Drug delivery system

Abstract

A medical device includes a container for storing a medication; an agitator positioned adjacent to or within the container and configured to oscillate relative to the container; and an outlet having a first end in fluid communication with the container and a second end in fluid communication with a passageway of a delivery tube. Oscillation of the agitator causes the medication to move toward the outlet.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 957,540, filed on January 6, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] Aspects of the present invention generally relate to drug delivery systems, devices, and related methods. More specifically, at least some embodiments of the present invention relate to, among other aspects, systems, devices, and related methods for metering a dose of a therapeutic agent delivered to a target treatment site. Background Art

[0004] During certain medical procedures, it may be necessary to stop or minimize bleeding in the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the gastrointestinal tract, such as the esophagus, stomach, or intestines.

[0005] During an endoscopic procedure, a user inserts an endoscope sheath into a patient's body cavity. The user controls the endoscope using the endoscope handle during the procedure. Tools are passed through the endoscope's working channel, for example, via a port in the handle, to deliver therapy to a surgical site near the distal end of the endoscope. The surgical site is distal to the operator.

[0006] To achieve hemostasis at a distal site, a hemostatic agent may be delivered. For example, delivery of the agent can be accomplished by utilizing a pressurized fluid system. However, such a system can make it difficult to control the agent delivery rate. Consequently, the desired agent delivery rate or desired agent dosage may not be achieved, which may result in the agent clogging portions of the delivery device, inconsistent agent dosage, or the agent failing to reach the treatment site deep within the GI tract. The present invention may address one or more of these and other issues in the art. Summary of the Invention

[0007] Aspects of the present invention relate, among other things, to systems, devices, and methods for metering the delivery of a dose of a medicament.Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0008] According to one example, a medical device includes a container for storing a medication; an agitator positioned adjacent to or within the container and configured to oscillate relative to the container; and an outlet having a first end in fluid communication with the container and a second end in fluid communication with a passageway of a delivery tube. Oscillation of the agitator causes the medication to move toward the outlet.

[0009] Any of the medical devices described herein may have any of the following features. A delivery tube is fluidically connected to a pressurized medium source storing a pressurized fluid. The delivery tube receives the pressurized fluid through the delivery tube, such that the delivery tube is configured to deliver a medicament received from the outlet through the delivery tube via the pressurized fluid. The container is fluidically connected to a pneumatic system via a valve, wherein the pneumatic system stores a second pressurized fluid. The valve is configured to allow the second pressurized fluid to be delivered from the pneumatic system to the container in response to actuation of the valve. The agitator is configured to oscillate relative to the container in response to the container receiving the second pressurized fluid from the pneumatic system. The medicament includes hemostatic powder. The agitator includes a diaphragm, a plunger, a piston, or a screw conveyor. The outlet includes a valve. The agitator includes a diaphragm and one or more walls defining a void, wherein at least one of the one or more walls is configured to move relative to the container in response to movement of the diaphragm. At least one of the diaphragm and the one or more walls is configured to oscillate when receiving the pressurized medium within the void. The device further includes a connecting rod and a wheel, wherein the connecting rod has a first end connected to the wheel and a second end connected to the agitator. The connecting rod is configured to cause the agitator to oscillate in response to rotation of the wheel.The wheel is connected to a motor that is operable to rotate the wheel.

[0010] According to another example, a medical device includes a container for storing a medication. The medical device includes an agitator positioned adjacent to or within the container. The agitator is configured to induce a pressure change within the container by oscillating the agitator relative to the container. The medical device includes an outlet having a first end in fluidic communication with the container and a second end in fluidic communication with a delivery tube. In response to the oscillation of the agitator, the medication is positioned toward the delivery tube, such that activation of the pressurized fluid propels the medication through the delivery tube.

[0011] Any of the medical devices described herein may have any of the following features. The outlet is configured to control the dosage of the medicament delivered from the container toward the delivery tube. The agitator includes a diaphragm, one or more walls coupled to the diaphragm, and a space defined between the diaphragm and the one or more walls. The diaphragm is configured to oscillate relative to the container in response to the space receiving a pressurized medium and at least one of the one or more walls moving away from the diaphragm. The agitator includes a piston configured to oscillate relative to the container in response to the piston receiving a force generated by the motor.

