Apparatuses and methods for delivering powdered agents

Abstract

To provide apparatuses and methods for the endoscopic delivery of hemostatic powders.SOLUTION: In one aspect of the present disclosure, an apparatus for delivering a powdered agent into a subject's body may include a powder chamber housing the powdered agent. The apparatus also may include a chassis in fluid connection with the powder chamber. The chassis may include a first passage for receiving a pressurized gas, a second passage for receiving the powdered agent from the powder chamber, and a junction in fluid communication with the first passage and the second passage. At least a first portion of the pressurized gas is introduced into the powdered agent at the junction to fluidize the powdered agent.SELECTED DRAWING: None

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to devices and methods for delivering powder medications. More particularly, the present disclosure relates to devices and methods for endoscopic delivery of hemostatic powder.

Background Art

[0002] When bleeding occurs within a subject's body during a medical procedure, the user performing the procedure may seek a way to reduce or eliminate the bleeding. One way to effectively address bleeding is by applying a hemostatic powder to the bleeding site. When the medical procedure being performed is an endoscopic procedure, applying a hemostatic powder to the site involves delivering the powder to the site using a catheter. The ability to reliably deliver the hemostatic powder properly through the catheter to the site leads to improved outcomes.

Summary of the Invention

[0003] Aspects of the present disclosure relate, among other things, to devices and methods for delivering powder medications. Each of the aspects disclosed herein can include one or more of the features described with respect to any of the other disclosed aspects.

[0004] In one aspect of the present disclosure, an apparatus for delivering a powder agent into a subject's body can include a powder chamber that houses the powder agent. The apparatus can also include a chassis fluidly connected to the powder chamber. The chassis can include a first passage for receiving pressurized gas, a second passage for receiving the powder agent from the powder chamber, and a junction fluidly communicating with the first passage and the second passage. At least a first portion of the pressurized gas is directed into the powder agent at the junction to fluidize the powder agent. The chassis can also include a third passage fluidly communicating with the junction. The third passage can receive the fluidized powder agent from the junction for delivery out of the chassis. The chassis can also include a fourth passage fluidly communicating with the first passage and the second passage, and can send a second portion of the pressurized gas from the first passage into the second passage to move the powder agent within the second passage before the powder agent is sent from the second passage to the junction.

[0005] Aspects of the apparatus can include one or more of the following features. Gravity can assist the movement of the powder agent out of the powder chamber and into the second passage. The first passage, the junction, and the third passage can be substantially aligned. The central longitudinal axis of the second passage can be substantially orthogonal to at least one of the central longitudinal axes of the first passage and the third passage. An opening can be formed in the wall of the second passage where the second passage and the fourth passage intersect. The second passage can include a tapered region, and the opening can be formed in the tapered region. The angle of the fourth passage with respect to the second passage can cause the second portion of the pressurized gas to be discharged tangentially to the wall of the second passage to generate a vortex of the pressurized gas and the powder agent within the second passage.

[0006] In another aspect of the present disclosure, an apparatus for delivering a powder drug into the body can include a source of pressurized gas, a source of powder drug, and a mixing chamber for coupling to a catheter. The mixing chamber can include a first passage for receiving pressurized gas from the pressurized gas source, a second passage for receiving the powder drug from the powder drug source, and a junction downstream from the first passage and the second passage. The junction can be configured to direct the pressurized gas from the first passage into the powder drug from the second passage to fluidize the powder drug. The chassis can also include a third passage downstream of the junction. The third passage can be configured to receive the fluidized powder drug from the junction and send the fluidized powder drug into the catheter. The chassis can also include a fourth passage that branches from the first passage and leads directly to the second passage. The fourth passage can be configured to send a portion of the pressurized gas from the first passage to the second passage.

[0007] Aspects of the apparatus can include one or more of the following features. The second passage can be disposed above the junction, such that gravity assists in moving the agitated powder drug from the second passage into the junction. The first passage, the junction, and the third passage can be substantially aligned. The central longitudinal axis of the second passage can be substantially orthogonal to the central longitudinal axis of at least one of the first passage and the third passage. An opening can be formed in the wall of the second passage where the fourth passage intersects the second passage. The second passage can include a tapered region, and the opening can be formed on the tapered region. The angle of the fourth passage with respect to the second passage can be such that a portion of the pressurized gas is discharged substantially tangentially to the wall of the second passage to generate a vortex of the pressurized gas and the powder drug within the second passage.

