and the inlet channel. The filter is coupled to the conical assembly in the inlet channel such that the filter is removable from the inlet channel. The filter is integrally formed with the conical assembly. The housing includes a first body and a second body configured to engage the conical assembly along an outer rim of the conical assembly. The medicament is a powder having a particle size of 320 microns to 500 microns, and the plurality of pores have a diameter of 40 microns to 100 microns.

[0007] According to another example, a device for delivering a drug may include a housing configured to store the drug; a conical assembly coupled to the housing and configured to receive the drug, the conical assembly including a wall configured to be adjacent to the drug and an intermediate channel positioned relatively lower than the wall at an end of the wall opposite the end of the wall that receives the drug, for controlling fluid flow toward the drug; and a filter coupled to the conical assembly next to the intermediate channel, the filter including a plurality of pores configured to allow fluid flow through the filter and through the intermediate channel into a cavity defined by an inner surface of the wall to agitate the drug in the conical assembly.

[0008] Any of the devices described herein may include any of the following features: The filter is positioned to allow fluid flow through the intermediate channel only after passing through the plurality of pores, the plurality of pores being configured to prevent the drug from passing through the filter. The housing includes a first body and a second body configured to engage an outer rim of the cone assembly to securely couple the cone assembly to the housing. The filter is sintered, includes a porous metal, or includes a lattice printed material.

[0009] According to another example, a device for delivering a medication may include a housing configured to hold the medication; a cone coupled to the housing for funneling the medication toward an opening, the cone including an outlet in fluid communication with the opening, an inlet in fluid communication with the outlet, and an intermediate channel between the outlet and the inlet; and a sintered filter disposed within the inlet and positioned adjacent to the intermediate channel, the sintered filter comprising a plurality of pores configured to allow gas to pass through the filter and enter the cone via the intermediate channel to move the medication within the housing, the intermediate channel being sized to control the flow of gas into the cone to move the medication.

[0010] It can be understood that both the foregoing general description and the following Detailed Description are exemplary and explanatory only and are not limiting of the invention as claimed. As used herein, the terms "comprises", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that includes a list of elements does not comprise only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "diameter" may refer to the width when an element is not circular. The term "top" refers to a direction or side of a device relative to the orientation of the device in use, and the term "bottom" refers to a direction or side of a device relative to the orientation of the device in use that is opposite the "top". The term "exemplary" is used in the sense of "example" and not "ideal". The term "approximately" or similar terms (eg, "substantially") include values ​​of ±10% of the stated value.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief description of the drawings]

[0012] [Figure 1] 1 illustrates an exemplary delivery device. [Diagram 2] 2 shows a side view of an exemplary dispensing portion having a cone assembly for the delivery device of FIG. 1. [Diagram 3] 3 shows a cross-sectional view of the dispensing portion of FIG. 2 taken along line 3-3 of FIG. 2. [Figure 4] 3 shows a cross-sectional side view of the dispensing portion of FIG. 2. [Diagram 5] FIG. 3 shows a partial side view of the dispensing portion of FIG. 2. [Figure 6]FIG. 3 shows a side view of the cone assembly of FIG. 2. [Figure 7] 7 shows a cross-sectional view of the cone assembly of FIG. 2 taken along line 7-7 of FIG. 6. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] An embodiment of the present disclosure relates to a dispensing portion having a cone-shaped assembly for storing a medicament (e.g., a powdered medicament) and a mechanism for delivering the medicament to a site of a medical procedure. The cone-shaped assembly may house a porous filter through which pressurized fluid may pass before impinging on the medicament. The medicament may be received within a housing of the dispensing portion and in fluid communication with the pressurized fluid through the porous filter. Thus, once the pressurized fluid has passed through the porous filter, it may enter the housing to agitate the medicament before being delivered to the site of the medical procedure. Aspects of the dispensing portion and the cone-shaped assembly, such as the housing and / or the porous filter, may facilitate mobilization of the medicament by the flow of pressurized fluid before the medicament is delivered, which may help prevent or minimize clogging during delivery.