[0012] According to another example, a method for delivering a medication to a target site via a medical device including a container, an agitator, and a delivery tube includes oscillating the agitator relative to the container to direct medication stored in the container to the delivery tube. The agitator oscillates in response to actuation of a first pressure source in fluid communication with the container. The method also includes delivering the medication to the target site via the delivery tube in response to actuation of a second pressure source in fluid communication with the delivery tube.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0015] Figure 1 is a side view of an exemplary medical system according to aspects of the present invention;

[0016] Figure 2A According to various aspects of the present invention, Figure 1 An illustrative schematic diagram of an exemplary medical device of a medical system includes an agitator in a first position;

[0017] Figure 2B According to various aspects of the present invention Figure 2A An illustrative schematic diagram of a medical device wherein the agitator oscillates to a second position;

[0018] Figure 3A According to various aspects of the present invention Figure 1 An illustrative schematic diagram of an exemplary medical device of a medical system includes an agitator in a first position;

[0019] Figure 3B According to various aspects of the present invention Figure 3A An illustrative schematic diagram of a medical device wherein the agitator oscillates to a second position;

[0020] Figure 4A According to various aspects of the present invention Figure 1 An illustrative schematic diagram of an exemplary medical device of a medical system including an agitator in a first position; and

[0021] Figure 4B According to various aspects of the present invention Figure 4A An illustrative schematic diagram of a medical device wherein the agitator is oscillated to a second position. DETAILED DESCRIPTION

[0022] The present invention relates, among other things, to systems, devices, and methods for, for example, endoscopic delivery of hemostatic agents. Reference will now be made in detail to various aspects of the invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device that is farthest from the user when introduced into a patient. Conversely, the term "proximal" refers to the portion of the device that is closest to the user when placed into a patient. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to be non-exclusive, such that a process, method, article, or apparatus that includes a list of elements does not necessarily include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "exemplary." As used herein, the terms "approximately," "substantially," and "about" indicate a range of values that is within + / - 10% of the stated value.

[0023] Embodiments of the present invention can be used to deliver material to a target treatment site of bleeding to achieve hemostasis. For example, a hemostatic agent in powder form can be delivered to treat gastrointestinal bleeding by a medical device that includes an agitator that oscillates to deliver the hemostatic agent. In some embodiments, the agitator can oscillate to deliver the hemostatic agent via a system separate from the delivery mechanism of the medical device. Embodiments of the present invention are not limited to such devices and methods, but can relate to devices and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, some portions of the esophagus, any other portion of the gastrointestinal tract, and / or any other suitable patient anatomical structure (collectively referred to herein as the "target treatment site"). The various embodiments described herein include single-use or disposable medical devices.

[0024] In an exemplary embodiment, a medical device for delivering a hemostatic material may include a container for storing a medicament and an agitator positioned adjacent to or within the container, wherein the agitator of the medical device is capable of oscillating relative to the container. The medical device also includes an outlet having a first end in communication with the container fluid and a second end in communication with the channel fluid of a delivery tube. The oscillation of the agitator is configured to provide movement of the medicament toward the outlet first end and the outlet second end so that the medicament is received within the delivery tube. Reference will now be made in detail to the examples of the present invention described above and shown in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.

[0025] Figure 1A side view of an exemplary medical system 100 according to one embodiment of the present invention is shown. The medical system 100 may include an insertion portion 109 and a proximal portion 110. The proximal portion 110 may have a body 10 defined by a distal end 12 and a proximal end 14, wherein the distal end 12 of the proximal portion 110 includes a port 16 coupled to the insertion portion 109. In some embodiments, the insertion portion 109 of the medical system 100 may include a catheter, endoscope, tube, or the like for delivering material to a target treatment site within a patient. The proximal end 14 of the proximal portion 110 may include a handle 18 sized and shaped to be manually grasped by a user of the proximal portion 110, for example, during a procedure. It should be understood that the size, shape, profile, and / or configuration of the insertion portion 109 and / or proximal portion 110 shown and described herein are merely illustrative, such that various other suitable arrangements may be included without departing from the scope of the present invention.

[0026] The proximal portion 110 of the medical system 100 may further include a housing 111 that is sized and shaped to store therein one or more components of the proximal portion 110. In this embodiment, the housing 111 is positioned adjacent the distal end 12 of the body 10, however, it should be understood that the housing 111 may be located at various other locations along the body 10. Additionally and / or alternatively, in other embodiments, the housing 111, for example, and one or more components stored therein, may be disposed within the body 10.