[0008] In another aspect of the present disclosure, a method for providing a powder drug to a treatment site in a body can include delivering the powder drug to the treatment site using a powder chamber that houses the powder drug, a catheter, and a chassis coupled to the powder chamber and the catheter. The step of delivering the powder drug can include sending a first flow of pressurized gas into the powder drug. The step of delivering can also include fluidizing the agitated powder drug by sending a second flow of pressurized gas, separate from the first flow of pressurized gas, into the agitated powder drug. The step of delivering can also include sending the fluidized powder drug into the catheter. The step of delivering can also include discharging the fluidized powder drug from the distal end of the catheter to the treatment site.

[0009] Aspects of the method can include one or more of the following features. That is, sending the first flow of pressurized gas into the powder drug to form a vortex of the pressurized gas and the powder drug. Branching the first flow of pressurized gas and the second flow of pressurized gas from the same flow of pressurized gas. Sending a third flow of pressurized gas around the powder drug to bypass the powder drug, where bypassing maintains the pressure within the catheter when the powder drug forms a clog within the chassis. At least one of (i) coagulating the blood at the site by interaction between the powder drug and the blood and (ii) forming a pseudo-coagulation at the site by interaction between the powder drug and one or more fluids at the site. At least one of (i) agitating the powder drug using a rotating helical portion housed in at least one of the chassis and the powder chamber, (ii) agitating the powder drug using a vibrating wire housed in the chassis, (iii) agitating the powder drug using a vibrating ring attached to the powder chamber, and (iv) discharging the powder drug from the powder chamber by folding at least a portion of the powder chamber.

[0010] It will be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. 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

[0011]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6A

Figure 6B

Figure 6C

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Mode for Carrying Out the Invention

[0012] The present disclosure has been made generally with respect to devices and methods for delivering powdered medicaments, and more particularly with respect to devices and methods for endoscopic delivery of hemostatic powders. Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. The term "distal" refers to the portion that is furthest from the user when the instrument is introduced into the subject. In contrast, the term "proximal" refers to the portion that is closest to the user when the instrument is placed within the subject. The following description refers to "endoscopes" or "endoscopy", but the principles / aspects described herein can be used with any suitable introduction sheath or device, even if such sheath or device may not normally include one or more features associated with an "endoscope". It will be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed features. Further, as used herein, the terms "comprises", "comprising", or any other variation thereof are intended to cover non-exclusively including, and thus, a process, method, product, or apparatus that comprises the recited elements does not necessarily include only these elements, but may include other elements not expressly listed or inherent to such process, method, product, or apparatus. The term "exemplary" is used in the sense of "example" and not "ideal". The terms "substantially", "about", and "approximately" refer to a plus or minus 10 percent variation from the stated value.

[0013] FIG. 1 shows an example of an apparatus 10 for delivering a powder agent according to aspects of the present disclosure. The apparatus 10 can include, for example, a chassis 12, a gas supply unit 14 for supplying pressurized gas to the chassis 12, a powder chamber 16 for supplying a powder agent 54 (FIG. 2) to the chassis 12, and / or a catheter 18 for receiving the fluidized powder agent from the chassis 12. The fluidized powder agent can include a mixture of pressurized gas and the powder agent. In one example, the pressurized gas can include air, and the powder agent can include a hemostatic powder. The hemostatic powder can include, for example, particulate matter capable of stopping bleeding by initiating a coagulation cascade for coagulating the bleeding, and / or particulate matter capable of forming a pseudo-coagulation when contacting blood due to the hydrophilic property of the powder.

[0014] During use in a subject (e.g., a patient), the chassis 12, the gas supply unit 14, and the powder chamber 16 can be outside the subject, but the catheter 18 can enter the subject through, for example, an endoscope or other introducer sheath (not shown). In one contemplated use, the catheter 18 can be inserted through an endoscope or sheath so as to position the distal end 20 of the catheter 18 at or near the bleeding site of the subject. The fluidized powder agent can be released from the distal end 20 toward the site to reduce or stop the bleeding.

[0015] The gas supply unit 14 can include, for example, a gas line 22. The gas line 22 can include a flexible length of tubing. The proximal end of the gas line 22 is coupled to a pressurized gas source (not shown), and the distal end of the gas line 22 is coupled to the chassis 12, thereby creating a path for the pressurized gas to flow from the pressurized gas source to the chassis 12. The pressurized gas source can include, for example, a pump device, wall access in a hospital room, a canister, a manually operated pump, a foot pedal operated pump, and / or other suitable pressurized gas sources. The gas line 22 can be fixedly attached or removably attached to the chassis 12 and / or the pressurized gas source.

[0016] The powder chamber 16 can include any suitable receptacle for holding the powder agent 54. The powder chamber 16 can include a substantially rigid container, such as a bottle, for example. Alternatively, the powder chamber 16 can include a substantially flexible container, such as a bag. The powder chamber 16 can have a closed end 24 and an open end 26 (FIG. 2). The powder agent 54 can proceed through the open end 26 to the chassis 12.