[0014] FIG. 1 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 a housing 14 (or other source) that stores a drug. The housing 14 may be coupled to the body 12 to provide the drug to the body 12, or a drug cap / housing may be screwed or otherwise coupled to the housing 14 to provide the drug to the housing 14. The drug may be, for example, a powdered drug, such as a hemostatic drug. Alternatively, the drug may be another type of drug or material, or another form of drug (e.g., a liquid or gel drug), and may have any desired functionality. The housing 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 will be described in more detail herein. U.S. Patent Application No. 16 / 589,633, filed October 1, 2019, discloses features of exemplary delivery devices and systems, the disclosure of which is incorporated herein by reference in its entirety. Features of the present disclosure may be combined with any of the features described in the above-referenced applications. Features described herein may be used alone or in combination and are not mutually exclusive. Wherever possible, like reference numbers and / or terms are used to denote like structures.

[0015] An actuation mechanism 30 may be used to actuate the flow of pressurized fluid (e.g., gas). The fluid alone or a combination of agent and fluid may be delivered from an outlet 34 in the body 12. The outlet 34 may be in fluid communication with a catheter 36 or other component to deliver the agent and fluid combination to a desired location within a patient's body lumen.

[0016] FIG. 2 illustrates an embodiment of an exemplary dispensing portion 100. The dispensing portion 100 may be used in place of the housing 14 of the delivery system 10. The dispensing portion 100 may include a housing 102 (which may have any of the properties of the housing 14) for storing a medicament. In this embodiment, the housing 102 may include a first body 104 and a second body 106 coupled to one another along corresponding ends. For example, the first body 104 may include a lower (second) end 103 configured to interface with an upper (first) end 107 of the second body 106, thereby defining a cavity 101 of the housing 102. Each of the first body 104 and the second body 106 may have an inner surface that defines a cavity 101 for storing a medicament within the housing 102.

[0017] The dispensing portion 100 may include an insert at least partially received within the housing 102, such as a cone-shaped assembly 110 coupled between the first body 104 and the second body 106. The cone-shaped assembly 110 may be positioned relatively lower than the first body 104 and / or the second body 106 such that the cone-shaped assembly 110 may be configured to receive (e.g., by gravity) a medicament stored within the housing 102 when coupled to the bodies 104, 106. In some embodiments, the dispensing portion 100 may include a valve system configured to meter a medicament into the cone-shaped assembly 110.

[0018] The cone-shaped assembly 110 may further be in fluid communication with a pressurized fluid source (not shown) coupled to the cone-shaped assembly via an inlet tube, such as a fluid inlet 120. The fluid inlet 120 may include an inlet port 122, which may be fluidly coupled to a channel and / or tube in fluid communication with the pressurized fluid source when disposed within the body 12 of the delivery system 10. As described herein, the fluid inlet 120 may be configured to transfer fluid received from the pressurized fluid source through the cone-shaped assembly 110 and into the housing 102, thereby moving a drug stored within the cavity 101 within the first body 104 and the second body 106.

[0019] Although the fluid inlet 120 is shown on the side of the cone assembly 110, it will be understood that the fluid inlet 120 may be fluidly coupled to the dispensing portion 100 at additional and / or alternative locations. For example, the fluid inlet 120 may be fluidly coupled to the housing 102, such as along the first body 104 or the second body 106, instead of and / or in addition to the cone assembly 110.

[0020] 2, the dispensing portion 100 may also have an outlet at the cone assembly 110. An outlet tube 130 (e.g., a hypotube) may define the outlet of the dispensing portion 100 and may include an upper (first) end 132 coupled to the cone assembly 110 and a lower (second) end 134 in fluid communication with the outlet 34 (see FIG. 1) of the delivery system 10. In some embodiments, the upper (first) end 132 may be removably coupled to the cone assembly 110 via a luer connection, compression fit, or other suitable means. In other embodiments, the upper (first) end 132 may be fixedly attached to the cone assembly 110. As described herein, the dispensing portion 100 may be configured and operable to deliver the drug stored within the housing 102 and / or pressurized fluid received from a pressurized fluid source to the catheter 36 via the outlet tube 130 upon fluidizing the drug within the cavity 101.

[0021] 3, a lower portion of the first body 104 is shown with a cone-shaped assembly 110 coupled to the housing 102. The first body 104 may be coupled to the second body 106 via one or more fastening mechanisms 105 (e.g., screws, bolts, etc.) to allow the lower (second) end 103 of the first body 104 to be securely attached to the upper (first) end 107 of the second body 106. In some embodiments, the housing 102 may be selectively assembled and disassembled, respectively attaching and separating the first body 104 and the second body 106 by actuating the one or more fastening mechanisms 105. In other embodiments, the first body 104 and the second body 106 may be secured to one another without the ability to remove the housing 102.