[0027] Now refer to Figure 2A , depicts a schematic diagram of a medical system 100 in which an insertion portion 109 and a proximal portion 110 are in fluid communication with each other via one or more components of the proximal portion 110. In some embodiments, the proximal portion 110 may include a first pressurized medium source 102, a second pressurized medium source 108, and a delivery tube 114. The first pressurized medium source 102 and the second pressurized medium source 108 may each store a pressurized medium therein, such as, for example, a pressurized fluid, such as air / gas (e.g., CO2). The first pressurized medium source 102 and / or the second pressurized medium source 108 may include a pneumatic system, such as, for example, a pressurized cylinder. In some embodiments, the first pressurized medium source 102 and the second pressurized medium source 108 may be disposed within the body 10 of the proximal portion 110, and in other embodiments, may be positioned external to the body 10 of the proximal portion 110. As described in greater detail herein, the first pressurized medium source 102 may be configured to supply pressurized medium to the housing 111 , and the second pressurized medium source 108 may be configured to supply pressurized medium to the delivery tube 114 .

[0028] In this embodiment, the first pressurized medium source 102 is in fluid communication with the housing 111 of the proximal portion 110 via the inlet 104, such that a first end of the inlet 104 is fluidly coupled to the first pressurized medium source 102 and a second end of the inlet 104 is fluidly coupled to the housing 111. The proximal portion 110 may include a valve 106 positioned within the inlet 104 and configured to control the rate at which pressurized medium is delivered from the first pressurized medium source 102 to the housing 111. In some embodiments, the valve 106 may include, for example, a safety valve, a duckbill valve, a shelf, a rotatable wheel, and / or various other suitable devices capable of controlling and / or limiting the rate at which pressurized medium is delivered from the first pressurized medium source 102 to the housing 111 via the inlet 104. For example, the valve 106 may be electrically actuated by a user of the proximal portion 110 to control the delivery of the pressurized medium. In other embodiments, the first pressurized medium source 102 may include a pressure regulator mechanism in addition to or in lieu of the valve 106 for controlling and / or limiting the delivery of pressurized medium to the housing 111. As a further example, in some embodiments, the valve 106 may include an orifice having a predefined and / or adjustable size (eg, diameter) to regulate the delivery rate of the pressurized medium.

[0029] In this embodiment, housing 111 is in fluid communication with delivery tube 114 via outlet 116, such that a first end of outlet 116 is fluidly coupled to housing 111 and a second end of outlet 116 is fluidly coupled to delivery tube 114. Valve 118 is positioned within outlet 116 and is configured to control the rate of delivery of material (e.g., medicament 50) stored in housing 111 to delivery tube 114. In some embodiments, valve 118 may comprise, for example, a safety valve, a duckbill valve, a shelf, a rotatable wheel, and / or various other suitable devices capable of controlling and / or limiting the rate at which medicament 50 is delivered from housing 111 to delivery tube 114 via outlet 116.

[0030] Still refer to Figure 2A, the proximal portion 110 may include a container 112 and an agitator 120 disposed within the housing 111. The container 112 is positioned within the housing 111 such that the container 112 at least partially divides the housing 111. In this embodiment, the container 112 defines a space within the housing 111 that is sized, shaped, and configured to store a material, such as, for example, a medicament 50 therein. The medicament 50 may include a therapeutic substance operable to coagulate blood, such as, for example, a hemostatic powder. In other embodiments, the medicament 50 may include various other materials and / or substances suitable for delivery. The agitator 120 is positioned within the housing 111 adjacent to the container 112, and in some embodiments, the agitator 120 may be at least partially positioned within the container 112 such that the agitator 120 at least partially divides the container 112. The agitator 120 is positioned relative to the container 112 such that an opening 113 is defined between the agitator 120 and the container 112 , wherein the opening 113 facilitates fluid communication between the space defined by the container 112 and the remaining cavity of the housing 111 .

[0031] In this embodiment, the agitator 120 can include a diaphragm 122, a central rod 124, a fixed bottom plate 125, a movable top plate 126, and a pair of sidewalls 128. The diaphragm 122 of the agitator 120 can be formed of a flexible, deformable material such that the diaphragm 122 is configured to flex in response to movement of the diaphragm 122 relative to the container 112. For example, the diaphragm 122 can be at least partially formed as a silicon (Si) film, a low-density polyethylene (LDPE) polymer, etc. As described in more detail herein, the diaphragm 122 is configured to move relative to the container 112 in response to the housing 111 receiving the pressurized medium from the first pressurized medium source 102.