[0017] The powder chamber 16 can be fixedly attached or removably attached to the chassis 12. When the powder chamber 16 is fixedly attached to the chassis 12, refilling the chassis 12 with the powder agent 54 can include removing a cap, cover, etc. from the powder chamber 16 and pouring the powder agent 54 into the powder chamber 16. When the powder chamber 16 is removably attached to the chassis 12, refilling the chassis 12 with the powder agent 54 will include removing the empty powder chamber 16 from the chassis 12 and coupling the filled powder chamber 16 to the chassis 12.

[0018] The catheter 18 can include a tubular length of medical grade material and can have a proximal end with a proximal opening (not visible) and a distal end 20 with a distal opening 30. The proximal end of the catheter 18 can be coupled to the chassis 12. The catheter 18 can include a lumen 28 that extends therethrough from the proximal opening to the distal opening 30. The fluidized powder agent 54 from the chassis 12 can flow through the lumen 28 and be discharged from the distal opening 30. The catheter 18 can be rigid enough to maintain its shape when inserted into a subject's body. Alternatively, the catheter 18 can be flexible enough to bend and conform to the passageways within a subject's body. The catheter 18 can be fixedly or removably attached to the chassis 12.

[0019] The chassis 12 can include an inlet or port 32 to which the gas line 22 can be coupled, an inlet or port 34 to which the powder chamber 16 can be coupled, and an outlet or port 36 to which the catheter 18 can be coupled. The chassis 12 can include a mixing chamber 38 that can be in fluid communication with its inlet 32, inlet 34, and outlet 36. In use, pressurized gas from the gas line 22 can enter the mixing chamber 38 via the inlet 32, and the powder agent 54 can enter the mixing chamber 38 via the inlet 34. The pressurized gas and the powder agent 54 are mixed within the mixing chamber 38 to create a fluidized powder agent 54, which then exits the mixing chamber 38 and enters the catheter 18 via the outlet 36. The powder agent 54 can be fluidized in the sense that pressurized gas is introduced into the powder agent 54 to form a medium that is partially gas and partially solid and has the properties and characteristics of a fluid such as a liquid.

[0020] The chassis 12 can also include a handle 40 for the user to grip and a trigger 42 for handling the flow of the fluidized powder agent 54. For example, the trigger 42 can be operably coupled to one or more valves (not shown) in one or more of the inlet 32, inlet 34, mixing chamber 38, and outlet 36 to control the flow of one or more of the pressurized gas, powder agent, and fluidized powder agent.

[0021] The mixing chamber 38 can be fixedly attached to or removably attached to the remainder of the chassis 12. The removable attachment can be accomplished by any suitable mechanical attachment mechanism such as snap-fit engagement, friction fit, a latch mechanism, etc. The removable attachment allows the user to exchange one mixing chamber for another. FIGS. 2-11 show examples of mixing chambers. It is contemplated that any of the mixing chambers can be used in place of any other mixing chamber, including the mixing chamber 38. It is also contemplated that any aspect of any mixing chamber can be used in any other mixing chamber.

[0022] Figure 2 shows mixing chamber 44. Mixing chamber 44 can be used in place of mixing chamber 38 of FIG. 1. The same applies to the other mixing chambers described below. Mixing chamber 44 can include an opening 46 and a passage 48 for pressurized gas. Mixing chamber 44 can also include an opening 50 and a passage 52 for powder agent 54. Passage 48 and passage 52 can intersect at a junction 55, where the pressurized gas is introduced into powder agent 54, thereby enabling the powder agent 54 to be fluidized. Mixing chamber 44 can also include a passage 56 and an opening 58 for the fluidized powder agent 54. Any of the openings in mixing chamber 44 can have a circular shape. Any of the passages in mixing chamber 44 can have a circular cross-sectional shape. For example, other suitable opening shapes / cross-sectional shapes can be used, including polygonal and irregular shapes. It is contemplated that the central longitudinal axes of passages 48 and 56 can be substantially aligned or coaxial. Additionally or alternatively, the central longitudinal axis of passage 52 can be substantially orthogonal to at least one of the central longitudinal axes of passages 48 and 56.

[0023] Passage 52 can include portions having different widths or diameters. For example, passage 52 can include a first portion 60 and a second portion 62. The first portion 60 can be wider than the second portion 62. The width or diameter of the first portion 60 can be designed to receive the open end 26 of powder chamber 16. The second portion 62 can be designed to control the flow rate of powder agent 54 to the junction 55, including its width or diameter. Powder chamber 16 and passage 52 are disposed above the junction 55, and thus gravity can assist the powder agent 54 to move downward from the powder chamber 16 and passage 52 to the junction 55.