[0022] The cone-shaped assembly 110 may include an inner wall 112 that extends downwardly away from the first body 104 toward the second body 106 and terminates in an exit opening 114 located at the center of the inner wall 112. As best seen in FIG. 4, the cone-shaped assembly 110 may have a longitudinal length parallel to a central axis A of the cone-shaped assembly 110. Further, the cone-shaped assembly 110 may extend about the central axis A, and the inner wall 112 may be angled / tapered radially inward toward the central axis A. The exit opening 114, which terminates at the center of the inner wall 112, may be located in alignment with the central axis A. Thus, the inner wall 112 may form a cone or funnel shape about the central axis A. The inner surface of the inner wall 112 may be shaped such that the interior of the conical assembly 110 may have a varying diameter that decreases from the upper (first) end 111 of the conical assembly 110 (e.g., adjacent the upper (first) end 107) to the lower (second) end 113 of the conical assembly 110 (e.g., adjacent the exit opening 114).

[0023] Specifically, at the first (upper) end 111 (top of the inner wall 112), the interior within the inner wall 112 may have its largest diameter. The inner wall 112 may be angled relative to the central axis A such that moving downward toward the lower (second) end 113, the interior within the inner wall 112 may taper to a smaller diameter. In this example, the cone-shaped assembly 110 may have a height defined between the upper and lower ends of the inner wall 112 in a range of about 0.70 inches (1.7780 centimeters) to about 0.80 inches (2.0320 centimeters). Additionally, the interior of the cone-shaped assembly 110 may have a first diameter defined at the upper end of the inner wall 112 in a range of about 0.80 inches (2.0320 centimeters) to about 0.90 inches (2.2860 centimeters). As described below, the interior of the cone assembly 110 may have a second diameter at the lower end of the inner wall 112 that corresponds to the diameter of the exit opening 114 .

[0024] As described herein, as the medicament travels down through the cone-shaped assembly 110, it may strike a portion of the inner wall 112 that changes diameter, which may reduce clogging of the medicament within the dispensing portion 100. The medicament may be prone to bridging, which may result in clogging, absent a change in the diameter of the cone-shaped assembly 110 and, specifically, the diameter of the interior space within the inner wall 112. In some embodiments, the outlet opening 114 may have a cone-like shape and a varying diameter to further reduce clogging of the medicament at the outlet opening 114 before exiting the dispensing portion 100 via the outlet tube 130. In this example, the outlet opening 114 may have a diameter in the range of approximately 0.05 inches (0.1270 centimeters) to 0.07 inches (0.1778 centimeters).

[0025] 4, the cone assembly 110 may include an outer annular rim 116 extending around the upper (first) end 111 of the inner wall 112. The outer annular rim 116 may be received between the lower (second) end 103 of the first body 104 and the upper (first) end 107 of the second body 106. Thus, the first body 104 and the second body 106 may secure the cone assembly 110 to the housing 102 by engaging the outer rim 116. The outer annular rim 116 may have a diameter ranging from about 1.50 inches (3.8100 centimeters) to about 1.60 inches (4.0640 centimeters).

[0026] The conical assembly 110 may further include an outlet channel 117, an intermediate channel 118, and an inlet channel 119 positioned below the outlet opening 114. The outlet channel 117 is aligned with and in fluid communication with the outlet opening 114 and may be configured to receive a top (first) end 132 of an outlet tube 130. For example, an outer surface of the outlet tube 130 may fit against an inner surface of the outlet channel 117, and the top (first) end 132 may be secured to the outlet channel 117 via a variety of suitable means, such as adhesives, a friction fit, ridges / grooves, etc.

[0027] The outlet tube 130 may have a first opening at an upper (first) end 132 and a second opening at a lower (second) end 134. In some embodiments, the first and second openings of the outlet tube 130 may have a diameter ranging from about 0.06 inches (0.1524 centimeters) to about 0.10 inches (0.2540 centimeters). The lower (second) end 134 may be in fluid communication with the outlet 34, such that the outlet channel 117 may be configured to deliver the agent stored within the housing 102 and / or pressurized fluid received from a pressurized fluid source to the catheter 36 via the outlet tube 130 upon fluidization of the agent within the cavity 101. The outlet channel 117 may thus define an outlet for the cone assembly 110.