[0032] The diaphragm 122 is secured to and extends between the pair of side walls 128 of the agitator 120 such that opposite end ends of the diaphragm 122 are attached to the pair of side walls 128. Furthermore, the diaphragm 122 is attached to the center rod 124 along a mid-portion of the diaphragm 122. In this embodiment, the diaphragm 122 is attached to a first end of the center rod 124, and the movable top plate 126 is attached to a second end of the center rod 124. Thus, the diaphragm 122 is separated from the movable top plate 126 by a longitudinal length of the center rod 124 disposed therebetween. The agitator 120 defines a gap 130 between the diaphragm 122 and the movable top plate 126, and as further described herein, the agitator 120 is configured to receive pressurized medium from the first pressurized medium source 102 in the gap 130.

[0033] Still refer to Figure 2A, the movable top plate 126 of the agitator 120 is movably coupled to the pair of side walls 128 such that the movable top plate 126 is configured to move (e.g., translate) relative to the pair of side walls 128. In this example, the movable top plate 126 is slidably coupled to the pair of side walls 128 such that the movable top plate 126 is configured to move along the longitudinal length of the side walls 128. In some examples, the opposing ends of the movable top plate 126 can be configured to move symmetrically, uniformly, and / or evenly relative to each other along the respective side walls 128. In other examples, the opposing ends of the movable top plate 126 can be configured to move asymmetrically relative to each other along the respective side walls 128.

[0034] With the movable top plate 126 coupled to the central rod 124, and the central rod 124 further coupled to the diaphragm 122, the movable top plate 126 is operable to move the central rod 124 and the diaphragm 122 in response to movement (e.g., translation) of the movable top plate 126 relative to the pair of side walls 128. It should be understood that the size, shape, profile, and / or configuration of the container 112 and / or blender 120 shown and described herein are merely illustrative, such that the container 112 and / or blender 120 may include various other suitable arrangements without departing from the scope of the present invention.

[0035] Still refer to Figure 2A , the stationary base 125 of the agitator 120 can be fixed relative to the diaphragm 122, the center rod 124, and the movable top plate 126. In this example, the stationary base 125 extends between the pair of side walls 128 and is positioned between the diaphragm 122 and the movable top plate 126. Furthermore, the stationary base 125 can be oriented relatively parallel to the diaphragm 122 and the movable top plate 126, and transverse to the center rod 124. In some examples, the center rod 124 can extend through the stationary base 125, such as, for example, through a hole (not shown) formed in the stationary base 125. In other examples, the center rod 124 can extend adjacent to the stationary base 125.

[0036] As described in further detail herein, the fixed base plate 125 is configured to engage the diaphragm 122 of the agitator 120 when the center rod 124 and the movable top plate 126 are moved (e.g., in an upward direction) relative to the pair of side walls 128. In such circumstances, the fixed base plate 125 can operate to form an obstacle to further translation of the center rod 124 and / or deformation of the diaphragm 122 relative to the container 112 and / or the pair of side walls 128 beyond a predetermined degree. It should be understood that in other embodiments, the fixed base plate 125 of the agitator 120 can be omitted entirely, such that the center rod 124 and / or the diaphragm 122 can translate and deform, respectively, to various other suitable degrees besides those shown and described herein.

[0037] According to an example method of using the medical system 100, the medicament 50 can initially be stored in the container 112 of the housing 111, and the insertion portion 109 can be fluidly coupled to the delivery tube 114 of the proximal portion 110 (e.g., at the port 16 of the body 10). In this case, upon activation of the first pressurized medium source 102, the pressurized medium can be delivered to the housing 111 via the inlet 104. The pressurized medium can be delivered through the inlet 104 in a direction B and enter the housing 111 via the valve 106. The agitator 120 can receive the pressurized medium within the void 130 and, in response, move the movable top plate 126 relative to the pair of side walls 128. For example, the movable top plate 126 can move away from the diaphragm 122 when the void 130 receives the pressurized medium therein, causing the central rod 124 to move (e.g., translate) simultaneously with the movable top plate 126. With the center rod 124 coupled to the diaphragm 122 , the diaphragm 122 is configured to move relative to the container 112 and toward the movable top plate 126 .

