Device for delivering powdered medicament

By designing a device that can be used for delivery of medicines in endoscopic surgery, the device has a transformable body shape to achieve the combination of the dosage and mixing of medicines with fluids, the problem of inconsistent delivery rate and dose of medicines in the prior art is solved, and the accurate delivery of medicines to the deep treatment site is achieved.

CN119971275APending Publication Date: 2025-05-13BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202510290824.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2020-01-06
Filing Date
2020-12-31
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

The prior art systems used to deliver hemostatic agents in endoscopic surgery may not achieve the required rate or dose of the agent delivery and may result in clogged or inconsistent doses that make it difficult to reach deep treatment sites.

Method used

A device for delivering a medicament is designed, the device comprising a body movable on a longitudinal axis, the body having two forms: one allows the medicament to flow into the chamber and the other prevents the medicament from flowing into the chamber. Through the restoration force of the spring or the meshing of the gear, the body can be transformed between the first and second forms, thereby achieving the metering of the agent and the combination of the fluid.

Benefits of technology

The device can effectively deliver a predetermined amount of the agent and combine it with the fluid to ensure that the agent can accurately reach the treatment site, solving the problem of inconsistent delivery rate and dosage of the agent in the prior art.

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Abstract

A device for delivering a medicament may include a chamber for receiving a medicament through a medicament inlet; and a body received within the chamber. The body is movable in a first direction and a second direction along a longitudinal axis of the chamber. In a first configuration of the body, an amount of the medicament may flow into the chamber via the medicament inlet. In a second configuration of the body, the medicament is prevented from flowing into the chamber via the medicament inlet. When the body transitions from the first configuration to the second configuration, the amount of medicament may be moved from a first position along the longitudinal axis of the chamber to a second position along the longitudinal axis of the chamber.
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Description

This case is a divisional application of invention patent application number 202080087287.X CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 957,519, filed on January 6, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of the present invention generally relate to devices and methods for delivering medicaments. More specifically, in embodiments, the present invention relates to devices for delivering powdered medicaments, such as hemostats. Background Art

[0003] In certain medical procedures, it may be necessary to stop or minimize bleeding within the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the gastrointestinal tract, such as within the esophagus, stomach, or intestines.

[0004] During endoscopic surgery, a user inserts the sheath of an endoscope into a patient's body cavity. The user controls the endoscope using the handle of the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle to deliver therapy at a surgical site near the distal end of the endoscope. The surgical site is distal to the operator.

[0005] To achieve hemostasis at a remote site, a hemostatic agent may be delivered by a device inserted into a working channel of an endoscope. Delivery of an agent may be achieved, for example, by a mechanical system. However, such a system may require many steps or actuations to achieve delivery, may not achieve a desired agent delivery rate or a desired agent dosage, may result in the agent blocking portions of a delivery device, may result in inconsistent agent dosages, or may result in the agent not being able to reach a treatment site deep within the GI tract. The present invention may address one or more of these or other problems in the art. Summary of the invention

[0006] Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0007] In one example, a device for delivering a medicament may include a chamber for receiving a medicament through a medicament inlet; and a body received in the chamber. The body can move in a first direction and a second direction along a longitudinal axis of the chamber. In a first form of the body, a certain amount of medicament can flow into the chamber via the medicament inlet. In a second form of the body, the medicament can be prevented from flowing into the chamber via the medicament inlet. When the body is transformed from the first form to the second form, the certain amount of medicament can move from a first position along the longitudinal axis of the chamber to a second position along the longitudinal axis of the chamber.

[0008] Any of the devices described herein may have any of the following features. When the body is in the second form, a fluid may flow into the chamber via a fluid inlet and combine with a certain amount of medicament. The fluid inlet may be located between (a) an outlet for conveying a fluid combined with a certain amount of medicament from the chamber and (b) a medicament inlet. A spring may be attached to the body. Due to the restoring force of the spring, the body may be transformed from a first form to a second form. The device may include a yoke and at least one track for receiving the yoke. In the first form, the yoke may contact the body. When the yoke stops contacting the body, the body may be transformed from the first form to the second form. The gear may have gear teeth, wherein the body includes body teeth for mating with the gear teeth. Only a portion of the circumference of the gear may include gear teeth, and wherein when the gear teeth are not meshed with the body teeth, the body is transformed from the first form to the second form. The arm may have a finger and the guide may have a protrusion. When the finger contacts the protrusion, the body may be transformed from the first form to the second form. A source of medicament may be connected to the body. The chamber is a first chamber and also includes a second chamber, wherein the body defines a body opening, wherein in the first form, the body opening is in fluid communication with the medicament inlet, and wherein in the second form, the body opening is not in fluid communication with the medicament inlet, but is in fluid communication with a chamber opening located between the first chamber and the second chamber. The body can be connected to the arm via a hinge. The arm can be connected to a trigger. Pressing the trigger can cause the arm to pivot and cause the body to move in a first direction. Releasing the trigger can cause the arm to pivot and cause the body to move in a second direction, thereby transforming the body from the first form to the second form. The chamber opening can be proximal to the medicament inlet.

[0009] In another example, a device for delivering a medicament may include: a medicament source; a mixing chamber in fluid communication with the medicament source via a medicament inlet; and a body received in the mixing chamber and movable between a first configuration and a second configuration. In the first configuration, the distal end of the body is proximal to the medicament inlet, and the medicament flows from the medicament inlet into the mixing chamber. When the body is transformed from the first configuration to the second configuration, the distal end of the body may push the medicament distally toward the fluid inlet. In the second configuration, the distal end of the body may be distal to the medicament inlet and proximal to the fluid inlet, so as to allow the medicament to mix with the fluid received from the fluid inlet.

[0010] Any of the devices described herein may have any of the following features. The body may be attached to a spring. The restoring force of the spring may cause the body to transform from a first configuration to a second configuration.

[0011] In another example, a device for delivering a medicament may include a first chamber in fluid communication with a medicament inlet; a second chamber in fluid communication with the fluid inlet; and a wall formed between the first chamber and the second chamber. The wall may define a chamber opening between the first chamber and the second chamber. A body may be received in the first chamber and define a body opening. The body may be configured to transform from a first configuration to a second configuration, in which the body opening is in fluid communication with the medicament inlet and not in fluid communication with the chamber opening, and in which the body opening is in fluid communication with the chamber opening and not in fluid communication with the medicament inlet.

[0012] Any of the devices disclosed herein may have any of the following features. The body may be connected to the pivotable arm via a hinge. The pivotable arm may be connected to a trigger. The trigger may be operable to control fluid flow through the fluid inlet.

[0013] It is understood that the foregoing general description and the following detailed description are merely exemplary and explanatory of the invention as claimed, rather than restrictive descriptions. As used herein, the terms "include," "comprise," or any other variation thereof are intended to encompass non-exclusive contents, so that a process, method, article, or device comprising a list of elements may include not only those elements, but may include other elements that are not explicitly listed or are not inherent to such process, method, article, or device. The term "distal" refers to a direction away from an operator, and the term "proximal" refers to a direction toward an operator. The term "exemplary" is used in the sense of "example" rather than "ideal." The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / -10% of a specified value. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0015] Figure 1 An exemplary delivery device is shown.

[0016] FIG. 2A to FIG. 7B A delivery device is shown, comprising Figure 1 Various exemplary actuation mechanisms in a delivery device. DETAILED DESCRIPTION

[0017] Embodiments of the present invention relate to a metering / actuating mechanism for delivering a medicament (e.g., a powdered medicament) from a delivery system to a medical surgical site. The actuating mechanism can deliver a predetermined amount of powder or particles in a desired form to be propelled by a fluid or combined with a fluid for delivery to the treatment site.