[0028] 4, the inlet channel 119 may be in fluid communication with the outlet channel 117 via the intermediate channel 118 and configured to receive at least a portion of the fluid inlet 120. In this example, the outlet channel 117 may be disposed in a vertical orientation (e.g., parallel to the central axis A) within the conical assembly 110 and may have a longitudinal length defined between opposed ends that extends below the outlet opening 114. The inlet channel 119 may have a longitudinal length defined between opposed ends that is disposed in a horizontal orientation (e.g., parallel to the central axis B of the fluid inlet 120) that is perpendicular (or otherwise angled) to the vertical orientation of the outlet channel 117 (and central axis A).

[0029] In this example, the diameter of the inlet channel 119 may be sized to be relatively larger than the diameter of the outlet channel 117. Further, the inlet channel 119 may be sized, shaped, and configured to form a cavity and / or gap between a portion of the fluid inlet 120 (received within the inlet channel 119) and the intermediate channel 118. The fluid inlet 120 may include an inlet port 122, an outlet port 124, and a channel 126 positioned between the inlet port 122 and the outlet port 124. The outlet port 124 may be sized, shaped, and configured to extend into the inlet channel 119.

[0030] 4, an exterior surface of the outlet port 124 may include a fastening mechanism, such as a threaded portion, configured to mate with a corresponding fastening mechanism (e.g., a complementary threaded portion) of the inlet channel 119 to secure the fluid inlet 120 to the conical assembly 110. The inlet port 122 may be fluidly coupled to tubing or other suitable components within the delivery system 10 that is in fluid communication with a source of pressurized fluid for delivering fluid to the inlet channel 119. As described in more detail below, the conical assembly 110 may include / contain a filter 140 (e.g., a sintered disk insert, see FIG. 5), and the inlet channel 119 may be configured to receive the filter 140 within a cavity and / or void formed between the intermediate channel 118 and the fluid inlet 120.

[0031] 5, a filter 140 may be disposed within the inlet channel 119. The filter 140 may be sized and shaped according to a cross-sectional profile (e.g., diameter) of the inlet channel 119 such that an outer surface of the filter 140 may contact an inner surface of the inlet channel 119. Thus, pressurized fluid received into the inlet channel 119 via the fluid inlet 120 may need to pass through the filter 140 before entering the intermediate channel 118 and the outlet channel 117. The filter 140 may have a generally cylindrical shape sized to abut the inner surface of the inlet channel 119 such that the surfaces of the filter 140 and the inlet channel 119 may function to form a boundary that only allows the passage of the pressurized fluid through the filter 140. As described further herein, the filter 140 may be configured to block the passage of a drug from the housing 102 to the fluid inlet 120. In some embodiments, the filter 140 may be sealed (e.g., with an O-ring seal, adhesive, or other substance) against the inlet channel 119 to prevent the agent from passing between the cavity 101 and the fluid inlet 120. In this example, the filter 140 may have a diameter in the range of about 0.15 inches (0.3810 centimeters) to about 0.20 inches (0.5080 centimeters).

[0032] The filter 140 may have a constant thickness (i.e., cross-sectional profile measured along the longitudinal length of the filter 140). The filter 140 may be sintered such that openings and tortuous paths / passages are formed between opposing ends of the filter 140. The openings and tortuous paths may be sized such that the drug does not pass through a passage between a first end of the filter 140 (e.g., adjacent the middle channel 118) and a second end of the filter 140 (e.g., adjacent the fluid inlet 120). In this embodiment, the filter 140 may include a sintered metal disk received within the inlet channel 119. In other embodiments, the filter 140 may be an injection molded porous structure integral with the inlet channel 119. In some latter embodiments, the filter 140 and the inlet channel 119 may form a unitary body.

[0033] Fluid from the fluid inlet 120 may be able to flow through the openings in the filter 140. In some examples, the openings may have a size of about 2 microns to 200 microns, such as 40 microns to 100 microns. The drug stored within the cavity 101 of the housing 102 may include, for example, a semi-cohesive material such as chitosan acetate. The drug may generally include particles having a round shape with a particle size ranging from about 320 microns to 500 microns, such that the drug is too large to pass through the openings in the filter 140. The density of the drug particles may be about 1.5 g / cm. 3 It could be.