[0038] Now refer to Figure 2B , the diaphragm 122, center rod 124, and movable top plate 126 of the agitator 120 are depicted as being in a second actuated position in response to the void 130 receiving the pressurized medium therein. Thus, because the diaphragm 122 is fixed to the pair of side walls 128 at opposite ends of the diaphragm 122 and is coupled to the center rod 124 along a mid-portion of the diaphragm 122, the diaphragm 122 is configured to flexibly deform in response to movement of the movable top plate 126 relative to the container 112. The center rod 124 pulls and / or pushes the diaphragm 122 in the direction of movement of the movable top plate 126 until the diaphragm 122 and / or center rod 124 engage the fixed bottom plate 125 of the agitator 120. In this instance, the fixed bottom plate 125 acts as an obstacle to further translation of the center rod 124 and / or deformation of the diaphragm 122 relative to the container 112 and / or the pair of side walls 128 beyond a predetermined extent. It should be understood that in other embodiments, the fixed base 125 of the agitator 120 may be omitted entirely, such that the central rod 124 and / or the diaphragm 122 may translate and deform, respectively, to various other suitable extents beyond those shown and described herein.

[0039] In this embodiment, the movement of the diaphragm 122 of the agitator 120 creates a pressure change within the container 112 of the housing 111, thereby causing the medicament 50 stored in the container 112 to move. The diaphragm 122 is configured to oscillate relative to the container 112 in response to the first pressurized medium source 102 delivering the pressurized medium to the housing 111 via the inlet 104 and the valve 106 controlling and / or limiting the rate of delivery of the pressurized medium. Therefore, the diaphragm 122 of the agitator 120 can repeatedly oscillate relative to the container 112 to a position relative to the initial position (see Figure 2A ) and actuation position (see Figure 2B) at multiple positions within the container 112. In response to the pressure change (e.g., a pressure drop followed by a pressure increase) generated by the agitator 120 within the container 112, the medicament 50 is agitated (e.g., moved) within the container 112 toward the outlet 116 of the proximal portion 110 via the opening 113. In other words, the oscillation of the agitator 120 can cause the medicament 50 to move from the container 112 toward the outlet 116. It should be understood that gravity within the container 112 of the housing 111 can further facilitate the movement of the medicament 50 toward the outlet 116, such as, for example, between oscillations of the agitator 120. In examples where the medicament 50 includes styptic powder, the agitator 120 can be configured to at least temporarily suspend particles of the medicament 50 in the air within the container 112 due to the oscillations of the agitator 120.

[0040] Still refer to Figure 2B , the medicament 50 can be received at the delivery tube 114 via the outlet 116. Because the delivery tube 114 is fluidly coupled to the second pressurized medium source 108 at a first end of the delivery tube 114 and to the insertion portion 109 at a second end of the delivery tube 114, the medicament 50 can be delivered through the delivery tube 114 to the insertion portion 109 via the pressurized medium passing through the delivery tube 114 in a direction A. In this case, the pressurized medium can fluidize the medicament 50 (e.g., hemostatic powder), causing the medicament 50 to flow through the delivery tube 114 in a manner similar to a liquid. In other words, the pressurized medium (gas or liquid) can pass through and / or surround the particles of the hemostatic powder, causing the medicament 50 to move fluidly and / or freely through the delivery tube 114 with minimal restriction. It should be understood that the delivery rate of the medicament 50 to the delivery tube 114 can be controlled and / or limited by the valve 118 in the outlet 116. Thus, when delivering the medicament 50 to a patient, the dose of the medicament 50 received by the insertion portion 109 from the delivery tube 114 may be metered by the proximal portion 110 .

[0041] Additionally and / or alternatively, the dose of the medicament 50 received by the insertion portion 109 can be metered by controlling the activation of the first pressurized medium source 102. As described above, in some embodiments, the first pressurized medium source 102 can include a pressure regulator mechanism for controlling and / or limiting the delivery of the pressurized medium to the housing 111. For example, the pressure regulator mechanism of the first pressurized medium source 102 can automatically activate and deactivate the first pressurized medium source 102 to selectively deliver the first pressurized medium to the housing 111, thereby causing the agitator 120 to oscillate. In this case, activating and deactivating the first pressurized medium source 102 can provide controlled delivery of the pressurized medium source, thereby causing the pressure within the housing 111 and the container 112, where the agitator 120 is located, to alternately increase and decrease.