[0024] Figure 3 shows a mixing chamber 64 that includes a passageway 66 having a first portion 68 with a first width, a second portion 70 having a second width smaller than the first width, and a third portion 72. The first portion 68 and the second portion 70 can be similar to the first portion 60 and the second portion 62 of the mixing chamber 44, including having a constant width / diameter along their lengths. The third portion 72 can extend between the first portion 68 and the second portion 70 and can have a varying width or diameter. For example, the third portion 72 can include a tapered region 74 having a decreasing width or diameter in a direction extending from the first portion 68 to the second portion 70. The tapered region 74 can act as a funnel to facilitate delivery of the powder agent 54 in the direction of the junction 76. This can reduce or eliminate the powder agent 54 from clogging or jamming within the passageway 66.

[0025] Figure 4 shows another mixing chamber 78. The mixing chamber 78 can include a tapered region 80 similar to the tapered region 74 of the mixing chamber 64. The mixing chamber 78 can be shorter than the mixing chamber 44 and / or the mixing chamber 64 when measured along the direction of the pressurized gas flow through the mixing chamber. For example, the length of the mixing chamber 78 (measured left to right in Figure 4) can be shorter than the height of the mixing chamber 78 (measured top to bottom in Figure 4). Accordingly, the passageway 82 for the pressurized fluid and / or the passageway 84 for the fluidized powder agent 54 can correspondingly be shorter. Reducing the passage length reduces the amount of time the powder agent 54 is within the mixing chamber 78, thereby reducing or eliminating clogging or jamming at the junction 86 and / or in the passageway 84. It is contemplated that the width or diameter of one or more of the passageways 82, 84, and 88 for the powder agent 54 can be widened to further reduce or eliminate clogging.

[0026] FIG. 5 shows another mixing chamber 90. The mixing chamber 90 can include a tapered region 92 similar to the tapered region 74 of the mixing chamber 64. The mixing chamber 90 can be shorter than the mixing chamber 44 and / or the mixing chamber 64, similar to the mixing chamber 78. In the mixing chamber 90, a portion 94 of the passage 96 can be angled with respect to the central longitudinal axis 98 of another portion 100 of the passage 96. In some examples, the central longitudinal axis of the portion 94 can form an angle between about 25 degrees and about 90 degrees with respect to the central longitudinal axis of the junction 102. In one example, the angle can be about 45 degrees. The portion 100 can be designed to receive the open end 26 of the powder chamber 16, and the portion 94 can be designed to deliver the powder agent 54 to the junction 102. Due to the angle of the portion 94, the powder agent 54 can be delivered to the junction 102 at a slower rate than when the portion 94 is aligned with the central longitudinal axis 100. The slower rate can reduce or eliminate clogging or jamming of the powder agent 54 at or near the junction 102 when the powder agent 54 is mixed with the pressurized gas.

[0027] Figure 6A shows another mixing chamber 104. The mixing chamber 104 can include a tapered region 106 similar to the tapered region 74 of the mixing chamber 64. The mixing chamber 104 can also include a passageway 108 that connects a passageway 110 for pressurized gas to a passageway 112 for the powder agent 54. The passageway 108 can extend alongside the passageway 110. The passageway 108 is contemplated to be angled with respect to the passageway 110 when viewing the mixing chamber 104 from the side view of FIG. 6A. For example, the passageway 108 can be inclined with respect to the passageway 110, and thus, the passageway 108 can extend away from the passageway 110 along the direction of the flow of the pressurized gas through the passageways 108 and 110. An opening 114 where the passageway 108 intersects the passageway 112 can be disposed in the tapered region 106. The pressurized fluid can be split into two branches, one branch flowing directly into the passageway 112 through the passageway 108 and the other branch flowing through the passageway 110 in the direction of the junction 116 of the passageways 110 and 112. Thus, some of the pressurized gas exits the passageway 110 between the upstream opening 111 of the passageway 110 and the junction 116 where the passageway 110 intersects the passageway 112. The pressurized fluid exiting in the middle of the passageway 110 enters the passageway 108, flows directly into the passageway 112 upstream of the junction 116, and agitates the powder agent 54 within the passageway 112, which can reduce or eliminate clogging or jamming of the powder agent 54. Doing so can facilitate the outflow of the powder agent 54 from the powder chamber 16 to the junction 116.