[0018] Figure 1 A delivery system 10 that can be a powder delivery system is shown. The delivery system 10 may include a body 12. The body 12 may include or may be configured to receive a housing 14 (or other source) storing a medicament. The housing 14 may be coupled to the body 12 to provide the medicament to the body 12, or the cover / housing of the medicament may be screwed onto the housing 14, or otherwise coupled to the housing 14 to supply the medicament to the housing 14. The medicament may be, for example, a powdered medicament, such as a hemostatic agent. Alternatively, the medicament may be another type of medicament or material or medicament form (e.g., a liquid or gel medicament) and may have any desired function. 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 a variety of features, which will be discussed in further detail herein. U.S. Patent Application No. 16 / 589,633 filed on October 1, 2019, the disclosure of which is incorporated herein by reference in its entirety, discloses features of an exemplary delivery device and system. Features of the present invention may be combined with any of the features described in the above-mentioned application. The features described herein may be used alone or in combination and are not mutually exclusive. Where possible, similar reference numerals and / or terms are used to represent similar structures.

[0019] The combination of medication and fluid can be delivered from the outlet 34 of the body 12. As used herein, the term "distal" / "first direction" can refer to a direction toward the outlet 34, and the term "proximal" / "second direction" can refer to the opposite direction. The outlet 34 can be in fluid communication with a catheter 36 or other component for delivering the combination of medication and fluid to a desired location within a patient's body cavity.

[0020] FIG. 2A to FIG. 2C An exemplary metering assembly 100 for use with a drug delivery system 10 is shown. The metering assembly 100 may include a body 112, which may have any of the characteristics of the body 12 described above. The body 112 may define a cavity or chamber 114 (see Figure 2B to Figure 2C ), which can extend from a first end / proximal end 116 of the body 112 to a second end / distal end 117 of the body 112. Near the second end 117, the wall of the body 112 can taper toward the central longitudinal axis of the cavity 114, thereby causing the cross-sectional width of the cavity 114 to also taper. For example, the wall of the body 112 can form an approximately conical shape. The cavity 114 can terminate at the second end 117 in an outlet 134, which can have any of the characteristics of the outlet 34.

[0021] The body 112 can include a protrusion 122 that can define a cavity 124 that is in fluid communication with the cavity 114 via an opening 126. The end of the cavity 124 opposite the opening 126 can define a fluid inlet 120. The protrusion 112 can be configured to connect to a fluid source. For example, the protrusion 112 can include ridges, grooves, or other features to facilitate connection with the fluid source. When the fluid source is connected to the protrusion 112, the fluid source can be in fluid communication with the fluid inlet 120, the cavity 124, the opening 126, the cavity 114, and the outlet 134.

[0022] The body 112 may also include a bracket 140, which may be defined by a wall 142 that projects radially outward from the body 112 in a direction perpendicular to the longitudinal axis of the cavity 114. The bracket 140 may be in fluid communication with the cavity 114 via the medication inlet 118. The bracket 140 of the body 112 may be configured to receive a housing 14 (or other source) storing a medication 16 ( Figure 2B to Figure 2C ). The housing 14 may include a funnel 15 and a cap 17. The cap 17 may be fixedly or removably attached to the remainder of the housing 14 via any suitable mechanism (e.g., by screwing the cap 17 onto threads on another portion of the housing 14). The funnel 15 may have an angle (between the inside surface of the funnel 15 and a line perpendicular to the longitudinal axis of the housing 14) that is greater than the angle of repose of the agent 16. The angle of repose of the agent 16 may be the angle formed by the conical pile of the agent 16 as the agent 16 flows through the orifice and accumulates on the surface of the conical pile. The angle of repose may be the angle between the surface onto which the agent 16 flows and the surface of the conical pile. The angle of repose may be related to friction between particles of the agent 16 or resistance to movement. Because the funnel 15 may have an angle that is greater than the angle of repose of the agent 16, the agent 16 may flow freely through the funnel 15 due to gravity.

[0023] The housing 14 may have an opening 141 formed at an end of the housing 14 that is received by the bracket 142. The housing 14 includes threads, grooves, ridges, or other structures for mating with corresponding features of the wall 142 or other portions of the body 112. For example, the housing 14 may be screwed into the bracket 140. When the housing 14 is received in the bracket 140, the housing 14 may be in fluid communication with the cavity 114 via the opening 141 and the medicament inlet 118.

[0024] Moving longitudinally along the cavity 114 from the first end 116 of the body 112 to the second end 117 of the body 112, the agent inlet 118 can be closest to the first end 116. The fluid inlet 120 can be between the agent inlet 118 and the outlet 134. The agent outlet 134 can be at the second end 117. The agent inlet 118 and the fluid inlet 120 can be offset from each other along the periphery of the cavity 114. For example, in addition to being longitudinally offset from each other, the agent inlet 118 and the fluid inlet 120 can be opposite to each other (e.g., opposite to each other in diameter). Alternatively, the agent inlet 118 and the fluid inlet 120 can be aligned along a longitudinal line that extends axially along the exterior of the body 112 (i.e., on the same side of the body 112, without a circumferential offset).

[0025] A plunger or other body 150 may be slidably received within the cavity 114. The combination of the plunger 150 and the body 112 (including the cavity 114) may function as a syringe. The plunger 150 may slide along the entire length of the cavity 114 having a sufficiently large cross-sectional width to receive the plunger 150. For example, the plunger 150 may slide from the portion of the cavity 114 close to the first end 116 until the tapered wall of the body 112 close to the outlet 134 prevents further advancement of the plunger 150. The surface defining the cavity 114 may alternatively have a protrusion (not shown) extending into the cavity 114 that prevents the plunger 150 from passing through the protrusion. For example, such a protrusion may extend proximally from the fluid inlet 120 / opening 126 into the cavity 114 to prevent the plunger 150 from moving distally past the fluid inlet 120 / opening 126.

[0026] Figure 2B The plunger 150 is shown in a first configuration, and Figure 2C The plunger 150 is shown in a second configuration. Figure 2B ), the distal end of the plunger 150 may be proximal to the fluid inlet 120 / opening 126, but distal to the medicament inlet 118. The plunger 150 may include a seal or may be formed of a material such as a seal that forms with a surface defining the cavity 114 (such as seal 668, which is included on the plunger 650, as described below). Therefore, when the plunger 150 is in the first configuration, the medicament 16 may not be able to enter the cavity 114 through the plunger 150. If the fluid flows through the fluid inlet 120, the fluid may be able to enter the cavity 114 and flow out of the outlet 134. Due to the seal formed between the plunger 150 and the surface defining the cavity 114, the fluid may not be able to move proximally past the plunger 150. Additionally or alternatively, the opening 126 or another portion of the metering assembly 100 may be configured to direct the fluid 120 in a generally distal direction after it enters the cavity 114, so that a significant amount of the fluid is prevented from passing proximally.

[0027] In the second form ( Figure 2C ), the distal end of the plunger 150 may be proximal to the fluid inlet 120 / opening 126 and the medicament inlet 118. Thus, both the fluid and the medicament 16 may be able to enter the cavity 114 via the fluid inlet 120 and the medicament inlet 118, respectively. When the plunger 150 is in the second configuration, the fluid may or may not flow. If the fluid flows in the second configuration, the fluid may be directed distally, as discussed above, so that in the second configuration, the fluid does not mix with the medicament 16 because the medicament 16 is located proximal to the fluid inlet 120. Alternatively, the fluid flow may be such that the fluid does mix with the medicament 16 in the second configuration (e.g., the fluid may be allowed to flow proximally).