[0042] Now refer to Figures 3A to 3B, an exemplary medical system 200 including a proximal portion 210 is depicted in accordance with an embodiment of the present invention. Unless otherwise described below, the medical system 200 and the proximal portion 210 may be substantially similar to the medical system 100 and the proximal portion 110 described above, respectively, such that the same reference numerals are used to identify the same components. Therefore, it should be understood that the medical system 200 and the proximal portion 210 may be configured and operated like the medical system 100 and the proximal portion 110, respectively, except for the differences expressly noted herein. For example, the proximal portion 210 may include a motor 202, a wheel 206, and an agitator 120. The motor 202 is coupled to the wheel 206 via a cable or rod 204 such that actuation of the motor 202 is transmitted to the wheel 206 via the rod 204. The wheel 206 is configured to rotate in response to actuation of the motor 202 and, as described in more detail herein, in response, cause oscillation of the agitator 120.

[0043] In this embodiment, the movable top plate 126 of the agitator 120 is coupled to the wheel 206 via a coupling rod 208, such that rotation of the wheel 206 can provide movement of the movable top plate 126 relative to the container 112 and / or the pair of sidewalls 128. For example, the proximal portion 210 can be configured such that rotation of the wheel 206 provides translation of the movable top plate 126 of the agitator 120. Because the movable top plate 126 is coupled to the central rod 124, and the central rod 124 is further coupled to the diaphragm 122, movement (e.g., translation) of the movable top plate 126 can simultaneously cause movement (e.g., translation) of the central rod 124 and / or deformation of the diaphragm 122 relative to the container 112. It should be understood that in some embodiments, the motor 202, rod 204, and / or wheel 206 are disposed within the body 10 of the proximal portion 210 and, in other embodiments, can be positioned external to the body 10 of the proximal portion 210.

[0044] According to an example method of using the medical system 200, the medicament 50 can initially be stored in the container 112 of the housing 111, and the insertion portion 109 can be fluidly coupled to the delivery tube 114 of the proximal portion 210 (e.g., at the port 16 of the body 10). In this case, when the motor 202 is activated, the wheel 206 can rotate, such as, for example, in a clockwise and / or counterclockwise direction relative to the housing 111 and / or the container 112. The rotation of the wheel 206 can transmit an oscillating force (e.g., a pulling force, a pushing force, etc.) to the agitator 120, for example, to the movable top plate 126, in response causing the movable top plate 126 to move relative to the pair of sidewalls 128. For example, the movable top plate 126 can move away from the diaphragm 122 when the wheel 206 rotates, causing the center rod 124 to move (e.g., translate) simultaneously with the movable top plate 126. With the central rod 124 coupled to the diaphragm 122 , the diaphragm 122 is configured to move relative to the container 112 toward the movable top plate 126 .

[0045] Now refer to Figure 3B , the diaphragm 122, center rod 124, and movable top plate 126 of the agitator 120 are depicted in a second actuated position in response to rotation of the wheel 206 in direction C. Thus, because the diaphragm 122 is secured to the pair of side walls 128 at opposite ends of the diaphragm 122 and is coupled to the center rod 124 along a mid-portion of the diaphragm 122, the diaphragm 122 is configured to flexibly deform in response to movement of the movable top plate 126 relative to the container 112. The center rod 124 pulls and / or pushes the diaphragm 122 in the direction of movement of the movable top plate 126 until the diaphragm 122 and / or center rod 124 engage the fixed bottom plate 125 of the agitator 120. In this instance, the fixed bottom plate 125 acts as an obstacle to further translation of the center rod 124 and / or deformation of the diaphragm 122 relative to the container 112 beyond a predetermined degree, however, it should be understood that in other embodiments, the fixed bottom plate 125 may be omitted entirely.

[0046] In this embodiment, the movement of the diaphragm 122 of the agitator 120 creates a pressure change within the container 112, which causes the medication 50 stored in the container 112 to move. The diaphragm 122 is configured to oscillate relative to the container 112 in response to the rotation of the wheel 206 caused by the motor 202. Thus, the diaphragm 122 of the agitator 120 can repeatedly oscillate relative to the container 112 to a position relative to the initial position (see Figure 3A ) and actuation position (see Figure 3B In response to the pressure changes (e.g., a repeating sequence of decreasing and increasing pressure) generated by the agitator 120 within the container 112, the medicament 50 is agitated (e.g., moved) within the container 112 toward the outlet 116 of the proximal portion 210 via the opening 113.