[0028] Figures 6B and 6C show versions of a mixing chamber identified as mixing chamber 118A in FIG. 6B and mixing chamber 118B in FIG. 6C. The mixing chambers 118A and 118B can be similar to the mixing chamber 104. Each of the mixing chambers 118A and 118B can include a tapered region 120 of a passageway 126 for the powder agent 54, a passageway 124A or 124B that connects a passageway 122 for pressurized gas to the passageway 126, and an opening 128 in the passageway 126. In one example, the mixing chambers 118A and 118B can potentially look substantially the same as the mixing chamber 104 when viewed from the side.

[0029] In the mixing chamber 118A, the opening 128 is disposed farther from the central longitudinal axis 130 of the passage 126 than the mixing chamber 118B. As shown in FIG. 6B, the passage 124A of the mixing chamber 118A can be angled with respect to the passage 122 when viewed from above the mixing chamber 118A. For example, the central longitudinal axes (not shown) of the passage 124A and the passage 122 are angled with respect to each other in the top view of FIG. 6B. The gap between the passage 124A and the passage 122 may increase along the direction in which the pressurized gas flows through the passages 122 and 124A to the passage 126. The pressurized gas entering the passage 126 swirls near the passage 126 to generate a vortex that swirls the powder agent 54 near the passage 126. This swirling can reduce or eliminate clogging or jamming of the powder agent 54 in the passage 122.

[0030] In the mixing chamber 118B, the opening 128 is disposed closer to the central longitudinal axis 130 of the passage 126 than in the mixing chamber 118A. As shown in FIG. 6C, the passage 124B can extend substantially parallel to the passage 122 when viewed from above the mixing chamber 118B. For example, the central longitudinal axes (not shown) of the passage 124B and the passage 122 are parallel to each other in the top view of FIG. 6C. The gap between the passage 124B and the passage 122 can remain substantially constant along the flow direction of the pressurized gas through the passages 122 and 124B to the passage 126. Just before the powder agent 54 enters the bottleneck created by the narrower end of the tapered section 120, the pressurized gas entering the passage 126 can agitate the powder agent 54. The agitation can be provided by a smaller vortex than that for FIG. 6B. In any situation, the vortex can reduce or eliminate clogging or jamming of the powder agent 54 in the passage 126. This vortex can also constitute the first stage of fluidization, and the second stage of fluidization occurs at the junction, resulting in improved fluidization of the powder agent 54.

[0031] FIG. 7 shows a mixing chamber 132 including an opening 134 and a passage 136 for pressurized gas, an opening 138 and a passage 140 for powder agent 54, a junction 142 where the pressurized gas can be directed to the powder agent 54 to fluidize the powder agent 54, and a passage 144 and an opening 146 for the fluidized powder agent 54. The junction 142 is enlarged relative to the passages 136, 140, and 144 and can provide a relatively large volume in which the powder agent 54 can be fluidized by the pressurized gas. For example, the junction 142 can have a cross-sectional width or diameter that is larger than one or more of the passages 136 and 144. The junction 142 is tapered inwardly at both ends so as to transition from its relatively large cross-sectional width or diameter to the respective cross-sectional widths or diameters of the passages 136 and 144. Gravity can force the powder agent 54 downward from the powder chamber 16 into the junction 142.

[0032] FIG. 8 shows a mixing chamber 148 that includes an auger 150. The auger 150 can include a shaft 152 and a helical flange 154 that extends longitudinally along the shaft 152. The shaft 152 can be rotatably coupled to a portion of the mixing chamber 148, such as a wall 156 of the junction 158. The shaft 152 can be rotated by a manually operated dial or knob, a motor, an actuator (not shown) such as a gear assembly, and / or any other suitable actuator. When the shaft 152 rotates, the helical flange 154 can convey the powder agent 54 from the powder chamber 16 through the passage 164 to the junction 158. In one example, the diameter or width of the auger 150 can be smaller than the diameter or width of the passage 164. The radially outer edge portion of the helical flange 154 may contact a wall portion that defines the passage 164. The rate at which the powder agent 54 can be conveyed to the junction 158 can be controlled by adjusting the rotational speed of the auger 150. Additionally, the auger 150 can help loosen the powder agent 154, thereby reducing or eliminating blockages or jams. Pressurized gas from the passage 160 can enter the junction 158 and fluidize the powder agent 54. The fluidized powder agent 54 can exit the junction 158 through the passage 162. It is contemplated that the pressurized gas can impinge on one or more surfaces of the auger 150, such as the helical flange 154, to rotate the auger 150 with or without the assistance of another actuator.

[0033] In one example, the shaft 152 can extend substantially orthogonally to the joint 158, the passage 160, and / or the passage 162. For example, the central longitudinal axis of the shaft 152 can extend substantially orthogonally to one or more central longitudinal axes of the joint 158, the passage 160, and the passage 162. Further, or alternatively, the shaft 152 can be aligned with the passage 164. For example, the central longitudinal axis of the shaft 152 can be substantially coaxial or parallel with the central longitudinal axis of the passage 164. The helical portion 150 is contemplated to be used in any of the other mixing chambers described herein and shown in other figures.