[0028] The operation of the meter assembly 100 will now be described. FIG. 3A to FIG. 5B Various actuation mechanisms for transitioning the plunger 150 between the first and second configurations are shown. In operation, the plunger 150 may initially be used as described herein. FIG. 3A to FIG. 5B Any one of the actuating mechanisms is positioned in the first state ( Figure 2B ). In the first configuration, the fluid may not flow through the fluid inlet 120. Alternatively, the fluid may flow through the fluid inlet 120, and the fluid flow without the medicament 16 may be delivered via the outlet 134.

[0029] The plunger 150 may then be transformed into a second configuration ( Figure 2C ), wherein the medicament 16 can enter the cavity 114. The time that the plunger 150 is maintained in the second configuration (or the time that the distal end of the plunger 150 is proximal to the medicament inlet 118) can determine the amount of medicament 16 that can enter the cavity 114 via the medicament inlet 118. The desired amount of medicament 16 can form a dose of the medicament 16. When the plunger 150 is in the second configuration, the fluid may or may not enter the cavity 114 via the fluid inlet 120. As discussed above, if the fluid enters the cavity 114 when the plunger 150 is in the second configuration, the fluid may or may not mix with the medicament 16 when the plunger is in the second configuration, depending at least in part on the flow pattern of the fluid.

[0030] The plunger 150 can then be transformed back to the first configuration ( Figure 2B ). The distal end of the plunger 150 can push the medicament 16 within the cavity 114 distally toward the fluid inlet 120 / opening 126. The fluid can flow into the cavity 114 via the fluid inlet 120 / opening 126. The medicament 16 can mix with the fluid, and the combined medicament 16 and fluid can exit the cavity 114 via the outlet 134.

[0031] The fluid flow through the fluid inlet 120 can be controlled by a valve, such as a push button valve (not shown). The same actuation mechanism (e.g., actuation mechanism 30) can control the movement of both the plunger 150 and the valve, or a separate actuation mechanism can be used. For example, the actuation mechanism 30 (e.g., a trigger) can be configured to transform the plunger 150 into the second configuration ( Figure 2C ), while not yet activating fluid flow (e.g., without opening the valve). Then, the plunger 150 can be transformed into the first configuration ( Figure 2B ), and shortly before, during, or after the transition to the first form, fluid through the fluid inlet 120 may be activated to deliver the medicament 16 within the cavity 114 via the outlet 134. When the actuation mechanism 30 is released by the user, the fluid flow through the fluid inlet 120 may be stopped.

[0032] The fluid inlet 120 may have features that prevent the medicament 16 from flowing from the cavity 114 into the fluid inlet 120. For example, a filter or screen of appropriate size may be provided in the cavity 114, the opening 126, or the fluid inlet 120, which prevents the medicament 16 from flowing through the filter or screen. Additionally or alternatively, the orientation of the fluid inlet 120 may be such that gravity prevents the medicament 16 from flowing into the fluid inlet 120. For example, the fluid inlet 120 may be above the opening 126, or the opening 126 may be formed in the top surface of the body 112. The terms above, top, etc. may refer to an orientation relative to gravity, rather than the orientation depicted in the figure.

[0033] A vent (not shown) may be formed in body 112 to allow air to flow into cavity 114 when plunger 150 is pulled proximally to prevent a vacuum effect from being formed in cavity 114 due to the movement of plunger 150, which is in sealing contact with the surface defining cavity 114. Such a vent may prevent catheter 36 ( Figure 1 ) in the suction effect.

[0034] As mentioned above, FIG. 3A to FIG. 5B An exemplary actuation assembly is shown that can be used to cause the plunger 150 to move in a Figure 2B to Figure 2C Where possible, the same reference numerals are used below to represent the same structures.

[0035] FIG. 3A to FIG. 3D A first actuation assembly 200 is shown. The actuation assembly 200 can be used to move a plunger or other body 250, which can have any of the features of the plunger 150, within the cavity 114 of the metering assembly 100 in a first direction or a second direction (proximally or distally). FIG. 3C to FIG. 3D As shown, the actuator assembly 200 may include a yoke 204. The yoke 204 may be configured to move proximally and distally along the track 202 ( FIG. 3A to FIG. 3B). The yoke 204 may include a first arm 206 and a second arm 208, which may be joined by a spring 210. The spring 210 may be fixed to the ends of the first arm 206 and the second arm 208. The spring 210 may bias the first arm 206 and the second arm 208 so that the portions of the first arm 206 and the second arm 208 connected to the spring 210 are separated from each other by a predetermined distance. The function of the spring 210 will be discussed in more detail below. The arms 206, 208 may pivot about a pivot pin 211, as discussed in further detail below. Alternatively, the spring 210 and the pivot pin 211 may be omitted, and the first arm 206 and the second arm 208 may be formed of a shape memory material and / or may be joined together by any suitable structure or formed by a single integral piece of material.

[0036] The slide 214 may be disposed at the end of the arms 206, 208 opposite the end connected to the spring 210. The slide 214 may be configured to be received within the track 202. The track 202 may include an opening (not shown) to receive the arms 206, 208. The slide 214 may protrude outwardly perpendicular to the longitudinal axis of the arms 206, 208 to retain the slide 214 in the track 202. The slide 214 may be wider than the opening to prevent the arms 206, 208 from disengaging from the track 202.

[0037] The arms 206, 208 may also include a lug 216 for contacting the plunger 250. The lug 216 may protrude from the arms 206, 208 toward the other of the arms 206, 208. The lug 216 may be disposed adjacent to the slide 214. The arms 206, 208 may each be formed from a single unitary piece of material including the slide 214 and the lug 216. Alternatively, the slide 214 and / or the lug 216 may be formed from another material and fixed to the arms 206, 208.

[0038] like Figure 3A and 3BAs shown, track 202 may include two tracks 222, 224. Tracks 222, 224 may have a symmetrical shape. Tracks 222, 224 may be shaped so that tracks 222, 224 are closer to each other at the distal portion of tracks 222, 224 than at the proximal portion of tracks 222, 224. For example, tracks 222, 224 may be spaced apart by a first distance at the distal portion of tracks 222, 224. Tracks 222, 224 may be spaced apart by a first larger distance at the proximal portion of tracks 222, 224. For a portion of tracks 222, 224, tracks 222, 224 may have a constant interval (e.g., a first distance). For example, the length of tracks 222, 224 separated by a first distance may correspond to the distance that plunger 250 is to move proximally. Tracks 222, 224 may have an inflection point X, at which tracks 222, 224 bend so that the distance between tracks 222, 224 increases. The increase in distance between the tracks 222, 224 may be gradual or may be abrupt. The tracks 222, 224 may be curved, such as FIG. 3A to FIG. 3B As shown, or may be composed of a plurality of straight segments. The tracks 222, 224 may have a constant spacing (eg, a second distance) proximal to the inflection point, or the spacing of the tracks 222, 224 may vary.

[0039] The slide 214 may be slidably disposed in the tracks 222, 224 such that the slide 214 may be slidably moved proximally and distally along the tracks 222, 224. The slide 214 may be retained within the tracks 222, 224 by any suitable mechanism. For example, the tracks 222, 224 may have walls that retain the slide 214.

[0040] The spring 220 can extend from the proximal end (eg, near the flange 244) of the plunger 250. The spring 220 can be fixedly coupled to the plunger 250 and another surface of the delivery system 100 proximal to the plunger 250.