[0034] In some embodiments, the filter 140 may be formed, for example, by additive manufacturing techniques (e.g., three-dimensional printing). For example, a pattern or model created to form the filter 140 may incorporate sintered openings and / or pores. Such openings may be formed in a variety of suitable shapes and may be substantially uniform or different. In other words, the size, shape, and / or distribution of the multiple openings / pores in the filter 140 may be substantially uniform from one another. In other embodiments, the multiple openings / pores may have different sizes, shapes, and / or spatial distributions from one another along and within the filter 140. In some embodiments, the filter 140 may be sintered, formed from a porous metal, formed from a lattice printed material, or the like. It should be appreciated that the provision of a sintered and / or porous filter may increase the consistency of fluidization and reduce the likelihood of clogging caused by the drug, as further described herein.

[0035] Filter 140 may be printed, for example, using a powder bed fusion method (e.g., with an electron beam or laser beam). Alternatively, a solid model of filter 140 may be created and energy applied to form pores (passages) in filter 140. For example, a laser may be applied to a combination of metal powder and a foaming agent, which results in the formation of pores / passages through filter 140. Alternatively, a laser may be applied with energy tuned to form pores as the metal powder melts.

[0036] The tortuous path of the filter 140 may cause the pressurized fluid flowing through the filter 140 (e.g., from the fluid inlet 120) to simultaneously enter the intermediate channel 118 at a variety of vectors, including random velocity fields, i.e., angles, velocities, and / or pressures. The fluid exiting the filter 140 may have a turbulent flow pattern (e.g., a radial pattern). The varying vectors at which the pressurized fluid may enter the intermediate channel 118 and ultimately enter the portion of the cavity 101 storing the drug via the exit opening 114 may cause the drug within the housing 102 to be fluidized, e.g., to have a fluid-like consistency and / or flow. It should be understood that the size, shape, and / or position of the sintered / porous filter 140 may at least partially determine the delivery rate of the drug from the delivery system 10, and that the size, position, and / or shape of the filter 140 may result in varying fluidization performance capabilities, such as the average delivery rate of the drug. As shown and described in more detail herein, the intermediate channel 118 may be further configured to at least partially determine the delivery rate of the agent from the delivery system 10 .

[0037] 4-7, intermediate channel 118 may include a notch formed in the body of conical assembly 110 between outlet channel 117 and inlet channel 119. Intermediate channel 118 may have a width measured along central axis B and a height measured along central axis A that defines a cross-sectional passage for receiving pressurized fluid from filter 140. Intermediate channel 118 may be configured to allow pressurized fluid flowing from filter 140 to enter a cavity defined by inner wall 112 at an optimal velocity and / or pressure, thereby creating a turbulent flow of fluid that may mobilize the drug within housing 102.

[0038] The turbulent flow of the fluid (which may result in fluidization, such as a liquid sand effect, of the drug) may further aid in the flow of the drug through the outlet opening 114 and the outlet channel 117 while preventing or minimizing clogging of the drug as it is received into the outlet tube 130. When fluidized, the drug retains fluid-like properties as the movement of multiple particles of the drug may resemble the movement of a liquid. Thus, the turbulent flow of the fluid may mimic the liquid sand effect, where the drug moves freely without resistance. The fluidization may further aid in breaking down agglomerates of the drug before exiting the cone-shaped assembly 110. The middle channel 118 may be configured to transfer the pressurized fluid into the cavity 101, vent the drug, and deliver the drug-fluid mixture from the cone-shaped assembly 110 at an acceptable delivery rate. Thus, the middle channel 118 may prevent clogging and deliver large amounts of fluidized drug at an acceptable rate. In this example, the intermediate channel 118 can be configured to produce a fluidized drug delivery rate in the range of about 0.03 g / sec to about 0.13 g / sec, such as 0.1 g / sec (having a fluid flow rate of 5 SLPM).