[0034] A helical portion 150 having a length across the joint 158 and the passage 164 is shown, but it is contemplated that the length can vary. For example, as shown in FIG. 9, the helical portion 166 can cross the joint 168 and extend through the passage 170 into the powder chamber 16. The helical portion can extend all the way from the wall of the joint 168 that is furthest from the powder chamber 16 to the closed end 24 of the powder chamber 16, where it is also contemplated that one end of the shaft of the helical portion can be rotatably coupled. Alternatively, the helical portion (not shown) can be entirely contained within the joint 158, for example, without extending into the passage 164.

[0035] FIG. 10 shows a mixing chamber 172 that includes a passage 174 for a pressurized fluid, a junction 176 where the powder agent 54 can be fluidized by the pressurized fluid, and a passage 178 through which the fluidized powder agent 54 can exit the junction 176. The mixing chamber 172 can also include a passage 180 that directly and fluidly couples the passage 174 to the passage 178. A portion of the pressurized fluid from the passage 174 can bypass the junction 176 and flow directly into the passage 178 via the passage 180. In some examples, when body fluids or other contaminants enter the catheter 18 from the distal end 20, they can form clogs or coagulations within the catheter 18 when they contact the fluidized powder agent 54 within the catheter 18. Body fluids / contaminants tend to enter the distal end 20 when there is no outflow from the catheter 18. The passage 180 can ensure that at least some pressurized fluid can flow through the catheter 18 even when the junction 176 is clogged, thereby preventing further body fluids / contaminants from entering the distal end 20. The pressurized fluid can also help to expel the clog / coagulation from within the catheter 18.

[0036] The mixing chamber 172 can also include a valve assembly 182 that can control the amount of pressurized fluid that can flow to the junction 176 and the passage 180. For example, during normal operation, the valve assembly 182 can send all of the pressurized fluid from the passage 174 to the junction 176 to fluidize the powder agent 54. If the pressure at the junction 176 increases due to a clog within it, the valve assembly 182 can send at least some pressurized fluid to the passage 180 to prevent body fluids / contaminants from entering the distal end 20 of the catheter 18.

[0037] FIG. 11 shows a mixing chamber 184 that includes a passage 186 for a pressurized fluid, a junction 188 where the powder agent 54 can be fluidized by the pressurized fluid, and a passage 190 for the fluidized powder agent 54. A curved, corrugated, and / or sinusoidal wire 192 can extend within the junction 188. In one example, the junction 188 can include both ends, and the wire 192 can pass through the junction 188 and extend longitudinally from one of these ends to the other. The wire 192 can vibrate so as not to be blocked or clogged when the powder agent 54 enters the junction 188. The wire 192 can vibrate due to the force generated there by the pressurized gas, and / or the wire 192 can be vibrated by a suitable actuator (not shown). For example, one end of the wire 192 can be coupled to the actuator. Alternatively, both ends of the wire 192 may be coupled to the actuator. The wire 192 is contemplated to be able to extend into the passage 186 and / or the passage 190 so as to facilitate its vibration and / or assist in the fluidization of the powder agent 54.

[0038] The mixing chamber 184 can also include a valve assembly 194. The valve assembly 194 can be disposed along the passage 186. In one example, the valve assembly 194 can include a one-way valve that allows the pressurized gas to flow from the passage 186 into the junction 188 but prevents the powder agent 54 from flowing from the junction 188 into the passage 186. Preventing such backflow can help ensure that the gas line 22 and / or the pressurized gas supply source are not clogged by being exposed to the powder agent 54.

[0039] Figures 12 to 16 show examples of powder chambers. It is contemplated that any of the powder chambers, including powder chamber 16, can be used in place of any of the others. It is also contemplated that any aspect of any of the powder chambers can be used with any of the other powder chambers. The powder chamber 196 shown in FIG. 12 can include a closed end 198. The closed end 198 can have at least one perforation 200. During use, when the powder agent 54 is drawn from the powder chamber 196, a vacuum pressure can be generated in the powder chamber 196. An increase in the vacuum pressure within the powder chamber 196 can make it more difficult for the powder agent 54 to exit the powder chamber 196. The perforation 200 allows air to be drawn into the powder chamber 196, thereby reducing the vacuum pressure and facilitating the outflow of the powder agent 54. The closed end 198 can include a foil sheet through which the user can punch a hole to create the perforation 200. Alternatively, the closed end 198 can include a pre-formed perforation 200 covered by a liner (not shown). The liner can be removed by the user to expose the perforation 200.