[0041] like Figure 3A As shown, in a first configuration, the slide 214 can be disposed proximate the distal ends of the tracks 222, 224, wherein the tracks 222, 224 are relatively closer together than they are at a more proximal portion of the tracks. Figure 3A The form can correspond to Figure 2A The shape of the plunger 150. Figure 3C204 in the first configuration. In the first configuration, the lug 216 may engage the plunger 250. For example, the plunger 250 may include a flange 244 extending radially outwardly from a proximal portion of the plunger 250. The lug 216 may be positioned distally of the plunger 250 (e.g., distally of the flange 244). In the first configuration, the spring 210 may be at its resting length. In the first configuration, the spring 220 may be at its relaxed length or approximately at its relaxed length. In the first configuration, the spring 220 may not exert a force on the plunger 250.

[0042] Activation of the actuation mechanism 30 (e.g., a trigger or rod) can cause the yoke 204 to move in a second direction (proximal direction), thereby traveling along the tracks 222, 224. For example, the yoke 204 can be mounted in a structure such as a rod or trigger (not shown), which can be activated / pulled by squeezing by hand or fingers. The pivot pin 211 can be used to mount the yoke 204 to the structure so that the arms 206, 208 can pivot about the pivot pin 211. The lug 216 can exert a force on the flange 244 or another portion of the plunger 250 in the second direction (proximal direction). The force of the lug 216 on the plunger 250 can cause the plunger 250 to move in the second direction with the yoke 204. The plunger 250 can exert a force on the spring 220, causing the spring 220 to compress. When the plunger 250 moves proximally, the medicament 16 can begin to flow through the medicament inlet 118, as described above with respect to FIG. 2A to FIG. 2C described.

[0043] When the yoke 204 reaches the inflection point X, the arms 206, 208 of the yoke 204 can begin to separate from each other and pivot about the pivot pin 11. When the arms 206, 208 are sufficiently separated, the lug 216 will stop contacting the flange 244 or another portion of the plunger 250, such as Figure 3B and Figure 3D Just before contact is lost between lug 216 and flange 244, plunger 250 may be in a position similar to Figure 2C In the configuration of the middle plunger 150, the spring 210 may be compressed so that it has a shorter length than its relaxed state.

[0044] Figure 3B 2 shows a second configuration of the actuation mechanism 200 after the lug 216 has lost contact with the plunger 250. Once the lug 216 no longer exerts a force on the plunger 250, the force from the compression spring 220 can push the plunger 250 in the first direction (distal direction), as shown in FIG. Figure 3B The force of the spring 220 can cause the plunger 250 to transform back to a position corresponding to the shape of the plunger 150, as shown in FIG. Figure 2B This action may cause the agent 16 to mix with the fluid, as described above with respect to FIG. 2A to FIG. 2CMovement of the plunger 250 in the first direction may cease once the spring 220 is in a relaxed state (and no longer exerts a force on the plunger 250), once the plunger 250 contacts a stop mechanism (not shown), or due to some other condition.

[0045] When the actuation mechanism 30 is released, the yoke 204 can move in the first direction (distal). The slide 214 can travel through the tracks 222, 224 in the first direction. The spring 210 can expand, thereby returning to its natural length. The yoke 204 can then reengage the plunger 250. For example, the lug 216 can be flexible or bendable only in the second direction and include a shape memory material or spring so that when the lug 216 passes the flange 244 of the plunger 250, the lug 216 temporarily squeezes the arms 206, 208 until the lug 216 passes the flange 244 of the plunger 250. Due to the shape memory property or the spring, the lug 216 can then return to its expanded configuration. The lug 216 can then engage with the plunger 250 or another portion of the plunger 250 on the far side of the flange 44. Alternatively or additionally, the geometry of the yoke 204 and the plunger 250 can be such that the lug 216 can slide past the flange 244. Once the lug 216 is engaged with the plunger 250, the actuation assembly 200 can be again in Figure 3A In the first form (corresponding to Figure 2B The position of the middle plunger 150).

[0046] FIG. 4A to FIG. 4C Another actuation assembly 300 is shown. The actuation assembly 300 can be used to move a plunger or other body 350 proximally or distally within the cavity 114 of the metering assembly 100, which can have any of the features of the plungers 150 or 250. The actuation assembly 300 can include a circular gear 302. The gear 302 can have a toothed portion 304 and a smooth portion 306. Figure 4A As shown, the toothed portion 304 and the smooth portion 306 can each occupy approximately half of the circumference of the gear 302. Alternatively, the toothed portion 304 and the smooth portion 306 can occupy different proportions of the circumference of the gear 302. Although one toothed portion 304 and one smooth portion 306 are shown in FIG. 4, other numbers of toothed portions 304 and smooth portions 306 can also be used.

[0047] The plunger 350 may include teeth 360 configured to mesh with the teeth of the toothed portion 304. FIG. 4A to FIG. 4CAs shown, the teeth 360 may extend along only a portion of the length of the plunger 350. Alternatively, the teeth 360 may extend along the entire length of the plunger 350. The teeth 360 may be formed on only one side of the plunger 350 (the side facing the gear 302) or may surround the entire plunger 350. The spring 320 may be attached to the end of the plunger 350 opposite the distal end 342 of the plunger 350 (i.e., the proximal end of the plunger 350). The second end of the spring 320 may be fixedly coupled to another portion of the delivery system 10.

[0048] The gear 302 may be disposed between the main body 140 and the housing 14 ( FIG. 2A to FIG. 2C The side opposite to the main body 140 below) ( Figure 2A-2C ). An opening (e.g., a longitudinal opening or slit) can be formed through the wall of the body 140 so that the gear 302 can extend through the wall and into the cavity 114 where the plunger 350 is located. Alternatively, the teeth 360 of the plunger 350 can extend through the opening.

[0049] A protrusion 346 of the plunger 350 proximal to the distal portion 342 of the plunger 350 and proximal to the tapered tip of the plunger 350 can have a larger cross-section than the remainder of the plunger 350 proximal to the protrusion 346. The protrusion 346 may include a recess 348. The recess 348 may receive a seal 362, such as an O-ring seal. The seal 362 may prevent unwanted movement of the medicament 16 or fluid. Alternatively, the protrusion 346 or other portion of the plunger 350 may receive the seal. Although one protrusion 346 and seal 362 are shown, the plunger 350 may also include other protrusions and seals (e.g., proximal to the tooth 360). As described with respect to FIG. 2A to FIG. 2C As described, the positioning of the seal can be selected to facilitate the flow of medicament 16 and fluid. The distal portion 342, the tapered tip 344 and / or the projection 346 can include rubber or other materials that provide a gasket-like or O-ring-like seal with a surface that receives the cavity 14 (or alternative features) of the plunger 350.

[0050] Before the user activates the actuation mechanism 30, the plunger 350 may be in a Figure 4A The form shown in , which corresponds to Figure 2B The configuration of the middle plunger 150. The gear 302 can be positioned so that when the gear 302 begins to rotate clockwise, the toothed portion 304 will mesh with the teeth 360. The spring 320 can be in a natural position at its natural length.

[0051] When the user activates the actuation mechanism 30, the gear 302 may begin to rotate about its axis. The toothed portion 304 may mesh with the teeth 360, thereby exerting a force on the plunger 350 in the second (proximal) direction, causing the plunger 350 to move in the second (proximal) direction. As the plunger 350 moves in the second direction, it may compress the spring 320, which may exert a restoring force on the plunger 350 in the first direction. The plunger 350 may continue to move in the second direction until it reaches Figure 4B form. Figure 4B The form can correspond to Figure 2C After the tip 344 is proximal to the medicament inlet 118, the medicament 16 can begin to flow into the cavity 114, as discussed above.