[0047] Still refer to Figure 3B , the medicament 50 can be received at the delivery tube 114 via the outlet 116. Because the delivery tube 114 is fluidly coupled to the second pressurized medium source 108 at a first end of the delivery tube 114 and to the insertion portion 109 at a second end of the delivery tube 114, the medicament 50 can be delivered through the delivery tube 114 to the insertion portion 109 in a direction A via the pressurized medium passing through the delivery tube 114. It should be understood that the delivery rate of the medicament 50 to the delivery tube 114 can be controlled and / or limited by the valve 118 in the outlet 116. Thus, when delivering the medicament 50 to the patient, the dose of the medicament 50 received by the insertion portion 109 from the delivery tube 114 can be metered by the proximal portion 210.

[0048] Now refer to Figures 4A to 4B, depicts an exemplary medical system 300 including a proximal portion 310 according to an embodiment of the present invention. Unless otherwise described below, the medical system 300 and the proximal portion 310 can be substantially similar to the medical systems 100, 200 and the proximal portions 110, 210 described above, respectively, such that like reference numerals are used to identify like components. Thus, it should be understood that the medical system 300 and the proximal portion 310 can be configured and operated like the medical systems 100, 200 and the proximal portions 110, 210, respectively, except for the differences explicitly noted herein. For example, the proximal portion 310 can include a delivery tube 114, a motor 202, and an agitator 320. The agitator 320 is disposed within the housing 111 of the proximal portion 310 and positioned adjacent to and / or at least partially within the container 112.

[0049] In this embodiment, the agitator 320 may include a piston, a plunger, an auger, and / or any other similar structure. For example, the agitator 320 may include a crown 322 and a shaft 324. The motor 202 is coupled to the agitator 320 via the inlet 104, for example, the motor 202 is coupled to the shaft 324 that extends through the inlet 104. The crown 322 of the agitator 320 is positioned at a distal end of the shaft 324, which is opposite the proximal end of the shaft 324 that is coupled to the motor 202. Thus, actuation of the motor 202 is transmitted to the crown 322 of the agitator 320 via the shaft 324. The shaft 324 is configured to move in response to actuation of the motor 202 and, as described in more detail herein, to cause oscillation of the crown 322 of the agitator 320 in response. For example, the proximal portion 310 can be configured such that translation of the shaft 324 relative to the inlet 104 provides translation of the crown 322 relative to the container 112 and / or the housing 111. It should be understood that in some embodiments, the motor 202 is disposed within the body 10 of the proximal portion 310 and, in other embodiments, can be positioned external to the body 10 of the proximal portion 310.

[0050] According to an example method of using the medical system 300, the medicament 50 can initially be stored in the container 112 of the housing 111, and the insertion portion 109 can be fluidly coupled to the delivery tube 114 of the proximal portion 310 (e.g., at the port 16 of the body 10). In this case, when the motor 202 is activated, the shaft 324 of the agitator 320 can move relative to the housing 111 and / or the container 112. The translation of the shaft 324 can transmit a force (e.g., a pulling force, a pushing force, etc.) to the crown 322 of the agitator 320, which in response causes the crown 322 to move relative to the container 112. It should be understood that in other embodiments, the medical system 300 can include the first pressurized medium source 102 in place of the motor 202 for actuating the agitator 320 of the proximal portion 310.

[0051] Now refer to Figure 4B, the agitator 320 is depicted as being in a second actuated position in response to actuating the motor 202 to move the shaft 324. Thus, because the crown 322 is secured to the shaft 324, the crown 322 is configured to translate relative to the container 112 in response to the shaft 324. The shaft 324 pushes and / or pulls the crown 322 in the direction of movement of the shaft 324. In this embodiment, the movement of the crown 322 of the agitator 320 creates a pressure change within the container 112 that causes the medicament 50 stored within the container 112 to move. The crown 322 is configured to oscillate relative to the container 112 in response to the motor 202 causing movement of the shaft 324. Thus, the crown 322 of the agitator 320 can repeatedly oscillate relative to the container 112 to a position relative to the initial position (see Figure 4A ) and actuation position (see Figure 4B ) in multiple positions. In response to the pressure changes generated by the agitator 320 within the container 112, the medicament 50 is agitated (eg, moved) within the container 112 toward the outlet 116 of the proximal portion 310.