[0040] FIG. 13 shows a powder chamber 202 having a vibration ring 204 attached thereto. When activated by the user, the vibration ring 204 vibrates, thereby shaking the powder chamber 202. Shaking can help agitate the powder agent 54, reduce or eliminate clogging, and facilitate the outflow of the powder agent 54 from the powder chamber 202. Although the vibration ring 204 is shown attached to the outer surface of the powder chamber 202, it is contemplated that the vibration ring 204 can be provided within the powder chamber 202 or embedded within the material forming the powder chamber 202. It is also contemplated that any suitable vibration device, not necessarily in the shape of a ring, can be used to shake the powder chamber 202. The vibration can be driven by any suitable mechanical or electromechanical mechanism.

[0041] Figure 14 shows the powder chamber 206. The powder chamber 206 can be folded from a first state (shown by the dashed line) to a second state (shown by the solid line). In one example, the powder chamber 206 can include a bellows 208. The folded configuration of the bellows 208 can expand and contract the powder chamber 206. In another example, the powder chamber 206 may be made of a flexible material that can be crushed and folded. Folding the powder chamber 206 can apply a force to the powder agent 54 inside it that can eject the powder agent 54 from the powder chamber 206.

[0042] Figure 15 shows the powder chamber 210. The powder chamber 210 can include a gas line 212 and a gas line 214. In one example, the gas line 212 can be fluidly coupled to the wall 216 of the powder chamber 210. The central longitudinal axis of the gas line 212 can be offset from the central longitudinal axis of the powder chamber 210. For example, the central longitudinal axis of the gas line 212 may not intersect the central longitudinal axis of the powder chamber 210. The pressurized gas ejected from the gas line 212 can thus swirl inside the powder chamber 210 along the wall 216, generating a swirling vortex of the pressurized gas and the powder agent 54 inside the powder chamber 210. This movement can reduce or eliminate clogging or jamming of the powder agent 54 in the powder chamber 210. The gas line 214 can extend into the powder chamber 210. The central longitudinal axis of the gas line 214 can be coaxial or parallel with the central longitudinal axis of the powder chamber 210. The pressurized gas ejected from the gas line 214 forces the swirling powder agent 54 out of the powder chamber 210, moving the powder agent 54 against the force of gravity. In one example, the gas line 214 includes one or more side perforations through which the pressurized gas can be ejected and can help to sweep through the powder chamber 210. The powder chamber 210 is attached to the bottom of the mixing chamber and / or the chassis, and thus the powder agent 54 can flow upward into the mixing chamber / chassis. The gas line 212 and the gas line 214 can receive one or more pressurized gases from any suitable supply source (not shown).

[0043] FIG. 16 shows a powder chamber 218 including gas conduits 220 and 222 similar to gas conduits 212 and 214. A plate or disk 224 can be slidably mounted on gas conduit 222. Initially, plate 224 can contact the wall 226 of powder chamber 218, thereby preventing powder agent 54 from exiting powder chamber 218. When pressurized gas is discharged from gas conduit 222 into powder chamber 218, the increase in gas pressure within powder chamber 218 can force plate 224 to a retracted state (shown by the dashed line). In the retracted state of plate 224, powder agent 54 can flow around the edge of plate 224 and out of powder chamber 218. Pressurized gas from gas conduit 220 can swirl powder agent 54, but plate 224 is intended to prevent powder agent 54 from exiting powder chamber 218. The swirled powder agent 54 can always flow out of powder chamber 218 when the pressurized gas from gas conduit 220 generates sufficient gas pressure to force plate 224 away from wall 226 and create a path for powder agent 54 to flow around plate 224.

[0044] In some examples where powder chamber 210 and / or powder chamber 218 are used, the pressurized gas discharged therein can be sufficient to fluidize powder agent 54. This allows for simplification of the chassis to which powder chamber 218 is coupled. For example, the chassis need not include a pressurized gas passage or a mixing / fluidization junction. The fluidized powder agent 54 can flow from powder chamber 218 into the chassis, out of the chassis and into a catheter, and be delivered to the site. Alternatively, a chassis having a pressurized gas passage and a mixing / fluidization junction can also be used with powder chamber 210 and / or powder chamber 218 to facilitate fluidization of powder agent 54 using two-stage fluidization.