[0052] As gear 302 continues to rotate, the last tooth of toothed portion 304 may disengage from tooth 360, and smooth portion 306 may face plunger 350. Figure 4C As shown, the restoring force of the spring 320 can exert a force on the plunger 350 in the first direction, thereby causing the plunger 350 to move in the first direction until it reaches the position corresponding to the plunger 350 again. Figure 2B The form shown in the plunger 150 in the first direction. The movement of the plunger 350 in the first direction can push the medicament 16 in the first direction. The actuation mechanism 30 can be configured so that when the plunger 350 moves in the first direction, the fluid flow through the fluid inlet 120 is initiated. As described above, the medicament 16 can be combined with the fluid from the fluid inlet 120 and can be delivered via the outlet 134.

[0053] After the actuation mechanism 30 is released, the gear 302 can return to a configuration in which the toothed portion 304 is ready to engage the teeth 360. For example, a ratchet mechanism can be used to position the gear 302 in a position in which the gear 302 is in a position in which the toothed portion 304 is ready to engage the teeth 360. Figure 4A Alternatively, the gear 302 may continue to rotate as the plunger 350 moves in the first direction, and may be configured to align the toothed portion 304 in the Figure 4A 302 is in the position such that when the actuation mechanism 30 is activated again, the toothed portion 304 will engage the teeth 360. Alternatively, the gear 302 may be biased to return the gear 302 to the Figure 4A The form shown.

[0054] FIG. 5A to FIG. 5B Another actuation assembly 400 is shown. The actuation assembly 400 can be used to move a plunger or other body 450 proximally or distally within the cavity 114 of the metering assembly 100, which can have any of the features of the plungers 150, 250, or 350, such as FIG. 2A to FIG. 2C shown.

[0055] The actuation assembly 400 may include an arm 402. The arm 402 may have a finger 404 that protrudes substantially perpendicularly from the longitudinal axis of the arm 402. The finger 404 may be configured to engage with a surface of a plunger 450. For example, the plunger 250 may include a flange 444 at the proximal end of the plunger 250. The finger 404 may be positioned distal to the flange 444 so that when the arm 402 moves proximally, it engages with the flange 444 and exerts a force on the flange 444, thereby pulling the plunger 450 proximally. The arm 402 may be attached to an actuation mechanism, such as the actuation mechanism 30, which may include a trigger, a rod, or other structure. When the actuation mechanism 30 is activated, the arm 402 may move in a second direction via, for example, a trigger or a rod.

[0056] The actuator assembly 400 may also include a guide 410. The guide 410 may be an elongated member extending along the longitudinal axis, or may be a surface of the body 112. The guide 410 may extend generally parallel to the arm 402. The guide 410 may include a protrusion 412, which may extend toward the arm 402. The protrusion 412 may have a rounded surface, such as FIG. 5A to FIG. 5B As shown, or may have an alternative shape. The shape of the protrusion 412 may be selected to interact with the finger 404 as described below.

[0057] The spring 460 can be secured to a portion of the arm 402, such as a portion of the arm 402 proximal to the finger 404. As discussed in further detail below, the spring 460 can be configured to deliver a force in a direction transverse to the longitudinal axis of the plunger 450 and / or the guide 410. The spring 420 can be secured to the proximal end of the plunger 450 and can have any of the properties of the springs 220, 320 described above.

[0058] In operation, before a user activates the actuation mechanism 30, the actuation assembly 400 may be in a Figure 5A In the first form, it can correspond to Figure 2B The springs 420, 460 can be in a relaxed state at their natural length.

[0059] The user can activate the actuation mechanism 30 so that the arm 402 moves in the second direction (proximally), as described above. The fluid can begin to flow through the fluid inlet 120, or the fluid flow can be delayed until the time described below. When the arm 402 moves in the second direction, the finger 404 can contact the flange 444 (or another part of the plunger 450), thereby applying a force on the plunger 450 in the second direction. The plunger 450 can move in the second direction with the arm 402. When the plunger 450 moves in the first direction, the plunger 450 can compress the spring 420. As shown, if the spring 460 is aligned so that the part of the spring 460 extends parallel to the arm 402, the movement of the arm 402 can also compress the spring 460. Initially, the guide 410 including the protrusion 412 may not interfere with the movement of the arm 402. When the plunger 450 moves proximally through the medicament inlet 118, the medicament 16 can begin to flow through the medicament inlet 118.

[0060] When the finger 404 encounters the protrusion 412 of the guide 410, the protrusion 412 can exert a force on the finger 404, which causes the finger 404 to move in a direction transverse to the longitudinal axis of the plunger 450 (at least partially in a downward direction in the figure). Figure 5B As shown, such movement of the finger 404 may cause the finger 404 to disengage from the flange 444 (or another portion of the plunger 450). Because the finger 404 is no longer in contact with the plunger 450, it may no longer exert a force on the plunger 450. When the finger 404 disengages from the plunger 450, the position of the plunger 450 may correspond to Figure 2C The position of the middle plunger 150.

[0061] The restoring force of the spring 420 can move the plunger 450 in a first (distal) direction (to the left in the figure). The plunger 450 can contact the medicament 16 that has passed through the medicament inlet 18, thereby pushing the medicament 16 distally toward the fluid inlet 120 until the spring 420 is in its natural length again (for example, when the position of the plunger 450 corresponds to Figure 2B At about this time, fluid may begin to flow through the fluid inlet 120, such that the medicament 16 may combine with the fluid from the fluid inlet 120 and may pass through the outlet 134. The actuation mechanism 30 may be released, and the fluid flow through the fluid inlet 120 may be stopped. The spring 460 may exert a restoring force on the arm 402, so that when the arm 402 returns to the Figure 5A After the position shown, the finger 404 can be disengaged from the plunger 450 (e.g., flange 444). Alternatively, the arm 402 can be biased to Figure 5A The illustrated configuration is formed of a flexible, elastic material or shape memory material (eg, a long flexible material).

[0062] FIG. 6A to FIG. 6B Another exemplary metering assembly 500 for use with the drug delivery system 10 is shown. The metering assembly 500 can include a body 512, which can have any of the characteristics of the above-described bodies 12, 112. The body 512 can be configured to receive a housing 14 (or other source) storing a drug 16. The body 512 can include threads, grooves, ridges, or other features for mating with corresponding features of the housing 14.

[0063] A first cavity or chamber 546 can be formed in the body 512. The first cavity 546 can be in fluid communication with an outlet, such as the outlet 34. The nozzle 544 can include an opening 545. The internal chamber of the nozzle 544 can be in fluid communication with the first cavity 546 via the opening 545. The nozzle 544 can be disposed within the first cavity 546 or can be otherwise in communication with the first cavity 546. The nozzle 544 can receive fluid from an inlet (e.g., the fluid inlet 120). The fluid flow entering the nozzle 544 can be controlled by a valve 540, such as a button valve, which can control the passage of fluid into the passage 542 in fluid communication with the nozzle 544. The valve 540 can be opened by depressing a trigger 548. The trigger 548 can compress a spring 550, which can exert a force on a button 552, which can open the valve 540.

[0064] The trigger 548 may also be connected to an arm 560 that may pivot about point Y. The arm 560 may be connected to a slider, piston, plunger, or other body 562 via a hinge or similar structure. An opening 564 may be formed in the slider 562. The slider 562 may be slidably received in a second cavity or chamber 514 of the body 512. The second cavity 514 may have a longitudinal axis extending parallel or substantially parallel to the longitudinal axis of the first cavity or chamber 546. The second cavity 514 may be in fluid communication with the housing 14 via a medicament inlet 518. A wall 572 may separate the first cavity 546 from the second cavity 514. An opening 570 may be formed in the wall 572 so that the first cavity 546 is in fluid communication with the second cavity 514. The opening 570 may be longitudinally aligned or substantially aligned with the opening 545 of the nozzle 544. The opening 570 may be proximal to the medicament inlet 518.