[0039] 5 and 7, the mid-channel 118 may include a cutout formed in the cone-shaped assembly 110 having one or more interior walls and / or an inner surface sized to extend at least partially into the outlet channel 117. Stated differently, the walls and / or surfaces defining the cutout of the mid-channel 118 may have a longitudinal length extending parallel to the central axis B, at which point the mid-channel 118 is at least partially within the lumen of the outlet channel 117. In some examples, the outlet tube 130 may be positioned relative to the outlet channel 117 with the top (first) end 132 positioned relatively below the mid-channel 118. In other examples, the top (first) end 132 may be positioned to at least partially overlap the mid-channel 118.

[0040] The rate at which the fluidized agent is delivered from the delivery system 10 may be based at least in part on the relative positions of the exit tube 130 and the intermediate channel 118. For example, the cone assembly 110 may be configured to selectively adjust the rate at which the fluidized agent is delivered from the delivery system 10 depending on the separation distance between the top end 132 (within the exit channel 117) and the intermediate channel 118. In one embodiment, the delivery rate of the agent may increase as the distance (along the central axis A) between the top end 132 and the intermediate channel 118 increases. The distance between the exit tube 130 and the intermediate channel 118 may range from about 0.10 inches (0.2540 centimeters) to about 0.5 inches (1.2700 centimeters).

[0041] In an exemplary use of the delivery system 10, the actuation mechanism 30 may be activated to allow pressurized fluid (such as pressurized carbon dioxide) stored in a pressurized fluid source (such as a canister) to flow to the fluid inlet 120. Fluid received at the inlet port 122 may pass through the channel 126 and pass into the inlet channel 119 via the outlet port 124. The fluid may impinge on the sintered filter 140 before being received by the intermediate channel 118. The angle, velocity, and / or pressure of the pressurized fluid may be controlled based on the size (e.g., diameter) and / or longitudinal length of the intermediate channel 118 to deliver the fluid in a turbulent flow pattern (e.g., radial pattern) into the cavity defined by the inner wall 112. Thus, a random velocity field may be formed within the cone-shaped assembly 110, specifically within the drug-containing cavity 101. It should be appreciated that pressurized fluid may be delivered to a drug stored adjacent to the inner wall 112 by passing through the outlet channel 117 and the outlet opening 114, respectively.

[0042] As the medicament is forced to move downward by the pressurized fluid, the medicament may strike a portion of the inner wall 112 that changes diameter, which may reduce clogging of the medicament within the cone assembly 110. The medicament may be prone to bridging, which may result in clogging without the change in diameter of the inner wall 112.

[0043] As mentioned above, at the top (first) end 111, the inner surface of the inner wall 112 may taper inwardly as one moves in a downward direction. In some embodiments, the angle of the inner wall 112 (relative to the central axis A) may be greater (i.e., steeper) than the angle of repose of the drug. The angle of repose of the drug may be the angle formed by a cone-shaped deposit of the drug as it flows through the cone-shaped assembly 110 and collects on the surface of the cone-shaped deposit. The angle of repose may be the angle between the surface of the inner wall 112 through which the drug flows and the surface of the cone-shaped deposit. The angle of repose may be related to friction or resistance to movement between particles of the drug. The inner wall 112 may have an angle greater than the angle of repose of the drug so that the drug may flow freely through the outlet opening 114 by the force of gravity.

[0044] As best seen in FIG. 7, the upper end of the outlet opening 114 may be wider than the lower end of the outlet opening 114 adjacent the outlet channel 117. In this case, the inner surface of the outlet opening 114 may taper radially inward and downward toward the central axis A such that the size of the outlet opening 114 decreases. Alternatively, the upper end of the outlet opening 114 may have substantially the same diameter as the lower end. In this case, the outlet opening 114 may have a constant or substantially constant diameter. In either case, the lower end of the outlet opening 114 may have the same or substantially the same size as the size of the outlet channel 117 adjacent the lower end of the outlet opening 114. As the medicament passes through the cone-shaped assembly 110, it may travel through the ever-narrowing portion of the inner wall 112 and the outlet opening 114, which may reduce clogging of the medicament. The tapered and / or angled portion of the inner wall 112 may have an angle of about 45 degrees with respect to the central axis A.