[0052] Still refer to Figure 4B , the medicament 50 can be received at the delivery tube 114 via the outlet 116. Because the delivery tube 114 is fluidly coupled to the second pressurized medium source 108 at a first end of the delivery tube 114 and to the insertion portion 109 at a second end of the delivery tube 114, the medicament 50 can be delivered through the delivery tube 114 to the insertion portion 109 in a direction A via the pressurized medium passing through the delivery tube 114. It should be understood that the delivery rate of the medicament 50 to the delivery tube 114 can be controlled and / or limited by the valve 118 in the outlet 116. Thus, when delivering the medicament 50 to the patient, the dose of the medicament 50 from the delivery tube 114 received by the insertion portion 109 can be metered by the proximal portion 310. Additionally and / or alternatively, as described in detail above with respect to the medical systems 100, 200, the delivery rate of the medicament 50 can be increased and / or decreased in response to the oscillation rate of the agitator 320. In this embodiment, the oscillation of the agitator 320 may be controlled by repeatedly starting and stopping activation of the motor 202, alternating between increasing and / or decreasing the speed of the motor 202, and the like.

[0053] Each of the aforementioned devices, assemblies, and methods can be used to provide, for example, controlled delivery of a hemostatic agent to a target treatment site. Any of the medical systems 100, 200, 300, such as the insertion portion 109 of the medical systems 100, 200, 300 shown and described above, can be inserted into an endoscope or similar device having an imaging system, a lighting system, etc. to assist in positioning the medical system 100, 200, 300. By providing a surgical assembly that allows a user to interact with bleeding patient tissue using an agitator during surgery, the user can reduce overall surgical time, improve surgical efficiency, and avoid unnecessary harm to the patient's body caused by limited access to the patient's target tissue and / or ineffective blood coagulation.

[0054] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the description and examples be considered exemplary only.

Claims

1. A medical device comprising: a container for storing a medicament, the container having an inlet and an outlet; an agitator positioned within the container between the inlet and the outlet, the agitator having a diaphragm that is flexibly deformable and configured to oscillate relative to the container; as well as wherein the outlet has a first end in fluid communication with the container and a second end in fluid communication with a passageway of the delivery tube; wherein the container is configured to receive a first pressurized fluid via the inlet, the agitator being configured to combine the first pressurized fluid with the medicament within the container when the first pressurized fluid enters the container via the inlet; and Oscillation of the agitator below the inlet and above the outlet moves the combination of the first pressurized fluid and the medicament away from the inlet and toward the outlet, exiting the container.

2. The medical device of claim 1 , wherein the container is in fluid communication with a first pressurized medium source via the inlet, wherein the first pressurized medium source stores the first pressurized fluid, and the delivery tube is in fluid communication with a second pressurized medium source storing a second pressurized fluid.

3. The medical device of claim 2, wherein the container receives the first pressurized fluid through the inlet, such that the diaphragm is configured to oscillate in response to the container receiving the first pressurized fluid at the inlet above the diaphragm; and The delivery tube receives the second pressurized fluid through the delivery tube such that the delivery tube is configured to deliver the combination of the first pressurized fluid received from the outlet and the medicament through the delivery tube via the second pressurized fluid.

4. The medical device of any one of claims 2-3, wherein the container is fluidly connected to the first source of pressurized medium via a valve. 5 . The medical device of claim 4 , wherein the valve is configured to allow the first pressurized fluid to be delivered from the first pressurized medium source to the container in response to actuation of the valve.

6. The medical device of claim 5, wherein the agitator is configured to oscillate relative to the container in response to the container receiving the first pressurized fluid from the first pressurized medium source.

7. The medical device according to any one of claims 1 to 3, wherein the medicament comprises a hemostatic powder.

8. The medical device of any one of claims 1 to 3, wherein the diaphragm is configured to flex between a plurality of positions when oscillating between the inlet and the outlet.

9. The medical device of any one of claims 1 to 3, wherein the inlet is configured to deliver the first pressurized fluid into the container; and The outlet is configured to deliver a combination of the first pressurized fluid and the medicament, wherein the outlet comprises a valve.

10. The medical device of any one of claims 2 to 3, wherein the agitator comprises the diaphragm and one or more walls defining a void, wherein at least one of the one or more walls is configured to move relative to the container in response to movement of the diaphragm.

11. The medical device of claim 10, wherein the at least one of the diaphragm and the one or more walls is configured to oscillate when a first pressurized fluid from the first pressurized medium source is received within the void via the inlet.

12. The medical device of any one of claims 1 to 3, further comprising a connecting rod and a wheel, wherein the connecting rod has a first end connected to the wheel and a second end connected to the agitator.

13. The medical device of claim 12, wherein the linkage is configured to cause the agitator to oscillate in response to rotation of the wheel.

14. The medical device of claim 13, wherein the wheel is coupled to a motor, the motor being operable to rotate the wheel.

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