[0065] When trigger 548 is depressed or released, arm 560 can rotate about point Y. Slider 562 can move in a second direction (proximally) or in a first direction (distally) via its pivot connection with arm 560. Fig. 6A ), the opening 564 can be in fluid communication with the drug inlet 518. In other embodiments ( Figure 6B ), the opening 564 can be fluidically connected to the opening 570.

[0066] Fig. 6AThe metering assembly 500 is shown in a first configuration. In the first configuration, the opening 564 in the slider 562 can be aligned with the medicament inlet 518 or otherwise fluidly connected so that the medicament 16 can flow into the opening 564. The slider 562 can be sized so that the slider 562 has a substantially same cross-sectional width as the second cavity 514. Additionally or alternatively, the slider 562 or the second cavity 514 can include a seal disposed thereon. Thus, the medicament 16 may not move along the sides of the slider 562 within the second cavity 514. Thus, the medicament 16 can be captured within the opening 564. In the first configuration, the trigger 548 can be depressed.

[0067] The delivery system 10 can optionally be shipped with the metering assembly 500 in a first configuration, wherein the trigger 548 is depressed via a collar or other mechanism, thereby compressing the spring 550. Thus, the delivery system 10 can optionally be shipped with a dose of the medicament 16 disposed within the opening 564. Prior to use (e.g., prior to connection to a source of pressurized fluid), the user can remove the collar, which can cause the spring 550 to return to its natural length, thereby returning the trigger 548 to an undepressed state, and converting the metering assembly 500 to a first configuration. Figure 6B The second form. The opening 564 can move proximally from the fluid inlet 518 to the opening 570 of the wall 572 along with the medicament 16 received in the opening 564. Thus, the opening 564 can shuttle the medicament 16 from the fluid inlet 518 to the opening 570. Figure 6B In the second form, the opening 564 can be aligned with the opening 570 of the wall 572 or otherwise fluidly connected. In the second form, the dose of the medicament 16 can enter the opening 570 from the opening 564 and enter the first cavity 546 near the opening 545 of the nozzle 544.

[0068] In both the first and second configurations, the housing 14 may not be in fluid communication with the nozzle 544 (which is a fluid source). The medicament 16 may be shuttled through the opening 564, but the opening 564 and other components of the metering assembly 500 may be configured such that the housing 14 is never in fluid communication with the fluid source (e.g., the nozzle 544).

[0069] Alternatively, the delivery system 10 can be shipped in the second configuration, wherein the trigger 548 is not depressed, and no medicament can be received within the opening 564. As described above, the user can depress the trigger 548 to initially place the metering assembly 500 in the first configuration to allow a dose of the medicament 16 to enter the opening 564. For example, the user can transform the metering assembly 500 into the first configuration before connecting the delivery system 10 to a fluid source, such that fluid flow is prevented when the trigger is depressed. Alternatively, if the fluid source is connected to the delivery system 10 before the metering assembly 500 is first transformed into the first configuration, then when the metering assembly 500 is transformed into the first configuration (depressing the trigger 548 causes the valve 540 to open, as discussed above), no fluid flow of the medicament 16 can pass through the outlet 34. Then, the trigger 548 can be released to transform the metering assembly 500 into the second configuration and shuttle a dose of the medicament 16 into the first chamber 546, as described above.

[0070] As a further alternative, a valve (not shown) may be present in the cavity 546 (e.g., proximate the outlet 34). The valve may prevent the flow of the medicament 16 through the valve. During manufacturing, the trigger 548 may be depressed once and then released (causing the metering assembly 500 to transform into the first configuration and then return to the second configuration), thereby causing a dose of the medicament 16 to be present in the cavity 546. The dose of the medicament 16 may be prevented from leaving the outlet 34 until the trigger 548 is depressed by the user causing fluid flow, as described in further detail below. The fluid flow may cause the valve to open.

[0071] Once a dose of medicament 16 is deposited in cavity 546 as a result of the above actions, the user can depress trigger 548 while delivery system 10 is connected to a fluid source, thereby placing metering assembly 500 in the first configuration ( Fig. 6A ). Depressing the trigger 548 can cause the valve 540 to open, as described above. The fluid can flow through the nozzle 544 and out of the opening 545, into the chamber 546, where the fluid can combine with the dose of the medicament 16. The combined fluid and medicament 16 can then pass through the outlet 34 to be delivered to the treatment site (via, for example, the catheter 36). At the same time, another dose of the medicament 16 can enter the opening 564, as described above. When the trigger 548 is released (and the metering assembly 500 is converted to Figure 6B ), the dose of medication 16 can enter the cavity 546 so that when the trigger 548 is pressed again, the next dose of medication 16 will be delivered, as described above.

[0072] exist Fig. 6A and Figure 6B570. In an alternative configuration (not shown), the opening 570 may be distal to the medicament inlet 518. In such a configuration, when the trigger 548 is not depressed, the opening 564 may be in fluid communication with the medicament inlet 518, thereby allowing a dose of the medicament 16 to enter the opening 564. When the trigger 548 is depressed, the opening 564 may slide in a first direction (distal) such that the opening 564 is in fluid communication with the opening 570, thereby delivering the dose of the medicament 16 to the first chamber 546. The opening of the valve 540 upon depression of the trigger 548 may be timed so that fluid will begin to flow once the dose of the medicament 16 has been delivered to the first chamber 546, or fluid flow may begin before or during delivery of the dose of the medicament 16 to the first chamber 546 (sealing of portions of the metering assembly 500 may prevent fluid from flowing through the second chamber 572).

[0073] Fig. 7A and 7B Another example metering assembly 600 is shown. The metering assembly 600 can have any of the characteristics of the metering assemblies 100, 500 described above. The metering assembly 600 can include a plunger 650, which can have the characteristics of the plunger 150 described above. The plunger 650 can be actuated by an arm 660 having a trigger 648, which can have any of the characteristics of the arm 560 and the trigger 548, respectively. Alternatively, the actuation assembly 200, 300, 400 can be used in conjunction with the plunger 650.

[0074] The meter assembly 600 can include a body 612 that can have any of the characteristics of the above-described bodies 12, 112, 512. The body 612 can be configured to receive the housing 14 by any of the mechanisms described above with respect to the bodies 12, 112, 512. A first cavity or chamber 614 can be formed in the body 612. The longitudinal axis of the cavity 614 can extend substantially perpendicular to the longitudinal axis of the housing 14.

[0075] The plunger 650 can be slidably received within the cavity 614. The plunger 50 can include a hole 664 formed therein. The longitudinal axis of the hole 664 can extend substantially parallel to the longitudinal axis of the housing 14 and substantially perpendicular to the longitudinal axis of the cavity 614. The hole 664 can extend through the entire plunger 650, substantially perpendicular to the longitudinal axis of the plunger 650. A seal 668 can be provided around the outer periphery of the plunger 650. Each seal 668 can be, for example, assembled around a groove 670 formed on the outer surface of the plunger 650. The seal 668 can have characteristics (e.g., material and size) such that the plunger 650 can slide within the cavity 614, but fluid, medicament 16 or other materials cannot pass between the seal 668 and the surface defining the cavity 614.