[0045] FIG. 17 shows a mixing chamber 228 that includes a passageway 230 for pressurized gas and a passageway 232 filled with powder charge 54. The powder charge 54 can be pre-filled into passageway 232, and thus, no separate powder chamber is required. Alternatively, passageway 232 can receive powder charge 54 from a separate powder chamber as shown in the other examples described above. The mixing chamber 228 can also include a helical portion 234. The helical portion 234 can be disposed in passageway 232. The helical portion 234 can include a shaft 236 and a helical flange 238 that extends longitudinally along shaft 236. The shaft 236 can be rotatably mounted and rotated by a manually operated dial or knob, a motor, a gear assembly, an actuator (not shown) such as a motor, and / or any other suitable actuator. Alternatively, the force generated by the pressurized fluid can rotate the helical portion 234.

[0046] In one example, the helical portion 234 can be disposed at or near the downstream / outlet end of passageway 232. The shaft 236 can extend longitudinally through passageway 232. For example, it is contemplated that the central longitudinal axis of shaft 236 can be parallel or coaxial with the central longitudinal axis of passageway 232. It is also contemplated that the helical portion 234 can have a width or diameter that is substantially equal to or less than the width or diameter of passageway 232. As shown in FIG. 17, the width or diameter of the helical portion 234 can have a taper in the downstream direction. The tapered width or diameter can help position the edge of the helical flange 238 at or near the tapered end of passageway 232.

[0047] In use, pressurized gas from passageway 230 can enter passageway 232 and fluidize powder medicament 54. The pressurized gas and / or the fluidized powder medicament 54 can impinge on helical portion 234. This impingement can rotate helical portion 234. The helical portion 234 can help loosen the powder medicament 54, thereby facilitating its fluidization and / or helping to control the delivery rate of the fluidized powder medicament 54 out of mixing chamber 228.

[0048] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed systems and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art upon considering the specification and practicing the features disclosed herein. The specification and examples are intended to be regarded as merely illustrative.

Claims

1. 1. A device for delivering a powdered medicament into a body of a subject, comprising: a powder chamber for containing the powdered medicament; a chassis in fluid communication with the powder chamber, the chassis comprising: a first passageway for receiving pressurized gas; a second passageway for receiving the powdered medicament from the powder chamber; a junction in fluid communication with the first passageway and the second passageway, wherein at least a first portion of the pressurized gas is directed into the powdered medicament at the junction to fluidize the powdered medicament; a third passageway in fluid communication with the interface, the third passageway receiving the fluidized powdered medicament from the interface for delivery from the chassis; and the chassis including a fourth passageway in fluid communication with the first passageway and the second passageway to direct a second portion of the pressurized gas from the first passageway to the second passageway to displace the powdered medicament within the second passageway before the powdered medicament is directed from the second passageway to the junction; An apparatus comprising:

2. 10. The device of claim 1, wherein the powder chamber is disposed on the chassis such that gravity assists movement of the powdered medicament out of the powder chamber and into the second passageway.

3. The apparatus of claim 1 or 2, wherein the first passage, the junction, and the third passage are substantially aligned.

4. 4. The apparatus of claim 1, wherein a central longitudinal axis of the second passage is substantially perpendicular to a central longitudinal axis of at least one of the first passage and the third passage.

5. 5. The apparatus of claim 1, wherein an opening is formed in a wall of the second passage where the second passage and the fourth passage intersect.

6. The apparatus of claim 5 , wherein the second passage includes a tapered region, and the opening is formed in the tapered region.

7. 7. The device of claim 1, wherein the angle of the fourth passage relative to the second passage causes the second portion of the pressurized gas to be discharged tangentially to a wall of the second passage to generate a vortex of the pressurized gas and the powdered medicament within the second passage.

8. 8. The device of claim 1, further comprising a catheter in fluid communication with the third passageway for receiving the fluidized powdered medicament exiting the chassis.

9. 9. The apparatus of claim 1, further comprising a fifth passage in fluid communication with the first passage and the third passage, the fifth passage directing a third portion of the pressurized gas from the first passage directly to the third passage, the fifth passage bypassing the second passage and the junction.

10. The apparatus of claim 1 , further comprising a helical portion extending into at least one of the second passageway and the junction.

11. The device of claim 10 , wherein the helical portion includes a shaft and a helical flange extending longitudinally along the shaft.

12. 12. The apparatus of claim 1, further comprising a vibrating wire extending within at least one of the first passageway, the junction, and the third passageway.

13. 13. The apparatus of claim 1 , further comprising a vibrating ring attached to the powder chamber.

14. 14. The device of any one of claims 1 to 13, wherein the powder chamber is transitional from an extended state to a collapsed state, and transition of the powder chamber from the extended state to the collapsed state expels the powdered medicament from within the powder chamber.

15. 15. The device of claim 1, wherein a central longitudinal axis of the second passage is angled relative to a central longitudinal axis of at least one of the first passage and the third passage.

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