[0045] Upon moving (e.g., aerating, agitating, fluidizing) the agent within the cone assembly 110 and / or housing 102, the fluidized agent may exit the cone assembly 110 by flowing through the outlet opening 114 and the outlet channel 117 and into the outlet tube 130. The fluidized agent may be transported by the outlet tube 130 toward the outlet 34 and into the catheter 36 for delivery to the target treatment site. As the fluidized agent moves through the outlet channel 117 and into the outlet tube 130, at least a portion of the fluidized agent may be received within the intermediate channel 118. However, the fluidized agent may not enter the inlet channel 119 and may not flow toward the fluid inlet 120 due to the filter 140. As described in detail above, the filter 140 may be configured to prevent the fluidized agent from passing through the sintered filter 140.

[0046] The dispensing portion 100 may provide a number of advantages in certain embodiments. For example, the filter 140 may provide turbulence in the fluid and the intermediate channel 118 may control the rate of delivery of the turbulent fluid as the fluid combines with the drug. The turbulent fluid delivered at a controlled rate may provide improved flow of drug through the outlet 34 compared to devices without the filter 140 and / or intermediate channel 118 that cannot control the rate of delivery of the turbulent fluid. The configuration of the cone-shaped assembly 110, specifically the inner wall 112 and the outlet opening 114, may further facilitate delivery of the drug without clogging (or without significant clogging) due to, for example, bridging of the drug adjacent the outlet channel 117. Fluidization of the drug may have various advantages, including aeration of the drug, reduction of friction between particles of the drug, suspending the particles of the drug in a fluid (e.g., air or carbon dioxide) to propel them forward, faster delivery of the particles of the drug, and / or delivery of the drug using less fluid. Fluidization may break up aggregates of the drug.

[0047] Although the principles of the present disclosure are described herein with reference to illustrative examples of certain applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize that additional modifications, applications, and equivalent substitutions are all within the scope of the examples described herein. Thus, the present invention should not be considered as limited by the foregoing description.

Claims

1. 1. A device for delivering a medicament, comprising: a housing configured to store the medicament; a cone assembly at least partially received within the housing, an inner wall configured to be adjacent to the medicament; an outlet channel extending from the interior wall; an inlet channel; a conical assembly including an intermediate channel between the outlet channel and the inlet channel, the intermediate channel being such that the inlet channel is in fluid communication with the outlet channel through the intermediate channel; a filter disposed within the inlet channel and positioned adjacent to the intermediate channel, the filter including a plurality of pores configured to allow fluid received by the inlet channel to pass through the intermediate channel to mix with the agent adjacent the inner wall.

2. 10. The device of claim 1, wherein the outlet channel is coupled to an outlet tube, the outlet tube being in fluid communication with the medication via the outlet channel, and the inlet channel is coupled to an inlet tube, the inlet tube being in fluid communication with the medication via the inlet channel.

3. The device of claim 2 , wherein the inlet tube is configured to deliver the fluid to the intermediate channel and through the filter for mixing with the medication.

4. The device of claim 3 , wherein the outlet tube is configured to receive the agent from the interior wall via the outlet channel as the agent is displaced by the fluid supplied from the inlet tube.

5. The device of claim 3 , wherein the outlet tube includes a first end disposed within the outlet channel and positioned relatively below the intermediate channel.

6. The device of claim 3 , wherein the outlet tube includes a first end disposed within the outlet channel, the first end positioned relative to the intermediate channel so as to overlap the intermediate channel.

7. The device of claim 1 , wherein the filter includes an insert received within the inlet channel.

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

9. The device of claim 1 , wherein the plurality of pores extend along a tortuous path between opposing ends of the filter.

10. 10. The device of claim 1, wherein the conical assembly includes an opening at a first end of the conical assembly, and wherein a diameter of a space defined by an outer surface of the inner wall decreases in a direction toward the opening at the first end.

11. The device of claim 10 , wherein the intermediate channel is positioned relatively below the opening and extends at least partially into the outlet channel and the inlet channel.

12. The device of any one of claims 1 to 9, wherein the filter is coupled to the conical assembly within the inlet channel such that the filter is removable from the inlet channel.

13. The device of any one of claims 1 to 9, wherein the filter is integrally formed with the conical assembly.

14. The device of any one of claims 1 to 9, wherein the housing comprises a first body and a second body configured to engage the cone assembly along an outer rim of the cone assembly.

15. 10. The device of any one of claims 1 to 9, wherein the drug is a powder having a particle size of 320 microns to 500 microns, and the plurality of pores have a diameter of 40 microns to 100 microns.

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