[0076] The plunger 650 can be moved from a first state (see Fig. 7A ) moves to the second form (see Figure 7B ). Similar to arm 560, arm 660 can rotate about axis Y. Arm 660 can be pivotally connected to plunger 650 via, for example, a hinge. For example, openings in arm 660 and plunger 650 can couple arm 660 to plunger 650. When arm 660 rotates about axis Y, plunger 650 can move along the longitudinal axis of cavity 614 / plunger 650. Plunger 650 can be prevented from moving in other directions (e.g., radially) by the walls defining cavity 614.

[0077] The trigger 648 can be operated to control fluid flow, as described in further detail below. For example, the valve 640 can have any of the characteristics of the valve 540. The valve 640 can be opened by depressing the trigger 648. The trigger 648 can compress the spring 651, which can exert a force on the button 652, which can open the valve 640.

[0078] The metering assembly 600 may also include a mixing assembly 680 to facilitate mixing of the medicament 16 with the fluid. The mixing assembly 600 may include a first nozzle 682 that receives fluid from the fluid inlet 620. The fluid inlet 620 may be in fluid communication with a passage 642 extending from a valve 640. The valve 640 may control the fluid flow through the fluid inlet 620. The fluid may enter the nozzle 682 from the fluid inlet 620 and enter a mixing chamber 684. The mixing chamber 684 may be in fluid communication with the cavity 614 via a passage 692, depending on the position of the plunger 650, as discussed below. As discussed in further detail below, the fluid from the fluid inlet 620 and the medicament 16 may be combined together in the mixing chamber 684. The combined fluid and medicament 16 may be discharged through a second nozzle 686 at the outlet 634.

[0079] In operation, when the trigger 648 is not depressed by the operator, the plunger 650 may be in Fig. 7A 618 and the housing 14. The medicament 16 can flow through the medicament inlet 618 and into the opening 664, where it can be captured. In the configuration in which the trigger 648 is not depressed, the mixing assembly 680 including the fluid inlet 620 may not be in fluid communication with the medicament inlet 618 (or the housing 614). The seal 668 may cause or contribute to the lack of fluid communication.

[0080] Depressing the trigger 648 can cause fluid to flow through the valve 640 and through the fluid inlet 620. Depressing the trigger 648 can also cause the fluid to flow through the valve 640 and through the fluid inlet 620. FIG. 7A to FIG. 7B The left side of the piston 650 is transformed into Figure 7BWhen the plunger 650 moves distally, the medicament 16 that has flowed into the opening 664 and is captured by the opening 664 can move distally, carried by the distal movement of the opening 664. Figure 7B In the second configuration, the opening 664 can be aligned with the passage 692 so that the opening 664 is in fluid communication with the passage 692 and thus with the mixing chamber 684. The agent 16 captured by the opening 664 can flow from the opening 664 through the passage 692 and into the mixing chamber 684. There, it can combine with the fluid from the fluid inlet 620. The combined fluid and agent 16 can pass through the outlet 634.

[0081] With the first form ( Fig. 7A ) is the same as the medicine inlet 620 in the second state ( Figure 7B ) is not in fluid communication with the housing 14. The plunger 650 including the seal 668 can prevent the flow of medication or fluid between the housing 14 and the fluid inlet 620 in any configuration of the metering assembly 600. Although the opening 664 can be used to shuttle medication 16 between the housing 14 and the mixing chamber 684, the housing 14 and the mixing chamber 684 may never be in fluid communication.

[0082] The components of the metering assembly 600, including the trigger 648, the plunger 650, and the valve 640, can be configured to appropriately time the release of the medicament 16 and / or fluid into the mixing chamber 684. For example, the fluid can flow through the fluid inlet 620 before, after, or simultaneously with the initial flow of the medicament 16 into the mixing chamber 684.

[0083] In an alternative embodiment, when the trigger 648 is not depressed, the plunger 650 can be in a configuration such that the opening 664 is not aligned with and in fluid communication with the medication inlet 618. For example, the plunger 650 can be displaced to Fig. 7A 664 is positioned to the right of the position shown, so that the opening 664 is proximal to the medicament inlet 618. When the trigger 648 is depressed, the opening 664 can move distally (to the left in the figure) until the opening 664 begins to overlap with the medicament inlet 618, at which point the medicament 16 can begin to flow into the opening 664. The medicament 16 can continue to flow into the opening 664 until the opening 664 no longer overlaps with the medicament inlet 618 (when the entire opening 664 is distal to the medicament inlet 618). As described above, the opening 664 can continue to move distally until the opening 664 is aligned with the passage 692. In such an alternative configuration, the medicament 16 may never come to rest within the opening 664 because the opening 664 may move distally while the powder 16 flows into the opening 664.

[0084] Although the principles of the present invention are described herein with reference to illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skills in the art and access to the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A device for delivering a drug, comprising: a body, the body comprising a cavity; a housing configured to store a medicament, the housing being coupled to the body; a movable body slidably received within the cavity, the movable body being configured to move within the cavity and relative to the cavity; as well as a fluid inlet configured to receive a fluid, the fluid inlet being in fluid communication with the cavity; Wherein, in the first form of the body, the movable body is positioned relative to the cavity to allow the medicine stored in the housing to enter the cavity and allow the fluid to enter the cavity from the fluid inlet, thereby forming a mixture of the medicine and the fluid in the cavity.

2. The device of claim 1, wherein the housing is configured to be removably attached to the body, wherein the body includes a bracket configured to receive the housing via one or more fastening mechanisms. 3 . The device of claim 1 , wherein the fluid inlet comprises a filter configured to prevent the medicament received within the cavity from entering the fluid inlet.

4. The device of claim 1, wherein the housing includes a funnel angled radially inwardly toward a medication inlet fluidly connecting the housing to the cavity, the funnel configured to direct the medication toward the medication inlet via gravity.

5. A device according to claim 1, wherein in the second form, the movable body is configured to guide a first portion of the fluid received in the cavity to flow proximally toward the agent received by the housing to form a mixture; and guide a second portion of the fluid received in the cavity to flow distally toward an outlet to guide the mixture out of the cavity.

6. A device according to claim 1, wherein the movable body is configured to form a seal with the inner surface of the cavity, so that in the first form, the movable body can prevent the agent from entering the inner cavity via the seal formed with the inner surface, and at the same time prevent the fluid from entering the shell.

7. The device of claim 1, wherein the cavity comprises one or more protrusions disposed adjacent to the fluid inlet, and wherein in the second form, the one or more protrusions are configured to contact the movable body to prevent the movable body from moving above the fluid inlet.

8. The apparatus according to claim 1, further comprising: An actuator is configured to move the movable body relative to the cavity to control fluid flow through the fluid inlet.

9. The device of claim 8, wherein the actuator is configured to transform the movable body from the first configuration to the second configuration by moving the movable body distally in a first direction relative to the lumen; and Wherein the actuator is configured to transform the movable body from the second configuration to the first configuration by moving the movable body proximally relative to the cavity in a second direction opposite to the first direction.

10. The device of claim 9, wherein when the movable body is in the second configuration, the actuator is configured to control the amount of medicament flowing from the housing to the cavity by maintaining the movable body in the second configuration for a predetermined duration.

11. The device according to claim 1, wherein when the movable body moves distally to the second form, the movable body is configured to push the agent received in the cavity toward the fluid inlet to mix with the fluid in the cavity, thereby directing the mixture of the agent and the fluid toward the outlet.

12. A device for delivering a drug, comprising: a body, the body comprising a cavity; a housing coupled to the body and configured to store a medicament; a movable body slidably received within the cavity; as well as an actuation assembly configured to transform the movable body from a first configuration toward a second configuration, the actuation assembly comprising: a yoke configured to move along a pair of tracks; as well as A first spring is connected to the movable body and is configured to move the movable body within the cavity, wherein the first spring is configured to exert no force on the movable body when the movable body is in the first configuration.

13. The device according to claim 12, wherein: The yoke comprises: a first arm and a second arm, the first arm and the second arm being connected to each other by a second spring, wherein the second spring is configured to bias the first arm to maintain a predetermined distance from the second arm; and A pair of slides, the slides are slidably disposed in the pair of tracks, the pair of slides comprising a first slide disposed at one end of the first arm and a second slide disposed on the second arm, wherein the pair of slides are configured to be received in the pair of tracks so that the yoke moves along the pair of tracks.

14. The device of claim 13, wherein the first arm comprises a first lug protruding from a side of the first arm opposite to an end of the first arm; the second arm comprises a second lug protruding from a side of the second arm opposite to an end of the second arm, wherein: The first lug and the second lug are configured to contact the movable body.

15. The apparatus of claim 14, wherein the pair of tracks comprises a first track and a second track that are symmetrical to each other, wherein the first track and the second track each comprise a first portion and a second portion; and wherein first portions of each of the first track and the second track are spaced apart from each other by a first distance at a distal end of the pair of tracks, and second portions of each of the first track and the second track are spaced apart from each other by a second distance at a proximal end of the pair of tracks, wherein, The first distance is smaller than the second distance.

16. The device of claim 15, wherein when the actuating assembly is activated, the yoke is configured to move along the pair of tracks in response to expansion of the first spring, so that the first lug and the second lug are configured to apply a force to the movable body, thereby causing the movable body to move within the cavity.

17. The device of claim 15, wherein when the actuation assembly is released, the first spring is configured to apply a force to the movable body to move it within the cavity, thereby causing the medicament and the fluid to mix within the cavity.

18. A device for delivering a drug, comprising: a body, the body comprising a cavity; a housing coupled to the body and configured to store a medicament; a movable body slidably received within the cavity; as well as an actuation assembly configured to transform the movable body from a first configuration toward a second configuration, the actuation assembly comprising: Gears that can rotate; a spring connected to the movable body and configured to move the movable body within the cavity; and The movable body includes a plurality of teeth configured to mesh with the rotatable gear, thereby causing the movable body to move within the cavity in response to rotation of the rotatable gear.

19. The device according to claim 18, wherein: The rotatable gear comprises at least a first portion and a second portion; and Wherein the first portion comprises a plurality of teeth, and the second portion comprises a smooth outer surface.

20. The device of claim 19, wherein when the actuation assembly is activated, the rotatable gear is configured to rotate and the plurality of teeth on the first portion are configured to engage with the plurality of teeth of the movable body, thereby moving the movable body within the cavity until the plurality of teeth are disengaged from the plurality of teeth of the movable body; and Wherein when the actuation assembly is released, the spring is configured to move the movable body to mix the medicament and the fluid within the cavity for delivery via the outlet.

21. A device for delivering a drug, comprising: a housing configured to store a medicament; a chamber configured to receive the medicament through the medicament inlet of the housing; a metering member received in a cavity disposed between the chamber and the housing; wherein when the metering member is in the first configuration, the metering member is positioned relative to the medicament inlet to allow the medicament to enter the opening of the metering member and prevent the medicament from entering the chamber; as well as When the metering member is in the second configuration, the metering member is positioned relative to the chamber to allow the medicament deposited in the metering member opening to enter the opening of the chamber and to allow fluid from the fluid inlet to enter the chamber, thereby forming a mixture of the medicament and the fluid in the chamber.

22. The device according to claim 21, wherein When the metering member is in the first configuration: The opening of the metering member is aligned with the medicine inlet, thereby allowing the medicine to enter the cavity; as well as The opening of the metering member is not aligned with the opening of the chamber, thereby preventing the medicament from entering the chamber.

23. The device according to claim 21, wherein When the metering member is in the second configuration: The opening of the metering member is aligned with the opening of the chamber so that the medicine deposited in the opening of the metering member can enter the chamber; The opening of the metering member is not arranged in alignment with the medicament inlet, thereby preventing the medicament from entering the cavity.

24. The apparatus according to claim 21, further comprising: a nozzle disposed at a proximal end of the chamber, the nozzle comprising a fluid inlet configured to receive a fluid; as well as An outlet is disposed at a distal end within the chamber, the outlet being configured to deliver at least one of a fluid received from the fluid inlet or a mixture of the fluid and the medicament.

25. The apparatus of claim 21, further comprising: an actuator configured to transition the metering mechanism between the first configuration and the second configuration; as well as An arm is operably connected to the actuator, the arm being configured to move the metering member within the cavity in response to release of the actuator.

26. The device of claim 25, wherein the actuator comprises a spring configured to apply a force to a trigger of the arm.

27. The device of claim 25, wherein the actuator is configured to transition the metering member between the first configuration and the second configuration upon a single actuation.

28. The device according to claim 27, wherein In response to the single actuation, the actuator is configured to: (1) release a first amount of fluid while transitioning the metering member toward the second configuration; (2) releasing the mixture of the medicament and the fluid when the metering member is transformed toward the first configuration; and wherein in response to ceasing the single actuation, the actuator is configured to transition the metering member from the second configuration toward the first configuration and cease releasing the mixture through the outlet.

29. The device of claim 25, wherein the actuator is configured to transition the metering member between the first configuration and the second configuration upon a plurality of actuations; wherein in response to a first actuation of the plurality of actuations, the actuator is configured to release a first amount of fluid from the nozzle; wherein in response to a second actuation of the plurality of actuations, the actuator is configured to transition the metering member from the first configuration toward the second configuration such that an opening of the metering member is aligned with the medicament inlet and the chamber, thereby enabling the medicament to mix with the fluid in the chamber; and Wherein in response to a third actuation of the plurality of actuations, the actuator is configured to transition the metering member from the second configuration toward the first configuration, thereby delivering the mixture of the medicament and the fluid out of the device via an outlet.

30. A device for delivering a medicament, comprising: a body, the body comprising a cavity; a housing connected to the body and configured to store a medicament; a movable body slidably received within the cavity; as well as an actuation assembly configured to transform the movable body from a first configuration toward a second configuration, the actuation assembly comprising: an arm including fingers; and a first spring connected to the movable body, the first spring being configured to contract and expand according to movement of the movable body; The movable body includes a surface configured to engage the finger such that the movable body moves within the cavity in response to movement of the arm in at least one of a proximal direction or a distal direction.

31. The device of claim 30, wherein the finger projects radially outward from the arm distal to the surface of the movable body, wherein the surface of the movable body includes a flange disposed at a distal-most end of the movable body.

32. The apparatus of claim 31 , further comprising: a guide extending parallel to the arm, the guide including a protrusion extending toward the arm and configured to apply a force to the finger to cause the finger to move laterally relative to a longitudinal axis of the movable body; as well as A second spring is secured to the arm, the second spring being configured to provide a force transverse to the longitudinal axis of the movable body.

33. The apparatus of claim 32, further comprising: an actuation member configured to move the arm proximally, thereby bringing the arm into contact with the flange and allowing fluid to flow through the fluid inlet; wherein the actuation member is configured to move the arm and the movable body proximally such that the movable body is configured to compress the first spring and the arm is configured to compress the second spring; as well as The movable body is configured to allow the medicament to flow through the medicament inlet and into the cavity in response to moving proximally and past the medicament inlet of the housing.

34. The device of claim 32, wherein the first spring is configured to move the movable body distally toward a fluid inlet in response to the projection applying a force to the finger to mix the medicament with a fluid in the cavity.

Citation Information

Patent Citations

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